The STAR care pathway for patients with pain at 3 months after total knee replacement: a multicentre, pragmatic, randomised, controlled trial

STAR trial group

doi:10.1016/S2665-9913(21)00371-4

The STAR care pathway for patients with pain at 3 months after total knee replacement: a multicentre, pragmatic, randomised, controlled trial

STAR trial group

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

28 Citations (SciVal)

Abstract

Background: Approximately 20% of people experience chronic pain after total knee replacement, but effective treatments are not available. We aimed to evaluate the clinical effectiveness and cost-effectiveness of a new care pathway for chronic pain after total knee replacement. Methods: We did an unmasked, parallel group, pragmatic, superiority, randomised, controlled trial at eight UK National Health Service (NHS) hospitals. People with chronic pain at 3 months after total knee replacement surgery were randomly assigned (2:1) to the Support and Treatment After Replacement (STAR) care pathway plus usual care, or to usual care alone. The STAR intervention aimed to identify underlying causes of chronic pain and enable onward referrals for targeted treatment through a 3-month post-surgery assessment with an extended scope practitioner and telephone follow-up over 12 months. Co-primary outcomes were self-reported pain severity and pain interference in the replaced knee, assessed with the Brief Pain Inventory (BPI) pain severity and interference scales at 12 months (scored 0–10, best to worst) and analysed on an as-randomised basis. Resource use, collected from electronic hospital records and participants, was valued with UK reference costs. Quality-adjusted life-years (QALYs) were calculated from EQ-5D-5L responses. This trial is registered with ISRCTN, ISRCTN92545361. Findings: Between Sept 6, 2016, and May 31, 2019, 363 participants were randomly assigned to receive the intervention plus usual care (n=242) or to receive usual care alone (n=121). Participants had a median age of 67 years (IQR 61 to 73), 217 (60%) of 363 were female, and 335 (92%) were White. 313 (86%) patients provided follow-up data at 12 months after randomisation (213 assigned to the intervention plus usual care and 100 assigned to usual care alone). At 12 months, the mean between-group difference in the BPI severity score was −0·65 (95% CI −1·17 to −0·13; p=0·014) and the mean between-group difference in the BPI interference score was −0·68 (−1·29 to −0·08; p=0·026), both favouring the intervention. From an NHS and personal social services perspective, the intervention was cost-effective (greater improvement with lower cost), with an incremental net monetary benefit of £1256 (95% CI 164 to 2348) at £20 000 per QALY threshold. One adverse reaction of participant distress was reported in the intervention group. Interpretation: STAR is a clinically effective and cost-effective intervention to improve pain outcomes over 1 year for people with chronic pain at 3 months after total knee replacement surgery. Funding: National Institute for Health Research.

Original language	English
Pages (from-to)	e188-e197
Number of pages	10
Journal	The Lancet Rheumatology
Volume	4
Issue number	3
Early online date	28 Jan 2022
DOIs	https://doi.org/10.1016/S2665-9913(21)00371-4
Publication status	Published - 31 Mar 2022

Bibliographical note

Funding Information:
The STAR team acknowledges the following people for their help and input into the STAR trial: Andrew Judge, Athene Lane, Fiona MacKichan, Nicolas Ambler, Susan Bridgewater, Leigh Morrison, Gemma Munkenbeck, Candida McCabe, Rowenna Stroud, Kate Button, Nigel Arden, Andrew Price, Rafael Pinedo-Villaneuva, Anushka Soni, and the Patient Experience Partnership in Research (PEP-R) group. We also thank colleagues at Versus Arthritis for their support. This study is funded by the NIHR (Programme Grant for Applied Research; Grant Reference Number RP-PG-0613–20001). 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.

