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Article ; Online: Determining external randomised pilot trial feasibility in preparation for a definitive trial

Katie Mellor / Susan J. Dutton / Sally Hopewell

Trials, Vol 24, Iss 1, Pp 1-

a web-based survey of corresponding authors of external pilot trial publications

2023 Volume 11

Abstract: Abstract Background External randomised pilot trials aim to determine whether a future definitive randomised controlled trial (RCT) should be conducted, and if so, how. However, not every pilot trial that suggests that a definitive trial will be feasible ...

Abstract	Abstract Background External randomised pilot trials aim to determine whether a future definitive randomised controlled trial (RCT) should be conducted, and if so, how. However, not every pilot trial that suggests that a definitive trial will be feasible will progress to a definitive study. In this study, we surveyed corresponding authors of external randomised pilot trial publications to assess pilot trial outcomes in terms of feasibility and progression. Methods Web-based surveys were sent to corresponding authors of external randomised pilot trial publications, open for four weeks between January and February 2022. Four surveys were produced depending on whether the corresponding author had published a trial protocol or results publication, and whether progression criteria were reported. Surveys asked whether a future RCT was considered feasible, whether progression criteria were met (if applicable), what other factors informed the assessment of pilot trial feasibility, and whether the pilot trial has progressed to further research. Data was analysed using descriptive statistics and conventional content analysis. Results 98 of 276 corresponding authors completed the survey (average response rate of 36% across all surveys). Of these, 89 respondents indicated that their trial had completed. Ninety per cent of respondents who were corresponding authors of completed pilot trials stated that their pilot trial was either feasible (42/89, 47%) or feasible with changes to the trial design (38/89, 43%), yet only 66% (59/89) reported the intention to conduct a future definitive trial. Availability of funding for a future definitive trial and changing priorities of the Chief Investigator were the most common barriers to progression identified. Qualitative research findings was the most frequent factor considered both by corresponding authors who reported and who did not report progression criteria when determining trial feasibility. Conclusions Just under one quarter (21/89, 24%) of respondents who considered their ...
Keywords	Pilot trials ; Randomised controlled trials ; Feasibility studies ; Progression criteria ; Medicine (General) ; R5-920
Subject code	310
Language	English
Publishing date	2023-01-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: How are progression decisions made following external randomised pilot trials? A qualitative interview study and framework analysis

Katie Mellor / Susan J. Dutton / Sally Hopewell / Charlotte Albury

Trials, Vol 23, Iss 1, Pp 1-

2022 Volume 15

Abstract: Abstract Background External randomised pilot trials help researchers decide whether, and how, to do a future definitive randomised trial. The progression criteria are often prespecified to inform the interpretation of pilot trial findings and subsequent ...

Abstract	Abstract Background External randomised pilot trials help researchers decide whether, and how, to do a future definitive randomised trial. The progression criteria are often prespecified to inform the interpretation of pilot trial findings and subsequent progression decision-making. We aimed to explore and understand the perspectives and experiences of key stakeholders when making progression decisions following external pilot trials. Methods Thirty-five remote semi-structured interviews with external randomised pilot trial team members including chief investigators, trial managers, statisticians and patient and public involvement (PPI) representatives. Questions focussed on experiences and perceptions of pilot trial progression decisions and whether and how progression criteria informed this decision. Data were analysed using the framework method approach to thematic analysis. Strategies to ensure trustworthiness and rigour were used. Results Interviews were conducted between December 2020 and July 2021. Six descriptive themes were developed to capture the experiences and perspectives of participants. These were (1) divided opinions on the value and development of progression criteria, (2) (avoiding) the potential for personal interest to influence progression criteria and progression decision-making, (3) stakeholder engagement in setting progression criteria and making progression decisions, (4) lessons learned from doing the pilot trial and their impact on progression criteria applicability, (5) other factors that inform the progression decision and (6) progression of external randomised pilot trials—funding considerations and constraints. These themes were underpinned by an overarching interpretative theme ‘a one-size approach to progression does not fit all’ to describe the highly nuanced and complex decision-making process that occurs following external randomised pilot trials. The progression criteria are rarely the only consideration informing the decision to progress to future research; unanticipated events, signals of efficacy and continuity of the research team are other factors that researchers consider. Conclusions One size does not fit all when it comes to the progression criteria and pilot trial progression. The progression criteria are only one of many considerations researchers have when deciding whether a pilot trial is feasible. External pilot trial progression is not guaranteed even when a pilot trial is considered feasible (based on the progression criteria and/or other considerations), indicating inefficiency and potential research waste. Trial registration Open Science Framework osf.io/5N2KZ
Keywords	Qualitative research ; Pilot trials ; Randomised controlled trials ; Feasibility studies ; Progression criteria ; Medicine (General) ; R5-920
Subject code	306
Language	English
Publishing date	2022-02-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Recommendations for progression criteria during external randomised pilot trial design, conduct, analysis and reporting

