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Sample records for care dicision randomised

  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

    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. Care practices are an inherent part of producing scientific facts but they are removed from the recognised results of scientific practice and thus from common public health recommendations. However, knowledge about the strategic use of care practices in lifestyle interventions is important for...

  2. Stepped care and cognitive–behavioural therapy for bulimia nervosa: randomised trial

    OpenAIRE

    Mitchell, James E; Agras, Stewart; Crow, Scott; Halmi, Katherine; Fairburn, Christopher G.; Bryson, Susan; Kraemer, Helena

    2011-01-01

    Background This study compared the best available treatment for bulimia nervosa, cognitive–behavioural therapy (CBT) augmented by fluoxetine if indicated, with a stepped-care treatment approach in order to enhance treatment effectiveness. Aims To establish the relative effectiveness of these two approaches. Method This was a randomised trial conducted at four clinical centres (Clinicaltrials.gov registration number: NCT00733525). A total of 293 participants with bulimia nervosa were randomise...

  3. Primary care referral to a commercial provider for weight loss treatment versus standard care: a randomised controlled trial

    OpenAIRE

    Jebb, Susan A.; Ahern, Amy L; Olson, Ashley D.; Aston, Louise M.; Holzapfel, Christina; Stoll, Julia; Amann-Gassner, Ulrike; Simpson, Annie E; Fuller, Nicholas R.; Pearson, Suzanne; Lau, Namson S; Mander, Adrian P; Hauner, Hans; Ian D. Caterson

    2011-01-01

    Summary Background The increasing prevalence of overweight and obesity needs effective approaches for weight loss in primary care and community settings. We compared weight loss with standard treatment in primary care with that achieved after referral by the primary care team to a commercial provider in the community. Methods In this parallel group, non-blinded, randomised controlled trial, 772 overweight and obese adults were recruited by primary care practices in Australia, Germany, and the...

  4. 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...

  5. 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...

  6. Effects of group prenatal care on psychosocial risk in pregnancy: Results from a randomised controlled trial

    OpenAIRE

    Ickovics, Jeannette R.; Reed, Elizabeth; Magriples, Urania; Westdahl, Claire; Rising, Sharon Schindler; Kershaw, Trace S.

    2011-01-01

    Few interventions have succeeded in reducing psychosocial risk among pregnant women. The objective of this study was to determine whether an integrated group prenatal care intervention already shown to improve perinatal and sexual risk outcomes can also improve psychosocial outcomes compared to standard individual care. This randomised controlled trial included pregnant women ages 14–25 from two public hospitals (N = 1047) who were randomly assigned to standard individual care, group prenatal...

  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. 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

  9. Effectiveness of dementia follow-up care by memory clinics or general practitioners: randomised controlled trial

    OpenAIRE

    2012-01-01

    Objective To examine the effectiveness of post-diagnosis dementia treatment and coordination of care by memory clinics compared with general practitioners. Design Multicentre randomised controlled trial. Setting Nine memory clinics and 159 general practitioners in the Netherlands. Participants 175 patients with a new diagnosis of mild to moderate dementia living in the community and their informal caregivers. Interventions Usual care provided by memory clinic or general practitioner. Main out...

  10. The demise of the randomised controlled trial: bibliometric study of the German-language health care literature, 1948 to 2004

    OpenAIRE

    Antes Gerd; Schwarzer Guido; Galandi Daniel

    2006-01-01

    Abstract Background In order to reduce systematic errors (such as language bias) and increase the precision of the summary treatment effect estimate, a comprehensive identification of randomised controlled trials (RCT), irrespective of publication language, is crucial in systematic reviews and meta-analyses. We identified trials in the German general health care literature. Methods Eight German language general health care journals were searched for randomised controlled trials and analysed w...

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

    OpenAIRE

    2000-01-01

    BACKGROUND: 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 involved in patient recruitment and to present measures to minimise bias during outcome assessment. METHOD: A recently conducted trial comparing the effects of corticosteroid injections and physiotherapy for painful stiff shoulder was used to i...

  12. Routine follow up of breast cancer in primary care: randomised trial.

    OpenAIRE

    Grunfeld, E.; Mant, D.; Yudkin, P; Adewuyi-Dalton, R; Cole, D; Stewart, J; Fitzpatrick, R.; Vessey, M.

    1996-01-01

    OBJECTIVE: To assess the effect on time to diagnosis of recurrence and on quality of life of transferring primary responsibility for follow up of women with breast cancer in remission from hospital to general practice. DESIGN: Randomised controlled trial with 18 month follow up in which women received routine follow up either in hospital or in general practice. SUBJECTS AND SETTING: 296 women with breast cancer in remission receiving regular follow up care at district general hospitals in Eng...

  13. 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.

  14. 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...

  15. 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.

  16. 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.

  17. The effectiveness of an aged care specific leadership and management program on workforce, work environment, and care quality outcomes: design of a cluster randomised controlled trial

    OpenAIRE

    Jeon, Yun-Hee; Simpson, Judy M; Chenoweth, Lynn; Cunich, Michelle; Kendig, Hal

    2013-01-01

    Background A plethora of observational evidence exists concerning the impact of management and leadership on workforce, work environment, and care quality. Yet, no randomised controlled trial has been conducted to test the effectiveness of leadership and management interventions in aged care. An innovative aged care clinical leadership program (Clinical Leadership in Aged Care − CLiAC) was developed to improve managers’ leadership capacities to support the delivery of quality care in Australi...

  18. 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...

  19. 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...

  20. 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...

  1. 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...

  2. 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

  3. 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...

  4. 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...

  5. 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...

  6. 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

  7. 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.

  8. A randomised controlled trial of caseload midwifery care: M@NGO (Midwives @ New Group practice Options

    Directory of Open Access Journals (Sweden)

    Tracy Sally K

    2011-10-01

    Full Text Available Abstract Background Australia has an enviable record of safety for women in childbirth. There is nevertheless growing concern at the increasing level of intervention and consequent morbidity amongst childbearing women. Not only do interventions impact on the cost of services, they carry with them the potential for serious morbidities for mother and infant. Models of midwifery have proliferated in an attempt to offer women less fragmented hospital care. One of these models that is gaining widespread consumer, disciplinary and political support is caseload midwifery care. Caseload midwives manage the care of approximately 35-40 a year within a small Midwifery Group Practice (usually 4-6 midwives who plan their on call and leave within the Group Practice. We propose to compare the outcomes and costs of caseload midwifery care compared to standard or routine hospital care through a randomised controlled trial. Methods/design A two-arm RCT design will be used. Women will be recruited from tertiary women's hospitals in Sydney and Brisbane, Australia. Women allocated to the caseload intervention will receive care from a named caseload midwife within a Midwifery Group Practice. Control women will be allocated to standard or routine hospital care. Women allocated to standard care will receive their care from hospital rostered midwives, public hospital obstetric care and community based general medical practitioner care. All midwives will collaborate with obstetricians and other health professionals as necessary according to the woman's needs. Discussion Data will be collected at recruitment, 36 weeks antenatally, six weeks and six months postpartum by web based or postal survey. With 750 women or more in each of the intervention and control arms the study is powered (based on 80% power; alpha 0.05 to detect a difference in caesarean section rates of 29.4 to 22.9%; instrumental birth rates from 11.0% to 6.8%; and rates of admission to neonatal intensive

  9. 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

  10. A cluster randomised controlled trial of educational prompts in diabetes care: study protocol

    Directory of Open Access Journals (Sweden)

    Hrisos Susan

    2007-07-01

    Full Text Available Abstract Background Laboratory services have a central role in supporting screening, diagnosis, and management of patients. The increase in chronic disease management in primary care for conditions such as diabetes mellitus requires regular monitoring of patients' biochemical parameters. This process offers a route for improving the quality of care that patients receive by using test results as a vehicle for delivering educational messages as well as the test result itself. Aim To develop and evaluate the effectiveness of a quality improvement initiative to improve the care of patients with diabetes using test report reminders. Design A programme of four cluster randomised controlled trials within one population of general practices. Participants General practices in Newcastle-upon-Tyne, UK. Intervention Brief educational messages added to paper and electronic general practice laboratory test reports introduced over two phases. Phase One messages, attached to Haemoglobin A1c (HbA1c reports, targeted glycaemic and cholesterol control. Phase Two messages, attached to albumin:creatinine ratio (ACR reports, targeted blood pressure (BP control and foot inspection. Outcomes General practice mean levels of HbA1c and cholesterol (Phase One and diastolic and systolic BP and proportions of patients having undergone foot inspections (Phase Two; number of tests requested. Trial registration Current Controlled Trial ISRCTN2186314.

  11. 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

  12. 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

  13. 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

  14. 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

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

    OpenAIRE

    McKenzie Joanne E; French Simon D; Page Matthew J; O'Connor Denise A; Green Sally E

    2011-01-01

    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 ...

  16. Effect of using protocols on medical care: randomised trial of three methods of taking an antenatal history.

    OpenAIRE

    Lilford, R J; Kelly, M; Baines, A.; Cameron, S.; Cave, M.; Guthrie, K.; Thornton, J

    1992-01-01

    OBJECTIVE--To compare the effectiveness of three methods of taking an antenatal history on the quality of obstetric care. DESIGN--Randomised controlled trial. SETTING--Antenatal clinic of St James's University Hospital, Leeds. SUBJECTS--2424 women attending the hospital for the first (booking) visit. INTERVENTIONS--Histories were taken by midwives using an unstructured paper questionnaire, a structured paper questionnaire (incorporating a checklist), or an interactive computerised questionnai...

  17. 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...

  18. A cluster randomised trial of educational messages to improve the primary care of diabetes

    Directory of Open Access Journals (Sweden)

    Foy Robbie

    2011-12-01

    Full Text Available Abstract Background Regular laboratory test monitoring of patient parameters offers a route for improving the quality of chronic disease care. We evaluated the effects of brief educational messages attached to laboratory test reports on diabetes care. Methods A programme of cluster randomised controlled trials was set in primary care practices in one primary care trust in England. Participants were the primary care practices' constituent healthcare professionals and patients with diabetes. Interventions comprised brief educational messages added to paper and electronic primary care practice laboratory test reports and introduced over two phases. Phase one messages, attached to Haemoglobin A1c (HbA1c reports, targeted glycaemic and cholesterol control. Phase two messages, attached to albumin:creatinine ratio (ACR reports, targeted blood pressure (BP control, and foot inspection. Main outcome measures comprised practice mean HbA1c and cholesterol levels, diastolic and systolic BP, and proportions of patients having undergone foot inspections. Results Initially, 35 out of 37 eligible practices participated. Outcome data were available for a total of 8,690 patients with diabetes from 32 practices. The BP message produced a statistically significant reduction in diastolic BP (-0.62 mmHg; 95% confidence interval -0.82 to -0.42 mmHg but not systolic BP (-0.06 mmHg, -0.42 to 0.30 mmHg and increased the odds of achieving target BP control (odds ratio 1.05; 1.00, 1.10. The foot inspection message increased the likelihood of a recorded foot inspection (incidence rate ratio 1.26; 1.18 to 1.36. The glycaemic control message had no effect on mean HbA1c (increase 0.01%; -0.03 to 0.04 despite increasing the odds of a change in likelihood of HbA1c tests being ordered (OR 1.06; 1.01, 1.11. The cholesterol message had no effect (decrease 0.01 mmol/l, -0.04 to 0.05. Conclusions Three out of four interventions improved intermediate outcomes or process of diabetes

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

    Directory of Open Access Journals (Sweden)

    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

  20. The effectiveness and cost-effectiveness of opportunistic screening and stepped care interventions for older hazardous alcohol users in primary care (AESOPS – A randomised control trial protocol

    Directory of Open Access Journals (Sweden)

    Morton Veronica

    2008-06-01

    Full Text Available Abstract Background There is a wealth of evidence regarding the detrimental impact of excessive alcohol consumption. In older populations excessive alcohol consumption is associated with increased risk of coronary heart disease, hypertension, stroke and a range of cancers. Alcohol consumption is also associated with an increased risk of falls, early onset of dementia and other cognitive deficits. Physiological changes that occur as part of the ageing process mean that older people experience alcohol related problems at lower consumption levels. There is a strong evidence base for the effectiveness of brief psychosocial interventions in reducing alcohol consumption in populations identified opportunistically in primary care settings. Stepped care interventions involve the delivery of more intensive interventions only to those in the population who fail to respond to less intensive interventions and provide a potentially resource efficient means of meeting the needs of this population. Methods/design The study design is a pragmatic prospective multi-centre two arm randomised controlled trial. The primary hypothesis is that stepped care interventions for older hazardous alcohol users reduce alcohol consumption compared with a minimal intervention at 12 months post randomisation. Potential participants are identified using the AUDIT questionnaire. Eligible and consenting participants are randomised with equal probability to either a minimal intervention or a three step treatment approach. The step treatment approach incorporates as step 1 behavioural change counselling, step 2 three sessions of motivational enhancement therapy and step 3 referral to specialist services. The primary outcome is measured using average standard drinks per day and secondary outcome measures include the Drinking Problems Index, health related quality of life and health utility. The study incorporates a comprehensive economic analysis to assess the relative cost

  1. 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

    , 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...... of their disease trajectory, is an important next step in an era of increased focus on patient centered healthcare and shared decision-making. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Number: ISRCTN63110516 . Date of registration: 10/3/2014....

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

    Directory of Open Access Journals (Sweden)

    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

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

    Directory of Open Access Journals (Sweden)

    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

  4. 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...

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

    Directory of Open Access Journals (Sweden)

    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

  6. 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

  7. 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...

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

    Directory of Open Access Journals (Sweden)

    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

  9. 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

    Directory of Open Access Journals (Sweden)

    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.

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

    Directory of Open Access Journals (Sweden)

    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

  11. 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

  12. 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...

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

    Directory of Open Access Journals (Sweden)

    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

  14. 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...

  15. 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

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

    Directory of Open Access Journals (Sweden)

    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

  17. 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...

  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. A randomised controlled trial to assess the effectiveness of a nurse-led palliative care intervention for HIV positive patients on antiretroviral therapy: recruitment, refusal, randomisation and missing data.

    OpenAIRE

    Lowther, K; Higginson, IJ; Simms, V.; Gikaara, N; Ahmed, A.; Ali, Z; Afuande, G; Kariuki, H; Sherr, L; Jenkins, R; Selman, L.; Harding, R

    2014-01-01

    Background Despite the life threatening nature of an HIV diagnosis and the multidimensional problems experienced by this patient population during antiretroviral therapy, the effectiveness of a palliative care approach for HIV positive patients on ART is as yet unknown. Findings A randomised controlled trial (RCT) was conducted in a sample of 120 HIV positive patients on ART in an urban clinic in Mombasa, Kenya. The intervention was a minimum of seven sessions of multidimensional, person-cent...

  1. 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...

  2. 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

  3. 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...

  4. A randomised controlled non-inferiority trial of primary care-based facilitated access to an alcohol reduction website (EFAR-FVG): the study protocol

    OpenAIRE

    Struzzo, P.; Scafato, E.; McGregor, R.; Della Vedova, R.; Verbano, L.; Lygidakis, C.; Tersar, C.; Crapesi, L.; Tubaro, G.; Freemantle, N; Wallace, P.

    2013-01-01

    Introduction There is a strong body of evidence demonstrating the effectiveness of brief interventions by primary care professionals for risky drinkers. However, implementation levels remain low because of time constraints and other factors. Facilitated access to an alcohol reduction website offers primary care professionals a time-saving alternative to standard face-to-face intervention, but it is not known whether it is as effective. Methods and analysis A randomised controlled non-inferior...

  5. 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...

  6. Cost-Effectiveness of One Year Dementia Follow-Up Care by Memory Clinics or General Practitioners: Economic Evaluation of a Randomised Controlled Trial

    OpenAIRE

    2013-01-01

    Objective To evaluate the cost-effectiveness of post-diagnosis dementia treatment and coordination of care by memory clinics compared to general practitioners’ care. Methods A multicentre randomised trial with 175 community dwelling patients newly diagnosed with mild to moderate dementia, and their informal caregivers, with twelve months’ follow-up. Cost-effectiveness was evaluated from a societal point of view and presented as incremental cost per quality adjusted life year. To establish cos...

  7. Effects of communication training with the MAAS-Global-D instrument on the antibiotic prescribing for respiratory infections in primary care: study protocol of a randomised controlled trial

    OpenAIRE

    Hammersen, Friederike; Goetz, Katja; Soennichsen, Andreas; Emcke, Timo; Steinhaeuser, Jost

    2016-01-01

    Background Primary care physicians account for the majority of antibiotic prescribing in ambulatory care in Germany. Respiratory diseases are, regardless of effectiveness, often treated with antibiotics. Research has found this use without indication to be caused largely by communication problems (e.g. expectations on the patient’s part or false assumptions about them by the physician). The present randomised controlled trial (RCT) study evaluates whether communication training for primary ca...

  8. 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 ...

  9. The outcome and cost-effectiveness of nurse-led care in people with rheumatoid arthritis: a multicentre randomised controlled trial

    OpenAIRE

    Ndosi , Mwidimi; Lewis, Martyn; Hale, Claire; Quinn, Helen; Ryan, Sarah; Emery, Paul; Bird, Howard; Hill, Jackie

    2013-01-01

    Objective To determine the clinical effectiveness and cost-effectiveness of nurse-led care (NLC) for people with rheumatoid arthritis (RA). Methods In a multicentre pragmatic randomised controlled trial, the assessment of clinical effects followed a non-inferiority design, while patient satisfaction and cost assessments followed a superiority design. Participants were 181 adults with RA randomly assigned to either NLC or rheumatologist-led care (RLC), both arms carrying out their normal pract...

  10. 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...

  11. 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...

  12. Stepped care for depression and anxiety in visually impaired older adults: multicentre randomised controlled trial

    OpenAIRE

    van der Aa, Hilde P. A.; van Rens, Ger H. M. B.; Comijs, Hannie C; Margrain, Tom H; Gallindo-Garre, Francisca; Twisk, Jos W. R.; van Nispen, Ruth M A

    2015-01-01

    Study question Is stepped care compared with usual care effective in preventing the onset of major depressive, dysthymic, and anxiety disorders in older people with visual impairment (caused mainly by age related eye disease) and subthreshold depression and/or anxiety? Methods 265 people aged ≥50 were randomly assigned to a stepped care programme plus usual care (n=131) or usual care only (n=134). Supervised occupational therapists, social workers, and psychologists from low vision rehabilita...

  13. 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.

  14. 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.

  15. 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 ...

  16. 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

  17. 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

  18. Randomised controlled trial of tailored interventions to improve the management of anxiety and depressive disorders in primary care

    Directory of Open Access Journals (Sweden)

    Terluin Berend

    2011-07-01

    Full Text Available Abstract Background Anxiety and depressive disorders are highly prevalent disorders and are mostly treated in primary care. The management of these disorders by general practitioners is not always consistent with prevailing guidelines because of a variety of factors. Designing implementation strategies tailored to prospectively identified barriers could lead to more guideline-recommended care. Although tailoring of implementation strategies is promoted in practice, little is known about the effect on improving the quality of care for the early recognition, diagnosis, and stepped care treatment allocation in patients with anxiety or depressive disorders in general practice. This study examines whether the tailored strategy supplemented with training and feedback is more effective than providing training and feedback alone. Methods In this cluster randomised controlled trial, a total of 22 general practices will be assigned to one of two conditions: (1 training, feedback, and tailored interventions and (2 training and feedback. The primary outcome measure is the proportion of patients who have been recognised to have anxiety and/or depressive disorder. The secondary outcome measures in patients are severity of anxiety and depressive symptoms, level of functioning, expectation towards and experience with care, quality of life, and economic costs. Measures are taken after the start of the intervention at baseline and at three- and six-month follow-ups. Secondary outcome measures in general practitioners are adherence to guideline-recommended care in care that has been delivered, the proportion of antidepressant prescriptions, and number of referrals to specialised mental healthcare facilities. Data will be gathered from the electronic medical patient records from the patients included in the study. In a process evaluation, the identification of barriers to change and the relations between prospectively identified barriers and improvement

  19. 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

  20. 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...

  1. Evaluation of an individualised programme to promote self-care in sleep-activity in patients with coronary artery disease - a randomised intervention study

    OpenAIRE

    Johansson, Anna; Adamson, Anita; Ejdeback, Jan; Edéll-Gustafsson, Ulla

    2014-01-01

    Aims and objectives. To evaluate the effectiveness of an individualised programme to promote self-care in sleep-activity in patients with coronary artery disease. Background. Recent scientific findings have shown that low physical exercise and stress interfere with coronary artery disease patients sleep quality and sleep efficiency independent of gender, age and co-morbidity. Design. A randomised pretest-post-test control design. Methods. Forty-seven patients who had undergone a coronary reva...

  2. E-health empowers patients with ulcerative colitis: a randomised controlled trial of the web-guided 'Constant-care' approach

    DEFF Research Database (Denmark)

    Elkjaer, Margarita; Shuhaibar, Mary; Burisch, Johan;

    2010-01-01

    The natural history of ulcerative colitis requires continuous monitoring of medical treatment via frequent outpatient visits. The European health authorities' focus on e-health is increasing. Lack of easy access to inflammatory bowel disease (IBD) clinics, patients' education and understanding of...... the importance of early treatment at relapse is leading to poor compliance. To overcome these limitations a randomised control trial 'Constant-care' was undertaken in Denmark and Ireland....

