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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:Falls and fall-related injuries are a serious cause of morbidity and cost to society. Foot problems and inappropriate footwear may increase the risk of falls; therefore podiatric interventions may play a role in reducing falls. Two Cochrane systematic reviews identified only one study of a podiatry intervention aimed to reduce falls, which was undertaken in Australia. The REFORM trial aims to evaluate the clinical and cost-effectiveness of a multifaceted podiatry intervention in reducing falls in people aged 65 years and over in a UK and Irish setting. METHODS AND ANALYSIS:This multicentre, cohort randomised controlled trial will recruit 2600 participants from routine podiatry clinics in the UK and Ireland to the REFORM cohort. In order to detect a 10% point reduction in falls from 50% to 40%, with 80% power 890 participants will be randomised to receive routine podiatry care and a falls prevention leaflet or routine podiatry care, a falls prevention leaflet and a multifaceted podiatry intervention. The primary outcome is rate of falls (falls/person/time) over 12 months assessed by patient self-report falls diary. Secondary self-report outcome measures include: the proportion of single and multiple fallers and time to first fall over a 12-month period; Short Falls Efficacy Scale-International; fear of falling in the past 4 weeks; Frenchay Activities Index; fracture rate; Geriatric Depression Scale; EuroQoL-five dimensional scale 3-L; health service utilisation at 6 and 12 months. A qualitative study will examine the acceptability of the package of care to participants and podiatrists. ETHICS AND DISSEMINATION:The trial has received a favourable opinion from the East of England-Cambridge East Research Ethics Committee and Galway Research Ethics Committee. The trial results will be published in peer-reviewed journals and at conference presentations. TRIAL REGISTRATION NUMBER:Current Controlled Trials ISRCTN68240461 assigned 01/07/2011.

Project description:BACKGROUND:Clinical teaching plays a crucial role in the transition of medical students into the world of professional practice. Faculty development initiatives contribute to strengthening clinicians' approach to teaching. In order to inform the design of such initiatives, we thought that it would be useful to discover how senior medical students' experience of clinical teaching may impact on how learning during clinical training might be strengthened. METHODS:This qualitative study was conducted using convenience sampling of medical students in the final two months of study before qualifying. Three semi-structured focus group discussions were held with a total of 23 students. Transcripts were analysed from an interpretivist stance, looking for underlying meanings. The resultant themes revealed a tension between the students' expectations and experience of clinical teaching. We returned to our data looking for how students had responded to these tensions. RESULTS:Students saw clinical rotations as having the potential for them to apply their knowledge and test their procedural abilities in the environment where their professional practice and identity will develop. They expected engagement in the clinical workplace. However, their descriptions were of tensions between prior expectations and actual experiences in the environment. They appreciated that learning required them to move out of their "comfort zone", but seemed to persist in the idea of being recipients of teaching rather than becoming directors of their own learning. Students seem to need help in participating in the clinical setting, understanding how this participation will construct the knowledge and skills required as they join the workplace. Students did not have a strong sense of agency to negotiate participation in the clinical workplace. CONCLUSIONS:There is the potential for clinicians to assist students in adapting their way of learning from the largely structured classroom based learning of theoretical knowledge, to the more experiential informal workplace-based learning of practice. This suggests that faculty developers could broaden their menu of offerings to clinicians by intentionally incorporating ways not only of offering students affordances in the clinical learning environment, but also of attending to the development of students' agentic capability to engage with those affordances offered.

Project description:Backgroundfoot problems are independent risk factors for falls in older people. Podiatrists diagnose and treat a wide range of problems affecting the feet, ankles and lower limbs. However, the effectiveness of podiatry interventions to prevent falls in older people is unknown. This systematic review examined podiatry interventions for falls prevention delivered in the community and in care homes.Methodssystematic review and meta-analysis. We searched multiple electronic databases with no language restrictions. Randomised or quasi-randomised-controlled trials documenting podiatry interventions in older people (aged 60+) were included. Two reviewers independently applied selection criteria and assessed methodological quality using the Cochrane Risk of Bias tool. TiDieR guidelines guided data extraction and where suitable statistical summary data were available, we combined the selected outcome data in pooled meta-analyses.Resultsfrom 35,857 titles and 5,201 screened abstracts, nine studies involving 6,502 participants (range 40-3,727) met the inclusion criteria. Interventions were single component podiatry (two studies), multifaceted podiatry (three studies), or multifactorial involving other components and referral to podiatry component (four studies). Seven studies were conducted in the community and two in care homes. Quality assessment showed overall low risk for selection bias, but unclear or high risk of detection bias in 4/9 studies. Combining falls rate data showed significant effects for multifaceted podiatry interventions compared to usual care (falls rate ratio 0.77 [95% CI 0.61, 0.99]); and multifactorial interventions including podiatry (falls rate ratio: 0.73 [95% CI 0.54, 0.98]). Single component podiatry interventions demonstrated no significant effects on falls rate.Conclusionsmultifaceted podiatry interventions and multifactorial interventions involving referral to podiatry produce significant reductions in falls rate. The effect of multi-component podiatry interventions and of podiatry within multifactorial interventions in care homes is unknown and requires further trial data.Prospero registration numberCRD42017068300.

Project description:Infectious disease forecasting is gaining traction in the public health community; however, limited systematic comparisons of model performance exist. Here we present the results of a synthetic forecasting challenge inspired by the West African Ebola crisis in 2014-2015 and involving 16 international academic teams and US government agencies, and compare the predictive performance of 8 independent modeling approaches. Challenge participants were invited to predict 140 epidemiological targets across 5 different time points of 4 synthetic Ebola outbreaks, each involving different levels of interventions and "fog of war" in outbreak data made available for predictions. Prediction targets included 1-4 week-ahead case incidences, outbreak size, peak timing, and several natural history parameters. With respect to weekly case incidence targets, ensemble predictions based on a Bayesian average of the 8 participating models outperformed any individual model and did substantially better than a null auto-regressive model. There was no relationship between model complexity and prediction accuracy; however, the top performing models for short-term weekly incidence were reactive models with few parameters, fitted to a short and recent part of the outbreak. Individual model outputs and ensemble predictions improved with data accuracy and availability; by the second time point, just before the peak of the epidemic, estimates of final size were within 20% of the target. The 4th challenge scenario - mirroring an uncontrolled Ebola outbreak with substantial data reporting noise - was poorly predicted by all modeling teams. Overall, this synthetic forecasting challenge provided a deep understanding of model performance under controlled data and epidemiological conditions. We recommend such "peace time" forecasting challenges as key elements to improve coordination and inspire collaboration between modeling groups ahead of the next pandemic threat, and to assess model forecasting accuracy for a variety of known and hypothetical pathogens.

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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