key: cord-0804197-bu9lvgjj authors: Wylde, Vikki; Bertram, Wendy; Sanderson, Emily; Noble, Sian; Howells, Nicholas; Peters, Tim J; Beswick, Andrew D; Blom, Ashley W; Moore, Andrew J; Bruce, Julie; Walsh, David A; Eccleston, Christopher; Harris, Shaun; Garfield, Kirsty; White, Simon; Toms, Andrew; Gooberman-Hill, Rachael title: The STAR care pathway for patients with pain at 3 months after total knee replacement: a multicentre, pragmatic, randomised, controlled trial date: 2022-01-28 journal: Lancet Rheumatol DOI: 10.1016/s2665-9913(21)00371-4 sha: 7b000952bfe3c94cc98019334d4959b5ee864b20 doc_id: 804197 cord_uid: bu9lvgjj 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. For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome Results -first and second paragraph; Figure 1 13b For each group, losses and exclusions after randomisation, together with reasons Results -second paragraph; Figure 1 Recruitment Table 1 Numbers analysed 16 For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups Tables Outcomes and estimation 17a For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval) Table 2 17b For binary outcomes, presentation of both absolute and relative effect sizes is recommended Comparison of results of 'as randomised' analysis of complete cases with 'as randomised' analysis where missing data were imputed using "best" and "worst" case scenarios and the method of mice for primary outcome of BPI Severity Score. Comparison of results of 'as randomised' analysis of complete cases with 'as randomised' analysis where missing data were imputed using "best" and "worst" case scenarios and the method of mice for primary outcome of BPI Interference Score. • 9 intervention patients did not have an assessment clinic. 9/363 = 97.52% and so CACE is not necessary according to section 6.4 Compliance of the SAP. Comparison of results of 'as randomised' analysis of complete cases with per protocol analysis and CACE analysis for primary outcome of BPI Severity Score. Comparison of results of 'as randomised' analysis of complete cases with per protocol analysis and CACE for primary outcome of BPI Interference Score. Accounting for potential impact of COVID-19 Crossover Refractory chronic knee pain for more than 6 months after total knee replacement Clinical opinion was used to ensure only admissions, outpatient visits and emergency department attendances which were related to the STAR pathway, pain or knee replacement were included in the analysis. To avoid double counting all outpatient appointments and x rays occurring on the STAR clinic dates were deleted from the informatics data. Each hospital admission was classified into Daycase, short stay (<2 days) and longstay. The following sensitivity analyses were conducted where there was methodological uncertainty, or assumptions were made during the study and analysis: 1) Changing the ratio of direct to indirect time in the calculation of the unit cost for the ESPs. 2) Altering the assumption that the home care worker visit use, would be the same for the whole of the 6 months as it was for one week (as asked in the follow-up questionnaires) to 3 months and 1 month. 3) Costing the Home changes and equipment at a quarter and a half of the initial cost, to take into account that some of the equipment would be returned. Assuming that when it was unclear who paid for the home changes and equipment, the provider was the NHS/PSS. Excluding "other" community-based services such as hydrotherapy, which may have been accounted for in the outpatient attendances. 6) Costing HRG's using an elective inpatient cost, rather than non-elective inpatient short stay and long stay costs. For each intervention, report mean values for the main categories of estimated costs and outcomes of interest, as well as mean differences between the comparator groups. If applicable, report incremental cost-effectiveness ratios. Results: pg 18 & Table 3 Characterising uncertainty 20a Single study-based economic evaluation: Describe the effects of sampling uncertainty for the estimated incremental cost and incremental effectiveness parameters, together with the impact of methodological assumptions (such as discount rate, study perspective). Results: pg18-19 Supplementary material Table 60 20b 1 If the question item had not been answered, but other items within the question section had been answered then no contact or use of this resource was assumed. 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