  3. A randomised translational trial of lifestyle intervention using a 3-tier shared care approach on pregnancy outcomes in Chinese women with gestational diabetes mellitus but without diabetes

    OpenAIRE

    Yang, Xilin; Tian, Huiguang; Zhang, Fuxia; Zhang, Cuiping; Li, Yi; Leng, Junhong; Wang, Leishen; Liu, Gongsu; Dong, Ling; Yu, Zhijie; Hu, Gang; Chan, Juliana CN

    2014-01-01

    Background There are no randomised controlled trials to demonstrate whether lifestyle modifications can improve pregnancy outcomes of gestational diabetes mellitus (GDM) diagnosed by the International Association of Diabetes and Pregnancy Study Group’s (IADPSG) criteria. We tested the effectiveness of lifestyle modifications implemented in a 3-tier’s shared care (SC) on pregnancy outcomes of GDM. Methods Between December 2010 and October 2012, we randomly assigned 700 women with IADPSG-define...

  4. 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...

  5. 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

  6. A randomised clinical trial of subgrouping and targeted treatment for low back pain compared with best current care. The STarT Back Trial Study Protocol

    Directory of Open Access Journals (Sweden)

    Vohora Kanchan

    2008-04-01

    Full Text Available Abstract Background Back pain is a major health problem and many sufferers develop persistent symptoms. Detecting relevant subgroups of patients with non-specific low back pain has been highlighted as a priority area for research, as this could enable better secondary prevention through the targeting of prognostic indicators for persistent, disabling symptoms. We plan to conduct a randomised controlled trial to establish whether subgrouping using a novel tool, combined with targeted treatment, is better than best current care at reducing long-term disability from low back pain. Methods/Design We will recruit 800 participants aged 18 years and over with non-specific low back pain from 8–10 GP practices within two Primary Care Trusts in Staffordshire, England. Our primary outcome measures are low back pain disability and catastrophising. Secondary outcomes include back pain intensity, global change, leg pain, fear avoidance, anxiety, depression, illness perceptions, patient satisfaction, overall health status and cost-effectiveness. Data will be collected before randomisation, and 4 and 12 months later. Participants are randomised to receive either newly developed interventions, delivered by trained physiotherapists and targeted according to subgroups defined by tool scores, or best current care. Discussion This paper presents detail on the rationale, design, methods and operational aspects of the trial. Trial registration Current Controlled Trials ISRCTN37113406.

  7. Enoxaparin, effective dosage for intensive care patients: double-blinded, randomised clinical trial

    DEFF Research Database (Denmark)

    Robinson, Sian; Zincuk, Aleksander; Strøm, Thomas; Larsen, Torben Bjerregaard; Rasmussen, Bjarne; Toft, Palle

    2010-01-01

    an increase in enoxaparin dose, from 0.13 IU/ml at 40 mg, to 0.14 IU/ml at 50 mg, 0.27 IU/ml at 60 mg, and 0.29 IU/ml at 70 mg (P = 0.002). At 12 hours after administration, median aFXa levels were still within therapeutic range for those patients who received 60 mg (P = 0.02). CONCLUSIONS: Our study...... the subcutaneous (SC) dose of enoxaparin that would give the best anti-factor Xa levels in ICU patients. METHODS: The 72 patients admitted to a mixed ICU at Odense University Hospital (OUH) in Denmark were randomised into four groups to receive 40, 50, 60, or 70 mg SC enoxaparin for a period of 24...... hours. Anti-factor Xa activity (aFXa) was measured before, and at 4, 12, and 24 hours after administration. An AFXa level between 0.1 to 0.3 IU/ml was considered evidence of effective antithrombotic activity. RESULTS: Median peak (4 hours after administration), aFXa levels increased significantly with...

  8. 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

  9. 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

  10. 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.

  11. Feasibility of integrating early stimulation into primary care for undernourished Jamaican children: cluster randomised controlled trial

    OpenAIRE

    Powell, Christine; Baker-Henningham, Helen; Walker, Susan; Gernay, Jacqueline; Grantham-McGregor, Sally

    2004-01-01

    Objectives To assess the feasibility of integrating early psychosocial stimulation into primary care for undernourished children and to determine the effect on children's development and mothers' knowledge and practices of childrearing.

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

    Directory of Open Access Journals (Sweden)

    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

  13. Primary care randomised controlled trial of a tailored interactive website for the self-management of respiratory infections (Internet Doctor)

    Science.gov (United States)

    Little, Paul; Stuart, Beth; Andreou, Panayiota; McDermott, Lisa; Joseph, Judith; Mullee, Mark; Moore, Mike; Broomfield, Sue; Thomas, Tammy; Yardley, Lucy

    2016-01-01

    Objective To assess an internet-delivered intervention providing advice to manage respiratory tract infections (RTIs). Design Open pragmatic parallel group randomised controlled trial. Setting Primary care in UK. Participants Adults (aged ≥18) registered with general practitioners, recruited by postal invitation. Intervention Patients were randomised with computer-generated random numbers to access the intervention website (intervention) or not (control). The intervention tailored advice about the diagnosis, natural history, symptom management (particularly paracetamol/ibuprofen use) and when to seek further help. Outcomes Primary: National Health Service (NHS) contacts for those reporting RTIs from monthly online questionnaires for 20 weeks. Secondary: hospitalisations; symptom duration/severity. Results 3044 participants were recruited. 852 in the intervention group and 920 in the control group reported 1 or more RTIs, among whom there was a modest increase in NHS direct contacts in the intervention group (intervention 37/1574 (2.4%) versus control 20/1661 (1.2%); multivariate risk ratio (RR) 2.25 (95% CI 1.00 to 5.07, p=0.048)). Conversely, reduced contact with doctors occurred (239/1574 (15.2%) vs 304/1664 (18.3%); RR 0.71, 0.52 to 0.98, p=0.037). Reduction in contacts occurred despite slightly longer illness duration (11.3 days vs 10.7 days, respectively; multivariate estimate 0.60 days longer (−0.15 to 1.36, p=0.118) and more days of illness rated moderately bad or worse illness (0.52 days; 0.06 to 0.97, p=0.026). The estimate of slower symptom resolution in the intervention group was attenuated when controlling for whether individuals had used web pages which advocated ibuprofen use (length of illness 0.22 days, −0.51 to 0.95, p=0.551; moderately bad or worse symptoms 0.36 days, −0.08 to 0.80, p=0.105). There was no evidence of increased hospitalisations (risk ratio 0.25; 0.05 to 1.12; p=0.069). Conclusions An internet

  14. 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

  15. Protocol for Care After Lymphoma (CALy) trial: a phase II pilot randomised controlled trial of a lymphoma nurse-led model of survivorship care

    Science.gov (United States)

    Joske, David; Bulsara, Max; Bulsara, Caroline; Monterosso, Leanne

    2016-01-01

    Introduction Lymphoma is the sixth most common cancer diagnosed in Australia and internationally. Owing to the aggressive nature of the disease and intensity of treatment, survivors face long-term effects that impact on quality of life. Current models of follow-up post-treatment fail to address these complex issues. Given that 74% of patients with lymphoma cancer now survive 5 years beyond diagnosis and treatment, it is important to address this gap in care. Aim To determine self-reported informational and practical needs, anxiety, depression, stress, coping and empowerment at baseline, 3 and 6 months. Methods and analysis A pilot randomised controlled trial will test the effect of a nurse-led lymphoma survivorship clinic compared with usual post-treatment care at a large tertiary cancer centre in Western Australia. The intervention will comprise three face-to-face appointments with delivery of tailored resources, a survivorship care plan and treatment summary (SCP TS). The SCP TS will be given to the participant and general practitioner (GP). Intervention participants will be interviewed at completion to explore the perceived value of the intervention components and preferred dose. An evaluation developed for GPs will assess receipt and use of SCP TS. The primary intent of analysis will be to address the feasibility of a larger trial and requisite effect and sample size. Ethics and dissemination Ethics approval has been granted by the University of Notre Dame Australia and Sir Charles Gairdner Hospital in Western Australia. Peer-reviewed publications and conference presentations will report the results of this phase II trial. Trial registration number ANZCTRN12615000530527; Pre-results. PMID:27194317

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

    OpenAIRE

    Voort, T.Y. van der; Meijel, B van; Goossens, P.J.J.; Renes, J.; Beekman, A.T.; Kupka, R.W.

    2011-01-01

    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, subs...

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

    OpenAIRE

    Beekman Aartjan TF; Renes Janwillem; Goossens Peter JJ; van Meijel Berno; van der Voort Trijntje YG; Kupka Ralph W

    2011-01-01

    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 disorde...

  18. 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

  19. A randomised controlled trial on the efficacy of advance care planning on the quality of end-of-life care and communication in patients with COPD: the research protocol

    OpenAIRE

    Houben, Carmen H M; Spruit, Martijn A.; Wouters, Emiel F.M.; Janssen, Daisy J A

    2014-01-01

    Introduction Recent research shows that advance care planning (ACP) for patients with chronic obstructive pulmonary disease (COPD) is uncommon and poorly carried out. The aim of the present study was to explore whether and to what extent structured ACP by a trained nurse, in collaboration with the chest physician, can improve outcomes in Dutch patients with COPD and their family. Methods and analysis A multicentre cluster randomised controlled trial in patients with COPD who are recently disc...

  20. Protocol for the Foot in Juvenile Idiopathic Arthritis trial (FiJIA: a randomised controlled trial of an integrated foot care programme for foot problems in JIA

    Directory of Open Access Journals (Sweden)

    Hendry Gordon J

    2009-06-01

    Full Text Available Abstract Background Foot and ankle problems are a common but relatively neglected manifestation of juvenile idiopathic arthritis. Studies of medical and non-medical interventions have shown that clinical outcome measures can be improved. However existing data has been drawn from small non-randomised clinical studies of single interventions that appear to under-represent the adult population suffering from juvenile idiopathic arthritis. To date, no evidence of combined therapies or integrated care for juvenile idiopathic arthritis patients with foot and ankle problems exists. Methods/design An exploratory phase II non-pharmacological randomised controlled trial where patients including young children, adolescents and adults with juvenile idiopathic arthritis and associated foot/ankle problems will be randomised to receive integrated podiatric care via a new foot care programme, or to receive standard podiatry care. Sixty patients (30 in each arm including children, adolescents and adults diagnosed with juvenile idiopathic arthritis who satisfy the inclusion and exclusion criteria will be recruited from 2 outpatient centres of paediatric and adult rheumatology respectively. Participants will be randomised by process of minimisation using the Minim software package. The primary outcome measure is the foot related impairment measured by the Juvenile Arthritis Disability Index questionnaire's impairment domain at 6 and 12 months, with secondary outcomes including disease activity score, foot deformity score, active/limited foot joint counts, spatio-temporal and plantar-pressure gait parameters, health related quality of life and semi-quantitative ultrasonography score for inflammatory foot lesions. The new foot care programme will comprise rapid assessment and investigation, targeted treatment, with detailed outcome assessment and follow-up at minimum intervals of 3 months. Data will be collected at baseline, 6 months and 12 months from baseline

  1. 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

  2. Physiotherapy informed by Acceptance and Commitment Therapy (PACT): protocol for a randomised controlled trial of PACT versus usual physiotherapy care for adults with chronic low back pain

    Science.gov (United States)

    Godfrey, Emma; Galea Holmes, Melissa; Wileman, Vari; McCracken, Lance; Moss-Morris, Rona; Pallet, John; Sanders, Duncan; Barcellona, Massimo; Critchley, Duncan

    2016-01-01

    Introduction Chronic low back pain (CLBP) is a common condition and source of significant suffering, disability and healthcare costs. Current physiotherapy treatment is moderately effective. Combining theory-based psychological methods with physiotherapy could improve outcomes for people with CLBP. The primary aim of this randomised controlled trial (RCT) is to evaluate the efficacy of Physiotherapy informed by Acceptance and Commitment Therapy (PACT) on functioning in patients with CLBP. Methods and analysis The PACT trial is a two-armed, parallel-group, multicentre RCT to assess the efficacy of PACT in comparison with usual physiotherapy care (UC). 240 patients referred to physiotherapy with CLBP will be recruited from three National Health Service (NHS) hospitals trusts. Inclusion criteria are: age ≥18 years, CLBP ≥12-week duration, scoring ≥3 points on the Roland-Morris Disability Questionnaire (RMDQ) and adequate understanding of spoken and written English to participate. Patients will be randomised to PACT or UC (120 per arm stratified by centre) by an independent randomisation service and followed up at 3 and 12 months post randomisation. The sample size of 240 will provide adequate power to detect a standardised mean difference of 0.40 in the primary outcome (RMDQ; 5% significance, 80% power) assuming attrition of 20%. Analysis will be by intention to treat conducted by the trial statistician, blind to treatment group, following a prespecified analysis plan. Estimates of treatment effect at the follow-up assessments will use an intention-to-treat framework, implemented using a linear mixed-effects model. Ethics and dissemination This trial has full ethical approval (14/SC/0277). It will be disseminated via peer-reviewed publications and conference presentations. The results will enable clinicians, patients and health service managers to make informed decisions regarding the efficacy of PACT for patients with CLBP. Trial registration number ISRCTN

  3. 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

  4. 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

  5. Cost-effectiveness of collaborative care for chronically ill patients with comorbid depressive disorder in the general hospital setting, a randomised controlled trial

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    Beekman Aartjan TF

    2007-02-01

    Full Text Available Abstract Background Depressive disorder is one of the most common disorders, and is highly prevalent in chronically ill patients. The presence of comorbid depression has a negative influence on quality of life, health care costs, self-care, morbidity, and mortality. Early diagnosis and well-organized treatment of depression has a positive influence on these aspects. Earlier research in the USA has reported good results with regard to the treatment of depression with a collaborative care approach and an antidepressant algorithm. In the UK 'Problem Solving Treatment' has proved to be feasible. However, in the general hospital setting this approach has not yet been evaluated. Methods/Design CC: DIM (Collaborative Care: Depression Initiative in the Medical setting is a two-armed randomised controlled trial with randomisation at patient level. The aim of the trial is to evaluate the treatment of depressive disorder in general hospitals in the Netherlands based on a collaborative care framework, including contracting, 'Problem Solving Treatment', antidepressant algorithm, and manual-guided self-help. 126 outpatients with diabetes mellitus, chronic obstructive pulmonary disease, or cardiovascular diseases will be randomised to either the intervention group or the control group. Patients will be included if they have been diagnosed with moderate to severe depression, based on the DSM-IV criteria in a two-step screening method. The intervention group will receive treatment based on the collaborative care approach; the control group will receive 'care as usual'. Baseline and follow-up measurements (after 3, 6, 9, and 12 months will be performed by means of questionnaires. The primary outcome measure is severity of depressive symptoms, as measured with the PHQ-9. The secondary outcome measure is the cost-effectiveness of these treatments according to the TiC-P, the EuroQol and the SF-36. Discussion Earlier research has indicated that depressive disorder is

  6. 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

  7. 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

  8. 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.

  9. 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

    Directory of Open Access Journals (Sweden)

    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

  10. 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

    -up. For type of intervention and duration of intervention there was a non-significant effect on effect size in favour of educational techniques and short interventions. CONCLUSION: In type 2 diabetes, there are improvements in glycaemic control in people who receive self-care management treatment with a......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...

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

    Directory of Open Access Journals (Sweden)

    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

  12. 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

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

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    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

  14. 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

  15. 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

  16. 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

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

    Science.gov (United States)

    2011-01-01

    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-intervention commencement. The

  18. The European quality of care pathways (EQCP study on the impact of care pathways on interprofessional teamwork in an acute hospital setting: study protocol: for a cluster randomised controlled trial and evaluation of implementation processes

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    Deneckere Svin

    2012-05-01

    Full Text Available Abstract Background Although care pathways are often said to promote teamwork, high-level evidence that supports this statement is lacking. Furthermore, knowledge on conditions and facilitators for successful pathway implementation is scarce. The objective of the European Quality of Care Pathway (EQCP study is therefore to study the impact of care pathways on interprofessional teamwork and to build up understanding on the implementation process. Methods/design An international post-test-only cluster Randomised Controlled Trial (cRCT, combined with process evaluations, will be performed in Belgium, Ireland, Italy, and Portugal. Teams caring for proximal femur fracture (PFF patients and patients hospitalized with an exacerbation of chronic obstructive pulmonary disease (COPD will be randomised into an intervention and control group. The intervention group will implement a care pathway for PFF or COPD containing three active components: a formative evaluation of the actual teams’ performance, a set of evidence-based key interventions, and a training in care pathway-development. The control group will provide usual care. A set of team input, process and output indicators will be used as effect measures. The main outcome indicator will be relational coordination. Next to these, process measures during and after pathway development will be used to evaluate the implementation processes. In total, 132 teams have agreed to participate, of which 68 were randomly assigned to the intervention group and 64 to the control group. Based on power analysis, a sample of 475 team members per arm is required. To analyze results, multilevel analysis will be performed. Discussion Results from our study will enhance understanding on the active components of care pathways. Through this, preferred implementation strategies can be defined. Trail registration NCT01435538

  19. 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

  20. 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

  1. 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

  2. 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

  3. Evaluating Acupuncture and Standard carE for pregnant women with Back pain (EASE Back): a feasibility study and pilot randomised trial.

    Science.gov (United States)

    Foster, Nadine E; Bishop, Annette; Bartlam, Bernadette; Ogollah, Reuben; Barlas, Panos; Holden, Melanie; Ismail, Khaled; Jowett, Sue; Kettle, Christine; Kigozi, Jesse; Lewis, Martyn; Lloyd, Alison; Waterfield, Jackie; Young, Julie

    2016-01-01

    BACKGROUND Many pregnant women experience low back pain. Acupuncture appears to be a safe, promising intervention but evidence is needed about its clinical effectiveness and cost-effectiveness. OBJECTIVES To assess the feasibility of a future large randomised controlled trial (RCT) testing the additional benefit of adding acupuncture to standard care (SC) for pregnancy-related back pain. DESIGN Phase 1: a questionnaire survey described current care for pregnancy-related back pain. Focus groups and interviews with midwives, physiotherapists and pregnant women explored acceptability and feasibility of acupuncture and the proposed RCT. Phase 2: a single-centre pilot RCT. Participants were identified using six methods and randomised to SC, SC plus true acupuncture or SC plus non-penetrating acupuncture. PARTICIPANTS Phase 1: 1093 physiotherapists were surveyed and 15 midwives, 21 physiotherapists and 17 pregnant women participated in five focus groups and 20 individual interviews. Phase 2: 125 women with pregnancy-related back pain participated. INTERVENTIONS SC: a self-management booklet and onward referral for one-to-one physiotherapy (two to four sessions) for those who needed it. SC plus true acupuncture: the self-management booklet and six to eight treatments with a physiotherapist comprising true (penetrating) acupuncture, advice and exercise. SC plus non-penetrating acupuncture: the self-management booklet and six to eight treatments with a physiotherapist comprising non-penetrating acupuncture, advice and exercise. MAIN OUTCOME MEASURES Pilot RCT outcomes included recruitment rates, treatment fidelity, follow-up rate, patient-reported pain and function, quality of life and health-care resource use. Birth and neonatal outcomes were also assessed. Staff overseeing outcome data collection were blind to treatment allocation. RESULTS Phase 1: 629 (57.5%) physiotherapists responded to the survey, 499 were experienced in treating pregnancy-related back pain and

  4. 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

  5. A Pragmatic Randomised, Controlled Trial of Intensive Care follow up programmes in improving Longer-term outcomes from critical illness. The PRACTICAL study

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    Ramsey Craig

    2007-07-01

    Full Text Available Abstract Background A number of intensive care (ICU patients experience significant problems with physical, psychological, and social functioning for some time after discharge from ICU. These problems have implications not just for patients, but impose a continuing financial burden for the National Health Service. To support recovery, a number of hospitals across the UK have developed Intensive Care follow-up clinics. However, there is a lack of evidence base to support these, and this study aims to test the hypothesis that intensive care follow up programmes are effective and cost-effective at improving physical and psychological quality of life in the year after intensive care discharge. Methods/Design This is a multi-centre, pragmatic, randomised controlled trial. Patients (n = 270 will be recruited prior to hospital discharge from three intensive care units in the UK, and randomised to one of two groups. The control group will receive standard in-hospital follow-up and the intervention group will participate in an ICU follow-up programme with clinic appointments 2–3 and 9 months after ICU discharge. The primary outcome measure is Health-related Quality of Life (HRQoL 12 months after ICU discharge as measured by the Short Form-36. Secondary measures include: HRQoL at six months; Quality-adjusted life years using EQ-5D; posttraumatic psychopathology as measured by Davidson Trauma Scale; and anxiety and depression using the Hospital Anxiety and Depression Scale at both six and twelve months after ICU discharge. Contacts with health services in the twelve months after ICU discharge will be measured as part of the economic analysis. Discussion The provision of intensive care follow-up clinics within the UK has developed in an ad hoc manner, is inconsistent in both the number of hospitals offering such a service or in the type of service offered. This study provides the opportunity to evaluate such services both in terms of patient benefit and

  6. 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

  7. 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.