Funding Information:
The STAR team acknowledges the following people for their help and input into the STAR trial: Andrew Judge, Athene Lane, Fiona MacKichan, Nicolas Ambler, Susan Bridgewater, Leigh Morrison, Gemma Munkenbeck, Candida McCabe, Rowenna Stroud, Kate Button, Nigel Arden, Andrew Price, Rafael Pinedo-Villaneuva, Anushka Soni, and the Patient Experience Partnership in Research (PEP-R) group. We also thank colleagues at Versus Arthritis for their support. This study is funded by the NIHR (Programme Grant for Applied Research; Grant Reference Number RP-PG-0613?20001). 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.

Funding Information:
AWB and VW have received funding from Stryker for research unrelated to this work. DAW has received grant funding from Pfizer; consulting fees from Pfizer, AbbVie, GlaxoSmithKline, Reckitt- Benckiser, Galapagos, and EliLilly; and payment for lectures, presentations, and educational events from Pfizer and AbbVie, all unrelated to this work. All other authors declare no competing interests.

Funding

The STAR team acknowledges the following people for their help and input into the STAR trial: Andrew Judge, Athene Lane, Fiona MacKichan, Nicolas Ambler, Susan Bridgewater, Leigh Morrison, Gemma Munkenbeck, Candida McCabe, Rowenna Stroud, Kate Button, Nigel Arden, Andrew Price, Rafael Pinedo-Villaneuva, Anushka Soni, and the Patient Experience Partnership in Research (PEP-R) group. We also thank colleagues at Versus Arthritis for their support. This study is funded by the NIHR (Programme Grant for Applied Research; Grant Reference Number RP-PG-0613–20001). 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. The STAR team acknowledges the following people for their help and input into the STAR trial: Andrew Judge, Athene Lane, Fiona MacKichan, Nicolas Ambler, Susan Bridgewater, Leigh Morrison, Gemma Munkenbeck, Candida McCabe, Rowenna Stroud, Kate Button, Nigel Arden, Andrew Price, Rafael Pinedo-Villaneuva, Anushka Soni, and the Patient Experience Partnership in Research (PEP-R) group. We also thank colleagues at Versus Arthritis for their support. This study is funded by the NIHR (Programme Grant for Applied Research; Grant Reference Number RP-PG-0613?20001). 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.

ASJC Scopus subject areas

Rheumatology
Immunology and Allergy
Immunology

Access to Document

10.1016/S2665-9913(21)00371-4Licence: CC BY

Cite this

@article{13f2abcae9794a028ea5b449e3e9d578,

title = "The STAR care pathway for patients with pain at 3 months after total knee replacement: a multicentre, pragmatic, randomised, controlled trial",

abstract = "Background: Approximately 20% of people experience chronic pain after total knee replacement, but effective treatments are not available. We aimed to evaluate the clinical effectiveness and cost-effectiveness of a new care pathway for chronic pain after total knee replacement. Methods: We did an unmasked, parallel group, pragmatic, superiority, randomised, controlled trial at eight UK National Health Service (NHS) hospitals. People with chronic pain at 3 months after total knee replacement surgery were randomly assigned (2:1) to the Support and Treatment After Replacement (STAR) care pathway plus usual care, or to usual care alone. The STAR intervention aimed to identify underlying causes of chronic pain and enable onward referrals for targeted treatment through a 3-month post-surgery assessment with an extended scope practitioner and telephone follow-up over 12 months. Co-primary outcomes were self-reported pain severity and pain interference in the replaced knee, assessed with the Brief Pain Inventory (BPI) pain severity and interference scales at 12 months (scored 0–10, best to worst) and analysed on an as-randomised basis. Resource use, collected from electronic hospital records and participants, was valued with UK reference costs. Quality-adjusted life-years (QALYs) were calculated from EQ-5D-5L responses. This trial is registered with ISRCTN, ISRCTN92545361. Findings: Between Sept 6, 2016, and May 31, 2019, 363 participants were randomly assigned to receive the intervention plus usual care (n=242) or to receive usual care alone (n=121). Participants had a median age of 67 years (IQR 61 to 73), 217 (60%) of 363 were female, and 335 (92%) were White. 313 (86%) patients provided follow-up data at 12 months after randomisation (213 assigned to the intervention plus usual care and 100 assigned to usual care alone). At 12 months, the mean between-group difference in the BPI severity score was −0·65 (95% CI −1·17 to −0·13; p=0·014) and the mean between-group difference in the BPI interference score was −0·68 (−1·29 to −0·08; p=0·026), both favouring the intervention. From an NHS and personal social services perspective, the intervention was cost-effective (greater improvement with lower cost), with an incremental net monetary benefit of £1256 (95% CI 164 to 2348) at £20 000 per QALY threshold. One adverse reaction of participant distress was reported in the intervention group. Interpretation: STAR is a clinically effective and cost-effective intervention to improve pain outcomes over 1 year for people with chronic pain at 3 months after total knee replacement surgery. Funding: National Institute for Health Research.",