Katie Mellor / Charlotte Albury / Susan J Dutton / Sandra Eldridge / Sally Hopewell

Pilot and Feasibility Studies, Vol 9, Iss 1, Pp 1-

2023 Volume 10

Abstract: Abstract Background External randomised pilot trials aim to assess whether a future definitive Randomised Controlled Trial (RCT) is feasible. Prespecified progression criteria help guide the interpretation of pilot trial findings to decide whether, and ... ...

Abstract	Abstract Background External randomised pilot trials aim to assess whether a future definitive Randomised Controlled Trial (RCT) is feasible. Prespecified progression criteria help guide the interpretation of pilot trial findings to decide whether, and how, a definitive RCT should be conducted. This commentary presents a set of proposed recommendations for progression criteria to guide researchers when (i) designing, (ii) conducting, (iii) analysing and (iv) reporting external randomised pilot trials. Methods Recommendations were developed following a mixed methods approach. This involved (i) a methodological review of pilot trial publications, (ii) a cross-sectional study of pilot trial research funding applications, (iii) qualitative interviews with pilot trial researchers and (iv) a survey of corresponding authors of identified pilot trial publications. Initial recommendations were refined following two consultation stakeholder workshops held in July 2022. Recommendations for progression criteria for external randomised pilot trials: i. Design: consider progression criteria from the earliest opportunity; map progression criteria to feasibility objectives; consider quantitative and qualitative interpretations of feasibility; provide justification; develop guidelines rather than rules; seek input from relevant stakeholders. ii. Conduct: regularly monitor pilot trial data against progression criteria. iii. Analysis: avoid considering each progression criterion in isolation; engage in discussion with relevant stakeholders; consider context and other factors external to the pilot trial; consider feasibility (can we?) and progression (will we?). iv. Reporting: we propose a reporting checklist in relation to progression criteria and recommend reporting in a table format for clarity. Conclusion These recommendations provide a helpful resource for researchers to consider progression criteria at different stages of external randomised pilot trials. We have produced a simple infographic tool to summarise these ...
Keywords	Pilot ; Feasibility ; PAFS ; Progression criteria ; Recommendations ; Medicine (General) ; R5-920
Language	English
Publishing date	2023-04-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Inclusion of progression criteria in external randomised pilot trials

Katie Mellor / James Harwood / Jennie Hejdenberg / Ben Morgan / Susan J. Dutton / Sally Hopewell

Trials, Vol 23, Iss 1, Pp 1-

a cross-sectional study of funding applications submitted to the NIHR Research for Patient Benefit Programme

2022 Volume 11

Abstract: Abstract Background External randomised pilot trials aim to assess whether a future definitive randomised controlled trial (RCT) is feasible. Pre-specified progression criteria help guide the interpretation of pilot trial findings to decide whether, and ... ...

Abstract	Abstract Background External randomised pilot trials aim to assess whether a future definitive randomised controlled trial (RCT) is feasible. Pre-specified progression criteria help guide the interpretation of pilot trial findings to decide whether, and how, a definitive trial should be conducted. We aimed to examine how researchers report and plan to assess progression criteria in external pilot trial funding applications submitted to the NIHR Research for Patient Benefit Programme. Methods We conducted a cross-sectional study of progression criteria inclusion in Stage 1 (outline) and corresponding Stage 2 (full) funding applications for external randomised external pilot trials submitted to NIHR RfPB between July 2017 and July 2019. Results Of the 100 Stage 1 outline applications assessed, 95 were eligible for inclusion (of these, 52 were invited to Stage 2 full application; 43 were rejected) and 49/52 were eligible for inclusion at Stage 2 full application (of these, 35 were awarded funding; 14 were rejected). Over half of applications assessed at Stage 1 (48/95, 51%), and 73% of those assessed at Stage 2 (36/49) included progression criteria in their research plans. Progression criteria were most often reported in a stop-go format, often with additional specified factors that should be considered when determining feasibility (Stage 1 33/48, 69%; Stage 2 21/36, 58%). Recruitment and retention were the most frequent indicators of feasibility to inform progression criteria. One-third of applications provided some justification or rationale for their targets (Stage 1 16/48, 33%; Stage 2 12/36, 33%). Funding committee feedback mentioned progression criteria in over 20% of applications (Stage 1 22/95, 23%; Stage 2 11/49, 22%) to either request the addition of progression criteria or provide justification for the criteria stipulated. Conclusions Our findings indicate that researchers do not always include progression criteria in external randomised pilot trial applications submitted to research funders. This can ...
Keywords	Pilot trials ; Randomised controlled trials ; Feasibility studies ; Progression criteria ; Medicine (General) ; R5-920
Language	English
Publishing date	2022-11-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Correction to

