WorldWideScience

Sample records for controlled trial rct

  1. Effectiveness in practice-based research: Looking for alternatives to the randomized controlled trial (RCT)

    NARCIS (Netherlands)

    L. Tavecchio

    2015-01-01

    Over the last decade, the status of the randomized controlled trial (RCT), hallmark of evidence-based medicine (research), has been growing strongly in general practice, social work and public health. But this type of research is only practicable under strictly controlled and well-defined settings a

  2. Treating adolescents with cannabis use disorder with Multidimensional Family Therapy (MDFT): Main results of a Randomized Controlled Trial (RCT)

    NARCIS (Netherlands)

    P. Tossmann (Peter); B. Jonas (Benjamin); H. Rigter (Henk); A. Gantner (Andreas)

    2012-01-01

    textabstractAims: To determine the effectiveness of Multidimensional Family Therapy (MDFT) among adolescents with cannabis use disorder in Germany. Methods: In a randomized controlled trial (RCT), MDFT was compared with Youth Psychotherapy (JUP), an individual intervention including Cognitive Behavi

  3. Working alliance and its relationship to outcomes in a randomized controlled trial (RCT of antipsychotic medication

    Directory of Open Access Journals (Sweden)

    Wykes Til

    2013-01-01

    Full Text Available Abstract Background Long acting injections (LAI have been associated with perceptions of coercion in cross sectional studies but there have been no longitudinal studies of the effects on clinical relationships with newer depot medications. Method Randomized controlled trial with (50 participants with a diagnosis of schizophrenia randomized to risperidone LAI or oral atypical antipsychotic medication. The main outcome was the Working Alliance Inventory (WAI with background variables (symptoms, side effect, social functioning, quality of life measured before randomization and at two years. Results At follow-up (14 risperidone LAI and 16 oral medication analyses including predictors of missing data and baseline score showed a trend for those on risperidone LAI to reduce WAI score and those on oral medication showing no change. Sensitivity analyses showed (i a significant detrimental effect of LAI on WAI and (ii the pattern of results was not affected by change in symptoms over the study. Conclusion This is the first study to show that the prescription of depot atypical depot medication is associated with detrimental effects on clinical relationships after 2 years of continual treatment.

  4. A pilot randomised controlled trial (RCT) investigating the effectiveness of reflexology for managing pregnancy low back and/or pelvic pain.

    Science.gov (United States)

    Close, Ciara; Sinclair, Marlene; Cullough, Julie Mc; Liddle, Dianne; Hughes, Ciara

    2016-05-01

    Many pregnant women with low back and/or pelvic pain (LBPP) use pain medications to manage this pain, much of which is self-prescribed and potentially harmful. Therefore, there is a need to find effective nonpharmacological treatments for the condition. Reflexology has previously been shown to help nonspecific low back pain. Therefore; a pilot RCT was conducted investigating reflexology in the management of pregnancy-LBPP. 90 primiparous women were randomised to either usual care, a reflexology or footbath intervention. Primary outcome measures were; the Pain Visual Analogue Scale (VAS). 64 women completed the RCT; retention rates for the reflexology group were 80%, usual care group 83.33% and footbath group 50%. The reflexology group demonstrated a Clinically Important Change (CIC) in pain frequency (1.64 cm). Results indicate it is feasible to conduct an RCT in this area, although a footbath is an unsuitable sham treatment. Reflexology may help manage pregnancy-LBPP; however a fully powered trial is needed to confirm this.

  5. RCT: Module 2.08, Radiological Source Control, Course 8774

    Energy Technology Data Exchange (ETDEWEB)

    Hillmer, Kurt T. [Los Alamos National Lab. (LANL), Los Alamos, NM (United States)

    2017-08-10

    radioactive source is material used for its emitted radiation. Sources are sealed or unsealed and are classified as accountable or exempt. Radioactive sources are used for response checks, functional checks, and the calibration of instruments and monitors to traceable standards. To ensure the safety and welfare of all personnel, it is important to maintain control of radioactive sources to minimize the potential for the spread of contamination, unnecessary exposure to personnel, loss or theft, and improper disposal. This course will prepare the student with the skills necessary for RCT qualification by passing quizzes, tests, and the RCT Comprehensive Phase 1, Unit 2 Examination (TEST 27566) and will provide in-the-field skills.

  6. Design of a Randomised Controlled Trial (RCT on the effectiveness of a Dutch patient advocacy case management intervention among severely disabled Multiple Sclerosis patients

    Directory of Open Access Journals (Sweden)

    Annema Coby

    2010-05-01

    Full Text Available Abstract Background Case management has been suggested as an innovative strategy that facilitates the improvement of a patient's quality of life, reduction of hospital length of stay, optimization of self-care and improvement of satisfaction of patients and professionals involved. However, there is little evidence about the effectiveness of the patient advocacy case management model in clinical practice. Therefore, the objective of our study was to examine the effects of the Dutch patient advocacy case management model for severely disabled Multiple Sclerosis (MS patients and their caregivers compared to usual care. Methods/design In this randomized controlled trial the effectiveness of casemanagement on quality of life of patients and their caregivers, quality of care, service use and economic aspects were evaluated. The primary outcomes of this study were quality of life of MS-patients and caregiver burden of caregivers. Furthermore, we examined quality of life of caregivers, quality of care, service use and costs. Discussion This is a unique trial in which we examined the effectiveness of case management from a broad perspective. We meticulously prepared this study and applied important features and created important conditions for both intervention and research protocol to increase the likelihood of finding evidence for the effectiveness of patient advocacy case management. Concerning the intervention we anticipated to five important conditions: 1 the contrast between the case management intervention compared to the usual care seems to be large enough to detect intervention effects; 2 we included patients with complex care situations and/or were at risk for critical situations; 3 the case managers were familiar with disease specific health-problems and a broad spectrum of solutions; 4 case managers were competent and authorized to perform a medical neurological examination and worked closely with neurologists specialized in MS; and 5 the

  7. Prospective 10-year cohort study based on a randomized controlled trial (RCT) on implant-supported full-arch maxillary prostheses. Part 1: sandblasted and acid-etched implants and mucosal tissue.

    Science.gov (United States)

    Fischer, Kerstin; Stenberg, Torsten

    2012-12-01

    There have been very few long-term controlled studies (i.e., over 5 years duration) focusing on marginal conditions for implants with a sandblasted, large grit, and acid-etched (SLA) surface. To evaluate and report 10-year data on outcomes of implants with an SLA surface placed in the edentulous maxilla. In a randomized controlled trial (RCT) cohort of 24 patients, the outcomes of implants with an SLA surface were registered. The RCT cohort has previously been reported after 1 year, 3 years, and 5 years of loading. One patient dropped out of the study prior to the 10-year control. Of the 23 remaining patients, the implant survival rate was 95.1%. If implants of unknown status were also considered lost, that is, one drop-out patient with three implants for whom no information could be obtained, the implant survival rate was 93%. The mean marginal bone loss from baseline (139 implants) to 10 years (102 implants) was 1.07 mm (standard deviation 0.98). One implant out of 102 available for radiographic examination according to the original protocol showed a bone loss exceeding 4 mm. Of the 84 implants available for clinical examination, none showed a Plaque Index or sulcus bleeding index of 3. The mean implant stability quotient was significantly higher for mesial-distal versus buccal-palatal measurements. The implant survival was 95.1%. The mean value of bone loss after 10 years was 1.07 mm. Peri-implantitis were noted at the 5-year follow-up for one patient with a previous history of periodontitis; this patient did not attend the 10-year follow-up. This study shows that sandblasted and acid-etched implants offers predictable long-term results as support for full-arch maxillary prostheses. © 2011 Wiley Periodicals, Inc.

  8. Early identification in primary health care of people at risk for sick leave due to work-related stress - study protocol of a randomized controlled trial (RCT).

    Science.gov (United States)

    Holmgren, Kristina; Sandheimer, Christine; Mårdby, Ann-Charlotte; Larsson, Maria E H; Bültmann, Ute; Hange, Dominique; Hensing, Gunnel

    2016-11-25

    Early identification of persons at risk of sickness absence due to work-related stress is a crucial problem for society in general, and primary health care in particular. Tho date, no established method to do this exists. This project's aim is to evaluate whether systematic early identification of work-related stress can prevent sickness absence. This paper presents the study design, procedure and outcome measurements, as well as allocation and baseline characteristics of the study population. The study is a two-armed randomized controlled trial with follow-up at 3, 6 and 12 months. Non-sick-listed employed women and men, aged 18 to 64 years, who had mental and physical health complaints and sought care at primary health care centers (PHCC) were eligible to participate. At baseline work-related stress was measured by the Work Stress Questionnaire (WSQ), combined with feedback at consultation, at PHCC. The preventive intervention included early identification of work-related stress by the WSQ, GP training in the use of WSQ, GP feedback at consultation and finding suitable preventive measures. A process evaluation was used to explore how to facilitate future implementation and structural use of the WSQ at the PHCC. The primary outcome to compare the preventive sick leave intervention by the general practitioner (GP) versus treatment as usual is sick leave data obtained from the Swedish Social Insurance Agency register. Early screening for sick leave due to work-related stress makes it possible not only to identify those at risk for sick leave, but also to put focus on the patient's specific work-related stress problems, which can be helpful in finding suitable preventive measures. This study investigates if use of the WSQ by GPs at PHCCs, combined with feedback at consultation, prevents future sickness absence. ClinicalTrials.gov. Identifier: NCT02480855 . Registered 20 May 2015.

  9. Neuromuscular exercise and back counselling for female nursing personnel with recurrent non-specific low back pain: study protocol of a randomised controlled trial (NURSE-RCT).

    Science.gov (United States)

    Suni, Jaana H; Rinne, Marjo; Kankaanpää, Markku; Taulaniemi, Annika; Lusa, Sirpa; Lindholm, Harri; Parkkari, Jari

    2016-01-01

    Nursing personnel have high risk for incidence of low back pain (LBP) followed by development of chronic pain and disability. Multiple risk factors such as patient handling, night shift work and lack of supporting work culture have been identified. In subacute LBP, high-fear avoidance is prognostic for more pain, disability and not returning to work. Lack of leisure-time physical activity predicts long-term sickness absence. The purpose of this study is to compare effectiveness of 6-month neuromuscular exercise and counselling in treating back pain in female nursing personnel with recurrent non-specific LBP pain compared with either (exercise or counselling) alone and a non-treatment control group. The design is of a double-blinded four-arm randomised controlled trial with cost-effectiveness evaluation at 12 and 24 months. The study is conducted in 3 consecutive substudies. The main eligibility criteria are experience of LBP during the past 4 weeks with intensity of at least 2 (Numeric Rating Scale 0-10) and engagement in patient handling. Sample size was estimated for the primary outcome of pain intensity (visual analogue scale). Study measurements are outlined according to the model of International Classification of Functioning, Disability and Health, which incorporates the biopsychosocial processes assessed. This study is carried out conforming to the guidelines of good scientific practice and provisions of the declaration of Helsinki. Increasing physical and mental capacity with interventions taking place immediately after working hours near the worksite may reduce development of chronic LBP and work disability in female nursing personnel with recurrent non-specific LBP. NCT04165698.

  10. Prospective 10-year cohort study based on a randomized, controlled trial (RCT) on implant-supported full-arch maxillary prostheses. part II: prosthetic outcomes and maintenance.

    Science.gov (United States)

    Fischer, Kerstin; Stenberg, Torsten

    2013-08-01

    Long-term follow-up studies (i.e., over 5 years), focusing on prosthetic outcomes and maintenance of implant-supported reconstructions in the edentulous maxilla, are scarce in the literature. The purpose of this study was to evaluate and report 10-year data on outcomes and maintenance of screw-retained implant-supported full-arch casted titanium-resin prostheses in the edentulous maxilla. In the randomized control trial cohort of 24 patients, the outcome and maintenance of 23 bridges were registered. One patient dropped out of the study prior to the 10-year control. Of the 23 remaining patients, 21 still had their original frameworks; one framework fractured after 8 years and one was remade after 7 years to create better support for the acrylic. The remaining 23 prostheses showed criteria of success, survival, and failure in 9, 82, and 9%, respectively. Tightening of two assembly screws was necessary in one patient. No detrimental effects were seen because of long cantilever extensions or opposing dentition. A total of 4.7 resin-related complications per prosthesis were observed; tooth fracture was the most common prosthetic complication. There was an indication of greater prevention in the number of resin-related complications with the use of lingual gold onlay compared with a resilient mouth guard, 0.71 and 1.67, respectively per bridge. The bridges were removed and reinserted 0.83 times per patient. No abutment or abutment screw fractures were registered. Fracture or wear of the reconstruction materials were considered predictable risks when using resin-based suprastructure materials. Status of opposing dentition and length of cantilevers did not confer additional risk. The use of a lingual gold onlay indicated prevention of resin-related complications. Future research should focus on the suprastructure materials to predict better overall treatment results of implant-supported full-arch bridges in the edentulous maxilla. © 2011 Wiley Periodicals, Inc.

  11. Informed decision-making with and for people with dementia - efficacy of the PRODECIDE education program for legal representatives: protocol of a randomized controlled trial (PRODECIDE-RCT).

    Science.gov (United States)

    Lühnen, Julia; Haastert, Burkhard; Mühlhauser, Ingrid; Richter, Tanja

    2017-09-15

    In Germany, the guardianship system provides adults who are no longer able to handle their own affairs a court-appointed legal representative, for support without restriction of legal capacity. Although these representatives only rarely are qualified in healthcare, they nevertheless play decisive roles in the decision-making processes for people with dementia. Previously, we developed an education program (PRODECIDE) to address this shortcoming and tested it for feasibility. Typical, autonomy-restricting decisions in the care of people with dementia-namely, using percutaneous endoscopic gastrostomy (PEG) or physical restrains (PR), or the prescription of antipsychotic drugs (AP)-were the subject areas trained. The training course aims to enhance the competency of legal representatives in informed decision-making. In this study, we will evaluate the efficacy of the PRODECIDE education program. A randomized controlled trial with a six-month follow-up will be conducted to compare the PRODECIDE education program with standard care, enrolling legal representatives (N = 216). The education program lasts 10 h and comprises four modules: A, decision-making processes and methods; and B, C and D, evidence-based knowledge about PEG, PR and AP, respectively. The primary outcome measure is knowledge, which is operationalized as the understanding of decision-making processes in healthcare affairs and in setting realistic expectations about benefits and harms of PEG, PR and AP in people with dementia. Secondary outcomes are sufficient and sustainable knowledge and percentage of persons concerned affected by PEG, FEM or AP. A qualitative process evaluation will be performed. Additionally, to support implementation, a concept for translating the educational contents into e-learning modules will be developed. The study results will show whether the efficacy of the education program could justify its implementation into the regular training curricula for legal representatives

  12. A failed RCT to determine if antibiotics prevent mastitis: Cracked nipples colonized with Staphylococcus aureus: A randomized treatment trial [ISRCTN65289389

    OpenAIRE

    Garland Suzanne M; Lumley Judith; Amir Lisa

    2004-01-01

    Abstract Background A small, non-blinded, RCT (randomised controlled trial) had reported that oral antibiotics reduced the incidence of mastitis in lactating women with Staphylococcus aureus (S. aureus)- colonized cracked nipples. We aimed to replicate the study with a more rigorous design and adequate sample size. Methods Our intention was to conduct a double-blind placebo-controlled trial to determine if an antibiotic (flucloxacillin) could prevent mastitis in lactating women with S. aureus...

  13. RCT: Module 2.10, Access Control and Work Area Setup, Course 8776

    Energy Technology Data Exchange (ETDEWEB)

    Hillmer, Kurt T. [Los Alamos National Lab. (LANL), Los Alamos, NM (United States)

    2017-08-11

    This course presents information on radiological work permits (RWPs), various types of postings used in radiological areas, radiological area setups, access controls, and releases of material from radiological areas. All of these are fundamental duties of RCTs. This course will prepare the student with the skills necessary for radiological control technician (RCT) qualification by passing quizzes, tests, and the RCT Comprehensive Phase 1, Unit 2 Examination (TEST 27566) and providing in-thefield skills.

  14. The effectiveness and cost-evaluation of manual therapy and physical therapy in patients with sub-acute and chronic non specific neck pain. Rationale and design of a Randomized Controlled Trial (RCT

    Directory of Open Access Journals (Sweden)

    van Assen Luite

    2010-01-01

    Full Text Available Abstract Background Manual Therapy applied to patients with non specific neck pain has been investigated several times. In the Netherlands, manual therapy as applied according to the Utrecht School of Manual Therapy (MTU has not been the subject of a randomized controlled trial. MTU differs in diagnoses and treatment from other forms of manual therapy. Methods/Design This is a single blind randomized controlled trial in patients with sub-acute and chronic non specific neck pain. Patients with neck complaints existing for two weeks (minimum till one year (maximum will participate in the trial. 180 participants will be recruited in thirteen primary health care centres in the Netherlands. The experimental group will be treated with MTU during a six week period. The control group will be treated with physical therapy (standard care, mainly active exercise therapy, also for a period of six weeks. Primary outcomes are Global Perceived Effect (GPE and functional status (Neck Disability Index (NDI-DV. Secondary outcomes are neck pain (Numeric Rating Scale (NRS, Eurocol, costs and quality of life (SF36. Discussion This paper presents details on the rationale of MTU, design, methods and operational aspects of the trial. Trial registration ClinicalTrials.gov Identifier: NCT00713843

  15. The effectiveness and cost-evaluation of manual therapy and physical therapy in patients with sub-acute and chronic non specific neck pain. Rationale and design of a Randomized Controlled Trial (RCT).

    NARCIS (Netherlands)

    Groeneweg, R.; Kropman, H.; Leopold, H.; Assen, L. van; Mulder, J.; Tulder, M.W. van; Oostendorp, R.A.B.

    2010-01-01

    BACKGROUND: Manual Therapy applied to patients with non specific neck pain has been investigated several times. In the Netherlands, manual therapy as applied according to the Utrecht School of Manual Therapy (MTU) has not been the subject of a randomized controlled trial. MTU differs in diagnoses an

  16. Aivoverenkiertohäiriön sairastaneiden tasapainoharjoittelun vaikuttavuus RCT-tutkimusten perusteella : evidence on the effectiveness of balance training after stroke : a systematic review and meta-analysis of randomized controlled trials

    OpenAIRE

    Sahinoja, Hanna

    2013-01-01

    Tausta: Tasapainon ongelmat ovat yleisiä aivoverenkiertöhäiriön (AVH) sairastamisen jälkeen. Vaikka AVH-kuntoutujien kuntoutusmenetelmät ovat kiinnostuksen kohteena, on tasapainoharjoittelun vaikuttavuudesta niukasti näyttöön perustuvaa tietoa. Tarkoitus: Tutkia AVH-kuntoutujien tasapainoharjoittelun vaikuttavuutta tasapainoon tasapaino- ja kävelymuuttujilla RCT-tutkimusten perusteella. Aineisto ja menetelmät: Systemaattinen kirjallisuushaku tehtiin Ovid Medline, CINAHL, Embase, Physio...

  17. The DYD-RCT protocol: an on-line randomised controlled trial of an interactive computer-based intervention compared with a standard information website to reduce alcohol consumption among hazardous drinkers

    Directory of Open Access Journals (Sweden)

    Godfrey Christine

    2007-10-01

    Full Text Available Abstract Background Excessive alcohol consumption is a significant public health problem throughout the world. Although there are a range of effective interventions to help heavy drinkers reduce their alcohol consumption, these have little proven population-level impact. Researchers internationally are looking at the potential of Internet interventions in this area. Methods/Design In a two-arm randomised controlled trial, an on-line psychologically enhanced interactive computer-based intervention is compared with a flat, text-based information web-site. Recruitment, consent, randomisation and data collection are all on-line. The primary outcome is total past-week alcohol consumption; secondary outcomes include hazardous or harmful drinking, dependence, harm caused by alcohol, and mental health. A health economic analysis is included. Discussion This trial will provide information on the effectiveness and cost-effectiveness of an on-line intervention to help heavy drinkers drink less. Trial registration International Standard Randomised Controlled Trial Number Register ISRCTN31070347

  18. RCT: 2.05 Contamination Control, Course #8770

    Energy Technology Data Exchange (ETDEWEB)

    Hillmer, Kurt T. [Los Alamos National Lab. (LANL), Los Alamos, NM (United States)

    2016-05-23

    This report focuses on the detection and control of radioactive contamination, which are an integral part of an aggressive ALARA program and provide an indication of the effectiveness of engineering controls and proper work practices in preventing the release of radioactive material. Radioactive contamination, if undetected or not properly controlled, can be spread and contaminate areas, equipment, personnel, and the environment.

  19. The Multi-Center Randomized Controlled Trial (RCT) Published by the Journal of the American Medical Association (JAMA) on the Effect of Periodontal Therapy on Glycated Hemoglobin (HbA1c) Has Fundamental Problems

    Science.gov (United States)

    Borgnakke, Wenche S.; Chapple, Iain L.C.; Genco, Robert J.; Armitage, Gary; Bartold, P. Mark; D’Aiuto, Francesco; Eke, Paul I.; Giannobile, William V.; Kocher, Thomas; Kornman, Kenneth S.; Lang, Niklaus P.; Madianos, Phoebus N.; Murakami, Shinya; Nishimura, Fusanori; Offenbacher, Steven; Preshaw, Philip M.; Rahman, Amin ur; Sanz, Mariano; Slots, Jørgen; Tonetti, Maurizio S.; Van Dyke, Thomas E.

    2015-01-01

    SUMMARY Subject Participants had type 2 diabetes, were on stable medication regimens, had HbA1c levels between 7% and <9%, retained at least 16 natural teeth, and had untreated chronic periodontitis. A total of 514 participants were enrolled between November 2009 and March 2012 from diabetes and dental clinics and communities affiliated with five participating academic medical centers. They were randomized with half (n = 257) allocated to a treatment group and the other half (n = 257) to a control group. Key Exposure/Study Factor The exposure was non-surgical periodontal treatment comprising scaling and root planing, oral hygiene instruction, and oral rinsing with chlorhexidine provided to the treatment group at baseline. Supportive periodontal therapy was also provided at 3 and 6 months. The control group received no treatment for the 6-month duration of the study. Main Outcome Measure The primary outcome measure was “the difference in change in HbA1c level from baseline between the two groups at 6 months.” Secondary outcomes included changes in periodontal probing depth (PPD), clinical attachment loss, bleeding on probing (BOP), gingival index, fasting glucose level, and Homeostasis Model Assessment (HOMA2) score. Main Results The authors report that enrollment into their Diabetes and Periodontal Therapy Trial (DPTT) was terminated early due to futility. At 6 months, mean HbA1c levels in the periodontal therapy group increased 0.17 (±1.0)%, compared with 0.11 (±1.0)% in the control group, with no significant difference between groups based on a linear regression model adjusting for clinical site (mean difference, −0.05% [95% CI: −0.23% to 0.12%]; p = 0.55). Periodontal measures improved in the treatment group compared with the control group at 6 months, with adjusted between-group differences of 0.28 mm (95% CI: 0.18–0.37) for PPD; 0.25 mm (95% CI: 0.14–0.36) for clinical attachment loss; 13.1% (95% CI: 8.1%–18.1%) for BOP; and 0.27 (95% CI: 0.17

  20. 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

  1. Using Randomized Controlled Trials to Evaluate Interventions for Releasing Prisoners

    Science.gov (United States)

    Pettus-Davis, Carrie; Howard, Matthew Owen; Dunnigan, Allison; Scheyett, Anna M.; Roberts-Lewis, Amelia

    2016-01-01

    Randomized controlled trials (RCTs) are rarely used to evaluate social and behavioral interventions designed for releasing prisoners. Objective: We use a pilot RCT of a social support intervention (Support Matters) as a case example to discuss obstacles and strategies for conducting RCT intervention evaluations that span prison and community…

  2. A failed RCT to determine if antibiotics prevent mastitis: Cracked nipples colonized with Staphylococcus aureus: A randomized treatment trial [ISRCTN65289389

    Directory of Open Access Journals (Sweden)

    Garland Suzanne M

    2004-09-01

    Full Text Available Abstract Background A small, non-blinded, RCT (randomised controlled trial had reported that oral antibiotics reduced the incidence of mastitis in lactating women with Staphylococcus aureus (S. aureus- colonized cracked nipples. We aimed to replicate the study with a more rigorous design and adequate sample size. Methods Our intention was to conduct a double-blind placebo-controlled trial to determine if an antibiotic (flucloxacillin could prevent mastitis in lactating women with S. aureus-colonized cracked nipples. We planned to recruit two groups of 133 women with S. aureus-colonized cracked nipples. Results We spent over twelve months submitting applications to five hospital ethics committees and seven funding bodies, before commencing the trial. Recruitment to the trial was very slow and only ten women were randomized to the trial after twelve months, and therefore the trial was stopped early. Conclusions In retrospect we should have conducted a feasibility study, which would have revealed the low number of women in these Melbourne hospitals (maternity wards and breastfeeding clinics with damaged nipples. The appropriate use of antibiotics for breastfeeding women with cracked nipples still needs to be tested.

  3. 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.

  4. Smartphone app design for the wireless control of a neuromuscular electrical stimulator device with integrated randomization allocation process for RCT applications.

    Science.gov (United States)

    Sweeney, Dean; Quinlan, Leo R; OLaighin, Gearoid

    2015-08-01

    The use of NMES has evolved over the last five decades. Technological advancements have transformed these once complex systems into user-friendly devices with enhanced control functions, leading to new applications of NMES being investigated. The use of Randomized Control Trial (RCT) methodology in evaluating the effectiveness of new and existing applications of NMES is a demanding process adding time and cost to a translation into clinical practice. Poor quality trials may result in poor evidence of NMES effectiveness. In this paper some of the key challenges encountered in NMES clinical trials are identified with the aim of purposing a solution to address these challenges through the adoption of Smartphone technology. The design and evaluation of a smartphone application to provide automatic blind randomization control and facilitating the wireless temporal control of a portable Bluetooth enabled NMES is presented.

  5. Automation of the 1.3-meter Robotically Controlled Telescope (RCT)

    Science.gov (United States)

    Gelderman, Richard; Treffers, Richard R.

    2011-03-01

    This poster describes the automation for the Robotically Controlled Telescope (RCT) Consortium of the 50-inch telescope at Kitt Peak National Observatory. Building upon the work of the previous contractor the telescope, dome and instrument were wired for totally autonomous (robotic) observations. The existing motors, encoders, limit switches and cables were connected to an open industrial panel that allows easy interconnection, troubleshooting and modifications. A sixteen axis Delta Tau Turbo PMAC controller is used to control all motors, encoders, flat field lights and many of the digital functions of the telescope. ADAM industrial I/O bricks are used for additional digital and analog I/O functions. Complex relay logic problems, such as the mirror cover opening sequence and the slit control, are managed using Allen Bradley Pico PLDs. Most of the low level software is written in C using the GNU compiler. The basic functionality uses an ASCII protocol communicating over Berkeley sockets. Early versions of this software were developed at U.C. Berkeley, for what was to become the Katzman Automatic Imaging Telescope (KAIT) at Lick Observatory. ASCII communications are useful for control, testing and easy to debug by looking at the log files; C-shell scripts are written to form more complex orchestrations.

  6. The importance of piloting an RCT intervention.

    Science.gov (United States)

    Feeley, Nancy; Cossette, Sylvie; Côté, José; Héon, Marjolaine; Stremler, Robyn; Martorella, Geraldine; Purden, Margaret

    2009-06-01

    The pilot study provides a unique opportunity to identify and prepare for the challenges of evaluating an intervention. Ultimately, it will enhance the scientific rigour and value of the full-scale study. Although some journals publish reports of pilot studies, little attention has been given to the types of research questions and issues specific to these studies. This article focuses on the utility of a pilot randomized controlled trial (RCT) as a first step towards conducting an RCT. Three major objectives of a pilot RCT are discussed: assessing the feasibility and acceptability of the intervention, assessing the feasibility and acceptability of the design and procedures, and facilitating the determination of effect sizes for use in sample-size calculations.

  7. Unmeasured confounding caused slightly better response to HAART within than outside a randomized controlled trial

    DEFF Research Database (Denmark)

    Hansen, Anders Bach Bergstrøm; Gerstoft, J.; Kirk, O.

    2008-01-01

    OBJECTIVE: To compare the outcome of highly active antiretroviral therapy (HAART) in HIV-infected patients initiating equivalent regimens within and outside a randomized controlled trial (RCT). STUDY DESIGN AND SETTING: The Danish Protease Inhibitor Study (DAPIS) was a national multicenter RCT co...

  8. Hearing aid effectiveness after aural rehabilitation - individual versus group (HEARING trial: RCT design and baseline characteristics

    Directory of Open Access Journals (Sweden)

    Heagerty Patrick J

    2009-12-01

    Full Text Available Abstract Background Hearing impairment is the most common body system disability in veterans. In 2008, nearly 520,000 veterans had a disability for hearing loss through the Department of Veterans Affairs (VA. Changes in eligibility for hearing aid services, along with the aging population, contributed to a greater than 300% increase in the number of hearing aids dispensed from 1996 to 2006. In 2006, the VA committed to having no wait times for patient visits while providing quality clinically-appropriate care. One approach to achieving this goal is the use of group visits as an alternative to individual visits. We sought to determine: 1 if group hearing aid fitting and follow-up visits were at least as effective as individual visits, and 2 whether group visits lead to cost savings through the six month period after the hearing aid fitting. We describe the rationale, design, and characteristics of the baseline cohort of the first randomized clinical trial to study the impact of group versus individual hearing aid fitting and follow-up visits. Methods Participants were recruited from the VA Puget Sound Health Care System Audiology Clinic. Eligible patients had no previous hearing aid use and monaural or binaural air-conduction hearing aids were ordered at the evaluation visit. Participants were randomized to receive the hearing aid fitting and the hearing aid follow-up in an individual or group visit. The primary outcomes were hearing-related function, measured with the first module of the Effectiveness of Aural Rehabilitation (Inner EAR, and hearing aid adherence. We tracked the total cost of planned and unplanned audiology visits over the 6-month interval after the hearing aid fitting. Discussion A cohort of 659 participants was randomized to receive group or individual hearing aid fitting and follow-up visits. Baseline demographic and self-reported health status and hearing-related measures were evenly distributed across the treatment arms

  9. Evaluation of occupational health interventions using a randomized controlled trial: challenges and alternative research designs

    NARCIS (Netherlands)

    Schelvis, R.M; Oude Hengel, K.M.; Burdorf, A.; Blatter, B.M.; Strijk, J.E.; Beek, A.J. van

    2015-01-01

    Occupational health researchers regularly conduct evaluative intervention research for which a randomized controlled trial (RCT) may not be the most appropriate design (eg, effects of policy measures, organizational interventions on work schedules). This article demonstrates the appropriateness of a

  10. Changes Within Clinical Practice After a Randomized Controlled Trial of Knee Arthroscopy for Osteoarthritis

    OpenAIRE

    Amin, Nirav H; Hussain, Waqas; Ryan, John; Morrison, Shannon; Miniaci, Anthony; Jones, Morgan H.

    2017-01-01

    Background: In 2002, Moseley et al published a randomized controlled trial (RCT) that showed no difference between knee arthroscopy and placebo for patients with osteoarthritis (OA). We wanted to assess the impact of the trial on clinical practice in the United States. Purpose/Hypothesis: To evaluate changes in knee arthroscopy practice before and after publication of the article by Moseley et al and to assess the effect of this landmark RCT on the behavior of practicing orthopaedic surgeons....

  11. High-Precision Photometry with the RCT

    Science.gov (United States)

    Everett, M.; Howell, S.; Davis, D.; McGruder, C. H., III; Gelderman, R.; Guinan, E.; Mattox, J. R.; Walter, D. K.

    2003-05-01

    We plan to conduct a high-precision photometric search for transitting extra-solar planets using the refurbished 1.3 m (50 inch) Robotically-Controlled Telescope (RCT) at Kitt Peak. The photometric capabilities and extra-solar planet search strategy for the RCT are discussed. Refurbishment of the RCT has been made possible by NASA grant NAG58762.

  12. Autonomous Scheduling of the 1.3-meter Robotically Controlled Telescope (RCT)

    Science.gov (United States)

    Strolger, Louis-Gregory; Gelderman, Richard; Carini, Michael T.; Davis, Donald R.; Engle, Scott G.; Guinan, Edward F.; McGruder, Charles H., III; Tedesco, Edward F.; Walter, Donald K.

    2011-03-01

    The 1.3-meter telescope at Kitt Peak operates as a fully robotic instrument for optical imaging. An autonomous scheduling algorithm is an essential component of this observatory, and has been designed to manage numerous requests in various imaging modes in a manner similar to how requests are managed at queue-scheduled observatories, but with greater efficiency. Built from the INSGEN list generator and process spawner originally developed for the Berkeley Automatic Imaging Telescope, the RCT scheduler manages and integrates multi-user observations in real time, according to target and exposure information and program-specific constraints (e.g., user assigned priority, moon avoidance, airmass, or temporal constraints), while accounting for instrument limitations, meteorologic conditions, and other technical constraints. The robust system supports time-critical requests, such as with coordinated observations, while also providing short-term (hours) and long-term (days) monitoring capabilities, and one-off observations. We discuss the RCT scheduler, its current decision tree, and future prospects including integration with active partner-share monitoring (which factor into future observation requests) to insure fairness and parity of requests.

  13. 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...

  14. Internet-based cognitive bias modification for obsessive compulsive disorder : study protocol for a randomized controlled trial

    NARCIS (Netherlands)

    Williams, Alishia D; Pajak, Rosanna; O'Moore, Kathleen; Andrews, Gavin; Grisham, Jessica R

    2014-01-01

    BACKGROUND: Cognitive bias modification (CBM) interventions have demonstrated efficacy in augmenting core biases implicated in psychopathology. The current randomized controlled trial (RCT) will evaluate the efficacy of an internet-delivered positive imagery cognitive bias modification intervention

  15. The 1.3-m Robotically Controlled Telescope (RCT) at Kitt Peak - A Fifty year old dream Realized: Telescope Characteristics, Current Research and Education Progr

    Science.gov (United States)

    Guinan, Edward; Gelderman, Richard; Strolger, Louis-Gregory; Carini, Michael T.; McGruder, Charles, III; Campbell, Rachel; Walter, Donald K.; Davis, Donald R.; Tedesco, Edward F.; Engle, Scott G.

    2011-03-01

    The 1.3 m Robotically Controlled Telescope (RCT) on Kitt Peak has a rich history, including its role as a prototype for remotely controlled telescopes during the 1960s. As such, the RCT could be considered one of the first - Telescopes from Afar. The telescope, originally called the Remotely Controlled Telescope, has been renamed the Robotically Controlled Telescope to reflect the change in operational control and mode of use. The RCT was a conceptual precursor of today's robotic telescopes, but the actual operation of a remotely controlled telescope was technologically premature for its time, and was subsequently manually operated primarily to conduct optical and infrared observations as well being used as a test bed for new spectroscopic and photometric instruments. In 1995 budget constraints forced the closing of the telescope as part of the Kitt Peak National Observatory (KPNO), following nearly 30 years of distinguished service to KPNO. A request for proposals to operate this telescope was issued to the science community. The RCT consortium, lead by Western Kentucky University, was the successful proposer for operation of the telescope. After several difficult years of retrofitting, refurbishing, and automating the telecope and observatory dome, the telescope has returned to routine science operations in November 2009. The RCT has operated smoothly since that time, with no major interruptions. Observations of objects of interest to the consortium partners (including: comets & asteroids, variable & binary stars, exoplanets, supernovae, quasars & blazars) are being routinely obtained and evaluated. One of the distinguishing features of the RCT is that it is an autonomous observatory designed to handle diverse optical imaging and photometry programs. These include being able to automatically deal with a wide range of observing parameters such as -integration time, sky conditions, repetitions, return visits, filters, air mass, non-sidereal objects, transients etc

  16. A pragmatic multi-centred randomised controlled trial of yoga for chronic low back pain: Trial protocol

    OpenAIRE

    Cox, Helen; Tilbrook, Helen; Aplin, John; Chuang, Ling-Hsiang; Hewitt, Catherine; Jayakody, Shalmini; Semlyen, Anna; Soares, Marta O; Torgerson, David; Trewhela, Alison; Watt, Ian; Worthy, Gill

    2010-01-01

    A systematic review revealed three small randomised controlled trials of yoga for low back pain, all of which showed effects on back pain that favoured the yoga group. To build on these studies a larger trial, with longer term follow-up, and a number of different yoga teachers delivering the intervention is required. This study protocol describes the details of a randomised controlled trial (RCT) to determine the effectiveness and cost-effectiveness of Yoga for chronic Low Back Pain, which is...

  17. Feasibility of a multidimensional home-based exercise programme for the elderly with structured support given by the general practitioner's surgery: Study protocol of a single arm trial preparing an RCT [ISRCTN58562962

    Directory of Open Access Journals (Sweden)

    Burghaus Ina

    2009-08-01

    Full Text Available Abstract Background Physical activity programmes can help to prevent functional decline in the elderly. Until now, such programmes use to target either on healthy community-dwelling seniors or on elderly living in special residences or care institutions. Sedentary or frail people, however, are difficult to reach when they live in their own homes. The general practitioner's (GP practice offers a unique opportunity to acquire these people for participation in activity programmes. We conceptualised a multidimensional home-based exercise programme that shall be delivered to the target group through cooperation between GPs and exercise therapists. In order to prepare a randomised controlled trial (RCT, a feasibility study is being conducted. Methods The study is designed as a single arm interventional trial. We plan to recruit 90 patients aged 70 years and above through their GPs. The intervention lasts 12 weeks and consists of physical activity counselling, a home-exercise programme, and exercise consultations provided by an exercise therapist in the GP's practice and via telephone. The exercise programme consists of two main components: 1. a combination of home-exercises to improve strength, flexibility and balance, 2. walking for exercise to improve aerobic capacity. Primary outcome measures are: appraisal by GP, undesirable events, drop-outs, adherence. Secondary outcome measures are: effects (a. motor tests: timed-up-and-go, chair rising, grip strength, tandem stand, tandem walk, sit-and-reach; b. telephone interview: PRISCUS-Physical Activity Questionnaire, Short Form-8 Health Survey, three month recall of frequency of falls, Falls Efficacy Scale, appraisal by participant, exercise performance, focus group discussion. Data analyses will focus on: 1. decision-making concerning the conduction of a RCT, 2. estimation of the effects of the programme, detection of shortcomings and identification of subgroups with contrary results, 3. feedback to

  18. Mixing Methods in Randomized Controlled Trials (RCTs): Validation, Contextualization, Triangulation, and Control

    Science.gov (United States)

    Spillane, James P.; Pareja, Amber Stitziel; Dorner, Lisa; Barnes, Carol; May, Henry; Huff, Jason; Camburn, Eric

    2010-01-01

    In this paper we described how we mixed research approaches in a Randomized Control Trial (RCT) of a school principal professional development program. Using examples from our study we illustrate how combining qualitative and quantitative data can address some key challenges from validating instruments and measures of mediator variables to…

  19. Mixing Methods in Randomized Controlled Trials (RCTs): Validation, Contextualization, Triangulation, and Control

    Science.gov (United States)

    Spillane, James P.; Pareja, Amber Stitziel; Dorner, Lisa; Barnes, Carol; May, Henry; Huff, Jason; Camburn, Eric

    2010-01-01

    In this paper we described how we mixed research approaches in a Randomized Control Trial (RCT) of a school principal professional development program. Using examples from our study we illustrate how combining qualitative and quantitative data can address some key challenges from validating instruments and measures of mediator variables to…

  20. Identifying Controlled Clinical Trials for Systematic Reviews Requires Searching Multiple Resources – and, Even Then, Comprehensiveness is Questionable. A review of: Crumley, Ellen T., Natasha Wiebe, Kristie Cramer, Terry P. Klassen, and Lisa Hartling. “Which Resources Should be Used to Identify RCT/CCTs for Systematic Reviews: A Systematic Review.” BMC Medical Research Methodology 5.24 (2005. 4 Nov. 2006 .

    Directory of Open Access Journals (Sweden)

    Gale G. Hannigan

    2006-12-01

    Full Text Available Objective – To determine the value of searching different databases to identify relevant controlled clinical trial (CCT and randomized controlled trial (RCT reports for systematic reviews.Design – Systematic review.Methods – Seven electronic databases MEDLINE, EMBASE, CINAHL, ERIC, PsycINFO, Web of Science, and Cochrane Library were searched to April 2004. Four journals, Health Information & Libraries Journal – (formerly Health Libraries Review, Hypothesis, Journal of the Medical LibraryA ssociation– (formerly Bulletin of the Medical Library Association, and Medical Reference Services Quarterly were handsearched from 1990 to 2004. All abstracts of the Cochrane Colloquia (1993‐2003 were handsearched,and key authors found from any portion of the searching process were contacted and relevant article references screened. Two reviewers independently screened results for studies that compared two or more resources to find RCTs or CCTs using defined inclusion and exclusion criteria. Two reviewers assessed studies for quality using four criteria: adequate descriptions of what the search was attempting to identify, the methods used to search, the reference standard, and evidence that bias was avoided in selection of relevant studies. Screening and assessment differences between reviewers were resolved through discussion. Using a standard form, one investigator extracted data for each study, including study design and results (e.g., recall, precision, and a second investigator checked these data. Authors were contacted to provide missing data. Results were grouped by the compared resources and these comparisons were summarized using medians and ranges. Using a classification modified from Hopewell et al., search strategies were categorized as Complex (using a combination of types of search terms, Cochrane (the Cochrane Highly Sensitive Search Strategy or HSSS, Simple (using five or fewer search terms which may include a combination of Me

  1. Acupuncture for Posttraumatic Stress Disorder: A Systematic Review of Randomized Controlled Trials and Prospective Clinical Trials

    Directory of Open Access Journals (Sweden)

    Young-Dae Kim

    2013-01-01

    Full Text Available To evaluate the current evidence for effectiveness of acupuncture for posttraumatic stress disorder (PTSD in the form of a systematic review, a systematic literature search was conducted in 23 electronic databases. Grey literature was also searched. The key search terms were “acupuncture” and “PTSD.” No language restrictions were imposed. We included all randomized or prospective clinical trials that evaluated acupuncture and its variants against a waitlist, sham acupuncture, conventional therapy control for PTSD, or without control. Four randomized controlled trials (RCTs and 2 uncontrolled clinical trials (UCTs out of 136 articles in total were systematically reviewed. One high-quality RCT reported that acupuncture was superior to waitlist control and therapeutic effects of acupuncture and cognitive-behavioral therapy (CBT were similar based on the effect sizes. One RCT showed no statistical difference between acupuncture and selective serotonin reuptake inhibitors (SSRIs. One RCT reported a favorable effect of acupoint stimulation plus CBT against CBT alone. A meta-analysis of acupuncture plus moxibustion versus SSRI favored acupuncture plus moxibustion in three outcomes. This systematic review and meta-analysis suggest that the evidence of effectiveness of acupuncture for PTSD is encouraging but not cogent. Further qualified trials are needed to confirm whether acupuncture is effective for PTSD.

  2. Acupuncture for posttraumatic stress disorder: a systematic review of randomized controlled trials and prospective clinical trials.

    Science.gov (United States)

    Kim, Young-Dae; Heo, In; Shin, Byung-Cheul; Crawford, Cindy; Kang, Hyung-Won; Lim, Jung-Hwa

    2013-01-01

    To evaluate the current evidence for effectiveness of acupuncture for posttraumatic stress disorder (PTSD) in the form of a systematic review, a systematic literature search was conducted in 23 electronic databases. Grey literature was also searched. The key search terms were "acupuncture" and "PTSD." No language restrictions were imposed. We included all randomized or prospective clinical trials that evaluated acupuncture and its variants against a waitlist, sham acupuncture, conventional therapy control for PTSD, or without control. Four randomized controlled trials (RCTs) and 2 uncontrolled clinical trials (UCTs) out of 136 articles in total were systematically reviewed. One high-quality RCT reported that acupuncture was superior to waitlist control and therapeutic effects of acupuncture and cognitive-behavioral therapy (CBT) were similar based on the effect sizes. One RCT showed no statistical difference between acupuncture and selective serotonin reuptake inhibitors (SSRIs). One RCT reported a favorable effect of acupoint stimulation plus CBT against CBT alone. A meta-analysis of acupuncture plus moxibustion versus SSRI favored acupuncture plus moxibustion in three outcomes. This systematic review and meta-analysis suggest that the evidence of effectiveness of acupuncture for PTSD is encouraging but not cogent. Further qualified trials are needed to confirm whether acupuncture is effective for PTSD.

  3. Ear Acupuncture for Acute Sore Throat: A Randomized Controlled Trial

    Science.gov (United States)

    2014-09-26

    SEP 2014 2. REPORT TYPE Final 3. DATES COVERED 4. TITLE AND SUBTITLE Ear acupuncture for acute sore throat. A randomized controlled trial...Auncular Acupuncture is a low risk option for acute pain control •Battlefield acupuncture (BFA) IS a specific auncular acupuncture technique •BFA IS...Strengths: Prospect1ve RCT •Weaknesses Small sample stze. no sham acupuncture performed, patients not blinded to treatment •Th1s study represents an

  4. "Hitting" voices of schizophrenia patients may lastingly reduce persistent auditory hallucinations and their burden : 18-month outcome of a randomized controlled trial

    NARCIS (Netherlands)

    Jenner, JA; Nienhuis, FJ; van de Willige, G; Wiersma, D

    2006-01-01

    Objective: This study aimed to investigate the outcome of an 18-month randomized controlled trial (RCT) on subjective burden and psychopathology of patients suffering from schizophrenia. Method: An RCT was used to compare hallucination-focused integrative treatment (HIT) and routine treatment (RT) i

  5. Protein misfolding, amyotrophic lateral sclerosis and guanabenz: protocol for a phase II RCT with futility design (ProMISe trial).

    Science.gov (United States)

    Bella, Eleonora Dalla; Tramacere, Irene; Antonini, Giovanni; Borghero, Giuseppe; Capasso, Margherita; Caponnetto, Claudia; Chiò, Adriano; Corbo, Massimo; Eleopra, Roberto; Filosto, Massimiliano; Giannini, Fabio; Granieri, Enrico; Bella, Vincenzo La; Lunetta, Christian; Mandrioli, Jessica; Mazzini, Letizia; Messina, Sonia; Monsurrò, Maria Rosaria; Mora, Gabriele; Riva, Nilo; Rizzi, Romana; Siciliano, Gabriele; Silani, Vincenzo; Simone, Isabella; Sorarù, Gianni; Volanti, Paolo; Lauria, Giuseppe

    2017-08-11

    Recent studies suggest that endoplasmic reticulum stress may play a critical role in the pathogenesis of amyotrophic lateral sclerosis (ALS) through an altered regulation of the proteostasis, the cellular pathway-balancing protein synthesis and degradation. A key mechanism is thought to be the dephosphorylation of eIF2α, a factor involved in the initiation of protein translation. Guanabenz is an alpha-2-adrenergic receptor agonist safely used in past to treat mild hypertension and is now an orphan drug. A pharmacological action recently discovered is its ability to modulate the synthesis of proteins by the activation of translational factors preventing misfolded protein accumulation and endoplasmic reticulum overload. Guanabenz proved to rescue motoneurons from misfolding protein stress both in in vitro and in vivo ALS models, making it a potential disease-modifying drug in patients. It is conceivable investigating whether its neuroprotective effects based on the inhibition of eIF2α dephosphorylation can change the progression of ALS. Protocolised Management In Sepsis is a multicentre, randomised, double-blind, placebo-controlled phase II clinical trial with futility design. We will investigate clinical outcomes, safety, tolerability and biomarkers of neurodegeneration in patients with ALS treated with guanabenz or riluzole alone for 6 months. The primary aim is to test if guanabenz can reduce the proportion of patients progressed to a higher stage of disease at 6 months compared with their baseline stage as measured by the ALS Milano-Torino Staging (ALS-MITOS) system and to the placebo group. Secondary aims are safety, tolerability and change in at least one biomarker of neurodegeneration in the guanabenz arm compared with the placebo group. Findings will provide reliable data on the likelihood that guanabenz can slow the course of ALS in a phase III trial. The study protocol was approved by the Ethics Committee of IRCCS 'Carlo Besta Foundation' of Milan

  6. Smart-phone obesity prevention trial for adolescent boys in low-income communities: the ATLAS RCT.

    Science.gov (United States)

    Smith, Jordan J; Morgan, Philip J; Plotnikoff, Ronald C; Dally, Kerry A; Salmon, Jo; Okely, Anthony D; Finn, Tara L; Lubans, David R

    2014-09-01

    The goal of this study was to evaluate the impact of the Active Teen Leaders Avoiding Screen-time (ATLAS) intervention for adolescent boys, an obesity prevention intervention using smartphone technology. ATLAS was a cluster randomized controlled trial conducted in 14 secondary schools in low-income communities in New South Wales, Australia. Participants were 361 adolescent boys (aged 12-14 years) considered at risk of obesity. The 20-week intervention was guided by self-determination theory and social cognitive theory and involved: teacher professional development, provision of fitness equipment to schools, face-to-face physical activity sessions, lunchtime student mentoring sessions, researcher-led seminars, a smartphone application and Web site, and parental strategies for reducing screen-time. Outcome measures included BMI and waist circumference, percent body fat, physical activity (accelerometers), screen-time, sugar-sweetened beverage intake, muscular fitness, and resistance training skill competency. Overall, there were no significant intervention effects for BMI, waist circumference, percent body fat, or physical activity. Significant intervention effects were found for screen-time (mean ± SE: -30 ± 10.08 min/d; P = .03), sugar-sweetened beverage consumption (mean: -0.6 ± 0.26 glass/d; P = .01), muscular fitness (mean: 0.9 ± 0.49 repetition; P = .04), and resistance training skills (mean: 5.7 ± 0.67 units; P < .001). This school-based intervention targeting low-income adolescent boys did not result in significant effects on body composition, perhaps due to an insufficient activity dose. However, the intervention was successful in improving muscular fitness, movement skills, and key weight-related behaviors. Copyright © 2014 by the American Academy of Pediatrics.

  7. Gaps exist in the current guidance on the use of randomized controlled trial study protocols in systematic reviews.

    Science.gov (United States)

    Boden, Catherine; Bidonde, Julia; Busch, Angela

    2017-05-01

    The use of trial registry records and randomized controlled trial (RCT) study protocols can assist systematic reviewers in evaluating and, possibly, minimizing publication and selective reporting biases. This study examined current guidance on the use of registry records and RCT study protocols from key systematic review organizations, institutes, and collaborations. Handbooks, guidelines, and standard documents from key systematic review organizations and the EQUATOR network database were identified. Textual excerpts providing guidance on the use of trial registry records, RCT protocols, and ongoing/unpublished studies were extracted independently by two reviewers and coded into a systematic review framework. Eleven documents published in English between 2009 and 2016 were included. Guidance for using RCT protocols and trial registry records was provided for 7 of 16 framework categories, and guidance for using unpublished and ongoing studies was available for 8 of 16 categories. This study identified gaps and ambiguities in language in guidance on the use of RCT protocols and trial registry records. To encourage and assist reviewers to use trial registry records and RCT study protocols in systematic reviews, current guidance should be expanded and clarified. Copyright © 2017 Elsevier Inc. All rights reserved.

  8. Randomized controlled trials - a matter of design.

    Science.gov (United States)

    Spieth, Peter Markus; Kubasch, Anne Sophie; Penzlin, Ana Isabel; Illigens, Ben Min-Woo; Barlinn, Kristian; Siepmann, Timo

    2016-01-01

    Randomized controlled trials (RCTs) are the hallmark of evidence-based medicine and form the basis for translating research data into clinical practice. This review summarizes commonly applied designs and quality indicators of RCTs to provide guidance in interpreting and critically evaluating clinical research data. It further reflects on the principle of equipoise and its practical applicability to clinical science with an emphasis on critical care and neurological research. We performed a review of educational material, review articles, methodological studies, and published clinical trials using the databases MEDLINE, PubMed, and ClinicalTrials.gov. The most relevant recommendations regarding design, conduction, and reporting of RCTs may include the following: 1) clinically relevant end points should be defined a priori, and an unbiased analysis and report of the study results should be warranted, 2) both significant and nonsignificant results should be objectively reported and published, 3) structured study design and performance as indicated in the Consolidated Standards of Reporting Trials statement should be employed as well as registration in a public trial database, 4) potential conflicts of interest and funding sources should be disclaimed in study report or publication, and 5) in the comparison of experimental treatment with standard care, preplanned interim analyses during an ongoing RCT can aid in maintaining clinical equipoise by assessing benefit, harm, or futility, thus allowing decision on continuation or termination of the trial.

  9. Drug versus placebo randomized controlled trials in neonates: A review of ClinicalTrials.gov registry.

    Science.gov (United States)

    Desselas, Emilie; Pansieri, Claudia; Leroux, Stephanie; Bonati, Maurizio; Jacqz-Aigrain, Evelyne

    2017-01-01

    Despite specific initiatives and identified needs, most neonatal drugs are still used off-label, with variable dosage administrations and schedules. In high risk preterm and term neonates, drug evaluation is challenging and randomized controlled trials (RCT) are difficult to conduct and even more is the use of a placebo, required in the absence of a reference validated drug to be used as comparator. We analyzed the complete ClinicalTrials.gov registry 1) to describe neonatal RCT involving a placebo, 2) to report on the medical context and ethical aspects of placebo use. Placebo versus drug RCT (n = 146), either prevention trials (n = 57, 39%) or therapeutic interventions (n = 89, 61%), represent more than a third of neonatal trials registered in the National Institute of Health clinical trial database (USA) since 1999. They mainly concerned preterm infants, evaluating complications of prematurity. Most trials were conducted in the USA, were single centered, and funded by non-profit organizations. For the three top drug trials evaluating steroids (n = 13, 9.6%), erythropoietin (EPO, n = 10, 6.8%) and nitric oxide (NO, n = 9, 6.2%), the objectives of the trial and follow-up were analyzed in more details. Although a matter of debate, the use of placebo should be promoted in neonates to evaluate a potential new treatment, in the absence of reference drug. Analysis of the trials evaluating steroids showed that long-term follow-up of exposed patients, although required by international guidelines, is frequently missing and should be planned to collect additional information and optimize drug evaluation in these high-risk patients.

  10. Drug versus placebo randomized controlled trials in neonates: A review of ClinicalTrials.gov registry

    Science.gov (United States)

    Desselas, Emilie; Pansieri, Claudia; Leroux, Stephanie; Bonati, Maurizio; Jacqz-Aigrain, Evelyne

    2017-01-01

    Background Despite specific initiatives and identified needs, most neonatal drugs are still used off-label, with variable dosage administrations and schedules. In high risk preterm and term neonates, drug evaluation is challenging and randomized controlled trials (RCT) are difficult to conduct and even more is the use of a placebo, required in the absence of a reference validated drug to be used as comparator. Methods We analyzed the complete ClinicalTrials.gov registry 1) to describe neonatal RCT involving a placebo, 2) to report on the medical context and ethical aspects of placebo use. Results Placebo versus drug RCT (n = 146), either prevention trials (n = 57, 39%) or therapeutic interventions (n = 89, 61%), represent more than a third of neonatal trials registered in the National Institute of Health clinical trial database (USA) since 1999. They mainly concerned preterm infants, evaluating complications of prematurity. Most trials were conducted in the USA, were single centered, and funded by non-profit organizations. For the three top drug trials evaluating steroids (n = 13, 9.6%), erythropoietin (EPO, n = 10, 6.8%) and nitric oxide (NO, n = 9, 6.2%), the objectives of the trial and follow-up were analyzed in more details. Conclusion Although a matter of debate, the use of placebo should be promoted in neonates to evaluate a potential new treatment, in the absence of reference drug. Analysis of the trials evaluating steroids showed that long-term follow-up of exposed patients, although required by international guidelines, is frequently missing and should be planned to collect additional information and optimize drug evaluation in these high-risk patients. PMID:28192509

  11. Understanding involvement in surgical orthopaedic randomized controlled trials: A qualitative study of patient and health professional views and experiences

    Science.gov (United States)

    Horwood, Jeremy; Johnson, Emma; Gooberman-Hill, Rachael

    2016-01-01

    Background Factors influencing patients' motivations for enrolling in, and their experiences of, orthopaedic randomized controlled trials (RCTs) are not fully understood. Less is known about healthcare professionals' (HCP) experiences of RCT involvement. Aim This study investigates patients' and HCPs' views and experiences of RCT participation and delivery to inform the planning of future RCTs. Methods Total hip or knee replacement patients (n = 24) participating in the single-center double-blind APEX RCTs of an intra-operative anesthetic intervention and HCPs (n = 15) involved in trial delivery were interviewed. Data were audio-recorded, transcribed, anonymized and thematically analyzed. Results Although altruistic reasons for RCT participation were common, patients also weighed up demands of the RCT with the potential benefits of taking part, demonstrating the complex and conditional nature of trial participation. HCPs were interested in RCT involvement as a means of contributing towards advances in medical knowledge and also considered the costs and benefits of RCT involvement. Conclusion Patients and HCPs value involvement in RCTs that they see as relevant and of value, while imposing minimum burden. These findings have important implications for the design of methods to recruit patients to RCTs and for planning how an RCT might best interface with HCP clinical commitments. PMID:26772763

  12. Evaluating a community-based early childhood education and development program in Indonesia: study protocol for a pragmatic cluster randomized controlled trial with supplementary matched control group

    NARCIS (Netherlands)

    M. Pradhan; S.A. Brinkman; A. Beatty; A. Maika; E. Satriawan; J. de Ree; A. Hasan

    2013-01-01

    Background This paper presents the study protocol for a pragmatic cluster randomized controlled trial (RCT) with a supplementary matched control group. The aim of the trial is to evaluate a community-based early education and development program launched by the Government of Indonesia. The program w

  13. Independent control of replication initiation of the two Vibrio cholerae chromosomes by DnaA and RctB

    DEFF Research Database (Denmark)

    Duigou, Stephane; Knudsen, Kristine Groth; Skovgaard, Ole

    2006-01-01

    Although the two Vibrio cholerae chromosomes initiate replication in a coordinated fashion, we show here that each chromosome appears to have a specific replication initiator. DnaA overproduction promoted overinitiation of chromosome I and not chromosome II. In contrast, overproduction of Rct...

  14. RANDOMIZED CONTROLLED CLINICAL TRIALS IN ORTHOPEDICS: DIFFICULTIES AND LIMITATIONS

    Science.gov (United States)

    Malavolta, Eduardo Angeli; Demange, Marco Kawamura; Gobbi, Riccardo Gomes; Imamura, Marta; Fregni, Felipe

    2015-01-01

    Randomized controlled clinical trials (RCTs) are considered to be the gold standard for evidence-based medicine nowadays, and are important for directing medical practice through consistent scientific observations. Steps such as patient selection, randomization and blinding are fundamental for conducting a RCT, but some additional difficulties are presented in trials that involve surgical procedures, as is common in orthopedics. The aim of this article was to highlight and discuss some difficulties and possible limitations on RCTs within the field of surgery. PMID:27027037

  15. Prophylactic antibiotic regimens in tumour surgery (PARITY) A PILOT MULTICENTRE RANDOMISED CONTROLLED TRIAL

    NARCIS (Netherlands)

    Ghert, M.; Bhandari, M.; Deheshi, B.; Guyatt, G.; Holt, G.; O'Shea, T.; Randall, R. L.; Thabane, L.; Wunder, J.; Evaniew, N.; McKay, P.; Schneider, P.; Turcotte, R.; Madden, K.; Scott, T.; Sprague, S.; Simunovic, N.; Swinton, M.; Racano, A.; Heels-Ansdell, D.; Buckingham, L.; Rose, P.; Brigman, B.; Pullenayegum, E.; Ghert, M.; Evaniew, N.; Mckay, P.; Schneider, P.; Sobhi, G.; Chan, R.; Biljan, M.; Ferguson, P.; Wunder, J.; Griffin, A.; Mantas, I.; Wylie, A.; Han, A.; Grewal, G.; Turcotte, R.; Goulding, K.; Dandachli, F.; Matte, G.; Werier, J.; Abdelbary, H.; Paquin, K.; Cosgrove, H.; Dugal, A-M.; Fetzer, S.; Aikens, W.; Clarkson, P.; Wang, B.; Kondo, L.; Yip, J.; Isler, M.; Mottard, S.; Barry, J.; St Yves, H.; Quach, M.; Assayag, H.; Daoust, K.; Goyette, K.; Projean, D.; Dion, N.; Arteau, A.; Turmel, S.; Bertrand, A.; Gagnon, N.; Labbe, V.; Holt, G.; Halpern, J.; Schwartz, H.; Atkinson, A.; Daniels, J.; Moore, M. S.; Anderson, M.; Gebhardt, M.; Wagner, K.; Patel, H.; Jolin, H.; Anderson, M.; Gebhardt, M.; Allar, B.; Naqvi, M.; Bennett, J.; Albuquerque, S.; Randall, R. L.; Jones, K.; Crabtree, S.; Davis, R.; Sorenson, S.; Healey, J. H.; Galle, J.; O'Neill, G.; Del Corral, B.; Lopez, S.; Galli Serra, M.; Parizzia, W.; Podrzaj, A.; Foa Torres, M.; Clayer, M.; Chai, Y.; Slobodian, P.; Balach, T.; Coyle, K.; LaCasse, R.; Abraham, J.; Morrison, T.; Angelos, M.; Sailor, L.; Sadaka, R.; Miller, B.; Milhem, M.; McCurdy, N.; Kain, J.; Nohr, J.; Johnson, K.; Merriss, A.; Cheng, E.; Luke, D. G.; Scharschmidt, T. J.; Crist, M. K.; Dimeo, A.; Marmon, L.; Reimer, N.; Monson, D.; Oskouei, S.; Lomba, C.; Rogers, S.; Avedian, R.; Jordan, L.; Chinn, S.; Hamilton, M.; Ghert, M.; Evaniew, N.; McKay, P.; Schneider, P.; Sobhi, G.; Chan, R.; Bil-Jan, M.; Ferguson, P.; Wunder, J.; Griffin, A.; Mantas, I.; Wylie, A.; Han, A.; Grewal, G.; Turcotte, R.; Goulding, K.; Dandachli, F.; Matte, G.; Werier, J.; Abdelbary, H.; Paquin, K.; Cosgrove, H.; Dugal, A-M.; Fetzer, S.; Aikens, W.; Clarkson, P.; Wang, B.; Kondo, L.; Yip, J.; Isler, M.; Mottard, S.; Barry, J.; Yves, H. St.; Quach, M.; Assayag, H.; Daoust, K.; Goyette, Kristine; Projean, D.; Dion, N.; Arteau, A.; Turmel, S.; Bertrand, A.; Gagnon, N.; Labbe, V.; Holt, G.; Halpern, J.; Schwartz, H.; Atkinson, A.; Daniels, J.; Moore, M. S.; Anderson, M.; Gebhardt, M.; Wagner, K.; Patel, H.; Jolin, H.; Anderson, M.; Gebhardt, M.; Allar, B.; Naqvi, M.; Bennett, J.; Albuquerque, S.; Randall, R. L.; Jones, K.; Crabtree, S.; Davis, R.; Sorenson, S.; Healey, J. H.; Galle, J.; O'Neill, G.; Del Corral, B.; Lopez, S.; Galli Serra, M.; Parizzia, W.; Podrzaj, A.; Foa Torres, M.; Clayer, M.; Tran, N.; Slobodian, P.; Balach, T.; Coyle, K.; LaCasse, R.; Abraham, J.; Morrison, T.; Angelos, M.; Sailor, L.; Sadaka, R.; Miller, B.; Milhem, M.; McCurdy, N.; Kain, J.; Nohr, J.; Johnson, K.; Merriss, A.; Cheng, E.; Luke, D. G.; Scharschmidt, T. J.; Crist, M. K.; Dimeo, A.; Marmon, L.; Reimer, N.; Monson, D.; Oskouei, S.; Lomba, C.; Rogers, S.; Geller, D.; Hoang, B.; Tingling, J.; Solorzano, C.; Avedian, R.; Jordan, L.; Chinn, S.; Hamilton, M.; Puloski, S.; Monument, M.; Carcary, K.; Cameron, C.; Aboulafia, A.; Loo-Mis, M.; Bosley, J.; Bonvegna, R.; Kassa, M.; Damron, T.; Craig, T.; Reale, M.; Goodman, H. J.; Culbertson, M. Deza; Caruso, P.; Garling, E.; Schwab, J.; Fiore, A.; Phukan, R.; Park, C.; Joshi, L.; Aboulafia, A.; Wallace, M.; Flack, J.; Vaughan, K.; Avergas, A.; Brady, M.; Brown, S.; Schadie, N.; Battersby, R.; Weiss, K.; Goodman, M.; Heyl, A.; Yeschke, C. A.; Sumic, P.; Dudgeon, M.; Prosser, R.; Korenoski, C.; DiCaprio, M.; Palmer, B.; Cioppa, E.; Schaeffer, T. M.; Paul, P.; Toreson, J.; Cummings, J.; Schwartz, L.; Zahner, B.; Morris, C.; Laljani, V.; Mesko, N.; Joyce, M.; Lietman, S.; Wustrack, R.; O'Donnell, R.; Stevenson, C.; Carmody, E.; Tyler, W.; McIntyre, A.; Spiguel, A.; Scarborough, M.; Gibbs, C. P.; Steshyn, J.; Nunn, B.; Rosenthal, H.; Haynes, K.; Leddy, L.; Walton, Z.; Doung, Y-C.; Hayden, J.; Velez, R.; Aguirre, M.; Perez, M.; Barrera, S.; Garca Lopez, A.; Grimer, R.; Dunn, K.; Virdee, H.; Rankin, K.; Beckingsale, T.; Gerrand, C.; Campbell, I.; Allen, M.; Khan, S. Alam; Bakshi, S.; Rastogi, S.; Poudel, R.; Kumar, V. Sampath; Rai, A.; Baptista, A. M.; de Camargo, O. P.; Marais, L.; Rodseth, R.; Ferreira, N.; Rajah, C.; Gumede, S.; Gortzak, Y.; Sternheim, A.; Bickels, J.; Kolander, Y.; Lev, S.; Hettwer, W.; Petersen, M. M.; Grum-Schwensen, T.; Jutte, P.; Ploegmakers, J. J. W.; Stevens, M.; Mahendra, A.; Gupta, S.; Bergovec, M.; Leithner, A.; Funovics, P.; Dijkstra, P. D. S.; Van De Sande, M.; Hoogenstraaten, A.; Leijerzapf, N.; Steadman, P.; Steadman, P.; Boffano, M.; Piana, R.; Marone, S.; Albertini, U.; Boux, E.; Maiello, A.; Repsa, L.; Zile, S.; Aston, W.; Pollock, R.; Cool, P.; Gibbons, M.; Whit-Well, D.; Cosker, T.; Hemingway, J.; Porter, D.; Patton, S.; Navia, J.; Betancur, A. F.; Laitenen, M.; Pakarinen, K.; Nieminen, J.; Yla-Mononen, S.; Rautiainen, S.; Fiorenza, F.

    Objective Clinical studies of patients with bone sarcomas have been challenged by insufficient numbers at individual centres to draw valid conclusions. Our objective was to assess the feasibility of conducting a definitive multi-centre randomised controlled trial (RCT) to determine whether a

  16. Do hospitalized premature infants benefit from music interventions? A systematic review of randomized controlled trials

    NARCIS (Netherlands)

    M.J.E. Van Der Heijden (Marianne J. E.); S.O. Araghi (Sadaf Oliai); J. Jeekel (Hans); I.K.M. Reiss (Irwin); M.G.M. Hunink (Myriam); M. Van Dijk (Monique)

    2016-01-01

    textabstractObjective: Neonatal intensive care units (NICU) around the world increasingly use music interventions. The most recent systematic review of randomized controlled trials (RCT) dates from 2009. Since then, 15 new RCTs have been published. We provide an updated systematic review on the poss

  17. RANDOMIZED CONTROLLED TRIALS OF MATERNAL-FETAL SURGERY : A CHALLENGE TO CLINICAL EQUIPOISE

    NARCIS (Netherlands)

    Rodrigues, H. C. M. L.; van den Berg, P. P.

