Maximising the impact of qualitative research in feasibility studies for randomised controlled trials: guidance for researchers

O’Cathain, Alicia; Hoddinott, Pat; Lewin, Simon; Thomas, Kate; Young, Bridget; Adamson, Joy; Jansen, Yvonne; Mills, Nicola; Moore, Graham; Donovan, Jennifer L.

doi:10.1186/s40814-015-0026-y

Cited by 268 publications

(280 citation statements)

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“…The amount of qualitative work conducted at the pilot and feasibility stage, its relation with any pilot trial, and the way investigators want to report this work, varies. Stand-alone qualitative studies that are reported separately from the pilot trial, such as Hoddinott et al and Schoultz et al [22, 23] should follow appropriate reporting guidelines [24–26] and should provide link references to other pilot work carried out in preparation for the same definitive trial. When qualitative work is reported within the primary report of a pilot trial [27], it is not always possible to put sufficient detail into the methods section of the report to comply with reporting guidelines for qualitative studies.…”

Section: Scope Of This Papermentioning

confidence: 99%

See 1 more Smart Citation

CONSORT 2010 statement: extension to randomised pilot and feasibility trials

Eldridge

Chan

Campbell

et al. 2016

Pilot Feasibility Stud

1,645

1,227

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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.Electronic supplementary materialThe online version of this article (doi:10.1186/s40814-016-0105-8) contains supplementary material, which is available to authorized users.

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Section: Scope Of This Papermentioning

confidence: 99%

“…If this is the case, we recommend an online supplement or appendix to report the methods in detail. O’Cathain et al, Hoddinott et al, and Schoultz et al have provided guidelines and examples for conducting qualitative feasibility studies alongside pilot trials [22, 23, 26, 28, 29]. …”

Section: Scope Of This Papermentioning

confidence: 99%

CONSORT 2010 statement: extension to randomised pilot and feasibility trials

Eldridge

Chan

Campbell

et al. 2016

Pilot Feasibility Stud

1,645

1,227

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“…Rationale and worldview 118 /epistemology 119 We employed qualitative research to help understand the implementation of, and response to, the interventions and research protocols, [120][121][122] thereby better understanding causal pathways to their success or failure. [120][121][122][123] The pragmatic rationale 124 was to provide a basis for 'organising future observations and 126 of future decisions, rather than to advance, build or test social science theory.…”

Section: Theoretical and Thematic Frameworkmentioning

confidence: 99%

“…[120][121][122][123] The pragmatic rationale 124 was to provide a basis for 'organising future observations and 126 of future decisions, rather than to advance, build or test social science theory. 123,127 Research design, 118 methodology 119 and approach 128 The qualitative research had a multiple case design 129 with the unit of analysis variably at the participant level and at the level of the two experimental intervention programmes (n = 11 staff interviews).…”

Section: Theoretical and Thematic Frameworkmentioning

confidence: 99%

The feasibility of early pulmonary rehabilitation and activity after COPD exacerbations: external pilot randomised controlled trial, qualitative case study and exploratory economic evaluation

Cox

O’Connor

Biggs

et al. 2018

Health Technol Assess

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BackgroundChronic obstructive pulmonary disease (COPD) affects > 3 million people in the UK. Acute exacerbations of COPD (AECOPD) are the second most common reason for emergency hospital admission in the UK. Pulmonary rehabilitation is usual care for stable COPD but there is little evidence for early pulmonary rehabilitation (EPR) following AECOPD, either in hospital or immediately post discharge.ObjectiveTo assess the feasibility of recruiting patients, collecting data and delivering EPR to patients with AECOPD to evaluate EPR compared with usual care.DesignParallel-group, pilot 2 × 2 factorial randomised trial with nested qualitative research and an economic analysis.SettingTwo acute hospital NHS trusts. Recruitment was carried out from September 2015 to April 2016 and follow-up was completed in July 2016.ParticipantsEligible patients were those aged ≥ 35 years who were admitted with AECOPD, who were non-acidotic and who maintained their blood oxygen saturation level (SpO2) within a prescribed range. Exclusions included the presence of comorbidities that affected the ability to undertake the interventions.Interventions(1) Hospital EPR: muscle training delivered at the patient’s hospital bed using a cycle ergometer and (2) home EPR: a pulmonary rehabilitation programme delivered in the patient’s home. Both interventions were delivered by trained physiotherapists. Participants were allocated on a 1 : 1 : 1 : 1 ratio to (1) hospital EPR (n = 14), (2) home EPR (n = 15), (3) hospital EPR and home EPR (n = 14) and (4) control (n = 15). Outcome assessors were blind to treatment allocation; it was not possible to blind patients.Main outcome measuresFeasibility of recruiting 76 participants in 7 months at two centres; intervention delivery; views on intervention/research acceptability; clinical outcomes including the 6-minute walk distance (6WMD); and costs. Semistructured interviews with participants (n = 27) and research health professionals (n = 11), optimisation assessments and an economic analysis were also undertaken.ResultsOver 7 months 449 patients were screened, of whom most were not eligible for the trial or felt too ill/declined entry. In total, 58 participants (76%) of the target 76 participants were recruited to the trial. The primary clinical outcome (6MWD) was difficult to collect (hospital EPR,n = 5; home EPR,n = 6; hospital EPR and home EPR,n = 5; control,n = 5). Hospital EPR was difficult to deliver over 5 days because of patient discharge/staff availability, with 34.1% of the scheduled sessions delivered compared with 78.3% of the home EPR sessions. Serious adverse events were experienced by 26 participants (45%), none of which was related to the interventions. Interviewed participants generally found both interventions to be acceptable. Home EPR had a higher rate of acceptability, mainly because patients felt too unwell when in hospital to undergo hospital EPR. Physiotherapists generally found the interventions to be acceptable and valued them but found delivery difficult because of staffing issues. The health economic analysis results suggest that there would be value in conducting a larger trial to assess the cost-effectiveness of the hospital EPR and hospital EPR plus home EPR trial arms and collect more information to inform the hospital cost and quality-adjusted life-year parameters, which were shown to be key drivers of the model.ConclusionsA full-scale randomised controlled trial using this protocol would not be feasible. Recruitment and delivery of the hospital EPR intervention was difficult. The data obtained can be used to design a full-scale trial of home EPR. Because of the small sample and large confidence intervals, this study should not be used to inform clinical practice.Trial registrationCurrent Controlled Trials ISRCTN18634494.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 22, No. 11. See the NIHR Journals Library website for further project information.

