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  1. Careful science? Bodywork and care practices in randomised clinical trials

    DEFF Research Database (Denmark)

    Jespersen, Astrid Pernille; Bønnelycke, Julie; Eriksen, Hanne Hellerup

    2013-01-01

    Concern about obesity has prompted numerous public health campaigns that urge people to be more physically active. The campaigns often include normative statements and attempt to impose restrictions on individuals' lives without considering the complexities of daily life. We suggest that broadening...... the focus to reflect everyday practices would foster better targeted public health campaigns. This article is based on our participation in FINE, a multidisciplinary Danish research project. The core methodology of FINE was a randomised controlled trial in which 61 moderately overweight men were put...... into different exercise groups. In this article we analyse the scientific work of the trial as representing entangled processes of bodywork, where data are extracted and objectified bodies are manipulated and care practices address the emotional, social and mundane aspects of the participants' everyday lives...

  2. Practical aspects of conducting a pragmatic randomised trial in primary care: patient recruitment and outcome assessment

    NARCIS (Netherlands)

    D.A.W.M. van der Windt (Daniëlle); B.W. Koes (Bart); M. van Aarst; M.A. Heemskerk; L.M. Bouter (Lex)

    2000-01-01

    textabstractBACKGROUND: Conducting a pragmatic randomised trial in primary care is often accompanied by practical problems. Such problems are seldom reported and may constitute useful lessons for researchers planning future trials. AIM: To address the difficulties invol

  3. Supervised exercise therapy versus usual care for patellofemoral pain syndrome : an open label randomised controlled trial

    NARCIS (Netherlands)

    van Linschoten, R.; van Middelkoop, M.; Berger, M. Y.; Heintjes, E. M.; Verhaar, J. A. N.; Willemsen, S. P.; Koes, B. W.; Bierma-Zeinstra, S. M.

    2009-01-01

    Objective To assess the effectiveness of supervised exercise therapy compared with usual care with respect to recovery, pain, and function in patients with patellofemoral pain syndrome. Design Open label randomised controlled trial. Setting General practice and sport physician practice. Participants

  4. Advance care planning - a multi-centre cluster randomised clinical trial

    DEFF Research Database (Denmark)

    Rietjens, Judith A C; Korfage, Ida J; Dunleavy, Lesley;

    2016-01-01

    BACKGROUND: Awareness of preferences regarding medical care should be a central component of the care of patients with advanced cancer. Open communication can facilitate this but can occur in an ad hoc or variable manner. Advance care planning (ACP) is a formalized process of communication between......, and improve their quality of life. METHODS/DESIGN: We will study the effects of the ACP program Respecting Choices on the quality of life of patients with advanced lung or colorectal cancer. In a phase III multicenter cluster randomised controlled trial, 22 hospitals in 6 countries will be randomised...

  5. Buprenorphine versus dihydrocodeine for opiate detoxification in primary care: a randomised controlled trial

    OpenAIRE

    Adams Clive E; Tompkins Charlotte NE; Sheard Laura; Wright Nat MJ; Allgar Victoria L; Oldham Nicola S

    2007-01-01

    Abstract Background Many drug users present to primary care requesting detoxification from illicit opiates. There are a number of detoxification agents but no recommended drug of choice. The purpose of this study is to compare buprenorphine with dihydrocodeine for detoxification from illicit opiates in primary care. Methods Open label randomised controlled trial in NHS Primary Care (General Practices), Leeds, UK. Sixty consenting adults using illicit opiates received either daily sublingual b...

  6. Cognitive–behavioural therapy v. structured care for medically unexplained symptoms: randomised controlled trial

    OpenAIRE

    Sumathipala, A.; Siribaddana, S.; Abeysingha, M. R. N.; Silva, P.; Dewey, M; Prince, M.; Mann, A.H.

    2008-01-01

    Background A pilot trial in Sri Lanka among patients with medically unexplained symptoms revealed that cognitive–behavioural therapy (CBT) administered by a psychiatrist was efficacious. Aims To evaluate CBT provided by primary care physicians in a comparison with structured care. Method A randomised control trial (n=75 in each arm) offered six 30 min sessions of structured care or therapy. The outcomes of the two interventions were compared at 3 months, 6 months, 9 months and 12 months. Resu...

  7. Effects of Dementia-Care Mapping on Residents and Staff of Care Homes: A Pragmatic Cluster-Randomised Controlled Trial

    OpenAIRE

    Geertje van de Ven; Irena Draskovic; Eddy M M Adang; Rogier Donders; Zuidema, Sytse U.; Koopmans, Raymond T C M; Vernooij-Dassen, Myrra J. F. J.

    2013-01-01

    BACKGROUND: The effectiveness of dementia-care mapping (DCM) for institutionalised people with dementia has been demonstrated in an explanatory cluster-randomised controlled trial (cRCT) with two DCM researchers carrying out the DCM intervention. In order to be able to inform daily practice, we studied DCM effectiveness in a pragmatic cRCT involving a wide range of care homes with trained nursing staff carrying out the intervention. METHODS: Dementia special care units were randomly assigned ...

  8. Supervised exercise therapy versus usual care for patellofemoral pain syndrome: an open label randomised controlled trial.

    NARCIS (Netherlands)

    R. van Linschoten (Robbart); M. van Middelkoop (Marienke); M.Y. Berger (Marjolein); E.M. Heintjes (Edith); J.A.N. Verhaar (Jan); S.P. Willemsen (Sten); B.W. Koes (Bart); S.M. Bierma-Zeinstra (Sita)

    2009-01-01

    textabstractOBJECTIVE: To assess the effectiveness of supervised exercise therapy compared with usual care with respect to recovery, pain, and function in patients with patellofemoral pain syndrome. DESIGN: Open label randomised controlled trial. SETTING: General practice and sport physician practic

  9. Community based occupational therapy for patients with dementia and their care givers: randomised controlled trial.

    NARCIS (Netherlands)

    Graff, M.J.L.; Vernooij-Dassen, M.J.F.J.; Thijssen, M.; Dekker, J.; Hoefnagels, W.H.L.; Olde Rikkert, M.G.M.

    2006-01-01

    OBJECTIVE: To determine the effectiveness of community based occupational therapy on daily functioning of patients with dementia and the sense of competence of their care givers. DESIGN: Single blind randomised controlled trial. Assessors were blinded for treatment allocation. SETTING: Memory clinic

  10. Aged Residential Care Health Utilisation Study (ARCHUS: a randomised controlled trial to reduce acute hospitalisations from residential aged care

    Directory of Open Access Journals (Sweden)

    Foster Susan J

    2012-09-01

    Full Text Available Abstract Background For residents of long term care, hospitalisations can cause distress and disruption, and often result in further medical complications. Multi-disciplinary team interventions have been shown to improve the health of Residential Aged Care (RAC residents, decreasing the need for acute hospitalisation, yet there are few randomised controlled trials of these complex interventions. This paper describes a randomised controlled trial of a structured multi-disciplinary team and gerontology nurse specialist (GNS intervention aiming to reduce residents’ avoidable hospitalisations. Methods/Design This Aged Residential Care Healthcare Utilisation Study (ARCHUS is a cluster- randomised controlled trial (n = 1700 residents of a complex multi-disciplinary team intervention in long-term care facilities. Eligible facilities certified for residential care were selected from those identified as at moderate or higher risk of resident potentially avoidable hospitalisations by statistical modelling. The facilities were all located in the Auckland region, New Zealand and were stratified by District Health Board (DHB. Intervention The intervention provided a structured GNS intervention including a baseline facility needs assessment, quality indicator benchmarking, a staff education programme and care coordination. Alongside this, three multi-disciplinary team (MDT meetings were held involving a geriatrician, facility GP, pharmacist, GNS and senior nursing staff. Outcomes Hospitalisations are recorded from routinely-collected acute admissions during the 9-month intervention period followed by a 5-month follow-up period. ICD diagnosis codes are used in a pre-specified definition of potentially reducible admissions. Discussion This randomised-controlled trial will evaluate a complex intervention to increase early identification and intervention to improve the health of residents of long term care. The results of this trial are expected in early

  11. Dementia in residential care: education intervention trial (DIRECT; protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Lautenschlager Nicola T

    2010-05-01

    Full Text Available Abstract Background There is scope to improve the quality of life (QOL of people with dementia living in residential care facilities (RCF. The DIRECT study will determine if delivery of education to General Practitioners (GPs and care staff improves the quality of life of residential care recipients with cognitive impairment. Methods/Design A prospective randomised controlled trial conduced in residential aged care facilities in the metropolitan area of Perth, Western Australia. Participants are care facility residents, aged 65 years and older and with mini-mental state examination scores less than 25. GPs and care facility staff have been independently randomised to intervention or control groups. An education programme, designed to meet the perceived needs of learners, will be delivered to GPs and care staff in the intervention groups. The primary outcome of the study will be quality of life of the people with dementia, measured using the QOL-Alzheimer's Disease Scale (QOL-AD and Alzheimer Disease Related QOL Scale (ADRQL, 4 weeks and 6 months after the conclusion of the education intervention. Results Recruitment of 351 people with dementia, cared for by staff in 39 residential facilities and 55 GPs, was undertaken between May 2007 and July 2008. Collection of baseline data is complete. Education has been delivered to GPs and Care staff between September 2008 and July 2009. Follow- up data collection is underway. Discussion The study results will have tangible implications for proprietors, managers and staff from the residential care sector and policy makers. The results have potential to directly benefit the quality of life of both patients and carers. Trial registration These trial methods have been prospectively registered (ACTRN12607000417482.

  12. Pharmacist-led management of chronic pain in primary care:results from a randomised controlled exploratory trial

    OpenAIRE

    Bruhn, Hanne; Christine M. Bond; Elliott, Alison M; Hannaford, Philip C; Amanda J Lee; McNamee, Paul; Smith, Blair H; Watson, Margaret C; Holland, Richard; Wright, David

    2013-01-01

    Objectives To compare the effectiveness of pharmacist medication review, with or without pharmacist prescribing, with standard care, for patients with chronic pain. Design An exploratory randomised controlled trial. Setting Six general practices with prescribing pharmacists in Grampian (3) and East Anglia (3). Participants Patients on repeat prescribed pain medication (4815) were screened by general practitioners (GPs), and mailed invitations (1397). 196 were randomised and 180 (92%) complete...

  13. Photoageing Intervention ( PAINT: A proposal for a randomised controlled trial in Australian Primary Care

    Directory of Open Access Journals (Sweden)

    Oksana Burford

    2009-07-01

    Full Text Available The adverse health impacts of tobacco smoking are adrain on national resources. This study will test anintervention to promote smoking cessation among youngadults aged 18-30years. The intervention will be deliveredwithin two settings in Australian health care; communitypharmacies and general practice. The new study builds onthe pilot data, reported here, which inform the feasibility,recruitment strategy, outcome measure, effect size andattrition rate. The new study is a randomised controlledtrial with 200 clients recruited from general practice andcommunity pharmacies in Western Australia.

  14. Buprenorphine versus dihydrocodeine for opiate detoxification in primary care: a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Adams Clive E

    2007-01-01

    Full Text Available Abstract Background Many drug users present to primary care requesting detoxification from illicit opiates. There are a number of detoxification agents but no recommended drug of choice. The purpose of this study is to compare buprenorphine with dihydrocodeine for detoxification from illicit opiates in primary care. Methods Open label randomised controlled trial in NHS Primary Care (General Practices, Leeds, UK. Sixty consenting adults using illicit opiates received either daily sublingual buprenorphine or daily oral dihydrocodeine. Reducing regimens for both interventions were at the discretion of prescribing doctor within a standard regimen of not more than 15 days. Primary outcome was abstinence from illicit opiates at final prescription as indicated by a urine sample. Secondary outcomes during detoxification period and at three and six months post detoxification were recorded. Results Only 23% completed the prescribed course of detoxification medication and gave a urine sample on collection of their final prescription. Risk of non-completion of detoxification was reduced if allocated buprenorphine (68% vs 88%, RR 0.58 CI 0.35–0.96, p = 0.065. A higher proportion of people allocated to buprenorphine provided a clean urine sample compared with those who received dihydrocodeine (21% vs 3%, RR 2.06 CI 1.33–3.21, p = 0.028. People allocated to buprenorphine had fewer visits to professional carers during detoxification and more were abstinent at three months (10 vs 4, RR 1.55 CI 0.96–2.52 and six months post detoxification (7 vs 3, RR 1.45 CI 0.84–2.49. Conclusion Informative randomised trials evaluating routine care within the primary care setting are possible amongst drug using populations. This small study generates unique data on commonly used treatment regimens.

  15. Use of strategies to improve retention in primary care randomised trials: a qualitative study with in-depth interviews

    OpenAIRE

    Brueton, V C; Stevenson, F; Vale, C L; Stenning, S P; Tierney, J F; Harding, S; Nazareth, I.; Meredith, S.; Rait, G.

    2014-01-01

    Objective: To explore the strategies used to improve retention in primary care randomised trials.Design: Qualitative in-depth interviews and thematic analysis.Participants: 29 UK primary care chief and principal investigators, trial managers and research nurses.Methods: In-depth face-to-face interviews.Results: Primary care researchers use incentive and communication strategies to improve retention in trials, but were unsure of their effect. Small monetary incentives were used to increase res...

  16. Use of strategies to improve retention in primary care randomised trials: a qualitative study with in-depth interviews.

    OpenAIRE

    Brueton, V C; Stevenson, F; Vale, C L

    2014-01-01

    Objective: To explore the strategies used to improve retention in primary care randomised trials. Design: Qualitative in-depth interviews and thematic analysis. Participants: 29 UK primary care chief and principal investigators, trial managers and research nurses. Methods: In-depth face-to-face interviews. Results: Primary care researchers use incentive and communication strategies to improve retention in trials, but were unsure of their effect. Small monetary in...

  17. An occupational therapy intervention for residents with stroke related disabilities in UK care homes (OTCH): cluster randomised controlled trial

    OpenAIRE

    Sackley, Catherine M.; Walker, Marion F; Burton, Chris R; Watkins, Caroline L; Mant, Jonathan; Roalfe, Andrea K; Wheatley, Keith; Sheehan, Bart; Sharp, Leslie; Stant, Katie E.; Fletcher-Smith, Joanna; Steel, Kerry; Wilde, Kate; Irvine, Lisa; Peryer, Guy

    2015-01-01

    Objective To evaluate the clinical efficacy of an established programme of occupational therapy in maintaining functional activity and reducing further health risks from inactivity in care home residents living with stroke sequelae. Design Pragmatic, parallel group, cluster randomised controlled trial. Setting 228 care homes (>10 beds each), both with and without the provision of nursing care, local to 11 trial administrative centres across the United Kingdom. Participants 1042 ca...

  18. A randomised controlled trial of a client-centred self-care intervention after stroke

    DEFF Research Database (Denmark)

    Guidetti, Susanne; Ytterberg, Charlotte

    2011-01-01

    PURPOSE: The aim of this randomised controlled pilot study of a client-centred self-care intervention (CCSCI) in individuals with stroke was to study (i) the feasibility of the study design, (ii) effects up to 12 months on activities of daily living (ADL), use of informal care and home help...... services and the caregiver burden. METHOD: An intervention group (IG) received CCSCI and a control group (CG) received ordinary training. Forty individuals with stroke (IG n = 19, CG n = 21) were included. Data were collected at 3, 6 and 12 months using established instruments. RESULTS: After 12 months 24...... people remained in the study (IG = 10, CG = 14). The data collection method was acceptable to most participants. At 12 months there were no differences in ADL, use of services or caregiver's burden. Both groups improved significantly and clinically important improvements were achieved by 80% in the IG...

  19. Advance care planning: A systematic review of randomised controlled trials conducted with older adults.

    Science.gov (United States)

    Weathers, Elizabeth; O'Caoimh, Rónán; Cornally, Nicola; Fitzgerald, Carol; Kearns, Tara; Coffey, Alice; Daly, Edel; O'Sullivan, Ronan; McGlade, Ciara; Molloy, D William

    2016-09-01

    Advance care planning (ACP), involving discussions between patients, families and healthcare professionals on future healthcare decisions, in advance of anticipated impairment in decision-making capacity, improves satisfaction and end-of-life care while respecting patient autonomy. It usually results in the creation of a written advanced care directive (ACD). This systematic review examines the impact of ACP on several outcomes (including symptom management, quality of care and healthcare utilisation) in older adults (>65years) across all healthcare settings. Nine randomised controlled trials (RCTs) were identified by searches of the CINAHL, PubMed and Cochrane databases. A total of 3646 older adults were included (range 72-88 years). Seven studies were conducted with community dwellers and the other two RCTs were conducted in nursing homes. Most studies did not implement a standardised ACD, or measure the impact on quality of end-of-life care or on the death and dying experience. All studies had some risk of bias, with most scoring poorly on the Oxford Quality Scale. While ACP interventions are well received by older adults and generally have positive effects on outcomes, this review highlights the need for well-designed RCTs that examine the economic impact of ACP and its effect on quality of care in nursing homes and other sectors. PMID:27451328

  20. E-health and consultation rates for respiratory illnesses in infants : a randomised clinical trial in primary care

    NARCIS (Netherlands)

    van der Gugten, Anne C; Uiterwaal, Cuno S P M; Verheij, Theo J M; van der Ent, Cornelis K.

    2015-01-01

    BACKGROUND: It is assumed that clear and complete information on the internet can reduce healthcare consumption. AIM: We assessed in a randomised clinical trial whether a personalised online parent information program on infant respiratory symptoms can reduce primary care utilisation. DESIGN AND SET

  1. Recruitment issues when primary care population clusters are used in randomised controlled clinical trials: climbing mountains or pushing boulders uphill?

    Science.gov (United States)

    Hoddinott, Pat; Britten, Jane; Harrild, Kirsten; Godden, David J

    2007-05-01

    Cluster randomised controlled trials for health promotion, education, public health or organisational change interventions are becoming increasingly common to inform evidence-based policy. However, there is little published methodological evidence on recruitment strategies for primary care population clusters. In this paper, we discuss how choosing which population cluster to randomise can impact on the practicalities of recruitment in primary care. We describe strategies developed through our experiences of recruiting primary care organisations to participate in a national randomised controlled trial of a policy to provide community breastfeeding groups for pregnant and breastfeeding mothers, the BIG (Breastfeeding in Groups) trial. We propose an iterative qualitative approach to recruitment; collecting data generated through the recruitment process, identifying themes and using the constant comparative method of analysis. This can assist in developing successful recruitment strategies and contrasts with the standardised approach commonly used when recruiting individuals to participate in randomised controlled trials. Recruiting primary care population clusters to participate in trials is currently an uphill battle in Britain. It is a complex process, which can benefit from applying qualitative methods to inform trial design and recruitment strategy. Recruitment could be facilitated if health service managers were committed to supporting peer reviewed, funded and ethics committee approved research at national level. PMID:16996320

  2. Intermediate care at a community hospital as an alternative to prolonged general hospital care for elderly patients: a randomised controlled trial

    OpenAIRE

    Johnsen Roar; Windspoll Rolf; Garåsen Helge

    2007-01-01

    Abstract Background Demographic changes together with an increasing demand among older people for hospital beds and other health services make allocation of resources to the most efficient care level a vital issue. The aim of this trial was to study the efficacy of intermediate care at a community hospital compared to standard prolonged care at a general hospital. Methods In a randomised controlled trial 142 patients aged 60 or more admitted to a general hospital due to acute illness or exace...

  3. Clinical score and rapid antigen detection test to guide antibiotic use for sore throats: randomised controlled trial of PRISM (primary care streptococcal management)

    OpenAIRE

    P. Little; Hobbs, F D R; Moore, M.; Mant, D; Williamson, I.; McNulty, C; Cheng, Y.E.; Leydon, G; McManus, R; Kelly, J; Barnett, J; Glasziou, P.; Mullee, M

    2013-01-01

    OBJECTIVE: To determine the effect of clinical scores that predict streptococcal infection or rapid streptococcal antigen detection tests compared with delayed antibiotic prescribing. DESIGN: Open adaptive pragmatic parallel group randomised controlled trial. SETTING: Primary care in United Kingdom. PATIENTS: Patients aged ?3 with acute sore throat. INTERVENTION: An internet programme randomised patients to targeted antibiotic use according to: delayed antibiotics (the compara...

  4. Methodological considerations for a randomised controlled trial of podiatry care in rheumatoid arthritis: lessons from an exploratory trial

    OpenAIRE

    Helliwell Philip S; Turner Deborah E; Woodburn James

    2007-01-01

    Abstract Background Whilst evidence exists to support the use of single treatments such as orthoses and footwear, the effectiveness of podiatry-led care as a complex intervention for patients with rheumatoid arthritis (RA) related foot problems is unknown. The aim of this study was to undertake an exploratory randomised controlled parallel arm clinical trial (RheumAFooT) to inform the design and implementation of a definitive trial and to understand the potential benefits of this care. Method...

  5. Continuity of midwifery care and gestational weight gain in obese women: a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Patterson Denise

    2011-03-01

    Full Text Available Abstract Background The increased prevalence of obesity in pregnant women in Australia and other developed countries is a significant public health concern. Obese women are at increased risk of serious perinatal complications and guidelines recommend weight gain restriction and additional care. There is limited evidence to support the effectiveness of dietary and physical activity lifestyle interventions in preventing adverse perinatal outcomes and new strategies need to be evaluated. The primary aim of this project is to evaluate the effect of continuity of midwifery care on restricting gestational weight gain in obese women to the recommended range. The secondary aims of the study are to assess the impact of continuity of midwifery care on: women's experience of pregnancy care; women's satisfaction with care and a range of psychological factors. Methods/Design A two arm randomised controlled trial (RCT will be conducted with primigravid women recruited from maternity services in Victoria, Australia. Participants will be primigravid women, with a BMI≥30 who are less than 17 weeks gestation. Women allocated to the intervention arm will be cared for in a midwifery continuity of care model and receive an informational leaflet on managing weight gain in pregnancy. Women allocated to the control group will receive routine care in addition to the same informational leaflet. Weight gain during pregnancy, standards of care, medical and obstetric information will be extracted from medical records. Data collected at recruitment (self administered survey and at 36 weeks by postal survey will include socio-demographic information and the use of validated scales to measure secondary outcomes. Discussion Continuity of midwifery care models are well aligned with current Victorian, Australian and many international government policies on maternity care. Increasingly, midwifery continuity models of care are being introduced in low risk maternity care, and

  6. Effects of dementia-care mapping on residents and staff of care homes: a pragmatic cluster-randomised controlled trial.

    Directory of Open Access Journals (Sweden)

    Geertje van de Ven

    Full Text Available BACKGROUND: The effectiveness of dementia-care mapping (DCM for institutionalised people with dementia has been demonstrated in an explanatory cluster-randomised controlled trial (cRCT with two DCM researchers carrying out the DCM intervention. In order to be able to inform daily practice, we studied DCM effectiveness in a pragmatic cRCT involving a wide range of care homes with trained nursing staff carrying out the intervention. METHODS: Dementia special care units were randomly assigned to DCM or usual care. Nurses from the intervention care homes received DCM training and conducted the 4-months DCM-intervention twice during the study. The primary outcome was agitation, measured with the Cohen-Mansfield agitation inventory (CMAI. The secondary outcomes included residents' neuropsychiatric symptoms (NPSs and quality of life, and staff stress and job satisfaction. The nursing staff made all measurements at baseline and two follow-ups at 4-month intervals. We used linear mixed-effect models to test treatment and time effects. RESULTS: 34 units from 11 care homes, including 434 residents and 382 nursing staff members, were randomly assigned. Ten nurses from the intervention units completed the basic and advanced DCM training. Intention-to-treat analysis showed no statistically significant effect on the CMAI (mean difference between groups 2·4, 95% CI -2·7 to 7·6; p = 0·34. More NPSs were reported in the intervention group than in usual care (p = 0·02. Intervention staff reported fewer negative and more positive emotional reactions during work (p = 0·02. There were no other significant effects. CONCLUSIONS: Our pragmatic findings did not confirm the effect on the primary outcome of agitation in the explanatory study. Perhaps the variability of the extent of implementation of DCM may explain the lack of effect. TRIAL REGISTRATION: Dutch Trials Registry NTR2314.

  7. Effect of removing direct payment for health care on utilisation and health outcomes in Ghanaian children: a randomised controlled trial.

    Directory of Open Access Journals (Sweden)

    Evelyn Korkor Ansah

    2009-01-01

    Full Text Available BACKGROUND: Delays in accessing care for malaria and other diseases can lead to disease progression, and user fees are a known barrier to accessing health care. Governments are introducing free health care to improve health outcomes. Free health care affects treatment seeking, and it is therefore assumed to lead to improved health outcomes, but there is no direct trial evidence of the impact of removing out-of-pocket payments on health outcomes in developing countries. This trial was designed to test the impact of free health care on health outcomes directly. METHODS AND FINDINGS: 2,194 households containing 2,592 Ghanaian children under 5 y old were randomised into a prepayment scheme allowing free primary care including drugs, or to a control group whose families paid user fees for health care (normal practice; 165 children whose families had previously paid to enrol in the prepayment scheme formed an observational arm. The primary outcome was moderate anaemia (haemoglobin [Hb] < 8 g/dl; major secondary outcomes were health care utilisation, severe anaemia, and mortality. At baseline the randomised groups were similar. Introducing free primary health care altered the health care seeking behaviour of households; those randomised to the intervention arm used formal health care more and nonformal care less than the control group. Introducing free primary health care did not lead to any measurable difference in any health outcome. The primary outcome of moderate anaemia was detected in 37 (3.1% children in the control and 36 children (3.2% in the intervention arm (adjusted odds ratio 1.05, 95% confidence interval 0.66-1.67. There were four deaths in the control and five in the intervention group. Mean Hb concentration, severe anaemia, parasite prevalence, and anthropometric measurements were similar in each group. Families who previously self-enrolled in the prepayment scheme were significantly less poor, had better health measures, and used

  8. Exercise therapy for Stress-related mental disorder, a randomised controlled trial in primary care

    Directory of Open Access Journals (Sweden)

    Donker Marieke

    2011-07-01

    Full Text Available Abstract Background to investigate whether a structured physical exercise programme (PEP improves the recovery of general health in patients suffering from Stress-related Mental Disorder (SMD. Method Study design: randomised open trial in general practice. Patients from two regions in the Netherlands were included between September 2003 and December 2005, and followed up for 12 weeks. Intervention: the patients were referred to a physical therapist for instruction in and monitoring of physical exercise of an intermediate intensity. Following the Dutch Guidelines for Healthy Physical Exercise, the patients were instructed to exercise at least five times a week, for at least 30 minutes per day. Control group: usual care from the GP Outcome Primary: improvement of general health after 6 weeks according to the 'general health' dimension of the Short-Form 36. Secondary: total days off work, percentage that resumed work after 6 and 12 weeks, change in distress score and change in remaining SF36 dimensions after 6 and 12 weeks. Results out of 102 randomised patients (mean age 43, 60 (59% female, 70 (68% completed the trial, of whom 31 were in the intervention group. After 6 weeks, the mean (SD general health score was 54.6 (22.1 for the intervention group and 57.5 (19.2 for the controls. The corresponding effect size (Cohen's d with 95% confidence interval from analysis of covariance was -0.06 (-0.41, 0.30 indicating no effect on general health. No significant effects of the intervention were detected for any secondary outcome parameter either. Conclusion Notwithstanding the relatively high drop-out rate, our results suggest that referral to a physical therapist for structured physical exercise is not likely to be very effective in improving recovery from SMD. Trial registry Current Controlled Trials ISRCTN15609105

  9. Collaborative care for patients with bipolar disorder: a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Beekman Aartjan TF

    2011-08-01

    Full Text Available Abstract Background Bipolar disorder is a severe mental illness with serious consequences for daily living of patients and their caregivers. Care as usual primarily consists of pharmacotherapy and supportive treatment. However, a substantial number of patients show a suboptimal response to treatment and still suffer from frequent episodes, persistent interepisodic symptoms and poor social functioning. Both psychiatric and somatic comorbid disorders are frequent, especially personality disorders, substance abuse, cardiovascular diseases and diabetes. Multidisciplinary collaboration of professionals is needed to combine all expertise in order to achieve high-quality integrated treatment. 'Collaborative Care' is a treatment method that could meet these needs. Several studies have shown promising effects of these integrated treatment programs for patients with bipolar disorder. In this article we describe a research protocol concerning a study on the effects of Collaborative Care for patients with bipolar disorder in the Netherlands. Methods/design The study concerns a two-armed cluster randomised clinical trial to evaluate the effectiveness of Collaborative Care (CC in comparison with Care as usual (CAU in outpatient clinics for bipolar disorder or mood disorders in general. Collaborative Care includes individually tailored interventions, aimed at personal goals set by the patient. The patient, his caregiver, the nurse and the psychiatrist all are part of the Collaborative Care team. Elements of the program are: contracting and shared decision making; psycho education; problem solving treatment; systematic relapse prevention; monitoring of outcomes and pharmacotherapy. Nurses coordinate the program. Nurses and psychiatrists in the intervention group will be trained in the intervention. The effects will be measured at baseline, 6 months and 12 months. Primary outcomes are psychosocial functioning, psychiatric symptoms, and quality of life. Caregiver

  10. Streamlining tasks and roles to expand treatment and care for HIV: randomised controlled trial protocol

    Directory of Open Access Journals (Sweden)

    van Vuuren Cloete

    2008-04-01

    Full Text Available Abstract Background A major barrier to accessing free government-provided antiretroviral treatment (ART in South Africa is the shortage of suitably skilled health professionals. Current South African guidelines recommend that only doctors should prescribe ART, even though most primary care is provided by nurses. We have developed an effective method of educational outreach to primary care nurses in South Africa. Evidence is needed as to whether primary care nurses, with suitable training and managerial support, can initiate and continue to prescribe and monitor ART in the majority of ART-eligible adults. Methods/design This is a protocol for a pragmatic cluster randomised trial to evaluate the effectiveness of a complex intervention based on and supporting nurse-led antiretroviral treatment (ART for South African patients with HIV/AIDS, compared to current practice in which doctors are responsible for initiating ART and continuing prescribing. We will randomly allocate 31 primary care clinics in the Free State province to nurse-led or doctor-led ART. Two groups of patients aged 16 years and over will be included: a 7400 registering with the programme with CD4 counts of ≤ 350 cells/mL (mainly to evaluate treatment initiation and b 4900 already receiving ART (to evaluate ongoing treatment and monitoring. The primary outcomes will be time to death (in the first group and viral suppression (in the second group. Patients' survival, viral load and health status indicators will be measured at least 6-monthly for at least one year and up to 2 years, using an existing province-wide clinical database linked to the national death register. Trial registration Controlled Clinical Trials ISRCTN46836853

  11. Methodological considerations for a randomised controlled trial of podiatry care in rheumatoid arthritis: lessons from an exploratory trial

    Directory of Open Access Journals (Sweden)

    Helliwell Philip S

    2007-11-01

    Full Text Available Abstract Background Whilst evidence exists to support the use of single treatments such as orthoses and footwear, the effectiveness of podiatry-led care as a complex intervention for patients with rheumatoid arthritis (RA related foot problems is unknown. The aim of this study was to undertake an exploratory randomised controlled parallel arm clinical trial (RheumAFooT to inform the design and implementation of a definitive trial and to understand the potential benefits of this care. Methods Patients with a definite diagnosis of RA, stable drug management 3 months prior to entry, and a current history of foot problems (pain, deformity, stiffness, skin or nail lesions, or footwear problems were recruited from a hospital outpatient rheumatology clinic and randomised to receive 12 months of podiatry treatment or no care. The primary outcome was change in foot health status using the impairment/footwear (LFISIF and activity limitation/participation restriction (LFISAP subscales of the Leeds Foot Impact Scale. Disease Activity Score (DAS, Health Assessment Questionnaire (HAQ score and walking speed (m/s were also recorded. Results Of the 80 patients identified, 64 patients were eligible to participate in the pilot and 34 were recruited. 16 patients were randomised to receive podiatry led foot care and 18 received no care. Against a backdrop of stable disease (DAS and HAQ scores, there was a statistically significant between group difference in the change in foot health status for foot impairment (LFISIF but not activity/participation (LFISAP or function (walking speed over 12 months. In the podiatry arm, 1 patient declined treatment following randomisation (did not want additional hospital visits and 3 self-withdrew (lost to follow-up. Patients received an average of 3 consultations for assessment and treatment comprising routine care for skin and nail lesions (n = 3, foot orthoses (n = 9, footwear referral to the orthotist (n = 5, and ultrasound

  12. Pharmacist-led management of chronic pain in primary care: costs and benefits in a pilot randomised controlled trial

    OpenAIRE

    Neilson, Aileen R; Bruhn, Hanne; Christine M. Bond; Elliott, Alison M; Smith, Blair H; Hannaford, Philip C; Holland, Richard; Amanda J Lee; Watson, Margaret; Wright, David; McNamee, Paul

    2015-01-01

    Objectives To explore differences in mean costs (from a UK National Health Service perspective) and effects of pharmacist-led management of chronic pain in primary care evaluated in a pilot randomised controlled trial (RCT), and to estimate optimal sample size for a definitive RCT. Design Regression analysis of costs and effects, using intention-to-treat and expected value of sample information analysis (EVSI). Setting Six general practices: Grampian (3); East Anglia (3). Participants 125 pat...

  13. Randomised controlled trial of a new palliative care service: Compliance, recruitment and completeness of follow-up

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    Saleem Tariq

    2008-05-01

    Full Text Available Abstract Background Palliative care has been proposed for progressive non-cancer conditions but there have been few evaluations of service developments. We analysed recruitment, compliance and follow-up data of a fast track (or wait list control randomised controlled trial of a new palliative care service – a design not previously used to assess palliative care. Methods/Design An innovative palliative care service (comprising a consultant in palliative medicine, a clinical nurse specialist, an administrator and a psychosocial worker was delivered to people severely affected by multiple sclerosis (MS, and their carers, in southeast London. Our design followed the MRC Framework for the Evaluation of Complex Interventions. In phase II we conducted randomised controlled trial, of immediate referral to the service (fast-track versus a 12-week wait (standard best practice. Main outcome measures were: compliance (the extent the trial protocol was adhered to, recruitment (target 50 patients, attrition and missing data rates; trial outcomes were Palliative Care Outcome Scale and MS Impact Scale. Results 69 patients were referred, 52 entered the trial (26 randomised to each arm, 5 refused consent and 12 were excluded from the trial for other reasons, usually illness or urgent needs, achieving our target numbers. 25/26 fast track and 21/26 standard best practice patients completed the trial, resulting in 217/225 (96% of possible interviews completed, 87% of which took place in the patient's home. Main reasons for failure to interview and/or attrition were death or illness. There were three deaths in the standard best practice group and one in the fast-track group during the trial. At baseline there were no differences between groups. Missing data for individual questionnaire items were small (median 0, mean 1–5 items out of 56+ items per interview, not associated with any patient or carer characteristics or with individual questionnaires, but were

  14. Effect of the Uganda Newborn Study on care-seeking and care practices: a cluster-randomised controlled trial

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    Peter Waiswa

    2015-03-01

    Full Text Available Background: Care for women and babies before, during, and after the time of birth is a sensitive measure of the functionality of any health system. Engaging communities in preventing newborn deaths is a promising strategy to achieve further progress in child survival in sub-Saharan Africa. Objective: To assess the effect of a home visit strategy combined with health facility strengthening on uptake of newborn care-seeking, practices and services, and to link the results to national policy and scale-up in Uganda. Design: The Uganda Newborn Study (UNEST was a two-arm cluster-randomised controlled trial in rural eastern Uganda. In intervention villages volunteer community health workers (CHWs were trained to identify pregnant women and make five home visits (two during pregnancy and three in the first week after birth to offer preventive and promotive care and counselling, with extra visits for sick and small newborns to assess and refer. Health facility strengthening was done in all facilities to improve quality of care. Primary outcomes were coverage of key essential newborn care behaviours (breastfeeding, thermal care, and cord care. Analyses were by intention to treat. This study is registered as a clinical trial, number ISRCTN50321130. Results: The intervention significantly improved essential newborn care practices, although many interventions saw major increases in both arms over the study period. Immediate breastfeeding after birth and exclusive breastfeeding were significantly higher in the intervention arm compared to the control arm (72.6% vs. 66.0%; p=0.016 and 81.8% vs. 75.9%, p=0.042, respectively. Skin-to-skin care immediately after birth and cord cutting with a clean instrument were marginally higher in the intervention arm versus the control arm (80.7% vs. 72.2%; p=0.071 and 88.1% vs. 84.4%; p=0.023, respectively. Half (49.6% of the mothers in the intervention arm waited more than 24 hours to bathe the baby, compared to 35.5% in

  15. A cluster randomised controlled trial of an occupational therapy intervention for residents with stroke living in UK care homes (OTCH: study protocol

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    Sackley Cath M

    2012-07-01

    Full Text Available Abstract Background The occupational therapy (OT in care homes study (OTCH aims to investigate the effect of a targeted course of individual OT (with task training, provision of adaptive equipment, minor environmental adaptations and staff education for stroke survivors living in care homes, compared to usual care. Methods/Design A cluster randomised controlled trial of United Kingdom (UK care homes (n = 90 with residents (n = 900 who have suffered a stroke or transient ischaemic attack (TIA, and who are not receiving end-of-life care. Homes will be stratified by centre and by type of care provided and randomised (50:50 using computer generated blocked randomisation within strata to receive either the OT intervention (3 months intervention from an occupational therapist or control (usual care. Staff training on facilitating independence and mobility and the use of adaptive equipment, will be delivered to every home, with control homes receiving this after the 12 month follow-up. Allocation will be concealed from the independent assessors, but the treating therapists, and residents will not be masked to the intervention. Measurements are taken at baseline prior to randomisation and at 3, 6 and 12 months post randomisation. The primary outcome measure is independence in self-care activities of daily living (Barthel Activities of Daily Living Index. Secondary outcome measures are mobility (Rivermead Mobility Index, mood (Geriatric Depression Scale, preference based quality of life measured from EQ-5D and costs associated with each intervention group. Quality adjusted life years (QALYs will be derived based on the EQ-5D scores. Cost effectiveness analysis will be estimated and measured by incremental cost effectiveness ratio. Adverse events will be recorded. Discussion This study will be the largest cluster randomised controlled trial of OT in care homes to date and will clarify the currently inconclusive literature on the efficacy of OT for

  16. Health care costs associated with gestational diabetes mellitus among high-risk women – results from a randomised trial

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    Kolu Päivi

    2012-07-01

    Full Text Available Abstract Background The costs of gestational diabetes mellitus (GDM screening have been frequently reported, but total GDM-related health care costs compared to the health care costs of women without GDM have not been reported. The aim of this study was to analyse GDM-related health care costs among women with an elevated risk of GDM. Methods The study was based on a cluster-randomised GDM prevention trial (N = 848 carried out at maternity clinics, combined with data from the Finnish Medical Birth Register and Care Registers for Social Welfare and Health Care. Costs of outpatient visits to primary and secondary care, cost of inpatient hospital care before and after delivery, the use of insulin, delivery costs and babies’ stay in the neonatal intensive care unit were analysed. Women who developed GDM were compared to those who were not diagnosed with GDM. Results Total mean health care costs adjusted for age, body mass index and education were 25.1% higher among women diagnosed with GDM (€6,432 vs. €5,143, p  Conclusions A confirmed GDM diagnosis was associated with a significant increase in total health care costs. Effective lifestyle counselling by primary health care providers may offer a means of reducing the high costs of secondary care.

  17. Women's evaluation of abuse and violence care in general practice: a cluster randomised controlled trial (weave

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    Feder Gene

    2010-01-01

    Full Text Available Abstract Background Intimate partner abuse (IPA is a major public health problem with serious implications for the physical and psychosocial wellbeing of women, particularly women of child-bearing age. It is a common, hidden problem in general practice and has been under-researched in this setting. Opportunities for early intervention and support in primary care need to be investigated given the frequency of contact women have with general practice. Despite the high prevalence and health consequences of abuse, there is insufficient evidence for screening in primary care settings. Furthermore, there is little rigorous evidence to guide general practitioners (GPs in responding to women identified as experiencing partner abuse. This paper describes the design of a trial of a general practice-based intervention consisting of screening for fear of partner with feedback to GPs, training for GPs, brief counselling for women and minimal practice organisational change. It examines the effect on women's quality of life, mental health and safety behaviours. Methods/Design weave is a cluster randomised controlled trial involving 40 general practices in Victoria, Australia. Approximately 500 women (16-50 years seen by the GP in the previous year are mailed a short lifestyle survey containing an item to screen for IPA. Women who indicate that they were afraid of a partner/ex-partner in the last year and provide contact details are invited to participate. Once baseline data are collected, GPs are randomly assigned to either a group involving healthy relationship and responding to IPA training plus inviting women for up to 6 sessions of counselling or to a group involving basic education and usual care for women. Outcomes will be evaluated by postal survey at 6 and 12 months following delivery of the intervention. There will be an economic evaluation, and process evaluation involving interviews with women and GPs, to inform understanding about implementation

  18. Using the theory of planned behaviour as a process evaluation tool in randomised trials of knowledge translation strategies: A case study from UK primary care

    OpenAIRE

    Grimshaw Jeremy M; Croal Bernard L; Thomas Ruth E; Ramsay Craig R; Eccles Martin P

    2010-01-01

    Abstract Background Randomised trials of knowledge translation strategies for professional behaviour change can provide robust estimates of effectiveness, but offer little insight into the causal mechanisms by which any change is produced. To illustrate the applicability of causal methods within randomised trials, we undertook a theory-based process evaluation study within an implementation trial to explore whether the cognitions of primary care doctors' predicted their test requesting behavi...

  19. Effect of intermediate care on mortality following emergency abdominal surgery. The InCare trial: study protocol, rationale and feasibility of a randomised multicentre trial

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    Vester-Andersen Morten

    2013-02-01

    Full Text Available Abstract Background Emergency abdominal surgery carries a 15% to 20% short-term mortality rate. Postoperative medical complications are strongly associated with increased mortality. Recent research suggests that timely recognition and effective management of complications may reduce mortality. The aim of the present trial is to evaluate the effect of postoperative intermediate care following emergency major abdominal surgery in high-risk patients. Methods and design The InCare trial is a randomised, parallel-group, non-blinded clinical trial with 1:1 allocation. Patients undergoing emergency laparotomy or laparoscopic surgery with a perioperative Acute Physiology and Chronic Health Evaluation II score of 10 or above, who are ready to be transferred to the surgical ward within 24 h of surgery are allocated to either intermediate care for 48 h, or surgical ward care. The primary outcome measure is all-cause 30-day mortality. We aim to enrol 400 patients in seven Danish hospitals. The sample size allows us to detect or refute a 34% relative risk reduction of mortality with 80% power. Discussion This trial evaluates the benefits and possible harm of intermediate care. The results may potentially influence the survival of many high-risk surgical patients. As a pioneer trial in the area, it will provide important data on the feasibility of future large-scale randomised clinical trials evaluating different levels of postoperative care. Trial registration Clinicaltrials.gov identifier: NCT01209663

  20. Effect of pelvic floor muscle training compared with watchful waiting in older women with symptomatic mild pelvic organ prolapse : randomised controlled trial in primary care

    NARCIS (Netherlands)

    Wiegersma, Marian; Panman, Chantal M. C. R.; Kollen, Boudewijn J.; Berger, Marjolein Y.; Lisman-Van Leeuwen, Yvonne; Dekker, Janny H.

    2014-01-01

    Objective To compare the effects of pelvic floor muscle training and watchful waiting on pelvic floor symptoms in a primary care population of women aged 55 years and over with symptomatic mild pelvic organ prolapse. Design Randomised controlled trial. Setting Dutch primary care. Participants Women

  1. Implementation and effectiveness of 'care navigation', coordinated management for people with complex chronic illness: rationale and methods of a randomised controlled

    OpenAIRE

    Plant, Natalie; Mallitt, Kylie-Ann; Kelly, Patrick J.; Usherwood, Tim; Gillespie, James; Boyages, Steven; Jan, Stephen; McNab, Justin; Essue, Beverley M.; Gradidge, Kathy; Maranan, Nereus; Ralphs, David; Aspin, Clive; Leeder, Stephen

    2013-01-01

    Background Chronic illness is a significant driver of the global burden of disease and associated health care costs. People living with severe chronic illness are heavy users of acute hospital services; better coordination of their care could potentially improve health outcomes while reducing hospital use. The Care Navigation trial will evaluate an in-hospital coordinated care intervention on health service use and quality of life in chronically ill patients. Methods/Design A randomised contr...

  2. Getting better at chronic care in remote communities: study protocol for a pragmatic cluster randomised controlled of community based management

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    Schmidt Barbara

    2012-11-01

    Full Text Available Abstract Background Prevalence and incidence of diabetes and other common comorbid conditions (hypertension, coronary heart disease, renal disease and chronic lung disease are extremely high among Indigenous Australians. Recent measures to improve quality of preventive care in Indigenous community settings, while apparently successful at increasing screening and routine check-up rates, have shown only modest or little improvements in appropriate care such as the introduction of insulin and other scaled-up drug regimens in line with evidence-based guidelines, together with support for risk factor reduction. A new strategy is required to ensure high quality integrated family-centred care is available locally, with continuity and cultural safety, by community-based care coordinators with appropriate system supports. Methods/design The trial design is open parallel cluster randomised controlled trial. The objective of this pragmatic trial is to test the effectiveness of a model of health service delivery that facilitates integrated community-based, intensive chronic condition management, compared with usual care, in rural and remote Indigenous primary health care services in north Queensland. Participants are Indigenous adults (aged 18–65 years with poorly controlled diabetes (HbA1c>=8.5 and at least one other chronic condition. The intervention is to employ an Indigenous Health Worker to case manage the care of a maximum caseload of 30 participants. The Indigenous Health Workers receive intensive clinical training initially, and throughout the study, to ensure they are competent to coordinate care for people with chronic conditions. The Indigenous Health Workers, supported by the local primary health care (PHC team and an Indigenous Clinical Support Team, will manage care, including coordinating access to multidisciplinary team care based on best practice standards. Allocation by cluster to the intervention and control groups is by simple

  3. House dust mite barrier bedding for childhood asthma: randomised placebo controlled trial in primary care [ISRCTN63308372

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    Barnes Greta

    2002-06-01

    Full Text Available Abstract Background The house dust mite is the most important environmental allergen implicated in the aetiology of childhood asthma in the UK. Dust mite barrier bedding is relatively inexpensive, convenient to use, and of proven effectiveness in reducing mattress house dust mite load, but no studies have evaluated its clinical effectiveness in the control of childhood asthma when dispensed in primary care. We therefore aimed to evaluate the effectiveness of house dust mite barrier bedding in children with asthma treated in primary care. Methods Pragmatic, randomised, double-blind, placebo controlled trial conducted in eight family practices in England. Forty-seven children aged 5 to 14 years with confirmed house dust mite sensitive asthma were randomised to receive six months treatment with either house dust mite barrier or placebo bedding. Peak expiratory flow was the main outcome measure of interest; secondary outcome measures included asthma symptom scores and asthma medication usage. Results No difference was noted in mean monthly peak expiratory flow, asthma symptom score, medication usage or asthma consultations, between children who received active bedding and those who received placebo bedding. Conclusions Treating house dust mite sensitive asthmatic children in primary care with house dust mite barrier bedding for six months failed to improve peak expiratory flow. Results strongly suggest that the intervention made no impact upon other clinical features of asthma.

  4. Living with prostate cancer: randomised controlled trial of a multimodal supportive care intervention for men with prostate cancer

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    Lepore Stephen

    2011-07-01

    Full Text Available Abstract Background Prostate cancer is the most common male cancer in developed countries and diagnosis and treatment carries with it substantial morbidity and related unmet supportive care needs. These difficulties may be amplified by physical inactivity and obesity. We propose to apply a multimodal intervention approach that targets both unmet supportive care needs and physical activity. Methods/design A two arm randomised controlled trial will compare usual care to a multimodal supportive care intervention "Living with Prostate Cancer" that will combine self-management with tele-based group peer support. A series of previously validated and reliable self-report measures will be administered to men at four time points: baseline/recruitment (when men are approximately 3-6 months post-diagnosis and at 3, 6, and 12 months after recruitment and intervention commencement. Social constraints, social support, self-efficacy, group cohesion and therapeutic alliance will be included as potential moderators/mediators of intervention effect. Primary outcomes are unmet supportive care needs and physical activity levels. Secondary outcomes are domain-specific and health-related quality of life (QoL; psychological distress; benefit finding; body mass index and waist circumference. Disease variables (e.g. cancer grade, stage will be assessed through medical and cancer registry records. An economic evaluation will be conducted alongside the randomised trial. Discussion This study will address a critical but as yet unanswered research question: to identify a population-based way to reduce unmet supportive care needs; promote regular physical activity; and improve disease-specific and health-related QoL for prostate cancer survivors. The study will also determine the cost-effectiveness of the intervention. Trial Registration ACTRN12611000392965

  5. Reducing unnecessary hospital days to improve quality of care through physician accountability: a cluster randomised trial

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    Caminiti Caterina

    2013-01-01

    Full Text Available Abstract Background Over 20% of hospital bed use is inappropriate, implying a waste of resources and the increase of patient iatrogenic risk. Methods This is a cluster, pragmatic, randomised controlled trial, carried out in a large University Hospital of Northern Italy, aiming to evaluate the effect of a strategy to reduce unnecessary hospital days. The primary outcome was the percentage of patient-days compatible with discharge. Among secondary objectives, to describe the strategy’s effect in the long-term, as well as on hospital readmissions, considered to be a marker of the quality of hospital care. The 12 medical wards with the longest length of stay participated. Effectiveness was measured at the individual level on 3498 eligible patients during monthly index days. Patients admitted or discharged on index days, or with stay >90 days, were excluded. All ward staff was blinded to the index days, while staff in the control arm and data analysts were blinded to the trial’s objectives and interventions. The strategy comprised the distribution to physicians of the list of their patients whose hospital stay was compatible with discharge according to a validated Delay Tool, and of physician length of stay profiles, followed by audits managed autonomously by the physicians of the ward. Results During the 12 months of data collection, over 50% of patient-days were judged to be compatible with discharge. Delays were mainly due to problems with activities under medical staff control. Multivariate analysis considering clustering showed that the strategy reduced patient-days compatible with discharge by 16% in the intervention vs control group, (OR=0.841; 95% CI, 0.735 to 0.963; P=0.012. Follow-up at 1 year did not yield a statistically significant difference between the percentages of patient-days judged to be compatible with discharge between the two arms (OR=0.818; 95% CI, 0.476 to 1.405; P=0.47. There was no significant difference in 30-day

  6. Exercise therapy for Stress-related mental disorder, a randomised controlled trial in primary care

    NARCIS (Netherlands)

    Quartero, A. Otto; Burger, Huib; Donker, Marieke; de Wit, Niek J.

    2011-01-01

    Background: to investigate whether a structured physical exercise programme (PEP) improves the recovery of general health in patients suffering from Stress-related Mental Disorder (SMD). Method: Study design: randomised open trial in general practice. Patients from two regions in the Netherlands wer

  7. Stepped care for depression and anxiety: from primary care to specialized mental health care: a randomised controlled trial testing the effectiveness of a stepped care program among primary care patients with mood or anxiety disorders

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    Seekles Wike

    2009-06-01

    Full Text Available Abstract Background Mood and anxiety disorders are highly prevalent and have a large impact on the lives of the affected individuals. Therefore, optimal treatment of these disorders is highly important. In this study we will examine the effectiveness of a stepped care program for primary care patients with mood and anxiety disorders. A stepped care program is characterized by different treatment steps that are arranged in order of increasing intensity. Methods This study is a randomised controlled trial with two conditions: stepped care and care as usual, whereby the latter forms the control group. The stepped care program consists of four evidence based interventions: (1 Watchful waiting, (2 Guided self-help, (3 Problem Solving Treatment and (4 Medication and/or specialized mental health care. The study population consists of primary care attendees aged 18–65 years. Screeners are sent to all patients of the participating general practitioners. Individuals with a Diagnostic and Statistical Manual of mental disorders (DSM diagnosis of major depression, dysthymia, panic disorder (with or without agoraphobia, generalized anxiety disorder, or social phobia are included as well as individuals with minor depression and anxiety disorders. Primary focus is the reduction of depressive and anxiety symptoms. Both conditions are monitored at 8, 16 and 24 weeks. Discussion This study evaluates the effectiveness of a stepped care program for patients with depressive and anxiety disorder. If effective, a stepped care program can form a worthwhile alternative for care as usual. Strengths and limitations of this study are discussed. Trial Registration Current Controlled Trails: ISRCTN17831610.

  8. A single blinded randomised controlled pilot trial of prism adaptation for improving self-care in stroke patients with neglect.

    Science.gov (United States)

    Turton, Ailie J; O'Leary, Kelly; Gabb, Judith; Woodward, Rebecca; Gilchrist, Iain D

    2010-04-01

    Prism adaptation has been shown to alleviate the symptoms of unilateral spatial neglect following stroke in single case and small group studies. The purposes of this single blinded pilot randomised controlled trial were to determine the feasibility of delivering prism adaptation treatment in a clinically valid sample and to assess its impact on self-care. Thirty seven right hemisphere stroke patients with unilateral spatial neglect were randomised into either prism adaptation (using 10 dioptre, 6 degree prisms) or sham treatment (using plain glasses) groups. Treatment was delivered each weekday for two weeks. Pointing accuracy, without vision of the finger, was recorded each day before treatment. Outcome was measured, by blinded assessors, four days and eight weeks after the end of treatment using the Catherine Bergego Scale (CBS) and the conventional neuropsychological tests from the Behavioural Inattention Test (BIT). Thirty four patients received treatment: 16 with prisms, 18 sham. Mean compliance was 99% and 97%, respectively. Over the treatment days only the prism treated group showed increased leftward bias in open loop pointing to targets on a touch screen. However, despite the group level changes in pointing behaviour no overall effect of the treatment on self-care or BIT were found.

  9. Extra Physiotherapy in Critical Care (EPICC) Trial Protocol: a randomised controlled trial of intensive versus standard physical rehabilitation therapy in the critically ill

    OpenAIRE

    Thomas, Kirsty; Wright, Stephen E.; Watson, Gillian; Baker, Catherine; Stafford, Victoria; Wade, Clare; Chadwick, Thomas J.; Mansfield, Leigh; Wilkinson, Jennifer; Shen, Jing; Deverill, Mark; Bonner, Stephen; Hugill, Keith; Howard, Philip; Henderson, Andrea

    2015-01-01

    Introduction Patients discharged from Critical Care suffer from excessive longer term morbidity and mortality. Physical and mental health measures of quality of life show a marked and immediate fall after admission to Critical Care with some recovery over time. However, physical function is still significantly reduced at 6 months. The National Institute for Health and Care Excellence clinical guideline on rehabilitation after critical illness, identified the need for high-quality randomised c...

  10. Improving person-centred care in nursing homes through dementia-care mapping: design of a cluster-randomised controlled trial

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    van de Ven Geertje

    2012-01-01

    Full Text Available Abstract Background The effectiveness and efficiency of nursing-home dementia care are suboptimal: there are high rates of neuropsychiatric symptoms among the residents and work-related stress among the staff. Dementia-care mapping is a person-centred care method that may alleviate both the resident and the staff problems. The main objective of this study is to evaluate the effectiveness and cost-effectiveness of dementia-care mapping in nursing-home dementia care. Methods/Design The study is a cluster-randomised controlled trial, with nursing homes grouped in clusters. Studywise minimisation is the allocation method. Nursing homes in the intervention group will receive a dementia-care-mapping intervention, while the control group will receive usual care. The primary outcome measure is resident agitation, to be assessed with the Cohen-Mansfield Agitation Inventory. The secondary outcomes are resident neuropsychiatric symptoms, assessed with the Neuropsychiatric Inventory - Nursing Homes and quality of life, assessed with Qualidem and the EQ-5D. The staff outcomes are stress reactions, job satisfaction and job-stress-related absenteeism, and staff turnover rate, assessed with the Questionnaire about Experience and Assessment of Work, the General Health Questionnaire-12, and the Maastricht Job Satisfaction Scale for Health Care, respectively. We will collect the data from the questionnaires and electronic registration systems. We will employ linear mixed-effect models and cost-effectiveness analyses to evaluate the outcomes. We will use structural equation modelling in the secondary analysis to evaluate the plausibility of a theoretical model regarding the effectiveness of the dementia-care mapping intervention. We will set up process analyses, including focus groups with staff, to determine the relevant facilitators of and barriers to implementing dementia-care mapping broadly. Discussion A novelty of dementia-care mapping is that it offers an

  11. Integrated primary care for patients with mental and physical multimorbidity: cluster randomised controlled trial of collaborative care for patients with depression comorbid with diabetes or cardiovascular disease

    OpenAIRE

    Chew-Graham, CA

    2015-01-01

    Objective To test the effectiveness of an integrated collaborative care model for people with depression and long term physical conditions. Design Cluster randomised controlled trial. Setting 36 general practices in the north west of England. Participants 387 patients with a record of diabetes or heart disease, or both, who had depressive symptoms (≥10 on patient health questionaire-9 (PHQ-9)) for at least two weeks. Mean age was 58.5 (SD 11.7). Participants reported a mean of 6.2 (SD 3.0) lo...

  12. The feasibility of creating a checklist for the assessment of the methodological quality both of randomised and non-randomised studies of health care interventions

    OpenAIRE

    Downs, S. H.; Black, N.

    1998-01-01

    OBJECTIVE: To test the feasibility of creating a valid and reliable checklist with the following features: appropriate for assessing both randomised and non-randomised studies; provision of both an overall score for study quality and a profile of scores not only for the quality of reporting, internal validity (bias and confounding) and power, but also for external validity. DESIGN: A pilot version was first developed, based on epidemiological principles, reviews, and existing checklists...

  13. Effectiveness of osteopathic manipulative treatment in neonatal intensive care units: protocol for a multicentre randomised clinical trial

    Science.gov (United States)

    Cerritelli, Francesco; Pizzolorusso, Gianfranco; Renzetti, Cinzia; D'Incecco, Carmine; Fusilli, Paola; Perri, Paolo Francesco; Tubaldi, Lucia; Barlafante, Gina

    2013-01-01

    Introduction Neonatal care has been considered as one of the first priorities for improving quality of life in children. In 2010, 10% of babies were born prematurely influencing national healthcare policies, economic action plans and political decisions. The use of complementary medicine has been applied to the care of newborns. One previous study documented the positive effect of osteopathic manipulative treatment (OMT) in reducing newborns’ length of stay (LOS). Aim of this multicentre randomised controlled trial is to examine the association between OMT and LOS across three neonatal intensive care units (NICUs). Methods and analysis 690 preterm infants will be recruited from three secondary and tertiary NICUs from north and central Italy and allocated into two groups, using permuted-block randomisation. The two groups will receive standard medical care and OMT will be applied, twice a week, to the experimental group only. Outcome assessors will be blinded of study design and group allocation. The primary outcome is the mean difference in days between discharge and entry. Secondary outcomes are difference in daily weight gain, number of episodes of vomit, regurgitation, stooling, use of enema, time to full enteral feeding and NICU costs. Statistical analyses will take into account the intention-to-treat method. Missing data will be handled using last observation carried forward (LOCF) imputation technique. Ethics and dissemination Written informed consent will be obtained from parents or legal guardians at study enrolment. The trial has been approved by the ethical committee of Macerata hospital (n°22/int./CEI/27239) and it is under review by the other regional ethics committees. Results Dissemination of results from this trial will be through scientific medical journals and conferences. Trial registration This trial has been registered at http://www.clinicaltrials.org (identifier NCT01645137). PMID:23430598

  14. Transcutaneous electrical nerve stimulation as adjunct to primary care management for tennis elbow: pragmatic randomised controlled trial (TATE trial)

    Science.gov (United States)

    Lewis, A Martyn; Sim, Julius; Mallen, Christian D; Mason, Elizabeth E; Hay, Elaine M; van der Windt, Daniëlle A

    2013-01-01

    Objective To investigate the effectiveness of supplementing information and advice on analgesia and exercise from a general practitioner with transcutaneous electrical nerve stimulation (TENS) as a non-drug form of analgesia to reduce pain intensity in patients with tennis elbow. Design Pragmatic randomised controlled trial in primary care. Setting and 38 general practices in the West Midlands, UK. Participants 241 adults consulting with a first or new (no consultation in previous six months) clinical diagnosis of tennis elbow. Interventions Participants were randomly allocated to either primary care management alone, consisting of a consultation with a general practitioner followed by information and advice on exercises, or primary care management plus TENS to be used once a day for 45 minutes over six weeks (or until symptom resolution) for pain relief. Outcome measures The primary outcome was self reported intensity of elbow pain (0-10 rating scale) at six weeks. Primary and secondary outcomes were measured at baseline and at six weeks, six months, and 12 months by postal questionnaire. Analysis was by intention to treat. Results 121 participants were randomised to primary care management plus TENS and 120 to primary care management only (first episode, n=197 (82%); duration <1-3 months, n=138 (57%)). Adherence to exercise and TENS recommendations reported at six weeks was low; only 42 participants in the primary care management plus TENS group met a priori defined adherence criteria. Both intervention groups showed large improvements in pain and secondary outcomes, especially during the first six weeks of follow-up. However, no clinically or statistically significant differences were seen between groups at any follow-up timepoint. At the primary endpoint (six weeks), the between group difference in improvement of pain was −0.33 (95% confidence interval −0.96 to 0.31; P=0.31) in favour of the primary care management only group, with adjustment for age, sex

  15. A cluster randomised controlled trial of the efficacy of a brief walking intervention delivered in primary care: Study protocol

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    Szczepura Ala

    2011-06-01

    Full Text Available Abstract Background The aim of the present research is to conduct a fully powered explanatory trial to evaluate the efficacy of a brief self-regulation intervention to increase walking. The intervention will be delivered in primary care by practice nurses (PNs and Healthcare Assistants (HCAs to patients for whom increasing physical activity is a particular priority. The intervention has previously demonstrated efficacy with a volunteer population, and subsequently went through an iterative process of refinement in primary care, to maximise acceptability to both providers and recipients. Methods/ Design This two arm cluster randomised controlled trial set in UK general practices will compare two strategies for increasing walking, assessed by pedometer, over six months. Patients attending practices randomised to the self-regulation intervention arm will receive an intervention consisting of behaviour change techniques designed to increase walking self-efficacy (confidence in ability to perform the behaviour, and to help people translate their "good" intentions into behaviour change by making plans. Patients attending practices randomised to the information provision arm will receive written materials promoting walking, and a short unstructured discussion about increasing their walking. The trial will recruit 20 PN/HCAs (10 per arm, who will be trained by the research team to deliver the self-regulation intervention or information provision control intervention, to 400 patients registered at their practices (20 patients per PN/HCA. This will provide 85% power to detect a mean difference of five minutes/day walking between the self-regulation intervention group and the information provision control group. Secondary outcomes include health services costs, and intervention effects in sub-groups defined by age, ethnicity, gender, socio-economic status, and clinical condition. A mediation analysis will investigate the extent to which changes in

  16. A cluster randomised controlled trial of nurse and GP partnership for care of Chronic Obstructive Pulmonary Disease

    Directory of Open Access Journals (Sweden)

    Middleton Sandy

    2008-06-01

    Full Text Available Abstract Background Chronic obstructive pulmonary disease (COPD is a significant health problem worldwide. This randomised controlled trial aims at testing a new approach that involves a registered nurse working in partnership with patients, general practitioners (GPs and other health professionals to provide care to patients according to the evidence-based clinical practice guidelines. The aim is to determine the impact of this partnership on the quality of care and patient outcomes. Methods A cluster randomised control trial design was chosen for this study. Randomisation occurred at practice level. GPs practising in South Western Sydney, Australia and their COPD patients were recruited for the study. The intervention was implemented by nurses specifically recruited and trained for this study. Nurses, working in partnership with GPs, developed care plans for patients based on the Australian COPDX guidelines. The aim was to optimise patient management, improve function, prevent deterioration and enhance patient knowledge and skills. Control group patients received 'usual' care from their GPs. Data collection includes patient demographic profiles and their co-morbidities. Spirometry is being performed to assess patients' COPD status and CO analyser to validate their smoking status. Patients' quality of life and overall health status are being measured by St George's Respiratory Questionnaire and SF-12 respectively. Other patient measures being recorded include health service use, immunisation status, and knowledge of COPD. Qualitative methods will be used to explore participants' satisfaction with the intervention and their opinion about the value of the partnership. Analysis Analysis will be by intention to treat. Intra-cluster (practice correlation coefficients will be determined and published for all primary outcome variables to assist future research. The effect of the intervention on outcomes measured on a continuous scale will be estimated

  17. Randomised controlled trial of effects of coordinating care for terminally ill cancer patients.

    OpenAIRE

    Addington-Hall, J M; MacDonald, L D; Anderson, H R; Chamberlain, J.; Freeling, P.; Bland, J. M.; Raftery, J

    1992-01-01

    OBJECTIVES--To measure effects on terminally ill cancer patients and their families of coordinating the services available within the NHS and from local authorities and the voluntary sector. DESIGN--Randomised controlled trial. SETTING--Inner London health district. PATIENTS--Cancer patients were routinely notified from 1987 to 1990. 554 patients expected to survive less than one year entered the trial and were randomly allocated to a coordination or a control group. INTERVENTION--All patient...

  18. Prolonged conservative care versus early surgery in patients with sciatica caused by lumbar disc herniation: Two year results of a randomised controlled trial

    NARCIS (Netherlands)

    W.C. Peul (Wilco); W.B. van den Hout (Wilbert); R. Brand (René); R.T.W.M. Thomeer (Raph); B.W. Koes (Bart)

    2008-01-01

    textabstractObjectives: To evaluate the effects of early lumbar disc surgery compared with prolonged conservative care for patients with sciatica over two years of follow-up. Design: Randomised controlled trial. Setting: Nine Dutch hospitals. Participants: 283 patients with 6-12 weeks of sciatica. I

  19. Prolonged conservative care versus early surgery in patients with sciatica caused by lumbar disc herniation : two year results of a randomised controlled trial

    NARCIS (Netherlands)

    Peul, W.C.; Hout, van den W.B.; Brand, R.; Thomeer, R.T.W.M.; Koes, B.W.

    2008-01-01

    Objectives: To evaluate the effects of early lumbar disc surgery compared with prolonged conservative care for patients with sciatica over two years of follow-up. Design: Randomised controlled trial. Setting: Nine Dutch hospitals. Participants: 283 patients with 6-12 weeks of sciatica. Interventions

  20. Training general practitioners in the treatment of functional somatic symptoms: effects on patient health in a cluster-randomised controlled trial (the Functional Illness in Primary Care study)

    DEFF Research Database (Denmark)

    Toft, Tomas; Rosendal, Marianne; Ørnbøl, Eva;

    2010-01-01

    BACKGROUND: Patients with medically unexplained or functional somatic symptoms (FSS) are prevalent in primary care. In this pragmatic cluster-randomised controlled trial we aimed to test the effect of a training programme (The Extended Reattribution and Management model) for general practitioners...... (GPs) in the treatment of FSS. METHODS: 38 participating GPs were randomised to the control group or the training group. The GPs included consecutive 18- to 65-year-old patients presenting during a 3-week period for new health complaints. We assessed a stratified subsample with the psychiatric...

  1. Cost-effectiveness of collaborative care including PST and an antidepressant treatment algorithm for the treatment of major depressive disorder in primary care; a randomised clinical trial

    Directory of Open Access Journals (Sweden)

    Beekman Aartjan TF

    2007-03-01

    Full Text Available Abstract Background Depressive disorder is currently one of the most burdensome disorders worldwide. Evidence-based treatments for depressive disorder are already available, but these are used insufficiently, and with less positive results than possible. Earlier research in the USA has shown good results in the treatment of depressive disorder based on a collaborative care approach with Problem Solving Treatment and an antidepressant treatment algorithm, and research in the UK has also shown good results with Problem Solving Treatment. These treatment strategies may also work very well in the Netherlands too, even though health care systems differ between countries. Methods/design This study is a two-armed randomised clinical trial, with randomization on patient-level. The aim of the trial is to evaluate the treatment of depressive disorder in primary care in the Netherlands by means of an adapted collaborative care framework, including contracting and adherence-improving strategies, combined with Problem Solving Treatment and antidepressant medication according to a treatment algorithm. Forty general practices will be randomised to either the intervention group or the control group. Included will be patients who are diagnosed with moderate to severe depression, based on DSM-IV criteria, and stratified according to comorbid chronic physical illness. Patients in the intervention group will receive treatment based on the collaborative care approach, and patients in the control group will receive care as usual. Baseline measurements and follow up measures (3, 6, 9 and 12 months are assessed using questionnaires and an interview. The primary outcome measure is severity of depressive symptoms, according to the PHQ9. Secondary outcome measures are remission as measured with the PHQ9 and the IDS-SR, and cost-effectiveness measured with the TiC-P, the EQ-5D and the SF-36. Discussion In this study, an American model to enhance care for patients with a

  2. Effect of home-based counselling on newborn care practices in southern Tanzania one year after implementation: a cluster-randomised controlled trial

    OpenAIRE

    Penfold, S.; Manzi, F.; Mkumbo, E; Temu, S; Jaribu, J.; Shamba, DD; Mshinda, H; Cousens, S.; Marchant, T; Tanner, M; Schellenberg, D; Armstrong Schellenberg, J

    2014-01-01

    BACKGROUND In Sub-Saharan Africa over one million newborns die annually. We developed a sustainable and scalable home-based counselling intervention for delivery by community volunteers in rural southern Tanzania to improve newborn care practices and survival. Here we report the effect on newborn care practices one year after full implementation. METHODS All 132 wards in the 6-district study area were randomised to intervention or comparison groups. Starting in 2010, in intervention area...

  3. Protocol for the Northern Manhattan Diabetes Community Outreach Project. A randomised trial of a community health worker intervention to improve diabetes care in Hispanic adults

    OpenAIRE

    Palmas, Walter; Teresi, Jeanne A.; Findley, Sally; Mejia, Miriam; Batista, Milagros; Kong, Jian; Silver, Stephanie; Luchsinger, Jose A.; Carrasquillo, Olveen

    2012-01-01

    Objective Hispanics in the USA are affected by the diabetes epidemic disproportionately, and they consistently have lower access to care, poorer control of the disease and higher risk of complications. This study evaluates whether a community health worker (CHW) intervention may improve clinically relevant markers of diabetes care in adult underserved Hispanics. Methods and analysis The Northern Manhattan Diabetes Community Outreach Project (NOCHOP) is a two-armed randomised controlled trial ...

  4. Treating postnatal depressive symptoms in primary care: a randomised controlled trial of GP management, with and without adjunctive counselling

    Directory of Open Access Journals (Sweden)

    Leigh Bronwyn

    2011-05-01

    Full Text Available Abstract Background Postnatal depression (PND is under-diagnosed and most women do not access effective help. We aimed to evaluate comparative management of (PND following screening with the Edinburgh Postnatal Depression Scale, using three best-practice care pathways by comparing management by general practitioners (GPs alone compared to adjunctive counselling, based on cognitive behavioural therapy (CBT, delivered by postnatal nurses or psychologists. Methods This was a parallel, three-group randomised controlled trial conducted in a primary care setting (general practices and maternal & child health centres and a psychology clinic. A total of 3,531 postnatal women were screened for symptoms of depression; 333 scored above cut-off on the screening tool and 169 were referred to the study. Sixty-eight of these women were randomised between the three treatment groups. Results Mean scores on the Beck Depression Inventory (BDI-II at entry were in the moderate-to-severe range. There was significant variation in the post-study frequency of scores exceeding the threshold indicative of mild-to-severe depressive symptoms, such that more women receiving only GP management remained above the cut-off score after treatment (p = .028. However, all three treatment conditions were accompanied by significant reductions in depressive symptoms and mean post-study BDI-II scores were similar between groups. Compliance was high in all three groups. Women rated the treatments as highly effective. Rates of both referral to the study (51%, and subsequent treatment uptake (40% were low. Conclusions Data from this small study suggest that GP management of PND when augmented by a CBT-counselling package may be successful in reducing depressive symptoms in more patients compared to GP management alone. The relatively low rates of referral and treatment uptake, suggest that help-seeking remains an issue for many women with PND, consistent with previous research. Trial

  5. The Economics of Dementia-Care Mapping in Nursing Homes: A Cluster-Randomised Controlled Trial

    OpenAIRE

    Geertje van de Ven; Irena Draskovic; Elke van Herpen; Koopmans, Raymond T C M; Rogier Donders; Zuidema, Sytse U.; Eddy M M Adang; Vernooij-Dassen, Myrra J. F. J.

    2014-01-01

    BACKGROUND: Dementia-care mapping (DCM) is a cyclic intervention aiming at reducing neuropsychiatric symptoms in people with dementia in nursing homes. Alongside an 18-month cluster-randomized controlled trial in which we studied the effectiveness of DCM on residents and staff outcomes, we investigated differences in costs of care between DCM and usual care in nursing homes. METHODS: Dementia special care units were randomly assigned to DCM or usual care. Nurses from the intervention care hom...

  6. Cost-effectiveness and cost-utility analyses of hospital-based home care compared to hospital-based care for children diagnosed with type 1 diabetes; a randomised controlled trial; results after two years’ follow-up

    OpenAIRE

    Tiberg, Irén; Lindgren, Björn; Carlsson, Annelie; Hallström, Inger

    2016-01-01

    Background Practices regarding hospitalisation of children at diagnosis of type 1 diabetes vary both within countries and internationally, and high-quality evidence of best practice is scarce. The objective of this study was to close some of the gaps in evidence by comparing two alternative regimens for children diagnosed with type 1 diabetes: hospital-based care and hospital-based home care (HBHC), referring to specialist care in a home-based setting. Methods A randomised controlled trial, i...

  7. Nurse-Led Medicines' Monitoring for Patients with Dementia in Care Homes: A Pragmatic Cohort Stepped Wedge Cluster Randomised Trial.

    Directory of Open Access Journals (Sweden)

    Susan Jordan

    Full Text Available People with dementia are susceptible to adverse drug reactions (ADRs. However, they are not always closely monitored for potential problems relating to their medicines: structured nurse-led ADR Profiles have the potential to address this care gap. We aimed to assess the number and nature of clinical problems identified and addressed and changes in prescribing following introduction of nurse-led medicines' monitoring.Pragmatic cohort stepped-wedge cluster Randomised Controlled Trial (RCT of structured nurse-led medicines' monitoring versus usual care.Five UK private sector care homes.41 service users, taking at least one antipsychotic, antidepressant or anti-epileptic medicine.Nurses completed the West Wales ADR (WWADR Profile for Mental Health Medicines with each participant according to trial step.Problems addressed and changes in medicines prescribed.Information was collected from participants' notes before randomisation and after each of five monthly trial steps. The impact of the Profile on problems found, actions taken and reduction in mental health medicines was explored in multivariate analyses, accounting for data collection step and site.Five of 10 sites and 43 of 49 service users approached participated. Profile administration increased the number of problems addressed from a mean of 6.02 [SD 2.92] to 9.86 [4.48], effect size 3.84, 95% CI 2.57-4.11, P <0.001. For example, pain was more likely to be treated (adjusted Odds Ratio [aOR] 3.84, 1.78-8.30, and more patients attended dentists and opticians (aOR 52.76 [11.80-235.90] and 5.12 [1.45-18.03] respectively. Profile use was associated with reduction in mental health medicines (aOR 4.45, 1.15-17.22.The WWADR Profile for Mental Health Medicines can improve the quality and safety of care, and warrants further investigation as a strategy to mitigate the known adverse effects of prescribed medicines.ISRCTN 48133332.