Mandy Maredza / Kamran Khan / Ioana R. Marian / Susan J. Dutton / Esther Williamson / Sarah E. Lamb / Stavros Petrou

Cost Effectiveness and Resource Allocation, Vol 21, Iss 1, Pp 1-

Economic costs, health-related quality of life outcomes and cost-utility of a physical and psychological group intervention targeted at older adults with neurogenic claudication

2023 Volume 1

Keywords	Medicine (General) ; R5-920
Language	English
Publishing date	2023-04-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Economic costs, health-related quality of life outcomes and cost-utility of a physical and psychological group intervention targeted at older adults with neurogenic claudication

Mandy Maredza / Kamran Khan / Ioana R. Marian / Susan J. Dutton / Esther Williamson / Sarah E. Lamb / Stavros Petrou

Cost Effectiveness and Resource Allocation, Vol 21, Iss 1, Pp 1-

2023 Volume 12

Abstract: Abstract Background Emerging evidence suggests that structured and progressive exercise underpinned by a cognitive behavioural approach can improve functional outcomes in patients with neurogenic claudication (NC). However, evidence surrounding its ... ...

Abstract	Abstract Background Emerging evidence suggests that structured and progressive exercise underpinned by a cognitive behavioural approach can improve functional outcomes in patients with neurogenic claudication (NC). However, evidence surrounding its economic benefits is lacking. Objectives To estimate the economic costs, health-related quality of life outcomes and cost-effectiveness of a physical and psychological group intervention (BOOST programme) versus best practice advice (BPA) in older adults with NC. Methods An economic evaluation was conducted based on data from a pragmatic, multicentre, superiority, randomised controlled trial. The base-case economic evaluation took the form of an intention-to-treat analysis conducted from a UK National Health Service (NHS) and personal social services (PSS) perspective and separately from a societal perspective. Costs (£ 2018–2019 prices) were collected prospectively over a 12 month follow-up period. A bivariate regression of costs and quality-adjusted life-years (QALYs), with multiple imputation of missing data, was conducted to estimate the incremental cost per QALY gained and the incremental net monetary benefit (INMB) of the BOOST programme in comparison to BPA. Sensitivity and pre-specified subgroup analyses explored uncertainty and heterogeneity in cost-effectiveness estimates. Results Participants (N = 435) were randomised to the BOOST programme (n = 292) or BPA (n = 143). Mean (standard error [SE]) NHS and PSS costs over 12 months were £1,974 (£118) in the BOOST arm versus £1,827 (£169) in the BPA arm (p = 0.474). Mean (SE) QALY estimates were 0.620 (0.009) versus 0.599 (0.006), respectively (p = 0.093). The probability that the BOOST programme is cost-effective ranged between 67 and 83% (NHS and PSS perspective) and 79–89% (societal perspective) at cost-effectiveness thresholds between £15,000 and £30,000 per QALY gained. INMBs ranged between £145 and £464 at similar cost-effectiveness thresholds. The cost-effectiveness results remained robust to sensitivity ...
Keywords	Economic costs ; Health-related quality of life ; Cost-effectiveness ; Spinal stenosis ; Neurogenic claudication ; Rehabilitation ; Medicine (General) ; R5-920
Subject code	360
Language	English
Publishing date	2023-02-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Cast versus functional brace in the rehabilitation of patients with a rupture of the Achilles tendon

Ioana R. Marian / Matthew L. Costa / Susan J. Dutton

Trials, Vol 20, Iss 1, Pp 1-

statistical analysis plan for the UK study of tendo Achilles rehabilitation (UK STAR) multi-centre randomised controlled trial

2019 Volume 7

Abstract: Abstract Background The incidence of Achilles tendon rupture in the UK is increasing and the best rehabilitation strategy for patients treated non-operatively remains unclear. We describe a statistical analysis plan (SAP) for the UK study of tendo ... ...

