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Published in: Trials 1/2018

Open Access 01-12-2018 | Research

Development of a complex intervention for people with chronic pain after knee replacement: the STAR care pathway

Authors: Vikki Wylde, Nicholas Howells, Wendy Bertram, Andrew J. Moore, Julie Bruce, Candy McCabe, Ashley W. Blom, Jane Dennis, Amanda Burston, Rachael Gooberman-Hill

Published in: Trials | Issue 1/2018

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Abstract

Background

Approximately 20% of people who have total knee replacement experience chronic pain afterwards, but there is little evidence about effective interventions for managing this type of pain. This article describes the systematic development and refinement of a complex intervention for people with chronic pain after knee replacement. The intervention is a care pathway involving an assessment clinic and onward referral, with telephone follow-up as required. In the design of this multistage study, we chose to focus on ensuring that the intervention was deliverable, implementable and acceptable.

Methods

In line with the UK Medical Research Council’s recommendations for comprehensive development of complex interventions, multiple phases of work were undertaken. Following on from initial development work to design the intervention, the draft intervention content was refined through consensus questionnaires with 22 health professionals and discussion at meetings with 18 healthcare professionals. Testing of intervention delivery and acceptability to patients was undertaken by two health professionals delivering the assessment clinic to ten patients. Views about future implementation within the context of a randomised trial were evaluated through a questionnaire based on the Normalisation Measure Development (NoMAD) instrument with ten health professional stakeholders.

Results

Consensus work with health professionals ensured the components of the intervention were appropriate and informed a number of substantive changes to improve the intervention. Testing of intervention delivery identified a number of logistical issues that were then addressed in the development of a comprehensive intervention training manual. Engagement with stakeholders indicated that the intervention could be successfully implemented in a clinical setting for evaluation in a randomised trial.