    2014-01-01

    This article focuses on maternal-fetal surgery (MFS) and on the concept of clinical equipoise that is a widely accepted requirement for conducting randomized controlled trials (RCT). There are at least three reasons why equipoise is unsuitable for MFS. First, the concept is based on a misconception

  18. Do hospitalized premature infants benefit from music interventions? A systematic review of randomized controlled trials

    NARCIS (Netherlands)

    M.J.E. Van Der Heijden (Marianne J. E.); S.O. Araghi (Sadaf Oliai); J. Jeekel (Hans); I.K.M. Reiss (Irwin); M.G.M. Hunink (Myriam); M. Van Dijk (Monique)

    2016-01-01

    textabstractObjective: Neonatal intensive care units (NICU) around the world increasingly use music interventions. The most recent systematic review of randomized controlled trials (RCT) dates from 2009. Since then, 15 new RCTs have been published. We provide an updated systematic review on the

  19. Prophylactic antibiotic regimens in tumour surgery (PARITY) A PILOT MULTICENTRE RANDOMISED CONTROLLED TRIAL

    NARCIS (Netherlands)

    Ghert, M.; Bhandari, M.; Deheshi, B.; Guyatt, G.; Holt, G.; O'Shea, T.; Randall, R. L.; Thabane, L.; Wunder, J.; Evaniew, N.; McKay, P.; Schneider, P.; Turcotte, R.; Madden, K.; Scott, T.; Sprague, S.; Simunovic, N.; Swinton, M.; Racano, A.; Heels-Ansdell, D.; Buckingham, L.; Rose, P.; Brigman, B.; Pullenayegum, E.; Ghert, M.; Evaniew, N.; Mckay, P.; Schneider, P.; Sobhi, G.; Chan, R.; Biljan, M.; Ferguson, P.; Wunder, J.; Griffin, A.; Mantas, I.; Wylie, A.; Han, A.; Grewal, G.; Turcotte, R.; Goulding, K.; Dandachli, F.; Matte, G.; Werier, J.; Abdelbary, H.; Paquin, K.; Cosgrove, H.; Dugal, A-M.; Fetzer, S.; Aikens, W.; Clarkson, P.; Wang, B.; Kondo, L.; Yip, J.; Isler, M.; Mottard, S.; Barry, J.; St Yves, H.; Quach, M.; Assayag, H.; Daoust, K.; Goyette, K.; Projean, D.; Dion, N.; Arteau, A.; Turmel, S.; Bertrand, A.; Gagnon, N.; Labbe, V.; Holt, G.; Halpern, J.; Schwartz, H.; Atkinson, A.; Daniels, J.; Moore, M. S.; Anderson, M.; Gebhardt, M.; Wagner, K.; Patel, H.; Jolin, H.; Anderson, M.; Gebhardt, M.; Allar, B.; Naqvi, M.; Bennett, J.; Albuquerque, S.; Randall, R. L.; Jones, K.; Crabtree, S.; Davis, R.; Sorenson, S.; Healey, J. H.; Galle, J.; O'Neill, G.; Del Corral, B.; Lopez, S.; Galli Serra, M.; Parizzia, W.; Podrzaj, A.; Foa Torres, M.; Clayer, M.; Chai, Y.; Slobodian, P.; Balach, T.; Coyle, K.; LaCasse, R.; Abraham, J.; Morrison, T.; Angelos, M.; Sailor, L.; Sadaka, R.; Miller, B.; Milhem, M.; McCurdy, N.; Kain, J.; Nohr, J.; Johnson, K.; Merriss, A.; Cheng, E.; Luke, D. G.; Scharschmidt, T. J.; Crist, M. K.; Dimeo, A.; Marmon, L.; Reimer, N.; Monson, D.; Oskouei, S.; Lomba, C.; Rogers, S.; Avedian, R.; Jordan, L.; Chinn, S.; Hamilton, M.; Ghert, M.; Evaniew, N.; McKay, P.; Schneider, P.; Sobhi, G.; Chan, R.; Bil-Jan, M.; Ferguson, P.; Wunder, J.; Griffin, A.; Mantas, I.; Wylie, A.; Han, A.; Grewal, G.; Turcotte, R.; Goulding, K.; Dandachli, F.; Matte, G.; Werier, J.; Abdelbary, H.; Paquin, K.; Cosgrove, H.; Dugal, A-M.; Fetzer, S.; Aikens, W.; Clarkson, P.; Wang, B.; Kondo, L.; Yip, J.; Isler, M.; Mottard, S.; Barry, J.; Yves, H. St.; Quach, M.; Assayag, H.; Daoust, K.; Goyette, Kristine; Projean, D.; Dion, N.; Arteau, A.; Turmel, S.; Bertrand, A.; Gagnon, N.; Labbe, V.; Holt, G.; Halpern, J.; Schwartz, H.; Atkinson, A.; Daniels, J.; Moore, M. S.; Anderson, M.; Gebhardt, M.; Wagner, K.; Patel, H.; Jolin, H.; Anderson, M.; Gebhardt, M.; Allar, B.; Naqvi, M.; Bennett, J.; Albuquerque, S.; Randall, R. L.; Jones, K.; Crabtree, S.; Davis, R.; Sorenson, S.; Healey, J. H.; Galle, J.; O'Neill, G.; Del Corral, B.; Lopez, S.; Galli Serra, M.; Parizzia, W.; Podrzaj, A.; Foa Torres, M.; Clayer, M.; Tran, N.; Slobodian, P.; Balach, T.; Coyle, K.; LaCasse, R.; Abraham, J.; Morrison, T.; Angelos, M.; Sailor, L.; Sadaka, R.; Miller, B.; Milhem, M.; McCurdy, N.; Kain, J.; Nohr, J.; Johnson, K.; Merriss, A.; Cheng, E.; Luke, D. G.; Scharschmidt, T. J.; Crist, M. K.; Dimeo, A.; Marmon, L.; Reimer, N.; Monson, D.; Oskouei, S.; Lomba, C.; Rogers, S.; Geller, D.; Hoang, B.; Tingling, J.; Solorzano, C.; Avedian, R.; Jordan, L.; Chinn, S.; Hamilton, M.; Puloski, S.; Monument, M.; Carcary, K.; Cameron, C.; Aboulafia, A.; Loo-Mis, M.; Bosley, J.; Bonvegna, R.; Kassa, M.; Damron, T.; Craig, T.; Reale, M.; Goodman, H. J.; Culbertson, M. Deza; Caruso, P.; Garling, E.; Schwab, J.; Fiore, A.; Phukan, R.; Park, C.; Joshi, L.; Aboulafia, A.; Wallace, M.; Flack, J.; Vaughan, K.; Avergas, A.; Brady, M.; Brown, S.; Schadie, N.; Battersby, R.; Weiss, K.; Goodman, M.; Heyl, A.; Yeschke, C. A.; Sumic, P.; Dudgeon, M.; Prosser, R.; Korenoski, C.; DiCaprio, M.; Palmer, B.; Cioppa, E.; Schaeffer, T. M.; Paul, P.; Toreson, J.; Cummings, J.; Schwartz, L.; Zahner, B.; Morris, C.; Laljani, V.; Mesko, N.; Joyce, M.; Lietman, S.; Wustrack, R.; O'Donnell, R.; Stevenson, C.; Carmody, E.; Tyler, W.; McIntyre, A.; Spiguel, A.; Scarborough, M.; Gibbs, C. P.; Steshyn, J.; Nunn, B.; Rosenthal, H.; Haynes, K.; Leddy, L.; Walton, Z.; Doung, Y-C.; Hayden, J.; Velez, R.; Aguirre, M.; Perez, M.; Barrera, S.; Garca Lopez, A.; Grimer, R.; Dunn, K.; Virdee, H.; Rankin, K.; Beckingsale, T.; Gerrand, C.; Campbell, I.; Allen, M.; Khan, S. Alam; Bakshi, S.; Rastogi, S.; Poudel, R.; Kumar, V. Sampath; Rai, A.; Baptista, A. M.; de Camargo, O. P.; Marais, L.; Rodseth, R.; Ferreira, N.; Rajah, C.; Gumede, S.; Gortzak, Y.; Sternheim, A.; Bickels, J.; Kolander, Y.; Lev, S.; Hettwer, W.; Petersen, M. M.; Grum-Schwensen, T.; Jutte, P.; Ploegmakers, J. J. W.; Stevens, M.; Mahendra, A.; Gupta, S.; Bergovec, M.; Leithner, A.; Funovics, P.; Dijkstra, P. D. S.; Van De Sande, M.; Hoogenstraaten, A.; Leijerzapf, N.; Steadman, P.; Steadman, P.; Boffano, M.; Piana, R.; Marone, S.; Albertini, U.; Boux, E.; Maiello, A.; Repsa, L.; Zile, S.; Aston, W.; Pollock, R.; Cool, P.; Gibbons, M.; Whit-Well, D.; Cosker, T.; Hemingway, J.; Porter, D.; Patton, S.; Navia, J.; Betancur, A. F.; Laitenen, M.; Pakarinen, K.; Nieminen, J.; Yla-Mononen, S.; Rautiainen, S.; Fiorenza, F.

    2015-01-01

    Objective Clinical studies of patients with bone sarcomas have been challenged by insufficient numbers at individual centres to draw valid conclusions. Our objective was to assess the feasibility of conducting a definitive multi-centre randomised controlled trial (RCT) to determine whether a five-da

  20. Methylprednisolone in the management of spinal cord injuries: Lessons from randomized, controlled trials

    Directory of Open Access Journals (Sweden)

    Vincent Cheung

    2015-01-01

    Full Text Available The efficacy of glucocorticoid for treatment of acute spinal cord injuries remains a controversial topic. Differing medical societies have issued conflicting recommendations in this regard. Here we review the available randomized, controlled trial (RCT data on this subject and offer a synthesis of these data sets.

  1. Low quality of reporting adverse drug reactions in paediatric randomised controlled trials

    NARCIS (Netherlands)

    de Vries, Tjalling W; van Roon, Eric N

    2010-01-01

    OBJECTIVE: Randomised controlled trials (RCT) offer an opportunity to learn about frequency and character of adverse drug reactions. To improve the quality of reporting adverse effects, the Consort group published recommendations. The authors studied the application of these recommendations in RCTs

  2. Do hospitalized premature infants benefit from music interventions? A systematic review of randomized controlled trials

    NARCIS (Netherlands)

    M.J.E. Van Der Heijden (Marianne J. E.); S.O. Araghi (Sadaf Oliai); J. Jeekel (Hans); I.K.M. Reiss (Irwin); Hunink, M.G.M. (M.G. Myriam); M. Van Dijk (Monique)

    2016-01-01

    textabstractObjective: Neonatal intensive care units (NICU) around the world increasingly use music interventions. The most recent systematic review of randomized controlled trials (RCT) dates from 2009. Since then, 15 new RCTs have been published. We provide an updated systematic review on the poss

  3. [On-site quality control of acupuncture randomized controlled trial: design of content and checklist of quality control based on PICOST].

    Science.gov (United States)

    Li, Hong-Jiao; He, Li-Yun; Liu, Zhi-Shun; Sun, Ya-Nan; Yan, Shi-Yan; Liu, Jia; Zhao, Ye; Liu, Bao-Yan

    2014-02-01

    To effectively guarantee quality of randomized controlld trial (RCT) of acupuncture and develop reasonable content and checklist of on-site quality control, influencing factors on quality of acupuncture RCT are analyzed and scientificity of quality control content and feasibility of on-site manipulation are put into overall consideration. Based on content and checklist of on-site quality control in National 11th Five-Year Plan Project Optimization of Comprehensive Treatment Plan for TCM in Prevention and Treatment of Serious Disease and Clinical Assessment on Generic Technology and Quality Control Research, it is proposed that on-site quality control of acupuncture RCT should be conducted with PICOST (patient, intervention, comparison, out come, site and time) as core, especially on quality control of interveners' skills and outcome assessment of blinding, and checklist of on-site quality control is developed to provide references for undertaking groups of the project.

  4. Transparency of Outcome Reporting and Trial Registration of Randomized Controlled Trials Published in the Journal of Consulting and Clinical Psychology.

    Directory of Open Access Journals (Sweden)

    Marleine Azar

    Full Text Available Confidence that randomized controlled trial (RCT results accurately reflect intervention effectiveness depends on proper trial conduct and the accuracy and completeness of published trial reports. The Journal of Consulting and Clinical Psychology (JCCP is the primary trials journal amongst American Psychological Association (APA journals. The objectives of this study were to review RCTs recently published in JCCP to evaluate (1 adequacy of primary outcome analysis definitions; (2 registration status; and, (3 among registered trials, adequacy of outcome registrations. Additionally, we compared results from JCCP to findings from a recent study of top psychosomatic and behavioral medicine journals.Eligible RCTs were published in JCCP in 2013-2014. For each RCT, two investigators independently extracted data on (1 adequacy of outcome analysis definitions in the published report, (2 whether the RCT was registered prior to enrolling patients, and (3 adequacy of outcome registration.Of 70 RCTs reviewed, 12 (17.1% adequately defined primary or secondary outcome analyses, whereas 58 (82.3% had multiple primary outcome analyses without statistical adjustment or undefined outcome analyses. There were 39 (55.7% registered trials. Only two trials registered prior to patient enrollment with a single primary outcome variable and time point of assessment. However, in one of the two trials, registered and published outcomes were discrepant. No studies were adequately registered as per Standard Protocol Items: Recommendation for Interventional Trials guidelines. Compared to psychosomatic and behavioral medicine journals, the proportion of published trials with adequate outcome analysis declarations was significantly lower in JCCP (17.1% versus 32.9%; p = 0.029. The proportion of registered trials in JCCP (55.7% was comparable to behavioral medicine journals (52.6%; p = 0.709.The quality of published outcome analysis definitions and trial registrations in JCCP is

  5. Transparency of Outcome Reporting and Trial Registration of Randomized Controlled Trials Published in the Journal of Consulting and Clinical Psychology.

    Science.gov (United States)

    Azar, Marleine; Riehm, Kira E; McKay, Dean; Thombs, Brett D

    2015-01-01

    Confidence that randomized controlled trial (RCT) results accurately reflect intervention effectiveness depends on proper trial conduct and the accuracy and completeness of published trial reports. The Journal of Consulting and Clinical Psychology (JCCP) is the primary trials journal amongst American Psychological Association (APA) journals. The objectives of this study were to review RCTs recently published in JCCP to evaluate (1) adequacy of primary outcome analysis definitions; (2) registration status; and, (3) among registered trials, adequacy of outcome registrations. Additionally, we compared results from JCCP to findings from a recent study of top psychosomatic and behavioral medicine journals. Eligible RCTs were published in JCCP in 2013-2014. For each RCT, two investigators independently extracted data on (1) adequacy of outcome analysis definitions in the published report, (2) whether the RCT was registered prior to enrolling patients, and (3) adequacy of outcome registration. Of 70 RCTs reviewed, 12 (17.1%) adequately defined primary or secondary outcome analyses, whereas 58 (82.3%) had multiple primary outcome analyses without statistical adjustment or undefined outcome analyses. There were 39 (55.7%) registered trials. Only two trials registered prior to patient enrollment with a single primary outcome variable and time point of assessment. However, in one of the two trials, registered and published outcomes were discrepant. No studies were adequately registered as per Standard Protocol Items: Recommendation for Interventional Trials guidelines. Compared to psychosomatic and behavioral medicine journals, the proportion of published trials with adequate outcome analysis declarations was significantly lower in JCCP (17.1% versus 32.9%; p = 0.029). The proportion of registered trials in JCCP (55.7%) was comparable to behavioral medicine journals (52.6%; p = 0.709). The quality of published outcome analysis definitions and trial registrations in JCCP is

  6. OARSI Clinical Trials Recommendations

    DEFF Research Database (Denmark)

    Emery, C. A.; Roos, Ewa M.; Verhagen, E.;

    2015-01-01

    The risk of post-traumatic osteoarthritis (PTOA) substantially increases following joint injury. Research efforts should focus on investigating the efficacy of preventative strategies in high quality randomized controlled trials (RCT). The objective of these OARSI RCT recommendations is to inform...

  7. Interrupted time-series analysis yielded an effect estimate concordant with the cluster-randomized controlled trial result.

    Science.gov (United States)

    Fretheim, Atle; Soumerai, Stephen B; Zhang, Fang; Oxman, Andrew D; Ross-Degnan, Dennis

    2013-08-01

    We reanalyzed the data from a cluster-randomized controlled trial (C-RCT) of a quality improvement intervention for prescribing antihypertensive medication. Our objective was to estimate the effectiveness of the intervention using both interrupted time-series (ITS) and RCT methods, and to compare the findings. We first conducted an ITS analysis using data only from the intervention arm of the trial because our main objective was to compare the findings from an ITS analysis with the findings from the C-RCT. We used segmented regression methods to estimate changes in level or slope coincident with the intervention, controlling for baseline trend. We analyzed the C-RCT data using generalized estimating equations. Last, we estimated the intervention effect by including data from both study groups and by conducting a controlled ITS analysis of the difference between the slope and level changes in the intervention and control groups. The estimates of absolute change resulting from the intervention were ITS analysis, 11.5% (95% confidence interval [CI]: 9.5, 13.5); C-RCT, 9.0% (95% CI: 4.9, 13.1); and the controlled ITS analysis, 14.0% (95% CI: 8.6, 19.4). ITS analysis can provide an effect estimate that is concordant with the results of a cluster-randomized trial. A broader range of comparisons from other RCTs would help to determine whether these are generalizable results. Copyright © 2013 Elsevier Inc. All rights reserved.

  8. Exercise and manual physiotherapy arthritis research trial (EMPART): a multicentre randomised controlled trial.

    LENUS (Irish Health Repository)

    French, Helen P

    2009-01-01

    Osteoarthritis (OA) of the hip is a major cause of functional disability and reduced quality of life. Management options aim to reduce pain and improve or maintain physical functioning. Current evidence indicates that therapeutic exercise has a beneficial but short-term effect on pain and disability, with poor long-term benefit. The optimal content, duration and type of exercise are yet to be ascertained. There has been little scientific investigation into the effectiveness of manual therapy in hip OA. Only one randomized controlled trial (RCT) found greater improvements in patient-perceived improvement and physical function with manual therapy, compared to exercise therapy.

  9. High Precision Photometry of Variable Stars in Clusters of Different Ages with the 1.3 m Robotically Controlled Telescope (RCT)

    Science.gov (United States)

    Guinan, E. F.; McCook, G. P.; DeWarf, L. E.; Gelderman, R. F.; McGruder, C. H.; Walter, D. K.; Howell, S. B.; Davis, D. R.; Everett, M.; Mattox, J. R.

    2003-05-01

    We discuss a new program of carrying out high precision VRI CCD photometry of several star clusters of different ages. The photometry is being carried out using the 1.3 m Robotically Controlled Telescope (RCT), located at KPNO. This program focuses on the study of variable stars in mostly open clusters. Selected astrophysically important eclipsing binaries, pulsating variables, blue stragglers, and chromospherically active variable stars will be studied. Also, searches of new variable stars will be made from the expected large samples of cluster stars. For example, photometry is planned of the several W UMa eclipsing binaries and blue straggler stars in the old open cluster NGC 188. Photometry also will be carried out of the young open cluster NGC 7790. This cluster is unique because has three confirmed classical cepheid members: CE Cas A (V ˜ +10.9 mag; F8 Ib; P = 4.446 d ), CE Cep B (V ˜ +11.0 mag; F9 Ib; 5.128 d), and CF Cas (V ˜ +11.1 mag; F8 Ib; 4.875 d). NGC 7790 also contains the 10th mag eccentric B0+B0 eclipsing binary QX Cas. The observations of QX Cas are being conducted to determine the accurate distance to this star and thus to the cluster and its cepheid members. When complete these observations, combined with spectroscopy, will permit a reliable calibration of the ``zero-point'' of the galactic cepheid Period-Luminosity Law. Another possible project is the search of light variations of PMS stars and chromospherically active stars (from star spot rotational modulations) in young clusters such as the alpha Perseus Cluster, h & χ Per, M34, and the Pleiades. Refurbishment of the RCT has been made possible by NASA grant NAG 58762. The RCT Consortium includes: Western Kentucky Univ., S. Carolina St Univ., Francis Marion Univ., Villanova Univ., and the Planetary Science Institute (PSI).

  10. Effects of the search technique on the measurement of the change in quality of randomized controlled trials over time in the field of brain injury

    Directory of Open Access Journals (Sweden)

    Yamada Chisa

    2005-02-01

    Full Text Available Abstract Background To determine if the search technique that is used to sample randomized controlled trial (RCT manuscripts from a field of medical science can influence the measurement of the change in quality over time in that field. Methods RCT manuscripts in the field of brain injury were identified using two readily-available search techniques: (1 a PubMed MEDLINE search, and (2 the Cochrane Injuries Group (CIG trials registry. Seven criteria of quality were assessed in each manuscript and related to the year-of-publication of the RCT manuscripts by regression analysis. Results No change in the frequency of reporting of any individual quality criterion was found in the sample of RCT manuscripts identified by the PubMed MEDLINE search. In the RCT manuscripts of the CIG trials registry, three of the seven criteria showed significant or near-significant increases over time. Conclusions We demonstrated that measuring the change in quality over time of a sample of RCT manuscripts from the field of brain injury can be greatly affected by the search technique. This poorly recognized factor may make measurements of the change in RCT quality over time within a given field of medical science unreliable.

  11. Qualitative methods in early-phase drug trials: broadening the scope of data and methods from an RCT of N-acetylcysteine in schizophrenia.

    Science.gov (United States)

    Berk, Michael; Munib, Ahmed; Dean, Olivia; Malhi, Gin S; Kohlmann, Kristy; Schapkaitz, Ian; Jeavons, Sue; Katz, Fiona; Anderson-Hunt, Murray; Conus, Philippe; Hanna, Barbara; Otmar, Renée; Ng, Felicity; Copolov, David L; Bush, Ashley I

    2011-07-01

    The pharmacokinetic profile of a drug often gives little indication of its potential therapeutic application, with many therapeutic uses of drugs being discovered serendipitously while being studied for different indications. As hypothesis-driven, quantitative research methodology is exclusively used in early-phase trials, unexpected but important phenomena may escape detection. In this context, this study aimed to examine the potential for integrating qualitative research methods with quantitative methods in early-phase drug trials. To our knowledge, this mixed methodology has not previously been applied to blinded psychopharmacologic trials. We undertook qualitative data analysis of clinical observations on the dataset of a randomized, double-blind, placebo-controlled trial of N-acetylcysteine (NAC) in patients with DSM-IV-TR-diagnosed schizophrenia (N = 140). Textual data on all participants, deliberately collected for this purpose, were coded using NVivo 2, and emergent themes were analyzed in a blinded manner in the NAC and placebo groups. The trial was conducted from November 2002 to July 2005. The principal findings of the published trial could be replicated using a qualitative methodology. In addition, significant differences between NAC- and placebo-treated participants emerged for positive and affective symptoms, which had not been captured by the rating scales utilized in the quantitative trial. Qualitative data in this study subsequently led to a positive trial of NAC in bipolar disorder. The use of qualitative methods may yield broader data and has the potential to complement traditional quantitative methods and detect unexpected efficacy and safety signals, thereby maximizing the findings of early-phase clinical trial research. www.anzctr.org.au Identifier: ACTRN12605000363684. © Copyright 2011 Physicians Postgraduate Press, Inc.

  12. Statistical issues in randomised controlled trials: a narrative synthesis

    Directory of Open Access Journals (Sweden)

    Bolaji Emmanuel Egbewale

    2015-05-01

    Full Text Available Randomised controlled trials (RCT s are gold standard in the evaluation of treatment efficacy in medical investigations, only if well designed and implemented. Till date, distorted views and misapplications of statistical procedures involved in RCTs are still in practice. Hence, clarification of concepts and acceptable practices related to certain statistical issues involved in the design, conduct and reporting of randomised controlled trials is needed. This narrative synthesis aimed at providing succinct but clear information on the concepts and practices of selected statistical issues in RCT s to inform correct applications. The use of tests of significance is no longer acceptable as means to compare baseline similarity between treatment groups and in determining which covariate(s should be included in the model for adjustment. Distribution of baseline attributes simply presented in tabular form is however, rather preferred. Regarding covariate selection, such approach that makes use of information on the degree of correlation between the covariate(s and the outcome variable is more in tandem with statistical principle(s than that based on tests of significance. Stratification and minimisation are not alternatives to covariate adjusted analysis; in fact they establish the need for one. Intention-to-treat is the preferred approach for the evaluation of primary outcome measures and researchers have responsibility to report whether or not the procedure was followed. A major use of results from subgroup analysis is to generate hypothesis for future clinical trials. Since RCT s are gold standard in the comparison of medical interventions, researchers cannot afford the practices of distorted allocation or statistical procedures in this all important experimental design method.

  13. The effectiveness of participatory ergonomics to prevent low-back and neck pain - results of a cluster randomized controlled trial

    NARCIS (Netherlands)

    Driessen, M.T.; Proper, K.I.; Anema, J.R.; Knol, D.L.; Bongers, P.M.; Beek, A.J. van der

    2011-01-01

    Objective The aim of this randomized controlled trial (RCT) was to investigate the effectiveness of the Stay@ Work participatory ergonomics (PE) program to prevent low-back and neck pain. Methods A total of 37 departments were randomly allocated to either the intervention (PE) or control group (no P

  14. Why did an effective Dutch complex psycho-social intervention for people with dementia not work in the German healthcare context? Lessons learnt from a process evaluation alongside a multicentre RCT

    National Research Council Canada - National Science Library

    Voigt-Radloff, S; Graff, M.J.L; Leonhart, R; Hull, M; Olde Rikkert, M.G.M; Vernooij-Dassen, M.J.F.J

    2011-01-01

    Background The positive effects of the Dutch Community Occupational Therapy in Dementia programme on patients' daily functioning were not found in a multicentre randomised controlled trial (RCT) in Germany...

  15. Impact of industry collaboration on randomised controlled trials in oncology.

    Science.gov (United States)

    Linker, Anne; Yang, Annie; Roper, Nitin; Whitaker, Evans; Korenstein, Deborah

    2017-02-01

    Industry funders can simply provide money or collaborate in trial design, analysis or reporting of clinical trials. Our aim was to assess the impact of industry collaboration on trial methodology and results of randomised controlled trials (RCT). We searched PubMed for oncology RCTs published May 2013 to December 2015 in peer-reviewed journals with impact factor > 5 requiring reporting of funder role. Two authors extracted methodologic (primary end-point; blinding of the patient, clinician and outcomes assessor; and analysis) and outcome data. We used descriptive statistics and two-sided Fisher exact tests to compare characteristics of trials with collaboration, with industry funding only, and without industry funding. We included 224 trials. Compared to those without industry funding, trials with collaboration used more placebo control (RR 3·59, 95% CI [1·88-6·83], p industry collaboration were more likely to use some high-quality methods than those without industry funding, with similar rates of positive results. Our findings suggest that collaboration is not associated with trial outcomes and that mandatory disclosure of funder roles may mitigate bias. Copyright © 2016 Elsevier Ltd. All rights reserved.

  16. HElmet therapy Assessment in infants with Deformed Skulls (HEADS: protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    van Wijk Renske M

    2012-07-01

    Full Text Available Abstract Background In The Netherlands, helmet therapy is a commonly used treatment in infants with skull deformation (deformational plagiocephaly or deformational brachycephaly. However, evidence of the effectiveness of this treatment remains lacking. The HEADS study (HElmet therapy Assessment in Deformed Skulls aims to determine the effects and costs of helmet therapy compared to no helmet therapy in infants with moderate to severe skull deformation. Methods/design Pragmatic randomised controlled trial (RCT nested in a cohort study. The cohort study included infants with a positional preference and/or skull deformation at two to four months (first assessment. At 5 months of age, all children were assessed again and infants meeting the criteria for helmet therapy were asked to participate in the RCT. Participants were randomly allocated to either helmet therapy or no helmet therapy. Parents of eligible infants that do not agree with enrolment in the RCT were invited to stay enrolled for follow up in a non-randomisedrandomised controlled trial (nRCT; they were then free to make the decision to start helmet therapy or not. Follow-up assessments took place at 8, 12 and 24 months of age. The main outcome will be head shape at 24 months that is measured using plagiocephalometry. Secondary outcomes will be satisfaction of parents and professionals with the appearance of the child, parental concerns about the future, anxiety level and satisfaction with the treatment, motor development and quality of life of the infant. Finally, compliance and costs will also be determined. Discussion HEADS will be the first study presenting data from an RCT on the effectiveness of helmet therapy. Outcomes will be important for affected children and their parents, health care professionals and future treatment policies. Our findings are likely to influence the reimbursement policies of health insurance companies. Besides these health outcomes, we will be able to

  17. Enhancing adoptive parenting: a randomized controlled trial.

    Science.gov (United States)

    Rushton, Alan; Monck, Elizabeth; Leese, Morven; McCrone, Paul; Sharac, Jessica

    2010-10-01

    The aim was to conduct a pragmatic randomized controlled trial (RCT) to evaluate two parenting programmes designed for adopters of children late placed from care. Adoptive parents, with children between 3 and 8 years who were screened to have serious behavioural problems early in the placement, participated in home-based, manualized, parenting programmes delivered by trained and supervised family social workers. The adopters who agreed to join the study were randomly allocated to one of two parenting interventions or to a "services as usual" group. Baseline, immediate post-intervention and six-month follow-ups were assessed using questionnaires and adopter interviews. No cases were lost to follow-up at any point and satisfaction was high with both parenting interventions. At the six-month follow-up, a significant difference (p parenting" in favour of the intervention group (Effect Size d = 0.7). Negative parenting approaches were reduced in the intervention group. However, no significant differences in child problems were found between the intervention groups and control group, adjusting for baseline scores. Costs analysis showed that a relatively modest investment in post-adoption support would be well spent in improving adopters' satisfaction with parenting in the intervention group compared to the routine service group.

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

    NARCIS (Netherlands)

    van de Ven, Geertje; Draskovic, Irena; Adang, Eddy M. M.; Donders, Rogier; 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

  19. Translation of randomised controlled trial findings into clinical practice: comparison of olanzapine and valproate in the EMBLEM study

    DEFF Research Database (Denmark)

    Novick, D; Gonzalez-Pinto, A; Haro, J M

    2009-01-01

    OBJECTIVES: The aim of this study was to compare the outcomes of olanzapine- and valproate-treated patients in an observational study of acute mania with the results of a randomised controlled trial (RCT) assessing the same treatments. METHODS: EMBLEM (European Mania in Bipolar Evaluation...

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

    NARCIS (Netherlands)

    van de Ven, Geertje; Draskovic, Irena; Adang, Eddy M. M.; Donders, Rogier; 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 stud

  1. Trauma-focused treatment for posttraumatic stress disorder combined with CBT for severe substance use disorder: a randomized controlled trial

    NARCIS (Netherlands)

    van Dam, D.; Ehring, T.; Vedel, E.; Emmelkamp, P.M.G.

    2013-01-01

    Background: This randomized controlled trial (RCT) investigated the effectiveness of a combined treatment for co-morbid Posttraumatic Stress Disorder (PTSD) and severe Substance Use Disorder (SUD). Methods: Structured Writing Therapy for PTSD (SWT), an evidence-based traumafocused intervention, was

  2. Study protocol: a randomised controlled trial of cognitive remediation for a national cohort of forensic mental health patients with schizophrenia or schizoaffective disorder.

    LENUS (Irish Health Repository)

    O'Reilly, Ken

    2016-01-01

    Evidence is accumulating that cognitive remediation therapy (CRT) is an effective intervention for patients with schizophrenia or schizoaffective disorder. To date there has been no randomised controlled trial (RCT) cohort study of cognitive remediation within a forensic hospital. The goal of this study is to examine the effectiveness of a trial of cognitive remediation for forensic mental health patients with schizophrenia or schizoaffective disorder.

  3. 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

  4. Pilot study of feasibility of a randomised controlled trial of asthma risk with paracetamol versus ibuprofen use in infancy.

    Science.gov (United States)

    Riley, Judith; Hunt, Anna; McDouall, Alice; Waqanivavalagi, Steve; Braithwaite, Irene; Weatherall, Mark; Stanley, Thorsten; Beasley, Richard; Mitchell, Edwin A; Dalziel, Stuart R

    2016-10-14

    To undertake a randomised controlled trial (RCT) of paracetamol versus ibuprofen use during infancy to determine if paracetamol is associated with an increased risk of developing asthma, the preferred method of recruitment needs to be determined. We assessed three different recruitment domains to determine the likely enrolment rates of newborn infants into a three-year or six-year RCT of paracetamol versus ibuprofen and the development of asthma symptoms. The proposed RCT would require 1,806 participants. A questionnaire was administered to a convenience sample of Auckland and Wellington based parents/guardians within three different recruitment domains: antenatal classes, postnatal wards and six-week well-child visits at primary healthcare centres. Over a twelve-week period 19/586 (3.2%), 196/861 (22.8%), and 0/110 (0%) questionnaires were completed by parents/guardians of newborn infants in antenatal, postnatal and primary healthcare domains. In the postnatal recruitment domain, the likelihood of newborn infants being enrolled in the proposed RCT was rated 'very likely', 'likely' and 'neutral' by 15 (8%, CI 4-12%), 65 (33%, CI 26-40%) and 64 (33%, CI 25-39%) of respondents for a RCT of three years duration; and by 5 (3%, CI 1-5%), 37 (19%, CI 14-25%) and 59 (30%, CI 24-36%) of respondents respectively for a RCT of six years duration. Postnatal wards are expected to be the most successful recruitment domain for the proposed RCT, likely a reflection of the face-to-face direct recruitment by researchers. It appears feasible to recruit into the proposed RCT using three large New Zealand tertiary hospitals.

  5. Do Hospitalized Premature Infants Benefit from Music Interventions? A Systematic Review of Randomized Controlled Trials

    OpenAIRE

    Van Der Heijden, Marianne J. E.; Araghi, Sadaf Oliai; Jeekel, Hans; Reiss, Irwin; Hunink, M G M; van Dijk, Monique

    2016-01-01

    textabstractObjective: Neonatal intensive care units (NICU) around the world increasingly use music interventions. The most recent systematic review of randomized controlled trials (RCT) dates from 2009. Since then, 15 new RCTs have been published. We provide an updated systematic review on the possible benefits of music interventions on premature infants' well-being. Methods: We searched 13 electronic databases and 12 journals from their first available date until August 2016. Included were ...

  6. Randomized controlled trials – a matter of design

    Science.gov (United States)

    Spieth, Peter Markus; Kubasch, Anne Sophie; Penzlin, Ana Isabel; Illigens, Ben Min-Woo; Barlinn, Kristian; Siepmann, Timo

    2016-01-01

    Randomized controlled trials (RCTs) are the hallmark of evidence-based medicine and form the basis for translating research data into clinical practice. This review summarizes commonly applied designs and quality indicators of RCTs to provide guidance in interpreting and critically evaluating clinical research data. It further reflects on the principle of equipoise and its practical applicability to clinical science with an emphasis on critical care and neurological research. We performed a review of educational material, review articles, methodological studies, and published clinical trials using the databases MEDLINE, PubMed, and ClinicalTrials.gov. The most relevant recommendations regarding design, conduction, and reporting of RCTs may include the following: 1) clinically relevant end points should be defined a priori, and an unbiased analysis and report of the study results should be warranted, 2) both significant and nonsignificant results should be objectively reported and published, 3) structured study design and performance as indicated in the Consolidated Standards of Reporting Trials statement should be employed as well as registration in a public trial database, 4) potential conflicts of interest and funding sources should be disclaimed in study report or publication, and 5) in the comparison of experimental treatment with standard care, preplanned interim analyses during an ongoing RCT can aid in maintaining clinical equipoise by assessing benefit, harm, or futility, thus allowing decision on continuation or termination of the trial. PMID:27354804

  7. Trends in RCT nursing research over 20 years: mind the gap.

    Science.gov (United States)

    Baldi, Ileana; Dal Lago, Elisa; De Bardi, Sara; Sartor, Giada; Soriani, Nicola; Zanotti, Renzo; Gregori, Dario

    Randomised controlled trial (RCT) literature plays a fundamental role in informing evidence-based medicine and nursing. This paper aims to track geographical and temporal trends in the publication of RCTs in nursing over the past 20 years by means of a bibliometric analysis. The PubMed database was searched for articles published from 1 January 1991 to 31 October 2011 and satisfying this search strategy: nursing [MeSH Terms] AND (RCT OR trial* OR 'experimental study' OR randomised OR randomisation) AND (English[lang]). Abstracts were reviewed to assess whether they met the criteria for an RCT. A manual search of information on country of origin was carried out and Journal Citation Reports® was used to allocate journals to subject areas. RCT methodology is increasingly drawing the attention of nursing researchers worldwide. However, there is a large disparity in research productivity, at least in terms of number of published RCTs in the English language and listed on PubMed, between the most productive continents, North America and Europe, and the others.

  8. Impact of Length or Relevance of Questionnaires on Attrition in Online Trials: Randomized Controlled Trial

    Science.gov (United States)

    Kalaitzaki, Eleftheria; White, Ian R; Khadjesari, Zarnie; Murray, Elizabeth; Linke, Stuart; Thompson, Simon G; Godfrey, Christine; Wallace, Paul

    2011-01-01

    Background There has been limited study of factors influencing response rates and attrition in online research. Online experiments were nested within the pilot (study 1, n = 3780) and main trial (study 2, n = 2667) phases of an evaluation of a Web-based intervention for hazardous drinkers: the Down Your Drink randomized controlled trial (DYD-RCT). Objectives The objective was to determine whether differences in the length and relevance of questionnaires can impact upon loss to follow-up in online trials. Methods A randomized controlled trial design was used. All participants who consented to enter DYD-RCT and completed the primary outcome questionnaires were randomized to complete one of four secondary outcome questionnaires at baseline and at follow-up. These questionnaires varied in length (additional 23 or 34 versus 10 items) and relevance (alcohol problems versus mental health). The outcome measure was the proportion of participants who completed follow-up at each of two follow-up intervals: study 1 after 1 and 3 months and study 2 after 3 and 12 months. Results At all four follow-up intervals there were no significant effects of additional questionnaire length on follow-up. Randomization to the less relevant questionnaire resulted in significantly lower rates of follow-up in two of the four assessments made (absolute difference of 4%, 95% confidence interval [CI] 0%-8%, in both study 1 after 1 month and in study 2 after 12 months). A post hoc pooled analysis across all four follow-up intervals found this effect of marginal statistical significance (unadjusted difference, 3%, range 1%-5%, P = .01; difference adjusted for prespecified covariates, 3%, range 0%-5%, P = .05). Conclusions Apparently minor differences in study design decisions may have a measurable impact on attrition in trials. Further investigation is warranted of the impact of the relevance of outcome measures on follow-up rates and, more broadly, of the consequences of what we ask participants to

  9. Exercise and manual physiotherapy arthritis research trial (EMPART: a multicentre randomised controlled trial

    Directory of Open Access Journals (Sweden)

    O'Connell Paul

    2009-01-01

    Full Text Available Abstract Background Osteoarthritis (OA of the hip is a major cause of functional disability and reduced quality of life. Management options aim to reduce pain and improve or maintain physical functioning. Current evidence indicates that therapeutic exercise has a beneficial but short-term effect on pain and disability, with poor long-term benefit. The optimal content, duration and type of exercise are yet to be ascertained. There has been little scientific investigation into the effectiveness of manual therapy in hip OA. Only one randomized controlled trial (RCT found greater improvements in patient-perceived improvement and physical function with manual therapy, compared to exercise therapy. Methods and design An assessor-blind multicentre RCT will be undertaken to compare the effect of a combination of manual therapy and exercise therapy, exercise therapy only, and a waiting-list control on physical function in hip OA. One hundred and fifty people with a diagnosis of hip OA will be recruited and randomly allocated to one of 3 groups: exercise therapy, exercise therapy with manual therapy and a waiting-list control. Subjects in the intervention groups will attend physiotherapy for 6–8 sessions over 8 weeks. Those in the control group will remain on the waiting list until after this time and will then be re-randomised to one of the two intervention groups. Outcome measures will include physical function (WOMAC, pain severity (numerical rating scale, patient perceived change (7-point Likert scale, quality of life (SF-36, mood (hospital anxiety and depression scale, patient satisfaction, physical activity (IPAQ and physical measures of range of motion, 50-foot walk and repeated sit-to stand tests. Discussion This RCT will compare the effectiveness of the addition of manual therapy to exercise therapy to exercise therapy only and a waiting-list control in hip OA. A high quality methodology will be used in keeping with CONSORT guidelines. The

  10. The regression discontinuity design showed to be a valid alternative to a randomized controlled trial for estimating treatment effects.

    Science.gov (United States)

    Maas, Iris L; Nolte, Sandra; Walter, Otto B; Berger, Thomas; Hautzinger, Martin; Hohagen, Fritz; Lutz, Wolfgang; Meyer, Björn; Schröder, Johanna; Späth, Christina; Klein, Jan Philipp; Moritz, Steffen; Rose, Matthias

    2017-02-01

    To compare treatment effect estimates obtained from a regression discontinuity (RD) design with results from an actual randomized controlled trial (RCT). Data from an RCT (EVIDENT), which studied the effect of an Internet intervention on depressive symptoms measured with the Patient Health Questionnaire (PHQ-9), were used to perform an RD analysis, in which treatment allocation was determined by a cutoff value at baseline (PHQ-9 = 10). A linear regression model was fitted to the data, selecting participants above the cutoff who had received the intervention (n = 317) and control participants below the cutoff (n = 187). Outcome was PHQ-9 sum score 12 weeks after baseline. Robustness of the effect estimate was studied; the estimate was compared with the RCT treatment effect. The final regression model showed a regression coefficient of -2.29 [95% confidence interval (CI): -3.72 to -.85] compared with a treatment effect found in the RCT of -1.57 (95% CI: -2.07 to -1.07). Although the estimates obtained from two designs are not equal, their confidence intervals overlap, suggesting that an RD design can be a valid alternative for RCTs. This finding is particularly important for situations where an RCT may not be feasible or ethical as is often the case in clinical research settings. Copyright © 2016 Elsevier Inc. All rights reserved.

  11. What qualitative research can contribute to a randomized controlled trial of a complex community intervention.

    Science.gov (United States)

    Nelson, Geoffrey; Macnaughton, Eric; Goering, Paula

    2015-11-01

    Using the case of a large-scale, multi-site Canadian Housing First research demonstration project for homeless people with mental illness, At Home/Chez Soi, we illustrate the value of qualitative methods in a randomized controlled trial (RCT) of a complex community intervention. We argue that quantitative RCT research can neither capture the complexity nor tell the full story of a complex community intervention. We conceptualize complex community interventions as having multiple phases and dimensions that require both RCT and qualitative research components. Rather than assume that qualitative research and RCTs are incommensurate, a more pragmatic mixed methods approach was used, which included using both qualitative and quantitative methods to understand program implementation and outcomes. At the same time, qualitative research was used to examine aspects of the intervention that could not be understood through the RCT, such as its conception, planning, sustainability, and policy impacts. Through this example, we show how qualitative research can tell a more complete story about complex community interventions.

  12. Evaluating cognitive effort in a randomized controlled trial.

    Science.gov (United States)

    Turner, Travis H; Renfroe, Jenna B; Morella, Kristen; Marriott, Bernadette P

    2016-09-01

    Many randomized controlled trials (RCTs) of neuropsychiatric conditions involve cognitive outcome measures; however, validity of cognitive data relies on adequate effort during testing, and such screening is seldom performed. Given well-established rates of 10 to 30% poor effort in clinical settings, this is not a trivial concern. This preliminary study evaluated effort during cognitive testing in an RCT of omega-3 supplementation to reduce suicidality in a high-risk psychiatric population. An interim analysis of sustained attentions measures from the Connors Performance Test (CPT-2) at baseline for the first 60 participants was conducted. Previously validated cut points to detect insufficient effort on the CPT-2 were applied. At baseline, 12% (7) were identified as giving poor effort. Follow-up analyses indicated less psychiatric distress and suicidality among those who gave poor effort. Results suggest comparable likelihood of a poor effort on cognitive testing in clinical and RCT participation. Reduced psychiatric distress in the poor effort group raises concern regarding interpretation of other measures. The importance of screening cognitive data for effort in RCTs is highlighted. Future studies will examine effort at follow-up visits, and explore relationships to attrition, adherence, and response to treatment. Copyright © 2016 John Wiley & Sons, Ltd.

  13. High-Intensity Strength Training Improves Function of Chronically Painful Muscles: Case-Control and RCT Studies

    Directory of Open Access Journals (Sweden)

    Lars L. Andersen

    2014-01-01

    Full Text Available Aim. This study investigates consequences of chronic neck pain on muscle function and the rehabilitating effects of contrasting interventions. Methods. Women with trapezius myalgia (MYA, n=42 and healthy controls (CON, n=20 participated in a case-control study. Subsequently MYA were randomized to 10 weeks of specific strength training (SST, n=18, general fitness training (GFT, n=16, or a reference group without physical training (REF, n=8. Participants performed tests of 100 consecutive cycles of 2 s isometric maximal voluntary contractions (MVC of shoulder elevation followed by 2 s relaxation at baseline and 10-week follow-up. Results. In the case-control study, peak force, rate of force development, and rate of force relaxation as well as EMG amplitude were lower in MYA than CON throughout all 100 MVC. Muscle fiber capillarization was not significantly different between MYA and CON. In the intervention study, SST improved all force parameters significantly more than the two other groups, to levels comparable to that of CON. This was seen along with muscle fiber hypertrophy and increased capillarization. Conclusion. Women with trapezius myalgia have lower strength capacity during repetitive MVC of the trapezius muscle than healthy controls. High-intensity strength training effectively improves strength capacity during repetitive MVC of the painful trapezius muscle.

  14. Birth Control in Clinical Trials

    Science.gov (United States)

    Stewart, J.; Beyer, B. K.; Chadwick, K.; De Schaepdrijver, L.; Desai, M.; Enright, B.; Foster, W.; Hui, J. Y.; Moffat, G. J.; Tornesi, B.; Van Malderen, K.; Wiesner, L.; Chen, C. L.

    2015-01-01

    The Health and Environmental Sciences Institute (HESI) Developmental and Reproductive Toxicology Technical Committee sponsored a pharmaceutical industry survey on current industry practices for contraception use during clinical trials. The objectives of the survey were to improve our understanding of the current industry practices for contraception requirements in clinical trials, the governance processes set up to promote consistency and/or compliance with contraception requirements, and the effectiveness of current contraception practices in preventing pregnancies during clinical trials. Opportunities for improvements in current practices were also considered. The survey results from 12 pharmaceutical companies identified significant variability among companies with regard to contraception practices and governance during clinical trials. This variability was due primarily to differences in definitions, areas of scientific uncertainty or misunderstanding, and differences in company approaches to enrollment in clinical trials. The survey also revealed that few companies collected data in a manner that would allow a retrospective understanding of the reasons for failure of birth control during clinical trials. In this article, suggestions are made for topics where regulatory guidance or scientific publications could facilitate best practice. These include provisions for a pragmatic definition of women of childbearing potential, guidance on how animal data can influence the requirements for male and female birth control, evidence-based guidance on birth control and pregnancy testing regimes suitable for low- and high-risk situations, plus practical methods to ascertain the risk of drug-drug interactions with hormonal contraceptives. PMID:27042398

  15. Should we embed randomized controlled trials within action research: arguing from a case study of telemonitoring

    Directory of Open Access Journals (Sweden)

    Karen Day

    2016-06-01

    Full Text Available Abstract Background Action research (AR and randomized controlled trials (RCTs are usually considered to be theoretically and practically incompatible. However, we argue that their respective strengths and weaknesses can be complementary. We illustrate our argument from a recent study assessing the effect of telemonitoring on health-related quality of life, self-care, hospital use, costs and the experiences of patients, informal carers and health care professionals in two urban hospital services and one remote rural primary care service in New Zealand. Methods Data came from authors’ observations and field notes of discussions with three groups: the healthcare providers and healthcare consumers who participated in the research, and a group of 17 researchers and collaborators. The consumers had heart failure (Site A, urban, airways disease (Site B, urban, and diabetes (Site C, rural. The research ran from 2008 (project inception until 2012 (project close-off. Researchers came from a wide range of disciplines. Both RCT and AR methods were recognised from early in the process but often worked in parallel rather than together. In retrospect, we have mapped our observed research processes to the AR cycle characteristics (creation of communicative space, democracy and participation, iterative learning and improvement, emergence, and accommodation of different ways of knowing. Results We describe the context, conduct and outcomes of the telemonitoring trial, framing the overall process in the language of AR. Although not fully articulated at the time, AR processes made the RCT sensitive to important context, e.g. clinical processes. They resulted in substantive changes to the design and conduct of the RCT, and to interpretation and uptake of findings, e.g. a simpler technology procurement process emerged. Creating a communicative space enabled co-design between the researcher group and collaborators from the provider participant group, and a stronger

  16. The challenge of recruiting patients into a placebo-controlled surgical trial

    DEFF Research Database (Denmark)

    Hare, Kristoffer B; Lohmander, L Stefan; Roos, Ewa M.

    2014-01-01

    patient into the RCT, 11.9 individuals needed to be screened. A total of 69% of participating patients considered the oral information to be the most important and the most common reason for participating was the contribution to research (90%). CONCLUSIONS: Patients are willing to participate...... in an orthopedic placebo-controlled surgical trial. Oral information given by the surgeon to the patient and the contribution to research are important aspects to enhance patient recruitment. TRIAL REGISTRATION: ClinicalTrials.gov NCT01264991, registered 21 December 2010....... component only adds to this complexity. The purpose of this study was to report the challenges of recruiting patients into an orthopedic placebo-controlled surgical trial, to determine the number of patients needed to be screened and allocated in order to include one participant into the trial...

  17. Reflecting on the methodological challenges of recruiting to a United Kingdom-wide, multi-centre, randomised controlled trial in gynaecology outpatient settings

    OpenAIRE

    2013-01-01

    Background Successful recruitment of participants to any trial is central to its success. Trial results are routinely published, and recruitment is often cited to be slower and more difficult than anticipated. This article reflects on the methodological challenges of recruiting women with prolapse attending United Kingdom (UK) gynaecology outpatient clinics to a multi-centre randomised controlled trial (RCT) of physiotherapy, and the systems put in place in an attempt to address them. Methods...

  18. Randomized controlled trials – a matter of design

    Directory of Open Access Journals (Sweden)

    Spieth PM

    2016-06-01

    Full Text Available Peter Markus Spieth,1,2 Anne Sophie Kubasch,3 Ana Isabel Penzlin,4 Ben Min-Woo Illigens,2,5 Kristian Barlinn,6 Timo Siepmann2,6,7 1Department of Anesthesiology and Critical Care Medicine, University Hospital Carl Gustav Carus, Technische Universität Dresden, 2Center for Clinical Research and Management Education, Division of Health Care Sciences, Dresden International University, 3Pediatric Rheumatology and Immunology, Children’s Hospital, University Hospital Carl Gustav Carus, Technische Universität Dresden, 4Institute of Clinical Pharmacology, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Saxony, Germany; 5Department of Neurology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA; 6Department of Neurology, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Saxony, Germany; 7Radcliffe Department of Medicine, John Radcliffe Hospital, University of Oxford, Oxford, Oxfordshire, UK Abstract: Randomized controlled trials (RCTs are the hallmark of evidence-based medicine and form the basis for translating research data into clinical practice. This review summarizes commonly applied designs and quality indicators of RCTs to provide guidance in interpreting and critically evaluating clinical research data. It further reflects on the principle of equipoise and its practical applicability to clinical science with an emphasis on critical care and neurological research. We performed a review of educational material, review articles, methodological studies, and published clinical trials using the databases MEDLINE, PubMed, and ClinicalTrials.gov. The most relevant recommendations regarding design, conduction, and reporting of RCTs may include the following: 1 clinically relevant end points should be defined a priori, and an unbiased analysis and report of the study results should be warranted, 2 both significant and nonsignificant results should be objectively

  19. Searching for Controlled Trials of Complementary and Alternative Medicine: A Comparison of 15 Databases

    Directory of Open Access Journals (Sweden)

    Elise Cogo

    2011-01-01

    Full Text Available This project aims to assess the utility of bibliographic databases beyond the three major ones (MEDLINE, EMBASE and Cochrane CENTRAL for finding controlled trials of complementary and alternative medicine (CAM. Fifteen databases were searched to identify controlled clinical trials (CCTs of CAM not also indexed in MEDLINE. Searches were conducted in May 2006 using the revised Cochrane highly sensitive search strategy (HSSS and the PubMed CAM Subset. Yield of CAM trials per 100 records was determined, and databases were compared over a standardized period (2005. The Acudoc2 RCT, Acubriefs, Index to Chiropractic Literature (ICL and Hom-Inform databases had the highest concentrations of non-MEDLINE records, with more than 100 non-MEDLINE records per 500. Other productive databases had ratios between 500 and 1500 records to 100 non-MEDLINE records—these were AMED, MANTIS, PsycINFO, CINAHL, Global Health and Alt HealthWatch. Five databases were found to be unproductive: AGRICOLA, CAIRSS, Datadiwan, Herb Research Foundation and IBIDS. Acudoc2 RCT yielded 100 CAM trials in the most recent 100 records screened. Acubriefs, AMED, Hom-Inform, MANTIS, PsycINFO and CINAHL had more than 25 CAM trials per 100 records screened. Global Health, ICL and Alt HealthWatch were below 25 in yield. There were 255 non-MEDLINE trials from eight databases in 2005, with only 10% indexed in more than one database. Yield varied greatly between databases; the most productive databases from both sampling methods were Acubriefs, Acudoc2 RCT, AMED and CINAHL. Low overlap between databases indicates comprehensive CAM literature searches will require multiple databases.

  20. Searching for Controlled Trials of Complementary and Alternative Medicine: A Comparison of 15 Databases

    Science.gov (United States)

    Cogo, Elise; Sampson, Margaret; Ajiferuke, Isola; Manheimer, Eric; Campbell, Kaitryn; Daniel, Raymond; Moher, David

    2011-01-01

    This project aims to assess the utility of bibliographic databases beyond the three major ones (MEDLINE, EMBASE and Cochrane CENTRAL) for finding controlled trials of complementary and alternative medicine (CAM). Fifteen databases were searched to identify controlled clinical trials (CCTs) of CAM not also indexed in MEDLINE. Searches were conducted in May 2006 using the revised Cochrane highly sensitive search strategy (HSSS) and the PubMed CAM Subset. Yield of CAM trials per 100 records was determined, and databases were compared over a standardized period (2005). The Acudoc2 RCT, Acubriefs, Index to Chiropractic Literature (ICL) and Hom-Inform databases had the highest concentrations of non-MEDLINE records, with more than 100 non-MEDLINE records per 500. Other productive databases had ratios between 500 and 1500 records to 100 non-MEDLINE records—these were AMED, MANTIS, PsycINFO, CINAHL, Global Health and Alt HealthWatch. Five databases were found to be unproductive: AGRICOLA, CAIRSS, Datadiwan, Herb Research Foundation and IBIDS. Acudoc2 RCT yielded 100 CAM trials in the most recent 100 records screened. Acubriefs, AMED, Hom-Inform, MANTIS, PsycINFO and CINAHL had more than 25 CAM trials per 100 records screened. Global Health, ICL and Alt HealthWatch were below 25 in yield. There were 255 non-MEDLINE trials from eight databases in 2005, with only 10% indexed in more than one database. Yield varied greatly between databases; the most productive databases from both sampling methods were Acubriefs, Acudoc2 RCT, AMED and CINAHL. Low overlap between databases indicates comprehensive CAM literature searches will require multiple databases. PMID:19468052

  1. Association between funding, risk of bias, and outcome of randomised controlled trials in oral and maxillofacial surgery.

    Science.gov (United States)

    Oomens, M A E M; Lazzari, S; Heymans, M W; Forouzanfar, T

    2016-01-01

    The influence of funding on the main outcome of a random control trial (RCT) is important, as it could potentially lead to bias towards industry, and results that are too optimistic. We investigated the association between funding, the published outcome, and the risk of bias in trials in oral and maxillofacial surgery (OMFS) published from January 2000 to May 2013 listed in PubMed. The methods used were scored using the risk of bias items given in a Delphi List. Sources of funding were recorded and categorised five ways: not funded, funded by industry, not funded by industry, supported by industry, and source of funds not clear. A total of 390 RCT met the inclusion criteria, and there was a correlation between funding and favourable main outcomes, although this was not significant. There was no correlation between the risk of bias and favourable results of the main outcome of a trial, or between the risk of bias and the reported source of funding in post-hoc analysis. We were unable to show a significant correlation between funding and a higher likelihood of a favourable result for the primary outcome in RCT in OMFS. We also failed to show a significant correlation between the risk of bias of a trial and its main outcome. In contrast, the source of funding proved to affect the risk of bias of a trial significantly, although not in post-hoc analysis. Funded trials were better organised, and so had a lower risk of bias.

  2. Current situation on the reporting quality of randomized controlled trials in 5 leading Chinese medical journals

    Institute of Scientific and Technical Information of China (English)

    Xu Wei; Li Tiejun; Wu Cheng

    2009-01-01

    Objective: The Consolidated Standards for Reporting of Trials (CONSORT) statement has already proved to be an efficient standard for reporting quality of randomized controlled trials (RCTs). However, most of the Chinese medical journals have not endorsed the CONSORT statement. The current situation about the reporting quality of RCTs in Chinese medical journals is still unclear. The purpose of the study was to evaluate the reporting quality of RCTs on papers published in 5 leading Chinese medical journals. Methods: We evaluated 232 original RCT papers using a reporting quality scale based on CONSORT statement from 2001 to 2006 in 5 Chinese medical journals (Journal type 1) without adoption of CONSORT and Chinese Journal of Evidence-based Medicine (Journal type 2) which adopted CONSORT in 2004. We measured the inclusion of 26 items for the reporting quality scale and 6 core items of each RCT report, gave score to each item and calculated the total score obtained in each report and the proportion of reports including individual items. The reporting quality of RCT trials from 2001 to 2003 (pre-adoption period) was compared with that from 2004 to 2006 (post-adoption period). Results: The average reporting quality of RCTs was moderate (mean score, 15.18), and the mean score of the 6 core items was low (mean score, 1.09)in 5 leading journals. The difference in the total score and the score of the 6 core items between pre-adoption period (2001-2003) and post-adoption period (2004-2006) was statistically significant (P=0.003; P=0.000). Interaction between journal type and period was not significant (F=0.76; P=0.383). We concluded that the change tendency of reporting quality between Journal type 1 and 2 was not different. But as to the core items of sequence concealment and intention-to-treat analysis,the increases were greater for Journal type 2 when evaluated against Journal type 1 (P=0.038; P=0.016). Conclusion: The reporting quality of RCT trials in 5 leading Chinese

  3. 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.

  4. Implementation of a Manualized Communication Intervention for School-Aged Children with Pragmatic and Social Communication Needs in a Randomized Controlled Trial: The Social Communication Intervention Project

    Science.gov (United States)

    Adams, Catherine; Lockton, Elaine; Gaile, Jacqueline; Earl, Gillian; Freed, Jenny

    2012-01-01

    Background: Speech-language interventions are often complex in nature, involving multiple observations, variable outcomes and individualization in treatment delivery. The accepted procedure associated with randomized controlled trials (RCT) of such complex interventions is to develop and implement a manual of intervention in order that reliable…

  5. The effects of the prevention program 'New Perspectives' (NP) on juvenile delinquency and other life domains: study protocol for a randomized controlled trial

    NARCIS (Netherlands)

    de Vries, L.A.; Hoeve, M.; Asscher, J.J.; Stams, G.J.J.M.

    2014-01-01

    Background: New Perspectives (NP) is a prevention program aiming to prevent that youth at onset of a criminal career will develop a persistent criminal behaviour pattern. The effects of NP on juvenile delinquency and other life domains are investigated, using a randomized controlled trial (RCT). Met

  6. Randomized controlled trial of a self-management intervention in persons with spinal cord injury : design of the HABITS (Healthy Active Behavioural IntervenTion in SCI) study

    NARCIS (Netherlands)

    Kooijmans, H.; Post, M. W. M.; van der Woude, L. H. V.; de Groot, S.; Stam, H. J.; Bussmann, J. B. J.

    2013-01-01

    Purpose: To evaluate the effectiveness of a 16-week self-management intervention on physical activity level and self-management skills (self-efficacy, proactive coping and problem solving skills) in persons with chronic SCI. Method and design: Multicenter randomized controlled trial (RCT). Eighty pe

  7. The effects of the prevention program 'New Perspectives' (NP) on juvenile delinquency and other life domains: study protocol for a randomized controlled trial

    NARCIS (Netherlands)

    de Vries, L.A.; Hoeve, M.; Asscher, J.J.; Stams, G.J.J.M.

    2014-01-01

    Background: New Perspectives (NP) is a prevention program aiming to prevent that youth at onset of a criminal career will develop a persistent criminal behaviour pattern. The effects of NP on juvenile delinquency and other life domains are investigated, using a randomized controlled trial (RCT).

  8. Comparison of Gait in Patients Following a Computer-Navigated Minimally Invasive Anterior Approach and a Conventional Posterolateral Approach for Total Hip Arthroplasty : A Randomized Controlled Trial

    NARCIS (Netherlands)

    Reininga, Inge H. F.; Stevens, Martin; Wagenmakers, Robert; Boerboom, Alexander L.; Groothoff, Johan W.; Bulstra, Sjoerd K.; Zijlstra, Wiebren

    2013-01-01

    Minimally invasive total hip arthroplasty (MIS THA) aims at minimizing damage to muscles and tendons to accelerate postoperative recovery. Computer navigation allows a precise prosthesis alignment without complete visualization of the bony landmarks during MIS THA. A randomized controlled trial (RCT

  9. A Randomised Controlled Treatment Trial of Two Forms of Family Therapy in Adolescent Anorexia Nervosa: A Five-Year Follow-Up

    Science.gov (United States)

    Eisler, Ivan; Simic, Mima; Russell, Gerald F. M.; Dare, Christopher

    2007-01-01

    Background: There is growing evidence that family therapy is an effective treatment for adolescent anorexia nervosa. This study aimed to ascertain the long-term impact of two forms of outpatient family intervention previously evaluated in a randomised controlled trial (RCT). Method: A five-year follow-up was conducted on a cohort of 40 patients…

  10. Health Coaching Reduces HbA1c in Type 2 Diabetic Patients From a Lower-Socioeconomic Status Community: A Randomized Controlled Trial

    National Research Council Canada - National Science Library

    Wayne, Noah; Perez, Daniel F; Kaplan, David M; Ritvo, Paul

    2015-01-01

    .... In this noninferiority, pragmatic randomized controlled trial (RCT), patients from two primary care health centers in Toronto, Canada, with type 2 diabetes and a glycated hemoglobin/hemoglobin A1c (HbA1c) level of ≥7.3% (56.3 mmol/mol...

  11. Design of a randomized-controlled trial on low-intensity aerobic wheelchair exercise for inactive persons with chronic spinal cord injury

    NARCIS (Netherlands)

    van der Scheer, Jan W.; de Groot, Sonja; Postema, Klaas; Veeger, DirkJan H. E. J.; van der Woude, Lucas H. V.

    Purpose: To investigate effects and working mechanisms of low-intensity aerobic wheelchair exercise on fitness, (upper-body) health and active lifestyle in inactive persons with chronic spinal cord injury (SCI). Methods: A multicenter randomized-controlled trial (RCT) in 40 inactive manual

  12. A randomised controlled trial of complete denture impression materials.

    Science.gov (United States)

    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; Brown, S; Dukanovic, G; Brunton, P A

    2014-08-01

    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. Eighty-five patients were recruited, using published eligibility criteria, to the trial at Leeds Dental Institute, UK. Each patient received two sets of dentures; made using either alginate or silicone impressions. Randomisations determined the order of assessment and order of impressions. The primary outcome was patient blinded preference for unadjusted dentures. Secondary outcomes were patient preference for the adjusted dentures, rating of comfort, stability and chewing efficiency, experience of each impression, and an OHIP-EDENT questionnaire. Seventy-eight (91.8%) patients completed the primary assessment. 53(67.9%) patients preferred dentures made from silicone impressions while 14(17.9%) preferred alginate impressions. 4(5.1%) patients found both dentures equally satisfactory and 7 (9.0%) found both equally unsatisfactory. There was a 50% difference in preference rates (in favour of silicone) (95%CI 32.7-67.3%, pUnilever Hatton Award of the International Assocation for Dental Research, Capetown, South Africa, June 2014. Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.

  13. Randomized control trial of computer-based rehabilitation of spatial neglect syndrome: the RESPONSE trial protocol.

    Science.gov (United States)

    Vleet, Thomas Van; DeGutis, Joseph; Dabit, Sawsan; Chiu, Christopher

    2014-02-07

    Spatial neglect is a frequent and debilitating consequence of acquired brain injury and currently has no widely accepted standard of care. While previous interventions for spatial neglect have targeted patients' overt spatial deficits (e.g., reduced contralesional visual scanning), far fewer have directly targeted patients' non-spatial deficits (e.g., sustained attention deficits). Considering that non-spatial deficits have shown to be highly predictive of long-term disability, we developed a novel computer based training program that targets both sustained (tonic) and moment-to-moment (phasic) aspects of non-spatial attention (Tonic and Phasic Alertness Training, TAPAT). Preliminary studies demonstrate that TAPAT is safe and effective in improving both spatial and non-spatial attention deficits in the post-acute recovery phase in neglect patients. The purpose of the current trial (referred to as the REmediation of SPatial Neglect or RESPONSE trial) is to compare TAPAT to an active control training condition, include a larger sample of patients, and assess both cognitive and functional outcomes. We will employ a multi-site, longitudinal, blinded randomized controlled trial (RCT) design with a target sample of 114 patients with spatial neglect. Patients will either perform, at their home, the experimental TAPAT training program or an active control computer games condition for thirty minutes/day, five days a week, over three months. Patients will be assessed on a battery of cognitive and functional outcomes on three occasions: a) immediately before training, b) within forty-eight hours post completion of total training, and c) after a three-month no-contact period post completion of total training, to assess the longevity of potential training effects. The strengths of this protocol are that it tests an innovative, in-home administered treatment that targets a fundamental deficit in neglect, employs highly sensitive computer-based assessments of cognition as well as

  14. Effect of soya protein on blood pressure: a meta-analysis of randomised controlled trials.

    Science.gov (United States)

    Dong, Jia-Yi; Tong, Xing; Wu, Zhi-Wei; Xun, Peng-Cheng; He, Ka; Qin, Li-Qiang

    2011-08-01

    Observational studies have indicated that soya food consumption is inversely associated with blood pressure (BP). Evidence from randomised controlled trials (RCT) on the BP-lowering effects of soya protein intake is inconclusive. We aimed to evaluate the effectiveness of soya protein intake in lowering BP. The PubMed database was searched for published RCT in the English language through to April 2010, which compared a soya protein diet with a control diet. We conducted a random-effects meta-analysis to examine the effects of soya protein on BP. Subgroup and meta-regression analyses were performed to explore possible explanations for heterogeneity among trials. Meta-analyses of twenty-seven RCT showed a mean decrease of 2·21 mmHg (95 % CI - 4·10, - 0·33; P = 0·021) for systolic BP (SBP) and 1·44 mmHg (95 % CI - 2·56, - 0·31; P = 0·012) for diastolic BP (DBP), comparing the participants in the soya protein group with those in the control group. Soya protein consumption significantly reduced SBP and DBP in both hypertensive and normotensive subjects, and the reductions were markedly greater in hypertensive subjects. Significant and greater BP reductions were also observed in trials using carbohydrate, but not milk products, as the control diet. Meta-regression analyses further revealed a significantly inverse association between pre-treatment BP and the level of BP reductions. In conclusion, soya protein intake, compared with a control diet, significantly reduces both SBP and DBP, but the BP reductions are related to pre-treatment BP levels of subjects and the type of control diet used as comparison.

  15. Facilitating sunscreen use in women by a theory-based online intervention: a randomized controlled trial.

    Science.gov (United States)

    Craciun, Catrinel; Schüz, Natalie; Lippke, Sonia; Schwarzer, Ralf

    2012-03-01

    This study compares a motivational skin cancer prevention approach with a volitional planning and self-efficacy intervention to enhance regular sunscreen use. A randomized controlled trial (RCT) was conducted with 205 women (mean age 25 years) in three groups: motivational; volitional; and control. Sunscreen use, action planning, coping planning and coping self-efficacy were assessed at three points in time. The volitional intervention improved sunscreen use. Coping planning emerged as the only mediator between the intervention and sunscreen use at Time 3. Findings point to the role played by coping planning as an ingredient of sun protection interventions.

  16. Improvisational music therapy in nonverbal communication of children with autism in the school context: randomized controlled trial

    DEFF Research Database (Denmark)

    Gattino, Gustavo; Figueiredo, Felipe; de Souza, Felipe

    2017-01-01

    Individuals with autism spectrum disorders (ASD) can demonstrate better functioning to express and understand pre-verbal communication from interaction with music. In this sense, a randomized controlled trial (RCT) was developed to investigate the effects of improvisational music therapy on the p....... Although the present research did not present positive results for all outcomes, its results confirm the effectiveness of music therapy verified in previous RCTs and systematic reviews on music therapy and autism....

  17. Playing to (self-)rehabilitate: A month-long randomized control trial with brain lesion patients and a tablet game

    DEFF Research Database (Denmark)

    Knoche, Hendrik Ole; Hald, Kasper; Jørgensen, Helle Rovsing Møller;

    2016-01-01

    We designed and evaluated a whack-a-mole (WAM) style game (see Figure 1) in a clinical randomized controlled trial (RCT) with reminder-assisted but self-initiated use over the period of a month with 43 participants from a post-lesion pool. While game play did not moderate rehabilitative progress ...... in the attention training properties of the game. The game showed potential for bedside assessment, insight support, and motivation by providing knowledge about rehabilitative progress....

  18. Upper limb children action-observation training (UP-CAT): a randomised controlled trial in Hemiplegic Cerebral Palsy

    OpenAIRE

    Biagi Laura; Guzzetta Andrea; Cossu Giuseppe; Ferrari Adriano; Sgandurra Giuseppina; Tosetti Michela; Fogassi Leonardo; Cioni Giovanni

    2011-01-01

    Abstract Background Rehabilitation for children with hemiplegic cerebral palsy (HCP) aimed to improve function of the impaired upper limb (UL) uses a wide range of intervention programs. A new rehabilitative approach, called Action-Observation Therapy, based on the recent discovery of mirror neurons, has been used in adult stroke but not in children. The purpose of the present study is to design a randomised controlled trial (RCT) for evaluating the efficacy of Action-Observation Therapy in i...

  19. Upper limb children action-observation training (UP-CAT): a randomised controlled trial in Hemiplegic Cerebral Palsy

    OpenAIRE

    Biagi Laura; Guzzetta Andrea; Cossu Giuseppe; Ferrari Adriano; Sgandurra Giuseppina; Tosetti Michela; Fogassi Leonardo; Cioni Giovanni

    2011-01-01

    Abstract Background Rehabilitation for children with hemiplegic cerebral palsy (HCP) aimed to improve function of the impaired upper limb (UL) uses a wide range of intervention programs. A new rehabilitative approach, called Action-Observation Therapy, based on the recent discovery of mirror neurons, has been used in adult stroke but not in children. The purpose of the present study is to design a randomised controlled trial (RCT) for evaluating the efficacy of Action-Observation Therapy in i...

  20. Assessment of pharmacist-led patient counseling in randomized controlled trials: a systematic review.

    Science.gov (United States)

    Okumura, Lucas Miyake; Rotta, Inajara; Correr, Cassyano Januário

    2014-10-01

    Background Pharmacists' counseling has improved health-related outcomes in many acute and chronic conditions. Several studies have shown how pharmacists have been contributing to reduce morbidity and mortality related to drug-therapy (MMRDT). However, there still is a lack of reviews that assemble evidence-based clinical pharmacists' counseling. Equally, there is also a need to understand structure characteristics, processes and technical contents of these clinical services. Aim of the review To review the structure, processes and technical contents of pharmacist counseling or education reported in randomized controlled trials (RCT) that had positive health-related outcomes. Methods We performed a systematic search in specialized databases to identify RCT published between 1990 and 2013 that have evaluated pharmacists' counseling or educational interventions to patients. Methodological quality of the trials was assessed using the Jadad scale. Pharmacists' interventions with positive clinical outcomes (p Pharmacists were more likely to provide counseling at ambulatories (60 %) and hospital discharge (25 %); on the other hand pharmacists intervention were less likely to happen when dispensing a medication. Teaching back and explanations about the drug therapy purposes and precautions related to its use were often reported in RCT, whereas few studies used reminder charts, diaries, group or electronic counseling. Most of studies reported the provision of a printed material (letter, leaflet or medication record card), regarding accessible contents and cultural-concerned informations about drug therapy and disease. Conclusion Pharmacist counseling is an intervention directed to patients' health-related needs that improve inter-professional and inter-institutional communication, by collaborating to integrate health services. In spite of reducing MMRDT, we found that pharmacists' counseling reported in RCT should be better explored and described in details, hence

  1. Internet-based cognitive behavioural therapy (iCBT) for posttraumatic stress disorder versus waitlist control: study protocol for a randomised controlled trial

    OpenAIRE

    Allen, Adrian R; Jill M. Newby; Smith, Jessica; Andrews, Gavin

    2015-01-01

    Background This randomised controlled trial (RCT) with two parallel arms will evaluate the efficacy of an internet-delivered six-lesson 10-week cognitive behavioural therapy (iCBT) intervention for posttraumatic stress disorder (PTSD). It will also investigate the association between changes in PTSD symptoms, intolerance of uncertainty (IU) and emotion regulation. Methods/Design Patients with PTSD will be recruited via the research arm of a not-for-profit clinical and research unit in Austral...