author = "{STAR trial group} and Vikki Wylde and Wendy Bertram and Emily Sanderson and Sian Noble and Nicholas Howells and Peters, {Tim J.} and Beswick, {Andrew D.} and Blom, {Ashley W.} and Moore, {Andrew J.} and Julie Bruce and Walsh, {David A.} and Christopher Eccleston and Shaun Harris and Kirsty Garfield and Simon White and Andrew Toms and Rachael Gooberman-Hill and Amanda Burston and Jane Dennis and Paul Dieppe and Benjamin Burston and Vikram Desai and Tim Board and Colin Esler and Michael Parry and Phillips, {Jonathan R.A.}",

note = "Funding Information: The STAR team acknowledges the following people for their help and input into the STAR trial: Andrew Judge, Athene Lane, Fiona MacKichan, Nicolas Ambler, Susan Bridgewater, Leigh Morrison, Gemma Munkenbeck, Candida McCabe, Rowenna Stroud, Kate Button, Nigel Arden, Andrew Price, Rafael Pinedo-Villaneuva, Anushka Soni, and the Patient Experience Partnership in Research (PEP-R) group. We also thank colleagues at Versus Arthritis for their support. This study is funded by the NIHR (Programme Grant for Applied Research; Grant Reference Number RP-PG-0613–20001). 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. Funding Information: The STAR team acknowledges the following people for their help and input into the STAR trial: Andrew Judge, Athene Lane, Fiona MacKichan, Nicolas Ambler, Susan Bridgewater, Leigh Morrison, Gemma Munkenbeck, Candida McCabe, Rowenna Stroud, Kate Button, Nigel Arden, Andrew Price, Rafael Pinedo-Villaneuva, Anushka Soni, and the Patient Experience Partnership in Research (PEP-R) group. We also thank colleagues at Versus Arthritis for their support. This study is funded by the NIHR (Programme Grant for Applied Research; Grant Reference Number RP-PG-0613?20001). 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. Funding Information: AWB and VW have received funding from Stryker for research unrelated to this work. DAW has received grant funding from Pfizer; consulting fees from Pfizer, AbbVie, GlaxoSmithKline, Reckitt- Benckiser, Galapagos, and EliLilly; and payment for lectures, presentations, and educational events from Pfizer and AbbVie, all unrelated to this work. All other authors declare no competing interests. ",

year = "2022",

month = mar,

day = "31",

doi = "10.1016/S2665-9913(21)00371-4",

language = "English",

volume = "4",

pages = "e188--e197",

journal = "The Lancet Rheumatology",

issn = "2665-9913",

publisher = "Elsevier",

number = "3",

}

TY - JOUR

T1 - The STAR care pathway for patients with pain at 3 months after total knee replacement

T2 - a multicentre, pragmatic, randomised, controlled trial

AU - STAR trial group

AU - Wylde, Vikki

AU - Bertram, Wendy

AU - Sanderson, Emily

AU - Noble, Sian

AU - Howells, Nicholas

AU - Peters, Tim J.

