Dataset Information

Understanding the mechanisms of a combined physical and psychological intervention for people with neurogenic claudication: protocol for a causal mediation analysis of the BOOST trial.

ABSTRACT:

Introduction

Conservative treatments such as exercise are recommended for the management of people with neurogenic claudication from spinal stenosis. However, the effectiveness and mechanisms of effect are unknown. This protocol outlines an a priori plan for a secondary analysis of a multicentre randomised controlled trial of a physiotherapist-delivered, combined physical and psychological intervention (Better Outcomes for Older people with Spinal Trouble (BOOST) programme).

Methods and analyses

We will use causal mediation analysis to estimate the mechanistic effects of the BOOST programme on the primary outcome of disability (measured by the Oswestry Disability Index). The primary mechanism of interest is walking capacity, and secondary mediators include fear-avoidance behaviour, walking self-efficacy, physical function, physical activity and/or symptom severity. All mediators will be measured at 6 months and the outcome will be measured at 12 months from randomisation. Patient characteristics and possible confounders of the mediator-outcome effect will be measured at baseline. Sensitivity analyses will be conducted to evaluate the robustness of the estimated effects to varying levels of residual confounding.

Ethics and dissemination

Ethical approval was given on 3 March 2016 (National Research Ethics Committee number: 16/LO/0349). The results of this analysis will be disseminated in peer-reviewed journals and at relevant scientific conferences.

Trial registration number

ISRCTN12698674.

SUBMITTER: Comer C

PROVIDER: S-EPMC7470505 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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Publications

Understanding the mechanisms of a combined physical and psychological intervention for people with neurogenic claudication: protocol for a causal mediation analysis of the BOOST trial.

Comer Christine C Lee Hopin H Williamson Esther E Lamb Sarah S

BMJ open 20200902 9

<h4>Introduction</h4>Conservative treatments such as exercise are recommended for the management of people with neurogenic claudication from spinal stenosis. However, the effectiveness and mechanisms of effect are unknown. This protocol outlines an a priori plan for a secondary analysis of a multicentre randomised controlled trial of a physiotherapist-delivered, combined physical and psychological intervention (Better Outcomes for Older people with Spinal Trouble (BOOST) programme).<h4>Methods a ...[more]

PMID: 32878759

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Project description:IntroductionNeurogenic claudication due to spinal stenosis is common in older adults. The effectiveness of conservative interventions is not known. The aim of the study is to estimate the clinical and cost-effectiveness of a physiotherapist-delivered, combined physical and psychological intervention.Methods and analysisThis is a pragmatic, multicentred, randomised controlled trial. Participants are randomised to a combined physical and psychological intervention (Better Outcomes for Older people with Spinal Trouble (BOOST) programme) or best practice advice (control). Community-dwelling adults, 65 years and over, with neurogenic claudication are identified from community and secondary care services. Recruitment is supplemented using a primary care-based cohort. Participants are registered prospectively and randomised in a 2:1 ratio (intervention:control) using a web-based service to ensure allocation concealment. The target sample size is a minimum of 402. The BOOST programme consists of an individual assessment and twelve 90 min classes, including education and discussion underpinned by cognitive behavioural techniques, exercises and walking circuit. During and after the classes, participants undertake home exercises and there are two support telephone calls to promote adherence with the exercises. Best practice advice is delivered in one to three individual sessions with a physiotherapist. The primary outcome is the Oswestry Disability Index at 12 months. Secondary outcomes include the 6 Minute Walk Test, Short Physical Performance Battery, Fear Avoidance Beliefs Questionnaire and Gait Self-Efficacy Scale. Outcomes are measured at 6 and 12 months by researchers who are masked to treatment allocation. The primary statistical analysis will be by 'intention to treat'. There is a parallel health economic evaluation and qualitative study.Ethics and disseminationEthical approval was given on 3 March 2016 (National Research Ethics Committee number: 16/LO/0349). This protocol adheres to the Standard Protocol Items: Recommendations for Interventional Trials checklist. The results will be reported at conferences and in peer-reviewed publications using the Consolidated Standards of Reporting Trials guidelines. A plain English summary will be published on the BOOST website.Trial registration numberISRCTN12698674; Pre-results.