  2. Snow Control - An RCT protocol for a web-based self-help therapy to reduce cocaine consumption in problematic cocaine users

    Directory of Open Access Journals (Sweden)

    Sullivan Robin

    2011-09-01

    Full Text Available Abstract Background Cocaine use has increased in most European countries, including Switzerland, and many states worldwide. The international literature has described treatment models that target the general population. In addition to supplying informative measures at the level of primary and secondary prevention, the literature also offers web-based self-help tools for problematic substance users, which is in line with tertiary prevention. Such programs, however, have been primarily tested on individuals with problematic alcohol and cannabis consumption, but not on cocaine-dependent individuals. Methods/Design This paper presents the protocol of a randomised clinical trial to test the effectiveness of a web-based self-help therapy to reduce cocaine use in problematic cocaine users. The primary outcome is severity of cocaine dependence. Secondary outcome measures include cocaine craving, consumption of cocaine and other substances of abuse in the past month, and changes in depression characteristics. The therapy group will receive a 6-week self-help therapy to reduce cocaine consumption based on methods of Cognitive Behavioural Therapy, principles of Motivational Interviewing and self-control practices. The control group will be presented weekly psycho-educative information with a quiz. The predictive validity of participant characteristics on treatment retention and outcome will be explored. Discussion To the best of our knowledge, this will be the first randomised clinical trial to test the effectiveness of online self-help therapy to reduce or abstain from cocaine use. It will also investigate predictors of outcome and retention. This trial is registered at Current Controlled Trials and is traceable as NTR-ISRCTN93702927.

  3. UK Dermatology Clinical Trials Network’s STOP GAP trial (a multicentre trial of prednisolone versus ciclosporin for pyoderma gangrenosum: protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Craig Fiona F

    2012-04-01

    Full Text Available Abstract Background Pyoderma gangrenosum (PG is a rare inflammatory skin disorder characterised by painful and rapidly progressing skin ulceration. PG can be extremely difficult to treat and patients often require systemic immunosuppression. Recurrent lesions of PG are common, but the relative rarity of this condition means that there is a lack of published evidence regarding its treatment. A systematic review published in 2005 found no randomised controlled trials (RCTs relating to the treatment of PG. Since this time, one small RCT has been published comparing infliximab to placebo, but none of the commonly used systemic treatments for PG have been formally assessed. The UK Dermatology Clinical Trials Network’s STOP GAP Trial has been designed to address this lack of trial evidence. Methods The objective is to assess whether oral ciclosporin is more effective than oral prednisolone for the treatment of PG. The trial design is a two-arm, observer-blind, parallel-group, randomised controlled trial comparing ciclosporin (4 mg/kg/day to prednisolone (0.75 mg/kg/day. A total of 140 participants are to be recruited over a period of 4 years, from up to 50 hospitals in the UK and Eire. Primary outcome of velocity of healing at 6 weeks is assessed blinded to treatment allocation (using digital images of the ulcers. Secondary outcomes include: (i time to healing; (ii global assessment of improvement; (iii PG inflammation assessment scale score; (iv self-reported pain; (v health-related quality of life; (vi time to recurrence; (vii treatment failures; (viii adverse reactions to study medications; and (ix cost effectiveness/utility. Patients with a clinical diagnosis of PG (excluding granulomatous PG; measurable ulceration (that is, not pustular PG; and patients aged over 18 years old who are able to give informed consent are included in the trial. Randomisation is by computer generated code using permuted blocks of randomly varying size

  4. A Randomised Controlled Trial of complete denture impression materials

    Science.gov (United States)

    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.; Brown, S.; 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 Dental Institute, UK. Each patient received two sets of dentures; made using either alginate or silicone impressions. Randomisations determined the order of assessment and order of impressions. The primary outcome was patient blinded preference for unadjusted dentures. Secondary outcomes were patient preference for the adjusted dentures, rating of comfort, stability and chewing efficiency, experience of each impression, and an OHIP-EDENT questionnaire. Results Seventy-eight (91.8%) patients completed the primary assessment. 53(67.9%) patients preferred dentures made from silicone impressions while 14(17.9%) preferred alginate impressions. 4(5.1%) patients found both dentures equally satisfactory and 7 (9.0%) found both equally unsatisfactory. There was a 50% difference in preference rates (in favour of silicone) (95%CI 32.7–67.3%, p silicone impressions were preferred by patients. Clinical significance Given the strength of the clinical findings within this paper, dentists should consider choosing silicone rather than alginate as their material of choice for secondary impressions for complete dentures. Trial Registration: ISRCTN 01528038.

 This article forms part of a project for which the author (TPH) won the Senior Clinical Unilever Hatton Award of the International Assocation for Dental Research, Capetown, South Africa, June 2014. PMID:24995473

  5. Melodic Intonation Therapy in chronic aphasia: evidence from a pilot randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Ineke Van Der Meulen

    2016-11-01

    Full Text Available AbstractMelodic Intonation Therapy (MIT is a language production therapy for severely non-fluent aphasic patients using melodic intoning and rhythm to restore language. Although many studies have reported its beneficial effects on language production, randomized controlled trials (RCT examining the efficacy of MIT are rare. In an earlier publication, we presented the results of an RCT on MIT in subacute aphasia and found that MIT was effective on trained and untrained items. Further, we observed a clear trend in improved functional language use after MIT. Subacute aphasic patients receiving MIT improved considerably on language tasks measuring connected speech and daily life verbal communication. Here, we present the results of a pilot RCT on MIT in chronic aphasia and compare these to the results observed in subacute aphasia. We used a multicenter waiting-list randomized controlled trial design. Patients with chronic (>1 year post-stroke aphasia were randomly allocated to the experimental group (6 weeks MIT or to the control group (6 weeks no intervention followed by 6 weeks MIT. Assessments were done at baseline (T1, after 6 weeks (T2, and 6 weeks later (T3. Efficacy was evaluated at T2 using univariable linear regression analyses. Outcome measures were chosen to examine several levels of therapy success: improvement on trained items, generalization to untrained items, and generalization to verbal communication. Of 17 included patients, 10 were allocated to the experimental condition and 7 to the control condition. MIT significantly improved repetition of trained items (β=13.32, p=.02. This effect did not remain stable at follow-up assessment. In contrast to earlier studies, we found only a limited and temporary effect of MIT, without generalization to untrained material or to functional communication. The results further suggest that the effect of MIT in chronic aphasia is more restricted than its effect in earlier stages post stroke. This

  6. Randomized controlled trials of maternal-fetal surgery: a challenge to clinical equipoise.

    Science.gov (United States)

    Rodrigues, H C M L; van den Berg, P P

    2014-10-01

    This article focuses on maternal-fetal surgery (MFS) and on the concept of clinical equipoise that is a widely accepted requirement for conducting randomized controlled trials (RCT). There are at least three reasons why equipoise is unsuitable for MFS. First, the concept is based on a misconception about the nature of clinical research and the status of research subjects. Second, given that it is not clear who the research subject/s in MFS is/are, if clinical equipoise is to be used as a criterion to test the ethical appropriateness of RCT, its meaning should be unambiguous. Third, because of the multidisciplinary character of MFS, it is not clear who should be in equipoise. As a result, we lack an adequate criterion for the ethical review of MFS protocols. In our account, which is based on Chervenak and McCullough's seminal work in the field of obstetric ethics, equipoise is abandoned. and RCT involving MFS can be ethically initiated when a multidisciplinary ethics review board (ERB), having an evidence-based assessment of the risks involved, is convinced that the value of answering the research hypothesis, for the sake of the health interests of future pregnant women carrying fetuses with certain congenital birth defects, justifies the actual risks research participants might suffer within a set limit of low/manageable.

  7. The chronic kidney disease Water Intake Trial (WIT): results from the pilot randomised controlled trial

    Science.gov (United States)

    Clark, William F; Sontrop, Jessica M; Huang, Shih-Han; Gallo, Kerri; Moist, Louise; House, Andrew A; Weir, Matthew A; Garg, Amit X

    2013-01-01

    Background and objectives Increased water intake may benefit kidney function. Prior to initiating a larger randomised controlled trial (RCT), we examined the safety and feasibility of asking adults with chronic kidney disease (CKD) to increase their water intake. Design, setting, participants and measurements Beginning in October 2012, we randomly assigned 29 adults with stage 3 CKD (estimated glomerular filtration rate (eGFR) 30–60 mL/min/1.73 m2 and albuminuria) to one of the two groups of water intake: hydration (n=18) or standard (n=11). We asked the hydration group to increase their water intake by 1.0–1.5 L/day (in addition to usual intake, depending on sex and weight) for 6 weeks, while the control group carried on with their usual intake. Participants collected a 24 h urine sample at baseline and at 2 and 6 weeks after randomisation. Our primary outcome was the between-group difference in change in 24 h urine volume from baseline to 6 weeks. Results (63%)of participants were men, 81% were Caucasians and the average age was 61 years (SD 14 years). The average baseline eGFR was 40 mL/min/1.73 m2 (SD 11 mL/min/1.73 m2); the median albumin to creatinine ratio was 19 mg/mmol (IQR 6–74 mg/mmol). Between baseline and 6-week follow-up, the hydration group's average 24 h urine volume increased by 0.7 L/day (from 2.3 to 3.0 L/day) and the control group's 24 h urine decreased by 0.3 L/day (from 2.0 to 1.7 L/day; between-group difference in change: 0.9 L/day (95% CI 0.4 to 1.5; p=0.002)). We found no significant changes in urine, serum osmolality or electrolyte concentrations, or eGFR. No serious adverse events or changes in quality of life were reported. Conclusions A pilot RCT indicates adults with stage 3 CKD can successfully and safely increase water intake by up to 0.7 L/day in addition to usual fluid intake. Trial registration Registered with Clinical Trials—government identifier NCT01753466. PMID:24362012

  8. PLUTO trial protocol: percutaneous shunting for lower urinary tract obstruction randomised controlled trial.

    Science.gov (United States)

    Kilby, Mark; Khan, Khalid; Morris, Katie; Daniels, Jane; Gray, Richard; Magill, Laura; Martin, Bill; Thompson, Peter; Alfirevic, Zarko; Kenny, Simon; Bower, Sarah; Sturgiss, Stephen; Anumba, Dilly; Mason, Gerald; Tydeman, Graham; Soothill, Peter; Brackley, Karen; Loughna, Pamela; Cameron, Alan; Kumar, Sailesh; Bullen, Phil

    2007-07-01

    The primary objective is to determine whether intrauterine vesicoamniotic shunting for fetal bladder outflow obstruction, compared with conservative, noninterventional care, improves prenatal and perinatal mortality and renal function. The secondary objectives are to determine if shunting for fetal bladder outflow obstruction improves perinatal morbidity, to determine if improvement in outcomes is related to prognostic assessment at diagnosis and, if possible, derive a prognostic risk index and to determine the safety and long-term efficacy of shunting. A multicentre randomised controlled trial (RCT). Fetal medicine units. Pregnant women with singleton, male fetus with isolated lower urinary tract obstruction (LUTO). Following ultrasound diagnosis of LUTO in a male fetus and exclusion of other structural and chromosomal anomalies, participation in the trial will be discussed with the mother and written information given. Consent for participation in the trial will be taken and the mother randomised via the internet to either insertion of a vesicoamniotic shunt or expectant management. During pregnancy, both groups will be followed with regular ultrasound scans looking at viability, renal measurements and amniotic fluid volume. Following delivery, babies will be followed up by paediatric nephrologists/urologists at 4-6 weeks, 12 months and 3 and 5 years to assess renal function via serum creatinine, renal ultrasound and need for dialysis/transplant. The main outcome measures will be perinatal mortality rates and renal function at 4-6 weeks and 12 months measured via serum creatinine, renal ultrasound and need for dialysis/transplant. Wellbeing of Women. ESTIMATED COMPLETION DATE: September 2010. TRIAL ALGORITHM: [flowchart: see text].

  9. RCT: Module 2.11, Radiological Work Coverage, Course 8777

    Energy Technology Data Exchange (ETDEWEB)

    Hillmer, Kurt T. [Los Alamos National Lab. (LANL), Los Alamos, NM (United States)

    2017-07-20

    Radiological work is usually approved and controlled by radiation protection personnel by using administrative and procedural controls, such as radiological work permits (RWPs). In addition, some jobs will require working in, or will have the potential for creating, very high radiation, contamination, or airborne radioactivity areas. Radiological control technicians (RCTs) providing job coverage have an integral role in controlling radiological hazards. This course will prepare the student with the skills necessary for RCT qualification by passing quizzes, tests, and the RCT Comprehensive Phase 1, Unit 2 Examination (TEST 27566) and will provide in-the-field skills.

  10. Assessing the quality of randomized controlled trials published in the Journal of Korean Medical Science from 1986 to 2011.

    Science.gov (United States)

    Chung, Jae Hoon; Kang, Dong Hyuk; Jo, Jung Ki; Lee, Seung Wook

    2012-09-01

    Low quality clinical trials have a possibility to have errors in the process of deriving the results and therefore distort the study. Quality assessment of clinical trial is necessary in order to prevent any clinical application erroneous results is important. Randomized controlled trial (RCT) is a design for evaluate the effectiveness of medical procedure. This study was conducted by extracting the RCTs from the original articles published in the Journal of Korean Medical Science (JKMS) from 1986 to 2011 and conducting a qualitative analysis using three types of analysis tools: Jadad scale, van Tulder scale and Cochrane Collaboration risk of bias Tool. To compare the quality of articles of JKMS, quality analysis of the RCTs published in Yonsei Medical Journal (YMJ) and Korean Journal of Internal Medicine was also conducted. In the JKMS, YMJ and Korean Journal of Internal Medicine, the quantitative increase of RCT presented over time was observed but no qualitative improvement of RCT was observed over time. From the results of this study, it is required for the researchers to plan for and perform higher quality studies.

  11. Sample Size Calculation: Inaccurate A Priori Assumptions for Nuisance Parameters Can Greatly Affect the Power of a Randomized Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Elsa Tavernier

    Full Text Available We aimed to examine the extent to which inaccurate assumptions for nuisance parameters used to calculate sample size can affect the power of a randomized controlled trial (RCT. In a simulation study, we separately considered an RCT with continuous, dichotomous or time-to-event outcomes, with associated nuisance parameters of standard deviation, success rate in the control group and survival rate in the control group at some time point, respectively. For each type of outcome, we calculated a required sample size N for a hypothesized treatment effect, an assumed nuisance parameter and a nominal power of 80%. We then assumed a nuisance parameter associated with a relative error at the design stage. For each type of outcome, we randomly drew 10,000 relative errors of the associated nuisance parameter (from empirical distributions derived from a previously published review. Then, retro-fitting the sample size formula, we derived, for the pre-calculated sample size N, the real power of the RCT, taking into account the relative error for the nuisance parameter. In total, 23%, 0% and 18% of RCTs with continuous, binary and time-to-event outcomes, respectively, were underpowered (i.e., the real power was 90%. Even with proper calculation of sample size, a substantial number of trials are underpowered or overpowered because of imprecise knowledge of nuisance parameters. Such findings raise questions about how sample size for RCTs should be determined.

  12. Study protocol: effect of playful training on functional abilities of older adults - a randomized controlled trial

    DEFF Research Database (Denmark)

    Jessen, Jari Due; Lund, Henrik Hautop

    2017-01-01

    paired t-test, otherwise using Wilcoxon signed-rank test. "Intention to treat" analysis will be done.Discussion: The trial tests for increased mobility, agility, balancing and general fitness of community-dwelling elderly as a result of playing, in this case on modular interactive tiles. A positive...... of community dwelling elderly as a result of short-term playing with an exergame system in the form of interactive modular tiles. Such playful training may be motivational to perform and viewed by the subjects to offer life-fulfilling quality, while providing improvement in physical abilities, e.g. related...... to prevent fall accidents. The RCT will test for a variety of health parameters of community-dwelling elderly playing on interactive modular tiles.Methods: The study will be a single blinded, randomized controlled trial with 60 community-dwelling adults 70+ years. The trial will consist an intervention group...

  13. RCT: Module 2.07, Respiratory Protection, Course 8773

    Energy Technology Data Exchange (ETDEWEB)

    Hillmer, Kurt T. [Los Alamos National Lab. (LANL), Los Alamos, NM (United States)

    2017-08-10

    Internal dosimetry controls require the use of engineering controls to prevent the internal deposition of radioactive and nonradiological contaminants. However, when engineering and administrative controls are not available or feasible, respiratory protection may be necessary. The radiation control technician (RCT) should know and apply the considerations used in determining the respiratory protection equipment that is most appropriate for the job. The inappropriate use of or the use of the wrong respiratory protection equipment may result in undesirable health effects. This course will prepare the student with the skills necessary for RCT qualification by passing quizzes, tests, and the RCT Comprehensive Phase 1, Unit 2 Examination (TEST 27566) and will provide in-the-field skills.

  14. Supported employment: randomised controlled trial*

    Science.gov (United States)

    Howard, Louise M.; Heslin, Margaret; Leese, Morven; McCrone, Paul; Rice, Christopher; Jarrett, Manuela; Spokes, Terry; Huxley, Peter; Thornicroft, Graham

    2010-01-01

    Background There is evidence from North American trials that supported employment using the individual placement and support (IPS) model is effective in helping individuals with severe mental illness gain competitive employment. There have been few trials in other parts of the world. Aims To investigate the effectiveness and cost-effectiveness of IPS in the UK. Method Individuals with severe mental illness in South London were randomised to IPS or local traditional vocational services (treatment as usual) (ISRCTN96677673). Results Two hundred and nineteen participants were randomised, and 90% assessed 1 year later. There were no significant differences between the treatment as usual and intervention groups in obtaining competitive employment (13% in the intervention group and 7% in controls; risk ratio 1.35, 95% CI 0.95–1.93, P = 0.15), nor in secondary outcomes. Conclusions There was no evidence that IPS was of significant benefit in achieving competitive employment for individuals in South London at 1-year follow-up, which may reflect suboptimal implementation. Implementation of IPS can be challenging in the UK context where IPS is not structurally integrated with mental health services, and economic disincentives may lead to lower levels of motivation in individuals with severe mental illness and psychiatric professionals. PMID:20435968

  15. A Randomized Controlled Trial (RCT) to Assess and Improve the Effectiveness of Post-Deployment Screening for Mental Illness

    Science.gov (United States)

    2014-09-01

    and comparing them to the rates in other studies carried out at King’s Centre for Mental Health Research (KCMHR) such as the in- theatre assessment...Department of Defense, 2010 38 10 Rona RJ, Jones M, French C, Hooper R, Wessely S. Screening for physical and psychological illness in the...12 French C, Rona RJ, Jones M, Wessely S. Screening for physical and psychological illness in the British Armed Forces: II: Barriers to screening

  16. A Randomized Controlled Trial (RCT) to Assess and Improve the Effectiveness of Post-deployment Screening for Mental Illness

    Science.gov (United States)

    2012-03-01

    following problems? Not bothered at all Bothered a little Bothered a lot a. Stomach pain b. Back pain c. Pain in your arms, legs... pain g. Dizziness h. Fainting spells i. Feeling your heart pound or race j. Shortness of breath k. Pain or...therapy, e.g. acupuncture provided by the military Please specify: ________________________ Yes No Military provided telephone

  17. Mixing a Grounded Theory Approach with a Randomized Controlled Trial Related to Intimate Partner Violence: What Challenges Arise for Mixed Methods Research?

    Directory of Open Access Journals (Sweden)

    Cristina Catallo

    2013-01-01

    Full Text Available Little is known about how to systematically integrate complex qualitative studies within the context of randomized controlled trials. A two-phase sequential explanatory mixed methods study was conducted in Canada to understand how women decide to disclose intimate partner violence in emergency department settings. Mixing a RCT (with a subanalysis of data with a grounded theory approach required methodological modifications to maintain the overall rigour of this mixed methods study. Modifications were made to the following areas of the grounded theory approach to support the overall integrity of the mixed methods study design: recruitment of participants, maximum variation and negative case sampling, data collection, and analysis methods. Recommendations for future studies include: (1 planning at the outset to incorporate a qualitative approach with a RCT and to determine logical points during the RCT to integrate the qualitative component and (2 consideration for the time needed to carry out a RCT and a grounded theory approach, especially to support recruitment, data collection, and analysis. Data mixing strategies should be considered during early stages of the study, so that appropriate measures can be developed and used in the RCT to support initial coding structures and data analysis needs of the grounded theory phase.

  18. Mixing a Grounded Theory Approach with a Randomized Controlled Trial Related to Intimate Partner Violence: What Challenges Arise for Mixed Methods Research?

    Science.gov (United States)

    Catallo, Cristina; Jack, Susan M.; Ciliska, Donna; MacMillan, Harriet L.

    2013-01-01

    Little is known about how to systematically integrate complex qualitative studies within the context of randomized controlled trials. A two-phase sequential explanatory mixed methods study was conducted in Canada to understand how women decide to disclose intimate partner violence in emergency department settings. Mixing a RCT (with a subanalysis of data) with a grounded theory approach required methodological modifications to maintain the overall rigour of this mixed methods study. Modifications were made to the following areas of the grounded theory approach to support the overall integrity of the mixed methods study design: recruitment of participants, maximum variation and negative case sampling, data collection, and analysis methods. Recommendations for future studies include: (1) planning at the outset to incorporate a qualitative approach with a RCT and to determine logical points during the RCT to integrate the qualitative component and (2) consideration for the time needed to carry out a RCT and a grounded theory approach, especially to support recruitment, data collection, and analysis. Data mixing strategies should be considered during early stages of the study, so that appropriate measures can be developed and used in the RCT to support initial coding structures and data analysis needs of the grounded theory phase. PMID:23577245

  19. Mixing a grounded theory approach with a randomized controlled trial related to intimate partner violence: what challenges arise for mixed methods research?

    Science.gov (United States)

    Catallo, Cristina; Jack, Susan M; Ciliska, Donna; Macmillan, Harriet L

    2013-01-01

    Little is known about how to systematically integrate complex qualitative studies within the context of randomized controlled trials. A two-phase sequential explanatory mixed methods study was conducted in Canada to understand how women decide to disclose intimate partner violence in emergency department settings. Mixing a RCT (with a subanalysis of data) with a grounded theory approach required methodological modifications to maintain the overall rigour of this mixed methods study. Modifications were made to the following areas of the grounded theory approach to support the overall integrity of the mixed methods study design: recruitment of participants, maximum variation and negative case sampling, data collection, and analysis methods. Recommendations for future studies include: (1) planning at the outset to incorporate a qualitative approach with a RCT and to determine logical points during the RCT to integrate the qualitative component and (2) consideration for the time needed to carry out a RCT and a grounded theory approach, especially to support recruitment, data collection, and analysis. Data mixing strategies should be considered during early stages of the study, so that appropriate measures can be developed and used in the RCT to support initial coding structures and data analysis needs of the grounded theory phase.

  20. Comparison of the long-term skeletal stability between a biodegradable and a titanium fixation system following BSSO advancement - A cohort study based on a multicenter randomised controlled trial

    NARCIS (Netherlands)

    van Bakelen, N. B.; Boermans, B. D. A.; Buijs, G. J.; Jansma, J.; Pruim, G. J.; Hoppenreijs, Th. J. M.; Bergsma, J. E.; Stegenga, B.; Bos, R. R. M.

    2014-01-01

    Biodegradable fixation systems could reduce or eliminate the problems associated with removal of titanium plates. A multicenter randomised controlled trial (RCT) was performed in the Netherlands from December 2006-July 2009, and originally 230 injured and orthognathic patients were included. The

  1. What works best for whom? An exploratory, subgroup analysis in a randomized, controlled trial on the effectiveness of a workplace intervention in low back pain patients on return to work

    NARCIS (Netherlands)

    Steenstra, I.A.; Knol, D.L.; Bongers, P.M.; Anema, J.R.; Mechelen, W. van; Vet, H.C.W. de

    2009-01-01

    STUDY DESIGN. Exploratory subgroup analysis in a randomized controlled trial (RCT). OBJECTIVE. To detect possible moderators in the effectiveness of a workplace intervention in a population of workers with sick leave due to sub acute nonspecific low back pain. SUMMARY OF BACKGROUND DATA. In a recent

  2. Cost effectiveness of a multi-stage return to work program for workers on sick leave due to low back pain, design of a population based controlled trial [ISRCTN60233560

    NARCIS (Netherlands)

    Steenstra, I.A.; Anema, J.R.; Bongers, P.M.; Vet, H.C.W. de; Mechelen, W. van

    2003-01-01

    Background: To describe the design of a population based randomized controlled trial (RCT), including a cost-effectiveness analysis, comparing participative ergonomics interventions between 2-8 weeks of sick leave and Graded Activity after 8 weeks of sick leave with usual care, in occupational back

  3. Methods for specifying the target difference in a randomised controlled trial: the Difference ELicitation in TriAls (DELTA) systematic review.

    Science.gov (United States)

    Hislop, Jenni; Adewuyi, Temitope E; Vale, Luke D; Harrild, Kirsten; Fraser, Cynthia; Gurung, Tara; Altman, Douglas G; Briggs, Andrew H; Fayers, Peter; Ramsay, Craig R; Norrie, John D; Harvey, Ian M; Buckley, Brian; Cook, Jonathan A

    2014-05-01

    Randomised controlled trials (RCTs) are widely accepted as the preferred study design for evaluating healthcare interventions. When the sample size is determined, a (target) difference is typically specified that the RCT is designed to detect. This provides reassurance that the study will be informative, i.e., should such a difference exist, it is likely to be detected with the required statistical precision. The aim of this review was to identify potential methods for specifying the target difference in an RCT sample size calculation. A comprehensive systematic review of medical and non-medical literature was carried out for methods that could be used to specify the target difference for an RCT sample size calculation. The databases searched were MEDLINE, MEDLINE In-Process, EMBASE, the Cochrane Central Register of Controlled Trials, the Cochrane Methodology Register, PsycINFO, Science Citation Index, EconLit, the Education Resources Information Center (ERIC), and Scopus (for in-press publications); the search period was from 1966 or the earliest date covered, to between November 2010 and January 2011. Additionally, textbooks addressing the methodology of clinical trials and International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) tripartite guidelines for clinical trials were also consulted. A narrative synthesis of methods was produced. Studies that described a method that could be used for specifying an important and/or realistic difference were included. The search identified 11,485 potentially relevant articles from the databases searched. Of these, 1,434 were selected for full-text assessment, and a further nine were identified from other sources. Fifteen clinical trial textbooks and the ICH tripartite guidelines were also reviewed. In total, 777 studies were included, and within them, seven methods were identified-anchor, distribution, health economic, opinion-seeking, pilot study, review of

  4. Methods for specifying the target difference in a randomised controlled trial: the Difference ELicitation in TriAls (DELTA systematic review.

    Directory of Open Access Journals (Sweden)

    Jenni Hislop

    2014-05-01

    Full Text Available Randomised controlled trials (RCTs are widely accepted as the preferred study design for evaluating healthcare interventions. When the sample size is determined, a (target difference is typically specified that the RCT is designed to detect. This provides reassurance that the study will be informative, i.e., should such a difference exist, it is likely to be detected with the required statistical precision. The aim of this review was to identify potential methods for specifying the target difference in an RCT sample size calculation.A comprehensive systematic review of medical and non-medical literature was carried out for methods that could be used to specify the target difference for an RCT sample size calculation. The databases searched were MEDLINE, MEDLINE In-Process, EMBASE, the Cochrane Central Register of Controlled Trials, the Cochrane Methodology Register, PsycINFO, Science Citation Index, EconLit, the Education Resources Information Center (ERIC, and Scopus (for in-press publications; the search period was from 1966 or the earliest date covered, to between November 2010 and January 2011. Additionally, textbooks addressing the methodology of clinical trials and International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH tripartite guidelines for clinical trials were also consulted. A narrative synthesis of methods was produced. Studies that described a method that could be used for specifying an important and/or realistic difference were included. The search identified 11,485 potentially relevant articles from the databases searched. Of these, 1,434 were selected for full-text assessment, and a further nine were identified from other sources. Fifteen clinical trial textbooks and the ICH tripartite guidelines were also reviewed. In total, 777 studies were included, and within them, seven methods were identified-anchor, distribution, health economic, opinion-seeking, pilot

  5. Reporting quality of randomized controlled trial abstracts: survey of leading general dental journals.

    Science.gov (United States)

    Hua, Fang; Deng, Lijia; Kau, Chung How; Jiang, Han; He, Hong; Walsh, Tanya

    2015-09-01

    The authors conducted a study to assess the reporting quality of randomized controlled trial (RCT) abstracts published in leading general dental journals, investigate any improvement after the release of the Consolidated Standards of Reporting Trials (CONSORT) for Abstracts guidelines, and identify factors associated with better reporting quality. The authors searched PubMed for RCTs published in 10 leading general dental journals during the periods from 2005 to 2007 (pre-CONSORT period) and 2010 to 2012 (post-CONSORT period). The authors evaluated and scored the reporting quality of included abstracts by using the original 16-item CONSORT for Abstracts checklist. The authors used risk ratios and the t test to compare the adequate reporting rate of each item and the overall quality in the 2 periods. The authors used univariate and multivariate regressions to identify predictors of better reporting quality. The authors included and evaluated 276 RCT abstracts. Investigators reported significantly more checklist items during the post-CONSORT period (mean [standard deviation {SD}], 4.53 [1.69]) than during the pre-CONSORT period (mean [SD], 3.87 [1.10]; mean difference, -0.66 [95% confidence interval, -0.99 to -0.33]; P 80%). In contrast, the authors saw sufficient reporting of randomization, recruitment, outcome in the results section, and funding in none of the pre-CONSORT abstracts and less than 2% of the post-CONSORT abstracts. On the basis of the multivariate analysis, a higher impact factor (P journals has improved significantly, but there is still room for improvement. Joint efforts by authors, reviewers, journal editors, and other stakeholders to improve the reporting of dental RCT abstracts are needed. Copyright © 2015 American Dental Association. Published by Elsevier Inc. All rights reserved.

  6. Non-pharmacological interventions in hypertension: A community-based cross-over randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Hema Subramanian

    2011-01-01

    Full Text Available Background: Hypertension is the most prevalent non-communicable disease causing significant morbidity/mortality through cardiovascular, cerebrovascular, and renal complications. Objectives: This community-based study tested the efficacy of non-pharmacological interventions in preventing/controlling hypertension. Materials and Methods: This is a cross-over randomized controlled trial (RCT of the earlier RCT (2007 of non-pharmacological interventions in hypertension, conducted in the urban service area of our Institute. The subjects, prehypertensive and hypertensive young adults (98 subjects: 25, 23, 25, 25 in four groups were randomly allotted into a group that he/she had not belonged to in the earlier RCT: Control (New Group I, Physical Exercise (NG II-brisk walking for 50 to 60 minutes, three to four days/week, Salt Intake Reduction (NG III to at least half of their previous intake, Yoga (NG IV for 30 to 45 minutes/day, five days/week. Blood pressure was measured before and after eight weeks of intervention. Analysis was by ANOVA with a Games-Howell post hoc test. Results: Ninety-four participants (25, 23, 21, 25 completed the study. All three intervention groups showed significant reduction in BP (SBP/DBP mmHg: 5.3/6.0 in NG II, 2.5/2.0 in NG III, and 2.3/2.4 in NG IV, respectively, while the Control Group showed no significant difference. Persistence of significant reduction in BP in the three intervention groups after cross-over confirmed the biological plausibility of these non-pharmacological interventions. This study reconfirmed that physical exercise was more effective than Salt Reduction or Yoga. Salt Reduction, and Yoga were equally effective. Conclusion: Physical exercise, salt intake reduction, and yoga are effective non-pharmacological methods for reducing blood pressure in young pre-hypertensive and hypertensive adults.

  7. Intracranial pressure monitoring in severe traumatic brain injury in latin america: process and methods for a multi-center randomized controlled trial.

    Science.gov (United States)

    Carney, Nancy; Lujan, Silvia; Dikmen, Sureyya; Temkin, Nancy; Petroni, Gustavo; Pridgeon, Jim; Barber, Jason; Machamer, Joan; Cherner, Mariana; Chaddock, Kelley; Hendrix, Terence; Rondina, Carlos; Videtta, Walter; Celix, Juanita M; Chesnut, Randall

    2012-07-20

    In patients with severe traumatic brain injury (TBI), the influence on important outcomes of the use of information from intracranial pressure (ICP) monitoring to direct treatment has never been tested in a randomized controlled trial (RCT). We are conducting an RCT in six trauma centers in Latin America to test this question. We hypothesize that patients randomized to ICP monitoring will have lower mortality and better outcomes at 6-months post-trauma than patients treated without ICP monitoring. We selected three centers in Bolivia to participate in the trial, based on (1) the absence of ICP monitoring, (2) adequate patient accession and data collection during the pilot phase, (3) preliminary institutional review board approval, and (4) the presence of equipoise about the value of ICP monitoring. We conducted extensive training of site personnel, and initiated the trial on September 1, 2008. Subsequently, we included three additional centers. A total of 176 patients were entered into the trial as of August 31, 2010. Current enrollment is 81% of that expected. The trial is expected to reach its enrollment goal of 324 patients by September of 2011. We are conducting a high-quality RCT to answer a question that is important globally. In addition, we are establishing the capacity to conduct strong research in Latin America, where TBI is a serious epidemic. Finally, we are demonstrating the feasibility and utility of international collaborations that share resources and unique patient populations to conduct strong research about global public health concerns.

  8. Partner randomized controlled trial: study protocol and coaching intervention

    Directory of Open Access Journals (Sweden)

    Garbutt Jane M

    2012-04-01

    Full Text Available Abstract Background Many children with asthma live with frequent symptoms and activity limitations, and visits for urgent care are common. Many pediatricians do not regularly meet with families to monitor asthma control, identify concerns or problems with management, or provide self-management education. Effective interventions to improve asthma care such as small group training and care redesign have been difficult to disseminate into office practice. Methods and design This paper describes the protocol for a randomized controlled trial (RCT to evaluate a 12-month telephone-coaching program designed to support primary care management of children with persistent asthma and subsequently to improve asthma control and disease-related quality of life and reduce urgent care events for asthma care. Randomization occurred at the practice level with eligible families within a practice having access to the coaching program or to usual care. The coaching intervention was based on the transtheoretical model of behavior change. Targeted behaviors included 1 effective use of controller medications, 2 effective use of rescue medications and 3 monitoring to ensure optimal control. Trained lay coaches provided parents with education and support for asthma care, tailoring the information provided and frequency of contact to the parent's readiness to change their child's day-to-day asthma management. Coaching calls varied in frequency from weekly to monthly. For each participating family, follow-up measurements were obtained at 12- and 24-months after enrollment in the study during a telephone interview. The primary outcomes were the mean change in 1 the child's asthma control score, 2 the parent's quality of life score, and 3 the number of urgent care events assessed at 12 and 24 months. Secondary outcomes reflected adherence to guideline recommendations by the primary care pediatricians and included the proportion of children prescribed controller medications

  9. Continued versus discontinued oxytocin stimulation, protocol of an rct

    DEFF Research Database (Denmark)

    Boie, Sidsel; Glavind, Julie; Uldbjerg, Niels

    outcome Caesarean delivery Secondary outcomes Postpartum haemorrhage Duration of labour Instrumental delivery Neonatal morbidity Birth experience Breastfeeding Results: Results are expected in 2018. Conclusions: This is the first double-blind RCT on discontinuation or continuation of oxytocin stimulation......, when the active phase of labour is established. The trial will have a major impact on both national and international clinical practice concerning induction of labour with Syntocinon®....

  10. Randomised controlled trials cited in pharmaceutical advertisements targeting New Zealand health professionals: do they support the advertising claims and what is the risk of bias?

    Science.gov (United States)

    Ma, Alison; Parkin, Lianne

    2015-09-04

    To determine whether pharmaceutical advertisement claims targeting health professionals were supported by the randomised controlled trials (RCTs) cited in the advertisements, and to assess the risk of bias in those trials. Pharmaceutical advertisements were obtained from New Zealand Doctor and Pharmacy Today for the period July 2013 to June 2014. All claims made regarding efficacy, safety, and indications were identified and RCTs cited to substantiate these claims were examined. A claim was defined as supported by an RCT if the conclusions drawn in the paper were consistent with the claim. The quality of the RCT was assessed separately, using the Cochrane Risk of Bias Assessment Tool. In 25 (19%) of the 133 instances in which an RCT was cited, the published paper did not support the promotional claim. Moreover, there were only 10 (8%) instances in which the claim was supported by an RCT with a low risk of bias. Of the 78 cited RCTs, only 14% had a low risk of bias, while 49% had an unclear risk and 37% had a high risk. A high proportion of advertisements failed to meet New Zealand regulatory requirements that claims "are valid and have been substantiated".

  11. Sample bias from different recruitment strategies in a randomised controlled trial for alcohol dependence.

    Science.gov (United States)

    Morley, Kirsten C; Teesson, Maree; Sannibale, Claudia; Haber, Paul S

    2009-05-01

    Participants may be recruited from diverse sources for randomised controlled trials (RCT) of treatments for alcohol dependence. A mixed recruitment strategy might facilitate recruitment and increase generalisability at the expense of introducing systematic selection bias. The current study aims to compare the effects of recruitment method on socio-demographics, baseline illness characteristics, treatment retention and treatment outcome measures. A secondary analysis from a previous 12 week RCT of naltrexone, acamprosate and placebo for alcohol dependence was conducted. Participants (n = 169) were obtained via four channels of recruitment including in-patient and outpatient referral, live media and print media solicitation. Baseline parameters, retention in treatment and treatment outcomes were compared in these groups. Relative to in-patient subjects, those recruited via live and print media had significantly lower scores on taking steps, less in-patient rehabilitation admissions and less previous abstinence before entering the trial. Subjects recruited via print media had significantly lower scores of alcohol dependence relative to all other modes recruitment. There were no differences between recruitment strategies on treatment retention or compliance. At outcome, no significant effect of recruitment method was detected. These results suggest that different recruitment methods may be sourcing subjects with different baseline characteristics of illness. Nonetheless, these differences did not significantly impact on treatment retention or outcome, suggesting that in this population it was appropriate to recruit subjects from mixed sources.

  12. Fructus Mume Formula in the Treatment of Type 2 Diabetes Mellitus: A Randomized Controlled Pilot Trial

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    Xiang Tu

    2013-01-01

    Full Text Available Background. “Fructus Mume or Dark Plum” (pilule form has been used for many years in Traditional Chinese Medicine (TCM and may be a valid treatment for type 2 diabetes mellitus (T2DM. Aim. One aspect toward efficacy validation is the evaluation of the blood glucose-lowering effect of Fructus Mume (FM with T2DM patients in a randomized controlled trial (RCT. Methods. This pilot study uses a RCT procedure to assess efficacy of FM and Metformin. The trial was for 12 weeks, with 80 T2DM subjects. Both groups were standardized in their diet and exercise routine. Comparisons of several variables were analyzed. Results. No significant differences were found between groups in the fasting and postprandial glucose levels although both had significant decreases. The values of glycosylated hemoglobin were significantly reduced in both groups. For patients whose body mass index (BMI was 25, both FM and Metformin significantly reduce the BMI. Conclusions. In this pilot study, it was demonstrated that Fructus Mume formula may reduce the levels of blood glucose in patients with type 2 diabetes.

  13. Risk compensation is not associated with male circumcision in Kisumu, Kenya: a multi-faceted assessment of men enrolled in a randomized controlled trial.

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    Christine L Mattson

    Full Text Available BACKGROUND: Three randomized controlled trials (RCTs have confirmed that male circumcision (MC significantly reduces acquisition of HIV-1 infection among men. The objective of this study was to perform a comprehensive, prospective evaluation of risk compensation, comparing circumcised versus uncircumcised controls in a sample of RCT participants. METHODS AND FINDINGS: Between March 2004 and September 2005, we systematically recruited men enrolled in a RCT of MC in Kenya. Detailed sexual histories were taken using a modified Timeline Followback approach at baseline, 6, and 12 months. Participants provided permission to obtain circumcision status and laboratory results from the RCT. We evaluated circumcised and uncircumcised men's sexual behavior using an 18-item risk propensity score and acquisition of incident infections of gonorrhea, chlamydia, and trichomoniasis. Of 1780 eligible RCT participants, 1319 enrolled (response rate = 74%. At the baseline RCT visit, men who enrolled in the sub-study reported the same sexual behaviors as men who did not. We found a significant reduction in sexual risk behavior among both circumcised and uncircumcised men from baseline to 6 (p<0.01 and 12 (p = 0.05 months post-enrollment. Longitudinal analyses indicated no statistically significant differences between sexual risk propensity scores or in incident infections of gonorrhea, chlamydia, and trichomoniasis between circumcised and uncircumcised men. These results are based on the most comprehensive analysis of risk compensation yet done. CONCLUSION: In the context of a RCT, circumcision did not result in increased HIV risk behavior. Continued monitoring and evaluation of risk compensation associated with circumcision is needed as evidence supporting its' efficacy is disseminated and MC is widely promoted for HIV prevention.

  14. Short-term effects of acupuncture and stretching on myofascial trigger point pain of the neck: a blinded, placebo-controlled RCT.

    Science.gov (United States)

    Wilke, J; Vogt, L; Niederer, D; Hübscher, M; Rothmayr, J; Ivkovic, D; Rickert, M; Banzer, W

    2014-10-01

    This trial aimed to evaluate the short-term effectiveness of acupuncture plus stretching to reduce pain and improve range of motion in patients afflicted by cervical myofascial pain syndrome. Randomized, blinded, placebo-controlled crossover study. Nineteen patients (11 females, eight males, 33 ± 14 years) with myofascial neck pain in randomized order received the following treatments with one week washout between: acupuncture, acupuncture plus stretching, and placebo laser acupuncture. Mechanical pain threshold (MPT, measured with a pressure algometer) represented the primary outcome. Secondary outcomes were motion-related pain (Visual Analogue Scale, VAS) and cervical range of motion (ROM, recorded by means of an ultrasonic 3D movement analysis system). Outcomes were assessed immediately prior as well as 5, 15 and 30 min post treatment. Friedman tests with post hoc Bonferroni-Holm correction were applied to compare differences between treatments. Both acupuncture as well as acupuncture plus stretching increased MPT by five, respectively, 11 percent post treatment. However, only acupuncture in combination with stretching was superior to placebo (pstretching, ROM was significantly increased in the frontal and the transversal plane compared to placebo (pstretching could represent a suitable treatment option to improve cervical movement behavior and reduce trigger point pain in the short-term. However, additional studies further discriminating the placebo effects are still warranted. Copyright © 2014 Elsevier Ltd. All rights reserved.

  15. Video-game based exercises for older people with chronic low back pain: a protocol for a feasibility randomised controlled trial (the GAMEBACK trial).

    Science.gov (United States)

    Zadro, Joshua Robert; Shirley, Debra; Simic, Milena; Mousavi, Seyed Javad; Ceprnja, Dragana; Maka, Katherine; Ferreira, Paulo

    2017-06-01

    To investigate the feasibility of implementing a video-game exercise programme for older people with chronic low back pain (LBP). Single-centred single-blinded randomised controlled trial (RCT). Physiotherapy outpatient department in a public hospital in Western Sydney, Australia. We will recruit 60 participants over 55 years old with chronic LBP from the waiting list. Participants will be randomised to receive video-game exercise (n=30) or to remain on the waiting list (n=30) for 8 weeks, with follow up at 3 and 6 months. Participants engaging in video-game exercises will be unsupervised and will complete video-game exercise for 60minutes, 3 times per week. Participants allocated to remain on the waiting list will be encouraged to maintain their usual levels of physical activity. The primary outcomes for this feasibility study will be study processes (recruitment and response rates, adherence to and experience with the intervention, and incidence of adverse events) relevant to the future design of a large RCT. Estimates of treatment efficacy (point estimates and 95% confidence intervals) on pain self-efficacy, care seeking, physical activity, fear of movement/re-injury, pain, physical function, disability, falls-efficacy, strength, and walking speed, will be our secondary outcome measures. Recruitment for this trial began in November 2015. This study describes the rationale and processes of a feasibility study investigating a video-game exercise programme for older people with chronic LBP. Results from the feasibility study will inform on the design and sample required for a large multicentre RCT. Australian New Zealand Clinical Trials Registry: ACTRN12615000703505. Copyright © 2016 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.

  16. Collaborative Depression Trial (CADET: multi-centre randomised controlled trial of collaborative care for depression - study protocol

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    Kessler David

    2009-10-01

    Full Text Available Abstract Background Comprising of both organisational and patient level components, collaborative care is a potentially powerful intervention for improving depression treatment in UK primary Care. However, as previous models have been developed and evaluated in the United States, it is necessary to establish the effect of collaborative care in the UK in order to determine whether this innovative treatment model can replicate benefits for patients outside the US. This Phase III trial was preceded by a Phase II patient level RCT, following the MRC Complex Intervention Framework. Methods/Design A multi-centre controlled trial with cluster-randomised allocation of GP practices. GP practices will be randomised to usual care control or to "collaborative care" - a combination of case manager coordinated support and brief psychological treatment, enhanced specialist and GP communication. The primary outcome will be symptoms of depression as assessed by the PHQ-9. Discussion If collaborative care is demonstrated to be effective we will have evidence to enable the NHS to substantially improve the organisation of depressed patients in primary care, and to assist primary care providers to deliver a model of enhanced depression care which is both effective and acceptable to patients. Trial Registration Number ISRCTN32829227

  17. Placement Of Cardiac PacemaKEr Trial (POCKET – rationale and design: a randomized controlled trial

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    Peter Magnusson

    2017-04-01

    Full Text Available Background: A pacemaker system consists of one or two leads connected to a device that is implanted into a pocket formed just below the collarbone. This pocket is typically subcutaneous, that is, located just above the pectoral fascia. Even though the size of pacemakers has decreased markedly, complications due to superficial implants do occur. An alternative technique would be intramuscular placement of the pacemaker device, but there are no randomized controlled trials (RCTs to support this approach, which is the rationale for the Placement Of Cardiac PacemaKEr Trial (POCKET. The aim is to study if intramuscular is superior to subcutaneous placement of a pacemaker pocket. Methods: In October 2016, we started to enroll 200 consecutive patients with an indication for bradycardia pacemaker implantation. Patients are randomized to random block sizes, stratified by age group (cut-off: 65 years and sex, and then randomized to either subcutaneous or intramuscular implant. A concealed allocation procedure is employed, using sequentially numbered, sealed envelopes. Pocket site is blinded to the patient and in all subsequent care. The primary endpoint is patient overall satisfaction with the pocket location at 24 months as measured using a visual analog scale (VAS 0-10. Secondary endpoints are: complications, patient-reported satisfaction at 1, 12, and 24 months (overall satisfaction, pain, discomfort, degree of unsightly appearance, movement problems, and sleep problems due to device. Conclusions: POCKET is a prospective interventional RCT designed to evaluate if intramuscular is superior to subcutaneous placement of a bradycardia pacemaker during a two-year follow-up.

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

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    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

  19. Describing qualitative research undertaken with randomised controlled trials in grant proposals: a documentary analysis.

    Science.gov (United States)

    Drabble, Sarah J; O'Cathain, Alicia; Thomas, Kate J; Rudolph, Anne; Hewison, Jenny

    2014-02-18

    There is growing recognition of the value of conducting qualitative research with trials in health research. It is timely to reflect on how this qualitative research is presented in grant proposals to identify lessons for researchers and research commissioners. As part of a larger study focusing on how to maximise the value of undertaking qualitative research with trials, we undertook a documentary analysis of proposals of funded studies. Using the metaRegister of Controlled Trials (mRCT) database we identified trials funded in the United Kingdom, ongoing between 2001 and 2010, and reporting the use of qualitative research. We requested copies of proposals from lead researchers. We extracted data from the proposals using closed and open questions, analysed using descriptive statistics and content analysis respectively. 2% (89/3812) of trials in the mRCT database described the use of qualitative research undertaken with the trial. From these 89 trials, we received copies of 36 full proposals, of which 32 met our inclusion criteria. 25% used less than a single paragraph to describe the qualitative research. The aims of the qualitative research described in these proposals focused mainly on the intervention or trial conduct. Just over half (56%) of the proposals included an explicit rationale for conducting the qualitative research with the trial, the most frequent being to optimise implementation into clinical practice or to interpret trial findings. Key information about methods, expertise and resources was missing in a large minority of proposals, in particular sample size, type of analysis, and non-personnel resources. 28% specifically stated that qualitative researchers would conduct the qualitative research. Our review of proposals of successfully funded studies identified good practice but also identified limited space given to describing the qualitative research, with an associated lack of attention to the rationale for doing the qualitative research and

  20. Describing qualitative research undertaken with randomised controlled trials in grant proposals: a documentary analysis

    Science.gov (United States)

    2014-01-01

    Background There is growing recognition of the value of conducting qualitative research with trials in health research. It is timely to reflect on how this qualitative research is presented in grant proposals to identify lessons for researchers and research commissioners. As part of a larger study focusing on how to maximise the value of undertaking qualitative research with trials, we undertook a documentary analysis of proposals of funded studies. Methods Using the metaRegister of Controlled Trials (mRCT) database we identified trials funded in the United Kingdom, ongoing between 2001 and 2010, and reporting the use of qualitative research. We requested copies of proposals from lead researchers. We extracted data from the proposals using closed and open questions, analysed using descriptive statistics and content analysis respectively. Results 2% (89/3812) of trials in the mRCT database described the use of qualitative research undertaken with the trial. From these 89 trials, we received copies of 36 full proposals, of which 32 met our inclusion criteria. 25% used less than a single paragraph to describe the qualitative research. The aims of the qualitative research described in these proposals focused mainly on the intervention or trial conduct. Just over half (56%) of the proposals included an explicit rationale for conducting the qualitative research with the trial, the most frequent being to optimise implementation into clinical practice or to interpret trial findings. Key information about methods, expertise and resources was missing in a large minority of proposals, in particular sample size, type of analysis, and non-personnel resources. 28% specifically stated that qualitative researchers would conduct the qualitative research. Conclusions Our review of proposals of successfully funded studies identified good practice but also identified limited space given to describing the qualitative research, with an associated lack of attention to the rationale for

  1. A Pilot Study Evaluating the Effectiveness of Platelet-Rich Plasma Therapy for Treating Degenerative Tendinopathies: A Randomized Control Trial with Synchronous Observational Cohort.

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    Marni Wesner

    Full Text Available This pilot study aimed to inform future research evaluating the effectiveness of Platelet Rich Plasma (PRP injection for tendinopathy.Randomized control trial (RCT and synchronous observational cohort studies. For the RCT, consecutive consenting patients treated at an academic sports medicine clinic were randomly assigned to either a PRP or placebo control group.The Glen Sather Sport Medicine Clinic, Edmonton, Canada.The RCT included 9 participants with rotator cuff tendinopathy. The cohort study included 178 participants with a variety of tendinopathies.Patients receiving PRP were injected with 4 ml of platelets into the supraspinatus and/or infraspinatus, while patients in the placebo group were injected with 4 ml of saline. All participants undertook a 3-month standardized, home-based, daily exercise program.Participants in the RCT were re-evaluated 3, and 6 months post-injection. Change scores before and after injection on pain, disability and MRI-documented pathology outcomes were compared. In the cohort study, pain and disability were measured at 1, 2 and 3 months post-injection.For the RCT, 7 participants received PRP and 2 received placebo injections. Patients receiving PRP reported clinically important improvements in pain (>1.5/10 on VAS, disability (>15 point DASH change, and tendon pathology while those receiving placebo injections did not. In the observational cohort, statistically and clinically significant improvements in pain and disability were observed.This pilot study provides information for planning future studies of PRP effectiveness. Preliminary results indicate intratendinous, ultrasound-guided PRP injection may lead to improvements in pain, function, and MRI-documented tendon pathology.Controlled-Trials.com ISRCTN68341698.

  2. Participants’ perspectives on mindfulness-based cognitive therapy for inflammatory bowel disease: a qualitative study nested within a pilot randomised controlled trial

    OpenAIRE

    Schoultz, Mariyana; Macaden, Leah; Hubbard, Gill

    2016-01-01

    Background Mindfulness-based interventions have shown to improve depression and anxiety symptoms as well as quality of life in patients with inflammatory bowel disease (IBD). However, little is known about the experiences of this group of patients participating in mindfulness interventions. This paper sets out to explore the perspectives of patients with IBD recruited to a pilot randomised controlled trial (RCT) of mindfulness-based cognitive therapy (MBCT) about the intervention. Methods In ...

  3. Neural manual vs. robotic assisted mobilization to improve motion and reduce pain hypersensitivity in hand osteoarthritis: study protocol for a randomized controlled trial

    OpenAIRE

    Villafa?e, Jorge Hugo; Valdes, Kristin; Imperio, Grace; Borboni, Alberto; Cantero-T?llez, Raquel; Galeri, Silvia; Negrini, Stefano

    2017-01-01

    [Purpose] The aim of the present study is to detail the protocol for a randomised controlled trial (RCT) of neural manual vs. robotic assisted on pain in sensitivity as well as analyse the quantitative and qualitative movement of hand in subjects with hand osteoarthritis. [Subjects and Methods] Seventy-two patients, aged 50 to 90?years old of both genders, with a diagnosis of hand Osteoarthritis (OA), will be recruited. Two groups of 36 participants will receive an experimental intervention (...

  4. 'The trial is owned by the team, not by an individual': a qualitative study exploring the role of teamwork in recruitment to randomised controlled trials in surgical oncology.

    Science.gov (United States)

    Strong, Sean; Paramasivan, Sangeetha; Mills, Nicola; Wilson, Caroline; Donovan, Jenny L; Blazeby, Jane M

    2016-04-26

    Challenges exist in recruitment to trials involving interventions delivered by different clinical specialties. Collaboration is required between clinical specialty and research teams. The aim of this study was to explore how teamwork influences recruitment to a multicentre randomised controlled trial (RCT) involving interventions delivered by different clinical specialties. Semi-structured interviews were conducted in three centres with a purposeful sample of members of the surgical, oncology and research teams recruiting to a feasibility RCT comparing definitive chemoradiotherapy with chemoradiotherapy and surgery for oesophageal squamous cell carcinoma. Interviews explored factors known to influence healthcare team effectiveness and were audio-recorded and thematically analysed. Sampling, data collection and analysis were undertaken iteratively and concurrently. Twenty-one interviews were conducted. Factors that influenced how team working impacted upon trial recruitment were centred on: (1) the multidisciplinary team (MDT) meeting, (2) leadership of the trial, and (3) the recruitment process. The weekly MDT meeting was reported as central to successful recruitment and formed the focus for creating a 'study team', bringing together clinical and research teams. Shared study leadership positively influenced healthcare professionals' willingness to participate. Interviewees perceived their clinical colleagues to have strong treatment preferences which led to scepticism regarding whether the treatments were being described to patients in a balanced manner. This study has highlighted a number of aspects of team functioning that are important for recruitment to RCTs that span different clinical specialties. Understanding these issues will aid the production of guidance on team-relevant issues that should be considered in trial management and the development of interventions that will facilitate teamwork and improve recruitment to these challenging RCTs. International

  5. Functional and psychosocial effects of health qigong in patients with COPD: a randomized controlled trial.

    Science.gov (United States)

    Ng, Bobby H P; Tsang, Hector W H; Jones, Alice Y M; So, C T; Mok, Thomas Y W

    2011-03-01

    The initial gain from a Pulmonary Rehabilitation Program (PRP) among patients with chronic obstructive pulmonary disease (COPD) begins to fade away 6 months after the completion of a rehabilitation program. One possible reason may be due to the poor compliance of the patients to the existing forms of home exercise program (e.g., walking, weight training activities, etc.). This study tested the efficacy of health qigong (HQG), a traditional Chinese exercise, as an adjunct home exercise program in optimizing the gains obtained from PRP until 6 months after discharge. This was a randomized controlled trial (RCT) on a mind-body exercise intervention. Eighty (80) patients with COPD receiving conventional PRP pulmonary rehabilitation program were randomized to the HQG intervention group (n = 40) and control group (n = 40). Assessments were undertaken by blinded assessors at baseline, discharge from training, and follow-up (FU) at 3 and 6 months. Primary outcomes involved functional capacity scales and secondary outcomes involved quality-of-life scales. Intention-to-treat analysis identified trends of improvement in all outcome measures in the HQG group, whereas lesser improvement and trends of deteriorations were identified in the control group. Ancillary analysis using a per-protocol method, however, identified significantly better improvements in functional capacity measures among the HQG at the 6-month FU. This RCT provided some evidence to support the positive effect of HQG as an adjunct home exercise for rehabilitation among people with COPD and to support further related research.

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

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    Buck Deborah

    2012-10-01

    Full Text Available Abstract Background Childhood intermittent exotropia [X(T] is a type of strabismus (squint in which one eye deviates outward at times, usually when the child is tired. It may progress to a permanent squint, loss of stereovision and/or amblyopia (reduced vision. Treatment options for X(T include eye patches, glasses, surgery and active monitoring. There is no consensus regarding how this condition should be managed, and even when surgery is the preferred option clinicians disagree as to the optimal timing. Reports on the natural history of X(T are limited, and there is no randomised controlled trial (RCT evidence on the effectiveness or efficiency of surgery compared with active monitoring. The SamExo (Surgery versus Active Monitoring in Intermittent Exotropia pilot study has been designed to test the feasibility of such a trial in the UK. Methods Design: an external pilot patient randomised controlled trial. Setting: four UK secondary ophthalmology care facilities at Newcastle NHS Hospitals Foundation Trust, Sunderland Eye Infirmary, Moorfields Eye Hospital and York NHS Trust. Participants: children aged between 6 months and 16 years referred with suspected and subsequently diagnosed X(T. Recruitment target is a total of 144 children over a 9-month period, with 120 retained by 9-month outcome visit. Randomisation: permuted blocks stratified by collaborating centre, age and severity of X(T. Interventions: initial clinical assessment; randomisation (eye muscle surgery or active monitoring; 3-, 6- and 9-month (primary outcome clinical assessments; participant/proxy completed questionnaire covering time and travel costs, health services use and quality of life (Intermittent Exotropia Questionnaire; qualitative interviews with parents to establish reasons for agreeing or declining participation in the pilot trial. Outcomes: recruitment and retention rates; nature and extent of participation bias; nature and extent of biases arising from crossover or

  7. Activity Increase Despite Arthritis (AÏDA: design of a Phase II randomised controlled trial evaluating an active management booklet for hip and knee osteoarthritis [ISRCTN24554946

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    Edwards Rhiannon T

    2009-09-01

    Full Text Available Abstract Background Hip and knee osteoarthritis is a common cause of pain and disability, which can be improved by exercise interventions. However, regular exercise is uncommon in this group because the low physical activity level in the general population is probably reduced even further by pain related fear of movement. The best method of encouraging increased activity in this patient group is not known. A booklet has been developed for patients with hip or knee osteoarthritis. It focuses on changing disadvantageous beliefs and encouraging increased physical activity. Methods/Design This paper describes the design of a Phase II randomised controlled trial (RCT to test the effectiveness of this new booklet for patients with hip and knee osteoarthritis in influencing illness and treatment beliefs, and to assess the feasibility of conducting a larger definitive RCT in terms of health status and exercise behaviour. A computerised search of four general medical practice patients' record databases will identify patients older than 50 years of age who have consulted with hip or knee pain in the previous twelve months. A random sample of 120 will be invited to participate in the RCT comparing the new booklet with a control booklet, and we expect 100 to return final questionnaires. This trial will assess the feasibility of recruitment and randomisation, the suitability of the control intervention and outcome measurement tools, and will provide an estimate of effect size. Outcomes will include beliefs about hip and knee pain, beliefs about exercise, fear avoidance, level of physical activity, health status and health service costs. They will be measured at baseline, one month and three months. Discussion We discuss the merits of testing effectiveness in a phase II trial, in terms of intermediate outcome measures, whilst testing the processes for a larger definitive trial. We also discuss the advantages and disadvantages of testing the psychometric

  8. The Feedback Intervention Trial (FIT) — Improving Hand-Hygiene Compliance in UK Healthcare Workers: A Stepped Wedge Cluster Randomised Controlled Trial

    Science.gov (United States)

    Fuller, Christopher; Michie, Susan; Savage, Joanne; McAteer, John; Besser, Sarah; Charlett, Andre; Hayward, Andrew; Cookson, Barry D.; Cooper, Ben S.; Duckworth, Georgia; Jeanes, Annette; Roberts, Jenny; Teare, Louise; Stone, Sheldon

    2012-01-01

    Introduction Achieving a sustained improvement in hand-hygiene compliance is the WHO’s first global patient safety challenge. There is no RCT evidence showing how to do this. Systematic reviews suggest feedback is most effective and call for long term well designed RCTs, applying behavioural theory to intervention design to optimise effectiveness. Methods Three year stepped wedge cluster RCT of a feedback intervention testing hypothesis that the intervention was more effective than routine practice in 16 English/Welsh Hospitals (16 Intensive Therapy Units [ITU]; 44 Acute Care of the Elderly [ACE] wards) routinely implementing a national cleanyourhands campaign). Intervention-based on Goal & Control theories. Repeating 4 week cycle (20 mins/week) of observation, feedback and personalised action planning, recorded on forms. Computer-generated stepwise entry of all hospitals to intervention. Hospitals aware only of own allocation. Primary outcome: direct blinded hand hygiene compliance (%). Results All 16 trusts (60 wards) randomised, 33 wards implemented intervention (11 ITU, 22 ACE). Mixed effects regression analysis (all wards) accounting for confounders, temporal trends, ward type and fidelity to intervention (forms/month used). Intention to Treat Analysis Estimated odds ratio (OR) for hand hygiene compliance rose post randomisation (1.44; 95% CI 1.18, 1.76;phygiene compliance, in wards implementing a national hand-hygiene campaign. Further implementation studies are needed to maximise the intervention’s effect in different settings. Trial Registration Controlled-Trials.com ISRCTN65246961 PMID:23110040

  9. Increasing participation of cancer patients in randomised controlled trials: a systematic review

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    Stirk Lisa

    2006-05-01

    Full Text Available Abstract Background There are many barriers to patient participation in randomised controlled trials of cancer treatments. To increase participation in trials, strategies need to be identified to overcome these barriers. Our aim was to assess the effectiveness of interventions to overcome barriers to patient participation in randomised controlled trials (RCTs of cancer treatments. Methods A systematic review was conducted. Published and unpublished studies in any language were searched for in fifteen electronic databases, including MEDLINE, EMBASE, CINAHL and PsycINFO, from inception to the end of 2004. Studies of any interventions to improve cancer patient participation in RCTs, which reported the change in recruitment rates, were eligible for inclusion. RCTs and non-randomised controlled trials as well as before and after studies reporting baseline rates specific to the population being investigated were included. Data were extracted by one reviewer into structured summary tables and checked for accuracy by a second reviewer. Each included study was assessed against a checklist for methodological quality by one reviewer and checked by a second reviewer. A narrative synthesis was conducted. Results Eight studies were identified that met the inclusion criteria: three RCTs, two non-randomised controlled trials and three observational studies. Six of the studies had an intervention that had some relevance to the UK. There was no robust evidence that any of the interventions investigated led to an increase in cancer patient participation in RCTs, though one good quality RCT found that urologists and nurses were equally effective at recruiting participants to a treatment trial for prostate cancer. Although there was no evidence of an effect in any of the studies, the evidence was not of sufficient quality to be able to conclude that these interventions therefore do not work. Conclusion There is not a strong evidence-base for interventions that

  10. A randomized controlled trial to evaluate self-determination theory for exercise adherence and weight control: rationale and intervention description

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    Matos Margarida G

    2008-07-01

    Full Text Available Abstract Background Research on the motivational model proposed by Self-Determination Theory (SDT provides theoretically sound insights into reasons why people adopt and maintain exercise and other health behaviors, and allows for a meaningful analysis of the motivational processes involved in behavioral self-regulation. Although obesity is notoriously difficult to reverse and its recidivism is high, adopting and maintaining a physically active lifestyle is arguably the most effective strategy to counteract it in the long-term. The purposes of this study are twofold: i to describe a 3-year randomized controlled trial (RCT aimed at testing a novel obesity treatment program based on SDT, and ii to present the rationale behind SDT's utility in facilitating and explaining health behavior change, especially physical activity/exercise, during obesity treatment. Methods Study design, recruitment, inclusion criteria, measurements, and a detailed description of the intervention (general format, goals for the participants, intervention curriculum, and main SDT strategies are presented. The intervention consists of a 1-year group behavioral program for overweight and moderately obese women, aged 25 to 50 (and pre-menopausal, recruited from the community at large through media advertisement. Participants in the intervention group meet weekly or bi-weekly with a multidisciplinary intervention team (30 2 h sessions in total, and go through a program covering most topics considered critical for successful weight control. These topics and especially their delivery were adapted to comply with SDT and Motivational Interviewing guidelines. Comparison group receive a general health education curriculum. After the program, all subjects are follow-up for a period of 2 years. Discussion Results from this RCT will contribute to a better understanding of how motivational characteristics, particularly those related to physical activity/exercise behavioral self

  11. Assertive Community Treatment For People With Alcohol Dependence: A Pilot Randomized Controlled Trial

    Science.gov (United States)

    Gilburt, Helen; Burns, Tom; Copello, Alex; Crawford, Michael; Day, Ed; Deluca, Paolo; Godfrey, Christine; Parrott, Steve; Rose, Abigail; Sinclair, Julia; Coulton, Simon

    2017-01-01

    Abstract Aims A pilot randomized controlled trial (RCT) to assess the feasibility and potential efficacy of assertive community treatment (ACT) in adults with alcohol dependence. Methods Single blind, individually randomized, pilot RCT of 12 months of ACT plus treatment as usual (TAU) versus TAU alone in adults (age 18+ years) with alcohol dependence and a history of previous unsuccessful alcohol treatment attending specialist community alcohol treatment services. ACT aimed to actively engage participants for 12 months with assertive, regular, minimum weekly contact. ACT was combined with TAU. TAU comprised access to the full range of services provided by the community teams. Primary outcome is mean drinks per drinking day and percent days abstinent at 12 months follow up. Analysis of covariance was conducted using 80% confidence intervals, appropriate in the context of a pilot trial. Results A total of 94 participants were randomized, 45 in ACT and 49 in TAU. Follow-up was achieved with 98 and 88%, respectively at 12 months. Those in ACT had better treatment engagement, and were more often seen in their homes or local community than TAU participants. At 12 months the ACT group had more problems related to drinking and lower quality of life than TAU but no differences in drinking measures. The ACT group had a higher percentage of days abstinent but lower quality of life at 6 months. The ACT group had less unplanned healthcare use than TAU. Conclusions An trial of ACT was feasible to implement in an alcohol dependent treatment population. Trial registration ISRCTN22775534 PMID:27940571

  12. EMDR for Syrian refugees with posttraumatic stress disorder symptoms: results of a pilot randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Ceren Acarturk

    2015-05-01

    Full Text Available Background: The most common mental health problems among refugees are depression and posttraumatic stress disorder (PTSD. Eye movement desensitization and reprocessing (EMDR is an effective treatment for PTSD. However, no previous randomized controlled trial (RCT has been published on treating PTSD symptoms in a refugee camp population. Objective: Examining the effect of EMDR to reduce the PTSD and depression symptoms compared to a wait-list condition among Syrian refugees. Method: Twenty-nine adult participants with PTSD symptoms were randomly allocated to either EMDR sessions (n=15 or wait-list control (n=14. The main outcome measures were Impact of Event Scale-Revised (IES-R and Beck Depression Inventory (BDI-II at posttreatment and 4-week follow-up. Results: Analysis of covariance showed that the EMDR group had significantly lower trauma scores at posttreatment as compared with the wait-list group (d=1.78, 95% CI: 0.92–2.64. The EMDR group also had a lower depression score after treatment as compared with the wait-list group (d=1.14, 95% CI: 0.35–1.92. Conclusion: The pilot RCT indicated that EMDR may be effective in reducing PTSD and depression symptoms among Syrian refugees located in a camp. Larger RCTs to verify the (cost- effectiveness of EMDR in similar populations are needed.

  13. Recovery of chronically lame dairy cows following treatment for claw horn lesions: a randomised controlled trial.

    Science.gov (United States)

    Thomas, H J; Remnant, J G; Bollard, N J; Burrows, A; Whay, H R; Bell, N J; Mason, C; Huxley, J N

    2016-01-30

    A positively controlled, randomised controlled trial (RCT) was undertaken to test recovery of cows with claw horn lesions resulting in lameness of greater than two weeks duration. Cows on seven commercial farms were mobility scored fortnightly and selected by lameness severity and chronicity. Study cows all received a therapeutic trim then random allocation of: no further treatment (trim only (TRM)), plastic shoe (TS) or plastic shoe and NSAID (TSN). Recovery was assessed by mobility score at 42 (±4) days post treatment by an observer blind to treatment group. Multivariable analysis showed no significant effect of treatment with an almost identical, low response rate to treatment across all groups (Percentage non-lame at outcome: TRM--15 per cent, TS--15 per cent, TSN--16 per cent). When compared with results of a similar RCT on acutely lame cows, where response rates to treatment were substantially higher, it can be concluded that any delay in treatment is likely to reduce the rate of recovery, suggesting early identification and treatment is key. Thirty-eight per cent of animals treated in this study were lame on the contralateral limb at outcome suggesting that both hindlimbs should be examined and a preventive or if necessary a therapeutic foot trim performed when lameness is identified particularly if the duration of lameness is unknown.

  14. Diet and lifestyle interventions in postpartum women in China: study design and rationale of a multicenter randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Fu Juan

    2010-02-01

    Full Text Available Abstract Background "Doing the month", or "sitting month", is a traditional practice for postpartum women in China and other Asian countries, which includes some taboos against well-accepted healthy diet and lifestyles in general population. Previous studies have shown this practice may be associated with higher prevalence of postpartum problems. The current multicenter randomized controlled trial (RCT aims to evaluate outcomes of diet and lifestyle interventions in Chinese postpartum women. Methods/Design The current multicenter RCT will be conducted in three representative areas in China, Shandong province, Hubei province and Guangdong province, which locate in northern, central and southern parts of China, respectively. Women who attend routine pregnancy diagnosis in hospitals or maternal healthcare centers will be invited to take part in this study. At least 800 women who meet our eligibility criteria will be recruited and randomly assigned to the intervention group (n > = 400 and the control group (n > = 400. A three-dimension comprehensive intervention strategy, which incorporates intervention measures simultaneously to individual postpartum woman, their family members and community environment, will be utilized to maximize the effectiveness of intervention. Regular visiting and follow-up will be done in both group; nutrition and health-related measurements will be assessed both before and after the intervention. Discussion To our knowledge, this current study is the first and largest multicenter RCT which focus on the effectiveness of diet and lifestyle intervention on reducing the incidence rate of postpartum diseases and improving health status in postpartum women. We hypothesize that the intervention will reduce the incidence rates of postpartum diseases and improve nutrition and health status due to a balanced diet and reasonable lifestyle in comparison with the control condition. If so, the results of our study will provide

  15. Persistent occiput posterior: OUTcomes following digital rotation: a pilot randomised controlled trial.

    Science.gov (United States)

    Graham, Kathryn; Phipps, Hala; Hyett, Jon A; Ludlow, Joanne P; Mackie, Adam; Marren, Anthony; De Vries, Bradley

    2014-06-01

    To determine the feasibility of a multicentre randomised controlled trial (RCT) to investigate whether digital rotation of the fetal head from occiput posterior (OP) position in the second stage of labour reduces the risk of operative delivery (defined as caesarean section (CS) or instrumental delivery). We conducted the study between December 2010 and December 2011 in a tertiary referral hospital in Australia. A transabdominal ultrasound was performed early in the second stage of labour on women with cephalic, singleton pregnancies to determine the fetal position. Those women with a fetus in the OP position were randomised to either a digital rotation or a sham procedure. In all other ways, participants received their usual intrapartum care. Data regarding demographics, mode of delivery, labour, post natal period and neonatal outcomes were collected. One thousand and four women were consented, 834 achieved full dilatation, and 30 were randomised. An additional portable ultrasound scan and a blinded 'sham' digital rotation were acceptable to women and staff. Operative delivery rates were 13/15 in the digital rotation (four CS and nine instrumental) and 12/15 in the sham (three CS and nine instrumental) groups, respectively. A large double-blinded multicentre RCT would be feasible and acceptable to women and staff. Strategies to improve recruitment such as consenting women with an effective epidural in active labour should be considered. This would be the first RCT to answer a clinically important question which could significantly affect the operative delivery rate in Australia and internationally. © 2014 The Royal Australian and New Zealand College of Obstetricians and Gynaecologists.

