Patients' preferences and randomised trials

Brewin, Thurstan; Thornton, Hazel; Bradley, Clare; McPherson, Klim; Gore, S M; Silverman, William A.; Altman, D G

doi:10.1016/s0140-6736(96)90317-7

Cited by 15 publications

(7 citation statements)

References 13 publications

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“…Particular risks for stroke rehabilitation trials are resentful demoralisation of participants randomised to the control group [40] and competitive therapy bias, where therapy staff may feel that patients in the control group are disadvantaged and subsequently provide them with increased rehabilitation [41]. We did consider developing an attention control treatment, but this would have added to the complexity and cost of the trial.…”

Section: Discussionmentioning

confidence: 99%

Repetitive arm functional tasks after stroke (RAFTAS): a pilot randomised controlled trial

Brkic

Shaw

Wijck

et al. 2016

Pilot Feasibility Stud

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BackgroundRepetitive functional task practise (RFTP) is a promising treatment to improve upper limb recovery following stroke. We report the findings of a study to determine the feasibility of a multi-centre randomised controlled trial to evaluate this intervention.MethodsA pilot randomised controlled trial recruited patients with new reduced upper limb function within 14 days of acute stroke from three stroke units. Participants were randomised to receive a four week upper limb RFTP therapy programme consisting of goal setting, independent activity practise, and twice weekly therapy reviews in addition to usual post stroke rehabilitation, or usual post stroke rehabilitation. The recruitment rate; adherence to the RFTP therapy programme; usual post stroke rehabilitation received; attrition rate; data quality; success of outcome assessor blinding; adverse events; and the views of study participants and therapists about the intervention were recorded.ResultsFifty five eligible patients were identified, 4-6 % of patients screened at each site. Twenty four patients participated in the pilot study. Two study sites met the recruitment target of 1–2 participants per month. The median number of face to face therapy sessions received was 6 [IQR 3–8]. The median number of daily repetitions of activities recorded was 80 [IQR 39–80]. Data about usual post stroke rehabilitation were available for 18/24 (75 %). Outcome data were available for 22/24 (92 %) at one month and 20/24 (83 %) at three months. Outcome assessors were unblinded to participant group allocation for 11/22 (50 %) at one month and 6/20 (30 %) at three months. Four adverse events were considered serious as they resulted in hospitalisation. None were related to study treatment. Feedback from patients and therapists about the RFTP programme was mainly positive.ConclusionsA multi-centre randomised controlled trial to evaluate an upper limb RFTP therapy programme provided early after stroke is feasible and acceptable to patients and therapists, but there are issues which need to be addressed when designing a Phase III study. A Phase III study will need to monitor and report not only recruitment and attrition but also adherence to the intervention, usual post stroke rehabilitation received, and outcome assessor blinding.Trial registrationInternational Standard Randomised Controlled Trials Number (ISRCTN) 58527251

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Section: Discussionmentioning

confidence: 99%

Repetitive arm functional tasks after stroke (RAFTAS): a pilot randomised controlled trial

Brkic

Shaw

Wijck

et al. 2016

Pilot Feasibility Stud

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“…Thus, random allocation – which is considered a great strength in traditional RCTs – can be considered a weakness in lifestyle/behavioural intervention trials because it eliminates participant choice. Choosing one’s preferred intervention, it is argued, can increase motivation and thereby the success of the intervention [53,60]. One solution here may be to adopt a non-randomised approach which capitalises on, rather than ignores, motivational differences between participants by allowing patient choice to dictate the intervention group rather than chance allocation.…”

Section: Discussion/conclusionmentioning

confidence: 99%

Reasons for participation and non-participation in a diabetes prevention trial among women with prior gestational diabetes mellitus (GDM)

