The STAR care pathway for patients with chronic pain after total knee replacement: four-year follow-up of a randomised controlled trial

Wendy Bertram; Vikki Wylde; Nick Howells; Beverly Shirkey; Tim J. Peters; Liang Zhu; Sian Noble; Emma Johnson; Andrew D. Beswick; Andrew Moore; Julie Bruce; David Walsh; Christopher Eccleston; Rachael Gooberman-Hill

doi:10.1186/s12891-023-07099-x

The STAR care pathway for patients with chronic pain after total knee replacement: four-year follow-up of a randomised controlled trial

Wendy Bertram, Vikki Wylde, Nick Howells, Beverly Shirkey, Tim J. Peters, Liang Zhu, Sian Noble, Emma Johnson, Andrew D. Beswick, Andrew Moore, Julie Bruce, David Walsh, Christopher Eccleston, Rachael Gooberman-Hill

Research output: Contribution to journal › Article › peer-review

Abstract

Background: The Support and Treatment After Replacement (STAR) care pathway is a clinically important and cost-effective intervention found to improve pain outcomes over one year for people with chronic pain three months after total knee replacement (TKR). We followed up STAR trial participants to evaluate the longer-term clinical- and cost-effectiveness of this care pathway. Methods: Participants who remained enrolled on the trial at one year were contacted by post at a median of four years after randomisation and invited to complete a questionnaire comprising the same outcomes collected during the trial. We captured pain (co-primary outcome using the Brief Pain Inventory (BPI) pain severity and interference scales; scored 0–10, best to worst), function, neuropathic characteristics, emotional aspects of pain, health-related quality of life, and satisfaction. Electronic hospital informatics data on hospital resource use for the period of one to four years post-randomisation were collected from participating hospital sites. The economic evaluation took an National Health Service (NHS) secondary care perspective, with a four-year time horizon. Results: Overall, 226/337 (67%) of participants returned completed follow-up questionnaires, yielding adjusted between-group differences in BPI means of -0.42 (95% confidence interval, CI (-1.07, 0.23); p = 0.20) for pain severity and − 0.64 (95% CI -1.41, 0.12); p = 0.10) for pain interference. Analysis using a multiple imputed data set (n = 337) showed an incremental net monetary benefit in favour of the STAR care pathway of £3,525 (95% CI -£990 to £8,039) at a £20,000/QALY willingness-to-pay threshold, leading to a probability that the intervention was cost-effective of 0.94. Conclusions: The magnitude of the longer-term benefits of the STAR care pathway are uncertain due to attrition of trial participants; however, there is a suggestion of some degree of sustained clinical benefit at four years. The care pathway remained cost-effective at four years. Trial registration: ISRCTN: 92,545,361.

Original language	English
Article number	972
Journal	BMC Musculoskeletal Disorders
Volume	24
Issue number	1
Early online date	16 Dec 2023
DOIs	https://doi.org/10.1186/s12891-023-07099-x
Publication status	Published - 16 Dec 2023

Acknowledgements

The STAR team acknowledges the following people for their help and input into the STAR follow-up study: Leigh Morrison, Gemma Munkenbeck, Christine Hobson, Paolo Buscemi, the STAR Patient Advisory Group and the Patient Experience Partnership in Research (PEP-R) group. We also thank colleagues at Versus Arthritis for their support.

The research team acknowledges the support of the NIHR, through the Clinical Research Network. This work was also supported by the NIHR Biomedical Research Centre at University Hospitals Bristol and Weston NHS Foundation Trust and the University of Bristol. The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. The Bristol Trials Centre (formed through a merger of the Bristol Randomised Trials Collaboration with another UK Clinical Research Collaboration registered Clinical Trials Unit [CTU]) receives NIHR CTU Support Funding to underpin the development and conduct of NIHR-funded trials. JB is supported by NIHR Research Capability Funding via University Hospitals Coventry and the Warwickshire NHS Trust.

