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Qualitative research to inform hypothesis testing for fidelity-based sub-group analysis in clinical trials: lessons learnt from the process evaluation of a multifaceted podiatry intervention for falls prevention.

ABSTRACT: BACKGROUND:Ensuring fidelity to complex interventions is a challenge when conducting pragmatic randomised controlled trials. We explore fidelity through a qualitative process evaluation, which was conducted alongside a pragmatic, multicentre, two-arm cohort randomised controlled trial: the REFORM (Reducing Falls with Orthoses and a Multifaceted podiatry intervention) trial. The paper aims, through a qualitative process evaluation, to explore some of the factors that may have affected the delivery of the REFORM intervention and highlight how project-specific fidelity can be assessed using a truly mixed-methods approach when informed by qualitative insights. DESIGN:Semi-structured qualitative interviews carried out as part of a process evaluation. Interviews were analysed thematically. SETTING:Seven NHS trusts in the UK and a University podiatry school in Ireland. Interviews were undertaken face-to-face or over the telephone. PARTICIPANTS:Twenty-one REFORM trial participants and 14 podiatrists who delivered the REFORM intervention. RESULTS:Factors affecting fidelity included: how similar the intervention was to routine practice; the challenges of delivering a multifaceted intervention to a heterogeneous older population; and practical issues with delivery such as time and training. Trial participants' views of the intervention, whether falls prevention is a personal priority, their experience of being part of a trial and individual factors such as medical conditions may also have affected intervention fidelity. CONCLUSIONS:Our process evaluation highlighted factors that were perceived to have affected the fidelity of the REFORM intervention and in doing so demonstrates the importance of considering fidelity when designing and evaluating pragmatic trials. We propose a number of recommendations of how important project-specific insights from qualitative work can be incorporated into the design of fidelity measurement of future trials, which build on existing conceptual fidelity frameworks. In particular, we encourage adopting a mixed-methods approach whereby qualitative insights can be used to suggest ways to enhance quantitative data collection facilitating integration through hypothesis generation, hypothesis testing and seeking explanation for trial findings. This will provide a framework of enabling measures of fidelity to be incorporated into the understanding of trial results which has been relatively neglected by existing literature. TRIAL REGISTRATION:ISRCTN Registry: ISRCTN68240461. Registered on 01/07/2011.

SUBMITTER: Scantlebury A

PROVIDER: S-EPMC7171824 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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Qualitative research to inform hypothesis testing for fidelity-based sub-group analysis in clinical trials: lessons learnt from the process evaluation of a multifaceted podiatry intervention for falls prevention.

Scantlebury Arabella A Cockayne Sarah S Fairhurst Caroline C Rodgers Sara S Torgerson David D Hewitt Catherine C Adamson Joy J

Trials 20200421 1

<h4>Background</h4>Ensuring fidelity to complex interventions is a challenge when conducting pragmatic randomised controlled trials. We explore fidelity through a qualitative process evaluation, which was conducted alongside a pragmatic, multicentre, two-arm cohort randomised controlled trial: the REFORM (Reducing Falls with Orthoses and a Multifaceted podiatry intervention) trial. The paper aims, through a qualitative process evaluation, to explore some of the factors that may have affected the ...[more]

PMID: 32317024

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Project description:BackgroundDespite emerging evidence that foot problems and inappropriate footwear increase the risk of falls, there is little evidence as to whether foot-related intervention strategies can be successfully implemented. The aim of this study was to evaluate adherence rates, barriers to adherence, and the predictors of adherence to a multifaceted podiatry intervention for the prevention of falls in older people.MethodsThe intervention group (n = 153, mean age 74.2 years) of a randomised trial that investigated the effectiveness of a multifaceted podiatry intervention to prevent falls was assessed for adherence to the three components of the intervention: (i) foot orthoses, (ii) footwear advice and footwear cost subsidy, and (iii) a home-based foot and ankle exercise program. Adherence to each component and the barriers to adherence were documented, and separate discriminant function analyses were undertaken to identify factors that were significantly and independently associated with adherence to the three intervention components.ResultsAdherence to the three components of the intervention was as follows: foot orthoses (69%), footwear (54%) and home-based exercise (72%). Discriminant function analyses identified that being younger was the best predictor of orthoses use, higher physical health status and lower fear of falling were independent predictors of footwear adherence, and higher physical health status was the best predictor of exercise adherence. The predictive accuracy of these models was only modest, with 62 to 71% of participants correctly classified.ConclusionsAdherence to a multifaceted podiatry intervention in this trial ranged from 54 to 72%. People with better physical health, less fear of falling and a younger age exhibited greater adherence, suggesting that strategies need to be developed to enhance adherence in frailer older people who are most at risk of falling.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12608000065392.

