Dataset Information

Understanding usual care in randomised controlled trials of complex interventions: A multi-method approach.

ABSTRACT:

Background

Evaluations of complex interventions compared to usual care provided in palliative care are increasing. Not describing usual care may affect the interpretation of an intervention's effectiveness, yet how it can be described remains unclear.

Aim

To demonstrate the feasibility of using multi-methods to describe usual care provided in randomised controlled trials (RCTs) of complex interventions, shown within a feasibility cluster RCT.

Design

Multi-method approach comprising usual care questionnaires, baseline case note review and focus groups with ward staff completed at study end. Thematic analysis of qualitative data, descriptive statistics of quantitative data, followed by methodological triangulation to appraise approach in relation to study aim.

Setting/participants

Four general medical wards chosen from UK hospitals. Purposive sampling of healthcare professionals for usual care questionnaires, and focus groups. Review of 20 patients' notes from each ward who died during admission or within 100?days of discharge.

Results

Twenty-three usual care questionnaires at baseline, two focus groups comprising 20 healthcare professionals and 80 case note reviews. Triangulation of findings resulted in understanding the usual care provided to the targeted population in terms of context, structures, processes and outcomes for patients, families and healthcare professionals. Usual care was described, highlighting (1) similarities and embedded practices, (2) heterogeneity and (3) subtle changes in care during the trial within and across sites.

Conclusions

We provide a feasible approach to defining usual care that can be practically adopted in different settings. Understanding usual care enhances the reliability of tested complex interventions, and informs research and policy priorities.

SUBMITTER: Yorganci E

PROVIDER: S-EPMC7238505 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

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Publications

Understanding usual care in randomised controlled trials of complex interventions: A multi-method approach.

Yorganci Emel E Evans Catherine J CJ Johnson Halle H Barclay Stephen S Murtagh Fliss Em FE Yi Deokhee D Gao Wei W Pickles Andrew A Koffman Jonathan J

Palliative medicine 20200221 5

<h4>Background</h4>Evaluations of complex interventions compared to usual care provided in palliative care are increasing. Not describing usual care may affect the interpretation of an intervention's effectiveness, yet how it can be described remains unclear.<h4>Aim</h4>To demonstrate the feasibility of using multi-methods to describe usual care provided in randomised controlled trials (RCTs) of complex interventions, shown within a feasibility cluster RCT.<h4>Design</h4>Multi-method approach co ...[more]

PMID: 32081088

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Project description:ObjectivesRecent evidence has highlighted the high prevalence and impact of multimorbidity, but the evidence base for improving management is limited. We have tested a new complex intervention for multimorbidity (the 3D model). The paper describes the baseline characteristics of practices and patients in order to establish the external validity of trial participants. It also explores current 'usual primary care' for multimorbidity, against which the 3D intervention was tested.DesignAnalysis of baseline data from patients in a cluster-randomised controlled trial and additional data from practice staff.SettingPrimary care in the UK.ParticipantsPatients with multimorbidity (n=5253) and 154 practice staff.Primary and secondary outcome measuresUsing surveys and routinely available data, we compared the characteristics of participating and non-participating practices and participating and non-participating eligible patients.Baseline questionnaire data from patient participants was used to examine participant illness burden, treatment burden and perceptions of receiving patient-centred care. We obtained data about usual care preintervention from practice staff using questionnaires and a structured pro forma.ResultsParticipating practices were slightly larger, in less deprived areas, and with slightly higher scores for patient satisfaction compared with non-participating practices. Patients with dementia or learning difficulties were likely to be excluded by their general practitioners, but comparison of participants with non-participants identified only minor differences in characteristics, suggesting that the sample was otherwise representative. Patients reported substantial illness burden, and an important minority reported high treatment burden. Although patients reported relatively high levels of satisfaction with care, many reported not having received potentially important components of care.ConclusionThis trial achieved good levels of external validity. Although patients were generally satisfied with primary care services, there was significant room for improvement in important aspects of care for multimorbidity that are targeted by the 3D intervention.Trial registration numberISRCTN06180958; Post-results.