  8. The effectiveness of the Liverpool care pathway in improving end of life care for dying cancer patients in hospital. A cluster randomised trial

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    Pellegrini Fabio

    2011-01-01

    Full Text Available Abstract Background Most cancer patients still die in hospital, mainly in medical wards. Many studies in different countries have shown the poor quality of end-of-life care delivery in hospitals. The Program "Liverpool Care Pathway for the dying patient" (LCP, developed in the UK to transfer the hospice model of care into hospitals and other care settings, is a complex intervention to improve the quality of end-of-life care. The results from qualitative and quantitative studies suggest that the LCP Program can improve significantly the quality of end-of-life care delivery in hospitals, but no randomised trial has been conducted till now. Methods and design This is a randomized cluster trial, stratified by regions and matched for assessment period. Pairs of eligible medical wards from different hospitals will be randomized to receive the LCP-I Program or no intervention until the end of the trial. The LCP-I Program will be implemented by a Palliative Care Unit. The assessment of the end-points will be performed for all cancer deaths occurred in the six months after the end of the LCP-I implementation in the experimental wards and, in the same period of time, in the matched control wards. The primary end-point is the overall quality of end-of-life care provided on the ward to dying cancer patients and their families, assessed using the Global Scale of the Italian version of the Toolkit "After-death Bereaved Family Member Interview". Discussion This study can be interpreted as a Phase III trial according to the Medical Research Council Framework. In this study, the effectiveness of a fully defined intervention is assessed by comparing the distribution of the endpoints in the experimental and in the control arm. Research ID RFPS-2006-6-341619 Trial registration ClinicalTrials.gov Identifier: NCT01081899

  9. Evaluation of a blood conservation strategy in the intensive care unit: a prospective, randomised study.

    LENUS (Irish Health Repository)

    Mahdy, Saad

    2009-06-01

    Anemia is a common problem in the ICU population. Most patients are anemic at admission, their hemoglobin concentrations declining further thereafter. The aim of the present study was to evaluate the effect of a combination strategy, involving closed arterial blood gas sampling and the use of pediatric vials for phlebotomy (Group A), on the sampling-induced blood loss and the rate of decline in hemoglobin in adult ICU patients. Combination (Group A) was compared to the current standard technique of arterial line sampling and adult vial phlebotomy (Group B) in a prospective, randomised, ethically-approved trial for the first 72 hours of their ICU stay. Peri-operative, oncology, coagulopathic and uremic patients were excluded. All other ICU patients with arterial cannulae and predicted to stay beyond 3 days, were enrolled.

  10. The Diabetes Care Project: an Australian multicentre, cluster randomised controlled trial [study protocol

    OpenAIRE

    Leach, Matthew J; Segal, Leonie; Esterman, Adrian; Armour, Caroline; McDermott, Robyn; Fountaine, Tim

    2013-01-01

    Background Diabetes mellitus is an increasingly prevalent metabolic disorder that is associated with substantial disease burden. Australia has an opportunity to improve ways of caring for the growing number of people with diabetes, but this may require changes to the way care is funded, organised and delivered. To inform how best to care for people with diabetes, and to identify the extent of change that is required to achieve this, the Diabetes Care Project (DCP) will evaluate the impact of ...

  11. Brief Cognitive Behavioural Therapy compared to optimised general practitioners’ care for depression : A randomised trial

    NARCIS (Netherlands)

    Schene, A.H.; Baas, K.D.; Koeter, M.W.J.; Lucassen, P.; Bockting, C.L.H.; Wittkampf, K.A.; Huyser, J.; van Weert, H.C.

    2014-01-01

    Background: How to treat Major Depressive Disorder (MDD) in primary care? Studies that compared (brief) Cognitive Behavioural Therapy (CBT) with care as usual by the General Practitioner (GP) found the first to be more effective. However, to make a fair comparison GP care should be optimised and pro

  12. Brief Cognitive Behavioural Therapy Compared to Optimised General Practitioners? Care for Depression: A Randomised Trial

    NARCIS (Netherlands)

    Schene, A. H.; Baas, Kim D.; Koeter, Maarten; Lucassen, Peter; Bockting, Claudi; Wittkampf, K.F.; van Weert, H.C.; Huyser, J.

    2014-01-01

    Background: How to treat Major Depressive Disorder (MDD) in primary care? Studies that compared (brief) Cognitive Behavioural Therapy (CBT) with care as usual by the General Practitioner (GP) found the first to be more effective. However, to make a fair comparison GP care should be optimised and pro

  13. Somatisation in primary care: experiences of primary care physicians involved in a training program and in a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Salazar Agustín

    2009-11-01

    Full Text Available Abstract Background A new intervention aimed at managing patients with medically unexplained symptoms (MUS based on a specific set of communication techniques was developed, and tested in a cluster randomised clinical trial. Due to the modest results obtained and in order to improve our intervention we need to know the GPs' attitudes towards patients with MUS, their experience, expectations and the utility of the communication techniques we proposed and the feasibility of implementing them. Physicians who took part in 2 different training programs and in a randomised controlled trial (RCT for patients with MUS were questioned to ascertain the reasons for the doctors' participation in the trial and the attitudes, experiences and expectations of GPs about the intervention. Methods A qualitative study based on four focus groups with GPs who took part in a RCT. A content analysis was carried out. Results Following the RCT patients are perceived as true suffering persons, and the relationship with them has improved in GPs of both groups. GPs mostly valued the fact that it is highly structured, that it made possible a more comfortable relationship and that it could be applied to a broad spectrum of patients with psychosocial problems. Nevertheless, all participants consider that change in patients is necessary; GPs in the intervention group remarked that that is extremely difficult to achieve. Conclusion GPs positively evaluate the communication techniques and the interventions that help in understanding patient suffering, and express the enormous difficulties in handling change in patients. These findings provide information on the direction in which efforts for improving intervention should be directed. Trial registration US ClinicalTrials.gov NCT00130988

  14. Case management for patients with chronic systolic heart failure in primary care: The HICMan exploratory randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Kunz Cornelia U

    2010-05-01

    Full Text Available Abstract Background Chronic (systolic heart failure (CHF represents a clinical syndrome with high individual and societal burden of disease. Multifaceted interventions like case management are seen as promising ways of improving patient outcomes, but lack a robust evidence base, especially for primary care. The aim of the study was to explore the effectiveness of a new model of CHF case management conducted by doctors' assistants (DAs, equivalent to a nursing role and supported by general practitioners (GPs. Methods This patient-randomised controlled trial (phase II included 31 DAs and employing GPs from 29 small office-based practices in Germany. Patients with CHF received either case management (n = 99 consisting of telephone monitoring and home visits or usual care (n = 100 for 12 months. We obtained clinical data, health care utilisation data, and patient-reported data on generic and disease-specific quality of life (QoL, SF-36 and KCCQ, CHF self-care (EHFScBS and on quality of care (PACIC-5A. To compare between groups at follow-up, we performed analyses of covariance and logistic regression models. Results Baseline measurement showed high guideline adherence to evidence-based pharmacotherapy and good patient self-care: Patients received angiotensin converting enzyme inhibitors (or angiotensin-2 receptor antagonists in 93.8% and 95%, and betablockers in 72.2% and 84%, and received both in combination in 68% and 80% of cases respectively. EHFScBS scores (SD were 25.4 (8.4 and 25.0 (7.1. KCCQ overall summary scores (SD were 65.4 (22.6 and 64.7 (22.7. We found low hospital admission and mortality rates. EHFScBS scores (-3.6 [-5.7;-1.6] and PACIC and 5A scores (both 0.5, [0.3;0.7/0.8] improved in favour of CM but QoL scores showed no significant group differences (Physical/Mental SF-36 summary scores/KCCQ-os [95%CI]: -0.3 [-3.0;2.5]/-0.1 [-3.4;3.1]/1.7 [-3.0;6.4]. Conclusions In this sample, with little room for improvement regarding evidence

  15. Collaborative community based care for people and their families living with schizophrenia in India: protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Dabholkar Hamid

    2011-01-01

    Full Text Available Abstract Background There is a large treatment gap with few community services for people with schizophrenia in low income countries largely due to the shortage of specialist mental healthcare human resources. Community based rehabilitation (CBR, involving lay health workers, has been shown to be feasible, acceptable and more effective than routine care for people with schizophrenia in observational studies. The aim of this study is to evaluate whether a lay health worker led, Collaborative Community Based Care (CCBC intervention, combined with usual Facility Based Care (FBC, is superior to FBC alone in improving outcomes for people with schizophrenia and their caregivers in India. Methods/Design This trial is a multi-site, parallel group randomised controlled trial design in India. The trial will be conducted concurrently at three sites in India where persons with schizophrenia will be screened for eligibility and recruited after providing informed consent. Trial participants will be randomly allocated in a 2:1 ratio to the CCBC+FBC and FBC arms respectively using an allocation sequence pre-prepared through the use of permuted blocks, stratified within site. The structured CCBC intervention will be delivered by trained lay community health workers (CHWs working together with the treating Psychiatrist. We aim to recruit 282 persons with schizophrenia. The primary outcomes are reduction in severity of symptoms of schizophrenia and disability at 12 months. The study will be conducted according to good ethical practice, data analysis and reporting guidelines. Discussion If the additional CCBC intervention delivered by front line CHWs is demonstrated to be effective and cost-effective in comparison to usually available care, this intervention can be scaled up to expand coverage and improve outcomes for persons with schizophrenia and their caregivers in low income countries. Trial registration The trial is registered with the International Society

  16. A randomised trial of a psychosocial intervention for cancer patients integrated into routine care: the PROMPT study (promoting optimal outcomes in mood through tailored psychosocial therapies)

    OpenAIRE

    Jolley Damien; Aranda Sanchia; Yates Patsy; Clarke David; Kelly Brian; Turner Jane; Chambers Suzanne; Hargraves Maryanne; McFadyen Lisa

    2011-01-01

    Abstract Background Despite evidence that up to 35% of patients with cancer experience significant distress, access to effective psychosocial care is limited by lack of systematic approaches to assessment, a paucity of psychosocial services, and patient reluctance to accept treatment either because of perceived stigma or difficulties with access to specialist psycho-oncology services due to isolation or disease burden. This paper presents an overview of a randomised study to evaluate the effe...

  17. A process evaluation of a cluster randomised trial to reduce potentially inappropriate prescribing in older people in primary care (OPTI-SCRIPT study)

    OpenAIRE

    Clyne, Barbara; Cooper, Janine A; Hughes, Carmel M.; Fahey, Tom; Smith, Susan M

    2016-01-01

    BackgroundThe OPTI-SCRIPT cluster randomised controlled trial (RCT) found that a three-phase multifaceted intervention including academic detailing with a pharmacist, GP-led medicines reviews, supported by web-based pharmaceutical treatment algorithms, and tailored patient information leaflets, was effective in reducing potentially inappropriate prescribing (PIP) in Irish primary care. We report a process evaluation exploring the implementation of the intervention, the experiences of those pa...

  18. Recruitment difficulties in a primary care cluster randomised trial: investigating factors contributing to general practitioners' recruitment of patients

    Directory of Open Access Journals (Sweden)

    McKenzie Joanne E

    2011-03-01

    Full Text Available Abstract Background Recruitment of patients by health professionals is reported as one of the most challenging steps when undertaking studies in primary care settings. Numerous investigations of the barriers to patient recruitment in trials which recruit patients to receive an intervention have been published. However, we are not aware of any studies that have reported on the recruitment barriers as perceived by health professionals to recruiting patients into cluster randomised trials where patients do not directly receive an intervention. This particular subtype of cluster trial is commonly termed a professional-cluster trial. The aim of this study was to investigate factors that contributed to general practitioners recruitment of patients in a professional-cluster trial which evaluated the effectiveness of an intervention to increase general practitioners adherence to a clinical practice guideline for acute low-back pain. Method General practitioners enrolled in the study were posted a questionnaire, consisting of quantitative items and an open-ended question, to assess possible reasons for poor patient recruitment. Descriptive statistics were used to summarise quantitative items and responses to the open-ended question were coded into categories. Results Seventy-nine general practitioners completed at least one item (79/94 = 84%, representing 68 practices (85% practice response rate, and 44 provided a response to the open-ended question. General practitioners recalled inviting a median of two patients with acute low-back pain to participate in the trial over a seven-month period; they reported that they intended to recruit patients, but forgot to approach patients to participate; and they did not perceive that patients had a strong interest or disinterest in participating. Additional open-ended comments were generally consistent with the quantitative data. Conclusion A number of barriers to the recruitment of patients with acute low

  19. Predictors of primary care referrals to a vascular disease prevention lifestyle program among participants in a cluster randomised trial

    Directory of Open Access Journals (Sweden)

    Passey Megan E

    2012-08-01

    Full Text Available Abstract Background Cardiovascular disease accounts for a large burden of disease, but is amenable to prevention through lifestyle modification. This paper examines patient and practice predictors of referral to a lifestyle modification program (LMP offered as part of a cluster randomised controlled trial (RCT of prevention of vascular disease in primary care. Methods Data from the intervention arm of a cluster RCT which recruited 36 practices through two rural and three urban primary care organisations were used. In each practice, 160 eligible high risk patients were invited to participate. Practices were randomly allocated to intervention or control groups. Intervention practice staff were trained in screening, motivational interviewing and counselling and encouraged to refer high risk patients to a LMP involving individual and group sessions. Data include patient surveys; clinical audit; practice survey on capacity for preventive care; referral records from the LMP. Predictors of referral were examined using multi-level logistic regression modelling after adjustment for confounding factors. Results Of 301 eligible patients, 190 (63.1% were referred to the LMP. Independent predictors of referral were baseline BMI ≥ 25 (OR 2.87 95%CI:1.10, 7.47, physical inactivity (OR 2.90 95%CI:1.36,6.14, contemplation/preparation/action stage of change for physical activity (OR 2.75 95%CI:1.07, 7.03, rural location (OR 12.50 95%CI:1.43, 109.7 and smaller practice size (1–3 GPs (OR 16.05 95%CI:2.74, 94.24. Conclusions Providing a well-structured evidence-based lifestyle intervention, free of charge to patients, with coordination and support for referral processes resulted in over 60% of participating high risk patients being referred for disease prevention. Contrary to expectations, referrals were more frequent from rural and smaller practices suggesting that these practices may be more ready to engage with these programs. Trial registration ACTRN

  20. Diagnostic accuracy of point-of-care testing for acute coronary syndromes, heart failure and thromboembolic events in primary care: a cluster-randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Diemand Albert

    2011-03-01

    Full Text Available Abstract Background Evidence of the clinical benefit of 3-in-1 point-of-care testing (POCT for cardiac troponin T (cTnT, N-terminal pro-brain natriuretic peptide (NT-proBNP and D-dimer in cardiovascular risk stratification at primary care level for diagnosing acute coronary syndromes (ACS, heart failure (HF and thromboembolic events (TE is very limited. The aim of this study is to analyse the diagnostic accuracy of POCT in primary care. Methods Prospective multicentre controlled trial cluster-randomised to POCT-assisted diagnosis and conventional diagnosis (controls. Men and women presenting in 68 primary care practices in Zurich County (Switzerland with chest pain or symptoms of dyspnoea or TE were consecutively included after baseline consultation and working diagnosis. A follow-up visit including confirmed diagnosis was performed to determine the accuracy of the working diagnosis, and comparison of working diagnosis accuracy between the two groups. Results The 218 POCT patients and 151 conventional diagnosis controls were mostly similar in characteristics, symptoms and pre-existing diagnoses, but differed in working diagnosis frequencies. However, the follow-up visit showed no statistical intergroup difference in confirmed diagnosis frequencies. Working diagnoses overall were significantly more correct in the POCT group (75.7% vs 59.6%, p = 0.002, as were the working diagnoses of ACS/HF/TE (69.8% vs 45.2%, p = 0.002. All three biomarker tests showed good sensitivity and specificity. Conclusion POCT confers substantial benefit in primary care by correctly diagnosing significantly more patients. Trial registration DRKS: DRKS00000709

  1. The economics of dementia-care mapping in nursing homes: a cluster-randomised controlled trial.

    Directory of Open Access Journals (Sweden)

    Geertje van de Ven

    Full Text Available BACKGROUND: Dementia-care mapping (DCM is a cyclic intervention aiming at reducing neuropsychiatric symptoms in people with dementia in nursing homes. Alongside an 18-month cluster-randomized controlled trial in which we studied the effectiveness of DCM on residents and staff outcomes, we investigated differences in costs of care between DCM and usual care in nursing homes. METHODS: Dementia special care units were randomly assigned to DCM or usual care. Nurses from the intervention care homes received DCM training, a DCM organizational briefing day and conducted the 4-months DCM-intervention twice during the study. A single DCM cycle consists of observation, feedback to the staff, and action plans for the residents. We measured costs related to health care consumption, falls and psychotropic drug use at the resident level and absenteeism at the staff level. Data were extracted from resident files and the nursing home records. Prizes were determined using the Dutch manual of health care cost and the cost prices delivered by a pharmacy and a nursing home. Total costs were evaluated by means of linear mixed-effect models for longitudinal data, with the unit as a random effect to correct for dependencies within units. RESULTS: 34 units from 11 nursing homes, including 318 residents and 376 nursing staff members participated in the cost analyses. Analyses showed no difference in total costs. However certain changes within costs could be noticed. The intervention group showed lower costs associated with outpatient hospital appointments over time (p = 0.05 than the control group. In both groups, the number of falls, costs associated with the elderly-care physician and nurse practitioner increased equally during the study (p<0.02. CONCLUSIONS: DCM is a cost-neutral intervention. It effectively reduces outpatient hospital appointments compared to usual care. Other considerations than costs, such as nursing homes' preferences, may determine whether they

  2. Cluster randomised trial in the General Practice Research Database: 1. Electronic decision support to reduce antibiotic prescribing in primary care (eCRT study

    Directory of Open Access Journals (Sweden)

    Charlton Judith

    2011-05-01

    Full Text Available Abstract Background The purpose of this research is to develop and evaluate methods for conducting cluster randomised trials in a primary care database that contains electronic patient records for large numbers of family practices. Cluster randomised trials are trials in which the units allocated represent groups of individuals, in this case family practices and their registered patients. Cluster randomised trials often suffer from the limitation that they include too few clusters, leading to problems of insufficient power and only imprecise estimation of the intraclass correlation coefficient, a key design parameter. This difficulty might be overcome by utilising databases that already hold electronic patient records for large numbers of practices. The protocol describes one application: a study of antibiotic prescribing for acute respiratory infection; a second protocol outlines an intervention in a less frequent chronic condition of public health importance, stroke. Methods/Design The objective of the study is to implement a cluster randomised trial to test the effectiveness of an electronic record-based intervention at achieving a reduction in antibiotic prescribing at consultations for respiratory illness in patients aged 18 and 59 years old in intervention family practices as compared with controls. Family practices will be recruited from the practices that presently contribute data to the UK General Practice Research Database (GPRD. Following randomisation, electronic prompts will be installed remotely at intervention practices to promote adherence with evidence-based standards of medical practice. The intervention was developed through qualitative research at non-intervention practices. Data for outcome assessment will be obtained from anonymised electronic patient records that are routinely collected into GPRD. This protocol outlines the proposed study designs, data sources, sample size requirements, analysis methods and dissemination

  3. Evaluation of a blood conservation strategy in the intensive care unit: a prospective, randomised study.

    LENUS (Irish Health Repository)

    Mahdy, Saad

    2012-02-01

    OBJECTIVE AND METHODS: Anemia is a common problem in the ICU population. Most patients are anemic at admission, their hemoglobin concentrations declining further thereafter. The aim of the present study was to evaluate the effect of a combination strategy, involving closed arterial blood gas sampling and the use of pediatric vials for phlebotomy (Group A), on the sampling-induced blood loss and the rate of decline in hemoglobin in adult ICU patients. Combination (Group A) was compared to the current standard technique of arterial line sampling and adult vial phlebotomy (Group B) in a prospective, randomised, ethically-approved trial for the first 72 hours of their ICU stay. Peri-operative, oncology, coagulopathic and uremic patients were excluded. All other ICU patients with arterial cannulae and predicted to stay beyond 3 days, were enrolled. RESULTS: 39 patients entered the study, 20 in Group A, and 19 in Group B. Data collection was complete for all. There was a statistically significant difference in sampling-induced blood loss between the groups over the first 72 hours of treatment (mean +\\/- standard deviation: 15.16 +\\/- 5.3 ml Group A vs 45.11 +\\/- 14 ml Group B, p<0.001). There was a smaller decline in mean hemoglobin level, which was not statistically significant (0.79 +\\/- 0.6 g\\/dL vs 1.30 +\\/- 1.13, p = 0.09). CONCLUSIONS: Overall, this strategy reduced measurable blood losses from phlebotomy. In larger trials it might also preserve hemoglobin levels.

  4. Feasibility of evidence-based diagnosis and management of heart failure in older people in care: a pilot randomised controlled trial

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    Hancock Helen C

    2012-11-01

    Full Text Available Abstract Background Many older people in long-term care do not receive evidence-based diagnosis or management for heart failure; it is not known whether this can be achieved for this population. We initiated an onsite heart failure service, compared with ‘usual care’ with the aim of establishing the feasibility of accurate diagnosis and appropriate management. Methods A pilot randomised controlled trial which randomised residents from 33 care facilities in North-East England with left ventricular systolic dysfunction (LVSD to usual care or an onsite heart failure service. The primary outcome was the optimum prescription of angiotensin-converting enzyme inhibitors and beta-adrenergic antagonists at 6 months. Results Of 399 echocardiographically-screened residents aged 65–100 years, 30 subjects with LVSD were eligible; 28 (93% consented and were randomised (HF service: 16; routine care: 12. Groups were similar at baseline; six month follow-up was completed for 25 patients (89%; 3 (11% patients died. Results for the primary outcome were not statistically significant but there was a consistent pattern of increased drug use and titration to optimum dose in the intervention group (21% compared to 0% receiving routine care, p=0.250. Hospitalisation rates, quality of life and mortality at 6 months were similar between groups. Conclusions This study demonstrated the feasibility of an on-site heart failure service for older long-term care populations. Optimisation of medication appeared possible without adversely affecting quality of life; this questions clinicians’ concerns about adverse effects in this group. This has international implications for managing such patients. These methods should be replicated in a large-scale study to quantify the scale of benefit. Trial registration ISRCTN19781227 http://www.controlled-trials.com/ISRCTN19781227

  5. Effectiveness of a stepped primary care smoking cessation intervention (ISTAPS study: design of a cluster randomised trial

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    Zarza Elvira

    2009-02-01

    Full Text Available Abstract Background There is a considerable body of evidence on the effectiveness of specific interventions in individuals who wish to quit smoking. However, there are no large-scale studies testing the whole range of interventions currently recommended for helping people to give up smoking; specifically those interventions that include motivational interviews for individuals who are not interested in quitting smoking in the immediate to short term. Furthermore, many of the published studies were undertaken in specialized units or by a small group of motivated primary care centres. The objective of the study is to evaluate the effectiveness of a stepped smoking cessation intervention based on a trans-theoretical model of change, applied to an extensive group of Primary Care Centres (PCC. Methods/Design Cluster randomised clinical trial. Unit of randomization: basic unit of care consisting of a family physician and a nurse, both of whom care for the same population (aprox. 2000 people. Intention to treat analysis. Study population: Smokers (n = 3024 aged 14 to 75 years consulting for any reason to PCC and who provided written informed consent to participate in the trial. Intervention: 6-month implementation of recommendations of a Clinical Practice Guideline which includes brief motivational interviews for smokers at the precontemplation – contemplation stage, brief intervention for smokers in preparation-action who do not want help, intensive intervention with pharmacotherapy for smokers in preparation-action who want help, and reinforcing intervention in the maintenance stage. Control group: usual care. Outcome measures: Self-reported abstinence confirmed by exhaled air carbon monoxide concentration of ≤ 10 parts per million. Points of assessment: end of intervention period and 1 and 2 years post-intervention; continuous abstinence rate for 1 year; change in smoking cessation stage; health status measured by SF-36. Discussion The

  6. The acceptability and impact of a randomised controlled trial of welfare rights advice accessed via primary health care: qualitative study

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    Howel Denise

    2006-06-01

    Full Text Available Abstract Background Qualitative research is increasingly used alongside randomised controlled trials (RCTs to study a range of factors including participants' experiences of a trial. The need for a sound evidence base within public health will increase the need for RCTs of non-clinical interventions. Welfare rights advice has been proposed as an intervention with potential to reduce health inequalities. This qualitative study, nested within an RCT of the impact of welfare rights advice, examined the acceptability of the intervention, the acceptability of the research process and the perceived impact of the intervention. Methods 25 men and women aged 60 years or over were recruited from four general practices in Newcastle upon Tyne (UK, a sub-sample of those who consented to be contacted (n = 96 during the RCT baseline interview. Semi-structured interviews were undertaken and analysed using the Framework Method. Results Participants viewed the trial positively although, despite agreeing that the information leaflet was clear, some had agreed to participate without being fully aware of what was involved. Some participants were unaware of the implications of randomisation. Most thought it fair, but a few concerns were raised about the control condition. The intervention was acceptable and made participants feel confident about applying for benefit entitlements. 14 out of 25 participants received some financial award; median weekly income gain was £57 (€84, $101. The perceived impact of additional finances was considerable and included: increased affordability of necessities and occasional expenses; increased capacity to deal with emergencies; and a reduction in stress related to financial worries. Overall, perceived independence and ability to participate in society increased. Most participants perceived benefits to their mental well-being, but no-one reported an improvement in physical health. The RCT showed little or no effect on a wide range

  7. Guided self-help cognitive behavioural therapy for depression in primary care: a randomised controlled trial.

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    Christopher Williams

    Full Text Available BACKGROUND: Access to Cognitive behavioural therapy (CBT for depression is limited. One solution is CBT self-help books. Trial Objectives: To assess the impact of a guided self-help CBT book (GSH-CBT on mood, compared to treatment as usual (TAU. HYPOTHESES: GSH-CBT will have improved mood and knowledge of the causes and treatment of depression compared to the control receiving TAUGuided self-help will be acceptable to patients and staff. METHODS AND FINDINGS: PARTICIPANTS: Adults attending seven general practices in Glasgow, UK with a BDI-II score of ≥14. 141 randomised to GSH-CBT and 140 to TAU. INTERVENTIONS: RCT comparing 'Overcoming Depression: A Five Areas Approach' book plus 3-4 short face to face support appointments totalling up to 2 hours of guided support, compared with general practitioner TAU. PRIMARY OUTCOME: The BDI (II score at 4 months. Numbers analysed: 281 at baseline, 203 at 4 months (primary outcome, 117 at 12 months. OUTCOME: Mean BDI-II scores were lower in the GSH-CBT group at 4 months by 5.3 points (2.6 to 7.9, p<0.001. At 4 and 12 months there were also significantly higher proportions of participants achieving a 50% reduction in BDI-II in the GSH-CBT arm. The mean support was 2 sessions with 42.7 minutes for session 1, 41.4 minutes for session 2 and 40.2 minutes of support for session 3. Adverse effects/Harms: Significantly less deterioration in mood in GSH-CBT (2.0% compared to 9.8% in the TAU group for BDI-II category change. LIMITATIONS: Weaknesses: Our follow-up rate of 72.2% at 4 months is better than predicted but is poorer at 12 months (41.6%. In the GSH-CBT arm, around 50% of people attended 2 or fewer sessions. 22% failed to take up treatment. CONCLUSIONS: GSH-CBT is substantially more effective than TAU. TRIAL REGISTRATION: Controlled-Trials.com ISRCTN13475030.

  8. Care staff training in detection of depression in residential homes for the elderly - Randomised trial

    NARCIS (Netherlands)

    Eisses, AMH; Kluiter, H; Jongenelis, K; Beekman, ATF; Ormel, J

    2005-01-01

    Background. Many people with depression in residential care homes for the elderly do not receive treatment because their depression remains undetected. Aims. To determine the effects of staff training on the detection, treatment and outcome of depression in residents often homes. Method. We conducte

  9. A shared-care model of obesity treatment for 3–10 year old children: Protocol for the HopSCOTCH randomised controlled trial

    Science.gov (United States)

    2012-01-01

    Background Despite record rates of childhood obesity, effective evidence-based treatments remain elusive. While prolonged tertiary specialist clinical input has some individual impact, these services are only available to very few children. Effective treatments that are easily accessible for all overweight and obese children in the community are urgently required. General practitioners are logical care providers for obese children but high-quality trials indicate that, even with substantial training and support, general practitioner care alone will not suffice to improve body mass index (BMI) trajectories. HopSCOTCH (the Shared Care Obesity Trial in Children) will determine whether a shared-care model, in which paediatric obesity specialists co-manage obesity with general practitioners, can improve adiposity in obese children. Design Randomised controlled trial nested within a cross-sectional BMI survey conducted across 22 general practices in Melbourne, Australia. Participants Children aged 3–10 years identified as obese by Centers for Disease Control criteria at their family practice, and randomised to either a shared-care intervention or usual care. Intervention A single multidisciplinary obesity clinic appointment at Melbourne’s Royal Children’s Hospital, followed by regular appointments with the child’s general practitioner over a 12 month period. To support both specialist and general practice consultations, web-based shared-care software was developed to record assessment, set goals and actions, provide information to caregivers, facilitate communication between the two professional groups, and jointly track progress. Outcomes Primary - change in BMI z-score. Secondary - change in percentage fat and waist circumference; health status, body satisfaction and global self-worth. Discussion This will be the first efficacy trial of a general-practitioner based, shared-care model of childhood obesity management. If effective, it could greatly improve

  10. A shared-care model of obesity treatment for 3–10 year old children: Protocol for the HopSCOTCH randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Wake Melissa

    2012-03-01

    Full Text Available Abstract Background Despite record rates of childhood obesity, effective evidence-based treatments remain elusive. While prolonged tertiary specialist clinical input has some individual impact, these services are only available to very few children. Effective treatments that are easily accessible for all overweight and obese children in the community are urgently required. General practitioners are logical care providers for obese children but high-quality trials indicate that, even with substantial training and support, general practitioner care alone will not suffice to improve body mass index (BMI trajectories. HopSCOTCH (the Shared Care Obesity Trial in Children will determine whether a shared-care model, in which paediatric obesity specialists co-manage obesity with general practitioners, can improve adiposity in obese children. Design Randomised controlled trial nested within a cross-sectional BMI survey conducted across 22 general practices in Melbourne, Australia. Participants Children aged 3–10 years identified as obese by Centers for Disease Control criteria at their family practice, and randomised to either a shared-care intervention or usual care. Intervention A single multidisciplinary obesity clinic appointment at Melbourne’s Royal Children’s Hospital, followed by regular appointments with the child’s general practitioner over a 12 month period. To support both specialist and general practice consultations, web-based shared-care software was developed to record assessment, set goals and actions, provide information to caregivers, facilitate communication between the two professional groups, and jointly track progress. Outcomes Primary - change in BMI z-score. Secondary - change in percentage fat and waist circumference; health status, body satisfaction and global self-worth. Discussion This will be the first efficacy trial of a general-practitioner based, shared-care model of childhood obesity management. If effective

  11. Study protocol: Brief intervention for medication overuse headache - A double-blinded cluster randomised parallel controlled trial in primary care

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    Kristoffersen Espen

    2012-08-01

    Full Text Available Abstract Background Chronic headache (headache ≥ 15 days/month for at least 3 months affects 2–5% of the general population. Medication overuse contributes to the problem. Medication-overuse headache (MOH can be identified by using the Severity of Dependence Scale (SDS. A “brief intervention” scheme (BI has previously been used for detoxification from drug and alcohol overuse in other settings. Short, unstructured, individualised simple information may also be enough to detoxify a large portion of those with MOH. We have adapted the structured (BI scheme to be used for MOH in primary care. Methods/Design A double-blinded cluster randomised parallel controlled trial (RCT of BI vs. business as usual. Intervention will be performed in primary care by GPs trained in BI. Patients with MOH will be identified through a simple screening questionnaire sent to patients on the GPs lists. The BI method involves an approach for identifying patients with high likelihood of MOH using simple questions about headache frequency and the SDS score. Feedback is given to the individual patient on his/her score and consequences this might have regarding the individual risk of medication overuse contributing to their headache. Finally, advice is given regarding measures to be taken, how the patient should proceed and the possible gains for the patient. The participating patients complete a headache diary and receive a clinical interview and neurological examination by a GP experienced in headache diagnostics three months after the intervention. Primary outcomes are number of headache days and number of medication days per month at 3 months. Secondary outcomes include proportions with 25 and 50% improvement at 3 months and maintenance of improvement and quality of life after 12 months. Discussion There is a need for evidence-based and cost-effective strategies for treatment of MOH but so far no consensus has been reached regarding an optimal medication

  12. Patient and family satisfaction levels in the intensive care unit after elective cardiac surgery: study protocol for a randomised controlled trial of a preoperative patient education intervention

    Science.gov (United States)

    Leung, Patricia; Chiu, Chun Hung; Ho, Ka Man; Gomersall, Charles David; Underwood, Malcolm John

    2016-01-01

    Introduction Patients and their families are understandably anxious about the risk of complications and unfamiliar experiences following cardiac surgery. Providing information about postoperative care in the intensive care unit (ICU) to patients and families may lead to lower anxiety levels, and increased satisfaction with healthcare. The objectives of this study are to evaluate the effectiveness of preoperative patient education provided for patients undergoing elective cardiac surgery. Methods and analysis 100 patients undergoing elective coronary artery bypass graft, with or without valve replacement surgery, will be recruited into a 2-group, parallel, superiority, double-blinded randomised controlled trial. Participants will be randomised to either preoperative patient education comprising of a video and ICU tour with standard care (intervention) or standard education (control). The primary outcome measures are the satisfaction levels of patients and family members with ICU care and decision-making in the ICU. The secondary outcome measures are patient anxiety and depression levels before and after surgery. Ethics and dissemination Ethical approval has been obtained from the Joint Chinese University of Hong Kong—New Territories East Cluster Clinical Research Ethics Committee (reference number CREC 2015.308). The findings will be presented at conferences and published in peer-reviewed journals. Study participants will receive a 1-page plain language summary of results. Trial registration number ChiCTR-IOR-15006971. PMID:27334883

  13. Cost-effectiveness of counselling, graded-exercise and usual care for chronic fatigue: evidence from a randomised trial in primary care

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    Sabes-Figuera Ramon

    2012-08-01

    Full Text Available Abstract Background Fatigue is common and has been shown to result in high economic costs to society. The aim of this study is to compare the cost-effectiveness of two active therapies, graded-exercise (GET and counselling (COUN with usual care plus a self-help booklet (BUC for people presenting with chronic fatigue. Methods A randomised controlled trial was conducted with participants consulting for fatigue of over three months’ duration recruited from 31 general practices in South East England and allocated to one of three arms. Outcomes and use of services were assessed at 6-month follow-up. The main outcome measure used in the economic evaluation was clinically significant improvements in fatigue, measured using the Chalder fatigue scale. Cost-effectiveness was assessed using the net-benefit approach and cost-effectiveness acceptability curves. Results Full economic and outcome data at six months were available for 163 participants; GET = 51, COUN = 58 and BUC = 54. Those receiving the active therapies (GET and COUN had more contacts with care professionals and therefore higher costs, these differences being statistically significant. COUN was more expensive and less effective than the other two therapies. The incremental cost-effectiveness ratio of GET compared to BUC was equal to £987 per unit of clinically significant improvement. However, there was much uncertainty around this result. Conclusion This study does not provide a clear recommendation about which therapeutic option to adopt, based on efficiency, for patients with chronic fatigue. It suggests that COUN is not cost-effective, but it is unclear whether GET represents value for money compared to BUC. Clinical Trial Registration number at ISRCTN register: 72136156

  14. Exercise augmentation compared to usual care for Post Traumatic Stress Disorder: A Randomised Controlled Trial (The REAP study: Randomised Exercise Augmentation for PTSD

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    van der Ploeg Hidde P

    2011-07-01

    Full Text Available Abstract Background The physical wellbeing of people with mental health conditions can often be overlooked in order to treat the primary mental health condition as a priority. Exercise however, can potentially improve both the primary psychiatric condition as well as physical measures that indicate risk of other conditions such as diabetes mellitus and cardiovascular disease. Evidence supports the role of exercise as an important component of treatment for depression and anxiety, yet no randomised controlled trials (RCT's have been conducted to evaluate the use of exercise in the treatment of people with post traumatic stress disorder (PTSD. This RCT will investigate the effects of structured, progressive exercise on PTSD symptoms, functional ability, body composition, physical activity levels, sleep patterns and medication usage. Methods and design Eighty participants with a Diagnostic and Statistical Manual of Mental Disorders (DSM-IV diagnosis of PTSD will be recruited. Participants will have no contraindications to exercise and will be cognitively able to provide consent to participate in the study. The primary outcome measures will be PTSD symptoms, measured through the PTSD Checklist Civilian (PCL-C scale. Secondary outcome measures will assess depression and anxiety, mobility and strength, body composition, physical activity levels, sleep patterns and medication usage. All outcomes will be assessed by a health or exercise professional masked to group allocation at baseline and 12 weeks after randomisation. The intervention will be a 12 week individualised program, primarily involving resistance exercises with the use of exercise bands. A walking component will also be incorporated. Participants will complete one supervised session per week, and will be asked to perform at least two other non-supervised exercise sessions per week. Both intervention and control groups will receive all usual non-exercise interventions including psychotherapy

  15. Using the theory of planned behaviour as a process evaluation tool in randomised trials of knowledge translation strategies: A case study from UK primary care

    Science.gov (United States)

    2010-01-01

    Background Randomised trials of knowledge translation strategies for professional behaviour change can provide robust estimates of effectiveness, but offer little insight into the causal mechanisms by which any change is produced. To illustrate the applicability of causal methods within randomised trials, we undertook a theory-based process evaluation study within an implementation trial to explore whether the cognitions of primary care doctors' predicted their test requesting behaviours and, secondly, whether the trial results were mediated by the theoretical constructs. Methods The process evaluation comprised a cross-sectional questionnaire survey of a random 50% sample of the randomised groups of primary care practices in Grampian (NHS Grampian), UK, who took part in a trial of the effect of enhanced feedback and brief educational reminders on test requesting behaviour. The process evaluation was based upon the Theory of Planned Behaviour and focussed on three of the test requesting behaviours that were targeted in the trial -- ferritin, follicle stimulating hormone (FSH), and Helicobacter Pylori serology (HPS). Results The questionnaire was completed by 131 primary care doctors (56%) from 42 (98%) of the sampled practices. Behavioural intention, attitude, and subjective norm were highly correlated for all the tests. There was no evidence that perceived behavioural control was correlated with any of the other measures. Simple linear regression analysis of the rate of test requests on minimum behavioural intentions had R2 of 11.1%, 12.5%, and 0.1% for ferritin, FSH, and HPS requesting, respectively. Mediational analysis showed that the trial results for ferritin and FSH were partially mediated (between 23% and 78% mediation) through intentions. The HPS trial result was not mediated through intention. Conclusions This study demonstrated that a theory-based process evaluation can provide useful information on causal mechanisms that aid not only interpretation of

  16. Using the theory of planned behaviour as a process evaluation tool in randomised trials of knowledge translation strategies: A case study from UK primary care

    Directory of Open Access Journals (Sweden)

    Grimshaw Jeremy M

    2010-09-01

    Full Text Available Abstract Background Randomised trials of knowledge translation strategies for professional behaviour change can provide robust estimates of effectiveness, but offer little insight into the causal mechanisms by which any change is produced. To illustrate the applicability of causal methods within randomised trials, we undertook a theory-based process evaluation study within an implementation trial to explore whether the cognitions of primary care doctors' predicted their test requesting behaviours and, secondly, whether the trial results were mediated by the theoretical constructs. Methods The process evaluation comprised a cross-sectional questionnaire survey of a random 50% sample of the randomised groups of primary care practices in Grampian (NHS Grampian, UK, who took part in a trial of the effect of enhanced feedback and brief educational reminders on test requesting behaviour. The process evaluation was based upon the Theory of Planned Behaviour and focussed on three of the test requesting behaviours that were targeted in the trial -- ferritin, follicle stimulating hormone (FSH, and Helicobacter Pylori serology (HPS. Results The questionnaire was completed by 131 primary care doctors (56% from 42 (98% of the sampled practices. Behavioural intention, attitude, and subjective norm were highly correlated for all the tests. There was no evidence that perceived behavioural control was correlated with any of the other measures. Simple linear regression analysis of the rate of test requests on minimum behavioural intentions had R2 of 11.1%, 12.5%, and 0.1% for ferritin, FSH, and HPS requesting, respectively. Mediational analysis showed that the trial results for ferritin and FSH were partially mediated (between 23% and 78% mediation through intentions. The HPS trial result was not mediated through intention. Conclusions This study demonstrated that a theory-based process evaluation can provide useful information on causal mechanisms that aid not

  17. Screening uptake rates and the clinical and cost effectiveness of screening for gestational diabetes mellitus in primary versus secondary care: study protocol for a randomised controlled trial.

    LENUS (Irish Health Repository)

    O Dea, Angela

    2014-01-17

    The risks associated with gestational diabetes mellitus (GDM) are well recognized, and there is increasing evidence to support treatment of the condition. However, clear guidance on the ideal approach to screening for GDM is lacking. Professional groups continue to debate whether selective screening (based on risk factors) or universal screening is the most appropriate approach. Additionally, there is ongoing debate about what levels of glucose abnormalities during pregnancy respond best to treatment and which maternal and neonatal outcomes benefit most from treatment. Furthermore, the implications of possible screening options on health care costs are not well established. In response to this uncertainty there have been repeated calls for well-designed, randomised trials to determine the efficacy of screening, diagnosis, and management plans for GDM. We describe a randomised controlled trial to investigate screening uptake rates and the clinical and cost effectiveness of screening in primary versus secondary care settings. The objective of this study is to assess screening uptake rates, and the clinical and cost effectiveness of screening for GDM in primary versus secondary care.

  18. Meropenem vs standard of care for treatment of late onset sepsis in children of less than 90 days of age: study protocol for a randomised controlled trial

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    de Cabre Vincent

    2011-09-01

    Full Text Available Abstract Background Late onset neonatal sepsis (LOS with the mortality of 17 to 27% is still a serious disease. Meropenem is an antibiotic with wide antibacterial coverage. The advantage of it over standard of care could be its wider antibacterial coverage and thus the use of mono-instead of combination therapy. Methods NeoMero-1, an open label, randomised, comparator controlled, superiority trial aims to compare the efficacy of meropenem with a predefined standard of care (ampicillin + gentamicin or cefotaxime + gentamicin in the treatment of LOS in neonates and infants aged less than 90 days admitted to a neonatal intensive care unit. A total of 550 subjects will be recruited following a 1:1 randomisation scheme. The trial includes patients with culture confirmed (at least one positive culture from normally sterile site except coagulase negative staphylococci in addition to one clinical or laboratory criterion or clinical sepsis (at least two laboratory and two clinical criteria suggestive of LOS in subjects with postmenstrual age The study will start recruitment in September 2011; the total duration is of 24 months. Trial registration EudraCT 2011-001515-31

  19. Making co-enrolment feasible for randomised controlled trials in paediatric intensive care.

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    Katie Harron

    Full Text Available AIMS: Enrolling children into several trials could increase recruitment and lead to quicker delivery of optimal care in paediatric intensive care units (PICU. We evaluated decisions taken by clinicians and parents in PICU on co-enrolment for two large pragmatic trials: the CATCH trial (CATheters in CHildren comparing impregnated with standard central venous catheters (CVCs for reducing bloodstream infection in PICU and the CHIP trial comparing tight versus standard control of hyperglycaemia. METHODS: We recorded the period of trial overlap for all PICUs taking part in both CATCH and CHiP and reasons why clinicians decided to co-enrol children or not into both studies. We examined parental decisions on co-enrolment by measuring recruitment rates and reasons for declining consent. RESULTS: Five PICUs recruited for CATCH and CHiP during the same period (an additional four opened CATCH after having closed CHiP. Of these five, three declined co-enrolment (one of which delayed recruiting elective patients for CATCH whilst CHiP was running, due to concerns about jeopardising CHiP recruitment, asking too much of parents, overwhelming amounts of information to explain to parents for two trials and a policy against co-enrolment. Two units co-enrolled in order to maximise recruitment to both trials. At the first unit, 35 parents were approached for both trials. 17/35 consented to both; 13/35 consented to one trial only; 5/35 declined both. Consent rates during co-enrolment were 29/35 (82% and 18/35 (51% for CATCH and CHiP respectively compared with 78% and 51% respectively for those approached for a single trial within this PICU. The second unit did not record data on approaches or refusals, but successfully co-enrolled one child. CONCLUSIONS: Co-enrolment did not appear to jeopardise recruitment or overwhelm parents. Strategies for seeking consent for multiple trials need to be developed and should include how to combine information for parents and

  20. The third Symptom Management Research Trial in Oncology (SMaRT Oncology-3: a randomised trial to determine the efficacy of adding a complex intervention for major depressive disorder (Depression Care for People with Lung Cancer to usual care, compared to usual care alone in patients with lung cancer

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    Sharpe Michael

    2009-09-01

    Full Text Available Abstract Background Depression Care for People with Lung Cancer is a complex intervention delivered by specially trained cancer nurses, under the supervision of a psychiatrist. It is given as a supplement to the usual care for depression, which patients receive from their general practitioner and cancer service. The third Symptom Management Research Trial in Oncology (SMaRT Oncology-3 Trial will test its efficacy when compared to usual care alone. Design A two arm parallel group multi-centre randomised controlled trial. 200 patients will be recruited through established systematic Symptom Monitoring Services, which screen patients for depression. Patients will have: a diagnosis of lung cancer; an estimated life expectancy of three months or more and a diagnosis of Major Depressive Disorder. Patients will be randomised to usual care or usual care plus Depression Care for People with Lung Cancer. Randomisation will be carried out by telephoning a secure computerised central randomisation system or by using a secure web interface. The primary outcome measure is average depression severity. This will be assessed using scores on the 20-item Symptom Hopkins Checklist (SCL-20D, collected every four weeks over 32 weeks. Secondary outcomes include severity of anxiety, pain and fatigue; self-rated improvement of depression; quality of life and satisfaction with depression care. Trial Registration Current controlled trials ISRCTN75905964

  1. Protocol for the Effective Feedback to Improve Primary Care Prescribing Safety (EFIPPS) study: a cluster randomised controlled trial using ePrescribing data

    Science.gov (United States)

    Guthrie, Bruce; Treweek, Shaun; Petrie, Dennis; Barnett, Karen; Ritchie, Lewis D; Robertson, Chris; Bennie, Marion

    2012-01-01

    Introduction High-risk prescribing in primary care is common and causes considerable harm. Feedback interventions to improve care are attractive because they are relatively cheap to widely implement. There is good evidence that feedback has small to moderate effects, but the most recent Cochrane review called for more high-quality, large trials that explicitly test different forms of feedback. Methods and analysis The study is a three-arm cluster-randomised trial with general practices being randomised and outcomes measured at patient level. 262 practices in three Scottish Health Board areas have been randomised (94% of all possible practices). The two active arms receive different forms of prescribing safety data feedback, with rates of high-risk prescribing compared with a ‘usual care’ arm. Sample size estimation used baseline data from participating practices. With 85 practices randomised to each arm, then there is 93% power to detect a 25% difference in the percentage of high-risk prescribing (from 6.1% to 4.5%) between the usual care arm and each intervention arm. The primary outcome is a composite of six high-risk prescribing measures (antipsychotic prescribing to people aged ≥75 years; non-steroidal anti-inflammatory drug (NSAID) prescribing to people aged ≥75 without gastroprotection; NSAID prescribing to people prescribed aspirin/clopidogrel without gastroprotection; NSAID prescribing to people prescribed an ACE inhibitor/angiotensin receptor blocker and a diuretic; NSAID prescription to people prescribed an oral anticoagulant without gastroprotection; aspirin/clopidogrel prescription to people prescribed an oral anticoagulant without gastroprotection). The primary analysis will use multilevel modelling to account for repeated measurement of outcomes in patients clustered within practices. Ethics and dissemination The study was reviewed and approved by the NHS Tayside Committee on Medical Research Ethics B (11/ES/0001). The study will be

  2. How to build and evaluate an integrated health care system for chronic patients: study design of a clustered randomised controlled trial in rural China

    Directory of Open Access Journals (Sweden)

    Wenxi Tang

    2015-03-01

    Full Text Available Background: While integrated health care system has been proved an effective way to help improving patient health and system efficiency, the exact behaviour model and motivation approach are not so clear in poor rural areas where health human resources and continuous service provision are urgently needed. To gather solid evidence, we initiated a comprehensive intervention project in Qianjiang District, southwest part of rural China in 2012. And after one-year's pilot, we developed an intervention package of team service, comprehensive pathway and prospective- and performance-based payment system. Methods: To testify the potential influence of payment interventions, we use clustered randomised controlled trial, 60 clusters are grouped into two treatment groups and one control group to compare the time and group differences. Difference-in-differences model and structural equation modelling will be used to analyse the intervention effects and pathway. The outcomes are: quality of care, disease burden, supplier cooperative behaviour and patient utilisation behaviour and system efficiency. Repeated multivariate variance analysis will be used to statistically examine the outcome differences. Discussion: This is the first trial of its kind to prove the effects and efficiency of integrated care. Though we adopted randomised controlled trial to gather the highest rank of evidence, still the fully randomisation was hard to realise in health policy reform experiment. To compensate, the designer should take efforts on control for the potential confounders as much as possible. With this trial, we assume the effects will come from: (1 improvement on the quality of life through risk factors control and lifestyles change on patient's behaviours; (2 improvement on quality of care through continuous care and coordinated supplier behaviours; (3 improvement on the system efficiency through active interaction between suppliers and patients. Conclusion

  3. How to build and evaluate an integrated health care system for chronic patients: study design of a clustered randomised controlled trial in rural China

    Directory of Open Access Journals (Sweden)

    Wenxi Tang

    2015-03-01

    Full Text Available Background: While integrated health care system has been proved an effective way to help improving patient health and system efficiency, the exact behaviour model and motivation approach are not so clear in poor rural areas where health human resources and continuous service provision are urgently needed. To gather solid evidence, we initiated a comprehensive intervention project in Qianjiang District, southwest part of rural China in 2012. And after one-year's pilot, we developed an intervention package of team service, comprehensive pathway and prospective- and performance-based payment system.Methods: To testify the potential influence of payment interventions, we use clustered randomised controlled trial, 60 clusters are grouped into two treatment groups and one control group to compare the time and group differences. Difference-in-differences model and structural equation modelling will be used to analyse the intervention effects and pathway. The outcomes are: quality of care, disease burden, supplier cooperative behaviour and patient utilisation behaviour and system efficiency. Repeated multivariate variance analysis will be used to statistically examine the outcome differences.Discussion: This is the first trial of its kind to prove the effects and efficiency of integrated care. Though we adopted randomised controlled trial to gather the highest rank of evidence, still the fully randomisation was hard to realise in health policy reform experiment. To compensate, the designer should take efforts on control for the potential confounders as much as possible. With this trial, we assume the effects will come from: (1 improvement on the quality of life through risk factors control and lifestyles change on patient's behaviours; (2 improvement on quality of care through continuous care and coordinated supplier behaviours; (3 improvement on the system efficiency through active interaction between suppliers and patients

  4. Study rationale and design of OPTIMISE, a randomised controlled trial on the effect of benchmarking on quality of care in type 2 diabetes mellitus

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    Hermans Michel P

    2011-09-01

    Full Text Available Abstract Background To investigate the effect of physician- and patient-specific feedback with benchmarking on the quality of care in adults with type 2 diabetes mellitus (T2DM. Methods Study centres in six European countries were randomised to either a benchmarking or control group. Physicians in both groups received feedback on modifiable outcome indicators (glycated haemoglobin [HbA1c], glycaemia, total cholesterol, high density lipoprotein-cholesterol, low density lipoprotein [LDL]-cholesterol and triglycerides for each patient at 0, 4, 8 and 12 months, based on the four times yearly control visits recommended by international guidelines. The benchmarking group also received comparative results on three critical quality indicators of vascular risk (HbA1c, LDL-cholesterol and systolic blood pressure [SBP], checked against the results of their colleagues from the same country, and versus pre-set targets. After 12 months of follow up, the percentage of patients achieving the pre-determined targets for the three critical quality indicators will be assessed in the two groups. Results Recruitment was completed in December 2008 with 3994 evaluable patients. Conclusions This paper discusses the study rationale and design of OPTIMISE, a randomised controlled study, that will help assess whether benchmarking is a useful clinical tool for improving outcomes in T2DM in primary care. Trial registration NCT00681850

  5. Efficacy of azacitidine compared with that of conventional care regimens in the treatment of higher-risk myelodysplastic syndromes: a randomised, open-label, phase III study

    Science.gov (United States)

    Fenaux, Pierre; Mufti, Ghulam J; Hellstrom-Lindberg, Eva; Santini, Valeria; Finelli, Carlo; Giagounidis, Aristoteles; Schoch, Robert; Gattermann, Norbert; Sanz, Guillermo; List, Alan; Gore, Steven D; Seymour, John F; Bennett, John M; Byrd, John; Backstrom, Jay; Zimmerman, Linda; McKenzie, David; Beach, C L; Silverman, Lewis R

    2014-01-01

    Summary Background Drug treatments for patients with high-risk myelodysplastic syndromes provide no survival advantage. In this trial, we aimed to assess the effect of azacitidine on overall survival compared with the three commonest conventional care regimens. Methods In a phase III, international, multicentre, controlled, parallel-group, open-label trial, patients with higher-risk myelodysplastic syndromes were randomly assigned one-to-one to receive azacitidine (75 mg/m² per day for 7 days every 28 days) or conventional care (best supportive care, low-dose cytarabine, or intensive chemotherapy as selected by investigators before randomisation). Patients were stratified by French–American–British and international prognostic scoring system classifications; randomisation was done with a block size of four. The primary endpoint was overall survival. Efficacy analyses were by intention to treat for all patients assigned to receive treatment. This study is registered with ClinicalTrials.gov, number NCT00071799. Findings Between Feb 13, 2004, and Aug 7, 2006, 358 patients were randomly assigned to receive azacitidine (n=179) or conventional care regimens (n=179). Four patients in the azacitidine and 14 in the conventional care groups received no study drugs but were included in the intention-to-treat efficacy analysis. After a median follow-up of 21·1 months (IQR 15·1–26·9), median overall survival was 24·5 months (9·9–not reached) for the azacitidine group versus 15·0 months (5·6–24·1) for the conventional care group (hazard ratio 0·58; 95% CI 0·43–0·77; stratified log-rank p=0·0001). At last follow-up, 82 patients in the azacitidine group had died compared with 113 in the conventional care group. At 2 years, on the basis of Kaplan-Meier estimates, 50·8% (95% CI 42·1–58·8) of patients in the azacitidine group were alive compared with 26·2% (18·7–34·3) in the conventional care group (p<0·0001). Peripheral cytopenias were the most

  6. Building the capacity of family day care educators to promote children's social and emotional wellbeing: an exploratory cluster randomised controlled trial

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    Sims Margaret

    2011-11-01

    Full Text Available Abstract Background Childhood mental health problems are highly prevalent, experienced by one in five children living in socioeconomically disadvantaged families. Although childcare settings, including family day care are ideal to promote children's social and emotional wellbeing at a population level in a sustainable way, family day care educators receive limited training in promoting children's mental health. This study is an exploratory wait-list control cluster randomised controlled trial to test the appropriateness, acceptability, cost, and effectiveness of "Thrive," an intervention program to build the capacity of family day care educators to promote children's social and emotional wellbeing. Thrive aims to increase educators' knowledge, confidence and skills in promoting children's social and emotional wellbeing. Methods/Design This study involves one family day care organisation based in a low socioeconomic area of Melbourne. All family day care educators (term used for registered carers who provide care for children for financial reimbursement in the carers own home are eligible to participate in the study. The clusters for randomisation will be the fieldworkers (n = 5 who each supervise 10-15 educators. The intervention group (field workers and educators will participate in a variety of intervention activities over 12 months, including workshops; activity exchanges with other educators; and focused discussion about children's social and emotional wellbeing during field worker visits. The control group will continue with their normal work practice. The intervention will be delivered to the intervention group and then to the control group after a time delay of 15 months post intervention commencement. A baseline survey will be conducted with all consenting educators and field workers (n = ~70 assessing outcomes at the cluster and individual level. The survey will also be administered at one month, six months and 12 months post

  7. Comparing group-based acceptance and commitment therapy (ACT) with enhanced usual care for adolescents with functional somatic syndromes: a study protocol for a randomised trial

    Science.gov (United States)

    Kallesøe, Karen Hansen; Schröder, Andreas; Wicksell, Rikard K; Fink, Per; Ørnbøl, Eva; Rask, Charlotte Ulrikka

    2016-01-01

    Introduction Functional somatic syndromes (FSS) are common in adolescents, characterised by severe disability and reduced quality of life. Behavioural treatments such as acceptance and commitment therapy (ACT) has shown promising results in children and adolescents with FSS, but has focused on specific syndromes such as functional pain. The current study will compare the efficacy of group-based ACT with that of enhanced usual care (EUC) in adolescents with a range of FSS operationalised by the unifying construct of multiorgan bodily distress syndrome (BDS). Methods and analysis A total of 120 adolescents aged 15–19 and diagnosed with multiorgan BDS, of at least 12 months duration, will be assessed and randomised to either: (1) EUC: a manualised consultation with a child and adolescent psychiatrist and individualised treatment plan or (2) manualised ACT-based group therapy plus EUC. The ACT programme consists of 9 modules (ie, 27 hours) and 1 follow-up meeting (3 hours). The primary outcome is physical health, assessed by an Short Form Health Survey (SF-36) aggregate score 12 months after randomisation. Secondary outcomes include self-reported symptom severity, symptom interference, depression and anxiety, illness worry, perceived stress and global improvement; as well as objective physical activity and bodily stress response measured by heart rate variability, hair cortisol and inflammatory biomarkers. Process measures are illness perception, illness-related behaviour and psychological flexibility. Ethics and dissemination The study is conducted in accordance with Helsinki Declaration II. Approval has been obtained from the Science Ethics Committee of the Central Denmark Region and the Danish Data Protection. The results will be sought to be published according to the CONSORT statement in peer-reviewed journals. Discussion This is one of the first larger randomised clinical trials evaluating the effect of a group-based intervention for adolescents with a

  8. The effect of using an interactive booklet on childhood respiratory tract infections in consultations: Study protocol for a cluster randomised controlled trial in primary care

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    Nuttall Jacqueline

    2008-04-01

    Full Text Available Abstract Background Respiratory tract infections in children result in more primary care consultations than any other acute condition, and are the most common reason for prescribing antibiotics (which are largely unnecessary. About a fifth of children consult again for the same illness episode. Providing parents with written information on respiratory tract infections may result in a reduction in re-consultation rates and antibiotic prescribing for these illnesses. Asking clinicians to provide and discuss the information during the consultation may enhance effectiveness. This paper outlines the protocol for a study designed to evaluate the use of a booklet on respiratory tract infections in children within primary care consultations. Methods/Design This will be a cluster randomised controlled trial. General practices will be randomised to provide parents consulting because their child has an acute respiratory tract infection with either an interactive booklet, or usual care. The booklet provides information on the expected duration of their child's illness, the likely benefits of various treatment options, signs and symptoms that should prompt re-consultation, and symptomatic treatment advice. It has been designed for use within the consultation and aims to enhance communication through the use of specific prompts. Clinicians randomised to using the interactive booklet will receive online training in its use. Outcomes will be assessed via a telephone interview with the parent two weeks after first consulting. The primary outcome will be the proportion of children who re-consult for the same illness episode. Secondary outcomes include: antibiotic use, parental satisfaction and enablement, and illness costs. Consultation rates for respiratory tract infections for the subsequent year will be assessed by a review of practice notes. Discussion Previous studies in adults and children have shown that educational interventions can result in reductions

  9. A cluster randomised controlled trial of a pharmacist-led collaborative intervention to improve statin prescribing and attainment of cholesterol targets in primary care.

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    Richard Lowrie

    Full Text Available Small trials with short term follow up suggest pharmacists' interventions targeted at healthcare professionals can improve prescribing. In comparison with clinical guidance, contemporary statin prescribing is sub-optimal and achievement of cholesterol targets falls short of accepted standards, for patients with atherosclerotic vascular disease who are at highest absolute risk and who stand to obtain greatest benefit. We hypothesised that a pharmacist-led complex intervention delivered to doctors and nurses in primary care, would improve statin prescribing and achievement of cholesterol targets for incident and prevalent patients with vascular disease, beyond one year.We allocated general practices to a 12-month Statin Outreach Support (SOS intervention or usual care. SOS was delivered by one of 11 pharmacists who had received additional training. SOS comprised academic detailing and practical support to identify patients with vascular disease who were not prescribed a statin at optimal dose or did not have cholesterol at target, followed by individualised recommendations for changes to management. The primary outcome was the proportion of patients achieving cholesterol targets. Secondary outcomes were: the proportion of patients prescribed simvastatin 40 mg with target cholesterol achieved; cholesterol levels; prescribing of simvastatin 40 mg; prescribing of any statin and the proportion of patients with cholesterol tested. Outcomes were assessed after an average of 1.7 years (range 1.4-2.2 years, and practice level simvastatin 40 mg prescribing was assessed after 10 years.We randomised 31 practices (72 General Practitioners (GPs, 40 nurses. Prior to randomisation a subset of eligible patients were identified to characterise practices; 40% had cholesterol levels below the target threshold. Improvements in data collection procedures allowed identification of all eligible patients (n = 7586 at follow up. Patients in practices allocated to SOS were

  10. A mobile phone application for the assessment and management of youth mental health problems in primary care: a randomised controlled trial

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    Reid Sophie C

    2011-11-01

    Full Text Available Abstract Background Over 75% of mental health problems begin in adolescence and primary care has been identified as the target setting for mental health intervention by the World Health Organisation. The mobiletype program is a mental health assessment and management mobile phone application which monitors mood, stress, coping strategies, activities, eating, sleeping, exercise patterns, and alcohol and cannabis use at least daily, and transmits this information to general practitioners (GPs via a secure website in summary format for medical review. Methods We conducted a randomised controlled trial in primary care to examine the mental health benefits of the mobiletype program. Patients aged 14 to 24 years were recruited from rural and metropolitan general practices. GPs identified and referred eligible participants (those with mild or more mental health concerns who were randomly assigned to either the intervention group (where mood, stress, and daily activities were monitored or the attention comparison group (where only daily activities were monitored. Both groups self-monitored for 2 to 4 weeks and reviewed the monitoring data with their GP. GPs, participants, and researchers were blind to group allocation at randomisation. Participants completed pre-, post-, and 6-week post-test measures of the Depression, Anxiety, Stress Scale and an Emotional Self Awareness (ESA Scale. Results Of the 163 participants assessed for eligibility, 118 were randomised and 114 participants were included in analyses (intervention group n = 68, comparison group n = 46. Mixed model analyses revealed a significant group by time interaction on ESA with a medium size of effect suggesting that the mobiletype program significantly increases ESA compared to an attention comparison. There was no significant group by time interaction for depression, anxiety, or stress, but a medium to large significant main effect for time for each of these mental health measures. Post

  11. A randomised, feasibility trial of a tele-health intervention for Acute Coronary Syndrome patients with depression ('MoodCare': Study protocol

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    Hare David L

    2011-02-01

    Full Text Available Abstract Background Coronary heart disease (CHD and depression are leading causes of disease burden globally and the two often co-exist. Depression is common after Myocardial Infarction (MI and it has been estimated that 15-35% of patients experience depressive symptoms. Co-morbid depression can impair health related quality of life (HRQOL, decrease medication adherence and appropriate utilisation of health services, lead to increased morbidity and suicide risk, and is associated with poorer CHD risk factor profiles and reduced survival. We aim to determine the feasibility of conducting a randomised, multi-centre trial designed to compare a tele-health program (MoodCare for depression and CHD secondary prevention, with Usual Care (UC. Methods Over 1600 patients admitted after index admission for Acute Coronary Syndrome (ACS are being screened for depression at six metropolitan hospitals in the Australian states of Victoria and Queensland. Consenting participants are then contacted at two weeks post-discharge for baseline assessment. One hundred eligible participants are to be randomised to an intervention or a usual medical care control group (50 per group. The intervention consists of up to 10 × 30-40 minute structured telephone sessions, delivered by registered psychologists, commencing within two weeks of baseline screening. The intervention focuses on depression management, lifestyle factors (physical activity, healthy eating, smoking cessation, alcohol intake, medication adherence and managing co-morbidities. Data collection occurs at baseline (Time 1, 6 months (post-intervention (Time 2, 12 months (Time 3 and 24 months follow-up for longer term effects (Time 4. We are comparing depression (Cardiac Depression Scale [CDS] and HRQOL (Short Form-12 [SF-12] scores between treatment and UC groups, assessing the feasibility of the program through patient acceptability and exploring long term maintenance effects. A cost-effectiveness analysis of

  12. Delivering early care in diabetes evaluation (DECIDE: a protocol for a randomised controlled trial to assess hospital versus home management at diagnosis in childhood diabetes

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    Robling Michael

    2011-01-01

    Full Text Available Abstract Background There is increased incidence of new cases of type 1 diabetes in children younger than 15 years. The debate concerning where best to manage newly diagnosed children continues. Some units routinely admit children to hospital whilst others routinely manage children at home. A Cochrane review identified the need for a large well-designed randomised controlled trial to investigate any significant differences in comprehensive short and long-term outcomes between the two approaches. The DECIDE study will address these knowledge gaps, providing high quality evidence to inform national and international policy and practice. Methods/Design This is a multi-centre randomised controlled trial across eight UK paediatric diabetes centres. The study aims to recruit 240 children newly diagnosed with type 1 diabetes and their parents/carers. Eligible patients (aged 0-17 years will be remotely randomised to either 'hospital' or 'home' management. Parents/carers of patients will also be recruited. Nursing management of participants and data collection will be co-ordinated by a project nurse at each centre. Data will be collected for 24 months after diagnosis; at follow up appointments at 3, 12 and 24 months and every 3-4 months at routine clinic visits. The primary outcome measure is patients' glycosylated haemoglobin (HbA1c at 24 months after diagnosis. Additional measurements of HbA1c will be made at diagnosis and 3 and 12 months later. HbA1c concentrations will be analysed at a central laboratory. Secondary outcome measures include length of stay at diagnosis, growth, adverse events, quality of life, anxiety, coping with diabetes, diabetes knowledge, home/clinic visits, self-care activity, satisfaction and time off school/work. Questionnaires will be sent to participants at 1, 12 and 24 months and will include a questionnaire, developed and validated to measure impact of the diagnosis on social activity and independence. Additional

  13. ParaMED Home: A protocol for a randomised controlled trial of paramedic assessment and referral to access medical care at home

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    Johnston Steven

    2011-06-01

    Full Text Available Abstract Background In Australia approximately 25% of Emergency Department (ED attendances are via ambulance. ED overcrowding in Australia, as in many countries, is common. Measures to reduce overcrowding include the provision of enhanced timely primary care in the community for appropriate low risk injury and illness. Therefore paramedic assessment and referral to a community home hospital service, in preference to transfer to ED, may confer clinical and cost benefit. Methods/Design A randomised controlled trial. Consenting adult patients that call an ambulance and are assessed by paramedics as having an eligible low risk problem will be randomised to referral to ED via ambulance transfer or referral to a rapid response service that will assess and treat the patient in their own residence. The primary outcome measure is requirement for unplanned medical attention (in or out of hospital in the first 48 hours. Secondary outcomes will include a number of other clinical endpoints. A cost effectiveness analysis will be conducted. Discussion If this trial demonstrates clinical non-inferiority and cost savings associated with the primary assessment service, it will provide one means to safely address ED overcrowding. Trial Registration Australian and New Zealand Clinical Trials Registry Number 12610001064099

  14. Protocol for a multicentre, parallel-arm, 12-month, randomised, controlled trial of arthroscopic surgery versus conservative care for femoroacetabular impingement syndrome (FASHIoN)

    Science.gov (United States)

    Griffin, D R; Dickenson, E J; Wall, P D H; Donovan, J L; Foster, N E; Hutchinson, C E; Parsons, N; Petrou, S; Realpe, A; Achten, J; Achana, F; Adams, A; Costa, M L; Griffin, J; Hobson, R; Smith, J

    2016-01-01

    Introduction Femoroacetabular impingement (FAI) syndrome is a recognised cause of young adult hip pain. There has been a large increase in the number of patients undergoing arthroscopic surgery for FAI; however, a recent Cochrane review highlighted that there are no randomised controlled trials (RCTs) evaluating treatment effectiveness. We aim to compare the clinical and cost-effectiveness of arthroscopic surgery versus best conservative care for patients with FAI syndrome. Methods We will conduct a multicentre, pragmatic, assessor-blinded, two parallel arm, RCT comparing arthroscopic surgery to physiotherapy-led best conservative care. 24 hospitals treating NHS patients will recruit 344 patients over a 26-month recruitment period. Symptomatic adults with radiographic signs of FAI morphology who are considered suitable for arthroscopic surgery by their surgeon will be eligible. Patients will be excluded if they have radiographic evidence of osteoarthritis, previous significant hip pathology or previous shape changing surgery. Participants will be allocated in a ratio of 1:1 to receive arthroscopic surgery or conservative care. Recruitment will be monitored and supported by qualitative intervention to optimise informed consent and recruitment. The primary outcome will be pain and function assessed by the international hip outcome tool 33 (iHOT-33) measured 1-year following randomisation. Secondary outcomes include general health (short form 12), quality of life (EQ5D-5L) and patient satisfaction. The primary analysis will compare change in pain and function (iHOT-33) at 12 months between the treatment groups, on an intention-to-treat basis, presented as the mean difference between the trial groups with 95% CIs. The study is funded by the Health Technology Assessment Programme (13/103/02). Ethics and dissemination Ethical approval is granted by the Edgbaston Research Ethics committee (14/WM/0124). The results will be disseminated through open access peer

  15. Protocol for Past BP: a randomised controlled trial of different blood pressure targets for people with a history of stroke of transient ischaemic attack (TIA in primary care

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    Greenfield Sheila

    2010-08-01

    Full Text Available Abstract Background Blood pressure (BP lowering in people who have had a stroke or transient ischaemic attack (TIA leads to reduced risk of further stroke. However, it is not clear what the target BP should be, since intensification of therapy may lead to additional adverse effects. PAST BP will determine whether more intensive BP targets can be achieved in a primary care setting, and whether more intensive therapy is associated with adverse effects on quality of life. Methods/Design This is a randomised controlled trial (RCT in patients with a past history of stroke or TIA. Patients will be randomised to two groups and will either have their blood pressure (BP lowered intensively to a target of 130 mmHg systolic, (or by 10 mmHg if the baseline systolic pressure is between 125 and 140 mmHg compared to a standard group where the BP will be reduced to a target of 140 mmHg systolic. Patients will be managed by their practice at 1-3 month intervals depending on level of BP and followed-up by the research team at six monthly intervals for 12 months. 610 patients will be recruited from approximately 50 general practices. The following exclusion criteria will be applied: systolic BP The primary outcome will be change in systolic BP over twelve months. Secondary outcomes include quality of life, adverse events and cardiovascular events. In-depth interviews with 30 patients and 20 health care practitioners will be undertaken to investigate patient and healthcare professionals understanding and views of BP management. Discussion The results of this trial will inform whether intensive blood pressure targets can be achieved in people who have had a stroke or TIA in primary care, and help determine whether or not further research is required before recommending such targets for this population. Trial Registration ISRCTN29062286

  16. Does Interpersonal Psychotherapy improve clinical care for adolescents with depression attending a rural child and adolescent mental health service? Study protocol for a cluster randomised feasibility trial

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    Villanueva Elmer V

    2007-10-01

    Full Text Available Abstract Background Depression amongst adolescents is a costly societal problem. Little research documents the effectiveness of public mental health services in mapping this problem. Further, it is not clear whether usual care in such services can be improved via clinician training in a relevant evidence based intervention. One such intervention, found to be effective and easily learned amongst novice clinicians, is Interpersonal Psychotherapy (IPT. The study described in the current paper has two main objectives. First, it aims to investigate the impact on clinical care of implementing Interpersonal Psychotherapy for Adolescents for the treatment of adolescent depression within a rural mental health service compared with Treatment as Usual (TAU. The second objective is to record the process and challenges (i.e. feasibility, acceptability, sustainability associated with implementing and evaluating an evidence-based intervention within a community service. This paper outlines the study rationale and design for this community based research trial. Methods/design The study involves a cluster randomisation trial to be conducted within a Child and Adolescent Mental Health Service in rural Australia. All clinicians in the service will be invited to participate. Participating clinicians will be randomised via block design at each of four sites to (a training and delivery of IPT, or (b TAU. The primary measure of impact on care will be a clinically significant change in depressive symptomatology, with secondary outcomes involving treatment satisfaction and changes in other symptomatology. Participating adolescents with significant depressive symptomatology, aged 12 to 18 years, will complete assessment measures at Weeks 0, 12 and 24 of treatment. They will also complete a depression inventory once a month during that period. This study aims to recruit 60 adolescent participants and their parent/guardian/s. A power analysis is not indicated as an intra

  17. Improvement of primary care for patients with chronic heart failure: A study protocol for a cluster randomised trial comparing two strategies

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    Wensing Michel

    2011-03-01

    Full Text Available Abstract Background Many patients with chronic heart failure (CHF, a common condition with high morbidity and mortality rates, receive treatment in primary care. To improve the management of CHF in primary care, we developed an implementation programme comprised of educational and organisational components, with support by a practice visitor and focus both on drug treatment and lifestyle advice, and on organisation of care within the practice and collaboration with other healthcare providers. Tailoring has been shown to improve the success of implementation programmes, but little is known about what would be best methods for tailoring, specifically with respect to CHF in primary care. Methods/design We describe the study protocol of a cluster randomised controlled trial to examine the effectiveness of tailoring a CHF implementation programme to general practices compared to a standardised way of delivering a programme. The study population will consist of 60 general practitioners (GPs and the CHF patients they include. GPs are randomised in blocks of four, stratified according to practice size. With a tailored implementation programme GPs prioritise the issues that will form the bases of the support for the practice visits. These may comprise several issues, both educational and organizational. The primary outcome measures are patient's experience of receiving structured primary care for CHF (PACIC, a questionnaire related to the Chronic Care Model, patients' health-related utilities (EQ-5D, and drugs prescriptions using the guideline adherence index. Patients being clustered in practices, multilevel regression analyses will be used to explore the effect of practice size and type of intervention programme. In addition we will examine both changes within groups and differences at follow-up between groups with respect to drug dosages and advice on lifestyle issues. Furthermore, in interviews the feasibility of the programme and goal attainment

  18. A cluster-randomised trial of staff education to improve the quality of life of people with dementia living in residential care: the DIRECT study.

