Study Within A Trial
The OMACS PIL study: a randomised controlled trial within the OMACS observational study
... of study PILs and concluded that information presented to potential participants “needs to be well structured and designed in an appealing ...That study focused on how the appearance of a paper PIL might ...
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Does handwriting the name of a potential trial participant on an invitation letter improve recruitment rates? A randomised controlled study within a trial
... OTIS trial is a modified cohort (11), pragmatic, multicentre, two-armed ...main trial have been published elsewhere ...Health Study (YHS) (12); ii) cohorts of previous trials held by the YTU (13) ...
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Evaluation of the effects of an offer of a monetary incentive on the rate of questionnaire return during follow-up of a clinical trial: a randomised study within a trial
... BUMPES trial office at the Comprehensive Clinical Trials Unit at University College London via a secure ...BUMPES study. Each BUMPES participant was randomised once only. BUMPES trial staff were ...
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Evaluation of the effects of an offer of a monetary incentive on the rate of questionnaire return during follow-up of a clinical trial: a randomised study within a trial
... randomised Study Within A Trial (SWAT) nested within BUMPES, a multicentre randomised controlled trial of maternal position in the late stage of labour in women with an ...the ...
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The face of equipoise - delivering a structured education programme within a randomized controlled trial: qualitative study
... The strong sense of professionalism and commitment indicated by educators when describing working to conceal their personal preferences echoes the idea of ‘active’ or ‘responsible’ uncertainty as a way of making sense of ...
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Patient views about the impact of ulcerative colitis and its management with drug treatment and surgery: a nested qualitative study within the CONSTRUCT trial
... the trial in view of the belief that a total of 24 partici- pants, interviewed on two occasions (n = 48 data capture events), would yield a range of views and opinions re- garding therapy and surgical ...
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The face of equipoise delivering a structured education programme within a randomized controlled trial: qualitative study
... to trialists. We argue that the importance of intervention deliverers ‘buying into’ the purpose of research high- lights the value in training them in: the concept of equipoise, the potential impact of their preferences ...
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Effectiveness of olive oil for the prevention of pressure ulcers caused in immobilized patients within the scope of primary health care: study protocol for a randomized controlled trial
... The study is designed as a noninferiority, triple-blinded, parallel, multi-center, randomized clinical ...the study is the population attending primary health centers in Andalucía (Spain) in the regional ...
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The views of children and young people on the use of silk garments for the treatment of eczema: a nested qualitative study within the CLOTHES randomised controlled trial
... on trial design; Lucy Bradshaw, Medical Statistician; Rachel Haines, Trial Manager; Eleanor Mitchell, Senior Trial Manager; Alan Montgomery, Professor of Statistics and Clinical Trials; Andrew ...
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Open versus laparoscopic left lateral hepatic sectionectomy within an enhanced recovery ERAS® programme (ORANGE II – Trial): study protocol for a randomised controlled trial
... II trial is partly funded by the Profiling Fund of the Maastricht University Medical Center, Maastricht, The Netherlands number PF ...this trial with an unrestricted grand. Collaborators of the ORANGE II ...
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Compliance with mandatory reporting of clinical trial results on ClinicalTrials gov: cross sectional study
... results within one year (“trials subject to mandatory ...the study, as defined by the individual trial’s ...completing within this timeframe would have had at least one year in which to report ...
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Study protocol for a randomized controlled trial of telephone-delivered cognitive behavior therapy compared with befriending for treating depression and anxiety in older adults with COPD
... this study are as follows: first, a trial statistician conducting the computerized random- ization procedure ensures chance allocation of participants to the intervention or control group; second, the ...
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Enhancing Recruitment Using Teleconference and Commitment Contract (ERUTECC): study protocol for a randomised, stepped wedge cluster trial within the EFFECTS trial
... cluster trial embedded in ...the study will continue for 12 ...this study is that a structured teleconference re-visit with the study personnel at the centres, accompanied by a commitment ...
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Trial Forge Guidance 1: what is a Study Within A Trial (SWAT)?
... • Whether randomisation is needed depends on the question being asked. If the intention is to evaluate the effect of alternative ways of doing a trial process, then the alternatives being compared should be ...
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Trial Forge Guidance 1 : what is a Study Within A Trial (SWAT)?
... host trial sample size (the constraint is the size of the patient population approached, not ...host trial sample. It is highly unlikely that the size of the host trial will be changed for the ...
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ORIGINALRESEARCH Lifestyle Matters Randomized Controlled Trial of a Preventive Health Intervention for Older People: Qualitative Sub Study with Participants and Intervention Facilitators
... A small number of transcripts were coded to re fi ne the initial analytic framework, which was then applied to the same two transcripts by the researchers who also con- ducted the interviews to ensure comparable coding. ...
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Barriers to the sustainability of an intervention designed to improve patient engagement within NHS mental health rehabilitation units: a qualitative study nested within a randomised controlled trial
... the study, which were reflected in the topic guide, we adopted a critical realist stance to carry out a thematic data analysis ...both within and between groups, which formed our analysis, and the find- ...
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Protocol for a randomized controlled trial of the Breaking Free Online Health and Justice program for substance misuse in prison settings
... a study that includes substance-involved offenders as participants, as it can be particularly difficult to maintain engagement with individuals who may have issues around substance misuse and ...the study ...
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Minimal important improvement thresholds for the six minute walk test in a knee arthroplasty cohort: triangulation of anchor and distribution based methods
... This study was nested within a multicentre, two-armed randomised controlled trial (HIHO) with a third non- randomised, observational arm [2] ...controlled trial was de- signed to test the ...
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Two randomized controlled clinical trials to study the effectiveness of prednisolone treatment in preventing and restoring clinical nerve function loss in leprosy: the TENLEP study protocols
... Clinical trial leprosy patients with recent (< 6 months) clinical NFI, as determined by Monofilament Test and Voluntary Muscle Test, are ...Subclinical trial leprosy patients with subclinical neuropathy, ...
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