Coproduction for feasibility and pilot randomised controlled trials: learning outcomes for community partners, service users and the research team.
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SUBMITTER: McConnell T
PROVIDER: S-EPMC6174568 | biostudies-literature | 2018
REPOSITORIES: biostudies-literature
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Coproduction for feasibility and pilot randomised controlled trials: learning outcomes for community partners, service users and the research team.
McConnell Tracey T Best Paul P Davidson Gavin G McEneaney Tom T Cantrell Cherry C Tully Mark M
Research involvement and engagement 20181008
<h4>Plain english summary</h4>Co-producing research with members of the public is increasingly recognised as a valuable process. Yet, despite these good intentions, the literature on coproduction has struggled to keep pace with the coproduction 'movement'. There is a lack of clarity regarding acceptable levels of involvement and attempts at standardising approaches appear generic and lack detail. Moreover, relatively little research has captured the views of all the parties involved (academics, ...[more]
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Project description:The Consolidated Standards of Reporting Trials (CONSORT) statement is a guideline designed to improve the transparency and quality of the reporting of randomised controlled trials (RCTs). In this article we present an extension to that statement for randomised pilot and feasibility trials conducted in advance of a future definitive RCT. The checklist applies to any randomised study in which a future definitive RCT, or part of it, is conducted on a smaller scale, regardless of its design (eg, cluster, factorial, crossover) or the terms used by authors to describe the study (eg, pilot, feasibility, trial, study). The extension does not directly apply to internal pilot studies built into the design of a main trial, non-randomised pilot and feasibility studies, or phase II studies, but these studies all have some similarities to randomised pilot and feasibility studies and so many of the principles might also apply. The development of the extension was motivated by the growing number of studies described as feasibility or pilot studies and by research that has identified weaknesses in their reporting and conduct. We followed recommended good practice to develop the extension, including carrying out a Delphi survey, holding a consensus meeting and research team meetings, and piloting the checklist. The aims and objectives of pilot and feasibility randomised studies differ from those of other randomised trials. Consequently, although much of the information to be reported in these trials is similar to those in randomised controlled trials (RCTs) assessing effectiveness and efficacy, there are some key differences in the type of information and in the appropriate interpretation of standard CONSORT reporting items. We have retained some of the original CONSORT statement items, but most have been adapted, some removed, and new items added. The new items cover how participants were identified and consent obtained; if applicable, the prespecified criteria used to judge whether or how to proceed with a future definitive RCT; if relevant, other important unintended consequences; implications for progression from pilot to future definitive RCT, including any proposed amendments; and ethical approval or approval by a research review committee confirmed with a reference number. This article includes the 26 item checklist, a separate checklist for the abstract, a template for a CONSORT flowchart for these studies, and an explanation of the changes made and supporting examples. We believe that routine use of this proposed extension to the CONSORT statement will result in improvements in the reporting of pilot trials. Editor's note: In order to encourage its wide dissemination this article is freely accessible on the BMJ and Pilot and Feasibility Studies journal websites.
| S-EPMC5154046 | biostudies-literature
Project description: Not available
| S-EPMC5076380 | biostudies-literature
Project description:BackgroundInvolvement of end-users in research can enhance its quality, relevance, credibility and legitimacy; however, the processes through which these changes occur are unclear. Our aim was to explore a coproduction research team's experiences of their involvement in research about young people with type 1 diabetes mellitus (T1DM).MethodsSemi-structured interviews conducted with two young people with T1DM, two parents, one diabetes educator, one endocrinologist-scientist and one research-engineer explored experiences of coproduction research and its impact on both the research and the participants. Drawing on grounded theory, we undertook inductive analysis and storyline mapping to develop a theorized framework of mechanisms supporting the process of coproduction in T1DM research with young people.FindingsThe framework involving coproduction partners in research about young people with type 1 diabetes centres on the unique expertize that different team members bring to the research and describes conditions that enable expert contributions through the enactment of a variety of expert roles. The framework also describes outcomes-the impact of the expert contributions on both the research and the team members involved.ConclusionThe findings of this small exploratory study provide a sound foundation to develop further understanding about structures and processes that are integral for the success of coproduction research teams. The framework may provide a guide for researchers planning to incorporate coproduction, on elements that are important for this model of research to succeed. It may also inform coproduction impact assessment research and be used for hypothesis testing and expansion in future studies.