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    Christopher Beer

    Full Text Available BACKGROUND: The Dementia In Residential care: EduCation intervention Trial (DIRECT was conducted to determine if delivery of education designed to meet the perceived need of GPs and care staff improves the quality of life of participants with dementia living in residential care. METHODOLOGY/PRINCIPAL FINDINGS: This cluster-randomised controlled trial was conducted in 39 residential aged care facilities in the metropolitan area of Perth, Western Australia. 351 care facility residents aged 65 years and older with Mini-Mental State Examination ≤ 24, their GPs and facility staff participated. Flexible education designed to meet the perceived needs of learners was delivered to GPs and care facility staff in intervention groups. The primary outcome of the study was self-rated quality of life of participants with dementia, measured using the QOL-Alzheimer's Disease Scale (QOL-AD at 4 weeks and 6 months after the conclusion of the intervention. Analysis accounted for the effect of clustering by using multi-level regression analysis. Education of GPs or care facility staff did not affect the primary outcome at either 4 weeks or 6 months. In a post hoc analysis excluding facilities in which fewer than 50% of staff attended an education session, self-rated QOL-AD scores were 6.14 points (adjusted 95%CI 1.14, 11.15 higher at four-week follow-up among residents in facilities randomly assigned to the education intervention. CONCLUSION: The education intervention directed at care facilities or GPs did not improve the quality of life ratings of participants with dementia as a group. This may be explained by the poor adherence to the intervention programme, as participants with dementia living in facilities where staff participated at least minimally seemed to benefit. TRIAL REGISTRATION: ANZCTR.org.au ACTRN12607000417482.

  19. Cost-effectiveness of an intensive group training protocol compared to physiotherapy guideline care for sub-acute and chronic low back pain: design of a randomised controlled trial with an economic evaluation. [ISRCTN45641649

    OpenAIRE

    Franken Willemien K; van Mechelen Willem; Barendse Johanna M; van Tulder Maurits W; van der Roer Nicole; Ooms Arjan C; de Vet Henrica CW

    2004-01-01

    Abstract Background Low back pain is a common disorder in western industrialised countries and the type of treatments for low back pain vary considerably. Methods In a randomised controlled trial the cost-effectiveness and cost-utility of an intensive group training protocol versus physiotherapy guideline care for sub-acute and chronic low back pain patients is evaluated. Patients with back pain for longer than 6 weeks who are referred to physiotherapy care by their general practitioner or me...

  20. Electronically delivered, multicomponent intervention to reduce unnecessary antibiotic prescribing for respiratory infections in primary care: a cluster randomised trial using electronic health records—REDUCE Trial study original protocol

    OpenAIRE

    Juszczyk, Dorota; Charlton, Judith; McDermott, Lisa; Soames, Jamie; Sultana, Kirin; Ashworth, Mark; Fox, Robin; Hay, Alastair D; Little, Paul; Moore, Michael V.; Yardley, Lucy; Prevost, A Toby; Gulliford, Martin C

    2016-01-01

    Introduction Respiratory tract infections (RTIs) account for about 60% of antibiotics prescribed in primary care. This study aims to test the effectiveness, in a cluster randomised controlled trial, of electronically delivered, multicomponent interventions to reduce unnecessary antibiotic prescribing when patients consult for RTIs in primary care. The research will specifically evaluate the effectiveness of feeding back electronic health records (EHRs) data to general practices.Methods and an...

  1. Randomised controlled trial of an automated, interactive telephone intervention to improve type 2 diabetes self-management (Telephone-Linked Care Diabetes Project: study protocol

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    Scuffham Paul A

    2010-10-01

    Full Text Available Abstract Background An estimated 285 million people worldwide have diabetes and its prevalence is predicted to increase to 439 million by 2030. For the year 2010, it is estimated that 3.96 million excess deaths in the age group 20-79 years are attributable to diabetes around the world. Self-management is recognised as an integral part of diabetes care. This paper describes the protocol of a randomised controlled trial of an automated interactive telephone system aiming to improve the uptake and maintenance of essential diabetes self-management behaviours. Methods/Design A total of 340 individuals with type 2 diabetes will be randomised, either to the routine care arm, or to the intervention arm in which participants receive the Telephone-Linked Care (TLC Diabetes program in addition to their routine care. The intervention requires the participants to telephone the TLC Diabetes phone system weekly for 6 months. They receive the study handbook and a glucose meter linked to a data uploading device. The TLC system consists of a computer with software designed to provide monitoring, tailored feedback and education on key aspects of diabetes self-management, based on answers voiced or entered during the current or previous conversations. Data collection is conducted at baseline (Time 1, 6-month follow-up (Time 2, and 12-month follow-up (Time 3. The primary outcomes are glycaemic control (HbA1c and quality of life (Short Form-36 Health Survey version 2. Secondary outcomes include anthropometric measures, blood pressure, blood lipid profile, psychosocial measures as well as measures of diet, physical activity, blood glucose monitoring, foot care and medication taking. Information on utilisation of healthcare services including hospital admissions, medication use and costs is collected. An economic evaluation is also planned. Discussion Outcomes will provide evidence concerning the efficacy of a telephone-linked care intervention for self-management of

  2. Mediating the effect of self-care management intervention in type 2 diabetes: A meta-analysis of 47 randomised controlled trials

    DEFF Research Database (Denmark)

    Minet, Lisbeth; Møller, Sine; Vach, Werner;

    2010-01-01

    OBJECTIVE: To perform a meta-analysis assessing the effects of self-care management interventions in improving glycaemic control in type 2 diabetes by analysing the impact of different study characteristics on the effect size. METHODS: A literature search in eight scientific databases up to Novem......OBJECTIVE: To perform a meta-analysis assessing the effects of self-care management interventions in improving glycaemic control in type 2 diabetes by analysing the impact of different study characteristics on the effect size. METHODS: A literature search in eight scientific databases up...... to November 2007 included original studies of randomised controlled trials involving adult patients diagnosed with type 2 diabetes and evaluating a self-care management intervention. RESULTS: The 47 included studies yielded 7677 participants. The analysis showed a 0.36% (95% CI 0.21-0.51) improvement...... in glycaemic control in people who received self-care management treatment. In the univariate meta-regression sample size (effect size 0.42%, p=0.007) and follow-up period (effect size 0.49%, p=0.017) were identified to have significant effect on the effect size in favour of small studies and short follow...

  3. A randomised clinical trial of comprehensive cardiac rehabilitation versus usual care for patients treated for infective endocarditis—the CopenHeartIE trial protocol

    Science.gov (United States)

    Rasmussen, Trine Bernholdt; Zwisler, Ann-Dorthe; Sibilitz, Kirstine Lærum; Risom, Signe Stelling; Bundgaard, Henning; Gluud, Christian; Moons, Philip; Winkel, Per; Thygesen, Lau Caspar; Hansen, Jane Lindschou; Norekvål, Tone Merete; Berg, Selina Kikkenborg

    2012-01-01

    Introduction Infective endocarditis (IE) is among the most serious infectious diseases in the western world. Treatment requires lengthy hospitalisation, high-dosage antibiotic therapy and possible valve replacement surgery. Despite advances in treatment, the 1-year mortality remains at 20–40%. Studies indicate that patients experience persisting physical symptoms, diminished quality of life and difficulties returning to work up to a year postdischarge. No studies investigating the effects of rehabilitation have been published. We present the rationale and design of the CopenHeartIE trial, which investigates the effect of comprehensive cardiac rehabilitation versus usual care for patients treated for IE. Methods and analysis We will conduct a randomised clinical trial to investigate the effects of comprehensive cardiac rehabilitation versus usual care on the physical and psychosocial functioning of patients treated for IE. The trial is a multicentre, parallel design trial with 1 : 1 individual randomisation to either the intervention or control group. The intervention consists of five psychoeducational consultations provided by specialised nurses and a 12-week exercise training programme. The primary outcome is mental health (MH) measured by the standardised Short Form 36 (SF-36). The secondary outcome is peak oxygen uptake measured by the bicycle ergospirometry test. Furthermore, a number of exploratory analyses will be performed. Based on sample size calculation, 150 patients treated for left-sided (native or prosthetic valve) or cardiac device endocarditis will be included in the trial. A qualitative and a survey-based complementary study will be undertaken, to investigate postdischarge experiences of the patients. A qualitative postintervention study will explore rehabilitation participation experiences. Ethics and dissemination The study complies with the Declaration of Helsinki and was approved by the regional research ethics committee (no H-1

  4. The effect of a comprehensive lifestyle intervention on cardiovascular risk factors in pharmacologically treated patients with stable cardiovascular disease compared to usual care: a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    IJzelenberg Wilhelmina

    2012-09-01

    Full Text Available Abstract Background The additional benefit of lifestyle interventions in patients receiving cardioprotective drug treatment to improve cardiovascular risk profile is not fully established. The objective was to evaluate the effectiveness of a target-driven multidisciplinary structured lifestyle intervention programme of 6 months duration aimed at maximum reduction of cardiovascular risk factors in patients with cardiovascular disease (CVD compared with usual care. Methods A single centre, two arm, parallel group randomised controlled trial was performed. Patients with stable established CVD and at least one lifestyle-related risk factor were recruited from the vascular and cardiology outpatient departments of the university hospital. Blocked randomisation was used to allocate patients to the intervention (n = 71 or control group (n = 75 using an on-site computer system combined with allocations in computer-generated tables of random numbers kept in a locked computer file. The intervention group received the comprehensive lifestyle intervention offered in a specialised outpatient clinic in addition to usual care. The control group continued to receive usual care. Outcome measures were the lifestyle-related cardiovascular risk factors: smoking, physical activity, physical fitness, diet, blood pressure, plasma total/HDL/LDL cholesterol concentrations, BMI, waist circumference, and changes in medication. Results The intervention led to increased physical activity/fitness levels and an improved cardiovascular risk factor profile (reduced BMI and waist circumference. In this setting, cardiovascular risk management for blood pressure and lipid levels by prophylactic treatment for CVD in usual care was already close to optimal as reflected in baseline levels. There was no significant improvement in any other risk factor. Conclusions Even in CVD patients receiving good clinical care and using cardioprotective drug treatment, a comprehensive

  5. Comparison of midwife-led and consultant-led care of healthy women at low risk of childbirth complications in the Republic of Ireland: a randomised trial

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    Begley Cecily

    2011-10-01

    Full Text Available Abstract Background No midwifery-led units existed in Ireland before 2004. The aim of this study was to compare midwife-led (MLU versus consultant-led (CLU care for healthy, pregnant women without risk factors for labour and delivery. Methods An unblinded, pragmatic randomised trial was designed, funded by the Health Service Executive (Dublin North-East. Following ethical approval, all women booking prior to 24 weeks of pregnancy at two maternity hospitals with 1,300-3,200 births annually in Ireland were assessed for trial eligibility.1,653 consenting women were centrally randomised on a 2:1 ratio to MLU or CLU care, (1101:552. 'Intention-to-treat' analysis was used to compare 9 key neonatal and maternal outcomes. Results No statistically significant difference was found between MLU and CLU in the seven key outcomes: caesarean birth (163 [14.8%] vs 84 [15.2%]; relative risk (RR 0.97 [95% CI 0.76 to 1.24], induction (248 [22.5%] vs 138 [25.0%]; RR 0.90 [0.75 to 1.08], episiotomy (126 [11.4%] vs 68 [12.3%]; RR 0.93 [0.70 to 1.23], instrumental birth (139 [12.6%] vs 79 [14.3%]; RR 0.88 [0.68 to 1.14], Apgar scores vs 9 [1.6%]; RR 0.56 [0.23 to 1.36], postpartum haemorrhage (144 [13.1%] vs 75 [13.6%]; RR 0.96 [0.74 to 1.25]; breastfeeding initiation (616 [55.9%] vs 317 [57.4%]; RR 0.97 [0.89 to 1.06]. MLU women were significantly less likely to have continuous electronic fetal monitoring (397 [36.1%] vs 313 [56.7%]; RR 0.64 [0.57 to 0.71], or augmentation of labour (436 [39.6%] vs 314 [56.9%]; RR 0.50 [0.40 to 0.61]. Conclusions Midwife-led care, as practised in this study, is as safe as consultant-led care and is associated with less intervention during labour and delivery. Trial registration number ISRCTN: ISRCTN14973283

  6. Comparison of midwife-led and consultant-led care of healthy women at low risk of childbirth complications in the Republic of Ireland: a randomised trial.

    LENUS (Irish Health Repository)

    Begley, Cecily

    2011-10-29

    ABSTRACT: BACKGROUND: No midwifery-led units existed in Ireland before 2004. The aim of this study was to compare midwife-led (MLU) versus consultant-led (CLU) care for healthy, pregnant women without risk factors for labour and delivery. METHODS: An unblinded, pragmatic randomised trial was designed, funded by the Health Service Executive (Dublin North-East). Following ethical approval, all women booking prior to 24 weeks of pregnancy at two maternity hospitals with 1,300-3,200 births annually in Ireland were assessed for trial eligibility.1,653 consenting women were centrally randomised on a 2:1 ratio to MLU or CLU care, (1101:552). \\'Intention-to-treat\\' analysis was used to compare 9 key neonatal and maternal outcomes. RESULTS: No statistically significant difference was found between MLU and CLU in the seven key outcomes: caesarean birth (163 [14.8%] vs 84 [15.2%]; relative risk (RR) 0.97 [95% CI 0.76 to 1.24]), induction (248 [22.5%] vs 138 [25.0%]; RR 0.90 [0.75 to 1.08]), episiotomy (126 [11.4%] vs 68 [12.3%]; RR 0.93 [0.70 to 1.23]), instrumental birth (139 [12.6%] vs 79 [14.3%]; RR 0.88 [0.68 to 1.14]), Apgar scores <8 (10 [0.9%] vs 9 [1.6%]; RR 0.56 [0.23 to 1.36]), postpartum haemorrhage (144 [13.1%] vs 75 [13.6%]; RR 0.96 [0.74 to 1.25]); breastfeeding initiation (616 [55.9%] vs 317 [57.4%]; RR 0.97 [0.89 to 1.06]). MLU women were significantly less likely to have continuous electronic fetal monitoring (397 [36.1%] vs 313 [56.7%]; RR 0.64 [0.57 to 0.71]), or augmentation of labour (436 [39.6%] vs 314 [56.9%]; RR 0.50 [0.40 to 0.61]). CONCLUSIONS: Midwife-led care, as practised in this study, is as safe as consultant-led care and is associated with less intervention during labour and delivery. Trial registration: Current Controlled Trials ISRCTN14973283.

  7. Perceived quality of physiotherapist-led orthopaedic triage compared with standard practice in primary care: a randomised controlled trial

    OpenAIRE

    Samsson, Karin S.; Bernhardsson, Susanne; Larsson, Maria E. H.

    2016-01-01

    Background Physiotherapist-led orthopaedic triage, where physiotherapists diagnose and determine management plans, aims to enhance effectiveness and provide the best care. However, scientific evidence for the effectiveness of this model of care remains limited, and there are few studies reporting on patients’ perceptions of the care provided. The purpose of this study was to evaluate patients’ perceived quality of care in a physiotherapist-led orthopaedic triage in primary care, compared with...

  8. Improving the care for people with acute low-back pain by allied health professionals (the ALIGN trial: A cluster randomised trial protocol

    Directory of Open Access Journals (Sweden)

    Keating Jennifer L

    2010-11-01

    Full Text Available Abstract Background Variability between clinical practice guideline recommendations and actual clinical practice exists in many areas of health care. A 2004 systematic review examining the effectiveness of guideline implementation interventions concluded there was a lack of evidence to support decisions about effective interventions to promote the uptake of guidelines. Further, the review recommended the use of theory in the development of implementation interventions. A clinical practice guideline for the management of acute low-back pain has been developed in Australia (2003. Acute low-back pain is a common condition, has a high burden, and there is some indication of an evidence-practice gap in the allied health setting. This provides an opportunity to develop and test a theory-based implementation intervention which, if effective, may provide benefits for patients with this condition. Aims This study aims to estimate the effectiveness of a theory-based intervention to increase allied health practitioners' (physiotherapists and chiropractors in Victoria, Australia compliance with a clinical practice guideline for acute non-specific low back pain (LBP, compared with providing practitioners with a printed copy of the guideline. Specifically, our primary objectives are to establish if the intervention is effective in reducing the percentage of acute non-specific LBP patients who are either referred for or receive an x-ray, and improving mean level of disability for patients three months post-onset of acute LBP. Methods The design of the study is a cluster randomised trial. Restricted randomisation was used to randomise 210 practices (clusters to an intervention or control group. Practitioners in the control group received a printed copy of the guideline. Practitioners in the intervention group received a theory-based intervention developed to address prospectively identified barriers to practitioner compliance with the guideline. The

  9. Peer support in type 2 diabetes: a randomised controlled trial in primary care with parallel economic and qualitative analyses: pilot study and protocol

    Directory of Open Access Journals (Sweden)

    O'Kelly Fergus

    2007-07-01

    Full Text Available Abstract Background Diabetes is a chronic illness, which requires the individual to assume responsibility for their own care with the aim of maintaining glucose and blood pressure levels as close to normal as possible. Traditionally self-management training for diabetes has been delivered in a didactic manner. In recent times alternatives to the traditional delivery of diabetes care have been investigated, for example, the concept of peer support which emphasises patient rather than professional domination. This paper describes the pilot study and protocol for a study that aims to evaluate the effectiveness of a peer support intervention for people with type 2 diabetes in a primary care setting. Methods/Design A pilot study was conducted to access the feasibility of a randomized controlled trial of a peer support intervention. We used the MRC Framework for the evaluation of complex interventions. Elements of the intervention were defined and the study protocol was finalized. In this cluster randomised controlled trial twenty general practices are assigned to control and intervention groups. Each practice compiles a diabetes register and randomly selects 21 patients. All practices implement a standardised diabetes care system. In the intervention group all practices recruit three peer supporters. The peer supporters are trained to conduct nine group meetings in their general practice over a period of two years. Each meeting has a structured component. The primary outcomes are blood pressure, total cholesterol, HBA1c and the Diabetes Well-being score. In addition to biophysical, psychosocial, economic and health service utilization data peer supporter activity and qualitative data are collected. Discussion Peer support is a complex intervention and evaluating such an intervention presents challenges to researchers. This study will evaluate whether a peer support programme for patients with type 2 diabetes improves biophysical and psychosocial

  10. A cluster randomised trial to evaluate a physical activity intervention among 3-5 year old children attending long day care services: study protocol

    Directory of Open Access Journals (Sweden)

    Finch Meghan

    2010-09-01

    Full Text Available Abstract Background Young children are not participating in recommended levels of physical activity and exhibit high levels of sedentary behaviour. Childcare services provide access to large numbers of young children for prolonged periods, yet there is limited experimental evidence regarding the effectiveness of physical activity interventions implemented in this setting. The aim of this study is to assess the effectiveness and acceptability of a multi-component physical activity intervention, delivered by childcare service staff, in increasing the physical activity levels of children attending long day care services. Methods/Design The study will employ a cluster randomised controlled trial design. Three hundred children aged between 3-5 years from twenty randomly selected long day care services in the Hunter Region of New South Wales, Australia will be invited to participate in the trial. Ten of the 20 long day care services will be randomly allocated to deliver the intervention with the remaining ten services allocated to a wait list control group. The physical activity intervention will consist of a number of strategies including: delivering structured fundamental movement skill activities, increasing physical activity opportunities, increasing staff role modelling, providing children with a physical activity promoting indoor and outdoor environment and limiting children's small screen recreation and sedentary behaviours. Intervention effectiveness will be measured via child physical activity levels during attendance at long day care. The study also seeks to determine the acceptability and extent of implementation of the intervention by services and their staff participating in the study. Discussion The trial will address current gaps in the research evidence base and contribute to the design and delivery of future interventions promoting physical activity for young children in long day care settings. Trial registration Australian New

  11. The BLISS cluster randomised controlled trial of the effect of 'active dissemination of information' on standards of care for premature babies in England (BEADI study protocol [ISRCTN89683698

    Directory of Open Access Journals (Sweden)

    Houston Rosie

    2007-10-01

    Full Text Available Abstract Background Gaps between research knowledge and practice have been consistently reported. Traditional ways of communicating information have limited impact on practice changes. Strategies to disseminate information need to be more interactive and based on techniques reported in systematic reviews of implementation of changes. There is a need for clarification as to which dissemination strategies work best to translate evidence into practice in neonatal units across England. The objective of this trial is to assess whether an innovative active strategy for the dissemination of neonatal research findings, recommendations, and national neonatal guidelines is more likely to lead to changes in policy and practice than the traditional (more passive forms of dissemination in England. Methods/design Cluster randomised controlled trial of all neonatal units in England (randomised by hospital, n = 182 and stratified by neonatal regional networks and neonatal units level of care to assess the relative effectiveness of active dissemination strategies on changes in local policies and practices. Participants will be mainly consultant lead clinicians in each unit. The intervention will be multifaceted using: audit and feedback; educational meetings for local staff (evidence-based lectures on selected topics, interactive workshop to examine current practice and draw up plans for change; and quality improvement and organisational changes methods. Policies and practice outcomes for the babies involved will be collected before and after the intervention. Outcomes will assess all premature babies born in England during a three month period for timing of surfactant administration at birth, temperature control at birth, and resuscitation team (qualification and numbers present at birth. Trial registration Current controlled trials ISRCTN89683698

  12. Multidisciplinary Collaborative Care for Depressive Disorder in the Occupational Health Setting: design of a randomised controlled trial and cost-effectiveness study

    Directory of Open Access Journals (Sweden)

    Beekman Aartjan TF

    2008-05-01

    Full Text Available Abstract Background Major depressive disorder (MDD has major consequences for both patients and society, particularly in terms of needlessly long sick leave and reduced functioning. Although evidence-based treatments for MDD are available, they show disappointing results when implemented in daily practice. A focus on work is also lacking in the treatment of depressive disorder as well as communication of general practitioners (GPs and other health care professionals with occupational physicians (OPs. The OP may play a more important role in the recovery of patients with MDD. Purpose of the present study is to tackle these obstacles by applying a collaborative care model, which has proven to be effective in the USA, with a focus on return to work (RTW. From a societal perspective, the (costeffectiveness of this collaborative care treatment, as a way of transmural care, will be evaluated in depressed patients on sick leave in the occupational health setting. Methods/Design A randomised controlled trial in which the treatment of MDD in the occupational health setting will be evaluated in the Netherlands. A transmural collaborative care model, including Problem Solving Treatment (PST, a workplace intervention, antidepressant medication and manual guided self-help will be compared with care as usual (CAU. 126 Patients with MDD on sick leave between 4 and 12 weeks will be included in the study. Care in the intervention group will be provided by a multidisciplinary team of a trained OP-care manager and a consultant psychiatrist. The treatment is separated from the sickness certification. Data will be collected by means of questionnaires at baseline and at 3, 6, 9 and 12 months after baseline. Primary outcome measure is reduction of depressive symptoms, secondary outcome measure is time to RTW, tertiary outcome measure is the cost effectiveness. Discussion The high burden of MDD and the high level of sickness absence among people with MDD contribute to

  13. West End Walkers 65+: A randomised controlled trial of a primary care-based walking intervention for older adults: Study rationale and design

    Directory of Open Access Journals (Sweden)

    Rowe David A

    2011-02-01

    Full Text Available Abstract Background In Scotland, older adults are a key target group for physical activity intervention due to the large proportion who are inactive. The health benefits of an active lifestyle are well established but more research is required on the most effective interventions to increase activity in older adults. The 'West End Walkers 65+' randomised controlled trial aims to examine the feasibility of delivering a pedometer-based walking intervention to adults aged ≥65 years through a primary care setting and to determine the efficacy of this pilot. The study rationale, protocol and recruitment process are discussed in this paper. Methods/Design The intervention consisted of a 12-week pedometer-based graduated walking programme and physical activity consultations. Participants were randomised into an immediate intervention group (immediate group or a 12-week waiting list control group (delayed group who then received the intervention. For the pilot element of this study, the primary outcome measure was pedometer step counts. Secondary outcome measures of sedentary time and physical activity (time spent lying/sitting, standing or walking; activPAL™ monitor, mood (Positive and Negative Affect Schedule, functional ability (Perceived Motor-Efficacy Scale for Older Adults, quality of life (Short-Form (36 Health Survey version 2 and loneliness (UCLA Loneliness Scale were assessed. Focus groups with participants and semi-structured interviews with the research team captured their experiences of the intervention. The feasibility component of this trial examined recruitment via primary care and retention of participants, appropriateness of the intervention for older adults and the delivery of the intervention by a practice nurse. Discussion West End Walkers 65+ will determine the feasibility and pilot the efficacy of delivering a pedometer-based walking intervention through primary care to Scottish adults aged ≥65 years. The study will also

  14. Explaining the effects of an intervention designed to promote evidence-based diabetes care: a theory-based process evaluation of a pragmatic cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Kaner Eileen FS

    2008-11-01

    Full Text Available Abstract Background The results of randomised controlled trials can be usefully illuminated by studies of the processes by which they achieve their effects. The Theory of Planned Behaviour (TPB offers a framework for conducting such studies. This study used TPB to explore the observed effects in a pragmatic cluster randomised controlled trial of a structured recall and prompting intervention to increase evidence-based diabetes care that was conducted in three Primary Care Trusts in England. Methods All general practitioners and nurses in practices involved in the trial were sent a postal questionnaire at the end of the intervention period, based on the TPB (predictor variables: attitude; subjective norm; perceived behavioural control, or PBC. It focussed on three clinical behaviours recommended in diabetes care: measuring blood pressure; inspecting feet; and prescribing statins. Multivariate analyses of variance and multiple regression analyses were used to explore changes in cognitions and thereby better understand trial effects. Results Fifty-nine general medical practitioners and 53 practice nurses (intervention: n = 55, 41.98% of trial participants; control: n = 57, 38.26% of trial participants completed the questionnaire. There were no differences between groups in mean scores for attitudes, subjective norms, PBC or intentions. Control group clinicians had 'normatively-driven' intentions (i.e., related to subjective norm scores, whereas intervention group clinicians had 'attitudinally-driven' intentions (i.e., related to attitude scores for foot inspection and statin prescription. After controlling for effects of the three predictor variables, this group difference was significant for foot inspection behaviour (trial group × attitude interaction, beta = 0.72, p Conclusion Attitudinally-driven intentions are proposed to be more consistently translated into action than normatively-driven intentions. This proposition was supported by the

  15. A multicentre randomised controlled trial of Transfusion Indication Threshold Reduction on transfusion rates, morbidity and health-care resource use following cardiac surgery (TITRe2).

    Science.gov (United States)

    Reeves, Barnaby C; Pike, Katie; Rogers, Chris A; Brierley, Rachel Cm; Stokes, Elizabeth A; Wordsworth, Sarah; Nash, Rachel L; Miles, Alice; Mumford, Andrew D; Cohen, Alan; Angelini, Gianni D; Murphy, Gavin J

    2016-01-01

    BACKGROUND Uncertainty about optimal red blood cell transfusion thresholds in cardiac surgery is reflected in widely varying transfusion rates between surgeons and cardiac centres. OBJECTIVE To test the hypothesis that a restrictive compared with a liberal threshold for red blood cell transfusion after cardiac surgery reduces post-operative morbidity and health-care costs. DESIGN Multicentre, parallel randomised controlled trial and within-trial cost-utility analysis from a UK NHS and Personal Social Services perspective. We could not blind health-care staff but tried to blind participants. Random allocations were generated by computer and minimised by centre and operation. SETTING Seventeen specialist cardiac surgery centres in UK NHS hospitals. PARTICIPANTS Patients aged > 16 years undergoing non-emergency cardiac surgery with post-operative haemoglobin research steps to address the new hypothesis about the possible harm of red blood cell transfusion. TRIAL REGISTRATION Current Controlled Trials ISRCTN70923932. FUNDING This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 20, No. 60. See the NIHR Journals Library website for further project information. PMID:27527344

  16. A Phase II randomised controlled trial assessing the feasibility, acceptability and potential effectiveness of Dignity Therapy for older people in care homes: Study protocol

    Directory of Open Access Journals (Sweden)

    Richardson Alison

    2009-03-01

    Full Text Available Abstract Background Although most older people living in nursing homes die there, there is a dearth of robust evaluations of interventions to improve their end-of-life care. Residents usually have multiple health problems making them heavily reliant on staff for their care, which can erode their sense of dignity. Dignity Therapy has been developed to help promote dignity and reduce distress. It comprises a recorded interview, which is transcribed, edited then returned to the patient, who can bequeath it to people of their choosing. Piloting has suggested that Dignity Therapy is beneficial to people dying of cancer and their families. The aims of this study are to assess the feasibility, acceptability and potential effectiveness of Dignity Therapy to reduce psychological and spiritual distress in older people reaching the end of life in care homes, and to pilot the methods for a Phase III RCT. Methods/design A randomised controlled open-label trial. Sixty-four residents of care homes for older people are randomly allocated to one of two groups: (i Intervention (Dignity Therapy offered in addition to any standard care, and (ii Control group (standard care. Recipients of the "generativity" documents are asked their views on taking part in the study and the therapy. Both quantitative and qualitative outcomes are assessed in face-to-face interviews at baseline and at approximately one and eight weeks after the intervention (equivalent in the control group. The primary outcome is residents' sense of dignity (potential effectiveness assessed by the Patient Dignity Inventory. Secondary outcomes for residents include depression, hopefulness and quality of life. In view of the relatively small sample size, quantitative analysis is mainly descriptive. The qualitative analysis uses the Framework method. Discussion Dignity Therapy is brief, can be done at the bedside and could help both patients and their families. This detailed exploratory research shows if

  17. Mothers' AdvocateS In the Community (MOSAIC)- non-professional mentor support to reduce intimate partner violence and depression in mothers: a cluster randomised trial in primary care

    OpenAIRE

    Gold Lisa; Watson Lyndsey F; Hegarty Kelsey L; Small Rhonda; Taft Angela J; Lumley Judith A

    2011-01-01

    Abstract Background Effective interventions to increase safety and wellbeing of mothers experiencing intimate partner violence (IPV) are scarce. As much attention is focussed on professional intervention, this study aimed to determine the effectiveness of non-professional mentor support in reducing IPV and depression among pregnant and recent mothers experiencing, or at risk of IPV. Methods MOSAIC was a cluster randomised trial in 106 primary care (maternal and child health nurse and general ...

  18. A comparison of specialist rehabilitation and care assistant support with specialist rehabilitation alone and usual care for people with Parkinson's living in the community: study protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Gage Heather

    2011-11-01

    Full Text Available Abstract Background Parkinson's Disease is a degenerative neurological condition that causes movement problems and other distressing symptoms. People with Parkinson's disease gradually lose their independence and strain is placed on family members. A multidisciplinary approach to rehabilitation for people with Parkinson's is recommended but has not been widely researched. Studies are needed that investigate cost-effective community-based service delivery models to reduce disability and dependency and admission to long term care, and improve quality of life. Methods A pragmatic three parallel group randomised controlled trial involving people with Parkinson's Disease and live-in carers (family friends or paid carers, and comparing: management by a specialist multidisciplinary team for six weeks, according to a care plan agreed between the professionals and the patient and carer (Group A; multidisciplinary team management and additional support for four months from a trained care assistant (Group B; usual care, no coordinated team care planning or ongoing support (Group C. Follow up will be for six months to determine the impact and relative cost-effectiveness of the two interventions, compared to usual care. The primary outcomes are disability (patients and strain (carers. Secondary outcomes include patient mobility, falls, speech, pain, self efficacy, health and social care use; carer general health; patient and carer social functioning, psychological wellbeing, health related quality of life. Semi structured interviews will be undertaken with providers (team members, care assistants, service commissioners, and patients and carers in groups A and B, to gain feedback about the acceptability of the interventions. A cost - effectiveness evaluation is embedded in the trial. Discussion The trial investigates components of recent national policy recommendations for people with long term conditions, and Parkinson's Disease in particular, and will

  19. Cost-effectiveness of nurse-led self-help for recurrent depression in the primary care setting: design of a pragmatic randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Biesheuvel-Leliefeld Karolien EM

    2012-06-01

    Full Text Available Abstract Background Major Depressive Disorder is a leading cause of disability, tends to run a recurrent course and is associated with substantial economic costs due to increased healthcare utilization and productivity losses. Interventions aimed at the prevention of recurrences may reduce patients' suffering and costs. Besides antidepressants, several psychological treatments such as preventive cognitive therapy (PCT are effective in the prevention of recurrences of depression. Yet, many patients find long-term use of antidepressants unattractive, do not want to engage in therapy sessions and in the primary care setting psychologists are often not available. Therefore, it is important to study whether PCT can be used in a nurse-led self-help format in primary care. This study sets out to test the hypothesis that usual care plus nurse-led self-help for recurrent depression in primary care is feasible, acceptable and cost-effective compared to usual care only. Design Patients are randomly assigned to ‘nurse-led self-help treatment plus usual care’ (134 participants or ‘usual care’ (134 participants. Randomisation is stratified according to the number of previous episodes (2 or 3 previous episodes versus 4 or more. The primary clinical outcome is the cumulative recurrence rate of depression meeting DSM-IV criteria as assessed by the Structured-Clinical-Interview-for-DSM-IV- disorders at one year after completion of the intervention. Secondary clinical outcomes are quality of life, severity of depressive symptoms, co-morbid psychopathology and self-efficacy. As putative effect-moderators, demographic characteristics, number of previous episodes, type of treatment during previous episodes, age of onset, self-efficacy and symptoms of pain and fatigue are assessed. Cumulative recurrence rate ratios are obtained under a Poisson regression model. Number-needed-to-be-treated is calculated as the inverse of the risk-difference. The economic

  20. Cost-effectiveness of exercise therapy versus general practitioner care for osteoarthritis of the hip: design of a randomised clinical trial

    Directory of Open Access Journals (Sweden)

    Verhaar Jan AN

    2011-10-01

    Full Text Available Abstract Background Osteoarthritis (OA is the most common joint disease, causing pain and functional impairments. According to international guidelines, exercise therapy has a short-term effect in reducing pain/functional impairments in knee OA and is therefore also generally recommended for hip OA. Because of its high prevalence and clinical implications, OA is associated with considerable (healthcare costs. However, studies evaluating cost-effectiveness of common exercise therapy in hip OA are lacking. Therefore, this randomised controlled trial is designed to investigate the cost-effectiveness of exercise therapy in conjunction with the general practitioner's (GP care, compared to GP care alone, for patients with hip OA. Methods/Design Patients aged ≥ 45 years with OA of the hip, who consulted the GP during the past year for hip complaints and who comply with the American College of Rheumatology criteria, are included. Patients are randomly assigned to either exercise therapy in addition to GP care, or to GP care alone. Exercise therapy consists of (maximally 12 treatment sessions with a physiotherapist, and home exercises. These are followed by three additional treatment sessions in the 5th, 7th and 9th month after the first treatment session. GP care consists of usual care for hip OA, such as general advice or prescribing pain medication. Primary outcomes are hip pain and hip-related activity limitations (measured with the Hip disability Osteoarthritis Outcome Score [HOOS], direct costs, and productivity costs (measured with the PROductivity and DISease Questionnaire. These parameters are measured at baseline, at 6 weeks, and at 3, 6, 9 and 12 months follow-up. To detect a 25% clinical difference in the HOOS pain score, with a power of 80% and an alpha 5%, 210 patients are required. Data are analysed according to the intention-to-treat principle. Effectiveness is evaluated using linear regression models with repeated measurements. An

  1. The QICKD study protocol: a cluster randomised trial to compare quality improvement interventions to lower systolic BP in chronic kidney disease (CKD in primary care

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    du Bois Elizabeth

    2009-07-01

    Full Text Available Abstract Background Chronic kidney disease (CKD is a relatively newly recognised but common long-term condition affecting 5 to 10% of the population. Effective management of CKD, with emphasis on strict blood pressure (BP control, reduces cardiovascular risk and slows the progression of CKD. There is currently an unprecedented rise in referral to specialist renal services, which are often located in tertiary centres, inconvenient for patients, and wasteful of resources. National and international CKD guidelines include quality targets for primary care. However, there have been no rigorous evaluations of strategies to implement these guidelines. This study aims to test whether quality improvement interventions improve primary care management of elevated BP in CKD, reduce cardiovascular risk, and slow renal disease progression Design Cluster randomised controlled trial (CRT Methods This three-armed CRT compares two well-established quality improvement interventions with usual practice. The two interventions comprise: provision of clinical practice guidelines with prompts and audit-based education. The study population will be all individuals with CKD from general practices in eight localities across England. Randomisation will take place at the level of the general practices. The intended sample (three arms of 25 practices powers the study to detect a 3 mmHg difference in systolic BP between the different quality improvement interventions. An additional 10 practices per arm will receive a questionnaire to measure any change in confidence in managing CKD. Follow up will take place over two years. Outcomes will be measured using anonymised routinely collected data extracted from practice computer systems. Our primary outcome measure will be reduction of systolic BP in people with CKD and hypertension at two years. Secondary outcomes will include biomedical outcomes and markers of quality, including practitioner confidence in managing CKD. A small

  2. Can an alert in primary care electronic medical records increase participation in a population-based screening programme for colorectal cancer? COLO-ALERT, a randomised clinical trial

    International Nuclear Information System (INIS)

    Colorectal cancer is an important public health problem in Spain. Over the last decade, several regions have carried out screening programmes, but population participation rates remain below recommended European goals. Reminders on electronic medical records have been identified as a low-cost and high-reach strategy to increase participation. Further knowledge is needed about their effect in a population-based screening programme. The main aim of this study is to evaluate the effectiveness of an electronic reminder to promote the participation in a population-based colorectal cancer screening programme. Secondary aims are to learn population’s reasons for refusing to take part in the screening programme and to find out the health professionals’ opinion about the official programme implementation and on the new computerised tool. This is a parallel randomised trial with a cross-sectional second stage. Participants: all the invited subjects to participate in the public colorectal cancer screening programme that includes men and women aged between 50–69, allocated to the eleven primary care centres of the study and all their health professionals. The randomisation unit will be the primary care physician. The intervention will consist of activating an electronic reminder, in the patient’s electronic medical record, in order to promote colorectal cancer screening, during a synchronous medical appointment, throughout the year that the intervention takes place. A comparison of the screening rates will then take place, using the faecal occult blood test of the patients from the control and the intervention groups. We will also take a questionnaire to know the opinions of the health professionals. The main outcome is the screening status at the end of the study. Data will be analysed with an intention-to-treat approach. We expect that the introduction of specific reminders in electronic medical records, as a tool to facilitate and encourage direct referral by

  3. The Leeds Evaluation of Efficacy of Detoxification Study (LEEDS project: An open-label pragmatic randomised control trial comparing the efficacy of differing therapeutic agents for primary care detoxification from either street heroin or methadone [ISRCTN07752728

    Directory of Open Access Journals (Sweden)

    Sheard Laura

    2004-04-01

    Full Text Available Abstract Background Heroin is a synthetic opioid with an extensive illicit market leading to large numbers of people becoming addicted. Heroin users often present to community treatment services requesting detoxification and in the UK various agents are used to control symptoms of withdrawal. Dissatisfaction with methadone detoxification 8 has lead to the use of clonidine, lofexidine, buprenorphine and dihydrocodeine; however, there remains limited evaluative research. In Leeds, a city of 700,000 people in the North of England, dihydrocodeine is the detoxification agent of choice. Sublingual buprenorphine, however, is being introduced. The comparative value of these two drugs for helping people successfully and comfortably withdraw from heroin has never been compared in a randomised trial. Additionally, there is a paucity of research evaluating interventions among drug users in the primary care setting. This study seeks to address this by randomising drug users presenting in primary care to receive either dihydrocodeine or buprenorphine. Methods/design The Leeds Evaluation of Efficacy of Detoxification Study (LEEDS project is a pragmatic randomised trial which will compare the open use of buprenorphine with dihydrocodeine for illicit opiate detoxification, in the UK primary care setting. The LEEDS project will involve consenting adults and will be run in specialist general practice surgeries throughout Leeds. The primary outcome will be the results of a urine opiate screening at the end of the detoxification regimen. Adverse effects and limited data to three and six months will be acquired.

  4. Neuroprotective effect of therapeutic hypothermia versus standard care alone after convulsive status epilepticus: protocol of the multicentre randomised controlled trial HYBERNATUS.

    Science.gov (United States)

    Legriel, Stephane; Pico, Fernando; Tran-Dinh, Yves-Roger; Lemiale, Virginie; Bedos, Jean-Pierre; Resche-Rigon, Matthieu; Cariou, Alain

    2016-12-01

    Convulsive status epilepticus (CSE) is a major medical emergency associated with a 50 % morbidity rate. CSE guidelines have recommended prompt management for many years, but there is no evidence to date that they have significantly improved practices or outcomes. Developing neuroprotective strategies for use after CSE holds promise for diminishing morbidity and mortality rates. Hypothermia has been shown to afford neuroprotection in various health conditions. We therefore designed a trial to determine whether 90-day outcomes in mechanically ventilated patients with CSE requiring management in the intensive care unit (ICU) are improved by early therapeutic hypothermia (32-34 °C) for 24 h with propofol sedation. We are conducting a multicentre, open-label, parallel-group, randomised, controlled trial (HYBERNATUS) of potential neuroprotective effects of therapeutic hypothermia and routine propofol sedation started within 8 h after CSE onset in ICU patients requiring mechanical ventilation. Included patients are allocated to receive therapeutic hypothermia (32-34 °C) plus standard care or standard care alone. We plan to enrol 270 patients in 11 ICUs. An interim analysis is scheduled after the inclusion of 135 patients. The main study objective is to evaluate the effectiveness of therapeutic hypothermia (32-34 °C) for 24 h in diminishing 90-day morbidity and mortality (defined as a Glasgow Outcome Scale score <5). The HYBERNATUS trial is expected to a decreased proportion of patients with a Glasgow Outcome Scale score lower than 5 after CSE requiring ICU admission and mechanical ventilation. Trial registration Clinicaltrials.gov identifier NCT01359332 (registered on 23 May 2011). PMID:27325409

  5. Can diabetes management be safely transferred to practice nurses in a primary care setting? A randomised controlled trial

    NARCIS (Netherlands)

    Houweling, Sebastiaan T.; Kleefstra, Nanne; van Hateren, Kornelis J. J.; Groenier, Klaas H.; Meyboom-de Jong, Betty; Bilo, Henk J. G.

    2011-01-01

    Aims and objectives. To determine whether the management of type 2 diabetes mellitus in a primary care setting can be safely transferred to practice nurses. Background. Because of the increasing prevalence of type 2 diabetes mellitus and the burden of caring for individual patients, the demand type

  6. A cluster randomised controlled trial of the community effectiveness of two interventions in rural Malawi to improve health care and to reduce maternal, newborn and infant mortality

    Directory of Open Access Journals (Sweden)

    Vergnano Stefania

    2010-09-01

    Full Text Available Abstract Background The UN Millennium Development Goals call for substantial reductions in maternal and child mortality, to be achieved through reductions in morbidity and mortality during pregnancy, delivery, postpartum and early childhood. The MaiMwana Project aims to test community-based interventions that tackle maternal and child health problems through increasing awareness and local action. Methods/Design This study uses a two-by-two factorial cluster-randomised controlled trial design to test the impact of two interventions. The impact of a community mobilisation intervention run through women's groups, on home care, health care-seeking behaviours and maternal and infant mortality, will be tested. The impact of a volunteer-led infant feeding and care support intervention, on rates of exclusive breastfeeding, uptake of HIV-prevention services and infant mortality, will also be tested. The women's group intervention will employ local female facilitators to guide women's groups through a four-phase cycle of problem identification and prioritisation, strategy identification, implementation and evaluation. Meetings will be held monthly at village level. The infant feeding intervention will select local volunteers to provide advice and support for breastfeeding, birth preparedness, newborn care and immunisation. They will visit pregnant and new mothers in their homes five times during and after pregnancy. The unit of intervention allocation will be clusters of rural villages of 2500-4000 population. 48 clusters have been defined and randomly allocated to either women's groups only, infant feeding support only, both interventions, or no intervention. Study villages are surrounded by 'buffer areas' of non-study villages to reduce contamination between intervention and control areas. Outcome indicators will be measured through a demographic surveillance system. Primary outcomes will be maternal, infant, neonatal and perinatal mortality for the

  7. Towards a more efficient diabetes control in primary care: six-monthly monitoring compared with three-monthly monitoring in type 2 diabetes - The EFFIMODI trial. Design of a randomised controlled patient-preference equivalence trial in primary care

    Directory of Open Access Journals (Sweden)

    Ardine de Wit G

    2010-05-01

    Full Text Available Abstract Background Scientific evidence for the frequency of monitoring of type 2 diabetes patients is lacking. If three-monthly control in general practice could be reduced to six-monthly control in some patients, this would on the one hand reduce the use of medical services including involvement of practice nurses, and thus reduce costs, and on the other hand alleviate the burden of people with type 2 diabetes. The goal of this study is to make primary diabetes care as efficient as possible for patients and health care providers. Therefore, we want to determine whether six-monthly monitoring of well-controlled type 2 diabetes patients in primary care leads to equivalent cardiometabolic control compared to the generally recommended three-monthly monitoring. Methods and design The study is a randomised controlled patient-preference equivalence trial. Participants are asked if they prefer three-monthly (usual care or six-monthly diabetes monitoring. If they do not have a preference, they are randomised to a three-monthly or six-monthly monitoring group. Patients are eligible for the study if they are between 40 and 80 years old, diagnosed with type 2 diabetes more than one year ago, treated by a general practitioner, not on insulin treatment, and with HbA1c ≤7.5%, systolic blood pressure ≤145 mmHg and total cholesterol ≤5.2 mmol/l. The intervention group (six-monthly monitoring will receive the same treatment with the same treatment targets as the control group (three-monthly monitoring. The intervention period will last one and a half year. After the intervention, the three-monthly and six-monthly monitoring groups are compared on equivalence of cardiometabolic control. Secondary outcome measures are HbA1c, blood pressure, cholesterol level, Body Mass Index, smoking behaviour, physical activity, loss of work due to illness, health status, diabetes-specific distress, satisfaction with treatment and adherence to medications. We will use

  8. Early rehabilitation in critical care (eRiCC): functional electrical stimulation with cycling protocol for a randomised controlled trial

    OpenAIRE

    Parry, Selina M.; Berney, Sue; Koopman, René; Bryant, Adam; El-Ansary, Doa; Puthucheary, Zudin; Hart, Nicholas; Warrillow, Stephen; Denehy, Linda

    2012-01-01

    Introduction Intensive care-acquired weakness is a common problem, leads to significant impairment in physical functioning and muscle strength, and is prevalent in individuals with sepsis. Early rehabilitation has been shown to be safe and feasible; however, commencement is often delayed due to a patient's inability to co-operate. An intervention that begins early in an intensive care unit (ICU) admission without the need for patient volition may be beneficial in attenuating muscle wasting. T...

  9. Effectiveness of geriatric rehabilitative care after fractures of the proximal femur in elderly women: a randomised clinical trial.

    OpenAIRE

    Kennie, D C; Reid, J.; Richardson, I. R.; Kiamari, A. A.; Kelt, C.

    1988-01-01

    OBJECTIVE--To compare postoperative collaborative care between orthopaedic surgeons and physicians in geriatric medicine with routine orthopaedic care in elderly women with proximal femoral fracture. DESIGN--Exclusion of patients dying before fit enough to enter trial, those with pathological fractures, those likely to be discharged within seven days of entering the trial, and those remaining unfit for transfer to a peripheral hospital. Remainder allocated to two groups: treatment group and c...

  10. A randomised trial of a psychosocial intervention for cancer patients integrated into routine care: the PROMPT study (promoting optimal outcomes in mood through tailored psychosocial therapies

    Directory of Open Access Journals (Sweden)

    Jolley Damien

    2011-02-01

    Full Text Available Abstract Background Despite evidence that up to 35% of patients with cancer experience significant distress, access to effective psychosocial care is limited by lack of systematic approaches to assessment, a paucity of psychosocial services, and patient reluctance to accept treatment either because of perceived stigma or difficulties with access to specialist psycho-oncology services due to isolation or disease burden. This paper presents an overview of a randomised study to evaluate the effectiveness of a brief tailored psychosocial Intervention delivered by health professionals in cancer care who undergo focused training and participate in clinical supervision. Methods/design Health professionals from the disciplines of nursing, occupational therapy, speech pathology, dietetics, physiotherapy or radiation therapy will participate in training to deliver the psychosocial Intervention focusing on core concepts of supportive-expressive, cognitive and dignity-conserving care. Health professional training will consist of completion of a self-directed manual and participation in a skills development session. Participating health professionals will be supported through structured clinical supervision whilst delivering the Intervention. In the stepped wedge design each of the 5 participating clinical sites will be allocated in random order from Control condition to Training then delivery of the Intervention. A total of 600 patients will be recruited across all sites. Based on level of distress or risk factors eligible patients will receive up to 4 sessions, each of up to 30 minutes in length, delivered face-to-face or by telephone. Participants will be assessed at baseline and 10-week follow-up. Patient outcome measures include anxiety and depression, quality of life, unmet psychological and supportive care needs. Health professional measures include psychological morbidity, stress and burnout. Process evaluation will be conducted to assess perceptions

  11. The effectiveness of adding cognitive behavioural therapy aimed at changing lifestyle to managed diabetes care for patients with type 2 diabetes: design of a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    van Oppen Patricia

    2007-05-01

    Full Text Available Abstract Background In patients with type 2 diabetes, the risk for cardiovascular disease is substantial. To achieve a more favourable risk profile, lifestyle changes on diet, physical activity and smoking status are needed. This will involve changes in behaviour, which is difficult to achieve. Cognitive behavioural therapies focussing on self-management have been shown to be effective. We have developed an intervention combining techniques of Motivational Interviewing (MI and Problem Solving Treatment (PST. The aim of our study is to investigate if adding a combined behavioural intervention to managed care, is effective in achieving changes in lifestyle and cardiovascular risk profile. Methods Patients with type 2 diabetes will be selected from general practices (n = 13, who are participating in a managed diabetes care system. Patients will be randomised into an intervention group receiving cognitive behaviour therapy (CBT in addition to managed care, and a control group that will receive managed care only. The CBT consists of three to six individual sessions of 30 minutes to increase the patient's motivation, by using principles of MI, and ability to change their lifestyle, by using PST. The first session will start with a risk assessment of diabetes complications that will be used to focus the intervention. The primary outcome measure is the difference between intervention and control group in change in cardiovascular risk score. For this purpose blood pressure, HbA1c, total and HDL-cholesterol and smoking status will be assessed. Secondary outcome measures are quality of life, patient satisfaction, physical activity, eating behaviour, smoking status, depression and determinants of behaviour change. Differences between changes in the two groups will be analysed according to the intention-to-treat principle, with 95% confidence intervals. The power calculation is based on the risk for cardiovascular disease and we calculated that 97 patients

  12. The Hand Eczema Trial (HET): Design of a randomised clinical trial of the effect of classification and individual counselling versus no intervention among health-care workers with hand eczema

    DEFF Research Database (Denmark)

    Ibler, Kristina Sophie; Agner, Tove; Hansen, Jane L.;

    2010-01-01

    strategies are needed to reduce occupational hand eczema. METHODS/DESIGN: We describe the design of a randomised clinical trial to investigate the effects of classification of hand eczema plus individual counselling versus no intervention. The trial includes health-care workers with hand eczema identified...... from a self-administered questionnaire delivered to 3181 health-care workers in three Danish hospitals. The questionnaire identifies the prevalence of hand eczema, knowledge of skin-protection, and exposures that can lead to hand eczema. At entry, all participants are assessed regarding: disease...

  13. Improving person-centred care in nursing homes through dementia-care mapping: design of a cluster-randomised controlled trial.

    OpenAIRE

    van de Ven Geertje; Draskovic Irena; Adang Eddy MM; Donders Rogier ART; Post Aukje; Zuidema Sytse U; Koopmans Raymond TCM; Vernooij-Dassen Myrra JFJ

    2012-01-01

    Abstract Background The effectiveness and efficiency of nursing-home dementia care are suboptimal: there are high rates of neuropsychiatric symptoms among the residents and work-related stress among the staff. Dementia-care mapping is a person-centred care method that may alleviate both the resident and the staff problems. The main objective of this study is to evaluate the effectiveness and cost-effectiveness of dementia-care mapping in nursing-home dementia care. Methods/Design The study is...

  14. Effectiveness of interdisciplinary vs. dermatological care of moderate-to-severe psoriasis: a pragmatic randomised controlled trial.

    Science.gov (United States)

    Schmitt, Jochen; Wozel, Gottfried; Garzarolli, Marlene; Viehweg, Antje; Bauer, Michael; Leopold, Karolina

    2014-03-01

    Psychiatric morbidity is frequent in patients with psoriasis. We compared the effectiveness of dermatological vs. interdisciplinary dermatological and psychiatric care for psoriasis. Adults with moderate-to-severe psoriasis were randomly allocated to dermatological (n = 24) or interdisciplinary care (n = 23) and treated accordingly. Primary endpoint was the mean change in Dermatology Life Quality Index (DLQI) at 6 months. Data was analysed by intention-to-treat. Mean ± SD change in DLQI was 7.5 ± 7.3 and 10.5 ± 9.9 after 6 months of dermatological and interdisciplinary care, respectively (p = 0.27). At baseline, 10 patients in the interdisciplinary treatment group (43%) had at least one psychiatric disorder. These patients showed significantly better DLQI response (DLQI change 14.8 ± 9.7) than patients receiving dermatological care only (p = 0.03). Ninety percent of psoriasis patients with DLQI scores exceeding psoriasis area and severity index (PASI) scores had comorbid psychiatric disease. Although psychiatric co-treatment is not generally required for patients with moderate-to-severe psoriasis, those patients with higher DLQI scores than PASI scores might benefit from interdisciplinary care. PMID:23995849

  15. Protocol for Birmingham Atrial Fibrillation Treatment of the Aged study (BAFTA: a randomised controlled trial of warfarin versus aspirin for stroke prevention in the management of atrial fibrillation in an elderly primary care population [ISRCTN89345269

    Directory of Open Access Journals (Sweden)

    Fletcher Kate

    2003-08-01

    Full Text Available Abstract Background Atrial fibrillation (AF is an important independent risk factor for stroke. Randomised controlled trials have shown that this risk can be reduced substantially by treatment with warfarin or more modestly by treatment with aspirin. Existing trial data for the effectiveness of warfarin are drawn largely from studies in selected secondary care populations that under-represent the elderly. The Birmingham Atrial Fibrillation Treatment of the Aged (BAFTA study will provide evidence of the risks and benefits of warfarin versus aspirin for the prevention of stroke for older people with AF in a primary care setting. Study design A randomised controlled trial where older patients with AF are randomised to receive adjusted dose warfarin or aspirin. Patients will be followed up at three months post-randomisation, then at six monthly intervals there after for an average of three years by their general practitioner. Patients will also receive an annual health questionnaire. 1240 patients will be recruited from over 200 practices in England. Patients must be aged 75 years or over and have AF. Patients will be excluded if they have a history of any of the following conditions: rheumatic heart disease; major non-traumatic haemorrhage; intra-cranial haemorrhage; oesophageal varices; active endoscopically proven peptic ulcer disease; allergic hypersensitivity to warfarin or aspirin; or terminal illness. Patients will also be excluded if the GP considers that there are clinical reasons to treat a patient with warfarin in preference to aspirin (or vice versa. The primary end-point is fatal or non-fatal disabling stroke (ischaemic or haemorrhagic or significant arterial embolism. Secondary outcomes include major extra-cranial haemorrhage, death (all cause, vascular, hospital admissions (all cause, vascular, cognition, quality of life, disability and compliance with study medication.

  16. Can an EASYcare based dementia training programme improve diagnostic assessment and management of dementia by general practitioners and primary care nurses? The design of a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Lucassen PL

    2008-04-01

    Full Text Available Abstract Background Early diagnosis of dementia benefits both patient and caregiver. Nevertheless, dementia in primary care is currently under-diagnosed. Some educational interventions developed to improve dementia diagnosis and management were successful in increasing the number of dementia diagnoses and in changing attitudes and knowledge of health care staff. However, none of these interventions focussed on collaboration between GPs and nurses in dementia care. We developed an EASYcare-based Dementia Training Program (DTP aimed at stimulating collaboration in dementia primary care. We expect this program to increase the number of cognitive assessments and dementia diagnoses and to improve attitudes and knowledge of GPs and nurses. Methods The DTP is a complex educational intervention that consists of two workshops, a coaching program, access to an internet forum, and a Computerized Clinical Decision Support System on dementia diagnostics. One hundred duos of GPs and nurses will be recruited, from which 2/3 will be allocated to the intervention group and 1/3 to the control group. The effects of implementation of the DTP will be studied in a cluster-randomised controlled trial. Primary outcomes will be the number of cognitive assessments and dementia diagnoses in a period of 9 months following workshop participation. Secondary outcomes are measured on GP and nurse level: adherence to national guidelines for dementia, attitude, confidence and knowledge regarding dementia diagnosis and management; on patient level: number of emergency calls, visits and consultations and patient satisfaction; and on caregiver level: informal caregiver burden and satisfaction. Data will be collected from GPs' electronic medical records, self-registration forms and questionnaires. Statistical analysis will be performed using the MANOVA-method. Also, exploratory analyses will be performed, in order to gain insight into barriers and facilitators for implementation and

  17. The opportunities and challenges of pragmatic point-of-care randomised trials using routinely collected electronic records: evaluations of two exemplar trials.

    Science.gov (United States)

    van Staa, Tjeerd-Pieter; Dyson, Lisa; McCann, Gerard; Padmanabhan, Shivani; Belatri, Rabah; Goldacre, Ben; Cassell, Jackie; Pirmohamed, Munir; Torgerson, David; Ronaldson, Sarah; Adamson, Joy; Taweel, Adel; Delaney, Brendan; Mahmood, Samhar; Baracaia, Simona; Round, Thomas; Fox, Robin; Hunter, Tommy; Gulliford, Martin; Smeeth, Liam

    2014-01-01

    BACKGROUND Pragmatic trials compare the effects of different decisions in usual clinical practice. OBJECTIVES To develop and evaluate methods to implement simple pragmatic trials using routinely collected electronic health records (EHRs) and recruiting patients at the point of care; to identify the barriers and facilitators for general practitioners (GPs) and patients and the experiences of trial participants. DESIGN Two exemplar randomised trials (Retropro and eLung) with qualitative evaluations. SETTING Four hundred and fifty-nine English and Scottish general practices contributing EHRs to a research database, of which 17 participated in the trials. PARTICIPANTS Retropro aimed to recruit 300 patients with hypercholesterolaemia and high cardiovascular risk and eLung aimed to recruit 150 patients with a chronic obstructive pulmonary disease exacerbation. INTERVENTIONS Retropro randomised between simvastatin and atorvastatin and eLung between immediate antibiotics and deferred or non-use. eLung recruited during an unscheduled consultation using EHR flagging. MAIN OUTCOME MEASURE Successful trial completion with implementation of information technology (IT) system for flagging and data processing and documentation of operational and scientific experiences. DATA SOURCES EHR research database. RESULTS The governance approval process took over 3 years. A total of 58.8% of the practices (n = 270) expressed interest in participating. The number of interested practices dropped substantially with each stage of the governance process. In Retropro, 6.5% of the practices (n = 30) were eventually approved and 3.7% (n = 17) recruited patients; in eLung, these numbers were 6.8% (n = 31) and 1.3% (n = 6) respectively. Retropro successfully completed recruitment (301 patients) whereas eLung recruited 31 patients. Retropro recruited 20.6% of all statin starters in recruiting practices and 1.1% in the EHR database; the comparable numbers for eLung were 32.3% and 0

  18. An integrated palliative and respiratory care for patients with advanced disease and refractory breathlessness: a randomised controlled trial

    NARCIS (Netherlands)

    I.J. Higginson; C. Bausewein; C.C. Reilly; W. Gao; M. Gysels; M. Dzingina; P. McCrone; S. Booth; C.J. Jolley; J. Moxham

    2014-01-01

    Background Breathlessness is a common and distressing symptom, which increases in many diseases as they progress and is difficult to manage. We assessed the effectiveness of early palliative care integrated with respiratory services for patients with advanced disease and refractory breathlessness. M

  19. A multifaceted intervention to implement guidelines and improve admission paediatric care in Kenyan district hospitals: a cluster randomised trial.

    Directory of Open Access Journals (Sweden)

    Philip Ayieko

    2011-04-01

    Full Text Available BACKGROUND: In developing countries referral of severely ill children from primary care to district hospitals is common, but hospital care is often of poor quality. However, strategies to change multiple paediatric care practices in rural hospitals have rarely been evaluated. METHODS AND FINDINGS: This cluster randomized trial was conducted in eight rural Kenyan district hospitals, four of which were randomly assigned to a full intervention aimed at improving quality of clinical care (evidence-based guidelines, training, job aides, local facilitation, supervision, and face-to-face feedback; n  =  4 and the remaining four to control intervention (guidelines, didactic training, job aides, and written feedback; n  =  4. Prespecified structure, process, and outcome indicators were measured at baseline and during three and five 6-monthly surveys in control and intervention hospitals, respectively. Primary outcomes were process of care measures, assessed at 18 months postbaseline. In both groups performance improved from baseline. Completion of admission assessment tasks was higher in intervention sites at 18 months (mean  =  0.94 versus 0.65, adjusted difference 0.54 [95% confidence interval 0.05-0.29]. Uptake of guideline recommended therapeutic practices was also higher within intervention hospitals: adoption of once daily gentamicin (89.2% versus 74.4%; 17.1% [8.04%-26.1%]; loading dose quinine (91.9% versus 66.7%, 26.3% [-3.66% to 56.3%]; and adequate prescriptions of intravenous fluids for severe dehydration (67.2% versus 40.6%; 29.9% [10.9%-48.9%]. The proportion of children receiving inappropriate doses of drugs in intervention hospitals was lower (quinine dose >40 mg/kg/day; 1.0% versus 7.5%; -6.5% [-12.9% to 0.20%], and inadequate gentamicin dose (2.2% versus 9.0%; -6.8% [-11.9% to -1.6%]. CONCLUSIONS: Specific efforts are needed to improve hospital care in developing countries. A full, multifaceted intervention was associated

  20. The GRAIDS Trial: a cluster randomised controlled trial of computer decision support for the management of familial cancer risk in primary care

    OpenAIRE

    Emery, J.; Morris, H.; R. Goodchild; Fanshawe, T.; Prevost, A.T.; Bobrow, M.; Kinmonth, A L

    2007-01-01

    The objective was to evaluate the effect of an assessment strategy using the computer decision support system (the GRAIDS software), on the management of familial cancer risk in British general practice in comparison with best current practice. The design included cluster randomised controlled trial, and involved forty-five general practice teams in East Anglia, UK. Randomised to GRAIDS (Genetic Risk Assessment on the Internet with Decision Support) support (intervention n=23) or comparison (...

  1. A randomised, multicentre clinical trial of specialised palliative care plus standard treatment versus standard treatment alone for cancer patients with palliative care needs

    DEFF Research Database (Denmark)

    Johnsen, Anna Thit; Damkier, Anette; Vejlgaard, Tove Bahn;

    2013-01-01

    Advanced cancer patients experience considerable symptoms, problems, and needs. Early referral of these patients to specialised palliative care (SPC) could improve their symptoms and problems.The Danish Palliative Care Trial (DanPaCT) investigates whether patients with metastatic cancer, who report...... palliative needs in a screening, will benefit from being referred to 'early SPC'....

  2. A cluster randomised pragmatic trial applying Self-determination theory to type 2 diabetes care in general practice

    DEFF Research Database (Denmark)

    Juul, Lise; Maindal, Helle T; Zoffmann, Vibeke;

    2011-01-01

    BACKGROUND: Treatment recommendations for prevention of type 2 diabetes complications often require radical and life-long health behaviour changes. Observational studies based on Self-determination theory (SDT) propose substantial factors for the maintenance of behaviour changes and concomitant......, and well-being among a diabetes population, 2) the actual intervention to a level of detail that allows its replication, and 3) the connection between SDT recommendations for health care-provider behaviour and the content of the training course. METHODS/DESIGN: The study is a cluster...... intervention will be assessed on the diabetes populations with regard to well-being (PAID, SF-12), HbA1c- and cholesterol-levels, perceived autonomy support (HCCQ), type of motivation (TSRQ), and perceived competence for diabetes care (PCD) 15-21 months after the core course; the completion of the second...

  3. Effect of Removing Direct Payment for Health Care on Utilisation and Health Outcomes in Ghanaian Children: A Randomised Controlled Trial.

    OpenAIRE

    Evelyn Korkor Ansah; Solomon Narh-Bana; Sabina Asiamah; Vivian Dzordzordzi; Kingsley Biantey; Kakra Dickson; John Owusu Gyapong; Kwadwo Ansah Koram; Greenwood, Brian M; Anne Mills; Christopher J M Whitty

    2009-01-01

    Editors' Summary Background. Every year, about 10 million children worldwide die before their fifth birthday. About half these deaths occur in developing countries in sub-Saharan Africa. Here, 166 children out of every 1,000 die before they are five. A handful of preventable diseases—acute respiratory infections, diarrhea, malaria, measles, and HIV/AIDS—are responsible for most of these deaths. For all these diseases, delays in accessing medical care contribute to the high death rate. In the ...

  4. The impact of a disease management program (COACH on the attainment of better cardiovascular risk control in dyslipidaemic patients at primary care centres (The DISSEMINATE Study: a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Selvaraj Francis Jude

    2012-10-01

    Full Text Available Abstract Background To evaluate the efficacy of Counselling and Advisory Care for Health (COACH programme in managing dyslipidaemia among primary care practices in Malaysia. This open-label, parallel, randomised controlled trial compared the COACH programme delivered by primary care physicians alone (PCP arm and primary care physicians assisted by nurse educators (PCP-NE arm. Methods This was a multi-centre, open label, randomised trial of a disease management programme (COACH among dyslipidaemic patients in 21 Malaysia primary care practices. The participating centres enrolled 297 treatment naïve subjects who had the primary diagnosis of dyslipidaemia; 149 were randomised to the COACH programme delivered by primary care physicians assisted by nurse educators (PCP-NE and 148 to care provided by primary care physicians (PCP alone. The primary efficacy endpoint was the mean percentage change from baseline LDL-C at week 24 between the 2 study arms. Secondary endpoints included mean percentage change from baseline of lipid profile (TC, LDL-C, HDL-C, TG, TC: HDL ratio, Framingham Cardiovascular Health Risk Score and absolute risk change from baseline in blood pressure parameters at week 24. The study also assessed the sustainability of programme efficacy at week 36. Results Both study arms demonstrated improvement in LDL-C from baseline. The least squares (LS mean change from baseline LDL-C were −30.09% and −27.54% for PCP-NE and PCP respectively. The difference in mean change between groups was 2.55% (p=0.288, with a greater change seen in the PCP-NE arm. Similar observations were made between the study groups in relation to total cholesterol change at week 24. Significant difference in percentage change from baseline of HDL-C were observed between the PCP-NE and PCP groups, 3.01%, 95% CI 0.12-5.90, p=0.041, at week 24. There was no significant difference in lipid outcomes between 2 study groups at week 36 (12 weeks after the programme had

  5. Fitness consultations in routine care of patients with type 2 diabetes in general practice: an 18-month non-randomised intervention study

    Directory of Open Access Journals (Sweden)

    Siersma Volkert

    2010-11-01

    Full Text Available Abstract Background Increasing physical activity is a cornerstone in the treatment of type 2 diabetes and in general practice it is a challenge to achieve long-term adherence to this life style change. The aim of this study was to investigate in a non-randomised design whether the introduction of motivational interviewing combined with fitness tests in the type 2 diabetes care programme was followed by a change in cardio-respiratory fitness expressed by VO2max, muscle strength of upper and lower extremities, haemoglobin A1c (HbA1c and HDL-cholesterol. Methods Uncontrolled 18-month intervention study with follow-up and effect assessment every 3 months in a primary care unit in Denmark with six general practitioners (GPs. Of 354 eligible patients with type 2 diabetes, 127 (35.9% were included. Maximum work capacity was tested on a cycle ergometer and converted to VO2max. Muscle strength was measured with an arm curl test and a chair stand test. The results were used in a subsequent motivational interview conducted by one of the GPs. Patients were encouraged to engage in lifestyle exercise and simple home-based self-managed exercise programmes. Data were analysed with mixed models. Results At end of study, 102 (80.3% participants remained in the intervention. Over 18 months, VO2max increased 2.5% (p = 0.032 while increases of 33.2% (p 1c remained unchanged (p = 0.57 on a low level (6.8%. Patients without cardiovascular disease or pain from function limitation increased their VO2max by 5.2% (p Conclusions In this 18-month study, participants who had repeated fitness consultations, including physical testing and motivational interviewing to improve physical activity, improved VO2max, muscle strength, and lipid profile. Our results indicate that physical testing combined with motivational interviewing is feasible in a primary health care setting. Here, a fitness consultation tailored to the individual patient, his/her comorbidities and conditions in

  6. Cost-effectiveness of an intensive group training protocol compared to physiotherapy guideline care for sub-acute and chronic low back pain: design of a randomised controlled trial with an economic evaluation. [ISRCTN45641649

    Directory of Open Access Journals (Sweden)

    Franken Willemien K

    2004-11-01

    Full Text Available Abstract Background Low back pain is a common disorder in western industrialised countries and the type of treatments for low back pain vary considerably. Methods In a randomised controlled trial the cost-effectiveness and cost-utility of an intensive group training protocol versus physiotherapy guideline care for sub-acute and chronic low back pain patients is evaluated. Patients with back pain for longer than 6 weeks who are referred to physiotherapy care by their general practitioner or medical specialist are included in the study. The intensive group training protocol combines exercise therapy with principles of behavioural therapy ("graded activity" and back school. This training protocol is compared to physiotherapy care according to the recently published Low Back Pain Guidelines of the Royal Dutch College for Physiotherapy. Primary outcome measures are general improvement, pain intensity, functional status, work absenteeism and quality of life. The direct and indirect costs will be assessed using cost diaries. Patients will complete questionnaires at baseline and 6, 13, 26 and 52 weeks after randomisation. Discussion No trials are yet available that have evaluated the effect of an intensive group training protocol including behavioural principles and back school in a primary physiotherapy care setting and no data on cost-effectiveness and cost-utility are available.

  7. Dietary approach to hypertension based on low glycaemic index and principles of DASH (Dietary Approaches to Stop Hypertension): a randomised trial in a primary care service.

    Science.gov (United States)

    Lima, Sílvia Tereza Rodrigues Moreira; da Silva Nalin de Souza, Bárbara; França, Ana Karina Teixeira; Salgado Filho, Natalino; Sichieri, Rosely

    2013-10-01

    Hypertension is one of the leading causes of morbidity and mortality in Brazil. Diet may play an important role in reducing blood pressure (BP), as has been shown for diets high in fruits, vegetables and low-fat dairy products and low in salt (Dietary Approaches to Stop Hypertension (DASH)-Na). A low-glycaemic index Brazilian diet combined with the principles of the DASH-Na diet was evaluated in a randomised study of 206 individuals who were followed for 6 months. In the control group (CG), counselling was based on standard care and mainly focused on salt intake reduction. An intention-to-treat analysis showed that, after 6 months, systolic BP was reduced by 14·4 mmHg and diastolic BP by 9·7 mmHg in the experimental group (EG), compared with 6·7 and 4·6 mmHg, respectively, in the CG. After adjusting for body weight, BP at baseline and age, these changes were 12·1 and 7·9 mmHg, respectively. Urinary Na excretion was also reduced by 43·4 mEq/24 h in the EG. Food intake was modified accordingly during the intervention with an increase in the consumption of vegetables (2·97-5·85 frequency of consumption measured in three non-consecutive days), fruits (4·09-7·18), beans (1·94-3·13) and fish (1·80-2·74) by the EG. The present study showed the feasibility of a Brazilian dietary approach to treating hypertension by reducing urinary Na excretion and BP, changes that may have a great impact on public health and promote the benefits of controlling hypertension.

  8. Randomised controlled trial of counseling sessions, antidepressant medication, and combined treatment for major depression in primary care setting

    International Nuclear Information System (INIS)

    The study was made to determine whether counseling sessions using Egan's model combined with antidepressant medication is more effective than either treatment alone in the management of major depression in primary care. Patient aged 18 years and above with major depression on the research diagnostic criteria - a score of 13 or more on the 17 items. Hamilton rating scale for depression and a minimum duration of 4 weeks. Counseling sessions based on Egan's Model by research family physician or antidepressant medication or combination of both was performed. Hamilton rating scale for depression, Beck depression inventory, clinical interview schedule, and modified social adjustment schedule were used and assessed at 6 , 12 and 52 weeks. Patients in all groups showed a clear improvement after 12 weeks. The combination of counseling sessions and antidepressant medication is more effective than either treatment alone. Counseling sessions used by a trained family physician is an effective treatment for depressive disorders in primary care. The combination of this treatment with antidepressant medication is more effective than either treatment alone. (author)

  9. Protocol for the MoleMate™ UK Trial: a randomised controlled trial of the MoleMate system in the management of pigmented skin lesions in primary care [ISRCTN 79932379

    Directory of Open Access Journals (Sweden)

    Wilson Edward CF

    2010-05-01

    Full Text Available Abstract Background Suspicious pigmented lesions are a common presenting problem in general practice consultations; while the majority are benign a small minority are melanomas. Differentiating melanomas from other pigmented lesions in primary care is challenging: currently, 95% of all lesions referred to a UK specialist are benign. The MoleMate system is a new diagnostic aid, incorporating a hand-held SIAscopy scanner with a primary care diagnostic algorithm. This trial tests the hypothesis that adding the MoleMate system to current best primary care practice will increase the proportion of appropriate referrals of suspicious pigmented lesions to secondary care compared with current best practice alone. Methods/design The MoleMate UK Trial is a primary care based multi-centre randomised controlled trial, with randomisation at patient level using a validated block randomisation method for two age groups (45 years and under; 46 years and over. We aim to recruit adult patients seen in general practice with a pigmented skin lesion that cannot immediately be diagnosed as benign and the patient reassured. The trial has a 'two parallel groups' design, comparing 'best practice' with 'best practice' plus the MoleMate system in the intervention group. The primary outcome is the positive predictive value (PPV of referral defined as the proportion of referred lesions seen by secondary care experts that are considered 'clinically significant' (i.e. biopsied or monitored. Secondary outcomes include: the sensitivity, specificity and negative predictive value (NPV of the decision not to refer; clinical outcomes (melanoma thickness, 5 year melanoma incidence and mortality; clinician outcomes (Index of Suspicion, confidence, learning effects; patient outcomes (satisfaction, general and cancer-specific worry, and cost-utility. Discussion The MoleMate UK Trial tests a new technology designed to improve the management of suspicious pigmented lesions in primary care

  10. Interventions to improve executive functioning and working memory in school-aged children with AD(HD: a randomised controlled trial and stepped-care approach

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    van der Donk Marthe LA

    2013-01-01

    Full Text Available Abstract Background Deficits in executive functioning are of great significance in attention-deficit/hyperactivity disorder (ADHD. One of these executive functions, working memory, plays an important role in academic performance and is often seen as the core deficit of this disorder. There are indications that working memory problems and academic performance can be improved by school-oriented interventions but this has not yet been studied systematically. In this study we will determine the short- and long-term effects of a working memory - and an executive function training applied in a school situation for children with AD(HD, taking individual characteristics, the level of impairment and costs (stepped-care approach into account. Methods/design The study consists of two parts: the first part is a randomised controlled trial with school-aged children (8–12 yrs with AD(HD. Two groups (each n = 50 will be randomly assigned to a well studied computerized working memory training ‘Cogmed’, or to the ‘Paying attention in class’ intervention which is an experimental school-based executive function training. Children will be selected from regular -and special education primary schools in the region of Amsterdam, the Netherlands. The second part of the study will determine which specific characteristics are related to non-response of the ‘Paying attention in class’ intervention. School-aged children (8–12 yrs with AD(HD will follow the experimental school-based executive function training ‘Paying attention in class’ (n = 175. Academic performance and neurocognitive functioning (primary outcomes are assessed before, directly after and 6 months after training. Secondary outcome measures are: behaviour in class, behaviour problems and quality of life. Discussion So far, there is limited but promising evidence that working memory – and other executive function interventions can improve academic performance. Little is know about the

  11. The effectiveness of a home care program for supporting caregivers of persons with dementia in developing countries: a randomised controlled trial from Goa, India.