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Project description:INTRODUCTION:The effectiveness of complex interventions for the management of musculoskeletal disorders has been estimated in many randomised clinical trials (RCTs). These trials inform which interventions are the most effective, however they do not always inform how an intervention achieved its clinical outcomes, nor how and what elements of an intervention were delivered to patients. Such information is useful for translating findings into clinical practice. A few process evaluation studies have been conducted alongside RCTs and a variety of methods have been used. To gain a better understanding of current practices of process evaluation in RCTs in musculoskeletal disorders, this systematic review is designed to answer the following research question: How are process evaluation of complex interventions tested in RCTs in musculoskeletal disorders being conducted? METHODS AND ANALYSIS:We will systematically search seven electronic databases (MEDLINE, SCOPUS, CINAHL, PsycINFO, EMBASE, Web of Science and Cochrane database) from the date of inception to August 2018 for studies on process evaluation of RCTs on non-surgical and non-pharmacological management of musculoskeletal disorders. We will include qualitative and quantitative studies conducted alongside RCTs, reported with the RCTs or separate studies that assessed interventions for musculoskeletal disorders. Two reviewers will screen abstracts and apply prespecified inclusion criteria to identify relevant studies, extract the data and assess the risk of bias within included studies. We will follow recommendations from the 'Cochrane Qualitative and Implementation Methods Group Guidance Series' when assessing methodological strengths and limitations of included studies. We will use a narrative synthesis to describe findings. ETHICS AND DISSEMINATION:Ethical approval is not required as this review will not collect original data. Findings from this systematic review will be presented at a scientific conference and published in a peer reviewed journal. PROSPERO REGISTRATION NUMBER:CRD42018109600.

Project description:BackgroundFor medical conditions with numerous interventions worthy of investigation, there are many advantages of a multi-arm multi-stage (MAMS) platform trial approach. However, there is currently limited knowledge on uptake of the MAMS design, especially in the late-phase setting. We sought to examine uptake and characteristics of late-phase MAMS platform trials, to enable better planning for teams considering future use of this approach.DesignWe examined uptake of registered, late-phase MAMS platforms in the EU clinical trials register, Australian New Zealand Clinical Trials Registry, International Standard Randomised Controlled Trial Number registry, Pan African Clinical Trials Registry, WHO International Clinical Trial Registry Platform and databases: PubMed, Medline, Cochrane Library, Global Health Library and EMBASE. Searching was performed and review data frozen on 1 April 2021. MAMS platforms were defined as requiring two or more comparison arms, with two or more trial stages, with an interim analysis allowing for stopping of recruitment to arms and typically the ability to add new intervention arms.Results62 late-phase clinical trials using an MAMS approach were included. Overall, the number of late-phase trials using the MAMS design has been increasing since 2001 and been accelerated by COVID-19. The majority of current MAMS platforms were either targeting infectious diseases (52%) or cancers (29%) and all identified trials were for treatment interventions. 89% (55/62) of MAMS platforms were evaluating medications, with 45% (28/62) of the MAMS platforms having at least one or more repurposed medication as a comparison arm.ConclusionsHistorically, late-phase trials have adhered to long-established standard (two-arm) designs. However, the number of late-phase MAMS platform trials is increasing, across a range of different disease areas. This study highlights the potential scope of MAMS platform trials and may assist research teams considering use of this approach in the late-phase randomised clinical trial setting.Prospero registration numberCRD42019153910.

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Dataset Information

Understanding usual care in randomised controlled trials of complex interventions: A multi-method approach.

Background

Aim

Design

Setting/participants

Results

Conclusions

Publications

Understanding usual care in randomised controlled trials of complex interventions: A multi-method approach.

Similar Datasets

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