Conclusions

This work has informed the development and refinement of a complex intervention for people with chronic pain after knee replacement. The next stage is to evaluate the clinical and cost-effectiveness of the STAR care pathway in a multicentre randomised trial.
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Literature
1.
go back to reference National Joint Registry for England, Wales, Northern Ireland and the Isle of Man. 13th Annual Report. Hemel Hempstead: NJR Centre; 2016. National Joint Registry for England, Wales, Northern Ireland and the Isle of Man. 13th Annual Report. Hemel Hempstead: NJR Centre; 2016.
2.
go back to reference Nilsdotter AK, Toksvig-Larsen S, Roos EM. Knee arthroplasty: are patients’ expectations fulfilled? A prospective study of pain and function in 102 patients with 5-year follow-up. Acta Orthop. 2009;80(1):55–61.CrossRefPubMedPubMedCentral Nilsdotter AK, Toksvig-Larsen S, Roos EM. Knee arthroplasty: are patients’ expectations fulfilled? A prospective study of pain and function in 102 patients with 5-year follow-up. Acta Orthop. 2009;80(1):55–61.CrossRefPubMedPubMedCentral
3.
go back to reference Beswick AD, Wylde V, Gooberman-Hill R, Blom A, Dieppe P. What proportion of patients report long-term pain after total hip or knee replacement for osteoarthritis? A systematic review of prospective studies in unselected patients. BMJ Open. 2012;2(1):e000435.CrossRefPubMedPubMedCentral Beswick AD, Wylde V, Gooberman-Hill R, Blom A, Dieppe P. What proportion of patients report long-term pain after total hip or knee replacement for osteoarthritis? A systematic review of prospective studies in unselected patients. BMJ Open. 2012;2(1):e000435.CrossRefPubMedPubMedCentral
4.
go back to reference Werner MU, Kongsgaard UE. I. Defining persistent post-surgical pain: is an update required? Br J Anaesth. 2014;113(1):1–4.CrossRefPubMed Werner MU, Kongsgaard UE. I. Defining persistent post-surgical pain: is an update required? Br J Anaesth. 2014;113(1):1–4.CrossRefPubMed
5.
go back to reference Howells N, Murray J, Wylde V, Dieppe P, Blom A. Persistent pain after knee replacement: do factors associated with pain vary with degree of patient dissatisfaction? Osteoarthritis Cartilage. 2016;24(12):2061–8.CrossRefPubMed Howells N, Murray J, Wylde V, Dieppe P, Blom A. Persistent pain after knee replacement: do factors associated with pain vary with degree of patient dissatisfaction? Osteoarthritis Cartilage. 2016;24(12):2061–8.CrossRefPubMed
6.
go back to reference Jeffery AE, Wylde V, Blom AW, Horwood JP. “It’s there and I’m stuck with it”: patients’ experiences of chronic pain following total knee replacement surgery. Arthritis Care Res (Hoboken). 2011;63(2):286–92.CrossRef Jeffery AE, Wylde V, Blom AW, Horwood JP. “It’s there and I’m stuck with it”: patients’ experiences of chronic pain following total knee replacement surgery. Arthritis Care Res (Hoboken). 2011;63(2):286–92.CrossRef
7.
go back to reference Wylde V, Mackichan F, Dixon S, Gooberman-Hill R. Service provision for patients with chronic post-surgical pain after total knee replacement: an evaluation of current practice. J Pain Manag. 2014;7(2):147–54. Wylde V, Mackichan F, Dixon S, Gooberman-Hill R. Service provision for patients with chronic post-surgical pain after total knee replacement: an evaluation of current practice. J Pain Manag. 2014;7(2):147–54.
8.
go back to reference Beswick AD, Wylde V, Gooberman-Hill R. Interventions for the prediction and management of chronic postsurgical pain after total knee replacement: systematic review of randomised controlled trials. BMJ Open. 2015;5(5):e007387.CrossRefPubMedPubMedCentral Beswick AD, Wylde V, Gooberman-Hill R. Interventions for the prediction and management of chronic postsurgical pain after total knee replacement: systematic review of randomised controlled trials. BMJ Open. 2015;5(5):e007387.CrossRefPubMedPubMedCentral
9.
go back to reference Wylde V, Dennis J, Beswick A, Bruce J, Eccleston C, Howells N, Peters T, Gooberman-Hill R. Management of chronic pain after surgery: a systematic review. Br J Surg. 2017;104(10):1293–306.CrossRefPubMedPubMedCentral Wylde V, Dennis J, Beswick A, Bruce J, Eccleston C, Howells N, Peters T, Gooberman-Hill R. Management of chronic pain after surgery: a systematic review. Br J Surg. 2017;104(10):1293–306.CrossRefPubMedPubMedCentral
10.