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    Amit Dias

    Full Text Available OBJECTIVES: To develop and evaluate the effectiveness of a home based intervention in reducing caregiver burden, promoting caregiver mental health and reducing behavioural problems in elderly persons with dementia. METHODOLOGY AND PRINCIPAL FINDINGS: This was a randomised controlled trial in which the person with dementia-caregiver dyad was randomly allocated either to receive the intervention immediately or to a waiting list group which received the intervention after 6 months. It was carried out in communities based in two talukas (administrative blocks in Goa, India. Mild to moderate cases with dementia (diagnosed using the DSM IV criteria and graded using the Clinical Dementia Rating scale and their caregivers were included in the trial. Community based intervention provided by a team consisting of Home Care Advisors who were supervised by a counselor and a psychiatrist, focusing on supporting the caregiver through information on dementia, guidance on behaviour management, a single psychiatric assessment and psychotropic medication if needed. We measured caregiver mental health (General Health Questionnaire, caregiver burden (Zarit Burden Score, distress due to behavioural disturbances (NPI-D, behavioural problems in the subject (NPI-S and activities of daily living in the elder with dementia (EASI. Outcome evaluations were masked to the allocation status. We analysed each outcome with a mixed effects model. 81 families enrolled in the trial; 41 were randomly allocated to the intervention. 59 completed the trial and 18 died during the trial. The intervention led to a significant reduction of GHQ (-1.12, 95% CI -2.07 to -0.17 and NPI-D scores (-1.96, 95%CI -3.51 to -0.41 and non-significant reductions in the ZBS, EASI and NPI-S scores. We also observed a non-significant reduction in the total number of deaths in people with dementia in the intervention arm (OR 0.34, 95% CI 0.01 to 1.03. CONCLUSION: Home based support for caregivers of persons

  12. Effectiveness of a Home-Based Counselling Strategy on Neonatal Care and Survival: A Cluster-Randomised Trial in Six Districts of Rural Southern Tanzania.

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    Claudia Hanson

    2015-09-01

    Full Text Available We report a cluster-randomised trial of a home-based counselling strategy, designed for large-scale implementation, in a population of 1.2 million people in rural southern Tanzania. We hypothesised that the strategy would improve neonatal survival by around 15%.In 2010 we trained 824 female volunteers to make three home visits to women and their families during pregnancy and two visits to them in the first few days of the infant's life in 65 wards, selected randomly from all 132 wards in six districts in Mtwara and Lindi regions, constituting typical rural areas in Southern Tanzania. The remaining wards were comparison areas. Participants were not blinded to the intervention. The primary analysis was an intention-to-treat analysis comparing the neonatal mortality (day 0-27 per 1,000 live births in intervention and comparison wards based on a representative survey in 185,000 households in 2013 with a response rate of 90%. We included 24,381 and 23,307 live births between July 2010 and June 2013 and 7,823 and 7,555 live births in the last year in intervention and comparison wards, respectively. We also compared changes in neonatal mortality and newborn care practices in intervention and comparison wards using baseline census data from 2007 including 225,000 households and 22,243 births in five of the six intervention districts. Amongst the 7,823 women with a live birth in the year prior to survey in intervention wards, 59% and 41% received at least one volunteer visit during pregnancy and postpartum, respectively. Neonatal mortality reduced from 35.0 to 30.5 deaths per 1,000 live births between 2007 and 2013 in the five districts, respectively. There was no evidence of an impact of the intervention on neonatal survival (odds ratio [OR] 1.1, 95% confidence interval [CI] 0.9-1.2, p = 0.339. Newborn care practices reported by mothers were better in intervention than in comparison wards, including immediate breastfeeding (42% of 7,287 versus 35% of 7

  13. A cluster randomised controlled trial of the clinical and cost-effectiveness of a 'whole systems' model of self-management support for the management of long- term conditions in primary care: trial protocol

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    Bower Peter

    2012-01-01

    Full Text Available Abstract Background Patients with long-term conditions are increasingly the focus of quality improvement activities in health services to reduce the impact of these conditions on quality of life and to reduce the burden on care utilisation. There is significant interest in the potential for self-management support to improve health and reduce utilisation in these patient populations, but little consensus concerning the optimal model that would best provide such support. We describe the implementation and evaluation of self-management support through an evidence-based 'whole systems' model involving patient support, training for primary care teams, and service re-organisation, all integrated into routine delivery within primary care. Methods The evaluation involves a large-scale, multi-site study of the implementation, effectiveness, and cost-effectiveness of this model of self-management support using a cluster randomised controlled trial in patients with three long-term conditions of diabetes, chronic obstructive pulmonary disease (COPD, and irritable bowel syndrome (IBS. The outcome measures include healthcare utilisation and quality of life. We describe the methods of the cluster randomised trial. Discussion If the 'whole systems' model proves effective and cost-effective, it will provide decision-makers with a model for the delivery of self-management support for populations with long-term conditions that can be implemented widely to maximise 'reach' across the wider patient population. Trial registration number ISRCTN: ISRCTN90940049

  14. Enhanced maternal and child health nurse care for women experiencing intimate partner/family violence: protocol for MOVE, a cluster randomised trial of screening and referral in primary health care

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    Taft Angela J

    2012-09-01

    Full Text Available Abstract Background Intimate partner violence (IPV can result in significant harm to women and families and is especially prevalent when women are pregnant or recent mothers. Maternal and child health nurses (MCHN in Victoria, Australia are community-based nurse/midwives who see over 95% of all mothers with newborns. MCHN are in an ideal position to identify and support women experiencing IPV, or refer them to specialist family violence services. Evidence for IPV screening in primary health care is inconclusive to date. The Victorian government recently required nurses to screen all mothers when babies are four weeks old, offering an opportunity to examine the effectiveness of MCHN IPV screening practices. This protocol describes the development and design of MOVE, a study to examine IPV screening effectiveness and the sustainability of screening practice. Methods/design MOVE is a cluster randomised trial of a good practice model of MCHN IPV screening involving eight maternal and child health nurse teams in Melbourne, Victoria. Normalisation Process Theory (NPT was incorporated into the design, implementation and evaluation of the MOVE trial to enhance and evaluate sustainability. Using NPT, the development stage combined participatory action research with intervention nurse teams and a systematic review of nurse IPV studies to develop an intervention model incorporating consensus guidelines, clinical pathway and strategies for individual nurses, their teams and family violence services. Following twelve months’ implementation, primary outcomes assessed include IPV inquiry, IPV disclosure by women and referral using data from MCHN routine data collection and a survey to all women giving birth in the previous eight months. IPV will be measured using the Composite Abuse Scale. Process and impact evaluation data (online surveys and key stakeholders interviews will highlight NPT concepts to enhance sustainability of IPV identification and referral

  15. A pilot randomised controlled trial of personalised care for depressed patients with symptomatic coronary heart disease in South London general practices: the UPBEAT-UK RCT protocol and recruitment

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    Tylee André

    2012-06-01

    Full Text Available Abstract Background Community studies reveal people with coronary heart disease (CHD are twice as likely to be depressed as the general population and that this co-morbidity negatively affects the course and outcome of both conditions. There is evidence for the efficacy of collaborative care and case management for depression treatment, and whilst NICE guidelines recommend these approaches only where depression has not responded to psychological, pharmacological, or combined treatments, these care approaches may be particularly relevant to the needs of people with CHD and depression in the earlier stages of stepped care in primary care settings. Methods This pilot randomised controlled trial will evaluate whether a simple intervention involving a personalised care plan, elements of case management and regular telephone review is a feasible and acceptable intervention that leads to better mental and physical health outcomes for these patients. The comparator group will be usual general practitioner (GP care. 81 participants have been recruited from CHD registers of 15 South London general practices. Eligible participants have probable major depression identified by a score of ≥8 on the Hospital Anxiety and Depression Scale depression subscale (HADS-D together with symptomatic CHD identified using the Modified Rose Angina Questionnaire. Consenting participants are randomly allocated to usual care or the personalised care intervention which involves a comprehensive assessment of each participant’s physical and mental health needs which are documented in a care plan, followed by regular telephone reviews by the case manager over a 6-month period. At each review, the intervention participant’s mood, function and identified problems are reviewed and the case manager uses evidence based behaviour change techniques to facilitate achievement of goals specified by the patient with the aim of increasing the patient’s self efficacy to solve their

  16. Primary care based randomised, double blind trial of amoxicillin versus placebo for acute otitis media in children aged under 2 years

    NARCIS (Netherlands)

    Damoiseaux, RAMJ; van Balen, FAM; Hoes, AW; Verheij, TJM; de Melker, RA

    2000-01-01

    Objective To determine the effect of antibiotic treatment for acute otitis media in children between 6 months and 2 years of age. Design Practice based, double blind, randomised, placebo controlled trial. Setting 53 general practices in the Netherlands. Subjects 240 children aged 6 months to 2 years

  17. Improving management of patients with acute cough by C-reactive protein point of care testing and communication training (IMPAC3T: study protocol of a cluster randomised controlled trial

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    Severens Johan L

    2007-03-01

    Full Text Available Abstract Background Most antibiotic prescriptions for acute cough due to lower respiratory tract infections (LRTI in primary care are not warranted. Diagnostic uncertainty and patient expectations and worries are major drivers of unnecessary antibiotic prescribing. A C-reactive protein (CRP point of care test may help GPs to better guide antibiotic treatment by ruling out pneumonia in cases of low test results. Alternatively, enhanced communication skills training to help clinicians address patients' expectations and worries could lead to a decrease in antibiotic prescribing, without compromising clinical recovery, while enhancing patient enablement. The aim of this paper is to describe the design and methods of a study to assess two interventions for improving LRTI management in general practice. Methods/Design This cluster randomised controlled, factorial trial will introduce two interventions in general practice; point of care CRP testing and enhanced communication skills training for LRTI. Twenty general practices with two participating GPs per practice will recruit 400 patients with LRTI during two winter periods. Patients will be followed up for at least 28 days. The primary outcome measure is the antibiotic prescribing rate. Secondary outcomes are clinical recovery, cost-effectiveness, use of other diagnostic tests and medical services (including reconsultation, and patient enablement. Discussion This trial is the first cluster randomised trial to evaluate the influence of point of care CRP testing in the hands of the general practitioner and enhanced communication skills, on the management of LRTI in primary care. The pragmatic nature of the study, which leaves treatment decisions up to the responsible clinicians, will enhance the applicability and generalisability of findings. The factorial design will allow conclusion to be made about the value of CRP testing on its own, communication skills training on its own, and the two combined

  18. Enhanced relapse prevention for bipolar disorder – ERP trial. A cluster randomised controlled trial to assess the feasibility of training care coordinators to offer enhanced relapse prevention for bipolar disorder

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    Peters Sarah

    2007-02-01

    Full Text Available Abstract Background Bipolar Disorder (BD is a common and severe form of mental illness characterised by repeated relapses of mania or depression. Pharmacotherapy is the main treatment currently offered, but this has only limited effectiveness. A recent Cochrane review has reported that adding psycho-social interventions that train people to recognise and manage the early warning signs of their relapses is effective in increasing time to recurrence, improving social functioning and in reducing hospitalisations. However, the review also highlights the difficulties in offering these interventions within standard mental health services due to the need for highly trained therapists and extensive input of time. There is a need to explore the potential for developing Early Warning Sign (EWS interventions in ways that will enhance dissemination. Methods and design This article describes a cluster-randomised trial to assess the feasibility of training care coordinators (CCs in community mental health teams (CMHTs to offer Enhanced Relapse Prevention (ERP to people with Bipolar Disorder. CMHTs in the North West of England are randomised to either receive training in ERP and to offer this to their clients, or to continue to offer treatment as usual (TAU. The main aims of the study are (1 to determine the acceptability of the intervention, training and outcome measures (2 to assess the feasibility of the design as measured by rates of recruitment, retention, attendance and direct feedback from participants (3 to estimate the design effect of clustering for key outcome variables (4 to estimate the effect size of the impact of the intervention on outcome. In this paper we provide a rationale for the study design, briefly outline the ERP intervention, and describe in detail the study protocol. Discussion This information will be useful to researchers attempting to carry out similar feasibility assessments of clinical effectiveness trials and in particular

  19. A cluster randomised controlled trial of the community effectiveness of two interventions in rural Malawi to improve health care and to reduce maternal, newborn and infant mortality

    OpenAIRE

    Vergnano Stefania; Malamba Florida; Chapota Hilda; Rosato Mikey; Mganga Andrew; Phiri Tambosi; Kazembe Peter; Mwansambo Charles; Lewycka Sonia; Newell Marie-Louise; Osrin David; Costello Anthony

    2010-01-01

    Abstract Background The UN Millennium Development Goals call for substantial reductions in maternal and child mortality, to be achieved through reductions in morbidity and mortality during pregnancy, delivery, postpartum and early childhood. The MaiMwana Project aims to test community-based interventions that tackle maternal and child health problems through increasing awareness and local action. Methods/Design This study uses a two-by-two factorial cluster-randomised controlled trial design ...

  20. Protocol for Northern Ireland Caries Prevention in Practice Trial (NIC-PIP) trial: a randomised controlled trial to measure the effects and costs of a dental caries prevention regime for young children attending primary care dental services

    LENUS (Irish Health Repository)

    Tickle, Martin

    2011-10-10

    Abstract Background Dental caries is a persistent public health problem with little change in the prevalence in young children over the last 20 years. Once a child contracts the disease it has a significant impact on their quality of life. There is good evidence from Cochrane reviews including trials that fluoride varnish and regular use of fluoride toothpaste can prevent caries. The Northern Ireland Caries Prevention in Practice Trial (NIC-PIP) trial will compare the costs and effects of a caries preventive package (fluoride varnish, toothpaste, toothbrush and standardised dental health education) with dental health education alone in young children. Methods\\/Design A randomised controlled trial on children initially aged 2 and 3 years old who are regular attenders at the primary dental care services in Northern Ireland. Children will be recruited and randomised in dental practices. Children will be randomised to the prevention package of both fluoride varnish (twice per year for three years), fluoride toothpaste (1,450 ppm F) (supplied twice per year), a toothbrush (supplied twice a year) or not; both test and control groups receive standardised dental health education delivered by the dentist twice per year. Randomisation will be conducted by the Belfast Trust Clinical Research Support Centre ([CRSC] a Clinical Trials Unit). 1200 participants will be recruited from approximately 40 dental practices. Children will be examined for caries by independent dental examiners at baseline and will be excluded if they have caries. The independent dental examiners will examine the children again at 3 years blinded to study group. The primary end-point is whether the child develops caries (cavitation into dentine) or not over the three years. One secondary outcome is the number of carious surfaces in the primary dentition in children who experience caries. Other secondary outcomes are episodes of pain, extraction of primary teeth, other adverse events and costs which will

  1. Protocol for Northern Ireland Caries Prevention in Practice Trial (NIC-PIP trial: a randomised controlled trial to measure the effects and costs of a dental caries prevention regime for young children attending primary care dental services

    Directory of Open Access Journals (Sweden)

    Noble Solveig

    2011-10-01

    Full Text Available Abstract Background Dental caries is a persistent public health problem with little change in the prevalence in young children over the last 20 years. Once a child contracts the disease it has a significant impact on their quality of life. There is good evidence from Cochrane reviews including trials that fluoride varnish and regular use of fluoride toothpaste can prevent caries. The Northern Ireland Caries Prevention in Practice Trial (NIC-PIP trial will compare the costs and effects of a caries preventive package (fluoride varnish, toothpaste, toothbrush and standardised dental health education with dental health education alone in young children. Methods/Design A randomised controlled trial on children initially aged 2 and 3 years old who are regular attenders at the primary dental care services in Northern Ireland. Children will be recruited and randomised in dental practices. Children will be randomised to the prevention package of both fluoride varnish (twice per year for three years, fluoride toothpaste (1,450 ppm F (supplied twice per year, a toothbrush (supplied twice a year or not; both test and control groups receive standardised dental health education delivered by the dentist twice per year. Randomisation will be conducted by the Belfast Trust Clinical Research Support Centre ([CRSC] a Clinical Trials Unit. 1200 participants will be recruited from approximately 40 dental practices. Children will be examined for caries by independent dental examiners at baseline and will be excluded if they have caries. The independent dental examiners will examine the children again at 3 years blinded to study group. The primary end-point is whether the child develops caries (cavitation into dentine or not over the three years. One secondary outcome is the number of carious surfaces in the primary dentition in children who experience caries. Other secondary outcomes are episodes of pain, extraction of primary teeth, other adverse events and costs

  2. Hands4U: A multifaceted strategy to implement guideline-based recommendations to prevent hand eczema in health care workers: design of a randomised controlled trial and (cost effectiveness evaluation

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    van der Gulden Joost W

    2011-08-01

    Full Text Available Abstract Background Workers in wet work occupations have a risk for developing hand eczema. Prevention strategies exist, but compliance to the proposed recommendations is poor. Therefore, a multifaceted implementation strategy (MIS is developed to implement these recommendations to reduce hand eczema among health care workers performing wet work. Methods/Design This study is a randomised controlled trial in three university hospitals in the Netherlands. Randomisation to the control or intervention group is performed at department level. The control group receives a leaflet containing the recommendations only. The intervention group receives the MIS which consists of five parts: 1 within a department, a participatory working group is formed to identify problems with the implementation of the recommendations, to find solutions for it and implement these solutions; 2 role models will help their colleagues in performing the desired behaviour; 3 education to all workers will enhance knowledge about (the prevention of hand eczema; 4 reminders will be placed at the department reminding workers to use the recommendations; 5 workers receive the same leaflet as the control group containing the recommendations. Data are collected by questionnaires at baseline and after 3, 6, 9 and 12 months. The primary outcome measure is self-reported hand eczema. The most important secondary outcome measures are symptoms of hand eczema; actual use of the recommendations; sick leave; work productivity; and health care costs. Analyses will be performed according to the intention to treat principle. Cost-effectiveness of the MIS will be evaluated from both the societal and the employer's perspective. Discussion The prevention of hand eczema is important for the hospital environment. If the MIS has proven to be effective, a major improvement in the health of health care workers can be obtained. Results are expected in 2014. Trial registration number NTR2812

  3. Reducing errors in health care: cost-effectiveness of multidisciplinary team training in obstetric emergencies (TOSTI study; a randomised controlled trial

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    Mol Ben

    2010-10-01

    Full Text Available Abstract Background There are many avoidable deaths in hospitals because the care team is not well attuned. Training in emergency situations is generally followed on an individual basis. In practice, however, hospital patients are treated by a team composed of various disciplines. To prevent communication errors, it is important to focus the training on the team as a whole, rather than on the individual. Team training appears to be important in contributing toward preventing these errors. Obstetrics lends itself to multidisciplinary team training. It is a field in which nurses, midwives, obstetricians and paediatricians work together and where decisions must be made and actions must be carried out under extreme time pressure. It is attractive to belief that multidisciplinary team training will reduce the number of errors in obstetrics. The other side of the medal is that many hospitals are buying expensive patient simulators without proper evaluation of the training method. In the Netherlands many hospitals have 1,000 or less annual deliveries. In our small country it might therefore be more cost-effective to train obstetric teams in medical simulation centres with well trained personnel, high fidelity patient simulators, and well defined training programmes. Methods/design The aim of the present study is to evaluate the cost-effectiveness of multidisciplinary team training in a medical simulation centre in the Netherlands to reduce the number of medical errors in obstetric emergency situations. We plan a multicentre randomised study with the centre as unit of analysis. Obstetric departments will be randomly assigned to receive multidisciplinary team training in a medical simulation centre or to a control arm without any team training. The composite measure of poor perinatal and maternal outcome in the non training group was thought to be 15%, on the basis of data obtained from the National Dutch Perinatal Registry and the guidelines of the

  4. Evidence-based interventions in dementia: A pragmatic cluster-randomised trial of an educational intervention to promote earlier recognition and response to dementia in primary care (EVIDEM-ED

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    Koch Tamar

    2010-02-01

    Full Text Available Abstract Background The National Dementia Strategy seeks to enhance general practitioners' diagnostic and management skills in dementia. Early diagnosis in dementia within primary care is important as this allows those with dementia and their family care networks to engage with support services and plan for the future. There is, however, evidence that dementia remains under-detected and sub-optimally managed in general practice. An earlier unblinded, cluster randomised controlled study tested the effectiveness of educational interventions in improving detection rates and management of dementia in primary care. In this original trial, a computer decision support system and practice-based educational workshops were effective in improving rates of detecting dementia although not in changing clinical management. The challenge therefore is to find methods of changing clinical management. Our aim in this new trial is to test a customised educational intervention developed for general practice, promoting both earlier diagnosis and concordance with management guidelines. Design/Method The customised educational intervention combines practice-based workshops and electronic support material. Its effectiveness will be tested in an unblinded cluster randomised controlled trial with a pre-post intervention design, with two arms; normal care versus the educational intervention. Twenty primary care practices have been recruited with the aim of gaining 200 patient participants. We will examine whether the intervention is effective, pragmatic and feasible within the primary care setting. Our primary outcome measure is an increase in the proportion of patients with dementia who receive at least two dementia-specific management reviews per year. We will also examine important secondary outcomes such as practice concordance with management guidelines and benefits to patients and carers in terms of quality of life and carer strain. Discussion The EVIDEM-ED trial

  5. The Hand Eczema Trial (HET): Design of a randomised clinical trial of the effect of classification and individual counselling versus no intervention among health-care workers with hand eczema

    DEFF Research Database (Denmark)

    Ibler, Kristina Sophie; Agner, Tove; Hansen, Jane L.;

    2010-01-01

    from a self-administered questionnaire delivered to 3181 health-care workers in three Danish hospitals. The questionnaire identifies the prevalence of hand eczema, knowledge of skin-protection, and exposures that can lead to hand eczema. At entry, all participants are assessed regarding: disease...... severity (Hand Eczema Severity Index); self-evaluated disease severity; number of eruptions; quality of life; skin protective behaviour, and knowledge of skin protection. The patients are centrally randomised to intervention versus no intervention 1:1 stratified for hospital, profession, and severity score......BACKGROUND: Hand eczema is the most frequently recognized occupational disease in Denmark with an incidence of approximately 0.32 per 1000 person-years. Consequences of hand eczema include chronic severe eczema, prolonged sick leave, unemployment, and impaired quality of life. New preventive...

  6. Shared care or nursing consultations as an alternative to rheumatologist follow-up for rheumatoid arthritis outpatients with low disease activity--patient outcomes from a 2-year, randomised controlled trial

    DEFF Research Database (Denmark)

    Primdahl, Jette; Sørensen, Jan; Horn, Hans Christian;

    2014-01-01

    )-pain, fatigue, global health, confidence and satisfaction, quality-of-life by the Short Form 12 and self-efficacy measured by the RA Self-Efficacy questionnaire and the Arthritis Self-Efficacy Scale, were recorded annually and safety measures were recorded. x-Rays of hands and feet were taken at baseline.......049). The nursing group increased their self-efficacy (Arthritis Self-Efficacy Scale 18.8, p=0.001), confidence (10.7, p=0.001) and satisfaction (10.8, psatisfaction compared with the rheumatologist group after 1 year...... were randomised to 2-year follow-up by either: (1) planned rheumatologist consultations, (2) shared care without planned consultations or (3) planned nursing consultations. The primary outcome was change in disease activity. DAS28-CRP, Health Assessment Questionnaire, visual analogue scale (VAS...

  7. Protocol for the ADDITION-Plus study: a randomised controlled trial of an individually-tailored behaviour change intervention among people with recently diagnosed type 2 diabetes under intensive UK general practice care

    Directory of Open Access Journals (Sweden)

    Fanshawe Tom

    2011-04-01

    Full Text Available Abstract Background The increasing prevalence of type 2 diabetes poses both clinical and public health challenges. Cost-effective approaches to prevent progression of the disease in primary care are needed. Evidence suggests that intensive multifactorial interventions including medication and behaviour change can significantly reduce cardiovascular morbidity and mortality among patients with established type 2 diabetes, and that patient education in self-management can improve short-term outcomes. However, existing studies cannot isolate the effects of behavioural interventions promoting self-care from other aspects of intensive primary care management. The ADDITION-Plus trial was designed to address these issues among recently diagnosed patients in primary care over one year. Methods/Design ADDITION-Plus is an explanatory randomised controlled trial of a facilitator-led, theory-based behaviour change intervention tailored to individuals with recently diagnosed type 2 diabetes. 34 practices in the East Anglia region participated. 478 patients with diabetes were individually randomised to receive (i intensive treatment alone (n = 239, or (ii intensive treatment plus the facilitator-led individual behaviour change intervention (n = 239. Facilitators taught patients key skills to facilitate change and maintenance of key behaviours (physical activity, dietary change, medication adherence and smoking, including goal setting, action planning, self-monitoring and building habits. The intervention was delivered over one year at the participant's surgery and included a one-hour introductory meeting followed by six 30-minute meetings and four brief telephone calls. Primary endpoints are physical activity energy expenditure (assessed by individually calibrated heart rate monitoring and movement sensing, change in objectively measured dietary intake (plasma vitamin C, medication adherence (plasma drug levels, and smoking status (plasma cotinine levels at

  8. GILT - A randomised phase III study of oral vinorelbine and cisplatin with concomitant radiotherapy followed by either consolidation therapy with oral vinorelbine and cisplatin or best supportive care alone in stage III non-small cell lung cancer

    International Nuclear Information System (INIS)

    Concurrent chemoradiotherapy (CRT) is considered standard for inoperable stage III non-small cell lung cancer (NSCLC). Consolidation chemotherapy (CC) following CRT is intended to further improve outcomes, yet studies have shown discordant results. This phase III study assessed CRT followed by best supportive care (BSC) or consolidation with oral vinorelbine and cisplatin. Patients received two cycles of oral vinorelbine (50 mg/m2 days 1, 8 and 15) + cisplatin (20 mg/m2 days 1-4) q4w + radiotherapy (RT; 66 Gy). Patients with at least stable disease (SD) were randomised to either two cycles oral vinorelbine (60-80 mg/m2 days 1 and 8) + cisplatin (80 mg/m2 day 1) q3w + BSC or BSC alone. Primary endpoint was progression-free survival (PFS). A total of 279 patients were enrolled for CRT and 201 patients were randomised to CC or BSC. Both CRT and CC were well tolerated, with limited radiation-mediated grade 3/4 toxicities (CRT/CC/BSC: oesophagitis-related events 12.9 %/3.1 %/0 %; grade 3 pneumonitis 0 %/0 %/2 %) and chemotherapy-mediated grade 3/4 toxicities (CRT/CC: neutropenia 11.2 %/22.1 %; leukopenia 18.3 %/26.7 %; grade 3 nausea 5.0 %/2.3 %, grade 3 vomiting 3.2 %/3.5 %). Median PFS from randomisation was 6.4 (5.0-8.7) and 5.5 (3.8-7.4) months in the CC and BSC arms (hazard ratio, HR = 0.93 [0.69-1.26]; p = 0.63), respectively; median overall survival (OS) 20.8 (13.5-25.3) and 18.5 (13.6-24.7) months, respectively. Consolidation chemotherapy after concurrent CRT did not prolong PFS or OS. Concurrent RT with oral vinorelbine and cisplatin demonstrated a favourable safety profile and represents a suitable treatment regimen for inoperable stage III NSCLC. (orig.)

  9. A Vertical Handoff Algorithm for Multi-network Coexistence Based on Bayesian Dicision%多网络共存下基于贝叶斯的垂直切换算法

    Institute of Scientific and Technical Information of China (English)

    孔令斌; 王军选; 孙长印

    2016-01-01

    To solve the problem that current vertical switching technologies generally cannot support vertical handover in multi-network handover,this paper proposes an improved vertical handover algorithm based on Bayesian Decision Theory. First, the handover probability distribution associated with multi-condition is established according to the signal strength of access network,bit error rate( BER) ,blocking rate and actual demand on network from different customer service to calculate a priori handover probability. Then, the posterior probability is calculated on account of the Bayesian Decision Algorithm to perform a dicision com-parison,thereby selecting an optimal access network. Simulation results indicate that the algorithm can not only effectively achieve vertical handover among the different wireless access technologies,avoid needless handover,improve the successful probability of handover, but also reduce the blocking of communication hotspots so as to provide users with better quality services when an average load of each network reaches 30% ~40%.%针对目前的垂直切换技术普遍不能满足多网络下的切换问题,提出了一种改进的基于贝叶斯决策的垂直切换算法。首先根据接入终端网络的信号强度、网络负载、误码率和网络阻塞率以及用户业务对网络的实际需求偏好建立多条件相关的切换概率分布,计算出先验切换概率;然后通过贝叶斯决策算法计算出后验概率来进行判决比较,从而选取最优的接入网络。仿真结果表明,该算法不仅能有效地实现不同接入技术之间的垂直切换,从而减少不必要的切换,提高了切换成功的概率,而且还能在维持各网络平均负载达到30%~40%时减轻通信热点的阻塞情况,为用户提供更优的服务质量。

  10. The SPHERE Study. Secondary prevention of heart disease in general practice: protocol of a randomised controlled trial of tailored practice and patient care plans with parallel qualitative, economic and policy analyses. [ISRCTN24081411].

    LENUS (Irish Health Repository)

    Murphy, Andrew W

    2005-07-29

    BACKGROUND: The aim of the SPHERE study is to design, implement and evaluate tailored practice and personal care plans to improve the process of care and objective clinical outcomes for patients with established coronary heart disease (CHD) in general practice across two different health systems on the island of Ireland. CHD is a common cause of death and a significant cause of morbidity in Ireland. Secondary prevention has been recommended as a key strategy for reducing levels of CHD mortality and general practice has been highlighted as an ideal setting for secondary prevention initiatives. Current indications suggest that there is considerable room for improvement in the provision of secondary prevention for patients with established heart disease on the island of Ireland. The review literature recommends structured programmes with continued support and follow-up of patients; the provision of training, tailored to practice needs of access to evidence of effectiveness of secondary prevention; structured recall programmes that also take account of individual practice needs; and patient-centred consultations accompanied by attention to disease management guidelines. METHODS: SPHERE is a cluster randomised controlled trial, with practice-level randomisation to intervention and control groups, recruiting 960 patients from 48 practices in three study centres (Belfast, Dublin and Galway). Primary outcomes are blood pressure, total cholesterol, physical and mental health status (SF-12) and hospital re-admissions. The intervention takes place over two years and data is collected at baseline, one-year and two-year follow-up. Data is obtained from medical charts, consultations with practitioners, and patient postal questionnaires. The SPHERE intervention involves the implementation of a structured systematic programme of care for patients with CHD attending general practice. It is a multi-faceted intervention that has been developed to respond to barriers and solutions to

  11. Effectiveness of involving a nurse specialist for patients with urinary incontinence in primary care: results of a pragmatic multicentre randomised controlled trial.

    NARCIS (Netherlands)

    Albers-Heitner, P.C.; Lagro-Janssen, A.L.M.; Joore, M.M.; Berghmans, B.L.; Nieman, F.F.; Venema, P.P.; Severens, J.J.; Winkens, R.R.

    2011-01-01

    BACKGROUND: Urinary incontinence (UI) primary care management is substandard, offering care rather than cure despite the existence of guidelines that help to improve cure. Involving nurse specialists on incontinence in general practice could be a way to improve care for UI patients. AIMS: We studied

  12. Randomised controlled trials: important but overrated?

    LENUS (Irish Health Repository)

    Boylan, J F

    2012-02-01

    Practising physicians individualise treatments, hoping to achieve optimal outcomes by tackling relevant patient variables. The randomised controlled trial (RCT) is universally accepted as the best means of comparison. Yet doctors sometimes wonder if particular patients might benefit more from treatments that fared worse in the RCT comparisons. Such clinicians may even feel ostracised by their peers for stepping outside treatments based on RCTs and guidelines. Are RCTs the only acceptable evaluations of how patient care can be assessed and delivered? In this controversy we explore the interpretation of RCT data for practising clinicians facing individualised patient choices. First, critical care anaesthetists John Boylan and Brian Kavanagh emphasise the dangers of bias and show how Bayesian approaches utilise prior probabilities to improve posterior (combined) probability estimates. Secondly, Jane Armitage, of the Clinical Trial Service Unit in Oxford, argues why RCTs remain essential and explores how the quality of randomisation can be improved through systematic reviews and by avoiding selective reporting.

  13. Can a self-management programme delivered by a community pharmacist improve asthma control? A randomised trial

    OpenAIRE

    Barbanel, D; Eldridge, S; Griffiths, C

    2003-01-01

    Background: No randomised studies have addressed whether self-management for asthma can be successfully delivered by community pharmacists. Most randomised trials of asthma self-management have recruited participants from secondary care; there is uncertainty regarding its effectiveness in primary care. A randomised controlled study was undertaken to determine whether a community pharmacist could improve asthma control using self-management advice for individuals recruited during attendance at...

  14. Prevention of fall incidents in patients with a high risk of falling: design of a randomised controlled trial with an economic evaluation of the effect of multidisciplinary transmural care

    Directory of Open Access Journals (Sweden)

    Bouter Lex M

    2007-07-01

    Full Text Available Abstract Background Annually, about 30% of the persons of 65 years and older falls at least once and 15% falls at least twice. Falls often result in serious injuries, such as fractures. Therefore, the prevention of accidental falls is necessary. The aim is to describe the design of a study that evaluates the efficacy and cost-effectiveness of a multidisciplinary assessment and treatment of multiple fall risk factors in independently living older persons with a high risk of falling. Methods/Design The study is designed as a randomised controlled trial (RCT with an economic evaluation. Independently living persons of 65 years and older who recently experienced a fall are interviewed in their homes and screened for risk of recurrent falling using a validated fall risk profile. Persons at low risk of recurrent falling are excluded from the RCT. Persons who have a high risk of recurrent falling are blindly randomised into an intervention (n = 100 or usual care (n = 100 group. The intervention consists of a multidisciplinary assessment and treatment of multifactorial fall risk factors. The transmural multidisciplinary appraoch entails close cooperation between geriatrician, primary care physician, physical therapist and occupational therapist and can be extended with other specialists if relevant. A fall calendar is used to record falls during one year of follow-up. Primary outcomes are time to first and second falls. Three, six and twelve months after the home visit, questionnaires for economic evaluation are completed. After one year, during a second home visit, the secondary outcome measures are reassessed and the adherence to the interventions is evaluated. Data will be analysed according to the intention-to-treat principle and also an on-treatment analysis will be performed. Discussion Strengths of this study are the selection of persons at high risk of recurrent falling followed by a multidisciplinary intervention, its transmural character and

  15. A randomised controlled trial to compare a range of commercial or primary care led weight reduction programmes with a minimal intervention control for weight loss in obesity: the Lighten Up trial

    Directory of Open Access Journals (Sweden)

    Beach Jane

    2010-07-01

    Full Text Available Abstract Background Developed countries are facing a huge rise in the prevalence of obesity and its associated chronic medical problems. In the UK Primary Care Trusts are charged with addressing this in the populations they serve, but evidence about the most effective ways of delivering services is not available. The aim of this study is to determine the effectiveness of a range of weight loss programmes for obese patients in primary care and to determine the characteristics of patients who respond to an invitation to a free weight management programme. Methods/Design Lighten Up is a randomised controlled trial comparing a range of 12-week commercial and NHS weight reduction programmes with a comparator group who are provided with 12 vouchers enabling free entrance to a local leisure centre. The weight reduction programmes are: (i Weight Watchers, (ii Slimming World, (iii Rosemary Conley, (iv a group-based dietetics-led programme (Size Down, (v general practice one-to-one counselling, (vi pharmacy-led one-to-one counselling, (vii choice of any of the 6 programmes. People with obesity or overweight with a co-morbid disorder are invited to take part by a letter from their general practitioner. The sample size is 740 participants. The primary outcome is weight loss at programme-end (3 months. Secondary outcomes are weight-loss at one year, self-reported physical activity at 3 and 12 months follow-up and percentage weight-loss at 3 months and one year. Discussion This trial will provide evidence about the effectiveness of a range of different weight management programmes in a primary care population. Trial registration Current Controlled Trials ISRCTN25072883

  16. Effectiveness of a Peer Support Programme versus Usual Care in Disease Management of Diabetes Mellitus Type 2 regarding Improvement of Metabolic Control: A Cluster-Randomised Controlled Trial

    Directory of Open Access Journals (Sweden)

    Tim Johansson

    2016-01-01

    Full Text Available Aim. Testing the effectiveness of peer support additionally to a disease management programme (DMP for type 2 diabetes patients. Methods. Unblinded cluster-randomised controlled trial (RCT involving 49 general practices, province of Salzburg, Austria. All patients enrolled in the DMP were eligible, n=337 participated (intervention: 148 in 19 clusters; control: 189 in 20 clusters. The peer support intervention ran over 24 months and consisted of peer supporter recruitment and training, and group meetings weekly for physical exercise and monthly for discussion of diabetes related topics. Results. At two-year follow-up, adjusted analysis revealed a nonsignificant difference in HbA1c change of 0.14% (21.97 mmol/mol in favour of the intervention (95% CI −0.08 to 0.36%, p=0.22. Baseline values were 7.02 ± 1.25% in the intervention and 7.08 ± 1.25 in the control group. None of the secondary outcome measures showed significant differences except for improved quality of life (EQ-5D-VAS in controls (4.3 points on a scale of 100; 95% CI 0.08 to 8.53, p=0.046 compared to the intervention group. Conclusion. Our peer support intervention as an additional DMP component showed no significant effect on HbA1c and secondary outcome measures. Further RTCs with a longer follow-up are needed to reveal whether peer support will have clinically relevant effects. Trial Registration. This trial has been registered with Current Controlled Trials Ltd. (ISRCTN10291077.

  17. Effectiveness of a parenting programme in a public health setting: a randomised controlled trial of the positive parenting programme (Triple P level 3 versus care as usual provided by the preventive child healthcare (PCH

    Directory of Open Access Journals (Sweden)

    Jansen Daniëlle EMC

    2010-03-01

    Full Text Available Abstract Background Considering the high burden of disease of psychosocial problems in children and adolescents, early intervention regarding problem behaviour of young children is very important. The Preventive Child Healthcare (PCH offers a good setting to detect such problem behaviour and to provide parenting support to the parents concerned. This paper aims to describe the design of an effectiveness study of a parenting programme for parents of children with mild psychosocial problems after an initial, evidence based screening in routine PCH. Methods/Design The effects of the intervention will be studied in a randomised controlled trial. Prior to a routine PCH health examination, parents complete a screening questionnaire on psychosocial problems. Parents of children with increased but still subclinical levels of psychosocial problems will be assigned at random to the experimental group (Triple P, level 3 or to the control group (care as usual. Outcome measures, such as problem behaviour in the child and parenting behaviour, will be assessed before, directly after and 6 and 12 months after the intervention. Discussion Parenting support may be an effective intervention to reduce psychosocial problems in children but evidence-based parenting programmes that fit the needs of the PCH are not available as yet. Although the Triple P programme seems promising and suitable for a universal population approach, evidence on its effectiveness in routine PCH still lacks. Trial registration NTR1338

  18. The role of radiography in primary care patients with low back pain of at least 6 weeks duration. A randomised (unblinded) controlled trial

    International Nuclear Information System (INIS)

    Lumbar spine radiography in primary care patients with low back pain of at least 6 weeks duration is not associated with improved functioning, severity of pain or overall health status, and is associated with an increase in GP workload. Participants receiving X-rays are more satisfied with their care, but are not less worried or more reassured about serious disease causing their low back pain

  19. Randomised clinical trial

    DEFF Research Database (Denmark)

    Reimer, C; Lødrup, A B; Smith, G;

    2016-01-01

    of an alginate (Gaviscon Advance, Reckitt Benckiser, Slough, UK) on reflux symptoms in patients with persistent symptoms despite once daily PPI. METHODS: This was a multicentre, randomised, placebo-controlled, 7-day double-blind trial preceded by a 7-day run-in period. Reflux symptoms were assessed using...

  20. Randomised controlled trial of a complex intervention by primary care nurses to increase walking in patients aged 60–74 years: protocol of the PACE-Lift (Pedometer Accelerometer Consultation Evaluation - Lift trial

    Directory of Open Access Journals (Sweden)

    Harris Tess

    2013-01-01

    Full Text Available Abstract Background Physical activity is essential for older peoples’ physical and mental health and for maintaining independence. Guidelines recommend at least 150 minutes weekly, of at least moderate intensity physical activity, with activity on most days. Older people’s most common physical activity is walking, light intensity if strolling, moderate if brisker. Less than 20% of United Kingdom 65–74 year olds report achieving the guidelines, despite most being able to. Effective behaviour change techniques include strategies such as goal setting, self-monitoring, building self-efficacy and relapse prevention. Primary care physical activity consultations allow individual tailoring of advice. Pedometers measure step-counts and accelerometers measure physical activity intensity. This protocol describes an innovative intervention to increase walking in older people, incorporating pedometer and accelerometer feedback within a primary care nurse physical activity consultation, using behaviour change techniques. Methods/Design Design: Randomised controlled trial with intervention and control (usual care arms plus process and qualitative evaluations. Participants: 300 people aged 60–74 years registered with 3 general practices within Oxfordshire and Berkshire West primary care trusts, able to walk outside and with no restrictions to increasing their physical activity. Intervention: 3 month pedometer and accelerometer based intervention supported by practice nurse physical activity consultations. Four consultations based on behaviour change techniques, physical activity diary, pedometer average daily steps and accelerometer feedback on physical activity intensity. Individual physical activity plans based on increasing walking and other existing physical activity will be produced. Outcomes: Change in average daily steps (primary outcome and average time spent in at least moderate intensity physical activity weekly (secondary outcome at 3 months

  1. The CHICO (Children's Cough) Trial protocol: a feasibility randomised controlled trial investigating the clinical and cost-effectiveness of a complex intervention to improve the management of children presenting to primary care with acute respiratory tract infection

    Science.gov (United States)

    Turnbull, Sophie L; Redmond, Niamh M; Lucas, Patricia; Cabral, Christie; Ingram, Jenny; Hollinghurst, Sandra; Hay, Alastair D; Peters, Tim J; Horwood, Jeremy; Little, Paul; Francis, Nick; Blair, Peter S

    2015-01-01

    Introduction While most respiratory tract infections (RTIs) will resolve without treatment, many children will receive antibiotics and some will develop severe symptoms requiring hospitalisation. There have been calls for evidence to reduce uncertainty regarding the identification of children who will and will not benefit from antibiotics. The aim of this feasibility trial is to test recruitment and the acceptance of a complex behavioural intervention designed to reduce antibiotic prescribing, and to inform how best to conduct a larger trial. Methods and analysis The CHICO (Children's Cough) trial is a single-centre feasibility cluster randomised controlled trial (RCT) comparing a web-based, within-consultation, behavioural intervention with usual care for children presenting to general practitioner practices with RTI and acute cough. The trial aims to recruit at least 300 children between October 2014 and April 2015, in a single area in South West England. Following informed consent, demographic information will be recorded, and symptoms and signs measured. Parents/carers of recruited children will be followed up on a weekly basis to establish symptom duration, resource use and cost of the illness to the parent until the child's cough has resolved or up to 8 weeks, whichever occurs earlier. A review of medical notes, including clinical history, primary care reconsultations and hospitalisations will be undertaken 2 months after recruitment. The trial feasibility will be assessed by: determining acceptability of the intervention to clinicians and parent/carers; quantifying differential recruitment and follow-up; determining intervention fidelity; the success in gathering the data necessary to conduct a cost-effectiveness analysis; and collecting data about antibiotic prescribing rates to inform the sample size needed for a fully powered RCT. Ethics and dissemination The study was approved by the North West—Haydock Research Ethics Committee, UK (reference

  2. Management of irritable bowel syndrome in primary care: feasibility randomised controlled trial of mebeverine, methylcellulose, placebo and a patient self-management cognitive behavioural therapy website. (MIBS trial

    Directory of Open Access Journals (Sweden)

    Yardley Lucy

    2010-11-01

    Full Text Available Abstract Background IBS affects 10-22% of the UK population. Abdominal pain, bloating and altered bowel habit affect quality of life, social functioning and time off work. Current GP treatment relies on a positive diagnosis, reassurance, lifestyle advice and drug therapies, but many suffer ongoing symptoms. A recent Cochrane review highlighted the lack of research evidence for IBS drugs. Neither GPs, nor patients have good evidence to inform prescribing decisions. However, IBS drugs are widely used: In 2005 the NHS costs were nearly £10 million for mebeverine and over £8 million for fibre-based bulking agents. CBT and self-management can be helpful, but poor availability in the NHS restricts their use. We have developed a web-based CBT self-management programme, Regul8, based on an existing evidence based self-management manual and in partnership with patients. This could increase access with minimal increased costs. Methods/Design The aim is to undertake a feasibility factorial RCT to assess the effectiveness of the commonly prescribed medications in UK general practice for IBS: mebeverine (anti-spasmodic and methylcellulose (bulking-agent and Regul8, the CBT based self-management website. 135 patients aged 16 to 60 years with IBS symptoms fulfilling Rome III criteria, recruited via GP practices, will be randomised to 1 of 3 levels of the drug condition: mebeverine, methylcellulose or placebo for 6 weeks and to 1 of 3 levels of the website condition, Regul8 with a nurse telephone session and email support, Regul8 with minimal email support, or no website, thus creating 9 groups. Outcomes: Irritable bowel symptom severity scale and IBS-QOL will be measured at baseline, 6 and 12 weeks as the primary outcomes. An intention to treat analysis will be undertaken by ANCOVA for a factorial trial. Discussion This pilot will provide valuable information for a larger trial. Determining the effectiveness of commonly used drug treatments will help

  3. Protocol for the PACE trial: A randomised controlled trial of adaptive pacing, cognitive behaviour therapy, and graded exercise as supplements to standardised specialist medical care versus standardised specialist medical care alone for patients with the chronic fatigue syndrome/myalgic encephalomyelitis or encephalopathy

    Directory of Open Access Journals (Sweden)

    DeCesare Julia C

    2007-03-01

    Full Text Available Abstract Background Chronic fatigue syndrome (CFS, also called myalgic encephalomyelitis/encephalopathy or ME is a debilitating condition with no known cause or cure. Improvement may occur with medical care and additional therapies of pacing, cognitive behavioural therapy and graded exercise therapy. The latter two therapies have been found to be efficacious in small trials, but patient organisations' surveys have reported adverse effects. Although pacing has been advocated by patient organisations, it lacks empirical support. Specialist medical care is commonly provided but its efficacy when given alone is not established. This trial compares the efficacy of the additional therapies when added to specialist medical care against specialist medical care alone. Methods/Design 600 patients, who meet operationalised diagnostic criteria for CFS, will be recruited from secondary care into a randomised trial of four treatments, stratified by current comorbid depressive episode and different CFS/ME criteria. The four treatments are standardised specialist medical care either given alone, or with adaptive pacing therapy or cognitive behaviour therapy or graded exercise therapy. Supplementary therapies will involve fourteen sessions over 23 weeks and a 'booster session' at 36 weeks. Outcome will be assessed at 12, 24, and 52 weeks after randomisation. Two primary outcomes of self-rated fatigue and physical function will assess differential effects of each treatment on these measures. Secondary outcomes include adverse events and reactions, subjective measures of symptoms, mood, sleep and function and objective measures of physical activity, fitness, cost-effectiveness and cost-utility. The primary analysis will be based on intention to treat and will use logistic regression models to compare treatments. Secondary outcomes will be analysed by repeated measures analysis of variance with a linear mixed model. All analyses will allow for stratification

  4. Internet-based CBT for social phobia and panic disorder in a specialised anxiety clinic in routine care: Results of a pilot randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Kim Mathiasen

    2016-05-01

    This study was not able to document statistically significant clinical effect of iCBT with minimal therapist contact compared to a waiting list control group in a specialised anxiety clinic in routine care. However, a large and significant effect was seen on self-reported quality of life. Although these results offer an interesting perspective on iCBT in specialised care, they should be interpreted with caution, due to the limitations of the study. A large scale fully powered RCT is recommended.

  5. Responding to Young People's Health Risks in Primary Care: A Cluster Randomised Trial of Training Clinicians in Screening and Motivational Interviewing.

    Directory of Open Access Journals (Sweden)

    Lena Sanci

    Full Text Available To evaluate the effectiveness of a complex intervention implementing best practice guidelines recommending clinicians screen and counsel young people across multiple psychosocial risk factors, on clinicians' detection of health risks and patients' risk taking behaviour, compared to a didactic seminar on young people's health.Pragmatic cluster randomised trial where volunteer general practices were stratified by postcode advantage or disadvantage score and billing type (private, free national health, community health centre, then randomised into either intervention or comparison arms using a computer generated random sequence. Three months post-intervention, patients were recruited from all practices post-consultation for a Computer Assisted Telephone Interview and followed up three and 12 months later. Researchers recruiting, consenting and interviewing patients and patients themselves were masked to allocation status; clinicians were not.General practices in metropolitan and rural Victoria, Australia.General practices with at least one interested clinician (general practitioner or nurse and their 14-24 year old patients.This complex intervention was designed using evidence based practice in learning and change in clinician behaviour and general practice systems, and included best practice approaches to motivating change in adolescent risk taking behaviours. The intervention involved training clinicians (nine hours in health risk screening, use of a screening tool and motivational interviewing; training all practice staff (receptionists and clinicians in engaging youth; provision of feedback to clinicians of patients' risk data; and two practice visits to support new screening and referral resources. Comparison clinicians received one didactic educational seminar (three hours on engaging youth and health risk screening.Primary outcomes were patient report of (1 clinician detection of at least one of six health risk behaviours (tobacco, alcohol

  6. Collaborative care for sick-listed workers with major depressive disorder : a randomised controlled trial from the Netherlands Depression Initiative aimed at return to work and depressive symptoms

    NARCIS (Netherlands)

    Vlasveld, Moniek C.; van der Feltz-Cornelis, Christina M.; Ader, Herman J.; Anema, Johannes R.; Hoedeman, Rob; van Mechelen, Willem; Beekman, Aartjan T. F.

    2013-01-01

    Objectives Major depressive disorder (MDD) is associated with absenteeism. In this study, the effectiveness of collaborative care, with a focus on return to work (RTW), was evaluated in its effect on depressive symptoms and the duration until RTW in sick-listed workers with MDD in the occupational h

  7. The opportunities and challenges of pragmatic point-of-care randomised trials using routinely collected electronic records : evaluations of two exemplar trials

    NARCIS (Netherlands)

    van Staa, Tjeerd-Pieter; Dyson, Lisa; McCann, Gerard; Padmanabhan, Shivani; Belatri, Rabah; Goldacre, Ben; Cassell, Jackie; Pirmohamed, Munir; Torgerson, David; Ronaldson, Sarah; Adamson, Joy; Taweel, Adel; Delaney, Brendan; Mahmood, Samhar; Baracaia, Simona; Round, Thomas; Fox, Robin; Hunter, Tommy; Gulliford, Martin; Smeeth, Liam

    2014-01-01

    BACKGROUND: Pragmatic trials compare the effects of different decisions in usual clinical practice. OBJECTIVES: To develop and evaluate methods to implement simple pragmatic trials using routinely collected electronic health records (EHRs) and recruiting patients at the point of care; to identify th

  8. Effects of selective decontamination of digestive tract on mortality and acquisition of resistant bacteria in intensive care : a randomised controlled trial

    NARCIS (Netherlands)

    de Jonge, E; Schultz, MJ; Spanjaard, L; Bossuyt, PMM; Vroom, MB; Kesecioglu, J

    2003-01-01

    Background Selective decontamination of the digestive tract (SDD) is an infection-prevention regimen used in critically ill patients. We assessed the effects of SDD on intensive-care-unit (ICU) and hospital mortality, and on the acquisition of resistant bacteria in adult patients admitted to intensi

  9. Can an e-learning course improve nursing care for older people at risk of delirium: a stepped wedge cluster randomised trial.

    NARCIS (Netherlands)

    Steeg, L. van de; IJkema, R.; Langelaan, M.; Wagner, C.

    2014-01-01

    Background: Delirium occurs frequently in older hospitalised patients and is associated with several adverse outcomes. Ignorance among healthcare professionals and a failure to recognise patients suffering from delirium have been identified as the possible causes of poor care. The objective of the s

  10. The effectiveness of an intervention in increasing community health clinician provision of preventive care: a study protocol of a non-randomised, multiple-baseline trial

    Directory of Open Access Journals (Sweden)

    McElwaine Kathleen M

    2011-12-01

    Full Text Available Abstract Background The primary behavioural risks for the most common causes of mortality and morbidity in developed countries are tobacco smoking, poor nutrition, risky alcohol use, and physical inactivity. Evidence, guidelines and policies support routine clinician delivery of care to prevent these risks within primary care settings. Despite the potential afforded by community health services for the delivery of such preventive care, the limited evidence available suggests it is provided at suboptimal levels. This study aims to assess the effectiveness of a multi-strategic practice change intervention in increasing clinician's routine provision of preventive care across a network of community health services. Methods/Design A multiple baseline study will be conducted involving all 56 community health facilities in a single health district in New South Wales, Australia. The facilities will be allocated to one of three administratively-defined groups. A 12 month practice change intervention will be implemented in all facilities in each group to facilitate clinician risk assessment of eligible clients, and clinician provision of brief advice and referral to those identified as being 'at risk'. The intervention will be implemented in a non-random sequence across the three facility groups. Repeated, cross-sectional measurement of clinician provision of preventive care for four individual risks (smoking, poor nutrition, risky alcohol use, and physical inactivity will occur continuously for all three facility groups for 54 months via telephone interviews. The interviews will be conducted with randomly selected clients who have visited a community health facility in the last two weeks. Data collection will commence 12 months prior to the implementation of the intervention in the first group, and continue for six months following the completion of the intervention in the last group. As a secondary source of data, telephone interviews will be undertaken

  11. Uptake of Home-Based HIV Testing, Linkage to Care, and Community Attitudes about ART in Rural KwaZulu-Natal, South Africa: Descriptive Results from the First Phase of the ANRS 12249 TasP Cluster-Randomised Trial

    Science.gov (United States)

    Okesola, Nonhlanhla; Tanser, Frank; Thiebaut, Rodolphe; Rekacewicz, Claire; Newell, Marie-Louise

    2016-01-01

    Background The 2015 WHO recommendation of antiretroviral therapy (ART) for all immediately following HIV diagnosis is partially based on the anticipated impact on HIV incidence in the surrounding population. We investigated this approach in a cluster-randomised trial in a high HIV prevalence setting in rural KwaZulu-Natal. We present findings from the first phase of the trial and report on uptake of home-based HIV testing, linkage to care, uptake of ART, and community attitudes about ART. Methods and Findings Between 9 March 2012 and 22 May 2014, five clusters in the intervention arm (immediate ART offered to all HIV-positive adults) and five clusters in the control arm (ART offered according to national guidelines, i.e., CD4 count ≤ 350 cells/μl) contributed to the first phase of the trial. Households were visited every 6 mo. Following informed consent and administration of a study questionnaire, each resident adult (≥16 y) was asked for a finger-prick blood sample, which was used to estimate HIV prevalence, and offered a rapid HIV test using a serial HIV testing algorithm. All HIV-positive adults were referred to the trial clinic in their cluster. Those not linked to care 3 mo after identification were contacted by a linkage-to-care team. Study procedures were not blinded. In all, 12,894 adults were registered as eligible for participation (5,790 in intervention arm; 7,104 in control arm), of whom 9,927 (77.0%) were contacted at least once during household visits. HIV status was ever ascertained for a total of 8,233/9,927 (82.9%), including 2,569 ascertained as HIV-positive (942 tested HIV-positive and 1,627 reported a known HIV-positive status). Of the 1,177 HIV-positive individuals not previously in care and followed for at least 6 mo in the trial, 559 (47.5%) visited their cluster trial clinic within 6 mo. In the intervention arm, 89% (194/218) initiated ART within 3 mo of their first clinic visit. In the control arm, 42.3% (83/196) had a CD4 count

  12. Cost-utility of a walking programme for moderately depressed, obese, or overweight elderly women in primary care: a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Herrera Emilio

    2008-07-01

    Full Text Available Abstract Background There is a considerable public health burden due to physical inactivity, because it is a major independent risk factor for several diseases (e.g., type 2 diabetes, cardiovascular disease, moderate mood disorders neurotic diseases such as depression, etc.. This study assesses the cost utility of the adding a supervised walking programme to the standard "best primary care" for overweight, moderately obese, or moderately depressed elderly women. Methods One-hundred six participants were randomly assigned to an interventional group (n = 55 or a control group (n = 51. The intervention consisted of an invitation, from a general practitioner, to participate in a 6-month walking-based, supervised exercise program with three 50-minute sessions per week. The main outcome measures were the healthcare costs from the Health System perspective and quality adjusted life years (QALYs using EuroQol (EQ-5D. Results Of the patients invited to participate in the program, 79% were successfully recruited, and 86% of the participants in the exercise group completed the programme. Over 6 months, the mean treatment cost per patient in the exercise group was €41 more than "best care". The mean incremental QALY of intervention was 0.132 (95% CI: 0.104–0.286. Each extra QALY gained by the exercise programme relative to best care cost €311 (95% CI, €143–€394. The cost effectiveness acceptability curves showed a 90% probability that the addition of the walking programme is the best strategy if the ceiling of inversion is €350/QALY. Conclusion The invitation strategy and exercise programme resulted in a high rate of participation and is a feasible and cost-effective addition to best care. The programme is a cost-effective resource for helping patients to increase their physical activity, according to the recommendations of general practitioners. Moreover, the present study could help decision makers enhance the preventive role of primary care

  13. Fitness consultations in routine care of patients with type 2 diabetes in general practice: an 18-month non-randomised intervention study

    DEFF Research Database (Denmark)

    Lohmann, H.; Siersma, V.; Olivarius, Niels de Fine

    2010-01-01

    with an arm curl test and a chair stand test. The results were used in a subsequent motivational interview conducted by one of the GPs. Patients were encouraged to engage in lifestyle exercise and simple home-based self-managed exercise programmes. Data were analysed with mixed models. RESULTS: At end...... of motivational interviewing combined with fitness tests in the type 2 diabetes care programme was followed by a change in cardio-respiratory fitness expressed by VO2max, muscle strength of upper and lower extremities, haemoglobin A1c (HbA1c) and HDL-cholesterol. METHODS: Uncontrolled 18-month intervention study...... with follow-up and effect assessment every 3 months in a primary care unit in Denmark with six general practitioners (GPs). Of 354 eligible patients with type 2 diabetes, 127 (35.9%) were included. Maximum work capacity was tested on a cycle ergometer and converted to VO2max. Muscle strength was measured...

  14. PRImary care Streptococcal Management (PRISM) study:In vitro study, diagnostic cohorts and a pragmatic adaptive randomised controlled trial with nested qualitative study and cost-effectiveness study

    OpenAIRE

    Little, Paul; Hobbs, F. D. Richard; Moore, Michael; Mant, David; Williamson, Ian; McNulty, Cliodna; Lasseter, Gemma; Cheng, M. Y Edith; Leydon, Geraldine; McDermott, Lisa; Turner, David; Pinedo-Villanueva, Rafael; Raftery, James; Glasziou, Paul; Mullee, Mark

    2014-01-01

    Background: antibiotics are still prescribed to most patients attending primary care with acute sore throat, despite evidence that there is modest benefit overall from antibiotics. Targeting antibiotics using either clinical scoring methods or rapid antigen detection tests (RADTs) could help. However, there is debate about which groups of streptococci are important (particularly Lancefield groups C and G), and uncertainty about the variables that most clearly predict the presence of streptoco...

  15. Implementation of a guideline-based clinical pathway of care to improve health outcomes following whiplash injury (Whiplash ImPaCT: protocol of a randomised, controlled trial

    Directory of Open Access Journals (Sweden)

    Trudy Rebbeck

    2016-04-01

    Discussion: This research is significant as it will be the first study to address the heterogeneity of whiplash by implementing a clinical pathway of care that matches evidence-based interventions to projected risk of poor recovery. The results of this trial have the potential to change clinical practice for WAD, thereby maximising treatment effects, improving patient outcomes, reducing costs and maintaining the compulsory third party system.

  16. Diagnostic accuracy of pre-bronchodilator FEV1/FEV6 from microspirometry to detect airflow obstruction in primary care: a randomised cross-sectional study

    OpenAIRE

    Bemt, L. van den; Wouters, B.C.; Grootens, J.; Denis, J.; Poels, P.J.P.; Schermer, T.R.J.

    2014-01-01

    BACKGROUND: Forced expiratory volume in 1s/forced expiratory volume in 6 s ( FEV1/FEV6) assessment with a microspirometer may be useful in the diagnostic work up of subjects who are suspected of having COPD in primary care. AIM: To determine the diagnostic accuracy of a negative pre-bronchodilator (BD) microspirometry test relative to a full diagnostic spirometry test in subjects in whom general practitioners (GPs) suspect airflow obstruction. METHODS: Cross-sectional study in which the order...

  17. Opportunistic detection of atrial fibrillation in subjects aged 65 years or older in primare care: a randomised clinical trial of efficacy. DOFA-AP study protocol

    Directory of Open Access Journals (Sweden)

    Pérula-de-Torres LuisÁ

    2012-10-01

    Full Text Available Abstract Background Clinical Practice Guidelines recommend using peripheral blood pulse measuring as a screening test for Atrial Fibrillation. However, there is no adequate evidence supporting the efficacy of such procedure in primary care clinical practice. This paper describes a study protocol designed to verify whether early opportunistic screening for Atrial Fibrillation by measuring blood pulse is more effective than regular practice in subjects aged 65 years attending primary care centers. Methods/design An cluster-randomized controlled trial conducted in Primary Care Centers of the Spanish National Health Service. A total of 269 physicians and nurses will be allocated to one of the two arms of the trial by stratified randomization with a 3:2 ratio (three practitioners will be assigned to the Control Group for every two practitioners assigned to the Experimental Group. As many as 12 870 patients aged 65 years or older and meeting eligibility criteria will be recruited (8 580 will be allocated to the Experimental Group and 4 290 to the Control Group. Randomization and allocation to trial groups will be carried out by a central computer system. The Experimental Group practitioners will conduct an opportunistic case finding for patients with Atrial Fibrillation, while the Control Group practitioners will follow the regular guidelines. The first step will be finding new Atrial Fibrillation cases. A descriptive inferential analysis will be performed (bivariate and multivariate by multilevel logistic regression analysis. Discussion If our hypothesis is confirmed, we expect Primary Care professionals to take a more proactive approach and adopt a new protocol when a patient meeting the established screening criteria is identified. Finally, we expect this measure to be incorporated into Clinical Practice Guidelines. Trial registration The study is registered as NCT01291953 (ClinicalTrials.gob

  18. Improving the care for people with acute low-back pain by allied health professionals (the ALIGN trial): A cluster randomised trial protocol

    OpenAIRE

    Keating Jennifer L; Walker Bruce F; French Simon D; Mortimer Duncan S; Page Matthew J; O'Connor Denise A; McKenzie Joanne E; Grimshaw Jeremy M; Michie Susan; Francis Jill J; Green Sally E

    2010-01-01

    Abstract Background Variability between clinical practice guideline recommendations and actual clinical practice exists in many areas of health care. A 2004 systematic review examining the effectiveness of guideline implementation interventions concluded there was a lack of evidence to support decisions about effective interventions to promote the uptake of guidelines. Further, the review recommended the use of theory in the development of implementation interventions. A clinical practice gui...

  19. Impact of biomedical and biopsychosocial training sessions on the attitudes, beliefs, and recommendations of health care providers about low back pain: a randomised clinical trial.

    Science.gov (United States)

    Domenech, J; Sánchez-Zuriaga, D; Segura-Ortí, E; Espejo-Tort, B; Lisón, J F

    2011-11-01

    The beliefs and attitudes of health care providers may contribute to chronic low back pain (LBP) disability, influencing the recommendations that they provide to their patients. An excessively biomedical style of undergraduate training can increase negative beliefs and attitudes about LBP, whereas instruction following a biopsychosocial model could possibly lessen these negative beliefs in health care professionals. The objectives of this study were to determine the effectiveness of 2 brief educational modules with different orientations (biomedical or biopsychosocial) on changing the beliefs and attitudes of physical therapy students and the recommendations that they give to patients. The intervention in the experimental group was based on the general biopsychosocial model, whereas the sessions in the control group dealt with the basics of the biomechanics of back pain. The participants completed the Fear-Avoidance Beliefs Questionnaire (FABQ), Health Care Providers' Pain and Impairment Relationship Scale (HC-PAIRS), and Rainville et al. Clinical Cases questionnaire before and after the interventions. The participants attending the biopsychosocial session displayed a reduction in fear-avoidance beliefs (Pdevelopment of continuing medical education and the design of the training curriculum for undergraduate students.

  20. Identifying strategies to maximise recruitment and retention of practices and patients in a multicentre randomised controlled trial of an intervention to optimise secondary prevention for coronary heart disease in primary care.

    LENUS (Irish Health Repository)

    Leathem, Claire S

    2009-01-01

    BACKGROUND: Recruitment and retention of patients and healthcare providers in randomised controlled trials (RCTs) is important in order to determine the effectiveness of interventions. However, failure to achieve recruitment targets is common and reasons why a particular recruitment strategy works for one study and not another remain unclear. We sought to describe a strategy used in a multicentre RCT in primary care, to report researchers\\' and participants\\' experiences of its implementation and to inform future strategies to maximise recruitment and retention. METHODS: In total 48 general practices and 903 patients were recruited from three different areas of Ireland to a RCT of an intervention designed to optimise secondary prevention of coronary heart disease. The recruitment process involved telephoning practices, posting information, visiting practices, identifying potential participants, posting invitations and obtaining consent. Retention involved patients attending reviews and responding to questionnaires and practices facilitating data collection. RESULTS: We achieved high retention rates for practices (100%) and for patients (85%) over an 18-month intervention period. Pilot work, knowledge of the setting, awareness of change in staff and organisation amongst participant sites, rapid responses to queries and acknowledgement of practitioners\\' contributions were identified as being important. Minor variations in protocol and research support helped to meet varied, complex and changing individual needs of practitioners and patients and encouraged retention in the trial. A collaborative relationship between researcher and practice staff which required time to develop was perceived as vital for both recruitment and retention. CONCLUSION: Recruiting and retaining the numbers of practices and patients estimated as required to provide findings with adequate power contributes to increased confidence in the validity and generalisability of RCT results. A

  1. Identifying strategies to maximise recruitment and retention of practices and patients in a multicentre randomised controlled trial of an intervention to optimise secondary prevention for coronary heart disease in primary care

    Directory of Open Access Journals (Sweden)

    Houlihan Ailish

    2009-06-01

    Full Text Available Abstract Background Recruitment and retention of patients and healthcare providers in randomised controlled trials (RCTs is important in order to determine the effectiveness of interventions. However, failure to achieve recruitment targets is common and reasons why a particular recruitment strategy works for one study and not another remain unclear. We sought to describe a strategy used in a multicentre RCT in primary care, to report researchers' and participants' experiences of its implementation and to inform future strategies to maximise recruitment and retention. Methods In total 48 general practices and 903 patients were recruited from three different areas of Ireland to a RCT of an intervention designed to optimise secondary prevention of coronary heart disease. The recruitment process involved telephoning practices, posting information, visiting practices, identifying potential participants, posting invitations and obtaining consent. Retention involved patients attending reviews and responding to questionnaires and practices facilitating data collection. Results We achieved high retention rates for practices (100% and for patients (85% over an 18-month intervention period. Pilot work, knowledge of the setting, awareness of change in staff and organisation amongst participant sites, rapid responses to queries and acknowledgement of practitioners' contributions were identified as being important. Minor variations in protocol and research support helped to meet varied, complex and changing individual needs of practitioners and patients and encouraged retention in the trial. A collaborative relationship between researcher and practice staff which required time to develop was perceived as vital for both recruitment and retention. Conclusion Recruiting and retaining the numbers of practices and patients estimated as required to provide findings with adequate power contributes to increased confidence in the validity and generalisability of RCT

  2. The UPBEAT nurse-delivered personalized care intervention for people with coronary heart disease who report current chest pain and depression: a randomised controlled pilot study.

    Directory of Open Access Journals (Sweden)

    Elizabeth A Barley

    Full Text Available BACKGROUND: Depression is common in people with coronary heart disease (CHD and associated with worse outcome. This study explored the acceptability and feasibility of procedures for a trial and for an intervention, including its potential costs, to inform a definitive randomized controlled trial (RCT of a nurse-led personalised care intervention for primary care CHD patients with current chest pain and probable depression. METHODS: Multi-centre, outcome assessor-blinded, randomized parallel group study. CHD patients reporting chest pain and scoring 8 or more on the HADS were randomized to personalized care (PC or treatment as usual (TAU for 6 months and followed for 1 year. Primary outcome was acceptability and feasibility of procedures; secondary outcomes included mood, chest pain, functional status, well being and psychological process variables. RESULT: 1001 people from 17 General Practice CHD registers in South London consented to be contacted; out of 126 who were potentially eligible, 81 (35% female, mean age = 65 SD11 years were randomized. PC participants (n = 41 identified wide ranging problems to work on with nurse-case managers. Good acceptability and feasibility was indicated by low attrition (9%, high engagement and minimal nurse time used (mean/SD = 78/19 mins assessment, 125/91 mins telephone follow up. Both groups improved on all outcomes. The largest between group difference was in the proportion no longer reporting chest pain (PC 37% vs TAU 18%; mixed effects model OR 2.21 95% CI 0.69, 7.03. Some evidence was seen that self efficacy (mean scale increase of 2.5 vs 0.9 and illness perceptions (mean scale increase of 7.8 vs 2.5 had improved in PC vs TAU participants at 1 year. PC appeared to be more cost effective up to a QALY threshold of approximately £3,000. CONCLUSIONS: Trial and intervention procedures appeared to be feasible and acceptable. PC allowed patients to work on unaddressed problems and appears cheaper than TAU

  3. Point of care technology or standard laboratory service in an emergency department: is there a difference in time to action? A randomised trial

    DEFF Research Database (Denmark)

    Backer Mogensen, Christian; Borch, Anders; Brandslund, Ivan

    2011-01-01

    Emergency Departments (ED) have a high flow of patients and time is often crucial. New technologies for laboratory analysis have been developed, including Point of Care Technologies (POCT), which can reduce the transport time and time of analysis significantly compared with central laboratory...... services. However, the question is if the time to clinical action is also reduced if a decisive laboratory answer is available during the first contact between the patient and doctor. The present study addresses this question: Does a laboratory answer, provided by POCT to the doctor who first attends...... the patient on admission, change the time to clinical decision in commonly occurring diseases in an ED compared with the traditional service from a central laboratory?...

  4. Long-term treatment with probiotics in primary care patients with irritable bowel syndrome--a randomised, double-blind, placebo controlled trial

    DEFF Research Database (Denmark)

    Begtrup, Luise Mølenberg; de Muckadell, Ove B Schaffalitzky; Kjeldsen, Jens;

    2013-01-01

    with placebo in the management of IBS in primary care during a 6-month treatment period and with a 6-month follow-up. MATERIAL AND METHODS. We randomized IBS patients fulfilling Rome III criteria to receive two capsules twice daily either containing placebo or a probiotic mixture of Lactobacillus paracasei ssp...... paracasei F19, Lactobacillus acidophilus La5 and Bifidobacterium Bb12 in an amount of 1.3 × 10(10) CFU per capsule. Primary endpoint was proportion of responders defined as patients reporting adequate relief (AR) at least 50% of the time in the 6-month treatment period. Secondary outcomes were proportions...... of patients reporting AR at different time points, and change in gastrointestinal symptoms and health-related quality of life (HrQOL) from baseline to 6 and 12 months. RESULTS. A total of 131 patients were included in this study. The proportion of responders in the treatment period was 52% (35...