| S-EPMC8849360 | biostudies-literature
Project description:ObjectivesTo systematically review the quality of reporting of pilot and feasibility of cluster randomised trials (CRTs). In particular, to assess (1) the number of pilot CRTs conducted between 1 January 2011 and 31 December 2014, (2) whether objectives and methods are appropriate and (3) reporting quality.MethodsWe searched PubMed (2011-2014) for CRTs with 'pilot' or 'feasibility' in the title or abstract; that were assessing some element of feasibility and showing evidence the study was in preparation for a main effectiveness/efficacy trial. Quality assessment criteria were based on the Consolidated Standards of Reporting Trials (CONSORT) extensions for pilot trials and CRTs.ResultsEighteen pilot CRTs were identified. Forty-four per cent did not have feasibility as their primary objective, and many (50%) performed formal hypothesis testing for effectiveness/efficacy despite being underpowered. Most (83%) included 'pilot' or 'feasibility' in the title, and discussed implications for progression from the pilot to the future definitive trial (89%), but fewer reported reasons for the randomised pilot trial (39%), sample size rationale (44%) or progression criteria (17%). Most defined the cluster (100%), and number of clusters randomised (94%), but few reported how the cluster design affected sample size (17%), whether consent was sought from clusters (11%), or who enrolled clusters (17%).ConclusionsThat only 18 pilot CRTs were identified necessitates increased awareness of the importance of conducting and publishing pilot CRTs and improved reporting. Pilot CRTs should primarily be assessing feasibility, avoiding formal hypothesis testing for effectiveness/efficacy and reporting reasons for the pilot, sample size rationale and progression criteria, as well as enrolment of clusters, and how the cluster design affects design aspects. We recommend adherence to the CONSORT extensions for pilot trials and CRTs.
| S-EPMC5695336 | biostudies-literature
Project description:Background:Few studies have identified and compared profiles of mental health service networks (MHSN) in terms of structures, processes, and outcomes, based on cluster analyses and perceptions of team managers, MH professionals and service users. This study assessed these associations in Quebec metropolitan, urban and semi-urban MHSN. Methods:A framework adapted from the Donabedian model guided data management, and cluster analyses were used to identify categories. Study participants included team managers (n = 45), MH professionals (n = 311) and service users (n = 327). Results:For all three MHSN, a common outcome category emerged: service users with complex MH problems and negative outcomes. The Metropolitan network reported two categories for structures (specialized MH teams, primary care MH teams) and processes (senior medical professional, psychosocial professionals), and outcomes (middle-age men with positive outcomes, older women with few MH problems). The Urban and Semi-urban networks revealed one category for structures (all teams) and service user (young service users with drug disorders), but two for processes (psychosocial professionals: urban, all professionals: semi-urban). Conclusion:The Metropolitan MHSN showed greater heterogeneity regarding structures and team processes than the other two MHSN. Service user outcomes were largely associated with clinical characteristics, regardless of network configurations for structures and team processes.
| S-EPMC7292103 | biostudies-literature
Project description:ObjectivesTo assess the value of pilot and feasibility studies to randomised controlled trials (RCTs) funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme. To explore the methodological components of pilot/feasibility studies and how they inform full RCTs.Study designCross-sectional study.SettingBoth groups included NIHR HTA programme funded studies in the period 1 January 2010-31 December 2014 (decision date). Group 1: stand-alone pilot/feasibility studies published in the HTA Journal or accepted for publication. Group 2: all funded RCT applications funded by the HTA programme, including reference to an internal and/or external pilot/feasibility study. The methodological components were assessed using an adapted framework from a previous study.Main outcome measuresThe proportion of stand-alone pilot and feasibility studies which recommended proceeding to full trial and what study elements were assessed. The proportion of 'HTA funded' trials which used internal and external pilot and feasibility studies to inform the design of the trial.ResultsGroup 1 identified 15 stand-alone pilot/feasibility studies. Study elements most commonly assessed were testing recruitment (100% in both groups), feasibility (83%, 100%) and suggestions for further study/investigation (83%, 100%). Group 2 identified 161 'HTA funded' applications: 59 cited an external pilot/feasibility study where testing recruitment (50%, 73%) and feasibility (42%, 73%) were the most commonly reported study elements: 92 reported an internal pilot/feasibility study where testing recruitment (93%, 100%) and feasibility (44%, 92%) were the most common study elements reported.Conclusions'HTA funded' research which includes pilot and feasibility studies assesses a variety of study elements. Pilot and feasibility studies serve an important role when determining the most appropriate trial design. However, how they are reported and in what context requires caution when interpreting the findings and delivering a definitive trial.
| S-EPMC6169762 | biostudies-literature
Project description:PurposeThe aim of this study was to provide insight for the feasibility and outcomes of hybrid (combination of in-person office and Internet-based appointments) audiology services.MethodThis pilot included two phases. First, we surveyed audiologists regarding what elements of a best-practice, in-person delivery of a hearing intervention could be delivered via Internet-based appointments. Next, we piloted the feasibility and assessed outcomes of the procedures identified. Ten first-time hearing aid users aged 70 years and older were fit with Phonak Audeo M90-312T hearing aids. Two Internet-based follow-up appointments were completed using the myPhonak app. We administered the Hearing Handicap Inventory for the Elderly-Screening Version (HHIE-S), the Client Oriented Scale of Improvement (COSI), the Quick Speech-in-Noise Test (QuickSIN), and real-ear aided responses (REARs) to determine whether participants experienced improvements on hearing-related outcomes. The Telehealth Acceptance Questionnaire (TAQ) and the Visit-Specific Satisfaction Questionnaire (VSQ-9) were administered to gauge comfort with telehealth and satisfaction with Internet-based appointments.ResultsSurvey results revealed that after an initial in-person appointment, nearly all follow-up hearing intervention components could be delivered remotely. We performed Wilcoxon signed-ranks tests to determine if the baseline and outcome results differed for outcomes. Baseline scores improved after 6 weeks (ps = .02 and. 005 for QuickSIN and HHIE-S) for speech-in-noise performance and self-perceived hearing difficulties. REARs from 500 to 4000 Hz measured after 6 weeks did not differ from baseline (ps = .612 and .398 for the right and left ears), suggesting no significant deviation from prescriptive targets because of remote fitting adjustments. All participants reported improvement in COSI goals after the intervention. TAQ results suggested that comfort with telehealth improved after attending Internet-based appointments (p = .005). VSQ-9 results revealed no differences in reported patient satisfaction between in-person and Internet-based appointments.ConclusionsWe were able to develop a feasible hybrid audiology service delivery model for older adults. Our results enhance the evidence base for the implementation of telehealth audiology services.
