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Randomized Controlled Trial
. 2023 Dec 16;24(1):972.
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  1   2 , Vikki Wylde  3   4 , Nick Howells  5 , Beverly Shirkey  6 , Tim J Peters  3   7 , Liang Zhu  6 , Sian Noble  3 , Emma Johnson  3 , Andrew D Beswick  3   4 , Andrew Moore  3 , Julie Bruce  8 , David Walsh  9 , Christopher Eccleston  10 , Rachael Gooberman-Hill  3   4
Affiliations
Randomized Controlled Trial

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

Wendy Bertram et al. BMC Musculoskelet Disord. .

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.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Extended CONSORT for participant flow from randomisation follow-up at four years
Fig. 2
Fig. 2
Mean BPI severity over time by trial arm and response to the four-year follow-up
Fig. 3
Fig. 3
Mean BPI interference over time by trial arm and response to the four-year follow-up
Fig. 4
Fig. 4
Cost effectiveness acceptability curve showing the probability that the STAR care pathway is cost-effective at different willingness-to-pay thresholds
See this image and copyright information in PMC

References

    1. National Joint Registry. 17th annual report. Hemel Hempstead: NJR Service Centre; 2020.
    1. Scottish Arthroplasty Project. Annual report NHS National Services Scotland; 2020.
    1. Werner MU, Kongsgaard UE. Defining persistent post-surgical pain: is an update required? Br J Anaesth. 2014;113(1):1–4. doi: 10.1093/bja/aeu012. - DOI - PubMed
    1. Beswick AD, et al. 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. doi: 10.1136/bmjopen-2011-000435. - DOI - PMC - PubMed
    1. Ghomrawi HMK, et al. Do surgeon expectations predict clinically important improvements in WOMAC scores after THA and TKA? Clin Orthop Relat Res. 2017;475(9):2150–8. doi: 10.1007/s11999-017-5331-8. - DOI - PMC - PubMed

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