  8. 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...

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

    Directory of Open Access Journals (Sweden)

    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

  10. Primary care Identification and Referral to Improve Safety of women experiencing domestic violence (IRIS: protocol for a pragmatic cluster randomised controlled trial

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    Rutterford Clare

    2010-02-01

    Full Text Available Abstract Background Domestic violence, which may be psychological, physical, sexual, financial or emotional, is a major public health problem due to the long-term health consequences for women who have experienced it and for their children who witness it. In populations of women attending general practice, the prevalence of physical or sexual abuse in the past year from a partner or ex-partner ranges from 6 to 23%, and lifetime prevalence from 21 to 55%. Domestic violence is particularly important in general practice because women have many contacts with primary care clinicians and because women experiencing abuse identify doctors and nurses as professionals from whom they would like to get support. Yet health professionals rarely ask about domestic violence and have little or no training in how to respond to disclosure of abuse. Methods/Design This protocol describes IRIS, a pragmatic cluster randomised controlled trial with the general practice as unit of randomisation. Our trial tests the effectiveness and cost-effectiveness of a training and support programme targeted at general practice teams. The primary outcome is referral of women to specialist domestic violence agencies. Forty-eight practices in two UK cities (Bristol and London are randomly allocated, using minimisation, into intervention and control groups. The intervention, based on an adult learning model in an educational outreach framework, has been designed to address barriers to asking women about domestic violence and to encourage appropriate responses to disclosure and referral to specialist domestic violence agencies. Multidisciplinary training sessions are held with clinicians and administrative staff in each of the intervention practices, with periodic feedback of identification and referral data to practice teams. Intervention practices have a prompt to ask about abuse integrated in the electronic medical record system. Other components of the intervention include an IRIS

  11. 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

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    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

  12. An open randomised study of autoinflation in 4- to 11-year-old school children with otitis media with effusion in primary care.

    Science.gov (United States)

    Williamson, Ian; Vennik, Jane; Harnden, Anthony; Voysey, Merryn; Perera, Rafael; Breen, Maria; Bradley, Brendan; Kelly, Sadie; Yao, Guiqing; Raftery, James; Mant, David; Little, Paul

    2015-01-01

    BACKGROUND Otitis media with effusion (OME) is a very common problem in primary care, but one that lacks an evidence-based non-surgical treatment. OBJECTIVE To determine the clinical effectiveness of nasal balloon autoinflation for the treatment of OME in children. DESIGN A pragmatic, two-arm, open randomised controlled trial. SETTING Forty-three general practices from 17 UK primary care trusts recruited between January 2012 and February 2013. PARTICIPANTS School children aged 4-11 years with a history of OME symptoms or related concerns in the previous 3 months, and a type B tympanogram, diagnostic of a middle ear effusion, in one or both ears. INTERVENTION Three hundred and twenty children were randomised, 160 to each group, using independent web-based computer-generated randomisation (with minimisation based on age, sex and baseline severity of OME) to either nasal balloon autoinflation performed three times per day for 1-3 months plus usual care, or usual care alone. MAIN OUTCOME MEASURES The proportion of children demonstrating clearance of middle ear fluid in at least one ear (with normal tympanograms) at 1 and 3 months, assessed blind to treatment. An ear-related measure of quality of life (QoL) [a 14-point questionnaire on the impact of OME (OMQ-14)], weekly diary recorded symptoms, compliance and adverse events were all secondary outcomes. RESULTS At 1 month, the proportion of children with normal tympanograms was 47.3% (62/131) in those allocated to autoinflation and 35.6% (47/132) in those receiving usual care [adjusted relative risk (RR) 1.36, 95% confidence interval (CI) 0.99 to 1.88]. At 3 months, the proportions were 49.6% (62/125) and 38.3% (46/120), respectively (adjusted RR 1.37, 95% CI 1.03 to 1.83; number needed to treat = 9). The change in OMQ-14 also favoured the intervention arm (adjusted global score difference -0.42; p = 0.001). Reported compliance was good: 89% in the first month and 80% in months 2 and 3. Adverse events included

  13. 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...

  14. 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.

  15. 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

    Directory of Open Access Journals (Sweden)

    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

  16. Personalised long-term follow-up of cochlear implant patients using remote care, compared with those on the standard care pathway: study protocol for a feasibility randomised controlled trial

    Science.gov (United States)

    Kitterick, Padraig; DeBold, Lisa; Weal, Mark; Clarke, Nicholas; Newberry, Eva; Aubert, Lisa

    2016-01-01

    Introduction Many resources are required to provide postoperative care to patients who receive a cochlear implant. The implant service commits to lifetime follow-up. The patient commits to regular adjustment and rehabilitation appointments in the first year and annual follow-up appointments thereafter. Offering remote follow-up may result in more stable hearing, reduced patient travel expense, time and disruption, more empowered patients, greater equality in service delivery and more freedom to optimise the allocation of clinic resources. Methods and analysis This will be a two-arm feasibility randomised controlled trial (RCT) involving 60 adults using cochlear implants with at least 6 months device experience in a 6-month clinical trial of remote care. This project will design, implement and evaluate a person-centred long-term follow-up pathway for people using cochlear implants offering a triple approach of remote and self-monitoring, self-adjustment of device and a personalised online support tool for home speech recognition testing, information, self-rehabilitation, advice, equipment training and troubleshooting. The main outcome measure is patient activation. Secondary outcomes are stability and quality of hearing, stability of quality of life, clinic resources, patient and clinician experience, and any adverse events associated with remote care. We will examine the acceptability of remote care to service users and clinicians, the willingness of participants to be randomised, and attrition rates. We will estimate numbers required to plan a fully powered RCT. Ethics and dissemination Ethical approval was received from North West—Greater Manchester South Research Ethics Committee (15/NW/0860) and the University of Southampton Research Governance Office (ERGO 15329). Results Results will be disseminated in the clinical and scientific communities and also to the patient population via peer-reviewed research publications both online and in print, conference and

  17. 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

  18. 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

  19. 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

  20. 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

  1. Advance care planning – a multi-centre cluster randomised clinical trial: the research protocol of the ACTION study

    OpenAIRE

    Rietjens, Judith; Dunleavy, Lesley Jane; Preston, Nancy Jean; Payne, Sheila Alison

    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 patients, relatives and professional caregivers about patients’ values and care preferences. It raises awareness of the need to anticipate possible future deterioration of health. ACP has the potenti...

  2. Advance care planning - a multi-centre cluster randomised clinical trial: the research protocol of the ACTION study

    OpenAIRE

    Rietjens, Judith AC; Korfage, Ida J.; Dunleavy, Lesley; Preston, Nancy J.; Jabbarian, Lea J.; Christensen, Caroline Arnfeldt; de Brito, Maja; Bulli, Francesco; Caswell, Glenys; Červ, Branka; Delden, Johannes; Deliens, Luc; Gorini, Giuseppe; Groenvold, Mogens; Houttekier, Dirk

    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 patients, relatives and professional caregivers about patients' values and care preferences. It raises awareness of the need to anticipate possible future deterioration of health. ACP has the potent...

  3. 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

  4. 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

  5. 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

  6. 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

  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

    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 ...

  8. Searching for the evidence in pre-hospital care: a review of randomised controlled trials. On behalf of the Ambulance Response Time Sub-Group of the National Ambulance Advisory Committee.

    OpenAIRE

    Brazier, H; Murphy, A W; Lynch, C; Bury, G

    1999-01-01

    OBJECTIVES: To identify randomised controlled trials (RCTs) which evaluate aspects of pre-hospital care; to perform categorisation by theme; to compare the sensitivity and precision of the search databases. DATA SOURCES: August 1997 updates of MEDLINE and EMBASE databases, using the Datastar online system. Papers published in 1987 or later were included, with no language restrictions. STUDY SELECTION: A trial was eligible for inclusion if it was judged, by two independent and blinded assessor...

  9. 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

  10. 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

  11. 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

  12. 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

    Directory of Open Access Journals (Sweden)

    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

  13. 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.

  14. 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

  15. 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

  16. 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

  17. 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...

  18. Improving maternity care using a personal health record: study protocol for a stepped-wedge, randomised, controlled trial

    OpenAIRE

    Groenen, Carola J. M.; Faber, Marjan J; Kremer, Jan A.M.; Vandenbussche, Frank P. H. A.; van Duijnhoven, Noortje T. L.

    2016-01-01

    Background A personal health record (PHR) is an online application through which individuals can access, manage, and share their health information in a private, secure, and confidential environment. Personal health records empower patients, facilitate collaboration among healthcare professionals, and improve health outcomes. Given these anticipated positive effects, we want to implement a PHR, named MyPregn@ncy, in a Dutch maternity care setting and to evaluate its effects in routine care. T...

  19. 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...

  20. 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...

  1. 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

  2. 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

  3. McGRATH MAC videolaryngoscope versus Macintosh laryngoscope for orotracheal intubation in intensive care patients: the randomised multicentre MACMAN trial study protocol

    Science.gov (United States)

    Bailly, Arthur; Le Thuaut, Aurelie; Boisrame-Helms, Julie; Kamel, Toufik; Mercier, Emmanuelle; Ricard, Jean Damien; Lemiale, Virginie; Champigneulle, Benoit; Reignier, Jean

    2015-01-01

    Introduction Critically ill patients with acute respiratory, neurological or cardiovascular failure requiring invasive mechanical ventilation are at high risk of difficult intubation and have organ dysfunctions associated with complications of intubation and anaesthesia such as hypotension and hypoxaemia. The complication rate increases with the number of intubation attempts. Videolaryngoscopy improves elective endotracheal intubation. McGRATH MAC is the lightest videolaryngoscope and the most similar to the Macintosh laryngoscope. The primary goal of this trial was to determine whether videolaryngoscopy increased the frequency of successful first-pass intubation in critically ill patients, compared to direct view Macintosh laryngoscopy. Methods and analysis MACMAN is a multicentre, open-label, randomised controlled superiority trial. Consecutive patients requiring intubation are randomly allocated to either the McGRATH MAC videolaryngoscope or the Macintosh laryngoscope, with stratification by centre and operator experience. The expected frequency of successful first-pass intubation is 65% in the Macintosh group and 80% in the videolaryngoscope group. With α set at 5%, to achieve 90% power for detecting this difference, 185 patients are needed in each group (370 in all). The primary outcome is the proportion of patients with successful first-pass orotracheal intubation, compared between the two groups using a generalised mixed model to take the stratification factors into account. Ethics and dissemination The study project has been approved by the appropriate ethics committee (CPP Ouest 2, # 2014-A00674-43). Informed consent is not required, as both laryngoscopy methods are considered standard care in France; information is provided before study inclusion. If videolaryngoscopy proves superior to Macintosh laryngoscopy, its use will become standard practice, thereby decreasing first-pass intubation failure rates and, potentially, the frequency of intubation

  4. 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

  5. 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.

  6. The effectiveness of Stepping stones Triple P: the design of a randomised controlled trial on a parenting programme regarding children with mild intellectual disability and psychosocial problems versus care as usual

    Directory of Open Access Journals (Sweden)

    Jansen Daniëlle EMC

    2011-08-01

    Full Text Available Abstract Background Children with an intellectual disability are at increased risk of psychosocial problems. This leads to serious restrictions in the daily functioning of the children and to parental stress. Stepping Stones Triple P aims to prevent severe behavioural, emotional and developmental problems in children with a (intellectual disability by enhancing parenting knowledge and skills, and the self-confidence of parents. This paper aims to describe the design of a study of the effectiveness of parenting counselling using Stepping Stones Triple P compared to Care as Usual. Methods/Design The effects of Stepping Stones Triple P will be studied in a Randomised Controlled Trial. Parents of children aged 5-12 years with an IQ of 50-85 will be recruited from schools. Prior to randomisation, parents complete a screening questionnaire about their child's psychosocial problems and their parenting skills. Subsequently, parents of children with increased levels of psychosocial problems (score on Strengths and Difficulties Questionnaire ≥ 14 will be invited to participate in the intervention study. After obtaining consent, parents will be randomised either to the experimental group (Stepping Stones Triple P or to Care as Usual. The primary outcome is a change in the child's psychosocial problems according to parents and teachers. The secondary outcome is a change in parenting skills. Data will be collected before the start of the intervention, immediately after the intervention, and six months after. Discussion This paper presents an outline of the background and design of a randomised controlled trial to investigate the effectiveness of Stepping Stones Triple P, which aims to decrease psychosocial problems in children with a mild intellectual disability. Stepping Stones Triple P seems promising, but evidence on its effectiveness for this population is still lacking. This study provides evidence about the effects of this intervention in a community

  7. 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

  8. 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 (...

  9. 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

  10. 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...

  11. 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 ...

  12. 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。

  13. 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)

  14. 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

  15. The cost-effectiveness of point of care testing in a general practice setting: results from a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Briggs Nancy E

    2010-06-01

    Full Text Available Abstract Background While point of care testing (PoCT for general practitioners is becoming increasingly popular, few studies have investigated whether it represents value for money. This study aims to assess the relative cost-effectiveness of PoCT in general practice (GP compared to usual testing practice through a pathology laboratory. Methods A cost-effectiveness analysis based on a randomized controlled trial with 4,968 patients followed up for 18 months and fifty-three general practices in urban, rural and remote locations across three states in Australia. The incremental costs and health outcomes associated with a clinical strategy of PoCT for INR, HbA1c, lipids, and ACR were compared to those from pathology laboratory testing. Costs were expressed in year 2006 Australian dollars. Non-parametric bootstrapping was used to generate 95% confidence intervals. Results The point estimate of the total direct costs per patient to the health care sector for PoCT was less for ACR than for pathology laboratory testing, but greater for INR, HbA1c and Lipids, although none of these differences was statistically significant. PoCT led to significant cost savings to patients and their families. When uncertainty around the point estimates was taken into account, the incremental cost-effectiveness ratio (ICER for PoCT was found to be unfavourable for INR, but somewhat favourable for ACR, while substantial uncertainty still surrounds PoCT for HbA1c and Lipids. Conclusions The decision whether to fund PoCT will depend on the price society is willing to pay for achievement of the non-standard intermediate outcome indicator. Trial registration Australian New Zealand Clinical Trial Registry ACTRN12605000272695

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

    Directory of Open Access Journals (Sweden)

    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

  17. Preventing disease through opportunistic, rapid engagement by primary care teams using behaviour change counselling (PRE-EMPT: protocol for a general practice-based cluster randomised trial

    Directory of Open Access Journals (Sweden)

    Smith Christine

    2010-09-01

    Full Text Available Abstract Background Smoking, excessive alcohol consumption, lack of exercise and an unhealthy diet are the key modifiable factors contributing to premature morbidity and mortality in the developed world. Brief interventions in health care consultations can be effective in changing single health behaviours. General Practice holds considerable potential for primary prevention through modifying patients' multiple risk behaviours, but feasible, acceptable and effective interventions are poorly developed, and uptake by practitioners is low. Through a process of theoretical development, modeling and exploratory trials, we have developed an intervention called Behaviour Change Counselling (BCC derived from Motivational Interviewing (MI. This paper describes the protocol for an evaluation of a training intervention (the Talking Lifestyles Programme which will enable practitioners to routinely use BCC during consultations for the above four risk behaviours. Methods/Design This cluster randomised controlled efficacy trial (RCT will evaluate the outcomes and costs of this training intervention for General Practitioners (GPs and nurses. Training methods will include: a practice-based seminar, online self-directed learning, and reflecting on video recorded and simulated consultations. The intervention will be evaluated in 29 practices in Wales, UK; two clinicians will take part (one GP and one nurse from each practice. In intervention practices both clinicians will receive training. The aim is to recruit 2000 patients into the study with an expected 30% drop out. The primary outcome will be the proportion of patients making changes in one or more of the four behaviours at three months. Results will be compared for patients seeing clinicians trained in BCC with patients seeing non-BCC trained clinicians. Economic and process evaluations will also be conducted. Discussion Opportunistic engagement by health professionals potentially represents a cost effective

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

    Directory of Open Access Journals (Sweden)

    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

  19. 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

    Directory of Open Access Journals (Sweden)

    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

  20. 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

    (-8.8, p=0.004). No statistically significant differences were seen in other outcome variables. CONCLUSIONS: It is safe to implement shared care and nursing consultations as alternatives to rheumatologist consultations for RA outpatients with low disease activity without deterioration in disease......OBJECTIVES: To compare patient outcomes of three regimes of follow-up care for rheumatoid arthritis (RA) outpatients with low disease activity. METHODS: RA outpatients (n=287) with Disease Activity Score (DAS28-CRP)<3.2 and Health Assessment Questionnaire<2.5 from two Danish rheumatology clinics...... 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...

  1. 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

    Directory of Open Access Journals (Sweden)

    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

  2. Procalcitonin-guided antibiotic use versus a standard approach for acute respiratory tract infections in primary care: study protocol for a randomised controlled trial and baseline characteristics of participating general practitioners [ISRCTN73182671

    Directory of Open Access Journals (Sweden)

    Bucher Heiner C

    2005-08-01

    Full Text Available Abstract Background Acute respiratory tract infections (ARTI are among the most frequent reasons for consultations in primary care. Although predominantly viral in origin, ARTI often lead to the prescription of antibiotics for ambulatory patients, mainly because it is difficult to distinguish between viral and bacterial infections. Unnecessary antibiotic use, however, is associated with increased drug expenditure, side effects and antibiotic resistance. A novel approach is to guide antibiotic therapy by procalcitonin (ProCT, since serum levels of ProCT are elevated in bacterial infections but remain lower in viral infections and inflammatory diseases. The aim of this trial is to compare a ProCT-guided antibiotic therapy with a standard approach based on evidence-based guidelines for patients with ARTI in primary care. Methods/Design This is a randomised controlled trial in primary care with an open intervention. Adult patients judged by their general practitioner (GP to need antibiotics for ARTI are randomised in equal numbers either to standard antibiotic therapy or to ProCT-guided antibiotic therapy. Patients are followed-up after 1 week by their GP and after 2 and 4 weeks by phone interviews carried out by medical students blinded to the goal of the trial. Exclusion criteria for patients are antibiotic use in the previous 28 days, psychiatric disorders or inability to give written informed consent, not being fluent in German, severe immunosuppression, intravenous drug use, cystic fibrosis, active tuberculosis, or need for immediate hospitalisation. The primary endpoint is days with restrictions from ARTI within 14 days after randomisation. Secondary outcomes are antibiotic use in terms of antibiotic prescription rate and duration of antibiotic treatment in days, days off work and days with side-effects from medication within 14 days, and relapse rate from the infection within 28 days after randomisation. Discussion We aim to include 600

  3. 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

    Directory of Open Access Journals (Sweden)

    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

  4. 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

  5. A randomised evaluation of CollAborative care and active surveillance for Screen-Positive EldeRs with sub-threshold depression (CASPER: study protocol for a randomized controlled trial

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    Richards David

    2011-10-01

    Full Text Available Abstract Background Depression accounts for the greatest burden of disease among all mental health problems, and is expected to become the second-highest amongst all general health problems by 2020. By the age of 75, 1 in 7 older people meet formal diagnostic criteria for depression. Efforts to ameliorate the burden of illness and personal suffering associated with depression in older people have focussed on those with more severe depressive syndromes. Less attention has been paid to those with mild disorders/sub-threshold depressive syndromes but these patients also suffer impairments in their quality of life and level of functioning. Methods/Design The CASPER study has been designed to assemble an epidemiological cohort of people over 75 years of age (the CASPER cohort, from which we will identify those eligible to participate in a trial of collaborative care for sub-threshold depression (the CASPER trial. We aim to undertake a pragmatic randomised controlled multi-centre trial evaluating the effectiveness and cost-effectiveness of collaborative care; a low intensity psychological intervention in addition to usual general practitioner care versus usual general practitioner care alone. General practitioners from practices based in the North of England will be asked to identify potentially eligible patients over the age of 75 years. Patients will be sent a letter inviting them to participate in the study. We aim to recruit approximately 540 participants for the CASPER trial. A diagnostic interview will be carried out to ascertain trial eligibility with the major depressive episode module of the Mini International Neuropsychiatric Interview (M.I.N.I., eligible participants randomised to either the intervention or usual care. The primary outcome will be measured with the Patient Health Questionnaire-9 (PHQ-9 and additional quality of life measures will be collected. Data will be collected at baseline, 4 and 12 months for both trial and cohort

  6. 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

    Directory of Open Access Journals (Sweden)

    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

  7. 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

    Science.gov (United States)

    Lobban, Fiona; Gamble, Carol; Kinderman, Peter; Taylor, Lee; Chandler, Claire; Tyler, Elizabeth; Peters, Sarah; Pontin, Eleanor; Sellwood, William; Morriss, Richard K

    2007-01-01

    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 cluster randomised

  8. The effect of problem-based learning in patient education after an event of CORONARY heart disease – a randomised study in PRIMARY health care: design and methodology of the COR-PRIM study

    Directory of Open Access Journals (Sweden)

    Kärner Anita

    2012-11-01

    Full Text Available Abstract Background Even though there is convincing evidence that self-care, such as regular exercise and/or stopping smoking, alters the outcomes after an event of coronary heart disease (CHD, risk factors remain. Outcomes can improve if core components of secondary prevention programmes are structurally and pedagogically applied using adult learning principles e.g. problem-based learning (PBL. Until now, most education programs for patients with CHD have not been based on such principles. The basic aim is to discover whether PBL provided in primary health care (PHC has long-term effects on empowerment and self-care after an event of CHD. Methods/Design A randomised controlled study is planned for patients with CHD. The primary outcome is empowerment to reach self-care goals. Data collection will be performed at baseline at hospital and after one, three and five years in PHC using quantitative and qualitative methodologies involving questionnaires, medical assessments, interviews, diaries and observations. Randomisation of 165 patients will take place when they are stable in their cardiac condition and have optimised cardiac medication that has not substantially changed during the last month. All patients will receive conventional care from their general practitioner and other care providers. The intervention consists of a patient education program in PHC by trained district nurses (tutors who will apply PBL to groups of 6–9 patients meeting on 13 occasions for two hours over one year. Patients in the control group will not attend a PBL group but will receive home-sent patient information on 11 occasions during the year. Discussion We expect that the 1-year PBL-patient education will improve patients’ beliefs, self-efficacy and empowerment to achieve self-care goals significantly more than one year of standardised home-sent patient information. The assumption is that PBL will reduce cardiovascular events in the long-term and will also be

  9. The Effectiveness of a Home Care Program for Supporting Caregivers of Persons with Dementia in Developing Countries: A Randomised Controlled Trial from Goa, India

    OpenAIRE

    Dias, Amit; Dewey, Michael E.; D'Souza, Jean; Dhume, Rajesh; Motghare, Dilip D.; K S Shaji; Menon, Rajiv; Prince, Martin; Patel, Vikram

    2008-01-01

    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 ...