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Project description:Justifying sample size for a pilot trial is a reporting requirement, but few pilot trials report a clear rationale for their chosen sample size. Unlike full-scale trials, pilot trials should not be designed to test effectiveness, and so, conventional sample size justification approaches do not apply. Rather, pilot trials typically specify a range of primary and secondary feasibility objectives. Often, these objectives relate to estimation of parameters that inform the sample size justification for the full-scale trial, many of which are binary. These binary outcomes are referred to as "feasibility outcomes" and include expected prevalence of the primary trial outcome, primary outcome availability, or recruitment or retention proportions.For pilot cluster trials, sample size calculations depend on the number of clusters, the cluster sizes, the anticipated intra-cluster correlation coefficient for the feasibility outcome and the anticipated proportion for that outcome. Of key importance is the intra-cluster correlation coefficient for the feasibility outcome. It has been suggested that correlations for feasibility outcomes are larger than for clinical outcomes measuring effectiveness. Yet, there is a dearth of information on realised values for these correlations.In this tutorial, we demonstrate how to justify sample size in external pilot cluster trials where the objective is to estimate a binary feasibility outcome. We provide sample size calculation formulae for a variety of scenarios, make available an R Shiny app for implementation, and compile a report of intra-cluster correlations for feasibility outcomes from a convenience sample. We demonstrate that unless correlations are very low, external pilot cluster trials can be made more efficient by including more clusters and fewer observations per cluster.
| S-EPMC10507981 | biostudies-literature
Project description:Aims and methodPatient and public involvement (PPI) is a priority for health research. PPI improves the relevance and quality of research. The study aimed to involve service users in identifying research priorities for the service. A two-phase adapted Delphi technique was used to generate a list of research topics from service users in secure in-patient mental health settings and on specialist mental health prison wings. Topic content analysis was undertaken. Service users were further consulted, and research themes were ranked in order of priority.ResultsOf the eight research themes identified, the three given the highest priority by service users were, in descending order, physical health, future plans and moving on, and causes of illness and crime.Clinical implicationsService users are willing to be involved in setting research priorities for mental health services. Through non-tokenistic PPI, service users can uniquely shape the research agenda of mental health services.
| S-EPMC8727379 | biostudies-literature
Project description:IntroductionRandomised controlled trials (RCTs) with a placebo comparator are considered the gold standard study design when evaluating healthcare interventions. These are challenging to design and deliver in surgery. Guidance recommends pilot and feasibility work to optimise main trial design and conduct; however, the extent to which this occurs in surgery is unknown.MethodA systematic review identified randomised placebo-controlled surgical trials. Articles published from database inception to 31 December 2020 were retrieved from Ovid-MEDLINE, Ovid-EMBASE and CENTRAL electronic databases, hand-searching and expert knowledge. Pilot/feasibility work conducted prior to the RCTs was then identified from examining citations and reference lists. Where studies explicitly stated their intent to inform the design and/or conduct of the future main placebo-controlled surgical trial, they were included. Publication type, clinical area, treatment intervention, number of centres, sample size, comparators, aims and text about the invasive placebo intervention were extracted.ResultsFrom 131 placebo surgical RCTs included in the systematic review, 47 potentially eligible pilot/feasibility studies were identified. Of these, four were included as true pilot/feasibility work. Three were original articles, one a conference abstract; three were conducted in orthopaedic surgery and one in oral and maxillofacial surgery. All four included pilot RCTs, with an invasive surgical placebo intervention, randomising 9-49 participants in 1 or 2 centres. They explored the acceptability of recruitment and the invasive placebo intervention to patients and trial personnel, and whether blinding was possible. One study examined the characteristics of the proposed invasive placebo intervention using in-depth interviews.ConclusionPublished studies reporting feasibility/pilot work undertaken to inform main placebo surgical trials are scarce. In view of the difficulties of undertaking placebo surgical trials, it is recommended that pilot/feasibility studies are conducted, and more are reported to share key findings and optimise the design of main RCTs.Prospero registration numberCRD42021287371.
| S-EPMC10660967 | biostudies-literature