  5. Addressing risk factors for child abuse among high risk pregnant women: design of a randomised controlled trial of the nurse family partnership in Dutch preventive health care

    Directory of Open Access Journals (Sweden)

    Mejdoubi Jamila

    2011-10-01

    Full Text Available Abstract Background Low socio-economic status combined with other risk factors affects a person's physical and psychosocial health from childhood to adulthood. The societal impact of these problems is huge, and the consequences carry on into the next generation(s. Although several studies show these consequences, only a few actually intervene on these issues. In the United States, the Nurse Family Partnership focuses on high risk pregnant women and their children. The main goal of this program is primary prevention of child abuse. The Netherlands is the first country outside the United States allowed to translate and culturally adapt the Nurse Family Partnership into VoorZorg. The aim of the present study is to assess whether VoorZorg is as effective in the Netherland as in the United States. Methods The study consists of three partly overlapping phases. Phase 1 was the translation and cultural adaptation of Nurse Family Partnership and the design of a two-stage selection procedure. Phase 2 was a pilot study to examine the conditions for implementation. Phase 3 is the randomized controlled trial of VoorZorg compared to the care as usual. Primary outcome measures were smoking cessation during pregnancy and after birth, birth outcomes, child development, child abuse and domestic violence. The secondary outcome measure was the number of risk factors present. Discussion This study shows that the Nurse Family Partnership was successfully translated and culturally adapted into the Dutch health care system and that this program fulfills the needs of high-risk pregnant women. We hypothesize that this program will be effective in addressing risk factors that operate during pregnancy and childhood and compromise fetal and child development. Trial registration Current Controlled Trials ISRCTN16131117

  6. The protocol for the Be Our Ally Beat Smoking (BOABS study, a randomised controlled trial of an intensive smoking cessation intervention in a remote Aboriginal Australian health care setting

    Directory of Open Access Journals (Sweden)

    Marley Julia V

    2012-03-01

    Full Text Available Abstract Background Australian Aboriginal peoples and Torres Strait Islanders (Indigenous Australians smoke at much higher rates than non-Indigenous people and smoking is an important contributor to increased disease, hospital admissions and deaths in Indigenous Australian populations. Smoking cessation programs in Australia have not had the same impact on Indigenous smokers as on non-Indigenous smokers. This paper describes the protocol for a study that aims to test the efficacy of a locally-tailored, intensive, multidimensional smoking cessation program. Methods/Design This study is a parallel, randomised, controlled trial. Participants are Aboriginal and Torres Strait Islander smokers aged 16 years and over, who are randomly allocated to a 'control' or 'intervention' group in a 2:1 ratio. Those assigned to the 'intervention' group receive smoking cessation counselling at face-to-face visits, weekly for the first four weeks, monthly to six months and two monthly to 12 months. They are also encouraged to attend a monthly smoking cessation support group. The 'control' group receive 'usual care' (i.e. they do not receive the smoking cessation program. Aboriginal researchers deliver the intervention, the goal of which is to help Aboriginal peoples and Torres Strait Islanders quit smoking. Data collection occurs at baseline (when they enrol and at six and 12 months after enrolling. The primary outcome is self-reported smoking cessation with urinary cotinine confirmation at 12 months. Discussion Stopping smoking has been described as the single most important individual change Aboriginal and Torres Strait Islander smokers could make to improve their health. Smoking cessation programs are a major priority in Aboriginal and Torres Strait Islander health and evidence for effective approaches is essential for policy development and resourcing. A range of strategies have been used to encourage Aboriginal peoples and Torres Strait Islanders to quit

  7. Mothers' AdvocateS In the Community (MOSAIC- non-professional mentor support to reduce intimate partner violence and depression in mothers: a cluster randomised trial in primary care

    Directory of Open Access Journals (Sweden)

    Gold Lisa

    2011-03-01

    Full Text Available Abstract Background Effective interventions to increase safety and wellbeing of mothers experiencing intimate partner violence (IPV are scarce. As much attention is focussed on professional intervention, this study aimed to determine the effectiveness of non-professional mentor support in reducing IPV and depression among pregnant and recent mothers experiencing, or at risk of IPV. Methods MOSAIC was a cluster randomised trial in 106 primary care (maternal and child health nurse and general practitioner clinics in Melbourne, Australia. 63/106 clinics referred 215 eligible culturally and linguistically diverse women between January 2006 and December 2007. 167 in the intervention (I arm, and 91 in the comparison (C arm. 174 (80.9% were recruited. 133 (76.4% women (90 I and 43 C completed follow-up at 12 months. Intervention: 12 months of weekly home visiting from trained and supervised local mothers, (English & Vietnamese speaking offering non-professional befriending, advocacy, parenting support and referrals. Main outcome measures: Primary outcomes; IPV (Composite Abuse Scale CAS and depression (Edinburgh Postnatal Depression Scale EPDS; secondary measures included wellbeing (SF-36, parenting stress (PSI-SF and social support (MOS-SF at baseline and follow-up. Analysis: Intention-to-treat using multivariable logistic regression and propensity scoring. Results There was evidence of a true difference in mean abuse scores at follow-up in the intervention compared with the comparison arm (15.9 vs 21.8, AdjDiff -8.67, CI -16.2 to -1.15. There was weak evidence for other outcomes, but a trend was evident favouring the intervention: proportions of women with CAS scores ≥7, 51/88 (58.4% vs 27/42 (64.3% AdjOR 0.47, CI 0.21 to 1.05; depression (EPDS score ≥13 (19/85, 22% (I vs 14/43, 33% (C; AdjOR 0.42, CI 0.17 to 1.06; physical wellbeing mean scores (PCS-SF36: AdjDiff 2.79; CI -0.40 to 5.99; mental wellbeing mean scores (MCS-SF36: AdjDiff 2.26; CI -1

  8. GILT - A randomised phase III study of oral vinorelbine and cisplatin with concomitant radiotherapy followed by either consolidation therapy with oral vinorelbine and cisplatin or best supportive care alone in stage III non-small cell lung cancer

    Energy Technology Data Exchange (ETDEWEB)

    Flentje, Michael [University Hospital Wuerzburg, Dept. of Radiotherapy, Wuerzburg (Germany); Huber, Rudolf M. [University Hospital Munich, Member of the German Center for Lung Research (DZL CPC-M), Munich (Germany); Engel-Riedel, Walburga [University Hospital Merheim, Dept. of Pneumonology, Cologne (Germany); Andreas, Stefan [Dept. of Pneumonology, Immenhausen (Germany); Kollmeier, Jens [Helios Emil-von-Behring Hospital, Berlin (Germany); Staar, Susanne [Municipal Hospital Bremen-Mitte, Bremen (Germany); Dickgreber, Nicolas [University Hospital Hannover, Hannover (Germany); Vaissiere, Nathalie; Almeida, Cecilia de [Institut de Recherche Pierre Fabre, Boulogne (France); Edlich, Birgit [Pierre Fabre Pharma GmbH, Freiburg (Germany); Fietkau, Rainer [University Hospital Erlangen, Erlangen (Germany)

    2016-04-15

    Concurrent chemoradiotherapy (CRT) is considered standard for inoperable stage III non-small cell lung cancer (NSCLC). Consolidation chemotherapy (CC) following CRT is intended to further improve outcomes, yet studies have shown discordant results. This phase III study assessed CRT followed by best supportive care (BSC) or consolidation with oral vinorelbine and cisplatin. Patients received two cycles of oral vinorelbine (50 mg/m{sup 2} days 1, 8 and 15) + cisplatin (20 mg/m{sup 2} days 1-4) q4w + radiotherapy (RT; 66 Gy). Patients with at least stable disease (SD) were randomised to either two cycles oral vinorelbine (60-80 mg/m{sup 2} days 1 and 8) + cisplatin (80 mg/m{sup 2} day 1) q3w + BSC or BSC alone. Primary endpoint was progression-free survival (PFS). A total of 279 patients were enrolled for CRT and 201 patients were randomised to CC or BSC. Both CRT and CC were well tolerated, with limited radiation-mediated grade 3/4 toxicities (CRT/CC/BSC: oesophagitis-related events 12.9 %/3.1 %/0 %; grade 3 pneumonitis 0 %/0 %/2 %) and chemotherapy-mediated grade 3/4 toxicities (CRT/CC: neutropenia 11.2 %/22.1 %; leukopenia 18.3 %/26.7 %; grade 3 nausea 5.0 %/2.3 %, grade 3 vomiting 3.2 %/3.5 %). Median PFS from randomisation was 6.4 (5.0-8.7) and 5.5 (3.8-7.4) months in the CC and BSC arms (hazard ratio, HR = 0.93 [0.69-1.26]; p = 0.63), respectively; median overall survival (OS) 20.8 (13.5-25.3) and 18.5 (13.6-24.7) months, respectively. Consolidation chemotherapy after concurrent CRT did not prolong PFS or OS. Concurrent RT with oral vinorelbine and cisplatin demonstrated a favourable safety profile and represents a suitable treatment regimen for inoperable stage III NSCLC. (orig.) [German] Simultane Radiochemotherapie (CRT) wird als Standardtherapie beim inoperablen Stadium III des nicht-kleinzelligen Lungenkarzinoms (NSCLC) angesehen. Konsolidierende Chemotherapie (CC) nach der CRT zielt darauf ab, das Therapieergebnis zu verbessern, allerdings zeigen Studien

  9. The effect of changing movement and posture using motion-sensor biofeedback, versus guidelines-based care, on the clinical outcomes of people with sub-acute or chronic low back pain-a multicentre, cluster-randomised, placebo-controlled, pilot trial

    DEFF Research Database (Denmark)

    Kent, Peter; Laird, Robert; Haines, Terry

    2015-01-01

    sample size calculations for a fully powered trial. METHODS: A multicentre (8 clinics), cluster-randomised, placebo-controlled pilot trial compared two groups of patients seeking medical or physiotherapy primary care for sub-acute and chronic back pain. It was powered for longitudinal analysis......BACKGROUND: The aims of this pilot trial were to (i) test the hypothesis that modifying patterns of painful lumbo-pelvic movement using motion-sensor biofeedback in people with low back pain would lead to reduced pain and activity limitation compared with guidelines-based care, and (ii) facilitate......, but not for adjusted single-time point comparisons. The intervention group (n = 58) received modification of movement patterns augmented by motion-sensor movement biofeedback (ViMove, dorsaVi.com) plus guidelines-based medical or physiotherapy care. The control group (n = 54) received a placebo (wearing the motion...

  10. No significant improvement of cardiovascular disease risk indicators by a lifestyle intervention in people with Familial Hypercholesterolemia compared to usual care: results of a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Broekhuizen Karen

    2012-07-01

    Full Text Available Abstract Background People with Familial Hypercholesterolemia (FH may benefit from lifestyle changes supporting their primary treatment of dyslipidaemia. This project evaluated the efficacy of an individualised tailored lifestyle intervention on lipids (low density lipoprotein cholesterol (LDL-C, high density lipoprotein cholesterol (HDL-C, total cholesterol (TC and triglycerides, systolic blood pressure, glucose, body mass index (BMI and waist circumference in people with FH. Methods Adults with FH (n = 340, recruited from a Dutch cascade screening program, were randomly assigned to either a control group or an intervention group. The personalised intervention consisted of web-based tailored lifestyle advice and personal counselling. The control group received care as usual. Lipids, systolic blood pressure, glucose, BMI, and waist circumference were measured at baseline and after 12 months. Regression analyses were conducted to examine differences between both groups. Results After 12 months, no significant between-group differences of cardiovascular disease (CVD risk indicators were observed. LDL-C levels had decreased in both the intervention and control group. This difference between intervention and control group was not statistically significant. Conclusions This project suggests that an individually tailored lifestyle intervention did not have an additional effect in improving CVD risk indicators among people with FH. The cumulative effect of many small improvements in all indicators on long term CVD risk remains to be assessed in future studies. Trial registration NTR1899 at ww.trialregister.nl

  11. What parents of children who have received emergency care think about deferring consent in randomised trials of emergency treatments: postal survey.

    Directory of Open Access Journals (Sweden)

    Carrol Gamble

    Full Text Available OBJECTIVE: To investigate parents' views about deferred consent to inform management of trial disclosure after a child's death. METHODS: A postal questionnaire survey was sent to members of the Meningitis Research Foundation UK charity, whose child had suffered from bacterial meningitis or meningococcal septicaemia within the previous 5 years. Main outcome measures were acceptability of deferred consent; timing of requesting consent; and the management of disclosure of the trial after a child's death. RESULTS: 220 families were sent questionnaires of whom 63 (29% were bereaved. 68 families responded (31%, of whom 19 (28% were bereaved. The majority (67% was willing for their child to be involved in the trial without the trial being explained to them beforehand; 70% wanted to be informed about the trial as soon as their child's condition had stabilised. In the event of a child's death before the trial could be discussed the majority of bereaved parents (66% 12/18 anticipated wanting to be told about the trial at some time. This compared with 37% (18/49 of non-bereaved families (p = 0.06. Parents' free text responses indicated that the word 'trial' held strongly negative connotations. A few parents regarded gaps in the evidence base about emergency treatments as indicating staff lacked expertise to care for a critically ill child. Bereaved parents' free text responses indicated the importance of individualised management of disclosure about a trial following a child's death. DISCUSSION: Deferred consent is acceptable to the majority of respondents. Parents whose children had recovered differed in their views compared to bereaved parents. Most bereaved parents would want to be informed about the trial in the aftermath of a child's death, although a minority strongly opposed such disclosure. Distinction should be drawn between the views of bereaved and non-bereaved parents when considering the acceptability of different consent processes.

  12. Improving patient adherence to lifestyle advice (IMPALA: a cluster-randomised controlled trial on the implementation of a nurse-led intervention for cardiovascular risk management in primary care (protocol

    Directory of Open Access Journals (Sweden)

    Grol Richard

    2008-01-01

    Full Text Available Abstract Background Many patients at high risk of cardiovascular diseases are managed and monitored in general practice. Recommendations for cardiovascular risk management, including lifestyle change, are clearly described in the Dutch national guideline. Although lifestyle interventions, such as advice on diet, physical exercise, smoking and alcohol, have moderate, but potentially relevant effects in these patients, adherence to lifestyle advice in general practice is not optimal. The IMPALA study intends to improve adherence to lifestyle advice by involving patients in decision making on cardiovascular prevention by nurse-led clinics. The aim of this paper is to describe the design and methods of a study to evaluate an intervention aimed at involving patients in cardiovascular risk management. Methods A cluster-randomised controlled trial in 20 general practices, 10 practices in the intervention arm and 10 in the control arm, starting on October 2005. A total of 720 patients without existing cardiovascular diseases but eligible for cardiovascular risk assessment will be recruited. In both arms, the general practitioners and nurses will be trained to apply the national guideline for cardiovascular risk management. Nurses in the intervention arm will receive an extended training in risk assessment, risk communication, the use of a decision aid and adapted motivational interviewing. This communication technique will be used to support the shared decision-making process about risk reduction. The intervention comprises 2 consultations and 1 follow-up telephone call. The nurses in the control arm will give usual care after the risk estimation, according to the national guideline. Primary outcome measures are self-reported adherence to lifestyle advice and drug treatment. Secondary outcome measures are the patients' perception of risk and their motivation to change their behaviour. The measurements will take place at baseline and after 12 and 52

  13. Lay support for pregnant women with social risk: a randomised controlled trial

    OpenAIRE

    Kenyon, Sara; Jolly, Kate; Hemming, Karla; Hope, Lucy; Blissett, Jackie; Dann, Sophie-Anna; Lilford, Richard; MacArthur, Christine

    2016-01-01

    Objectives We sought evidence of effectiveness of lay support to improve maternal and child outcomes in disadvantaged families. Design Prospective, pragmatic, individually randomised controlled trial. Setting 3 Maternity Trusts in West Midlands, UK. Participants Following routine midwife systematic assessment of social risk factors, 1324 nulliparous women were assigned, using telephone randomisation, to standard maternity care, or addition of referral to a Pregnancy Outreach Worker (POW) serv...

  14. No identifiable Hb1Ac or lifestyle change after a comprehensive diabetes programme including motivational interviewing: A cluster randomised trial

    NARCIS (Netherlands)

    Jansink, R.M.E.; Braspenning, J.C.C.; Keizer, E.; Weijden, T. van der; Elwyn, G.; Grol, R.P.T.M.

    2013-01-01

    Abstract Objective. To study the effectiveness of a comprehensive diabetes programme in general practice that integrates patient-centred lifestyle counselling into structured diabetes care. Design and setting. Cluster randomised trial in general practices. Intervention. Nurse-led structured diabetes

  15. Comparing the effectiveness of an enhanced MOtiVational intErviewing InTervention (MOVE IT) with usual care for reducing cardiovascular risk in high risk subjects: study protocol for a randomised controlled trial

    OpenAIRE

    Bayley, Adam; de Zoysa, Nicole; Cook, Derek G.; Whincup, Peter H.; Stahl, Daniel; Twist, Katherine; Ridge, Katie; McCrone, Paul; Treasure, Janet; Ashworth, Mark; Greenough, Anne; Blythe, Clare; Winkley, Kirsty; Ismail, Khalida

    2015-01-01

    Background Interventions targeting multiple risk factors for cardiovascular disease (CVD), including poor diet and physical inactivity, are more effective than interventions targeting a single risk factor. A motivational interviewing (MI) intervention can provide modest dietary improvements and physical activity increases, while adding cognitive behaviour therapy (CBT) skills may enhance the effects of MI. We designed a randomised controlled trial (RCT) to examine whether specific behaviour c...

  16. Comparing the effectiveness of an enhanced MOtiVational intErviewing InTervention (MOVE IT) with usual care for reducing cardiovascular risk in high risk subjects:study protocol for a randomised controlled trial

    OpenAIRE

    Bayley, Adam; de Zoysa, Nicole; Cook, Derek G.; Whincup, Peter H.; Stahl, Daniel; Twist, Katherine; Ridge, Katie; McCrone, Paul; Treasure, Janet; Ashworth, Mark; Greenough, Anne; Blythe, Clare; Winkley, Kirsty; Ismail, Khalida

    2015-01-01

    Background: Interventions targeting multiple risk factors for cardiovascular disease (CVD), including poor diet and physical inactivity, are more effective than interventions targeting a single risk factor. A motivational interviewing (MI) intervention can provide modest dietary improvements and physical activity increases, while adding cognitive behaviour therapy (CBT) skills may enhance the effects of MI. We designed a randomised controlled trial (RCT) to examine whether specific behaviour ...

  17. Cognitive behaviour therapy plus aerobic exercise training to increase activity in patients with myotonic dystrophy type 1 (DM1) compared to usual care (OPTIMISTIC): study protocol for randomised controlled trial

    OpenAIRE

    van Engelen, B. G.; Groot, Perry

    2015-01-01

    BACKGROUND: Myotonic dystrophy type 1 (DM1) is a rare, inherited chronic progressive disease as well as an autosomal dominant multi-systemic disorder. It is probably one of the most common adult forms of muscular dystrophy, with a prevalence of approximately 10 per 100,000 people affected. With 733 million people in Europe, we estimate that 75,000 people in Europe are affected with DM1. METHODS/DESIGN: OPTIMISTIC is a multi-centre, randomised trial designed to compare an intervention comprisi...

  18. NEWHINTS cluster randomised trial to evaluate the impact on neonatal mortality in rural Ghana of routine home visits to provide a package of essential newborn care interventions in the third trimester of pregnancy and the first week of life: trial protocol

    Directory of Open Access Journals (Sweden)

    Pitt Catherine

    2010-05-01

    Full Text Available Abstract Background Tackling neonatal mortality is essential for the achievement of the child survival millennium development goal. There are just under 4 million neonatal deaths, accounting for 38% of the 10.8 million deaths among children younger than 5 years of age taking place each year; 99% of these occur in low- and middle-income countries where a large proportion of births take place at home, and where postnatal care for mothers and neonates is either not available or is of poor quality. WHO and UNICEF have issued a joint statement calling for governments to implement "Home visits for the newborn child: a strategy to improve survival", following several studies in South Asia which achieved substantial reductions in neonatal mortality through community-based approaches. However, their feasibility and effectiveness have not yet been evaluated in Africa. The Newhints study aims to do this in Ghana and to develop a feasible and sustainable community-based approach to improve newborn care practices, and by so doing improve neonatal survival. Methods Newhints is an integrated intervention package based on extensive formative research, and developed in close collaboration with seven District Health Management Teams (DHMTs in Brong Ahafo Region. The core component is training the existing community based surveillance volunteers (CBSVs to identify pregnant women and to conduct two home visits during pregnancy and three in the first week of life to address essential care practices, and to assess and refer very low birth weight and sick babies. CBSVs are supported by a set of materials, regular supervisory visits, incentives, sensitisation activities with TBAs, health facility staff and communities, and providing training for essential newborn care in health facilities. Newhints is being evaluated through a cluster randomised controlled trial, and intention to treat analyses. The clusters are 98 supervisory zones; 49 have been randomised for

  19. Effectiveness of quinine versus artemether-lumefantrine for treating uncomplicated falciparum malaria in Ugandan children: randomised trial

    OpenAIRE

    Achan, J.; Tibenderana, J. K.; Kyabayinze, D.; Mangen, F. W.; Kamya, M. R.; Dorsey, G.; D'Alessandro, U; Rosenthal, P. J.; Talisuna, A O

    2009-01-01

    OBJECTIVE: To compare the effectiveness of oral quinine with that of artemether-lumefantrine in treating uncomplicated malaria in children. DESIGN: Randomised, open label effectiveness study. SETTING: Outpatient clinic of Uganda's national referral hospital in Kampala. PARTICIPANTS: 175 children aged 6 to 59 months with uncomplicated malaria. INTERVENTIONS: Participants were randomised to receive oral quinine or artemether-lumefantrine administered by care givers at home. MAIN OUTCOME MEASURE...

  20. Randomised clinical trial

    DEFF Research Database (Denmark)

    Meineche-Schmidt, V.; Christensen, E.; Bytzer, P.

    2011-01-01

    Background: Response to proton pump inhibitor (PPI) treatment in dyspepsia is unpredictable. Aim: To identify symptoms associated with response to esomeprazole in order to target patients for empirical treatment. Methods: Eight hundred and five uninvestigated, primary care patients with upper GI ....... Conclusions In patients with uninvestigated dyspepsia, PPI responders can be reliably identified by a simple pocket chart using symptoms and patient characteristics (ClinicalTrials.gov NCT00318968). © 2010 Blackwell Publishing Ltd....

  1. 'Be active, eat right', evaluation of an overweight prevention protocol among 5-year-old children: design of a cluster randomised controlled trial

    OpenAIRE

    Veldhuis Lydian; Struijk Mirjam K; Kroeze Willemieke; Oenema Anke; Renders Carry M; Bulk-Bunschoten Anneke MW; HiraSing Remy A; Raat Hein

    2009-01-01

    Abstract Background The prevalence of overweight and obesity in children has at least doubled in the past 25 years with a major impact on health. In 2005 a prevention protocol was developed applicable within Youth Health Care. This study aims to assess the effects of this protocol on prevalence of overweight and health behaviour among children. Methods and design A cluster randomised controlled trial is conducted among 5-year-old children included by 44 Youth Health Care teams randomised with...

  2. Effectiveness of telemonitoring integrated into existing clinical services on hospital admission for exacerbation of chronic obstructive pulmonary disease: researcher blind, multicentre, randomised controlled trial

    OpenAIRE

    Pinnock, Hilary; Hanley, Janet; McCloughan, Lucy; Todd, Allison; Krishan, Ashma; Lewis, Stephanie; Stoddart, Andrew; van der Pol, Marjon; MacNee, William; Sheikh, Aziz; Pagliari, Claudia; McKinstry, Brian

    2013-01-01

    Objective: To test the effectiveness of telemonitoring integrated into existing clinical services such that intervention and control groups have access to the same clinical care. Design: Researcher blind, multicentre, randomised controlled trial. Setting: UK primary care (Lothian, Scotland). Participants: Adults with at least one admission for chronic obstructive pulmonary disease (COPD) in the year before randomisation. We excluded people who had other significant lung disease, who were unab...

  3. Effectiveness of telemonitoring integrated into existing clinical services on hospital admission for exacerbation of chronic obstructive pulmonary disease: researcher blind, multicentre, randomised controlled trial

    OpenAIRE

    Pinnock, Hilary; Hanley, Janet; McCloughan, Lucy; Todd, Allison; Krishan, Ashma; Lewis, Stephanie; Stoddart, Andrew; van der Pol, Marjon; MacNee, William; Sheikh, Aziz; Pagliari, Claudia; McKinstry, Brian

    2013-01-01

    Objective To test the effectiveness of telemonitoring integrated into existing clinical services such that intervention and control groups have access to the same clinical care. Design Researcher blind, multicentre, randomised controlled trial. Setting UK primary care (Lothian, Scotland). Participants Adults with at least one admission for chronic obstructive pulmonary disease (COPD) in the year before randomisation. We excluded people who had other significant lung disease, who were unable t...

  4. Patient safety in elderly hip fracture patients: design of a randomised controlled trial.

    NARCIS (Netherlands)

    Merten, H.; Lubberding, S.; Wagtendonk, I. van; Johannesma, P.C.; Wagner, C.

    2011-01-01

    BACKGROUND: The clinical environment in which health care providers have to work everyday is highly complex; this increases the risk for the occurrence of unintended events. The aim of this randomised controlled trial is to improve patient safety for a vulnerable group of patients that have to go th

  5. Effect of unsupervised home based proprioceptive training on recurrences of ankle sprain: randomised controlled trial

    NARCIS (Netherlands)

    Hupperets, M.D.W.; Verhagen, E.A.L.M.; Mechelen, van W.

    2009-01-01

    OBJECTIVE: To evaluate the effectiveness of an unsupervised proprioceptive training programme on recurrences of ankle sprain after usual care in athletes who had sustained an acute sports related injury to the lateral ankle ligament. DESIGN: Randomised controlled trial, with one year follow-up. SETT

  6. Multiple imputation methods for bivariate outcomes in cluster randomised trials.

    Science.gov (United States)

    DiazOrdaz, K; Kenward, M G; Gomes, M; Grieve, R

    2016-09-10

    Missing observations are common in cluster randomised trials. The problem is exacerbated when modelling bivariate outcomes jointly, as the proportion of complete cases is often considerably smaller than the proportion having either of the outcomes fully observed. Approaches taken to handling such missing data include the following: complete case analysis, single-level multiple imputation that ignores the clustering, multiple imputation with a fixed effect for each cluster and multilevel multiple imputation. We contrasted the alternative approaches to handling missing data in a cost-effectiveness analysis that uses data from a cluster randomised trial to evaluate an exercise intervention for care home residents. We then conducted a simulation study to assess the performance of these approaches on bivariate continuous outcomes, in terms of confidence interval coverage and empirical bias in the estimated treatment effects. Missing-at-random clustered data scenarios were simulated following a full-factorial design. Across all the missing data mechanisms considered, the multiple imputation methods provided estimators with negligible bias, while complete case analysis resulted in biased treatment effect estimates in scenarios where the randomised treatment arm was associated with missingness. Confidence interval coverage was generally in excess of nominal levels (up to 99.8%) following fixed-effects multiple imputation and too low following single-level multiple imputation. Multilevel multiple imputation led to coverage levels of approximately 95% throughout. © 2016 The Authors. Statistics in Medicine Published by John Wiley & Sons Ltd. PMID:26990655

  7. Implementing evidence-based recommended practices for the management of patients with mild traumatic brain injuries in Australian emergency care departments: study protocol for a cluster randomised controlled trial

    Science.gov (United States)

    2014-01-01

    Background Mild head injuries commonly present to emergency departments. The challenges facing clinicians in emergency departments include identifying which patients have traumatic brain injury, and which patients can safely be sent home. Traumatic brain injuries may exist with subtle symptoms or signs, but can still lead to adverse outcomes. Despite the existence of several high quality clinical practice guidelines, internationally and in Australia, research shows inconsistent implementation of these recommendations. The aim of this trial is to test the effectiveness of a targeted, theory- and evidence-informed implementation intervention to increase the uptake of three key clinical recommendations regarding the emergency department management of adult patients (18 years of age or older) who present following mild head injuries (concussion), compared with passive dissemination of these recommendations. The primary objective is to establish whether the intervention is effective in increasing the percentage of patients for which appropriate post-traumatic amnesia screening is performed. Methods/design The design of this study is a cluster randomised trial. We aim to include 34 Australian 24-hour emergency departments, which will be randomised to an intervention or control group. Control group departments will receive a copy of the most recent Australian evidence-based clinical practice guideline on the acute management of patients with mild head injuries. The intervention group will receive an implementation intervention based on an analysis of influencing factors, which include local stakeholder meetings, identification of nursing and medical opinion leaders in each site, a train-the-trainer day and standardised education and interactive workshops delivered by the opinion leaders during a 3 month period of time. Clinical practice outcomes will be collected retrospectively from medical records by independent chart auditors over the 2 month period following

  8. Looking inside the black box: a theory-based process evaluation alongside a randomised controlled trial of printed educational materials (the Ontario printed educational message, OPEM to improve referral and prescribing practices in primary care in Ontario, Canada

    Directory of Open Access Journals (Sweden)

    Lemyre Louise

    2007-11-01

    Full Text Available Abstract Background Randomised controlled trials of implementation strategies tell us whether (or not an intervention results in changes in professional behaviour but little about the causal mechanisms that produce any change. Theory-based process evaluations collect data on theoretical constructs alongside randomised trials to explore possible causal mechanisms and effect modifiers. This is similar to measuring intermediate endpoints in clinical trials to further understand the biological basis of any observed effects (for example, measuring lipid profiles alongside trials of lipid lowering drugs where the primary endpoint could be reduction in vascular related deaths. This study protocol describes a theory-based process evaluation alongside the Ontario Printed Educational Message (OPEM trial. We hypothesize that the OPEM interventions are most likely to operate through changes in physicians' behavioural intentions due to improved attitudes or subjective norms with little or no change in perceived behavioural control. We will test this hypothesis using a well-validated social cognition model, the theory of planned behaviour (TPB that incorporates these constructs. Methods/design We will develop theory-based surveys using standard methods based upon the TPB for the second and third replications, and survey a subsample of Ontario family physicians from each arm of the trial two months before and six months after the dissemination of the index edition of informed, the evidence based newsletter used for the interventions. In the third replication, our study will converge with the "TRY-ME" protocol (a second study conducted alongside the OPEM trial, in which the content of educational messages was constructed using both standard methods and methods informed by psychological theory. We will modify Dillman's total design method to maximise response rates. Preliminary analyses will initially assess the internal reliability of the measures and use

  9. A cluster randomised stepped wedge trial to evaluate the effectiveness of a multifaceted information technology-based intervention in reducing high-risk prescribing of non-steroidal anti-inflammatory drugs and antiplatelets in primary medical care: The DQIP study protocol

    Directory of Open Access Journals (Sweden)

    Dreischulte Tobias

    2012-03-01

    Full Text Available Abstract Background High-risk prescribing of non-steroidal anti-inflammatory drugs (NSAIDs and antiplatelet agents accounts for a significant proportion of hospital admissions due to preventable adverse drug events. The recently completed PINCER trial has demonstrated that a one-off pharmacist-led information technology (IT-based intervention can significantly reduce high-risk prescribing in primary care, but there is evidence that effects decrease over time and employing additional pharmacists to facilitate change may not be sustainable. Methods/design We will conduct a cluster randomised controlled with a stepped wedge design in 40 volunteer general practices in two Scottish health boards. Eligible practices are those that are using the INPS Vision clinical IT system, and have agreed to have relevant medication-related data to be automatically extracted from their electronic medical records. All practices (clusters that agree to take part will receive the data-driven quality improvement in primary care (DQIP intervention, but will be randomised to one of 10 start dates. The DQIP intervention has three components: a web-based informatics tool that provides weekly updated feedback of targeted prescribing at practice level, prompts the review of individual patients affected, and summarises each patient's relevant risk factors and prescribing; an outreach visit providing education on targeted prescribing and training in the use of the informatics tool; and a fixed payment of 350 GBP (560 USD; 403 EUR up front and a small payment of 15 GBP (24 USD; 17 EUR for each patient reviewed in the 12 months of the intervention. We hypothesise that the DQIP intervention will reduce a composite of nine previously validated measures of high-risk prescribing. Due to the nature of the intervention, it is not possible to blind practices, the core research team, or the data analyst. However, outcome assessment is entirely objective and automated. There will

  10. Randomised trial of glutamine and selenium supplemented parenteral nutrition for critically ill patients. Protocol Version 9, 19 February 2007 known as SIGNET (Scottish Intensive care Glutamine or seleNium Evaluative Trial)

    OpenAIRE

    Vale Luke D; Norrie John; Simpson William G; Croal Bernard L; Battison Claire G; Campbell Marion K; Noble David W; Avenell Alison; Andrews Peter JD; Cook Jonathon; de Verteuil Robyn; Milne Anne C

    2007-01-01

    Abstract Background Mortality rates in the Intensive Care Unit and subsequent hospital mortality rates in the UK remain high. Infections in Intensive Care are associated with a 2–3 times increased risk of death. It is thought that under conditions of severe metabolic stress glutamine becomes "conditionally essential". Selenium is an essential trace element that has antioxidant and anti-inflammatory properties. Approximately 23% of patients in Intensive Care require parenteral nutrition and gl...

  11. Effectiveness of training health professionals to provide smoking cessation interventions: systematic review of randomised controlled trials.

    OpenAIRE

    Silagy, C; Lancaster, T.; Gray, S.; Fowler, G

    1994-01-01

    OBJECTIVE--To assess the effectiveness of interventions that train healthcare professionals in methods for improving the quality of care delivered to patients who smoke. DESIGN--Systematic literature review. SETTING--Primary care medical and dental practices in the United States and Canada. Patients were recruited opportunistically. SUBJECTS--878 healthcare professionals and 11,228 patients who smoked and were identified in eight randomised controlled trials. In each of these trials healthcar...

  12. Effect of unsupervised home based proprioceptive training on recurrences of ankle sprain: randomised controlled trial

    OpenAIRE

    Hupperets, Maarten D W; Verhagen, Evert A L M; van Mechelen, Willem

    2009-01-01

    Objective To evaluate the effectiveness of an unsupervised proprioceptive training programme on recurrences of ankle sprain after usual care in athletes who had sustained an acute sports related injury to the lateral ankle ligament. Design Randomised controlled trial, with one year follow-up. Setting Primary care. Participants 522 athletes, aged 12-70, who had sustained a lateral ankle sprain up to two months before inclusion; 256 (120 female and 136 male) in the intervention group; 266 (128 ...

  13. Preoperative airway assessment - experience gained from a multicentre cluster randomised trial and the Danish Anaesthesia Database

    DEFF Research Database (Denmark)

    Nørskov, Anders Kehlet

    2016-01-01

    prospectively and compared with existing practice for airway assessment in a randomised trial setting. The first objective of this thesis was to quantify the proportion of unanticipated difficult intubation and difficult mask ventilation in Denmark. The second objective was to design a cluster randomised trial...... anticipations of airway difficulties was compared with actual airway management conditions, thus enabling an estimation of the proportion of unanticipated difficulties with intubation and mask ventilation. Papers 2 and 3 outline the methodology and the pre-trial calculations and considerations leading...... to the DIFFICAIR trial described in Paper 4. The trial was designed to randomise anaesthesia department to either thorough education in, and subsequent use of the SARI for preoperative airway assessment or to continue usual care. Registration of the SARI in DAD was made mandatory in SARI departments and impossible...

  14. Out-of-home day care and health.

    OpenAIRE

    Roberts, I

    1996-01-01

    Evidence from randomised trials indicates that out-of-home day care has important effects in domains that are integral to the health of mothers and children. The evidence that day care results in cognitive gains is compelling. These effects and the long term effects in reducing crime and violence should suffice to put the question of day care provision high on the paediatric agenda. However, some important questions remain to be answered. Evidence from a randomised trial suggests that the eff...

  15. A randomised comparison of cognitive behavioural therapy

    Directory of Open Access Journals (Sweden)

    Carlijn de Roos

    2011-04-01

    Full Text Available Background : Building on previous research with disaster-exposed children and adolescents, a randomised clinical trial was performed in the treatment of trauma-related symptoms. In the current study two active treatments were compared among children in a broad age range and from a wide diversity of ethnic populations. Objective : The primary aim was to compare the effectiveness and efficiency of Cognitive Behavioural Therapy (CBT and Eye Movement Desensitisation and Reprocessing (EMDR. Design : Children (n=52, aged 4–18 were randomly allocated to either CBT (n=26 or EMDR (n=26 in a disaster mental health after-care setting after an explosion of a fireworks factory. All children received up to four individual treatment sessions over a 4–8 week period along with up to four sessions of parent guidance. Blind assessment took place pre- and post-treatment and at 3 months follow-up on a variety of parent-rated and self-report measures of post-traumatic stress disorder symptomatology, depression, anxiety, and behaviour problems. Analyses of variance (general linear model repeated measures were conducted on the intention-to-treat sample and the completers. Results : Both treatment approaches produced significant reductions on all measures and results were maintained at follow-up. Treatment gains of EMDR were reached in fewer sessions. Conclusion : Standardised CBT and EMDR interventions can significantly improve functioning of disaster-exposed children.For the abstract in other languages, please see Supplementary files under Reading Tools online

  16. Study Protocol. IDUS – Instrumental delivery & ultrasound. A multi-centre randomised controlled trial of ultrasound assessment of the fetal head position versus standard care as an approach to prevent morbidity at instrumental delivery

    Directory of Open Access Journals (Sweden)

    Murphy Deirdre J

    2012-09-01

    Full Text Available Abstract Background Instrumental deliveries are commonly performed in the United Kingdom and Ireland, with rates of 12 – 17% in most centres. Knowing the exact position of the fetal head is a pre-requisite for safe instrumental delivery. Traditionally, diagnosis of the fetal head position is made on transvaginal digital examination by delineating the suture lines of the fetal skull and the fontanelles. However, the accuracy of transvaginal digital examination can be unreliable and varies between 20% and 75%. Failure to identify the correct fetal head position increases the likelihood of failed instrumental delivery with the additional morbidity of sequential use of instruments or second stage caesarean section. The use of ultrasound in determining the position of the fetal head has been explored but is not part of routine clinical practice. Methods/Design A multi-centre randomised controlled trial is proposed. The study will take place in two large maternity units in Ireland with a combined annual birth rate of 13,500 deliveries. It will involve 450 nulliparous women undergoing instrumental delivery after 37 weeks gestation. The main outcome measure will be incorrect diagnosis of the fetal head position. A study involving 450 women will have 80% power to detect a 10% difference in the incidence of inaccurate diagnosis of the fetal head position with two-sided 5% alpha. Discussion It is both important and timely to evaluate the use of ultrasound to diagnose the fetal head position prior to instrumental delivery before routine use can be advocated. The overall aim is to reduce the incidence of incorrect diagnosis of the fetal head position prior to instrumental delivery and improve the safety of instrumental deliveries. Trial registration Current Controlled Trials ISRCTN72230496

  17. Study Protocol. IDUS – Instrumental delivery & ultrasound. A multi-centre randomised controlled trial of ultrasound assessment of the fetal head position versus standard care as an approach to prevent morbidity at instrumental delivery

    Science.gov (United States)

    2012-01-01

    Background Instrumental deliveries are commonly performed in the United Kingdom and Ireland, with rates of 12 – 17% in most centres. Knowing the exact position of the fetal head is a pre-requisite for safe instrumental delivery. Traditionally, diagnosis of the fetal head position is made on transvaginal digital examination by delineating the suture lines of the fetal skull and the fontanelles. However, the accuracy of transvaginal digital examination can be unreliable and varies between 20% and 75%. Failure to identify the correct fetal head position increases the likelihood of failed instrumental delivery with the additional morbidity of sequential use of instruments or second stage caesarean section. The use of ultrasound in determining the position of the fetal head has been explored but is not part of routine clinical practice. Methods/Design A multi-centre randomised controlled trial is proposed. The study will take place in two large maternity units in Ireland with a combined annual birth rate of 13,500 deliveries. It will involve 450 nulliparous women undergoing instrumental delivery after 37 weeks gestation. The main outcome measure will be incorrect diagnosis of the fetal head position. A study involving 450 women will have 80% power to detect a 10% difference in the incidence of inaccurate diagnosis of the fetal head position with two-sided 5% alpha. Discussion It is both important and timely to evaluate the use of ultrasound to diagnose the fetal head position prior to instrumental delivery before routine use can be advocated. The overall aim is to reduce the incidence of incorrect diagnosis of the fetal head position prior to instrumental delivery and improve the safety of instrumental deliveries. Trial registration Current Controlled Trials ISRCTN72230496 PMID:22970933

  18. Study Protocol. IDUS -- Instrumental delivery & ultrasound. A multi-centre randomised controlled trial of ultrasound assessment of the fetal head position versus standard care as an approach to prevent morbidity at instrumental delivery

    LENUS (Irish Health Repository)

    Murphy, Deirdre J

    2012-09-13

    AbstractBackgroundInstrumental deliveries are commonly performed in the United Kingdom and Ireland, with rates of 12 – 17% in most centres. Knowing the exact position of the fetal head is a pre-requisite for safe instrumental delivery. Traditionally, diagnosis of the fetal head position is made on transvaginal digital examination by delineating the suture lines of the fetal skull and the fontanelles. However, the accuracy of transvaginal digital examination can be unreliable and varies between 20% and 75%. Failure to identify the correct fetal head position increases the likelihood of failed instrumental delivery with the additional morbidity of sequential use of instruments or second stage caesarean section. The use of ultrasound in determining the position of the fetal head has been explored but is not part of routine clinical practice.Methods\\/DesignA multi-centre randomised controlled trial is proposed. The study will take place in two large maternity units in Ireland with a combined annual birth rate of 13,500 deliveries. It will involve 450 nulliparous women undergoing instrumental delivery after 37 weeks gestation. The main outcome measure will be incorrect diagnosis of the fetal head position. A study involving 450 women will have 80% power to detect a 10% difference in the incidence of inaccurate diagnosis of the fetal head position with two-sided 5% alpha.DiscussionIt is both important and timely to evaluate the use of ultrasound to diagnose the fetal head position prior to instrumental delivery before routine use can be advocated. The overall aim is to reduce the incidence of incorrect diagnosis of the fetal head position prior to instrumental delivery and improve the safety of instrumental deliveries.Trial registrationCurrent Controlled Trials ISRCTN72230496

  19. The Procalcitonin And Survival Study (PASS – A Randomised multi-center investigator-initiated trial to investigate whether daily measurements biomarker Procalcitonin and pro-active diagnostic and therapeutic responses to abnormal Procalcitonin levels, can improve survival in intensive care unit patients. Calculated sample size (target population: 1000 patients

    Directory of Open Access Journals (Sweden)

    Fjeldborg Paul

    2008-07-01

    Full Text Available Abstract Background Sepsis and complications to sepsis are major causes of mortality in critically ill patients. Rapid treatment of sepsis is of crucial importance for survival of patients. The infectious status of the critically ill patient is often difficult to assess because symptoms cannot be expressed and signs may present atypically. The established biological markers of inflammation (leucocytes, C-reactive protein may often be influenced by other parameters than infection, and may be unacceptably slowly released after progression of an infection. At the same time, lack of a relevant antimicrobial therapy in an early course of infection may be fatal for the patient. Specific and rapid markers of bacterial infection have been sought for use in these patients. Methods Multi-centre randomized controlled interventional trial. Powered for superiority and non-inferiority on all measured end points. Complies with, "Good Clinical Practice" (ICH-GCP Guideline (CPMP/ICH/135/95, Directive 2001/20/EC. Inclusion: 1 Age ≥ 18 years of age, 2 Admitted to the participating intensive care units, 3 Signed written informed consent. Exclusion: 1 Known hyper-bilirubinaemia. or hypertriglyceridaemia, 2 Likely that safety is compromised by blood sampling, 3 Pregnant or breast feeding. Computerized Randomisation: Two arms (1:1, n = 500 per arm: Arm 1: standard of care. Arm 2: standard of care and Procalcitonin guided diagnostics and treatment of infection. Primary Trial Objective: To address whether daily Procalcitonin measurements and immediate diagnostic and therapeutic response on day-to-day changes in procalcitonin can reduce the mortality of critically ill patients. Discussion For the first time ever, a mortality-endpoint, large scale randomized controlled trial with a biomarker-guided strategy compared to the best standard of care, is conducted in an Intensive care setting. Results will, with a high statistical power answer the question: Can the survival

  20. Multicentre, open-label, randomised, parallel-group, superiority study to compare the efficacy of octreotide therapy 40 mg monthly versus standard of care in patients with refractory anaemia due to gastrointestinal bleeding from small bowel angiodysplasias: a protocol of the OCEAN trial

    Science.gov (United States)

    van Geenen, E J M; Drenth, J P H

    2016-01-01

    Introduction Gastrointestinal angiodysplasias are an important cause of difficult-to-manage bleeding, especially in older patients. Endoscopic coagulation of angiodysplasias is the mainstay of treatment, but may be difficult for small bowel angiodysplasias because of the inability to reach them for endoscopic intervention. Some patients are red blood cell (RBC) transfusion dependent due to frequent rebleeding despite endoscopic treatment. In small cohort studies, octreotide appears to decrease the number of bleeding episodes in patients with RBC transfusion dependency due to gastrointestinal angiodysplasias. This trial will assess the efficacy of octreotide in decreasing the need for RBC transfusions and parenteral iron in patients with anaemia due to gastrointestinal bleeding of small bowel angiodysplasias despite endoscopic intervention. Study design Randomised controlled, superiority, open-label multicentre trial. Participants 62 patients will be included with refractory anaemia due to small bowel angiodysplasias, who are RBC transfusion or iron infusion dependent despite endoscopic intervention and oral iron supplementation. Intervention Patients will be randomly assigned (1:1) to standard care or 40 mg long-acting octreotide once every 4 weeks for 52 weeks, in addition to standard care. The follow-up period is 8 weeks. Main outcome measures The primary outcome is the difference in the number of blood and iron infusions between the year prior to inclusion and the treatment period of 1 year. Important secondary outcomes are the per cent change in the number of rebleeds from baseline to end point, adverse events and quality of life. Ethics and dissemination The trial received ethical approval from the Central Committee on Research Involving Human Subjects and from the local accredited Medical Research Ethics Committee of the region Arnhem-Nijmegen, the Netherlands (reference number: 2014-1433). Results will be published in a peer-reviewed journal and

  1. Support and Assessment for Fall Emergency Referrals (SAFER 1 trial protocol. Computerised on-scene decision support for emergency ambulance staff to assess and plan care for older people who have fallen: evaluation of costs and benefits using a pragmatic cluster randomised trial

    Directory of Open Access Journals (Sweden)

    Roberts Stephen

    2010-01-01

    Full Text Available Abstract Background Many emergency ambulance calls are for older people who have fallen. As half of them are left at home, a community-based response may often be more appropriate than hospital attendance. The SAFER 1 trial will assess the costs and benefits of a new healthcare technology - hand-held computers with computerised clinical decision support (CCDS software - to help paramedics decide who needs hospital attendance, and who can be safely left at home with referral to community falls services. Methods/Design Pragmatic cluster randomised trial with a qualitative component. We shall allocate 72 paramedics ('clusters' at random between receiving the intervention and a control group delivering care as usual, of whom we expect 60 to complete the trial. Patients are eligible if they are aged 65 or older, live in the study area but not in residential care, and are attended by a study paramedic following an emergency call for a fall. Seven to 10 days after the index fall we shall offer patients the opportunity to opt out of further follow up. Continuing participants will receive questionnaires after one and 6 months, and we shall monitor their routine clinical data for 6 months. We shall interview 20 of these patients in depth. We shall conduct focus groups or semi-structured interviews with paramedics and other stakeholders. The primary outcome is the interval to the first subsequent reported fall (or death. We shall analyse this and other measures of outcome, process and cost by 'intention to treat'. We shall analyse qualitative data thematically. Discussion Since the SAFER 1 trial received funding in August 2006, implementation has come to terms with ambulance service reorganisation and a new national electronic patient record in England. In response to these hurdles the research team has adapted the research design, including aspects of the intervention, to meet the needs of the ambulance services. In conclusion this complex emergency care

  2. Support and Assessment for Fall Emergency Referrals (SAFER 1) trial protocol. Computerised on-scene decision support for emergency ambulance staff to assess and plan care for older people who have fallen: evaluation of costs and benefits using a pragmatic cluster randomised trial

    Science.gov (United States)

    2010-01-01

    Background Many emergency ambulance calls are for older people who have fallen. As half of them are left at home, a community-based response may often be more appropriate than hospital attendance. The SAFER 1 trial will assess the costs and benefits of a new healthcare technology - hand-held computers with computerised clinical decision support (CCDS) software - to help paramedics decide who needs hospital attendance, and who can be safely left at home with referral to community falls services. Methods/Design Pragmatic cluster randomised trial with a qualitative component. We shall allocate 72 paramedics ('clusters') at random between receiving the intervention and a control group delivering care as usual, of whom we expect 60 to complete the trial. Patients are eligible if they are aged 65 or older, live in the study area but not in residential care, and are attended by a study paramedic following an emergency call for a fall. Seven to 10 days after the index fall we shall offer patients the opportunity to opt out of further follow up. Continuing participants will receive questionnaires after one and 6 months, and we shall monitor their routine clinical data for 6 months. We shall interview 20 of these patients in depth. We shall conduct focus groups or semi-structured interviews with paramedics and other stakeholders. The primary outcome is the interval to the first subsequent reported fall (or death). We shall analyse this and other measures of outcome, process and cost by 'intention to treat'. We shall analyse qualitative data thematically. Discussion Since the SAFER 1 trial received funding in August 2006, implementation has come to terms with ambulance service reorganisation and a new national electronic patient record in England. In response to these hurdles the research team has adapted the research design, including aspects of the intervention, to meet the needs of the ambulance services. In conclusion this complex emergency care trial will provide

  3. Strategies to improve retention in randomised trials

    OpenAIRE

    Brueton, V. C.; Tierney, J.; Stenning, S; Harding, S; Meredith, S.; Nazareth, I; Rait, G

    2013-01-01

    Background Loss to follow-up from randomised trials can introduce bias and reduce study power, affecting the generalisability, validity and reliability of results. Many strategies are used to reduce loss to follow-up and improve retention but few have been formally evaluated. Objectives To quantify the effect of strategies to improve retention on the proportion of participants retained in randomised trials and to investigate if the effect varied by trial strategy and trial setting. Search met...

  4. Randomised trial of biofeedback training for encopresis.

    OpenAIRE

    Plas, R. N.; Benninga, M.A.; Redekop, W. K.; Taminiau, J A; Büller, H A

    1996-01-01

    AIMS: To evaluate biofeedback training in children with encopresis and the effect on psychosocial function. DESIGN: Prospective controlled randomised study. PATIENT INTERVENTIONS: A multimodal treatment of six weeks. Children were randomised into two groups. Each group received dietary and toilet advice, enemas, oral laxatives, and anorectal manometry. One group also received five biofeedback training sessions. MAIN OUTCOME MEASURES: Successful treatment was defined as less than two episodes ...

  5. Timing of birth for women with a twin pregnancy at term: a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Haslam Ross R

    2010-10-01

    Full Text Available Abstract Background There is a well recognized risk of complications for both women and infants of a twin pregnancy, increasing beyond 37 weeks gestation. Preterm birth prior to 37 weeks gestation is a recognized complication of a twin pregnancy, however, up to 50% of twins will be born after this time. The aims of this randomised trial are to assess whether elective birth at 37 weeks gestation compared with standard care in women with a twin pregnancy affects the risk of perinatal death, and serious infant complications. Methods/Design Design: Multicentred randomised trial. Inclusion Criteria: women with a twin pregnancy at 366 weeks or more without contraindication to continuation of pregnancy. Trial Entry & Randomisation: Following written informed consent, eligible women will be randomised from 36+6 weeks gestation. The randomisation schedule uses balanced variable blocks, with stratification for centre of birth and planned mode of birth. Women will be randomised to either elective birth or standard care. Treatment Schedules: Women allocated to the elective birth group will be planned for elective birth from 37 weeks gestation. Where the plan is for vaginal birth, this will involve induction of labour. Where the plan is for caesarean birth, this will involve elective caesarean section. For women allocated to standard care, birth will be planned for 38 weeks gestation or later. Where the plan is for vaginal birth, this will involve either awaiting the spontaneous onset of labour, or induction of labour if required. Where the plan is for caesarean birth, this will involve elective caesarean section (after 38 and as close to 39 weeks as possible. Primary Study Outcome: A composite of perinatal mortality or serious neonatal morbidity. Sample Size: 460 women with a twin pregnancy to show a reduction in the composite outcome from 16.3% to 6.7% with adjustment for the clustering of twin infants within mothers (p = 0.05, 80% power. Discussion This

  6. Generation of allocation sequences in randomised trials: chance, not choice.

    Science.gov (United States)

    Schulz, Kenneth F; Grimes, David A

    2002-02-01

    The randomised controlled trial sets the gold standard of clinical research. However, randomisation persists as perhaps the least-understood aspect of a trial. Moreover, anything short of proper randomisation courts selection and confounding biases. Researchers should spurn all systematic, non-random methods of allocation. Trial participants should be assigned to comparison groups based on a random process. Simple (unrestricted) randomisation, analogous to repeated fair coin-tossing, is the most basic of sequence generation approaches. Furthermore, no other approach, irrespective of its complexity and sophistication, surpasses simple randomisation for prevention of bias. Investigators should, therefore, use this method more often than they do, and readers should expect and accept disparities in group sizes. Several other complicated restricted randomisation procedures limit the likelihood of undesirable sample size imbalances in the intervention groups. The most frequently used restricted sequence generation procedure is blocked randomisation. If this method is used, investigators should randomly vary the block sizes and use larger block sizes, particularly in an unblinded trial. Other restricted procedures, such as urn randomisation, combine beneficial attributes of simple and restricted randomisation by preserving most of the unpredictability while achieving some balance. The effectiveness of stratified randomisation depends on use of a restricted randomisation approach to balance the allocation sequences for each stratum. Generation of a proper randomisation sequence takes little time and effort but affords big rewards in scientific accuracy and credibility. Investigators should devote appropriate resources to the generation of properly randomised trials and reporting their methods clearly. PMID:11853818

  7. Improving glycaemic control and life skills in adolescents with type 1 diabetes: A randomised, controlled intervention study using the Guided Self-Determination-Young method in triads of adolescents, parents and health care providers integrated into routine paediatric outpatient clinics

    DEFF Research Database (Denmark)

    Thorsteinsson, Birger; Esbensen, Bente Appel; Hommel, Eva;

    2011-01-01

    are lacking. The Guided Self-Determination method is proven effective in adult care and has been adapted to adolescents and parents (Guided Self-Determination-Young (GSD-Y)) for use in paediatric diabetes outpatient clinics. Our objective is to test whether GSD-Y used in routine paediatric outpatient clinic......ABSTRACT: BACKGROUND: Adolescents with type 1 diabetes face demanding challenges due to conflicting priorities between psychosocial needs and diabetes management. This conflict often results in poor glycaemic control and discord between adolescents and parents. Adolescent-parent conflicts are thus...... a barrier for health care providers (HCPs) to overcome in their attempts to involve both adolescents and parents in improvement of glycaemic control. Evidence-based interventions that involve all three parties (i.e., adolescents, parents and HCPs) and are integrated into routine outpatient clinic visits...

  8. Tele-guidance of chronic heart failure patients enhances knowledge about the disease. A multi-centre, randomised controlled study

    NARCIS (Netherlands)

    Balk, A.H.; Davidse, W.; Dommelen, P. van; Klaassen, E.; Caliskan, K.; Burgh, P. van der; Leenders, C.M.

    2008-01-01

    Background: New strategies are required to optimize care in increasing numbers of chronic heart failure patients. The aim of this randomised trial was to evaluate a remote guidance system. Methods: Intervention group patients received a home TV-channel providing educational materials. Tele-guidance

  9. A multi-centre randomised controlled trial of rehabilitation aimed at improving outdoor mobility for people after stroke: Study protocol for a randomised controlled trial

    OpenAIRE

    Logan Pip A; Leighton Mat P; Walker Marion F; Armstrong Sarah; Gladman John R F; Sach Tracey H; Smith Shirley; Newell Ossie; Avery Tony; Williams Hywel; Scott James; O’Neil Kathleen; McCluskey Annie; Leach Simon; Barer David

    2012-01-01

    Abstract Background Up to 42% of all stroke patients do not get out of the house as much as they would like. This can impede a person’s quality of life. This study is testing the clinical effectiveness and cost effectiveness of a new outdoor mobility rehabilitation intervention by comparing it to usual care. Methods/design This is a multi-centre parallel group individually randomised, controlled trial. At least 506 participants will be recruited through 15 primary and secondary care settings ...

  10. Deprescribing in Frail Older People: A Randomised Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Kathleen Potter

    Full Text Available Deprescribing has been proposed as a way to reduce polypharmacy in frail older people. We aimed to reduce the number of medicines consumed by people living in residential aged care facilities (RACF. Secondary objectives were to explore the effect of deprescribing on survival, falls, fractures, hospital admissions, cognitive, physical, and bowel function, quality of life, and sleep.Ninety-five people aged over 65 years living in four RACF in rural mid-west Western Australia were randomised in an open study. The intervention group (n = 47 received a deprescribing intervention, the planned cessation of non-beneficial medicines. The control group (n = 48 received usual care. Participants were monitored for twelve months from randomisation. Primary outcome was change in the mean number of unique regular medicines. All outcomes were assessed at baseline, six, and twelve months.Study participants had a mean age of 84.3 ± 6.9 years and 52% were female. Intervention group participants consumed 9.6 ± 5.0 and control group participants consumed 9.5 ± 3.6 unique regular medicines at baseline. Of the 348 medicines targeted for deprescribing (7.4 ± 3.8 per person, 78% of regular medicines, 207 medicines (4.4 ± 3.4 per person, 59% of targeted medicines were successfully discontinued. The mean change in number of regular medicines at 12 months was -1.9 ± 4.1 in intervention group participants and +0.1 ± 3.5 in control group participants (estimated difference 2.0 ± 0.9, 95%CI 0.08, 3.8, p = 0.04. Twelve intervention participants and 19 control participants died within 12 months of randomisation (26% versus 40% mortality, p = 0.16, HR 0.60, 95%CI 0.30 to 1.22 There were no significant differences between groups in other secondary outcomes. The main limitations of this study were the open design and small participant numbers.Deprescribing reduced the number of regular medicines consumed by frail older people living in residential care with no significant

  11. Virtual outreach: a randomised controlled trial and economic evaluation of joint teleconferenced medical consultations

    OpenAIRE

    Wallace, P.; Barber, J; Clayton, W.; Currell, R.; Fleming, K.; Garner, P.; Haines, A.; Harrison, R; Jacklin, P.; Jarrett, C.; Jayasuriya, R.; Lewis, L; Parker, S; Roberts, J.; Thompson, S

    2004-01-01

    Objectives: To test the hypotheses that virtual outreach would reduce offers of hospital follow-up appointments and reduce numbers of medical interventions and investigations, reduce numbers of contacts with the health care system, have a positive impact on patient satisfaction and enablement, and lead to improvements in patient health status. To perform an economic evaluation of virtual outreach.Design: A randomised controlled trial comparing joint teleconsultations between GPs, specialists ...

  12. Randomised controlled trial of topical kanuka honey for the treatment of acne

    OpenAIRE

    Semprini, Alex; Braithwaite, Irene; Corin, Andrew; Sheahan, Davitt; Tofield, Christopher; Helm, Colin; Montgomery, Barney; Fingleton, James; Weatherall, Mark; Beasley, Richard

    2016-01-01

    Objective To investigate the efficacy of Honevo, a topical 90% medical-grade kanuka honey, and 10% glycerine (honey product) as a treatment for facial acne. Design Randomised controlled trial with single blind assessment of primary outcome variable. Setting Outpatient primary care from 3 New Zealand localities. Participants Of 136 participants aged between 16 and 40 years with a diagnosis of acne and baseline Investigator's Global Assessment (IGA) for acne score of ≥2.68, participants were ra...

  13. Limiting weight gain in overweight and obese women during pregnancy to improve health outcomes: the LIMIT randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Crowther Caroline A

    2011-10-01

    Full Text Available Abstract Background Obesity is a significant global health problem, with the proportion of women entering pregnancy with a body mass index greater than or equal to 25 kg/m2 approaching 50%. Obesity during pregnancy is associated with a well-recognised increased risk of adverse health outcomes both for the woman and her infant, however there is more limited information available regarding effective interventions to improve health outcomes. The aims of this randomised controlled trial are to assess whether the implementation of a package of dietary and lifestyle advice to overweight and obese women during pregnancy to limit gestational weight gain is effective in improving maternal, fetal and infant health outcomes. Methods/Design Design: Multicentred randomised, controlled trial. Inclusion Criteria: Women with a singleton, live gestation between 10+0-20+0 weeks who are obese or overweight (defined as body mass index greater than or equal to 25 kg/m2, at the first antenatal visit. Trial Entry & Randomisation: Eligible, consenting women will be randomised between 10+0 and 20+0 weeks gestation using a central telephone randomisation service, and randomisation schedule prepared by non-clinical research staff with balanced variable blocks. Stratification will be according to maternal BMI at trial entry, parity, and centre where planned to give birth. Treatment Schedules: Women randomised to the Dietary and Lifestyle Advice Group will receive a series of inputs from research assistants and research dietician to limit gestational weight gain, and will include a combination of dietary, exercise and behavioural strategies. Women randomised to the Standard Care Group will continue to receive their pregnancy care according to local hospital guidelines, which does not currently include routine provision of dietary, lifestyle and behavioural advice. Outcome assessors will be blinded to the allocated treatment group. Primary Study Outcome: infant large for

  14. Rationale and design of a randomised controlled trial evaluating the effectiveness of an exercise program to improve the quality of life of patients with heart failure in primary care: The EFICAR study protocol

    Directory of Open Access Journals (Sweden)

    de la Torre Maria M

    2010-01-01

    Full Text Available Abstract Background Quality of life (QoL decreases as heart failure worsens, which is one of the greatest worries of these patients. Physical exercise has been shown to be safe for people with heart failure. Previous studies have tested heterogeneous exercise programs using different QoL instruments and reported inconsistent effects on QoL. The aim of this study is to evaluate the effectiveness of a new exercise program for people with heart failure (EFICAR, additional to the recommended optimal treatment in primary care, to improve QoL, functional capacity and control of cardiovascular risk factors. Methods/Design Multicenter clinical trial in which 600 patients with heart failure in NYHA class II-IV will be randomized to two parallel groups: EFICAR and control. After being recruited, through the reference cardiology services, in six health centres from the Spanish Primary Care Prevention and Health Promotion Research Network (redIAPP, patients are followed for 1 year after the beginning of the intervention. Both groups receive the optimized treatment according to the European Society of Cardiology guidelines. In addition, the EFICAR group performs a 3 month supervised progressive exercise program with an aerobic (high-intensity intervals and a strength component; and the programme continues linked with community resources for 9 months. The main outcome measure is the change in health-related QoL measured by the SF-36 and the Minnesota Living with Heart Failure Questionnaires at baseline, 3, 6 and 12 months. Secondary outcomes considered are changes in functional capacity measured by the 6-Minute Walking Test, cardiac structure (B-type natriuretic peptides, muscle strength and body composition. Both groups will be compared on an intention to treat basis, using multi-level longitudinal mixed models. Sex, age, social class, co-morbidity and cardiovascular risk factors will be considered as potential confounding and predictor variables. Discussion

  15. The OPERA trial: protocol for a randomised trial of an exercise intervention for older people in residential and nursing accommodation

    Directory of Open Access Journals (Sweden)

    Taylor Stephanie

    2011-02-01

    Full Text Available Abstract Background Depression is common in residents of Residential and Nursing homes (RNHs. It is usually undetected and often undertreated. Depression is associated with poor outcomes including increased morbidity and mortality. Exercise has potential to improve depression, and has been shown in existing trials to improve outcomes among younger and older people. Existing evidence comes from trials that are short, underpowered and not from RNH settings. The aim of the OPERA trial is to establish whether exercise is effective in reducing the prevalence of depression among older RNH residents. Method OPERA is a cluster randomised controlled trial. RNHs are randomised to one of two groups with interventions lasting 12 months Intervention group: a depression awareness and physical activity training session for care home staff, plus a whole home physical activation programme including twice weekly physiotherapist-led exercise groups. The intervention lasts for one year from randomisation, or Control group: a depression awareness training session for care home staff. Participants are people aged 65 or over who are free of severe cognitive impairment and willing to participate in the study. Our primary outcome is the prevalence of depressive symptoms, a GDS-15 score of five or more, in all participants at the end of the one year intervention period. Our secondary depression outcomes include remission of depressive symptoms and change in GDS-15 scores in those with depressive symptoms prior to randomisation. Other secondary outcomes include, fear of falling, mobility, fractures, pain, cognition, costs and health related quality of life. We aimed to randomise 77 RNHs. Discussion Home recruitment was completed in May 2010; 78 homes have been randomised. Follow up will finish in May 2011 and results will be available late 2011. Trial Registration [ISRCTN: ISRCTN43769277

  16. SMART: Self-Management of Anticoagulation, a Randomised Trial [ISRCTN19313375

    Directory of Open Access Journals (Sweden)

    Murray Ellen T

    2003-09-01

    Full Text Available Abstract Background Oral anticoagulation monitoring has traditionally taken place in secondary care because of the need for a laboratory blood test, the international normalised ratio (INR. The development of reliable near patient testing (NPT systems for INR estimation has facilitated devolution of testing to primary care. Patient self-management is a logical progression from the primary care model. This study will be the first to randomise non-selected patients in primary care, to either self-management or standard care. Method The study was a multi-centred randomised controlled trial with patients from 49 general practices recruited. Those suitable for inclusion were aged 18 or over, with a long term indication for oral anticoagulation, who had taken warfarin for at least six months. Patients randomised to the intervention arm attended at least two training sessions which were practice-based, 1 week apart. Each patient was assessed on their capability to undertake self management. If considered capable, they were given a near patient INR testing monitor, test strips and quality control material for home testing. Patients managed their own anticoagulation for a period of 12 months and performed their INR test every 2 weeks. Control patients continued with their pre-study care either attending hospital or practice based anticoagulant clinics. Discussion The methodology used in this trial will overcome concerns from previous trials of selection bias and relevance to the UK health service. The study will give a clearer understanding of the benefits of self-management in terms of clinical and cost effectiveness and patient preference.

  17. Careful science?

    DEFF Research Database (Denmark)

    Jespersen, Astrid P; Bønnelycke, Julie; Eriksen, Hanne Hellerup

    2014-01-01

    Concern about obesity has prompted numerous public health campaigns that urge people to be more physically active. The campaigns often include normative statements and attempt to impose restrictions on individuals' lives without considering the complexities of daily life. We suggest that broadening...... the focus to reflect everyday practices would foster better targeted public health campaigns. This article is based on our participation in FINE, a multidisciplinary Danish research project. The core methodology of FINE was a randomised controlled trial in which 61 moderately overweight men were put...... into different exercise groups. In this article we analyse the scientific work of the trial as representing entangled processes of bodywork, where data are extracted and objectified bodies are manipulated and care practices address the emotional, social and mundane aspects of the participants' everyday lives...

  18. Xylitol chewing gum in prevention of acute otitis media: double blind randomised trial.

    OpenAIRE

    Uhari, M.; Kontiokari, T; Koskela, M.; Niemelä, M. (Mika)

    1996-01-01

    OBJECTIVE: To examine whether xylitol, which reduces the growth of Streptococcus pneumoniae, might have clinical importance in the prevention of acute otitis media. DESIGN: A double blind randomised trial with xylitol administered in chewing gum. SETTING: Eleven day care nurseries in the city of Oulu. Most of the children had had problems with recurrent acute otitis media. SUBJECTS: 306 day care children: 149 children in the sucrose group (76 boys; mean (SD) age 4.9 (1.5) years) and 157 in th...

  19. Integrated care for diabetes: clinical, psychosocial, and economic evaluation. Diabetes Integrated Care Evaluation Team.

    OpenAIRE

    1994-01-01

    OBJECTIVES--To evaluate integrated care for diabetes in clinical, psychosocial, and economic terms. DESIGN--Pragmatic randomised trial. SETTING--Hospital diabetic clinic and three general practice groups in Grampian. PATIENTS--274 adult diabetic patients attending a hospital clinic and registered with one of three general practices. INTERVENTION--Random allocation to conventional hospital clinic care or integrated care. Integrated care patients seen in general practice every three or four mon...

  20. A randomised controlled trial linking mental health inpatients to community smoking cessation supports: A study protocol

    Directory of Open Access Journals (Sweden)

    Clancy Richard

    2011-07-01

    Full Text Available Abstract Background Mental health inpatients smoke at higher rates than the general population and are disproportionately affected by tobacco dependence. Despite the advent of smoke free policies within mental health hospitals, limited systems are in place to support a cessation attempt post hospitalisation, and international evidence suggests that most smokers return to pre-admission smoking levels following discharge. This protocol describes a randomised controlled trial that will test the feasibility, acceptability and efficacy of linking inpatient smoking care with ongoing community cessation support for smokers with a mental illness. Methods/Design This study will be conducted as a randomised controlled trial. 200 smokers with an acute mental illness will be recruited from a large inpatient mental health facility. Participants will complete a baseline survey and will be randomised to either a multimodal smoking cessation intervention or provided with hospital smoking care only. Randomisation will be stratified by diagnosis (psychotic, non-psychotic. Intervention participants will be provided with a brief motivational interview in the inpatient setting and options of ongoing smoking cessation support post discharge: nicotine replacement therapy (NRT; referral to Quitline; smoking cessation groups; and fortnightly telephone support. Outcome data, including cigarettes smoked per day, quit attempts, and self-reported 7-day point prevalence abstinence (validated by exhaled carbon monoxide, will be collected via blind interview at one week, two months, four months and six months post discharge. Process information will also be collected, including the use of cessation supports and cost of the intervention. Discussion This study will provide comprehensive data on the potential of an integrated, multimodal smoking cessation intervention for persons with an acute mental illness, linking inpatient with community cessation support. Trial Registration

  1. A pragmatic cluster randomised trial evaluating three implementation interventions

    Directory of Open Access Journals (Sweden)

    Rycroft-Malone Jo

    2012-08-01

    national randomised controlled trials conducted within acute care in implementation research. The evidence base for fasting practice was accepted by those participating in this study and the messages from it simple; however, implementation and practical challenges influenced the interventions’ impact. A set of conditions for implementation emerges from the findings of this study, which are presented as theoretically transferable propositions that have international relevance. Trial registration ISRCTN18046709 - Peri-operative Implementation Study Evaluation (POISE.

  2. The serious mental illness health improvement profile [HIP]: study protocol for a cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Swift Louise

    2011-07-01

    Full Text Available Abstract Background The serious mental illness Health Improvement Profile [HIP] is a brief pragmatic tool, which enables mental health nurses to work together with patients to screen physical health and take evidence-based action when variables are identified to be at risk. Piloting has demonstrated clinical utility and acceptability. Methods/Design A single blind parallel group cluster randomised controlled trial with secondary economic analysis and process observation. Unit of randomisation: mental health nurses [MHNs] working in adult community mental health teams across two NHS Trusts. Subjects: Patients over 18 years with a diagnosis of schizophrenia, schizoaffective or bipolar disorder on the caseload of participating MHNs. Primary objective: To determine the effects of the HIP programme on patients' physical wellbeing assessed by the physical component score of the Medical Outcome Study (MOS 36 Item Short Form Health Survey version 2 [SF-36v2]. Secondary objectives: To determine the effects of the HIP programme on: cost effectiveness, mental wellbeing, cardiovascular risk, physical health care attitudes and knowledge of MHNs and to determine the acceptability of the HIP Programme in the NHS. Consented nurses (and patients will be randomised to receive the HIP Programme or treatment as usual. Outcomes will be measured at baseline and 12 months with a process observation after 12 months to include evaluation of patients' and professionals' experience and observation of any effect on care plans and primary-secondary care interface communication. Outcomes will be analysed on an intention-to-treat (ITT basis. Discussion The results of the trial and process observation will provide information about the effectiveness of the HIP Programme in supporting MHNs to address physical comorbidity in serious mental illness. Given the current unacceptable prevalence of physical comorbidity and mortality in the serious mental illness population, it is

  3. A randomised comparison of cognitive behavioural therapy

    OpenAIRE

    De Roos, Carlijn; Greenwald, Ricky; Hollander-Gijsman, Margien den; Noorthoorn, Eric; van Buuren, Stef; Jongh, Ad De

    2011-01-01

    Background: Building on previous research with disaster-exposed children and adolescents, a randomised clinical trial was performed in the treatment of trauma-related symptoms. In the current study two active treatments were compared among children in a broad age range and from a wide diversity of ethnic populations. Objective: The primary aim was to compare the effectiveness and efficiency of Cognitive Behavioural Therapy (CBT) and Eye Movement Desensitisation and Reprocessing (EMDR). Design...

  4. Should desperate volunteers be included in randomised controlled trials?

    Science.gov (United States)

    Allmark, P; Mason, S

    2006-09-01

    Randomised controlled trials (RCTs) sometimes recruit participants who are desperate to receive the experimental treatment. This paper defends the practice against three arguments that suggest it is unethical first, desperate volunteers are not in equipoise. Second clinicians, entering patients onto trials are disavowing their therapeutic obligation to deliver the best treatment; they are following trial protocols rather than delivering individualised care. Research is not treatment; its ethical justification is different. Consent is crucial. Third, desperate volunteers do not give proper consent: effectively, they are coerced. This paper responds by advocating a notion of equipoise based on expert knowledge and widely shared values. Where such collective, expert equipoise exists there is a prima facie case for an RCT. Next the paper argues that trial entry does not involve clinicians disavowing their therapeutic obligation; individualised care based on insufficient evidence is not in patients best interest. Finally, it argues that where equipoise exists it is acceptable to limit access to experimental agents; desperate volunteers are not coerced because their desperation does not translate into a right to receive what they desire.

  5. Patch: platelet transfusion in cerebral haemorrhage: study protocol for a multicentre, randomised, controlled trial

    Directory of Open Access Journals (Sweden)

    Dijkgraaf Marcel G

    2010-03-01

    Full Text Available Abstract Background Patients suffering from intracerebral haemorrhage have a poor prognosis, especially if they are using antiplatelet therapy. Currently, no effective acute treatment option for intracerebral haemorrhage exists. Limiting the early growth of intracerebral haemorrhage volume which continues the first hours after admission seems a promising strategy. Because intracerebral haemorrhage patients who are on antiplatelet therapy have been shown to be particularly at risk of early haematoma growth, platelet transfusion may have a beneficial effect. Methods/Design The primary objective is to investigate whether platelet transfusion improves outcome in intracerebral haemorrhage patients who are on antiplatelet treatment. The PATCH study is a prospective, randomised, multi-centre study with open treatment and blind endpoint evaluation. Patients will be randomised to receive platelet transfusion within six hours or standard care. The primary endpoint is functional health after three months. The main secondary endpoints are safety of platelet transfusion and the occurrence of haematoma growth. To detect an absolute poor outcome reduction of 20%, a total of 190 patients will be included. Discussion To our knowledge this is the first randomised controlled trial of platelet transfusion for an acute haemorrhagic disease. Trial registration The Netherlands National Trial Register (NTR1303

  6. CYCLE pilot: a protocol for a pilot randomised study of early cycle ergometry versus routine physiotherapy in mechanically ventilated patients

    OpenAIRE

    Kho, Michelle E.; Molloy, Alexander J; Clarke, France; Herridge, Margaret S.; Koo, Karen K Y; Rudkowski, Jill; Seely, Andrew J E; Pellizzari, Joseph R; Tarride, Jean-Eric; Mourtzakis, Marina; Karachi, Timothy; Cook, Deborah J; ,

    2016-01-01

    Introduction Early exercise with in-bed cycling as part of an intensive care unit (ICU) rehabilitation programme has the potential to improve physical and functional outcomes following critical illness. The objective of this study is to determine the feasibility of enrolling adults in a multicentre pilot randomised clinical trial (RCT) of early in-bed cycling versus routine physiotherapy to inform a larger RCT. Methods and analysis 60-patient parallel group pilot RCT in 7 Canadian medical-sur...

  7. A randomised controlled trial of the use of aromatherapy and hand massage to reduce disruptive behaviour in people with dementia

    OpenAIRE

    Fu, Chieh-Yu; Moyle, Wendy; Cooke, Marie

    2013-01-01

    Background Aromatherapy and hand massage therapies have been reported to have some benefit for people with dementia who display behavioural symptoms; however there are a number of limitations of reported studies. The aim is to investigate the effect of aromatherapy (3% lavender oil spray) with and without hand massage on disruptive behaviour in people with dementia living in long-term care. Methods In a single blinded randomised controlled trial 67 people with a diagnosis of dementia and a hi...

  8. A 12-Week Exercise Program for Pregnant Women with Obesity to Improve Physical Activity Levels: An Open Randomised Preliminary Study

    OpenAIRE

    Bisson, Michèle; Alméras, Natalie; Sébastien S Dufresne; Robitaille, Julie; Rhéaume, Caroline; Bujold, Emmanuel; Frenette, Jérôme; Tremblay, Angelo; Marc, Isabelle

    2015-01-01

    Objective To evaluate whether a 12-week supervised exercise program promotes an active lifestyle throughout pregnancy in pregnant women with obesity. Methods In this preliminary randomised trial, pregnant women (body mass index ≥ 30 kg/m2) were allocated to either standard care or supervised training, from 15 to 27 weeks of gestation. Physical activity was measured by accelerometry at 14, 28 and 36 weeks, while fitness (oxygen consumption (VO2) at the anaerobic threshold), nutrition (caloric ...