  10. 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 ...

  11. Protocol for the Foot in Juvenile Idiopathic Arthritis trial (FiJIA): a randomised controlled trial of an integrated foot care programme for foot problems in JIA

    OpenAIRE

    Hendry Gordon J; Turner Deborah E; McColl John; Lorgelly Paula K; Sturrock Roger D; Watt Gordon F; Browne Michael; Gardner-Medwin Janet; Friel Lorraine; Woodburn Jim

    2009-01-01

    Abstract Background Foot and ankle problems are a common but relatively neglected manifestation of juvenile idiopathic arthritis. Studies of medical and non-medical interventions have shown that clinical outcome measures can be improved. However existing data has been drawn from small non-randomised clinical studies of single interventions that appear to under-represent the adult population suffering from juvenile idiopathic arthritis. To date, no evidence of combined therapies or integrated ...

  12. A randomised clinical trial of subgrouping and targeted treatment for low back pain compared with best current care. The STarT Back Trial Study Protocol

    OpenAIRE

    Vohora Kanchan; Somerville Simon; Sowden Gail; Konstantinou Kika; Mason Elizabeth E; Lewis Martyn; Hill Jonathan C; Dunn Kate M; Hay Elaine M; Whitehurst David; Main Chris J

    2008-01-01

    Abstract Background Back pain is a major health problem and many sufferers develop persistent symptoms. Detecting relevant subgroups of patients with non-specific low back pain has been highlighted as a priority area for research, as this could enable better secondary prevention through the targeting of prognostic indicators for persistent, disabling symptoms. We plan to conduct a randomised controlled trial to establish whether subgrouping using a novel tool, combined with targeted treatment...

  13. 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

    Directory of Open Access Journals (Sweden)

    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

  14. 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

  15. 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

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

    Directory of Open Access Journals (Sweden)

    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

  17. 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

    Directory of Open Access Journals (Sweden)

    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

  18. 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

    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...... diabetes (HbA1c > 8.0%) and their parents from 2 Danish hospitals and randomise into GSD-Y or control groups. During an 8-12 month period, the GSD-Y group will complete 8 outpatient GSD-Y visits, and the control group will completes an equal number of standard visits. The primary outcome is HbA1c...

  19. A cluster randomised controlled trial in primary dental care based intervention to improve professional performance on routine oral examinations and the management of asymptomatic impacted third molars: study protocol

    Directory of Open Access Journals (Sweden)

    Grol Richard PTM

    2007-04-01

    Full Text Available Abstract Background Routine oral examination (ROE refers to periodic monitoring of the general and oral health status of patients. In most developed Western countries a decreasing prevalence of oral diseases underpins the need for a more individualised approach in assigning individualised recall intervals for regular attendees instead of systematic fixed intervals. From a quality-of-care perspective, the effectiveness of the widespread prophylactic removal of mandibular impacted asymptomatic third molars (MIM in adolescents and adults is also questionable. Data on the effectiveness of appropriate interventions to tackle such problems, and for promoting continuing professional development in oral health care are rare. Methods/design This study is a cluster randomised controlled trial with groups of GDPs as the unit of randomisation. The aim is to determine the effectiveness and efficiency of small group quality improvement on professional decision-making of general dental practitioners (GDPs in daily practice. Six peer groups ('IQual-groups' shall be randomised either to the intervention arm I or arm II. Groups of GDPs allocated to either of these arms act as each other's control group. An IQual peer group consists of eight to ten GDPs who meet in monthly structured sessions scheduled for discussion on practice-related topics. GDPs in both trial arms receive recently developed evidence-based clinical practice guidelines (CPG on ROE or MIM. The implementation strategy consists of one interactive IQual group meeting of two to three hours. In addition, both groups of GDPs receive feedback on personal and group characteristics, and are invited to make use of web-based patient risk vignettes for further individual training on risk assessment policy. Reminders (flow charts will be sent by mail several weeks after the meeting. The main outcome measure for the ROE intervention arm is the use and appropriateness of individualised risk assessment in

  20. SCAMP: standardised, concentrated, additional macronutrients, parenteral nutrition in very preterm infants: a phase IV randomised, controlled exploratory study of macronutrient intake, growth and other aspects of neonatal care

    Directory of Open Access Journals (Sweden)

    Mayes Kelly

    2011-06-01

    Full Text Available Abstract Background Infants born Methods We propose a single centre, randomised controlled exploratory trial of two standardised, concentrated neonatal parenteral nutrition regimens comparing a standard macronutrient content (maximum protein 2.8 g/kg/day; lipid 2.8 g/kg/day, dextrose 10% with a higher macronutrient content (maximum protein 3.8 g/kg/day; lipid 3.8 g/kg/day, dextrose 12% over the first 28 days of life. 150 infants 24-28 completed weeks gestation and birthweight Trial registration Current controlled trials: ISRCTN76597892; EudraCT Number: 2008-008899-14

  1. 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

  2. A randomised, multicentre clinical trial of specialised palliative care plus standard treatment versus standard treatment alone for cancer patients with palliative care needs: the Danish palliative care trial (DanPaCT) protocol

    DEFF Research Database (Denmark)

    Johnsen, Anna Thit; Damkier, Anette; Vejlgaard, Tove Bahn; Lindschou, Jane; Sjøgren, Per; Gluud, Christian Nyfeldt; Neergaard, Mette Asbjørn; Petersen, Morten Aa; Lundorff, Lena Elisabeth; Pedersen, Lise; Fayers, Peter; Strömgren, Annette S; Higginson, Irene J; Groenvold, Mogens

    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'....

  3. 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.)

  4. 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

  5. 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...

  6. 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.

  7. 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

    OpenAIRE

    Lucassen PL; van Eijken MIJ; Borm GF; van Achterberg T; Drašković I; Perry M; Vernooij-Dassen MJFJ; Olde Rikkert MGM

    2008-01-01

    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-bas...

  8. 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

  9. A pragmatic cluster randomised controlled trial to evaluate the safety, clinical effectiveness, cost effectiveness and satisfaction with point of care testing in a general practice setting – rationale, design and baseline characteristics

    Directory of Open Access Journals (Sweden)

    Glastonbury Briony

    2008-08-01

    Full Text Available Abstract Background Point of care testing (PoCT may be a useful adjunct in the management of chronic conditions in general practice (GP. The provision of pathology test results at the time of the consultation could lead to enhanced clinical management, better health outcomes, greater convenience and satisfaction for patients and general practitioners (GPs, and savings in costs and time. It could also result in inappropriate testing, increased consultations and poor health outcomes resulting from inaccurate results. Currently there are very few randomised controlled trials (RCTs in GP that have investigated these aspects of PoCT. Design/Methods The Point of Care Testing in General Practice Trial (PoCT Trial was an Australian Government funded multi-centre, cluster randomised controlled trial to determine the safety, clinical effectiveness, cost effectiveness and satisfaction of PoCT in a GP setting. The PoCT Trial covered an 18 month period with the intervention consisting of the use of PoCT for seven tests used in the management of patients with diabetes, hyperlipidaemia and patients on anticoagulant therapy. The primary outcome measure was the proportion of patients within target range, a measure of therapeutic control. In addition, the PoCT Trial investigated the safety of PoCT, impact of PoCT on patient compliance to medication, stakeholder satisfaction, cost effectiveness of PoCT versus laboratory testing, and influence of geographic location. Discussion The paper provides an overview of the Trial Design, the rationale for the research methodology chosen and how the Trial was implemented in a GP environment. The evaluation protocol and data collection processes took into account the large number of patients, the broad range of practice types distributed over a large geographic area, and the inclusion of pathology test results from multiple pathology laboratories. The evaluation protocol developed reflects the complexity of the Trial setting

  10. Effect of educational outreach to nurses on tuberculosis case detection and primary care of respiratory illness: pragmatic cluster randomised controlled trial

    OpenAIRE

    Fairall, Lara R; Zwarenstein, Merrick; Bateman, Eric D; BACHMANN, Max; Lombard, Carl; Majara, Bosielo P; Joubert, Gina; English, Rene G; Bheekie, Angeni; Van Rensburg, Dingie; Myers, Pat; Peters, Annatjie C; Chapman, Ronald D

    2005-01-01

    Objectives To develop and implement an educational outreach programme for the integrated case management of priority respiratory diseases (practical approach to lung health in South Africa; PALSA) and to evaluate its effects on respiratory care and detection of tuberculosis among adults attending primary care clinics.

  11. 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.

  12. 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

  13. Documentation-based clinical decision support to improve antibiotic prescribing for acute respiratory infections in primary care: a cluster randomised controlled trial

    OpenAIRE

    Jeffrey Linder; Jeffrey Schnipper; Ruslana Tsurikova; Tony Yu; Lynn Volk; Andrea Melnikas; Matvey Palchuk; Maya Olsha-Yehiav; Blackford Middleton

    2009-01-01

    Background and objective Clinical guidelines discourage antibiotic prescribing for many acute respiratory infections (ARIs), especially for non-antibiotic appropriate diagnoses. Electronic health record (EHR)-based clinical decision support has the potential to improve antibiotic prescribing for ARIs. Methods We randomly assigned 27 primary care clinics to receive an EHR-integrated, documentation based clinical decision support system for the care of patients with ARIs - the ARI Smart Form...

  14. Reducing the psychological distress of family caregivers of home based palliative care patients: Longer term effects from a randomised controlled trial.

    OpenAIRE

    Hudson, Peter; Trauer, Tom; Kelly, Brian; O'Connor, Moira; Thomas, Kristina; Zordan, Rachel; Summers, Michael

    2015-01-01

    Background: Palliative care incorporates comprehensive support of family caregivers because many of them experience burden and distress. However, evidence-based support initiatives are few.Purpose: We evaluated a one-to-one psychoeducational intervention aimed at mitigating the distress of caregivers of patients with advanced cancer receiving home-based palliative care. We hypothesised that caregivers would report decreased distress as assessed by the General Health Questionnaire (GHQ).Method...

  15. A Pragmatic Randomised, Controlled Trial of Intensive Care follow up programmes in improving Longer-term outcomes from critical illness. The PRACTICAL study

    OpenAIRE

    Ramsey Craig; Hernendez Rodolfo; Wilson Edward; Wildsmith J Anthony; Johnston Marie; Rattray Janice; Cuthbertson Brian H; Hull Alastair M; Norrie John; Campbell Marion

    2007-01-01

    Abstract Background A number of intensive care (ICU) patients experience significant problems with physical, psychological, and social functioning for some time after discharge from ICU. These problems have implications not just for patients, but impose a continuing financial burden for the National Health Service. To support recovery, a number of hospitals across the UK have developed Intensive Care follow-up clinics. However, there is a lack of evidence base to support these, and this study...

  16. 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

  17. 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

  18. 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.

  19. Patient Engagement and Coaching for Health: The PEACH study – a cluster randomised controlled trial using the telephone to coach people with type 2 diabetes to engage with their GPs to improve diabetes care: a study protocol

    Directory of Open Access Journals (Sweden)

    Audehm Ralph

    2007-04-01

    Full Text Available Abstract Background The PEACH study is based on an innovative 'telephone coaching' program that has been used effectively in a post cardiac event trial. This intervention will be tested in a General Practice setting in a pragmatic trial using existing Practice Nurses (PN as coaches for people with type 2 diabetes (T2D. Actual clinical care often fails to achieve standards, that are based on evidence that self-management interventions (educational and psychological and intensive pharmacotherapy improve diabetes control. Telephone coaching in our study focuses on both. This paper describes our study protocol, which aims to test whether goal focused telephone coaching in T2D can improve diabetes control and reduce the treatment gap between guideline based standards and actual clinical practice. Methods/design In a cluster randomised controlled trial, general practices employing Practice Nurses (PNs are randomly allocated to an intervention or control group. We aim to recruit 546 patients with poorly controlled T2D (HbA1c >7.5% from 42 General Practices that employ PNs in Melbourne, Australia. PNs from General Practices allocated to the intervention group will be trained in diabetes telephone coaching focusing on biochemical targets addressing both patient self-management and engaging patients to work with their General Practitioners (GPs to intensify pharmacological treatment according to the study clinical protocol. Patients of intervention group practices will receive 8 telephone coaching sessions and one face-to-face coaching session from existing PNs over 18 months plus usual care and outcomes will be compared to the control group, who will only receive only usual care from their GPs. The primary outcome is HbA1c levels and secondary outcomes include cardiovascular disease risk factors, behavioral risk factors and process of care measures. Discussion Understanding how to achieve comprehensive treatment of T2D in a General Practice setting is

  20. 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...

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

    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...

  6. 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...

  7. Alexander Technique lessons, acupuncture sessions or usual care for patients with chronic neck pain (ATLAS) : study protocol for a randomised controlled trial.

    OpenAIRE

    Macpherson, H.; Tilbrook, H.E.; Richmond, S.J.; Atkin, K; Ballard, K.; Bland, M; Eldred, J.; Essex, H.N.; Hopton, A; Lansdown, H; Usman, M.; Parrott, S.; Torgerson, D; Wenham, A.; Woodman, J.

    2013-01-01

    Background: Chronic neck pain is a common condition in the adult population. More research is needed to evaluate interventions aiming to facilitate beneficial long-term change. We propose to evaluate the effect of Alexander Technique lessons and acupuncture in a rigorously conducted pragmatic trial with an embedded qualitative study. Methods/Design: We will recruit 500 patients who have been diagnosed with neck pain in primary care, who have continued to experience neck pain for at least ...

  8. 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.

  9. 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...

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

    OpenAIRE

    Herrera Emilio; Gonzalez-Guerrero Jose L; Reyes Maria C; Gusi Narcis; Garcia Jose M

    2008-01-01

    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 parti...

  11. The Melanoma care study: protocol of a randomised controlled trial of a psycho-educational intervention for melanoma survivors at high risk of developing new primary disease

    OpenAIRE

    Dieng, Mbathio; Kasparian, Nadine A.; Morton, Rachael L.; Mann, Graham J.; Butow, Phyllis; Menzies, Scott; Costa, Daniel S.J.; Cust, Anne E.

    2015-01-01

    Background Despite a good prognosis for most melanoma survivors, many experience substantial fear of new or recurrent melanoma, worry and anxiety about the future, and unmet healthcare needs. In this protocol, we outline the design and methods of the Melanoma Care Study for melanoma survivors at high risk of developing new primary disease. The objective of this study is to evaluate the efficacy and cost-effectiveness of a psycho-educational intervention for improving psychological and behavio...

  12. 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

  13. 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

  14. 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

  15. TOIB Study. Are topical or oral ibuprofen equally effective for the treatment of chronic knee pain presenting in primary care: a randomised controlled trial with patient preference study. [ISRCTN79353052

    Directory of Open Access Journals (Sweden)

    Parsons Suzanne

    2005-11-01

    Full Text Available Abstract Background Many older people have chronic knee pain. Both topical and oral non- steroidal anti-inflammatory drugs (NSAIDs are commonly used to treat this. Oral NSAIDS are effective, at least in the short term, but can have severe adverse effects. Topical NSAIDs also appear to be effective, at least in the short term. One might expect topical NSAIDs both to be less effective and to have fewer adverse effects than oral NSAIDs. If topical NSAIDs have fewer adverse effects this may outweigh both the reduction in effectiveness and the higher cost of topical compared to oral treatment. Patient preferences may influence the comparative effectiveness of drugs delivered via different routes. Methods TOIB is a randomised trial comparing topical and oral ibuprofen, with a parallel patient preference study. We are recruiting people aged 50 or over with chronic knee pain, from 27 MRC General Practice Research Framework practices across the UK. We are seeking to recruit 283 participants to the RCT and 379 to the PPS. Participants will be followed up for up to two years (with the majority reaching one year. Outcomes will be assessed by postal questionnaire, nurse examination, laboratory tests and medical record searches at one and two years or the end of the study. Discussion This study will provide new evidence on the overall costs and benefits of treating chronic knee pain with either oral or topical ibuprofen. The use of a patient preference design is unusual, but will allow us to explore how preference influences response to a medication. In addition, it will provide more information on adverse events. This study will provide evidence to inform primary care practitioners, and possibly influence practice.

  16. A randomised controlled non-inferiority trial of primary care-based facilitated access to an alcohol reduction website (EFAR Spain): the study protocol

    OpenAIRE

    Lopez-Pelayo, H.; Wallace, P.; Segura, L.; Miquel, L.; DIAZ, E; Teixido, L.; Baena, B.; Struzzo, P.; Palacio-Vieira, J.; Casajuana, C.; Colom, J; Gual, A.

    2014-01-01

    Introduction Early identification (EI) and brief interventions (BIs) for risky drinkers are effective tools in primary care. Lack of time in daily practice has been identified as one of the main barriers to implementation of BI. There is growing evidence that facilitated access by primary healthcare professionals (PHCPs) to a web-based BI can be a time-saving alternative to standard face-to-face BIs, but there is as yet no evidence about the effectiveness of this approach relative to conventi...

  17. 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

  18. 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

  19. 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

  20. 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

  1. 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, but not...... using motion-sensor biofeedback resulted in significant and sustained improvements in pain and activity limitation that persisted after treatment finished. This pilot trial also refined the procedures and sample size requirements for a fully powered RCT. This trial (Australian New Zealand Clinical...

  2. 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

  3. 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

  4. 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.

  5. Adding point of care ultrasound to assess volume status in heart failure patients in a nurse-led outpatient clinic. A randomised study

    Science.gov (United States)

    Gundersen, Guri Holmen; Norekval, Tone M; Haug, Hilde Haugberg; Skjetne, Kyrre; Kleinau, Jens Olaf; Graven, Torbjorn; Dalen, Havard

    2016-01-01

    Objectives Medical history, physical examination and laboratory testing are not optimal for the assessment of volume status in heart failure (HF) patients. We aimed to study the clinical influence of focused ultrasound of the pleural cavities and inferior vena cava (IVC) performed by specialised nurses to assess volume status in HF patients at an outpatient clinic. Methods HF outpatients were prospectively included and underwent laboratory testing, history recording and clinical examination by two nurses with and without an ultrasound examination of the pleural cavities and IVC using a pocket-size imaging device, in random order. Each nurse worked in a team with a cardiologist. The influence of the different diagnostic tests on diuretic dosing was assessed descriptively and in linear regression analyses. Results Sixty-two patients were included and 119 examinations were performed. Mean±SD age was 74±12 years, EF was 34±14%, and N-terminal pro-brain natriuretic peptide (NT-proBNP) value was 3761±3072 ng/L. Dosing of diuretics differed between the teams in 31 out of 119 consultations. Weight change and volume status assessed clinically with and without ultrasound predicted dose adjustment of diuretics at follow-up (p<0.05). Change of oedema, NT-proBNP, creatinine, and symptoms did not (p≥0.10). In adjusted analyses, only volume status based on ultrasound predicted dose adjustments of diuretics at first visit and follow-up (all ultrasound p≤0.01, all other p≥0.2). Conclusions Ultrasound examinations of the pleural cavities and IVC by nurses may improve diagnostics and patient care in HF patients at an outpatient clinic, but more studies are needed to determine whether these examinations have an impact on clinical outcomes. Trial registration number NCT01794715. PMID:26438785

  6. 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

  7. Findings from a pilot Randomised trial of an Asthma Internet Self-management Intervention (RAISIN)

    OpenAIRE

    Morrison, D; Wyke, S; Sauderson, K.; McConnachie, A.; Agur, K.; Chaudhuri, R.; M. Thomas; Thomson, N; Yardley, L; Mair, F S

    2016-01-01

    Objective: To evaluate the feasibility of a Phase 3 randomised controlled trial (RCT) of a web-site (Living Well with Asthma) to support self-management. Design and Setting: Phase 2, parallel group, RCT, participants recruited from 20 general practices across Glasgow, UK. Randomisation through automated voice response, after baseline data collection, to website access for minimum 12 weeks or usual care. Participants: Adults (age ? 16rs) with physician diagnosed, symptomatic asthma (a...