AU - Beswick, Andrew D.

AU - Blom, Ashley W.

AU - Moore, Andrew J.

AU - Bruce, Julie

AU - Walsh, David A.

AU - Eccleston, Christopher

AU - Harris, Shaun

AU - Garfield, Kirsty

AU - White, Simon

AU - Toms, Andrew

AU - Gooberman-Hill, Rachael

AU - Burston, Amanda

AU - Dennis, Jane

AU - Dieppe, Paul

AU - Burston, Benjamin

AU - Desai, Vikram

AU - Board, Tim

AU - Esler, Colin

AU - Parry, Michael

AU - Phillips, Jonathan R.A.

N1 - Funding Information: The STAR team acknowledges the following people for their help and input into the STAR trial: Andrew Judge, Athene Lane, Fiona MacKichan, Nicolas Ambler, Susan Bridgewater, Leigh Morrison, Gemma Munkenbeck, Candida McCabe, Rowenna Stroud, Kate Button, Nigel Arden, Andrew Price, Rafael Pinedo-Villaneuva, Anushka Soni, and the Patient Experience Partnership in Research (PEP-R) group. We also thank colleagues at Versus Arthritis for their support. This study is funded by the NIHR (Programme Grant for Applied Research; Grant Reference Number RP-PG-0613–20001). 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. Funding Information: The STAR team acknowledges the following people for their help and input into the STAR trial: Andrew Judge, Athene Lane, Fiona MacKichan, Nicolas Ambler, Susan Bridgewater, Leigh Morrison, Gemma Munkenbeck, Candida McCabe, Rowenna Stroud, Kate Button, Nigel Arden, Andrew Price, Rafael Pinedo-Villaneuva, Anushka Soni, and the Patient Experience Partnership in Research (PEP-R) group. We also thank colleagues at Versus Arthritis for their support. This study is funded by the NIHR (Programme Grant for Applied Research; Grant Reference Number RP-PG-0613?20001). 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. Funding Information: AWB and VW have received funding from Stryker for research unrelated to this work. DAW has received grant funding from Pfizer; consulting fees from Pfizer, AbbVie, GlaxoSmithKline, Reckitt- Benckiser, Galapagos, and EliLilly; and payment for lectures, presentations, and educational events from Pfizer and AbbVie, all unrelated to this work. All other authors declare no competing interests.

PY - 2022/3/31

Y1 - 2022/3/31

N2 - Background: Approximately 20% of people experience chronic pain after total knee replacement, but effective treatments are not available. We aimed to evaluate the clinical effectiveness and cost-effectiveness of a new care pathway for chronic pain after total knee replacement. Methods: We did an unmasked, parallel group, pragmatic, superiority, randomised, controlled trial at eight UK National Health Service (NHS) hospitals. People with chronic pain at 3 months after total knee replacement surgery were randomly assigned (2:1) to the Support and Treatment After Replacement (STAR) care pathway plus usual care, or to usual care alone. The STAR intervention aimed to identify underlying causes of chronic pain and enable onward referrals for targeted treatment through a 3-month post-surgery assessment with an extended scope practitioner and telephone follow-up over 12 months. Co-primary outcomes were self-reported pain severity and pain interference in the replaced knee, assessed with the Brief Pain Inventory (BPI) pain severity and interference scales at 12 months (scored 0–10, best to worst) and analysed on an as-randomised basis. Resource use, collected from electronic hospital records and participants, was valued with UK reference costs. Quality-adjusted life-years (QALYs) were calculated from EQ-5D-5L responses. This trial is registered with ISRCTN, ISRCTN92545361. Findings: Between Sept 6, 2016, and May 31, 2019, 363 participants were randomly assigned to receive the intervention plus usual care (n=242) or to receive usual care alone (n=121). Participants had a median age of 67 years (IQR 61 to 73), 217 (60%) of 363 were female, and 335 (92%) were White. 313 (86%) patients provided follow-up data at 12 months after randomisation (213 assigned to the intervention plus usual care and 100 assigned to usual care alone). At 12 months, the mean between-group difference in the BPI severity score was −0·65 (95% CI −1·17 to −0·13; p=0·014) and the mean between-group difference in the BPI interference score was −0·68 (−1·29 to −0·08; p=0·026), both favouring the intervention. From an NHS and personal social services perspective, the intervention was cost-effective (greater improvement with lower cost), with an incremental net monetary benefit of £1256 (95% CI 164 to 2348) at £20 000 per QALY threshold. One adverse reaction of participant distress was reported in the intervention group. Interpretation: STAR is a clinically effective and cost-effective intervention to improve pain outcomes over 1 year for people with chronic pain at 3 months after total knee replacement surgery. Funding: National Institute for Health Research.