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“…[152][153][154] Qualitative methods also enable research teams to capture how an intervention is implemented and experienced, thereby enabling better understanding of causal pathways. 131 …”

Section: Rationalementioning

confidence: 99%

Aquatic therapy for children with Duchenne muscular dystrophy: a pilot feasibility randomised controlled trial and mixed-methods process evaluation

Hind

Parkin

Whitworth

et al. 2017

Health Technol Assess

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BackgroundDuchenne muscular dystrophy (DMD) is a rare disease that causes the progressive loss of motor abilities such as walking. Standard treatment includes physiotherapy. No trial has evaluated whether or not adding aquatic therapy (AT) to land-based therapy (LBT) exercises helps to keep muscles strong and children independent.ObjectivesTo assess the feasibility of recruiting boys with DMD to a randomised trial evaluating AT (primary objective) and to collect data from them; to assess how, and how well, the intervention and trial procedures work.DesignParallel-group, single-blind, randomised pilot trial with nested qualitative research.SettingSix paediatric neuromuscular units.ParticipantsChildren with DMD aged 7–16 years, established on corticosteroids, with a North Star Ambulatory Assessment (NSAA) score of 8–34 and able to complete a 10-m walk without aids/assistance. Exclusions: > 20% variation between baseline screens 4 weeks apart and contraindications.InterventionsParticipants were allocated on a 1 : 1 ratio to (1) optimised, manualised LBT (prescribed by specialist neuromuscular physiotherapists) or (2) the same plus manualised AT (30 minutes, twice weekly for 6 months: active assisted and/or passive stretching regime; simulated or real functional activities; submaximal exercise). Semistructured interviews with participants, parents (n = 8) and professionals (n = 8) were analysed using Framework analysis. An independent rater reviewed patient records to determine the extent to which treatment was optimised. A cost-impact analysis was performed. Quantitative and qualitative data were mixed using a triangulation exercise.Main outcome measuresFeasibility of recruiting 40 participants in 6 months, participant and therapist views on the acceptability of the intervention and research protocols, clinical outcomes including NSAA, independent assessment of treatment optimisation and intervention costs.ResultsOver 6 months, 348 children were screened – most lived too far from centres or were enrolled in other trials. Twelve (30% of target) were randomised to AT (n = 8) or control (n = 4). People in the AT (n = 8) and control (n = 2: attrition because of parental report) arms contributed outcome data. The mean change in NSAA score at 6 months was –5.5 [standard deviation (SD) 7.8] for LBT and –2.8 (SD 4.1) in the AT arm. One boy suffered pain and fatigue after AT, which resolved the same day. Physiotherapists and parents valued AT and believed that it should be delivered in community settings. The independent rater considered AT optimised for three out of eight children, with other children given programmes that were too extensive and insufficiently focused. The estimated NHS costs of 6-month service were between £1970 and £2734 per patient.LimitationsThe focus on delivery in hospitals limits generalisability.ConclusionsNeither a full-scale frequentist randomised controlled trial (RCT) recruiting in the UK alone nor a twice-weekly open-ended AT course delivered at tertiary centres is feasible. Further intervention development research is needed to identify how community-based pools can be accessed, and how families can link with each other and community physiotherapists to access tailored AT programmes guided by highly specialised physiotherapists. Bayesian RCTs may be feasible; otherwise, time series designs are recommended.Trial registrationCurrent Controlled Trials ISRCTN41002956.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 21, No. 27. See the NIHR Journals Library website for further project information.

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Maximising the impact of qualitative research in feasibility studies for randomised controlled trials: guidance for researchers

Cited by 268 publications

References 47 publications

CONSORT 2010 statement: extension to randomised pilot and feasibility trials

CONSORT 2010 statement: extension to randomised pilot and feasibility trials

The feasibility of early pulmonary rehabilitation and activity after COPD exacerbations: external pilot randomised controlled trial, qualitative case study and exploratory economic evaluation

Aquatic therapy for children with Duchenne muscular dystrophy: a pilot feasibility randomised controlled trial and mixed-methods process evaluation

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