  8. Findings from a pilot randomised trial of an asthma internet self-management intervention (RAISIN)

    OpenAIRE

    Morrison, D; Wyke, S; Saunderson, K.; McConnachie, A.; Agur, K.; Chaudhuri, R.; M. Thomas; Thomson, N. C.; Yardley, L; Mair, F S

    2016-01-01

    Objective To evaluate the feasibility of a phase 3 randomised controlled trial (RCT) of a website (Living Well with Asthma) to support self-management. Design and setting Phase 2, parallel group, RCT, participants recruited from 20 general practices across Glasgow, UK. Randomisation through automated voice response, after baseline data collection, to website access for minimum 12 weeks or usual care. Participants Adults (age≥16 years) with physician diagnosed, sympt...

  9. 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...

  10. 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...

  11. 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 ...

  12. Promoting childbirth companions in South Africa: a randomised pilot study

    OpenAIRE

    Smith Helen; Nikodem V Cheryl; Hofmeyr G Justus; Brown Heather; Garner Paul

    2007-01-01

    Abstract Background Most women delivering in South African State Maternity Hospitals do not have a childbirth companion; in addition, the quality of care could be better, and at times women are treated inhumanely. We piloted a multi-faceted intervention to encourage uptake of childbirth companions in state hospitals, and hypothesised that lay carers would improve the behaviour of health professionals. Methods We conducted a pilot randomised controlled trial of an intervention to promote child...

  13. Tyranny of the randomised clinical trial.

    Science.gov (United States)

    Rosenbek, John C

    2016-06-01

    Researchers and clinicians often disagree about what it means to provide the best possible care. This paper's purpose is to propose ways of resolving the disagreements. The first is to have both groups re-examine the three equal components of evidence-based practice, a re-examination that begins with rejection of the randomised clinical trial's tyranny. The second is for researchers to design rehabilitation research based on a biopsychosocial rather than a biomedical model. The third is for both groups to redefine translational research so that it means both translation from the laboratory to the clinic and from the clinic to the laboratory. The fourth is to advocate for a science of dissemination that is as robust as rehabilitation's present science of discovery. Most examples are drawn from the literature on acquired neurologic speech and language disorders. PMID:27124262

  14. 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...

  15. 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

  16. 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...

  17. '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...

  18. 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...

  19. 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...

  20. '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; Kroeze, Willemieke; Oenema, Anke; Renders, Carry; Bulk-Bunschoten, Anneke; Hirasing, Remy; Raat, Hein

    2009-01-01

    textabstractBACKGROUND: 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...

  1. 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....

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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...

  7. 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...

  8. 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

  9. Effectiveness of continuous glucose monitoring in pregnant women with diabetes: randomised clinical trial

    OpenAIRE

    Murphy, Helen R.; Rayman, Gerry; Lewis, Karen; Kelly, Susan; Johal, Balroop; Duffield, Katherine; Fowler, Duncan; Campbell, Peter J.; Temple, Rosemary C

    2008-01-01

    Objective To evaluate the effectiveness of continuous glucose monitoring during pregnancy on maternal glycaemic control, infant birth weight, and risk of macrosomia in women with type 1 and type 2 diabetes. Design Prospective, open label randomised controlled trial. Setting Two secondary care multidisciplinary obstetric clinics for diabetes in the United Kingdom. Participants 71 women with type 1 diabetes (n=46) or type 2 diabetes (n=25) allocated to antenatal care plus continuous glucose mon...

  10. 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 ...

  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. 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

  13. Evaluating the clinical and cost effectiveness of a behaviour change intervention for lowering cardiovascular disease risk for people with severe mental illnesses in primary care (PRIMROSE study):Study protocol for a cluster randomised controlled trial

    OpenAIRE

    Osborn, David; Burton, Alexandra; Walters, Kate; Nazareth, Irwin; Heinkel, Samira; Atkins, Lou; Blackburn, Ruth; Holt, Richard I. G.; Hunter, Rachael Maree; King, Michael; Marston, Louise; Michie, Susan; Morris, Richard W.; Morris, Steve; Omar, Rumana Z.

    2016-01-01

    BackgroundPeople with severe mental illnesses die up to 20 years earlier than the general population, with cardiovascular disease being the leading cause of death. National guidelines recommend that the physical care of people with severe mental illnesses should be the responsibility of primary care; however, little is known about effective interventions to lower cardiovascular disease risk in this population and setting. Following extensive peer review, funding was secured from the United Ki...

  14. Study protocol of EMPOWER Participatory Action Research (EMPOWER-PAR): a pragmatic cluster randomised controlled trial of multifaceted chronic disease management strategies to improve diabetes and hypertension outcomes in primary care

    OpenAIRE

    Ramli, Anis S; Lakshmanan, Sharmila; Haniff, Jamaiyah; Selvarajah, Sharmini; Tong, Seng F; Bujang, Mohamad-Adam; Abdul-Razak, Suraya; Shafie, Asrul A.; Lee, Verna KM; Abdul-Rahman, Thuhairah H; Daud, Maryam H; Ng, Kien K; Ariffin, Farnaza; Abdul-Hamid, Hasidah; Mazapuspavina, Md-Yasin

    2014-01-01

    Background Chronic disease management presents enormous challenges to the primary care workforce because of the rising epidemic of cardiovascular risk factors. The chronic care model was proven effective in improving chronic disease outcomes in developed countries, but there is little evidence of its effectiveness in developing countries. The aim of this study was to evaluate the effectiveness of the EMPOWER-PAR intervention (multifaceted chronic disease management strategies based on the chr...

  15. 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

  16. 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

  17. 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

  18. 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

  19. A cluster-randomised, controlled trial to assess the impact of a workplace osteoporosis prevention intervention on the dietary and physical activity behaviours of working women: study protocol

    OpenAIRE

    Tan, Ai May; LaMontagne, Anthony D; Sarmugam, Rani; Howard, Peter

    2013-01-01

    Background Osteoporosis is a debilitating disease and its risk can be reduced through adequate calcium consumption and physical activity. This protocol paper describes a workplace-based intervention targeting behaviour change in premenopausal women working in sedentary occupations. Method/Design A cluster-randomised design was used, comparing the efficacy of a tailored intervention to standard care. Workplaces were the clusters and units of randomisation and intervention. Sample size calculat...

  20. A pragmatic multi-centre randomised controlled trial of fluid loading and level of dependency in high-risk surgical patients undergoing major elective surgery: trial protocol

    OpenAIRE

    Norrie John; Vale Luke; Stott Stephen A; Campbell Marion K; Cuthbertson Brian H; Kinsella John; Cook Jonathan; Brittenden Julie; Grant Adrian

    2010-01-01

    Abstract Background Patients undergoing major elective or urgent surgery are at high risk of death or significant morbidity. Measures to reduce this morbidity and mortality include pre-operative optimisation and use of higher levels of dependency care after surgery. We propose a pragmatic multi-centre randomised controlled trial of level of dependency and pre-operative fluid therapy in high-risk surgical patients undergoing major elective surgery. Methods/Design A multi-centre randomised cont...

  1. IQuaD dental trial; improving the quality of dentistry: a multicentre randomised controlled trial comparing oral hygiene advice and periodontal instrumentation for the prevention and management of periodontal disease in dentate adults attending dental primary care

    OpenAIRE

    Clarkson, J E; Ramsay, C. R.; Averley, P.; Bonetti, D.; Boyers, D.; L. Campbell; Chadwick, G.R.; Duncan, A; Elders, A.; Gouick, J.; Hall, A.F.; Heasman, L; Heasman, P.A.; Hodge, P.J.; C. Jones

    2013-01-01

    Background Periodontal disease is the most common oral disease affecting adults, and although it is largely preventable it remains the major cause of poor oral health worldwide. Accumulation of microbial dental plaque is the primary aetiological factor for both periodontal disease and caries. Effective self-care (tooth brushing and interdental aids) for plaque control and removal of risk factors such as calculus, which can only be removed by periodontal instrumentation (PI), are considered ne...

  2. 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...

  3. 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 ...

  4. 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

  5. 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

  6. 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

  7. 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 ...

  8. 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 ...

  9. Randomised trial of safety and efficacy of immediate postoperative enteral feeding in patients undergoing gastrointestinal resection.

    OpenAIRE

    Carr, C S; Ling, K. D.; Boulos, P.; Singer, M

    1996-01-01

    OBJECTIVES: To assess whether immediate post-operative enteral feeding in patients who have undergone gastrointestinal resection is safe and effective. DESIGN: Randomised trial of immediate post-operative enteral feeding through a nasojejunal tube v conventional postoperative intravenous fluids until the reintroduction of normal diet. SETTING: Teaching hospitals in London. SUBJECTS: 30 patients under the care of the participating consultant surgeon who were undergoing elective laparotomies wi...

  10. Limited benefits of ambulance telemetry in delivering early thrombolysis: a randomised controlled trial

    OpenAIRE

    Woollard, M; Pitt, K.; Hayward, A.; Taylor, N.

    2005-01-01

    Methods: This prospective randomised controlled trial recruited patients using the 999 ambulance service in a rural area of the UK with signs or symptoms of coronary heart disease. Subjects were assigned to receive either standard paramedic treatment or transmission of 12 lead ECG, blood pressure, pulse oximetry, and relevant medical history to a general hospital coronary care unit. Cardiology senior house officers then determined each patient's suitability for pre-hospital thrombolysis time,...

  11. 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...

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

    OpenAIRE

    Forster Anne; Young John; Barber Sally; Clegg Andrew; Iliffe Steve

    2011-01-01

    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 a...

  13. 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

  14. 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

  15. 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

  16. Cost-effectiveness of adherence therapy versus health education for people with schizophrenia: randomised controlled trial in four European countries

    OpenAIRE

    Patel, Anita; McCRONE, PAUL; Leese, Morven; Amaddeo, Francesco; Tansella, Michele; Kilian, Reinhold; Angermeyer, Matthias; Kikkert, Martijn; SCHENE, AART; Knapp, Martin

    2013-01-01

    Background Non-adherence to anti-psychotics is common, expensive and affects recovery. We therefore examine the cost-effectiveness of adherence therapy for people with schizophrenia by multi-centre randomised trial in Amsterdam, London, Leipzig and Verona. Methods Participants received 8 sessions of adherence therapy or health education. We measured lost productivity and use of health/social care, criminal justice system and informal care at baseline and one year to estimate and compare mean ...

  17. Predictive risk stratification model: a progressive cluster-randomised trial in chronic conditions management (PRISMATIC) research protocol

    OpenAIRE

    Hayley A Hutchings; Evans, Bridie A; Fitzsimmons, Deborah; Harrison, Jane; Heaven, Martin; Huxley, Peter; Kingston, Mark-Rhys; Lewis, Leo; Phillips, Ceri; Porter, Alison; Russell, Ian T; Sewell, Bernadette; Warm, Daniel; Watkins, Alan; Snooks, Helen A

    2013-01-01

    Background An ageing population increases demand on health and social care. New approaches are needed to shift care from hospital to community and general practice. A predictive risk stratification tool (Prism) has been developed for general practice that estimates risk of an emergency hospital admission in the following year. We present a protocol for the evaluation of Prism. Methods/Design We will undertake a mixed methods progressive cluster-randomised trial. Practices begin as controls, d...

  18. 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...

  19. 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

  20. 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...

  1. Structured personal care of type 2 diabetes: a 19 year follow-up of the study Diabetes Care in General Practice (DCGP)

    DEFF Research Database (Denmark)

    Hansen, Lars Jørgen; Siersma, Volkert Dirk; Beck-Nielsen, Henning; Olivarius, Niels

    2013-01-01

    This study is a 19 year observational follow-up of a pragmatic open multicentre cluster-randomised controlled trial of 6 years of structured personal diabetes care starting from diagnosis.......This study is a 19 year observational follow-up of a pragmatic open multicentre cluster-randomised controlled trial of 6 years of structured personal diabetes care starting from diagnosis....

  2. Promoting childbirth companions in South Africa: a randomised pilot study

    Directory of Open Access Journals (Sweden)

    Smith Helen

    2007-04-01

    Full Text Available Abstract Background Most women delivering in South African State Maternity Hospitals do not have a childbirth companion; in addition, the quality of care could be better, and at times women are treated inhumanely. We piloted a multi-faceted intervention to encourage uptake of childbirth companions in state hospitals, and hypothesised that lay carers would improve the behaviour of health professionals. Methods We conducted a pilot randomised controlled trial of an intervention to promote childbirth companions in hospital deliveries. We promoted evidence-based information for maternity staff at 10 hospitals through access to the World Health Organization Reproductive Health Library (RHL, computer hardware and training to all ten hospitals. We surveyed 200 women at each site, measuring companionship, and indicators of good obstetric practice and humanity of care. Five hospitals were then randomly allocated to receive an educational intervention to promote childbirth companions, and we surveyed all hospitals again at eight months through a repeat survey of postnatal women. Changes in median values between intervention and control hospitals were examined. Results At baseline, the majority of hospitals did not allow a companion, or access to food or fluids. A third of women were given an episiotomy. Some women were shouted at (17.7%, N = 2085, and a few reported being slapped or struck (4.3%, N = 2080. Despite an initial positive response from staff to the childbirth companion intervention, we detected no difference between intervention and control hospitals in relation to whether a companion was allowed by nursing staff, good obstetric practice or humanity of care. Conclusion The quality and humanity of care in these state hospitals needs to improve. Introducing childbirth companions was more difficult than we anticipated, particularly in under-resourced health care systems with frequent staff changes. We were unable to determine whether the presence

  3. Pragmatic trials in primary care: Methodological challenges and solutions demonstrated by the DIAMOND-study

    OpenAIRE

    Fransen, G.A.J.; Marrewijk, C.J. van; Mujakovic, S.; Muris, J.W.M.; Laheij, R.J.F.; Numans, M.E.; de Wit, N J; Samsom, M; Jansen, J. B. M. J.; Knottnerus, J A

    2007-01-01

    BACKGROUND: Pragmatic randomised controlled trials are often used in primary care to evaluate the effect of a treatment strategy. In these trials it is difficult to achieve both high internal validity and high generalisability. This article will discuss several methodological challenges in designing and conducting a pragmatic primary care based randomised controlled trial, based on our experiences in the DIAMOND-study and will discuss the rationale behind the choices we made. From the success...

  4. 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.

  5. Mobile phones improve antenatal care attendance in Zanzibar

    DEFF Research Database (Denmark)

    Lund, Stine; Nielsen, Birgitte B; Hemed, Maryam; Boas, Ida M; Said, Azzah; Said, Khadija; Makungu, Mkoko H; Rasch, Vibeke

    2014-01-01

    pregnancy. METHODS: This study was an open label pragmatic cluster-randomised controlled trial with primary healthcare facilities in Zanzibar as the unit of randomisation. 2550 pregnant women (1311 interventions and 1239 controls) who attended antenatal care at selected primary healthcare facilities were...... measure was four or more antenatal care visits during pregnancy. Secondary outcome measures were tetanus vaccination, preventive treatment for malaria, gestational age at last antenatal care visit, and antepartum referral. RESULTS: The mobile phone intervention was associated with an increase in antenatal...

  6. 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

  7. Early treatment of unstable angina in the coronary care unit: a randomised, double blind, placebo controlled comparison of recurrent ischaemia in patients treated with nifedipine or metoprolol or both. Report of The Holland Interuniversity Nifedipine/Metoprolol Trial (HINT) Research Group.

    OpenAIRE

    1986-01-01

    A multicentre, double blind, placebo controlled, randomised trial of nifedipine, metoprolol, and nifedipine and metoprolol combined was conducted in a group of 338 patients with unstable angina not pretreated with a beta blocker and of nifedipine in 177 patients pretreated with a beta blocker. The main outcome event was recurrent ischaemia or myocardial infarction within 48 hours. Trial medication effects were expressed as ratios of event rates relative to placebo. In patients not pretreated ...

  8. 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. PMID:16943339

  9. 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

  10. 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...

  11. Study protocol for the evaluation of an Infant Simulator based program delivered in schools: a pragmatic cluster randomised controlled trial

    OpenAIRE

    Hart Michael B; Codde James P; Lawrence David; Johnson Sarah E; Brinkman Sally A; Straton Judith AY; Silburn Sven

    2010-01-01

    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-c...

  12. Nebulised fentanyl for post-operative pain relief, a prospective double-blind controlled randomised clinical trial

    OpenAIRE

    Singh, Anil P.; Jena, Sritam S; Rajesh Kr Meena; Mallika Tewari; V Rastogi

    2013-01-01

    Background and Aim: Intravenous (IV) route for fentanyl administration is the gold standard for post-operative pain relief, but complications such as respiratory depression, bradycardia and hypotension have limited this route. The aim of this randomised controlled trial was to compare the efficacy of nebulised fentanyl with IV fentanyl for post-operative pain relief after lower abdominal surgery. Methods: In the post-operative care unit, at the time of first onset of pain (visual analogue sca...

  13. 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...

  14. Informed shared decision-making programme on the prevention of myocardial infarction in type 2 diabetes: a randomised controlled trial

    OpenAIRE

    Buhse, Susanne; Muhlhauser, Ingrid; Heller, Tabitha; Kuniss, Nadine; Muller, Ulrich; Kasper, Jürgen; Lehmann, Thomas; Lenz, Matthias

    2015-01-01

    Objective: To evaluate an informed shared decisionmaking programme (ISDM-P) for people with type 2 diabetes under high fidelity conditions. Design: Randomised, single-blinded trial with sham control intervention and follow-up of 6 months. Setting: Single-centre diabetes clinic providing care according to the national disease management programme in Germany. Participants: 154 people with type 2 diabetes without diagnosis of ischaemic heart disease or stroke. Inter...

  15. Implementing a Complex Intervention to Support Personal Recovery: A Qualitative Study Nested within a Cluster Randomised Controlled Trial

    OpenAIRE

    Leamy, Mary; Clarke, Eleanor; Le Boutillier, Clair; Bird, Victoria; Janosik, Monika; Sabas, Kai; Riley, Genevieve; Williams, Julie; Slade, Mike

    2014-01-01

    Objective To investigate staff and trainer perspectives on the barriers and facilitators to implementing a complex intervention to help staff support the recovery of service users with a primary diagnosis of psychosis in community mental health teams. Design Process evaluation nested within a cluster randomised controlled trial (RCT). Participants 28 interviews with mental health care staff, 3 interviews with trainers, 4 focus groups with intervention teams and 28 written trainer reports. Set...

  16. A randomised controlled trial of PEGASUS, a psychoeducational programme for young people with high-functioning autism spectrum disorder.

    OpenAIRE

    Gordon, K; Murin, M.; Baykaner, O.; Roughan, L.; Livermore-Hardy, V.; Skuse, D; Mandy, W.

    2015-01-01

    Background Psychoeducation is an essential component of postdiagnostic care for people with ASD (autism spectrum disorder), but there is currently no evidence base for clinical practice. We designed, manualised and evaluated PEGASUS (psychoeducation group for autism spectrum understanding and support), a group psychoeducational programme aiming to enhance the self-awareness of young people with ASD by teaching them about their diagnosis. Methods This single-blind RCT (randomised control trial...

  17. 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 ...

  18. 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...

  19. Evaluating a mental health assessment for older people with depressive symptoms in general practice: a randomised controlled trial.

    OpenAIRE

    Arthur, Antony J; Jagger, Carol; Lindesay, James; Matthews, Ruth J

    2002-01-01

    BACKGROUND: There is a lack of evidence on the most effective primary care management of older people with minor depression. AIM: To evaluate a follow-up assessment by the community mental health team (CMHT) for older people with depressive symptoms identified by practice nurses at a health check for people over the age of 75 years. DESIGN OF STUDY: A pragmatic randomised controlled trial. SETTING: A single large general practice in Leicestershire. METHOD: Patients receiving a health check ad...