Abstract	Abstract Background The incidence of Achilles tendon rupture in the UK is increasing and the best rehabilitation strategy for patients treated non-operatively remains unclear. We describe a statistical analysis plan (SAP) for the UK study of tendo Achilles rehabilitation (UK STAR) multi-centre randomised trial. Methods/design UK STAR is a 1:1, multi-centre, parallel, two-arm, superiority randomised controlled trial. This study aims to evaluate the use of functional bracing compared to plaster cast for the management of acute Achilles tendon rupture in adult patients treated non-operatively. The primary outcome is the Achilles Tendon Rupture Score measured at 9 months after injury and will be estimated based on a linear mixed effects regression model adjusted for the stratification factor (centre) and other key prognostic variables. Secondary outcomes include complications, quality of life and resource use evaluated at 8 weeks and at 3, 6 and 9 months after the injury. Missing data will be summarised and reported by treatment arm. Full details of the planned analysis methods are described in this paper. Further study design details are published in the UK STAR protocol. Discussion The planned statistical analyses for UK STAR aim to reduce the risk of outcome reporting bias arising from prior data knowledge. Any changes or deviations from the current SAP will be described and justified in the final study report. Trial registration International Standard Randomised Controlled Trial Number Registry, ISRCTN62639639. Registered on 22 June 2016.
Keywords	Rehabilitation ; Achilles tendon ; Rupture ; Statistical analysis plan ; Randomised controlled trial ; Medicine (General) ; R5-920
Subject code	310
Language	English
Publishing date	2019-05-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Tailored exercise management (TEMPO) versus usual care for people aged 80 years or older with hip/knee osteoarthritis

Philippa J. A. Nicolson / Melanie A. Holden / Ioana R. Marian / Esther Williamson / Susan J. Dutton / Angela Garrett / Sally Hopewell / Sarah E. Lamb

Pilot and Feasibility Studies, Vol 9, Iss 1, Pp 1-

study protocol for a feasibility randomised controlled trial

2023 Volume 13

Abstract: Abstract Background Exercise is recommended for all people with osteoarthritis. However, these recommendations are based on randomised clinical trials including people with an average age between 60 and 70 years, and these findings cannot reliably be ... ...

Abstract	Abstract Background Exercise is recommended for all people with osteoarthritis. However, these recommendations are based on randomised clinical trials including people with an average age between 60 and 70 years, and these findings cannot reliably be generalised to people aged 80 years or older. Rapid loss of muscle occurs after 70 years of age, and older people are more likely to also have other health conditions that contribute to difficulties with daily activities and impact on their response to exercise. To improve care for people aged 80 or older with osteoarthritis, it is thought that a tailored exercise intervention targeting both osteoarthritis and any other health conditions they have, may be needed. The aim of this study will be to test if it is possible to conduct a randomised controlled trial (RCT) for people over 80 years of age with hip/knee osteoarthritis of a tailored exercise intervention. Methods A multicentre, parallel, 2-group, feasibility RCT with embedded qualitative study, conducted in ≥ 3 UK NHS physiotherapy outpatient services. Participants (n ≥ 50) with clinical knee and/or hip osteoarthritis and ≥ 1 comorbidity will be recruited by screening referrals to participating NHS physiotherapy outpatient services, via screening of general practice records and via identification of eligible individuals from a cohort study run by our research group. Participants will be randomised (computer-generated: 1:1) to receive either: a 12-week education and tailored exercise intervention (TEMPO); or usual care and written information. The primary feasibility objectives are to estimate: (1) ability to screen and recruit eligible participants; (2) retention of participants, measured by the proportion of participants who provide outcome data at 14-week follow-up. Secondary quantitative objectives are to estimate: (1) participant engagement assessed by physiotherapy session attendance and home exercise adherence; (2) sample size calculation for a definitive RCT. One-to-one semi-structured interviews will ...
Keywords	Over 80-year-olds ; Osteoarthritis ; Comorbidities ; Exercise ; Rehabilitation ; Adherence ; Medicine (General) ; R5-920
Subject code	796
Language	English
Publishing date	2023-04-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Better Outcomes for Older people with Spinal Trouble (BOOST) trial

Ioana R. Marian / Esther Williamson / Angela Garrett / Sarah E. Lamb / Susan J. Dutton

Trials, Vol 21, Iss 1, Pp 1-

statistical analysis plan for a randomised controlled trial of a combined physical and psychological intervention for older adults with neurogenic claudication

2020 Volume 12

Abstract: Abstract Background Neurogenic claudication is a common spinal condition affecting older adults that has a major effect on mobility and implicitly independence. The effectiveness of conservative interventions in this population is not known. We describe ... ...