  16. Randomized Controlled Trials Evaluating Effect of Television Advertising on Food Intake in Children: Why Such a Sensitive Topic is Lacking Top-Level Evidence?

    Science.gov (United States)

    Gregori, Dario; Ballali, Simonetta; Vecchio, Maria Gabriella; Sciré, Antonella Silvia; Foltran, Francesca; Berchialla, Paola

    2014-01-01

    The aim of this study was to perform a systematic review of evidence coming from randomized controlled trials (RCT) aimed at assessing the effect of television advertising on food intake in children from 4 to 12 years old. Randomized controlled trials were searched in PubMed database and included if they assessed the effect of direct exposure to television food advertising over the actual energy intake of children. Seven studies out of 2166 fulfilled the inclusion criteria. The association between television advertising and energy intake is based on a very limited set of randomized researches lacking a solid ground of first-level evidence.

  17. Randomised controlled trials of veterinary homeopathy: characterising the peer-reviewed research literature for systematic review.

    Science.gov (United States)

    Mathie, Robert T; Hacke, Daniela; Clausen, Jürgen

    2012-10-01

    Systematic review of the research evidence in veterinary homeopathy has never previously been carried out. This paper presents the search methods, together with categorised lists of retrieved records, that enable us to identify the literature that is acceptable for future systematic review of randomised controlled trials (RCTs) in veterinary homeopathy. All randomised and controlled trials of homeopathic intervention (prophylaxis and/or treatment of disease, in any species except man) were appraised according to pre-specified criteria. The following databases were systematically searched from their inception up to and including March 2011: AMED; Carstens-Stiftung Homeopathic Veterinary Clinical Research (HomVetCR) database; CINAHL; Cochrane Central Register of Controlled Trials; Embase; Hom-Inform; LILACS; PubMed; Science Citation Index; Scopus. One hundred and fifty records were retrieved; 38 satisfied the acceptance criteria (substantive report of a clinical treatment or prophylaxis trial in veterinary homeopathic medicine randomised and controlled and published in a peer-reviewed journal), and were thus eligible for future planned systematic review. Approximately half of the rejected records were theses. Seven species and 27 different species-specific medical conditions were represented in the 38 papers. Similar numbers of papers reported trials of treatment and prophylaxis (n=21 and n=17 respectively) and were controlled against placebo or other than placebo (n=18, n=20 respectively). Most research focused on non-individualised homeopathy (n=35 papers) compared with individualised homeopathy (n=3). The results provide a complete and clarified view of the RCT literature in veterinary homeopathy. We will systematically review the 38 substantive peer-reviewed journal articles under the main headings: treatment trials; prophylaxis trials. Copyright © 2012 The Faculty of Homeopathy. Published by Elsevier Ltd. All rights reserved.

  18. Preventing repetition of attempted suicide-III. The Amager Project, 5-year follow-up of a randomized controlled trial

    DEFF Research Database (Denmark)

    Lahoz, Titia; Hvid, Marianne; Wang, August G

    2016-01-01

    BACKGROUND: The Amager Project was initiated as a quasi-experimental study in 2005, based on an active outreach suicide preventive intervention inspired by the Norwegian Baerum Model. A 1-year follow-up study was conducted as a randomized controlled trial showing that this kind of active outreach...... follow-up study. METHOD: One hundred and thirty-three suicide attempters were included at this 5-year follow-up RCT study at Copenhagen University Hospital, Amager, and randomized to a rapid outreach suicide preventive intervention (OPAC) or TAU. RESULTS: Offering OPAC intervention to patients after...

  19. JinQi-Jiangtang tablet, a Chinese patent medicine, for pre-diabetes: a randomized controlled trial

    OpenAIRE

    Hu Jing; Wang Xuemei; Li Xiantao; Wang Baohe; Wang Hui; Song Yuzhen; Zhang Junhua; Shang Hongcai; Guo Liping; Ren Ming; Cao Hongbo; Wang Dehui; Chen Jianzong; Li Shuanglei; Chen Liming

    2010-01-01

    Abstract Background Pre-diabetes is a growing health concern where a large percentage of these patients develop full type 2 diabetes. Effective interventions on pre-diabetes can prevent or delay the occurrence or development of diabetes. Pharmaco-dynamics and pre-clinical of JinQi-Jiangtang tablets (JQJT) suggest that it could be benefit for pre-diabetes. Methods/Design Randomized controlled trial (RCT) is implemented in this study. The study term is 24 months (12 months for intervention and ...

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

    Science.gov (United States)

    Buck, Deborah; McColl, Elaine; Powell, Christine J; Shen, Jing; Sloper, John; Steen, Nick; Taylor, Robert; Tiffin, Peter; Vale, Luke; Clarke, Michael P

    2012-10-16

    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. an external pilot patient randomised controlled trial. four UK secondary ophthalmology care facilities at Newcastle NHS Hospitals Foundation Trust, Sunderland Eye Infirmary, Moorfields Eye Hospital and York NHS Trust. 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). 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. recruitment and retention rates; nature and extent of participation bias; nature and extent of biases arising from crossover or loss to follow-up; reasons for agreeing/declining participation; variability of cure rates

  1. A Yoga Intervention for Posttraumatic Stress: A Preliminary Randomized Control Trial.

    Science.gov (United States)

    Jindani, Farah; Turner, Nigel; Khalsa, Sat Bir S

    2015-01-01

    Yoga may be effective in the reduction of PTSD symptomology. The purpose of this study was to evaluate the impact of a Kundalini Yoga (KY) treatment on PTSD symptoms and overall wellbeing. To supplement the current field of inquiry, a pilot randomized control trial (RCT) was conducted comparing an 8-session KY intervention with a waitlist control group. 80 individuals with current PTSD symptoms participated. Both groups demonstrated changes in PTSD symptomology but yoga participants showed greater changes in measures of sleep, positive affect, perceived stress, anxiety, stress, and resilience. Between-groups effect sizes were small to moderate (0.09-0.25). KY may be an adjunctive or alternative intervention for PTSD. Findings indicate the need for further yoga research to better understand the mechanism of yoga in relation to mental and physical health, gender and ethnic comparisons, and short- and long-term yoga practice for psychiatric conditions.

  2. A Yoga Intervention for Posttraumatic Stress: A Preliminary Randomized Control Trial

    Directory of Open Access Journals (Sweden)

    Farah Jindani

    2015-01-01

    Full Text Available Yoga may be effective in the reduction of PTSD symptomology. The purpose of this study was to evaluate the impact of a Kundalini Yoga (KY treatment on PTSD symptoms and overall wellbeing. To supplement the current field of inquiry, a pilot randomized control trial (RCT was conducted comparing an 8-session KY intervention with a waitlist control group. 80 individuals with current PTSD symptoms participated. Both groups demonstrated changes in PTSD symptomology but yoga participants showed greater changes in measures of sleep, positive affect, perceived stress, anxiety, stress, and resilience. Between-groups effect sizes were small to moderate (0.09–0.25. KY may be an adjunctive or alternative intervention for PTSD. Findings indicate the need for further yoga research to better understand the mechanism of yoga in relation to mental and physical health, gender and ethnic comparisons, and short- and long-term yoga practice for psychiatric conditions.

  3. Internet-based randomised controlled trials for the evaluation of complementary and alternative medicines: probiotics in spondyloarthropathy

    Directory of Open Access Journals (Sweden)

    Gravenor Michael B

    2008-01-01

    Full Text Available Abstract Background The clinical effectiveness of complementary and alternative medicines (CAMs is widely debated because of a lack of clinical trials. The internet may provide an effective and economical approach for undertaking randomised controlled trials (RCTs of low-risk interventions. We investigated whether the internet could be used to perform an internet-based RCT of a CAM fulfilling the revised CONSORT (Consolidated Standards of Reporting Trials statement quality checklist for reporting of RCTs. A secondary aim was to examine the effect of probiotics compared to placebo in terms of well-being over 12 weeks. Methods People aged ≥18 years with confirmed spondyloarthropathy living in the United Kingdom with internet access were invited to participate in an internet-based RCT of probiotic compared to placebo for improving well-being and bowel symptoms. The intervention was a probiotic containing 4 strains of live bacteria or identical placebo taken by mouth daily for 3 months. The primary outcome measure was the performance of the trial according to the revised CONSORT statement. Results 147 people were randomised into the trial. The internet-based trial of the CAM fulfilled the revised CONSORT statement such as efficient blinding, allocation concealment, intention to treat analysis and flow of participants through the trial. Recruitment of the required number of participants was completed in 19 months. Sixty-five percent (96/147 completed the entire 3 months of the trial. The trial was low cost and demonstrated that in an intention to treat analysis, probiotics did not improve well-being or bowel symptoms. Conclusion The internet-based RCT proved to be a successful and economical method for examining this CAM intervention. Recruitment, adherence and completion rate were all similar to those reported with conventional RCTs but at a fraction of the cost. Internet-based RCTs can fulfil all the criteria of the revised CONSORT statement and

  4. Effects of preventive family service coordination for parents with mental illnesses and their children, a RCT.

    Science.gov (United States)

    Wansink, Henny J; Janssens, Jan M A M; Hoencamp, Erik; Middelkoop, Barend J C; Hosman, Clemens M H

    2015-06-01

    Children of parents with a mental illness (COPMI) are at increased risk for developing psychiatric disorders, especially when parenting is compromised by multiple risk factors. Due to fragmented services, these families often do not get the support they need. Can coordination between services, as developed in the Preventive Basic Care Management (PBCM) program, improve parenting and prevent child behavioral problems? This randomized controlled clinical trial (RCT) compared the effectiveness of PBCM with a control condition. Ninety-nine outpatients of a community mental health center were randomized to intervention or control. Primary outcomes included parenting quality (assessed by the HOME instrument), parenting skills (parenting skills subscale of FFQ), and parenting stress (PDH). Secondary outcomes are child behavioral problems (SDQ). Outcomes were assessed at baseline and after 9 and 18 months. Effects were analyzed by Repeated Measures Analysis of Variance. Most families were single-parent families belonging to ethnic minorities. The results of the first RCT on effects of PBCM suggest that this intervention is feasible and has a positive effect on parenting skills. There was no evidence for effects on the quality of parenting and parenting stress, nor preventive effects on child behavioral problems. Replication studies in other sites, with more power, including monitoring of the implementation quality and studying a broader palette of child outcomes are needed to confirm the positive effects of PBCM. Long-term prospective studies are needed to investigate if improved parenting skills lead to positive effects in the children in the long run.

  5. a randomized controlled clinical trial

    OpenAIRE

    2013-01-01

    In this study we aimed to evaluate the effectiveness of Iyengar yoga in chronic neck pain by means of a randomized clinical trial. 77 with chronic neck pain who scored > 40 mm on a 100-mm visual analog scale (VAS) were randomized to a nine week Iyengar yoga program with weekly 90-minute classes or to a self-care/exercise program. The primary outcome measure was change of mean pain at rest (VAS) from baseline to week ten. Secondary outcomes included pain at motion, functional disabilit...

  6. The real world mental health needs of heart failure patients are not reflected by the depression randomized controlled trial evidence.

    Directory of Open Access Journals (Sweden)

    Phillip J Tully

    Full Text Available INTRODUCTION: International depression screening guidelines in heart failure (HF are partly based on depression treatment efficacy from randomized controlled trials (RCTs. Our aim was to test the external validity of depression RCT criteria in a sample of real-world HF patients. METHODS: HF patients admitted to 3 hospitals in South Australia were referred to a HF psychologist if not already receiving current psychiatric management by psychologist or psychiatrist elsewhere. Screening and referral protocol consisted of the following; (a. Patient Health Questionnaire ≥ 10; (b. Generalized Anxiety Disorder Questionnaire ≥ 7; (c. positive response to 1 item panic attack screener; (d. evidence of suicidality. Patients were evaluated against the most common RCT exclusion criteria personality disorder, high suicide risk, cognitive impairment, psychosis, alcohol or substance abuse or dependency, bi-polar depression. RESULTS: Total 81 HF patients were referred from 404 HF admissions, and 73 were assessed (age 60.6 ± 13.4, 47.9% female. Nearly half (47% met at least 1 RCT exclusion criterion, most commonly personality disorder (28.5%, alcohol/substance abuse (17.8% and high suicide risk (11.0%. RCT ineligibility criteria was more frequent among patients with major depression (76.5% vs. 46.2%, p<.01 and dysthymia (26.5% vs. 7.7%, p = .03 but not significantly associated with anxiety disorders. RCT ineligible patients reported greater severity of depression (M = 16.6 ± 5.0 vs. M = 12.9 ± 7.2, p = .02 and were higher consumers of HF psychotherapy services (M = 11.5 ± 4.7 vs. M = 8.5 ± 4.8, p = .01. CONCLUSION: In this real-world sample comparable in size to recent RCT intervention arms, patients with depression disorders presented with complex psychiatric needs including comorbid personality disorders, alcohol/substance use and suicide risk. These findings suggest external validity of depression screening and RCTs could serve as a basis for

  7. Narrow-band Imagery of the ISM using the RCT

    Science.gov (United States)

    Walter, D. K.; Gelderman, R.; Guinan, E.; Howell, S.; Mattox, J. R.; McGruder, C. H., III; Davis, D.; Everett, M.

    2003-05-01

    We present the first results of imaging the Interstellar Medium (ISM) using narrow-band filters with the Robotically Controlled Telescope (RCT). The RCT is the recently refurbished 1.3-meter telescope at the Kitt Peak National Observatory. Details regarding the RCT can be found elsewhere at this meeting (Gelderman, R. et al.). Our filters are centered on diagnostic, nebular emission lines of the ions H+, He+, S+, N+ and O++. Objects of interest in the galactic and extragalactic ISM were observed including the starburst galaxy NGC 4449. Ionization ratio maps include [OIII]/Hβ, [NII]/Hα and the C(Hβ) extinction map from the ratio of Hα/Hβ. Electron densities are derived from the ratio of images taken through filters centered on the sulfur lines at 671.7 and 673.1 nm. Refurbishment of the RCT has been made possible by NASA NAG 58-762. Funding for filters and additional equipment has been made possible by NASA OSS NAG 5-10145 and NASA MU-SPIN NCC 5-534.

  8. Bicycle Trains, Cycling, and Physical Activity: A Pilot Cluster RCT.

    Science.gov (United States)

    Mendoza, Jason A; Haaland, Wren; Jacobs, Maya; Abbey-Lambertz, Mark; Miller, Josh; Salls, Deb; Todd, Winifred; Madding, Rachel; Ellis, Katherine; Kerr, Jacqueline

    2017-10-01

    Increasing children's cycling to school and physical activity are national health goals. The objective was to conduct an RCT of a bicycle train program to assess impact on students' school travel mode and moderate-to-vigorous physical activity (MVPA). Pilot cluster RCT with randomization at the school level and N=54 participants. Fourth-fifth graders from four public schools serving low-income families in Seattle, WA in 2014 with analyses in 2015-2016. All participants were provided and fitted with bicycles, safety equipment (helmets, locks, and lights), and a 2- to 3-hour bicycle safety course. The intervention was a bicycle train offered daily (i.e., students volunteered to cycle with study staff to and from school). Time 1 assessments occurred prior to randomization. Time 2 assessments occurred after 3-5 weeks of the intervention (i.e., during Weeks 4-6 of the intervention period). The primary outcome was the percentage of daily commutes to school by cycling measured by validated survey. MVPA, measured by accelerometry and GPS units and processed by machine learning algorithms, was a secondary outcome. For two separate adjusted repeated measures linear mixed effects models in which students (N=54) were nested within schools (N=4), intervention participants had: (1) an absolute increase in mean percentage of daily commutes by cycling of 44.9%, (95% CI=26.8, 63.0) and (2) an increase in mean MVPA of 21.6 minutes/day, (95% CI=8.7, 34.6) from Time 1 to Time 2 compared with controls. A pilot bicycle train intervention increased cycling to school and daily MVPA in the short term among diverse, inner-city elementary school students. The bicycle train intervention appears promising and warrants further experimental trials among large, diverse samples with longer follow-up. This study is registered at www.clinicaltrials.gov NCT02006186. Copyright © 2017 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

  9. Data withdrawal in randomized controlled trials: Defining the problem and proposing solutions: a commentary.

    Science.gov (United States)

    Ye, Chenglin; Giangregorio, Lora; Holbrook, Anne; Pullenayegum, Eleanor; Goldsmith, Charlie H; Thabane, Lehana

    2011-05-01

    It is not uncommon for a participant to withdraw from a randomized controlled trial (RCT). The withdrawal of a participant results in missing data and the potential for withdrawal bias. Data withdrawal, or a request from a participant to withdraw all of their previously collected data from a study, is particularly problematic because it leaves little opportunity to characterize or statistically address those that have withdrawn to minimize withdrawal bias. The aim of this commentary is to (1) provide a synthesis of available information on the ethical and methodological issues related to data withdrawal in RCTs and (2) provide some suggestions on how to minimize the impact of data withdrawal during the execution or analysis phases of an RCT. We searched PubMed, EMBASE and JSTOR for published articles on data withdrawal. In addition, we used internet sources as an additional tool to identify content on data withdrawal from research ethics guidelines, legislation, research ethics boards, funding agencies, professional organizations and researchers. We did not find any definitive guidelines for dealing with data withdrawal. We propose recommendations for minimizing the occurrence of data withdrawal, including explicit and clear descriptions in consent forms of how data will be handled after participant withdrawal. We also suggest using imputation techniques to deal with the missing data during analysis. The current commentary can be used to minimize the impact of data withdrawal in RCTs. Copyright © 2011 Elsevier Inc. All rights reserved.

  10. Citations for Randomized Controlled Trials in Sepsis Literature: The Halo Effect Caused by Journal Impact Factor.

    Science.gov (United States)

    Zhang, Zhongheng; Poucke, Sven Van

    2017-01-01

    Citations for randomized controlled trials (RCT) are important for the dissemination of study results. However, predictors of citations for RCTs have not been investigated. The study aimed to investigate the predictors of citations for RCTs in sepsis literature. RCTs that investigated the efficacy of treatment strategies on clinical outcomes in sepsis patients were included, and publication dates were restricted to the period from 2000 to 2016. Risk of bias was assessed using the Cochrane handbook for systematic reviews and interventions. A multivariable linear regression model was built to investigate the independent variables associated with total citations. In total, 160 RCTs met our inclusion criteria and were included for analysis. The median of total citations was 28.5 (IQR: 6-76). The journal impact factor (IF) for articles was 6.312 (IQR: 3.143-7.214). The dependent variable was transformed by the square root to improve normality and meet the assumption of homoscedasticity. The journal IF (coefficient: 0.2; 95% CI: 0.16, 0.25) was independently associated with total citations. Large samples were associated with more total citations (coefficient: 0.0026; 95% CI: 0.0013, 0.0039). The study demonstrated that the journal IF was a major determinant of the RCT's total citation number.

  11. The psychophysiological effects of Tai-chi and exercise in residential schizophrenic patients: a 3-arm randomized controlled trial.

    Science.gov (United States)

    Ho, Rainbow Tin Hung; Wan, Adrian Ho Yin; Au-Yeung, Friendly So Wah; Lo, Phyllis Hau Yan; Siu, Pantha Joey Chung Yue; Wong, Cathy Pui Ki; Ng, Winnie Yuen Han; Cheung, Irene Kit Man; Ng, Siu Man; Chan, Cecilia Lai Wan; Chen, Eric Yu Hai

    2014-09-27

    Patients with schizophrenia are characterized by high prevalence rates and chronicity that often leads to long-term institutionalization. Under the traditional medical model, treatment usually emphasizes the management of psychotic symptoms through medication, even though anti-psychotic drugs are associated with severe side effects, which can diminish patients' physical and psychological well-being. Tai-chi, a mind-body exercise rooted in Eastern health philosophy, emphasizes the motor coordination and relaxation. With these potential benefits, a randomized controlled trial (RCT) is planned to investigate the effects of Tai-chi intervention on the cognitive and motor deficits characteristic of patients with schizophrenia. A 3-arm RCT with waitlist control design will be used in this study. One hundred and fifty three participants will be randomized into (i) Tai-chi, (ii) exercise or (iii) waitlist control groups. Participants in both the Tai-chi and exercise groups will receive 12-weeks of specific intervention, in addition to the standard medication and care received by the waitlist control group. The exercise group will serve as a comparison, to delineate any unique benefits of Tai-chi that are independent of moderate aerobic exercise. All three groups will undergo three assessment phases: (i) at baseline, (ii) at 12 weeks (post-intervention), and (iii) at 24 weeks (maintenance). All participants will be assessed in terms of symptom management, motor coordination, memory, daily living function, and stress levels based on self-perceived responses and a physiological marker. Based on a promising pilot study conducted prior to this RCT, subjects in the Tai-chi intervention group are expected to be protected against deterioration of motor coordination and interpersonal functioning. They are also expected to have better symptoms management and lower stress level than the other treatment groups. The trail has been registered in the Clinical Trials Center of the

  12. Razors versus clippers. A randomised controlled trial.

    Science.gov (United States)

    Taylor, Tracy; Tanner, Judith

    2005-12-01

    The purpose of this randomised controlled trial was to determine if patients showed a preference for preoperative hair removal with razors or clippers and to identify if one method was associated with more trauma or postoperative infections. The trial took place in a day surgery unit with patients who were having a range of surgical procedures including hernias and varicose veins. This study was sponsored by an award from the NATN/3M Clinical Fellowship.

  13. Control groups in recent septic shock trials

    DEFF Research Database (Denmark)

    Pettilä, Ville; Hjortrup, Peter Buhl; Jakob, Stephan M

    2016-01-01

    , and mortality outcomes, and calculated a data completeness score to provide an overall view of quality of reporting. RESULTS: A total of 24 RCTs were included (mean n = 287 patients and 71 % of eligible patients were randomized). Of the 24 studies, 14 (58 %) presented baseline data on vasopressors and 58......PURPOSE: The interpretation of septic shock trial data is profoundly affected by patients, control intervention, co-interventions and selected outcome measures. We evaluated the reporting of control groups in recent septic shock trials. METHODS: We searched for original articles presenting...... randomized clinical trials (RCTs) in adult septic shock patients from 2006 to 2016. We included RCTs focusing on septic shock patients with at least two parallel groups and at least 50 patients in the control group. We selected and evaluated data items regarding patients, control group characteristics...

  14. Exercise training and habitual physical activity: a randomized controlled trial.

    Science.gov (United States)

    Swift, Damon L; Johannsen, Neil M; Tudor-Locke, Catrine; Earnest, Conrad P; Johnson, William D; Blair, Steven N; Sénéchal, Martin; Church, Timothy S

    2012-12-01

    Exercise training reduces adiposity and risk of cardiovascular disease. However, the combined effects of habitual free-living physical activity and aerobic training on waist circumference, weight, fitness, and blood pressure in postmenopausal women are unknown. To evaluate the effects of habitual physical activity levels during aerobic training on weight, waist circumference, fitness, and blood pressure. Secondary analysis of an RCT. Original data collected April 2001 to June 2005 and analyzed in 2012. Postmenopausal women in a supervised exercise trial. Women (n=325) were randomized to 4, 8, or 12 kcal/kg per week of aerobic training or a control group for 6 months. All outcome measures were collected at baseline and follow-up. Changes in dependent variables within each training group were evaluated across tertiles of pedometer-determined habitual physical activity outside exercise training sessions. Changes in waist circumference and weight. Reductions in waist circumference were significantly greater with higher steps/day accumulated outside exercise training compared to lower levels in the 4 (high: -4.8 cm vs low: -1.4 cm, p=0.03); 8 (high: -4.2 cm vs low: -0.4 cm, p=0.03), and 12 kcal/kg per week groups (high: -4.1 cm vs low: -0.7 cm, p=0.05). For all groups, p-trend≤0.03. A trend was observed for greater weight reduction with higher steps/day in the 4 kcal/kg per week group (p-trend=0.04) but not for the other exercise doses. No effects were observed for blood pressure or fitness measures (all p>0.05). In postmenopausal women, higher habitual physical activity while participating in aerobic training was associated with greater reductions in central adiposity, and was supportive of weight loss compared to lower levels. Copyright © 2012 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

  15. Placebo-Controlled Trials, Ethics of

    NARCIS (Netherlands)

    van der Graaf, R; Rid, Annette

    2015-01-01

    There are often good scientific and ethical reasons for using placebo controls in clinical trials. At the same time placebo use is controversial, especially when an established effective treatment is being withheld from the control group. This article gives an overview of the key ethical positions

  16. Placebo-Controlled Trials, Ethics of

    NARCIS (Netherlands)

    van der Graaf, R; Rid, Annette

    2015-01-01

    There are often good scientific and ethical reasons for using placebo controls in clinical trials. At the same time placebo use is controversial, especially when an established effective treatment is being withheld from the control group. This article gives an overview of the key ethical positions i

  17. Successful Reach and Adoption of a workplace health promotion RCT targeting a group of high-risk workers

    Directory of Open Access Journals (Sweden)

    Ekner Dorte

    2010-06-01

    Full Text Available Abstract Background Cleaners are rarely introduced to workplace health promotion programs. The study's objective was to evaluate the reach and adoption of a workplace randomized controlled trial (RCT among cleaners in Denmark. Methods Cleaning businesses with at least 30 employees, that could offer a weekly 1-hour intervention during working hours, were invited to participate. Employees working at least 20 hours/week were invited to answer a screening questionnaire and consent to participate. Analyses determined the differences in health variables between responders and non-responders, consenters and non-consenters, participants and non-participants and between participants of the RCT's three groups: physical coordination training, cognitive-behavioural theory-based training and reference group. Results From 16 eligible workplaces, a representative sample of 50% adopted the trial. Of 758 eligible employees, 78% responded to the screening questionnaire and 49% consented to participate. Consenters and participants differed from non-consenters and non-participants by having higher BMI, more chronic diseases and poorer musculoskeletal health. Conclusions This study indicates that workplace health promotion programs directed at health risk factors among cleaners enable significant adoption and reach to a high-risk subgroup of the Danish workforce. Trial registration Trial registration ISRCTN96241850

  18. The Active for Life Year 5 (AFLY5 school based cluster randomised controlled trial: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Campbell Rona

    2011-07-01

    Full Text Available Abstract Background Low levels of physical activity, high levels of sedentary behaviour and low levels of fruit and vegetable consumption are common in children and are associated with adverse health outcomes. The aim of this paper is to describe the protocol for a cluster randomised controlled trial (RCT designed to evaluate a school-based intervention that aims to increase levels of physical activity, decrease sedentary behaviour and increase consumption of fruit and vegetables in school children. Methods/design The Active for Life Year 5 (AFLY5 study is a school-based, cluster RCT that targets school children in Year 5 (age 9-10 years. All state junior/primary schools in the area covered by Bristol City and North Somerset Council are invited to participate; special schools are excluded. Eligible schools are randomised to one of two arms: intervention arm (receive the intervention 2011-2012 and control arm (receive the intervention after the final follow-up assessment, 2013-2014. The primary outcomes of the trial are levels of accelerometer assessed physical activity and sedentary behaviour and questionnaire assessed fruit and vegetable consumption. A number of secondary outcomes will also be measured, including body mass index, waist circumference and overweight/obesity. Outcomes will be assessed at baseline (prior to intervention when the children are in Year 4, at the end of intervention 'immediate follow-up' and '12 months long-term' follow-up. We will use random effects linear and logistic regression models to compare outcomes by randomised arm. The economic evaluation from a societal perspective will take the form of a cost consequence analysis. Data from focus groups and interviews with pupils, parents and teachers will be used to increase understanding of how the intervention has any effect and is integrated into normal school activity. Discussion The results of the trial will provide information about the public health effectiveness

  19. Neck exercises, physical and cognitive behavioural-graded activity as a treatment for adult whiplash patients with chronic neck pain: Design of a randomised controlled trial

    DEFF Research Database (Denmark)

    Ris Hansen, Inge; Christensen, Robin Daniel Kjersgaard; Thomsen, Bente

    2011-01-01

    is to present the design of a randomised controlled trial (RCT) aimed at evaluating the effectiveness of a combined individual physical and cognitive behavioural-graded activity program on self-reported general physical function, in addition to neck function, pain, disability and quality of life in patients......ABSTRACT: BACKGROUND: Many patients suffer from chronic neck pain following a whiplash injury. A combination of cognitive, behavioural therapy with physiotherapy interventions has been indicated to be effective in the management of patients with chronic whiplash-associated disorders. The objective...... with chronic neck pain following whiplash injury compared with a matched control group measured at baseline and 4 and 12 months after baseline. METHODS: The design is a two-centre, RCT-study with a parallel group design. Included are whiplash patients with chronic neck pain for more than 6 months, recruited...

  20. Programming generality into a performance feedback writing intervention: A randomized controlled trial.

    Science.gov (United States)

    Hier, Bridget O; Eckert, Tanya L

    2016-06-01

    Substantial numbers of students in the United States are performing below grade-level expectations in core academic areas, and these deficits are most pronounced in the area of writing. Although performance feedback procedures have been shown to produce promising short-term improvements in elementary-aged students' writing skills, evidence of maintenance and generalization of these intervention effects is limited. The purpose of this study was to examine the immediate, generalized, and sustained effects of incorporating multiple exemplar training into the performance feedback procedures of a writing intervention using a randomized controlled trial (RCT). Results indicated that although the addition of multiple exemplar training did not improve students' writing performance on measures of stimulus and response generalization, it did result in greater maintenance of intervention effects in comparison to students who received performance feedback without generality programming and students who engaged in weekly writing practice alone.

  1. Randomized Controlled Trial: Multimodal Anxiety and Social Skill Intervention for Adolescents with Autism Spectrum Disorder

    Science.gov (United States)

    White, Susan W.; Ollendick, Thomas; Albano, Anne Marie; Oswald, Donald; Johnson, Cynthia; Southam-Gerow, Michael A.; Kim, Inyoung; Scahill, Lawrence

    2012-01-01

    Anxiety is common among adolescents with autism spectrum disorders (ASD) and may amplify the core social disability, thus necessitating combined treatment approaches. This pilot, randomized controlled trial (RCT) evaluated the feasibility and preliminary outcomes of the Multimodal Anxiety and Social Skills Intervention (MASSI) program in a sample of 30 adolescents with ASD and anxiety symptoms of moderate or greater severity. The treatment was acceptable to families, subject adherence was high, and therapist fidelity was high. A 16% improvement in ASD social impairment (within-group effect size = 1.18) was observed on a parent-reported scale. Although anxiety symptoms declined by 26%, the change was not statistically significant. These findings suggest MASSI is a feasible treatment program and further evaluation is warranted. PMID:22735897

  2. Can user testing of a clinical trial patient information sheet make it fit-for-purpose? - a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Silcock Jonathan

    2011-07-01

    Full Text Available Abstract Background The participant information sheet (PIS provided to potential trial participants is a critical part of the process of valid consent. However, there is long-standing concern that these lengthy and complex documents are not fit-for-purpose. This has been supported recently through the application of a performance-based approach to testing and improving readability called user testing. This method is now widely used to improve patient medicine leaflets - determining whether people can find and understand key facts. This study applied for the first time a controlled design to determine whether a PIS developed through user testing had improved readability over the original, using a sheet from a UK trial in acute myeloid leukemia (AML16. Methods In the first phase the performance of the original PIS was tested on people in the target group for the trial. There were three rounds of testing including 50 people in total - with the information revised according to its performance after each of the first 2 rounds. In the second phase, the revised PIS was compared with the original in a parallel groups randomised controlled trial (RCT A total of 123 participants were recruited and randomly allocated to read one version of the PIS to find and show understanding of 21 key facts. Results The first, developmental phase produced a revised PIS significantly altered in its wording and layout. In the second, trial phase 66% of participants who read the revised PIS were able to show understanding of all aspects of the trial, compared with 15% of those reading the original version (Odds Ratio 11.2; Chi-square = 31.5 p p Conclusions The original PIS for the AML16 trial may not have enabled valid consent. Combining performance-based user testing with expertise in writing for patients and information design led to a significantly improved and preferred information sheet. User testing is an efficient method for indicating strengths and weaknesses in

  3. An exploratory evaluation of Take Control: A novel computer-delivered behavioral platform for placebo-controlled pharmacotherapy trials for alcohol use disorder.

    Science.gov (United States)

    Devine, Eric G; Ryan, Megan L; Falk, Daniel E; Fertig, Joanne B; Litten, Raye Z

    2016-09-01

    Placebo-controlled pharmacotherapy trials for alcohol use disorder (AUD) require an active behavioral platform to avoid putting participants at risk for untreated AUD and to better assess the effectiveness of the medication. Therapist-delivered platforms (TDP) can be costly and present a risk to study design because of the variability in therapist fidelity. Take Control is a novel computer-delivered behavioral platform developed for use in pharmacotherapy trials sponsored by the National Institute on Alcohol Abuse and Alcoholism Clinical Investigations Group (NCIG). This behavioral platform was developed with the goal of reducing trial implementation costs and limiting potential bias introduced by therapists providing TDP. This exploratory study is the first to compare Take Control with TDP on measures related to placebo response rate, medication adherence, and participant retention. Data were drawn from the placebo arms of four multisite, double-blind, randomized controlled trials (RCT) for AUD conducted by NCIG from 2007 to 2015. Data were compared from subjects receiving TDP (n=156) in two RCTs and Take Control (n=155) in another two RCTs. Placebo response rate, as represented by weekly percentage of heavy drinking days, was similar between groups. Subjects who received Take Control had a higher rate of medication adherence than those who received TDP. Subject retention was not significantly different between groups. The findings suggest that Take Control is comparable to TDP on measures of retention, medication adherence, and placebo response. Additional research is needed to evaluate Take Control directly against TDPs in a randomized trial.

  4. EXERCISE in pediatric autologous stem cell transplant patients: a randomized controlled trial protocol

    Directory of Open Access Journals (Sweden)

    Chamorro-Viña Carolina

    2012-09-01

    Full Text Available Abstract Background Hematopoietic stem cell transplantation is an intensive therapy used to improve survivorship and cure various oncologic diseases. However, this therapy is associated with high mortality rates and numerous negative side-effects. The recovery of the immune system is a special concern and plays a key role in the success of this treatment. In healthy populations it is known that exercise plays an important role in immune system regulation, but little is known about the role of exercise in the hematological and immunological recovery of children undergoing hematopoietic stem cell transplant. The primary objective of this randomized-controlled trial (RCT is to study the effect of an exercise program (in- and outpatient on immune cell recovery in patients undergoing an autologous stem cell transplantation. The secondary objective is to determine if an exercise intervention diminishes the usual deterioration in quality of life, physical fitness, and the acquisition of a sedentary lifestyle. Methods This RCT has received approval from The Conjoint Health Research Ethics Board (CHREB of the University of Calgary (Ethics ID # E-24476. Twenty-four participants treated for a malignancy with autologous stem cell transplant (5 to 18 years in the Alberta Children’s Hospital will be randomly assigned to an exercise or control group. The exercise group will participate in a two-phase exercise intervention (in- and outpatient from hospitalization until 10 weeks after discharge. The exercise program includes strength, flexibility and aerobic exercise. During the inpatient phase this program will be performed 5 times/week and will be supervised. The outpatient phase will combine a supervised session with two home-based exercise sessions with the use of the Wii device. The control group will follow the standard protocol without any specific exercise program. A range of outcomes, including quantitative and functional recovery of immune system

  5. Paramedic Initiated Lisinopril For Acute Stroke Treatment (PIL-FAST: study protocol for a pilot randomised controlled trial

    Directory of Open Access Journals (Sweden)

    McColl Elaine

    2011-06-01

    Full Text Available Abstract Background High blood pressure during acute stroke is associated with poorer stroke outcome. Previous trials have failed to show benefit from lowering blood pressure but treatment may have been commenced too late to be effective. The earliest that acute stroke treatments could be initiated is during contact with the emergency medical services (paramedics. However, experience of pre-hospital clinical trials is limited and logistical challenges are likely to be greater than for trials performed in other settings. We report the protocol for a pilot randomised controlled trial of paramedic initiated blood pressure lowering treatment for hypertension in acute stroke. Methods Trial Design: Double blind parallel group external pilot randomised controlled trial. Setting: Participant recruitment and initial treatment by North East Ambulance Service research trained paramedics responding to the emergency call. Continued treatment in three study hospitals. Participants: Target is recruitment of 60 adults with acute arm weakness due to suspected stroke (within 3 hours of symptom onset and hypertension (systolic BP>160 mmHg. Intervention: Lisinopril 5-10 mg (intervention group, matched placebo (control group, daily for 7 days. Randomisation: Study medication contained within identical pre-randomised "trial packs" carried by research trained paramedics. Outcomes: Study feasibility (recruitment rate, compliance with data collection and clinical data to inform the design of a definitive randomised controlled trial (blood pressure monitoring, National Institute of Health Stroke Scale, Barthel ADL Index, Modified Rankin Scale, renal function. Discussion This pilot study is assessing the feasibility of a randomised controlled trial of paramedic initiated lisinopril for hypertension early after the onset of acute stroke. The results will inform the design of a definitive RCT to evaluate the effects of very early blood pressure lowering in acute stroke

  6. Individual Cognitive Stimulation Therapy for dementia (iCST: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Orrell Martin

    2012-09-01

    Full Text Available Abstract Background Improving the quality of care for people with dementia and their carers has become a national priority in many countries. Cognitive Stimulation Therapy (CST groups can be beneficial in improving cognition and quality of life for people with dementia. The aim of the current study is to develop and evaluate a home-based individual Cognitive Stimulation Therapy (iCST programme for people with dementia which can be delivered by their family carer. Methods This multi-centre, pragmatic randomised controlled trial (RCT will compare the effectiveness and cost-effectiveness of iCST for people with dementia with a treatment as usual control group. The intervention consists of iCST sessions delivered by a carer for 30 minutes, 3 times a week over 25 weeks. For people with dementia the primary outcome measures are cognition assessed by the ADAS-Cog, and quality of life assessed by QoL-AD. For carers, quality of life using the SF-12 is the primary outcome measure. Using a 5% significance level, comparison of 306 participants will yield 80% power to detect an effect size of 0.35 for cognition as measured by the ADAS-Cog, and quality of life as measured by the QoL-AD. Quality of life for the carer will be measured using the SF-12. The trial will include a cost-effectiveness analysis from a public sector perspective. Discussion The UK Department of Health has recently stressed that improving access to psychological therapies is a national priority, but many people with dementia are unable to access psychological interventions. The development of a home-based individual version of CST will provide an easy to use, widely available therapy package that will be evaluated for effectiveness and cost-effectiveness in a multi centre RCT.

  7. RCT: Module 2.04, Dosimetry, Course 8769

    Energy Technology Data Exchange (ETDEWEB)

    Hillmer, Kurt T. [Los Alamos National Lab. (LANL), Los Alamos, NM (United States)

    2017-08-11

    This course will introduce the types of instruments used to measure external and internal radiation to people. Dosimetry is the quantitative assessment of radiation received by the human body. Several types of dosimeters are used worldwide. This information is valuable to all radiological control personnel because dosimeters are the only direct method to measure and document personnel radiation exposure and ensure regulatory compliance with applicable limits. This course will cover dosimetry terms, Department of Energy (DOE) limits, Los Alamos National Laboratory (LANL) administrative guidelines, thermoluminescent dosimeters (TLDs), LANL dosimetry, and bioassay assessment methods. This course will prepare the student with the skills necessary for radiological control technician (RCT) qualification by passing quizzes, tests, and the RCT Comprehensive Phase 1, Unit 2 Examination (TEST 27566) and providing in-thefield skills.

  8. Sponsorship bias and quality of randomised controlled trials in veterinary medicine.

    Science.gov (United States)

    Wareham, K J; Hyde, R M; Grindlay, D; Brennan, M L; Dean, R S

    2017-08-14

    Randomised controlled trials (RCTs) are considered the gold standard form of evidence for assessing treatment efficacy, but many factors can influence their reliability including methodological quality, reporting quality and funding source. The aim of this study was to examine the relationship between funding source and positive outcome reporting in veterinary RCTs published in 2011 and to assess the risk of bias in the RCTs identified. A structured search of PubMed was used to identify feline, canine, equine, bovine and ovine clinical trials examining the efficacy of pharmaceutical interventions published in 2011. Funding source and outcomes were extracted from each RCT and an assessment of risk of bias made using the Cochrane risk of bias tool. Literature searches returned 972 papers, with 86 papers (comprising 126 individual RCTs) included in the analysis. There was found to be a significantly higher proportion of positive outcomes reported in the pharmaceutical funding group (P) compared to the non-pharmaceutical (NP) and 'no funding source stated' (NF) groups (P = 56.9%, NP = 34.9%, NF = 29.1%, p < 0.05). A high proportion of trials had an unclear risk of bias across the five criteria examined. We found evidence that veterinary RCTs were more likely to report positive outcomes if they have pharmaceutical industry funding or involvement. Consistently poor reporting of trials, including non-identification of funding source, was found which hinders the use of the available evidence.

  9. Ketamine as the anaesthetic for electroconvulsive therapy: the KANECT randomised controlled trial

    Science.gov (United States)

    Fernie, Gordon; Currie, James; Perrin, Jennifer S.; Stewart, Caroline A.; Anderson, Virginica; Bennett, Daniel M.; Hay, Steven; Reid, Ian C.

    2017-01-01

    Background Ketamine has recently become an agent of interest as an acute treatment for severe depression and as the anaesthetic for electroconvulsive therapy (ECT). Subanaesthetic doses result in an acute reduction in depression severity while evidence is equivocal for this antidepressant effect with anaesthetic or adjuvant doses. Recent systematic reviews call for high-quality evidence from further randomised controlled trials (RCTs). Aims To establish if ketamine as the anaesthetic for ECT results in fewer ECT treatments, improvements in depression severity ratings and less memory impairment than the standard anaesthetic. Method Double-blind, parallel-design, RCT of intravenous ketamine (up to 2 mg/kg) with an active comparator, intravenous propofol (up to 2.5 mg/kg), as the anaesthetic for ECT in patients receiving ECT for major depression on an informal basis. (Trial registration: European Clinical Trials Database (EudraCT): 2011-000396-14 and clinicalTrials.gov: NCT01306760.) Results No significant differences were found on any outcome measure during, at the end of or 1 month following the ECT course. Conclusions Ketamine as an anaesthetic does not enhance the efficacy of ECT. PMID:28254962

  10. Impact of spin in the abstracts of articles reporting results of randomized controlled trials in the field of cancer: the SPIIN randomized controlled trial.

    Science.gov (United States)

    Boutron, Isabelle; Altman, Douglas G; Hopewell, Sally; Vera-Badillo, Francisco; Tannock, Ian; Ravaud, Philippe

    2014-12-20

    We aimed to assess the impact of spin (ie, reporting to convince readers that the beneficial effect of the experimental treatment is greater than shown by the results) on the interpretation of results of abstracts of randomized controlled trials (RCTs) in the field of cancer. We performed a two-arm, parallel-group RCT. We selected a sample of published RCTs with statistically nonsignificant primary outcome and with spin in the abstract conclusion. Two versions of these abstracts were used-the original with spin and a rewritten version without spin. Participants were clinician corresponding authors of articles reporting RCTs, investigators of trials, and reviewers of French national grants. The primary outcome was clinicians' interpretation of the beneficial effect of the experimental treatment (0 to 10 scale). Participants were blinded to study hypothesis. Three hundred clinicians were randomly assigned using a Web-based system; 150 clinicians assessed an abstract with spin and 150 assessed an abstract without spin. For abstracts with spin, the experimental treatment was rated as being more beneficial (mean difference, 0.71; 95% CI, 0.07 to 1.35; P = .030), the trial was rated as being less rigorous (mean difference, -0.59; 95% CI, -1.13 to 0.05; P = .034), and clinicians were more interested in reading the full-text article (mean difference, 0.77; 95% CI, 0.08 to 1.47; P = .029). There was no statistically significant difference in the clinicians' rating of the importance of the study or the need to run another trial. Spin in abstracts can have an impact on clinicians' interpretation of the trial results. © 2014 by American Society of Clinical Oncology.

  11. The Utilization of the RCT Telescope for Studies of Blazar Continuum Emission during the GLAST Gamma-Ray Mission

    Science.gov (United States)

    Mattox, J. R.; Cominsky, L.; Spear, G.; Carinni, M.; Gelderman, R.; McGruder, C. H.; Guinan, E.; Howell, S.; Davis, D. R.; Everett, M.; Walter, D. K.

    2003-05-01

    The RCT Consortium successfully proposed to refurbish and automate the Kitt Peak 1.3-m telescope, and to operate it as the Robotically Controlled Telescope (RCT). Refurbishment is nearing completion, and observations have begun. The capabilities of the RCT for broad-band optical photometry will be described. A program for systematic optical monitoring of blazars with the RCT is planned. We anticipate that an important utilization of the RCT will be in conjunction with multi-wavelength studies of blazar continuum emission during the operation of NASA's Gamma-ray Large Area Space Telescope (GLAST) satellite, now scheduled for launch in 2006. Refurbishment of the RCT has been made possible by NASA grant NAG58762.

  12. A recovery program to improve quality of life, sense of coherence and psychological health in ICU survivors: a multicenter randomized controlled trial, the RAPIT study

    DEFF Research Database (Denmark)

    Jensen, Janet F.; Egerod, Ingrid; Bestle, Morten H.

    2016-01-01

    Purpose: The aim of this randomized controlled trial (RCT) was to test the effectiveness of a post-ICU recovery program compared to standard care during the first year after ICU discharge. Methods: A pragmatic, non-blinded, multicenter, parallel-group RCT was conducted between December 2012...... and December 2015, at ten intensive care units (ICUs) in Denmark. We randomly assigned 386 adult patients (≥18 years) after receiving mechanical ventilation (≥48 h) to standard care (SC) plus a nurse-led intensive care recovery program or standard care alone after ICU discharge (190 intervention, 196 SC......). Primary outcome was health-related quality of life (HRQOL) at 12 months. Secondary outcomes were sense of coherence (SOC), anxiety, depression, and posttraumatic stress disorder (PTSD) assessed at 3 and 12 months after ICU discharge including utilization of healthcare services at 12 months. Results: At 12...

  13. A recovery program to improve quality of life, sense of coherence and psychological health in ICU survivors: a multicenter randomized controlled trial, the RAPIT study

    DEFF Research Database (Denmark)

    Jensen, Janet F.; Egerod, Ingrid; Bestle, Morten H.

    2016-01-01

    Purpose: The aim of this randomized controlled trial (RCT) was to test the effectiveness of a post-ICU recovery program compared to standard care during the first year after ICU discharge. Methods: A pragmatic, non-blinded, multicenter, parallel-group RCT was conducted between December 2012...... and December 2015, at ten intensive care units (ICUs) in Denmark. We randomly assigned 386 adult patients (≥18 years) after receiving mechanical ventilation (≥48 h) to standard care (SC) plus a nurse-led intensive care recovery program or standard care alone after ICU discharge (190 intervention, 196 SC......). Primary outcome was health-related quality of life (HRQOL) at 12 months. Secondary outcomes were sense of coherence (SOC), anxiety, depression, and posttraumatic stress disorder (PTSD) assessed at 3 and 12 months after ICU discharge including utilization of healthcare services at 12 months. Results: At 12...

  14. 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

  15. Immediate vs. delayed insertion of intrauterine contraception after second trimester abortion: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Soon Judith A

    2011-06-01

    Full Text Available Abstract Background We describe the rationale and protocol for a randomized controlled trial (RCT to assess whether intrauterine contraception placed immediately after a second trimester abortion will result in fewer pregnancies than current recommended practice of intended placement at 4 weeks post-abortion. Decision analysis suggests the novel strategy could substantially reduce subsequent unintended pregnancies and abortions. This paper highlights considerations of design, implementation and evaluation of a trial expected to provide rigorous evidence for appropriate insertion timing and health economics of intrauterine contraception after second trimester abortion. Methods/Design Consenting women choosing to use intrauterine contraception after abortion for a pregnancy of 12 to 24 weeks will be randomized to insertion timing groups either immediately (experimental intervention or four weeks (recommended care post abortion. Primary outcome measure is pregnancy rate at one year. Secondary outcomes include: cumulative pregnancy rates over five year follow-up period, comprehensive health economic analyses comparing immediate and delayed insertion groups, and device retention rates, complication rates (infection, expulsion and, contraceptive method satisfaction. Web-based Contraception Satisfaction Questionnaires, clinical records and British Columbia linked health databases will be used to assess primary and secondary outcomes. Enrolment at all clinics in the province performing second trimester abortions began in May 2010 and is expected to complete in late 2011. Data on one year outcomes will be available for analysis in 2014. Discussion The RCT design combined with access to clinical records at all provincial abortion clinics, and to information in provincial single-payer linked administrative health databases, birth registry and hospital records, offers a unique opportunity to evaluate such an approach by determining pregnancy rate at one

  16. The Breathe Easier through Weight Loss Lifestyle (BE WELL Intervention: A randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Buist A

    2010-03-01

    Full Text Available Abstract Background Obesity and asthma have reached epidemic proportions in the US. Their concurrent rise over the last 30 years suggests that they may be connected. Numerous observational studies support a temporally-correct, dose-response relationship between body mass index (BMI and incident asthma. Weight loss, either induced by surgery or caloric restriction, has been reported to improve asthma symptoms and lung function. Due to methodological shortcomings of previous studies, however, well-controlled trials are needed to investigate the efficacy of weight loss strategies to improve asthma control in obese individuals. Methods/Design BE WELL is a 2-arm parallel randomized clinical trial (RCT of the efficacy of an evidence-based, comprehensive, behavioral weight loss intervention, focusing on diet, physical activity, and behavioral therapy, as adjunct therapy to usual care in the management of asthma in obese adults. Trial participants (n = 324 are patients aged 18 to 70 years who have suboptimally controlled, persistent asthma, BMI between 30.0 and 44.9 kg/m2, and who do not have serious comorbidities (e.g., diabetes, heart disease, stroke. The 12-month weight loss intervention to be studied is based on the principles of the highly successful Diabetes Prevention Program lifestyle intervention. Intervention participants will attend 13 weekly group sessions over a four-month period, followed by two monthly individual sessions, and will then receive individualized counseling primarily by phone, at least bi-monthly, for the remainder of the intervention. Follow-up assessment will occur at six and 12 months. The primary outcome variable is the overall score on the Juniper Asthma Control Questionnaire measured at 12 months. Secondary outcomes include lung function, asthma-specific and general quality of life, asthma medication use, asthma-related and total health care utilization. Potential mediators (e.g., weight loss and change in physical

  17. Challenges of a community based pragmatic, randomised controlled trial of weight loss maintenance.

    Science.gov (United States)

    Randell, Elizabeth; McNamara, Rachel; Shaw, Christine; Espinasse, Aude; Simpson, Sharon Anne

    2015-12-18

    Randomised controlled trials (RCTs) have a reputation for being inherently difficult to deliver as planned and often face unforeseen challenges and delays, particularly in relation to organisational and governance difficulties, participant interest, constraints due to allocation of costs, local investigator interest and lengthy bureaucracy. Recruitment is often difficult and the challenges faced often impact on the cost and delivery of a successful trial within the funded period. This paper reflects upon the challenges faced in delivering a pragmatic RCT of weight loss maintenance in a community setting and suggests some potential solutions. The weight loss maintenance in adults trial aimed to evaluate the impact of a 12 month, individually tailored weight maintenance intervention on BMI 3 years from randomisation. Participants were recruited primarily from participant identification centres (PICs)-GP surgeries, exercise on referral schemes and slimming world. The intervention was delivered in community settings. A recruitment strategy implementation plan was drafted to address and monitor poor recruitment. Delays in opening and recruitment were experienced early on. Some were beyond the control of the study team such as; disagreement over allocation of national health service costs and PIC classification as well as difficulties in securing support from research networks. That the intervention was delivered in community settings was often at the root of these issues. Key items to address at the design stage of future trials include feasibility of eligibility criteria. The most effective element of the recruitment implementation plan was to refocus sources of recruitment and target only those who could fulfil the eligibility criteria immediately. Learnings from this trial should be kept in mind by those designing similar studies in the future. Considering potential governance, cost and research network support implications at the design stage of pragmatic trials of

  18. The Randomised Controlled Trial in Medical Research: Using Bibliometric Methods to Identify Core Journals. A review of: Tsay, Migh-yueh, and Yen-hsu Yang. “Bibliometric Analysis of the Literature of Randomized Controlled Trials.” Journal of the Medical Library Association 93.4 (October 2005: 450-58.

    Directory of Open Access Journals (Sweden)

    John Loy

    2006-03-01

    Full Text Available Objective – To explore the characteristics and distribution of randomized controlled trials (RCTs in the medical literature. The study aims to identify the growth patterns of the RCT, key subject matter, country and language of publication, and determine a list of core journals which contain a substantial proportion of the RCT literature. Design – Retrospective analysis of RCTs. Setting – Medical journal literature. Subjects – A total of 160,213 articles published between 1965‐2001. Detailed analysis of a subset numbering 114,850 articles published from 1990‐2001. Methods – The study seeks to identify all RCTs in MEDLINE from 1965‐2001, and examines the growth rate of the RCT. The authors then do a more detailed analysis on a subset of data from 1990‐2001, using Access database and Excel spreadsheet software, and PERL programming language. The references were analyzed by five fields within MEDLINE; publication type, source, language, country of publication, and descriptor (subject index. Main results – An exponential growth rate for the RCT is demonstrated, suggesting that in the medical literature development has not yet matured and that research using this method continues to grow. A growth rate for the RCT of 11.2% per annum is identified. The most common form of publication is the journal article, making up approximately 98% of the RCT literature. Approximately 75% of the RCTs are multicentre trials indicating that this is the design of choice adopted by researchers. The United States proves to be the greatest source of RCT literature, with 39.9% of journals and 50.6% of articles originating there. After the USA, the most productive countries are England (15.8% of journals and 21.7% articles and Germany (6.5% journals and 6.1% articles. As might be expected, English is the predominant language providing 92.9% of the total publications. Of the remaining 7%, German is the most common language accounting for 2.2%. The top

  19. A RCT Comparing Daily Mindfulness Meditations, Biofeedback Exercises, and Daily Physical Exercise on Attention Control, Executive Functioning, Mindful Awareness, Self-Compassion, and Worrying in Stressed Young Adults.

    Science.gov (United States)

    de Bruin, Esther I; van der Zwan, J Esi; Bögels, Susan M

    2016-01-01

    Our Western society is characterized by multitasking, competition, and constant time pressure. Negative effects of stress for the individual (anxiety, depression, somatic complaints) and for organizations and society (costs due to work absence) are very high. Thus, time-efficient self-help interventions to address these issues are necessary. This study assessed the effects of daily mindfulness meditations (MM) versus daily heart rate variability biofeedback (HRV-BF) and daily physical exercise (PE) on attention control, executive functioning, mindful awareness, self-compassion, and worrying. Young adults (n = 75, age range 18 to 40) with elevated stress levels were randomized to MM, HRV-BF, or PE, and measurements were taken at pre-test, post-test, and follow-up. Interventions in all three groups were self-guided and lasted for 5 weeks. Generalized estimating equation analyses showed that overall, all three interventions were effective and did not differ from each other. However, practice time differed between groups, with participants in the PE group practicing much more than participants in the other two groups. Therefore, additional analyses were carried out in two subsamples. The optimal dose sample included only those participants who practiced for at least 70 % of the total prescribed time. In the equal dose sample, home practice intensity was equal for all three groups. Again, the effects of the three interventions did not differ. In conclusion, MM, HRV-BF, and PE are all effective self-help methods to improve attention control, executive functioning, mindful awareness, self-compassion, and worrying, and mindfulness meditation was not found to be more effective than HRV-biofeedback or physical exercise for these cognitive processes.

  20. Group hypnotherapy versus group relaxation for smoking cessation: an RCT study protocol

    Directory of Open Access Journals (Sweden)

    Dickson-Spillmann Maria

    2012-04-01

    Full Text Available Abstract Background A significant number of smokers would like to stop smoking. Despite the demonstrated efficacy of pharmacological smoking cessation treatments, many smokers are unwilling to use them; however, they are inclined to try alternative methods. Hypnosis has a long-standing reputation in smoking cessation therapy, but its efficacy has not been scientifically proven. We designed this randomised controlled trial to evaluate the effects of group hypnosis as a method for smoking cessation, and we will compare the results of group hypnosis with group relaxation. Methods/Design This is a randomised controlled trial (RCT to compare the efficacy of a single session of hypnosis with that of relaxation performed in groups of 8-15 smokers. We intend to include at least 220 participants in our trial. The inclusion criteria include smoking at least 5 cigarettes per day, not using other cessation methods and being willing to quit smoking. The intervention is performed by a trained hypnotist/relaxation therapist. Both groups first receive 40 min of mental preparation that is based on motivational interviewing. Then, a state of deep relaxation is induced in the hypnosis condition, and superficial relaxation is induced in the control condition. Suggestions are made in the hypnosis condition that aim to switch the mental self-image of the participants from that of smokers to that of non-smokers. Each intervention lasts for 40 min. The participants also complete questionnaires that assess their smoking status and symptoms of depression and anxiety at baseline, 2 weeks and 6 months post-intervention. In addition, saliva samples are collected to assess cotinine levels at baseline and at 6 months post-intervention. We also assess nicotine withdrawal symptoms at 2 weeks post-intervention. Discussion To the best of our knowledge, this RCT is the first to test the efficacy of group hypnosis versus group relaxation. Issues requiring discussion in the outcome

  1. The mPED randomized controlled clinical trial: applying mobile persuasive technologies to increase physical activity in sedentary women protocol

    Directory of Open Access Journals (Sweden)

    Fukuoka Yoshimi

    2011-12-01

    Full Text Available Abstract Background Despite the significant health benefits of regular physical activity, approximately half of American adults, particularly women and minorities, do not meet the current physical activity recommendations. Mobile phone technologies are readily available, easily accessible and may provide a potentially powerful tool for delivering physical activity interventions. However, we need to understand how to effectively apply these mobile technologies to increase and maintain physical activity in physically inactive women. The purpose of this paper is to describe the study design and protocol of the mPED (mobile phone based physical activity education randomized controlled clinical trial that examines the efficacy of a 3-month mobile phone and pedometer based physical activity intervention and compares two different 6-month maintenance interventions. Methods A randomized controlled trial (RCT with three arms; 1 PLUS (3-month mobile phone and pedometer based physical activity intervention and 6-month mobile phone diary maintenance intervention, 2 REGULAR (3-month mobile phone and pedometer based physical activity intervention and 6-month pedometer maintenance intervention, and 3 CONTROL (pedometer only, but no intervention will be conducted. A total of 192 physically inactive women who meet all inclusion criteria and successfully complete a 3-week run-in will be randomized into one of the three groups. The mobile phone serves as a means of delivering the physical activity intervention, setting individualized weekly physical activity goals, and providing self-monitoring (activity diary, immediate feedback and social support. The mobile phone also functions as a tool for communication and real-time data capture. The primary outcome is objectively measured physical activity. Discussion If efficacy of the intervention with a mobile phone is demonstrated, the results of this RCT will be able to provide new insights for current behavioral

  2. Study protocol: Münster tinnitus randomized controlled clinical trial-2013 based on tailor-made notched music training (TMNMT).

    Science.gov (United States)

    Pantev, Christo; Rudack, Claudia; Stein, Alwina; Wunderlich, Robert; Engell, Alva; Lau, Pia; Wollbrink, Andreas; Shaykevich, Alex

    2014-03-02

    Tinnitus is a result of hyper-activity/hyper-synchrony of auditory neurons coding the tinnitus frequency, which has developed to synchronous mass activity owing the lack of inhibition. We assume that removal of exactly these frequency components from an auditory stimulus will cause the brain to reorganize around tonotopic regions coding the tinnitus frequency. Based on this assumption a novel treatment for tonal tinnitus - tailor-made notched music training (TMNMT) (Proc Natl Acad Sci USA 107:1207-1210, 2010; Ann N Y Acad Sci 1252:253-258, 2012; Frontiers Syst Neurosci 6:50, 2012) has been introduced and will be tested in this clinical trial on a large number of tinnitus patients. A randomized controlled trial (RCT) in parallel group design will be performed in a double-blinded manner. The choice of the intervention we are going to apply is based on two "proof of concept" studies in humans (Proc Natl Acad Sci USA 107:1207-1210, 2010; Ann N Y Acad Sci 1252:253-258, 2012; Frontiers Syst Neurosci 6:50, 2012; PloS One 6(9):e24685, 2011) and on a recent animal study (Front Syst Neurosci 7:21, 2013).The RCT includes 100 participants with chronic, tonal tinnitus who listened to tailor-made notched music (TMNM) for two hours a day for three months. The effect of TMNMT is assessed by the tinnitus handicap questionnaire and visual analogue scales (VAS) measuring perceived tinnitus loudness, distress and handicap. This is the first randomized controlled trial applying TMNMT on a larger number of patients with tonal tinnitus. Our data will verify more securely and reliably the effectiveness of this kind of completely non-invasive and low-cost treatment approach on tonal tinnitus. Current Controlled Trials ISRCTN04840953.

  3. The OPTIMIST study: optimisation of cost effectiveness through individualised FSH stimulation dosages for IVF treatment. A randomised controlled trial

    Directory of Open Access Journals (Sweden)

    van Tilborg Theodora C

    2012-09-01

    Full Text Available Abstract Background Costs of in vitro fertilisation (IVF are high, which is partly due to the use of follicle stimulating hormone (FSH. FSH is usually administered in a standard dose. However, due to differences in ovarian reserve between women, ovarian response also differs with potential negative consequences on pregnancy rates. A Markov decision-analytic model showed that FSH dose individualisation according to ovarian reserve is likely to be cost-effective in women who are eligible for IVF. However, this has never been confirmed in a large randomised controlled trial (RCT. The aim of the present study is to assess whether an individualised FSH dose regime based on an ovarian reserve test (ORT is more cost-effective than a standard dose regime. Methods/Design Multicentre RCT in subfertile women indicated for a first IVF or intracytoplasmic sperm injection cycle, who are aged  Discussion The results of this study will be integrated into a decision model that compares cost-effectiveness of the three dose-adjustment strategies to a standard dose strategy. The study outcomes will provide scientific foundation for national and international guidelines. Trial registration NTR2657

  4. The effectiveness of self-help mindfulness-based cognitive therapy in a student sample: a randomised controlled trial.

    Science.gov (United States)

    Lever Taylor, Billie; Strauss, Clara; Cavanagh, Kate; Jones, Fergal

    2014-12-01

    Mindfulness-based cognitive therapy (MBCT) involves approximately twenty hours of therapist contact time and is not universally available. MBCT self-help (MBCT-SH) may widen access but little is known about its effectiveness. This paper presents a randomised controlled trial (RCT) of MBCT-SH for students. Eighty students were randomly assigned to an eight-week MBCT-SH condition or a wait-list control. ANOVAs showed significant group by time interactions in favour of MBCT-SH on measures of depression, anxiety, stress, satisfaction with life, mindfulness and self-compassion. Post-intervention between-group effect sizes ranged from Cohen's d = 0.22 to 1.07. Engagement with MBCT-SH was high: participants engaged in mindfulness practice a median of two to three times a week and 85% read at least half the intervention book. Only 5% of participants dropped out. This is the first published RCT of MBCT-SH and benefits were found relative to a control group. MBCT-SH has the potential to be a low-cost, readily available and highly acceptable intervention. Future research should include an active control condition and explore whether findings extend to clinical populations.

  5. Efficacy of composite versus ceramic inlays and onlays: study protocol for the CECOIA randomized controlled trial.

    Science.gov (United States)

    Fron Chabouis, Hélène; Prot, Caroline; Fonteneau, Cyrille; Nasr, Karim; Chabreron, Olivier; Cazier, Stéphane; Moussally, Christian; Gaucher, Alexandre; Khabthani Ben Jaballah, Inès; Boyer, Renaud; Leforestier, Jean-François; Caumont-Prim, Aurore; Chemla, Florence; Maman, Louis; Nabet, Cathy; Attal, Jean-Pierre

    2013-09-03

    Dental caries is a common disease and affects many adults worldwide. Inlay or onlay restoration is widely used to treat the resulting tooth substance loss. Two esthetic materials can be used to manufacture an inlay/onlay restoration of the tooth: ceramic or composite. Here, we present the protocol of a multicenter randomized controlled trial (RCT) comparing the clinical efficacy of both materials for tooth restoration. Other objectives are analysis of overall quality, wear, restoration survival and prognosis. The CEramic and COmposite Inlays Assessment (CECOIA) trial is an open-label, parallel-group, multicenter RCT involving two hospitals and five private practices. In all, 400 patients will be included. Inclusion criteria are adults who need an inlay/onlay restoration for one tooth (that can be isolated with use of a dental dam and has at least one intact cusp), can tolerate restorative procedures and do not have severe bruxism, periodontal or carious disease or poor oral hygiene. The decayed tissue will be evicted, the cavity will be prepared for receiving an inlay/onlay and the patient will be randomized by use of a centralized web-based interface to receive: 1) a ceramic or 2) composite inlay or onlay. Treatment allocation will be balanced (1:1). The inlay/onlay will be adhesively luted. Follow-up will be for 2 years and may be extended; two independent examiners will perform the evaluations. The primary outcome measure will be the score obtained with use of the consensus instrument of the Fédération Dentaire Internationale (FDI) World Dental Federation. Secondary outcomes include this instrument's items, inlay/onlay wear, overall quality and survival of the inlay/onlay. Data will be analyzed by a statistician blinded to treatments and an adjusted ordinal logistic regression model will be used to compare the efficacy of both materials. For clinicians, the CECOIA trial results may help with evidence-based recommendations concerning the choice of materials for

  6. A simple heuristic for Internet-based evidence search in primary care: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Eberbach A

    2016-08-01

    Full Text Available Andreas Eberbach,1 Annette Becker,1 Justine Rochon,2 Holger Finkemeler,1Achim Wagner,3 Norbert Donner-Banzhoff1 1Department of Family and Community Medicine, Philipp University of Marburg, Marburg, Germany; 2Institute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany; 3Department of Sport Medicine, Justus-Liebig-University of Giessen, Giessen, Germany Background: General practitioners (GPs are confronted with a wide variety of clinical questions, many of which remain unanswered. Methods: In order to assist GPs in finding quick, evidence-based answers, we developed a learning program (LP with a short interactive workshop based on a simple ­three-step-heuristic to improve their search and appraisal competence (SAC. We evaluated the LP ­effectiveness with a randomized controlled trial (RCT. Participants (intervention group [IG] n=20; ­control group [CG] n=31 rated acceptance and satisfaction and also answered 39 ­knowledge ­questions to assess their SAC. We controlled for previous knowledge in content areas covered by the test. Results: Main outcome – SAC: within both groups, the pre–post test shows significant (P=0.00 improvements in correctness (IG 15% vs CG 11% and confidence (32% vs 26% to find evidence-based answers. However, the SAC difference was not significant in the RCT. Other measures: Most workshop participants rated “learning atmosphere” (90%, “skills acquired” (90%, and “relevancy to my practice” (86% as good or very good. The ­LP-recommendations were implemented by 67% of the IG, whereas 15% of the CG already conformed to LP recommendations spontaneously (odds ratio 9.6, P=0.00. After literature search, the IG showed a (not significantly higher satisfaction regarding “time spent” (IG 80% vs CG 65%, “quality of information” (65% vs 54%, and “amount of information” (53% vs 47%.Conclusion: Long-standing established GPs have a good SAC. Despite high acceptance, strong

  7. LIVER TRANSPLANTATION IN A RANDOMIZED CONTROLLED TRIAL OF EMERGENCY TREATMENT OF ACUTELY BLEEDING ESOPHAGEAL VARICES IN CIRRHOSIS

    Science.gov (United States)

    Orloff, Marshall J.; Isenberg, Jon I.; Wheeler, Henry O.; Haynes, Kevin S.; Jinich-Brook, Horacio; Rapier, Roderick; Vaida, Florin; Hye, Robert J.; Orloff, Susan L.

    2010-01-01

    Background Bleeding esophageal varices (BEV) in cirrhosis has been considered an indication for liver transplantation (LT). This issue was examined in a randomized controlled trial (RCT) of unselected, consecutive patients with advanced cirrhosis and BEV that compared endoscopic sclerotherapy (EST) (n=106) to emergency direct portacaval shunt (EPCS) (n=105). Methods Diagnostic workup and treatment were initiated within 8 hours. Patients were evaluated for LT on admission and repeatedly thereafter. 96% underwent over 10 years of regular follow-up. The analysis was supplemented by 1300 unrandomized cirrhotic patients who previously underwent portacaval shunt (PCS) with 100% follow-up. Results In the RCT, long-term bleeding control was 100% following EPCS, only 20% following EST. 3, 5, 10, and 15-year survival rates were 75%, 73%, 46%, and 46% following EPCS, compared to 44%, 21%, 9%, and 9% following EST (p<0.001). Only 13 RCT patients (6%) were ultimately referred for LT mainly because of progressive liver failure; only 7 (3%) were approved for LT and only 4 (2%) underwent LT. 1- and 5-year LT survival rates were 0.68% and 0, compared to 81% and 73% after EPCS. In the 1300 unrandomized PCS patients. 50 (3.8%) were referred and 19 (1.5%) underwent LT. Five-year survival rate was 53% compared to 72% for all 1300 patients. Conclusions If bleeding is permanently controlled, as occurred invariably following EPCS, cirrhotic patients with BEV seldom require LT. PCS is effective first-line and long-term treatment. Should LT be required in patients with PCS, although technically more demanding, numerous studies have shown that PCS does not increase mortality or complications. EST is not effective emergency or long-term therapy. PMID:21168637

  8. Reporting quality of randomized controlled trial abstracts published in leading laser medicine journals: an assessment using the CONSORT for abstracts guidelines.