  9. Support and Assessment for Fall Emergency Referrals (SAFER 1): Cluster Randomised Trial of Computerised Clinical Decision Support for Paramedics

    OpenAIRE

    Helen Anne Snooks; Ben Carter; Jeremy Dale; Theresa Foster; Ioan Humphreys; Philippa Anne Logan; Ronan Anthony Lyons; Suzanne Margaret Mason; Ceri James Phillips; Antonio Sanchez; Mushtaq Wani; Alan Watkins; Bridget Elizabeth Wells; Richard Whitfield; Ian Trevor Russell

    2014-01-01

    Objective To evaluate effectiveness, safety and cost-effectiveness of Computerised Clinical Decision Support (CCDS) for paramedics attending older people who fall. Design Cluster trial randomised by paramedic; modelling. Setting 13 ambulance stations in two UK emergency ambulance services. Participants 42 of 409 eligible paramedics, who attended 779 older patients for a reported fall. Interventions Intervention paramedics received CCDS on Tablet computers to guide patient care. Control parame...

  10. Educational outreach to general practitioners reduces children's asthma symptoms: a cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Sladden Michael

    2007-09-01

    Full Text Available Abstract Background Childhood asthma is common in Cape Town, a province of South Africa, but is underdiagnosed by general practitioners. Medications are often prescribed inappropriately, and care is episodic. The objective of this study is to assess the impact of educational outreach to general practitioners on asthma symptoms of children in their practice. Methods This is a cluster randomised trial with general practices as the unit of intervention, randomisation, and analysis. The setting is Mitchells Plain (population 300,000, a dormitory town near Cape Town. Solo general practitioners, without nurse support, operate from storefront practices. Caregiver-reported symptom data were collected for 318 eligible children (2 to 17 years with moderate to severe asthma, who were attending general practitioners in Mitchells Plain. One year post-intervention follow-up data were collected for 271 (85% of these children in all 43 practices. Practices randomised to intervention (21 received two 30-minute educational outreach visits by a trained pharmacist who left materials describing key interventions to improve asthma care. Intervention and control practices received the national childhood asthma guideline. Asthma severity was measured in a parent-completed survey administered through schools using a symptom frequency and severity scale. We compared intervention and control group children on the change in score from pre-to one-year post-intervention. Results Symptom scores declined an additional 0.84 points in the intervention vs. control group (on a nine-point scale. p = 0.03. For every 12 children with asthma exposed to a doctor allocated to the intervention, one extra child will have substantially reduced symptoms. Conclusion Educational outreach was accepted by general practitioners and was effective. It could be applied to other health care quality problems in this setting.

  11. Observer bias in randomised clinical trials with binary outcomes

    DEFF Research Database (Denmark)

    Hróbjartsson, Asbjørn; Thomsen, Ann Sofia Skou; Emanuelsson, Frida;

    2012-01-01

    To evaluate the impact of non-blinded outcome assessment on estimated treatment effects in randomised clinical trials with binary outcomes.......To evaluate the impact of non-blinded outcome assessment on estimated treatment effects in randomised clinical trials with binary outcomes....

  12. Randomised Controlled Trials in Education Research: A Case Study of an Individually Randomised Pragmatic Trial

    Science.gov (United States)

    Torgerson, Carole J.

    2009-01-01

    The randomised controlled trial (RCT) is an evaluative method used by social scientists in order to establish whether or not an intervention is effective. This contribution discusses the fundamental aspects of good RCT design. These are illustrated through the use of a recently completed RCT which evaluated an information and communication…

  13. Physiotherapy screening of patients referred for orthopaedic consultation in primary healthcare - a randomised controlled trial.

    Science.gov (United States)

    Samsson, Karin; Larsson, Maria E H

    2014-10-01

    A large proportion of patients who consult primary healthcare for musculoskeletal pain are referred for orthopaedic consultation, but only a small number of these patients are appropriate for orthopaedic intervention. Experienced physiotherapists have the appropriate knowledge to manage musculoskeletal disorders. The primary aim of this randomised study was therefore to evaluate a screening by a physiotherapist of patients referred for orthopaedic consultation compared to standard practice in primary care. Patients referred for orthopaedic consultation (n=203) were randomised to physiotherapy screening or standard practice. Selection accuracy for orthopaedic intervention and other referrals were analysed with proportion analysis. Patient views of the quality of care were analysed with Mann-Whitney U-test, waiting time with Independent t-test. There was higher selection accuracy for orthopaedic intervention in the physiotherapy screening group (p=0.002). A smaller proportion of patients in the screening group were referred back to their general practitioner (GP) (pphysiotherapy clinic (pphysiotherapy screening group (p<0.039). Waiting time was shorter in the screening group (p<0.001). A large proportion of the patients reported no hesitation to attend the clinic for future care, no difference between the groups (p<0.95). The findings in this study suggest that an experienced physiotherapist effectively can screen patients referred for orthopaedic consultation in primary healthcare.

  14. Randomised controlled trial of GP-led in-hospital management of homeless people ('Pathway').

    Science.gov (United States)

    Hewett, Nigel; Buchman, Peter; Musariri, Jeflyn; Sargeant, Christopher; Johnson, Penny; Abeysekera, Kushala; Grant, Louise; Oliver, Emily A; Eleftheriades, Christopher; McCormick, Barry; Halligan, Aidan; Marlin, Nadine; Kerry, Sally; Foster, Graham R

    2016-06-01

    Homeless people have complex problems. GP enhanced care (Pathway) has shown benefits. We performed a randomised, -parallel arm trial at two large inner city hospitals. Inpatient homeless adults were randomly allocated to either standard care (all management by the hospital-based clinical team) or enhanced care with input from a homeless care team. The hospital data system provided healthcare usage information, and we used questionnaires to assess quality of life. 206 patients were allocated to enhanced care and 204 to usual care. Length of stay (up to 90 days after admission) did not differ between groups (standard care 14.0 days, enhanced care 13.3 days). Average reattendance at the emergency department within a year was 5.8 visits in the standard care group and 4.8 visits with enhanced care, but this decrease was not significant. -Quality of life scores after discharge (in 108 patients) improved with enhanced care (EQ-5D-5L score increased by 0.12 [95% CI 0.032 to 0.22] compared wtih 0.03 [-0.1 to 0.15; p=0.076] with standard care). The proportion of people sleeping on the streets after discharge was 14.6% in the standard care arm and 3.8% in the enhanced care arm (p=0.034). The quality-of-life cost per quality-adjusted life-year was £26,000. The Pathway approach doesn't alter length of stay but improves quality of life and reduces street -homelessness. PMID:27251910

  15. Putting telemedicine to the test: design and performance of a multi-centre randomised controlled trial and economic evaluation of joint tele-consultations

    OpenAIRE

    Wallace, P.; Haines, A.; Harrison, R; Barber, J; Thompson, S; Roberts, J.; Jacklin, P.; Lewis, L; Wainwright, P.; , ForTheVirtualOutreachProjectGroup

    2002-01-01

    BACKGROUND: Appropriate information flow is crucial to the care of patients, particularly at the interface between primary and secondary care. Communication problems can result from inadequate organisation and training, There is a major expectation that information and communication technologies may offer solutions, but little reliable evidence. This paper reports the design and performance of a multi-centre randomised controlled trial (RCT), unparalleled in telemedicine research in either sc...

  16. Design and performance of a multi-centre randomised controlled trial and economic evaluation of joint tele-consultations [ISRCTN54264250

    OpenAIRE

    Thompson Simon; Barber Julie A; Harrison Robert; Haines Andrew; Wallace Paul; Roberts Jennifer; Jacklin Paul B; Lewis Leo; Wainwright Paul

    2002-01-01

    Abstract Background Appropriate information flow is crucial to the care of patients, particularly at the interface between primary and secondary care. Communication problems can result from inadequate organisation and training, There is a major expectation that information and communication technologies may offer solutions, but little reliable evidence. This paper reports the design and performance of a multi-centre randomised controlled trial (RCT), unparalleled in telemedicine research in e...

  17. The Home-Based Older People's Exercise (HOPE trial: study protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Forster Anne

    2011-06-01

    Full Text Available Abstract Background Frailty is common in older age, and is associated with important adverse health outcomes including increased risk of disability and admission to hospital or long-term care. Exercise interventions for frail older people have the potential to reduce the risk of these adverse outcomes by increasing muscle strength and improving mobility. Methods/Design The Home-Based Older People's Exercise (HOPE trial is a two arm, assessor blind pilot randomised controlled trial (RCT to assess the effectiveness of a 12 week exercise intervention (the HOPE programme designed to improve the mobility and functional abilities of frail older people living at home, compared with usual care. The primary outcome is the timed-up-and-go test (TUGT, measured at baseline and 14 weeks post-randomisation. Secondary outcomes include the Barthel Index of activities of daily living (ADL, EuroQol Group 5-Dimension Self-Report Questionnaire (EQ-5D quality of life measure and the geriatric depression scale (GDS, measured at baseline and 14 weeks post-randomisation. We will record baseline frailty using the Edmonton Frail Scale (EFS, record falls and document muscle/joint pain. We will test the feasibility of collection of data to identify therapy resources required for delivery of the intervention. Discussion The HOPE trial will explore and evaluate a home-based exercise intervention for frail older people. Although previous RCTs have used operationalised, non-validated methods of measuring frailty, the HOPE trial is, to our knowledge, the first RCT of an exercise intervention for frail older people that includes a validated method of frailty assessment at baseline. Trial registration ISRCTN: ISRCTN57066881

  18. A randomised trial of the effect and cost-effectiveness of early intensive multifactorial therapy on 5-year cardiovascular outcomes in individuals with screen-detected type 2 diabetes: the Anglo-Danish-Dutch Study of Intensive Treatment in People with Screen-Detected Diabetes in Primary Care (ADDITION-Europe) study.

    Science.gov (United States)

    Simmons, Rebecca K; Borch-Johnsen, Knut; Lauritzen, Torsten; Rutten, Guy Ehm; Sandbæk, Annelli; van den Donk, Maureen; Black, James A; Tao, Libo; Wilson, Edward Cf; Davies, Melanie J; Khunti, Kamlesh; Sharp, Stephen J; Wareham, Nicholas J; Griffin, Simon J

    2016-01-01

    BACKGROUND Intensive treatment (IT) of cardiovascular risk factors can halve mortality among people with established type 2 diabetes but the effects of treatment earlier in the disease trajectory are uncertain. OBJECTIVE To quantify the cost-effectiveness of intensive multifactorial treatment of screen-detected diabetes. DESIGN Pragmatic, multicentre, cluster-randomised, parallel-group trial. SETTING Three hundred and forty-three general practices in Denmark, the Netherlands, and Cambridge and Leicester, UK. PARTICIPANTS Individuals aged 40-69 years with screen-detected diabetes. INTERVENTIONS Screening plus routine care (RC) according to national guidelines or IT comprising screening and promotion of target-driven intensive management (medication and promotion of healthy lifestyles) of hyperglycaemia, blood pressure and cholesterol. MAIN OUTCOME MEASURES The primary end point was a composite of first cardiovascular event (cardiovascular mortality/morbidity, revascularisation and non-traumatic amputation) during a mean [standard deviation (SD)] follow-up of 5.3 (1.6) years. Secondary end points were (1) all-cause mortality; (2) microvascular outcomes (kidney function, retinopathy and peripheral neuropathy); and (3) patient-reported outcomes (health status, well-being, quality of life, treatment satisfaction). Economic analyses estimated mean costs (UK 2009/10 prices) and quality-adjusted life-years from an NHS perspective. We extrapolated data to 30 years using the UK Prospective Diabetes Study outcomes model [version 1.3; (©) Isis Innovation Ltd 2010; see www.dtu.ox.ac.uk/outcomesmodel (accessed 27 January 2016)]. RESULTS We included 3055 (RC, n = 1377; IT, n = 1678) of the 3057 recruited patients [mean (SD) age 60.3 (6.9) years] in intention-to-treat analyses. Prescription of glucose-lowering, antihypertensive and lipid-lowering medication increased in both groups, more so in the IT group than in the RC group. There were clinically important improvements

  19. The effect of chlorhexidine in reducing oral colonisation in geriatric patients: a randomised controlled trial

    Science.gov (United States)

    Sharif-Abdullah, Sharifah Shafinaz Binti; Chong, Mei Chan; Surindar-Kaur, Surat Singh; Kamaruzzaman, Shahrul Bahyah; Ng, Kwan Hoong

    2016-01-01

    INTRODUCTION Inadequate oral care has been implicated in the development of aspiration pneumonia in frail geriatric patients and is a major cause of mortality, due to the colonisation of microbes in vulnerable patients. This type of pneumonia has been associated with an increase in respiratory pathogens in the oral cavity. The aim of this study was to evaluate the effects of chlorhexidine compared to routine oral care in edentulous geriatric inpatients. METHODS A double-blind, parallel-group randomised controlled trial was carried out. The intervention group received oral care with chlorhexidine 0.2%, while the control group received routine oral care with thymol. Nurses provided oral care with assigned solutions of 20 mL once daily over seven days. Oral cavity assessment using the Brief Oral Health Status Examination form was performed before each oral care procedure. Data on medication received and the subsequent development of aspiration pneumonia was recorded. An oral swab was performed on Day 7 to obtain specimens to test for colonisation. RESULTS The final sample consisted of 35 (control) and 43 (intervention) patients. Chlorhexidine was effective in reducing oral colonisation compared to routine oral care with thymol (p < 0.001). The risk of oral bacterial colonisation was nearly three times higher in the thymol group compared to the chlorhexidine group. CONCLUSION The use of chlorhexidine 0.2% significantly reduced oral colonisation and is recommended as an easier and more cost-effective alternative for oral hygiene. PMID:27211885

  20. Study Protocol: Screening and Treatment of Alcohol-Related Trauma (START – a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Jayaraj Rama

    2012-10-01

    Full Text Available Abstract Background The incidence of mandibular fractures in the Northern Territory of Australia is very high, especially among Indigenous people. Alcohol intoxication is implicated in the majority of facial injuries, and substance use is therefore an important target for secondary prevention. The current study tests the efficacy of a brief therapy, Motivational Care Planning, in improving wellbeing and substance misuse in youth and adults hospitalised with alcohol-related facial trauma. Methods and design The study is a randomised controlled trial with 6 months of follow-up, to examine the effectiveness of a brief and culturally adapted intervention in improving outcomes for trauma patients with at-risk drinking admitted to the Royal Darwin Hospital maxillofacial surgery unit. Potential participants are identified using AUDIT-C questionnaire. Eligible participants are randomised to either Motivational Care Planning (MCP or Treatment as Usual (TAU. The outcome measures will include quantity and frequency of alcohol and other substance use by Timeline Followback. The recruitment target is 154 participants, which with 20% dropout, is hoped to provide 124 people receiving treatment and follow-up. Discussion This project introduces screening and brief interventions for high-risk drinkers admitted to the hospital with facial trauma. It introduces a practical approach to integrating brief interventions in the hospital setting, and has potential to demonstrate significant benefits for at-risk drinkers with facial trauma. Trial Registration The trial has been registered in Australian New Zealand Clinical Trials Registry (ANZCTR and Trial Registration: ACTRN12611000135910.

  1. Immobilisation versus immediate mobilisation after intrauterine insemination: randomised controlled trial

    NARCIS (Netherlands)

    I.M. Custers; P.A. Flierman; P. Maas; T. Cox; T.J.H.M. van Dessel; M.H. Gerards; M.H. Mochtar; C.A.H. Janssen; F. van der Veen; B.W.J. Mol

    2009-01-01

    Objective To evaluate the effectiveness of 15 minutes of immobilisation versus immediate mobilisation after intrauterine insemination. Design Randomised controlled trial. Setting One academic teaching hospital and six non-academic teaching hospitals. Participants Women having intrauterine inseminati

  2. HIV prevention in Mexican schools: prospective randomised evaluation of intervention

    OpenAIRE

    Walker, D.; Gutierrez, JP; TORRES, P.; Bertozzi, SM

    2006-01-01

    OBJECTIVE: To assess effects on condom use and other sexual behaviour of an HIV prevention programme at school that promotes the use of condoms with and without emergency contraception. DESIGN: Cluster randomised controlled trial. SETTING: 40 public high schools in the state of Morelos, Mexico. PARTICIPANTS: 10 954 first year high school students. INTERVENTION: Schools were randomised to one of three arms: an HIV prevention course that promoted condom use, the same course with emergency contr...

  3. A Randomised Controlled Trial of complete denture impression materials

    OpenAIRE

    Hyde, T.P.; Craddock, H.L.; Gray, J C; Pavitt, S. H.; Hulme, C; Godfrey, M.; Fernandez, C; Navarro-Coy, N; Dillon, S.; Wright, J; S. Brown; Dukanovic, G.; Brunton, P.A.

    2014-01-01

    Objectives There is continuing demand for non-implant prosthodontic treatment and yet there is a paucity of high quality Randomised Controlled Trial (RCT) evidence for best practice. The aim of this research was to provide evidence for best practice in prosthodontic impressions by comparing two impression materials in a double-blind, randomised, crossover, controlled, clinical trial. Methods Eighty-five patients were recruited, using published eligibility criteria, to the trial at Leeds Denta...

  4. Multidisciplinary care planning in the primary care management of completed stroke: a systematic review

    Directory of Open Access Journals (Sweden)

    Erikssen Lars

    2008-08-01

    Full Text Available Abstract Background Chronic disease management requires input from multiple health professionals, both specialist and primary care providers. This study sought to assess the impact of co-ordinated multidisciplinary care in primary care, represented by the delivery of formal care planning by primary care teams or shared across primary-secondary teams, on outcomes in stroke, relative to usual care. Methods A Systematic review of Medline, EMBASE, CINAHL (all 1990–2006, Cochrane Library (Issue 1 2006, and grey literature from web based searching of web sites listed in the CCOHA Health Technology Assessment List Analysis used narrative analysis of findings of randomised and non-randomised trials, and observational and qualitative studies of patients with completed stroke in the primary care setting where care planning was undertaken by 1 a multi-disciplinary primary care team or 2 through shared care by primary and secondary providers. Results One thousand and forty-five citations were retrieved. Eighteen papers were included for analysis. Most care planning took part in the context of multidisciplinary team care based in hospitals with outreach to community patients. Mortality rates are not impacted by multidisciplinary care planning. Functional outcomes of the studies were inconsistent. It is uncertain whether the active engagement of GPs and other primary care professionals in the multidisciplinary care planning contributed to the outcomes in the studies showing a positive effect. There may be process benefits from multidisciplinary care planning that includes primary care professionals and GPs. Few studies actually described the tasks and roles GPs fulfilled and whether this matched what was presumed to be provided. Conclusion While multidisciplinary care planning may not unequivocally improve the care of patients with completed stroke, there may be process benefits such as improved task allocation between providers. Further study on the impact

  5. The Hawthorne Effect: a randomised, controlled trial

    Directory of Open Access Journals (Sweden)

    van Haselen Robbert

    2007-07-01

    Full Text Available Abstract Background The 'Hawthorne Effect' may be an important factor affecting the generalisability of clinical research to routine practice, but has been little studied. Hawthorne Effects have been reported in previous clinical trials in dementia but to our knowledge, no attempt has been made to quantify them. Our aim was to compare minimal follow-up to intensive follow-up in participants in a placebo controlled trial of Ginkgo biloba for treating mild-moderate dementia. Methods Participants in a dementia trial were randomised to intensive follow-up (with comprehensive assessment visits at baseline and two, four and six months post randomisation or minimal follow-up (with an abbreviated assessment at baseline and a full assessment at six months. Our primary outcomes were cognitive functioning (ADAS-Cog and participant and carer-rated quality of life (QOL-AD. Results We recruited 176 participants, mainly through general practices. The main analysis was based on Intention to treat (ITT, with available data. In the ANCOVA model with baseline score as a co-variate, follow-up group had a significant effect on outcome at six months on the ADAS-Cog score (n = 140; mean difference = -2.018; 95%CI -3.914, -0.121; p = 0.037 favouring the intensive follow-up group, and on participant-rated quality of life score (n = 142; mean difference = -1.382; 95%CI -2.642, -0.122; p = 0.032 favouring minimal follow-up group. There was no significant difference on carer quality of life. Conclusion We found that more intensive follow-up of individuals in a placebo-controlled clinical trial of Ginkgo biloba for treating mild-moderate dementia resulted in a better outcome than minimal follow-up, as measured by their cognitive functioning. Trial registration Current controlled trials: ISRCTN45577048

  6. Brief Intervention in Type 1 diabetes – Education for Self-efficacy (BITES: Protocol for a randomised control trial to assess biophysical and psychological effectiveness

    Directory of Open Access Journals (Sweden)

    Dromgoole Paul

    2007-09-01

    Full Text Available Abstract Background Self management is the cornerstone of effective preventive care in diabetes. Educational interventions that provide self-management skills for people with diabetes have been shown to reduce blood glucose concentrations. This in turn has the potential to reduce rates of complications. However, evidence to support type, quantity, setting and mode of delivery of self-management education is sparse. Objectives: To study the biophysical and psychological effectiveness of a brief psycho-educational intervention for type 1 diabetes in adults. Methods/Design Design: Randomised controlled clinical trial. Setting: Multidisciplinary specialist diabetes centre. Hypothesis: Our hypothesis was that the brief (2.5-day intervention would be biophysically and psychologically effective for people with type 1 diabetes. Intervention: A brief psycho-educational intervention for type 1 diabetes developed by a multi-professional team comprising of a consultant diabetologist, a diabetes specialist nurse, a specialist diabetes dietician and a clinical health psychologist and delivered in 20 hours over 2.5 days. Primary outcomes: HbA1c and severe hypoglycaemia. Secondary outcomes: Blood pressure, weight, height, lipid profile and composite psychometric scales. Participants: We shall consent and recruit 120 subjects with postal invitations sent to eligible participants. Volunteers are to be seen at randomisation clinics where independent researcher verify eligibility and obtain consent. We shall randomise 60 to BITES and 60 to standard care. Eligibility Criteria: Type 1 diabetes for longer than 12 months, multiple injection therapy for at least two months, minimum age of 18 and ability to read and write. Randomisation: An independent evaluator to block randomise (block-size = 6, to intervention or control groups using sealed envelopes in strict ascendant order. Control group will receive standard care. Assessment: Participants in both groups would

  7. Effectiveness and cost-effectiveness of an educational intervention for practice teams to deliver problem focused therapy for insomnia: rationale and design of a pilot cluster randomised trial

    Directory of Open Access Journals (Sweden)

    Ørner Roderick

    2009-01-01

    Full Text Available Abstract Background Sleep problems are common, affecting over a third of adults in the United Kingdom and leading to reduced productivity and impaired health-related quality of life. Many of those whose lives are affected seek medical help from primary care. Drug treatment is ineffective long term. Psychological methods for managing sleep problems, including cognitive behavioural therapy for insomnia (CBTi have been shown to be effective and cost effective but have not been widely implemented or evaluated in a general practice setting where they are most likely to be needed and most appropriately delivered. This paper outlines the protocol for a pilot study designed to evaluate the effectiveness and cost-effectiveness of an educational intervention for general practitioners, primary care nurses and other members of the primary care team to deliver problem focused therapy to adult patients presenting with sleep problems due to lifestyle causes, pain or mild to moderate depression or anxiety. Methods and design This will be a pilot cluster randomised controlled trial of a complex intervention. General practices will be randomised to an educational intervention for problem focused therapy which includes a consultation approach comprising careful assessment (using assessment of secondary causes, sleep diaries and severity and use of modified CBTi for insomnia in the consultation compared with usual care (general advice on sleep hygiene and pharmacotherapy with hypnotic drugs. Clinicians randomised to the intervention will receive an educational intervention (2 × 2 hours to implement a complex intervention of problem focused therapy. Clinicians randomised to the control group will receive reinforcement of usual care with sleep hygiene advice. Outcomes will be assessed via self-completion questionnaires and telephone interviews of patients and staff as well as clinical records for interventions and prescribing. Discussion Previous studies in adults

  8. Recruitment and retention in a multicentre randomised controlled trial in Bell's palsy: A case study

    Directory of Open Access Journals (Sweden)

    Daly Fergus

    2007-03-01

    Full Text Available Abstract Background It is notoriously difficult to recruit patients to randomised controlled trials in primary care. This is particularly true when the disease process under investigation occurs relatively infrequently and must be investigated during a brief time window. Bell's palsy, an acute unilateral paralysis of the facial nerve is just such a relatively rare condition. In this case study we describe the organisational issues presented in setting up a large randomised controlled trial of the management of Bell's palsy across primary and secondary care in Scotland and how we managed to successfully recruit and retain patients presenting in the community. Methods Where possible we used existing evidence on recruitment strategies to maximise recruitment and retention. We consider that the key issues in the success of this study were; the fact that the research was seen as clinically important by the clinicians who had initial responsibility for recruitment; employing an experienced trial co-ordinator and dedicated researchers willing to recruit participants seven days per week and to visit them at home at a time convenient to them, hence reducing missed patients and ensuring they were retained in the study; national visibility and repeated publicity at a local level delivered by locally based principal investigators well known to their primary care community; encouraging recruitment by payment to practices and reducing the workload of the referring doctors by providing immediate access to specialist care; good collaboration between primary and secondary care and basing local investigators in the otolarnygology trial centres Results Although the recruitment rate did not meet our initial expectations, enhanced retention meant that we exceeded our planned target of recruiting 550 patients within the planned time-scale. Conclusion While difficult, recruitment to and retention within multi-centre trials from primary care can be successfully

  9. The PRO-AGE study: an international randomised controlled study of health risk appraisal for older persons based in general practice

    Directory of Open Access Journals (Sweden)

    Bachmann Martin D

    2007-01-01

    Full Text Available Abstract Background This paper describes the study protocol, the recruitment, and base-line data for evaluating the success of randomisation of the PRO-AGE (PRevention in Older people – Assessment in GEneralists' practices project. Methods/Design A group of general practitioners (GPs in London (U.K., Hamburg (Germany and Solothurn (Switzerland were trained in risk identification, health promotion, and prevention in older people. Their non-disabled older patients were invited to participate in a randomised controlled study. Participants allocated to the intervention group were offered the Health Risk Appraisal for Older Persons (HRA-O instrument with a site-specific method for reinforcement (London: physician reminders in electronic medical record; Hamburg: one group session or two preventive home visits; Solothurn: six-monthly preventive home visits over a two-year period. Participants allocated to the control group received usual care. At each site, an additional group of GPs did not receive the training, and their eligible patients were invited to participate in a concurrent comparison group. Primary outcomes are self-reported health behaviour and preventative care use at one-year follow-up. In Solothurn, an additional follow-up was conducted at two years. The number of older persons agreeing to participate (% of eligible persons in the randomised controlled study was 2503 (66.0% in London, 2580 (53.6% in Hamburg, and 2284 (67.5% in Solothurn. Base-line findings confirm that randomisation of participants was successful, with comparable characteristics between intervention and control groups. The number of persons (% of eligible enrolled in the concurrent comparison group was 636 (48.8% in London, 746 (35.7% in Hamburg, and 1171 (63.0% in Solothurn. Discussion PRO-AGE is the first large-scale randomised controlled trial of health risk appraisal for older people in Europe. Its results will inform about the effects of implementing HRA-O with

  10. A multifaceted workplace intervention for low back pain in nurses' aides: a pragmatic stepped wedge cluster randomised controlled trial.

    Science.gov (United States)

    Rasmussen, Charlotte Diana Nørregaard; Holtermann, Andreas; Bay, Hans; Søgaard, Karen; Birk Jørgensen, Marie

    2015-09-01

    This study established the effectiveness of a workplace multifaceted intervention consisting of participatory ergonomics, physical training, and cognitive-behavioural training (CBT) for low back pain (LBP). Between November 2012 and May 2014, we conducted a pragmatic stepped wedge cluster randomised controlled trial with 594 workers from eldercare workplaces (nursing homes and home care) randomised to 4 successive time periods, 3 months apart. The intervention lasted 12 weeks and consisted of 19 sessions in total (physical training [12 sessions], CBT [2 sessions], and participatory ergonomics [5 sessions]). Low back pain was the outcome and was measured as days, intensity (worst pain on a 0-10 numeric rank scale), and bothersomeness (days) by monthly text messages. Linear mixed models were used to estimate the intervention effect. Analyses were performed according to intention to treat, including all eligible randomised participants, and were adjusted for baseline values of the outcome. The linear mixed models yielded significant effects on LBP days of -0.8 (95% confidence interval [CI], -1.19 to -0.38), LBP intensity of -0.4 (95% CI, -0.60 to -0.26), and bothersomeness days of -0.5 (95% CI, -0.85 to -0.13) after the intervention compared with the control group. This study shows that a multifaceted intervention consisting of participatory ergonomics, physical training, and CBT can reduce LBP among workers in eldercare. Thus, multifaceted interventions may be relevant for improving LBP in a working population. PMID:25993549

  11. Strong gametocytocidal effect of methylene blue-based combination therapy against falciparum malaria: a randomised controlled trial.

    Directory of Open Access Journals (Sweden)

    Boubacar Coulibaly

    Full Text Available BACKGROUND: With the availability of new preventive and curative interventions, global malaria control has been strengthened significantly in recent years. Drugs effective in reducing malaria gametocytaemia might contribute to local elimination and possible long-term eradication. We here report on the effects of methylene blue (MB-based malaria combination therapy on gametocytaemia during a randomised-controlled trial in Burkina Faso. METHODS: An open-label randomised controlled phase II study in 180 children aged 6-10 years with uncomplicated falciparum malaria was conducted in Nouna, north-western Burkina Faso. Children were randomised to MB-artesunate (AS, MB-amodiaquine (AQ, and AS-AQ (local standard of care. Overall follow-up was for 28 days, follow-up for gametocytaemia was for 14 days. FINDINGS: The treatment groups were similar in baseline characteristics and there was only one loss to follow-up. Compared to AS-AQ, both MB-containing regimens were associated with significantly reduced gametocyte carrier rates during follow-up days 3, 7, and 14. This effect was seen both in patients with and without P. falciparum gametocytaemia at baseline. INTERPRETATION: MB reveals pronounced gametocytocidal activity which appears to act against both existing and developing P. falciparum gametocytes. MB-based combination therapy thus has the potential to reduce transmission of P. falciparum malaria in endemic regions, which has important implications for future elimination and eradication strategies. TRIAL REGISTRATION: (ClinicalTrials.gov NCT00354380.

  12. Five-year follow up of a randomised controlled trial comparing subtotal with total abdominal hysterectomy

    DEFF Research Database (Denmark)

    Andersen, L L; Zobbe, V; Ottesen, B;

    2015-01-01

    OBJECTIVES: To compare the rates of urinary incontinence (UI) and other complications of subtotal abdominal hysterectomy (SAH) with total abdominal hysterectomy (TAH) at 5 years after surgery. DESIGN: Randomised clinical trial with central, computer-generated randomisation. SETTING: Danish multi-...

  13. Influence of reported study design characteristics on intervention effect estimates from randomised controlled trials

    DEFF Research Database (Denmark)

    Savović, J; Jones, He; Altman, Dg;

    2012-01-01

    The design of randomised controlled trials (RCTs) should incorporate characteristics (such as concealment of randomised allocation and blinding of participants and personnel) that avoid biases resulting from lack of comparability of the intervention and control groups. Empirical evidence suggests...

  14. Maximising response to postal questionnaires – A systematic review of randomised trials in health research

    Directory of Open Access Journals (Sweden)

    Gates Simon

    2006-02-01

    Full Text Available Abstract Background Postal self-completion questionnaires offer one of the least expensive modes of collecting patient based outcomes in health care research. The purpose of this review is to assess the efficacy of methods of increasing response to postal questionnaires in health care studies on patient populations. Methods The following databases were searched: Medline, Embase, CENTRAL, CDSR, PsycINFO, NRR and ZETOC. Reference lists of relevant reviews and relevant journals were hand searched. Inclusion criteria were randomised trials of strategies to improve questionnaire response in health care research on patient populations. Response rate was defined as the percentage of questionnaires returned after all follow-up efforts. Study quality was assessed by two independent reviewers. The Mantel-Haenszel method was used to calculate the pooled odds ratios. Results Thirteen studies reporting fifteen trials were included. Implementation of reminder letters and telephone contact had the most significant effect on response rates (odds ratio 3.7, 95% confidence interval 2.30 to 5.97 p = Conclusion Implementing repeat mailing strategies and/or telephone reminders may improve response to postal questionnaires in health care research. Making the questionnaire shorter may also improve response rates. There is a lack of evidence to suggest that incentives are useful. In the context of health care research all strategies to improve response to postal questionnaires require further evaluation.

  15. Promoting public awareness of randomised clinical trials using the media: the 'Get Randomised' campaign.

    Science.gov (United States)

    Mackenzie, Isla S; Wei, Li; Rutherford, Daniel; Findlay, Evelyn A; Saywood, Wendy; Campbell, Marion K; Macdonald, Thomas M

    2010-02-01

    WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT * Recruitment is key to the success of clinical trials. * Many clinical trials fail to achieve adequate recruitment. * Public understanding and engagement in clinical research could be improved. WHAT THIS STUDY ADDS * 'Get Randomised' is the first campaign of its kind in the UK. * It is possible to improve public awareness of clinical research using the media. * Further work is needed to determine whether improved public awareness leads to increased participation in clinical research in the future. AIM To increase public awareness and understanding of clinical research in Scotland. METHODS A generic media campaign to raise public awareness of clinical research was launched in 2008. The 'Get Randomised' campaign was a Scotland-wide initiative led by the University of Dundee in collaboration with other Scottish universities. Television, radio and newspaper advertising showed leading clinical researchers, general practitioners and patients informing the public about the importance of randomised clinical trials (RCTs). 'Get Randomised' was the central message and interested individuals were directed to the http://www.getrandomised.org website for more information. To assess the impact of the campaign, cross-sectional surveys were conducted in representative samples of 1040 adults in Scotland prior to campaign launch and again 6 months later. RESULTS There was an improvement in public awareness of clinical trials following the campaign; 56.7% [95% confidence interval (CI) 51.8, 61.6] of the sample recalled seeing or hearing advertising about RCTs following the campaign compared with 14.8% (10.8, 18.9) prior to the campaign launch (difference = 41.4%; 95% CI for difference 35.6, 48.3; P advertising, 49% felt that the main message was that people should take part more in medical research. However, on whether they would personally take part in a clinical trial if asked, there was little difference in response following the campaign

  16. Tweeting links to Cochrane Schizophrenia Group reviews: a randomised controlled trial

    Science.gov (United States)

    Adams, C E; Bodart, A Y M; Sampson, S; Zhao, S; Montgomery, A A

    2016-01-01

    Objective To assess the effects of using health social media on web activity. Design Individually randomised controlled parallel group superiority trial. Setting Twitter and Weibo. Participants 170 Cochrane Schizophrenia Group full reviews with an abstract and plain language summary web page. Interventions Three randomly ordered slightly different 140 character or less messages, each containing a short URL to the freely accessible summary page sent on specific times on one single day. This was compared with no messaging. Outcome The primary outcome was web page visits at 1 week. Secondary outcomes were other metrics of web activity at 1 week. Results 85 reviews were randomised to each of the intervention and control arms. Google Analytics allowed 100% follow-up within 1 week of completion. Intervention and control reviews received a total of 1162 and 449 visits, respectively (IRR 2.7, 95% CI 2.2 to 3.3). Fewer intervention reviews had single page only visits (16% vs 31%, OR 0.41, 0.19 to 0.88) and users spent more time viewing intervention reviews (geometric mean 76 vs 31 s, ratio 2.5, 1.3 to 4.6). Other secondary metrics of web activity all showed strong evidence in favour of the intervention. Conclusions Tweeting in this limited area of healthcare increases ‘product placement’ of evidence with the potential for that to influence care. Trial registration number ISRCTN84658943. PMID:26956164

  17. Levonorgestrel-releasing intrauterine system vs. usual medical treatment for menorrhagia: an economic evaluation alongside a randomised controlled trial.

    Directory of Open Access Journals (Sweden)

    Sabina Sanghera

    Full Text Available OBJECTIVE: To undertake an economic evaluation alongside the largest randomised controlled trial comparing Levonorgestrel-releasing intrauterine device ('LNG-IUS' and usual medical treatment for women with menorrhagia in primary care; and compare the cost-effectiveness findings using two alternative measures of quality of life. METHODS: 571 women with menorrhagia from 63 UK centres were randomised between February 2005 and July 2009. Women were randomised to having a LNG-IUS fitted, or usual medical treatment, after discussing with their general practitioner their contraceptive needs or desire to avoid hormonal treatment. The treatment was specified prior to randomisation. For the economic evaluation we developed a state transition (Markov model with a 24 month follow-up. The model structure was informed by the trial women's pathway and clinical experts. The economic evaluation adopted a UK National Health Service perspective and was based on an outcome of incremental cost per Quality Adjusted Life Year (QALY estimated using both EQ-5D and SF-6D. RESULTS: Using EQ-5D, LNG-IUS was the most cost-effective treatment for menorrhagia. LNG-IUS costs £100 more than usual medical treatment but generated 0.07 more QALYs. The incremental cost-effectiveness ratio for LNG-IUS compared to usual medical treatment was £1600 per additional QALY. Using SF-6D, usual medical treatment was the most cost-effective treatment. Usual medical treatment was both less costly (£100 and generated 0.002 more QALYs. CONCLUSION: Impact on quality of life is the primary indicator of treatment success in menorrhagia. However, the most cost-effective treatment differs depending on the quality of life measure used to estimate the QALY. Under UK guidelines LNG-IUS would be the recommended treatment for menorrhagia. This study demonstrates that the appropriate valuation of outcomes in menorrhagia is crucial.

  18. A pilot randomised controlled trial of negative pressure wound therapy to treat grade III/IV pressure ulcers [ISRCTN69032034

    Directory of Open Access Journals (Sweden)

    Ashby Rebecca L

    2012-07-01

    Full Text Available Abstract Background Negative pressure wound therapy (NPWT is widely promoted as a treatment for full thickness wounds; however, there is a lack of high-quality research evidence regarding its clinical and cost effectiveness. A trial of NPWT for the treatment of grade III/IV pressure ulcers would be worthwhile but premature without assessing whether such a trial is feasible. The aim of this pilot randomised controlled trial was to assess the feasibility of conducting a future full trial of NPWT for the treatment of grade III and IV pressure ulcers and to pilot all aspects of the trial. Methods This was a two-centre (acute and community, pilot randomised controlled trial. Eligible participants were randomised to receive either NPWT or standard care (SC (spun hydrocolloid, alginate or foam dressings. Outcome measures were time to healing of the reference pressure ulcer, recruitment rates, frequency of treatment visits, resources used and duration of follow-up. Results Three hundred and twelve patients were screened for eligibility into this trial over a 12-month recruitment period and 12/312 participants (3.8% were randomised: 6 to NPWT and 6 to SC. Only one reference pressure ulcer healed (NPWT group during follow-up (time to healing 79 days. The mean number of treatment visits per week was 3.1 (NPWT and 5.7 (SC; 6/6 NPWT and 1/6 SC participants withdrew from their allocated trial treatment. The mean duration of follow-up was 3.8 (NPWT and 5.0 (SC months. Conclusions This pilot trial yielded vital information for the planning of a future full study including projected recruitment rate, required duration of follow-up and extent of research nurse support required. Data were also used to inform the cost-effectiveness and value of information analyses, which were conducted alongside the pilot trial. Trial registration Current Controlled Trials ISRCTN69032034.

  19. Prehospital randomised assessment of a mechanical compression device in cardiac arrest (PaRAMeDIC trial protocol

    Directory of Open Access Journals (Sweden)

    McCabe Chris

    2010-11-01

    Full Text Available Abstract Background Survival after out-of-hospital cardiac arrest is closely linked to the quality of CPR, but in real life, resuscitation during prehospital care and ambulance transport is often suboptimal. Mechanical chest compression devices deliver consistent chest compressions, are not prone to fatigue and could potentially overcome some of the limitations of manual chest compression. However, there is no high-quality evidence that they improve clinical outcomes, or that they are cost effective. The Prehospital Randomised Assessment of a Mechanical Compression Device In Cardiac Arrest (PARAMEDIC trial is a pragmatic cluster randomised study of the LUCAS-2 device in adult patients with non-traumatic out-of-hospital cardiac arrest. Methods/design The primary objective of this trial is to evaluate the effect of chest compression using LUCAS-2 on mortality at 30 days post out-of-hospital cardiac arrest, compared with manual chest compression. Secondary objectives of the study are to evaluate the effects of LUCAS-2 on survival to 12 months, cognitive and quality of life outcomes and cost-effectiveness. Methods: Ambulance service vehicles will be randomised to either manual compression (control or LUCAS arms. Adult patients in out-of-hospital cardiac arrest, attended by a trial vehicle will be eligible for inclusion. Patients with traumatic cardiac arrest or who are pregnant will be excluded. The trial will recruit approximately 4000 patients from England, Wales and Scotland. A waiver of initial consent has been approved by the Research Ethics Committees. Consent will be sought from survivors for participation in the follow-up phase. Conclusion The trial will assess the clinical and cost effectiveness of the LUCAS-2 mechanical chest compression device. Trial Registration: The trial is registered on the International Standard Randomised Controlled Trial Number Registry (ISRCTN08233942.

  20. Physical activity as a treatment for depression: the TREAD randomised trial protocol

    Directory of Open Access Journals (Sweden)

    Lawlor Debbie A

    2010-11-01

    Full Text Available Abstract Background Depression is one of the most common reasons for consulting a General Practitioner (GP within the UK. Whilst antidepressants have been shown to be clinically effective, many patients and healthcare professionals would like to access other forms of treatment as an alternative or adjunct to drug therapy for depression. A recent systematic review presented some evidence that physical activity could offer one such option, although further investigation is needed to test its effectiveness within the context of the National Health Service. The aim of this paper is to describe the protocol for a randomised, controlled trial (RCT designed to evaluate an intervention developed to increase physical activity as a treatment for depression within primary care. Methods/design The TREAD study is a pragmatic, multi-centre, two-arm RCT which targets patients presenting with a new episode of depression. Patients were approached if they were aged 18-69, had recently consulted their GP for depression and, where appropriate, had been taking antidepressants for less than one month. Only those patients with a confirmed diagnosis of a depressive episode as assessed by the Clinical Interview Schedule-Revised (CIS-R, a Beck Depression Inventory (BDI score of at least 14 and informed written consent were included in the study. Eligible patients were individually randomised to one of two treatment groups; usual GP care or usual GP care plus facilitated physical activity. The primary outcome of the trial is clinical symptoms of depression assessed using the BDI four months after randomisation. A number of secondary outcomes are also measured at the 4-, 8- and 12-month follow-up points including quality of life, attitude to and involvement in physical activity and antidepressant use/adherence. Outcomes will be analysed on an intention-to-treat (ITT basis and will use linear and logistic regression models to compare treatments. Discussion The results of

  1. Phase 2, randomised placebo-controlled trial to evaluate the efficacy and safety of an anti-GM-CSF antibody (KB003) in patients with inadequately controlled asthma

    OpenAIRE

    Molfino, Nestor A; Kuna, Piotr; Leff, Jonathan A; Oh, Chad K; Singh, Dave; Chernow, Marlene; Sutton, Brian; Yarranton, Geoffrey

    2016-01-01

    Objectives We wished to evaluate the effects of an antigranulocyte-macrophage colony-stimulating factor monoclonal antibody (KB003) on forced expiratory volume in 1 s (FEV1), asthma control and asthma exacerbations in adult asthmatics inadequately controlled by long-acting bronchodilators and inhaled/oral corticosteroids. Settings 47 ambulatory asthma care centres globally. Primary outcome measures Change in FEV1 at week 24. Participants 311 were screened, 160 were randomised and 129 complete...

  2. Can social dancing prevent falls in older adults? a protocol of the Dance, Aging, Cognition, Economics (DAnCE) fall prevention randomised controlled trial

    OpenAIRE

    Merom, Dafna; Cumming, Robert; Mathieu, Erin; Anstey, Kaarin J; Rissel, Chris; Simpson, Judy M.; Morton, Rachael L; Cerin, Ester; Sherrington, Catherine; Lord, Stephen R.

    2013-01-01

    Background Falls are one of the most common health problems among older people and pose a major economic burden on health care systems. Exercise is an accepted stand-alone fall prevention strategy particularly if it is balance training or regular participation in Tai chi. Dance shares the ‘holistic’ approach of practices such as Tai chi. It is a complex sensorimotor rhythmic activity integrating multiple physical, cognitive and social elements. Small-scale randomised controlled trials have in...

  3. Celecoxib plus hormone therapy versus hormone therapy alone for hormone-sensitive prostate cancer: first results from the STAMPEDE multiarm, multistage, randomised controlled trial

    OpenAIRE

    James, Nicholas D.; Sydes, Matthew R.; Mason, Malcolm D; Clarke, Noel W; Anderson, John; Dearnaley, David P; Dwyer, John; Jovic, Gordana; Ritchie, Alastair WS; Russell, J Martin; Sanders, Karen; Thalmann, George N; Bertelli, Gianfilippo; Birtle, Alison J; O'Sullivan, Joe M

    2012-01-01

    Summary Background Long-term hormone therapy alone is standard care for metastatic or high-risk, non-metastatic prostate cancer. STAMPEDE—an international, open-label, randomised controlled trial—uses a novel multiarm, multistage design to assess whether the early additional use of one or two drugs (docetaxel, zoledronic acid, celecoxib, zoledronic acid and docetaxel, or zoledronic acid and celecoxib) improves survival in men starting first-line, long-term hormone therapy. Here, we report the...

  4. Effects of soft bracing or taping on a lateral ankle sprain: a non-randomised controlled trial evaluating recurrence rates and residual symptoms at one year

    OpenAIRE

    Kemler, Ellen; van de Port, Ingrid; Schmikli, Sandor; Huisstede, Bionka; Hoes, Arno; Backx, Frank

    2015-01-01

    Background After sustaining an ankle sprain, taping is often the standard treatment in primary care. Ankle braces are sometimes used as an alternative. This study aimed to compare the effects of four weeks of soft bracing or taping following acute lateral ankle ligamentous sprain (ALALS) on sprain recurrence rates and residual symptoms at one year. Methods In this pragmatic, non-randomised controlled trial, 157 adult participants with an ALALS caused by an inversion trauma were alternately al...

  5. Effects of soft bracing or taping on a lateral ankle sprain : a non-randomised controlled trial evaluating recurrence rates and residual symptoms at one year

    OpenAIRE

    Kemler, Ellen; van de Port, Ingrid; Schmikli, Sandor; Huisstede, Bionka; Hoes, Arno; Backx, Frank

    2015-01-01

    Background: After sustaining an ankle sprain, taping is often the standard treatment in primary care. Ankle braces are sometimes used as an alternative. This study aimed to compare the effects of four weeks of soft bracing or taping following acute lateral ankle ligamentous sprain (ALALS) on sprain recurrence rates and residual symptoms at one year. Methods: In this pragmatic, non-randomised controlled trial, 157 adult participants with an ALALS caused by an inversion trauma were alternately ...

  6. Does single application of topical chloramphenicol to high risk sutured wounds reduce incidence of wound infection after minor surgery? Prospective randomised placebo controlled double blind trial

    OpenAIRE

    Heal, Clare F; Petra G Buettner; Cruickshank, Robert; Graham, David; Browning, Sheldon; Pendergast, Jayne; Drobetz, Herwig; Gluer, Robert; Lisec, Carl

    2009-01-01

    Objective To determine the effectiveness of a single application of topical chloramphenicol ointment in preventing wound infection after minor dermatological surgery. Design Prospective randomised placebo controlled double blind multicentre trial. Setting Primary care in a regional centre in Queensland, Australia. Participants 972 minor surgery patients. Interventions A single topical dose of chloramphenicol (n=488) or paraffin ointment (n=484; placebo). Main outcome measure Incidence of infe...

  7. Perioperative medication management: expanding the role of the preadmission clinic pharmacist in a single centre, randomised controlled trial of collaborative prescribing

    OpenAIRE

    Hale, A.R.; Coombes, I D; Stokes, J.; D. McDougall; Whitfield, K; Maycock, E; Nissen, L

    2013-01-01

    Objectives Current evidence to support non-medical prescribing is predominantly qualitative, with little evaluation of accuracy, safety and appropriateness. Our aim was to evaluate a new model of service for the Australia healthcare system, of inpatient medication prescribing by a pharmacist in an elective surgery preadmission clinic (PAC) against usual care, using an endorsed performance framework. Design Single centre, randomised controlled, two-arm trial. Setting Elective surgery PAC in a ...

  8. Effects of soft bracing or taping on a lateral ankle sprain : a non-randomised controlled trial evaluating recurrence rates and residual symptoms at one year

    OpenAIRE

    Kemler, Ellen; van de Port, Ingrid; Schmikli, Sandor; Huisstede, Bionka; Hoes, Arno; Backx, Frank

    2015-01-01

    Background After sustaining an ankle sprain, taping is often the standard treatment in primary care. Ankle braces are sometimes used as an alternative. This study aimed to compare the effects of four weeks of soft bracing or taping following acute lateral ankle ligamentous sprain (ALALS) on sprain recurrence rates and residual symptoms at one year. Methods In this pragmatic, non-randomised controlled trial, 157 adult participants with an ALALS caused by an inversion trauma were alternately al...

  9. TREC-SAVE: a randomised trial comparing mechanical restraints with use of seclusion for aggressive or violent seriously mentally ill people: study protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Ferreira Marco AV

    2011-07-01

    Full Text Available Abstract Background Thousands of people whose aggression is thought due to serious mental illness are secluded or restrained every day. Without fair testing these techniques will continue to be used outside of a rigorous evidence base. With such coercive treatment this leaves all concerned vulnerable to abuse and criticism. This paper presents the protocol for a randomised trial comparing seclusion with restraints for people with serious mental illnesses. Methods/Design Setting-General psychiatric wards of a large psychiatric hospital in Rio de Janeiro, Brazil. Participants-Anyone aggressive or violent suspected or known to have serious mental illness for whom restriction is felt to be indicated by nursing and medical staff, but also for whom they are unsure whether seclusion or restraint would be indicated. Interventions-The standard care of either strong cotton banding to edge of bed with medications as indicated and close observation or the other standard care of use of a minimally furnished seclusion room but with open but barred windows onto the nursing station. Outcomes-time to restrictions lifted, early change of treatment, additional episodes, adverse effects/events, satisfaction with care during episode. Duration-2 weeks. Identifier: ISRCTN 49454276 http://www.controlled-trials.com/ISRCTN49454276

  10. Sources of Bias in Outcome Assessment in Randomised Controlled Trials: A Case Study

    Science.gov (United States)

    Ainsworth, Hannah; Hewitt, Catherine E.; Higgins, Steve; Wiggins, Andy; Torgerson, David J.; Torgerson, Carole J.

    2015-01-01

    Randomised controlled trials (RCTs) can be at risk of bias. Using data from a RCT, we considered the impact of post-randomisation bias. We compared the trial primary outcome, which was administered blindly, with the secondary outcome, which was not administered blindly. From 44 schools, 522 children were randomised to receive a one-to-one maths…

  11. Cost-effectiveness of chiropractic care versus self-management in patients with musculoskeletal chest pain

    DEFF Research Database (Denmark)

    Stochkendahl, Mette Jensen; Sørensen, Jan; Vach, Werner;

    2016-01-01

    , non-specific chest pain of musculoskeletal origin were recruited from a cardiology department in Denmark. After ruling out acute coronary syndrome and receiving usual care, patients with musculoskeletal chest pain were randomised to 4 weeks of community-based chiropractic care (n=59) or to a single...

  12. Community occupational therapy for older patients with dementia and their care givers: cost effectiveness study.

    NARCIS (Netherlands)

    Graff, M.J.L.; Adang, E.M.M.; Vernooij-Dassen, M.J.F.J.; Dekker, J.; Jonsson, L.; Thijssen, M.; Hoefnagels, W.H.L.; Olde Rikkert, M.G.M.

    2008-01-01

    OBJECTIVE: To assess the cost effectiveness of community based occupational therapy compared with usual care in older patients with dementia and their care givers from a societal viewpoint. DESIGN: Cost effectiveness study alongside a single blind randomised controlled trial. SETTING: Memory clinic,

  13. Randomised controlled trial of the clinical and cost effectiveness of a specialist team for managing refractory unipolar depressive disorder

    Directory of Open Access Journals (Sweden)

    Fox Richard

    2010-11-01

    Full Text Available Abstract Background Around 40 per cent of patients with unipolar depressive disorder who are treated in secondary care mental health services do not respond to first or second line treatments for depression. Such patients have 20 times the suicide rate of the general population and treatment response becomes harder to achieve and sustain the longer they remain depressed. Despite this there are no randomised controlled trials of community based service delivery interventions delivering both algorithm based pharmacotherapy and psychotherapy for patients with chronic depressive disorder in secondary care mental health services who remain moderately or severely depressed after six months treatment. Without such trials evidence based guidelines on services for such patients cannot be derived. Methods/design Single blind individually randomised controlled trial of a specialist depression disorder team (psychiatrist and psychotherapist jointly assessing and providing algorithm based drug and psychological treatment versus usual secondary care treatment. We will recruit 174 patients with unipolar depressive disorder in secondary mental health services with a Hamilton Depression Rating Scale (HDRS score ≥ 16 and global assessment of function (GAF ≤ 60 after ≥ 6 months treatment. The primary outcome measures will be the HDRS and GAF supplemented by economic analysis incuding the EQ5 D and analysis of barriers to care, implementation and the process of care. Audits to benchmark both treatment arms against national standards of care will aid the interpretation of the results of the study. Discussion This trial will be the first to assess the effectiveness and implementation of a community based specialist depression disorder team. The study has been specially designed as part of the CLAHRC Nottinghamshire, Derbyshire and Lincolnshire joint collaboration between university, health and social care organisations to provide information of direct relevance

  14. From randomised trials to rational practice.

    Science.gov (United States)

    van Gijn, J

    2005-01-01

    From the age of Enlightenment onwards, philosophical thinking has become increasingly influenced by empiricism: observations lead to theories, but experiments are needed to put the reasoning to the test. However, it was not until the middle of the 20th century that well-designed experiments were at last introduced in medical treatment, in the form of randomised controlled clinical trials. This design is now standard in medicine, but in everyday practice a multitude of management decisions must still be taken without good evidence. There are several reasons for this: there may not be a trial at all or only a single trial; trial results may be equivocal; patients may be different from those enrolled in trials; new procedures require practice, or a trial may not be feasible. 'Logical reasoning', with all its fallacies, is still required - not only to fill the gaps in empirical knowledge but also to interpret existing evidence and to plan new trials. In fact, the generation of new knowledge is a continuous, cyclical process in which newly gained insights in pathophysiology give rise to new therapeutic experiments, the results of which generate fresh hypotheses, and so on. Compassion, curiosity and doubt are the essential forces that keep the cycle moving. Conversely, the progress is slowed down by present-day legalism, which distorts investigator accountability and patient autonomy.

  15. Effect of corticosteroid injection for trochanter pain syndrome: design of a randomised clinical trial in general practice

    Directory of Open Access Journals (Sweden)

    Verhaar Jan AN

    2007-09-01

    Full Text Available Abstract Background Regional pain in the hip in adults is a common cause of a general practitioner visit. A considerable part of patients suffer from (greater trochanteric pain syndrome or trochanteric bursitis. Local corticosteroid injections is one of the treatment options. Although clear evidence is lacking, small observational studies suggest that this treatment is effective in the short-term follow-up. So far, there are no randomised controlled trials available evaluating the efficacy of injection therapy. This study will investigate the efficacy of local corticosteroid injections in the trochanter syndrome in the general practice, using a randomised controlled trial design. The cost effectiveness of the corticosteroid injection therapy will also be assessed. Secondly, the role of co-morbidity in relation to the efficacy of local corticosteroid injections will be investigated. Methods/Design This study is a pragmatic, open label randomised trial. A total of 150 patients (age 18–80 years visiting the general practitioner with complaints suggestive of trochanteric pain syndrome will be allocated to receive local corticosteroid injections or to receive usual care. Usual care consists of analgesics as needed. The randomisation is stratified for yes or no co-morbidity of low back pain, osteoarthritis of the hip, or both. The treatment will be evaluated by means of questionnaires at several time points within one year, with the 3 month and 1 year evaluation of pain and recovery as primary outcome. Analyses of primary and secondary outcomes will be made according to the intention-to-treat principle. Direct and indirect costs will be assessed by questionnaires. The cost effectiveness will be estimated using the following ratio: CE ratio = (cost of injection therapy minus cost of usual care/(effect of injection therapy minus effect of usual care. Discussion This study design is appropriate to estimate effectiveness and cost-effectiveness of the

  16. Oral vitamin B12 for patients suspected of subtle cobalamin deficiency: a multicentre pragmatic randomised controlled trial.

    OpenAIRE

    Ali Giuseppa; Burnand Bernard; Herzig Lilli; Vaucher Paul; Favrat Bernard; Boulat Olivier; Bischoff Thomas; Verdon François

    2011-01-01

    Abstract Background Evidence regarding the effectiveness of oral vitamin B12 in patients with serum vitamin B12 levels between 125-200 pM/l is lacking. We compared the effectiveness of one-month oral vitamin B12 supplementation in patients with a subtle vitamin B12 deficiency to that of a placebo. Methods This multicentre (13 general practices, two nursing homes, and one primary care center in western Switzerland), parallel, randomised, controlled, closed-label, observer-blind trial included ...

  17. A Feasibility Randomised Controlled Trial of the New Orleans Intervention for Infant Mental Health: A Study Protocol

    Directory of Open Access Journals (Sweden)

    Rachel Pritchett

    2013-01-01

    Full Text Available Child maltreatment is associated with life-long social, physical, and mental health problems. Intervening early to provide maltreated children with safe, nurturing care can improve outcomes. The need for prompt decisions about permanent placement (i.e., regarding adoption or return home is internationally recognised. However, a recent Glasgow audit showed that many maltreated children “revolve” between birth families and foster carers. This paper describes the protocol of the first exploratory randomised controlled trial of a mental health intervention aimed at improving placement permanency decisions for maltreated children. This trial compares an infant's mental health intervention with the new enhanced service as usual for maltreated children entering care in Glasgow. As both are new services, the trial is being conducted from a position of equipoise. The outcome assessment covers various fields of a child’s neurodevelopment to identify problems in any ESSENCE domain. The feasibility, reliability, and developmental appropriateness of all outcome measures are examined. Additionally, the potential for linkage with routinely collected data on health and social care and, in the future, education is explored. The results will inform a definitive randomised controlled trial that could potentially lead to long lasting benefits for the Scottish population and which may be applicable to other areas of the world. This trial is registered with ClinicalTrials.gov (NC01485510.

  18. Effect of a multimodal high intensity exercise intervention in cancer patients undergoing chemotherapy: randomised controlled trial

    DEFF Research Database (Denmark)

    Adamsen, Lis; Quist, Morten; Andersen, Christina;

    2009-01-01

    OBJECTIVE: To assess the effect of a multimodal group exercise intervention, as an adjunct to conventional care, on fatigue, physical capacity, general wellbeing, physical activity, and quality of life in patients with cancer who were undergoing adjuvant chemotherapy or treatment for advanced...... disease. DESIGN: Randomised controlled trial. SETTING: Two university hospitals in Copenhagen, Denmark. PARTICIPANTS: 269 patients with cancer; 73 men, 196 women, mean age 47 years (range 20-65) representing 21 diagnoses. Main exclusion criteria were brain or bone metastases. 235 patients completed follow...... and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), Medical Outcomes Study Short Form (MOS SF-36), Leisure Time Physical Activity Questionnaire, muscular strength (one repetition maximum), maximum oxygen consumption (Vo(2)max). Statistical methods The general linear model was used...

  19. DiPALS: Diaphragm Pacing in patients with Amyotrophic Lateral Sclerosis - a randomised controlled trial.

    Science.gov (United States)

    McDermott, Christopher J; Bradburn, Mike J; Maguire, Chin; Cooper, Cindy L; Baird, Wendy O; Baxter, Susan K; Cohen, Judith; Cantrill, Hannah; Dixon, Simon; Ackroyd, Roger; Baudouin, Simon; Bentley, Andrew; Berrisford, Richard; Bianchi, Stephen; Bourke, Stephen C; Darlison, Roy; Ealing, John; Elliott, Mark; Fitzgerald, Patrick; Galloway, Simon; Hamdalla, Hisham; Hanemann, C Oliver; Hughes, Philip; Imam, Ibrahim; Karat, Dayalan; Leek, Roger; Maynard, Nick; Orrell, Richard W; Sarela, Abeezar; Stradling, John; Talbot, Kevin; Taylor, Lyn; Turner, Martin; Simonds, Anita K; Williams, Tim; Wedzicha, Wisia; Young, Carolyn; Shaw, Pamela J

    2016-01-01

    BACKGROUND Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease resulting in death, usually from respiratory failure, within 2-3 years of symptom onset. Non-invasive ventilation (NIV) is a treatment that when given to patients in respiratory failure leads to improved survival and quality of life. Diaphragm pacing (DP), using the NeuRx/4(®) diaphragm pacing system (DPS)™ (Synapse Biomedical, Oberlin, OH, USA), is a new technique that may offer additional or alternative benefits to patients with ALS who are in respiratory failure. OBJECTIVE The Diaphragm Pacing in patients with Amyotrophic Lateral Sclerosis (DiPALS) trial evaluated the effect of DP on survival over the study duration in patients with ALS with respiratory failure. DESIGN The DiPALS trial was a multicentre, parallel-group, open-label, randomised controlled trial incorporating health economic analyses and a qualitative longitudinal substudy. PARTICIPANTS Eligible participants had a diagnosis of ALS (ALS laboratory-supported probable, clinically probable or clinically definite according to the World Federation of Neurology revised El Escorial criteria), had been stabilised on riluzole for 30 days, were aged ≥ 18 years and were in respiratory failure. We planned to recruit 108 patients from seven UK-based specialist ALS or respiratory centres. Allocation was performed using 1 : 1 non-deterministic minimisation. INTERVENTIONS Participants were randomised to either standard care (NIV alone) or standard care (NIV) plus DP using the NeuRX/4 DPS. MAIN OUTCOME MEASURES The primary outcome was overall survival, defined as the time from randomisation to death from any cause. Secondary outcomes were patient quality of life [assessed by European Quality of Life-5 Dimensions, three levels (EQ-5D-3L), Short Form questionnaire-36 items and Sleep Apnoea Quality of Life Index questionnaire]; carer quality of life (EQ-5D-3L and Caregiver Burden Inventory); cost-utility analysis and health-care

  20. Effectiveness of a community-based intervention for people with schizophrenia and their caregivers in India (COPSI): a randomised controlled trial

    Science.gov (United States)

    Chatterjee, Sudipto; Naik, Smita; John, Sujit; Dabholkar, Hamid; Balaji, Madhumitha; Koschorke, Mirja; Varghese, Mathew; Thara, Rangaswamy; Weiss, Helen A; Williams, Paul; McCrone, Paul; Patel, Vikram; Thornicroft, Graham

    2014-01-01

    Summary Background Observational evidence suggests that community-based services for people with schizophrenia can be successfully provided by community health workers, when supervised by specialists, in low-income and middle-income countries. We did the COmmunity care for People with Schizophrenia in India (COPSI) trial to compare the effectiveness of a collaborative community-based care intervention with standard facility-based care. Methods We did a multicentre, parallel-group, randomised controlled trial at three sites in India between Jan 1, 2009 and Dec 31, 2010. Patients aged 16–60 years with a primary diagnosis of schizophrenia according to the tenth edition of the International Classification of Diseases, Diagnostic Criteria for Research (ICD-10-DCR) were randomly assigned (2:1), via a computer-generated randomisation list with block sizes of three, six, or nine, to receive either collaborative community-based care plus facility-based care or facility-based care alone. Randomisation was stratified by study site. Outcome assessors were masked to group allocation. The primary outcome was a change in symptoms and disabilities over 12 months, as measured by the positive and negative syndrome scale (PANSS) and the Indian disability evaluation and assessment scale (IDEAS). Analysis was by modified intention to treat. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN 56877013. Findings 187 participants were randomised to the collaborative community-based care plus facility-based care group and 95 were randomised to the facility-based care alone group; 253 (90%) participants completed follow-up to month 12. At 12 months, total PANSS and IDEAS scores were lower in patients in the intervention group than in those in the control group (PANSS adjusted mean difference −3·75, 95% CI −7·92 to 0·42; p=0·08; IDEAS −0·95, −1·68 to −0·23; p=0·01). However, no difference was shown in the proportion of

  1. A multi-centre randomised controlled trial of rehabilitation aimed at improving outdoor mobility for people after stroke: Study protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Logan Pip A

    2012-06-01

    Full Text Available Abstract Background Up to 42% of all stroke patients do not get out of the house as much as they would like. This can impede a person’s quality of life. This study is testing the clinical effectiveness and cost effectiveness of a new outdoor mobility rehabilitation intervention by comparing it to usual care. Methods/design This is a multi-centre parallel group individually randomised, controlled trial. At least 506 participants will be recruited through 15 primary and secondary care settings and will be eligible if they are over 18 years of age, have had a stroke and wish to get out of the house more often. Participants are being randomly allocated to either the intervention group or the control group. Intervention group participants receive up to 12 rehabilitation outdoor mobility sessions over up to four months. The main component of the intervention is repeated practice of outdoor mobility with a therapist. Control group participants are receiving the usual intervention for outdoor mobility limitations: verbal advice and provision of leaflets provided over one session. Outcome measures are being collected using postal questionnaires, travel calendars and by independent assessors. The primary outcome measure is the Social Function domain of the SF36v2 quality of life assessment six months after recruitment. The secondary outcome measures include: functional ability, mobility, the number of journeys (monthly travel diaries, satisfaction with outdoor mobility, mood, health-related quality of life, resource use of health and social care. Carer mood information is also being collected. The mean Social Function score of the SF-36v2 will be compared between treatment arms using a multiple membership form of mixed effects multiple regression analysis adjusting for centre (as a fixed effect, age and baseline Social Function score as covariates and therapist as a multiple membership random effect. Regression coefficients and 95% confidence

  2. Effectiveness of mat Pilates or equipment-based Pilates in patients with chronic non-specific low back pain: a protocol of a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    da Luz Maurício Antônio

    2013-01-01

    Full Text Available Abstract Background Chronic low back pain is an expensive and difficult condition to treat. One of the interventions widely used by physiotherapists in the treatment of chronic non-specific low back pain is exercise therapy based upon the Pilates principles. Pilates exercises can be performed with or without specific equipment. These two types of Pilates exercises have never been compared on a high-quality randomised controlled trial. Methods/design This randomised controlled trial with a blinded assessor will evaluate eighty six patients of both genders with chronic low back pain, aged between 18 and 60 years, from one Brazilian private physiotherapy clinic. The patients will be randomly allocated into two groups: Mat Group will perform the exercises on the ground while the Equipment-based Group will perform the Pilates method exercises on the following equipment: Cadillac, Reformer, Ladder Barrel, and Step Chair. The general and specific disability of the patient, kinesiophobia, pain intensity and global perceived effect will be evaluated by a blinded assessor before randomisation and at six weeks and six months after randomisation. In addition, the expectation of the participants and their confidence with the treatment will be evaluated before randomisation and after the first treatment session, respectively. Discussion This will be the first study aiming to compare the effectiveness of Mat and Equipment-based Pilates exercises in patients with chronic non-specific low back pain. The results may help health-care professionals in clinical decision-making and could potentially reduce the treatment costs of this condition. Trial registration Brazilian Registry of Clinical Trials RBR-7tyg5j

  3. 'PhysioDirect' telephone assessment and advice services for physiotherapy: protocol for a pragmatic randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Hopper Cherida

    2009-08-01

    Full Text Available Abstract Background Providing timely access to physiotherapy has long been a problem for the National Health Service in the United Kingdom. In an attempt to improve access some physiotherapy services have introduced a new treatment pathway known as PhysioDirect. Physiotherapists offer initial assessment and advice by telephone, supported by computerised algorithms, and patients are sent written self-management and exercise advice by post. They are invited for face-to-face treatment only when necessary. Although several such services have been developed, there is no robust evidence regarding clinical and cost-effectiveness, nor the acceptability of PhysioDirect. Methods/Design This protocol describes a multi-centre pragmatic individually randomised trial, with nested qualitative research. The aim is to determine the effectiveness, cost-effectiveness, and acceptability of PhysioDirect compared with usual models of physiotherapy based on patients going onto a waiting list and receiving face-to-face care. PhysioDirect services will be established in four areas in England. Adult patients in these areas with musculoskeletal problems who refer themselves or are referred by a primary care practitioner for physiotherapy will be invited to participate in the trial. About 1875 consenting patients will be randomised in a 2:1 ratio to PhysioDirect or usual care. Data about outcome measures will be collected at baseline and 6 weeks and 6 months after randomisation. The primary outcome is clinical improvement at 6 months; secondary outcomes include cost, waiting times, time lost from work and usual activities, patient satisfaction and preference. The impact of PhysioDirect on patients in different age-groups and with different conditions will also be examined. Incremental cost-effectiveness will be assessed in terms of quality adjusted life years in relation to cost. Qualitative methods will be used to explore factors associated with the success or failure of

  4. Protocol for a randomised controlled trial of treatment of asymptomatic candidiasis for the prevention of preterm birth [ACTRN12610000607077

    Directory of Open Access Journals (Sweden)

    Rickard Kristen R

    2011-03-01

    Full Text Available Abstract Background Prevention of preterm birth remains one of the most important challenges in maternity care. We propose a randomised trial with: a simple Candida testing protocol that can be easily incorporated into usual antenatal care; a simple, well accepted, treatment intervention; and assessment of outcomes from validated, routinely-collected, computerised databases. Methods/Design Using a prospective, randomised, open-label, blinded-endpoint (PROBE study design, we aim to evaluate whether treating women with asymptomatic vaginal candidiasis early in pregnancy is effective in preventing spontaneous preterm birth. Pregnant women presenting for antenatal care The study protocol draws on the usual antenatal care schedule, has been pilot-tested and the intervention involves only a minor modification of current practice. Women who agree to participate will self-collect a vaginal swab and those who are culture positive for Candida will be randomised (central, telephone to open-label treatment or usual care (screening result is not revealed, no treatment, routine antenatal care. Outcomes will be obtained from population databases. A sample size of 3,208 women with Candida colonisation (1,604 per arm is required to detect a 40% reduction in the spontaneous preterm birth rate among women with asymptomatic candidiasis from 5.0% in the control group to 3.0% in women treated with clotrimazole (significance 0.05, power 0.8. Analyses will be by intention to treat. Discussion For our hypothesis, a placebo-controlled trial had major disadvantages: a placebo arm would not represent current clinical practice; knowledge of vaginal colonisation with Candida may change participants' behaviour; and a placebo with an alcohol preservative may have an independent affect on vaginal flora. These disadvantages can be overcome by the PROBE study design. This trial will provide definitive evidence on whether screening for and treating asymptomatic candidiasis in

  5. Dysphonia: medical treatment and a medical voice hygiene advice approach. A prospective randomised pilot study.

    Science.gov (United States)

    Pedersen, M; Beranova, A; Møller, S

    2004-07-01

    For many years all patients with dysphonia referred to in the literature as resulting from non-organic (functional) voice disorders were sent to speech therapy. Medical diagnoses were not taken into account. In our earlier Cochrane review on vocal cord nodules we discovered that evidence-based research in the area of benign voice disorders with dysphonia, and with or without slight benign swellings including nodules on the vocal cords, was lacking at that time. Therefore, a prospective randomised pilot study based on our Cochrane review has been made on dysphonic patients with non-organic (function provoked?) voice disorders as the basis for further evidence-based studies. Medical treatment was based on the scientific approach that once a micro-organic disorder caused by reflux, infection, allergy or environmental irritatants (e.g., dust or noise in the workplace) was discovered by very careful anamnesis and systematic objective routine analyses and was treated effectively, with documentation, the non-organic voice disorder disappeared, as, e.g., in the case of a diagnosis and treatment of helicobakter pylori. The reason is that the mucosal swelling/dysfunction of the vocal cords is secondary. In order to try to understand why the recommendation to all these patients for many years was only voice therapy, which the speech therapists "felt to be effective", updated voice-hygiene advice (for posture, accents of the diaphragm, intonation pattern and resonance) was given by experienced laryngologists, randomised with the updated medical diagnosis/therapy in order to elucidate what effect the training might have. No evidence-based studies in the literature document any effect. The crucial point seemed to be that doctors mostly did not examine any other diagnoses other than the "dysphonia" and did not dig down to any of the medical reasons when the vocal fold diagnosis of "non- organic disorders" was made. This should be changed in the future. This pilot study was based

  6. Community involvement in dengue vector control: cluster randomised trial

    OpenAIRE

    Vanlerberghe, V; Toledo, M. E.; Rodríguez, M.; Gomez, D.; Baly, A; Benitez, J. R.; Van der Stuyft, P.

    2009-01-01

    OBJECTIVE: To assess the effectiveness of an integrated community based environmental management strategy to control Aedes aegypti, the vector of dengue, compared with a routine strategy. DESIGN: Cluster randomised trial. SETTING: Guantanamo, Cuba. PARTICIPANTS: 32 circumscriptions (around 2000 inhabitants each). INTERVENTIONS: The circumscriptions were randomly allocated to control clusters (n=16) comprising routine Aedes control programme (entomological surveillance, source reduction, selec...

  7. Community involvement in dengue vector control: cluster randomised trial

    OpenAIRE

    Vanlerberghe, V; Toledo, M. E.; Rodriguez, M.; Gómez, D.; Baly, D; Baly, A; Benítez, J. R.; Van der Stuyft, P.

    2010-01-01

    Objective: To assess the effectiveness of an integrated community based environmental management strategy to control Aedes aegypti, the vector of dengue, compared with a routine strategy. Design Cluster randomised trial. Setting Guantanamo, Cuba. Participants 32 circumscriptions (around 2000 inhabitants each). Interventions: The circumscriptions were randomly allocated to control clusters (n=16) comprising routine Aedes control programme (entomological surveillance, sourc...

  8. Yoga in schizophrenia : a systematic review of randomised controlled trials

    NARCIS (Netherlands)

    Vancampfort, D.; Vansteelandt, K.; Scheewe, T.; Probst, M.; Knapen, J.; De Herdt, A.; De Hert, M.

    2012-01-01

    Vancampfort D, Vansteelandt K, Scheewe T, Probst M, Knapen J, De Herdt A, De Hert M. Yoga in schizophrenia: a systematic review of randomised controlled trials. Objective: The objective of this systematic review was to assess the effectiveness of yoga as a complementary treatment on general psychopa

  9. Radiotherapy for Graves' orbitopathy : randomised placebo-controlled study

    NARCIS (Netherlands)

    Mourits, MP; van Kempen-Harteveld, ML; Garcia, MBG; Koppeschaar, HPF; Tick, L; Terwee, CB

    2000-01-01

    Background The best treatment (steroids, irradiation, or both) for moderately severe Graves' orbitopathy, a self-limiting disease is not known. We tested the efficacy of external beam irradiation compared with sham-irradiation. Methods In a double-blind randomised clinical trial, 30 patients with mo

  10. Immobilisation versus immediate mobilisation after intrauterine insemination: randomised controlled trial

    OpenAIRE

    Custers, Inge M; Flierman, Paul A; Maas, Pettie; Cox, Tessa; Van Dessel, Thierry J H M; Gerards, Mariette H; Mochtar, Monique H; Janssen, Catharina A H; van der Veen, Fulco; Ben Willem J. Mol

    2009-01-01

    Objective To evaluate the effectiveness of 15 minutes of immobilisation versus immediate mobilisation after intrauterine insemination. Design Randomised controlled trial. Setting One academic teaching hospital and six non-academic teaching hospitals. Participants Women having intrauterine insemination for unexplained, cervical factor, or male subfertility. Interventions 15 minutes of immobilisation or immediate mobilisation after insemination. Main outcome measure Ongoing pregnancy per couple...