go back to reference Turk DC, Wilson HD, Cahana A. Treatment of chronic non-cancer pain. Lancet. 2011;377(9784):2226–35.CrossRefPubMed Turk DC, Wilson HD, Cahana A. Treatment of chronic non-cancer pain. Lancet. 2011;377(9784):2226–35.CrossRefPubMed
11.
go back to reference Toms AD, Mandalia V, Haigh R, Hopwood B. The management of patients with painful total knee replacement. J Bone Joint Surg (Br). 2009;91(2):143–50.CrossRef Toms AD, Mandalia V, Haigh R, Hopwood B. The management of patients with painful total knee replacement. J Bone Joint Surg (Br). 2009;91(2):143–50.CrossRef
12.
go back to reference Mandalia V, Eyres K, Schranz P, Toms AD. Evaluation of patients with a painful total knee replacement. J Bone Joint Surg (Br). 2008;90(3):265–71.CrossRef Mandalia V, Eyres K, Schranz P, Toms AD. Evaluation of patients with a painful total knee replacement. J Bone Joint Surg (Br). 2008;90(3):265–71.CrossRef
14.
go back to reference Gooberman-Hill R, Burston A, Clark E, Johnson E, Nolan S, Wells V, Betts L, Pep R. Involving patients in research: considering good practice. Musculoskeletal Care. 2013;11(4):187–90.CrossRefPubMedPubMedCentral Gooberman-Hill R, Burston A, Clark E, Johnson E, Nolan S, Wells V, Betts L, Pep R. Involving patients in research: considering good practice. Musculoskeletal Care. 2013;11(4):187–90.CrossRefPubMedPubMedCentral
15.
go back to reference Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M, G. Medical Research Council. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008;337:a1655.CrossRefPubMedPubMedCentral Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M, G. Medical Research Council. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008;337:a1655.CrossRefPubMedPubMedCentral
16.
go back to reference Hoffmann TC, Glasziou PP, Boutron I, Milne R, Perera R, Moher D, Altman DG, Barbour V, Macdonald H, Johnston M, Lamb SE, Dixon-Woods M, McCulloch P, Wyatt JC, Chan AW, Michie S. Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ. 2014;348:g1687.CrossRefPubMed Hoffmann TC, Glasziou PP, Boutron I, Milne R, Perera R, Moher D, Altman DG, Barbour V, Macdonald H, Johnston M, Lamb SE, Dixon-Woods M, McCulloch P, Wyatt JC, Chan AW, Michie S. Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ. 2014;348:g1687.CrossRefPubMed
17.
go back to reference Wylde V, Mackichan F, Bruce J, Gooberman-Hill R. Assessment of chronic post-surgical pain after knee replacement: development of a core outcome set. Eur J Pain. 2015;19(5):611–20.CrossRefPubMed Wylde V, Mackichan F, Bruce J, Gooberman-Hill R. Assessment of chronic post-surgical pain after knee replacement: development of a core outcome set. Eur J Pain. 2015;19(5):611–20.CrossRefPubMed
18.
go back to reference Raine R, Sanderson C, Hutchings A, Carter S, Larkin K, Black N. An experimental study of determinants of group judgments in clinical guideline development. Lancet. 2004;364(9432):429–37.CrossRefPubMed Raine R, Sanderson C, Hutchings A, Carter S, Larkin K, Black N. An experimental study of determinants of group judgments in clinical guideline development. Lancet. 2004;364(9432):429–37.CrossRefPubMed
19.
go back to reference Fitch K, Bernstein S, Aguilar M, Burnand B, LaCalle J, Lazaro P, van het Loo M, McDonnell J, Vader J, Kahan J. The RAND/UCLA Appropriateness Method User’s Manual. Santa Monica: RAND; 2001. Fitch K, Bernstein S, Aguilar M, Burnand B, LaCalle J, Lazaro P, van het Loo M, McDonnell J, Vader J, Kahan J. The RAND/UCLA Appropriateness Method User’s Manual. Santa Monica: RAND; 2001.
20.
go back to reference Dawson J, Fitzpatrick R, Murray D, Carr A. Questionnaire on the perceptions of patients about total knee replacement. J Bone Joint Surg (Br). 1998;80(1):63–9.CrossRef Dawson J, Fitzpatrick R, Murray D, Carr A. Questionnaire on the perceptions of patients about total knee replacement. J Bone Joint Surg (Br). 1998;80(1):63–9.CrossRef
21.
go back to reference Harris K, Dawson J, Doll H, Field RE, Murray DW, Fitzpatrick R, Jenkinson C, Price AJ, Beard DJ. Can pain and function be distinguished in the Oxford Knee Score in a meaningful way? An exploratory and confirmatory factor analysis. Qual Life Res. 2013;22(9):2561–8.CrossRefPubMed Harris K, Dawson J, Doll H, Field RE, Murray DW, Fitzpatrick R, Jenkinson C, Price AJ, Beard DJ. Can pain and function be distinguished in the Oxford Knee Score in a meaningful way? An exploratory and confirmatory factor analysis. Qual Life Res. 2013;22(9):2561–8.CrossRefPubMed
22.