    Science.gov (United States)

    Jin, Lu; Hua, Fang; Cao, Qiang

    2016-11-01

    The objectives of this study were to assess the reporting quality of randomized controlled trial (RCT) abstracts published in leading laser medicine journals and investigate the association between potential predictors and reporting quality. The official online archives of four leading laser medicine journals were hand-searched to identify RCTs published in 2014 and 2015. A reporting quality assessment was carried out using the original 16-item CONsolidated Standards Of Reporting Trials (CONSORT) for Abstracts checklist. For each abstract, an overall CONSORT score (OCS) was calculated (score range, 0 to 16). Univariable and multivariable linear regression analyses were performed to identify significant predictors of reporting quality. Chi-square (or Fisher's exact) tests were used to analyze the adequate reporting rate of each quality item by specialty area. A total of 129 RCT abstracts were included and assessed. The mean OCS was 4.5 (standard deviation, 1.3). Only three quality items (interventions, objective, conclusions) were reported adequately in most abstracts (>80 %). No abstract adequately reported results for the primary outcome, source of funding, and status of the trial. In addition, sufficient reporting of participants, outcome in the methods section, randomization, and trial registration was rare (journals is suboptimal. Joint efforts by authors, editors, and other stakeholders in the field to improve trial abstract reporting are needed.

  9. Clobazam: uncontrolled and standard controlled clinical trials.

    Science.gov (United States)

    Ban, T A; Amin, M M

    1979-01-01

    1 In an uncontrolled clinical trial, carried out in 11 psychiatric patients with the clinical diagnoses of anxiety neurosis and depressive neurosis, clobazam, a new benzodiazepine preparation, in the dosage range 10-60 mg daily produced statistically significant improvement in the total and both factor scores of the Hamilton Anxiety Scale (HAM-A). The lowest mean total HAM-A scores occurred with a mean clobazam dosage of 48 mg daily. 2 Results of the uncontrolled clinical trial were further substantiated in a standard-controlled clinical study in which no statistically significant difference between the therapeutic effectiveness of clobazam and diazepam could be revealed. The lowest mean total HAM-A scores occurred with a mean clobazam dosage of 49 mg daily. There was a lower incidence of adverse effects reported in patients receiving clobazam than in those taking the control drug (diazepam).

  10. Financial ties of principal investigators and randomized controlled trial outcomes: cross sectional study.

    Science.gov (United States)

    Ahn, Rosa; Woodbridge, Alexandra; Abraham, Ann; Saba, Susan; Korenstein, Deborah; Madden, Erin; Boscardin, W John; Keyhani, Salomeh

    2017-01-17

     To examine the association between the presence of individual principal investigators' financial ties to the manufacturer of the study drug and the trial's outcomes after accounting for source of research funding.  Cross sectional study of randomized controlled trials (RCTs).  Studies published in "core clinical" journals, as identified by Medline, between 1 January 2013 and 31 December 2013.  Random sample of RCTs focused on drug efficacy.  Association between financial ties of principal investigators and study outcome.  A total of 190 papers describing 195 studies met inclusion criteria. Financial ties between principal investigators and the pharmaceutical industry were present in 132 (67.7%) studies. Of 397 principal investigators, 231 (58%) had financial ties and 166 (42%) did not. Of all principal investigators, 156 (39%) reported advisor/consultancy payments, 81 (20%) reported speakers' fees, 81 (20%) reported unspecified financial ties, 52 (13%) reported honorariums, 52 (13%) reported employee relationships, 52 (13%) reported travel fees, 41 (10%) reported stock ownership, and 20 (5%) reported having a patent related to the study drug. The prevalence of financial ties of principal investigators was 76% (103/136) among positive studies and 49% (29/59) among negative studies. In unadjusted analyses, the presence of a financial tie was associated with a positive study outcome (odds ratio 3.23, 95% confidence interval 1.7 to 6.1). In the primary multivariate analysis, a financial tie was significantly associated with positive RCT outcome after adjustment for the study funding source (odds ratio 3.57 (1.7 to 7.7). The secondary analysis controlled for additional RCT characteristics such as study phase, sample size, country of first authors, specialty, trial registration, study design, type of analysis, comparator, and outcome measure. These characteristics did not appreciably affect the relation between financial ties and study outcomes (odds ratio 3.37, 1

  11. Development of an implementation plan for the 6-PACK falls prevention programme as part of a randomised controlled trial: protocol for a series of preimplementation studies.

    Science.gov (United States)

    Barker, Anna L; Morello, Renata T; Ayton, Darshini R; Hill, Keith D; Landgren, Fiona S; Brand, Caroline A

    2016-12-01

    Inhospital falls cause morbidity, staff burden and increased healthcare costs. It is unclear if the persistent problem of inhospital falls is due to the use of ineffective interventions or their suboptimal implementation. The 6-PACK programme appears to reduce fall injuries and a randomised controlled trial (RCT) was undertaken to confirm effects. This paper describes the protocol for the preimplementation studies that aimed to identify moderators of the effective use of the 6-PACK programme to inform the development of an implementation plan to be applied in the RCT. The 6-PACK project included five preimplementation studies: (1) a profile of safety climate; (2) review of current falls prevention practice; (3) epidemiology of inhospital falls; (4) acceptability of the 6-PACK programme; and (5) barriers and enablers to implementation of the 6-PACK programme. The Theoretical Domain Framework that includes 12 behaviour change domains informed the design of these studies that involved 540 staff and 8877 patients from 24 wards from six Australian hospitals. Qualitative and quantitative methods were applied with data collected via: structured bedside observation; daily nurse unit manager verbal report of falls; audit of medical records, incident reporting and hospital administrative data; surveys of ward nurses; focus groups with ward nurses; and key informant interviews with senior staff. Information on contextual, system, intervention, patient and provider level factors is critical to the development of an implementation plan. Information gained from these studies was used to develop a plan applied in the RCT that addressed the barriers and harnessed enablers. The RCT is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12611000332921. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  12. CanWalk: a feasibility study with embedded randomised controlled trial pilot of a walking intervention for people with recurrent or metastatic cancer

    Science.gov (United States)

    Tsianakas, Vicki; Ream, Emma; Van Hemelrijck, Mieke; Purushotham, Arnie; Mucci, Lorelei; Green, James S A; Fewster, Jacquetta; Armes, Jo

    2017-01-01

    Objectives Walking is an adaptable, inexpensive and accessible form of physical activity. However, its impact on quality of life (QoL) and symptom severity in people with advanced cancer is unknown. This study aimed to assess the feasibility and acceptability of a randomised controlled trial (RCT) of a community-based walking intervention to enhance QoL in people with recurrent/metastatic cancer. Design We used a mixed-methods design comprising a 2-centre RCT and nested qualitative interviews. Participants Patients with advanced breast, prostate, gynaecological or haematological cancers randomised 1:1 between intervention and usual care. Intervention The intervention comprised Macmillan's ‘Move More’ information, a short motivational interview with a recommendation to walk for at least 30 min on alternate days and attend a volunteer-led group walk weekly. Outcomes We assessed feasibility and acceptability of the intervention and RCT by evaluating study processes (rates of recruitment, consent, retention, adherence and adverse events), and using end-of-study questionnaires and qualitative interviews. Patient-reported outcome measures (PROMs) assessing QoL, activity, fatigue, mood and self-efficacy were completed at baseline and 6, 12 and 24 weeks. Results We recruited 42 (38%) eligible participants. Recruitment was lower than anticipated (goal n=60), the most commonly reported reason being unable to commit to walking groups (n=19). Randomisation procedures worked well with groups evenly matched for age, sex and activity. By week 24, there was a 45% attrition rate. Most PROMs while acceptable were not sensitive to change and did not capture key benefits. Conclusions The intervention was acceptable, well tolerated and the study design was judged acceptable and feasible. Results are encouraging and demonstrate that exercise was popular and conveyed benefit to participants. Consequently, an effectiveness RCT is warranted, with some modifications to the

  13. Both aerobic exercise and cognitive-behavioral therapy reduce chronic fatigue in FSHD: An RCT

    NARCIS (Netherlands)

    Voet, N.B.; Bleijenberg, G.; Hendriks, J.C.M.; Groot, I.M. de; Padberg, G.W.; Engelen, B.G. van; Geurts, A.C.

    2014-01-01

    OBJECTIVE: To investigate the effect of aerobic exercise training (AET) and cognitive-behavioral therapy (CBT) on chronic fatigue in patients with facioscapulohumeral muscular dystrophy (FSHD). METHODS: We performed a multicenter, assessor-blinded, randomized clinical trial (RCT). Fifty-seven patien

  14. "Mi voglio bene": a pediatrician-based randomized controlled trial for the prevention of obesity in Italian preschool children

    Directory of Open Access Journals (Sweden)

    Brambilla Paolo

    2010-08-01

    Full Text Available Abstract Background The first years of life are crucial to start preventive interventions that can have an impact on lifestyle and later overweight and obesity. Under the Italian National Health System (INHS, children are cared for by family pediatricians who perform health balances at regular intervals. The Italian Society of Preventive and Social Pediatrics (SIPPS has designed a randomized controlled trial (RCT to evaluate the effectiveness of family pediatricians for the prevention of childhood obesity in preschool children. We report the rationale and protocol of such trial, named the "Mi voglio bene" ("I love myself" study. Methods "Mi voglio bene" is a parallel-arm RCT. Family pediatricians willing to participate to the trial will be randomly assigned to a control group and to an experimental group. The control group will provide the usual standard of care while the experimental group will implement 10 preventive actions (promotion of breastfeeding, avoidance of solid foods, control of protein intake, avoidance of sugar-sweetened beverages, avoidance of bottle, active means of transportation, identification of early adiposity rebound, limitation of television viewing, promotion of movement, and teaching portion size at 10 time points during a 6-yr follow-up. The main outcome measures is the prevalence of overweight and obesity at 6 years of age. The experimental intervention is expected to reduce the prevalence of overweight and obesity from 25% to 20% and the study requires a total of 3610 children. Each pediatrician will enroll 30 consecutive newborns into the study so that a total of 120 pediatricians will participate to the study. Discussion "Mi voglio bene" is expected to provide important information for the INHS and possibly other institutional child care settings about the effectiveness of a pediatrician-based approach to the prevention of childhood obesity. We published this study protocol with the aim of opening a discussion with

  15. The extended Infant Feeding, Activity and Nutrition Trial (InFANT Extend) Program: a cluster-randomized controlled trial of an early intervention to prevent childhood obesity.

    Science.gov (United States)

    Campbell, Karen J; Hesketh, Kylie D; McNaughton, Sarah A; Ball, Kylie; McCallum, Zoë; Lynch, John; Crawford, David A

    2016-02-18

    Understanding how we can prevent childhood obesity in scalable and sustainable ways is imperative. Early RCT interventions focused on the first two years of life have shown promise however, differences in Body Mass Index between intervention and control groups diminish once the interventions cease. Innovative and cost-effective strategies seeking to continue to support parents to engender appropriate energy balance behaviours in young children need to be explored. The Infant Feeding Activity and Nutrition Trial (InFANT) Extend Program builds on the early outcomes of the Melbourne InFANT Program. This cluster randomized controlled trial will test the efficacy of an extended (33 versus 15 month) and enhanced (use of web-based materials, and Facebook® engagement), version of the original Melbourne InFANT Program intervention in a new cohort. Outcomes at 36 months of age will be compared against the control group. This trial will provide important information regarding capacity and opportunities to maximize early childhood intervention effectiveness over the first three years of life. This study continues to build the evidence base regarding the design of cost-effective, scalable interventions to promote protective energy balance behaviors in early childhood, and in turn, promote improved child weight and health across the life course. ACTRN12611000386932. Registered 13 April 2011.

  16. Wean Earlier and Automatically with New technology (the WEAN study: a protocol of a multicentre, pilot randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Lessard Martin R

    2009-09-01

    Full Text Available Abstract Background Weaning is the process during which mechanical ventilation is withdrawn and the work of breathing is transferred from the ventilator back to the patient. Prolonged weaning is associated with development of ventilator-related complications and longer stays in the Intensive Care Unit (ICU. Computerized or Automated Weaning is a novel weaning strategy that continuously measures and adapts ventilator support (by frequently measuring and averaging three breathing parameters and automatically conducts Spontaneous Breathing Trials to ascertain whether patients can resume autonomous breathing. Automated Weaning holds promise as a strategy to reduce the time spent on the ventilator, decrease ICU length of stay, and improve clinically important outcomes. Methods/Design A pilot weaning randomized controlled trial (RCT is underway in the ICUs of 8 Canadian hospitals. We will randomize 90 critically ill adults requiring invasive ventilation for at least 24 hours and identified at an early stage of the weaning process to either Automated Weaning (SmartCare™ or Protocolized Weaning. The results of a National Weaning Survey informed the design of the Protocolized Weaning arm. Both weaning protocols are operationalized in Pressure Support mode, include opportunities for Spontaneous Breathing Trials, and share a common sedation protocol, oxygen titration parameters, and extubation and reintubation criteria. The primary outcome of the WEAN study is to evaluate compliance with the proposed weaning and sedation protocols. A key secondary outcome of the pilot RCT is to evaluate clinician acceptance of the weaning and sedation protocols. Prior to initiating the WEAN Study, we conducted a run-in phase, involving two patients per centre (randomizing the first participant to either weaning strategy and assigning the second patient to the alternate strategy to ensure that participating centres could implement the weaning and sedation protocols and

  17. Bracing Patients with Idiopathic Scoliosis: Design of the Dutch Randomized Controlled Treatment Trial

    Directory of Open Access Journals (Sweden)

    de Koning Harry J

    2008-04-01

    Full Text Available Abstract Background The effectiveness of bracing patients with IS has not yet been convincingly established due to a lack of RCTs. Some authors suggest that their results confirm that bracing is effective; others conclude that the effectiveness of bracing is doubtful or recommend a RCT. The aim of this study was to establish whether bracing patients with idiopathic scoliosis (IS in an early stage will result in at least 5 degrees less mean progression of the curvature compared to the control group after two years of follow-up. Methods A randomized controlled trial was designed. Eligible patients are girls and boys in the age group 8–15 years whose diagnosis of IS has been established by an orthopedic surgeon, who have not yet been treated by bracing or surgery, and for whom further growth of physical height is still expected based on medical examination and maturation characteristics (Risser ≤ 2. The Cobb angle of the eligible patient should either be minimally 22 and maximally 29 degrees with established progression of more than 5 degrees, or should be minimally 30 and maximally 35 degrees; established progression for the latter is not necessary. A total of 100 patients will be included in this trial. The intervention group will be treated with full-time Boston brace wear; the control group will not be braced. Every four months, each patient will have a physical and an X-ray examination. The main outcomes will be the Cobb angle two years after inclusion and health-related quality of life. Discussion The results of this trial will be of great importance for the discussion on early treatment for scoliosis. Furthermore, the result will also be important for screening for scoliosis policies. Trial registration Nederlands Trialregister ISRCTN36964733

  18. A randomised controlled trial of a cognitive behavioural intervention for men who have hot flushes following prostate cancer treatment (MANCAN: trial protocol

    Directory of Open Access Journals (Sweden)

    Yousaf Omar

    2012-06-01

    Full Text Available Abstract Background This randomised controlled trial (RCT aims to evaluate the effectiveness of a guided self-help cognitive behavioural intervention to alleviate problematic hot flushes (HF and night sweats (NS in men who are undergoing prostate cancer treatment. The trial and the self-help materials have been adapted from a previous RCT, which showed that a cognitive behavioural intervention reduced the self-reported problem-rating of hot flushes in women with menopausal symptoms, and in women undergoing breast cancer treatment. We hypothesize that guided self-help will be more effective than usual care in reducing HF/NS problem-rating at post treatment assessment. Methods/Design Seventy men who are undergoing treatment for prostate cancer and who have been experiencing more than ten HF/NS weekly for over a month are recruited into the trial from urology clinics in London. They are randomly allocated to either a four-week self-help cognitive behavioural therapy (CBT treatment or to their usual care (control group. The treatment includes information and discussion about hot flushes and night sweats in the context of prostate cancer, monitoring and modifying precipitants, relaxation and paced respiration, stress management, cognitive therapy for unhelpful thoughts and beliefs, managing sleep and night sweats, and advice on maintaining these changes. Prior to randomisation, men attend a clinical interview, undergo 24-48-hour sternal skin conductance monitoring, and complete pre-treatment questionnaires (e.g., problem-rating and frequency of hot flushes and night sweats; quality of life; mood; hot flush beliefs and behaviours. Post-treatment measures (sternal skin conductance and the above questionnaires are collected four-six weeks later, and again at a six-month follow-up. Discussion MANCAN is the first randomised controlled trial of cognitive behavioural therapy for HF/NS for men that measures both self-reported and physiologically indexed

  19. The effectiveness of the Incredible Years Parents and Babies Program as a universal prevention intervention for parents of infants in Denmark: study protocol for a pilot randomized controlled trial

    DEFF Research Database (Denmark)

    Pontoppidan, Maiken W.

    2015-01-01

    support parents in providing sensitive and responsive care, and reinforce healthy development for their infants. This study aims to evaluate the impact of the Incredible Years™ Parents and Babies Program in a universal setting for parents with infants. Methods/Design: This is a pragmatic, two......-arm, parallel, pilot, randomized controlled trial (RCT) where 128 families with newborn infants up to four-months-old are recruited in two municipalities in Denmark. Families are randomized to the Incredible Years Parents and Babies Program or usual care with a 2:1 allocation ratio. The primary outcome....... Discussion: This is the first RCT of the Incredible Years Parents and Babies Program, and one of the first rigorous evaluations of a universally offered preventive intervention for parents with infants. The trial will provide important information on the effectiveness of a relatively brief, universally...

  20. 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

  1. Randomized-controlled trials of levetiracetam as an adjunctive therapy in epilepsy of multiple seizure types.

    Science.gov (United States)

    Fang, Youxin; Wu, Xunyi; Xu, Lan; Tang, Xinghua; Wang, Jianhong; Zhu, Guoxing; Hong, Zhen

    2014-01-01

    This meta-analysis aimed to systematically collect and synthesize the current evidence regarding the efficacy and tolerability of levetiracetam (LEV) as an adjunctive therapy for adults and children suffering from idiopathic and secondary epilepsy of multiple seizure types. We selected randomized-controlled trials (RCT) of LEV as an adjunctive therapy in epilepsy according to predefined criteria. Outcome measures included a > or =50% reduction in seizure frequency, seizure freedom, and adverse events. Thirteen RCT were analyzed. Results showed that the efficacy of adjunctive LEV was superior to placebo both in achieving > or =50% reduction in seizure frequency (pooled odds ratio [OR] 3.36, 95% confidence interval [CI] 2.78-4.07, Z=12.46; pseizure freedom (pooled OR 4.72, 95% CI 2.96-7.54, Z=6.50; p or =50% reduction in seizure frequency, and chi-squared=0.49, I2=0% in seizure freedom). Subgroup analysis suggested similar effects across different dosages in adults. The incidence of adverse reactions was not significantly different between the LEV group and the placebo group. The adverse events of relatively high incidence in the LEV group included somnolence, agitation, dizziness, asthenia, and infection. Incidence of serious adverse reaction such as rash and white blood cells and platelets decreasing was quite low. Adjunctive therapy with LEV was superior to placebo in reducing the frequency of seizures in patients with partial and idiopathic generalized epilepsy with effect in both adults and children, and demonstrated good tolerance in patients with epilepsy. Copyright © 2013 Elsevier Ltd. All rights reserved.

  2. Anthropometrics and body composition by dual energy X-ray in children of obese women: a follow-up of a randomized controlled trial (the Lifestyle in Pregnancy and Offspring [LiPO] study.

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    Mette Tanvig

    Full Text Available OBJECTIVE: In obese women, 1 to assess whether lower gestational weight gain (GWG during pregnancy in the lifestyle intervention group of a randomized controlled trial (RCT resulted in differences in offspring anthropometrics and body composition, and 2 to compare offspring outcomes to a reference group of children born to women with a normal Body Mass Index (BMI. RESEARCH DESIGN AND METHODS: The LiPO (Lifestyle in Pregnancy and Offspring study was an offspring follow-up of a RCT with 360 obese pregnant women with a lifestyle intervention during pregnancy including dietary advice, coaching and exercise. The trial was completed by 301 women who were eligible for follow-up. In addition, to the children from the RCT, a group of children born to women with a normal BMI were included as a reference group. At 2.8 (range 2.5-3.2 years, anthropometrics were measured in 157 children of the RCT mothers and in 97 reference group children with Body Mass Index (BMI Z-score as a primary outcome. Body composition was estimated by Dual Energy X-ray (DEXA in 123 successful scans out of 147 (84%. RESULTS: No differences between randomized groups were seen in mean (95% C.I. BMI Z-score (intervention group 0.06 [-0.17; 0.29] vs. controls -0.18 [-0.43; 0.05], in the percentage of overweight or obese children (10.9% vs. 6.7%, in other anthropometrics, or in body composition values by DEXA. Outcomes between children from the RCT and the reference group children were not significantly different. CONCLUSIONS: The RCT with lifestyle intervention in obese pregnant women did not result in any detectable effect on offspring anthropometrics or body composition by DEXA at 2.8 years of age. This may reflect the limited difference in GWG between intervention and control groups. Offspring of obese mothers from the RCT were comparable to offspring of mothers with a normal BMI.

  3. "To whom do the results of this trial apply?" External validity of a randomized controlled trial involving 130 patients scheduled for primary total hip replacement

    DEFF Research Database (Denmark)

    Petersen, Mette K; Andersen, Karen Vestergaard; Andersen, Niels T

    2007-01-01

    , but they should at least allow patients and clinicians to judge to whom trial results can reasonably be applied. We assessed the external validity of an RCT investigating the efficacy of a fast-track program after total hip replacement. METHODS: 130 patients were identified as potential participants.18 patients...

  4. Cost-effectiveness of minimal interventional procedures for chronic mechanical low back pain: design of four randomised controlled trials with an economic evaluation

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    Maas Esther T

    2012-12-01

    Full Text Available Abstract Background Minimal interventional procedures are frequently applied in patients with mechanical low back pain which is defined as pain presumably resulting from single sources: facet, disc, sacroiliac joint or a combination of these. Usually, these minimal interventional procedures are an integral part of a multidisciplinary pain programme. A recent systematic review issued by the Dutch Health Insurance Council showed that the effectiveness of these procedures for the total group of patients with chronic low back pain is yet unclear and cost-effectiveness unknown. The aim of the study is to evaluate whether a multidisciplinary pain programme with minimal interventional procedures is cost-effective compared to the multidisciplinary pain programme alone for patients with chronic mechanical low back pain who did not respond to conservative primary care and were referred to a pain clinic. Methods All patients with chronic low back pain who are referred to one of the 13 participating pain clinics will be asked to participate in an observational study. Patients with a suspected diagnosis of facet, disc or sacroiliac joint problems will receive a diagnostic block to confirm this diagnosis. If confirmed, they will be asked to participate in a Randomized Controlled Trial (RCT. For each single source a separate RCT will be conducted. Patients with a combination of facet, disc or sacroiliac joint problems will be invited for participation in a RCT as well. An economic evaluation from a societal perspective will be performed alongside these four RCTs. Patients will complete questionnaires at baseline, 3 and 6 weeks, 3, 6, 9 and 12 months after start of the treatment. Costs will be collected using self-completed cost questionnaires. Discussion No trials are yet available which have evaluated the cost-effectiveness of minimal interventional procedures in patients with chronic mechanical low back pain, which emphasizes the importance of this study

  5. Does oral polio vaccine have non-specific effects on all-cause mortality? Natural experiments within a randomised controlled trial of early measles vaccine

    Science.gov (United States)

    Aaby, Peter; Andersen, Andreas; Martins, Cesário L; Fisker, Ane B; Rodrigues, Amabelia; Whittle, Hilton C; Benn, Christine S

    2016-01-01

    Background BCG and measles vaccine (MV) may have beneficial non-specific effects (NSEs). If an unplanned intervention with a vaccine (a natural experiment) modifies the estimated effect in a randomised controlled trial (RCT), this suggests NSEs. We used this approach to test NSEs of triple oral polio vaccine (OPV). Methods During an RCT of 2 doses of MV at 4.5 and 9 months versus 1 dose of MV at 9 months of age, we experienced 2 natural experiments with OPV. We assessed whether these OPV experiments modified the effect of 2-dose MV in the MV trial. Setting MV RCT conducted in urban Guinea-Bissau 2003–2009. Interventions Natural experiments with OPV due to missing vaccine and the implementation of OPV campaigns. Main outcome measure Changes in the mortality rate ratio (MRR) for 2-dose MV versus 1-dose MV. Results First, the MRR (2-dose/1-dose MV) overall was 0.70 (0.52 to 0.94), but the MRR was 1.04 (0.53 to 2.04) when OPV at birth (OPV0) was not given, suggesting that early priming with OPV was important for the effect of 2-dose MV. The effect of OPV0 depended on age of administration; the MRR (2-dose/1-dose MV) was 0.45 (0.29 to 0.71) for children receiving OPV0 in the first week of life, but 3.63 (0.87 to 15.2) for those receiving OPV0 after the first month of life (p=0.007, test of no interaction). Second, campaign-OPV may have reduced the difference between the randomisation groups since the MRR (2-dose/1-dose MV) was 0.60 (0.42 to 0.85) for children who had not received campaign-OPV before RCT-enrolment versus 0.72 (0.23 to 2.31) and 1.42 (0.70 to 2.90) for children who had received 1 or 2 doses of campaign-OPV-before-enrolment, respectively. Conclusions Bissau had no polio infection during this trial, so OPV0 and campaign-OPV may have NSEs since they modified the effect of 2-dose MV in an RCT. Different interventions may interact to a much larger effect than usually assumed. PMID:28011813

  6. Promoting Recruitment using Information Management Efficiently (PRIME): study protocol for a stepped-wedge cluster randomised controlled trial within the REstart or STop Antithrombotics Randomised Trial (RESTART).

    Science.gov (United States)

    Maxwell, Amy E; Dennis, Martin; Rudd, Anthony; Weir, Christopher J; Parker, Richard A; Al-Shahi Salman, Rustam

    2017-03-01

    Research into methods to boost recruitment has been identified as the highest priority for randomised controlled trial (RCT) methodological research in the United Kingdom. Slow recruitment delays the delivery of research and inflates costs. Using electronic patient records has been shown to boost recruitment to ongoing RCTs in primary care by identifying potentially eligible participants, but this approach remains relatively unexplored in secondary care, and for stroke in particular. The REstart or STop Antithrombotics Randomised Trial (RESTART; ISRCTN71907627) is an ongoing RCT of secondary prevention after stroke due to intracerebral haemorrhage. Promoting Recruitment using Information Management Efficiently (PRIME) is a stepped-wedge cluster randomised trial of a complex intervention to help RESTART sites increase their recruitment and attain their own target numbers of participants. Seventy-two hospital sites that were located in England, Wales or Scotland and were active in RESTART in June 2015 opted into PRIME. Sites were randomly allocated (using a computer-generated block randomisation algorithm, stratified by hospital location in Scotland vs. England/Wales) to one of 12 months in which the intervention would be delivered. All sites began in the control state. The intervention was delivered by a recruitment co-ordinator via a teleconference with each site. The intervention involved discussing recruitment strategies, providing software for each site to extract from their own stroke audit data lists of patients who were potentially eligible for RESTART, and a second teleconference to review progress 6 months later. The recruitment co-ordinator was blinded to the timing of the intervention until 2 months before it was due at a site. Staff at RESTART sites were blinded to the nature and timing of the intervention. The primary outcome is the total number of patients randomised into RESTART per month per site and will be analysed in a negative binomial

  7. Physical activity and nutrition program for seniors (PANS: protocol of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Lee Andy

    2010-12-01

    Full Text Available Abstract Background Along with reduced levels of physical activity, older Australian's mean energy consumption has increased. Now over 60% of older Australians are considered overweight or obese. This study aims to confirm if a low-cost, accessible physical activity and nutrition program can improve levels of physical activity and diet of insufficiently active 60-70 year-olds. Methods/Design This 12-month home-based randomised controlled trial (RCT will consist of a nutrition and physical activity intervention for insufficiently active people aged 60 to 70 years from low to medium socio-economic areas. Six-hundred participants will be recruited from the Australian Federal Electoral Role and randomly assigned to the intervention (n = 300 and control (n = 300 groups. The study is based on the Social Cognitive Theory and Precede-Proceed Model, incorporating voluntary cooperation and self-efficacy. The intervention includes a specially designed booklet that provides participants with information and encourages dietary and physical activity goal setting. The booklet will be supported by an exercise chart, calendar, bi-monthly newsletters, resistance bands and pedometers, along with phone and email contact. Data will be collected over three time points: pre-intervention, immediately post-intervention and 6-months post-study. Discussion This trial will provide valuable information for community-based strategies to improve older adults' physical activity and dietary intake. The project will provide guidelines for appropriate sample recruitment, and the development, implementation and evaluation of a minimal intervention program, as well as information on minimising barriers to participation in similar programs. Trial Registration Australian and New Zealand Clinical Trials Registry ACTRN12609000735257

  8. Children Learning About Secondhand Smoke (CLASS II): protocol of a pilot cluster randomised controlled trial.

    Science.gov (United States)

    Siddiqi, Kamran; Huque, Rumana; Jackson, Cath; Parrott, Steve; Dogar, Omara; Shah, Sarwat; Thomson, Heather; Sheikh, Aziz

    2015-08-25

    Exposure to secondhand smoke (SHS) increases children's risk of acquiring chest and ear infections, tuberculosis, meningitis and asthma. Smoking bans in public places (where implemented) have significantly reduced adults' exposure to SHS. However, for children, homes remain the most likely place for them to be exposed to SHS. Additional measures are therefore required to protect children from SHS. In a feasibility study in Dhaka, Bangladesh, we have shown that a school-based smoke-free intervention (SFI) was successful in encouraging children to negotiate and implement smoking restrictions in homes. We will now conduct a pilot trial to inform plans to undertake a cluster randomised controlled trial (RCT) investigating the effectiveness and cost-effectiveness of SFI in reducing children's exposure to SHS. We plan to recruit 12 primary schools in Dhaka, Bangladesh. From these schools, we will recruit approximately 360 schoolchildren in year 5 (10-12 years old), that is, 30 per school. SFI consists of six interactive educational activities aimed at increasing pupils' knowledge about SHS and related harms, motivating them to act, providing skills to negotiate with adults to persuade them not to smoke inside homes and helping families to 'sign-up' to a voluntary contract to make their homes smoke-free. Children in the control arm will receive the usual education. We will estimate: recruitment and attrition rates, acceptability, fidelity to SFI, effect size, intracluster correlation coefficient, cost of intervention and adverse events. Our primary outcome will consist of SHS exposure in children measured by salivary cotinine. Secondary outcomes will include respiratory symptoms, lung function tests, healthcare contacts, school attendance, smoking uptake, quality of life and academic performance. The trial has received ethics approval from the Research Governance Committee at the University of York. Findings will help us plan for the definitive trial. ISRCTN68690577

  9. Singing teaching as a therapy for chronic respiratory disease - a randomised controlled trial and qualitative evaluation

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    Kelly Julia L

    2010-08-01

    Full Text Available Abstract Background Despite optimal pharmacological therapy and pulmonary rehabilitation, patients with COPD continue to be breathless. There is a need to develop additional strategies to alleviate symptoms. Learning to sing requires control of breathing and posture and might have benefits that translate into daily life. Methods To test this hypothesis we performed a randomised controlled trial, comparing a six week course of twice weekly singing classes to usual care, in 28 COPD patients. The experience of singing was assessed in a qualitative fashion, through interviews with a psychologist. In addition, we surveyed patients with chronic respiratory conditions who participated in a series of open singing workshops. Results In the RCT, the physical component score of the SF36 improved in the singers (n = 15 compared to the controls (n = 13; +7.5(14.6 vs. -3.8(8.4 p = 0.02. Singers also had a significant fall in HAD anxiety score; -1.1(2.7 vs. +0.8(1.7 p = 0.03. Singing did not improve single breath counting, breath hold time or shuttle walk distance. In the qualitative element, 8 patients from the singing group were interviewed. Positive effects on physical sensation, general well-being, community/social support and achievement/efficacy emerged as common themes. 150 participants in open workshops completed a questionnaire. 96% rated the workshops as "very enjoyable" and 98% thought the workshop had taught them something about breathing in a different way. 81% of attendees felt a "marked physical difference" after the workshop. Conclusion Singing classes can improve quality of life measures and anxiety and are viewed as a very positive experience by patients with respiratory disease; no adverse consequences of participation were observed. Trial Registration Current Controlled Trials - ISRCTN17544114.

  10. A Randomized Controlled Trial Exploring the Effects of Brief Anger Management on Community-Based Offenders in Malta.

    Science.gov (United States)

    Henwood, Kevin Sammut; Browne, Kevin Dominic; Chou, Shihning

    2016-09-25

    The aim of this article is to examine the effects of a short-term one-to-one anger management program delivered to community-based offenders in Malta. The program delivered was the Individual Managing Anger Program (I-MAP), a Cognitive behavioural therapy (CBT) and mindfulness-based anger management intervention developed as an EU project. A randomized control trial (RCT)with waitlist controls was carried out to investigate the effects of I-MAP on the reduction in anger dysfunction among offenders serving a community-based sanction. Participants were 24 male offenders aged between 18 and 57. Eligibility for treatment was based on screening for anger dysfunction and success of interventions was determined through psychometric measures. All the statistical analyses carried out showed significant reduction in psychometric scores on anger symptoms. Results of the interventions show clinical significance. These results are discussed in light of recent research. © The Author(s) 2016.

  11. Predicting Real-World Effectiveness of Cancer Therapies Using Overall Survival and Progression-Free Survival from Clinical Trials: Empirical Evidence for the ASCO Value Framework.

    Science.gov (United States)

    Lakdawalla, Darius N; Shafrin, Jason; Hou, Ningqi; Peneva, Desi; Vine, Seanna; Park, Jinhee; Zhang, Jie; Brookmeyer, Ron; Figlin, Robert A

    To measure the relationship between randomized controlled trial (RCT) efficacy and real-world effectiveness for oncology treatments as well as how this relationship varies depending on an RCT's use of surrogate versus overall survival (OS) endpoints. We abstracted treatment efficacy measures from 21 phase III RCTs reporting OS and either progression-free survival or time to progression endpoints in breast, colorectal, lung, ovarian, and pancreatic cancers. For these treatments, we estimated real-world OS as the mortality hazard ratio (RW MHR) among patients meeting RCT inclusion criteria in Surveillance and Epidemiology End Results-Medicare data. The primary outcome variable was real-world OS observed in the Surveillance and Epidemiology End Results-Medicare data. We used a Cox proportional hazard regression model to calibrate the differences between RW MHR and the hazard ratios on the basis of RCTs using either OS (RCT MHR) or progression-free survival/time to progression surrogate (RCT surrogate hazard ratio [SHR]) endpoints. Treatment arm therapies reduced mortality in RCTs relative to controls (average RCT MHR = 0.85; range 0.56-1.10) and lowered progression (average RCT SHR = 0.73; range 0.43-1.03). Among real-world patients who used either the treatment or the control arm regimens evaluated in the relevant RCT, RW MHRs were 0.6% (95% confidence interval -3.5% to 4.8%) higher than RCT MHRs, and RW MHRs were 15.7% (95% confidence interval 11.0% to 20.5%) higher than RCT SHRs. Real-world OS treatment benefits were similar to those observed in RCTs based on OS endpoints, but were 16% less than RCT efficacy estimates based on surrogate endpoints. These results, however, varied by tumor and line of therapy. Copyright © 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  12. Quality evaluation of randomized controlled trials reports of laparoscopy compared with open colorectal resection for colorectal cancer.

    Science.gov (United States)

    Huang, Dandan; Jin, Xin; Gao, Jie; Li, Yuying; Lu, Liming; Sun, Feng; Chen, Dan; Zhao, Wentao; Luo, Weimin; Li, Hongjie; Hu, Yunyun; Hu, Fengliang

    2015-06-01

    Previously, there were no data looking at the quality evaluation of randomized controlled trials (RCTs) on effect comparison of laparoscopic surgery and open surgery for colorectal cancer in China. Here, we evaluate the completeness and transparency of RCT reports in this field. The following databases were searched: Medline, EMbase, SCI Expanded, China National Knowledge Infrastructure, the Chinese Biological Medicine Database, VIP database and Wan Fang databases) to search RCT reports on the effect comparison of laparoscopic surgery and open surgery for colorectal cancer in China. Our study evaluated the reporting quality of RCTs based on 22 standards of Consolidated Standards for Reporting Trials (CONSORT) 2010 Statement. Two reviewers responded with 'yes' or 'no' to each standard to judge whether the authors had reported or had recorded concrete details of the reports accomplished in accordance with the requirement of each standard. A total of 40 relevant RCTs were included in the final analysis. For the 'Title and abstract', only three articles (7.5%) could be identified directly from its title as the report of RCTs. For the 'Methods', only three articles (7.5%) applied the method of random allocation of sequences; only two articles (5%) mentioned the type of randomization or gave the description of the mechanism of allocation concealment; no article referred the concrete implementation of random method. Only one article (2.5%) applied the method of blinding or sample size calculation; no article had analysis about the metaphase of an experiment or an explanation of its interruption. For 'results', only one article (2.5%) described participant flow, primary and secondary outcomes with estimated effect size or ancillary analyses. Only 13 articles (32.5%) showed baseline demographic and clinical characteristics, 10 (25%) referred to intention-to-treat analysis, and 12 (30%) mentioned important harms or unintended effects. For the 'discussion', only eight

  13. Replicability of sight word training and phonics training in poor readers: a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    G McArthur

    2015-05-01

    Full Text Available Given the importance of effective treatments for children with reading impairment, paired with growing concern about the lack of scientific replication in psychological science, the aim of this study was to replicate a quasi-randomised trial of sight word and phonics training using a randomised controlled trial (RCT design. One group of poor readers (N = 41 did 8 weeks of phonics training (i.e., phonological decoding and then 8 weeks of sight word training (i.e., whole-word recognition. A second group did the reverse order of training. Sight word and phonics training each had a large and significant valid treatment effect on trained irregular words and word reading fluency. In addition, combined sight word and phonics training had a moderate and significant valid treatment effect on nonword reading accuracy and fluency. These findings demonstrate the reliability of both phonics and sight word training in treating poor readers in an era where the importance of scientific reliability is under close scrutiny.

  14. Development and evaluation of an Individualized Outcome Measure (IOM) for randomized controlled trials in mental health.

    Science.gov (United States)

    Pesola, Francesca; Williams, Julie; Bird, Victoria; Freidl, Marion; Le Boutillier, Clair; Leamy, Mary; Macpherson, Rob; Slade, Mike

    2015-12-01

    Pre-defined, researcher-selected outcomes are routinely used as the clinical end-point in randomized controlled trials (RCTs); however, individualized approaches may be an effective way to assess outcome in mental health research. The present study describes the development and evaluation of the Individualized Outcome Measure (IOM), which is a patient-specific outcome measure to be used for RCTs of complex interventions. IOM was developed using a narrative review, expert consultation and piloting with mental health service users (n = 20). The final version of IOM comprises two components: Goal Attainment (GA) and Personalized Primary Outcome (PPO). For GA, patients identify one relevant goal at baseline and rate its attainment at follow-up. For PPO, patients choose an outcome domain related to their goal from a pre-defined list at baseline, and complete a standardized questionnaire assessing the chosen outcome domain at baseline and follow-up. A feasibility study indicated that IOM had adequate completion (89%) and acceptability (96%) rates in a clinical sample (n = 84). IOM was then evaluated in a RCT (ISRCTN02507940). GA and PPO components were associated with each other and with the trial primary outcome. The use of the PPO component of IOM as the primary outcome could be considered in future RCTs. Copyright © 2015 John Wiley & Sons, Ltd.

  15. Evolution of the randomized controlled trial in oncology over three decades.

    Science.gov (United States)

    Booth, Christopher M; Cescon, David W; Wang, Lisa; Tannock, Ian F; Krzyzanowska, Monika K

    2008-11-20

    The randomized controlled trial (RCT) is the gold standard for establishing new therapies in clinical oncology. Here we document changes with time in design, sponsorship, and outcomes of oncology RCTs. Reports of RCTs evaluating systemic therapy for breast, colorectal (CRC), and non-small-cell lung cancer (NSCLC) published 1975 to 2004 in six major journals were reviewed. Two authors abstracted data regarding trial design, results, and conclusions. Conclusions of authors were graded using a 7-point Likert scale. For each study the effect size for the primary end point was converted to a summary measure. A total of 321 eligible RCTs were included (48% breast, 24% CRC, 28% NSCLC). Over time, the number and size of RCTs increased considerably. For-profit/mixed sponsorship increased substantially during the study period (4% to 57%; P event measures (39% to 78%) and decreasing use of response rate (54% to 14%) as primary end point (P sponsorship were each independently associated with endorsement of the experimental agent (odds ratio [OR] = 19.6, 95% CI, 8.9 to 43.1, and OR = 3.5, 95% CI, 1.6 to 7.5, respectively). RCTs in oncology have become larger and are more likely to be sponsored by industry. Authors of modern RCTs are more likely to strongly endorse novel therapies. For-profit sponsorship and statistically significant results are independently associated with endorsement of the experimental arm.

  16. Movement control exercise versus general exercise to reduce disability in patients with low back pain and movement control impairment. A randomised controlled trial

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    Sieben Judith M

    2011-09-01

    Full Text Available Abstract Background Non-specific low back pain (NSLBP in subacute and chronic stages can be treated effectively with exercise therapy. Research guidelines recommend evaluating different treatments in defined subgroups of patients with NSLBP. A subgroup of patients with movement control impairment (MCI improved significantly on patient specific function and disability in a previous case series after movement control exercises. Methods/Design In a randomised controlled trial (RCT we will compare the effectiveness of movement control and general exercise in patients with MCI. 106 participants aged 18 - 75 will be recruited in 5 outpatient hospital departments and 7 private practices. Patients randomly assigned to the movement control exercise group will be instructed to perform exercises according to their MCI. The general exercise group will follow an exercise protocol aimed at improving endurance and flexibility. Patients in both groups will receive 9 - 18 treatments and will be instructed to do additional exercises at home. The primary outcome is the level of disability assessed using the patient specific functional scale (PSFS which links the perceived pain to functional situations and is measured before treatment and at 6 and 12 months follow-up. Secondary outcomes concern low back pain related disability (Roland Morris questionnaire, RMQ, graded chronic pain scale (GCPS, range of motion and tactile acuity. Discussion To our knowledge this study will be the first to compare two exercise programs for a specific subgroup of patients with NSLBP and MCI. Results of this study will provide insight into the effectiveness of movement control exercise and contribute to our understanding of the mechanisms behind MCI and its relation to NSLBP. Trial registration Current Controlled Trials ISRCTN80064281

  17. Diagnostic randomized controlled trials: the final frontier.

    Science.gov (United States)

    Rodger, Marc; Ramsay, Tim; Fergusson, Dean

    2012-08-16

    Clinicians, patients, governments, third-party payers, and the public take for granted that diagnostic tests are accurate, safe and effective. However, we may be seriously misled if we are relying on robust study design to ensure accurate, safe, and effective diagnostic tests. Properly conducted, randomized controlled trials are the gold standard for assessing the effectiveness and safety of interventions, yet are rarely conducted in the assessment of diagnostic tests. Instead, diagnostic cohort studies are commonly performed to assess the characteristics of a diagnostic test including sensitivity and specificity. While diagnostic cohort studies can inform us about the relative accuracy of an experimental diagnostic intervention compared to a reference standard, they do not inform us about whether the differences in accuracy are clinically important, or the degree of clinical importance (in other words, the impact on patient outcomes). In this commentary we provide the advantages of the diagnostic randomized controlled trial and suggest a greater awareness and uptake in their conduct. Doing so will better ensure that patients are offered diagnostic procedures that will make a clinical difference.

  18. Recent randomized controlled trials in otolaryngology.

    Science.gov (United States)

    Banglawala, Sarfaraz M; Lawrence, Lauren A; Franko-Tobin, Emily; Soler, Zachary M; Schlosser, Rodney J; Ioannidis, John

    2015-03-01

    To assess recent trends in the prevalence and quality of reporting of randomized controlled trials (RCTs) in 4 otolaryngology journals. Methodology and reporting analysis. Randomized controlled trials in 4 otolaryngology journals. All RCTs published from 2011 to 2013 in 4 major otolaryngology journals were examined for characteristics of study design, quality of design and reporting, and funding. Of 5279 articles published in 4 leading otolaryngology journals from 2011 to 2013, 189 (3.3%) were RCTs. The majority of RCTs were clinical studies (86%), with the largest proportion consisting of sinonasal topics (31%). Most interventions were medical (46%), followed by surgical (38%) and mixed (16%). In terms of quality, randomization method was reported in 54% of RCTs, blinding in 33%, and adverse events in 65%. Intention-to-treat analysis was used in 32%; P values were reported in 87% and confidence intervals in 10%. Research funding was most often absent or not reported (55%), followed by not-for-profit (25%). Based on review of 4 otolaryngology journals, RCTs are still a small proportion of all published studies in the field of otolaryngology. There seem to be trends toward improvement in quality of design and reporting of RCTs, although many quality features remain suboptimal. Practitioners both designing and interpreting RCTs should critically evaluate RCTs for quality. © American Academy of Otolaryngology—Head and Neck Surgery Foundation 2014.

  19. Mindfulness-based stress reduction for people with multiple sclerosis - a feasibility randomised controlled trial.

    Science.gov (United States)

    Simpson, Robert; Mair, Frances S; Mercer, Stewart W

    2017-05-16

    Multiple sclerosis (MS) is a stressful condition. Mental health comorbidity is common. Stress can increase the risk of depression, reduce quality of life (QOL), and possibly exacerbate disease activity in MS. Mindfulness-Based Stress Reduction (MBSR) may help, but has been little studied in MS, particularly among more disabled individuals. The objective of this study was to test the feasibility and likely effectiveness of a standard MBSR course for people with MS. Participant eligibility included: age > 18, any type of MS, an Expanded Disability Status Scale (EDSS) control. Outcome measures were collected at baseline, post-intervention, and three-months later. Primary outcomes were perceived stress and QOL. Secondary outcomes were common MS symptoms, mindfulness, and self-compassion. Fifty participants were recruited and randomised (25 per group). Trial retention and outcome measure completion rates were 90% at post-intervention, and 88% at 3 months. Sixty percent of participants completed the course. Immediately post-MBSR, perceived stress improved with a large effect size (ES 0.93; p < 0.01), compared to very small beneficial effects on QOL (ES 0.17; p = 0.48). Depression (ES 1.35; p < 0.05), positive affect (ES 0.87; p = 0.13), anxiety (ES 0.85; p = 0.05), and self-compassion (ES 0.80; p < 0.01) also improved with large effect sizes. At three-months post-MBSR (study endpoint) improvements in perceived stress were diminished to a small effect size (ES 0.26; p = 0.39), were negligible for QOL (ES 0.08; p = 0.71), but were large for mindfulness (ES 1.13; p < 0.001), positive affect (ES 0.90; p = 0.54), self-compassion (ES 0.83; p < 0.05), anxiety (ES 0.82; p = 0.15), and prospective memory (ES 0.81; p < 0.05). Recruitment, retention, and data collection demonstrate that a RCT of MBSR is feasible for people with MS. Trends towards improved outcomes suggest that a larger definitive RCT may be warranted. However

  20. 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

  1. Bluebelle study (phase A): a mixed-methods feasibility study to inform an RCT of surgical wound dressing strategies

    Science.gov (United States)

    2016-01-01

    Objectives Dressing primary surgical wounds is common, but the implications for surgical site infection (SSI) remain unknown. The Bluebelle study aimed to determine the feasibility of a randomised controlled trial (RCT) comparing ‘simple’, ‘complex’ or ‘no’ dressings on abdominal wounds, as prespecified in a funder's research brief. Bluebelle includes exploratory work (phase A) to inform a pilot version of the proposed RCT (phase B). Phase A aimed to investigate current dressing practices and perspectives on the proposed RCT, with a view to refining the forthcoming pilot. Design Mixed methods, including semi-structured interviews and document analysis. Setting 6 UK hospitals. Participants 51 patients and 92 clinical professionals from abdominal surgical specialities. Results Professionals had variable interpretations of what constitutes a ‘dressing’, particularly with respect to ‘glue’—a product listed under ‘wound-closure products’ in the British National Formulary, which some surgeons reportedly applied as a ‘wound covering’. Areas of ambiguity arising from interviews informed development of pragmatic definitions, including specification of conditions under which glue constituted a ‘dressing’. Professionals reported that ‘simple’ dressings were routinely used in practice, whereas ‘complex’ dressings were not. This raised questions about the relevance of comparison groups, prompting the design of a survey to determine the types/frequency of dressing use in abdominal surgery (reported elsewhere). This confirmed that complex dressings were rarely used, while ‘glue as a dressing’ was used relatively frequently. ‘Complex dressings’ were therefore substituted for ‘glue as a dressing’ (following an updated Cochrane review, which found insufficient evidence to determine the effectiveness of ‘glue as a dressing’). Patients and professionals acknowledged uncertainty around dressing use and SSI prevention, but felt

  2. The Walking Interventions Through Texting (WalkIT) Trial: Rationale, Design, and Protocol for a Factorial Randomized Controlled Trial of Adaptive Interventions for Overweight and Obese, Inactive Adults.

    Science.gov (United States)

    Hurley, Jane C; Hollingshead, Kevin E; Todd, Michael; Jarrett, Catherine L; Tucker, Wesley J; Angadi, Siddhartha S; Adams, Marc A

    2015-09-11

    Walking is a widely accepted and frequently targeted health promotion approach to increase physical activity (PA). Interventions to increase PA have produced only small improvements. Stronger and more potent behavioral intervention components are needed to increase time spent in PA, improve cardiometabolic risk markers, and optimize health. Our aim is to present the rationale and methods from the WalkIT Trial, a 4-month factorial randomized controlled trial (RCT) in inactive, overweight/obese adults. The main purpose of the study was to evaluate whether intensive adaptive components result in greater improvements to adults' PA compared to the static intervention components. Participants enrolled in a 2x2 factorial RCT and were assigned to one of four semi-automated, text message-based walking interventions. Experimental components included adaptive versus static steps/day goals, and immediate versus delayed reinforcement. Principles of percentile shaping and behavioral economics were used to operationalize experimental components. A Fitbit Zip measured the main outcome: participants' daily physical activity (steps and cadence) over the 4-month duration of the study. Secondary outcomes included self-reported PA, psychosocial outcomes, aerobic fitness, and cardiorespiratory risk factors assessed pre/post in a laboratory setting. Participants were recruited through email listservs and websites affiliated with the university campus, community businesses and local government, social groups, and social media advertising. This study has completed data collection as of December 2014, but data cleaning and preliminary analyses are still in progress. We expect to complete analysis of the main outcomes in late 2015 to early 2016. The Walking Interventions through Texting (WalkIT) Trial will further the understanding of theory-based intervention components to increase the PA of men and women who are healthy, insufficiently active and are overweight or obese. WalkIT is one of

  3. Implementation and results of an integrated data quality assurance protocol in a randomized controlled trial in Uttar Pradesh, India.

    Science.gov (United States)

    Gass, Jonathon D; Misra, Anamika; Yadav, Mahendra Nath Singh; Sana, Fatima; Singh, Chetna; Mankar, Anup; Neal, Brandon J; Fisher-Bowman, Jennifer; Maisonneuve, Jenny; Delaney, Megan Marx; Kumar, Krishan; Singh, Vinay Pratap; Sharma, Narender; Gawande, Atul; Semrau, Katherine; Hirschhorn, Lisa R

    2017-09-07

    There are few published standards or methodological guidelines for integrating Data Quality Assurance (DQA) protocols into large-scale health systems research trials, especially in resource-limited settings. The BetterBirth Trial is a matched-pair, cluster-randomized controlled trial (RCT) of the BetterBirth Program, which seeks to improve quality of facility-based deliveries and reduce 7-day maternal and neonatal mortality and maternal morbidity in Uttar Pradesh, India. In the trial, over 6300 deliveries were observed and over 153,000 mother-baby pairs across 120 study sites were followed to assess health outcomes. We designed and implemented a robust and integrated DQA system to sustain high-quality data throughout the trial. We designed the Data Quality Monitoring and Improvement System (DQMIS) to reinforce six dimensions of data quality: accuracy, reliability, timeliness, completeness, precision, and integrity. The DQMIS was comprised of five functional components: 1) a monitoring and evaluation team to support the system; 2) a DQA protocol, including data collection audits and targets, rapid data feedback, and supportive supervision; 3) training; 4) standard operating procedures for data collection; and 5) an electronic data collection and reporting system. Routine audits by supervisors included double data entry, simultaneous delivery observations, and review of recorded calls to patients. Data feedback reports identified errors automatically, facilitating supportive supervision through a continuous quality improvement model. The five functional components of the DQMIS successfully reinforced data reliability, timeliness, completeness, precision, and integrity. The DQMIS also resulted in 98.33% accuracy across all data collection activities in the trial. All data collection activities demonstrated improvement in accuracy throughout implementation. Data collectors demonstrated a statistically significant (p = 0.0004) increase in accuracy throughout

  4. Testing models of care for terminally ill people who live alone at home: is a randomised controlled trial the best approach?

    Science.gov (United States)

    Aoun, Samar M; O'Connor, Moira; Breen, Lauren J; Deas, Kathleen; Skett, Kim

    2013-03-01

    This project implemented and evaluated two models of care for terminally ill people living alone at home: installing personal alarms (PA) and providing extra care aide (CA) support. The primary aim was to assess the feasibility of using a randomised controlled trial (RCT) approach with this group. A secondary aim was to assess the potential impact of the models of care on the participants' quality of life, symptom distress, anxiety and depression, and perceived benefits and barriers to their use. The two models of care were piloted in collaboration with Silver Chain Hospice Care Service (SCHCS) in Western Australia during 2009-2010. Using a pilot RCT design, equal numbers of participants were randomised to receive extra CA time, PAs or standard care. Attrition reduced the sample size from 20 in each group to 12, 14 and 17 respectively. The intervention period was between 6 and 12 weeks depending on prognosis. The participants were functionally and psychologically well and the majority lived alone by choice. There were physical and psychological benefits associated with provision of the two models of care, particularly for the group supported by CAs in terms of improved sleeping and appetite. However, the impact was mostly not statistically significant due to small sample sizes. The study has highlighted two methodological challenges: the wide variation in the degree of living alone at home leading to complex inclusion criteria, and an RCT approach with attrition differing across groups and patients not wanting to be included in the assigned group. The RCT approach is not considered appropriate for the 'home alone' palliative care population that would have been better supported by providing each participant with a personalised model of care according to needs. However, the outcomes of the project have prompted changes in SCHCS practice when providing care to these patients.

  5. Hepato-biliary clinical trials and their inclusion in the Cochrane Hepato-Biliary Group register and reviews

    DEFF Research Database (Denmark)

    Klingenberg, Sarah Louise; Nikolova, Dimitrinka; Alexakis, Nicholas

    2011-01-01

    The Cochrane Hepato-Biliary Group (CHBG) is one of the 52 collaborative review groups within The Cochrane Collaboration. The activities of the CHBG focus on collecting hepato-biliary randomized clinical trials (RCT) and controlled clinical trials (CCT), and including them in systematic reviews...... with meta-analyses of the trials. In this overview, we present the growth of The CHBG Controlled Trials Register, as well as the systematic reviews that have been produced since March 1996....

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

    Directory of Open Access Journals (Sweden)

    Geertje van de Ven

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

  7. Early intervention of multiple home visits to prevent childhood obesity in a disadvantaged population: a home-based randomised controlled trial (Healthy Beginnings Trial

    Directory of Open Access Journals (Sweden)

    Alperstein Garth

    2007-05-01

    Full Text Available Abstract Background Studies have shown that a proportion of children as young as two years are already overweight. This indicates that obesity prevention programs that commence as early as possible and are family-focused are needed. This Healthy Beginnings Trial aims to determine the efficacy of a community-based randomized controlled trial (RCT of a home visiting intervention in preventing the early onset of childhood overweight and obesity. The intervention will be conducted over the first two years of life to increase healthy feeding behaviours and physical activity, decrease physical inactivity, enhance parent-child interaction, and hence reduce overweight and obesity among children at 2 and 5 years of age in the most socially and economically disadvantaged areas of Sydney, Australia. Methods/design This RCT will be conducted with a consecutive sample of 782 first time mothers with their newborn children. Pregnant women who are expecting their first child, and who are between weeks 24 and 34 of their pregnancy, will be invited to participate in the trial at the antenatal clinic. Informed consent will be obtained and participants will then be randomly allocated to the intervention or the control group. The allocation will be concealed by sequentially numbered, sealed opaque envelopes containing a computer generated random number. The intervention comprises eight home visits from a specially trained community nurse over two years and pro-active telephone support between the visits. Main outcomes include a duration of breastfeeding measured at 6 and 12 months, b introduction of solids measured at 4 and 6 months, c nutrition, physical activity and television viewing measured at 24 months, and d overweight/obesity status at age 2 and 5 years. Discussion The results of this trial will ascertain whether the home based early intervention is effective in preventing the early onset of childhood overweight and obesity. If proved to be effective, it

  8. Multimodal exercise training in multiple sclerosis: A randomized controlled trial in persons with substantial mobility disability.

    Science.gov (United States)

    Sandroff, Brian M; Bollaert, Rachel E; Pilutti, Lara A; Peterson, Melissa L; Baynard, Tracy; Fernhall, Bo; McAuley, Edward; Motl, Robert W

    2017-10-01

    Mobility disability is a common, debilitating feature of multiple sclerosis (MS). Exercise training has been identified as an approach to improve MS-related mobility disability. However, exercise randomized controlled trials (RCTs) on mobility in MS have generally not selectively targeted those with the onset of irreversible mobility disability. The current multi-site RCT compared the efficacy of 6-months of supervised, multimodal exercise training with an active control condition for improving mobility, gait, physical fitness, and cognitive outcomes in persons with substantial MS-related mobility disability. 83 participants with substantial MS-related mobility disability underwent initial mobility, gait, fitness, and cognitive processing speed assessments and were randomly assigned to 6-months of supervised multimodal (progressive aerobic, resistance, and balance) exercise training (intervention condition) or stretching-and-toning activities (control condition). Participants completed the same outcome assessments halfway through and immediately following the 6-month study period. There were statistically significant improvements in six-minute walk performance (F(2158)=3.12, p=0.05, ηp(2)=0.04), peak power output (F(2150)=8.16, pdisability. This is critical for informing the development of multi-site exercise rehabilitation programs in larger samples of persons with MS-related mobility disability. Copyright © 2017 Elsevier Inc. All rights reserved.

  9. Personalised Hip Therapy: development of a non-operative protocol to treat femoroacetabular impingement syndrome in the FASHIoN randomised controlled trial

    Science.gov (United States)

    Wall, Peter DH; Dickenson, Edward J; Robinson, David; Hughes, Ivor; Realpe, Alba; Hobson, Rachel; Griffin, Damian R; Foster, Nadine E

    2016-01-01

    Introduction Femoroacetabular impingement (FAI) syndrome is increasingly recognised as a cause of hip pain. As part of the design of a randomised controlled trial (RCT) of arthroscopic surgery for FAI syndrome, we developed a protocol for non-operative care and evaluated its feasibility. Methods In phase one, we developed a protocol for non-operative care for FAI in the UK National Health Service (NHS), through a process of systematic review and consensus gathering. In phase two, the protocol was tested in an internal pilot RCT for protocol adherence and adverse events. Results The final protocol, called Personalised Hip Therapy (PHT), consists of four core components led by physiotherapists: detailed patient assessment, education and advice, help with pain relief and an exercise-based programme that is individualised, supervised and progressed over time. PHT is delivered over 12–26 weeks in 6–10 physiotherapist-patient contacts, supplemented by a home exercise programme. In the pilot RCT, 42 patients were recruited and 21 randomised to PHT. Review of treatment case report forms, completed by physiotherapists, showed that 13 patients (62%) received treatment that had closely followed the PHT protocol. 13 patients reported some muscle soreness at 6 weeks, but there were no serious adverse events. Conclusion PHT provides a structure for the non-operative care of FAI and offers guidance to clinicians and researchers in an evolving area with limited evidence. PHT was deliverable within the National Health Service, is safe, and now forms the comparator to arthroscopic surgery in the UK FASHIoN trial (ISRCTN64081839). Trial registration number ISRCTN 09754699. PMID:27629405

  10. Seeds of prevention: the impact on health behaviors of young adolescent girls in Uttar Pradesh, India, a cluster randomized control trial.

    Science.gov (United States)

    Kapadia-Kundu, Nandita; Storey, Douglas; Safi, Basil; Trivedi, Geetali; Tupe, Rama; Narayana, G

    2014-11-01

    Of the world's 1.2 billion adolescents (10-19 years), India is home to the largest number globally, about 243 million. However not much is known about the health of young adolescent girls (11-14 years) in India who enter puberty with substantial nutritional and health deficits. Identifying early adolescence as a "gateway" moment, the Saloni pilot study is arandomized control trial (RCT) to improve nutrition, hygiene and reproductive health behaviors in 30 schools in rural Uttar Pradesh (UP), India. A prevention model that includes Sadharanikaran, an ancient Indian theory of communication, guided the development of the intervention. The Saloni strategy includes a 10 session in-school intervention based on compassion, self efficacy, emotional well being, peer and parental support, packaged in the form of short, easy-to-use instructional modules. A diary designed to engage adolescent girls is provided to each girl. The cluster RCT was conducted from January 2010 to October 2011 with adolescent girls (11-14 years of age) in Hardoi district. The trial is a two-level, nested RCT with the unit of randomization being the block with 15 schools in the intervention arm and 15 schools in the control arm. A sample of 1200 girls was randomly selected. The intervention had a significant impact on more than 13 preventive health behaviors. About 65 percent girls in the intervention group had adopted 13 or more health behaviors at end line compared 4.5 percent in the control group at end line and 5 percent at baseline. Behavioral impact was demonstrated in all three areas of nutrition, hygiene and reproductive health. The study provides evidence that early adolescence is indeed a "gateway moment" to build nutritional and health reserves.

  11. Designing medical and educational intervention studies. A review of some alternatives to conventional randomized controlled trials

    OpenAIRE

    Bradley, Clare

    1993-01-01

    The advantages and limitations of RCT designs are discussed, and a range of alternative designs for medical and educational intervention studies considered. Designs selected are those that address the much neglected psychological issues involved in the recruitment of patients and allocation of patients to treatments within trials. Designs include Zelen's (18) randomized consent design, Brewin and Bradley's (20) partially randomized patient-centered design, and Korn and Baumrind's (21) partial...

  12. Evaluating the feasibility and effectiveness of a critical care discharge information pack for patients and their families: a pilot cluster randomised controlled trial

    Science.gov (United States)

    Bench, Suzanne; Day, Tina; Heelas, Karina; Hopkins, Philip; White, Catherine; Griffiths, Peter

    2015-01-01

    Objectives To evaluate the feasibility and effectiveness of an information pack, based on self-regulation theory, designed to support patients and their families immediately before, during and after discharge from an intensive care unit (ICU). Design and setting Prospective assessor-blinded pilot cluster randomised controlled trial (RCT; in conjunction with a questionnaire survey of trial participants’ experience) in 2 ICUs in England. Participants Patients (+/− a family member) who had spent at least 72 h in an ICU, declared medically fit for discharge to a general ward. Randomisation Cluster randomisation (by day of discharge decision) was used to allocate participants to 1 of 3 study groups. Intervention A user-centred critical care discharge information pack (UCCDIP) containing 2 booklets; 1 for the patient (which included a personalised discharge summary) and 1 for the family, given prior to discharge to the ward. Primary outcome Psychological well-being measured using Hospital Anxiety and Depression Scores (HADS), assessed at 5±1 days postunit discharge and 28 days/hospital discharge. Statistical significance (p≤0.05) was determined using χ2 and Kruskal-Wallis (H). Results 158 patients were allocated to: intervention (UCCDIP; n=51), control 1: ad hoc verbal information (n=59), control 2: booklet published by ICUsteps (n=48). There were no statistically significant differences in the primary outcome. The a priori enrolment goal was not reached and attrition was high. Using HADS as a primary outcome measure, an estimated sample size of 286 is required to power a definitive trial. Conclusions Findings from this pilot RCT provide important preliminary data regarding the circumstances under which an intervention based on the principles of UCCDIP could be effective, and the sample size required to demonstrate this. Trial registration number Current Controlled Trials ISRCTN47262088; results. PMID:26614615

  13. Increasing recruitment to randomised trials: a review of randomised controlled trials

    Directory of Open Access Journals (Sweden)

    Torgerson David J

    2006-07-01

    Full Text Available Abstract Background Poor recruitment to randomised controlled trials (RCTs is a widespread and important problem. With poor recruitment being such an important issue with respect to the conduct of randomised trials, a systematic review of controlled trials on recruitment methods was undertaken in order to identify strategies that are effective. Methods We searched the register of trials in Cochrane library from 1996 to end of 2004. We also searched Web of Science for 2004. Additional trials were identified from personal knowledge. Included studies had to use random allocation and participants had to be allocated to different methods of recruitment to a 'real' randomised trial. Trials that randomised participants to 'mock' trials and trials of recruitment to non-randomised studies (e.g., case control studies were excluded. Information on the study design, intervention and control, and number of patients recruited was extracted by the 2 authors. Results We identified 14 papers describing 20 different interventions. Effective interventions included: telephone reminders; questionnaire inclusion; monetary incentives; using an 'open' rather than placebo design; and making trial materials culturally sensitive. Conclusion Few trials have been undertaken to test interventions to improve trial recruitment. There is an urgent need for more RCTs of recruitment strategies.

  14. Targeted physiotherapy for patellofemoral joint osteoarthritis: A protocol for a randomised, single-blind controlled trial

    Directory of Open Access Journals (Sweden)

    Schache Anthony G

    2008-09-01

    Full Text Available Abstract Background The patellofemoral joint (PFJ is one compartment of the knee that is frequently affected by osteoarthritis (OA and is a potent source of OA symptoms. However, there is a dearth of evidence for compartment-specific treatments for PFJ OA. Therefore, this project aims to evaluate whether a physiotherapy treatment, targeted to the PFJ, results in greater improvements in pain and physical function than a physiotherapy education intervention in people with symptomatic and radiographic PFJ OA. Methods 90 people with PFJ OA (PFJ-specific history, signs and symptoms and radiographic evidence of PFJ OA will be recruited from the community and randomly allocated into one of two treatments. A randomised controlled trial adhering to CONSORT guidelines will evaluate the efficacy of physiotherapy (8 individual sessions over 12 weeks, as well as a home exercise program 4 times/week compared to a physiotherapist-delivered OA education control treatment (8 individual sessions over 12 weeks. Physiotherapy treatment will consist of (i quadriceps muscle retraining; (ii quadriceps and hip muscle strengthening; (iii patellar taping; (iv manual PFJ and soft tissue mobilisation; and (v OA education. Resistance and dosage of exercises will be tailored to the participant's functional level and clinical state. Primary outcomes will be evaluated by a blinded examiner at baseline, 12 weeks and 9 months using validated and reliable pain, physical function and perceived global effect scales. All analyses will be conducted on an intention-to-treat basis using linear mixed regression models, including respective baseline scores as a covariate, subjects as a random effect, treatment condition as a fixed factor and the covariate by treatment interaction. Conclusion This RCT is targeting PFJ OA, an important sub-group of knee OA patients, with a specifically designed conservative intervention. The project's outcome will influence PFJ OA rehabilitation, with the

  15. Efficacy of highly bioavailable zinc from fortified water: a randomized controlled trial in rural Beninese children.

    Science.gov (United States)

    Galetti, Valeria; Kujinga, Prosper; Mitchikpè, Comlan Evariste S; Zeder, Christophe; Tay, Fabian; Tossou, Félicien; Hounhouigan, Joseph D; Zimmermann, Michael B; Moretti, Diego

    2015-11-01

    Zinc deficiency and contaminated water are major contributors to diarrhea in developing countries. Food fortification with zinc has not shown clear benefits, possibly because of low zinc absorption from inhibitory food matrices. We used a novel point-of-use water ultrafiltration device configured with glass zinc plates to produce zinc-fortified, potable water. The objective was to determine zinc bioavailability from filtered water and the efficacy of zinc-fortified water in improving zinc status. In a crossover balanced study, we measured fractional zinc absorption (FAZ) from the zinc-fortified water in 18 healthy Swiss adults using zinc stable isotopes and compared it with zinc-fortified maize porridge. We conducted a 20-wk double-blind randomized controlled trial (RCT) in 277 Beninese school children from rural settings who were randomly assigned to receive a daily portion of zinc-fortified filtered water delivering 2.8 mg Zn (Zn+filter), nonfortified filtered water (Filter), or nonfortified nonfiltered water (Pump) from the local improved supply, acting as the control group. The main outcome was plasma zinc concentration (PZn), and the 3 groups were compared by using mixed-effects models. Secondary outcomes were prevalence of zinc deficiency, diarrhea prevalence, and growth. Geometric mean (-SD, +SD) FAZ was 7-fold higher from fortified water (65.9%; 42.2, 102.4) than from fortified maize (9.1%; 6.0, 13.7; P diarrhea or growth, but our study did not have the duration and power to detect such effects. Consumption of filtered water fortified with a low dose of highly bioavailable zinc is an effective intervention in children from rural African settings. Large community-based trials are needed to assess the effectiveness of zinc-fortified filtered water on diarrhea and growth. These trials were registered at clinicaltrials.gov as NCT01636583 and NCT01790321. © 2015 American Society for Nutrition.