Keywords

Care pathway
Chronic post-surgical pain
Osteoarthritis
Total knee replacement

ASJC Scopus subject areas

Rheumatology
Orthopedics and Sports Medicine

Access to Document

10.1186/s12891-023-07099-xLicence: CC BY

Cite this

Bertram, W., Wylde, V., Howells, N., Shirkey, B., Peters, T. J., Zhu, L., Noble, S., Johnson, E., Beswick, A. D., Moore, A., Bruce, J., Walsh, D., Eccleston, C., & Gooberman-Hill, R. (2023). The STAR care pathway for patients with chronic pain after total knee replacement: four-year follow-up of a randomised controlled trial. BMC Musculoskeletal Disorders, 24(1), Article 972. https://doi.org/10.1186/s12891-023-07099-x

Bertram, W, Wylde, V, Howells, N, Shirkey, B, Peters, TJ, Zhu, L, Noble, S, Johnson, E, Beswick, AD, Moore, A, Bruce, J, Walsh, D, Eccleston, C & Gooberman-Hill, R 2023, 'The STAR care pathway for patients with chronic pain after total knee replacement: four-year follow-up of a randomised controlled trial', BMC Musculoskeletal Disorders, vol. 24, no. 1, 972. https://doi.org/10.1186/s12891-023-07099-x

@article{78be6c35a7c34f38964d70e67cd40980,

title = "The STAR care pathway for patients with chronic pain after total knee replacement: four-year follow-up of a randomised controlled trial",

abstract = "Background: The Support and Treatment After Replacement (STAR) care pathway is a clinically important and cost-effective intervention found to improve pain outcomes over one year for people with chronic pain three months after total knee replacement (TKR). We followed up STAR trial participants to evaluate the longer-term clinical- and cost-effectiveness of this care pathway. Methods: Participants who remained enrolled on the trial at one year were contacted by post at a median of four years after randomisation and invited to complete a questionnaire comprising the same outcomes collected during the trial. We captured pain (co-primary outcome using the Brief Pain Inventory (BPI) pain severity and interference scales; scored 0–10, best to worst), function, neuropathic characteristics, emotional aspects of pain, health-related quality of life, and satisfaction. Electronic hospital informatics data on hospital resource use for the period of one to four years post-randomisation were collected from participating hospital sites. The economic evaluation took an National Health Service (NHS) secondary care perspective, with a four-year time horizon. Results: Overall, 226/337 (67%) of participants returned completed follow-up questionnaires, yielding adjusted between-group differences in BPI means of -0.42 (95% confidence interval, CI (-1.07, 0.23); p = 0.20) for pain severity and − 0.64 (95% CI -1.41, 0.12); p = 0.10) for pain interference. Analysis using a multiple imputed data set (n = 337) showed an incremental net monetary benefit in favour of the STAR care pathway of £3,525 (95% CI -£990 to £8,039) at a £20,000/QALY willingness-to-pay threshold, leading to a probability that the intervention was cost-effective of 0.94. Conclusions: The magnitude of the longer-term benefits of the STAR care pathway are uncertain due to attrition of trial participants; however, there is a suggestion of some degree of sustained clinical benefit at four years. The care pathway remained cost-effective at four years. Trial registration: ISRCTN: 92,545,361.",

keywords = "Care pathway, Chronic post-surgical pain, Osteoarthritis, Total knee replacement",

author = "Wendy Bertram and Vikki Wylde and Nick Howells and Beverly Shirkey and Peters, {Tim J.} and Liang Zhu and Sian Noble and Emma Johnson and Beswick, {Andrew D.} and Andrew Moore and Julie Bruce and David Walsh and Christopher Eccleston and Rachael Gooberman-Hill",

year = "2023",

month = dec,

day = "16",

doi = "10.1186/s12891-023-07099-x",

language = "English",

volume = "24",

journal = "BMC Musculoskeletal Disorders",

issn = "1471-2474",

publisher = "BioMed Central",

number = "1",

}

TY - JOUR

T1 - The STAR care pathway for patients with chronic pain after total knee replacement

T2 - four-year follow-up of a randomised controlled trial

AU - Bertram, Wendy

AU - Wylde, Vikki

AU - Howells, Nick

AU - Shirkey, Beverly

AU - Peters, Tim J.

AU - Zhu, Liang

AU - Noble, Sian

AU - Johnson, Emma

AU - Beswick, Andrew D.