  11. Does a pre-hospital emergency pathway improve early diagnosis and referral in suspected stroke patients? – Study protocol of a cluster randomised trial [ISRCTN41456865

    Directory of Open Access Journals (Sweden)

    Lori Giuliano

    2005-10-01

    Full Text Available Abstract Background Early interventions proved to be able to improve prognosis in acute stroke patients. Prompt identification of symptoms, organised timely and efficient transportation towards appropriate facilities, become essential part of effective treatment. The implementation of an evidence based pre-hospital stroke care pathway may be a method for achieving the organizational standards required to grant appropriate care. We performed a systematic search for studies evaluating the effect of pre-hospital and emergency interventions for suspected stroke patients and we found that there seems to be only a few studies on the emergency field and none about implementation of clinical pathways. We will test the hypothesis that the adoption of emergency clinical pathway improves early diagnosis and referral in suspected stroke patients. We designed a cluster randomised controlled trial (C-RCT, the most powerful study design to assess the impact of complex interventions. The study was registered in the Current Controlled Trials Register: ISRCTN41456865 – Implementation of pre-hospital emergency pathway for stroke – a cluster randomised trial. Methods/design Two-arm cluster-randomised trial (C-RCT. 16 emergency services and 14 emergency rooms were randomised either to arm 1 (comprising a training module and administration of the guideline, or to arm 2 (no intervention, current practice. Arm 1 participants (152 physicians, 280 nurses, 50 drivers attended an interactive two sessions course with continuous medical education CME credits on the contents of the clinical pathway. We estimated that around 750 patients will be met by the services in the 6 months of observation. This duration allows recruiting a sample of patients sufficient to observe a 30% improvement in the proportion of appropriate diagnoses. Data collection will be performed using current information systems. Process outcomes will be measured at the cluster level six months after the

  12. A randomised controlled trial of a cognitive behavioural intervention for women who have menopausal symptoms following breast cancer treatment (MENOS 1: Trial protocol

    Directory of Open Access Journals (Sweden)

    Hellier Jennifer

    2011-01-01

    Full Text Available Abstract Background This trial aims to evaluate the effectiveness of a group cognitive behavioural intervention to alleviate menopausal symptoms (hot flushes and night sweats in women who have had breast cancer treatment. Hot flushes and night sweats are highly prevalent but challenging to treat in this population. Cognitive behaviour therapy has been found to reduce these symptoms in well women and results of an exploratory trial suggest that it might be effective for breast cancer patients. Two hypotheses are tested: Compared to usual care, group cognitive behavioural therapy will: 1. Significantly reduce the problem rating and frequency of hot flushes and nights sweats after six weeks of treatment and at six months post-randomisation. 2. Improve mood and quality of life after six weeks of treatment and at six months post-randomisation. Methods/Design Ninety-six women who have completed their main treatment for breast cancer and who have been experiencing problematic hot flushes and night sweats for over two months are recruited into the trial from oncology and breast clinics in South East London. They are randomised to either six weekly group cognitive behavioural therapy (Group CBT sessions or to usual care. Group CBT includes information and discussion about hot flushes and night sweats in the context of breast cancer, monitoring and modifying precipitants, relaxation and paced respiration, stress management, cognitive therapy for unhelpful thoughts and beliefs, managing sleep and night sweats and maintaining changes. Prior to randomisation women attend a clinical interview, undergo 24-hour sternal skin conductance monitoring, and complete questionnaire measures of hot flushes and night sweats, mood, quality of life, hot flush beliefs and behaviours, optimism and somatic amplification. Post-treatment measures (sternal skin conductance and questionnaires are collected six to eight weeks later and follow-up measures (questionnaires and a use

  13. Consumer satisfaction among patients and their general practitioners about involving nurse specialists in primary care for patients with urinary incontinence

    NARCIS (Netherlands)

    C.P. Albers-Heitner (C. P.); R.A.G. Winkens (R. A G); B. Berghmans; M.A. Joore (Manuela); F.H. Nieman (Fred); J.L. Severens (Hans); T. Lagro-Janssen (Toine)

    2013-01-01

    textabstractUrinary incontinence (UI) is a very common problem, but existing guidelines on UI are not followed. To bring care in line with guidelines, we planned an intervention to involve nurse specialists on UI in primary care and assessed this in a randomised controlled trial. Alongside this inte

  14. The feasibility of a single-blinded fast-track pragmatic randomised controlled trial of a complex intervention for breathlessness in advanced disease

    Directory of Open Access Journals (Sweden)

    Booth Sara

    2009-07-01

    Full Text Available Abstract Background The Breathlessness Intervention Service is a novel service for patients with intractable breathlessness regardless of aetiology. It is being evaluated using the Medical Research Council's framework for the evaluation of complex interventions. This paper describes the feasibility results of Phase II: a single-blinded fast-track pragmatic randomised controlled trial. Methods A single-blinded fast-track pragmatic randomised controlled trial was conducted for patients with chronic obstructive pulmonary disease referred to the service. Patients were randomised to either receive the intervention immediately for an eight-week period, or receive the intervention after an eight-week period on a waiting list during which time they received standard care. Outcomes examined included: response rates to the trial; response rates to the individual questionnaires and items; comments relating to the trial functioning made during interviews with patients, carers, referrers and service providers; and, researcher fieldwork notes. Results 16 of the 20 eligible patients agreed to participate in a recruitment visit (16/20; 14 respondents went on to complete a recruitment visit/baseline interview. The majority of those who completed a recruitment visit/baseline interview completed the RCT protocol (13/14; 12 of their carers were recruited and completed the protocol. An unblinding rate of 6/25 respondents (patients and carers was identified. Missing data were minimal and only one patient was lost to follow up. The fast-track trial methodology proved feasible and acceptable. Two of the baseline/outcome measures proved unsuitable: the WHO performance scale and the Schedule for the Evaluation of Individual Quality of Life-Direct Weighting (SEIQoL-DW. Conclusion This study adds to the evidence that fast-track randomised controlled trials are feasible and acceptable in evaluations of palliative care interventions for patients with non-malignant conditions

  15. Effects of patient safety culture interventions on incident reporting in general practice : A cluster randomised trial a cluster randomised trial

    NARCIS (Netherlands)

    Verbakel, Natasha J.; Langelaan, Maaike; Verheij, Theo J M; Wagner, Cordula; Zwart, Dorien L M

    2015-01-01

    Background: A constructive safety culture is essential for the successful implementation of patient safety improvements. Aim: To assess the effect of two patient safety culture interventions on incident reporting as a proxy of safety culture. Design and setting: A three-arm cluster randomised trial

  16. The use of spatial and randomisation-based methods for analysis of trials with treatments randomised into rows and columns

    DEFF Research Database (Denmark)

    Kristensen, Kristian

    2010-01-01

    The effect of restricted randomisations on the validity and efficiency of using spatial model as well as more common analysis of variance methods for analysing field trials was examined by simulating yields in agricultural fields with known spatial variation and analysing those using eight...

  17. Multidisciplinary transmural rehabilitation for older persons with a stroke: the design of a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Vluggen Tom PMM

    2012-12-01

    Full Text Available Abstract Background Stroke is one of the major causes of loss of independence, decreased quality of life and mortality among elderly people. About half of the elderly stroke patients discharged after rehabilitation in a nursing home still experience serious impairments in daily functioning one year post stroke, which can lead to difficulties in picking up and managing their social life. The aim of this study is to evaluate the effectiveness and feasibility of a new multidisciplinary transmural rehabilitation programme for older stroke patients. Methods A two group multicentre randomised controlled trial is used to evaluate the effects of the rehabilitation programme. The programme consists of three care modules: 1 neurorehabilitation treatment for elderly stroke patients; 2 empowerment training for patient and informal caregiver; and 3 stroke education for patient and informal caregiver. The total programme has a duration of between two and six months, depending on the individual problems of the patient and informal caregiver. The control group receives usual care in the nursing home and after discharge. Patients aged 65 years and over are eligible for study participation when they are admitted to a geriatric rehabilitation unit in a nursing home due to a recent stroke and are expected to be able to return to their original home environment after discharge. Data are gathered by face-to-face interviews, self-administered questionnaires, focus groups and registration forms. Primary outcomes for patients are activity level after stroke, functional dependence, perceived quality of life and social participation. Outcomes for informal caregivers are perceived care burden, objective care burden, quality of life and perceived health. Outcome measures of the process evaluation are implementation fidelity, programme deliverance and the opinion of the stroke professionals, patients and informal caregivers about the programme. Outcome measures of the

  18. Patients' experiences of postoperative intermediate care and standard surgical ward care after emergency abdominal surgery

    DEFF Research Database (Denmark)

    Thomsen, Thordis; Vester-Andersen, Morten; Nielsen, Martin Vedel;

    2015-01-01

    AIMS AND OBJECTIVES: To elicit knowledge of patient experiences of postoperative intermediate care in an intensive care unit and standard postoperative care in a surgical ward after emergency abdominal surgery. BACKGROUND: Emergency abdominal surgery is common, but little is known about how...... patients experience postoperative care. The patient population is generally older with multiple comorbidities, and the short-term postoperative mortality rate is 15-20%. Thus, vigilant surgeon and nursing attention is essential. The present study is a qualitative sub-study of a randomised trial evaluating...... postoperative intermediate care after emergency abdominal surgery, the InCare trial. DESIGN: A qualitative study with individual semi-structured interviews. METHODS: We analysed interviews using Systematic Text Condensation. RESULTS: Eighteen patients (nine intervention/nine controls) were strategically sampled...

  19. Can improving working memory prevent academic difficulties? a school based randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Anderson Peter

    2011-06-01

    Full Text Available Abstract Background Low academic achievement is common and is associated with adverse outcomes such as grade repetition, behavioural disorders and unemployment. The ability to accurately identify these children and intervene before they experience academic failure would be a major advance over the current 'wait to fail' model. Recent research suggests that a possible modifiable factor for low academic achievement is working memory, the ability to temporarily store and manipulate information in a 'mental workspace'. Children with working memory difficulties are at high risk of academic failure. It has recently been demonstrated that working memory can be improved with adaptive training tasks that encourage improvements in working memory capacity. Our trial will determine whether the intervention is efficacious as a selective prevention strategy for young children at risk of academic difficulties and is cost-effective. Methods/Design This randomised controlled trial aims to recruit 440 children with low working memory after a school-based screening of 2880 children in Grade one. We will approach caregivers of all children from 48 participating primary schools in metropolitan Melbourne for consent. Children with low working memory will be randomised to usual care or the intervention. The intervention will consist of 25 computerised working memory training sessions, which take approximately 35 minutes each to complete. Follow-up of children will be conducted at 6, 12 and 24 months post-randomisation through child face-to-face assessment, parent and teacher surveys and data from government authorities. The primary outcome is academic achievement at 12 and 24 months, and other outcomes include child behaviour, attention, health-related quality of life, working memory, and health and educational service utilisation. Discussion A successful start to formal learning in school sets the stage for future academic, psychological and economic well-being. If

  20. The effects of crisis plans for patients with psychotic and bipolar disorders: a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Roosenschoon BJ

    2009-07-01

    , insight into illness, recovery style, social support, locus of control, service engagement and coping with crises situations. The interviews take place before randomisation, nine month later and finally eighteen months after randomisation. Discussion This study examines the effects of two types of crisis plans. In addition, the results offer an understanding of the way these advance statements work and whether it is more effective to include a patients' advocate in the process of creating a psychiatric advance statement. These statements may be an intervention to prevent crises and the use of compulsion in mental health care. The strength and limitations of this study are discussed. Trial registration Current Controlled Trails NTR1166.

  1. How do parents experience being asked to enter a child in a randomised controlled trial?

    Directory of Open Access Journals (Sweden)

    Young Bridget

    2009-02-01

    Full Text Available Abstract Background As the number of randomised controlled trials of medicines for children increases, it becomes progressively more important to understand the experiences of parents who are asked to enrol their child in a trial. This paper presents a narrative review of research evidence on parents' experiences of trial recruitment focussing on qualitative research, which allows them to articulate their views in their own words. Discussion Parents want to do their best for their children, and socially and legally their role is to care for and protect them yet the complexities of the medical and research context can challenge their fulfilment of this role. Parents are simultaneously responsible for their child and cherish this role yet they are dependent on others when their child becomes sick. They are keen to exercise responsibility for deciding to enter a child in a trial yet can be fearful of making the 'wrong' decision. They make judgements about the threat of the child's condition as well as the risks of the trial yet their interpretations often differ from those of medical and research experts. Individual pants will experience these and other complexities to a greater or lesser degree depending on their personal experiences and values, the medical situation of their child and the nature of the trial. Interactions at the time of trial recruitment offer scope for negotiating these complexities if practitioners have the flexibility to tailor discussions to the needs and situation of individual parents. In this way, parents may be helped to retain a sense that they have acted as good parents to their child whatever decision they make. Summary Discussing randomised controlled trials and gaining and providing informed consent is challenging. The unique position of parents in giving proxy consent for their child adds to this challenge. Recognition of the complexities parents face in making decisions about trials suggests lines for future

  2. Occupational therapy discharge planning for older adults: A protocol for a randomised trial and economic evaluation

    Directory of Open Access Journals (Sweden)

    Wales Kylie

    2012-07-01

    Full Text Available Abstract Background Decreased functional ability is common in older adults after hospitalisation. Lower levels of functional ability increase the risk of hospital readmission and nursing care facility admission. Discharge planning across the hospital and community interface is suggested to increase functional ability and decrease hospital length of stay and hospital readmission. However evidence is limited and the benefits of occupational therapists providing this service has not been investigated. This randomised trial will investigate the clinical effectiveness of a discharge planning program in reducing functional difficulties of older adults post-discharge. This trial will also examine the cost of the intervention and cost effectiveness when compared to in-hospital discharge planning. Methods/design 400 participants admitted to participating hospitals will be recruited. Participants will be 70 years of age and over, have no significant cognitive impairment and be independently mobile at discharge. This study protocol was approved by the ethics committee of Ryde Rehabilitation Human Research Ethics Committee, Western Sydney Local Health District (Westmead Campus Human Research Ethics Committee, Alfred Health Human Research ethics committee for the randomised trial and NSW Population and Health Service Human Research Ethics Committee for data linkage. Participants will provide informed written consent. Participants will be randomly allocated to the intervention or control group. The intervention group will receive discharge planning therapies primarily within their home environment while the control group will receive an in-hospital consultation, both provided by trained occupational therapists. Primary outcome measures will be the Nottingham Extended Activities of Daily Living Scale (NEADL and the Late Life Disability Index (LLDI which will measure functional independence, and participation and limitation in daily life activities

  3. Study protocol: follow-up home visits with nutrition: a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Beck Anne Marie

    2011-12-01

    Full Text Available Abstract Background Geriatric patients are at high risk of re-admission after discharge. Pre-existing nutritional risk amongst these patients is of primary concern, with former nutritional intervention studies being largely ineffective. None of these studies has included individual dietary counselling by a registered dietician or has considered competing medical conditions in the participants. A former randomised study has shown that comprehensive discharge follow-up in geriatric patients homes by general practitioners and district nurses was effective in reducing the re-admission risk in the intervention group compared to the control group. That study did not include a nutritional intervention. The purpose of this study is to assess the combined benefits of an intervention consisting of discharge follow-up in geriatric patients' home by a general practitioner and a registered dietician. Methods/design This single-blind randomised controlled study, will recruit 160 hospitalised geriatric medical patients (65+ y at nutritional risk. Participants will be randomly allocated to receive in their homes, either 12 weeks individualised nutritional counselling by a registered dietician complemented with follow-up by general practitioners or a 12 weeks follow-up by general practitioners alone. Discussion This trial is the first of its kind to provide individual nutritional intervention combined with follow-up by general practitioner as an intervention to reduce risk of re-admission after discharge among geriatric medical patients. The results will hopefully help to guide the development of more effective rehabilitation programs following hospital admissions, which may ultimately lead to reduced health care costs, and improvement in mobility, independence and quality of life for geriatric patients at nutritional risk. Trial Registration ClinicalTrials.gov 2010 NCT01249716

  4. NHS health checks through general practice: randomised trial of population cardiovascular risk reduction

    Directory of Open Access Journals (Sweden)

    Cochrane Thomas

    2012-11-01

    Full Text Available Abstract Background The global burden of the major vascular diseases is projected to rise and to remain the dominant non-communicable disease cluster well into the twenty first century. The Department of Health in England has developed the NHS Health Check service as a policy initiative to reduce population vascular disease risk. The aims of this study were to monitor population changes in cardiovascular disease (CVD risk factors over the first year of the new service and to assess the value of tailored lifestyle support, including motivational interview with ongoing support and referral to other services. Methods Randomised trial comparing NHS Health Check service only with NHS Health Check service plus additional lifestyle support in Stoke on Trent, England. Thirty eight general practices and 601 (365 usual care, 236 additional lifestyle support patients were recruited and randomised independently between September 2009 and February 2010. Changes in population CVD risk between baseline and one year follow-up were compared, using intention-to-treat analysis. The primary outcome was the Framingham 10 year CVD risk score. Secondary outcomes included individual modifiable risk measures and prevalence of individual risk categories. Additional lifestyle support included referral to a lifestyle coach and free sessions as needed for: weight management, physical activity, cook and eat and positive thinking. Results Average population CVD risk decreased from 32.9% to 29.4% (p Conclusions The NHS Health Check service in Stoke on Trent resulted in significant reduction in estimated population CVD risk. There was no evidence of further benefit of the additional lifestyle support services in terms of absolute CVD risk reduction.

  5. Passive movement therapy in patients with moderate to severe paratonia; study protocol of a randomised clinical trial (ISRCTN43069940

    Directory of Open Access Journals (Sweden)

    de Bie Rob A

    2007-12-01

    Full Text Available Abstract Background Paratonia, a form of hypertonia, is associated with loss of mobility and with the development of contractures especially in the late stages of the dementia. Passive movement therapy (PMT currently is the main physiotherapeutic intervention. General doubt about the beneficial effects of this widely used therapy necessitates a randomised clinical trial (RCT to study the efficacy of PMT on the severity of paratonia and on the improvement of daily care. Methods/Design A RCT with a 4-week follow-up period. Patients with dementia (according to the DSM-IV-TR Criteria and moderate to severe paratonia are included in the study after proxy consent. By means of computerised and concealed block randomisation (block-size of 4 patients are included in one of two groups. The first group receives PMT, the second group receives usual care without PMT. PMT is given according to a protocol by physical therapist three times a week for four weeks in a row. The severity of paratonia (Modified Ashworth scale, the severity of the dementia (Global Deterioration Scale, the clinical improvement (Clinical Global Impressions, the difficulty in daily care (Patient Specific Complaints and the experienced pain in daily care of the participant (PACSLAC-D is assessed by assessors blind to treatment allocation at baseline, after 6 and 12 treatments. Success of the intervention is defined as a significant increase of decline on the modified Ashworth scale. The 'proportion of change' in two and four weeks time on this scale will be analysed. Also a multiple logistic regression analysis using declined/not declined criteria as dependent variable with correction for relevant confounders (e.g. stage of dementia, medication, co-morbidity will be used. Discussion This study is the first RCT of this size to gain further insight on the effect of passive movement therapy on the severity of paratonia. Trial registration Current Controlled Trials ISRCTN43069940

  6. A randomised controlled trial of ion-exchange water softeners for the treatment of eczema in children.

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    Kim S Thomas

    Full Text Available BACKGROUND: Epidemiological studies and anecdotal reports suggest a possible link between household use of hard water and atopic eczema. We sought to test whether installation of an ion-exchange water softener in the home can improve eczema in children. METHODS AND FINDINGS: This was an observer-blind randomised trial involving 336 children (aged 6 months to 16 years with moderate/severe atopic eczema. All lived in hard water areas (≥200 mg/l calcium carbonate. Participants were randomised to either installation of an ion-exchange water softener plus usual eczema care, or usual eczema care alone. The primary outcome was change in eczema severity (Six Area Six Sign Atopic Dermatitis Score, SASSAD at 12 weeks, measured by research nurses who were blinded to treatment allocation. Analysis was based on the intent-to-treat population. Eczema severity improved for both groups during the trial. The mean change in SASSAD at 12 weeks was -5.0 (20% improvement for the water softener group and -5.7 (22% improvement for the usual care group (mean difference 0.66, 95% confidence interval -1.37 to 2.69, p = 0.53. No between-group differences were noted in the use of topical corticosteroids or calcineurin inhibitors. CONCLUSIONS: Water softeners provided no additional benefit to usual care in this study population. Small but statistically significant differences were found in some secondary outcomes as reported by parents, but it is likely that such improvements were the result of response bias, since participants were aware of their treatment allocation. A detailed report for this trial is also available at http://www.hta.ac.uk. TRIAL REGISTRATION: Current Controlled Trials ISRCTN71423189 Please see later in the article for the Editors' Summary.

  7. Economic Evaluation of a General Hospital Unit for Older People with Delirium and Dementia (TEAM Randomised Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Lukasz Tanajewski

    Full Text Available One in three hospital acute medical admissions is of an older person with cognitive impairment. Their outcomes are poor and the quality of their care in hospital has been criticised. A specialist unit to care for older people with delirium and dementia (the Medical and Mental Health Unit, MMHU was developed and then tested in a randomised controlled trial where it delivered significantly higher quality of, and satisfaction with, care, but no significant benefits in terms of health status outcomes at three months.To examine the cost-effectiveness of the MMHU for older people with delirium and dementia in general hospitals, compared with standard care.Six hundred participants aged over 65 admitted for acute medical care, identified on admission as cognitively impaired, were randomised to the MMHU or to standard care on acute geriatric or general medical wards. Cost per quality adjusted life year (QALY gained, at 3-month follow-up, was assessed in trial-based economic evaluation (599/600 participants, intervention: 309. Multiple imputation and complete-case sample analyses were employed to deal with missing QALY data (55%.The total adjusted health and social care costs, including direct costs of the intervention, at 3 months was £7714 and £7862 for MMHU and standard care groups, respectively (difference -£149 (95% confidence interval [CI]: -298, 4. The difference in QALYs gained was 0.001 (95% CI: -0.006, 0.008. The probability that the intervention was dominant was 58%, and the probability that it was cost-saving with QALY loss was 39%. At £20,000/QALY threshold, the probability of cost-effectiveness was 94%, falling to 59% when cost-saving QALY loss cases were excluded.The MMHU was strongly cost-effective using usual criteria, although considerably less so when the less acceptable situation with QALY loss and cost savings were excluded. Nevertheless, this model of care is worthy of further evaluation.ClinicalTrials.gov NCT01136148.

  8. Effectiveness and cost of recruitment strategies for a community-based randomised controlled trial among rainwater drinkers

    Directory of Open Access Journals (Sweden)

    Cunliffe David

    2009-07-01

    Full Text Available Abstract Background Community-based recruitment is challenging particularly if the sampling frame is not easily defined as in the case of people who drink rainwater. Strategies for contacting participants must be carefully considered to maximise generalisability and minimise bias of the results. This paper assesses the recruitment strategies for a 1-year double-blinded randomised trial on drinking untreated rainwater. The effectiveness of the recruitment strategies and associated costs are described. Methods Community recruitment of households from Adelaide, Australia occurred from February to July 2007 using four methods: electoral roll mail-out, approaches to schools and community groups, newspaper advertising, and other media involvement. Word of mouth communication was also assessed. Results A total of 810 callers were screened, with 53.5% eligible. Of those who were eligible and sent further information, 76.7% were willing to participate in the study and 75.1% were enrolled. The target for recruitment was 300 households, and this was achieved. The mail-out was the most effective method with respect to number of households randomised, while recruitment via schools had the highest yield (57.3% and was the most cost effective when considering cost per household randomised (AUD$147.20. Yield and cost effectiveness were lowest for media advertising. Conclusion The use of electoral roll mail-out and advertising via schools were effective in reaching households using untreated rainwater for drinking. Employing multiple strategies enabled success in achieving the recruitment target. In countries where electoral roll extracts are available to researchers, this method is likely to have a high yield for recruitment into community-based epidemiological studies.

  9. Study protocol for the evaluation of an Infant Simulator based program delivered in schools: a pragmatic cluster randomised controlled trial

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    Hart Michael B

    2010-10-01

    Full Text Available Abstract Background This paper presents the study protocol for a pragmatic randomised controlled trial to evaluate the impact of a school based program developed to prevent teenage pregnancy. The program includes students taking care of an Infant Simulator; despite growing popularity and an increasing global presence of such programs, there is no published evidence of their long-term impact. The aim of this trial is to evaluate the Virtual Infant Parenting (VIP program by investigating pre-conceptual health and risk behaviours, teen pregnancy and the resultant birth outcomes, early child health and maternal health. Methods and Design Fifty-seven schools (86% of 66 eligible secondary schools in Perth, Australia were recruited to the clustered (by school randomised trial, with even randomisation to the intervention and control arms. Between 2003 and 2006, the VIP program was administered to 1,267 participants in the intervention schools, while 1,567 participants in the non-intervention schools received standard curriculum. Participants were all female and aged between 13-15 years upon recruitment. Pre and post-intervention questionnaires measured short-term impact and participants are now being followed through their teenage years via data linkage to hospital medical records, abortion clinics and education records. Participants who have a live birth are interviewed by face-to-face interview. Kaplan-Meier survival analysis and proportional hazards regression will test for differences in pregnancy, birth and abortion rates during the teenage years between the study arms. Discussion This protocol paper provides a detailed overview of the trial design as well as initial results in the form of participant flow. The authors describe the intervention and its delivery within the natural school setting and discuss the practical issues in the conduct of the trial, including recruitment. The trial is pragmatic and will directly inform those who provide

  10. A randomised clinical trial of intrapartum fetal monitoring with computer analysis and alerts versus previously available monitoring

    Directory of Open Access Journals (Sweden)

    Santos Cristina

    2010-10-01

    Full Text Available Abstract Background Intrapartum fetal hypoxia remains an important cause of death and permanent handicap and in a significant proportion of cases there is evidence of suboptimal care related to fetal surveillance. Cardiotocographic (CTG monitoring remains the basis of intrapartum surveillance, but its interpretation by healthcare professionals lacks reproducibility and the technology has not been shown to improve clinically important outcomes. The addition of fetal electrocardiogram analysis has increased the potential to avoid adverse outcomes, but CTG interpretation remains its main weakness. A program for computerised analysis of intrapartum fetal signals, incorporating real-time alerts for healthcare professionals, has recently been developed. There is a need to determine whether this technology can result in better perinatal outcomes. Methods/design This is a multicentre randomised clinical trial. Inclusion criteria are: women aged ≥ 16 years, able to provide written informed consent, singleton pregnancies ≥ 36 weeks, cephalic presentation, no known major fetal malformations, in labour but excluding active second stage, planned for continuous CTG monitoring, and no known contra-indication for vaginal delivery. Eligible women will be randomised using a computer-generated randomisation sequence to one of the two arms: continuous computer analysis of fetal monitoring signals with real-time alerts (intervention arm or continuous CTG monitoring as previously performed (control arm. Electrocardiographic monitoring and fetal scalp blood sampling will be available in both arms. The primary outcome measure is the incidence of fetal metabolic acidosis (umbilical artery pH ecf > 12 mmol/L. Secondary outcome measures are: caesarean section and instrumental vaginal delivery rates, use of fetal blood sampling, 5-minute Apgar score Discussion This study will provide evidence of the impact of intrapartum monitoring with computer analysis and real

  11. Transcutaneous electrical nerve stimulation (TENS reduces pain and postpones the need for pharmacological analgesia during labour: a randomised trial

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    Licia Santos Santana

    2016-01-01

    Full Text Available Questions: In the active phase of the first stage of labour, does transcutaneous electrical nerve stimulation (TENS relieve pain or change its location? Does TENS delay the request for neuraxial analgesia during labour? Does TENS produce any harmful effects in the mother or the foetus? Are women in labour satisfied with the care provided? Design: Randomised trial with concealed allocation, assessor blinding for some outcomes, and intention-to-treat analysis. Participants: Forty-six low-risk, primigravida parturients with a gestational age > 37 weeks, cervical dilation of 4 cm, and without the use of any medications from hospital admission until randomisation. Intervention: The principal investigator applied TENS to the experimental group for 30 minutes starting at the beginning of the active phase of labour. A second investigator assessed the outcomes in both the control and experimental groups. Both groups received routine perinatal care. Outcome measures: The primary outcome was pain severity after the intervention period, which was assessed using the 100-mm visual analogue scale. Secondary outcomes included: pain location, duration of the active phase of labour, time to pharmacological labour analgesia, mode of birth, neonatal outcomes, and the participant's satisfaction with the care provided. Results: After the intervention, a significant mean difference in change in pain of 15 mm was observed favouring the experimental group (95% CI 2 to 27. The application of TENS did not alter the location or distribution of the pain. The mean time to pharmacological analgesia after the intervention was 5.0 hours (95% CI 4.1 to 5.9 longer in the experimental group. The intervention did not significantly impact the other maternal and neonatal outcomes. Participants in both groups were satisfied with the care provided during labour. Conclusion: TENS produces a significant decrease in pain during labour and postpones the need for pharmacological

  12. Multidisciplinary and multifaceted outpatient management of patients with osteoarthritis: protocol for a randomised, controlled trial

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    Kvien Tore

    2010-11-01

    Full Text Available Abstract Background Osteoarthritis (OA is a prevalent joint disorder with a need for efficient and evidence-based management strategies. Objectives The primary purpose of this study is to compare the effects of a multidisciplinary outpatient clinic, including a brief group-based educational programme, with a traditional individual outpatient clinic for patients with hip, knee, hand or generalized OA. A secondary purpose is to investigate the effects of a telephone follow-up call. Methods This is a pragmatic randomised single-blind controlled study with a total of 400 patients with hip, knee, hand or generalized OA between 40 and 80 years referred to an outpatient rheumatology hospital clinic. The randomisation is stratified according to the diagnostic subgroups. The experimental group is exposed to a multidisciplinary and multifaceted intervention, including a 3.5 hour group-based patient education programme about OA in addition to individual consultations with members of a multidisciplinary team. The control intervention is based on regular care with an individual outpatient consultation with a rheumatologist (treatment as usual. Primary outcomes are patient satisfaction measured at 4 months and cost-effectiveness measured at 12 months. Secondary outcomes are pain and global disease activity measured on a numeric rating scales (NRS, generic and disease specific functioning and disability using Short Form-36 (SF-36 health survey, the Western Ontario and McMaster Universities Osteoarthritis Index 3 (WOMAC, the Australian/Canadian Osteoarthritis Hand Index (AUSCAN, and a patient-generated measure of disability (Patient-Specific Functional scale, PSFS. Global perceived effect of change in health status during the study period is also reported. At 4-month follow-up, patients in both groups will be randomly allocated to a 10-minute telephone call or no follow-up ("treatment as usual". After additional 8 months (12-month follow-up the four groups will

  13. Evaluation of Lay Support in Pregnant women with Social risk (ELSIPS: a randomised controlled trial

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    Kenyon Sara

    2012-02-01

    Full Text Available Abstract Background Maternal, neonatal and child health outcomes are worse in families from black and ethnic minority groups and disadvantaged backgrounds. There is little evidence on whether lay support improves maternal and infant outcomes among women with complex social needs within a disadvantaged multi-ethnic population in the United Kingdom (UK. Method/Design The aim of this study is to evaluate a lay Pregnancy Outreach Worker (POW service for nulliparous women identified as having social risk within a maternity service that is systematically assessing social risks alongside the usual obstetric and medical risks. The study design is a randomised controlled trial (RCT in nulliparous women assessed as having social risk comparing standard maternity care with the addition of referral to the POW support service. The POWs work alongside community midwifery teams and offer individualised support to women to encourage engagement with services (health and social care from randomisation (before 28 weeks gestation until 6 weeks after birth. The primary outcomes have been chosen on the basis that they are linked to maternal and infant health. The two primary outcomes are engagement with antenatal care, assessed by the number of antenatal visits; and maternal depression, assessed using the Edinburgh Postnatal Depression Scale at 8-12 weeks after birth. Secondary outcomes include maternal and neonatal morbidity and mortality, routine child health assessments, including immunisation uptake and breastfeeding at 6 weeks. Other psychological outcomes (self efficacy and mother-to-infant bonding will also be collected using validated tools. A sample size of 1316 will provide 90% power (at the 5% significance level to detect increased engagement with antenatal services of 1.5 visits and a reduction of 1.5 in the average EPDS score for women with two or more social risk factors, with power in excess of this for women with any social risk factor. Analysis will

  14. A cluster randomised stepped wedge trial to evaluate the effectiveness of a multifaceted information technology-based intervention in reducing high-risk prescribing of non-steroidal anti-inflammatory drugs and antiplatelets in primary medical care: the DQIP study protocol

    OpenAIRE

    Dreischulte Tobias; Grant Aileen; Donnan Peter; McCowan Colin; Davey Peter; Petrie Dennis; Treweek Shaun; Guthrie Bruce

    2012-01-01

    Abstract Background High-risk prescribing of non-steroidal anti-inflammatory drugs (NSAIDs) and antiplatelet agents accounts for a significant proportion of hospital admissions due to preventable adverse drug events. The recently completed PINCER trial has demonstrated that a one-off pharmacist-led information technology (IT)-based intervention can significantly reduce high-risk prescribing in primary care, but there is evidence that effects decrease over time and employing additional pharmac...

  15. Reported challenges in nurse-led randomised controlled trials

    DEFF Research Database (Denmark)

    Wang Vedelø, Tina; Lomborg, Kirsten

    2011-01-01

    ) nonadherence to research protocols and (iii) economic and organisational obstacles. These three challenges and barriers were inter-related and all were affected by time and timing. Conclusion: Randomised controlled trials are complex, expensive, time-consuming and highly demanding for researchers and the...... clinical nursing staff. Two lessons learned from this integrative review can be highlighted. First, we recommend researchers openly to share their experiences of barriers and challenges. They should describe factors that may have inhibited the desired outcome. Second, efforts to improve the collaboration...... between nurse researchers and clinicians, including education, training and support may increase the success rate and quality of nurse-led studies using the randomised controlled trial....

  16. Thermoregulatory effects of swaddling in Mongolia: a randomised controlled study

    OpenAIRE

    Tsogt, Bazarragchaa; Manaseki-Holland, Semira; Pollock, Jon; Blair, Peter S.; Fleming, Peter

    2015-01-01

    Objective To investigate thermal balance of infants in a Mongolian winter, and compare the effects of traditional swaddling with an infant sleeping-bag in apartments or traditional tents (Gers). Design A substudy within a randomised controlled trial. Setting Community in Ulaanbaatar, Mongolia. Subjects A stratified randomly selected sample of 40 swaddled and 40 non-swaddled infants recruited within 48 h of birth. Intervention Sleeping-bags and baby outfits of total thermal resistance equivale...

  17. Ear Acupressure for Smoking Cessation: A Randomised Controlled Trial

    OpenAIRE

    Zhang, Anthony L.; Yuan Ming Di; Christopher Worsnop; Brian H. May; Cliff Da Costa; Xue, Charlie C.L.

    2013-01-01

    This study investigated the efficacy and safety of ear acupressure (EAP) as a stand-alone intervention for smoking cessation and the feasibility of this study design. Adult smokers were randomised to receive EAP specific for smoking cessation (SSEAP) or a nonspecific EAP (NSEAP) intervention which is not typically used for smoking cessation. Participants received 8 weekly treatments and were requested to press the five pellets taped to one ear at least three times daily. Participants were fol...

  18. Randomised controlled trial of aminophylline for severe acute asthma

    OpenAIRE

    Yung, M; South, M

    1998-01-01

    OBJECTIVES—To determine whether children with severe acute asthma treated with large doses of inhaled salbutamol, inhaled ipratropium, and intravenous steroids are conferred any further benefits by the addition of aminophylline given intravenously.
STUDY DESIGN—Randomised, double blind, placebo controlled trial of 163 children admitted to hospital with asthma who were unresponsive to nebulised salbutamol.
RESULTS—The placebo and treatment groups of children were similar at b...

  19. Effect of intermediate care on mortality following emergency abdominal surgery. The InCare trial

    DEFF Research Database (Denmark)

    Vester-Andersen, Morten; Waldau, Tina; Wetterslev, Jørn;

    2013-01-01

    is all-cause 30-day mortality. We aim to enrol 400 patients in seven Danish hospitals. The sample size allows us to detect or refute a 34% relative risk reduction of mortality with 80% power. DISCUSSION: This trial evaluates the benefits and possible harm of intermediate care. The results may potentially....... The aim of the present trial is to evaluate the effect of postoperative intermediate care following emergency major abdominal surgery in high-risk patients.Methods and design: The InCare trial is a randomised, parallel-group, non-blinded clinical trial with 1:1 allocation. Patients undergoing emergency...... laparotomy or laparoscopic surgery with a perioperative Acute Physiology and Chronic Health Evaluation II score of 10 or above, who are ready to be transferred to the surgical ward within 24 h of surgery are allocated to either intermediate care for 48 h, or surgical ward care. The primary outcome measure...

  20. Randomised controlled feasibility trial of an evidence-informed behavioural intervention for obese adults with additional risk factors.

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    Falko F Sniehotta

    Full Text Available BACKGROUND: Interventions for dietary and physical activity changes in obese adults may be less effective for participants with additional obesity-related risk factors and co-morbidities than for otherwise healthy individuals. This study aimed to test the feasibility and acceptability of the recruitment, allocation, measurement, retention and intervention procedures of a randomised controlled trial of an intervention to improve physical activity and dietary practices amongst obese adults with additional obesity related risk factors. METHOD: Pilot single centre open-labelled outcome assessor-blinded randomised controlled trial of obese (Body Mass Index (BMI≥30 kg/m2 adults (age≥18 y with obesity related co-morbidities such as type 2 diabetes, impaired glucose tolerance or hypertension. Participants were randomly allocated to a manual-based group intervention or a leaflet control condition in accordance to a 2∶1 allocation ratio. Primary outcome was acceptability and feasibility of trial procedures, secondary outcomes included measures of body composition, physical activity, food intake and psychological process measures. RESULTS: Out of 806 potentially eligible individuals identified through list searches in two primary care general medical practices N = 81 participants (63% female; mean-age = 56.56(11.44; mean-BMI = 36.73(6.06 with 2.35(1.47 co-morbidities were randomised. Scottish Index of Multiple Deprivation (SIMD was the only significant predictor of providing consent to take part in the study (higher chances of consent for invitees with lower levels of deprivation. Participant flowcharts, qualitative and quantitative feedback suggested good acceptance and feasibility of intervention procedures but 34.6% of randomised participants were lost to follow-up due to overly high measurement burden and sub-optimal retention procedures. Participants in the intervention group showed positive trends for most psychological, behavioural

  1. Surgery versus Active Monitoring in Intermittent Exotropia (SamExo: study protocol for a pilot randomised controlled trial

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    Buck Deborah

    2012-10-01

    Full Text Available Abstract Background Childhood intermittent exotropia [X(T] is a type of strabismus (squint in which one eye deviates outward at times, usually when the child is tired. It may progress to a permanent squint, loss of stereovision and/or amblyopia (reduced vision. Treatment options for X(T include eye patches, glasses, surgery and active monitoring. There is no consensus regarding how this condition should be managed, and even when surgery is the preferred option clinicians disagree as to the optimal timing. Reports on the natural history of X(T are limited, and there is no randomised controlled trial (RCT evidence on the effectiveness or efficiency of surgery compared with active monitoring. The SamExo (Surgery versus Active Monitoring in Intermittent Exotropia pilot study has been designed to test the feasibility of such a trial in the UK. Methods Design: an external pilot patient randomised controlled trial. Setting: four UK secondary ophthalmology care facilities at Newcastle NHS Hospitals Foundation Trust, Sunderland Eye Infirmary, Moorfields Eye Hospital and York NHS Trust. Participants: children aged between 6 months and 16 years referred with suspected and subsequently diagnosed X(T. Recruitment target is a total of 144 children over a 9-month period, with 120 retained by 9-month outcome visit. Randomisation: permuted blocks stratified by collaborating centre, age and severity of X(T. Interventions: initial clinical assessment; randomisation (eye muscle surgery or active monitoring; 3-, 6- and 9-month (primary outcome clinical assessments; participant/proxy completed questionnaire covering time and travel costs, health services use and quality of life (Intermittent Exotropia Questionnaire; qualitative interviews with parents to establish reasons for agreeing or declining participation in the pilot trial. Outcomes: recruitment and retention rates; nature and extent of participation bias; nature and extent of biases arising from crossover or

  2. Reduction of adverse effects from intravenous acetylcysteine treatment for paracetamol poisoning: a randomised controlled trial:a randomised controlled trial

    OpenAIRE

    Bateman, D Nicholas; Dear, James W; Thanacoody, H K Ruben; Thomas, Simon H L; Eddleston, Michael; Sandilands, Euan A; Coyle, Judy; Cooper, Jamie G.; Rodriguez, Aryelly; Butcher, Isabella; Lewis, Steff C.; Vliegenthart, A D Bastiaan; Veiraiah, Aravindan; Webb, David J.; Gray, Alasdair

    2014-01-01

    BACKGROUND: Paracetamol poisoning is common worldwide. It is treated with intravenous acetylcysteine, but the standard regimen is complex and associated with frequent adverse effects related to concentration, which can cause treatment interruption. We aimed to ascertain whether adverse effects could be reduced with either a shorter modified acetylcysteine schedule, antiemetic pretreatment, or both. METHODS: We undertook a double-blind, randomised factorial study at three UK hospitals, between...

  3. Does aqueous or sucralfate cream affect the severity of erythematous radiation skin reactions? A randomised controlled trial

    International Nuclear Information System (INIS)

    Background and purpose: Evidence on which to base decisions about the management of radiation skin reactions is lacking. The purpose of this study was to investigate whether sucralfate or aqueous cream reduced acute skin toxicity during radiotherapy to the head and neck, breast or anorectal area (phase A), and to evaluate the effect of hydrogels and dry dressings on moist desquamation (phase B). This paper presents the results of phase A. Patients and methods: Three hundred and fifty seven patients were randomised to apply aqueous cream, sucralfate cream or no cream to the irradiated area from day one of radical radiotherapy treatment. All patients were instructed to wash using unperfumed soap. Acute skin toxicity was measured using a modified radiation therapy oncology group (RTOG) score, reflectance spectrophotometry, patient diary card and dermatology life quality index (DLQI). A cost minimisation approach was used to compare the costs of each skin care approach. Results: No consistent differences were found in the severity of skin reactions or levels of discomfort suffered by patients in each of the randomised groups. Patients with a higher body mass index, who smoked, received concomitant chemotherapy, boost or bolus during treatment were more likely to develop skin reactions. Conclusions: There is no evidence to support the prophylactic application of either of the creams tested for the prevention of radiation skin reactions. Our results show that it is possible to predict which patients are at greatest risk of skin reactions. We suggest that known risk factors should be incorporated into future study protocols

  4. Treatment of retained placenta with misoprostol: a randomised controlled trial in a low-resource setting (Tanzania

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    Fauteck Heiner

    2009-10-01

    Full Text Available Abstract Background Retained placenta is one of the common causes of maternal mortality in developing countries where access to appropriate obstetrical care is limited. Current treatment of retained placenta is manual removal of the placenta under anaesthesia, which can only take place in larger health care facilities. Medical treatment of retained placenta with prostaglandins E1 (misoprostol could be cost-effective and easy-to-use and could be a life-saving option in many low-resource settings. The aim of this study is to assess the efficacy and safety of sublingually administered misoprostol in women with retained placenta in a low resource setting. Methods Design: Multicentered randomised, double-blind, placebo-controlled trial, to be conducted in 5 hospitals in Tanzania, Africa. Inclusion criteria: Women with retained placenta, at a gestational age of 28 weeks or more and blood loss less than 750 ml, 30 minutes after delivery of the newborn despite active management of third stage of labour. Trial Entry & Randomisation & Study Medication: After obtaining informed consent, eligible women will be allocated randomly to the treatment groups using numbered envelopes that will be randomized in variable blocks containing identical capsules with either 800 microgram of misoprostol or placebo. The drugs will be given sublingually. The women, maternal care providers and researchers will be blinded to treatment allocation. Sample Size: 117 women, to show a 40% reduction in manual removals of the placenta (p = 0.05, 80% power. The randomization will be misoprostol: placebo = 2:1 Primary Study Outcome: Expulsion of the placenta without manual removal. Secondary outcome is the number of blood transfusions. Discussion This is a protocol for a randomized trial in a low resource setting to assess if medical treatment of women with retained placenta with misoprostol reduces the incidence of manual removal of the placenta. Clinical Trial Registration Current

  5. The Happy Life Club™ study protocol: A cluster randomised controlled trial of a type 2 diabetes health coach intervention

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    Yang Hui

    2011-02-01

    Full Text Available Abstract Background The Happy Life Club™ is an intervention that utilises health coaches trained in behavioural change and motivational interviewing techniques to assist with the management of type 2 diabetes mellitus (T2DM in primary care settings in China. Health coaches will support participants to improve modifiable risk factors and adhere to effective self-management treatments associated with T2DM. Methods/Design A cluster randomised controlled trial involving 22 Community Health Centres (CHCs in Fengtai District of Beijing, China. CHCs will be randomised into a control or intervention group, facilitating recruitment of at least 1320 individual participants with T2DM into the study. Participants in the intervention group will receive a combination of both telephone and face-to-face health coaching over 18 months, in addition to usual care received by the control group. Health coaching will be performed by CHC doctors and nurses certified in coach-assisted chronic disease management. Outcomes will be assessed at baseline and again at 6, 12 and 18 months by means of a clinical health check and self-administered questionnaire. The primary outcome measure is HbA1c level. Secondary outcomes include metabolic, physiological and psychological variables. Discussion This cluster RCT has been developed to suit the Chinese health care system and will contribute to the evidence base for the management of patients with T2DM. With a strong focus on self-management and health coach support, the study has the potential to be adapted to other chronic diseases, as well as other regions of China. Trial Registration Current Controlled Trials ISRCTN01010526

  6. COSTS AND BENEFITS OF HOSPITAL AND DAY TREATMENT WITH COMMUNITY CARE OF AFFECTIVE AND SCHIZOPHRENIC DISORDERS

    NARCIS (Netherlands)

    WIERSMA, D; KLUITER, H; NIENHUIS, FJ; RUPHAN, M; GIEL, R

    1995-01-01

    Background. A randomised controlled trial of day treatment with community care for patients with schizophrenic and affective disorders, referred for in-patient psychiatric treatment, was conducted to evaluate patterns of treatment and the course of illness with its psychosocial consequences over a p

  7. Evidence based evaluation of immuno-coagulatory interventions in critical care

    DEFF Research Database (Denmark)

    Afshari, Arash

    2011-01-01

    Cochrane systematic reviews with meta-analyses of randomised trials provide guidance for clinical practice and health-care decision-making. In case of disagreements between research evidence and clinical practice, high quality systematic reviews can facilitate implementation or deimplementation o...

  8. Effectiveness of transdiagnostic Internet cognitive behavioural treatment for mixed anxiety and depression in primary care

    NARCIS (Netherlands)

    Newby, Jill M; Mewton, Louise; Williams, Alishia D; Andrews, Gavin

    2014-01-01

    BACKGROUND: Internet-delivered cognitive behavioural treatment (iCBT) has been shown to be effective for the combined treatment of depression and anxiety in randomised controlled trials. The degree to which these findings generalise to patients in primary care awaits further investigation. METHODS:

  9. Wide Awake Parenting: study protocol for a randomised controlled trial of a parenting program for the management of post-partum fatigue

    Directory of Open Access Journals (Sweden)

    Dunning Melissa

    2013-01-01

    Full Text Available Abstract Background Exhaustion and fatigue are commonly experienced by parents during the post-partum period, and can have implications for daily functioning, mental health and parenting practices. There is a need for the development of effective interventions to assist parents with the management of fatigue. This paper outlines the procedure for a randomised controlled study which aims to test the efficacy of Wide Awake Parenting, a program for the management of fatigue in the postnatal period. Methods/design Parents with an infant less than 6 months of age, and from seven Local Government Areas in Melbourne, Australia were invited to participate in this study. Parents were randomised to receive the Wide Awake Parenting program (intervention groups or usual care (control group offered by health services. The Wide Awake Parenting program provides parents with psycho-education and information about fatigue, and strategies to reduce its effects either via a self-directed method, or professionally led with a home visit and telephone support. Baseline data will be collected prior to randomisation, and further data will be collected at 2- and 6-weeks post intervention. Discussion To our knowledge this is the first randomised controlled trial of a program which compares the efficacy of a self-management approach and health professional assistance for the management of fatigue in the early post-partum period. If effective, it could offer an important, universal public health management approach to this common health concern. Trial registration number Australian New Zealand Clinical Trials Registry, ACTRN12611000133932.

  10. Quit in General Practice: a cluster randomised trial of enhanced in-practice support for smoking cessation

    Directory of Open Access Journals (Sweden)

    Zwar Nicholas

    2010-08-01

    Full Text Available Abstract Background This study will test the uptake and effectiveness of a flexible package of smoking cessation support provided primarily by the practice nurse (PN and tailored to meet the needs of a diversity of patients. Methods/Design This study is a cluster randomised trial, with practices allocated to one of three groups 1 Quit with Practice Nurse 2 Quitline referral 3 GP usual care. PNs from practices randomised to the intervention group will receive a training course in smoking cessation followed by access to mentoring. GPs from practices randomised to the Quitline referral group will receive information about the study and the process of written referral and GPs in the usual care group will receive information about the study. Eligible patients are those aged 18 and over presenting to their GP who are daily or weekly smokers and who are able to give informed consent. Patients on low incomes in all three groups will be able to access free nicotine patches. Primary outcomes are sustained abstinence and point prevalence abstinence at the three month and 12 month follow-up points; and incremental cost effectiveness ratios at 12 months. Process evaluation on the reach and acceptability of the intervention approached will be collected through Computer Assisted Telephone Interviews (CATI with patients and semi-structured interviews with PNs and GPs. The primary analysis will be by intention to treat. Cessation outcomes will be compared between the three arms at three months and 12 month follow-up using multiple logistic regression. The incremental cost effectiveness ratios will be estimated for the 12 month quit rate for the intervention groups compared to usual care and to each other. Analysis of qualitative data on process outcomes will be based on thematic analysis. Discussion High quality evidence on effectiveness of practice nurse interventions is needed to inform health policy on development of practice nurse roles. If effective

  11. The effect of training doctors in communication skills on women’s satisfaction with doctor–woman relationship during labour and delivery: a stepped wedge cluster randomised trial in Damascus

    OpenAIRE

    Bashour, Hyam N; Kanaan, Mona; Kharouf, Mayada H; Abdulsalam, Asmaa A; Tabbaa, Mohammed A; Cheikha, Salah A

    2013-01-01

    Objectives To determine the effect of training residents in interpersonal and communication skills on women’s satisfaction with doctor–woman relationship in labour and delivery rooms. Design A stepped wedge cluster randomised trial. Setting 4 tertiary care teaching maternity hospitals in Damascus, Syria. Participants 2000 women who gave birth to a living baby in the four study hospitals and consented to participate in the intervention took part in the study. Women with difficult labour and hi...

  12. Promoting smoking cessation in Pakistani and Bangladeshi men in the UK: pilot cluster randomised controlled trial of trained community outreach workers

    Directory of Open Access Journals (Sweden)

    Barton Pelham

    2011-08-01

    Full Text Available Abstract Background Smoking prevalence is high among Pakistani and Bangladeshi men in the UK, but there are few tailored smoking cessation programmes for Pakistani and Bangladeshi communities. The aim of this study was to pilot a cluster randomised controlled trial comparing the effectiveness of Pakistani and Bangladeshi smoking cessation outreach workers with standard care to improve access to and the success of English smoking cessation services. Methods A pilot cluster randomised controlled trial was conducted in Birmingham, UK. Geographical lower layer super output areas were used to identify natural communities where more than 10% of the population were of Pakistani and Bangladeshi origin. 16 agglomerations of super output areas were randomised to normal care controls vs. outreach intervention. The number of people setting quit dates using NHS services, validated abstinence from smoking at four weeks, and stated abstinence at three and six months were assessed. The impact of the intervention on choice and adherence to treatments, attendance at clinic appointments and patient satisfaction were also assessed. Results We were able to randomise geographical areas and deliver the outreach worker-based services. More Pakistani and Bangladeshi men made quit attempts with NHS services in intervention areas compared with control areas, rate ratio (RR 1.32 (95%CI: 1.03-1.69. There was a small increase in the number of 4-week abstinent smokers in intervention areas (RR 1.30, 95%CI: 0.82-2.06. The proportion of service users attending weekly appointments was lower in intervention areas than control areas. No difference was found between intervention and control areas in choice and adherence to treatments or patient satisfaction with the service. The total cost of the intervention was £124,000; an estimated cost per quality-adjusted life year (QALY gained of £8,500. Conclusions The intervention proved feasible and acceptable. Outreach workers expanded

  13. The DAMASK trial protocol: a pragmatic randomised trial to evaluate whether GPs should have direct access to MRI for patients with suspected internal derangement of the knee

    Directory of Open Access Journals (Sweden)

    Orchard Jo

    2006-10-01

    Full Text Available Abstract Background Though new technologies like Magnetic Resonance Imaging (MRI may be accurate, they often diffuse into practice before thorough assessment of their value in diagnosis and management, and of their effects on patient outcome and costs. MRI of the knee is a common investigation despite concern that it is not always appropriate. There is wide variation in general practitioners (GPs access to, and use of MRI, and in the associated costs. The objective of this study was to resolve uncertainty whether GPs should refer patients with suspected internal derangement of the knee for MRI or to an orthopaedic specialist in secondary care. Methods/Design The design consisted of a pragmatic multi-centre randomised trial with two parallel groups and concomitant economic evaluation. Patients presenting in general practice with suspected internal derangement of the knee and for whom their GP was considering referral to an orthopaedic specialist in secondary care were eligible for inclusion. Within practices, GPs or practice nurses randomised eligible and consenting participants to the local radiology department for an MRI examination, or for consultation with an orthopaedic specialist. To ensure that the waiting time from GP consultation to orthopaedic appointment was similar for both trial arms, GPs made a provisional referral to orthopaedics when requesting the MRI examination. Thus we evaluated the more appropriate sequence of events independent of variations in waiting times. Follow up of participants was by postal questionnaires at six, twelve and 24 months after randomisation. This was to ensure that the evaluation covered all events up to and including arthroscopy. Discussion The DAMASK trial should make a major contribution to the development of evidence-based partnerships between primary and secondary care professionals and inform the debate when MRI should enter the diagnostic pathway.

  14. Effects of a training program after surgically treated ankle fracture: a prospective randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Ekdahl Charlotte S

    2009-09-01

    Full Text Available Abstract Background Despite conflicting results after surgically treated ankle fractures few studies have evaluated the effects of different types of training programs performed after plaster removal. The aim of this study was to evaluate the effects of a 12-week standardised but individually suited training program (training group versus usual care (control group after plaster removal in adults with surgically treated ankle fractures. Methods In total, 110 men and women, 18-64 years of age, with surgically treated ankle fracture were included and randomised to either a 12-week training program or to a control group. Six and twelve months after the injury the subjects were examined by the same physiotherapist who was blinded to the treatment group. The main outcome measure was the Olerud-Molander Ankle Score (OMAS which rates symptoms and subjectively scored function. Secondary outcome measures were: quality of life (SF-36, timed walking tests, ankle mobility tests, muscle strength tests and radiological status. Results 52 patients were randomised to the training group and 58 to the control group. Five patients dropped out before the six-month follow-up resulting in 50 patients in the training group and 55 in the control group. Nine patients dropped out between the six- and twelve-month follow-up resulting in 48 patients in both groups. When analysing the results in a mixed model analysis on repeated measures including interaction between age-group and treatment effect the training group demonstrated significantly improved results compared to the control group in subjects younger than 40 years of age regarding OMAS (p = 0.028, muscle strength in the plantar flexors (p = 0.029 and dorsiflexors (p = 0.030. Conclusion The results of this study suggest that when adjusting for interaction between age-group and treatment effect the training model employed in this study was superior to usual care in patients under the age of 40. However, as only three

  15. Feasibility study of an integrated stroke self-management programme : a cluster-randomised controlled trial

    OpenAIRE

    Jones, Fiona; Gage, Heather; Drummond, Avril; Bhalla, Ajay; Grant, Robert; Lennon, Sheila; McKevitt, Christopher; Riazi, Afsane; Liston, Matthew

    2016-01-01

    OBJECTIVES: To test the feasibility of conducting a controlled trial into the effectiveness of a self-management programme integrated into stroke rehabilitation. DESIGN: A feasibility cluster-randomised design was utilised with stroke rehabilitation teams as units of randomisation. SETTING: Community-based stroke rehabilitation teams in London. PARTICIPANTS: 78 patients with a diagnosis of stroke requiring community based rehabilitation. INTERVENTION: The interv...

  16. Quality of life endovascular and open AAA repair. Results of a randomised trial.

    NARCIS (Netherlands)

    Prinssen, M.; Buskens, E.; Blankensteijn, J.D.

    2004-01-01

    AIM: To compare the quality of life (QoL) in the first postoperative year after elective endovascular abdominal aortic aneurysm repair (EVAR) and open repair (OR) in a randomised study. METHODS: In the Dutch Randomised Endovascular Aneurysm Management (DREAM) trial, patients are randomly allocated t

  17. Clinical and cost effectiveness of mechanical support for severe ankle sprains: design of a randomised controlled trial in the emergency department [ISRCTN 37807450

    OpenAIRE

    Hutton JL; Wilson S; Marsh JL; Clark M; Withers EJ; Nakash RA; Lamb SE; Szczepura A; Dale JR; Cooke MW

    2005-01-01

    Abstract Background The optimal management for severe sprains (Grades II and III) of the lateral ligament complex of the ankle is unclear. The aims of this randomised controlled trial are to estimate (1) the clinical effectiveness of three methods of providing mechanical support to the ankle (below knee cast, Aircast® brace and Bledsoe® boot) in comparison to Tubigrip®, and (2) to compare the cost of each strategy, including subsequent health care costs. Methods/design Six hundred and fifty p...

  18. Preoperative airway assessment - experience gained from a multicentre cluster randomised trial and the Danish Anaesthesia Database.

    Science.gov (United States)

    Nørskov, Anders Kehlet

    2016-05-01

    Difficulties with airway management in relation to general anaesthesia have been a challenge for the anaesthesiologist since the birth of anaesthesia. Massive landmark improvements have been made and general anaesthesia is now regarded as a safe procedure. However, rare, difficult airway management still occurs and it prompts increased risk of morbidity and mortality - especially when not anticipated. Several preoperative risk factors for airway difficulties have been identified, yet none have convincing diagnostic accuracy as stand alone tests. Combining several risk factors increase the predictive value of the test and multivariable risk models have been developed. The Simplified Airway Risk Index (SARI) is a predictive model developed for anticipation of a difficult direct laryngoscopy. However, neither the diagnostic accuracy of the SARI nor of any other model has been tested prospectively and compared with existing practice for airway assessment in a randomised trial setting. The first objective of this thesis was to quantify the proportion of unanticipated difficult intubation and difficult mask ventilation in Denmark. The second objective was to design a cluster randomised trial, using state of the art methodology, in order to test the clinical impact of using the SARI for preoperative airway assessment compared with a clinical judgement based on usual practice for airway assessment. Finally, to test if implementation of the SARI would reduce the proportion of unanticipated difficult intubation compared with usual care for airway assessment. This thesis is based on data from the Danish Anaesthesia Database (DAD). Paper 1 presents an observational cohort study on 188,064 patients who underwent tracheal intubation from 2008 to 2011. Data on the anaesthesiologists' preoperative anticipations of airway difficulties was compared with actual airway management conditions, thus enabling an estimation of the proportion of unanticipated difficulties with intubation

  19. Lead editorial: Trials – using the opportunities of electronic publishing to improve the reporting of randomised trials

    Directory of Open Access Journals (Sweden)

    Grimshaw Jeremy M

    2006-03-01

    Full Text Available Abstract This editorial introduces the new online, open access, peer-reviewed journal Trials. The journal considers manuscripts on any aspect of the design, performance, and findings of randomised controlled trials in any discipline related to health care, and also encourages the publication of protocols. Trialists will be able to provide the necessary detail for a true and complete scientific record. They will be able to communicate not only all outcome measures, as well as varying analyses and interpretations, but also in-depth descriptions of what they did and honest reflections about what they learnt. Trials also encourages articles covering generic issues related to trials, for example focussing on the design, conduct, analysis, interpretation, or reporting.

  20. Electronic voting to encourage interactive lectures: a randomised trial

    Directory of Open Access Journals (Sweden)

    Palmer Edward

    2007-07-01

    Full Text Available Abstract Background Electronic Voting Systems have been used for education in a variety of disciplines. Outcomes from these studies have been mixed. Because results from these studies have been mixed, we examined whether an EVS system could enhance a lecture's effect on educational outcomes. Methods A cohort of 127 Year 5 medical students at the University of Adelaide was stratified by gender, residency status and academic record then randomised into 2 groups of 64 and 63 students. Each group received consecutive 40-minute lectures on two clinical topics. One group received the EVS for both topics. The other group received traditional teaching only. Evaluation was undertaken with two, 15-question multiple-choice questionnaires (MCQ assessing knowledge and problem solving and undertaken as a written paper immediately before and after the lectures and repeated online 8–12 weeks later. Standardised institutional student questionnaires were completed for each lecture and independent observers assessed student behaviour during the lectures. Lecturer's opinions were assessed by a questionnaire developed for this study. Results Two-thirds of students randomised to EVS and 59% of students randomised to traditional lectures attended. One-half of the students in the EVS group and 41% in the traditional group completed all questionnaires. There was no difference in MCQ scores between EVS and traditional lectures (p = 0.785. The cervical cancer lectures showed higher student ranking in favour of EVS in all parameters. The breast cancer lectures showed higher ranking in favour of traditional lectures in 5 of 7 parameters (p Conclusion In this setting, EVS technology used in large group lectures did not offer significant advantages over the more traditional lecture format.

  1. Randomised clinical trials with clinician-preferred treatment.

    Science.gov (United States)

    Korn, E L; Baumrind, S

    1991-01-19

    The standard design for randomised clinical trials may be inappropriate when the clinician believes that one of the treatments being tested is superior for the patient, or when the clinician has a preference for one of the treatments. For such instances the suggestion is that the patient is randomly allocated to treatment only when there is clinical disagreement about treatment of choice for that patient, and then the patient is assigned to a clinician who had thought that the regimen allocated is the one most appropriate for that patient.

  2. Mendelian Randomisation Study of Childhood BMI and Early Menarche

    OpenAIRE

    Hannah S. Mumby; Elks, Cathy E; Shengxu Li; Sharp, Stephen J.; Kay-Tee Khaw; Luben, Robert N; Wareham, Nicholas J; Loos, Ruth J. F.; Ken K Ong

    2011-01-01

    To infer the causal association between childhood BMI and age at menarche, we performed a mendelian randomisation analysis using twelve established “BMI-increasing” genetic variants as an instrumental variable (IV) for higher BMI. In 8,156 women of European descent from the EPIC-Norfolk cohort, height was measured at age 39–77 years; age at menarche was self-recalled, as was body weight at age 20 years, and BMI at 20 was calculated as a proxy for childhood BMI. DNA was genotyped for twelve BM...

  3. Bach flower remedies: a systematic review of randomised clinical trials.

    Science.gov (United States)

    Ernst, Edzard

    2010-01-01

    Bach flower remedies continue to be popular and its proponents make a range of medicinal claims for them. The aim of this systematic review was to critically evaluate the evidence for these claims. Five electronic databases were searched without restrictions on time or language. All randomised clinical trials of flower remedies were included. Seven such studies were located. All but one were placebo-controlled. All placebo-controlled trials failed to demonstrate efficacy. It is concluded that the most reliable clinical trials do not show any differences between flower remedies and placebos. PMID:20734279

  4. A randomised controlled trial of intervention site radiotherapy in malignant pleural mesothelioma

    International Nuclear Information System (INIS)

    Background and purpose: To assess the effectiveness of radiotherapy in preventing tumour seeding after chest drain or pleural biopsy in patients with malignant mesothelioma and to determine, if tract metastases appear, whether they are tender or troublesome to patients. Patients and methods: Patients with a histological diagnosis of pleural mesothelioma and an invasive procedure within the preceding 21 days were stratified by age, performance status and treatment centre. Randomisation was performed between immediate drain site radiotherapy 21 Gy in three fractions (XRT arm) or best supportive care (BSC) with follow-up to 12 months. Patients were asked to complete questionnaires on treatment toxicity and on symptoms from any tract metastases detected. Results: Sixty-one patients were recruited from two centres between 1998 and 2004; 56 men, 5 women, median age 70. 31 were allocated to drain site radiotherapy. Seven patients developed tract metastases associated with the drain site (four XRT arm, three BSC) and four developed metastases associated with subsequent procedures at other sites (three XRT, one BSC). Two patients each developed two tract metastases. Of the 12 metastases, nine overlay the previous drain site but three were adjacent to the site. No statistically significant difference was found in the risk of tract metastasis associated with the drain site between the arms (p = 0.748). Conclusions: Prophylactic drain site radiotherapy in malignant pleural mesothelioma does not reduce the incidence of tumour seeding by the margin indicated by previous studies

  5. Lavender-thymol as a new topical aromatherapy preparation for episiotomy: A randomised clinical trial.

    Science.gov (United States)

    Marzouk, T; Barakat, R; Ragab, A; Badria, F; Badawy, A

    2015-01-01

    The objective of this study was to evaluate the effectiveness of topical lavender-thymol in promoting episiotomy healing. This placebo-controlled, single-blinded, randomised clinical trial involved 60 primiparous women. REEDA score was used to evaluate the outcome of the trial. On the 7th post-partum day, women in Placebo-treated group had worse Redness, Edema, Ecchymosis, Discharge and Approximation (REEDA) score of 3.93 ± 3.65 compared with those in Lavender-thymol-treated group (2.03 ± 1.7) with significant difference (P = 0.013). Visual analogue Scale (VAS) score for pain at episiotomy in Lavender-thymol-treated group was 3.5 ± 1.9, whereas in Placebo-treated group it was 2.1 ± 2.2 (p = 0.011) for dyschezia, 3.8 ± 1.7 and 2.8 ± 1.6 in Placebo- and Lavender-thymol-treated women, respectively (p = 0.023). At 7th post-partum week, dyspareunia was more severe in Placebo-treated group compared with that in Lavender-thymol-treated group (5.3 ± 2.7 vs 2.7 ± 1.5 and p aromatherapy using lavender-thymol was highly effective, suitable and safe for episiotomy wound care with little or no expected side effects compared with that using placebo. PMID:25384116

  6. Topical tranexamic acid as a novel treatment for bleeding peptic ulcer: A randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Mandana Rafeey

    2016-01-01

    Full Text Available Background: Peptic ulcers are among the most common causes of upper gastrointestinal (GI bleeding in children. The standard care for GI bleeding is endoscopy for diagnostic and therapeutic purposes. We aimed to assess the effect of topical tranexamic acid (TXA via endoscopic procedures in children with GI bleeding caused by bleeding ulcers. Procedure: In this randomised controlled trial, 120 children were evaluated by diagnostic procedures for GI bleeding, of which 63 (30 girls, 33 boys aged 1-month to 15 years were recruited. The patients were randomly divided into case and control groups. In the case group, TXA was administered directly under endoscopic therapy. In the control group, epinephrine (1/10,000 was submucosally injected to the four quadrants of ulcer margins as the routine endoscopic therapy. In both groups, the patients received supportive medical therapy with intravenous fluids and proton pump inhibitor drugs. Results: The mean ± standard deviation age of the children was 5 ± 2.03 years. Rebleeding occurred in 15 (11.4% and 21 (9.8% patients in the case and control groups, respectively (P = 0.50. The frequency of blood transfusion episodes (P = 0.06 and duration of hospital stay (P = 0.07 were not statistically different between the groups. Conclusion: Using topical TXA via endoscopic procedures may be effective in cases of GI bleedings caused by active bleeding ulcers. In order to establish this therapeutic effect, a large number of clinical studies are needed.

  7. Hypnosis Antenatal Training for Childbirth (HATCh: a randomised controlled trial [NCT00282204

    Directory of Open Access Journals (Sweden)

    Baghurst Peter

    2006-03-01

    Full Text Available Abstract Background Although medical interventions play an important role in preserving lives and maternal comfort they have become increasingly routine in normal childbirth. This may increase the risk of associated complications and a less satisfactory birth experience. Antenatal hypnosis is associated with a reduced need for pharmacological interventions during childbirth. This trial seeks to determine the efficacy or otherwise of antenatal group hypnosis preparation for childbirth in late pregnancy. Methods/design A single centre, randomised controlled trial using a 3 arm parallel group design in the largest tertiary maternity unit in South Australia. Group 1 participants receive antenatal hypnosis training in preparation for childbirth administered by a qualified hypnotherapist with the use of an audio compact disc on hypnosis for re-enforcement; Group 2 consists of antenatal hypnosis training in preparation for childbirth using an audio compact disc on hypnosis administered by a nurse with no training in hypnotherapy; Group 3 participants continue with their usual preparation for childbirth with no additional intervention. Women > 34 and Discussion If effective, hypnosis would be a simple, inexpensive way to improve the childbirth experience, reduce complications associated with pharmacological interventions, yield cost savings in maternity care, and this trial will provide evidence to guide clinical practice.

  8. Protocol for economic evaluation alongside the IMPLEMENT cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    McKenzie Joanne E

    2008-02-01

    Full Text Available Abstract Background The recent development and publication of evidence-based clinical practice guidelines (CPGs for acute low back pain (LBP has resulted in evidence-based recommendations that, if implemented, have the potential to improve the quality and safety of care for acute LBP. While a strategy has been specified for dissemination of the CPG for acute LBP in Australia, there is no accompanying plan for active implementation. Evidence regarding the cost-effectiveness of active implementation of CPGs for acute LBP is sparse. The IMPLEMENT study will consider the incremental benefits and costs of progressing beyond development and dissemination to implementation. Methods/design Cost-effectiveness and cost-utility analyses alongside the IMPLEMENT cluster randomised controlled trial (CRCT from a societal perspective to quantify the additional costs (savings and health gains associated with a targeted implementation strategy as compared with access to the CPG via dissemination only. Discussion The protocol provided here registers our intent to conduct an economic evaluation alongside the IMPLEMENT study, facilitates peer-review of proposed methods and provides a transparent statement of planned analyses. Trial registration Australian New Zealand Clinical Trials Registry ACTRN012606000098538

  9. Sweeten, soother and swaddle for retinopathy of prematurity screening: a randomised placebo controlled trial.

    LENUS (Irish Health Repository)

    O'Sullivan, A

    2012-02-01

    OBJECTIVE: To assess the efficacy of oral sucrose combined with swaddling and non-nutritive suck (NNS) as a method for reducing pain associated with retinopathy of prematurity (ROP) screening. DESIGN: Randomised placebo controlled study. SETTING: Tertiary level neonatal intensive care unit. SAMPLE: 40 infants undergoing primary eye examination for ROP screening. INTERVENTION: The control group were swaddled, and received 0.2 ml of sterile water given by mouth using a syringe and a soother. The intervention group were swaddled, and received 0.2 ml of sucrose 24% given by mouth using a syringe and a soother. RESULTS: 40 infants were included in the study. There was no difference in mean gestational age at birth, mean birth weight or corrected gestational age at first examination between both groups. The sucrose group had a significantly lower median Neonatal Pain, Agitation and Sedation Scale (N-PASS) score during ROP screening, initially following insertion of the speculum (6.5 vs 5, p=0.02) and subsequently during scleral indentation (9.5 vs 7.5, p=0.03). Fewer infants experienced episodes of desaturations or bradycardia in the intervention group (1 vs 4, p=0.18). CONCLUSION: ROP screening is a necessary but recognised painful procedure. Sucrose combined with NNS and swaddling reduced the behavioural and physiological pain responses. However, pain scores remained consistently high and appropriate pain relief for ROP screening remains a challenge.

  10. Acupuncture for Treating Whiplash Associated Disorder: A Systematic Review of Randomised Clinical Trials

    Directory of Open Access Journals (Sweden)

    Tae-Woong Moon

    2014-01-01

    Full Text Available The aim of this systematic review was to determine the effectiveness of acupuncture for the treatment of whiplash associated disorder (WAD. Twenty databases were searched from their inceptions to Oct. 2013. Randomised clinical trials (RCTs of acupuncture (AT, electroacupuncture (EA, or dry needling (DN for the treatment of WAD were considered eligible. The risk of bias was assessed using the Cochrane tool. Six RCTs met the inclusion criteria. Most of the included RCTs have serious methodological flaws. Four of the RCTs showed effectiveness of AT, AT in addition to usual care (UC, AT in addition to herbal medicine (HM or EA was more effective than relaxation, sham EA, sham EA in addition to HM or UC for conditioned pain modulation (CPM and alleviating pain. In one RCT, DN in addition to physiotherapy (PT had no effect compared to sham-DN in addition to PT for the reduction of pain. None of the RCTs showed that AT/EA/DN was more effective than various types of control groups in reducing disability/function. One RCT did not report between-group comparisons of any outcome measures. The evidence for the effectiveness of AT/EA/DN for the treatment of WAD is limited. Therefore, more research in this area is warranted.

  11. A guide to performing a peer review of randomised controlled trials.

    Science.gov (United States)

    Del Mar, Chris; Hoffmann, Tammy C

    2015-11-02

    Peer review of journal articles is an important step in the research process. Editors rely on the expertise of peer reviewers to properly assess submissions. Yet, peer review quality varies widely and few receive training or guidance in how to approach the task. This paper describes some of the main steps that peer reviewers in general and, in particular, those performing reviewes of randomised controlled trials (RCT), can use when carrying out a review. It can be helpful to begin with a brief read to acquaint yourself with the study, followed by a detailed read and a careful check for flaws. These can be divided into 'major' (problems that must be resolved before publication can be considered) and 'minor' (suggested improvements that are discretionary) flaws. Being aware of the appropriate reporting checklist for the study being reviewed (such as CONSORT and its extensions for RCTs) can also be valuable. Competing interests or prejudices might corrode the review, so ensuring transparency about them is important. Finally, ensuring that the paper's strengths are acknowledged along with a dissection of the weaknesses provides balance and perspective to both authors and editors. Helpful reviews are constructive and improve the quality of the paper. The proper conduct of a peer review is the responsibility of all who accept the role.