  16. Traumatic Brain Injury in Latin America: Lifespan Analysis Randomized Control Trial Protocol

    Science.gov (United States)

    Chesnut, Randall M.; Temkin, Nancy; Carney, Nancy; Dikmen, Sureyya; Pridgeon, Jim; Barber, Jason; Celix, Juanita M.; Chaddock, Kelley; Cherner, Marianna; Hendrix, Terence; Lujan, Silvia; Machamer, Joan; Petroni, Gustavo; Rondina, Carlos; Videtta, Walter

    2012-01-01

    Background Although in the developed world the intracranial pressure (ICP) monitor is considered “standard of care” for patients with severe traumatic brain injury (TBI), its usefulness to direct treatment decisions has never been tested rigorously. Objective The primary focus is to conduct a high quality randomized, controlled trial to determine if ICP monitoring used to direct TBI treatment improves patient outcomes. By providing education, equipment, and structure, the project will enhance the research capacity of the collaborating investigators and will foster the collaborations established during earlier studies (add refs to papers from earlier studies). Methods Study centers were selected that routinely treated ICP based on clinical examination and CT imaging using internal protocols. We randomize patients to either an ICP Monitor Group or an Imaging and Clinical Examination Group. Treatment decisions for the ICP Monitor Group are guided by ICP monitoring, based on established guidelines. Treatment decisions for the Imaging and Clinical Examination Group are made using a single protocol derived from those previously being used at those centers. Expected Outcomes There are two study hypotheses: 1) Patients with severe TBI whose acute care treatment is managed using ICP monitors will have improved outcomes and 2) incorporating ICP monitoring into the care of patients with severe TBI will minimize complications and decrease length of ICU stay. Discussion This clinical trial tests the effectiveness of a management protocol based on technology considered pivotal to brain trauma treatment in the developed world - the ICP monitor. A randomized controlled trial of ICP monitoring has never been performed - a critical gap in the evidence base that supports the role of ICP monitoring in TBI care. As such, the results of this RCT will have global implications regardless of the level of development of the trauma system. PMID:22986600

  17. Randomized controlled trials of COX-2 inhibitors

    DEFF Research Database (Denmark)

    Stefansdottir, Gudrun; De Bruin, Marie L; Knol, Mirjam J

    2011-01-01

    BACKGROUND: Naproxen, ibuprofen and diclofenac are frequently used as comparators in randomized controlled trials (RCTs) on the safety and efficacy of cyclooxygenase (COX)-2 inhibitors. Different comparator doses may influence the results of RCTs. It has been hypothesized that RCTs of COX-2...... 1995 and 2009 in which celecoxib or rofecoxib were compared with naproxen, ibuprofen or diclofenac. All articles labelled as RCTs mentioning rofecoxib or celecoxib and one or more of the comparator drugs in the title and/or abstract were included. We extracted information on doses of both non...... dose trends in the case of rofecoxib. CONCLUSIONS: Although the dose trends over time differed for RCTs comparing rofecoxib and celecoxib with diclofenac, ibuprofen or naproxen, the results of our study do not support the hypothesis that dose trends influenced the decision to continue marketing...

  18. Vitamin D-enhanced eggs are protective of wintertime serum 25-hydroxyvitamin D in a randomized controlled trial of adults

    DEFF Research Database (Denmark)

    Hayes, Aoife; Duffy, Sarah; O'Grady, Michael;

    2016-01-01

    Despite numerous animal studies that have illustrated the impact of additional vitamin D in the diet of hens on the resulting egg vitamin D content, the effect of the consumption of such eggs on vitamin D status of healthy individuals has not, to our knowledge, been tested. We performed a randomi......Despite numerous animal studies that have illustrated the impact of additional vitamin D in the diet of hens on the resulting egg vitamin D content, the effect of the consumption of such eggs on vitamin D status of healthy individuals has not, to our knowledge, been tested. We performed...... a randomized controlled trial (RCT) to investigate the effect of the consumption of vitamin D-enhanced eggs (produced by feeding hens at the maximum concentration of vitamin D3 or serum 25-hydroxyvitamin D [25(OH)D3] lawfully allowed in feed) on winter serum 25(OH)D in healthy adults. We conducted an 8-wk...

  19. A web-based intervention (RESTORE) to support self-management of cancer-related fatigue following primary cancer treatment: a multi-centre proof of concept randomised controlled trial

    OpenAIRE

    Foster, Claire; Grimmett, Chloe; May, Christine M.; Ewings, Sean; Myall, Michelle; Hulme, Claire; Smith, Peter W.; Powers, Cassandra; Calman, Lynn; Armes, Jo; Breckons, Matthew; Corner, Jessica; Fenlon, Deborah; Batehup, Lynn; Lennan, Elaine

    2015-01-01

    Purpose: Cancer-related fatigue (CRF) is a frequent and distressing symptom experienced after cancer treatment. RESTORE is the first web-based resource designed to enhance self-efficacy to manage CRF following curative-intent treatment. The aim of this study is to test the proof of concept and inform the design of an effectiveness trial.\\ud \\ud Methods: A multi-centre parallel-group two-armed (1:1) exploratory randomised controlled trial (RCT) with qualitative process evaluation was employed ...

  20. Happy Family Kitchen II: A Cluster Randomized Controlled Trial of a Community-Based Family Intervention for Enhancing Family Communication and Well-being in Hong Kong.

    Science.gov (United States)

    Ho, Henry C Y; Mui, Moses; Wan, Alice; Ng, Yin-Lam; Stewart, Sunita M; Yew, Carol; Lam, Tai Hing; Chan, Sophia S

    2016-01-01

    Long working hours and stressful urban lifestyles pose major challenges to family communication and well-being in Hong Kong. A community-based family intervention derived from a positive psychology framework, by using cooking and dining as a platform, was developed for improving family communication and well-being. Social workers and teachers from 31 social service units and schools in collaboration with an academic partner organized and conducted the intervention programs for 2,070 individuals from 973 families in a deprived district in Hong Kong. The participants were randomly assigned into the intervention or control group in a cluster randomized controlled trial (cRCT). The core intervention covered one of five positive psychology themes: joy, gratitude, flow, savoring, and listening. Assessments at pre-intervention, immediate post-intervention, and 4 and 12 weeks post-intervention showed improved family communication and well-being with sustainable effects up to 12 weeks. Positive changes in family happiness and family health were greater in the intervention group than in the control group. The savoring intervention had the most improved outcomes among the five themes. We concluded that this large-scale brief cRCT developed and conducted in real-world settings provided evidence for the feasibility and effectiveness of a community-based family intervention. This study was registered under ClinicalTrials.gov (NCT01796275).

  1. Ankles back in randomized controlled trial (ABrCt: braces versus neuromuscular exercises for the secondary prevention of ankle sprains. Design of a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Verhagen Evert ALM

    2011-09-01

    Full Text Available Abstract Background Ankle sprains are the most common sports and physical activity related injury. There is extensive evidence that there is a twofold increased risk for injury recurrence for at least one year post injury. In up to 50% of all cases recurrences result in disability and lead to chronic pain or instability, requiring prolonged medical care. Therefore ankle sprain recurrence prevention in athletes is essential. This RCT evaluates the effect of the combined use of braces and neuromuscular training (e.g. proprioceptive training/sensorimotor training/balance training against the individual use of either braces or neuromuscular training alone on ankle sprain recurrences, when applied to individual athletes after usual care. Methods/Design This study was designed as three way randomized controlled trial with one year follow-up. Healthy individuals between 12 and 70 years of age, who were actively participating in sports and who had sustained a lateral ankle sprain in the two months prior to inclusion, were eligible for inclusion. After subjects had finished ankle sprain treatment by means of usual care, they were randomised to any of the three study groups. Subjects in group 1 received an eight week neuromuscular training program, subjects in group 2 received a sports brace to be worn during all sports activities for the duration of one year, and group 3 received a combination of the neuromuscular training program and a sports brace to be worn during all sports activities for the duration of eight weeks. Outcomes were assessed at baseline and every month for 12 months therafter. The primary outcome measure was incidence of ankle sprain recurrences. Secondary outcome measures included the direct and indirect costs of recurrent injury, the severity of recurrent injury, and the residual complaints during and after the intervention. Discussion The ABrCt is the first randomized controlled trial to directly compare the secondary preventive

  2. Hepato-biliary clinical trials and their inclusion in the Cochrane Hepato-Biliary Group register and reviews

    DEFF Research Database (Denmark)

    Klingenberg, Sarah Louise; Nikolova, Dimitrinka; Alexakis, Nicholas

    2011-01-01

    The Cochrane Hepato-Biliary Group (CHBG) is one of the 52 collaborative review groups within The Cochrane Collaboration. The activities of the CHBG focus on collecting hepato-biliary randomized clinical trials (RCT) and controlled clinical trials (CCT), and including them in systematic reviews wi...

  3. Medical Therapies for Uterine Fibroids - A Systematic Review and Network Meta-Analysis of Randomised Controlled Trials.

    Directory of Open Access Journals (Sweden)

    Kurinchi S Gurusamy

    Full Text Available Uterine fibroids are common, often symptomatic and a third of women need repeated time off work. Consequently 25% to 50% of women with fibroids receive surgical treatment, namely myomectomy or hysterectomy. Hysterectomy is the definitive treatment as fibroids are hormone dependent and frequently recurrent. Medical treatment aims to control symptoms in order to replace or delay surgery. This may improve the outcome of surgery and prevent recurrence.To determine whether any medical treatment can be recommended in the treatment of women with fibroids about to undergo surgery and in those for whom surgery is not planned based on currently available evidence.Two authors independently identified randomised controlled trials (RCT of all pharmacological treatments aimed at the treatment of fibroids from a list of references obtained by formal search of MEDLINE, EMBASE, Cochrane library, Science Citation Index, and ClinicalTrials.gov until December 2013.Two authors independently extracted data from identified studies.A Bayesian network meta-analysis was performed following the National Institute for Health and Care Excellence-Decision Support Unit guidelines. Odds ratios, rate ratios, or mean differences with 95% credible intervals (CrI were calculated.A total of 75 RCT met the inclusion criteria, 47 of which were included in the network meta-analysis. The overall quality of evidence was very low. The network meta-analysis showed differing results for different outcomes.There is currently insufficient evidence to recommend any medical treatment in the management of fibroids. Certain treatments have future promise however further, well designed RCTs are needed.

  4. Assessment of adherence to the CONSORT statement for quality of reports on randomized controlled trial abstracts from four high-impact general medical journals

    Directory of Open Access Journals (Sweden)

    Ghimire Saurav

    2012-06-01

    Full Text Available Abstract Background The extended Consolidated Standards of Reporting Trials (CONSORT Statement for Abstracts was developed to improve the quality of reports of randomized controlled trials (RCTs because readers often base their assessment of a trial solely on the abstract. To date, few data exist regarding whether it has achieved this goal. We evaluated the extent of adherence to the CONSORT for Abstract statement for quality of reports on RCT abstracts by four high-impact general medical journals. Methods A descriptive analysis of published RCT abstracts in The New England Journal of Medicine (NEJM, The Lancet, The Journal of American Medical Association (JAMA, and the British Medical Journal (BMJ in the year 2010 was conducted by two reviewers, independently extracting data from a MEDLINE/PubMed search. Results We identified 271 potential RCT abstracts meeting our inclusion criteria. More than half of the abstracts identified the study as randomized in the title (58.7%; 159/271, reported the specific objective/hypothesis (72.7%; 197/271, described participant eligibility criteria with settings for data collection (60.9%; 165/271, detailed the interventions for both groups (90.8%; 246/271, and clearly defined the primary outcome (94.8%; 257/271. However, the methodological quality domains were inadequately reported: allocation concealment (11.8%; 32/271 and details of blinding (21.0%; 57/271. Reporting the primary outcome results for each group was done in 84.1% (228/271. Almost all of the abstracts reported trial registration (99.3%; 269/271, whereas reports of funding and of harm or side effects from the interventions were found in only 47.6% (129/271 and 42.8% (116/271 of the abstracts, respectively. Conclusions These findings show inconsistencies and non-adherence to the CONSORT for abstract guidelines, especially in the methodological quality domains. Improvements in the quality of RCT reports can be expected by adhering to existing

  5. A pharmacy management service for adults with asthma: a cluster randomised controlled trial.

    Science.gov (United States)

    Wong, Lai-Yan; Chua, Siew-Siang; Husin, Abdul-Rahman; Arshad, Hanisah

    2017-05-03

    Although clinical guidelines are available for the management of asthma, this health condition is still poorly managed in many countries. To assess the effects of a Pharmacy Management Service (PharMS) on asthma control of adult patients. This study comprised of a cluster randomised controlled trial (RCT) that was conducted from April 2014 to July 2015 at four government health clinics. The control participants received usual pharmacy service, while the intervention participants were recruited into the PharMS. Each participant was monitored for 6 months, and the outcome measures included asthma control using the Asthma Control Test (ACT), inhaler technique using a checklist and medication adherence using the Malaysian Medication Adherence Scale. A total of 157 participants were recruited: 77 in the control and 80 in the intervention group. At the end of the study, 90% of the intervention participants achieved well-controlled asthma compared to 28.6% in the control group (P < 0.001). The differences in the proportion of participants with correct inhaler technique was also significant, with an adjusted effect size of 0.953 (P < 0.001). In addition, the intervention participants showed significantly higher medication adherence than the control group (92.5% versus 45.5%, P < 0.001). The Generalised Estimated Equation analysis further confirmed that the PharMS (P < 0.001) was significantly related to an improvement in the ACT scores. A community-based asthma management program, the PharMS, that provided asthma education and skill training by a trained pharmacist, resulted in positive and significant improvements in clinical and management outcomes of adult asthma patients.

  6. Effects of standard training in the use of closed-circuit televisions in visually impaired adults: design of a training protocol and a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    van Rens Ger HMB

    2010-03-01

    Full Text Available Abstract Background Reading problems are frequently reported by visually impaired persons. A closed-circuit television (CCTV can be helpful to maintain reading ability, however, it is difficult to learn how to use this device. In the Netherlands, an evidence-based rehabilitation program in the use of CCTVs was lacking. Therefore, a standard training protocol needed to be developed and tested in a randomized controlled trial (RCT to provide an evidence-based training program in the use of this device. Methods/Design To develop a standard training program, information was collected by studying literature, observing training in the use of CCTVs, discussing the content of the training program with professionals and organizing focus and discussion groups. The effectiveness of the program was evaluated in an RCT, to obtain an evidence-based training program. Dutch patients (n = 122 were randomized into a treatment group: normal instructions from the supplier combined with training in the use of CCTVs, or into a control group: instructions from the supplier only. The effect of the training program was evaluated in terms of: change in reading ability (reading speed and reading comprehension, patients' skills to operate the CCTV, perceived (vision-related quality of life and tasks performed in daily living. Discussion The development of the CCTV training protocol and the design of the RCT in the present study may serve as an example to obtain an evidence-based training program. The training program was adjusted to the needs and learning abilities of individual patients, however, for scientific reasons it might have been preferable to standardize the protocol further, in order to gain more comparable results. Trial registration http://www.trialregister.nl, identifier: NTR1031

  7. Managing cardiovascular risk in people with chronic kidney disease: a review of the evidence from randomized controlled trials.

    Science.gov (United States)

    Jun, Min; Lv, Jicheng; Perkovic, Vlado; Jardine, Meg J

    2011-07-01

    Cardiovascular disease is the leading cause of death and morbidity in people with chronic kidney disease (CKD) making measures to modify cardiovascular risk a clinical priority. The relationship between risk factors and cardiovascular outcomes is often substantially different in people with CKD compared with the general population, leading to uncertainty around pathophysiological mechanisms and the validity of generalizations from the general population. Furthermore, published reports of subgroup analyses from clinical trials have suggested that a range of interventions may have different effects in people with kidney disease compared with those with normal kidney function. There is a relative scarcity of randomized controlled trials (RCTs) conducted in CKD populations, and most such trials are small and underpowered. As a result, evidence to support cardiovascular risk modification measures for people with CKD is largely derived from small trials and post hoc analyses of RCTs conducted in the general population. In this review, we examine the available RCT evidence on interventions aimed at preventing cardiovascular events in people with kidney disease to identify beneficial treatments as well as current gaps in knowledge that should be a priority for future research.

  8. A systematic survey on reporting and methods for handling missing participant data for continuous outcomes in randomized controlled trials.

    Science.gov (United States)

    Zhang, Yuqing; Flórez, Ivan D; Colunga Lozano, Luis E; Aloweni, Fazila Abu Bakar; Kennedy, Sean Alexander; Li, Aihua; Craigie, Samantha; Zhang, Shiyuan; Agarwal, Arnav; Lopes, Luciane C; Devji, Tahira; Wiercioch, Wojtek; Riva, John J; Wang, Mengxiao; Jin, Xuejing; Fei, Yutong; Alexander, Paul; Morgano, Gian Paolo; Zhang, Yuan; Carrasco-Labra, Alonso; Kahale, Lara A; Akl, Elie A; Schünemann, Holger J; Thabane, Lehana; Guyatt, Gordon H

    2017-08-01

    To assess analytic approaches randomized controlled trial (RCT) authors use to address missing participant data (MPD) for patient-important continuous outcomes. We conducted a systematic survey of RCTs published in 2014 in the core clinical journals that reported at least one patient-important outcome analyzed as a continuous variable. Among 200 studies, 187 (93.5%) trials explicitly reported whether MPD occurred. In the 163 (81.5%) trials that reported the occurrence of MPD, the median and interquartile ranges of the percentage of participants with MPD were 11.4% (2.5%-22.6%).Among the 147 trials in which authors made clear their analytical approach to MPD, the approaches chosen included available data only (109, 67%); mixed-effect models (10, 6.1%); multiple imputation (9, 4.5%); and last observation carried forward (9, 4.5). Of the 163 studies reporting MPD, 16 (9.8%) conducted sensitivity analyses examining the impact of the MPD and (18, 11.1%) discussed the risk of bias associated with MPD. RCTs reporting continuous outcomes typically have over 10% of participant data missing. Most RCTs failed to use optimal analytic methods, and very few conducted sensitivity analyses addressing the possible impact of MPD or commented on how MPD might influence risk of bias. Copyright © 2017 Elsevier Inc. All rights reserved.

  9. Design of an international multicentre RCT on group schema therapy for borderline personality disorder.

    Science.gov (United States)

    Wetzelaer, Pim; Farrell, Joan; Evers, Silvia M A A; Jacob, Gitta A; Lee, Christopher W; Brand, Odette; van Breukelen, Gerard; Fassbinder, Eva; Fretwell, Heather; Harper, R Patrick; Lavender, Anna; Lockwood, George; Malogiannis, Ioannis A; Schweiger, Ulrich; Startup, Helen; Stevenson, Teresa; Zarbock, Gerhard; Arntz, Arnoud

    2014-11-18

    Borderline personality disorder (BPD) is a severe and highly prevalent mental disorder. Schema therapy (ST) has been found effective in the treatment of BPD and is commonly delivered through an individual format. A group format (group schema therapy, GST) has also been developed. GST has been found to speed up and amplify the treatment effects found for individual ST. Delivery in a group format may lead to improved cost-effectiveness. An important question is how GST compares to treatment as usual (TAU) and what format for delivery of schema therapy (format A; intensive group therapy only, or format B; a combination of group and individual therapy) produces the best outcomes. An international, multicentre randomized controlled trial (RCT) will be conducted with a minimum of fourteen participating centres. Each centre will recruit multiple cohorts of at least sixteen patients. GST formats as well as the orders in which they are delivered to successive cohorts will be balanced. Within countries that contribute an uneven number of sites, the orders of GST formats will be balanced within a difference of one. The RCT is designed to include a minimum of 448 patients with BPD. The primary clinical outcome measure will be BPD severity. Secondary clinical outcome measures will include measures of BPD and general psychiatric symptoms, schemas and schema modes, social functioning and quality of life. Furthermore, an economic evaluation that consists of cost-effectiveness and cost-utility analyses will be performed using a societal perspective. Lastly, additional investigations will be carried out that include an assessment of the integrity of GST, a qualitative study on patients' and therapists' experiences with GST, and studies on variables that might influence the effectiveness of GST. This trial will compare GST to TAU for patients with BPD as well as two different formats for the delivery of GST. By combining an evaluation of clinical effectiveness, an economic evaluation

  10. An Internet-Based Intervention for Depression in Primary Care in Spain: A Randomized Controlled Trial

    Science.gov (United States)

    Montero-Marín, Jesús; Araya, Ricardo; Mayoral, Fermín; Gili, Margalida; Botella, Cristina; Baños, Rosa; Castro, Adoración; Romero-Sanchiz, Pablo; López-Del-Hoyo, Yolanda; Nogueira-Arjona, Raquel; Vives, Margarita; Riera, Antoni; García-Campayo, Javier

    2016-01-01

    Background Depression is the most prevalent cause of illness-induced disability worldwide. Face-to-face psychotherapeutic interventions for depression can be challenging, so there is a need for other alternatives that allow these interventions to be offered. One feasible alternative is Internet-based psychological interventions. This is the first randomized controlled trial (RCT) on the effectiveness of an Internet-based intervention on depression in primary health care in Spain. Objective Our aim was to compare the effectiveness of a low-intensity therapist-guided (LITG) Internet-based program and a completely self-guided (CSG) Internet-based program with improved treatment as usual (iTAU) care for depression. Methods Multicenter, three-arm, parallel, RCT design, carried out between November 2012 and January 2014, with a follow-up of 15 months. In total, 296 adults from primary care settings in four Spanish regions, with mild or moderate major depression, were randomized to LITG (n=96), CSG (n=98), or iTAU (n=102). Research completers at follow-up were 63.5%. The intervention was Smiling is Fun, an Internet program based on cognitive behavioral therapy. All patients received iTAU by their general practitioners. Moreover, LITG received Smiling is Fun and the possibility of psychotherapeutic support on request by email, whereas CSG received only Smiling is Fun. The main outcome was the Beck Depression Inventory-II at 3 months from baseline. Mixed-effects multilevel analysis for repeated measures were undertaken. Results There was no benefit for either CSG [(B coefficient=-1.15; P=.444)] or LITG [(B=-0.71; P=.634)] compared to iTAU, at 3 months. There were differences at 6 months [iTAU vs CSG (B=-4.22; P=.007); iTAU vs LITG (B=-4.34; P=.005)] and 15 months [iTAU vs CSG (B=-5.10; P=.001); iTAU vs LITG (B=-4.62; P=.002)]. There were no differences between CSG and LITG at any time. Adjusted and intention-to-treat models confirmed these findings. Conclusions An Internet

  11. 'Help for Hay Fever', a goal-focused intervention for people with intermittent allergic rhinitis, delivered in Scottish community pharmacies: study protocol for a pilot cluster randomized controlled trial.

    Science.gov (United States)

    Porteous, Terry; Wyke, Sally; Smith, Sarah; Bond, Christine; Francis, Jill; Lee, Amanda J; Lowrie, Richard; Scotland, Graham; Sheikh, Aziz; Thomas, Mike; Smith, Lorraine

    2013-07-15

    Despite the availability of evidence-based guidelines for managing allergic rhinitis in primary care, management of the condition in the United Kingdom (UK) remains sub-optimal. Its high prevalence and negative effects on quality of life, school performance, productivity and co-morbid respiratory conditions (in particular, asthma), and high health and societal costs, make this a priority for developing novel models of care. Recent Australian research demonstrated the potential of a community pharmacy-based 'goal-focused' intervention to help people with intermittent allergic rhinitis to self-manage their condition better, reduce symptom severity and improve quality of life. In this pilot study we will assess the transferability of the goal-focused intervention to a UK context, the suitability of the intervention materials, procedures and outcome measures and collect data to inform a future definitive UK randomized controlled trial (RCT). A pilot cluster RCT with associated preliminary economic analysis and embedded qualitative evaluation. The pilot trial will take place in two Scottish Health Board areas: Grampian and Greater Glasgow & Clyde. Twelve community pharmacies will be randomly assigned to intervention or usual care group. Each will recruit 12 customers seeking advice or treatment for intermittent allergic rhinitis. Pharmacy staff in intervention pharmacies will support recruited customers in developing strategies for setting and achieving goals that aim to avoid/minimize triggers for, and eliminate/minimize symptoms of allergic rhinitis. Customers recruited in non-intervention pharmacies will receive usual care. The co-primary outcome measures, selected to inform a sample size calculation for a future RCT, are: community pharmacy and customer recruitment and completion rates; and effect size of change in the validated mini-Rhinoconjunctivitis Quality of Life Questionnaire between baseline, one-week and six-weeks post-intervention. Secondary outcome

  12. TEACCH-based group social skills training for children with high-functioning autism: a pilot randomized controlled trial.

    Science.gov (United States)

    Ichikawa, Kayoko; Takahashi, Yoshimitsu; Ando, Masahiko; Anme, Tokie; Ishizaki, Tatsuro; Yamaguchi, Hinako; Nakayama, Takeo

    2013-10-01

    Although social skills training programs for people with high-functioning autism (HFA) are widely practiced, the standardization of curricula, the examination of clinical effectiveness, and the evaluation of the feasibility of future trials have yet to be done in Asian countries. To compensate for this problem, a Japanese pilot randomized controlled trial (RCT) of the Treatment and Education of Autistic and Related Communication Handicapped Children (TEACCH)-based group social skills training for children with HFA and their mothers was conducted. Eleven children with HFA, aged 5-6 years, and their mothers were randomly assigned to the TEACCH program (n=5) or a waiting-list control group (n=6). The program involved comprehensive group intervention and featured weekly 2-hour sessions, totaling 20 sessions over six months. The adaptive behaviors and social reciprocity of the children, parenting stress, and parent-child interactions were assessed using the Strengths and Difficulties Questionnaire (SDQ), Parenting Stress Index (PSI), Beck depression inventory-II (BDI-II), and Interaction Rating Scale (IRS). Through this pilot trial, the intervention and evaluation of the program has been shaped. There were no dropouts from the program and the mothers' satisfaction was high. The outcome measurements improved more in the program group than in the control group, with moderate effect sizes (SDQ, 0.71; PSI, 0.58; BDI-II, 0.40; and IRS, 0.69). This pilot trial also implied that this program is more beneficial for high IQ children and mothers with low stress than for those who are not. We have standardized the TEACCH program, confirmed the feasibility of a future trial, and successfully estimated the positive effect size. These findings will contribute to a larger trial in the future and to forthcoming systematic reviews with meta-analyses. UMIN000004560.

  13. Alcohol email assessment and feedback study dismantling effectiveness for university students (AMADEUS-1: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    McCambridge Jim

    2012-07-01

    Full Text Available Abstract Background Alcohol causes huge problems for population health and for society, which require interventions with individuals as well as populations to prevent and reduce harms. Brief interventions can be effective and increasingly take advantage of the internet to reach high-risk groups such as students. The research literature on the effectiveness of online interventions is developing rapidly and is confronted by methodological challenges common to other areas of e-health including attrition and assessment reactivity and in the design of control conditions. Methods/design The study aim is to evaluate the effectiveness of a brief online intervention, employing a randomized controlled trial (RCT design that takes account of baseline assessment reactivity, and other possible effects of the research process. Outcomes will be evaluated after 3 months both among student populations as a whole including for a randomized no contact control group and among those who are risky drinkers randomized to brief assessment and feedback (routine practice or to brief assessment only. A three-arm parallel groups trial will also allow exploration of the magnitude of the feedback and assessment component effects. The trial will be undertaken simultaneously in 2 universities randomizing approximately 15,300 students who will all be blinded to trial participation. All participants will be offered routine practice intervention at the end of the study. Discussion This trial informs the development of routine service delivery in Swedish universities and more broadly contributes a new approach to the study of the effectiveness of online interventions in student populations, with relevance to behaviors other than alcohol consumption. The use of blinding and deception in this study raise ethical issues that warrant further attention. Trial registration ISRCTN28328154

  14. On-line randomized controlled trial of an internet based psychologically enhanced intervention for people with hazardous alcohol consumption.

    Directory of Open Access Journals (Sweden)

    Paul Wallace

    Full Text Available BACKGROUND: Interventions delivered via the Internet have the potential to address the problem of hazardous alcohol consumption at minimal incremental cost, with potentially major public health implications. It was hypothesised that providing access to a psychologically enhanced website would result in greater reductions in drinking and related problems than giving access to a typical alcohol website simply providing information on potential harms of alcohol. DYD-RCT Trial registration: ISRCTN 31070347. METHODOLOGY/PRINCIPAL FINDINGS: A two-arm randomised controlled trial was conducted entirely on-line through the Down Your Drink (DYD website. A total of 7935 individuals who screened positive for hazardous alcohol consumption were recruited and randomized. At entry to the trial, the geometric mean reported past week alcohol consumption was 46.0 (SD 31.2 units. Consumption levels reduced substantially in both groups at the principal 3 month assessment point to an average of 26.0 (SD 22.3 units. Similar changes were reported at 1 month and 12 months. There were no significant differences between the groups for either alcohol consumption at 3 months (intervention: control ratio of geometric means 1.03, 95% CI 0.97 to 1.10 or for this outcome and the main secondary outcomes at any of the assessments. The results were not materially changed following imputation of missing values, nor was there any evidence that the impact of the intervention varied with baseline measures or level of exposure to the intervention. CONCLUSIONS/SIGNIFICANCE: Findings did not provide support for the hypothesis that access to a psychologically enhanced website confers additional benefit over standard practice and indicate the need for further research to optimise the effectiveness of Internet-based behavioural interventions. The trial demonstrates a widespread and potentially sustainable demand for Internet based interventions for people with hazardous alcohol consumption

  15. Upper limb children action-observation training (UP-CAT): a randomised controlled trial in Hemiplegic Cerebral Palsy

    Science.gov (United States)

    2011-01-01

    Background Rehabilitation for children with hemiplegic cerebral palsy (HCP) aimed to improve function of the impaired upper limb (UL) uses a wide range of intervention programs. A new rehabilitative approach, called Action-Observation Therapy, based on the recent discovery of mirror neurons, has been used in adult stroke but not in children. The purpose of the present study is to design a randomised controlled trial (RCT) for evaluating the efficacy of Action-Observation Therapy in improving UL activity in children with HCP. Methods/Design The trial is designed according to CONSORT Statement. It is a randomised, evaluator-blinded, match-pair group trial. Children with HCP will be randomised within pairs to either experimental or control group. The experimental group will perform an Action-Observation Therapy, called UP-CAT (Upper Limb-Children Action-Observation Training) in which they will watch video sequences showing goal-directed actions, chosen according to children UL functional level, combined with motor training with their hemiplegic UL. The control group will perform the same tailored actions after watching computer games. A careful revision of psychometric properties of UL outcome measures for children with hemiplegia was performed. Assisting Hand Assessment was chosen as primary measure and, based on its calculation power, a sample size of 12 matched pairs was established. Moreover, Melbourne and ABILHAND-Kids were included as secondary measures. The time line of assessments will be T0 (in the week preceding the onset of the treatment), T1 and T2 (in the week after the end of the treatment and 8 weeks later, respectively). A further assessment will be performed at T3 (24 weeks after T1), to evaluate the retention of effects. In a subgroup of children enrolled in both groups functional Magnetic Resonance Imaging, exploring the mirror system and sensory-motor function, will be performed at T0, T1 and T2. Discussion The paper aims to describe the

  16. Upper limb children action-observation training (UP-CAT: a randomised controlled trial in Hemiplegic Cerebral Palsy

    Directory of Open Access Journals (Sweden)

    Biagi Laura

    2011-06-01

    Full Text Available Abstract Background Rehabilitation for children with hemiplegic cerebral palsy (HCP aimed to improve function of the impaired upper limb (UL uses a wide range of intervention programs. A new rehabilitative approach, called Action-Observation Therapy, based on the recent discovery of mirror neurons, has been used in adult stroke but not in children. The purpose of the present study is to design a randomised controlled trial (RCT for evaluating the efficacy of Action-Observation Therapy in improving UL activity in children with HCP. Methods/Design The trial is designed according to CONSORT Statement. It is a randomised, evaluator-blinded, match-pair group trial. Children with HCP will be randomised within pairs to either experimental or control group. The experimental group will perform an Action-Observation Therapy, called UP-CAT (Upper Limb-Children Action-Observation Training in which they will watch video sequences showing goal-directed actions, chosen according to children UL functional level, combined with motor training with their hemiplegic UL. The control group will perform the same tailored actions after watching computer games. A careful revision of psychometric properties of UL outcome measures for children with hemiplegia was performed. Assisting Hand Assessment was chosen as primary measure and, based on its calculation power, a sample size of 12 matched pairs was established. Moreover, Melbourne and ABILHAND-Kids were included as secondary measures. The time line of assessments will be T0 (in the week preceding the onset of the treatment, T1 and T2 (in the week after the end of the treatment and 8 weeks later, respectively. A further assessment will be performed at T3 (24 weeks after T1, to evaluate the retention of effects. In a subgroup of children enrolled in both groups functional Magnetic Resonance Imaging, exploring the mirror system and sensory-motor function, will be performed at T0, T1 and T2. Discussion The paper aims to

  17. A multicenter randomized controlled trial for bright light therapy in adults with intellectual disabilities and depression: Study protocol and obstacle management.

    Science.gov (United States)

    Hamers, Pauline C M; Evenhuis, Heleen M; Hermans, Heidi

    2017-01-01

    Due to the limited cognitive and communicative abilities of adults with intellectual disabilities (ID), current treatment options for depression are often limited to lifestyle changes and pharmacological treatment. Bright light therapy (BLT) is an effective intervention for both seasonal and non-seasonal depression in the general population. BLT is an inexpensive, easy to carry out intervention with minimal side effects. However, knowledge on its anti-depressant effect in adults with ID is lacking. Obstacles in realizing a controlled intervention study in this particular study population may have contributed to this lack. To study the effect of BLT on depression in this population, it is necessary to successfully execute a multicenter randomized controlled trial (RCT). Therefore, the study protocol and the management of anticipated obstacles regarding this trial are presented.

  18. Interventions for atopic dermatitis in dogs: a systematic review of randomized controlled trials.

    Science.gov (United States)

    Olivry, Thierry; Foster, Aiden P; Mueller, Ralf S; McEwan, Neil A; Chesney, Christopher; Williams, Hywel C

    2010-02-01

    The objective of this systematic review, which was performed following the guidelines of the Cochrane collaboration, was to assess the effects of interventions for treatment of atopic dermatitis (AD) in dogs. Citations identified from three databases (MEDLINE, Thomson's Science Citation Index Expanded and CAB Abstracts) and trials published by December 2007 were selected. Proceedings books from the major veterinary dermatology international congresses were hand searched for relevant citations. The authors selected randomized controlled trials (RCTs), published from January 1980 to December 2007, which reported the efficacy of topical or systemic interventions for treatment or prevention of canine AD. Studies had to report assessments of either pruritus or skin lesions, or both. Studies were selected and data extracted by two reviewers, with discrepancies resolved by a third arbitrator. Missing data were requested from study authors of recently published trials. Pooling of results and meta-analyses were performed for studies reporting similar interventions and outcome measures. A total of 49 RCTs were selected, which had enrolled 2126 dogs. This review found some evidence of efficacy of topical tacrolimus (3 RCTs), topical triamcinolone (1), oral glucocorticoids (5), oral ciclosporin (6), subcutaneous recombinant gamma-interferon (1) and subcutaneous allergen-specific immunotherapy (3) to decrease pruritus and/or skin lesions of AD in dogs. One high-quality RCT showed that an oral essential fatty acid supplement could reduce prednisolone consumption by approximately half. Additional RCTs of high design quality must be performed to remedy previous flaws and to test interventions for prevention of flares of this disease.

  19. A Randomized Controlled Trial of Puncturing and Bloodletting at Twelve Hand Jing Points to Treat Acute Carbon Monoxide Poisoning as Adjunct to First Aid Treatment: A Study Protocol

    Directory of Open Access Journals (Sweden)

    Ying Yue

    2015-01-01

    Full Text Available Background. Acute carbon monoxide poisoning (ACOP is a significant cause of morbidity and mortality in many countries. Twelve Hand Jing Points (THJP have been believed to be effective to treat all kinds of emergency calls in traditional Chinese medicine (TCM for more than 3000 years. This randomized controlled trial (RCT is designed to evaluate the effectiveness of THJP in curing acute carbon monoxide poisoning in first aid treatment. This paper reports the protocol of the trial. Methods/Design. This RCT is a multicenter, randomized, controlled study undergoing in China. The compliant patients are divided into the bloodletting group and standard of care group. With first aid treatments given to both of the groups, the bloodletting group is bleeding at THJP upon being hospitalized. Primary outcomes and secondary outcomes will be measured and compared between these two groups. Before treatment, immediately after treatment, and 30 minutes, 1 hour, and 4 hours after treatment, patients’ basic vital signs and state of consciousness were observed. Before treatment and 1 and 4 hours after treatment, carboxyhemoglobin concentration in venous blood samples was detected. Discussion. The objective of this study is to provide convincing evidence to clarify the efficacy and safety of THJP for early treatment of acute carbon monoxide poisoning.

  20. Design of a Randomised Controlled Trial (RCT) on the effectiveness of a Dutch patient advocacy case management intervention among severely disabled Multiple Sclerosis patients

    NARCIS (Netherlands)

    Wynia, Klaske; Annema, Coby; Nissen, Hans; De Keyser, Jacques; Middel, Berry

    2010-01-01

    Background: Case management has been suggested as an innovative strategy that facilitates the improvement of a patient's quality of life, reduction of hospital length of stay, optimization of self-care and improvement of satisfaction of patients and professionals involved. However, there is little e

  1. Early identification in primary health care of people at risk for sick leave due to work-related stress - study protocol of a randomized controlled trial (RCT)

    NARCIS (Netherlands)

    Holmgren, Kristina; Sandheimer, Christine; Mardby, Ann-Charlotte; Larsson, Maria E. H.; Bultmann, Ute; Hange, Dominique; Hensing, Gunnel

    2016-01-01

    Background: Early identification of persons at risk of sickness absence due to work-related stress is a crucial problem for society in general, and primary health care in particular. Tho date, no established method to do this exists. This project's aim is to evaluate whether systematic early identif

  2. A randomized controlled trial of subcutaneous closed-suction Blake drains for the prevention of incisional surgical site infection after colorectal surgery.

    Science.gov (United States)

    Watanabe, Jun; Ota, Mitsuyoshi; Kawamoto, Makoto; Akikazu, Yago; Suwa, Yusuke; Suwa, Hirokazu; Momiyama, Masashi; Ishibe, Atsushi; Watanabe, Kazuteru; Masui, Hidenobu; Nagahori, Kaoru

    2017-03-01

    The effects of subcutaneous closed-suction Blake drain for preventing incisional surgical site infections (SSIs) after colorectal surgery have never been evaluated in a randomized controlled trial (RCT). Thus, we performed a RCT to evaluate the clinical benefits of using a subcutaneous closed-suction Blake drain in patients undergoing colorectal surgery. Consecutive patients who underwent colorectal surgery were enrolled in this study. Patients were randomly assigned to the subcutaneous closed-suction drainage arm or the control (no subcutaneous drainage) arm. The primary endpoint was incidence rate of incisional SSIs. And, we performed logistic regression analysis to detect predictive factors for incisional SSIs after colorectal surgery. From November 2012 to September 2014, a total of 240 patients were enrolled in this study. One-hundred-seventeen patients who were treated by the control arm and 112 patients by the subcutaneous drainage arm were judged to be eligible for analysis. The incidence of incisional SSIs rate was 8.7 % in the overall patients. The incidence of incisional SSIs rate was 12.8 % in the control arm and 4.5 % in the subcutaneous drainage arm. There was significantly reduction of the incidence in the subcutaneous drainage arm than in the control arm (p = 0.025). Logistic regression analysis demonstrated that thickness of subcutaneous fat >3.0 cm, forced expiratory volume in 1 s as percent of forced vital capacity (FEV1.0 %) >70 %, and subcutaneous drain were independent predictors of postoperative incisional SSIs (p = 0.008, p = 0.004, and p = 0.017, respectively). The results of our RCT suggest that a subcutaneous Blake drain is beneficial for preventing incisional SSIs in patients undergoing colorectal surgery.

  3. Logging on for Better Sleep: RCT of the Effectiveness of Online Treatment for Insomnia

    Science.gov (United States)

    Vincent, Norah; Lewycky, Samantha

    2009-01-01

    Study Objectives: Despite effective cognitive behavioral treatments for chronic insomnia, such treatments are underutilized.1,2 This study evaluated the impact of a 5-week, online treatment for insomnia. Design: This was a randomized controlled trial with online treatment and waiting list control conditions. Participants: Participants were 118 adults with chronic insomnia. Setting: Participants received online treatment from their homes. Intervention: Online treatment consisted of psychoeducation, sleep hygiene, and stimulus control instruction, sleep restriction treatment, relaxation training, cognitive therapy, and help with medication tapering. Measurements and Results: From pre- to post-treatment, there was a 33% attrition rate, and attrition was related to referral status (i.e., drop-outs were more likely to have been referred for treatment rather than recruited from the community). Using a mixed model analysis of variance procedure (ANOVA), results showed that online treatment produced statistically significant improvements in the primary end points of sleep quality, insomnia severity, and daytime fatigue. Online treatment also produced significant changes in process variables of pre-sleep cognitive arousal and dysfunctional beliefs about sleep. Conclusions: Implications of these findings are that identification of who most benefits from online treatment is a worthy area of future study. Citation: Vincent N; Lewycky S. Logging on for better sleep: RCT of the effectiveness of online treatment for insomnia. SLEEP 2009;32(6):807-815. PMID:19544758

  4. Meditation awareness training for the treatment of fibromyalgia syndrome: A randomized controlled trial.

    Science.gov (United States)

    Van Gordon, William; Shonin, Edo; Dunn, Thomas J; Garcia-Campayo, Javier; Griffiths, Mark D

    2017-02-01

    The purpose of this study was to conduct the first randomized controlled trial (RCT) to evaluate the effectiveness of a second-generation mindfulness-based intervention (SG-MBI) for treating fibromyalgia syndrome (FMS). Compared to first-generation mindfulness-based interventions, SG-MBIs are more acknowledging of the spiritual aspect of mindfulness. A RCT employing intent-to-treat analysis. Adults with FMS received an 8-week SG-MBI known as meditation awareness training (MAT; n = 74) or an active control intervention known as cognitive behaviour theory for groups (n = 74). Assessments were performed at pre-, post-, and 6-month follow-up phases. Meditation awareness training participants demonstrated significant and sustained improvements over control group participants in FMS symptomatology, pain perception, sleep quality, psychological distress, non-attachment (to self, symptoms, and environment), and civic engagement. A mediation analysis found that (1) civic engagement partially mediated treatment effects for all outcome variables, (2) non-attachment partially mediated treatment effects for psychological distress and sleep quality, and (3) non-attachment almost fully mediated treatment effects for FMS symptomatology and pain perception. Average daily time spent in meditation was found to be a significant predictor of changes in all outcome variables. Meditation awareness training may be a suitable treatment for adults with FMS and appears to ameliorate FMS symptomatology and pain perception by reducing attachment to self. Statement of contribution What is already known on this subject? Designing interventions to treat fibromyalgia syndrome (FMS) continues to be a challenge. There is growing interest into the applications of mindfulness-based interventions for treating FMS. Second-generation mindfulness-based interventions (SG-MBIs) are a key new direction in mindfulness research. What does this study add? Meditation awareness training - an SG-MBI - resulted

  5. Exploring the effect of space and place on response to exercise therapy for knee and hip pain-a protocol for a double-blind randomised controlled clinical trial

    DEFF Research Database (Denmark)

    Sandal, Louise Fleng; Thorlund, Jonas Bloch; Ulrich, Roger S;

    2015-01-01

    INTRODUCTION: Context effects are described as effects of a given treatment, not directly caused by the treatment itself, but rather caused by the context in which treatment is delivered. Exercise is a recommended core treatment in clinical guidelines for musculoskeletal disorders. Although...... moderately effective overall, variation is seen in size of response to exercise across randomised controlled trial (RCT) studies. Part of this variation may be related to the fact that exercise interventions are performed in different physical environments, which may affect participants differently....... The study aims to investigate the effect of exercising in a contextually enhanced physical environment for 8 weeks in people with knee or hip pain. METHODS AND ANALYSIS: The study is a double-blind RCT. Eligible participants are 35 years or older with persisting knee and/or hip pain for 3 months...

  6. External validity of a randomised controlled trial on the treatment of severe infections caused by MRSA

    Science.gov (United States)

    Paul, Mical; Bronstein, Ella; Yahav, Dafna; Goldberg, Elad; Bishara, Jihad; Leibovici, Leonard

    2015-01-01

    Patient characteristics, outcome event rates and treatment effects differed significantly in the setting of a RCT, despite its pragmatic design, compared to patients treated outside the trial settings. PMID:26362666

  7. Effectiveness of alcohol brief intervention delivered by community pharmacists: study protocol of a two-arm randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Dhital Ranjita

    2013-02-01

    Full Text Available Abstract Background There is strong evidence to support the effectiveness of Brief Intervention (BI in reducing alcohol consumption in primary healthcare. Methods and design This study is a two-arm randomised controlled trial to determine the effectiveness of BI delivered by community pharmacists in their pharmacies. Eligible and consenting participants (aged 18 years or older will be randomised in equal numbers to either a BI delivered by 17 community pharmacists or a non-intervention control condition. The intervention will be a brief motivational discussion to support a reduction in alcohol consumption and will take approximately 10 minutes to deliver. Participants randomised to the control arm will be given an alcohol information leaflet with no opportunity for discussion. Study pharmacists will be volunteers who respond to an invitation to participate, sent to all community pharmacists in the London borough of Hammersmith and Fulham. Participating pharmacists will receive 7 hours training on trial procedures and the delivery of BI. Pharmacy support staff will also receive training (4 hours on how to approach and inform pharmacy customers about the study, with formal trial recruitment undertaken by the pharmacist in a consultation room. At three month follow up, alcohol consumption and related problems will be assessed with the Alcohol Use Disorders Identification Test (AUDIT administered by telephone. Discussion The UK Department of Health’s stated aim is to involve community pharmacists in the delivery of BI to reduce alcohol harms. This will be the first RCT study to assess the effectiveness of BI delivered by community pharmacists. Given this policy context, it is pragmatic in design. Trial registration Current Controlled Trials ISRCTN95216873

  8. Review of the Reporting of Survival Analyses within Randomised Controlled Trials and the Implications for Meta-Analysis.

    Directory of Open Access Journals (Sweden)

    Sarah Batson

    Full Text Available Meta-analysis is a growing approach to evidence synthesis and network meta-analysis in particular represents an important and developing method within Health Technology Assessment (HTA. Meta-analysis of survival data is usually performed using the individual summary statistic-the hazard ratio (HR from each randomised controlled trial (RCT.The objectives of this study are to: (i review the methods and reporting of survival analyses in oncology RCTs; and (ii assess the suitability and relevance of survival data reported in RCTs for inclusion into meta-analysis.Five oncology journals were searched to identify Phase III RCTs published between April and July 2015. Eligible studies included those that analysed a survival outcome.Thirty-two RCTs reporting survival outcomes in cancer populations were identified. None of the publications reported details relating to a strategy for statistical model building, the goodness of fit of the final model, or final model validation for the analysis of survival outcomes. The majority of studies (88% reported the use of Cox proportional hazards (PH regression to analyse survival endpoints. However, most publications failed to report the validation of the statistical models in terms of the PH assumption.This review highlights deficiencies in terms of reporting the methods and validity of survival analyses within oncology RCTs. We support previous recommendations to encourage authors to improve the reporting of survival analyses in journal publications. We also recommend that the final choice of a statistical model for survival should be informed by goodness of model fit to a given dataset, and that model assumptions are validated. The failure of trial investigators and statisticians to investigate the PH for RCT survival data is likely to result in clinical decisions based on inappropriate methods. The development of alternative approaches for the meta-analysis of survival outcomes when the PH assumption is

  9. A study protocol for a randomised controlled trial of an interactive web-based intervention: CancerCope

    Science.gov (United States)

    Chambers, Suzanne K; Ritterband, Lee; Thorndike, Frances; Nielsen, Lisa; Aitken, Joanne F; Clutton, Samantha; Scuffham, Paul; Youl, Philippa; Morris, Bronwyn; Baade, Peter; Dunn, Jeffrey

    2017-01-01

    Introduction Approximately 35% of patients with cancer experience clinically significant distress, and unmet psychological supportive care needs are prevalent. This study describes the protocol for a randomised controlled trial (RCT) to assess the efficacy and cost-effectiveness of an internet-based psychological intervention for distressed patients with cancer. Methods and analysis In phase I, the intervention was developed on an interactive web platform and pilot tested for acceptability using a qualitative methodology with 21 patients with cancer. Phase II is an RCT underway with patients with or at risk of elevated psychological distress comparing: (1) static patient education website with (2) individualised web-delivered cognitive behavioural intervention (CancerCope). Participants were recruited through the Queensland Cancer Registry and Cancer Council Helpline and met the following inclusion criteria: (1) recently diagnosed with cancer; (2) able to read and speak English; (3) no previous history of head injury, dementia or psychiatric illness; (4) no other concurrent cancer; (5) phone and internet access; (5) scored ≥4 on the Distress Thermometer. Participants are assessed at four time points: baseline/recruitment and 2, 6 and 12 months after recruitment and intervention commencement. Of the 163 participants recruited, 50% met caseness for distress. The area of highest unmet supportive care needs were psychological followed by physical and daily living needs. Primary outcomes are psychological and cancer-specific distress and unmet psychological supportive care needs. Secondary outcomes are positive adjustment, quality of life and cost-effectiveness. Ethics and dissemination Ethical approval was obtained from the Griffith University Human Research Ethics Committee (Approval: PSY/70/13/HREC) and the Metro South Human Research Ethics Committee (HREC/13/QPAH/601). All participants provide informed consent prior to taking part in the study. Once completed

  10. Review of the Reporting of Survival Analyses within Randomised Controlled Trials and the Implications for Meta-Analysis

    Science.gov (United States)

    Batson, Sarah; Greenall, Gemma; Hudson, Pollyanna

    2016-01-01

    Background Meta-analysis is a growing approach to evidence synthesis and network meta-analysis in particular represents an important and developing method within Health Technology Assessment (HTA). Meta-analysis of survival data is usually performed using the individual summary statistic—the hazard ratio (HR) from each randomised controlled trial (RCT). Objectives The objectives of this study are to: (i) review the methods and reporting of survival analyses in oncology RCTs; and (ii) assess the suitability and relevance of survival data reported in RCTs for inclusion into meta-analysis. Methods Five oncology journals were searched to identify Phase III RCTs published between April and July 2015. Eligible studies included those that analysed a survival outcome. Results Thirty-two RCTs reporting survival outcomes in cancer populations were identified. None of the publications reported details relating to a strategy for statistical model building, the goodness of fit of the final model, or final model validation for the analysis of survival outcomes. The majority of studies (88%) reported the use of Cox proportional hazards (PH) regression to analyse survival endpoints. However, most publications failed to report the validation of the statistical models in terms of the PH assumption. Conclusions This review highlights deficiencies in terms of reporting the methods and validity of survival analyses within oncology RCTs. We support previous recommendations to encourage authors to improve the reporting of survival analyses in journal publications. We also recommend that the final choice of a statistical model for survival should be informed by goodness of model fit to a given dataset, and that model assumptions are validated. The failure of trial investigators and statisticians to investigate the PH for RCT survival data is likely to result in clinical decisions based on inappropriate methods. The development of alternative approaches for the meta-analysis of survival

  11. Successful Reach and Adoption of a workplace health promotion RCT targeting a group of high-risk workers

    DEFF Research Database (Denmark)

    Jørgensen, Marie B; Rasmussen, Charlotte D N; Ekner, Dorte

    2010-01-01

    BACKGROUND: Cleaners are rarely introduced to workplace health promotion programs. The study's objective was to evaluate the reach and adoption of a workplace randomized controlled trial (RCT) among cleaners in Denmark. METHODS: Cleaning businesses with at least 30 employees, that could offer...... employees, 78% responded to the screening questionnaire and 49% consented to participate. Consenters and participants differed from non-consenters and non-participants by having higher BMI, more chronic diseases and poorer musculoskeletal health. CONCLUSIONS: This study indicates that workplace health...... a weekly 1-hour intervention during working hours, were invited to participate. Employees working at least 20 hours/week were invited to answer a screening questionnaire and consent to participate. Analyses determined the differences in health variables between responders and non-responders, consenters...

  12. Role of Lactobacillus in the prevention of Clostridium difficile-associated diarrhea: a meta-analysis of randomized controlled trials

    Institute of Scientific and Technical Information of China (English)

    WU Zhi-juan; DU Xi; ZHENG Jian

    2013-01-01

    Background Clostridium difficile-associated diarrhea (CDAD) is a major public health problem because of significant morbidity and mortality,and many clinicians pay attention to Lactobacillus as a potentially effective treatment.The purpose of this meta-analysis was to evaluate the efficacy of Lactobacillus in the prevention of CDAD.Methods The databases MEDLINE,the Cochrane Central Register of Controlled Trials,metaRegister of Controlled Trials,National Institutes of Health,CNKI,VIP,and Wanfang data were searched to locate all reported randomized controlled trials (RCT) from 1990 to December 2012.Only RCT in English and Chinese using Lactobacillus for the prevention of documented CDAD were considered for study inclusion.The data was analyzed by Review Manager and SPSS software.Results Seven placebo-controlled RCTs that evaluated the prevention of CDAD,which included 1486 subjects,accorded with inclusion and exclusion criteria.The mean age of the subjects ranged from 4.15 to 64.75 years and the proportion of male subjects ranged from 42.0% to 59.1%.The total daily dose of Lactobacillus ranged from 1.2×109-1.2×1012 colonyforming units (CFU).A low risk of bias was attributed to two studies and four studies evaluated a medium-level risk of bias.The combined risk ratio (RR) of developing CDAD was significantly lower in subjects who received Lactobacillus compared with subjects who received placebo (RR 0.38,95% confidence interval (CI) 0.22-0.67).A combination regimen of Lactobacillus acidophilus (L.acidophilus) and Lactobacillus casei (L.casei) (RR 0.05,95% CI 0.01-0.36) showed significant effect sizes for the prevention of CDAD,while single regimens of Lactobacillus plantarum (L.plantarum)and Lactobacillus rhamnosus (L.rhamnosus) did not.Across all trials,positive significant effects of Lactobacillus were observed in the elderly subgroup (RR 0.05,95% Cl 0.01-0.36).Whether the 1×1012-9×1012 CFU/d Lactobacillus could prevent CDAD significantly or not was

  13. RANDOMIZED CONTROLLED TRIALS IN ORTHOPEDICS AND TRAUMATOLOGY: SYSTEMATIC ANALYSIS ON THE NATIONAL EVIDENCE.

    Science.gov (United States)

    de Moraes, Vinícius Ynoe; Moreira, Cesar Domingues; Tamaoki, Marcel Jun Sugawara; Faloppa, Flávio; Belloti, Joao Carlos

    2010-01-01

    To assess whether there has been any improvement in the quality and quantity of randomized controlled trials (RCTs) in nationally published journals through the application of standardized and validated scores. We electronically selected all RCTs published in the two indexed Brazilian journals that focus on orthopedics, over the period 2000-2009: Acta Ortopédica Brasileira (AOB) and Revista Brasileira de Ortopedia (RBO). These RCTs were identified and scored by two independent researchers in accordance with the Jadad scale and the Cochrane Bone, Joint and Muscle Trauma Group score. The studies selected were grouped as follows: 1) publication period (2000-2004 or 2004-2009); 2) journal of publication (AOB or RBO). Twenty-two papers were selected: 10 from AOB and 12 from RBO. No statistically significant differences were found between the proportions (nRCT/nTotal of published papers) of RCTs published in the two journals (p = 0.458), or in the Jadad score (p = 0.722) and Cochrane score (p = 0.630). The relative quality and quantity of RCTs in the journals analyzed were similar. There was a trend towards improvement of quality, but there was no increase in the number of RCTs between the two periods analyzed.

  14. Effects of Mobility-Enhancing Nursing Intervention in Patients with MS and Stroke: Randomised Controlled Trial.

    Science.gov (United States)

    Imhof, Lorenz; Suter-Riederer, Susanne; Kesselring, Jürg

    2015-01-01

    Background. Multiple sclerosis (MS) or stroke causes functional impairment which can have a major impact on patients' life. Objectives. This RCT investigated the effect of a new nursing intervention (Mobility Enhancing Nursing Intervention-MFP) designed to improve rehabilitation outcomes. Method. The study took place in a rehabilitation clinic in Switzerland. One hundred forty participants diagnosed with MS, stroke, and brain injuries were randomly assigned to control group (CG = standard care) or intervention group (IG). The IG combined standard care with 30 days of MFB. MFP placed patients on a mattress on the floor and used tactile-kinaesthetic stimulation to increase spatial orientation and independency. Outcomes were functionality (Extended Barthel Index, EBI), quality of life (WHOQoL), and fall-related self-efficacy (FES-I). Results. There was a significant main effect of the intervention on functionality (EBI-diff/day mean = 0.30, versus mean = 0.16, P = 0.008). There was also a significant main effect on QoL (WHOQoL-diff mean = 13.8, versus mean = 5.4, P = 0.046). No significant effect was observed on fall-related self-efficacy. Conclusions. The positive effect of MFP on rehabilitation outcomes and quality of life suggests that this specialized nursing intervention could become an effective part of rehabilitation programs. The study was approved by the Ethics Committee of St. Gallen (KEK-SG Nr. 09/021) and registered at ClinicalTrial.gov NCT02198599.

  15. A guide to performing a peer review of randomised controlled trials.

    Science.gov (United States)

    Del Mar, Chris; Hoffmann, Tammy C

    2015-11-02

    Peer review of journal articles is an important step in the research process. Editors rely on the expertise of peer reviewers to properly assess submissions. Yet, peer review quality varies widely and few receive training or guidance in how to approach the task. This paper describes some of the main steps that peer reviewers in general and, in particular, those performing reviewes of randomised controlled trials (RCT), can use when carrying out a review. It can be helpful to begin with a brief read to acquaint yourself with the study, followed by a detailed read and a careful check for flaws. These can be divided into 'major' (problems that must be resolved before publication can be considered) and 'minor' (suggested improvements that are discretionary) flaws. Being aware of the appropriate reporting checklist for the study being reviewed (such as CONSORT and its extensions for RCTs) can also be valuable. Competing interests or prejudices might corrode the review, so ensuring transparency about them is important. Finally, ensuring that the paper's strengths are acknowledged along with a dissection of the weaknesses provides balance and perspective to both authors and editors. Helpful reviews are constructive and improve the quality of the paper. The proper conduct of a peer review is the responsibility of all who accept the role.

  16. RANDOMIZED CONTROLLED TRIALS IN ORTHOPEDICS AND TRAUMATOLOGY: SYSTEMATIC ANALYSIS ON THE NATIONAL EVIDENCE

    Science.gov (United States)

    de Moraes, Vinícius Ynoe; Moreira, Cesar Domingues; Tamaoki, Marcel Jun Sugawara; Faloppa, Flávio; Belloti, Joao Carlos

    2015-01-01

    Objective: To assess whether there has been any improvement in the quality and quantity of randomized controlled trials (RCTs) in nationally published journals through the application of standardized and validated scores. Methods: We electronically selected all RCTs published in the two indexed Brazilian journals that focus on orthopedics, over the period 2000-2009: Acta Ortopédica Brasileira (AOB) and Revista Brasileira de Ortopedia (RBO). These RCTs were identified and scored by two independent researchers in accordance with the Jadad scale and the Cochrane Bone, Joint and Muscle Trauma Group score. The studies selected were grouped as follows: 1) publication period (2000-2004 or 2004-2009); 2) journal of publication (AOB or RBO). Results: Twenty-two papers were selected: 10 from AOB and 12 from RBO. No statistically significant differences were found between the proportions (nRCT/nTotal of published papers) of RCTs published in the two journals (p = 0.458), or in the Jadad score (p = 0.722) and Cochrane score (p = 0.630). Conclusion: The relative quality and quantity of RCTs in the journals analyzed were similar. There was a trend towards improvement of quality, but there was no increase in the number of RCTs between the two periods analyzed. PMID:27026971

  17. The effectiveness of Long's manipulation on patients with chronic mechanical neck pain: a randomized controlled trial.

    Science.gov (United States)

    Lin, Jian Hua; Shen, Tong; Chung, Raymond Chi Keung; Chiu, Thomas Tai Wing

    2013-08-01

    Long's manipulation (LM) is a representative Chinese manipulation approach incorporating both spinal manipulation and traditional Chinese massage (TCM) techniques. This randomized controlled trial (RCT) aimed to compare the immediate and short-term relative effectiveness of LM to TCM on patients with chronic neck pain. Patients were randomly assigned to either LM group or TCM group. LM group was treated with Long's manipulation, while the TCM group received TCM therapy. Patients attended 8 sessions of treatment (one session every three days). Outcome measures included neck disability (Northwick Park Neck Pain Questionnaire; NPQ), pain intensity (Numeric Pain Rating Scale; NPRS), patient perceived satisfaction of care (PPS) (11-point scale), craniovertebral angle (CV angle) and cervical range of motion (ROM). A blinded assessor performed assessment at baseline, immediate after treatment and 3 months post treatment. LM group achieved significantly greater improvement than TCM group in pain intensity (p angle and most of cervical ROM between groups (p = 0.169 ∼ 0.888) with an exception of flexion at 3-month follow-up (p = 0.005). This study shows that LM could produce better effects than TCM in relieving pain and improving disability in the management of patients with chronic mechanical neck pain.

  18. Effectiveness of animal-assisted therapy: A systematic review of randomized controlled trials.

    Science.gov (United States)

    Kamioka, Hiroharu; Okada, Shinpei; Tsutani, Kiichiro; Park, Hyuntae; Okuizumi, Hiroyasu; Handa, Shuichi; Oshio, Takuya; Park, Sang-Jun; Kitayuguchi, Jun; Abe, Takafumi; Honda, Takuya; Mutoh, Yoshiteru

    2014-04-01

    The objectives of this review were to summarize the evidence from randomized controlled trials (RCTs) on the effects of animal-assisted therapy (AAT). Studies were eligible if they were RCTs. Studies included one treatment group in which AAT was applied. We searched the following databases from 1990 up to October 31, 2012: MEDLINE via PubMed, CINAHL, Web of Science, Ichushi Web, GHL, WPRIM, and PsycINFO. We also searched all Cochrane Database up to October 31, 2012. Eleven RCTs were identified, and seven studies were about "Mental and behavioral disorders". Types of animal intervention were dog, cat, dolphin, bird, cow, rabbit, ferret, and guinea pig. The RCTs conducted have been of relatively low quality. We could not perform meta-analysis because of heterogeneity. In a study environment limited to the people who like animals, AAT may be an effective treatment for mental and behavioral disorders such as depression, schizophrenia, and alcohol/drug addictions, and is based on a holistic approach through interaction with animals in nature. To most effectively assess the potential benefits for AAT, it will be important for further research to utilize and describe (1) RCT methodology when appropriate, (2) reasons for non-participation, (3) intervention dose, (4) adverse effects and withdrawals, and (5) cost.

  19. Mindful "Vitality in Practice": an intervention to improve the work engagement and energy balance among workers; the development and design of the randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Boot Cécile RL

    2011-09-01

    Full Text Available Abstract Background Modern working life has become more mental and less physical in nature, contributing to impaired mental health and a disturbed energy balance. This may result in mental health problems and overweight. Both are significant threats to the health of workers and thus also a financial burden for society, including employers. Targeting work engagement and energy balance could prevent impaired mental health and overweight, respectively. Methods/Design The study population consists of highly educated workers in two Dutch research institutes. The intervention was systematically developed, based on the Intervention Mapping (IM protocol, involving workers and management in the process. The workers' needs were assessed by combining the results of interviews, focus group discussions and a questionnaire with available literature. Suitable methods and strategies were selected resulting in an intervention including: eight weeks of customized mindfulness training, followed by eight sessions of e-coaching and supporting elements, such as providing fruit and snack vegetables at the workplace, lunch walking routes, and a buddy system. The effects of the intervention will be evaluated in a RCT, with measurements at baseline, six months (T1 and 12 months (T2. In addition, cost-effectiveness and process of the intervention will also be evaluated. Discussion At baseline the level of work engagement of the sample was "average". Of the study population, 60.1% did not engage in vigorous physical activity at all. An average working day consists of eight sedentary hours. For the Phase II RCT, there were no significant differences between the intervention and the control group at baseline, except for vigorous physical activity. The baseline characteristics of the study population were congruent with the results of the needs assessment. The IM protocol used for the systematic development of the intervention produced an appropriate intervention to test in

  20. Effects of low-carbohydrate diets v. low-fat diets on body weight and cardiovascular risk factors: a meta-analysis of randomised controlled trials.

    Science.gov (United States)

    Mansoor, Nadia; Vinknes, Kathrine J; Veierød, Marit B; Retterstøl, Kjetil

    2016-02-14

    The effects of low-carbohydrate (LC) diets on body weight and cardiovascular risk are unclear, and previous studies have found varying results. Our aim was to conduct a meta-analysis of randomised controlled trials (RCT), assessing the effects of LC diets v. low-fat (LF) diets on weight loss and risk factors of CVD. Studies were identified by searching MEDLINE, Embase and Cochrane Trials. Studies had to fulfil the following criteria: a RCT; the LC diet was defined in accordance with the Atkins diet, or carbohydrate intake of healthy; and the dietary intervention had a duration of 6 months or longer. Results from individual studies were pooled as weighted mean difference (WMD) using a random effect model. In all, eleven RCT with 1369 participants met all the set eligibility criteria. Compared with participants on LF diets, participants on LC diets experienced a greater reduction in body weight (WMD -2·17 kg; 95% CI -3·36, -0·99) and TAG (WMD -0·26 mmol/l; 95% CI -0·37, -0·15), but a greater increase in HDL-cholesterol (WMD 0·14 mmol/l; 95% CI 0·09, 0·19) and LDL-cholesterol (WMD 0·16 mmol/l; 95% CI 0·003, 0·33). This meta-analysis demonstrates opposite change in two important cardiovascular risk factors on LC diets--greater weight loss and increased LDL-cholesterol. Our findings suggest that the beneficial changes of LC diets must be weighed against the possible detrimental effects of increased LDL-cholesterol.

  1. Personalised Hip Therapy: development of a non-operative protocol to treat femoroacetabular impingement syndrome in the FASHIoN randomised controlled trial.

    Science.gov (United States)

    Wall, Peter Dh; Dickenson, Edward J; Robinson, David; Hughes, Ivor; Realpe, Alba; Hobson, Rachel; Griffin, Damian R; Foster, Nadine E

    2016-10-01

    Femoroacetabular impingement (FAI) syndrome is increasingly recognised as a cause of hip pain. As part of the design of a randomised controlled trial (RCT) of arthroscopic surgery for FAI syndrome, we developed a protocol for non-operative care and evaluated its feasibility. In phase one, we developed a protocol for non-operative care for FAI in the UK National Health Service (NHS), through a process of systematic review and consensus gathering. In phase two, the protocol was tested in an internal pilot RCT for protocol adherence and adverse events. The final protocol, called Personalised Hip Therapy (PHT), consists of four core components led by physiotherapists: detailed patient assessment, education and advice, help with pain relief and an exercise-based programme that is individualised, supervised and progressed over time. PHT is delivered over 12-26 weeks in 6-10 physiotherapist-patient contacts, supplemented by a home exercise programme. In the pilot RCT, 42 patients were recruited and 21 randomised to PHT. Review of treatment case report forms, completed by physiotherapists, showed that 13 patients (62%) received treatment that had closely followed the PHT protocol. 13 patients reported some muscle soreness at 6 weeks, but there were no serious adverse events. PHT provides a structure for the non-operative care of FAI and offers guidance to clinicians and researchers in an evolving area with limited evidence. PHT was deliverable within the National Health Service, is safe, and now forms the comparator to arthroscopic surgery in the UK FASHIoN trial (ISRCTN64081839). ISRCTN 09754699. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  2. Randomised controlled trial testing the effect of cotrimoxazole prophylaxis on morbidity and mortality outcomes in breastfed HIV-exposed uninfected infants: study protocol

    Science.gov (United States)

    Coutsoudis, Anna; Daniels, Brodie; Moodley-Govender, Eshia; Ngomane, Noluthando; Zako, Linda; Spooner, Elizabeth; Kiepiela, Photini; Reddy, Shabashini; Kuhn, Louise; Ramjee, Gita

    2016-01-01

    Introduction No randomised controlled trial (RCT) has examined the efficacy of cotrimoxazole (CTX) prophylaxis in HIV-exposed uninfected (HEU) infants during the breastfeeding period, in this new era of effective prevention of mother-to-child transmission (PMTCT) prophylaxis. The efficacy of CTX prophylaxis has presently been demonstrated only in HIV-infected children. The absence of proven benefits in HEU breastfed infants associated with infectious diseases justifies an RCT as proposed. Herewith lies the rationale for conducting the proposed study. Methods A partially blinded RCT is proposed to evaluate the efficacy of CTX prophylaxis administered from 6 weeks of age to HEU infants receiving a PMTCT regimen. A non-inferiority design will be used, randomising 1298 infants to receive CTX or not to receive CTX. Participants will be reviewed at the following time points: 6 weeks (enrolment and randomisation), 10 weeks, 14 weeks, 4 months and monthly thereafter until 12 months of age. They will be evaluated for anthropometric growth, interval illness, CTX adherence, signs and symptoms of study drug toxicity, concomitant medication use, breastfeeding status and HIV infection status. The study will compare the incidence of grade 3 and grade 4 common childhood illnesses (focusing on pneumonia and diarrhoea) and all-cause mortality until 12 months of age. In a subset of participants, we will compare grade 3 and grade 4 haemoglobin and alanine aminotransferase results as well as investigate gut integrity. Ethics and dissemination The study has ethical approval from the University of KwaZulu-Natal Biomedical Research Ethics Committee (BFC212/13). Trial registration numbers PACTR201311000621110 and DOH-27-0614-4728; Pre-results. PMID:27406638

  3. Effectiveness of a Minimal Intervention for Stress-related mental disorders with Sick leave (MISS; study protocol of a cluster randomised controlled trial in general practice [ISRCTN43779641

    Directory of Open Access Journals (Sweden)

    van Marwijk Harm WJ

    2006-05-01

    Full Text Available Abstract Background The main aims of this paper are to describe the setting and design of a Minimal Intervention in general practice for Stress-related mental disorders in patients on Sick leave (MISS, as well as to ascertain the study complies with the requirements for a cluster randomised controlled trial (RCT. The potential adverse consequences of sick leave due to Stress-related Mental Disorders (SMDs are extensive, but often not recognised. Since most people having SMDs with sick leave consult their general practitioner (GP at an early stage, a tailored intervention given by GPs is justified. We provide a detailed description of the MISS; that is more accurate assessment, education, advice and monitoring to treat SMDs in patients on sick leave. Our hypothesis is that the MISS will be more effective compared to the usual care, in reducing days of sick leave of these patients. Methods The design is a pragmatic RCT. Randomisation is at the level of GPs. They received the MISS-training versus no training, in order to compare the MISS vs. usual care at patient level. Enrolment of patients took place after screening in the source population, that comprised 20–60 year old primary care attendees. Inclusion criteria were: moderately elevated distress levels, having a paid job and sick leave for no longer than three months. There is a one year follow up. The primary outcome measure is lasting full return to work. Reduction of SMD- symptoms is one of the secondary outcome measures. Forty-six GPs and 433 patients agreed to participate. Discussion In our study design, attention is given to the practical application of the requirements for a pragmatic trial. The results of this cluster RCT will add to the evidence about treatment options in general practice for SMDs in patients on sick leave, and might contribute to a new and appropriate guideline. These results will be available at the end of 2006.

  4. RCT: Module 2.06, Air Sampling Program and Methods, Course 8772

    Energy Technology Data Exchange (ETDEWEB)

    Hillmer, Kurt T. [Los Alamos National Lab. (LANL), Los Alamos, NM (United States)

    2017-07-19

    The inhalation of radioactive particles is the largest cause of an internal radiation dose. Airborne radioactivity measurements are necessary to ensure that the control measures are and continue to be effective. Regulations govern the allowable effective dose equivalent to an individual. The effective dose equivalent is determined by combining the external and internal dose equivalent values. Typically, airborne radioactivity levels are maintained well below allowable levels to keep the total effective dose equivalent small. This course will prepare the student with the skills necessary for RCT qualification by passing quizzes, tests, and the RCT Comprehensive Phase 1, Unit 2 Examination (TEST 27566) and will provide in-the-field skills.