Project description:BackgroundFalls are a major cause of morbidity among older people. A multifaceted podiatry intervention may reduce the risk of falling. This study evaluated such an intervention.DesignPragmatic cohort randomised controlled trial in England and Ireland. 1010 participants were randomised (493 to the Intervention group and 517 to Usual Care) to either: a podiatry intervention, including foot and ankle exercises, foot orthoses and, if required, new footwear, and a falls prevention leaflet or usual podiatry treatment plus a falls prevention leaflet. The primary outcome was the incidence rate of self-reported falls per participant in the 12 months following randomisation. Secondary outcomes included: proportion of fallers and those reporting multiple falls, time to first fall, fear of falling, Frenchay Activities Index, Geriatric Depression Scale, foot pain, health related quality of life, and cost-effectiveness.ResultsIn the primary analysis were 484 (98.2%) intervention and 507 (98.1%) control participants. There was a small, non statistically significant reduction in the incidence rate of falls in the intervention group (adjusted incidence rate ratio 0.88, 95% CI 0.73 to 1.05, p = 0.16). The proportion of participants experiencing a fall was lower (49.7 vs 54.9%, adjusted odds ratio 0.78, 95% CI 0.60 to 1.00, p = 0.05) as was the proportion experiencing two or more falls (27.6% vs 34.6%, adjusted odds ratio 0.69, 95% CI 0.52 to 0.90, p = 0.01). There was an increase (p = 0.02) in foot pain for the intervention group. There were no statistically significant differences in other outcomes. The intervention was more costly but marginally more beneficial in terms of health-related quality of life (mean quality adjusted life year (QALY) difference 0.0129, 95% CI -0.0050 to 0.0314) and had a 65% probability of being cost-effective at a threshold of £30,000 per QALY gained.ConclusionThere was a small reduction in falls. The intervention may be cost-effective.Trial registrationISRCTN ISRCTN68240461.

Project description:ObjectiveTo determine the effectiveness of a multifaceted podiatry intervention in preventing falls in community dwelling older people with disabling foot pain.DesignParallel group randomised controlled trial.SettingUniversity health sciences clinic in Melbourne, Australia.Participants305 community dwelling men and women (mean age 74 (SD 6) years) with disabling foot pain and an increased risk of falling. 153 were allocated to a multifaceted podiatry intervention and 152 to routine podiatry care, with 12 months' follow-up.InterventionsMultifaceted podiatry intervention consisting of foot orthoses, advice on footwear, subsidy for footwear ($A100 voucher; £65; €74), a home based programme of foot and ankle exercises, a falls prevention education booklet, and routine podiatry care for 12 months. The control group received routine podiatry care for 12 months.Main outcome measuresProportion of fallers and multiple fallers, falling rate, and injuries resulting from falls during follow-up.ResultsOverall, 264 falls occurred during the study. 296 participants returned all 12 calendars: 147 (96%) in the intervention group and 149 (98%) in the control group. Adherence was good, with 52% of the participants completing 75% or more of the requested three exercise sessions weekly, and 55% of those issued orthoses reporting wearing them most of the time. Participants in the intervention group (n=153) experienced 36% fewer falls than participants in the control group (incidence rate ratio 0.64, 95% confidence interval 0.45 to 0.91, P=0.01). The proportion of fallers and multiple fallers did not differ significantly between the groups (relative risk 0.85, 0.66 to 1.08, P=0.19 and 0.63, 0.38 to 1.04, P=0.07). One fracture occurred in the intervention group and seven in the control group (0.14, 0.02 to 1.15, P=0.07). Significant improvements in the intervention group compared with the control group were found for the domains of strength (ankle eversion), range of motion (ankle dorsiflexion and inversion/eversion), and balance (postural sway on the floor when barefoot and maximum balance range wearing shoes).ConclusionsA multifaceted podiatry intervention reduced the rate of falls in community dwelling older people with disabling foot pain. The components of the intervention are inexpensive and relatively simple to implement, suggesting that the programme could be incorporated into routine podiatry practice or multidisciplinary falls prevention clinics.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12608000065392.

