To RCT or not to RCT? The ongoing saga of randomised trials in quality improvement

Parry, Gareth; Power, Maxine

doi:10.1136/bmjqs-2015-004862

Cited by 18 publications

(12 citation statements)

References 14 publications

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“…In updating the evidence base to incorporate the more recent advances in the context and QI literature—a rapidly developing field—this review also offers potential to take forward one of the conclusions of the recent Health Foundation review of the evidence for context which states: ‘The evidence base for intervening to modify contextual factors in order to positively impact on the outcomes of quality improvement interventions is currently very weak.’ [ 17 ]. This is a particularly important issue given that many QI approaches currently do not address contextual factors ‘up-front’ [ 38 ], instead making adaptations during later stages of the improvement cycle; considering context in advance would facilitate the scale and spread of improvement.…”

Section: Introductionmentioning

confidence: 99%

The influence of contextual factors on healthcare quality improvement initiatives: what works, for whom and in what setting? Protocol for a realist review

et al. 2017

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BackgroundContext shapes the effectiveness of knowledge implementation and influences health improvement. Successful healthcare quality improvement (QI) initiatives frequently fail to transfer to different settings, with local contextual factors often cited as the cause. Understanding and overcoming contextual barriers is therefore crucial to implementing effective improvement; yet context is still poorly understood. There is a paucity of information on the mechanisms underlying how and why QI projects succeed or fail in given settings. A realist review of empirical studies of healthcare QI initiatives will be undertaken to examine the influence and impact of contextual factors on quality improvement in healthcare settings and explore whether QI initiatives can work in all contexts.MethodsThe review will explore which contextual factors are important, and how, why, when and for whom they are important, within varied settings. The dynamic nature of context and change over time will be explored by examining which aspects of context impact at key points in the improvement trajectory. The review will also consider the influence of context on improvement outcomes (provider- and patient-level), spread and sustainability. The review process will follow five iterative steps: (1) clarify scope, (2) search for evidence, (3) appraise primary studies and extract data, (4) synthesise evidence and draw conclusions and (5) disseminate findings. The reviewers will consult with experts and stakeholders in the early stages to focus the review and develop a programme theory consisting of explanatory ‘context–mechanism–outcome’ configurations. Searches for primary evidence will be conducted iteratively. Data will be extracted and tested against the programme theory. A review advisory group will oversee the review process. Review findings will follow RAMESES guidelines and will be disseminated via a report, presentations and peer-reviewed publications.DiscussionThe review will update and consolidate evidence on the contextual conditions for effective improvement and distil new knowledge to inform the design and development of context-sensitive QI initiatives. This review ties in with the study of improvement programmes as vehicles of change and the development of an evidence base around healthcare improvement by addressing whether QI initiatives can work in all contexts.Systematic review registrationPROSPERO CRD42017062135

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Section: Introductionmentioning

confidence: 99%

The influence of contextual factors on healthcare quality improvement initiatives: what works, for whom and in what setting? Protocol for a realist review

et al. 2017

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“…Another approach incorporates impact evaluations designs -in particular experimental trial designs -into implementation research to enhance its rigor (Patsopoulos 2011;Hemming et al 2015). A third approach applies a greater use of implementation research elements in impact evaluations to better capture the heterogeneity of the real world in evaluations and bolster the relevance of evaluation findings for diverse decision makers (Habicht et al 1999;Kalibala et al 2016;Parry and Power 2016;Geng et al 2017).…”

Section: Integrating Impact Evaluation and Implementation Researchmentioning

confidence: 99%

Integrating impact evaluation and implementation research to accelerate evidence-informed action

Rutenberg¹,

researcher²,

Heard³

2018

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The International Initiative for Impact Evaluation (3ie) promotes evidence-informed equitable, inclusive and sustainable development. We support the generation and effective use of highquality evidence to inform decision-making and improve the lives of people living in poverty in low-and middle-income countries. We provide guidance and support to produce, synthesise and quality assure evidence of what works, for whom, how, why and at what cost. 3ie working papersThese papers cover a range of content. They may focus on current issues, debates and enduring challenges facing development policymakers, program managers, practitioners, and the impact evaluation and systematic review communities. Policy-relevant papers in this series synthesise or draw on relevant findings from mixed-method impact evaluations and systematic reviews funded by 3ie, as well as other rigorous evidence to offer new analyses, findings, insights and recommendations. Papers focusing on methods and technical guides also draw on similar sources to help advance understanding, design, and use of rigorous and appropriate evaluations and reviews. 3ie also uses this series to publish lessons learned from 3ie grant-making. About this working paperThis paper, Integrating impact evaluation and implementation research to accelerate evidenceinformed action, responds to a growing interest in implementation science and faster, less expensive evaluations that provide more timely and relevant information than large cluster randomized controlled trials. Implementation science was originally defined in the health sector but is now being applied in other sectors to address implementation-related questions.

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“…131,222 There is no standard way to develop complex interventions. 223 We did not use formal consensus methods that, in any case, may not be important until finalising an intervention's specifications.…”

Section: Development and Implementation Of The Interventionmentioning

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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To RCT or not to RCT? The ongoing saga of randomised trials in quality improvement

Cited by 18 publications

References 14 publications

The influence of contextual factors on healthcare quality improvement initiatives: what works, for whom and in what setting? Protocol for a realist review

The influence of contextual factors on healthcare quality improvement initiatives: what works, for whom and in what setting? Protocol for a realist review

Integrating impact evaluation and implementation research to accelerate evidence-informed action

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

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