  20. Default options in advance directives: study protocol for a randomised clinical trial

    Science.gov (United States)

    Gabler, Nicole B; Cooney, Elizabeth; Small, Dylan S; Troxel, Andrea B; Arnold, Robert M; White, Douglas B; Angus, Derek C; Loewenstein, George; Volpp, Kevin G; Bryce, Cindy L; Halpern, Scott D

    2016-01-01

    Introduction Although most seriously ill Americans wish to avoid burdensome and aggressive care at the end of life, such care is often provided unless patients or family members specifically request otherwise. Advance directives (ADs) were created to provide opportunities to set limits on aggressive care near life's end. This study tests the hypothesis that redesigning ADs such that comfort-oriented care is provided as the default, rather than requiring patients to actively choose it, will promote better patient-centred outcomes. Methods and analysis This multicentre trial randomises seriously ill adults to receive 1 of 3 different ADs: (1) a traditional AD that requires patients to actively choose their goals of care or preferences for specific interventions (eg, feeding tube insertion) or otherwise have their care guided by their surrogates and the prevailing societal default toward aggressive care; (2) an AD that defaults to life-extending care and receipt of life-sustaining interventions, enabling patients to opt out from such care; or (3) an AD that defaults to comfort care, enabling patients to opt into life-extending care. We seek to enrol 270 patients who return complete, legally valid ADs so as to generate sufficient power to detect differences in the primary outcome of hospital-free days (days alive and not in an acute care facility). Secondary outcomes include hospital and intensive care unit admissions, costs of care, hospice usage, decision conflict and satisfaction, quality of life, concordance of preferences with care received and bereavement outcomes for surrogates of patients who die. Ethics and dissemination This study has been approved by the Institutional Review Boards at all trial centres, and is guided by a data safety and monitoring board and an ethics advisory board. Study results will be disseminated using methods that describe the results in ways that key stakeholders can best understand and implement. Trial registration number NCT02017548

  1. 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.

  2. 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

  3. Observer bias in randomised clinical trials with binary outcomes

    DEFF Research Database (Denmark)

    Hróbjartsson, Asbjørn; Thomsen, Ann Sofia Skou; Emanuelsson, Frida; Tendal, Britta; Hilden, Jørgen; Boutron, Isabelle; Ravaud, Philippe; Brorson, Stig

    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....

  4. 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...

  5. 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...

  6. 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......-up. INTERVENTION: Supervised exercise comprising high intensity cardiovascular and resistance training, relaxation and body awareness training, massage, nine hours weekly for six weeks in addition to conventional care, compared with conventional care. MAIN OUTCOME MEASURES: European Organization for Research...

  7. 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…

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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.

  13. Increasing walking in patients with intermittent claudication: Protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    O'Carroll Ronan E

    2010-10-01

    Full Text Available Abstract Background People with intermittent claudication are at increased risk of death from heart attack and stroke compared to matched controls. Surgery for intermittent claudication is for symptom management and does not reduce the risk of cardiovascular morbidity and mortality. Increasing physical activity can reduce claudication symptoms and may improve cardiovascular health. This paper presents the pilot study protocol for a randomised controlled trial to test whether a brief psychological intervention leads to increased physical activity, improvement in quality of life, and a reduction in the demand for surgery, for patients with intermittent claudication. Methods/Design We aim to recruit 60 patients newly diagnosed with intermittent claudication, who will be randomised into two groups. The control group will receive usual care, and the treatment group will receive usual care and a brief 2-session psychological intervention to modify illness and walking beliefs and develop a walking action plan. The primary outcome will be walking, measured by pedometer. Secondary outcomes will include quality of life and uptake of surgery for symptom management. Participants will be followed up after (a 4 months, (b 1 year and (c 2 years. Discussion This study will assess the acceptability and efficacy of a brief psychological intervention to increase walking in patients with intermittent claudication, both in terms of the initiation, and maintenance of behaviour change. This is a pilot study, and the results will inform the design of a larger multi-centre trial. Trial Registration Current Controlled Trials ISRCTN28051878

  14. 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

  15. 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...

  16. Reporting of sample size calculation in randomised controlled trials: review

    OpenAIRE

    Charles, Pierre; Giraudeau, Bruno; Dechartres, Agnes; Baron, Gabriel; Ravaud, Philippe

    2009-01-01

    Objectives To assess quality of reporting of sample size calculation, ascertain accuracy of calculations, and determine the relevance of assumptions made when calculating sample size in randomised controlled trials. Design Review. Data sources We searched MEDLINE for all primary reports of two arm parallel group randomised controlled trials of superiority with a single primary outcome published in six high impact factor general medical journals between 1 January 2005 and 31 December 2006. All...

  17. 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...

  18. 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

  19. Pragmatic randomised controlled trial of group psychoeducation versus group support in the maintenance of bipolar disorder

    Directory of Open Access Journals (Sweden)

    Roberts Christopher

    2011-07-01

    Full Text Available Abstract Background Non-didactically delivered curriculum based group psychoeducation has been shown to be more effective than both group support in a specialist mood disorder centre in Spain (with effects lasting up to five years, and treatment as usual in Australia. It is unclear whether the specific content and form of group psychoeducation is effective or the chance to meet and work collaboratively with other peers. The main objective of this trial is to determine whether curriculum based group psychoeducation is more clinically and cost effective than unstructured peer group support. Methods/design Single blind two centre cluster randomised controlled trial of 21 sessions group psychoeducation versus 21 sessions group peer support in adults with bipolar 1 or 2 disorder, not in current episode but relapsed in the previous two years. Individual randomisation is to either group at each site. The groups are carefully matched for the number and type of therapists, length and frequency of the interventions and overall aim of the groups but differ in content and style of delivery. The primary outcome is time to next bipolar episode with measures of the therapeutic process, barriers and drivers to the effective delivery of the interventions and economic analysis. Follow up is for 96 weeks after randomisation. Discussion The trial has features of both an efficacy and an effectiveness trial design. For generalisability in England it is set in routine public mental health practice with a high degree of expert patient involvement. Trial Registration ISRCTN62761948 Funding National Institute for Health Research, England.

  20. 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

  1. 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

  2. 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,

  3. 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

  4. Routine general practice care for panic disorder within the lifestyle approach to managing panic study

    OpenAIRE

    Lambert, Rodney A.

    2012-01-01

    Routine general practice (GP) care is rarely comprehensively described in clinical trials. This paper examines routine GP care within the lifestyle approach to managing panic (LAMP) study. The aim of this paper is to describe/discuss routine GP care for panic disorder (PD) patients within both study arms in the LAMP study. An unblinded pragmatic randomised controlled trial in 15 East of England GP practices (2 primary care trusts). Participants met Diagnostic and Statistical Manual of Mental ...

  5. 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.

  6. 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...

  7. Intelligence and persisting with medication for two years: Analysis in a randomised controlled trial.

    Science.gov (United States)

    Deary, Ian J; Gale, Catharine R; Stewart, Marlene C W; Fowkes, F Gerald R; Murray, Gordon D; Batty, G David; Price, Jacqueline F

    2009-11-01

    The study examined whether verbal intelligence is associated with persisting to take medication for up to two years. The design is a prospective follow-up of compliance with taking medication in high-risk individuals participating in a randomised, placebo-controlled trial set in Central Scotland. Participants were 1993 people aged between 50 and 77 years with an ankle brachial index intelligence was associated with a greater likelihood of continuing to take medication up to two years after randomisation. For a standard deviation increase in Mill Hill Vocabulary Scale score, risk of stopping medication in the first two years of the study was 0.75 (95% CI 0.64 to 0.87, p intelligence is associated with continuing, medium-to-long term engagement with health self-care, even in the face of uncertainty about whether active treatment is being received, whether the treatment is known to be effective in general, and whether it will be helpful to the individual taking it. Such persisting with potentially helpful health behaviours in the face of uncertainty might partly explain why people with higher intelligence live longer and suffer less morbidity from chronic diseases. PMID:19907664

  8. Internet-based search of randomised trials relevant to mental health originating in the Arab world

    Directory of Open Access Journals (Sweden)

    Adams Clive E

    2005-07-01

    Full Text Available Abstract Background The internet is becoming a widely used source of accessing medical research through various on-line databases. This instant access to information is of benefit to busy clinicians and service users around the world. The population of the Arab World is comparable to that of the United States, yet it is widely believed to have a greatly contrasting output of randomised controlled trials related to mental health. This study was designed to investigate the existence of such research in the Arab World and also to investigate the availability of this research on-line. Methods Survey of findings from three internet-based potential sources of randomised trials originating from the Arab world and relevant to mental health care. Results A manual search of an Arabic online current contents service identified 3 studies, MEDLINE, EMBASE, and PsycINFO searches identified only 1 study, and a manual search of a specifically indexed, study-based mental health database, PsiTri, revealed 27 trials. Conclusion There genuinely seem to be few trials from the Arab world and accessing these on-line was problematic. Replication of some studies that guide psychiatric/psychological practice in the Arab world would seem prudent.

  9. 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

  10. 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...

  11. Moderating factors for the effectiveness of group art therapy for schizophrenia: secondary analysis of data from the MATISSE randomised controlled trial

    OpenAIRE

    Leurent, B.; Killaspy, H; Osborn, D. P.; Crawford, M J; Hoadley, A.; Waller, D.; King, M.

    2014-01-01

    Purpose Although some studies suggest that art therapy may be useful in the treatment of negative symptoms of schizophrenia, a recent large trial of group art therapy found no clinical advantage over standard care, but the study population was heterogeneous and uptake of the intervention was poor. This study aimed to investigate whether art therapy was more effective for specific subgroups of patients. Methods Secondary analysis of data from a randomised controlled trial of group art therapy ...

  12. A pragmatic cluster randomised controlled trial of an oral health intervention for people with serious mental illness (three shires early intervention dental trial)

    OpenAIRE

    Jones, Hannah; Adams, Clive; Clifton, Andrew; Callaghan, Patrick; Liddle, Peter; Buchanan, Heather; Aggarwal, Vishal

    2013-01-01

    People with mental illness have poor oral health compared to those without due to medication side effects, issues with self-care, barriers to treatment and poor recognition of dental problems. Guidelines recommend giving oral health advice and monitoring oral health for people with mental illness, but this is not reflected in current practice and Cochrane reviews found no existing randomised trials of these interventions.

  13. Protocol for a randomised controlled trial of telemonitoring and self-management in the control of hypertension: telemonitoring and self-management in hypertension. [ISRCTN17585681].

    OpenAIRE

    Little Paul; Jones Miren I; Bryan Stirling; Greenfield Sheila; Holder Roger; Mant Jonathan; Bray Emma P; McManus Richard J; Williams Bryan; Hobbs FD Richard

    2009-01-01

    Abstract Background Controlling blood pressure with drugs is a key aspect of cardiovascular disease prevention, but until recently has been the sole preserve of health professionals. Self-management of hypertension is an under researched area in which potential benefits for both patients and professionals are great. Methods and design The telemonitoring and self-management in hypertension trial (TASMINH2) will be a primary care based randomised controlled trial with embedded economic and qual...

  14. 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...

  15. 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...

  16. Experienced Carers Helping Others (ECHO): protocol for a pilot randomised controlled trial to examine a psycho-educational intervention for adolescents with anorexia nervosa and their carers

    OpenAIRE

    Rhind, Charlotte; Hibbs, Rebecca; Goddard, Elizabeth; Schmidt, Ulrike; Micali, Nadia; Gowers, Simon; Beecham, Jennifer; Macdonald, Pamela; Todd, Gillian; Tchanturia, Kate; Treasure, Janet

    2014-01-01

    Experienced Carers Helping Others (ECHO) is an intervention for carers of people with eating disorders. This paper describes the theoretical background and protocol of a pilot multicentre randomised controlled trial that will explore the use of two variants of ECHO for improving outcomes for adolescents with anorexia nervosa (AN) referred for outpatient care. Adolescent patients and their carers (typically parents and close others in a supportive role) will be recruited from 38 eating disorde...

  17. 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...

  18. 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 ...

  19. 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...

  20. 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...

  1. Use of weekly, low dose, high frequency ultrasound for hard to heal venous leg ulcers: The VenUS III randomised controlled trial

    OpenAIRE

    Watson, JM; Kang'ombe, AR; Soares, MO; Chuang, L-H; Worthy, G; Bland, JM; C. Iglesias; Cullum, N; Torgerson, D; Nelson, EA

    2011-01-01

    Objective: To assess the clinical effectiveness of weekly delivery of low dose, high frequency therapeutic ultrasound in conjunction with standard care for hard to heal venous leg ulcers. Design: Multicentre, pragmatic, two arm randomised controlled trial. Setting: Community and district nurse led services, community leg ulcer clinics, and hospital outpatient leg ulcer clinics in 12 urban and rural settings (11 in the United Kingdom and one in the Republic of Ireland). Participants: 337 patie...

  2. The Cost Effectiveness of Maintenance Schedules Following Pulmonary Rehabilitation in Patients with Chronic Obstructive Pulmonary Disease: An Economic Evaluation Alongside a Randomised Controlled Trial

    OpenAIRE

    Burns, Darren K.; Wilson, Edward C F; Browne, Paula; Olive, Sandra; Clark, Allan; Galey, Penny; Dix, Emma; Woodhouse, Helene; Robinson, Sue; Wilson, Andrew

    2015-01-01

    Background Chronic obstructive pulmonary disease (COPD) affects approximately 3 million people in the UK. An 8-week pulmonary rehabilitation (PR) course is recommended under current guidelines. However, studies show that initial benefits diminish over time. Objective We present here an economic evaluation conducted alongside a randomised controlled trial (RCT) of a low-intensity maintenance programme over a time horizon of 1 year delivered in UK primary and secondary care settings. Methods Pa...

  3. The cost effectiveness of maintenance schedules following pulmonary rehabilitation in patients with chronic obstructive pulmonary disease: an economic evaluation alongside a randomised controlled trial

    OpenAIRE

    Burns, Darren; Wilson, Edward; Browne, Paula; Olive, Sandra; Clark, Allan; Galey, Penny; Dix, Emma; Woodhouse, Helene; Robinson, Sue; Wilson, Andrew

    2016-01-01

    Background: Chronic obstructive pulmonary disease (COPD) affects approximately 3 million people in the UK. An 8-week pulmonary rehabilitation (PR) course is recommended under current guidelines. However, studies show that initial benefits diminish over time. Objective: We present here an economic evaluation conducted alongside a randomised controlled trial (RCT) of a low-intensity maintenance programme over a time horizon of 1 year delivered in UK primary and secondary care settings. Methods:...

  4. 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 ...

  5. Randomised phase II trial of hyperbaric oxygen therapy in patients with chronic arm lymphoedema after radiotherapy for cancer

    International Nuclear Information System (INIS)

    Background: A non-randomised phase II study suggested a therapeutic effect of hyperbaric oxygen (HBO) therapy on arm lymphoedema following adjuvant radiotherapy for early breast cancer, justifying further investigation in a randomised trial. Methods: Fifty-eight patients with ≥15% increase in arm volume after supraclavicular ± axillary radiotherapy (axillary surgery in 52/58 patients) were randomised in a 2:1 ratio to HBO (n = 38) or to best standard care (n = 20). The HBO group breathed 100% oxygen at 2.4 atmospheres absolute for 100 min on 30 occasions over 6 weeks. Primary endpoint was ipsilateral limb volume expressed as a percentage of contralateral limb volume. Secondary endpoints included fractional removal rate of radioisotopic tracer from the arm, extracellular water content, patient self-assessments and UK SF-36 Health Survey Questionnaire. Findings: Of 53/58 (91.4%) patients with baseline assessments, 46 had 12-month assessments (86.8%). Median volume of ipsilateral limb (relative to contralateral) at baseline was 133.5% (IQR 126.0-152.3%) in the control group, and 135.5% (IQR 126.5-146.0%) in the treatment group. Twelve months after baseline the median (IQR) volume of the ipsilateral limb was 131.2% (IQR 122.7-151.5%) in the control group and 133.5% (IQR 122.3-144.9%) in the treatment group. Results for the secondary endpoints were similar between randomised groups. Interpretation: No evidence has been found of a beneficial effect of HBO in the treatment of arm lymphoedema following primary surgery and adjuvant radiotherapy for early breast cancer.

  6. 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.

  7. 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.

  8. 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.

  9. 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

  10. 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

  11. 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

  12. In type 2 diabetes, randomisation to advice to follow a low-carbohydrate diet transiently improves glycaemic control compared with advice to follow a low-fat diet producing a similar weight loss

    OpenAIRE

    Guldbrand, Hans; Dizdar, B.; Bunjaku, B.; Lindström, Torbjörn; Bachrach-Lindström, Margareta; Fredrikson, Mats; Östgren, Carl Johan; Nyström, Fredrik H.

    2012-01-01

    Aims/hypothesis The study aimed to compare the effects of a 2 year intervention with a low-fat diet (LFD) or a low-carbohydrate diet (LCD), based on four group meetings to achieve compliance. Methods This was a prospective randomised parallel trial involving 61 adults with type 2 diabetes consecutively recruited in primary care and randomised by drawing ballots. Patients that did not speak Swedish could not be recruited. The primary outcomes in this non-blinded study were weight and HbA1c. Pa...

  13. 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…

  14. 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

  15. Structured home visits to older people. Are they only of benefit for women? A randomised controlled trial

    DEFF Research Database (Denmark)

    Vass, Mikkel; Avlund, Kirsten; Kvist, Kajsa; Hendriksen, Carsten; Andersen, Christian K; Keiding, Niels

    2004-01-01

    OBJECTIVE: To investigate whether education of primary care professionals improved functional ability in home-dwelling older people, with special focus on gender differences. DESIGN: A prospective controlled three-year follow-up study (1999-2001) with randomisation and intervention at municipality...... municipalities. SUBJECTS: 5788 home-dwelling 75- and 80-year-olds were invited. 4060 (70.1%) participated: 2104 in 17 intervention- and 1956 in 17 matched control-municipalities. The main outcome measure was obtained from 3383 (95.6%) of 3540 surviving participants. MAIN OUTCOME MEASURE: Functional ability...

  16. 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.

  17. Neonatal ECMO Study of Temperature (NEST - a randomised controlled trial

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    Juszczak Edmund

    2010-04-01

    Full Text Available Abstract Background Existing evidence indicates that once mature neonates with severe cardio-respiratory failure become eligible for Extra Corporeal Membrane Oxygenation (ECMO their chances of intact survival are doubled if they actually receive ECMO. However, significant numbers survive with disability. NEST is a multi-centre randomised controlled trial designed to test whether, in neonates requiring ECMO, cooling to 34°C for the first 48 to 72 hours of their ECMO course leads to improved later health status. Infants allocated to the control group will receive ECMO at 37°C throughout their course, which is currently standard practice around the world. Health status of both groups will be assessed formally at 2 years corrected age. Methods/Design All infants recruited to the study will be cared for in one of the four United Kingdom (UK ECMO centres. Babies who are thought to be eligible will be assessed by the treating clinician who will confirm eligibility, ensure that consent has been obtained and then randomise the baby using a web based system, based at the National Perinatal Epidemiology Unit (NPEU Clinical Trials Unit. Trial registration. Babies allocated ECMO without cooling will receive ECMO at 37°C ± 0.2°C. Babies allocated ECMO with cooling will be managed at 34°C ± 0.2°C for up to 72 hours from the start of their ECMO run. The minimum duration of cooling will be 48 hours. Rewarming (to 37°C will occur at a rate of no more than 0.5°C per hour. All other aspects of ECMO management will be identical. Primary outcome: Cognitive score from the Bayley Scales of Infant and Toddler Development, 3rd edition (Bayley-III at age of 2 years (24 - 27 months. Discussion For the primary analysis, children will be analysed in the groups to which they are assigned, comparing the outcome of all babies allocated to "ECMO with cooling" with all those allocated to "ECMO" alone, regardless of deviation from the protocol or treatment received. For

  18. 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

  19. Effectiveness of mat Pilates or equipment-based Pilates in patients with chronic non-specific low back pain: a protocol of a randomised controlled trial

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    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

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

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    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

  1. 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

    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......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...... 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...

  2. 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

  3. Practice nurse involvement in primary care depression management: an observational cost-effectiveness analysis

    OpenAIRE

    Gray, Jodi; Haji Ali Afzali, Hossein; Beilby, Justin; Holton, Christine; Banham, David; Karnon, Jonathan

    2014-01-01

    Background Most evidence on the effect of collaborative care for depression is derived in the selective environment of randomised controlled trials. In collaborative care, practice nurses may act as case managers. The Primary Care Services Improvement Project (PCSIP) aimed to assess the cost-effectiveness of alternative models of practice nurse involvement in a real world Australian setting. Previous analyses have demonstrated the value of high level practice nurse involvement in the manageme...

  4. Psychological treatment of depression in primary care: a meta-analysis

    OpenAIRE

    Cuijpers, P.; Straten, van, A.; Schaik, van, I.N.; Andersson, G.

    2009-01-01

    Abstract: Background Although most depressive disorders are treated in primary care and several studies have examined the effects of psychological treatment in primary care, hardly any meta-analytic research has been conducted in which the results of these studies are integrated. Aim To integrate the results of randomised controlled trials of psychological treatment of depression in adults in primary care, and to compare these results to psychological treatments in other settings. Design of s...