go back to reference Pinedo-Villanueva R, Khalid S, Wylde V, Gooberman-Hill R, Judge A. A cut-off point in the Oxford knee score to identify patients with chronic pain after knee replacement. Florence: World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases; 2017. Pinedo-Villanueva R, Khalid S, Wylde V, Gooberman-Hill R, Judge A. A cut-off point in the Oxford knee score to identify patients with chronic pain after knee replacement. Florence: World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases; 2017.
23.
go back to reference Finch TL, Girling M, May CR, Mair FS, Murray E, Treweek S, Steen IN, McColl EM, Dickinson C, Rapley T. NoMAD: Implementation measure based on Normalization Process Theory. [Measurement instrument]. 2015. Available at: http://www.normalizationprocess.org. Accessed 3 Jan 2018. Finch TL, Girling M, May CR, Mair FS, Murray E, Treweek S, Steen IN, McColl EM, Dickinson C, Rapley T. NoMAD: Implementation measure based on Normalization Process Theory. [Measurement instrument]. 2015. Available at: http://​www.​normalizationpro​cess.​org. Accessed 3 Jan 2018.
24.
go back to reference May CR, Mair F, Finch T, MacFarlane A, Dowrick C, Treweek S, Rapley T, Ballini L, Ong BN, Rogers A, Murray E, Elwyn G, Legare F, Gunn J, Montori VM. Development of a theory of implementation and integration: Normalization Process Theory. Implement Sci. 2009;4:29.CrossRefPubMedPubMedCentral May CR, Mair F, Finch T, MacFarlane A, Dowrick C, Treweek S, Rapley T, Ballini L, Ong BN, Rogers A, Murray E, Elwyn G, Legare F, Gunn J, Montori VM. Development of a theory of implementation and integration: Normalization Process Theory. Implement Sci. 2009;4:29.CrossRefPubMedPubMedCentral
25.
go back to reference Cleeland CS. The brief pain inventory: user guide. Houston: University of Texas. MD Anderson Cancer Center; 2009. Cleeland CS. The brief pain inventory: user guide. Houston: University of Texas. MD Anderson Cancer Center; 2009.
26.
go back to reference Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983;67(6):361–70.CrossRefPubMed Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983;67(6):361–70.CrossRefPubMed
27.
go back to reference Freynhagen R, Baron R, Gockel U, Tolle TR. painDETECT: a new screening questionnaire to identify neuropathic components in patients with back pain. Curr Med Res Opin. 2006;22(10):1911–20.CrossRefPubMed Freynhagen R, Baron R, Gockel U, Tolle TR. painDETECT: a new screening questionnaire to identify neuropathic components in patients with back pain. Curr Med Res Opin. 2006;22(10):1911–20.CrossRefPubMed
28.
go back to reference Bouhassira D, Attal N, Alchaar H, Boureau F, Brochet B, Bruxelle J, Cunin G, Fermanian J, Ginies P, Grun-Overdyking A. Comparison of pain syndromes associated with nervous or somatic lesions and development of a new neuropathic pain diagnostic questionnaire (DN4). Pain. 2005;114(1–2):29–36.CrossRefPubMed Bouhassira D, Attal N, Alchaar H, Boureau F, Brochet B, Bruxelle J, Cunin G, Fermanian J, Ginies P, Grun-Overdyking A. Comparison of pain syndromes associated with nervous or somatic lesions and development of a new neuropathic pain diagnostic questionnaire (DN4). Pain. 2005;114(1–2):29–36.CrossRefPubMed
29.
go back to reference Harden RN, Bruehl S, Perez RS, Birklein F, Marinus J, Maihofner C, Lubenow T, Buvanendran A, Mackey S, Graciosa J, Mogilevski M, Ramsden C, Chont M, Vatine JJ. Validation of proposed diagnostic criteria (the “Budapest Criteria”) for Complex Regional Pain Syndrome. Pain. 2010;150(2):268–74.CrossRefPubMedPubMedCentral Harden RN, Bruehl S, Perez RS, Birklein F, Marinus J, Maihofner C, Lubenow T, Buvanendran A, Mackey S, Graciosa J, Mogilevski M, Ramsden C, Chont M, Vatine JJ. Validation of proposed diagnostic criteria (the “Budapest Criteria”) for Complex Regional Pain Syndrome. Pain. 2010;150(2):268–74.CrossRefPubMedPubMedCentral
31.
go back to reference Hurley DA, Murphy LC, Hayes D, Hall AM, Toomey E, McDonough SM, Lonsdale C, Walsh NE, Guerin S, Matthews J. Using intervention mapping to develop a theory-driven, group-based complex intervention to support self-management of osteoarthritis and low back pain (SOLAS). Implement Sci. 2016;11(1):56.CrossRefPubMedPubMedCentral Hurley DA, Murphy LC, Hayes D, Hall AM, Toomey E, McDonough SM, Lonsdale C, Walsh NE, Guerin S, Matthews J. Using intervention mapping to develop a theory-driven, group-based complex intervention to support self-management of osteoarthritis and low back pain (SOLAS). Implement Sci. 2016;11(1):56.CrossRefPubMedPubMedCentral