  5. A Randomized, Controlled Clinical Trial Comparing Efficacy, Safety ...

    African Journals Online (AJOL)

    A Randomized, Controlled Clinical Trial Comparing Efficacy, Safety and Cost Effectiveness of ... Log in or Register to get access to full text downloads. ... Pharmacological control of pain is the mainstay of management of osteoarthritis.

  6. [Placebo control and clinical trial of Chinese medicine].

    Science.gov (United States)

    Wu, Jing

    2010-10-01

    World Health Organization aims to develop safe, effective and practical traditional medicine. Traditional Chinese medicine (TCM) and other complementary and alternative medicine are being recognized in the whole world nowadays. However, the definite effect of Chinese medicine is still in need of scientific research proof. Placebo control is of equal importance to active control and blank control in clinical trial of TCM. This article briefly reviewed the importance of placebo control and commented on its present situation in clinical trial of TCM. This article also brought up the preliminary proposals of placebo application in TCM clinical trial. We should emphasize scientific placebo preparation and good design of placebo-controlled trial, which are directed by International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. A good clinical trial project will avoid unnecessary wastes and provide safe and effective treatment for people.

  7. Computerised cognitive–behavioural therapy for depression in adolescents: feasibility results and 4-month outcomes of a UK randomised controlled trial

    Science.gov (United States)

    Wright, Barry; Tindall, Lucy; Littlewood, Elizabeth; Allgar, Victoria; Abeles, Paul; Trépel, Dominic; Ali, Shehzad

    2017-01-01

    Objectives Computer-administered cognitive–behavioural therapy (CCBT) may be a promising treatment for adolescents with depression, particularly due to its increased availability and accessibility. The feasibility of delivering a randomised controlled trial (RCT) comparing a CCBT program (Stressbusters) with an attention control (self-help websites) for adolescent depression was evaluated. Design Single centre RCT feasibility study. Setting The trial was run within community and clinical settings in York, UK. Participants Adolescents (aged 12–18) with low mood/depression were assessed for eligibility, 91 of whom met the inclusion criteria and were consented and randomised to Stressbusters (n=45) or websites (n=46) using remote computerised single allocation. Those with comorbid physical illness were included but those with psychosis, active suicidality or postnatal depression were not. Interventions An eight-session CCBT program (Stressbusters) designed for use with adolescents with low mood/depression was compared with an attention control (accessing low mood self-help websites). Primary and secondary outcome measures Participants completed mood and quality of life measures and a service Use Questionnaire throughout completion of the trial and 4 months post intervention. Measures included the Beck Depression Inventory (BDI) (primary outcome measure), Mood and Feelings Questionnaire (MFQ), Spence Children's Anxiety Scale (SCAS), the EuroQol five dimensions questionnaire (youth) (EQ-5D-Y) and Health Utility Index Mark 2 (HUI-2). Changes in self-reported measures and completion rates were assessed by treatment group. Results From baseline to 4 months post intervention, BDI scores and MFQ scores decreased for the Stressbusters group but increased in the website group. Quality of life, as measured by the EQ-5D-Y, increased for both groups while costs at 4 months were similar to baseline. Good feasibility outcomes were found, suggesting the trial process to be

  8. The effect of macronutrients on glycaemic control: a systematic review of dietary randomised controlled trials in overweight and obese adults with type 2 diabetes in which there was no difference in weight loss between treatment groups.

    Science.gov (United States)

    Emadian, Amir; Andrews, Rob C; England, Clare Y; Wallace, Victoria; Thompson, Janice L

    2015-11-28

    Weight loss is crucial for treating type 2 diabetes mellitus (T2DM). It remains unclear which dietary intervention is best for optimising glycaemic control, or whether weight loss itself is the main reason behind observed improvements. The objective of this study was to assess the effects of various dietary interventions on glycaemic control in overweight and obese adults with T2DM when controlling for weight loss between dietary interventions. A systematic review of randomised controlled trials (RCT) was conducted. Electronic searches of Medline, Embase, Cinahl and Web of Science databases were conducted. Inclusion criteria included RCT with minimum 6 months duration, with participants having BMI≥25·0 kg/m2, a diagnosis of T2DM using HbA1c, and no statistically significant difference in mean weight loss at the end point of intervention between dietary arms. Results showed that eleven studies met the inclusion criteria. Only four RCT indicated the benefit of a particular dietary intervention over another in improving HbA1c levels, including the Mediterranean, vegan and low glycaemic index (GI) diets. However the findings from one of the four studies showing a significant benefit are questionable because of failure to control for diabetes medications and poor adherence to the prescribed diets. In conclusion there is currently insufficient evidence to suggest that any particular diet is superior in treating overweight and obese patients with T2DM. Although the Mediterranean, vegan and low-GI diets appear to be promising, further research that controls for weight loss and the effects of diabetes medications in larger samples is needed.

  9. Pedometer-Based Behavioral Change Program Can Improve Dependency in Sedentary Older Adults: A Randomized Controlled Trial.

    Science.gov (United States)

    Yamada, M; Mori, S; Nishiguchi, S; Kajiwara, Y; Yoshimura, K; Sonoda, T; Nagai, K; Arai, H; Aoyama, T

    2012-01-01

    Recent studies suggested that pedometer-based walking programs are applicable to older adults. The purpose of this study was to evaluate the use of pedometer in sedentary older adults to improve physical activity, fear of falling, physical performance, and leg muscle mass. This was a pilot randomized controlled trial (RCT). Eighty-seven community dwelling sedentary older adults living in Japan. The intervention group (n=43) received a pedometer-based behavioural change program for 6 months, while the control group (n=44) did not. The participants in the intervention group were instructed to increase their mean daily steps by 10% each month. Thus, at the end of 6 months, participants in the intervention group were expected to have 77 % more daily steps than their baseline step counts. Written activity logs were monthly averaged to determine whether the participants were achieving their goal. Outcome measures were physical activity, fear of falling, physical performances, and leg muscle mass. In this 6-month trial 40 older adults (93%) completed the pedometer protocol with good adherence. In the intervention group, average daily steps were increased by 83.4% (from 20311323 to 3726 1607) during the study period, but not in the control group (from 20471698 to 22671837). The pedometer-based behavioral change program was more effective to improve their physical activity, fear of falling, locomotive function, and leg muscle mass than control (Pbehavioral change program can effectively improve the physical activity, fear of falling, physical performance, and leg muscle mass in sedentary older adults.

  10. DVB-RCT:交互电视的新标准%DVB-RCT: New standard on interactive TV

    Institute of Scientific and Technical Information of China (English)

    张凤超

    2002-01-01

    @@ DVB-RCT(地面数字电视系统回传信道)技术分小组(technical subgroup)创建于1999年12月,承担着规定物理层(RCT-PHY)、媒体接入控制层(RCT-MAC)和RF实施指南的巨大任务,它们构成DVB-RCT技术规范.

  11. The effect of weekly text-message communication on treatment completion among patients with latent tuberculosis infection: study protocol for a randomised controlled trial (WelTel LTBI).

    Science.gov (United States)

    van der Kop, Mia L; Memetovic, Jasmina; Patel, Anik; Marra, Fawziah; Sadatsafavi, Mohsen; Hajek, Jan; Smillie, Kirsten; Thabane, Lehana; Taylor, Darlene; Johnston, James; Lester, Richard T

    2014-04-09

    Interventions to improve adherence to treatment for latent tuberculosis infection (LTBI) are necessary to improve treatment completion rates and optimise tuberculosis (TB) control efforts. The high prevalence of cell phone use presents opportunities to develop innovative ways to engage patients in care. A randomised controlled trial (RCT), WelTel Kenya1, demonstrated that weekly text messages improved antiretroviral adherence and clinical outcomes among patients initiating HIV treatment. The aim of this study is to determine whether the WelTel intervention can improve treatment completion among patients with LTBI and to evaluate the intervention's cost-effectiveness. This open, two-site, parallel RCT (WelTel LTBI) will be conducted at TB clinics in Vancouver and New Westminster, British Columbia, Canada. Over 2 years, we aim to recruit 350 individuals initiating a 9-month isoniazid regimen. Participants will be randomly allocated to an intervention or control (standard care) arm in a 1:1 ratio. Intervention arm participants will receive a weekly text-message 'check-in' to which they will be asked to respond within 48 h. A TB clinician will follow-up instances of non-response and problems that are identified. Participants will be followed until treatment completion (up to 12 months) or discontinuation. The primary outcome is self-reported treatment completion (taking ≥80% of doses within 12 months). Secondary outcomes include daily adherence (percentage of days participants used medication as prescribed) and time to treatment completion. Patient satisfaction with the intervention will be evaluated, and the intervention's cost-effectiveness will be analysed through decision-analytic modelling. Ethical approval has been obtained from the University of British Columbia. This trial will test the efficacy and cost-effectiveness of the WelTel intervention to improve treatment completion among patients with LTBI. Trial results and economic evaluation will help inform

  12. A Mobile App for the Self-Management of Type 1 Diabetes Among Adolescents: A Randomized Controlled Trial

    Science.gov (United States)

    Rotondi, Michael; Couperthwaite, Amy B; Reiser, Sally; Simone, Angelo; Katzman, Debra K; Cafazzo, Joseph A; Palmert, Mark R

    2017-01-01

    Background While optimal blood glucose control is known to reduce the long-term complications associated with type 1 diabetes mellitus, adolescents often struggle to achieve their blood glucose targets. However, their strong propensity toward technology presents a unique opportunity for the delivery of novel self-management interventions. To support type 1 diabetes self-management in this population, we developed the diabetes self-management app bant, which included wireless blood glucose reading transfer, out-of-range blood glucose trend alerts, coaching around out-of-range trend causes and fixes, and a point-based incentive system. Objective The primary objective was to evaluate bant ’s effect on hemoglobin A1c (HbA1c) through a randomized controlled trial (RCT). Secondary measures (eg, self-monitoring of blood glucose [SMBG]) were also collected to assess bant ’s impact on the self-management behaviors of adolescents with type 1 diabetes. Methods We enrolled 92 adolescents into a 12-month RCT, with 46 receiving usual care and 46 receiving usual care plus bant. Clinical outcome data were collected at quarterly research visits via validated tools, electronic chart review, glucometer downloads, and semistructured interviews. App satisfaction was assessed at 6 and 12 months, and at trial end, users ranked bant components based on perceived usefulness. Mobile analytics captured frequency of blood glucose uploads, which were used to categorize participants into high, moderate, low, or very low engagement levels. Results Linear mixed models showed no changes in primary and secondary clinical outcomes. However, exploratory regression analysis demonstrated a statistically significant association between increased SMBG and improved HbA1c in the intervention group. For a subgroup of bant users taking SMBG ≥5 daily, there was a significant improvement in HbA1c of 0.58% (P=.02), while the parallel subgroup in the control arm experienced no significant change in HbA1c

  13. Upper limb children action-observation training (UP-CAT): a randomised controlled trial in hemiplegic cerebral palsy.

    Science.gov (United States)

    Sgandurra, Giuseppina; Ferrari, Adriano; Cossu, Giuseppe; Guzzetta, Andrea; Biagi, Laura; Tosetti, Michela; Fogassi, Leonardo; Cioni, Giovanni

    2011-06-28

    Rehabilitation for children with hemiplegic cerebral palsy (HCP) aimed to improve function of the impaired upper limb (UL) uses a wide range of intervention programs. A new rehabilitative approach, called Action-Observation Therapy, based on the recent discovery of mirror neurons, has been used in adult stroke but not in children. The purpose of the present study is to design a randomised controlled trial (RCT) for evaluating the efficacy of Action-Observation Therapy in improving UL activity in children with HCP. The trial is designed according to CONSORT Statement. It is a randomised, evaluator-blinded, match-pair group trial. Children with HCP will be randomised within pairs to either experimental or control group. The experimental group will perform an Action-Observation Therapy, called UP-CAT (Upper Limb-Children Action-Observation Training) in which they will watch video sequences showing goal-directed actions, chosen according to children UL functional level, combined with motor training with their hemiplegic UL. The control group will perform the same tailored actions after watching computer games. A careful revision of psychometric properties of UL outcome measures for children with hemiplegia was performed. Assisting Hand Assessment was chosen as primary measure and, based on its calculation power, a sample size of 12 matched pairs was established. Moreover, Melbourne and ABILHAND-Kids were included as secondary measures. The time line of assessments will be T0 (in the week preceding the onset of the treatment), T1 and T2 (in the week after the end of the treatment and 8 weeks later, respectively). A further assessment will be performed at T3 (24 weeks after T1), to evaluate the retention of effects. In a subgroup of children enrolled in both groups functional Magnetic Resonance Imaging, exploring the mirror system and sensory-motor function, will be performed at T0, T1 and T2. The paper aims to describe the methodology of a RCT for evaluating the

  14. Effect of running therapy on depression (EFFORT-D. Design of a randomised controlled trial in adult patients [ISRCTN 1894

    Directory of Open Access Journals (Sweden)

    Kruisdijk Frank R

    2012-01-01

    Full Text Available Abstract Background The societal and personal burden of depressive illness is considerable. Despite the developments in treatment strategies, the effectiveness of both medication and psychotherapy is not ideal. Physical activity, including exercise, is a relatively cheap and non-harmful lifestyle intervention which lacks the side-effects of medication and does not require the introspective ability necessary for most psychotherapies. Several cohort studies and randomised controlled trials (RCTs have been performed to establish the effect of physical activity on prevention and remission of depressive illness. However, recent meta-analysis's of all RCTs in this area showed conflicting results. The objective of the present article is to describe the design of a RCT examining the effect of exercise on depressive patients. Methods/Design The EFFect Of Running Therapy on Depression in adults (EFFORT-D is a RCT, studying the effectiveness of exercise therapy (running therapy (RT or Nordic walking (NW on depression in adults, in addition to usual care. The study population consists of patients with depressive disorder, Hamilton Rating Scale for Depression (HRSD ≥ 14, recruited from specialised mental health care. The experimental group receives the exercise intervention besides treatment as usual, the control group receives treatment as usual. The intervention program is a group-based, 1 h session, two times a week for 6 months and of increasing intensity. The control group only performs low intensive non-aerobic exercises. Measurements are performed at inclusion and at 3,6 and 12 months. Primary outcome measure is reduction in depressive symptoms measured by the HRSD. Cardio-respiratory fitness is measured using a sub maximal cycling test, biometric information is gathered and blood samples are collected for metabolic parameters. Also, co-morbidity with pain, anxiety and personality traits is studied, as well as quality of life and cost

  15. Protocol design and current status of CLIVIT: a randomized controlled multicenter relevance trial comparing clips versus ligatures in thyroid surgery

    Directory of Open Access Journals (Sweden)

    Wollermann C

    2006-09-01

    Full Text Available Abstract Background Annually, more than 90000 surgical procedures of the thyroid gland are performed in Germany. Strategies aimed at reducing the duration of the surgical procedure are relevant to patients and the health care system especially in the context of reducing costs. However, new techniques for quick and safe hemostasis have to be tested in clinically relevance randomized controlled trials before a general recommendation can be given. The current standard for occlusion of blood vessels in thyroid surgery is ligatures. Vascular clips may be a safe alternative but have not been investigated in a large RCT. Methods/design CLIVIT (Clips versus Ligatures in Thyroid Surgery is an investigator initiated, multicenter, patient-blinded, two-group parallel relevance randomized controlled trial designed by the Study Center of the German Surgical Society. Patients scheduled for elective resection of at least two third of the gland for benign thyroid disease are eligible for participation. After surgical exploration patients are randomized intraoperatively into either the conventional ligature group, or into the clip group. The primary objective is to test for a relevant reduction in operating time (at least 15 min when using the clip technique. Since April 2004, 121 of the totally required 420 patients were randomized in five centers. Discussion As in all trials the different forms of bias have to be considered, and as in this case, a surgical trial, the role of surgical expertise plays a key role, and will be documented and analyzed separately. This is the first randomized controlled multicenter relevance trial to compare different vessel occlusion techniques in thyroid surgery with adequate power and other detailed information about the design as well as framework. If significant, the results might be generalized and may change the current surgical practice.

  16. The efficacy of systemic therapy for childhood and adolescent externalizing disorders: a systematic review of 47 RCT.

    Science.gov (United States)

    von Sydow, Kirsten; Retzlaff, Ruediger; Beher, Stefan; Haun, Markus W; Schweitzer, Jochen

    2013-12-01

    Systemic (family) therapy is a widely used psychotherapy approach. However, most systematic efficacy reviews have focused solely on "family-based treatment" rather than on the theoretic orientation "systemic therapy." We systematically review trials on the efficacy of systemic therapy for the treatment of childhood and adolescent externalizing disorders. All randomized (or matched) controlled trials (RCT) evaluating systemic/systems-oriented therapy in various forms (family, individual, group, multi-family group therapy) with child or adolescent index patients (0-17 years) suffering from mental disorders were identified by data base searches and cross-references. Inclusion criteria were as follows: index patient diagnosed with a DSM- or ICD-listed mental disorder, and trial published in any language up to the end of 2011. The RCTs were analyzed for their research methodology, interventions applied, and results (postintervention; follow-up). A total of 47 trials from the United States, Europe, and China, published in English, German, and Mandarin, were identified. A total of 42 of them showed systemic therapy to be efficacious for the treatment of attention deficit hyperactivity disorders, conduct disorders, and substance use disorders. Results were stable across follow-up periods of up to 14 years. There is a sound evidence base for the efficacy of systemic therapy for children and adolescents (and their families) diagnosed with externalizing disorders.

  17. Pragmatic design in randomized controlled trials.

    Science.gov (United States)

    Purgato, M; Barbui, C; Stroup, S; Adams, C

    2015-01-01

    At more than 10 years after the paper by Hotopf and colleagues regarding pragmatic trials in psychiatry, the field has evolved and is evolving further. There have been many developments in our understanding of what pragmatism really means, and excellent examples of truly pragmatic trials in psychiatry are currently available. Funders have helped encourage more emphasis on the need for such studies, but 'local' and trans-national regulations could help more. Consumers of the evidence should have a greater voice in generating the research agenda and, as this happens, the questions generated are more likely to be answered by a pragmatic approach to trials.

  18. Improving the recruitment activity of clinicians in randomised controlled trials: a systematic review.

    Science.gov (United States)

    Fletcher, Ben; Gheorghe, Adrian; Moore, David; Wilson, Sue; Damery, Sarah

    2012-01-01

    Background Poor recruitment to randomised controlled trials (RCTs) is a widespread problem. Provision of interventions aimed at supporting or incentivising clinicians may improve recruitment to RCTs. Objectives To quantify the effects of strategies aimed at improving the recruitment activity of clinicians in RCTs, complemented with a synthesis of qualitative evidence related to clinicians' attitudes towards recruiting to RCTs. Data sources A systematic review of English and non-English articles identified from: The Cochrane Library, Ovid MEDLINE, Ovid EMBASE, Ovid PsycINFO, Ebsco CINAHL, Index to Theses and Open SIGLE from 2001 to March 2011. Additional reports were identified through citation searches of included articles. Study eligibility criteria Quantitative studies were included if they evaluated interventions aimed at improving the recruitment activity of clinicians or compared recruitment by different groups of clinicians. Information about host trial, study design, participants, interventions, outcomes and host RCT was extracted by one researcher and checked by another. Studies that met the inclusion criteria were assessed for quality using a standardised tool, the Effective Public Health Practice Project tool. Qualitative studies were included if they investigated clinicians' attitudes to recruiting patients to RCTs. All results/findings were extracted, and content analysis was carried out. Overarching themes were abstracted, followed by a metasummary analysis. Studies that met the inclusion criteria were assessed for quality using the Critical Appraisal Skills Programme qualitative checklist. Data extraction Data extraction was carried out by one researcher using predefined data fields, including study quality indicators, and verified by another. Results Eight quantitative studies were included describing four interventions and a comparison of recruiting clinicians. One study was rated as strong, one as moderate and the remaining six as weak when

  19. Internet-based cognitive behavioural therapy (iCBT) for posttraumatic stress disorder versus waitlist control: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Allen, Adrian R; Newby, Jill M; Smith, Jessica; Andrews, Gavin

    2015-12-01

    This randomised controlled trial (RCT) with two parallel arms will evaluate the efficacy of an internet-delivered six-lesson 10-week cognitive behavioural therapy (iCBT) intervention for posttraumatic stress disorder (PTSD). It will also investigate the association between changes in PTSD symptoms, intolerance of uncertainty (IU) and emotion regulation. Patients with PTSD will be recruited via the research arm of a not-for-profit clinical and research unit in Australia and randomised to a treatment group or waitlist control group. The minimum sample size for each group (alpha 0.05, power 0.80 for a g of 0.47) was identified as 72, but 10 % more will be recruited to hedge against expected attrition. PTSD diagnosis will be determined using the PTSD module from the Mini International Neuropsychiatric Interview version 5.0.0. The PTSD Checklist - Civilian version (PCL-C) will be used to measure PTSD symptoms (the primary outcome measure), with the Intolerance of Uncertainty Scale 12-item version (IUS-12) and the Emotion Regulation Questionnaire (ERQ) used to measure intolerance of uncertainty and emotion regulation, respectively. The PCL-C will be administered to the treatment group before each lesson of the PTSD program and at 3-month follow-up. The IUS-12 and ERQ will be administered before lessons 1 and 4, at post-treatment and at 3-month follow-up. The waitlist control group will complete these measures at week 1, week 5 and week 11 of the waitlist period. PTSD program efficacy will be determined using intent-to-treat mixed models. Maintenance of gains will be assessed at 3-month follow-up. Mediation analyses using PROCESS will be used to examine the association between change in PTSD symptoms over treatment and change in each of IU and emotion regulation ability in separate analyses. The current RCT seeks to replicate previous efficacy findings of iCBT for PTSD in a formally assessed PTSD sample from the general population. Findings may point to future lines of

  20. Evaluating transdiagnostic treatment for distress and impairment in veterans: a multi-site randomized controlled trial of Acceptance and Commitment Therapy.

    Science.gov (United States)

    Lang, Ariel J; Schnurr, Paula P; Jain, Sonia; Raman, Rema; Walser, Robyn; Bolton, Elisa; Chabot, Aimee; Benedek, David

    2012-01-01

    Military personnel who engaged in the conflicts in Afghanistan and Iraq frequently present for mental health care because of the stresses of service and readjustment. Although excellent treatments are available to treat the typical presenting problems, there is a need for additional empirically supported treatment approaches for this population. Because these veterans have high levels of comorbidity, transdiagnostic treatment - treatment that applies to more than one diagnosis - may be an efficient approach for this group. Acceptance and Commitment Therapy (ACT) is one such approach that is well-known and has high face validity for veterans, but it has not been rigorously evaluated as a treatment for trauma-related mental health problems. Described herein is an ongoing multi-site randomized clinical trial of ACT as compared to a psychotherapy control. Challenges in designing an RCT to evaluate transdiagnostic treatment and in executing a multi-site psychotherapy trial are discussed.

  1. 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

  2. EEG Neurofeedback treatments in children with ADHD: An updated meta-analysis of Randomized Controlled Trials

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    Jean-Arthur eMicoulaud Franchi

    2014-11-01

    Full Text Available Objective We undertook a meta-analysis of published Randomized Controlled Trials (RCT with semi-active control and sham-NF groups to determine whether EEG-NF significantly improves the overall symptoms, inattention and hyperactivity/impulsivity dimensions for probably unblinded assessment (parent assessment and probably blinded assessment (teacher assessment in children with Attention Deficit Hyperactivity Disorder (ADHD.Data Sources A systematic review identified independent studies that were eligible for inclusion in a random effects meta-analysis.Data Extraction Effect sizes for ADHD symptoms were expressed as standardized mean differences (SMD with 95% confidence intervals.ResultsFive identified studies met eligibility criteria, 263 patients with ADHD were included, 146 patients were trained with EEG-NF. On parent assessment (probably unblinded assessment, the overall ADHD score (SMD=-0.49 [-0.74, -0.24], the inattention score (SMD=-0.46 [-0.76, -0.15] and the hyperactivity/impulsivity score (SMD=-0.34 [-0.59, -0.09] were significantly improved in patients receiving EEG-NF compared to controls. On teacher assessment (probably blinded assessment, only the inattention score was significantly improved in patients receiving EEG-NF compared to controls (SMD=-0.30 [-0.58, -0.03]. ConclusionsThis meta-analysis of EEG-NF in children with ADHD highlights improvement in the inattention dimension of ADHD symptoms. Future investigations should pay greater attention to adequately blinded studies and EEG-NF protocols that carefully control the implementation and embedding of training.

  3. A randomised control trial of experiential learning to promote physical activity.

    Science.gov (United States)

    Cooke, Philip A; Tully, Mark A; Cupples, Margaret E; Gilliland, Andrew E; Gormley, Gerard J

    2013-09-01

    The paucity of training in physical activity (PA) promotion in UK medical schools is a barrier to health professionals' promotion of PA to their patients. Doctors who are more physically active are more likely to counsel patients in this regard. We used a randomised controlled trial (RCT) to examine the effect of an intervention which engaged students in goal-setting, using pedometer step counts, on their PA behaviour and intentions to promote PA in future practice. We invited fourth-year medical students to participate in the study during their four-week placement in primary care. Following baseline pedometer measurement of daily step counts for one week, students were randomly allocated to intervention (individual step count goal-setting) or control groups. Using pedometers, both groups monitored their PA during the following week. Intentions to promote PA were assessed using a questionnaire based on the theory of planned behaviour at baseline, four weeks and nine weeks. Focus groups explored the students' experiences of PA measurement, goalsetting for behaviour change and health promotion teaching. One-hundred and thirty-six students participated (70 intervention; 66 control). The mean change in daily step count was greater ( P =0.001) in the intervention group (1245, 95% CI 762 to 1727) than in the control group (-65, 95% CI -644 to 573). Scores for perceived behavioural control over PA counselling increased in both groups, with a trend for higher scores in the intervention group. Intervention group students described how experience of personal PA behaviour change gave insights into barriers patients may face and improved their confidence in PA counselling. Medical students' personal experience of goal setting in increasing PA appears to lead to a more positive perception of their ability to deliver effective PA promotion in future practice. Inclusion of this learning experience within the undergraduate curriculum may improve doctors' skills in health promotion.

  4. The Feedback Intervention Trial (FIT--improving hand-hygiene compliance in UK healthcare workers: a stepped wedge cluster randomised controlled trial.

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    Christopher Fuller

    Full Text Available INTRODUCTION: Achieving a sustained improvement in hand-hygiene compliance is the WHO's first global patient safety challenge. There is no RCT evidence showing how to do this. Systematic reviews suggest feedback is most effective and call for long term well designed RCTs, applying behavioural theory to intervention design to optimise effectiveness. METHODS: Three year stepped wedge cluster RCT of a feedback intervention testing hypothesis that the intervention was more effective than routine practice in 16 English/Welsh Hospitals (16 Intensive Therapy Units [ITU]; 44 Acute Care of the Elderly [ACE] wards routinely implementing a national cleanyourhands campaign. Intervention-based on Goal & Control theories. Repeating 4 week cycle (20 mins/week of observation, feedback and personalised action planning, recorded on forms. Computer-generated stepwise entry of all hospitals to intervention. Hospitals aware only of own allocation. PRIMARY OUTCOME: direct blinded hand hygiene compliance (%. RESULTS: All 16 trusts (60 wards randomised, 33 wards implemented intervention (11 ITU, 22 ACE. Mixed effects regression analysis (all wards accounting for confounders, temporal trends, ward type and fidelity to intervention (forms/month used. INTENTION TO TREAT ANALYSIS: Estimated odds ratio (OR for hand hygiene compliance rose post randomisation (1.44; 95% CI 1.18, 1.76;p<0.001 in ITUs but not ACE wards, equivalent to 7-9% absolute increase in compliance. PER-PROTOCOL ANALYSIS FOR IMPLEMENTING WARDS: OR for compliance rose for both ACE (1.67 [1.28-2.22]; p<0.001 & ITUs (2.09 [1.55-2.81]; p<0.001 equating to absolute increases of 10-13% and 13-18% respectively. Fidelity to intervention closely related to compliance on ITUs (OR 1.12 [1.04, 1.20]; p = 0.003 per completed form but not ACE wards. CONCLUSION: Despite difficulties in implementation, intention-to-treat, per-protocol and fidelity to intervention, analyses showed an intervention coupling feedback to

  5. Endorsement for improving the quality of reports on randomized controlled trials of traditional medicine journals in Korea: a systematic review.

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    Choi, Jiae; Jun, Ji Hee; Kang, Byoung Kab; Kim, Kun Hyung; Lee, Myeong Soo

    2014-11-05

    The aim of this study was to assess the endorsement of reporting guidelines in Korean traditional medicine (TM) journals by reviewing their instructions to authors. We examined the instructions to authors in all of the TM journals published in Korea to assess the appropriate use of reporting guidelines for research studies. The randomized controlled trials (RCTs) published after 2010 in journals that endorsed reporting guidelines were obtained. The reporting quality was assessed using the following guidelines: the 38-item Consolidated Standards of Reporting Trials (CONSORT) statement for non-pharmacological trials (NPT); the 17-item Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) statement, instead of the 5-item CONSORT for acupuncture trials; and the 22-item CONSORT extensions for herbal medicine trials. The overall item score was calculated and expressed as a proportion.One journal that endorsed reporting guidelines was identified. Twenty-nine RCTs published in this journal after 2010 met the selection criteria. General editorial policies such as those of the International Committee of Medical Journal Editors (ICMJE) were endorsed by 15 journals. In each of the CONSORT-NPT articles, 21.6 to 56.8% of the items were reported, with an average of 11.3 items (29.7%) being reported. In the 24 RCTs (24/29, 82.8%) appraised using the STRICTA items, an average of 10.6 items (62.5%) were addressed, with a range of 41.2 to 100%. For the herbal intervention reporting, 17 items (77.27%) were reported. In the RCT studies before and after the endorsement of CONSORT and STRICTA guidelines by each journal, all of the STRICTA items had significant improvement, whereas the CONSORT-NPT items improved without statistical significance.The endorsement of reporting guidelines is limited in the TM journals in Korea. Authors should adhere to the reporting guidelines, and editorial departments should refer authors to the various reporting guidelines to

  6. Impact of complementary therapies via mobile technologies on Icelandic same day surgical patients' reports of anxiety, pain and self-efficacy in healing: a randomized controlled trial in process.

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    Hansen, Margaret M

    2013-01-01

    Complementary and Alternative Therapies (CAT) are increasingly being utilized in conjunction with conventional medicine. Health Information Technology (HIT) and CAT are being scrutinized for evidence based health outcomes. The aim of this randomized controlled trial (RCT) is to determine if the use of mobile technologies delivering CAT, specifically relaxation technique (RT), medical music intervention (MMI), nature landscape applications with (NLAM) and without music (NLAWM) compared with no intervention (control group) will assist in decreasing pre- and post-surgical patients' anxiety and pain levels while increasing post-operative healing self-efficacy levels.

  7. 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

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    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

  8. 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

  9. Periodontal disease and chronic kidney disease among Aboriginal adults; an RCT.

    Science.gov (United States)

    Jamieson, Lisa; Skilton, Michael; Maple-Brown, Louise; Kapellas, Kostas; Askie, Lisa; Hughes, Jaqui; Arrow, Peter; Cherian, Sajiv; Fernandes, David; Pawar, Basant; Brown, Alex; Boffa, John; Hoy, Wendy; Harris, David; Mueller, Nicole; Cass, Alan

    2015-10-31

    This study will assess measures of vascular health and inflammation in Aboriginal Australian adults with chronic kidney disease (CKD), and determine if intensive periodontal intervention improves cardiovascular health, progression of renal disease and periodontal health over a 24-month follow-up. The study will be a randomised controlled trial. All participants will receive the periodontal intervention benefits, with the delayed intervention group receiving periodontal treatment 24 months following baseline. Inclusion criteria include being an Aboriginal Australian, having CKD (a. on dialysis; b. eGFR levels of Australia for the 2-year study duration. The intervention involves intensive removal of dental plaque biofilms by scaling, root-planing and removal of teeth that cannot be saved. The intervention will occur in three visits; baseline, 3-month and 6-month follow-up. The primary outcome will be changes in carotid intima-media thickness (cIMT). Secondary outcomes will include progression of CKD or death as a consequence of CKD/cardiovascular disease. Progression of CKD will be defined by time to the development of the first of: (1) new development of macroalbuminuria; (2) 30 % loss of baseline eGFR; (3) progression to end stage kidney disease defined by eGFR power of 0.80. Allowing for 20 % attrition, 592 participants are necessary at baseline, rounded to 600 for convenience. This will be the first RCT evaluating the effect of periodontal therapy on progression of CKD and cardiovascular disease among Aboriginal patients with CKD. Demonstration of a significant attenuation of CKD progression and cardiovascular disease has the potential to inform clinicians of an important, new and widely available strategy for reducing CKD progression and cardiovascular disease for Australia's most disadvantaged population. This trial is registered with the Australian New Zealand Clinical Trial Registry ANZCTR12614001183673.

  10. WELLFOCUS PPT - modified positive psychotherapy to improve well-being in psychosis: study protocol for a pilot randomised controlled trial.

    Science.gov (United States)

    Schrank, Beate; Riches, Simon; Coggins, Tony; Rashid, Tayyab; Tylee, Andre; Slade, Mike

    2014-06-03

    The promotion of well-being is an important goal of recovery oriented mental health services. No structured, evidence-based intervention exists that aims to increase the well-being in people with severe mental illness such as psychosis. Positive psychotherapy (PPT) is a promising intervention for this goal. Standard PPT was adapted for use with people with psychosis in the UK following the Medical Research Council framework for developing and testing complex interventions, resulting in the WELLFOCUS Model describing the intended impact of WELLFOCUS PPT. This study aims to test the WELLFOCUS Model, by piloting the intervention, trial processes, and evaluation strategy. This study is a non-blinded pragmatic pilot RCT comparing WELLFOCUS PPT provided as an 11-session group therapy in addition to treatment as usual to treatment as usual alone. Inclusion criteria are adults (aged 18-65 years) with a main diagnosis of psychosis who use mental health services. A target sample of 80 service users with psychosis are recruited from mental health services across the South London and Maudsley NHS Foundation Trust. Participants are randomised in blocks to the intervention and control group. WELLFOCUS PPT is provided to groups by specifically trained and supervised local therapists and members of the research team. Assessments are conducted before randomisation and after the group intervention. The primary outcome measure is well-being assessed by the Warwick-Edinburgh Mental Well-being Scale. Secondary outcomes include good feelings, symptom relief, connectedness, hope, self-worth, empowerment, and meaning. Process evaluation using data collected during the group intervention, post-intervention individual interviews and focus groups with participants, and interviews with trial therapists will complement quantitative outcome data. This study will provide data on the feasibility of the intervention and identify necessary adaptations. It will allow optimisation of trial processes

  11. A randomised controlled trial of extended brief intervention for alcohol dependent patients in an acute hospital setting (ADPAC

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    Williamson Paula

    2011-07-01

    Full Text Available Abstract Background Alcohol dependence affects approximately 3% of the English population, and accounts for significant medical and psychiatric morbidity. Only 5.6% of alcohol-dependent individuals ever access specialist treatment and only a small percentage ever seek treatment. As people who are alcohol dependent are more likely to have experienced health problems leading to frequent attendance at acute hospitals it would seem both sensible and practical to ensure that this setting is utilised as a major access point for treatment, and to test the effectiveness of these treatments. Methods/Design This is a randomised controlled trial with a primary hypothesis that extended brief interventions (EBI delivered to alcohol-dependent patients in a hospital setting by an Alcohol Specialist Nurse (ASN will be effective when compared to usual care in reducing overall alcohol consumption and improving on the standard measures of alcohol dependence. Consecutive patients will be screened for alcohol misuse in the Emergency Department (ED of a district general hospital. On identification of an alcohol-related problem, following informed written consent, we aim to randomize 130 patients per group. The ASN will discharge to usual clinical care all control group patients, and plan a programme of EBI for treatment group patients. Follow-up interview will be undertaken by a researcher blinded to the intervention at 12 and 24 weeks. The primary outcome measure is level of alcohol dependence as determined by the Severity of Alcohol Dependence Questionnaire (SADQ score. Secondary outcome measures include; Alcohol Use Disorders Identification Test (AUDIT score, quantity and frequency of alcohol consumption, health-related quality of life measures, service utilisation, and patient experience. The trial will also allow an assessment of the cost-effectiveness of EBI in an acute hospital setting. In addition, patient experience will be assessed using qualitative methods

  12. Challenges of randomized controlled trial design in plastic surgery.

    Science.gov (United States)

    Hassanein, Aladdin H; Herrera, Fernando A; Hassanein, Omar

    2011-01-01

    Randomized controlled trials are the gold standard of evidence-based medicine. In the field of plastic surgery, designing these studies is much more challenging than in pharmaceutical medicine. Randomized trials in plastic surgery encompass several road blocks including problems shared with other surgical trials: equipoise, high cost, placebo issues and learning curves following the establishment of a novel approach. In addition, plastic surgery has more subjective outcomes, thus making study design even more difficult in assessing the end result.

  13. Equipoise, design bias, and randomized controlled trials: the elusive ethics of new drug development.

    Science.gov (United States)

    Fries, James F; Krishnan, Eswar

    2004-01-01

    The concept of 'equipoise', or the 'uncertainty principle', has been represented as a central ethical principle, and holds that a subject may be enrolled in a randomized controlled trial (RCT) only if there is true uncertainty about which of the trial arms is most likely to benefit the patient. We sought to estimate the frequency with which equipoise conditions were met in industry-sponsored RCTs in rheumatology, to explore the reasons for any deviations from equipoise, to examine the concept of 'design bias', and to consider alternative ethical formulations that might improve subject safety and autonomy. We studied abstracts accepted for the 2001 American College of Rheumatology meetings that reported RCTs, acknowledged industry sponsorship, and had clinical end-points (n = 45), and examined the proportion of studies that favored the registration or marketing of the sponsor's drug. In every trial (45/45) results were favorable to the sponsor, indicating that results could have been predicted in advance solely by knowledge of sponsorship (P < 0.0001). Equipoise clearly was being systematically violated. Publication bias appeared to be an incomplete explanation for this dramatic result; this bias occurs after a study is completed. Rather, we hypothesize that 'design bias', in which extensive preliminary data are used to design studies with a high likelihood of being positive, is the major cause of the asymmetric results. Design 'bias' occurs before the trial is begun and is inconsistent with the equipoise principle. However, design bias increases scientific efficiency, decreases drug development costs, and limits the number of subjects required, probably reducing aggregate risks to participants. Conceptual and ethical issues were found with the equipoise principle, which encourages performance of negative studies; ignores patient values, patient autonomy, and social benefits; is applied at a conceptually inappropriate decision point (after randomization rather than

  14. Active video games as a tool to prevent excessive weight gain in adolescents: rationale, design and methods of a randomized controlled trial

    Science.gov (United States)

    2014-01-01

    Background Excessive body weight, low physical activity and excessive sedentary time in youth are major public health concerns. A new generation of video games, the ones that require physical activity to play the games –i.e. active games- may be a promising alternative to traditional non-active games to promote physical activity and reduce sedentary behaviors in youth. The aim of this manuscript is to describe the design of a study evaluating the effects of a family oriented active game intervention, incorporating several motivational elements, on anthropometrics and health behaviors in adolescents. Methods/Design The study is a randomized controlled trial (RCT), with non-active gaming adolescents aged 12 – 16 years old randomly allocated to a ten month intervention (receiving active games, as well as an encouragement to play) or a waiting-list control group (receiving active games after the intervention period). Primary outcomes are adolescents’ measured BMI-SDS (SDS = adjusted for mean standard deviation score), waist circumference-SDS, hip circumference and sum of skinfolds. Secondary outcomes are adolescents’ self-reported time spent playing active and non-active games, other sedentary activities and consumption of sugar-sweetened beverages. In addition, a process evaluation is conducted, assessing the sustainability of the active games, enjoyment, perceived competence, perceived barriers for active game play, game context, injuries from active game play, activity replacement and intention to continue playing the active games. Discussion This is the first adequately powered RCT including normal weight adolescents, evaluating a reasonably long period of provision of and exposure to active games. Next, strong elements are the incorporating motivational elements for active game play and a comprehensive process evaluation. This trial will provide evidence regarding the potential contribution of active games in prevention of excessive weight gain in

  15. Anesthetic management of cesarean section in cases of placenta accreta, with versus without abdominal aortic balloon occlusion: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Chu, Qinjun; Shen, Dan; He, Long; Wang, Hongwei; Zhao, Xianlan; Chen, Zhimin; Wang, Yanli; Zhang, Wei

    2017-05-26

    Placenta accreta (PA), a severe complication during delivery, is closely linked with massive hemorrhage which could endanger the lives of both mother and baby. Moreover, the incidence of PA has increased dramatically with the increasing rate of cesarean deliveries in the past few decades. Therefore, studies evaluating the effects of different perioperative managements based on different modalities in the treatment of PA are necessary. Among the numerous treatment measures, prophylactic abdominal aortic balloon occlusion (AABO) in combination with cesarean section for PA seems to be more advantageous than others. However, up to now, all studies on AABO were almost retrospective. Current evidence is insufficient to recommend for or against routinely using the AABO technology for control intraoperative hemorrhage in patients with PA. Thus, we hope to carry out a prospective, randomized controlled trial (RCT) study to confirm the effectiveness of the AABO technology in patients with PA. This trial is an investigator-initiated, prospective RCT that will test the superiority of AABO in combination with cesarean section compared to the traditional hysterectomy following cesarean section for parturients with PA. A total of 170 parturients with PA undergoing cesarean section will be randomized to receive either AABO in combination with cesarean section or the traditional hysterectomy following cesarean section. The primary outcome is estimated blood loss. The most important secondary outcome is the occurrence of cesarean hysterectomy during delivery; others include blood transfusion volume, operating time, neonate's Apgar scores (collected at 1, 5 and 10 min), length of stay in intensive care unit, total hospital stay, and balloon occlusion-relative data. This prospective trial will test the superiority of AABO in combination with cesarean section compared to the traditional hysterectomy following cesarean section for parturients with PA. It may provide strong evidence

  16. Just-in-time information improved decision-making in primary care: a randomized controlled trial.

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    Jessie McGowan

    Full Text Available BACKGROUND: The "Just-in-time Information" (JIT librarian consultation service was designed to provide rapid information to answer primary care clinical questions during patient hours. This study evaluated whether information provided by librarians to answer clinical questions positively impacted time, decision-making, cost savings and satisfaction. METHODS AND FINDING: A randomized controlled trial (RCT was conducted between October 2005 and April 2006. A total of 1,889 questions were sent to the service by 88 participants. The object of the randomization was a clinical question. Each participant had clinical questions randomly allocated to both intervention (librarian information and control (no librarian information groups. Participants were trained to send clinical questions via a hand-held device. The impact of the information provided by the service (or not provided by the service, additional resources and time required for both groups was assessed using a survey sent 24 hours after a question was submitted. The average time for JIT librarians to respond to all questions was 13.68 minutes/question (95% CI, 13.38 to 13.98. The average time for participants to respond their control questions was 20.29 minutes/question (95% CI, 18.72 to 21.86. Using an impact assessment scale rating cognitive impact, participants rated 62.9% of information provided to intervention group questions as having a highly positive cognitive impact. They rated 14.8% of their own answers to control question as having a highly positive cognitive impact, 44.9% has having a negative cognitive impact, and 24.8% with no cognitive impact at all. In an exit survey measuring satisfaction, 86% (62/72 responses of participants scored the service as having a positive impact on care and 72% (52/72 indicated that they would use the service frequently if it were continued. CONCLUSIONS: In this study, providing timely information to clinical questions had a highly positive impact on

  17. Neurofeedback as a Treatment for Impulsivity in a Forensic Psychiatric Population With Substance Use Disorder: Study Protocol of a Randomized Controlled Trial Combined With an N-of-1 Clinical Trial.

    Science.gov (United States)

    Fielenbach, Sandra; Donkers, Franc Cl; Spreen, Marinus; Bogaerts, Stefan

    2017-01-25

    Impulsivity and substance use disorder (SUD) are strongly interconnected, with persons scoring high on impulsivity being more vulnerable to develop substance abuse, facing more challenges for successful treatment, and being more prone to engage in criminal behavior. Studies have shown that impulsivity and craving for substances are strongly correlated. Neurofeedback is an effective treatment to reduce impulsive behavior. This study intends to determine to what extent a neurofeedback-intervention that is aimed at reducing impulsivity can also reduce levels of craving in forensic patients with SUD and comorbid Axis I and/or II diagnoses. The main objective of this study is to investigate to what extent a reduction in impulsivity by a sensorimotor rhythm (SMR)-neurofeedback intervention will lead to a reduction in craving in a population of forensic psychiatric patients with a diagnosis of SUD. Participants will be male SUD patients with various comorbidities residing in an inpatient forensic treatment facility approached through treatment supervisors for participation. Participants have tested positive for drug use in the past 24 months. The study consists of 2 parts: a randomized controlled trial (RCT) and a n-of-1 clinical series. In the RCT, 50 patients will be randomly assigned to an intervention (n=25) or a control (n=25) condition. Patients in the intervention group will receive 20 SMR neurofeedback sessions aimed at reducing impulsivity; participants in the control group receive treatment-as-usual (TAU). Additionally, 4 in depth n-of-1 clinical trials will be conducted where effects of an SMR neurofeedback intervention will be compared to effects of sham neurofeedback. Results of this study are expected by the end of 2017. This protocol describes the design of a study testing the effects of an impulsivity-based neurofeedback protocol among forensic patients with SUD and various comorbidities. We expect a significant reduction in impulsive behavior, level of

  18. A randomised controlled trial of a blended learning education intervention for teaching evidence-based medicine.

    Science.gov (United States)

    Ilic, Dragan; Nordin, Rusli Bin; Glasziou, Paul; Tilson, Julie K; Villanueva, Elmer

    2015-03-10

    Few studies have been performed to inform how best to teach evidence-based medicine (EBM) to medical trainees. Current evidence can only conclude that any form of teaching increases EBM competency, but cannot distinguish which form of teaching is most effective at increasing student competency in EBM. This study compared the effectiveness of a blended learning (BL) versus didactic learning (DL) approach of teaching EBM to medical students with respect to competency, self-efficacy, attitudes and behaviour toward EBM. A mixed methods study consisting of a randomised controlled trial (RCT) and qualitative case study was performed with medical students undertaking their first clinical year of training in EBM. Students were randomly assigned to receive EBM teaching via either a BL approach or the incumbent DL approach. Competency in EBM was assessed using the Berlin questionnaire and the 'Assessing Competency in EBM' (ACE) tool. Students' self-efficacy, attitudes and behaviour was also assessed. A series of focus groups was also performed to contextualise the quantitative results. A total of 147 students completed the RCT, and a further 29 students participated in six focus group discussions. Students who received the BL approach to teaching EBM had significantly higher scores in 5 out of 6 behaviour domains, 3 out of 4 attitude domains and 10 out of 14 self-efficacy domains. Competency in EBM did not differ significantly between students receiving the BL approach versus those receiving the DL approach [Mean Difference (MD)=-0.68, (95% CI-1.71, 0.34), p=0.19]. No significant difference was observed between sites (p=0.89) or by student type (p=0.58). Focus group discussions suggested a strong student preference for teaching using a BL approach, which integrates lectures, online learning and small group activities. BL is no more effective than DL at increasing medical students' knowledge and skills in EBM, but was significantly more effective at increasing student

  19. Internet-based prevention of posttraumatic stress symptoms in injured trauma patients: design of a randomized controlled trial

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    Joanne Mouthaan

    2011-11-01

    Full Text Available Background: Injured trauma victims are at risk of developing Posttraumatic Stress Disorder (PTSD and other post-trauma psychopathology. So far, interventions using cognitive behavioral techniques (CBT have proven most efficacious in treating early PTSD in highly symptomatic individuals. No early intervention for the prevention of PTSD for all victims has yet proven effective. In the acute psychosocial care for trauma victims, there is a clear need for easily applicable, accessible, cost-efficient early interventions. Objective: To describe the design of a randomized controlled trial (RCT evaluating the effectiveness of a brief Internet-based early intervention that incorporates CBT techniques with the aim of reducing acute psychological distress and preventing long-term PTSD symptoms in injured trauma victims. Method: In a two armed RCT, 300 injured trauma victims from two Level-1 trauma centers in Amsterdam, the Netherlands, will be assigned to an intervention or a control group. Inclusion criteria are: being 18 years of age or older, having experienced a traumatic event according to the diagnostic criteria of the DSM-IV and understanding the Dutch language. The intervention group will be given access to the intervention's website (www.traumatips.nl, and are specifically requested to login within the first month postinjury. The primary clinical study outcome is PTSD symptom severity. Secondary outcomes include symptoms of depression and anxiety, quality of life, and social support. In addition, a cost-effectiveness analysis of the intervention will be performed. Data are collected at one week post-injury, prior to first login (baseline, and at 1, 3, 6 and 12 months. Analyses will be on an intention-to-treat basis. Discussion: The results will provide more insight into the effects of preventive interventions in general, and Internet-based early interventions specifically, on acute stress reactions and PTSD, in an injured population, during the

  20. A new interdisciplinary treatment strategy versus usual medical care for the treatment of subacromial impingement syndrome: a randomized controlled trial

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    van der Meer Klaas

    2007-02-01

    Full Text Available Abstract Background Subacromial impingement syndrome (SIS is the most frequently recorded shoulder disorder. When conservative treatment of SIS fails, a subacromial decompression is warranted. However, the best moment of referral for surgery is not well defined. Both early and late referrals have disadvantages – unnecessary operations and smaller improvements in shoulder function, respectively. This paper describes the design of a new interdisciplinary treatment strategy for SIS (TRANSIT, which comprises rules to treat SIS in primary care and a well-defined moment of referral for surgery. Methods/Design The effectiveness of an arthroscopic subacromial decompression versus usual medical care will be evaluated in a randomized controlled trial (RCT. Patients are eligible for inclusion when experiencing a recurrence of SIS within one year after a first episode of SIS which was successfully treated with a subacromial corticosteroid injection. After inclusion they will receive injection treatment again by their general practitioner. When, after this treatment, there is a second recurrence within a year post-injection, the participants will be randomized to either an arthroscopic subacromial decompression (intervention group or continuation of usual medical care (control group. The latter will be performed by a general practitioner according to the Dutch National Guidelines for Shoulder Problems. At inclusion, at randomization and three, six and 12 months post-randomization an outcome assessment will take place. The primary outcome measure is the patient-reported Shoulder Disability Questionnaire. The secondary outcome measures include both disease-specific and generic measures, and an economic evaluation. Treatment effects will be compared for all measurement points by using a GLM repeated measures analyses. Discussion The rationale and design of an RCT comparing arthroscopic subacromial decompression with usual medical care for subacromial

  1. Snack purchasing is healthier when the cognitive demands of choice are reduced: A randomized controlled trial.

    Science.gov (United States)

    Allan, Julia L; Johnston, Marie; Campbell, Neil

    2015-07-01

    Individuals with inefficient executive (higher level cognitive) function have a reduced ability to resist dietary temptation. The present study aimed to design and test a theory-based point-of-purchase intervention for coffee shops that reduced the calorie content of customers' purchases by reducing the need for executive function (EF) at the moment of choice. Key facets of EF were identified by a multidisciplinary group and used to develop a point-of-purchase intervention (signage). This intervention was evaluated in a randomized controlled trial (RCT) in a public coffee shop on consumer purchases of >20,000 snacks and drinks over 12 weeks. A sample of customers (n = 128) was recruited to complete an embedded cross-sectional study measuring EF strength, dietary intentions, typical purchases, and purchases made after exposure to the intervention. The proportion of snack purchases that were high in calorie reduced significantly (t(10) = 2.34, p = .04) in intervention weeks relative to control. High calorie drink purchases were also lower in intervention than control weeks, however, this difference was not significant (t(10) = 1.56, p = .15). On average, customers purchased items containing 66 calories < usual after exposure to the intervention. The magnitude of the intervention's positive effect on customer behavior increased as EF strength decreased (β = .24, p = .03). The calorie content of cafe purchases can be lowered by reducing the cognitive demands of healthy food choice at the moment of purchase, especially in those with poor EF. Environmental changes like these have the potential to help achieve population weight control. (c) 2015 APA, all rights reserved.

  2. Study protocol on comparative effectiveness of mindfulness meditation and qigong on psychophysiological outcomes for patients with colorectal cancer: a randomized controlled trial.

    Science.gov (United States)

    Ho, Rainbow T H; Wan, Adrian H Y; Chan, Jessie S M; Ng, S M; Chung, K F; Chan, Cecilia L W

    2017-08-08

    Colorectal cancer imposes threats to patients' well-being. Although most physical symptoms can be managed by medication, psychosocial stressors may complicate survival and hamper quality of life. Mindfulness and Qigong, two kinds of mind-body exercise rooted in Eastern health philosophy, has been found effective in symptoms management, improving mental health, and reducing stress. With these potential benefits, a randomized controlled trial (RCT) is planned to investigate the comparative effectiveness of mindfulness and Baduanjin intervention on the bio-psychosocial wellbeing of people with colorectal cancer. A 3-arm RCT with waitlist control design will be used in this study. One hundred eighty-nine participants will be randomized into (i) Mindfulness, (ii) Baduanjin, or (iii) waitlist control groups. Participants in both the Baduanjin and mindfulness groups will receive 8-weeks of specific intervention. All three groups will undergo four assessment phases: (i) at baseline, (ii) at 4-week, (iii) at 8-week (post-intervention), and 6-month post-intervention (maintenance). All participants will be assessed in terms of cancer-related symptoms and symptom distress, mental health status, quality of life, stress level based on physiological marker. Based on prior research studies, participants in both the mindfulness and Baduanjn intervention group are expected to have better symptoms management, lower stress level, better mental health, and higher level of quality of life than the control group. This study contributes to better understanding on the common and unique effectiveness of mindfulness and Baduanjin qigong, as such patients and qualified healthcare professionals can select or provide practices which will produce maximum benefits, satisfaction, adherence, and sustainability. The trial has been registered in the Clinical Trials Centre of the University of Hong Kong ( HKCTR-2198 ) on 08 March 2017.

  3. A Mobile App for the Self-Management of Type 1 Diabetes Among Adolescents: A Randomized Controlled Trial.

    Science.gov (United States)

    Goyal, Shivani; Nunn, Caitlin A; Rotondi, Michael; Couperthwaite, Amy B; Reiser, Sally; Simone, Angelo; Katzman, Debra K; Cafazzo, Joseph A; Palmert, Mark R

    2017-06-19

    While optimal blood glucose control is known to reduce the long-term complications associated with type 1 diabetes mellitus, adolescents often struggle to achieve their blood glucose targets. However, their strong propensity toward technology presents a unique opportunity for the delivery of novel self-management interventions. To support type 1 diabetes self-management in this population, we developed the diabetes self-management app bant, which included wireless blood glucose reading transfer, out-of-range blood glucose trend alerts, coaching around out-of-range trend causes and fixes, and a point-based incentive system. The primary objective was to evaluate bant 's effect on hemoglobin A1c (HbA1c) through a randomized controlled trial (RCT). Secondary measures (eg, self-monitoring of blood glucose [SMBG]) were also collected to assess bant 's impact on the self-management behaviors of adolescents with type 1 diabetes. We enrolled 92 adolescents into a 12-month RCT, with 46 receiving usual care and 46 receiving usual care plus bant. Clinical outcome data were collected at quarterly research visits via validated tools, electronic chart review, glucometer downloads, and semistructured interviews. App satisfaction was assessed at 6 and 12 months, and at trial end, users ranked bant components based on perceived usefulness. Mobile analytics captured frequency of blood glucose uploads, which were used to categorize participants into high, moderate, low, or very low engagement levels. Linear mixed models showed no changes in primary and secondary clinical outcomes. However, exploratory regression analysis demonstrated a statistically significant association between increased SMBG and improved HbA1c in the intervention group. For a subgroup of bant users taking SMBG ≥5 daily, there was a significant improvement in HbA1c of 0.58% (P=.02), while the parallel subgroup in the control arm experienced no significant change in HbA1c (decrease of 0.06%, P=.84). Although app

  4. Analysis of scientific truth status in controlled rehabilitation trials.

    Science.gov (United States)

    Kerry, Roger; Madouasse, Aurélien; Arthur, Antony; Mumford, Stephen D

    2013-08-01

    Systematic reviews, meta-analyses and clinical guidelines (reviews) are intended to inform clinical practice, and in this sense can be thought of as scientific truthmakers. High-quality controlled trials should align to this truth, and method quality markers should predict truth status. We sought to determine in what way controlled trial quality relates to scientific truth, and to determine predictive utility of trial quality and bibliographic markers. A sample of reviews in rehabilitation medicine was examined. Two scientific truth dimensions were established based on review outcomes. Quality and bibliographic markers were extracted from associated trials for use in a regression analysis of their predictive utility for trial truth status. Probability analysis was undertaken to examine judgments of future trial truth status. Of the 93 trials included in contemporaneous reviews, overall, n = 45 (48%) were true. Randomization was found more in true trials than false trials in one truth dimension (P = 0.03). Intention-to-treat analysis was close to significant in one truth dimension (P = 0.058), being more commonly used in false trials. There were no other significant differences in quality or bibliographic variables between true and false trials. Regression analysis revealed no significant predictors of trial truth status. Probability analysis reported that the reasonable chance of future trials being true was between 2 and 5%, based on a uniform prior. The findings are at odds with what is considered gold-standard research methods, but in line with previous reports. Further work should focus on scientific dynamics within healthcare research and evidence-based practice constructs. © 2012 John Wiley & Sons Ltd.

  5. Healthy eating and obesity prevention for preschoolers: a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Swinburn Boyd

    2010-04-01

    Full Text Available Abstract Background Developing effective prevention and intervention programs for the formative preschool years is seen as an essential step in combating the obesity epidemic across the lifespan. The overall goal of the current project is to measure the effectiveness of a healthy eating and childhood obesity prevention intervention, the MEND (Mind Exercise Nutrition Do It! program that is delivered to parents of children aged 2-4 years. Methods/Design This randomised controlled trial will be conducted with 200 parents and their 2-4 year old children who attend the MEND 2-4 program in metropolitan and regional Victoria. Parent-child dyads will attend ten 90-minute group workshops. These workshops focus on general nutrition, as well as physical activity and behaviours. They are typically held at community or maternal and child health centres and run by a MEND 2-4 trained program leader. Child eating habits, physical activity levels and parental behaviours and cognitions pertaining to nutrition and physical activity will be assessed at baseline, the end of the intervention, and at 6 and 12 months post the intervention. Informed consent will be obtained from all parents, who will then be randomly allocated to the intervention or wait-list control group. Discussion Our study is the first RCT of a healthy eating and childhood obesity prevention intervention targeted specifically to Australian parents and their preschool children aged 2-4 years. It responds to the call by experts in the area of childhood obesity and child health that prevention of overweight in the formative preschool years should focus on parents, given that parental beliefs, attitudes, perceptions and behaviours appear to impact significantly on the development of early overweight. This is 'solution-oriented' rather than 'problem-oriented' research, with its focus being on prevention rather than intervention. If this is a positive trial, the MEND2-4 program can be implemented as a

  6. Attrition in longitudinal randomized controlled trials: home visits make a difference

    Directory of Open Access Journals (Sweden)

    Peterson Janey C

    2012-11-01

    Full Text Available Abstract Background Participant attrition in longitudinal studies can introduce systematic bias, favoring participants who return for follow-up, and increase the likelihood that those with complications will be underestimated. Our aim was to examine the effectiveness of home follow-up (Home F/U to complete the final study evaluation on potentially “lost” participants by: 1 evaluating the impact of including and excluding potentially “lost” participants (e.g., those who required Home F/U to complete the final evaluation on the rates of study complications; 2 examining the relationship between timing and number of complications on the requirement for subsequent Home F/U; and 3 determining predictors of those who required Home F/U. Methods We used data from a randomized controlled trial (RCT conducted from 1991–1994 among coronary artery bypass graft surgery patients that investigated the effect of High mean arterial pressure (MAP (intervention vs. Low MAP (control during cardiopulmonary bypass on 5 complications: cardiac morbidity/mortality, neurologic morbidity/mortality, all-cause mortality, neurocognitive dysfunction and functional decline. We enhanced completion of the final 6-month evaluation using Home F/U. Results Among 248 participants, 61 (25% required Home F/U and the remaining 187 (75% received Routine F/U. By employing Home F/U, we detected 11 additional complications at 6 months: 1 major neurologic complication, 6 cases of neurocognitive dysfunction and 4 cases of functional decline. Follow-up of 61 additional Home F/U participants enabled us to reach statistical significance on our main trial outcome. Specifically, the High MAP group had a significantly lower rate of the Combined Trial Outcome compared to the Low MAP group, 16.1% vs. 27.4% (p=0.032. In multivariate analysis, participants who were ≥ 75 years (OR=3.23, 95% CI 1.52-6.88, p=0.002 or on baseline diuretic therapy (OR=2.44, 95% CI 1.14-5.21, p=0.02 were more

  7. The role of fibrinogen and haemostatic assessment in postpartum haemorrhage: preparations for a randomised controlled trial.

    Science.gov (United States)

    Wikkelsø, Anne Juul

    2015-04-01

    to be the strongest predictor. Since this diagnosis is made very late and often in association with the onset of bleeding, tools to perform an early diagnosis is highly warranted. Paper IV includes recommendations of the European Society of Anaesthesiology regarding the use of fibrinogen concentrate in PPH, and is based on very weak (GRADE 2) evidence and low confidence in estimates of effect (GRADE C). Paper V describes the protocol for a RCT of early fibrinogen supplementation in women with severe postpartum haemorrhage. Several practical, ethical and trial management challenges need to be addressed when conducting independent clinical research involving parturients with severe bleeding, placebo-controlled and blinded administration of a drug in a multicenter set-up with enrolments during the entire day and with many personnel involved.

  8. Clinical Research Methodology 3: Randomized Controlled Trials.

    Science.gov (United States)

    Sessler, Daniel I; Imrey, Peter B

    2015-10-01

    Randomized assignment of treatment excludes reverse causation and selection bias and, in sufficiently large studies, effectively prevents confounding. Well-implemented blinding prevents measurement bias. Studies that include these protections are called randomized, blinded clinical trials and, when conducted with sufficient numbers of patients, provide the most valid results. Although conceptually straightforward, design of clinical trials requires thoughtful trade-offs among competing approaches-all of which influence the number of patients required, enrollment time, internal and external validity, ability to evaluate interactions among treatments, and cost.

  9. Design and Validity of Randomized Controlled Dental Restorative Trials

    Directory of Open Access Journals (Sweden)

    Gerd Göstemeyer

    2016-05-01

    Full Text Available Background: The evidence stemming from trials on restorative materials is shaped not only by trial findings, but also trial design and validity. We aimed to evaluate both aspects in randomized controlled dental restorative trials published from 2005–2015. Methods: Using systematic review methodology, we retrieved trials comparing restorative or adhesive dental materials. Two authors independently assessed design, risk of bias, registration status, and findings of trials. Descriptive and regression analyses were performed. Results: 114 studies on 15,321 restorations placed mainly in permanent teeth of 5232 patients were included. Per trial, the median number of patients was 37 (25th/75th percentiles: 30/51. Follow-up was 24 (20/48 months. Seventeen percent of trials reported on sample size calculations, 2% had been registered. Most trials (90% used US Public Health Service (USPHS criteria, and had a high risk of bias. More recent trials were more likely to have been registered, to have reported on sample size calculations, to be of low risk of bias, and to use other than USPHS-criteria. Twenty-three percent of trials yielded significant differences between groups. The likelihood of such differences was significantly increased in older studies, studies with potential reporting bias, published in journals with high impact factor (>2, longer follow-up periods, and not using USPHS-criteria. Conclusions: The majority of dental restorative trials published from 2005–2015 had limited validity. Risk of bias decreased in more recent trials. Future trials should aim for high validity, be registered, and use defined and appropriate sample sizes, follow-up periods, and outcome measures.

  10. Parenting Skills and Emotional Availability: An RCT.

    Science.gov (United States)

    Yousafzai, Aisha K; Rasheed, Muneera A; Rizvi, Arjumand; Armstrong, Robert; Bhutta, Zulfiqar A

    2015-05-01

    To investigate whether a responsive stimulation intervention delivered to caregivers of young children either alone or integrated with nutrition interventions would benefit parenting skills and emotional availability to promote children's development and growth compared with either a nutrition intervention alone or the usual standard of care. A cluster randomized factorial effectiveness trial was implemented in an impoverished community in Pakistan. The 4 trial arms were control (usual standard of care), responsive stimulation (responsive care and stimulation), enhanced nutrition (education and multiple micronutrients), and a combination of both enriched interventions. The 4 intervention packages were delivered by community health workers to 1489 mother-infant dyads in the first 2 years of life. Parenting skills and emotional availability indexed by mother-child interaction, caregiving environment, knowledge and practices pertaining to early childhood care and feeding, and maternal depressive symptoms were assessed at multiple intervals. An intention-to-treat factorial analysis was conducted. Intervention groups were comparable at baseline. Responsive stimulation significantly benefitted parenting skills with large effect sizes on mother-child interaction (Cohen's d 0.8), caregiving environment (Cohen's d 0.9-1.0), and knowledge and practices (Cohen's d 0.7-1.1) compared with small-modest significant effects as a result of nutrition intervention on mother-child interaction and caregiving environment only (Cohen's d 0.4 and 0.2, respectively). The combined intervention had a small significant effect on decreasing maternal depressive symptoms over time (Cohen's d 0-0.2). A responsive stimulation intervention can promote positive caregiving behaviors among impoverished families. Additional research is needed on interventions to reduce maternal depressive symptoms. Copyright © 2015 by the American Academy of Pediatrics.

  11. Subgroup analyses in randomised controlled trials: cohort study on trial protocols and journal publications.

    Science.gov (United States)

    Kasenda, Benjamin; Schandelmaier, Stefan; Sun, Xin; von Elm, Erik; You, John; Blümle, Anette; Tomonaga, Yuki; Saccilotto, Ramon; Amstutz, Alain; Bengough, Theresa; Meerpohl, Joerg J; Stegert, Mihaela; Olu, Kelechi K; Tikkinen, Kari A O; Neumann, Ignacio; Carrasco-Labra, Alonso; Faulhaber, Markus; Mulla, Sohail M; Mertz, Dominik; Akl, Elie A; Bassler, Dirk; Busse, Jason W; Ferreira-González, Ignacio; Lamontagne, Francois; Nordmann, Alain; Gloy, Viktoria; Raatz, Heike; Moja, Lorenzo; Rosenthal, Rachel; Ebrahim, Shanil; Vandvik, Per O; Johnston, Bradley C; Walter, Martin A; Burnand, Bernard; Schwenkglenks, Matthias; Hemkens, Lars G; Bucher, Heiner C; Guyatt, Gordon H; Briel, Matthias

    2014-07-16

    To investigate the planning of subgroup analyses in protocols of randomised controlled trials and the agreement with corresponding full journal publications. Cohort of protocols of randomised controlled trial and subsequent full journal publications. Six research ethics committees in Switzerland, Germany, and Canada. 894 protocols of randomised controlled trial involving patients approved by participating research ethics committees between 2000 and 2003 and 515 subsequent full journal publications. Of 894 protocols of randomised controlled trials, 252 (28.2%) included one or more planned subgroup analyses. Of those, 17 (6.7%) provided a clear hypothesis for at least one subgroup analysis, 10 (4.0%) anticipated the direction of a subgroup effect, and 87 (34.5%) planned a statistical test for interaction. Industry sponsored trials more often planned subgroup analyses compared with investigator sponsored trials (195/551 (35.4%) v 57/343 (16.6%), P<0.001). Of 515 identified journal publications, 246 (47.8%) reported at least one subgroup analysis. In 81 (32.9%) of the 246 publications reporting subgroup analyses, authors stated that subgroup analyses were prespecified, but this was not supported by 28 (34.6%) corresponding protocols. In 86 publications, authors claimed a subgroup effect, but only 36 (41.9%) corresponding protocols reported a planned subgroup analysis. Subgroup analyses are insufficiently described in the protocols of randomised controlled trials submitted to research ethics committees, and investigators rarely specify the anticipated direction of subgroup effects. More than one third of statements in publications of randomised controlled trials about subgroup prespecification had no documentation in the corresponding protocols. Definitive judgments regarding credibility of claimed subgroup effects are not possible without access to protocols and analysis plans of randomised controlled trials. © The DISCO study group 2014.

  12. Empowerment of personal injury victims through the internet: design of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Elbers Nieke A

    2011-02-01

    Full Text Available Abstract Background Research has shown that current claims settlement process can have a negative impact on psychological and physical recovery of personal injury (PI victims. One of the explanations for the negative impact on health is that the claims settlement process is a stressful experience and victims suffer from renewed victimization caused by the claims settlement process. PI victims can experience a lack of information, lack of involvement, lack of 'voice', and poor communication. We present the first study that aims to empower PI victims with respect to the negative impact of the claims settlement process by means of an internet intervention. Methods/design The study is a two armed, randomized controlled trial (RCT, in which 170 PI victims are randomized to either the intervention or control group. The intervention group will get access to a website providing 1 an information module, so participants learn what is happening and what to expect during the claims settlement process, and 2 an e-coach module, so participants learn to cope with problems they experience during the claims settlement process. The control group will get access to a website with hyperlinks to commonly available information only. Participants will be recruited via a PI claims settlement office. Participants are included if they have been involved in a traffic accident which happened less than two years ago, and are at least 18 years old. The main study parameter is the increase of empowerment within the intervention group compared to the control group. Empowerment will be measured by the mastery scale and a self-efficacy scale. The secondary outcomes are perceived justice, burden, well being, work ability, knowledge, amount of damages, and lawyer-client communication. Data are collected at baseline (T0 measurement before randomization, at three months, six months, and twelve months after baseline. Analyses will be conducted according to the intention

  13. Effect of diclofenac suppository on pain control during flexible cystoscopy-A randomized controlled trial

    National Research Council Canada - National Science Library

    Nadeem, Mehwash; Ather, M Hammad

    2016-01-01

    TRIAL DESIGN: To compare the difference in pain score during flexible cystoscopy between patients undergoing the procedure with plain lubricating gel only and plain gel with diclofenac suppository in a randomized control trial. METHODS...