Infanti

O’Dea

Gibson

et al. 2014

BMC Med Res Methodol

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BackgroundGestational diabetes mellitus (GDM) is a risk factor for the development of type 2 diabetes. Lifestyle intervention can prevent progression to type 2 diabetes in high risk populations. We designed a randomised controlled trial (RCT) to evaluate the effectiveness of an established lifestyle intervention compared to standard care for delaying diabetes onset in European women with recent GDM. Recruitment into the RCT was more challenging than anticipated with only 89 of 410 (22%) women agreeing to participate. This paper identifies factors that could enhance participation of the target population in future interventions.MethodsWe hypothesised that women who agreed to participate would have higher diabetes risk profiles than those who declined, and secondly that it would be possible to predict participation on the bases of those risk factors. To test our hypothesis, we identified the subset of women for whom we had comprehensive data on diabetes risks factors 3-5 years following GDM, reducing the sample to 43 participants and 73 decliners. We considered established diabetes risk factors: smoking, daily fruit and vegetable intake, participation in exercise, family history of diabetes, glucose values and BMI scores on post-partum re-screens, use of insulin during pregnancy, and age at delivery. We also analysed narrative data from 156 decliners to further understand barriers to and facilitators of participation.ResultsTwo factors differentiated participants and decliners: age at delivery (with women older than 34 years being more likely to participate) and insulin use during pregnancy (with women requiring the use of insulin in pregnancy less likely to participate). Binary logistic regression confirmed that insulin use negatively affected the odds of participation. The most significant barriers to participation included the accessibility, affordability and practicality of the intervention.ConclusionsWomen with recent GDM face multiple barriers to lifestyle change. Intervention designers should consider: (i) the practicalities of participation for this population, (ii) research designs that capitalise on motivational differences between participants, (iii) alleviating concerns about long-term diabetes management. We hope this work will support future researchers in developing interventions that are more relevant, effective and successful in recruiting the desired population.Trial registrationCurrent Controlled Trials ISRCTN41202110

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“…In Norway, we have data from large population-based studies that are well suited for comparison purposes. Recruitment to RCTs is also frequently problematic [73,74], and one concern in the present RCT is whether patients who are eligible will be disappointed when they are randomized to the control group and not to an intervention group receiving the Few Touch application or the application together with health counseling. There is reason to question whether an RCT is suited to this type of study when we are recruiting possibly motivated patients to participate in a TM intervention and they may be randomized to the control group.…”

Section: Discussionmentioning

confidence: 99%

Low-Intensity Self-Management Intervention for Persons With Type 2 Diabetes Using a Mobile Phone-Based Diabetes Diary, With and Without Health Counseling and Motivational Interviewing: Protocol for a Randomized Controlled Trial

Ribu¹,

Holmen²,

Torbjørnsen³

et al. 2013

JMIR Res Protoc

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BackgroundThe present study protocol is designed to cover the Norwegian part of the European Union Collaborative Project—REgioNs of Europe WorkINg together for HEALTH (RENEWING HEALTH). Self-management support is an important element of care for persons with type 2 diabetes (T2D) for achieving metabolic control and positive lifestyle changes. Telemedicine (TM) with or without health counseling may become an important technological aid for self-management and may provide a user-centered model of care. In spite of many earlier studies on TM, there remains a lack of consensus in research findings about the effect of TM interventions.ObjectiveThe aim of RENEWING HEALTH is to validate and evaluate innovative TM tools on a large scale through a common evaluation, making it easier for decision makers to choose the most efficient and cost-effective technological interventions. The Norwegian pilot study evaluates whether the introduction of a mobile phone with a diabetes diary application together with health counseling intervention produces benefits in terms of the desired outcomes, as reflected in the hemoglobin A1c level, health-related quality of life, behavior change, and cost-effectiveness.MethodsThe present study has a mixed-method design comprising a three-armed prospective randomized controlled trial and qualitative interviews with study data collected at three time points: baseline, after 4 months, and after 1 year. The patients’ registrations on the application are recorded continuously and are sent securely to a server.ResultsThe inclusion of patients started in March 2011, and 100% of the planned sample size is included (N=151). Of all the participants, 26/151 patients (17.2%) are lost to follow-up by now, and 11/151 patients (7.3%) are still in the trial. Results of the study protocol will be presented in 2014.ConclusionsThe key goals of this trial are to investigate the effect of an electronic diabetes diary app with and without health counseling, and to determine whether health counseling is important to the continued use of the application and the patients’ health competence and acceptability. Research within this area is needed because few studies have investigated the effectiveness of apps used in long-term interventions with this degree of self-management.Trial RegistrationClinicaltrials.gov NCT01315756; http://clinicaltrials.gov/ct2/show/NCT01315756 (Archived by WebCite at http://www.webcitation/6BTyuRMpH).

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Patients' preferences and randomised trials

Cited by 15 publications

References 13 publications

Repetitive arm functional tasks after stroke (RAFTAS): a pilot randomised controlled trial

Repetitive arm functional tasks after stroke (RAFTAS): a pilot randomised controlled trial

Reasons for participation and non-participation in a diabetes prevention trial among women with prior gestational diabetes mellitus (GDM)

Low-Intensity Self-Management Intervention for Persons With Type 2 Diabetes Using a Mobile Phone-Based Diabetes Diary, With and Without Health Counseling and Motivational Interviewing: Protocol for a Randomized Controlled Trial

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