AU - Moore, Andrew

AU - Bruce, Julie

AU - Walsh, David

AU - Eccleston, Christopher

AU - Gooberman-Hill, Rachael

PY - 2023/12/16

Y1 - 2023/12/16

N2 - Background: The Support and Treatment After Replacement (STAR) care pathway is a clinically important and cost-effective intervention found to improve pain outcomes over one year for people with chronic pain three months after total knee replacement (TKR). We followed up STAR trial participants to evaluate the longer-term clinical- and cost-effectiveness of this care pathway. Methods: Participants who remained enrolled on the trial at one year were contacted by post at a median of four years after randomisation and invited to complete a questionnaire comprising the same outcomes collected during the trial. We captured pain (co-primary outcome using the Brief Pain Inventory (BPI) pain severity and interference scales; scored 0–10, best to worst), function, neuropathic characteristics, emotional aspects of pain, health-related quality of life, and satisfaction. Electronic hospital informatics data on hospital resource use for the period of one to four years post-randomisation were collected from participating hospital sites. The economic evaluation took an National Health Service (NHS) secondary care perspective, with a four-year time horizon. Results: Overall, 226/337 (67%) of participants returned completed follow-up questionnaires, yielding adjusted between-group differences in BPI means of -0.42 (95% confidence interval, CI (-1.07, 0.23); p = 0.20) for pain severity and − 0.64 (95% CI -1.41, 0.12); p = 0.10) for pain interference. Analysis using a multiple imputed data set (n = 337) showed an incremental net monetary benefit in favour of the STAR care pathway of £3,525 (95% CI -£990 to £8,039) at a £20,000/QALY willingness-to-pay threshold, leading to a probability that the intervention was cost-effective of 0.94. Conclusions: The magnitude of the longer-term benefits of the STAR care pathway are uncertain due to attrition of trial participants; however, there is a suggestion of some degree of sustained clinical benefit at four years. The care pathway remained cost-effective at four years. Trial registration: ISRCTN: 92,545,361.

AB - Background: The Support and Treatment After Replacement (STAR) care pathway is a clinically important and cost-effective intervention found to improve pain outcomes over one year for people with chronic pain three months after total knee replacement (TKR). We followed up STAR trial participants to evaluate the longer-term clinical- and cost-effectiveness of this care pathway. Methods: Participants who remained enrolled on the trial at one year were contacted by post at a median of four years after randomisation and invited to complete a questionnaire comprising the same outcomes collected during the trial. We captured pain (co-primary outcome using the Brief Pain Inventory (BPI) pain severity and interference scales; scored 0–10, best to worst), function, neuropathic characteristics, emotional aspects of pain, health-related quality of life, and satisfaction. Electronic hospital informatics data on hospital resource use for the period of one to four years post-randomisation were collected from participating hospital sites. The economic evaluation took an National Health Service (NHS) secondary care perspective, with a four-year time horizon. Results: Overall, 226/337 (67%) of participants returned completed follow-up questionnaires, yielding adjusted between-group differences in BPI means of -0.42 (95% confidence interval, CI (-1.07, 0.23); p = 0.20) for pain severity and − 0.64 (95% CI -1.41, 0.12); p = 0.10) for pain interference. Analysis using a multiple imputed data set (n = 337) showed an incremental net monetary benefit in favour of the STAR care pathway of £3,525 (95% CI -£990 to £8,039) at a £20,000/QALY willingness-to-pay threshold, leading to a probability that the intervention was cost-effective of 0.94. Conclusions: The magnitude of the longer-term benefits of the STAR care pathway are uncertain due to attrition of trial participants; however, there is a suggestion of some degree of sustained clinical benefit at four years. The care pathway remained cost-effective at four years. Trial registration: ISRCTN: 92,545,361.

KW - Care pathway

KW - Chronic post-surgical pain

KW - Osteoarthritis

KW - Total knee replacement

UR - http://www.scopus.com/inward/record.url?scp=85179733822&partnerID=8YFLogxK

U2 - 10.1186/s12891-023-07099-x

DO - 10.1186/s12891-023-07099-x

M3 - Article

C2 - 38102656

AN - SCOPUS:85179733822

SN - 1471-2474

VL - 24

JO - BMC Musculoskeletal Disorders

JF - BMC Musculoskeletal Disorders

IS - 1

M1 - 972

ER -

The STAR care pathway for patients with chronic pain after total knee replacement: four-year follow-up of a randomised controlled trial

Abstract

Acknowledgements

Keywords

ASJC Scopus subject areas

Access to Document

Other files and links

Fingerprint

Cite this