AB - Background: Approximately 20% of people experience chronic pain after total knee replacement, but effective treatments are not available. We aimed to evaluate the clinical effectiveness and cost-effectiveness of a new care pathway for chronic pain after total knee replacement. Methods: We did an unmasked, parallel group, pragmatic, superiority, randomised, controlled trial at eight UK National Health Service (NHS) hospitals. People with chronic pain at 3 months after total knee replacement surgery were randomly assigned (2:1) to the Support and Treatment After Replacement (STAR) care pathway plus usual care, or to usual care alone. The STAR intervention aimed to identify underlying causes of chronic pain and enable onward referrals for targeted treatment through a 3-month post-surgery assessment with an extended scope practitioner and telephone follow-up over 12 months. Co-primary outcomes were self-reported pain severity and pain interference in the replaced knee, assessed with the Brief Pain Inventory (BPI) pain severity and interference scales at 12 months (scored 0–10, best to worst) and analysed on an as-randomised basis. Resource use, collected from electronic hospital records and participants, was valued with UK reference costs. Quality-adjusted life-years (QALYs) were calculated from EQ-5D-5L responses. This trial is registered with ISRCTN, ISRCTN92545361. Findings: Between Sept 6, 2016, and May 31, 2019, 363 participants were randomly assigned to receive the intervention plus usual care (n=242) or to receive usual care alone (n=121). Participants had a median age of 67 years (IQR 61 to 73), 217 (60%) of 363 were female, and 335 (92%) were White. 313 (86%) patients provided follow-up data at 12 months after randomisation (213 assigned to the intervention plus usual care and 100 assigned to usual care alone). At 12 months, the mean between-group difference in the BPI severity score was −0·65 (95% CI −1·17 to −0·13; p=0·014) and the mean between-group difference in the BPI interference score was −0·68 (−1·29 to −0·08; p=0·026), both favouring the intervention. From an NHS and personal social services perspective, the intervention was cost-effective (greater improvement with lower cost), with an incremental net monetary benefit of £1256 (95% CI 164 to 2348) at £20 000 per QALY threshold. One adverse reaction of participant distress was reported in the intervention group. Interpretation: STAR is a clinically effective and cost-effective intervention to improve pain outcomes over 1 year for people with chronic pain at 3 months after total knee replacement surgery. Funding: National Institute for Health Research.

UR - http://www.scopus.com/inward/record.url?scp=85125165562&partnerID=8YFLogxK

U2 - 10.1016/S2665-9913(21)00371-4

DO - 10.1016/S2665-9913(21)00371-4

M3 - Article

AN - SCOPUS:85125165562

SN - 2665-9913

VL - 4

SP - e188-e197

JO - The Lancet Rheumatology

JF - The Lancet Rheumatology

IS - 3

ER -

The STAR care pathway for patients with pain at 3 months after total knee replacement: a multicentre, pragmatic, randomised, controlled trial

Abstract

Bibliographical note

Funding

ASJC Scopus subject areas

Access to Document

Other files and links

Fingerprint

Cite this