  5. 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

  6. 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

  7. The angiotensin-receptor blocker candesartan for treatment of acute stroke (SCAST): a randomised, placebo-controlled, double-blind trial

    DEFF Research Database (Denmark)

    Sandset, Else Charlotte; Bath, Philip M W; Boysen, Gudrun;

    2011-01-01

    BACKGROUND: Raised blood pressure is common in acute stroke, and is associated with an increased risk of poor outcomes. We aimed to examine whether careful blood-pressure lowering treatment with the angiotensin-receptor blocker candesartan is beneficial in patients with acute stroke and raised...... blood pressure. METHODS: Participants in this randomised, placebo-controlled, double-blind trial were recruited from 146 centres in nine north European countries. Patients older than 18 years with acute stroke (ischaemic or haemorrhagic) and systolic blood pressure of 140 mm Hg or higher were included...... within 30 h of symptom onset. Patients were randomly allocated to candesartan or placebo (1:1) for 7 days, with doses increasing from 4 mg on day 1 to 16 mg on days 3 to 7. Randomisation was stratified by centre, with blocks of six packs of candesartan or placebo. Patients and investigators were masked...

  8. Stress ulcer prophylaxis versus placebo or no prophylaxis in critically ill patients. A systematic review of randomised clinical trials with meta-analysis and trial sequential analysis

    DEFF Research Database (Denmark)

    Krag, Mette; Perner, Anders; Wetterslev, Jørn;

    2014-01-01

    PURPOSE: To assess the effects of stress ulcer prophylaxis (SUP) versus placebo or no prophylaxis on all-cause mortality, gastrointestinal (GI) bleeding and hospital-acquired pneumonia in adult critically ill patients in the intensive care unit (ICU). METHODS: We performed a systematic review using...... meta-analysis and trial sequential analysis (TSA). Eligible trials were randomised clinical trials comparing proton pump inhibitors or histamine 2 receptor antagonists with either placebo or no prophylaxis. Two reviewers independently assessed studies for inclusion and extracted data. The Cochrane...... finding. CONCLUSIONS: This systematic review using meta-analysis and TSA demonstrated that both the quality and the quantity of evidence supporting the use of SUP in adult ICU patients is low. Consequently, large randomised clinical trials are warranted....

  9. 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...

  10. 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...

  11. 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

  12. Cluster randomised trials in the medical literature: two bibliometric surveys

    Directory of Open Access Journals (Sweden)

    Bland J Martin

    2004-08-01

    Full Text Available Abstract Background Several reviews of published cluster randomised trials have reported that about half did not take clustering into account in the analysis, which was thus incorrect and potentially misleading. In this paper I ask whether cluster randomised trials are increasing in both number and quality of reporting. Methods Computer search for papers on cluster randomised trials since 1980, hand search of trial reports published in selected volumes of the British Medical Journal over 20 years. Results There has been a large increase in the numbers of methodological papers and of trial reports using the term 'cluster random' in recent years, with about equal numbers of each type of paper. The British Medical Journal contained more such reports than any other journal. In this journal there was a corresponding increase over time in the number of trials where subjects were randomised in clusters. In 2003 all reports showed awareness of the need to allow for clustering in the analysis. In 1993 and before clustering was ignored in most such trials. Conclusion Cluster trials are becoming more frequent and reporting is of higher quality. Perhaps statistician pressure works.

  13. Outcomes in a Randomised Controlled Trial of Mathematics Tutoring

    Science.gov (United States)

    Topping, K. J.; Miller, D.; Murray, P.; Henderson, S.; Fortuna, C.; Conlin, N.

    2011-01-01

    Background: Large-scale randomised controlled trials (RCT) are relatively rare in education. The present study was an attempt to scale up previous small peer tutoring projects, while investing only modestly in continuing professional development for teachers. Purpose: A two-year RCT of peer tutoring in mathematics was undertaken in one local…

  14. 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...

  15. 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

  16. Telerehabilitation to improve outcomes for people with stroke: study protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Saywell Nicola

    2012-12-01

    Full Text Available Abstract Background In New Zealand, around 45,000 people live with stroke and many studies have reported that benefits gained during initial rehabilitation are not sustained. Evidence indicates that participation in physical interventions can prevent the functional decline that frequently occurs after discharge from acute care facilities. However, on-going stroke services provision following discharge from acute care is often related to non-medical factors such as availability of resources and geographical location. Currently most people receive no treatment beyond three months post stroke. The study aims to determine if the Augmented Community Telerehabilitation Intervention (ACTIV results in better physical function for people with stroke than usual care, as measured by the Stroke Impact Scale, physical subcomponent. Methods/design This study will use a multi-site, two-arm, assessor blinded, parallel randomised controlled trial design. People will be eligible if they have had their first ever stroke, are over 20 and have some physical impairment in either arm or leg, or both. Following discharge from formal physiotherapy services (inpatient, outpatient or community, participants will be randomised into ACTIV or usual care. ACTIV uses readily available technology, telephone and mobile phones, combined with face-to-face visits from a physiotherapist over a six-month period, to help people with stroke resume activities they enjoyed before the stroke. The impact of stroke on physical function and quality of life will be assessed, measures of cost will be collected and a discrete choice survey will be used to measure preferences for rehabilitation options. These outcomes will be collected at baseline, six months and 12 months. In-depth interviews will be used to explore the experiences of people participating in the intervention arm of the study. Discussion The lack of on-going rehabilitation for people with stroke diminishes the chance of their

  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. 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...

  19. 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

  20. 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

  1. 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.

  2. 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

    . 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...

  3. A randomised controlled trial of ion-exchange water softeners for the treatment of eczema in children.

    Directory of Open Access Journals (Sweden)

    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.

  4. 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

  5. ProsCan for Men: Randomised controlled trial of a decision support intervention for men with localised prostate cancer

    Directory of Open Access Journals (Sweden)

    Gardiner RA

    2008-07-01

    Full Text Available Abstract Background Prostate cancer is the most common male cancer in the Western world but is highly heterogeneous in disease progression and outcomes. Consequently, the most substantial morbidity may actually arise from the adverse psychosocial impact of distress in decision-making and long term quality of life effects such as impotence. This paper presents the design of a randomised controlled trial of a decision support/psychosocial intervention for men newly diagnosed with localised prostate cancer. Methods/Design 350 men per condition (700 men in total have been recruited after diagnosis and before treatment through urology private practices and hospital outpatient clinics and randomised to 1 a tele-based nurse delivered five session decision support/psychosocial intervention or 2 a usual care control group. Two intervention sessions are delivered before treatment that address decision support, stress management and preparation for treatment. Three further sessions are provided three weeks, seven weeks and five months after treatment that focus on adjustment to cancer, problem solving and coping with treatment side effects. Participants are assessed at baseline (before treatment and 2, 6, 12, 24 and 36 months post-treatment. Outcome measures include: cancer threat appraisal; decision-related distress and bother from treatment side effects; involvement in decision making; satisfaction with health care; heath care utilisation; use of health care resources; and a return to previous activities. Discussion The study will provide recommendations about the efficacy of early decision support to facilitate adjustment after prostate cancer. As well the study will identify men diagnosed with localised prostate cancer at risk of poorer long term psychosocial adjustment. Trial Registration ACTRN012607000233426.

  6. 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

  7. 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

  8. A randomised controlled trial of patient led training in medical education: protocol

    Directory of Open Access Journals (Sweden)

    Watt Ian

    2010-12-01

    Full Text Available Abstract Background Estimates suggest that approximately 1 in 10 patients admitted to hospital experience an adverse event resulting in harm. Methods to improve patient safety have concentrated on developing safer systems of care and promoting changes in professional behaviour. There is a growing international interest in the development of interventions that promote the role of patients preventing error, but limited evidence of effectiveness of such interventions. The present study aims to undertake a randomised controlled trial of patient-led teaching of junior doctors about patient safety. Methods/Design A randomised cluster controlled trial will be conducted. The intervention will be incorporated into the mandatory training of junior doctors training programme on patient safety. The study will be conducted in the Yorkshire and Humber region in the North of England. Patients who have experienced a safety incident in the NHS will be recruited. Patients will be identified through National Patient Safety Champions and local Trust contacts. Patients will receive training and be supported to talk to small groups of trainees about their experiences. The primary aim of the patient-led teaching module is to increase the awareness of patient safety issues amongst doctors, allow reflection on their own attitudes towards safety and promote an optimal culture among the doctors to improve safety in practice. A mixture of qualitative and quantitative methods will be used to evaluate the impact of the intervention, using the Attitudes to Patient Safety Questionnaire (APSQ as our primary quantitative outcome, as well as focus groups and semi-structured interviews. Discussion The research team face a number of challenges in developing the intervention, including integrating a new method of teaching into an existing curriculum, facilitating effective patient involvement and identifying suitable outcome measures. Trial Registration Current controlled Trials

  9. 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

  10. 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.

  11. 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...

  12. Protocol for the OUTREACH trial: a randomised trial comparing delivery of cancer systemic therapy in three different settings - patient's home, GP surgery and hospital day unit

    Directory of Open Access Journals (Sweden)

    McCrone Paul

    2011-10-01

    Full Text Available Abstract Background The national Cancer Reform Strategy recommends delivering care closer to home whenever possible. Cancer drug treatment has traditionally been administered to patients in specialist hospital-based facilities. Technological developments mean that nowadays, most treatment can be delivered in the out-patient setting. Increasing demand, care quality improvements and patient choice have stimulated interest in delivering some treatment to patients in the community, however, formal evaluation of delivering cancer treatment in different community settings is lacking. This randomised trial compares delivery of cancer treatment in the hospital with delivery in two different community settings: the patient's home and general practice (GP surgeries. Methods/design Patients due to receive a minimum 12 week course of standard intravenous cancer treatment at two hospitals in the Anglia Cancer Network are randomised on a 1:1:1 basis to receive treatment in the hospital day unit (control arm, or their own home, or their choice of one of three neighbouring GP surgeries. Overall patient care, treatment prescribing and clinical review is undertaken according to standard local practice. All treatment is dispensed by the local hospital pharmacy and treatment is delivered by the hospital chemotherapy nurses. At four time points during the 12 week study period, information is collected from patients, nursing staff, primary and secondary care teams to address the primary end point, patient-perceived benefits (using the emotional function domain of the EORTC QLQC30 patient questionnaire, as well as secondary end points: patient satisfaction, safety and health economics. Discussion The Outreach trial is the first randomised controlled trial conducted which compares delivery of out-patient based intravenous cancer treatment in two different community settings with standard hospital based treatment. Results of this study may better inform all key

  13. 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...

  14. 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:

  15. Transcutaneous electrical nerve stimulation (TENS reduces pain and postpones the need for pharmacological analgesia during labour: a randomised trial

    Directory of Open Access Journals (Sweden)

    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

  16. A randomised clinical trial of intrapartum fetal monitoring with computer analysis and alerts versus previously available monitoring

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    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

  17. 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.

  18. Evaluation of Lay Support in Pregnant women with Social risk (ELSIPS: a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    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

  19. Multidisciplinary and multifaceted outpatient management of patients with osteoarthritis: protocol for a randomised, controlled trial

    Directory of Open Access Journals (Sweden)

    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

  20. Comparison communities in a cluster randomised trial innovate in response to 'being controlled'.

    Science.gov (United States)

    Hawe, Penelope; Riley, Therese; Gartrell, Alexandra; Turner, Karen; Canales, Claudia; Omstead, Darlene

    2015-05-01

    We conducted qualitative interviews among primary health care teams and community agencies in eight communities in Victoria, Australia which had (1) agreed to be part of a universal primary care and community development intervention to reduce post natal depression and promote maternal health; and (2) were randomised to the comparison arm. The purpose was to document their experience with and interpretation of the trial. Although 'control' in a controlled trial refers to the control of confounding of the trial result by factors other than allocation to the intervention, participants interpreted 'control' to mean restrictions on what they were allowed to do during the trial period. They had agreed not to use the Edinburgh Post Natal Depression Scale or the SF 36 in clinical practice and not to implement any of the elements of the intervention. We found that no elements of the intervention were implemented. However, the extension of the trial from three to five years made the trial agreement a strain. The imposition of trial conditions also encouraged a degree of lateral thinking and innovation in service delivery (quality improvement). This may have potentially contributed to the null trial results. The observations invite interrogation of intervention theory and consequent rethinking of the way contamination in a cluster trial is defined. PMID:25863725

  1. The SafeBoosC Phase II Randomised Clinical Trial

    DEFF Research Database (Denmark)

    Pellicer, Adelina; Greisen, Gorm; Benders, Manon;

    2013-01-01

    Near-infrared spectroscopy-derived regional tissue oxygen saturation of haemoglobin (rStO2) reflects venous oxygen saturation. If cerebral metabolism is stable, rStO2 can be used as an estimate of cerebral oxygen delivery. The SafeBoosC phase II randomised clinical trial hypothesises....... The treatment guideline is presented to assist neonatologists in making decisions in relation to cerebral oximetry readings in preterm infants within the SafeBoosC phase II randomised clinical trial. The evidence grades were relatively low and the guideline cannot be recommended outside a research setting...... of the literature and assessment of the quality of evidence and the grade of recommendation for each of the interventions. Results and Conclusions: A clinical intervention algorithm based on the main determinants of cerebral perfusion-oxygenation changes during the first hours after birth was generated...

  2. 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....

  3. The effect of motivational interviewing on glycaemic control and perceived competence of diabetes self-management in patients with type 1 and type 2 diabetes mellitus after attending a group education programme: a randomised controlled trial

    DEFF Research Database (Denmark)

    Rosenbek Minet, L K; Wagner, L; Lønvig, E M;

    2011-01-01

    education programme, 349 patients were randomised to either a usual care control group or an intervention group, which received up to five individual counselling sessions in 1 year based on MI, in addition to usual care. A randomised parallel design was used and open-label allocation was done by random...... permuted blocks, with allocation concealment by sequentially numbered, sealed, opaque envelopes. The primary outcome was glycated haemoglobin (HbA(1c)). Analysis regarding measurements of glycated haemoglobin (HbA(1c)) and competence of self-management (using the Problem Areas in Diabetes Scale [PAID] and...... programme, and who have well-regulated diabetes. TRIAL REGISTRATION: Clinical Trials NCT00555854. FUNDING: The National Board of Health, Funen County, Danish Association of Diabetes, Odense University Hospital, University of Southern Denmark and TRYG Fonden....

  4. Whole home exercise intervention for depression in older care home residents (the OPERA study): a process evaluation

    OpenAIRE

    Ellard, DR; Thorogood, M; Underwood, M; Seale, C.; Taylor, SJC

    2014-01-01

    Background: The 'Older People's Exercise intervention in Residential and nursing Accommodation' (OPERA) cluster randomised trial evaluated the impact of training for care home staff together with twice-weekly, physiotherapist-led exercise classes on depressive symptoms in care home residents, but found no effect. We report a process evaluation exploring potential explanations for the lack of effect.Methods: The OPERA trial included over 1,000 residents in 78 care homes in the UK. We used a mi...

  5. 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...

  6. Psychological rehabilitation after myocardial infarction: multicentre randomised controlled trial.

    OpenAIRE

    Jones, D. A.; West, R R

    1996-01-01

    OBJECTIVE: To evaluate rehabilitation after myocardial infarction. DESIGN: Randomised controlled trial of rehabilitation in unselected myocardial infarction patients in six centres, baseline data being collected on admission and by structured interview (of patients and spouses) shortly after discharge and outcome being assessed by structured interview at six months and clinical examination at 12 months. SETTING: Six district general hospitals. SUBJECTS: All 2328 eligible patients admitted ove...

  7. 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...

  8. Randomised controlled trial of intrapartum fetal heart rate monitoring.

    OpenAIRE

    Mahomed, K.; Nyoni, R.; Mulambo, T.; Kasule, J.; Jacobus, E.

    1994-01-01

    OBJECTIVE--To compare effectiveness of different methods of monitoring intrapartum fetal heart rate. DESIGN--Prospective randomised controlled trial. SETTING--Referral maternity hospital, Harare, Zimbabwe. SUBJECTS--1255 women who were 37 weeks or more pregnant with singleton cephalic presentation and normal fetal heart rate before entry into study. INTERVENTIONS--Intermittent monitoring of fetal heart rate by electronic monitoring, Doppler ultrasound, use of Pinard stethoscope by a research ...

  9. Colostomy or ileostomy after colorectal anastomosis?: a randomised trial.

    OpenAIRE

    Khoury, G A; Lewis, M.C.; Meleagros, L; Lewis, A A

    1987-01-01

    Sixty one patients were entered in a randomised trial to compare transverse loop colostomy with loop ileostomy after a colorectal anastomosis thought to be at risk of dehiscence. Radiologically proven breakdown of the colorectal anastomosis occurred in 13% of these selected patients and most frequently in the colostomy group. Ileostomies functioned earlier than colostomies (P less than 0.001) but there was no other significant difference in outcome between the groups. In 52 patients intestina...

  10. Compliance therapy in psychotic patients: randomised controlled trial.

    OpenAIRE

    Kemp, R; Hayward, P.; Applewhaite, G.; Everitt, B; David, A

    1996-01-01

    OBJECTIVE--To determine whether compliance therapy, a cognitive-behavioural intervention, could improve compliance with treatment and hence social adjustment in acutely psychotic inpatients, and if so, whether the effect persisted six months later. DESIGN--Randomised controlled trial of compliance therapy and non-specific counselling, each comprising 4-6 sessions lasting 10-60 minutes. SETTING--Acute psychiatric admissions ward serving an inner London catchment area. SUBJECTS--47 patients wit...

  11. Improper analysis of trials randomised using stratified blocks or minimisation

    OpenAIRE

    Kahan, B. C.; Morris, T. P.

    2012-01-01

    Many clinical trials restrict randomisation using stratified blocks or minimisation to balance prognostic factors across treatment groups. It is widely acknowledged in the statistical literature that the subsequent analysis should reflect the design of the study, and any stratification or minimisation variables should be adjusted for in the analysis. However, a review of recent general medical literature showed only 14 of 41 eligible studies reported adjusting their primary analysis for strat...

  12. 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...

  13. Randomised controlled trial of azathioprine withdrawal in ulcerative colitis.

    OpenAIRE

    Hawthorne, A. B.; Logan, R. F.; Hawkey, C. J.; Foster, P. N.; Axon, A T; Swarbrick, E T; Scott, B B; Lennard-Jones, J E

    1992-01-01

    OBJECTIVE--To determine whether azathioprine can prevent relapse in ulcerative colitis. DESIGN--One year placebo controlled double blind trial of withdrawal or continuation of azathioprine. SETTING--Outpatient clinics of five hospitals. SUBJECTS--79 patients with ulcerative colitis who had been taking azathioprine for six months or more. Patients in full remission for two months or more (67), and patients with chronic low grade or corticosteroid dependent disease (12) were randomised separate...

  14. The Happy Life Club™ study protocol: A cluster randomised controlled trial of a type 2 diabetes health coach intervention

    Directory of Open Access Journals (Sweden)

    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

  15. Improving the management of multimorbidity in general practice: protocol of a cluster randomised controlled trial (The 3D Study)

    Science.gov (United States)

    Chaplin, Katherine; Bower, Peter; Brookes, Sara; Fitzpatrick, Bridie; Guthrie, Bruce; Shaw, Alison; Mercer, Stewart; Rafi, Imran; Thorn, Joanna

    2016-01-01

    Introduction An increasing number of people are living with multimorbidity. The evidence base for how best to manage these patients is weak. Current clinical guidelines generally focus on single conditions, which may not reflect the needs of patients with multimorbidity. The aim of the 3D study is to develop, implement and evaluate an intervention to improve the management of patients with multimorbidity in general practice. Methods and analysis This is a pragmatic two-arm cluster randomised controlled trial. 32 general practices around Bristol, Greater Manchester and Glasgow will be randomised to receive either the ‘3D intervention’ or usual care. 3D is a complex intervention including components affecting practice organisation, the conduct of patient reviews, integration with secondary care and measures to promote change in practice organisation. Changes include improving continuity of care and replacing reviews of each disease with patient-centred reviews with a focus on patients' quality of life, mental health and polypharmacy. We aim to recruit 1383 patients who have 3 or more chronic conditions. This provides 90% power at 5% significance level to detect an effect size of 0.27 SDs in the primary outcome, which is health-related quality of life at 15 months using the EQ-5D-5L. Secondary outcome measures assess patient centredness, illness burden and treatment burden. The primary analysis will be a multilevel regression model adjusted for baseline, stratification/minimisation, clustering and important co-variables. Nested process evaluation will assess implementation, mechanisms of effectiveness and interaction of the intervention with local context. Economic analysis of cost-consequences and cost-effectiveness will be based on quality-adjusted life years. Ethics and dissemination This study has approval from South-West (Frenchay) National Health Service (NHS) Research Ethics Committee (14/SW/0011). Findings will be disseminated via final report, peer

  16. 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

  17. Randomised controlled feasibility trial of an evidence-informed behavioural intervention for obese adults with additional risk factors.

