Dataset Information

Effectiveness and cost-effectiveness of a progressive, individualised walking and education program for prevention of low back pain recurrence in adults: statistical analysis plan for the WalkBack randomised controlled trial.

ABSTRACT:

Background

Exercise for the prevention of low back pain recurrences is recommended, but under-researched. The effectiveness and cost-effectiveness of a walking program for preventing low back pain recurrence remains unknown. This a priori statistical analysis plan describes the methods of analysis for the WalkBack trial.

Methods

WalkBack is a prospectively registered, pragmatic, randomised controlled trial. The aim is to investigate the effectiveness and cost-effectiveness of a 6-month progressive and individualised walking and education program (intervention) for the prevention of low back pain recurrences, compared to a no-treatment control group. The primary outcome is days to the first recurrence of an episode of activity-limiting low back pain. Key secondary outcomes include days to any recurrence of low back pain, days to a care-seeking recurrence of low back pain, disability level, health-related quality of life, costs associated with low back pain and adverse events. All participants will be followed for a minimum of 12 months. Analysis will follow the intention-to-treat principle. Cox regression is planned to assess the effects for the outcomes of time to activity-limiting, minimal and care-seeking recurrence. Hazard ratios and median survival times with 95% confidence intervals will be calculated. The effect of the intervention on continuous outcomes will be estimated with repeated-measure linear mixed models. An economic evaluation will be performed from the societal perspective for recurrence prevented (yes/no) and quality-adjusted life years. The proportion of adverse events between groups will be compared using Fisher's exact test.

Discussion

The WalkBack trial will provide evidence on the effectiveness and cost-effectiveness of a walking intervention to prevent low back pain recurrences. This statistical analysis plan provides transparency on the analysis of the trial.

Trial registration

WalkBack - Effectiveness and cost-effectiveness of a progressive individualised walking and education program for the prevention of a recurrence of low back pain. ACTRN12619001134112 . Date Registered: 14/08/2019.

SUBMITTER: Pocovi NC

PROVIDER: S-EPMC10019396 | biostudies-literature | 2023 Mar

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Effectiveness and cost-effectiveness of a progressive, individualised walking and education program for prevention of low back pain recurrence in adults: statistical analysis plan for the WalkBack randomised controlled trial.

Pocovi Natasha C NC Graham Petra L PL Lin Chung-Wei Christine CC French Simon D SD Latimer Jane J Merom Dafna D Tiedemann Anne A Maher Christopher G CG van Dongen Johanna M JM Clavisi Ornella O Hancock Mark J MJ

Trials 20230316 1

<h4>Background</h4>Exercise for the prevention of low back pain recurrences is recommended, but under-researched. The effectiveness and cost-effectiveness of a walking program for preventing low back pain recurrence remains unknown. This a priori statistical analysis plan describes the methods of analysis for the WalkBack trial.<h4>Methods</h4>WalkBack is a prospectively registered, pragmatic, randomised controlled trial. The aim is to investigate the effectiveness and cost-effectiveness of a 6- ...[more]

PMID: 36927497

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Project description:IntroductionLow back pain (LBP) is recognised globally as a prevalent, costly and disabling condition. Recurrences are common and contribute to much of the burden of LBP. Current evidence favours exercise and education for prevention of LBP recurrence, but an optimal intervention has not yet been established. Walking is a simple, widely accessible, low-cost intervention that has yet to be evaluated. This randomised controlled trial (RCT) aims to establish the effectiveness and cost-effectiveness of a progressive and individualised walking and education programme (intervention) for the prevention of LBP recurrences in adults compared with no treatment (control).Methods and analysisA pragmatic, two-armed RCT comparing walking and education (n=349) with a no treatment control group (n=349). Inclusion criteria are adults recovered from an episode of non-specific LBP within the last 6 months. Those allocated to the intervention group will receive six sessions (three face to face and three telephone delivered) with a trained physiotherapist to facilitate a progressive walking programme and education over a 6-month period. The primary outcome will be days to first recurrence of an episode of activity-limiting LBP. The secondary outcomes include days to recurrence of an episode of LBP, days to recurrence of an episode of LBP leading to care seeking, disability and quality of life measured at 3, 6, 9 and 12 months and costs associated with LBP recurrence. All participants will be followed up monthly for a minimum of 12 months. The primary intention-to-treat analysis will assess difference in survival curves (days to recurrence) using the log-rank statistic. The cost-effectiveness analysis will be conducted from the societal perspective.Ethics and disseminationApproved by Macquarie University Human Research Ethics Committee (Reference: 5201949218164, May 2019). Findings will be disseminated through publication in peer-reviewed journals and conference presentations.Trial registration numberACTRN12619001134112.