  12. Protocol for SAMS (Support and Advice for Medication Study: A randomised controlled trial of an intervention to support patients with type 2 diabetes with adherence to medication

    Directory of Open Access Journals (Sweden)

    Sutton Stephen

    2008-04-01

    Full Text Available Abstract Background Although some interventions have been shown to improve adherence to medication for diabetes, results are not consistent. We have developed a theory-based intervention which we will evaluate in a well characterised population to test efficacy and guide future intervention development and trial design. Methods and Design The SAMS (Supported Adherence to Medication Study trial is a primary care based multi-centre randomised controlled trial among 200 patients with type 2 diabetes and an HbA1c of 7.5% or above. It is designed to evaluate the efficacy of a two-component motivational intervention based on the Theory of Planned Behaviour and volitional action planning to support medication adherence compared with standard care. The intervention is delivered by practice nurses. Nurses were trained using a workshop approach with role play and supervised using assessment of tape-recorded consultations. The trial has a two parallel groups design with an unbalanced three-to-two individual randomisation eight weeks after recruitment with twelve week follow-up. The primary outcome is medication adherence measured using an electronic medication monitor over 12 weeks and expressed as the difference between intervention and control in mean percentage of days on which the correct number of medication doses is taken. Subgroup analyses will explore impact of number of medications taken, age, HbA1c, and self-reported adherence at baseline on outcomes. The study also measures the effect of dispensing medication to trial participants packaged in the electronic medication-monitoring device compared with conventional medication packaging. This will be achieved through one-to-one randomisation at recruitment to these conditions with assessment of the difference between groups in self-report of medication adherence and change in mean HbA1c from baseline to eight weeks. Anonymised demographic data are collected on non-respondents. Central randomisation

  13. Computerised therapy for depression with clinician vs. assistant and brief vs. extended phone support: study protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Gega Lina

    2012-08-01

    Full Text Available Abstract Background Computerised cognitive behaviour therapy (cCBT involves standardised, automated, interactive self-help programmes delivered via a computer. Randomised controlled trials (RCTs and observational studies have shown than cCBT reduces depressive symptoms as much as face-to-face therapy and more than waiting lists or treatment as usual. cCBT’s efficacy and acceptability may be influenced by the “human” support offered as an adjunct to it, which can vary in duration and can be offered by people with different levels of training and expertise. Methods/design This is a two-by-two factorial RCT investigating the effectiveness, cost-effectiveness and acceptability of cCBT supplemented with 12 weekly phone support sessions are either brief (5–10 min or extended (20–30 min and are offered by either an expert clinician or an assistant with no clinical training. Adults with non-suicidal depression in primary care can self-refer into the study by completing and posting to the research team a standardised questionnaire. Following an assessment interview, eligible referrals have access to an 8-session cCBT programme called Beating the Blues and are randomised to one of four types of support: brief-assistant, extended-assistant, brief-clinician or extended-clinician. A sample size of 35 per group (total 140 is sufficient to detect a moderate effect size with 90% power on our primary outcome measure (Work and Social Adjustment Scale; assuming a 30% attrition rate, 200 patients will be randomised. Secondary outcome measures include the Beck Depression and Anxiety Inventories and the PHQ-9 and GAD-7. Data on clinical outcomes, treatment usage and patient experiences are collected in three ways: by post via self-report questionnaires at week 0 (randomisation and at weeks 12 and 24 post-randomisation; electronically by the cCBT system every time patients log-in; by phone during assessments, support sessions and exit interviews. Discussion

  14. A cluster randomised controlled effectiveness trial evaluating perinatal home visiting among South African mothers/infants.

    Directory of Open Access Journals (Sweden)

    Mary Jane Rotheram-Borus

    Full Text Available Interventions are needed to reduce poor perinatal health. We trained community health workers (CHWs as home visitors to address maternal/infant risks.In a cluster randomised controlled trial in Cape Town townships, neighbourhoods were randomised within matched pairs to 1 the control, healthcare at clinics (n = 12 neighbourhoods; n = 594 women, or 2 a home visiting intervention by CBW trained in cognitive-behavioural strategies to address health risks (by the Philani Maternal, Child Health and Nutrition Programme, in addition to clinic care (n = 12 neighbourhoods; n = 644 women. Participants were assessed during pregnancy (2% refusal and 92% were reassessed at two weeks post-birth, 88% at six months and 84% at 18 months later. We analysed 32 measures of maternal/infant well-being over the 18 month follow-up period using longitudinal random effects regressions. A binomial test for correlated outcomes evaluated overall effectiveness over time. The 18 month post-birth assessment outcomes also were examined alone and as a function of the number of home visits received.Benefits were found on 7 of 32 measures of outcomes, resulting in significant overall benefits for the intervention compared to the control when using the binomial test (p = 0.008; nevertheless, no effects were observed when only the 18 month outcomes were analyzed. Benefits on individual outcomes were related to the number of home visits received. Among women living with HIV, intervention mothers were more likely to implement the PMTCT regimens, use condoms during all sexual episodes (OR = 1.25; p = 0.014, have infants with healthy weight-for-age measurements (OR = 1.42; p = 0.045, height-for-age measurements (OR = 1.13, p<0.001, breastfeed exclusively for six months (OR = 3.59; p<0.001, and breastfeed longer (OR = 3.08; p<0.001. Number of visits was positively associated with infant birth weight ≥2500 grams (OR = 1.07; p = 0

  15. The impact of behavioural screening on intervention outcomes in a randomised, controlled multiple behaviour intervention trial

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    Fjeldsoe Brianna S

    2011-03-01

    Full Text Available Abstract Background With an increasing research focus on multiple health behaviour change interventions, a methodological issue requiring further investigation is whether or not to employ pre-trial behavioural screening to exclude participants who are achieving a pre-specified level of one or more behaviours. Behavioural screening can be used to direct limited resources to participants most in need of a behaviour change intervention; but may reduce the representativeness of the sample and limit comparability with trials that do not employ pre-trial behavioural screening. Furthermore, the impact of this type of screening on intervention participation and intervention effects is unknown. Methods Data for this study come from the Logan Healthy Living Program, a randomised, controlled telephone counselling lifestyle intervention trial which did not employ behavioural screening prior to randomisation. Screening for physical activity, diet or the combination was simulated using baseline trial data. To examine the impact of behavioural screening on intervention participation (in terms of participant characteristics, intervention dose received and retention, characteristics of participants included an excluded under the various screening scenarios were compared. To examine the impact of behavioural screening on intervention effects, results from the main trial analysis were compared with results obtained from the same analyses performed separately for each of the screened groups. Results Simulated pre-trial behavioural screening impacted minimally on intervention dose received and trial retention rate. Beyond the anticipated effect of reducing baseline levels of the behaviours being screened for, behavioural screening affected baseline levels of behaviours not targeted by screening, and participants' demographic and health-related characteristics. Behavioural screening impacted on intervention effects in ways that were anticipated and positive, but also

  16. Evaluation of an online Diabetes Needs Assessment Tool (DNAT for health professionals: a randomised controlled trial

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    Kellner Thomas

    2009-07-01

    Full Text Available Abstract Background Continuous medical education is traditionally reliant to a large extent on self-directed learning based on individuals' perceived learning priorities. Evidence suggests that this ability to self-assess is limited, and more so in the least competent. Therefore, it may be of benefit to utilise some form of external assessment for this purpose. Many diabetes educational programmes have been introduced, but few have been assessed for their benefit in a systematic manner. As diabetes is an increasingly prevalent disease, methods for the dissemination and understanding of clinical guidelines need to be explored for their effectiveness. This paper describes the study design of a randomised controlled trial to evaluate the effectiveness of using an interactive online Diabetes Needs Assessment Tool (DNAT, that builds a learning curriculum based on identified knowledge gaps, compared with conventional self-directed learning. The study assesses the effect of these interventions on health professionals' knowledge of diabetes management, evaluates the acceptability of this process of learning and self-reported changes in clinical practice as a result of this novel educational process. Methods Following a baseline assessment, participants will be randomised to undergo a 4-month learning period where they will either be given access to the diabetes learning modules alone (control group or a Diabetes Needs Assessment Tool (DNAT plus the diabetes learning modules (intervention group. On completion of the DNAT, a personalised learning report will be created for each participant identifying needs alongside individualised recommendations of the most appropriate learning modules to meet those requirements. All participants will complete a Diabetes Knowledge Test before and immediately after the allocated learning and the primary outcome will be the state of knowledge at 4 months. Learners will also be surveyed immediately after the learning

  17. Cardiac rehabilitation adapted to transient ischaemic attack and stroke (CRAFTS: a randomised controlled trial

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    Blake Catherine

    2009-02-01

    Full Text Available Abstract Background Coronary Heart Disease and Cerebrovascular Disease share many predisposing, modifiable risk factors (hypertension, abnormal blood lipids and lipoproteins, cigarette smoking, physical inactivity, obesity and diabetes mellitus. Lifestyle interventions and pharmacological therapy are recognised as the cornerstones of secondary prevention. Cochrane review has proven the benefits of programmes incorporating exercise and lifestyle counselling in the cardiac disease population. A Cochrane review highlighted as priority, the need to establish feasibility and efficacy of exercise based interventions for Cerebrovascular Disease. Methods A single blind randomised controlled trial is proposed to examine a primary care cardiac rehabilitation programme for adults post transient ischemic attack (TIA and stroke in effecting a positive change in the primary outcome measures of cardiac risk scores derived from Blood Pressure, lipid profile, smoking and diabetic status and lifestyle factors of habitual smoking, exercise and healthy eating participation. Secondary outcomes of interest include health related quality of life as measured by the Hospital Anxiety and Depression Scale, the Stroke Specific Quality of Life scale and WONCA COOP Functional Health Status charts and cardiovascular fitness as measured by a sub-maximal fitness test. A total of 144 patients, over 18 years of age with confirmed diagnosis of ischaemic stroke or TIA, will be recruited from Dublin community stroke services and two tertiary T.I.A clinics. Exclusion criteria will include oxygen dependence, unstable cardiac conditions, uncontrolled diabetes, major medical conditions, claudication, febrile illness, pregnancy or cognitive impairment. Participants will be block-statified, randomly allocated to one of two groups using a pre-prepared computer generated randomisation schedule. Both groups will receive a two hour education class on risk reduction post stroke. The

  18. Effectiveness of topiramate for tobacco dependence in patients with depression; a randomised, controlled trial

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    Alda Marta

    2008-05-01

    Full Text Available Abstract Background Tobacco dependence management is a multi-component intervention that includes pharmacological treatments such as Nicotine Substitution Therapy (NST or bupropion, and psychological therapy. There are some preliminary reports on topiramate efficacy for tobacco dependence. The aim of this study is to determine whether topiramate is as effective as the standard NST treatment for tobacco cessation at 1-year follow-up in patients with depression. Method/design Design: A randomised, controlled trial involving two groups, one of which is the control group consisting of patients on the standard pharmacological treatment for tobacco cessation (NST and the other is the intervention group consisting of patients on topiramate as pharmacological treatment. Setting: 29 primary care health centres in the city of Zaragoza, Spain. Sample: 180 patients, aged 18–65 years, diagnosed with major depression, smoke more than 20 cigarettes/day, who have voluntarily asked for tobacco cessation therapy. Intervention: A multi-component programme for tobacco cessation is offered to all of the patients in the study. This programme is made up of pharmacological therapy + group cognitive-behavioural therapy. Pharmacological therapy consists of NST for the control group and topiramate (200 mg/day for the intervention group. Psychological therapy is made up of 16 sessions of manualised group therapy. Measurements: Cessation will be assessed by patient self-declared abstinence, expired air carbon monoxide levels, and cotinine levels in saliva. Questionnaires on tobacco dependence, anxiety, depression, impulsiveness and self-efficacy will be administered. The interviewers will not know which group the patient belongs to (blind. The assessments will be carried out at baseline, D (cessation day -1, D+1, weeks 1, 2, 3, 4, 6, 8, 10 and 13, and months 4, 5, 6, 8, 10 and 12. Main variables: Tobacco cessation rates and tobacco dependence. Analysis: The analysis will

  19. A randomised controlled trial of a smoking cessation intervention delivered by dental hygienists: a feasibility study

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    Jenkins William

    2007-05-01

    Full Text Available Abstract Background Tobacco use continues to be a global public health problem. Helping patients to quit is part of the preventive role of all health professionals. There is now increasing interest in the role that the dental team can play in helping their patients to quit smoking. The aim of this study was to determine the feasibility of undertaking a randomised controlled smoking cessation intervention, utilising dental hygienists to deliver tobacco cessation advice to a cohort of periodontal patients. Methods One hundred and eighteen patients who attended consultant clinics in an outpatient dental hospital department (Periodontology were recruited into a trial. Data were available for 116 participants, 59 intervention and 57 control, and were analysed on an intention-to-treat basis. The intervention group received smoking cessation advice based on the 5As (ask, advise, assess, assist, arrange follow-up and were offered nicotine replacement therapy (NRT, whereas the control group received 'usual care'. Outcome measures included self-reported smoking cessation, verified by salivary cotinine measurement and CO measurements. Self-reported measures in those trial participants who did not quit included number and length of quit attempts and reduction in smoking. Results At 3 months, 9/59 (15% of the intervention group had quit compared to 5/57 (9% of the controls. At 6 months, 6/59 (10% of the intervention group quit compared to 3/57 (5% of the controls. At one year, there were 4/59 (7% intervention quitters, compared to 2/59 (4% control quitters. In participants who described themselves as smokers, at 3 and 6 months, a statistically higher percentage of intervention participants reported that they had had a quit attempt of at least one week in the preceding 3 months (37% and 47%, for the intervention group respectively, compared with 18% and 16% for the control group. Conclusion This study has shown the potential that trained dental hygienists

  20. Implementing referral guidelines: lessons from a negative outcome cluster randomised factorial trial in general practice

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    Shaw Lindsey

    2006-11-01

    Full Text Available Abstract Background Few patients with lower bowel symptoms who consult their general practitioner need a specialist opinion. However data from referred patients suggest that those who are referred would benefit from detailed assessment before referral. Methods A cluster randomised factorial trial. 44 general practices in North Trent, UK. Practices were offered either an electronic interactive referral pro forma, an educational outreach visit by a local colorectal surgeon, both or neither. The main outcome measure was the proportion of cases with severe diverticular disease, cancer or precancerous lesions and inflammatory bowel disease in those referred by each group. A secondary outcome was a referral letter quality score. Semi-structured interviews were conducted to identify key themes relating to the use of the software Results From 150 invitations, 44 practices were recruited with a total list size of 265,707. There were 716 consecutive referrals recorded over a six-month period, for which a diagnosis was available for 514. In the combined software arms 14% (37/261 had significant pathology, compared with 19% (49/253 in the non-software arms, relative risk 0.73 (95% CI: 0.46 to 1.15. In the combined educational outreach arms 15% (38/258 had significant pathology compared with 19% (48/256 in the non-educational arms, relative risk 0.79 (95% CI: 0.50 to 1.24. Pro forma practices documented better assessment of patients at referral. Conclusion There was a lack of evidence that either intervention increased the proportion of patients with organic pathology among those referred. The interactive software did improve the amount of information relayed in referral letters although we were unable to confirm if this made a significant difference to patients or their health care providers. The potential value of either intervention may have been diminished by their limited uptake within the context of a cluster randomised clinical trial. A number of

  1. Consequences from use of reminiscence - a randomised intervention study in ten Danish nursing homes

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    Sørensen Jan

    2010-06-01

    Full Text Available Abstract Background Reminiscence is the systematic use of memories and recollections to strengthen self-identity and self-worth. The study aim was to investigate the consequences for nursing home residents and staff of integrating reminiscence into daily nursing care. Methods In this randomised study, ten nursing homes were matched into two groups on the basis of location, type and size. In the period August 2006 - August 2007, staff in the Intervention Group were trained and supported in the use of reminiscence, involving individual and group sessions with residents as well as reminiscence boxes, posters and exhibitions. At baseline and again 6 and 12 months after the intervention start, data were collected on residents' cognitive level, agitated behaviour, general functioning and proxy-assessed quality of life, as well as on staff well-being and job satisfaction. Mixed linear modelling was used to analyse differences in outcome between the intervention and control groups. Results Project drop-out rates were 32% for residents and 38% for nursing staff. Most staff in the Intervention Group considered reminiscence a useful tool that improved their communication with residents, and that they would recommend to other nursing homes. There were no significant differences between residents in the Intervention and the Control Group in cognitive level, agitated behaviour or general functioning. Residents in the Intervention Group showed significant higher score at 6 months in quality of life subscale 'Response to surroundings', but there was no significant difference at 12 months. Positive effects of reminiscence were observed for all staff outcome measures, the only exception being SF-12 self-rated physical health. At 6 months after start of reminiscence, staff in the Intervention Group had significantly better scores than those in the Control Group for Personal accomplishment, Emotional exhaustion, Depersonalisation, 'Attitude towards individual

  2. Pharmacists’ response to anaphylaxis in the community (PRAC): a randomised, simulated patient study of pharmacist practice

    Science.gov (United States)

    Salter, Sandra M; Delfante, Brock; de Klerk, Sarah; Sanfilippo, Frank M; Clifford, Rhonda M

    2014-01-01

    Objective To evaluate how community pharmacists manage patients with anaphylaxis. Design A randomised, cross-sectional, simulated patient study of community pharmacist practice. Setting 300 metropolitan pharmacies located in Perth Australia, randomised to three groups of 100 pharmacies. Each group corresponded to a different epinephrine autoinjector: original EpiPen, new-look EpiPen or Anapen. Participants 300 pharmacies were visited with 271 simulated patient visits included in the final analysis (88=original EpiPen, 92=new-look EpiPen, 91=Anapen). Outcome measures Primary anaphylaxis preparedness (readiness to treat acute anaphylaxis). Secondary anaphylaxis engagement (willingness to engage the patient in a discussion about their anaphylaxis). Methods Simulated patients approached pharmacists, using a standardised scenario, for assistance with epinephrine autoinjector use and advice about the use of antihistamines in anaphylaxis. Scores for each outcome were obtained based on the number of predefined statements addressed by the pharmacist during the consultation (maximum score=5 for preparedness and 8 for engagement). Results The mean anaphylaxis preparedness score was 2.39 points (SD 1.17). Scores for new-look EpiPen were significantly higher than for original EpiPen and Anapen (2.75 vs 2.38 points, p=0.027; 2.75 vs 2.03 points, pEpiPen were similar to original EpiPen and Anapen (3.11 vs 3.32 points; 3.11 vs 2.90 points, both p=0.42). Engagement was associated with preparedness. For each additional engagement point, preparedness increased by 7% (0.357 points; 95% CI 0.291 to 0.424; p<0.001). Conclusions Pharmacists demonstrated reasonable knowledge of anaphylaxis symptoms and emergency care, but had poor epinephrine autoinjector technique and rarely discussed anaphylaxis action plans. Pharmacists who had a more comprehensive discussion about anaphylaxis with patients, were more prepared for anaphylaxis emergencies. Future research should evaluate the nature and

  3. Pralidoxime in acute organophosphorus insecticide poisoning--a randomised controlled trial.

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    Michael Eddleston

    2009-06-01

    Full Text Available BACKGROUND: Poisoning with organophosphorus (OP insecticides is a major global public health problem, causing an estimated 200,000 deaths each year. Although the World Health Organization recommends use of pralidoxime, this antidote's effectiveness remains unclear. We aimed to determine whether the addition of pralidoxime chloride to atropine and supportive care offers benefit. METHODS AND FINDINGS: We performed a double-blind randomised placebo-controlled trial of pralidoxime chloride (2 g loading dose over 20 min, followed by a constant infusion of 0.5 g/h for up to 7 d versus saline in patients with organophosphorus insecticide self-poisoning. Mortality was the primary outcome; secondary outcomes included intubation, duration of intubation, and time to death. We measured baseline markers of exposure and pharmacodynamic markers of response to aid interpretation of clinical outcomes. Two hundred thirty-five patients were randomised to receive pralidoxime (121 or saline placebo (114. Pralidoxime produced substantial and moderate red cell acetylcholinesterase reactivation in patients poisoned by diethyl and dimethyl compounds, respectively. Mortality was nonsignificantly higher in patients receiving pralidoxime: 30/121 (24.8% receiving pralidoxime died, compared with 18/114 (15.8% receiving placebo (adjusted hazard ratio [HR] 1.69, 95% confidence interval [CI] 0.88-3.26, p = 0.12. Incorporating the baseline amount of acetylcholinesterase already aged and plasma OP concentration into the analysis increased the HR for patients receiving pralidoxime compared to placebo, further decreasing the likelihood that pralidoxime is beneficial. The need for intubation was similar in both groups (pralidoxime 26/121 [21.5%], placebo 24/114 [21.1%], adjusted HR 1.27 [95% CI 0.71-2.29]. To reduce confounding due to ingestion of different insecticides, we further analysed patients with confirmed chlorpyrifos or dimethoate poisoning alone, finding no evidence of

  4. Physical Activity during Cancer Treatment (PACT Study: design of a randomised clinical trial

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    de Wit G Ardine

    2010-06-01

    Full Text Available Abstract Background Fatigue is a major problem of cancer patients. Thirty percent of cancer survivors report serious fatigue three years after finishing treatment. There is evidence that physical exercise during cancer treatment reduces fatigue. This may also lead to an improvement of quality of life. Such findings may result in a decrease of healthcare related expenditures and societal costs due to sick leave. However, no studies are known that investigated these hypotheses. Therefore, the primary aim of our study is to assess the effect of exercise during cancer treatment on reducing complaints of fatigue and on reducing health service utilisation and sick leave. Methods/Design The Physical Activity during Cancer Treatment study is a multicentre randomised controlled trial in 150 breast and 150 colon cancer patients undergoing cancer treatment. Participants will be randomised to an exercise or a control group. In addition to the usual care, the exercise group will participate in an 18-week supervised group exercise programme. The control group will be asked to maintain their habitual physical activity pattern. Study endpoints will be assessed after 18 weeks (short term and after 9 months (long term. Validated questionnaires will be used. Primary outcome: fatigue (Multidimensional Fatigue Inventory and Fatigue Quality List and cost-effectiveness, health service utilisation and sick leave. Secondary outcome: health related quality of life (European Organisation Research and Treatment of Cancer-Quality of Life questionnaire-C30, Short Form 36 healthy survey, impact on functioning and autonomy (Impact on functioning and autonomy questionnaire, anxiety and depression (Hospital Anxiety and Depression Scale, physical fitness (aerobic peak capacity, muscle strength, body composition and cognitive-behavioural aspects. To register health service utilisation and sick leave, participants will keep diaries including the EuroQuol-5D. Physical activity level

  5. Satisfaction of patients hospitalised in psychiatric hospitals: a randomised comparison of two psychiatric-specific and one generic satisfaction questionnaires

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    Cléopas Agatta

    2006-08-01

    Full Text Available Abstract Background While there is interest in measuring the satisfaction of patients discharged from psychiatric hospitals, it might be important to determine whether surveys of psychiatric patients should employ generic or psychiatry-specific instruments. The aim of this study was to compare two psychiatric-specific and one generic questionnaires assessing patients' satisfaction after a hospitalisation in a psychiatric hospital. Methods We randomised adult patients discharged from two Swiss psychiatric university hospitals between April and September 2004, to receive one of three instruments: the Saphora-Psy questionnaire, the Perceptions of Care survey questionnaire or the Picker Institute questionnaire for acute care hospitals. In addition to the comparison of response rates, completion time, mean number of missing items and mean ceiling effect, we targeted our comparison on patients and asked them to answer ten evaluation questions about the questionnaire they had just completed. Results 728 out of 1550 eligible patients (47% participated in the study. Across questionnaires, response rates were similar (Saphora-Psy: 48.5%, Perceptions of Care: 49.9%, Picker: 43.4%; P = 0.08, average completion time was lowest for the Perceptions of Care questionnaire (minutes: Saphora-Psy: 17.7, Perceptions of Care: 13.7, Picker: 17.5; P = 0.005, the Saphora-Psy questionnaire had the largest mean proportion of missing responses (Saphora-Psy: 7.1%, Perceptions of Care: 2.8%, Picker: 4.0%; P P Conclusion Despite differences in the intended target population, content, lay-out and length of questionnaires, none appeared to be obviously better based on our comparison. All three presented advantages and drawbacks and could be used for the satisfaction evaluation of psychiatric inpatients. However, if comparison across medical services or hospitals is desired, using a generic questionnaire might be advantageous.

  6. Prenatal Care

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    ... am thinking about getting pregnant. How can I take care of myself? You should start taking care of ... What should I do — or not do — to take care of myself and my unborn baby? Follow these ...

  7. Critical Care

    Science.gov (United States)

    Critical care helps people with life-threatening injuries and illnesses. It might treat problems such as complications from surgery, ... attention by a team of specially-trained health care providers. Critical care usually takes place in an ...

  8. Palliative Care

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    Palliative care is treatment of the discomfort, symptoms, and stress of serious illness. It provides relief from distressing symptoms ... of the medical treatments you're receiving. Hospice care, care at the end of life, always includes ...

  9. Self Care

    Science.gov (United States)

    ... Care Connections Experiences Research Learning Evaluation Print Email Self Care If you are living with a chronic ... help you cope can make a real difference. Self-care techniques are things you can do for ...

  10. Outpatient Foley catheter versus inpatient prostaglandin E2 gel for induction of labour: a randomised trial

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    Henry Amanda

    2013-01-01

    Full Text Available Abstract Background Induction of labour (IOL is one of the commonest obstetric interventions, with significant impact on both the individual woman and health service delivery. Outpatient IOL is an attractive option to reduce these impacts. To date there is little data comparing outpatient and inpatient IOL methods, and potential safety concerns (hyperstimulation if prostaglandins, the standard inpatient IOL medications, are used in the outpatient setting. The purpose of this study was to assess feasibility, clinical effectiveness and patient acceptability of outpatient Foley catheter (OPC vs. inpatient vaginal PGE2 (IP for induction of labour (IOL at term. Methods Women with an unfavourable cervix requiring IOL at term (N = 101 were randomised to outpatient care using Foley catheter (OPC, n = 50 or inpatient care using vaginal PGE2 (IP, n = 51. OPC group had Foley catheter inserted and were discharged overnight following a reassuring cardiotocograph. IP group received 2 mg/1 mg vaginal PGE2 if nulliparous or 1 mg/1 mg if multiparous. Main outcome measures were inpatient stay (prior to birth, in Birthing Unit, total, mode of birth, induction to delivery interval, adverse reactions and patient satisfaction. Results OPC group had shorter hospital stay prior to birth (21.3 vs. 32.4 hrs, p  Conclusions OPC was feasible and acceptable for IOL of women with an unfavourable cervix at term compared to IP, however did not show a statistically significant reduction in total inpatient stay and was associated with increased oxytocin IOL. Trial registration Australian New Zealand Clinical Trials Registry, ACTRN:12609000420246.

  11. Cost-effectiveness modelling of telehealth for patients with raised cardiovascular disease risk: evidence from a cohort simulation conducted alongside the Healthlines randomised controlled trial

    Science.gov (United States)

    Dixon, Padraig; Ara, Roberta; Edwards, Louisa; Foster, Alexis

    2016-01-01

    Objectives To investigate the long-term cost-effectiveness (measured as the ratio of incremental NHS cost to incremental quality-adjusted life years) of a telehealth intervention for patients with raised cardiovascular disease (CVD) risk. Design A cohort simulation model developed as part of the economic evaluation conducted alongside the Healthlines randomised controlled trial. Setting Patients recruited through primary care, and intervention delivered via telehealth service. Participants Participants with a 10-year CVD risk ≥20%, as measured by the QRISK2 algorithm, and with at least 1 modifiable risk factor, individually randomised from 42 general practices in England. Intervention A telehealth service delivered over a 12-month period. The intervention involved a series of responsive, theory-led encounters between patients and trained health information advisors who provided access to information resources and supported medication adherence and coordination of care. Primary and secondary outcome measures Cost-effectiveness measured by net monetary benefit over the simulated lifetime of trial participants from a UK National Health Service perspective. Results The probability that the intervention was cost-effective depended on the duration of the effect of the intervention. The intervention was cost-effective with high probability if effects persisted over the lifetime of intervention recipients. The probability of cost-effectiveness was lower for shorter durations of effect. Conclusions The intervention was likely to be cost-effective under a lifetime perspective. Trial registration number ISRCTN27508731; Results. PMID:27670521

  12. The IDEAL study: investigation of dietary advice and lifestyle for women with borderline gestational diabetes: a randomised controlled trial - study protocol

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    Crowther Caroline A

    2012-10-01

    Full Text Available Abstract Background The Australian Carbohydrate Intolerance Study in Pregnant Women (ACHOIS showed that treatment of pregnant women with mild gestational diabetes mellitus is beneficial for both women and their infants. It is still uncertain whether there are benefits of similar treatment for women with borderline gestational diabetes. This trial aims to assess whether dietary and lifestyle advice and treatment given to pregnant women who screen for borderline gestational diabetes reduces neonatal complications and maternal morbidities. Methods/design Design: Multicentre, randomised controlled trial. Inclusion criteria: Women between 240 and 346 weeks gestation with a singleton pregnancy, a positive oral glucose challenge test (venous plasma glucose ≥7.8 mmol/L and a normal oral 75 gram glucose tolerance test (fasting venous plasma glucose Trial entry and randomisation: Women with an abnormal oral glucose tolerance test (fasting venous plasma glucose ≥5.5 mmol/L or 2 hour glucose ≥7.8 mmol/L will not be eligible and will be offered treatment for gestational diabetes, consistent with recommendations based on results of the ACHOIS trial. Eligible women will be randomised into either the ‘Routine Care Group’ or the ‘Intervention Group’. Study groups: Women in the ‘Routine Care Group’ will receive routine obstetric care reflecting current clinical practice in Australian hospitals. Women in the ‘Intervention Group’ will receive obstetric care, which will include dietary and lifestyle advice, monitoring of blood glucose and further medical treatment for hyperglycaemia as appropriate. Primary study outcome: Incidence of large for gestational age infants. Sample size: A sample size of 682 women will be sufficient to show a 50% reduction in the risk of large for gestational age infants (alpha 0.05 two-tailed, 80% power, 4% loss to follow up from 14% to 7% with dietary and lifestyle advice and treatment. Discussion A conclusive trial

  13. Electronic voting to encourage interactive lectures: a randomised trial

    Science.gov (United States)

    2007-01-01

    Background Electronic Voting Systems have been used for education in a variety of disciplines. Outcomes from these studies have been mixed. Because results from these studies have been mixed, we examined whether an EVS system could enhance a lecture's effect on educational outcomes. Methods A cohort of 127 Year 5 medical students at the University of Adelaide was stratified by gender, residency status and academic record then randomised into 2 groups of 64 and 63 students. Each group received consecutive 40-minute lectures on two clinical topics. One group received the EVS for both topics. The other group received traditional teaching only. Evaluation was undertaken with two, 15-question multiple-choice questionnaires (MCQ) assessing knowledge and problem solving and undertaken as a written paper immediately before and after the lectures and repeated online 8–12 weeks later. Standardised institutional student questionnaires were completed for each lecture and independent observers assessed student behaviour during the lectures. Lecturer's opinions were assessed by a questionnaire developed for this study. Results Two-thirds of students randomised to EVS and 59% of students randomised to traditional lectures attended. One-half of the students in the EVS group and 41% in the traditional group completed all questionnaires. There was no difference in MCQ scores between EVS and traditional lectures (p = 0.785). The cervical cancer lectures showed higher student ranking in favour of EVS in all parameters. The breast cancer lectures showed higher ranking in favour of traditional lectures in 5 of 7 parameters (p lecturer-students interactions were increased in the EVS lecture for one lecturer and reduced for the other. Both lecturers felt that the EVS lectures were difficult to prepare, that they were able to keep to time in the traditional lectures, that the educational value of both lecture styles was similar, and that they were neutral-to-slightly favourably disposed

  14. Oral care in patients on mechanical ventilation in intensive care unit: literature review

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    Selma Atay

    2014-06-01

    Full Text Available intensive care patients needs to oral assessment and oral care for avoid complications caused by orafarengeal bacteria. In this literature review, it is aimed to determine the practice over oral hygiene in mechanical ventilator patients in intensive care unit. For the purpose of collecting data, Medline/pub MED and EBSCO HOST databases were searched with the keywords and lsquo;oral hygiene, oral hygiene practice, mouth care, mouth hygiene, intubated, mechanical ventilation, intensive care and critical care and rdquo; between the years of 2000- 2012. Inclusion criteria for the studies were being performed in adult intensive care unit patients on mechanical ventilation, published in peer-reviewed journals in English between the years of 2000-2012, included oral care practice and presence of a nurse among researchers. A total of 304 articles were identified. Six descriptive evaluation studies, three randomised controlled trials, four literature reviews, three meta-Analysis randomized clinical trials, one qualitative study and one semi-experimental study total 18 papers met all of the inclusion criteria. Oral care is emphasized as an infection control practice for the prevention of Ventilator-Associated Pneumonia (VAP. In conclusion, we mention that oral care is an important nursing practice to prevent VAP development in intensive care unit patients; however, there is no standard oral evaluation tool and no clarity on oral care practice frequency, appropriate solution and appropriate material. It can be recommended that the study projects on oral care in intensive care patients to have high proof level and be experimental, and longitudinal. [Int J Res Med Sci 2014; 2(3.000: 822-829

  15. Access to a polymerase chain reaction assay method targeting 13 respiratory viruses can reduce antibiotics: a randomised, controlled trial

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    Lindh Magnus

    2011-04-01

    Full Text Available Abstract Background Viral respiratory infections are common worldwide and range from completely benign disease to life-threatening illness. Symptoms can be unspecific, and an etiologic diagnosis is rarely established because of a lack of suitable diagnostic tools. Improper use of antibiotics is common in this setting, which is detrimental in light of the development of bacterial resistance. It has been suggested that the use of diagnostic tests could reduce antibiotic prescription rates. The objective of this study was to evaluate whether access to a multiplex polymerase chain reaction (PCR assay panel for etiologic diagnosis of acute respiratory tract infections (ARTIs would have an impact on antibiotic prescription rate in primary care clinical settings. Methods Adult patients with symptoms of ARTI were prospectively included. Nasopharyngeal and throat swabs were analysed by using a multiplex real-time PCR method targeting thirteen viruses and two bacteria. Patients were recruited at 12 outpatient units from October 2006 through April 2009, and samples were collected on the day of inclusion (initial visit and after 10 days (follow-up visit. Patients were randomised in an open-label treatment protocol to receive a rapid or delayed result (on the following day or after eight to twelve days. The primary outcome measure was the antibiotic prescription rate at the initial visit, and the secondary outcome was the total antibiotic prescription rate during the study period. Results A total sample of 447 patients was randomised. Forty-one were excluded, leaving 406 patients for analysis. In the group of patients randomised for a rapid result, 4.5% (9 of 202 of patients received antibiotics at the initial visit, compared to 12.3% (25 of 204 (P = 0.005 of patients in the delayed result group. At follow-up, there was no significant difference between the groups: 13.9% (28 of 202 in the rapid result group and 17.2% (35 of 204 in the delayed result group (P

  16. Study protocol for a pragmatic randomised controlled trial in general practice investigating the effectiveness of acupuncture against migraine

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    Carbrera-Iboleón Justo

    2008-04-01

    Full Text Available Abstract Background Migraine is a chronic neurologic disease that can severely affect the patient's quality of life. Although in recent years many randomised studies have been carried out to investigate the effectiveness of acupuncture as a treatment for migraine, it remains a controversial issue. Our aim is to determine whether acupuncture, applied under real conditions of clinical practice in the area of primary healthcare, is more effective than conventional treatment. Methods/Design The design consists of a pragmatic multi-centre, three-armed randomised controlled trial, complemented with an economic evaluation of the results achieved, comparing the effectiveness of verum acupuncture with sham acupuncture, and with a control group receiving normal care only. Patients eligible for inclusion will be those presenting in general practice with migraine and for whom their General Practitioner (GP is considering referral for acupuncture. Sampling will be by consecutive selection, and by randomised allocation to the three branches of the study, in a centralised way following a 1:1:1 distribution (verum acupuncture; sham acupuncture; conventional treatment. Secondly, one patient in three will be randomly selected from each of the acupuncture (verum or sham groups for a brain perfusion study (by single photon emission tomography. The treatment with verum acupuncture will consist of 8 treatment sessions, once a week, at points selected individually by the acupuncturist. The sham acupuncture group will receive 8 sessions, one per week, with treatment being applied at non-acupuncture points in the dorsal and lumbar regions, using the minimal puncture technique. The control group will be given conventional treatment, as will the other two groups. Discussion This trial will contribute to available evidence on acupuncture for the treatment of migraine. The primary endpoint is the difference in the number of days with migraine among the three groups, between

  17. Upper limb children action-observation training (UP-CAT: a randomised controlled trial in Hemiplegic Cerebral Palsy

    Directory of Open Access Journals (Sweden)

    Biagi Laura

    2011-06-01

    Full Text Available Abstract Background Rehabilitation for children with hemiplegic cerebral palsy (HCP aimed to improve function of the impaired upper limb (UL uses a wide range of intervention programs. A new rehabilitative approach, called Action-Observation Therapy, based on the recent discovery of mirror neurons, has been used in adult stroke but not in children. The purpose of the present study is to design a randomised controlled trial (RCT for evaluating the efficacy of Action-Observation Therapy in improving UL activity in children with HCP. Methods/Design The trial is designed according to CONSORT Statement. It is a randomised, evaluator-blinded, match-pair group trial. Children with HCP will be randomised within pairs to either experimental or control group. The experimental group will perform an Action-Observation Therapy, called UP-CAT (Upper Limb-Children Action-Observation Training in which they will watch video sequences showing goal-directed actions, chosen according to children UL functional level, combined with motor training with their hemiplegic UL. The control group will perform the same tailored actions after watching computer games. A careful revision of psychometric properties of UL outcome measures for children with hemiplegia was performed. Assisting Hand Assessment was chosen as primary measure and, based on its calculation power, a sample size of 12 matched pairs was established. Moreover, Melbourne and ABILHAND-Kids were included as secondary measures. The time line of assessments will be T0 (in the week preceding the onset of the treatment, T1 and T2 (in the week after the end of the treatment and 8 weeks later, respectively. A further assessment will be performed at T3 (24 weeks after T1, to evaluate the retention of effects. In a subgroup of children enrolled in both groups functional Magnetic Resonance Imaging, exploring the mirror system and sensory-motor function, will be performed at T0, T1 and T2. Discussion The paper aims to

  18. A randomised trial of lung sealant versus medical therapy for advanced emphysema

    OpenAIRE

    Come, Carolyn E.; Kramer, Mordechai R.; Dransfield, Mark T.; Abu-Hijleh, Muhanned; Berkowitz, David; Bezzi, Michela; Bhatt, Surya P; Boyd, Michael B.; Cases, Enrique; Chen, Alexander C.; Christopher B. Cooper; Flandes, Javier; Gildea, Thomas; Gotfried, Mark; Hogarth, D. Kyle

    2015-01-01

    Uncontrolled pilot studies demonstrated promising results of endoscopic lung volume reduction using emphysematous lung sealant (ELS) in patients with advanced, upper lobe predominant emphysema. We aimed to evaluate the safety and efficacy of ELS in a randomised controlled setting.

  19. A randomised controlled trial of azithromycin therapy in bronchiolitis obliterans syndrome (BOS) post lung transplantation

    OpenAIRE

    Corris, Paul A; Ryan, Victoria A; Small, Therese; Lordan, James; Fisher, Andrew J.; Meachery, Gerard; Johnson, Gail; Ward, Chris

    2015-01-01

    Background We conducted a placebo-controlled trial of azithromycin therapy in bronchiolitis obliterans syndrome (BOS) post lung transplantation. Methods We compared azithromycin (250 mg alternate days, 12 weeks) with placebo. Primary outcome was FEV1 change at 12 weeks. Results 48 patients were randomised; (25 azithromycin, 23 placebo). It was established, post randomisation that two did not have BOS. 46 patients were analysed as intention to treat (ITT) with 33 ‘Completers’. ITT analysis inc...

  20. Randomised comparison of silicone versus Teflon cannulas for peripheral intravenous nutrition.

    OpenAIRE

    Reynolds, J V; Walsh, K; Ruigrok, J; Hyland, J M

    1995-01-01

    The use of peripheral intravenous nutrition using standard Teflon cannulas is limited by a high incidence of thrombophlebitis, with resultant frequent line changes and compromised nutritional therapy. Fine-bore silicone catheters may reduce the incidence of thrombophlebitis; we prospectively compared the silicone catheter with a Teflon cannula in a randomised trial. Seventy-nine surgical patients were randomised to receive peripheral nutrition (10 g nitrogen; 1770 kcal; 650 mOsm/l) either via...

  1. A 2-year randomised placebo-controlled trial of doxycycline for lymphangioleiomyomatosis

    OpenAIRE

    Chang, William Y.C.; Cane, Jennifer L; Kumaran, Maruti; Lewis, Sarah; Tattersfield, Anne E.; Johnson, Simon R

    2014-01-01

    Lymphangioleiomyomatosis (LAM) is characterised by lung cysts and airflow obstruction. Matrix metalloproteinases have been implicated in lung destruction in LAM. We performed a randomised, double-blind trial, comparing the matrix metalloproteinases inhibitor doxycycline with placebo on the progression of LAM. 23 females with LAM were randomised to doxycycline 100 mg daily for 3 months followed by 200 mg daily for 21 months, or matched placebo. Lung function, exercise capacity, quality of...

  2. Evaluation of benefit to patients of training mental health professionals in suicide guidelines: cluster randomised trial.

    OpenAIRE

    Beurs, D.P. de; Groot, M.H. de; Keijser, J. de; Duijn, E. van; Winter, R.F.P. de; Kerkhof, A.J.F.M.

    2015-01-01

    Background: Randomised studies examining the effect on patients of training professionals in adherence to suicide guidelines are scarce. Aims: To assess whether patients benefited from the training of professionals in adherence to suicide guidelines. Method: In total 45 psychiatric departments were randomised (Dutch trial register: NTR3092). In the intervention condition, all staff in the departments were trained with an e-learning supported train-the-trainer programme. After the intervention...

  3. Homoeopathy for delayed onset muscle soreness: a randomised double blind placebo controlled trial.

    OpenAIRE

    Vickers, A J; Fisher, P.; Smith, C.; Wyllie, S E; Lewith, G T

    1997-01-01

    OBJECTIVE: To pilot a model for determining whether a homoeopathic medicine is superior to placebo for delayed onset muscle soreness (DOMS). DESIGN: Randomised double blind placebo controlled trial. SETTING: Physiotherapy department of a homoeopathic hospital. SUBJECTS: Sixty eight healthy volunteers (average age 30; 41% men) undertook a 10 minute period of bench stepping carrying a small weight and were randomised to a homoeopathic medicine or placebo. OUTCOME MEASURES: Mean muscle soreness ...

  4. Developing, delivering and documenting rehabilitation in a multi-centre randomised controlled surgical trial

    OpenAIRE

    Handoll, H. H. G.; Goodchild, L; Brealey, S. D.; Hanchard, N. C. A.; Jefferson, L.; Keding, A; Rangan, A.

    2014-01-01

    Objectives A rigorous approach to developing, delivering and documenting rehabilitation within randomised controlled trials of surgical interventions is required to underpin the generation of reliable and usable evidence. This article describes the key processes used to ensure provision of good quality and comparable rehabilitation to all participants of a multi-centre randomised controlled trial comparing surgery with conservative treatment of proximal humeral fractures in adults. Methods Th...

  5. Maximising the impact of qualitative research in feasibility studies for randomised controlled trials: guidance for researchers

    OpenAIRE

    O’Cathain, A.; Hoddinott, P.; Lewin, S; Thomas, K J; Young, B; Adamson, J.; Jansen, J.F.M.; Mills, N; Moore, G.; Donovan, J.L.

    2015-01-01

    Feasibility studies are increasingly undertaken in preparation for randomised controlled trials in order to explore uncertainties and enable trialists to optimise the intervention or the conduct of the trial. Qualitative research can be used to examine and address key uncertainties prior to a full trial. We present guidance that researchers, research funders and reviewers may wish to consider when assessing or undertaking qualitative research within feasibility studies for randomised controll...

  6. The gastrointestinal toxicity of aspirin: an overview of randomised controlled trials.

    OpenAIRE

    Roderick, P. J.; Wilkes, H C; Meade, T W

    1993-01-01

    The proven benefit of aspirin in the secondary prevention of cardiovascular disease and its possible value in primary prevention must be weighted against its potential hazards. This paper is an overview of the gastrointestinal toxicity of aspirin, its most serious complication after intracerebral haemorrhage. Information on toxicity has been drawn only from randomised trials, thus avoiding the potential biases of observational studies. All randomised placebo controlled trials listed in the An...

  7. A randomised controlled trial on hypnotherapy for irritable bowel syndrome: design and methodological challenges (the IMAGINE study

    Directory of Open Access Journals (Sweden)

    Flik Carla E

    2011-12-01

    Full Text Available Abstract Background Irritable Bowel Syndrome (IBS is a common gastro-intestinal disorder in primary and secondary care, characterised by abdominal pain, discomfort, altered bowel habits and/or symptoms of bloating and distension. In general the efficacy of drug therapies is poor. Hypnotherapy as well as Cognitive Behaviour Therapy and short Psychodynamic Therapy appear to be useful options for patients with refractory IBS in secondary care and are cost-effective, but the evidence is still limited. The IMAGINE-study is therefore designed to assess the overall benefit of hypnotherapy in IBS as well as comparing the efficacy of individual versus group hypnotherapy in treating this condition. Methods/Design The design is a randomised placebo-controlled trial. The study group consists of 354 primary care and secondary care patients (aged 18-65 with IBS (Rome-III criteria. Patients will be randomly allocated to either 6 sessions of individual hypnotherapy, 6 sessions of group hypnotherapy or 6 sessions of educational supportive therapy in a group (placebo, with a follow up of 9 months post treatment for all patients. Ten hospitals and four primary care psychological practices in different parts of The Netherlands will collaborate in this study. The primary efficacy parameter is the responder rate for adequate relief of IBS symptoms. Secondary efficacy parameters are changes in the IBS symptom severity, quality of life, cognitions, psychological complaints, self-efficacy as well as direct and indirect costs of the condition. Hypnotherapy is expected to be more effective than the control therapy, and group hypnotherapy is expected not to be inferior to individual hypnotherapy. Discussion If hypnotherapy is effective and if there is no difference in efficacy between individual and group hypnotherapy, this group form of treatment could be offered to more IBS patients, at lower costs. Trial registration number ISRCTN: ISRCTN22888906

  8. Randomised controlled trial of a supervised exercise rehabilitation program for colorectal cancer survivors immediately after chemotherapy: study protocol

    Directory of Open Access Journals (Sweden)

    Eakin Elizabeth G

    2007-08-01

    Full Text Available Abstract Background Colorectal cancer (CRC diagnosis and the ensuing treatments can have a substantial impact on the physical and psychological health of survivors. As the number of CRC survivors increases, so too does the need to develop viable rehabilitation programs to help these survivors return to good health as quickly as possible. Exercise has the potential to address many of the adverse effects of CRC treatment; however, to date, the role of exercise in the rehabilitation of cancer patients immediately after the completion of treatment has received limited research attention. This paper presents the design of a randomised controlled trial which will evaluate the feasibility and efficacy of a 12-week supervised aerobic exercise program (ImPACT Program on the physiological and psychological markers of rehabilitation, in addition to biomarkers of standard haematological outcomes and the IGF axis. Methods/Design Forty CRC patients will be recruited through oncology clinics and randomised to an exercise group or a usual care control group. Baseline assessment will take place within 4 weeks of the patient completing adjuvant chemotherapy treatment. The exercise program for patients in the intervention group will commence a week after the baseline assessment. The program consists of three supervised moderate-intensity aerobic exercise sessions per week for 12 weeks. All participants will have assessments at baseline (0 wks, mid-intervention (6 wks, post-intervention (12 wks and at a 6-week follow-up (18 wks. Outcome measures include cardio-respiratory fitness, biomarkers associated with health and survival, and indices of fatigue and quality of life. Process measures are participants' acceptability of, adherence to, and compliance with the exercise program, in addition to the safety of the program. Discussion The results of this study will provide valuable insight into the role of supervised exercise in improving life after CRC. Additionally

  9. PACE - The first placebo controlled trial of paracetamol for acute low back pain: design of a randomised controlled trial

    Science.gov (United States)

    2010-01-01

    Background Clinical practice guidelines recommend that the initial treatment of acute low back pain (LBP) should consist of advice to stay active and regular simple analgesics such as paracetamol 4 g daily. Despite this recommendation in all international LBP guidelines there are no placebo controlled trials assessing the efficacy of paracetamol for LBP at any dose or dose regimen. This study aims to determine whether 4 g of paracetamol daily (in divided doses) results in a more rapid recovery from acute LBP than placebo. A secondary aim is to determine if ingesting paracetamol in a time-contingent manner is more effective than paracetamol taken when required (PRN) for recovery from acute LBP. Methods/Design The study is a randomised double dummy placebo controlled trial. 1650 care seeking people with significant acute LBP will be recruited. All participants will receive advice to stay active and will be randomised to 1 of 3 treatment groups: time-contingent paracetamol dose regimen (plus placebo PRN paracetamol), PRN paracetamol (plus placebo time-contingent paracetamol) or a double placebo study arm. The primary outcome will be time (days) to recovery from pain recorded in a daily pain diary. Other outcomes will be pain intensity, disability, function, global perceived effect and sleep quality, captured at baseline and at weeks 1, 2, 4 and 12 by an assessor blind to treatment allocation. An economic analysis will be conducted to determine the cost-effectiveness of treatment from the health sector and societal perspectives. Discussion The successful completion of the trial will provide the first high quality evidence on the effectiveness of the use of paracetamol, a guideline endorsed treatment for acute LBP. Trail registration ACTRN12609000966291. PMID:20650012

  10. PACE - The first placebo controlled trial of paracetamol for acute low back pain: design of a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Day Richard O

    2010-07-01

    Full Text Available Abstract Background Clinical practice guidelines recommend that the initial treatment of acute low back pain (LBP should consist of advice to stay active and regular simple analgesics such as paracetamol 4 g daily. Despite this recommendation in all international LBP guidelines there are no placebo controlled trials assessing the efficacy of paracetamol for LBP at any dose or dose regimen. This study aims to determine whether 4 g of paracetamol daily (in divided doses results in a more rapid recovery from acute LBP than placebo. A secondary aim is to determine if ingesting paracetamol in a time-contingent manner is more effective than paracetamol taken when required (PRN for recovery from acute LBP. Methods/Design The study is a randomised double dummy placebo controlled trial. 1650 care seeking people with significant acute LBP will be recruited. All participants will receive advice to stay active and will be randomised to 1 of 3 treatment groups: time-contingent paracetamol dose regimen (plus placebo PRN paracetamol, PRN paracetamol (plus placebo time-contingent paracetamol or a double placebo study arm. The primary outcome will be time (days to recovery from pain recorded in a daily pain diary. Other outcomes will be pain intensity, disability, function, global perceived effect and sleep quality, captured at baseline and at weeks 1, 2, 4 and 12 by an assessor blind to treatment allocation. An economic analysis will be conducted to determine the cost-effectiveness of treatment from the health sector and societal perspectives. Discussion The successful completion of the trial will provide the first high quality evidence on the effectiveness of the use of paracetamol, a guideline endorsed treatment for acute LBP. Trail registration ACTRN12609000966291.

  11. Cognitive behaviour therapy (CBT for anxiety and depression in adults with mild intellectual disabilities (ID: a pilot randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Blizard Robert

    2011-04-01

    Full Text Available Abstract Background Several studies have showed that people with intellectual disabilities (ID have suitable skills to undergo cognitive behavioural therapy (CBT. Case studies have reported successful use of cognitive behavioural therapy techniques (with adaptations in people with ID. Modified cognitive behavioural therapy may be a feasible and effective approach for the treatment of depression, anxiety, and other mood disorders in ID. To date, two studies have reported group-based manaulised cognitive behavioural treatment programs for depression in people with mild ID. However, there is no individual manualised programme for anxiety or depression in people with intellectual disabilities. The aims of the study are to determine the feasibility of conducting a randomised controlled trial for CBT in people with ID. The data will inform the power calculation and other aspects of carrying out a definitive randomised controlled trial. Methods Thirty participants with mild ID will be allocated randomly to either CBT or treatment as usual (TAU. The CBT group will receive up to 20 hourly individual CBT over a period of 4 months. TAU is the standard treatment which is available to any adult with an intellectual disability who is referred to the intellectual disability service (including care management, community support, medical, nursing or social support. Beck Youth Inventories (Beck Anxiety Inventory & Beck Depression Inventory will be administered at baseline; end of treatment (4 months and at six months to evaluate the changes in depression and anxiety. Client satisfaction, quality of life and the health economics will be secondary outcomes. Discussion The broad outcome of the study will be to produce clear guidance for therapists to apply an established psychological intervention and identify how and whether it works with people with intellectual disabilities. Trial registration ISRCTN: ISRCTN38099525

  12. Splint: the efficacy of orthotic management in rest to prevent equinus in children with cerebral palsy, a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Maas Josina C

    2012-03-01

    Full Text Available Abstract Background Range of motion deficits of the lower extremity occur in about the half of the children with spastic cerebral palsy (CP. Over time, these impairments can cause joint deformities and deviations in the children's gait pattern, leading to limitations in moblity. Preventing a loss of range of motion is important in order to reduce secondary activity limitations and joint deformities. Sustained muscle stretch, imposed by orthotic management in rest, might be an effective method of preventing a decrease in range of motion. However, no controlled study has been performed. Methods A single blind randomised controlled trial will be performed in 66 children with spastic CP, divided over three groups with each 22 participants. Two groups will be treated for 1 year with orthoses to prevent a decrease in range of motion in the ankle (either with static or dynamic knee-ankle-foot-orthoses and a third group will be included as a control group and will receive usual care (physical therapy, manual stretching. Measurements will be performed at baseline and at 3, 6, 9 and 12 months after treatment allocation. The primary outcome measure will be ankle dorsiflexion at full knee extension, measured with a custom designed hand held dynamometer. Secondary outcome measures will be i ankle and knee flexion during gait and ii gross motor function. Furthermore, to gain more insight in the working mechanism of the orthotic management in rest, morphological parameters like achilles tendon length, muscle belly length, muscle fascicle length, muscle physiological cross sectional area length and fascicle pennation angle will be measured in a subgroup of 18 participants using a 3D imaging technique. Discussion This randomised controlled trial will provide more insight into the efficacy of orthotic management in rest and the working mechanisms behind this treatment. The results of this study could lead to improved treatments. Trial Registration Number

  13. Choosing a control intervention for a randomised clinical trial

    Directory of Open Access Journals (Sweden)

    Djulbegovic Benjamin

    2003-04-01

    Full Text Available Abstract Background Randomised controlled clinical trials are performed to resolve uncertainty concerning comparator interventions. Appropriate acknowledgment of uncertainty enables the concurrent achievement of two goals : the acquisition of valuable scientific knowledge and an optimum treatment choice for the patient-participant. The ethical recruitment of patients requires the presence of clinical equipoise. This involves the appropriate choice of a control intervention, particularly when unapproved drugs or innovative interventions are being evaluated. Discussion We argue that the choice of a control intervention should be supported by a systematic review of the relevant literature and, where necessary, solicitation of the informed beliefs of clinical experts through formal surveys and publication of the proposed trial's protocol. Summary When clinical equipoise is present, physicians may confidently propose trial enrollment to their eligible patients as an act of therapeutic beneficence.

  14. Bronchodilators for treatment of mild bronchiolitis: a factorial randomised trial.

    Science.gov (United States)

    Wang, E E; Milner, R; Allen, U; Maj, H

    1992-01-01

    A randomised double blind trial was conducted to determine the efficacy of inhaled bronchodilators, salbutamol and ipratropium bromide, compared with placebo in the treatment of bronchiolitis. Patients, who were 2 months to 2 years of age and without underlying cardiac or pulmonary disease, received drug 1 (salbutamol or saline placebo) followed one hour later by drug 2 (ipratropium bromide or placebo). Both agents were administered every four hours. The patients were allocated to one of four groups according to a factorial design. The four groups were similar in demographic characteristics, initial oxygenation, and clinical score. The change in oxygen saturation of recipients of both agents was significantly better than that of recipients of salbutamol alone or ipratropium bromide alone. This change, however, was not statistically different from that of the control group. No difference was observed in the clinical score or hospital duration. Inhaled bronchodilators did not improve the condition of hospitalised mild bronchiolitis. PMID:1533504

  15. Strengthening and stretching for rheumatoid arthritis of the hand (SARAH: design of a randomised controlled trial of a hand and upper limb exercise intervention - ISRCTN89936343

    Directory of Open Access Journals (Sweden)

    Adams Jo

    2012-11-01

    Full Text Available Abstract Background Rheumatoid Arthritis (RA commonly affects the hands and wrists with inflammation, deformity, pain, weakness and restricted mobility leading to reduced function. The effectiveness of exercise for RA hands is uncertain, although evidence from small scale studies is promising. The Strengthening And Stretching for Rheumatoid Arthritis of the Hand (SARAH trial is a pragmatic, multi-centre randomised controlled trial evaluating the clinical and cost effectiveness of adding an optimised exercise programme for hands and upper limbs to best practice usual care for patients with RA. Methods/design 480 participants with problematic RA hands will be recruited through 17 NHS trusts. Treatments will be provided by physiotherapists and occupational therapists. Participants will be individually randomised to receive either best practice usual care (joint protection advice, general exercise advice, functional splinting and assistive devices or best practice usual care supplemented with an individualised exercise programme of strengthening and stretching exercises. The study assessors will be blinded to treatment allocation and will follow participants up at four and 12 months. The primary outcome measure is the Hand function subscale of the Michigan Hand Outcome Questionnaire, and secondary outcomes include hand and wrist impairment measures, quality of life, and resource use. Economic and qualitative studies will also be carried out in parallel. Discussion This paper describes the design and development of a trial protocol of a complex intervention study based in therapy out-patient departments. The findings will provide evidence to support or refute the use of an optimised exercise programme for RA of the hand in addition to best practice usual care. Trial registration Current Controlled Trials ISRCTN89936343

  16. Statistical issues in randomised controlled trials: a narrative synthesis

    Institute of Scientific and Technical Information of China (English)

    Bolaji; Emmanuel; Egbewale

    2015-01-01

    Randomised controlled trials(RCTs) are gold standard in the evaluation of treatment efficacy in medical investigations, only if well designed and implemented. Till date, distorted views and misapplications of statistical procedures involved in RCTs are still in practice. Hence, clarification of concepts and acceptable practices related to certain statistical issues involved in the design, conduct and reporting of randomised controlled trials is needed. This narrative synthesis aimed at providing succinct but clear information on the concepts and practices of selected statistical issues in RCTs to inform correct applications. The use of tests of significance is no longer acceptable as means to compare baseline similarity between treatment groups and in determining which covariate(s) should be included in the model for adjustment. Distribution of baseline attributes simply presented in tabular form is however, rather preferred. Regarding covariate selection, such approach that makes use of information on the degree of correlation between the covariate(s) and the outcome variable is more in tandem with statistical principle(s) than that based on tests of significance. Stratification and minimisation are not alternatives to covariate adjusted analysis; in fact they establish the need for one. Intention-totreat is the preferred approach for the evaluation of primary outcome measures and researchers have responsibility to report whether or not the procedure was followed. A major use of results from subgroup analysis is to generate hypothesis for future clinical trials. Since RCTs are gold standard in the comparison of medical interventions, researchers cannot afford the practices of distorted allocation or statistical procedures in this all important experimental design method.

  17. Medical communication and technology: a video-based process study of the use of decision aids in primary care consultations

    OpenAIRE

    Graham Ruth; Murtagh Madeleine; Rapley Tim; Heaven Ben; Kaner Eileen; Thomson Richard; May Carl

    2007-01-01

    Abstract Background Much of the research on decision-making in health care has focused on consultation outcomes. Less is known about the process by which clinicians and patients come to a treatment decision. This study aimed to quantitatively describe the behaviour shown by doctors and patients during primary care consultations when three types of decision aids were used to promote treatment decision-making in a randomised controlled trial. Methods A video-based study set in an efficacy trial...

  18. More Than Needles: The Importance of Explanations and Self-Care Advice in Treating Primary Dysmenorrhea with Acupuncture

    OpenAIRE

    Michael Armour; Dahlen, Hannah G.; Smith, Caroline A.

    2016-01-01

    Background. Primary dysmenorrhea is a common gynaecological condition. Traditional Chinese medicine (TCM) acupuncturists commonly treat primary dysmenorrhea and dispense specific self-care advice for this condition. The impact of self-care advice on primary dysmenorrhea is unknown. Methods. 19 TCM acupuncture practitioners from New Zealand or Australia and 12 New Zealand women who had recently undergone acupuncture treatment for primary dysmenorrhea as part of a randomised controlled trial pa...

  19. Quality of care in for-profit and not-for-profit nursing homes: systematic review and meta-analysis

    OpenAIRE

    Comondore, Vikram R; Devereaux, P.J.; Zhou, Qi; Stone, Samuel B.; Busse, Jason W.; Ravindran, Nikila C; Karen E Burns; Haines, Ted; Stringer, Bernadette; Cook, Deborah J.; Walter, Stephen D.; Sullivan, Terrence; Berwanger, Otavio; Bhandari, Mohit; Banglawala, Sarfaraz

    2009-01-01

    Objective To compare quality of care in for-profit and not-for-profit nursing homes. Design Systematic review and meta-analysis of observational studies and randomised controlled trials investigating quality of care in for-profit versus not-for-profit nursing homes. Results A comprehensive search yielded 8827 citations, of which 956 were judged appropriate for full text review. Study characteristics and results of 82 articles that met inclusion criteria were summarised, and results for the fo...

  20. Randomised controlled trial of the effects of physical activity feedback on awareness and behaviour in UK adults: the FAB study protocol [ISRCTN92551397

    Directory of Open Access Journals (Sweden)

    Marteau Theresa

    2010-03-01

    Full Text Available Abstract Background While there are increasing data implicating poor recognition of physical inactivity as a potential barrier to healthy behaviour change, the efficacy of feedback to promote physical activity is uncertain. Using a randomised controlled trial nested within a population-based cohort study, we plan to test three variations of physical activity feedback against a control group. Our primary objective is to assess the efficacy of physical activity feedback in promoting physical activity behaviour change. Secondary objectives are to determine the influence of feedback on physical activity awareness and cognitions, and to compare behavioural effects by type of feedback. Methods/Design We aim to recruit 500 healthy participants aged 30 to 55 years from the ongoing Fenland Study (Cambridge, UK. Following careful phenotyping during baseline measurement (anthropometric, clinical, body composition and fitness measurements, as well as questionnaires assessing self-reported and self-rated physical activity, psychosocial correlates of physical activity behaviour, diet, lifestyle and general health, participants wear a combined heart rate and movement sensor (Actiheart® for six continuous days and nights. After receipt of the physical activity data (around 2 weeks later, participants are randomly allocated to either a control group (no feedback or one of three types of personalised physical activity feedback ('simple', 'visualised' or 'contextualised', and complete repeat measures of self-rated physical activity and psychosocial correlates. Approximately five weeks after receiving feedback, all participants wear the Actiheart® for another six-day follow-up period and complete repeat questionnaires. Values at outcome, adjusted for baseline, will be compared between randomised groups. Discussion Given the randomised trial design and use of objective measure of physical activity, this study is likely to provide valuable insights into the

  1. A Randomised Controlled Trial of Consent Procedures for the Use of Residual Tissues for Medical Research: Preferences of and Implications for Patients, Research and Clinical Practice

    Science.gov (United States)

    Rebers, S.; Vermeulen, E.; Brandenburg, A. P.; Stoof, T. J.; Zupan-Kajcovski, B.; Bos, W. J. W.; Jonker, M. J.; Bax, C. J.; van Driel, W. J.; Verwaal, V. J.; van den Brekel, M. W.; Grutters, J. C.; Tupker, R. A.; Plusjé, L.; de Bree, R.; Schagen van Leeuwen, J. H.; Vermeulen, E. G. J.; de Leeuw, R. A.; Brohet, R. M.; Aaronson, N. K.; Van Leeuwen, F. E.; Schmidt, M. K.

    2016-01-01

    Background Despite much debate, there is little evidence on consequences of consent procedures for residual tissue use. Here, we investigated these consequences for the availability of residual tissue for medical research, clinical practice, and patient informedness. Methods We conducted a randomised clinical trial with three arms in six hospitals. Participants, patients from whom tissue had been removed for diagnosis or treatment, were randomised to one of three arms: informed consent, an opt-out procedure with active information provision (opt-out plus), and an opt-out procedure without active information provision. Participants received a questionnaire six weeks post-intervention; a subsample of respondents was interviewed. Health care providers completed a pre- and post-intervention questionnaire. We assessed percentage of residual tissue samples available for medical research, and patient and health care provider satisfaction and preference. Health care providers and outcome assessors could not be blinded. Results We randomised 1,319 patients, 440 in the informed consent, 434 in the opt-out plus, and 445 in the opt-out arm; respectively 60.7%, 100%, and 99.8% of patients’ tissue samples could be used for medical research. Of the questionnaire respondents (N = 224, 207, and 214 in the informed consent, opt-out plus, and opt-out arms), 71%, 69%, and 31%, respectively, indicated being (very) well informed. By questionnaire, the majority (53%) indicated a preference for informed consent, whereas by interview, most indicated a preference for opt-out plus (37%). Health care providers (N = 35) were more likely to be (very) satisfied with opt-out plus than with informed consent (p = 0.002) or opt-out (p = 0.039); the majority (66%) preferred opt-out plus. Conclusion We conclude that opt-out with information (opt-out plus) is the best choice to balance the consequences for medical research, patients, and clinical practice, and is therefore the most optimal consent

  2. The effectiveness of the Austrian disease management programme for type 2 diabetes: a cluster-randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Klima Gert

    2010-11-01

    Full Text Available Abstract Background Disease management programmes (DMPs are costly and impose additional work load on general practitioners (GPs. Data on their effectiveness are inconclusive. We therefore conducted a cluster-randomised controlled trial to evaluate the effectiveness of the Austrian DMP for diabetes mellitus type 2 on HbA1c and quality of care for adult patients in primary care. Methods All GPs of Salzburg-province were invited to participate. After cluster-randomisation by district, all patients with diabetes type 2 were recruited consecutively from 7-11/2007. The DMP, consisting mainly of physician and patient education, standardised documentation and agreement on therapeutic goals, was implemented in the intervention group while the control group received usual care. We aimed to show superiority of the intervention regarding metabolic control and process quality. The primary outcome measure was a change in HbA1c after one year. Secondary outcomes were days in the hospital, blood pressure, lipids, body mass index (BMI, enrolment in patient education and regular guideline-adherent examination. Blinding was not possible. Results 92 physicians recruited 1489 patients (649 intervention, 840 control. After 401 ± 47 days, 590 intervention-patients and 754 controls had complete data. In the intention to treat analysis (ITT of all 1489 patients, HbA1c decreased 0.41% in the intervention group and 0.28% in controls. The difference of -0.13% (95% CI -0.24; -0.02 was significant at p = 0.026. Significance was lost in mixed models adjusted for baseline value and cluster-effects (adjusted mean difference -0.03 (95% CI -0.15; 0.09, p = 0.607. Of the secondary outcome measures, BMI and cholesterol were significantly reduced in the intervention group compared to controls in ITT after adjustments (-0.53 kg/m²; 95% CI -1.03;-0.02; p = 0.014 and -0.10 mmol/l; 95% CI -0.21; -0.003; p = 0.043. Additionally, more patients received patient education (49.5% vs. 20

  3. Acupuncture and Counselling for Depression in Primary Care: A Randomised Controlled Trial

    OpenAIRE

    Hugh MacPherson; Stewart Richmond; Martin Bland; Stephen Brealey; Rhian Gabe; Ann Hopton; Ada Keding; Harriet Lansdown; Sara Perren; Mark Sculpher; Eldon Spackman; David Torgerson; Ian Watt

    2013-01-01

    Editors' Summary Background Depression–overwhelming sadness and hopelessness–is responsible for a substantial proportion of the global disease burden and is a major cause of suicide. It affects more than 350 million people worldwide and about one in six people will have an episode of depression during their lifetime. Depression is different from everyday mood fluctuations. For people who are clinically depressed, feelings of severe sadness, anxiety, hopelessness, and worthlessness can last fo...

  4. A randomised controlled trial and cost-effectiveness analysis of high-frequency oscillatory ventilation against conventional artificial ventilation for adults with acute respiratory distress syndrome. The OSCAR (OSCillation in ARDS) study.

    Science.gov (United States)

    Lall, Ranjit; Hamilton, Patrick; Young, Duncan; Hulme, Claire; Hall, Peter; Shah, Sanjoy; MacKenzie, Iain; Tunnicliffe, William; Rowan, Kathy; Cuthbertson, Brian; McCabe, Chris; Lamb, Sallie

    2015-01-01

    BACKGROUND Patients with the acute respiratory distress syndrome (ARDS) require artificial ventilation but this treatment may produce secondary lung damage. High-frequency oscillatory ventilation (HFOV) may reduce this damage. OBJECTIVES To determine the clinical benefit and cost-effectiveness of HFOV in patients with ARDS compared with standard mechanical ventilation. DESIGN A parallel, randomised, unblinded clinical trial. SETTING UK intensive care units. PARTICIPANTS Mechanically ventilated patients with a partial pressure of oxygen in arterial blood/fractional concentration of inspired oxygen (P : F) ratio of 26.7 kPa (200 mmHg) or less and an expected duration of ventilation of at least 2 days at recruitment. INTERVENTIONS Treatment arm HFOV using a Novalung R100(®) ventilator (Metran Co. Ltd, Saitama, Japan) ventilator until the start of weaning. Control arm Conventional mechanical ventilation using the devices available in the participating centres. MAIN OUTCOME MEASURES The primary clinical outcome was all-cause mortality at 30 days after randomisation. The primary health economic outcome was the cost per quality-adjusted life-year (QALY) gained. RESULTS One hundred and sixty-six of 398 patients (41.7%) randomised to the HFOV group and 163 of 397 patients (41.1%) randomised to the conventional mechanical ventilation group died within 30 days of randomisation (p = 0.85), for an absolute difference of 0.6% [95% confidence interval (CI) -6.1% to 7.5%]. After adjustment for study centre, sex, Acute Physiology and Chronic Health Evaluation II score, and the initial P : F ratio, the odds ratio for survival in the conventional ventilation group was 1.03 (95% CI 0.75 to 1.40; p = 0.87 logistic regression). Survival analysis showed no difference in the probability of survival up to 12 months after randomisation. The average QALY at 1 year in the HFOV group was 0.302 compared to 0.246. This gives an incremental cost-effectiveness ratio (ICER) for the cost to

  5. Singing teaching as a therapy for chronic respiratory disease - a randomised controlled trial and qualitative evaluation

    Directory of Open Access Journals (Sweden)

    Kelly Julia L

    2010-08-01

    Full Text Available Abstract Background Despite optimal pharmacological therapy and pulmonary rehabilitation, patients with COPD continue to be breathless. There is a need to develop additional strategies to alleviate symptoms. Learning to sing requires control of breathing and posture and might have benefits that translate into daily life. Methods To test this hypothesis we performed a randomised controlled trial, comparing a six week course of twice weekly singing classes to usual care, in 28 COPD patients. The experience of singing was assessed in a qualitative fashion, through interviews with a psychologist. In addition, we surveyed patients with chronic respiratory conditions who participated in a series of open singing workshops. Results In the RCT, the physical component score of the SF36 improved in the singers (n = 15 compared to the controls (n = 13; +7.5(14.6 vs. -3.8(8.4 p = 0.02. Singers also had a significant fall in HAD anxiety score; -1.1(2.7 vs. +0.8(1.7 p = 0.03. Singing did not improve single breath counting, breath hold time or shuttle walk distance. In the qualitative element, 8 patients from the singing group were interviewed. Positive effects on physical sensation, general well-being, community/social support and achievement/efficacy emerged as common themes. 150 participants in open workshops completed a questionnaire. 96% rated the workshops as "very enjoyable" and 98% thought the workshop had taught them something about breathing in a different way. 81% of attendees felt a "marked physical difference" after the workshop. Conclusion Singing classes can improve quality of life measures and anxiety and are viewed as a very positive experience by patients with respiratory disease; no adverse consequences of participation were observed. Trial Registration Current Controlled Trials - ISRCTN17544114.

  6. Massage or music for pain relief in labour: a pilot randomised placebo controlled trial.

    Science.gov (United States)

    Kimber, L; McNabb, M; Mc Court, C; Haines, A; Brocklehurst, P

    2008-11-01

    Research on massage therapy for maternal pain and anxiety in labour is currently limited to four small trials. Each used different massage techniques, at different frequencies and durations, and relaxation techniques were included in three trials. Given the need to investigate massage interventions that complement maternal neurophysiological adaptations to labour and birth pain(s), we designed a pilot randomised controlled trial (RCT) to test the effects of a massage programme practised during physiological changes in pain threshold, from late pregnancy to birth, on women's reported pain, measured by a visual analogue scale (VAS) at 90 min following birth. To control for the potential bias of the possible effects of support offered within preparation for the intervention group, the study included 3 arms--intervention (massage programme with relaxation techniques), placebo (music with relaxation techniques) and control (usual care). The placebo offered a non-pharmacological coping strategy, to ensure that use of massage was the only difference between intervention and placebo groups. There was a trend towards slightly lower mean pain scores in the intervention group but these differences were not statistically significant. No differences were found in use of pharmacological analgesia, need for augmentation or mode of delivery. There was a trend towards more positive views of labour preparedness and sense of control in the intervention and placebo groups, compared with the control group. These findings suggest that regular massage with relaxation techniques from late pregnancy to birth is an acceptable coping strategy that merits a large trial with sufficient power to detect differences in reported pain as a primary outcome measure. PMID:18304848

  7. The benefits of exercise training in interstitial lung disease: protocol for a multicentre randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Dowman Leona

    2013-02-01

    Full Text Available Abstract Background Interstitial lung disease encompasses a diverse group of chronic lung conditions characterised by distressing dyspnoea, fatigue, reduced exercise tolerance and poor health-related quality of life. Exercise training is one of the few treatments to induce positive changes in exercise tolerance and symptoms, however there is marked variability in response. The aetiology and severity of interstitial lung disease may influence the response to treatment. The aims of this project are to establish the impact of exercise training across the range of disease severity and to identify whether there is an optimal time for patients with interstitial lung disease to receive exercise training. Methods/Design One hundred and sixteen participants with interstitial lung disease recruited from three tertiary institutions will be randomised to either an exercise training group (supervised exercise training twice weekly for eight weeks or a usual care group (weekly telephone support. The 6-minute walk distance, peripheral muscle strength, health-related quality of life, dyspnoea, anxiety and depression will be measured by a blinded assessor at baseline, immediately following the intervention and at six months following the intervention. The primary outcome will be change in 6-minute walk distance following the intervention, with planned subgroup analyses for participants with idiopathic pulmonary fibrosis, dust-related interstitial lung disease and connective-tissue related interstitial lung disease. The effects of disease severity on outcomes will be evaluated using important markers of disease severity and survival, such as forced vital capacity, carbon monoxide transfer factor and pulmonary hypertension. Discussion This trial will provide certainty regarding the role of exercise training in interstitial lung disease and will identify at what time point within the disease process this treatment is most effective. The results from this study will