    Directory of Open Access Journals (Sweden)

    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

  18. Surgery versus Active Monitoring in Intermittent Exotropia (SamExo: study protocol for a pilot randomised controlled trial

    Directory of Open Access Journals (Sweden)

    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

  19. Clinical effectiveness of a skills training intervention for caregivers in improving patient and caregiver health following in-patient treatment for severe anorexia nervosa:Pragmatic randomised controlled trial

    OpenAIRE

    Hibbs, Rebecca Joanne; Magill, Nicholas; Goddard, Elizabeth; Rhind, Charlotte Anne-Marie Navarra; Raenker, Simone; Macdonald, Pamela; Todd, Gill; Arcelus, Jon; Morgan, John; Beecham, Jennifer; Schmidt, Ulrike Hermine; Landau, Sabine; Treasure, Janet Linda

    2015-01-01

    Background Families express a need for information to support people with severe anorexia nervosa.Aims To examine the impact of the addition of a skills training intervention for caregivers (Experienced Caregivers Helping Others, ECHO) to standard care.Method Patients over the age of 12 (mean age 26 years, duration 72 months illness) with a primary diagnosis of anorexia nervosa and their caregivers were recruited from 15 in-patient services in the UK. Families were randomised to ECHO (a book,...

  20. 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...

  1. 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.

  2. 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

  3. Preventing mental health problems in children: the Families in Mind population-based cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Hiscock Harriet

    2012-06-01

    Full Text Available Abstract Background Externalising and internalising problems affect one in seven school-aged children and are the single strongest predictor of mental health problems into early adolescence. As the burden of mental health problems persists globally, childhood prevention of mental health problems is paramount. Prevention can be offered to all children (universal or to children at risk of developing mental health problems (targeted. The relative effectiveness and costs of a targeted only versus combined universal and targeted approach are unknown. This study aims to determine the effectiveness, costs and uptake of two approaches to early childhood prevention of mental health problems ie: a Combined universal-targeted approach, versus a Targeted only approach, in comparison to current primary care services (Usual care. Methods/design Three armed, population-level cluster randomised trial (2010–2014 within the universal, well child Maternal Child Health system, attended by more than 80% of families in Victoria, Australia at infant age eight months. Participants were families of eight month old children from nine participating local government areas. Randomised to one of three groups: Combined, Targeted or Usual care. The interventions comprises (a the Combined universal and targeted program where all families are offered the universal Toddlers Without Tears group parenting program followed by the targeted Family Check-Up one-on-one program or (b the Targeted Family Check-Up program. The Family Check-Up program is only offered to children at risk of behavioural problems. Participants will be analysed according to the trial arm to which they were randomised, using logistic and linear regression models to compare primary and secondary outcomes. An economic evaluation (cost consequences analysis will compare incremental costs to all incremental outcomes from a societal perspective. Discussion This trial will inform public health policy by making

  4. 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...

  5. 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.

  6. Are adaptive randomised trials or non-randomised studies the best way to address the Ebola outbreak in west Africa?

    Science.gov (United States)

    Lanini, Simone; Zumla, Alimuddin; Ioannidis, John P A; Di Caro, Antonino; Krishna, Sanjeev; Gostin, Lawrence; Girardi, Enrico; Pletschette, Michel; Strada, Gino; Baritussio, Aldo; Portella, Gina; Apolone, Giovanni; Cavuto, Silvio; Satolli, Roberto; Kremsner, Peter; Vairo, Francesco; Ippolito, Giuseppe

    2015-06-01

    The Ebola outbreak that has devastated parts of west Africa represents an unprecedented challenge for research and ethics. Estimates from the past three decades emphasise that the present effort to contain the epidemic in the three most affected countries (Guinea, Liberia, and Sierra Leone) has been insufficient, with more than 24,900 cases and about 10,300 deaths, as of March 25, 2015. Faced with such an exceptional event and the urgent response it demands, the use of randomised controlled trials (RCT) for Ebola-related research might be both unethical and infeasible and that potential interventions should be assessed in non-randomised studies on the basis of compassionate use. However, non-randomised studies might not yield valid conclusions, leading to large residual uncertainty about how to interpret the results, and can also waste scarce intervention-related resources, making them profoundly unethical. Scientifically sound and rigorous study designs, such as adaptive RCTs, could provide the best way to reduce the time needed to develop new interventions and to obtain valid results on their efficacy and safety while preserving the application of ethical precepts. We present an overview of clinical studies registered at present at the four main international trial registries and provide a simulation on how adaptive RCTs can behave in this context, when mortality varies simultaneously in either the control or the experimental group. PMID:25881871

  7. 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

  8. 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...

  9. Prenatal Care

    Science.gov (United States)

    ... 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 ...

  10. 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 ...

  11. Is an Intervention Using Computer Software Effective in Literacy Learning? A Randomised Controlled Trial

    Science.gov (United States)

    Brooks, G.; Miles, J. N. V.; Torgerson, C. J.; Torgerson, D. J.

    2006-01-01

    Background: Computer software is widely used to support literacy learning. There are few randomised trials to support its effectiveness. Therefore, there is an urgent need to rigorously evaluate computer software that supports literacy learning. Methods: We undertook a pragmatic randomised controlled trial among pupils aged 11-12 within a single…

  12. 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...

  13. Inconsistent reporting of surrogate outcomes in randomised clinical trials: cohort study

    DEFF Research Database (Denmark)

    La Cour, Jeppe Lerche; Brok, Jesper; Gøtzsche, Peter C

    2010-01-01

    To assess if authors of randomised clinical trials convey the fact that they have used surrogate outcomes and discussed their validity.......To assess if authors of randomised clinical trials convey the fact that they have used surrogate outcomes and discussed their validity....

  14. A randomised trial of an internet weight control resource: The UK Weight Control Trial [ISRCTN58621669

    Directory of Open Access Journals (Sweden)

    Thomas James D

    2003-10-01

    Full Text Available Abstract Background Obesity treatment is notoriously unsuccessful and one of the barriers to successful weight loss reported by patients is a lack of social support. The Internet offers a novel and fast approach to the delivery of health information, enabling 24-hour access to help and advice. However, much of the health information available on the Internet is unregulated or not written by qualified health professionals to provide unbiased information. The proposed study aims to compare a web-based weight loss package with traditional dietary treatment of obesity in participants. The project aims to deliver high quality information to the patient and to evaluate the effectiveness of this information, both in terms of weight loss outcomes and cost-effectiveness. Methods This study is a randomised controlled trial of a weight loss package against usual care provided within General Practice (GP surgeries in Leeds, UK. Participants will be recruited via posters placed in participating practices. A target recruitment figure of 220 will enable 180 people to be recruited (allowing for 22% dropout. Participants agreeing to take part in the study will be randomly allocated using minimisation to either the intervention group, receiving access to the Internet site, or the usual care group. The primary outcome of the study will be the ability of the package to promote change in BMI over 6 and 12 months compared with traditional treatment. Secondary outcomes will be the ability of the Internet package to promote change in reported lifestyle behaviours. Data will be collected on participant preferences, adherence to treatment, health care use and time off work. Difference in cost between groups in provision of the intervention and the cost of the primary outcome will also be estimated. Conclusion A positive result from this study would enhance the repertoire of treatment approaches available for the management of obesity. A negative result would be used to

  15. 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

  16. 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.

  17. Practices, patients and (imperfect data - feasibility of a randomised controlled clinical drug trial in German general practices

    Directory of Open Access Journals (Sweden)

    Hummers-Pradier Eva

    2011-04-01

    Full Text Available Abstract Background Randomised controlled clinical (drug trials supply high quality evidence for therapeutic strategies in primary care. Until now, experience with drug trials in German general practice has been sparse. In 2007/2008, the authors conducted an investigator-initiated, non-commercial, double-blind, randomised controlled pilot trial (HWI-01 to assess the clinical equivalence of ibuprofen and ciprofloxacin in the treatment of uncomplicated urinary tract infection (UTI. Here, we report the feasibility of this trial in German general practices and the implementation of Good Clinical Practice (GCP standards as defined by the International Conference on Harmonisation (ICH in mainly inexperienced general practices. Methods This report is based on the experience of the HWI-01 study conducted in 29 German general practices. Feasibility was defined by 1 successful practice recruitment, 2 sufficient patient recruitment, 3 complete and accurate data collection and 4 appropriate protection of patient safety. Results The final practice recruitment rate was 18%. In these practices, 79 of 195 screened UTI patients were enrolled. Recruitment differed strongly between practices (range 0-12, mean 2.8 patients per practice and was below the recruitment goal of approximately 100 patients. As anticipated, practice nurses became the key figures in the screening und recruitment of patients. Clinical trial demands, in particular for completing symptom questionnaires, documentation of source data and reporting of adverse events, did not agree well with GPs' documentation habits and required support from study nurses. In many cases, GPs and practice staff seemed to be overwhelmed by the amount of information and regulations. No sudden unexpected serious adverse reactions (SUSARs were observed during the trial. Conclusions To enable drug trials in general practice, it is necessary to adapt the setup of clinical research infrastructure to the needs of GPs and

  18. 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.

  19. The impact of gender on the long-term morbidity and mortality of patients with type 2 diabetes receiving structured personal care

    DEFF Research Database (Denmark)

    Krag, Marlene Øhrberg; Hasselbalch, Lotte; Siersma, Volkert Dirk;

    2016-01-01

    diabetes-related endpoint, myocardial infarction, stroke, peripheral vascular disease and microvascular disease. Results: In women, but not men, a lower HR for structured personal care vs routine care emerged for any diabetes-related endpoint (0.65, p = 0.004, adjusted; 73.4 vs 107.7 events per 1......Aims/hypothesis: The aim of this study was to assess gender differences in mortality and morbidity during 13 follow-up years after 6 years of structured personal care in patients with type 2 diabetes mellitus. Methods: In the Diabetes Care in General Practice (DCGP) multicentre, cluster......-randomised, controlled trial (ClinicalTrials.gov registration no. NCT01074762), 1,381 patients newly diagnosed with type 2 diabetes were randomised to receive 6 years of either structured personal care or routine care. The intervention included regular follow-up, individualised goal setting and continuing medical...

  20. 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

  1. Oral care in patients on mechanical ventilation in intensive care unit: literature review

    Directory of Open Access Journals (Sweden)

    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

  2. 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. PMID:1670796

  3. 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...

  4. 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

  5. Randomised controlled trial of nicotine chewing-gum.

    OpenAIRE

    Jarvis, M. J.; Raw, M.; Russell, M A; Feyerabend, C

    1982-01-01

    The effectiveness of 2 mg nicotine chewing-gum as an aid to stopping smoking was compared with a placebo containing 1 mg nicotine, but unbuffered, in a double-blind randomised trial. Of 58 subjects given the active gum, 27 (47%) were not smoking at one-year follow-up compared with 12 (21%) of the 58 subjects treated with placebo (p less than 0.025). By the most stringent criterion of outcome, 18 (31%) subjects in the active treatment group and eight (14%) in the placebo group had not smoked a...

  6. Randomised controlled trial of colloid infusions in hypotensive preterm infants.

    OpenAIRE

    Emery, E F; Greenough, A; Gamsu, H R

    1992-01-01

    Colloid infusions are often given to treat hypotension in preterm infants. The aim of this work was to assess whether it was the amount of protein or the volume of the colloid infused which accounted for the observed increase in blood pressure. Sixty preterm infants were randomised (20 in each group) to receive 5 ml/kg 20% albumin, 15 ml/kg fresh frozen plasma, or 15 ml/kg 4.5% albumin. All infusions were given at a rate of 5 ml/kg/hour in addition to maintenance fluids. The infants were rand...

  7. 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.

  8. 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

  9. 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.

  10. 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

  11. Health promotion and the randomised controlled trial: a square peg in a round hole?

    Directory of Open Access Journals (Sweden)

    Freeman Ruth

    2009-01-01

    Full Text Available Abstract In their paper published in BMC Oral Health in March, Barker and Horton present qualitative data which explored Latino parents' main concerns regarding accessing dental care for their pre-school children. In the radical discourse of health promotion the use of participant narratives is a first and essential step in community development interventions. While there is agreement regarding the development and implementation of health promotion, the means by which it is evaluated or the type of evaluation design used, is hotly debated. This commentary outlines the rationale of adopting a randomised controlled trial methodology, contrasts it with realistic evaluation and considers design evaluation in the light of the Medical Research Council's (MRC guidance of 2000 and 2008. It is at this juncture that the commentary suggests that, despite the MRC's acknowledgement of the limitations of its 2000 guidance, there remains, in the 2008 guidance, an underlying insistence to use design evaluations which control for selection bias and confounding extraneous factors. For the evaluation of health promotion interventions it may remain a case of fitting a square peg into a round hole.

  12. 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.

  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. Satisfaction of patients hospitalised in psychiatric hospitals: a randomised comparison of two psychiatric-specific and one generic satisfaction questionnaires

    Directory of Open Access Journals (Sweden)

    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.

  15. 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

  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. 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

  19. 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

  20. A cluster randomised controlled effectiveness trial evaluating perinatal home visiting among South African mothers/infants.

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    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

  1. 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

  2. Cost-effectiveness of an exercise program during pregnancy to prevent gestational diabetes: Results of an economic evaluation alongside a randomised controlled trial

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    Oostdam Nicolette

    2012-07-01

    Full Text Available Abstract Background The prevalence of gestational diabetes mellitus (GDM is increasing worldwide. GDM and the risks associated with GDM lead to increased health care costs and losses in productivity. The objective of this study is to evaluate whether the FitFor2 exercise program during pregnancy is cost-effective from a societal perspective as compared to standard care. Methods A randomised controlled trial (RCT and simultaneous economic evaluation of the FitFor2 program were conducted. Pregnant women at risk for GDM were randomised to an exercise program to prevent high maternal blood glucose (n = 62 or to standard care (n = 59. The exercise program consisted of two sessions of aerobic and strengthening exercises per week. Clinical outcome measures were maternal fasting blood glucose levels, insulin sensitivity and infant birth weight. Quality of life was measured using the EuroQol 5-D and quality-adjusted life-years (QALYs were calculated. Resource utilization and sick leave data were collected by questionnaires. Data were analysed according to the intention-to-treat principle. Missing data were imputed using multiple imputations. Bootstrapping techniques estimated the uncertainty surrounding the cost differences and incremental cost-effectiveness ratios. Results There were no statistically significant differences in any outcome measure. During pregnancy, total health care costs and costs of productivity losses were statistically non-significant (mean difference €1308; 95%CI €-229 - €3204. The cost-effectiveness analyses showed that the exercise program was not cost-effective in comparison to the control group for blood glucose levels, insulin sensitivity, infant birth weight or QALYs. Conclusion The twice-weekly exercise program for pregnant women at risk for GDM evaluated in the present study was not cost-effective compared to standard care. Based on these results, implementation of this exercise program for the prevention of

  3. Alcohol intake and cardiovascular risk factors: A Mendelian randomisation study.

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    Cho, Yoonsu; Shin, So-Youn; Won, Sungho; Relton, Caroline L; Davey Smith, George; Shin, Min-Jeong

    2015-01-01

    Mendelian randomisation studies from Asia suggest detrimental influences of alcohol on cardiovascular risk factors, but such associations are observed mainly in men. The absence of associations of genetic variants (e.g. rs671 in ALDH2) with such risk factors in women - who drank little in these populations - provides evidence that the observations are not due to genetic pleiotropy. Here, we present a Mendelian randomisation study in a South Korean population (3,365 men and 3,787 women) that 1) provides robust evidence that alcohol consumption adversely affects several cardiovascular disease risk factors, including blood pressure, waist to hip ratio, fasting blood glucose and triglyceride levels. Alcohol also increases HDL cholesterol and lowers LDL cholesterol. Our study also 2) replicates sex differences in associations which suggests pleiotropy does not underlie the associations, 3) provides further evidence that association is not due to pleiotropy by showing null effects in male non-drinkers, and 4) illustrates a way to measure population-level association where alcohol intake is stratified by sex. In conclusion, population-level instrumental variable estimation (utilizing interaction of rs671 in ALDH2 and sex as an instrument) strengthens causal inference regarding the largely adverse influence of alcohol intake on cardiovascular health in an Asian population. PMID:26687910

  4. Preventive evidence into practice (PEP study: implementation of guidelines to prevent primary vascular disease in general practice protocol for a cluster randomised controlled trial

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    Harris Mark F

    2013-01-01

    Full Text Available Abstract Background There are significant gaps in the implementation and uptake of evidence-based guideline recommendations for cardiovascular disease (CVD and diabetes in Australian general practice. This study protocol describes the methodology for a cluster randomised trial to evaluate the effectiveness of a model that aims to improve the implementation of these guidelines in Australian general practice developed by a collaboration between researchers, non-government organisations, and the profession. Methods We hypothesise that the intervention will alter the behaviour of clinicians and patients resulting in improvements of recording of lifestyle and physiological risk factors (by 20% and increased adherence to guideline recommendations for: the management of CVD and diabetes risk factors (by 20%; and lifestyle and physiological risk factors of patients at risk (by 5%. Thirty-two general practices will be randomised in a 1:1 allocation to receive either the intervention or continue with usual care, after stratification by state. The intervention will be delivered through: small group education; audit of patient records to determine preventive care; and practice facilitation visits adapted to the needs of the practices. Outcome data will be extracted from electronic medical records and patient questionnaires, and qualitative evaluation from provider and patient interviews. Discussion We plan to disseminate study findings widely and directly inform implementation strategies by governments, professional bodies, and non-government organisations including the partner organisations.

  5. Protocol for a pragmatic cluster randomised controlled trial for reducing irrational antibiotic prescribing among children with upper respiratory infections in rural China

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    Zou, Guanyang; Wei, Xiaolin; Hicks, Joseph P; Hu, Yanhong; Walley, John; Zeng, Jun; Elsey, Helen; King, Rebecca; Zhang, Zhitong; Deng, Simin; Huang, Yuanyuan; Blacklock, Claire; Yin, Jia; Sun, Qiang; Lin, Mei

    2016-01-01

    Introduction Irrational use of antibiotics is a serious issue within China and internationally. In 2012, the Chinese Ministry of Health issued a regulation for antibiotic prescriptions limiting them to cluster-randomised superiority trial, with blinded evaluation of outcomes and data analysis, and un-blinded treatment. From two counties in Guangxi Province, 12 township hospitals will be randomised to the intervention arm and 13 to the control arm. In the control arm, the management of antibiotics prescriptions will continue through usual care via clinical consultations. In the intervention arm, a provider and patient/caregiver focused intervention will be embedded within routine primary care practice. The provider intervention includes operational guidelines, systematic training, peer review of antibiotic prescribing and provision of health education to patient caregivers. We will also provide printed educational materials and educational videos to patients' caregivers. The primary outcome is the proportion of all prescriptions issued by providers for upper respiratory infections in children aged 2–14 years old, which include at least one antibiotic. Ethics and dissemination The trial has received ethical approval from the Ethics Committee of Guangxi Provincial Centre for Disease Control and Prevention, China. The results will be disseminated through workshops, policy briefs, peer-reviewed publications, local and international conferences. Trial registration number ISRCTN14340536; Pre-results. PMID:27235297

  6. Exercise Training in Pregnancy for obese women (ETIP: study protocol for a randomised controlled trial

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    Vik Torstein

    2011-06-01

    Full Text Available Background Both maternal pre-pregnancy obesity and excessive gestational weight gain are increasing in prevalence and associated with a number of adverse pregnancy outcomes for both mother and child. Observational studies regarding physical activity in pregnancy have found reduced weight gain in active mothers, as well as reduced risk of adverse pregnancy outcomes. There is however a lack of high quality, randomized controlled trials on the effects of regular exercise training in pregnancy, especially those with a pre-pregnancy body mass index (BMI at or above 30 kg/m2. Methods We are conducting a randomised, controlled trial in Norway with two parallel arms; one intervention group and one control group. We will enroll 150 previously sedentary, pregnant women with a pre-pregnancy BMI at or above 30 kg/m2. The intervention group will meet for organized exercise training three times per week, starting in gestation week 14 (range 12-16. The control group will get standard antenatal care. The main outcome measure will be weight gain from baseline to delivery. Among the secondary outcome measures are changes in exercise capacity, endothelial function, physical activity level, body composition, serum markers of cardiovascular risk, incontinence, lumbopelvic pain and cardiac function from baseline to gestation week 37 (range 36-38. Offspring outcome measures include anthropometric variables at birth, Apgar score, as well as serum markers of inflammation and metabolism in cord blood. Discussion The results of this trial will provide knowledge about effects of regular exercise training in previously sedentary, obese pregnant women. If the program proves effective in reducing gestational weight gain and adverse pregnancy outcomes, such programs should be considered as part of routine pregnancy care for obese women. Trial Registration ClinicalTrials.gov: NCT01243554

  7. 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.

  8. Quality of care in for-profit and not-for-profit nursing homes: systematic review and meta-analysis

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    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...

  9. More Than Needles: The Importance of Explanations and Self-Care Advice in Treating Primary Dysmenorrhea with Acupuncture

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    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...

  10. Patients’ expectations of ‘first-contact care’ consultations with nurse and general practitioners in primary care

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    Redsell, Sarah; Jackson, Clare; Stokes, Tim; Hastings, Adrian; Baker, Richard

    2007-01-01

    Background Patients’ attending UK primary care currently receive first-contact care services from nurses as well as general practitioners (GPs). Although randomised trials have reported higher satisfaction following nurse consultations,the relationship between patients’ prior expectations and satisfaction for nurse consultations has not been fully explored. Objective To explore patients’ expectations of their consultations with nurses or GPs,whether or not they are met,and t...

  11. Medical communication and technology: a video-based process study of the use of decision aids in primary care consultations

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    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...

  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