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What do RCTs tell us, and could they tell us more? Looking within and beyond the study sample (2024)
Book Chapter
Sim, J., Lancaster, G., & Lewis, M. (2024). What do RCTs tell us, and could they tell us more? Looking within and beyond the study sample. In A Medical Educator's Guide to Thinking Critically about Randomised Controlled Trials: Deconstructing the "Gold Standard" (109-144). Springer Nature [academic journals on nature.com]. https://doi.org/10.1007/978-3-031-25859-6_5

Randomised controlled trials (RCTs) are generally regarded as the gold-standard method to answer questions of treatment effectiveness. Carefully designed and rigorously implemented, they can provide unbiased estimates of average treatment effectivene... Read More about What do RCTs tell us, and could they tell us more? Looking within and beyond the study sample.

The CO-produced Psychosocial INtervention delivered by GPs to young people after self-harm (COPING): protocol for a feasibility study (2024)
Journal Article
Mughal, F., Chew-Graham, C. A., Saunders, B., Lawton, S. A., Lewis, S., Smith, J., …Lewis, M. (in press). The CO-produced Psychosocial INtervention delivered by GPs to young people after self-harm (COPING): protocol for a feasibility study. NIHR Open Research, 4(27), https://doi.org/10.3310/nihropenres.13576.1

Background Self-harm in young people is a growing concern and reducing rates a global priority. General practitioners (GPs) can intervene early after self-harm but there are no effective treatments presently available. We developed the GP-led COPING... Read More about The CO-produced Psychosocial INtervention delivered by GPs to young people after self-harm (COPING): protocol for a feasibility study.

The cost-effectiveness of adding an ultrasound corticosteroid and local anaesthetic injection to advice and education for hip osteoarthritis (2023)
Journal Article
Kigozi, J., Oppong, R., Paskins, Z., Bromley, K., Lewis, M., Hughes, G., …Roddy, E. (2023). The cost-effectiveness of adding an ultrasound corticosteroid and local anaesthetic injection to advice and education for hip osteoarthritis. Rheumatology, https://doi.org/10.1093/rheumatology/kead659

Objectives. Evidence for the comparative cost-effectiveness of intra-articular corticosteroid injection in people with hip osteoarthritis (OA) remains unclear. This study investigated the cost-effectiveness of best current treatment (BCT) comprising... Read More about The cost-effectiveness of adding an ultrasound corticosteroid and local anaesthetic injection to advice and education for hip osteoarthritis.

Experiences of living with hip osteoarthritis and of receiving advice, education and ultrasound-guided intra-articular hip injection in the hip injection trial. A qualitative study (2023)
Journal Article
Hawarden, A., Holden, M. A., Paskins, Z., Roddy, E., Mallen, C. D., Liddle, J., …Jinks, C. (2023). Experiences of living with hip osteoarthritis and of receiving advice, education and ultrasound-guided intra-articular hip injection in the hip injection trial. A qualitative study. Musculoskeletal Care, https://doi.org/10.1002/msc.1830

Objectives: The Hip Injection Trial (HIT) compared the effectiveness of adding a single ultrasound-guided intra-articular injection of either corticosteroid and local anaesthetic, or local anaesthetic alone, to advice and education among people with... Read More about Experiences of living with hip osteoarthritis and of receiving advice, education and ultrasound-guided intra-articular hip injection in the hip injection trial. A qualitative study.

Traditional healers working with primary care and mental health for early intervention in psychosis in young persons: protocol for the feasibility cluster randomised controlled trial (2023)
Journal Article
Farooq, S., Sheikh, S., Dikomitis, L., Haq, M. M. U., Khan, A. J., Sanauddin, N., …Lewis, M. (2023). Traditional healers working with primary care and mental health for early intervention in psychosis in young persons: protocol for the feasibility cluster randomised controlled trial. BMJ Open, 13(7), Article e072471. https://doi.org/10.1136/bmjopen-2023-072471

Objectives In low/middle-income countries (LMICs), more than half of patients with first-episode psychosis initially seek treatment from traditional and religious healers as their first care. This contributes to an excessively long duration of untrea... Read More about Traditional healers working with primary care and mental health for early intervention in psychosis in young persons: protocol for the feasibility cluster randomised controlled trial.