Project description:BackgroundCurrent evidence supports the use of exercise-based treatment for chronic low back pain that encourages the patient to assume an active role in their recovery. Walking has been shown it to be an acceptable type of exercise with a low risk of injury. However, it is not known whether structured physical activity programmes are any more effective than giving advice to remain active.Methods/designThe proposed study will test the feasibility of using a pedometer-driven walking programme, as an adjunct to a standard education and advice session in participants with chronic low back pain. Fifty adult participants will be recruited via a number of different sources. Baseline outcome measures including self reported function; objective physical activity levels; fear-avoidance beliefs and health-related quality of life will be recorded. Eligible participants will be randomly allocated under strict, double blind conditions to one of two treatments groups. Participants in group A will receive a single education and advice session with a physiotherapist based on the content of the 'Back Book'. Participants in group B will receive the same education and advice session. In addition, they will also receive a graded pedometer-driven walking programme prescribed by the physiotherapist. Follow up outcomes will be recorded by the same researcher, who will remain blinded to group allocation, at eight weeks and six months post randomisation. A qualitative exploration of participants' perception of walking will also be examined by use of focus groups at the end of the intervention. As a feasibility study, treatment effects will be represented by point estimates and confidence intervals. The assessment of participant satisfaction will be tabulated, as will adherence levels and any recorded difficulties or adverse events experienced by the participants or therapists. This information will be used to modify the planned interventions to be used in a larger randomised controlled trial.DiscussionThis paper describes the rationale and design of a study which will test the feasibility of using a structured, pedometer-driven walking programme in participants with chronic low back pain.Trial registration[ISRCTN67030896].

Project description:Aims/hypothesisUsing variable diabetic retinopathy screening intervals, informed by personal risk levels, offers improved engagement of people with diabetes and reallocation of resources to high-risk groups, while addressing the increasing prevalence of diabetes. However, safety data on extending screening intervals are minimal. The aim of this study was to evaluate the safety and cost-effectiveness of individualised, variable-interval, risk-based population screening compared with usual care, with wide-ranging input from individuals with diabetes.MethodsThis was a two-arm, parallel-assignment, equivalence RCT (minimum 2 year follow-up) in individuals with diabetes aged 12 years or older registered with a single English screening programme. Participants were randomly allocated 1:1 at baseline to individualised screening at 6, 12 or 24 months for those at high, medium and low risk, respectively, as determined at each screening episode by a risk-calculation engine using local demographic, screening and clinical data, or to annual screening (control group). Screening staff and investigators were observer-masked to allocation and interval. Data were collected within the screening programme. The primary outcome was attendance (safety). A secondary safety outcome was the development of sight-threatening diabetic retinopathy. Cost-effectiveness was evaluated within a 2 year time horizon from National Health Service and societal perspectives.ResultsA total of 4534 participants were randomised. After withdrawals, there were 2097 participants in the individualised screening arm and 2224 in the control arm. Attendance rates at first follow-up were equivalent between the two arms (individualised screening 83.6%; control arm 84.7%; difference -1.0 [95% CI -3.2, 1.2]), while sight-threatening diabetic retinopathy detection rates were non-inferior in the individualised screening arm (individualised screening 1.4%, control arm 1.7%; difference -0.3 [95% CI -1.1, 0.5]). Sensitivity analyses confirmed these findings. No important adverse events were observed. Mean differences in complete case quality-adjusted life-years (EuroQol Five-Dimension Questionnaire, Health Utilities Index Mark 3) did not significantly differ from zero; multiple imputation supported the dominance of individualised screening. Incremental cost savings per person with individualised screening were £17.34 (95% CI 17.02, 17.67) from the National Health Service perspective and £23.11 (95% CI 22.73, 23.53) from the societal perspective, representing a 21% reduction in overall programme costs. Overall, 43.2% fewer screening appointments were required in the individualised arm.Conclusions/interpretationStakeholders involved in diabetes care can be reassured by this study, which is the largest ophthalmic RCT in diabetic retinopathy screening to date, that extended and individualised, variable-interval, risk-based screening is feasible and can be safely and cost-effectively introduced in established systematic programmes. Because of the 2 year time horizon of the trial and the long time frame of the disease, robust monitoring of attendance and retinopathy rates should be included in any future implementation.Trial registrationISRCTN 87561257 FUNDING: The study was funded by the UK National Institute for Health Research. Graphical abstract.

Dataset Information

Effectiveness and cost-effectiveness of a progressive, individualised walking and education program for prevention of low back pain recurrence in adults: statistical analysis plan for the WalkBack randomised controlled trial.

Background

Methods

Discussion

Trial registration

Publications

Effectiveness and cost-effectiveness of a progressive, individualised walking and education program for prevention of low back pain recurrence in adults: statistical analysis plan for the WalkBack randomised controlled trial.

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