  14. Primary hemiarthroplasty versus conservative treatment for comminuted fractures of the proximal humerus in the elderly (ProCon: A Multicenter Randomized Controlled trial

    Directory of Open Access Journals (Sweden)

    Van der Vis Harm M

    2010-05-01

    Full Text Available Abstract Background Fractures of the proximal humerus are associated with a profound temporary and sometimes permanent, impairment of function and quality of life. The treatment of comminuted fractures of the proximal humerus like selected three-or four-part fractures and split fractures of the humeral head is a demanding and unresolved problem, especially in the elderly. Locking plates appear to offer improved fixation; however, screw cut-out rates ranges due to fracture collapse are high. As this may lead to higher rates of revision surgery, it may be preferable to treat comminuted fractures in the elderly primarily with a prosthesis or non-operatively. Results from case series and a small-sample randomized controlled trial (RCT suggest improved function and less pain after primary hemiarthroplasty (HA; however these studies had some limitations and a RCT is needed. The primary aim of this study is to compare the Constant scores (reflecting functional outcome and pain at one year after primary HA versus non-operative treatment in elderly patients who sustained a comminuted proximal humeral fracture. Secondary aims include effects on functional outcome, pain, complications, quality of life, and cost-effectiveness. Methods/Design A prospective, multi-center RCT will be conducted in nine centers in the Netherlands and Belgium. Eighty patients over 65 years of age, who have sustained a three-or four part, or split head proximal humeral fracture will be randomized between primary hemiarthroplasty and conservative treatment. The primary outcome is the Constant score, which indicates pain and function. Secondary outcomes include the Disability of the Arm and Shoulder (DASH score, Visual Analogue Scale (VAS for pain, radiographic healing, health-related quality of life (Short-form-36, EuroQol-5D and healthcare consumption. Cost-effectiveness ratios will be determined for both trial arms. Outcome will be monitored at regular intervals over the

  15. Sexual assault resistance education for university women: study protocol for a randomized controlled trial (SARE trial)

    National Research Council Canada - National Science Library

    Senn, Charlene Y; Eliasziw, Misha; Barata, Paula C; Thurston, Wilfreda E; Newby-Clark, Ian R; Radtke, H Lorraine; Hobden, Karen L

    2013-01-01

    .... The aim of this randomized controlled trial is to determine whether a novel, small-group sexual assault resistance education program can reduce the incidence of sexual assault among university...

  16. The effect of communicating the genetic risk of cardiometabolic disorders on motivation and actual engagement in preventative lifestyle modification and clinical outcome: a systematic review and meta-analysis of randomised controlled trials.

    Science.gov (United States)

    Li, Sherly X; Ye, Zheng; Whelan, Kevin; Truby, Helen

    2016-09-01

    Genetic risk prediction of chronic conditions including obesity, diabetes and CVD currently has limited predictive power but its potential to engage healthy behaviour change has been of immense research interest. We aimed to understand whether the latter is indeed true by conducting a systematic review and meta-analysis investigating whether genetic risk communication affects motivation and actual behaviour change towards preventative lifestyle modification. We included all randomised controlled trials (RCT) since 2003 investigating the impact of genetic risk communication on health behaviour to prevent cardiometabolic disease, without restrictions on age, duration of intervention or language. We conducted random-effects meta-analyses for perceived motivation for behaviour change and clinical changes (weight loss) and a narrative analysis for other outcomes. Within the thirteen studies reviewed, five were vignette studies (hypothetical RCT) and seven were clinical RCT. There was no consistent effect of genetic risk on actual motivation for weight loss, perceived motivation for dietary change (control v. genetic risk group standardised mean difference (smd) -0·15; 95 % CI -1·03, 0·73, P=0·74) or actual change in dietary behaviour. Similar results were observed for actual weight loss (control v. high genetic risk SMD 0·29 kg; 95 % CI -0·74, 1·31, P=0·58). This review found no clear or consistent evidence that genetic risk communication alone either raises motivation or translates into actual change in dietary intake or physical activity to reduce the risk of cardiometabolic disorders in adults. Of thirteen studies, eight were at high or unclear risk of bias. Additional larger-scale, high-quality clinical RCT are warranted.

  17. Herd effect from influenza vaccination in non-healthcare settings: a systematic review of randomised controlled trials and observational studies

    Science.gov (United States)

    Mertz, Dominik; Fadel, Shaza A.; Lam, Po-Po; Tran, Dat; Srigley, Jocelyn A; Asner, Sandra A; Science, Michelle; Kuster, Stefan P; Nemeth, Johannes; Johnstone, Jennie; Ortiz, Justin R; Loeb, Mark

    2016-01-01

    Influenza vaccination programmes are assumed to have a herd effect and protect contacts of vaccinated persons from influenza virus infection. We searched MEDLINE, EMBASE, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), Global Health and the Cochrane Central Register of Controlled Trials (CENTRAL) from inception to March 2014 for studies assessing the protective effect of influenza vaccination vs no vaccination on influenza virus infections in contacts. We calculated odds ratios (ORs) and 95% confidence intervals (CIs) using a random-effects model. Of 43,082 screened articles, nine randomised controlled trials (RCTs) and four observational studies were eligible. Among the RCTs, no statistically significant herd effect on the occurrence of influenza in contacts could be found (OR: 0.62; 95% CI: 0.34–1.12). The one RCT conducted in a community setting, however, showed a significant effect (OR: 0.39; 95% CI: 0.26–0.57), as did the observational studies (OR: 0.57; 95% CI: 0.43–0.77). We found only a few studies that quantified the herd effect of vaccination, all studies except one were conducted in children, and the overall evidence was graded as low. The evidence is too limited to conclude in what setting(s) a herd effect may or may not be achieved. PMID:27784531

  18. A randomised controlled trial for overweight and obese parents to prevent childhood obesity - Early STOPP (STockholm Obesity Prevention Program

    Directory of Open Access Journals (Sweden)

    Cao Yingting

    2011-05-01

    Full Text Available Abstract Background Overweight and obesity have a dramatic negative impact on children's health not only during the childhood but also throughout the adult life. Preventing the development of obesity in children is therefore a world-wide health priority. There is an obvious urge for sustainable and evidenced-based interventions that are suitable for families with young children, especially for families with overweight or obese parents. We have developed a prevention program, Early STOPP, combating multiple obesity-promoting behaviors such unbalanced diet, physical inactivity and disturbed sleeping patterns. We also aim to evaluate the effectiveness of the early childhood obesity prevention in a well-characterized population of overweight or obese parents. This protocol outlines methods for the recruitment phase of the study. Design and methods This randomized controlled trial (RCT targets overweight and/or obese parents with infants, recruited from the Child Health Care Centers (CHCC within the Stockholm area. The intervention starts when infants are one year of age and continues until they are six and is regularly delivered by a trained coach (dietitian, physiotherapist or a nurse. The key aspects of Early STOPP family intervention are based on Swedish recommendations for CHCC, which include advices on healthy food choices and eating patterns, increasing physical activity/reducing sedentary behavior and regulating sleeping patterns. Discussion The Early STOPP trial design addresses weaknesses of previous research by recruiting from a well-characterized population, defining a feasible, theory-based intervention and assessing multiple measurements to validate and interpret the program effectiveness. The early years hold promise as a time in which obesity prevention may be most effective. To our knowledge, this longitudinal RCT is the first attempt to demonstrate whether an early, long-term, targeted health promotion program focusing on healthy

  19. Internet-based stress management for distressed managers: results from a randomised controlled trial.

    Science.gov (United States)

    Persson Asplund, Robert; Dagöö, Jesper; Fjellström, Ida; Niemi, Linnea; Hansson, Katja; Zeraati, Forough; Ziuzina, Masha; Geraedts, Anna; Ljótsson, Brjánn; Carlbring, Per; Andersson, Gerhard

    2017-08-30

    The aim of this randomised controlled trial (RCT) was to evaluate the efficacy of a guided internet-based stress management intervention (iSMI) among distressed managers compared with a attention control group (AC) with full access to treatment-as-usual. A total sample of 117 distressed managers, mainly employed in the healthcare, IT, communication and educational sector, were randomised to either iSMI (n=59) or an AC group (n=58). The iSMI consisted of eight modules including cognitive behavioural stress management and positive management techniques. Participants received a minimal and weekly guidance from a psychologist or master-level psychology student focusing on support, feedback and adherence to the intervention. Self-report data were assessed at pre, post and 6 months after the intervention. The primary outcome was perceived stress (Perceived Stress Scale-14). The secondary outcomes included mental and work-related health outcomes. Participants in the iSMI intervention reported significantly less symptoms of perceived stress (d=0.74, 95% CI 0.30 to 1.19) and burnout (d=0.95, 95% CI 0.53 to 1.37) compared with controls, at postassessment. Significant medium-to-large effect sizes were also found for depression, insomnia and job satisfaction. Long-term effects (6 months) were seen on the mental health outcomes. This is one of the first studies showing that iSMIs can be an effective, accessible and potentially time-effective approach of reducing stress and other mental-related and work-related health symptoms among distressed managers. Future studies are needed addressing distressed managers and the potential of indirect effects on employee stress and satisfaction at work. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  20. The effect of local anaesthetic wound infiltration on chronic pain after lower limb joint replacement: A protocol for a double-blind randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Smith Alison J

    2011-02-01

    Full Text Available Abstract Background For the majority of patients with osteoarthritis (OA, joint replacement is a successful intervention for relieving chronic joint pain. However, between 10-30% of patients continue to experience chronic pain after joint replacement. Evidence suggests that a risk factor for chronic pain after joint replacement is the severity of acute post-operative pain. The aim of this randomised controlled trial (RCT is to determine if intra-operative local anaesthethic wound infiltration additional to a standard anaethesia regimen can reduce the severity of joint pain at 12-months after total knee replacement (TKR and total hip replacement (THR for OA. Methods 300 TKR patients and 300 THR patients are being recruited into this single-centre double-blind RCT. Participants are recruited before surgery and randomised to either the standard care group or the intervention group. Participants and outcome assessors are blind to treatment allocation throughout the study. The intervention consists of an intra-operative local anaesthetic wound infiltration, consisting of 60 mls of 0.25% bupivacaine with 1 in 200,000 adrenaline. Participants are assessed on the first 5 days post-operative, and then at 3-months, 6-months and 12-months. The primary outcome is the WOMAC Pain Scale, a validated measure of joint pain at 12-months. Secondary outcomes include pain severity during the in-patient stay, post-operative nausea and vomiting, satisfaction with pain relief, length of hospital stay, joint pain and disability, pain sensitivity, complications and cost-effectiveness. A nested qualitative study within the RCT will examine the acceptability and feasibility of the intervention for both patients and healthcare professionals. Discussion Large-scale RCTs assessing the effectiveness of a surgical intervention are uncommon, particulary in orthopaedics. The results from this trial will inform evidence-based recommendations for both short-term and long-term pain

  1. Hallucination focused integrative treatment : A randomized controlled trial

    NARCIS (Netherlands)

    Jenner, JA; Nienhuis, FJ; Wiersma, D; van de Willige, G

    2004-01-01

    Improvements in psychopathology, subjective burden, and coping with voices after hallucination focused integrative treatment (HIT) were studied in chronic schizophrenic patients with persistent (> 10 years), drug-refractory auditory hallucinations. In a randomized controlled trial, routine care was

  2. The ethics of placebo-controlled trials: methodological justifications.

    Science.gov (United States)

    Millum, Joseph; Grady, Christine

    2013-11-01

    The use of placebo controls in clinical trials remains controversial. Ethical analysis and international ethical guidance permit the use of placebo controls in randomized trials when scientifically indicated in four cases: (1) when there is no proven effective treatment for the condition under study; (2) when withholding treatment poses negligible risks to participants; (3) when there are compelling methodological reasons for using placebo, and withholding treatment does not pose a risk of serious harm to participants; and, more controversially, (4) when there are compelling methodological reasons for using placebo, and the research is intended to develop interventions that can be implemented in the population from which trial participants are drawn, and the trial does not require participants to forgo treatment they would otherwise receive. The concept of methodological reasons is essential to assessing the ethics of placebo controls in these controversial last two cases. This article sets out key considerations relevant to considering whether methodological reasons for a placebo control are compelling.

  3. Survey Email Scheduling and Monitoring in eRCTs (SESAMe): A Digital Tool to Improve Data Collection in Randomized Controlled Clinical Trials.

    Science.gov (United States)

    Skonnord, Trygve; Steen, Finn; Skjeie, Holgeir; Fetveit, Arne; Brekke, Mette; Klovning, Atle

    2016-11-22

    Electronic questionnaires can ease data collection in randomized controlled trials (RCTs) in clinical practice. We found no existing software that could automate the sending of emails to participants enrolled into an RCT at different study participant inclusion time points. Our aim was to develop suitable software to facilitate data collection in an ongoing multicenter RCT of low back pain (the Acuback study). For the Acuback study, we determined that we would need to send a total of 5130 emails to 270 patients recruited at different centers and at 19 different time points. The first version of the software was tested in a pilot study in November 2013 but was unable to deliver multiuser or Web-based access. We resolved these shortcomings in the next version, which we tested on the Web in February 2014. Our new version was able to schedule and send the required emails in the full-scale Acuback trial that started in March 2014. The system architecture evolved through an iterative, inductive process between the project study leader and the software programmer. The program was tested and updated when errors occurred. To evaluate the development of the software, we used a logbook, a research assistant dialogue, and Acuback trial participant queries. We have developed a Web-based app, Survey Email Scheduling and Monitoring in eRCTs (SESAMe), that monitors responses in electronic surveys and sends reminders by emails or text messages (short message service, SMS) to participants. The overall response rate for the 19 surveys in the Acuback study increased from 76.4% (655/857) before we introduced reminders to 93.11% (1149/1234) after the new function (P<.001). Further development will aim at securing encryption and data storage. The SESAMe software facilitates consecutive patient data collection in RCTs and can be used to increase response rates and quality of research, both in general practice and in other clinical trial settings.

  4. A cluster randomized controlled trial of the Promoting Alternative Thinking Strategies (PATHS) curriculum.

    Science.gov (United States)

    Humphrey, Neil; Barlow, Alexandra; Wigelsworth, Michael; Lendrum, Ann; Pert, Kirsty; Joyce, Craig; Stephens, Emma; Wo, Lawrence; Squires, Garry; Woods, Kevin; Calam, Rachel; Turner, Alex

    2016-10-01

    This randomized controlled trial (RCT) evaluated the efficacy of the Promoting Alternative Thinking Strategies curriculum (PATHS; Kusche & Greenberg, 1994) as a means to improve children's social-emotional competence (assessed via the Social Skills Improvement System (SSIS); Gresham & Elliot, 2008) and mental health outcomes (assessed via the Strengths and Difficulties Questionnaire (SDQ); Goodman, 1997). Forty-five schools in Greater Manchester, England, were randomly assigned to treatment and control groups. Allocation was balanced by proportions of children eligible for free school meals and speaking English as an additional language via minimization. Children (N=4516) aged 7-9years at baseline in the participating schools were the target cohort. During the two-year trial period, teachers of this cohort in schools allocated to the intervention group delivered the PATHS curriculum, while their counterparts in the control group continued their usual provision. Teachers in PATHS schools received initial training and on-going support and assistance from trained coaches. Hierarchical linear modeling of outcome data was undertaken to identify both primary (e.g., for all children) and secondary (e.g., for children classified as "at-risk") intervention effects. A primary effect of the PATHS curriculum was found, demonstrating increases in teacher ratings of changes in children's social-emotional competence. Additionally, secondary effects of PATHS were identified, showing reductions in teacher ratings of emotional symptoms and increases in pro-social behavior and child ratings of engagement among children identified as at-risk at baseline. However, our analyses also identified primary effects favoring the usual provision group, showing reductions in teacher ratings of peer problems and emotional symptoms, and secondary effects demonstrating reductions in teacher ratings of conduct problems and child ratings of co-operation among at-risk children. Effect sizes were small

  5. 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

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

    Science.gov (United States)

    2011-01-01

    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 care of all neonates from 9

  7. Managing pain and fatigue in people with spinal cord injury: a randomized controlled trial feasibility study examining the efficacy of massage therapy.

    Science.gov (United States)

    Lovas, J; Tran, Y; Middleton, J; Bartrop, R; Moore, N; Craig, A

    2017-02-01

    A randomized controlled trial (RCT). To determine the efficacy of massage therapy (MT) as a treatment that could be implemented to reduce pain and fatigue in people with chronic spinal cord injury (SCI). Laboratory setting in Sydney, Australia. Participants included 40 people with SCI living in the community who were randomly assigned into one of two RCT arms: MT (Swedish massage to upper body) or an active concurrent control (guided imagery (GI) relaxation). All participants received 30 min once a week of either massage or GI over 5 consecutive weeks. In addition to sociodemographic and injury factors, assessments and reliable measures including the short-form McGill Pain Questionnaire and Chalder's Fatigue Scale were validated. Chronic pain and fatigue were significantly reduced in the massage group when assessed at the end of 5 weeks (PMassage and GI are both active treatments that provide potential clinical benefits for adults with SCI. Future research should clarify the role of massage and GI in managing pain and fatigue in SCI and assess outcomes into the longer-term.

  8. JinQi-Jiangtang tablet, a Chinese patent medicine, for pre-diabetes: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Hu Jing

    2010-03-01

    Full Text Available Abstract Background Pre-diabetes is a growing health concern where a large percentage of these patients develop full type 2 diabetes. Effective interventions on pre-diabetes can prevent or delay the occurrence or development of diabetes. Pharmaco-dynamics and pre-clinical of JinQi-Jiangtang tablets (JQJT suggest that it could be benefit for pre-diabetes. Methods/Design Randomized controlled trial (RCT is implemented in this study. The study term is 24 months (12 months for intervention and 12 months for follow up. Participants are recruited from four cities of China: Beijing, Tianjin, Xi'an and Nanning. Four hundred participants are randomized to treatment group (JQJT tablets and control group (Placebo; two hundred participants each. People being included in this study must have been diagnosed as pre-diabetes via western medicine criteria and traditional Chinese medicine (TCM criteria. The end-point indexes include: incidence of diabetes mellitus and reversion rate. Primary outcome indexes include: oral glucose tolerance test; insulin releasing test; glycosylated hemoglobin (HA1c. Secondary outcome indexes include: score of the Short Form 36 Health Survey Questionnaire (SF-36; score of TCM symptoms; blood lipid test. Indexes of safety include: general medical examination; blood and urine regular test; electrocardiogram (ECG, liver function (ALT and renal function (BUN, Creatinine test; record of adverse event, such as headache, faint, etc. Qualitative control will be implemented and a number of standard operating processes (SOPs will be formed throughout the study: laboratory quality control measures; compliance control for researchers and participants; researcher training before study; supervision; investigational drug management and others. Discussion The aim of this study is to evaluate the effectiveness and safety of JinQi JiangTang (JQJT tablets for the treatment of patients with pre-diabetes. Trial registration Chinese clinical trials

  9. Qigong and Fibromyalgia: Randomized Controlled Trials and Beyond

    OpenAIRE

    Jana Sawynok; Mary Lynch

    2014-01-01

    Introduction. Qigong is currently considered as meditative movement, mindful exercise, or complementary exercise and is being explored for relief of symptoms in fibromyalgia. Aim. This narrative review summarizes randomized controlled trials, as well as additional studies, of qigong published to the end of 2013 and discusses relevant methodological issues. Results. Controlled trials indicate regular qigong practice (daily, 6–8 weeks) produces improvements in core domains for fibromyalgia (pai...

  10. Effect of etanercept in polymyalgia rheumatica: a randomized controlled trial

    DEFF Research Database (Denmark)

    Kreiner, Frederik; Galbo, Henrik

    2010-01-01

    To elucidate in polymyalgia rheumatica (PMR) the role of tumor necrosis factor (TNF) α and the therapeutic potential of blockade with soluble TNF-α receptor, we carried out the first randomized controlled trial with etanercept in PMR.......To elucidate in polymyalgia rheumatica (PMR) the role of tumor necrosis factor (TNF) α and the therapeutic potential of blockade with soluble TNF-α receptor, we carried out the first randomized controlled trial with etanercept in PMR....

  11. Effect of etanercept in polymyalgia rheumatica: a randomized controlled trial

    DEFF Research Database (Denmark)

    Kreiner, Frederik; Galbo, Henrik

    2010-01-01

    To elucidate in polymyalgia rheumatica (PMR) the role of tumor necrosis factor (TNF) a and the therapeutic potential of blockade with soluble TNF-a receptor, we carried out the first randomized controlled trial with etanercept in PMR.......To elucidate in polymyalgia rheumatica (PMR) the role of tumor necrosis factor (TNF) a and the therapeutic potential of blockade with soluble TNF-a receptor, we carried out the first randomized controlled trial with etanercept in PMR....

  12. The effectiveness of community action in reducing risky alcohol consumption and harm: a cluster randomised controlled trial.

    Directory of Open Access Journals (Sweden)

    Anthony Shakeshaft

    2014-03-01

    Full Text Available BACKGROUND: The World Health Organization, governments, and communities agree that community action is likely to reduce risky alcohol consumption and harm. Despite this agreement, there is little rigorous evidence that community action is effective: of the six randomised trials of community action published to date, all were US-based and focused on young people (rather than the whole community, and their outcomes were limited to self-report or alcohol purchase attempts. The objective of this study was to conduct the first non-US randomised controlled trial (RCT of community action to quantify the effectiveness of this approach in reducing risky alcohol consumption and harms measured using both self-report and routinely collected data. METHODS AND FINDINGS: We conducted a cluster RCT comprising 20 communities in Australia that had populations of 5,000-20,000, were at least 100 km from an urban centre (population ≥ 100,000, and were not involved in another community alcohol project. Communities were pair-matched, and one member of each pair was randomly allocated to the experimental group. Thirteen interventions were implemented in the experimental communities from 2005 to 2009: community engagement; general practitioner training in alcohol screening and brief intervention (SBI; feedback to key stakeholders; media campaign; workplace policies/practices training; school-based intervention; general practitioner feedback on their prescribing of alcohol medications; community pharmacy-based SBI; web-based SBI; Aboriginal Community Controlled Health Services support for SBI; Good Sports program for sports clubs; identifying and targeting high-risk weekends; and hospital emergency department-based SBI. Primary outcomes based on routinely collected data were alcohol-related crime, traffic crashes, and hospital inpatient admissions. Routinely collected data for the entire study period (2001-2009 were obtained in 2010. Secondary outcomes based on pre

  13. Early Intensive Leg Training to Enhance Walking in Children With Perinatal Stroke: Protocol for a Randomized Controlled Trial.

    Science.gov (United States)

    Hurd, Caitlin; Livingstone, Donna; Brunton, Kelly; Teves, Michelle; Zewdie, Ephrem; Smith, Allison; Ciechanski, Patrick; Gorassini, Monica A; Kirton, Adam; Watt, Man-Joe; Andersen, John; Yager, Jerome; Yang, Jaynie F

    2017-08-01

    Development of motor pathways is modulated by activity in these pathways, when they are maturing (ie, critical period). Perinatal stroke injures motor pathways, including the corticospinal tracts, reducing their activity and impairing motor function. Current intervention for the lower limb emphasizes passive approaches (stretching, braces, botulinum toxin injections). The study hypothesis was that intensive, early, child-initiated activity during the critical period will enhance connectivity of motor pathways to the legs and improve motor function. The study objective was to determine whether early intervention with intensive activity is better than standard care, intervention delivered during the proposed critical period is better than after, and the outcomes are different when the intervention is delivered by a physical therapist in an institution vs. a parent at home. A prospective, delay-group, single-blind, randomized controlled trial (RCT) and a parallel, cohort study of children living beyond commuting distance and receiving an intervention delivered by their parent. The RCT intervention was provided in university laboratories, and parent training was provided in the childs home. Children 8 months to 3 years old with MRI-confirmed perinatal ischemic stroke and early signs of hemiparesis. Intensive, play-based leg activity with weights for the affected leg and foot, 1 hour/day, 4 days/week for 12 weeks. The primary outcome was the Gross Motor Function Measure-66 score. Secondary outcomes were motion analysis of walking, full-day step counts, motor evoked potentials from transcranial magnetic stimulation, and patellar tendon reflexes. Inter-individual heterogeneity in the severity of the stroke and behavioral differences are substantial but measurable. Differences in intervention delivery and assessment scoring are minimized by standardization and training. The intervention, contrary to current practice, could change physical therapy interventions for children

  14. Child Feeding and Parenting Style Outcomes and Composite Score Measurement in the 'Feeding Healthy Food to Kids Randomised Controlled Trial'.

    Science.gov (United States)

    Duncanson, Kerith; Burrows, Tracy L; Collins, Clare E

    2016-11-10

    Child feeding practices and parenting style each have an impact on child dietary intake, but it is unclear whether they influence each other or are amenable to change. The aims of this study were to measure child feeding and parenting styles in the Feeding Healthy Food to Kids (FHFK) Randomized Controlled Trial (RCT) and test a composite child feeding score and a composite parenting style score. Child feeding and parenting style data from 146 parent-child dyads (76 boys, aged 2.0-5.9 years) in the FHFK study were collected over a 12-month intervention. Parenting style was measured using parenting questions from the Longitudinal Study of Australian Children and the Child Feeding Questionnaire (CFQ) was used to measure child feeding practices. Data for both measures were collected at baseline, 3 and 12 months and then modelled to develop a composite child feeding score and a parenting score. Multivariate mixed effects linear regression was used to measure associations between variables over time. All child feeding domains from the CFQ were consistent between baseline and 12 months (p parenting style domain scores were consistent over 12 months (p parenting style score within the FHFK RCT. In conclusion, composite scores have potential applications in the analysis of relationships between child feeding and dietary or anthropometric data in intervention studies aimed at improving child feeding or parenting style. These applications have the potential to make a substantial contribution to the understanding of child feeding practices and parenting style, in relation to each other and to dietary intake and health outcomes amongst pre-school aged children.

  15. Negative Pressure Wound Therapy on Surgical Site Infections in Women Undergoing Elective Caesarean Sections: A Pilot RCT.

    Science.gov (United States)

    Chaboyer, Wendy; Anderson, Vinah; Webster, Joan; Sneddon, Anne; Thalib, Lukman; Gillespie, Brigid M

    2014-09-30

    Obese women undergoing caesarean section (CS) are at increased risk of surgical site infection (SSI). Negative Pressure Wound Therapy (NPWT) is growing in use as a prophylactic approach to prevent wound complications such as SSI, yet there is little evidence of its benefits. This pilot randomized controlled trial (RCT) assessed the effect of NPWT on SSI and other wound complications in obese women undergoing elective caesarean sections (CS) and also the feasibility of conducting a definitive trial. Ninety-two obese women undergoing elective CS were randomized in theatre via a central web based system using a parallel 1:1 process to two groups i.e., 46 women received the intervention (NPWT PICO™ dressing) and 46 women received standard care (Comfeel Plus(®) dressing). All women received the intended dressing following wound closure. The relative risk of SSI in the intervention group was 0.81 (95% CI 0.38-1.68); for the number of complications excluding SSI it was 0.98 (95% CI 0.34-2.79). A sample size of 784 (392 per group) would be required to find a statistically significant difference in SSI between the two groups with 90% power. These results demonstrate that a larger definitive trial is feasible and that careful planning and site selection is critical to the success of the overall study.

  16. Negative Pressure Wound Therapy on Surgical Site Infections in Women Undergoing Elective Caesarean Sections: A Pilot RCT

    Directory of Open Access Journals (Sweden)

    Wendy Chaboyer

    2014-09-01

    Full Text Available Obese women undergoing caesarean section (CS are at increased risk of surgical site infection (SSI. Negative Pressure Wound Therapy (NPWT is growing in use as a prophylactic approach to prevent wound complications such as SSI, yet there is little evidence of its benefits. This pilot randomized controlled trial (RCT assessed the effect of NPWT on SSI and other wound complications in obese women undergoing elective caesarean sections (CS and also the feasibility of conducting a definitive trial. Ninety-two obese women undergoing elective CS were randomized in theatre via a central web based system using a parallel 1:1 process to two groups i.e., 46 women received the intervention (NPWT PICO™ dressing and 46 women received standard care (Comfeel Plus® dressing. All women received the intended dressing following wound closure. The relative risk of SSI in the intervention group was 0.81 (95% CI 0.38–1.68; for the number of complications excluding SSI it was 0.98 (95% CI 0.34–2.79. A sample size of 784 (392 per group would be required to find a statistically significant difference in SSI between the two groups with 90% power. These results demonstrate that a larger definitive trial is feasible and that careful planning and site selection is critical to the success of the overall study.

  17. A sensitivity analysis of the Children's Treatment Network trial: a randomized controlled trial of integrated services versus usual care for children with special health care needs

    Directory of Open Access Journals (Sweden)

    Ye C

    2013-09-01

    Full Text Available Chenglin Ye,1,2 Gina Browne,1,3 Joseph Beyene,1 Lehana Thabane1,2 1Department of Clinical Epidemiology and Biostatistics, McMaster University, 2Biostatistcs Unit, St Joseph's Healthcare Hamilton, 3School of Nursing, McMaster University, Hamilton, ON, Canada Background: The value of integrated care through comprehensive, coordinated, and family-centered services has been increasingly recognized for improving health outcomes of children with special health care needs (CSHCN. In a randomized controlled trial (RCT, the integrated care provided through the Children's Treatment Network (CTN was compared with usual care in improving the psychosocial health of target CSHCN. In this paper, we aimed to estimate the effect of CTN care by conducting multiple analyses to handle noncompliance in the trial. Methods: The trial recruited target children in Simcoe County and York Region, ON, Canada. Children were randomized to receive CTN or usual care and were followed for 2 years. The CTN group received integrated services through multiple providers to address their specific needs while the usual care group continued to receive care directed by their parents. The outcome was change in psychosocial quality of life at 2 years. We conducted intention-to-treat, as-treated, per-protocol, and instrumental variable analyses to analyze the outcome. Results: The trial randomized 445 children, with 229 in the intervention group and 216 in the control group. During follow-up, 52% of children in the intervention group did not receive complete CTN care for various reasons. At 2 years, we did not find a significant improvement in psychosocial quality of life among the children receiving CTN care compared with usual care (intention-to-treat mean difference 1.50, 95% confidence interval −1.49 to 4.50; P = 0.32. Other methods of analysis yielded similar results. Conclusion: Although the effect of CTN care was not significant, there was evidence showing benefits of integrated

  18. Sentence retrieval for abstracts of randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Chung Grace Y

    2009-02-01

    Full Text Available Abstract Background The practice of evidence-based medicine (EBM requires clinicians to integrate their expertise with the latest scientific research. But this is becoming increasingly difficult with the growing numbers of published articles. There is a clear need for better tools to improve clinician's ability to search the primary literature. Randomized clinical trials (RCTs are the most reliable source of evidence documenting the efficacy of treatment options. This paper describes the retrieval of key sentences from abstracts of RCTs as a step towards helping users find relevant facts about the experimental design of clinical studies. Method Using Conditional Random Fields (CRFs, a popular and successful method for natural language processing problems, sentences referring to Intervention, Participants and Outcome Measures are automatically categorized. This is done by extending a previous approach for labeling sentences in an abstract for general categories associated with scientific argumentation or rhetorical roles: Aim, Method, Results and Conclusion. Methods are tested on several corpora of RCT abstracts. First structured abstracts with headings specifically indicating Intervention, Participant and Outcome Measures are used. Also a manually annotated corpus of structured and unstructured abstracts is prepared for testing a classifier that identifies sentences belonging to each category. Results Using CRFs, sentences can be labeled for the four rhetorical roles with F-scores from 0.93–0.98. This outperforms the use of Support Vector Machines. Furthermore, sentences can be automatically labeled for Intervention, Participant and Outcome Measures, in unstructured and structured abstracts where the section headings do not specifically indicate these three topics. F-scores of up to 0.83 and 0.84 are obtained for Intervention and Outcome Measure sentences. Conclusion Results indicate that some of the methodological elements of RCTs are

  19. Acupuncture, Counseling, and Usual care for Depression (ACUDep: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    MacPherson Hugh

    2012-11-01

    Full Text Available Abstract Background The evidence on the effect of acupuncture or counseling for depression is not conclusive yet is sufficient to warrant further research. Our aim is to conduct a full-scale RCT to determine the clinical and cost effectiveness of acupuncture and counseling compared to usual care alone. We will explore the experiences and perspectives of patients and practitioners. Methods/Design Randomized controlled trial with three parallel arms: acupuncture plus usual care, counseling plus usual care, and usual care alone, in conjunction with a nested qualitative study using in-depth interviews with purposive samples of trial participants. Participants: Patients aged over 18 years diagnosed with depression or mood disorder by their GP and with a score of 20 or above on the Beck Depression Inventory (BDI-II. Randomization: Computer randomization by York Trials Unit to acupuncture, counseling, and usual care alone in proportions of 2:2:1, respectively, with secure allocation concealment. Interventions: Patients allocated to acupuncture and counseling groups receive the offer of up to 12 weekly sessions. Both interventions allow flexibility to address patient variation, yet are constrained within defined protocols. Acupuncture is based on traditional Chinese medicine and counseling is non-directive within the humanistic tradition. Outcome: The PHQ-9 is the primary outcome measure, collected at baseline, 3, 6, 9, and 12 months. Also measured is BDI-II, SF-36 Bodily pain subscale, and EQ-5D. Texted mood scores are collected weekly over the first 15 weeks. Health-related resource use is collected over 12 months. Analysis: The sample size target was for 640 participants, calculated for an effect size of 0.32 on the PHQ-9 when comparing acupuncture with counseling given 90% power, 5% significance, and 20% loss to follow-up. Analysis of covariance will be used on an intention-to-treat basis. Thematic analysis will be used for qualitative data. We will

  20. COSMOS: COmparing Standard Maternity care with One-to-one midwifery Support: a randomised controlled trial

    Science.gov (United States)

    McLachlan, Helen L; Forster, Della A; Davey, Mary-Ann; Lumley, Judith; Farrell, Tanya; Oats, Jeremy; Gold, Lisa; Waldenström, Ulla; Albers, Leah; Biro, Mary Anne

    2008-01-01

    Background In Australia and internationally, there is concern about the growing proportion of women giving birth by caesarean section. There is evidence of increased risk of placenta accreta and percreta in subsequent pregnancies as well as decreased fertility; and significant resource implications. Randomised controlled trials (RCTs) of continuity of midwifery care have reported reduced caesareans and other interventions in labour, as well as increased maternal satisfaction, with no statistically significant differences in perinatal morbidity or mortality. RCTs conducted in the UK and in Australia have largely measured the effect of teams of care providers (commonly 6–12 midwives) with very few testing caseload (one-to-one) midwifery care. This study aims to determine whether caseload (one-to-one) midwifery care for women at low risk of medical complications decreases the proportion of women delivering by caesarean section compared with women receiving 'standard' care. This paper presents the trial protocol in detail. Methods/design A two-arm RCT design will be used. Women who are identified at low medical risk will be recruited from the antenatal booking clinics of a tertiary women's hospital in Melbourne, Australia. Baseline data will be collected, then women randomised to caseload midwifery or standard low risk care. Women allocated to the caseload intervention will receive antenatal, intrapartum and postpartum care from a designated primary midwife with one or two antenatal visits conducted by a 'back-up' midwife. The midwives will collaborate with obstetricians and other health professionals as necessary. If the woman has an extended labour, or if the primary midwife is unavailable, care will be provided by the back-up midwife. For women allocated to standard care, options include midwifery-led care with varying levels of continuity, junior obstetric care and community based general medical practitioner care. Data will be collected at recruitment (self

  1. Enhanced efficacy of sequential administration of Albendazole for the clearance of Wuchereria bancrofti infection: Double blind RCT.

    Science.gov (United States)

    De Britto, R L; Vanamail, P; Sankari, T; Vijayalakshmi, G; Das, L K; Pani, S P

    2015-06-01

    Till today, there is no effective treatment protocol for the complete clearance of Wuchereria bancrofti (W.b) infection that causes secondary lymphoedema. In a double blind randomized control trial (RCT), 146 asymptomatic W. b infected individuals were randomly assigned to one of the four regimens for 12 days, DEC 300 mg + Doxycycline 100 mg coadministration or DEC 300 mg + Albendazole 400 mg co-administration or DEC 300 mg + Albendazole 400 mg sequential administration or control regimen DEC 300 mg and were followed up at 13, 26 and 52 weeks post-treatment for the clearance of infection. At intake, there was no significant variation in mf counts (F(3,137)=0.044; P=0.988) and antigen levels (F(3,137)=1.433; P=0.236) between the regimens. Primary outcome analysis showed that DEC + Albendazole sequential administration has an enhanced efficacy over DEC + Albendazole co-administration (80.6 Vs 64.7%), and this regimen is significantly different when compared to DEC + doxycycline co-administration and control (PAlbendazole sequential administration appears to be a better option for rapid clearance of W. b microfilariae in 13 weeks time. (Clinical trials.gov identifier - NCT02005653).

  2. Prospective Preference Assessment of Patients' Willingness to Participate in a Randomized Controlled Trial of Intensity-Modulated Radiotherapy Versus Proton Therapy for Localized Prostate Cancer

    Energy Technology Data Exchange (ETDEWEB)

    Shah, Anand [Department of Radiation Oncology, University of Pennsylvania, Philadelphia, PA (United States); Efstathiou, Jason A.; Paly, Jonathan J. [Department of Radiation Oncology, Massachusetts General Hospital, Boston, MA (United States); Halpern, Scott D. [Department of Medicine, University of Pennsylvania, Philadelphia, PA (United States); Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, PA (United States); Center for Bioethics, University of Pennsylvania, Philadelphia, PA (United States); Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA (United States); Bruner, Deborah W. [Winship Cancer Institute, Emory University, Atlanta, GA (United States); Christodouleas, John P. [Department of Radiation Oncology, University of Pennsylvania, Philadelphia, PA (United States); Coen, John J. [Department of Radiation Oncology, Massachusetts General Hospital, Boston, MA (United States); Deville, Curtiland; Vapiwala, Neha [Department of Radiation Oncology, University of Pennsylvania, Philadelphia, PA (United States); Shipley, William U.; Zietman, Anthony L. [Department of Radiation Oncology, Massachusetts General Hospital, Boston, MA (United States); Hahn, Stephen M. [Department of Radiation Oncology, University of Pennsylvania, Philadelphia, PA (United States); Bekelman, Justin E., E-mail: bekelman@uphs.upenn.edu [Department of Radiation Oncology, University of Pennsylvania, Philadelphia, PA (United States); Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA (United States)

    2012-05-01

    Purpose: To investigate patients' willingness to participate (WTP) in a randomized controlled trial (RCT) comparing intensity-modulated radiotherapy (IMRT) with proton beam therapy (PBT) for prostate cancer (PCa). Methods and Materials: We undertook a qualitative research study in which we prospectively enrolled patients with clinically localized PCa. We used purposive sampling to ensure a diverse sample based on age, race, travel distance, and physician. Patients participated in a semi-structured interview in which they reviewed a description of a hypothetical RCT, were asked open-ended and focused follow-up questions regarding their motivations for and concerns about enrollment, and completed a questionnaire assessing characteristics such as demographics and prior knowledge of IMRT or PBT. Patients' stated WTP was assessed using a 6-point Likert scale. Results: Forty-six eligible patients (33 white, 13 black) were enrolled from the practices of eight physicians. We identified 21 factors that impacted patients' WTP, which largely centered on five major themes: altruism/desire to compare treatments, randomization, deference to physician opinion, financial incentives, and time demands/scheduling. Most patients (27 of 46, 59%) stated they would either 'definitely' or 'probably' participate. Seventeen percent (8 of 46) stated they would 'definitely not' or 'probably not' enroll, most of whom (6 of 8) preferred PBT before their physician visit. Conclusions: A substantial proportion of patients indicated high WTP in a RCT comparing IMRT and PBT for PCa.

  3. Mindful "Vitality in Practice": an intervention to improve the work engagement and energy balance among workers; the development and design of the randomised controlled trial.

    Science.gov (United States)

    van Berkel, Jantien; Proper, Karin I; Boot, Cécile R L; Bongers, Paulien M; van der Beek, Allard J

    2011-09-27

    Modern working life has become more mental and less physical in nature, contributing to impaired mental health and a disturbed energy balance. This may result in mental health problems and overweight. Both are significant threats to the health of workers and thus also a financial burden for society, including employers. Targeting work engagement and energy balance could prevent impaired mental health and overweight, respectively. The study population consists of highly educated workers in two Dutch research institutes. The intervention was systematically developed, based on the Intervention Mapping (IM) protocol, involving workers and management in the process. The workers' needs were assessed by combining the results of interviews, focus group discussions and a questionnaire with available literature. Suitable methods and strategies were selected resulting in an intervention including: eight weeks of customized mindfulness training, followed by eight sessions of e-coaching and supporting elements, such as providing fruit and snack vegetables at the workplace, lunch walking routes, and a buddy system. The effects of the intervention will be evaluated in a RCT, with measurements at baseline, six months (T1) and 12 months (T2). In addition, cost-effectiveness and process of the intervention will also be evaluated. At baseline the level of work engagement of the sample was "average". Of the study population, 60.1% did not engage in vigorous physical activity at all. An average working day consists of eight sedentary hours. For the Phase II RCT, there were no significant differences between the intervention and the control group at baseline, except for vigorous physical activity. The baseline characteristics of the study population were congruent with the results of the needs assessment. The IM protocol used for the systematic development of the intervention produced an appropriate intervention to test in the planned RCT. Netherlands Trial Register (NTR): NTR2199.

  4. Vitamin D and risk of preterm birth: Up-to-date meta-analysis of randomized controlled trials and observational studies.

    Science.gov (United States)

    Zhou, Shan-Shan; Tao, Yong-Hao; Huang, Kun; Zhu, Bei-Bei; Tao, Fang-Biao

    2017-02-01

    We performed a meta-analysis of randomized controlled trials (RCT) and observational studies to answer the two following questions: (i) whether low maternal circulating 25 hydroxyvitamin D (25-OHD) is associated with an increased risk of preterm birth (PTB) or spontaneous PTB (sPTB); and (ii) whether vitamin D supplementation alone during pregnancy can reduce the risk of PTB. Literature search was carried out using Pubmed, Web of Science and Embase databases up to June 2016. Pooled OR or relative risk (RR) with 95%CI were computed using fixed or random effects models depending on the size of heterogeneity. Subgroup analysis was used to explore potential sources of between-study heterogeneity. Publication bias was evaluated using Egger's test and Begg's test. Twenty-four articles (six RCT and 18 observational studies) were identified. Maternal circulating 25-OHD deficiency (pooled OR, 1.25; 95%CI: 1.13-1.38) rather than insufficiency (pooled OR, 1.09; 95%CI: 0.89-1.35) was associated with an increased risk of PTB, and vitamin D supplementation alone during pregnancy could reduce the risk of PTB (pooled RR, 0.57; 95%CI: 0.36-0.91). This was also the case for the sPTB subgroup (circulating 25-OHD 50 nmol/L; pooled OR, 1.45; 95%CI: 1.20-1.75). Maternal circulating 25-OHD deficiency could increase PTB risk and vitamin D supplementation alone during pregnancy could reduce PTB risk. Extrapolation of the results, however, must be done with caution, and there is urgent need for larger, better-designed RCT to confirm this effect. © 2017 Japan Society of Obstetrics and Gynecology.

  5. Recruitment of older adults with type 2 diabetes into a community-based exercise and nutrition randomised controlled trial.

    Science.gov (United States)

    Miller, Eliza G; Nowson, Caryl A; Dunstan, David W; Kerr, Deborah A; Solah, Vicky; Menzies, David; Daly, Robin M

    2016-09-26

    Recruitment of participants into long-term community-based lifestyle intervention trials, particularly adults with a chronic disease, is often slow and challenging. Currently there is limited data on successful recruitment strategies suitable for older adults with type 2 diabetes into community-based exercise and nutrition programs, and no information on cost estimates associated with such recruitment. The aim of this report is to describe the recruitment strategies used and the success of each approach in recruiting older adults with type 2 diabetes into a 6-month community-based exercise and nutritional supplementation randomised controlled trial (RCT). A secondary aim is to assess the costs associated with the recruitment methods used. The Resistance Exercise, Vitamin D and Muscle Protein Intervention Trial (REVAMP-IT) for type 2 diabetes is a 24-week RCT targeting 202 adults with type 2 diabetes which is designed to evaluate whether post-exercise ingestion of a whey- protein and vitamin D-enriched drink can enhance the effects of progressive resistance training (PRT) on glycaemic control, body composition and cardiometabolic health. Participants in this trial were randomly allocated to either: (1) the Lift for Life® community-based PRT program combined with additional whey protein and vitamin D, or (2) the Lift for Life® PRT program alone. Recruitment strategies included state and local newspaper and radio advertisements, targeted mail-outs, doctor and allied health referrals, community presentations, web-based media and word of mouth. The number of expressions of interest, participants screened and included in the trial, and how they first heard about the study were recorded by research staff during the screening process. Reasons for ineligibility or non-participation in the trial were also recorded as was the cost of each recruitment method used. A total of 1157 expressions of interest were received over a 21-month recruitment period. Overall 959 (83

  6. The effectiveness of the Incredible Years Parents and Babies Program as a universal prevention intervention for parents of infants in Denmark: study protocol for a pilot randomized controlled trial

    DEFF Research Database (Denmark)

    Pontoppidan, Maiken W.

    2015-01-01

    -arm, parallel, pilot, randomized controlled trial (RCT) where 128 families with newborn infants up to four-months-old are recruited in two municipalities in Denmark. Families are randomized to the Incredible Years Parents and Babies Program or usual care with a 2:1 allocation ratio. The primary outcome...... is parenting confidence measured after 20 weeks by the Karitane Parenting Confidence Scale and Parental Stress Scale. Secondary outcomes include measures of parent health, reflective functioning, relationship with the infant, and infant development. Interviewers and data analysts are blind to allocation status...

  7. Effects of Home Visitation on Maternal Competencies, Family Environment, and Child Development: a Randomized Controlled Trial.

    Science.gov (United States)

    Sierau, Susan; Dähne, Verena; Brand, Tilman; Kurtz, Vivien; von Klitzing, Kai; Jungmann, Tanja

    2016-01-01

    Based on the US Nurse-Family Partnership (NFP) program, the German home visiting program "Pro Kind" offered support for socially and financially disadvantaged first-time mothers from pregnancy until the children's second birthday. A multi-centered, longitudinal randomized controlled trial (RCT) was conducted to assess its effectiveness on mothers and children. A total of 755 women with multiple risk factors were recruited, 394 received regular home visits (treatment group), while 361 only had access to standard community services (control group). Program influences on family environment (e.g., quality of home, social support), maternal competencies (e.g., maternal self-efficacy, empathy, parenting style), and child development (e.g., cognitive and motor development) were assessed from mothers' program intake in pregnancy to children's second birthday based on self-reports in regular interviews and developmental tests. Generalized estimating equations (GEE) models showed small, but significant positive treatment effects on parental self-efficacy, and marginally significant effects on social support, and knowledge on child rearing. Maternal stress, self-efficacy, and feelings of attachment in the TG tend to show a more positive development over time. Subgroup effects were found for high-risk mothers in the TG, who reported more social support over time and, generally, had children with higher developmental scores compared to their CG counterparts. Post hoc analyses of implementation variables revealed the quality of the helping relationship as a significant indicator of treatment effects. Results are discussed in terms of implementation and public policy differences between NFP and Pro Kind.

  8. Do Hospitalized Premature Infants Benefit from Music Interventions? A Systematic Review of Randomized Controlled Trials

    Science.gov (United States)

    Oliai Araghi, Sadaf; Jeekel, Johannes; Reiss, Irwin K. M; Hunink, M. G. Myriam; van Dijk, Monique

    2016-01-01

    Objective Neonatal intensive care units (NICU) around the world increasingly use music interventions. The most recent systematic review of randomized controlled trials (RCT) dates from 2009. Since then, 15 new RCTs have been published. We provide an updated systematic review on the possible benefits of music interventions on premature infants’ well-being. Methods We searched 13 electronic databases and 12 journals from their first available date until August 2016. Included were all RCTs published in English with at least 10 participants per group, including infants born prematurely and admitted to the NICU. Interventions were either recorded music interventions or live music therapy interventions. All control conditions were accepted as long as the effects of the music intervention could be analysed separately. A meta-analysis was not possible due to incompleteness and heterogeneity of the data. Results After removal of duplicates the searches retrieved 4893 citations, 20 of which fulfilled the inclusion/exclusion criteria. The 20 included studies encompassed 1128 participants receiving recorded or live music interventions in the NICU between 24 and 40 weeks gestational age. Twenty-six different outcomes were reported which we classified into three categories: physiological parameters; growth and feeding; behavioural state, relaxation outcomes and pain. Live music interventions were shown to improve sleep in three out of the four studies and heart rate in two out of the four studies. Recorded music improved heart rate in two out of six studies. Better feeding and sucking outcomes were reported in one study using live music and in two studies using recorded music. Conclusions Although music interventions show promising results in some studies, the variation in quality of the studies, age groups, outcome measures and timing of the interventions across the studies makes it difficult to draw strong conclusions on the effects of music in premature infants. PMID

  9. Clinical efficacy and prognostic indicators for lower limb pedalling exercise early after stroke: Study protocol for a pilot randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Myint Phyo

    2011-03-01

    Full Text Available Abstract Background It is known that repetitive, skilled, functional movement is beneficial in driving functional reorganisation of the brain early after stroke. This study will investigate a whether pedalling an upright, static exercise cycle, to provide such beneficial activity, will enhance recovery and b which stroke survivors might be able to participate in pedalling. Methods/Design Participants (n = 24 will be up to 30 days since stroke onset, with unilateral weakness and unable to walk without assistance. This study will use a modified exercise bicycle fitted with a UniCam crank. All participants will give informed consent, then undergo baseline measurements, and then attempt to pedal. Those able to pedal will be entered into a single-centre, observer-blinded randomised controlled trial (RCT. All participants will receive routine rehabilitation. The experimental group will, in addition, pedal daily for up to ten minutes, for up to ten working days. Prognostic indicators, measured at baseline, will be: site of stroke lesion, trunk control, ability to ambulate, and severity of lower limb paresis. The primary outcome for the RCT is ability to voluntarily contract paretic lower limb muscle, measured by the Motricity Index. Secondary outcomes include ability to ambulate and timing of onset and offset of activity in antagonist muscle groups during pedalling, measured by EMG. Discussion This protocol is for a trial of a novel therapy intervention. Findings will establish whether there is sufficient evidence of benefit to justify proceeding with further research into clinical efficacy of upright pedalling exercise early after stroke. Information on potential prognostic indicators will suggest which stroke survivors could benefit from the intervention. Trial Registration ISRCTN: ISRCTN45392701

  10. Statistical power in parallel group point exposure studies with time-to-event outcomes: an empirical comparison of the performance of randomized controlled trials and the inverse probability of treatment weighting (IPTW) approach.

    Science.gov (United States)

    Austin, Peter C; Schuster, Tibor; Platt, Robert W

    2015-10-15

    Estimating statistical power is an important component of the design of both randomized controlled trials (RCTs) and observational studies. Methods for estimating statistical power in RCTs have been well described and can be implemented simply. In observational studies, statistical methods must be used to remove the effects of confounding that can occur due to non-random treatment assignment. Inverse probability of treatment weighting (IPTW) using the propensity score is an attractive method for estimating the effects of treatment using observational data. However, sample size and power calculations have not been adequately described for these methods. We used an extensive series of Monte Carlo simulations to compare the statistical power of an IPTW analysis of an observational study with time-to-event outcomes with that of an analysis of a similarly-structured RCT. We examined the impact of four factors on the statistical power function: number of observed events, prevalence of treatment, the marginal hazard ratio, and the strength of the treatment-selection process. We found that, on average, an IPTW analysis had lower statistical power compared to an analysis of a similarly-structured RCT. The difference in statistical power increased as the magnitude of the treatment-selection model increased. The statistical power of an IPTW analysis tended to be lower than the statistical power of a similarly-structured RCT.

  11. 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

  12. The optimized acupuncture treatment for neck pain caused by cervical spondylosis: a study protocol of a multicentre randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Liang Zhao-Hui

    2012-07-01

    Full Text Available Abstract Background Neck pain is one of the chief symptoms of cervical spondylosis (CS. Acupuncture is a well-accepted and widely used complementary therapy for the management of neck pain caused by CS. In this paper, we present a randomized controlled trial protocol evaluating the use of acupuncture for CS neck pain, comparing the effects of the optimized acupuncture therapy in real practice compared with sham and shallow acupuncture. Methods/Design This trial uses a multicentre, parallel-group, randomized, sham acupuncture and shallow acupuncture, controlled single-blind design. Nine hospitals are involved as trial centres. 945 patients who meet inclusion criteria are randomly assigned to receive optimized acupuncture therapy, sham acupuncture or shallow acupuncture by a computerized central randomization system. The interventions past for 4 weeks with eight to ten treatments in total. The group allocations and interventions are concealed to patients and statisticians. The Northwick Park Neck Pain Questionnaire (NPQ is used as the primary outcome measure, and the McGill Pain Questionnaire (MPQ and The Short Form (36 Health Survey (SF-36 are applied as secondary outcome measures. The evaluation is performed at baseline, at the end of the intervention, and at the end of the first month and the third month during follow-up. The statistical analyses will include baseline data comparison and repeated measures of analysis of variance (ANOVA for primary and secondary outcomes of group and time differences. Adverse events (AEs will be reported if they occur. Discussion This trial is a multicentre randomized control trial (RCT on the efficacy of acupuncture for CS neck pain and has a large sample size and central randomization in China. It will strictly follow the CONSORT statement and STRICTA extension guideline to report high-quality study results. By setting the control groups as sham and shallow acupuncture, this study attempts to reveal the

  13. Study protocol of a parent-focused child feeding and dietary intake intervention: the feeding healthy food to kids randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Duncanson Kerith

    2012-07-01

    Full Text Available Abstract Background Poor childhood nutrition is a more pervasive and insidious risk factor for lifestyle-related chronic disease than childhood obesity. Parents find it difficult to address the reported barriers to optimal child feeding, and to improve child dietary patterns. To impact at the population level, nutrition interventions need to be easy to disseminate, have a broad reach and appeal to parents while overcoming the barriers parents face when trying to improve child feeding behaviours. The Feeding Healthy Food to Kids (FHFK Randomised Control Trial (RCT examines the impact of providing low cost, self-directed nutrition and parenting resources to rural parents, on child dietary intake and parent–child feeding practices. Methods/Design Up to 150 parents of two-to-five year old children will be recruited in five rural Australian towns. Eligible, consenting parents will be randomly allocated to intervention or 12-month wait-list control groups. Intervention group parents will receive an interactive nutrition CD and parenting DVD, and be provided with instructions for optimal resource utilisation. Intervention and control group participants will also receive a generic nutrition and physical activity brochure and a physical activity resource to blind participants to group allocation. Primary outcome measures are dietary intake of vegetables (serves/day, fruit and energy dense nutrient poor foods (serves/day and %Energy. Secondary outcome measures are total energy (kCal, other food groups (serves/day and %Energy, key nutrients (mg/day, child feeding domains and parenting style domains. Analysis of dietary outcome measures, child feeding and parenting domains will be conducted on an intention-to-treat basis and compared at baseline, three and 12 months using the random effects model, using STATA software. Details of the methodological aspects of recruitment, inclusion criteria, randomisation and statistical analysis are described

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

    Directory of Open Access Journals (Sweden)

    Christopher Williams

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

  15. Structuring communication relationships for interprofessional teamwork (SCRIPT: a cluster randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Kenaszchuk Chris

    2007-09-01

    Full Text Available Abstract Background Despite a burgeoning interest in using interprofessional approaches to promote effective collaboration in health care, systematic reviews find scant evidence of benefit. This protocol describes the first cluster randomized controlled trial (RCT to design and evaluate an intervention intended to improve interprofessional collaborative communication and patient-centred care. Objectives The objective is to evaluate the effects of a four-component, hospital-based staff communication protocol designed to promote collaborative communication between healthcare professionals and enhance patient-centred care. Methods The study is a multi-centre mixed-methods cluster randomized controlled trial involving twenty clinical teaching teams (CTTs in general internal medicine (GIM divisions of five Toronto tertiary-care hospitals. CTTs will be randomly assigned either to receive an intervention designed to improve interprofessional collaborative communication, or to continue usual communication practices. Non-participant naturalistic observation, shadowing, and semi-structured, qualitative interviews were conducted to explore existing patterns of interprofessional collaboration in the CTTs, and to support intervention development. Interviews and shadowing will continue during intervention delivery in order to document interactions between the intervention settings and adopters, and changes in interprofessional communication. The primary outcome is the rate of unplanned hospital readmission. Secondary outcomes are length of stay (LOS; adherence to evidence-based prescription drug therapy; patients' satisfaction with care; self-report surveys of CTT staff perceptions of interprofessional collaboration; and frequency of calls to paging devices. Outcomes will be compared on an intention-to-treat basis using adjustment methods appropriate for data from a cluster randomized design. Discussion Pre-intervention qualitative analysis revealed that a

  16. Aquatic therapy for boys with Duchenne muscular dystrophy (DMD): an external pilot randomised controlled trial.

    Science.gov (United States)

    Hind, Daniel; Parkin, James; Whitworth, Victoria; Rex, Saleema; Young, Tracey; Hampson, Lisa; Sheehan, Jennie; Maguire, Chin; Cantrill, Hannah; Scott, Elaine; Epps, Heather; Main, Marion; Geary, Michelle; McMurchie, Heather; Pallant, Lindsey; Woods, Daniel; Freeman, Jennifer; Lee, Ellen; Eagle, Michelle; Willis, Tracey; Muntoni, Francesco; Baxter, Peter

    2017-01-01

    Standard treatment of Duchenne muscular dystrophy (DMD) includes regular physiotherapy. There are no data to show whether adding aquatic therapy (AT) to land-based exercises helps maintain motor function. We assessed the feasibility of recruiting and collecting data from boys with DMD in a parallel-group pilot randomised trial (primary objective), also assessing how intervention and trial procedures work. Ambulant boys with DMD aged 7-16 years established on steroids, with North Star Ambulatory Assessment (NSAA) score ≥8, who were able to complete a 10-m walk test without aids or assistance, were randomly allocated (1:1) to 6 months of either optimised land-based exercises 4 to 6 days/week, defined by local community physiotherapists, or the same 4 days/week plus AT 2 days/week. Those unable to commit to a programme, with >20% variation between NSAA scores 4 weeks apart, or contraindications to AT were excluded. The main outcome measures included feasibility of recruiting 40 participants in 6 months from six UK centres, clinical outcomes including NSAA, independent assessment of treatment optimisation, participant/therapist views on acceptability of intervention and research protocols, value of information (VoI) analysis and cost-impact analysis. Over 6 months, 348 boys were screened: most lived too far from centres or were enrolled in other trials; 12 (30% of the targets) were randomised to AT (n = 8) or control (n = 4). The mean change in NSAA at 6 months was -5.5 (SD 7.8) in the control arm and -2.8 (SD 4.1) in the AT arm. Harms included fatigue in two boys, pain in one. Physiotherapists and parents valued AT but believed it should be delivered in community settings. Randomisation was unattractive to families, who had already decided that AT was useful and who often preferred to enrol in drug studies. The AT prescription was considered to be optimised for three boys, with other boys given programmes that were too extensive and insufficiently

  17. HIV treatment as prevention: considerations in the design, conduct, and analysis of cluster randomized controlled trials of combination HIV prevention.

    Directory of Open Access Journals (Sweden)

    Marie-Claude Boily

    Full Text Available The rigorous evaluation of the impact of combination HIV prevention packages at the population level will be critical for the future of HIV prevention. In this review, we discuss important considerations for the design and interpretation of cluster randomized controlled trials (C-RCTs of combination prevention interventions. We focus on three large C-RCTs that will start soon and are designed to test the hypothesis that combination prevention packages, including expanded access to antiretroviral therapy, can substantially reduce HIV incidence. Using a general framework to integrate mathematical modelling analysis into the design, conduct, and analysis of C-RCTs will complement traditional statistical analyses and strengthen the evaluation of the interventions. Importantly, even with combination interventions, it may be challenging to substantially reduce HIV incidence over the 2- to 3-y duration of a C-RCT, unless interventions are scaled up rapidly and key populations are reached. Thus, we propose the innovative use of mathematical modelling to conduct interim analyses, when interim HIV incidence data are not available, to allow the ongoing trials to be modified or adapted to reduce the likelihood of inconclusive outcomes. The preplanned, interactive use of mathematical models during C-RCTs will also provide a valuable opportunity to validate and refine model projections.

  18. Randomized Controlled Trial to Assess the Effectiveness of a Self-Care Program for Pregnant Women for Relieving Hiesho.

    Science.gov (United States)

    Nakamura, Sachiyo; Horiuchi, Shigeko

    2017-01-01

    To assess differences in improvement of hiesho (sensitivity to cold) through a randomized controlled trial (RCT) of one group that used a self-care program (the Home Care Package Program for Relieving Hiesho) and another that did not. Participants were pregnant women experiencing hiesho in the 28th to 33rd weeks of pregnancy. The group carried out the intervention program for 4 weeks by wearing leg warmers, performing exercises, and pressing acupuncture points. The control group did not take any specific actions. Hiesho condition was assessed by using thermography to measure temperature in the four limbs; the changes were analyzed. Findings for 140 pregnant women (73 in the experimental group and 67 in the control group) were analyzed. Participants' body temperatures were measured after completion of the program for 4 weeks and compared to their temperatures before start of the program. Compared with the control group, the experimental group had arm skin temperature 3.0°C (p < 0.001) higher and leg skin temperature 1.93°C (p = 0.02) higher; both differences were significant. The Home Care Package Program for Relieving Hiesho self-care program significantly relieved hiesho.

  19. World’s largest case management RCT

    OpenAIRE

    2016-01-01

    We have developed and implemented a large scale, centralized case management program to prevent healthcare consumption for frequent visitors to Emergency Departments. In a randomized trial of more than 12 000 patients we demonstrate sustained reductions of up to 20-40% in health care utilization. This session will focus on results and learnings gathered during a 5-year multicenter trial, growing from a small pilot to an international concept.The results have been published in several articles...

  20. Improving the relationship between the randomized clinical trial and real-world clinical practice.

    Science.gov (United States)

    Gottdiener, William H

    2011-09-01

    I comment on the article by Krause (see record 2011-19228-002), which discusses a number of ways for clinical psychotherapy outcome researchers to make the results of randomized controlled trials (RCT) more useful to practicing psychotherapists primarily by making the distributions of raw data from those studies available to the public. In this way, it would be possible for psychotherapists to determine which treatment of an RCT (experimental or control) would be best for a specific patient. Problems with this proposal are discussed and an alternative model that integrates psychotherapy outcome data from group means and clinical case studies is offered. (c) 2011 APA, all rights reserved.

  1. Clinical trial participants’ experiences of completing questionnaires: a qualitative study

    Science.gov (United States)

    Holmberg, Christine; Karner, Julia J; Rappenecker, Julia; Witt, Claudia M

    2014-01-01

    Objectives To improve clinical study developments for elderly populations, we aim to understand how they transfer their experiences into validated, standardised self-completed study measurement instruments. We analysed how women (mean 78±8 years of age) participating in a randomised controlled trial (RCT) cognised study instruments used to evaluate outcomes of the intervention. Setting The interview study was nested in an RCT on chronic neck pain using common measurement instruments situated in an elderly community in Berlin, Germany, which comprised of units for independent and assisted-living options. Participants The sample (n=20 women) was selected from the RCT sample (n=117, 95% women, mean age 76 (SD±8) years). Interview participants were selected using a purposive sampling list based on the RCT outcomes. Outcomes We asked participants about their experiences completing the RCT questionnaires. Interviews were analysed thematically, then compared with the questionnaires. Results Interviewees had difficulties in translating complex experiences into a single value on a scale and understanding the relationship of the questionnaires to study aims. Interviewees considered important for the trial that their actual experiences were understood by trial organisers. This information was not transferrable by means of the questionnaires. To rectify these difficulties, interviewees used strategies such as adding notes, adding response categories or skipping an item. Conclusions Elderly interview participants understood the importance of completing questionnaires for trial success. This led to strategies of completing the questionnaires that resulted in ‘missing’ or ambiguous data. To improve data collection in elderly populations, educational materials addressing the differential logics should be developed and tested. Pilot testing validated instruments using cognitive interviews may be particularly important in such populations. Finally, when the target of an

  2. Control groups in recent septic shock trials: a systematic review.

    Science.gov (United States)

    Pettilä, Ville; Hjortrup, Peter Buhl; Jakob, Stephan M; Wilkman, Erika; Perner, Anders; Takala, Jukka

    2016-12-01

    The interpretation of septic shock trial data is profoundly affected by patients, control intervention, co-interventions and selected outcome measures. We evaluated the reporting of control groups in recent septic shock trials. We searched for original articles presenting randomized clinical trials (RCTs) in adult septic shock patients from 2006 to 2016. We included RCTs focusing on septic shock patients with at least two parallel groups and at least 50 patients in the control group. We selected and evaluated data items regarding patients, control group characteristics, and mortality outcomes, and calculated a data completeness score to provide an overall view of quality of reporting. A total of 24 RCTs were included (mean n = 287 patients and 71 % of eligible patients were randomized). Of the 24 studies, 14 (58 %) presented baseline data on vasopressors and 58 % the proportion of patients with elevated lactate values. Five studies (21 %) provided data to estimate the proportion of septic shock patients fulfilling the Sepsis-3 definition. The mean data completeness score was 19 out of 36 (range 8-32). Of 18 predefined control group characteristics, a mean of 8 (range 2-17) were reported. Only 2 (8 %) trials provided adequate data to confirm that their control group treatment represented usual care. Recent trials in septic shock provide inadequate data on the control group treatment and hemodynamic values. We propose a standardized trial dataset to be created and validated, comprising characteristics of patient population, interventions administered, hemodynamic values achieved, surrogate organ dysfunction, and mortality outcomes, to allow better analysis and interpretation of future trial results.

  3. Changes in Physical Activity Following a Genetic-Based Internet-Delivered Personalized Intervention: Randomized Controlled Trial (Food4Me)

    Science.gov (United States)

    Livingstone, Katherine M; Fallaize, Rosalind; Kolossa, Silvia; Hallmann, Jacqueline; San-Cristobal, Rodrigo; Navas-Carretero, Santiago; O'Donovan, Clare B; Woolhead, Clara; Forster, Hannah; Moschonis, George; Lambrinou, Christina-Paulina; Surwillo, Agnieszka; Godlewska, Magdalena; Hoonhout, Jettie; Goris, Annelies; Macready, Anna L; Walsh, Marianne C; Gibney, Eileen R; Brennan, Lorraine; Manios, Yannis; Traczyk, Iwona; Drevon, Christian A; Lovegrove, Julie A; Martinez, J Alfredo; Daniel, Hannelore; Gibney, Michael J; Mathers, John C; Saris, Wim HM

    2016-01-01

    Background There is evidence that physical activity (PA) can attenuate the influence of the fat mass- and obesity-associated (FTO) genotype on the risk to develop obesity. However, whether providing personalized information on FTO genotype leads to changes in PA is unknown. Objective The purpose of this study was to determine if disclosing FTO risk had an impact on change in PA following a 6-month intervention. Methods The single nucleotide polymorphism (SNP) rs9939609 in the FTO gene was genotyped in 1279 participants of the Food4Me study, a four-arm, Web-based randomized controlled trial (RCT) in 7 European countries on the effects of personalized advice on nutrition and PA. PA was measured objectively using a TracmorD accelerometer and was self-reported using the Baecke questionnaire at baseline and 6 months. Differences in baseline PA variables between risk (AA and AT genotypes) and nonrisk (TT genotype) carriers were tested using multiple linear regression. Impact of FTO risk disclosure on PA change at 6 months was assessed among participants with inadequate PA, by including an interaction term in the model: disclosure (yes/no) × FTO risk (yes/no). Results At baseline, data on PA were available for 874 and 405 participants with the risk and nonrisk FTO genotypes, respectively. There were no significant differences in objectively measured or self-reported baseline PA between risk and nonrisk carriers. A total of 807 (72.05%) of the participants out of 1120 in the personalized groups were encouraged to increase PA at baseline. Knowledge of FTO risk had no impact on PA in either risk or nonrisk carriers after the 6-month intervention. Attrition was higher in nonrisk participants for whom genotype was disclosed (P=.01) compared with their at-risk counterparts. Conclusions No association between baseline PA and FTO risk genotype was observed. There was no added benefit of disclosing FTO risk on changes in PA in this personalized intervention. Further RCT studies

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

    Directory of Open Access Journals (Sweden)

    Kristoffersen Espen

    2012-08-01

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

  5. The meaningful assessment of therapy outcomes: Incorporating a qualitative study into a randomized controlled trial evaluating the treatment of adolescent depression.

    Science.gov (United States)

    Midgley, Nick; Ansaldo, Flavia; Target, Mary

    2014-03-01

    For many years, there have been heated debates about the best way to evaluate the efficacy and effectiveness of psychological therapies. On the one hand, there are those who argue that the randomized controlled trial (RCT) is the only reliable and scientifically credible way to assess psychological interventions. On the other hand, there are those who have argued that psychological therapies cannot be meaningfully assessed using a methodology developed to evaluate the impact of drug treatments, and that the findings of RCTs lack "external validity" and are difficult to translate into routine clinical practice. In this article, we advocate the use of mixed-method research designs for RCTs, combining the rigor of quantitative data about patterns of change with the phenomenological contextualized insights that can be derived from qualitative data. We argue that such an approach is especially important if we wish to understand more fully the impact of therapeutic interventions within complex clinical settings. To illustrate the value of a mixed-method approach, we describe a study currently underway in the United Kingdom, in which a qualitative study (IMPACT-My Experience [IMPACT-ME]) has been "nested" within an RCT (the Improving Mood With Psychoanalytic and Cognitive Behavioral Therapy [IMPACT] study) designed to evaluate the effectiveness of psychological therapies in the treatment of adolescent depression. We argue that such a mixed-methods approach can help us to evaluate the effectiveness of psychological therapies and support the real-world implementation of our findings within increasingly complex and multidisciplinary clinical contexts.

  6. Current preventive treatment for recurrence after curative hepatectomy for liver metastases of colorectal carcinoma: A literature review of randomized control trials

    Institute of Scientific and Technical Information of China (English)

    Peng Wang; Zhen Chen; Wen-Xia Huang; Lu-Ming Liu

    2005-01-01

    To review the preventive approaches for recurrence after curative resection of hepatic metastases from coloreclal carcinoma, we have summarized all available publications reporting randomized control trials (RCTs) covered in PubMed. The treatment approaches presented above include adjuvant intrahepatic arterial infusion chemotherapy,systemic chemotherapy, neoadjuvant chemotherapy, and immunotherapy. Although no standard treatment has been established, several approaches present promising results, which are both effective and tolerable in posthepatectomy patients. Intrahepatic arterial infusion chemotherapy should be regarded as effective and tolerable and it increases overall survival (OS) and diseasefree survival (DFS) of patients, while 5-fluorouracil-based systemic chemotherapy has not shown any significant survival benefit. Fortunately chemotherapy combined with hepatic arterial infusion and intravenous infusion has shown OS and DFS benefit in many researches. Few neoadjuvant RCT studies have been conduced to evaluate its effect on prolonging survivals although many retrospective studies a