Traditional healers working with primary care and mental health for early intervention in psychosis in young persons: protocol for the feasibility cluster randomised controlled trial (2023)
Journal Article
Farooq, S., Sheikh, S., Dikomitis, L., Haq, M. M. U., Khan, A. J., Sanauddin, N., …Lewis, M. (2023). Traditional healers working with primary care and mental health for early intervention in psychosis in young persons: protocol for the feasibility cluster randomised controlled trial. BMJ Open, 13(7), e072471. https://doi.org/10.1136/bmjopen-2023-072471

Objectives: In low/middle-income countries (LMICs), more than half of patients with first-episode psychosis initially seek treatment from traditional and religious healers as their first care. This contributes to an excessively long duration of untre... Read More about Traditional healers working with primary care and mental health for early intervention in psychosis in young persons: protocol for the feasibility cluster randomised controlled trial.

Stratified primary care for adults with musculoskeletal pain: the STarT MSK research programme including RCTs (2023)
Report
E Foster, N., M Dunn, K., Protheroe, J., C Hill, J., Lewis, M., Saunders, B., …Chudyk, A. (2023). Stratified primary care for adults with musculoskeletal pain: the STarT MSK research programme including RCTs. NIHR

Background Usual primary care for patients with musculoskeletal pain varies widely and treatment outcomes are suboptimal. Stratified care involves targeting treatments according to patient subgroups, in the hope of maximising treatment benefit and re... Read More about Stratified primary care for adults with musculoskeletal pain: the STarT MSK research programme including RCTs.

Supported self-management for all with musculoskeletal pain: an inclusive approach to intervention development: the EASIER study (2023)
Journal Article
Healey, E. L., Lewis, M., Corp, N., Shivji, N. A., van der Windt, D. A., Babatunde, O. O., …Protheroe, J. (2023). Supported self-management for all with musculoskeletal pain: an inclusive approach to intervention development: the EASIER study. BMC Musculoskeletal Disorders, 24(1), Article 474. https://doi.org/10.1186/s12891-023-06452-4

Background Supported self-management interventions for patients with musculoskeletal (MSK) conditions may not adequately support those with limited health literacy, leading to inequalities in care and variable outcomes. The aim of this study was to... Read More about Supported self-management for all with musculoskeletal pain: an inclusive approach to intervention development: the EASIER study.

Pain catastrophising and kinesiophobia mediate pain and physical function improvements with Pilates exercise in chronic low back pain: a mediation analysis of a randomised controlled trial. (2023)
Journal Article
Wood, L., Bejarano, G., Csiernik, B., Miyamoto, G. C., Mansell, G., Hayden, J. A., …Cashin, A. G. (in press). Pain catastrophising and kinesiophobia mediate pain and physical function improvements with Pilates exercise in chronic low back pain: a mediation analysis of a randomised controlled trial. Journal of Physiotherapy, 69(3), 168-174. https://doi.org/10.1016/j.jphys.2023.05.008

How much are the reductions in pain intensity and improvements in physical function from Pilates exercise mediated by changes in pain catastrophising and kinesiophobia? This was a secondary causal mediation analysis of a four-arm randomised controlle... Read More about Pain catastrophising and kinesiophobia mediate pain and physical function improvements with Pilates exercise in chronic low back pain: a mediation analysis of a randomised controlled trial..

Benchmarking quality of care using patient reported outcome measure data for patients presenting with musculoskeletal conditions in primary care GP practices (2023)
Journal Article
Burgess, R., Lewis, M., & Hill, J. C. (2023). Benchmarking quality of care using patient reported outcome measure data for patients presenting with musculoskeletal conditions in primary care GP practices. Musculoskeletal Care, https://doi.org/10.1002/msc.1744

BACKGROUND: Patient Reported Outcome Measures (PROMs) evaluate health status from a patient perspective. They can be used to support care at a patient level but also collectively to review quality of care across care providers. Vast amounts of patien... Read More about Benchmarking quality of care using patient reported outcome measure data for patients presenting with musculoskeletal conditions in primary care GP practices.