Project description:BackgroundEmerging 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.ObjectivesTo 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.MethodsAn 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.ResultsParticipants (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 analyses.ConclusionsThe BOOST programme resulted in modest QALY gains over the 12 month follow-up period. Future studies with longer intervention and follow-up periods are needed to address uncertainty around the health-related quality of life impacts and cost-effectiveness of such programmes. Trial registration This study has been registered in the International Standard Randomised Controlled Trial Number registry, reference number ISRCTN12698674. Registered on 10 November 2015.

Project description:ObjectivesNeurogenic claudication (NC) causes pain and reduced mobility, particularly in older people, and can negatively affect mental and social well-being, so limiting successful ageing. This qualitative study explored how people with NC changed over 12 months.DesignA longitudinal qualitative study using semi-structured interviews.SettingParticipants were recruited from a UK clinical trial of a physiotherapy intervention for NC.ParticipantsInterviews were undertaken at baseline, 1 month after receiving any intervention and at 12 months. We analysed 30 sets of three interviews.ResultsInterview data were summarised for each time point into biopsychosocial domains: pain, mobility and activities of daily living, psychological impact, and social and recreational participation. Through comparative analysis we explored participant trajectories over time.Progressive improvement in at least one domain was experienced by 13 participants, but there was variability in trajectories with early improvements that remained the same, transient changes and no change also commonly observed.Eleven participants described co-present improvement trajectories in all domains. Three participants described co-present improvement in all domains except participation; one had never stopped their participation and two had unattainable expectations. Five participants described co-present improvement in one domain and deterioration in another and 14 participants described co-present no change in one domain and change in another.There was evidence of interaction between domains; for example, improved mobility led to improved participation and for some participants, specific factors influenced change. Of the 15 participants who experienced improved participation, 10 reported improvements in all other domains and five participants did not; for two, pain did not prevent participation, one used a walking aid and two had a positive psychological outlook.ConclusionThe daily lived experiences of older adults with NC are variable and include interaction between biopsychosocial domains. Therapist understanding of these trajectories and their interactions may help to provide personalised therapy TRIAL REGISTRATION NUMBER: ISRCTN12698674.

Project description:BackgroundIllness beliefs are significant contributors to health outcomes. Beliefs about the cause of physical symptoms are considered particularly important among those with medically unexplained symptoms and illnesses (MUS); yet little is known about causal beliefs among those with the most severe MUS (i.e., Veterans). The goal of the current study was to examine Veteran's causal attributions of their physical symptoms.MethodA total of 91 combat Veterans with MUS were surveyed using a mixed-methods design about the cause of their physical symptoms, physical symptom severity, and PTSD symptoms. Causal attributions of physical symptoms were analyzed through thematic response analysis and grouped into categories. Chi-square analysis was used to assess the distribution of causal attribution types across Veterans with varying physical symptom severity and PTSD symptom severity.ResultsVeterans with MUS reported an average of 7.9 physical symptoms, and attributed the cause of their symptoms to seven different categories ("Do not Know," "Stress/Mental Health," "Deployment/Environment," "Functional/Symptom," "Medically Explained," "Medically Unexplained Syndrome," and "Lifestyle"). Exploratory chi-square analysis revealed significant differences in causal attributions across physical symptom severity and severity of PTSD symptoms. Veterans with more severe PTSD and Veterans with more severe physical symptoms were more likely to attribute their MUS to stress/mental health or to a medically unexplained syndrome compared with those with low/no PTSD symptoms and physical symptom severity. Veterans with minimal PTSD and Veterans with minimal physical symptom severity were more likely to attribute the cause of their MUS to lifestyle choices (e.g., exercise/diet) compared with those with high PTSD and physical symptom severity.ConclusionVeterans with MUS endorse multiple, varied causal attributions for their physical symptoms, suggesting more complex causal beliefs than typically assumed. This has important implications for patient-provider communication and development of concordance around MUS treatment.

Dataset Information

Understanding the mechanisms of a combined physical and psychological intervention for people with neurogenic claudication: protocol for a causal mediation analysis of the BOOST trial.

Introduction

Methods and analyses

Ethics and dissemination

Trial registration number

Publications

Understanding the mechanisms of a combined physical and psychological intervention for people with neurogenic claudication: protocol for a causal mediation analysis of the BOOST trial.

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