Abstract	Abstract Background Neurogenic claudication is a common spinal condition affecting older adults that has a major effect on mobility and implicitly independence. The effectiveness of conservative interventions in this population is not known. We describe the statistical analysis plan for the Better Outcomes for Older people with Spinal trouble (BOOST) randomised controlled trial. Methods/design BOOST is a pragmatic, multicentre, parallel, two-arm, randomised controlled trial. Participants are community-dwelling adults, 65 years or older, with neurogenic claudication, registered prospectively, and randomised 2:1 (intervention to control) to the combined physical and psychological BOOST group physiotherapy programme or best practice advice. The primary outcome is the Oswestry Disability Index at 12 months. Secondary outcomes include the Short Physical Performance Battery, Swiss Spinal Stenosis Scale, 6 Minute Walk Test, Fear Avoidance Beliefs Questionnaire, and Tilburg Frailty Indicator. Outcomes are measured at 6 and 12 months by researchers blinded to treatment allocation. The primary statistical analysis is by intention to treat. Further study design details are published in the BOOST protocol. Discussion The planned statistical analyses for the BOOST trial aim to reduce the risk of outcome reporting bias from prior data knowledge. Any changes or deviations from this statistical analysis plan will be described and justified in the final study report. Trial registration This study has been registered in the International Standard Randomised Controlled Trial Number registry, reference number ISRCTN12698674 . Registered on 10 November 2015.
Keywords	Statistical analysis plan ; Randomised controlled trial ; Neurogenic claudication ; Lower back pain ; Medicine (General) ; R5-920
Subject code	796
Language	English
Publishing date	2020-07-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: COmmunity-based Rehabilitation after Knee Arthroplasty (CORKA)

Karan Vadher / Ruth Knight / Karen L. Barker / Susan J. Dutton

Trials, Vol 19, Iss 1, Pp 1-

statistical analysis plan for a randomised controlled trial

2018 Volume 7

Abstract: Abstract Background About 15% of patients fail to achieve a satisfactory clinical outcome following knee replacement, which may indicate the existing model of rehabilitation after surgery is possibly not the most efficacious. The COmmunity-based ... ...

Abstract	Abstract Background About 15% of patients fail to achieve a satisfactory clinical outcome following knee replacement, which may indicate the existing model of rehabilitation after surgery is possibly not the most efficacious. The COmmunity-based Rehabilitation after Knee Arthroplasty (CORKA) trial evaluates the effects of a new multi-component community-based rehabilitation programme following knee replacement compared with usual care. Methods/design The CORKA trial is a multi-centre, single-blind, two-arm randomised controlled trial. The primary outcome is the Late Life Function and Disability Instrument (LLFDI) overall function score measured at 12 months post-randomisation which will be analysed using a linear mixed effects model. Secondary outcomes are measured at 6 and 12 months post-randomisation and include the LLFDI frequency and limitation total dimension scores, the Oxford Knee Score, the Knee injury and Osteoarthritis Outcome Score quality of life subscale, the Physical Activity Scale for the Elderly, the EuroQol EQ-5D-5L, and several measurements of physical function. Full details of the planned analysis approaches for the primary and secondary outcomes are described here, as are the descriptive statistics which will be reported. This is an update to the CORKA protocol which has already been published in this journal. Discussion This paper provides details of the planned statistical analyses for this trial and will reduce the risks of outcome reporting bias and data-driven results. Trial registration ISRCTN registry, 13517704. Registered on 12 February 2015. Funding/sponsor The trial is funded by the National Institute for Health Research Health Technology Assessment programme under its commissioned research programme (HTA 12/196/08). The trial sponsor is the University of Oxford.
Keywords	Statistical analysis plan ; Randomised controlled trial ; Knee arthroplasty ; Physiotherapy ; Occupational therapy ; Rehabilitation ; Medicine (General) ; R5-920
Subject code	796
Language	English
Publishing date	2018-11-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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