Comparison of healthcare utilisation, costs and health-related quality of life across the subgroups defined by the Keele STarT MSK Tool (2022)
Journal Article
Oppong, R., Lewis, A., Campbell, P., Dunn, K., Foster, N., Hill, J., & Jowett, S. (2022). Comparison of healthcare utilisation, costs and health-related quality of life across the subgroups defined by the Keele STarT MSK Tool. Rheumatology, https://doi.org/10.1093/rheumatology/keac560

Objectives: The aim of this study was to describe and compare health economic outcomes (healthcare utilisation, costs, work outcomes and health-related quality of life (EQ-5D-5L)) in patients classified into different risk subgroups by the Keele STar... Read More about Comparison of healthcare utilisation, costs and health-related quality of life across the subgroups defined by the Keele STarT MSK Tool.

Benchmarking community/primary care musculoskeletal services: A narrative review and recommendation (2022)
Journal Article
Burgess, R., Lewis, M., & Hill, J. (2023). Benchmarking community/primary care musculoskeletal services: A narrative review and recommendation. Musculoskeletal Care, 21(1), 148-158. https://doi.org/10.1002/msc.1676

INTRODUCTION: High quality data on service performance is essential in healthcare to evidence efficacy, efficiency, and value. There remains a paucity of publicly reported data in community and primary care musculoskeletal (MSK) services. There is al... Read More about Benchmarking community/primary care musculoskeletal services: A narrative review and recommendation.

Matching the outcomes to treatment targets of exercise for low back pain: does it make a difference? Results of secondary analyses from individual patient data of randomised controlled trials and pooling of results across trials in comparative meta-analyses. (2022)
Journal Article
Lewis, A. M. (2022). Matching the outcomes to treatment targets of exercise for low back pain: does it make a difference? Results of secondary analyses from individual patient data of randomised controlled trials and pooling of results across trials in comparative meta-analyses. Archives of Physical Medicine and Rehabilitation, 218-228. https://doi.org/10.1016/j.apmr.2022.07.012

OBJECTIVE: To explore whether using a single matched or composite outcome might impact the results of previous randomised controlled trials (RCTs) testing exercise for non-specific low back pain (NSLBP). The first objective was to explore whether a s... Read More about Matching the outcomes to treatment targets of exercise for low back pain: does it make a difference? Results of secondary analyses from individual patient data of randomised controlled trials and pooling of results across trials in comparative meta-analyses..

Risk-based stratified primary care for common musculoskeletal pain presentations (STarT MSK): a cluster-randomised, controlled trial (2022)
Journal Article
Hill, J. C., Garvin, S., Bromley, K., Saunders, B., Kigozi, J., Cooper, V., …Foster, N. E. (2022). Risk-based stratified primary care for common musculoskeletal pain presentations (STarT MSK): a cluster-randomised, controlled trial. The Lancet Rheumatology, 4(9), e591 - e602. https://doi.org/10.1016/S2665-9913%2822%2900159-X

Background Risk-based stratified care shows clinical effectiveness and cost-effectiveness versus usual primary care for non-specific low back pain but is untested for other common musculoskeletal disorders. We aimed to test the clinical effectiveness... Read More about Risk-based stratified primary care for common musculoskeletal pain presentations (STarT MSK): a cluster-randomised, controlled trial.