32.
go back to reference Lakshman R, Griffin S, Hardeman W, Schiff A, Kinmonth AL, Ong KK. Using the Medical Research Council framework for the development and evaluation of complex interventions in a theory-based infant feeding intervention to prevent childhood obesity: the baby milk intervention and trial. J Obes. 2014;2014:646504.CrossRefPubMedPubMedCentral Lakshman R, Griffin S, Hardeman W, Schiff A, Kinmonth AL, Ong KK. Using the Medical Research Council framework for the development and evaluation of complex interventions in a theory-based infant feeding intervention to prevent childhood obesity: the baby milk intervention and trial. J Obes. 2014;2014:646504.CrossRefPubMedPubMedCentral
33.
go back to reference Wylde V, Marques E, Artz N, Blom AW, Gooberman-Hill R. Effectiveness and cost-effectiveness of a group-based pain self-management intervention for patients undergoing total hip replacement: feasibility study for a randomized controlled trial. Trials. 2014;15:176.CrossRefPubMedPubMedCentral Wylde V, Marques E, Artz N, Blom AW, Gooberman-Hill R. Effectiveness and cost-effectiveness of a group-based pain self-management intervention for patients undergoing total hip replacement: feasibility study for a randomized controlled trial. Trials. 2014;15:176.CrossRefPubMedPubMedCentral
34.
go back to reference Ackerman IN, Buchbinder R, Osborne RH. Factors limiting participation in arthritis self-management programmes: an exploration of barriers and patient preferences within a randomized controlled trial. Rheumatology (Oxford). 2013;52(3):472–9.CrossRef Ackerman IN, Buchbinder R, Osborne RH. Factors limiting participation in arthritis self-management programmes: an exploration of barriers and patient preferences within a randomized controlled trial. Rheumatology (Oxford). 2013;52(3):472–9.CrossRef
36.
go back to reference Eldridge S, Spencer A, Cryer C, Parsons S, Underwood M, Feder G. Why modelling a complex intervention is an important precursor to trial design: lessons from studying an intervention to reduce falls-related injuries in older people. J Health Serv Res Policy. 2005;10(3):133–42.CrossRefPubMed Eldridge S, Spencer A, Cryer C, Parsons S, Underwood M, Feder G. Why modelling a complex intervention is an important precursor to trial design: lessons from studying an intervention to reduce falls-related injuries in older people. J Health Serv Res Policy. 2005;10(3):133–42.CrossRefPubMed
37.
go back to reference Emery J, Walton R, Coulson A, Glasspool D, Ziebland S, Fox J. Computer support for recording and interpreting family histories of breast and ovarian cancer in primary care (RAGs): qualitative evaluation with simulated patients. BMJ. 1999;319(7201):32–6.CrossRefPubMedPubMedCentral Emery J, Walton R, Coulson A, Glasspool D, Ziebland S, Fox J. Computer support for recording and interpreting family histories of breast and ovarian cancer in primary care (RAGs): qualitative evaluation with simulated patients. BMJ. 1999;319(7201):32–6.CrossRefPubMedPubMedCentral
38.
go back to reference Collins LM, Trail JB, Kugler KC, Baker TB, Piper ME, Mermelstein RJ. Evaluating individual intervention components: making decisions based on the results of a factorial screening experiment. Transl Behav Med. 2014;4(3):238–51.CrossRefPubMed Collins LM, Trail JB, Kugler KC, Baker TB, Piper ME, Mermelstein RJ. Evaluating individual intervention components: making decisions based on the results of a factorial screening experiment. Transl Behav Med. 2014;4(3):238–51.CrossRefPubMed
39.
go back to reference Lancaster GA, Dodd S, Williamson PR. Design and analysis of pilot studies: recommendations for good practice. J Eval Clin Pract. 2004;10(2):307–12.CrossRefPubMed Lancaster GA, Dodd S, Williamson PR. Design and analysis of pilot studies: recommendations for good practice. J Eval Clin Pract. 2004;10(2):307–12.CrossRefPubMed
Metadata
Title
Development of a complex intervention for people with chronic pain after knee replacement: the STAR care pathway
Authors
Vikki Wylde
Nicholas Howells
Wendy Bertram
Andrew J. Moore
Julie Bruce
Candy McCabe
Ashley W. Blom
Jane Dennis
Amanda Burston
Rachael Gooberman-Hill
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Trials / Issue 1/2018
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-017-2391-8

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