A core outcome set of measurement instruments for assessing effectiveness and efficacy of perioperative pain management: results of the international IMI-PainCare PROMPT Delphi consensus process

Abstract

Background: Effective perioperative pain management is crucial to prevent patient suffering, delayed recovery, chronic postsurgical pain, and long-term opioid use. However, the heterogeneous use of outcomes in studies complicates evidence synthesis and might not accurately reflect the experiences of individual patients. We initiated a consensus process to establish a core outcome set (COS) of patient-reported outcome measures (PROMs) in postoperative pain, building upon the earlier consensus on a COS of domains.

Methods: Potential PROMs were identified via systematic literature searches for the domains pain intensity (with subdomains at rest and during activity), physical function, self-efficacy, and adverse events, followed by appraisal of psychometric properties according to the COnsensus-based Standards for the selection of health Measurement INstruments methodology. Then, a consensus meeting was convened, followed by a Delphi process with an international, multiprofessional panel of stakeholders, including those with lived experience. A conclusive consensus meeting approved the final COS of PROMs.

Results: The final COS consists of one unidimensional numerical rating scale for assessing pain intensity on average, worst pain intensity, pain intensity at rest, and procedure-specific pain intensity during activity; one unidimensional scale for pain interfering with activities in bed; one procedure-specific scale for assessing physical function; the IMI-PainCare PROMPT adaptation of the Arthritis Self-Efficacy Scale for assessing self-efficacy; and the IMI-PainCare PROMPT adaptation of the Opioid-Related Symptom Distress Scale for assessing adverse events.

Conclusions: Comprehensive use of a core outcome set will help harmonise outcome assessment, facilitate comparisons between studies, promote patient-centred research, and improve postoperative pain care.

Keywords: Delphi approach; consensus process; core outcome set; patient-reported outcome measure; postoperative pain; psychometric properties; questionnaire.

Fig 1

Overall study design of the IMI-PainCare PROMPT development process for a core outcome set (COS) of patient-reported outcome measures (PROMs) for the assessment of acute postoperative pain in adults. The COS process began with developing a COS of domains (I, in orange), followed by the development of a COS of PROMs (II, in green; this study). (I) Following SLRs on domains assessed in clinical postoperative pain, the IMI-PainCare PROMPT consensus panel consented on a COS of domains comprising four overarching outcome domains: pain intensity with the subdomains ‘in general’, ‘at rest’, and ‘during activity’; physical function; adverse events; and self-efficacy. (II) Subsequently, SLRs were conducted to identify PROMs potentially suitable to assess pain intensity (in general, at rest, and during activity), physical function (physical function after TKA¹¹), adverse events, and self-efficacy after surgery. The identified instruments were evaluated following COSMIN recommendations (e.g. regarding content validity assessment of scales). Sensitivity-to-change analysis of preselected PROMs was carried out in a prospective multicentre trial. Results of these analyses were presented to the IMI-PainCare PROMPT consensus panel in an online meeting, followed by an online Delphi process and a concluding consensus meeting. Finally, a COS of PROMs was recommended for assessing effectiveness and efficacy of perioperative pain management. Similar to the process on domains, representative types of surgery were selected: BS, ST, TKA, and ES. The reasoning behind choosing these four types of surgery is detailed in a previous publication., AE, adverse event; BS, breast surgery; COS, core outcome set; ES, surgery related to endometriosis; NIT- 1, non-interventional trial 1; PF, physical function; PI, pain intensity; PROM, patient-reported outcome measure; PROMPT, PROMs for postoperative pain treatment; SE, self-efficacy; SLR, systematic literature search; ST, sternotomy; TKA, total knee arthroplasty.

Fig 2

Final voting results of the second round for each domain: (a) pain intensity, (b) physical function, (c) self-efficacy, and (d) adverse events. Inclusion criteria for a PROM to be included in the final COS were that ≥50% of the panel rated the PROM between 7 and 9 (‘appropriate’, green). The vertical red dotted line indicates the 50% cut-off threshold for inclusion, and the PROMs ultimately included (after final discussion in the second meeting) are highlighted in the green-bordered box. Rating scale consists of 1–3, not appropriate (red); 4–7, potentially appropriate (blue); and 7–9, appropriate (green). all, all types of surgery; ASES-8, Arthritis Self-Efficacy Scale Short Form; ASES, Arthritis Self-Efficacy Scale; BBUSQ-22, Birmingham Bowel and Urinary Symptoms Questionnaire; BS, breast surgery; DASH, Disabilities of the Arm, Shoulder and Hand; ES, endometriosis related surgery; FDQ, Functional Difficulties Questionnaire; K-SES, Knee Self-Efficacy Scale; OKS, Oxford Knee Score; OR-SDS, Opioid-Related Symptom Distress Scale; PROM, patient-reported outcome measure; PROMPT, Providing Standardized Consented PROMs for Improving Pain Treatment; RASE, Rheumatoid Arthritis Self-Efficacy Scale; ST, sternotomy; TKA, total knee arthroplasty; WOMAC, Western Ontario and McMaster Universities Osteoarthritis Index.

Fig 3

Final COS of PROMs enabling assessment of efficacy and effectiveness of pain management in the acute phase after surgery. BS, breast surgery; COS, core outcome set; ES, endometriosis-related surgery; PROM, patient-reported outcome measure; ST, sternotomy; TKA, total knee arthroplasty.