Clinical effectiveness of one ultrasound guided intra-articular corticosteroid and local anaesthetic injection in addition to advice and education for hip osteoarthritis (HIT trial): single blind, parallel group, three arm, randomised controlled trial (2022)
Journal Article
Paskins, Z., Bromley, K., Lewis, M., Hughes, G., Hughes, E., Hennings, S., …Mallen, C. D. (2022). Clinical effectiveness of one ultrasound guided intra-articular corticosteroid and local anaesthetic injection in addition to advice and education for hip osteoarthritis (HIT trial): single blind, parallel group, three arm, randomised controlled trial. BMJ, 377, Article ARTN e068446. https://doi.org/10.1136/bmj-2021-068446

Objectives: to compare the clinical effectiveness of best current treatment (BCT) plus single ultrasound-guided intra-articular hip injection (USGI) of 40mg triamcinolone acetonide and 4ml 1% lidocaine hydrochloride [BCT+US-Triamcinolone-Lidocaine] w... Read More about Clinical effectiveness of one ultrasound guided intra-articular corticosteroid and local anaesthetic injection in addition to advice and education for hip osteoarthritis (HIT trial): single blind, parallel group, three arm, randomised controlled trial.

Rehabilitation following rotator cuff repair: Multi-centre pilot and feasibility randomised controlled trial (RaCeR) (2021)
Journal Article
Littlewood, C., Bateman, M., Butler-Walley, S., Bathers, S., Cookson, T., Bromley, K., …Foster, N. (2021). Rehabilitation following rotator cuff repair: Multi-centre pilot and feasibility randomised controlled trial (RaCeR). Physiotherapy, 113(S1), e13-e14. https://doi.org/10.1016/j.physio.2021.10.238

Purpose: Shoulder pain is a highly prevalent complaint and disorders of the rotator cuff, including tears, are thought to be the most common cause. The number of operations to repair the torn rotator cuff has risen significantly in recent years. Whil... Read More about Rehabilitation following rotator cuff repair: Multi-centre pilot and feasibility randomised controlled trial (RaCeR).

Developing a core outcome set for community and primary care musculoskeletal services: A consensus approach. (2021)
Journal Article
Lewis, M., & Hill, J. (2021). Developing a core outcome set for community and primary care musculoskeletal services: A consensus approach. Musculoskeletal Science and Practice, 1- 10. https://doi.org/10.1016/j.msksp.2021.102415

BACKGROUND: At present there is no core outcome set (COS) for use in community and primary care Musculoskeletal (MSK) services across the UK. Services are therefore collecting different MSK outcomes and metrics in different ways and at different time... Read More about Developing a core outcome set for community and primary care musculoskeletal services: A consensus approach..

The relationship between multisite peripheral joint pain and physical activity levels in older adults: A cross-sectional survey. (2021)
Journal Article
Smith, R. D., McHugh, G. A., Quicke, J. G., Finney, A., Lewis, M., Dziedzic, K. S., & Healey, E. L. (2022). The relationship between multisite peripheral joint pain and physical activity levels in older adults: A cross-sectional survey. Musculoskeletal Care, 20(2), 341-348. https://doi.org/10.1002/msc.1593

INTRODUCTION: Research on levels of physical activity (PA) in those with peripheral joint pain have only focused on single sites, in the knee or hips. This study investigated the levels of PA in adults with single-site and multisite peripheral joint... Read More about The relationship between multisite peripheral joint pain and physical activity levels in older adults: A cross-sectional survey..

Integrating case-finding and initial management for osteoarthritis, anxiety, and depression into primary care long-term condition reviews: results from the ENHANCE pilot trial. (2021)
Journal Article
Healey, E. L., Mallen, C. D., Chew-Graham, C. A., Nicholls, E., Lewis, M., Lawton, S. A., …Jinks, C. (2022). Integrating case-finding and initial management for osteoarthritis, anxiety, and depression into primary care long-term condition reviews: results from the ENHANCE pilot trial. Family Practice, 39(4), 592–602. https://doi.org/10.1093/fampra/cmab113

Background: Multimorbidity is increasingly the norm; however, primary care remains focused on single diseases. Osteoarthritis, anxiety, and depression are frequently comorbid with other long-term conditions (LTCs), but rarely prioritized by clinician... Read More about Integrating case-finding and initial management for osteoarthritis, anxiety, and depression into primary care long-term condition reviews: results from the ENHANCE pilot trial..