Project description:INTRODUCTION:Older adults recently discharged from hospital have greater incidence of adverse events, functional decline, falls and subsequent readmission. Providing education to hospitalised patients on how to prevent falls at home could reduce postdischarge falls. There has been limited research investigating how older adults respond to tailored falls prevention education provided at hospital discharge. The aim of this study is to evaluate how providing tailored falls prevention education to older patients at the point of, and immediately after hospital discharge in addition to usual care, affects engagement in falls prevention strategies in the 6-months postdischarge period, including their capability and motivation to engage in falls prevention strategies. METHODS AND ANALYSES:This prospective observational cohort study is a process evaluation of a randomised controlled trial, using an embedded mixed-method design. Participants (n=390) who have been enrolled in the trial are over the age of 60 years, scoring greater than 7/10 on the Abbreviated Mental Test Score. Participants are being discharged from hospital rehabilitation wards in Perth, Western Australia, and followed up for 6?months postdischarge. Primary outcome measures for the process evaluation are engagement in falls prevention strategies, including exercise, home modifications and receiving assistance with activities of daily living. Secondary outcomes will measure capability, motivation and opportunity to engage in falls prevention strategies, based on the constructs of the Capability Opportunity Motivation Behaviour system. Quantitative data are collected at baseline, then at 6?months postdischarge using structured phone interviews. Qualitative data are collected from a purposive sample of the cohort, using semistructured in-depth phone interviews. Quantitative data will be analysed using regression modelling and qualitative data will be analysed using interpretive phenomenological analysis. ETHICS AND DISSEMINATION:Results will be presented in peer-reviewed journals and at conferences worldwide. This study is approved by hospital and university Human Research Ethics Committees.

Project description:IntroductionFalls are a worldwide health problem among community-dwelling older adults. Emerging evidence suggests that foot problems increase the risk of falling, so the podiatrist may be crucial in detecting foot-related fall risk. However, there is no screening tool available which can be used in podiatry practice. The predictive value of existing tools is limited, and the implementation is poor. The development of risk models for specific clinical populations might increase the prediction accuracy and implementation. Therefore, the aim of this study was to develop and internally validate an easily applicable clinical prediction model (CPM) that can be used in podiatry practice to predict falls in community-dwelling older adults with foot (-related) problems.MethodsThis was a prospective study including community-dwelling older adults (≥65 years) visiting podiatry practices. General fall-risk variables, and foot-related and function-related variables were considered as predictors for the occurrence of falls during the 12-month follow-up. Logistic regression analysis was used for model building, and internal validation was done by bootstrap resampling.Results407 participants were analyzed; the event rate was 33.4%. The final model included fall history in the previous year, unsteady while standing and walking, plantarflexor strength of the lesser toes, and gait speed. The area under the receiver operating characteristic curve was 0.71 (95% CI: 0.66-0.76) in the sample and estimated as 0.65 after shrinkage.ConclusionA CPM based on fall history in the previous year, feeling unsteady while standing and walking, decreased plantarflexor strength of the lesser toes, and reduced gait speed has acceptable accuracy to predict falls in our sample of podiatry community-dwelling older adults and is easily applicable in this setting. The accuracy of the model in clinical practice should be demonstrated through external validation of the model in a next study.

Project description:BackgroundIn support of UCB pharmaceutical research programs, the aim of this research was to implement a novel process for patient involvement in a multidisciplinary research group to co-create a clinical outcome assessment strategy to accurately reflect the experience of people living with early-stage Parkinson's. Patient experts were an integral part of the decision-making process for patient-reported outcome (PRO) research and instrument development.MethodsIn partnership with two patient organizations (Parkinson's UK and the Parkinson's Foundation), 6 patient experts were recruited into a multidisciplinary research group alongside clinical, patient engagement and involvement, regulatory science, and outcome measurement experts. The group was involved across two phases of research; the first phase identified what symptoms are cardinal to the experience of living with early-stage Parkinson's and the second phase involved the development of PRO instruments to better assess the symptoms that are important to people living with early-stage Parkinson's. Patient experts were important in performing a variety of roles, in particular, qualitative study protocol design, conceptual model development, and subsequent co-creation of two PRO instruments.ResultsInvolving people with Parkinson's in PRO research ensured that the expertise of these representatives from the Parkinson's community shaped and drove the research; as such, PRO instruments were being developed with the patient at the forefront. Working with patient experts required considerable resource and time allocation for planning, communication, document development, and organizing meetings; however, their input enriched the development of PRO instruments and was vital in developing PRO instruments that are more meaningful for people with Parkinson's and clinicians.ConclusionsConducting PRO research, in the context of clinical development involving pharmaceutical companies, requires balancing regulatory and scientific rigor with tight time constraints. Incorporating a multi-stakeholder perspective, which included patient experts as joint investigators, had a strong positive impact on our research, despite the logistical complexities of their involvement. Due to the input of patient experts, the innovative clinical outcome assessment strategy and the co-created novel PRO instruments were more relevant and holistic to the patient experience of early-stage Parkinson's.

Dataset Information

Qualitative research to inform hypothesis testing for fidelity-based sub-group analysis in clinical trials: lessons learnt from the process evaluation of a multifaceted podiatry intervention for falls prevention.

Publications

Qualitative research to inform hypothesis testing for fidelity-based sub-group analysis in clinical trials: lessons learnt from the process evaluation of a multifaceted podiatry intervention for falls prevention.

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