Responsiveness of multiple patient-reported outcome measures for acute postsurgical pain: primary results from the international multi-centre PROMPT NIT-1 study.

BACKGROUND: Postsurgical outcome measures are crucial to define the efficacy of perioperative pain management; however, it is unclear which are most appropriate. We conducted a prospective study aiming to assess sensitivity-to-change of patient-reported outcome measures assessing the core outcome set of domains pain intensity (at rest/during activity), physical function, adverse events, and self-efficacy. METHODS: Patient-reported outcome measures were assessed preoperatively, on day 1 (d1), d3, and d7 after four surgical procedures (total knee replacement, breast surgery, endometriosis-related surgery, and sternotomy). Primary outcomes were sensitivity-to-change of patient-reported outcome measures analysed by correlating their changes (d1-d3) with patients' global impression of change and patients' specific impression of change items as anchor criteria. Secondary outcomes included identification of baseline and patient characteristic variables explaining variance in change for each of the scales and descriptive analysis of various patient-reported outcome measures from different domains and after different surgeries. RESULTS: Of 3322 patients included (18 hospitals, 10 countries), data from 2661 patients were analysed. All patient-reported outcome measures improved on average over time; the median calculated sensitivity-to-change for all patient-reported outcome measures (overall surgeries) was 0.22 (range: 0.07-0.31, scale: 0-10); all changes were independent of baseline data or patient characteristics and similar between different procedures. CONCLUSIONS: Pain-related patient-reported outcome measures have low to moderate sensitivity-to-change; those showing higher sensitivity-to-change from the same domain should be considered for inclusion in a core outcome set of patient-reported outcome measures to assess the effectiveness and efficacy of perioperative pain management.

Pain management after cardiac surgery via median sternotomy: A systematic review with procedure-specific postoperative pain management (PROSPECT) recommendations.

BACKGROUND: Pain after cardiac surgery via median sternotomy can be difficult to treat, and if inadequately managed can lead to respiratory complications, prolonged hospital stays and chronic pain. OBJECTIVES: To evaluate available literature and develop recommendations for optimal pain management after cardiac surgery via median sternotomy. DESIGN: A systematic review using PROcedure-SPECific Pain Management (PROSPECT) methodology. ELIGIBILITY CRITERIA: Randomised controlled trials and systematic reviews published in the English language until November 2020 assessing postoperative pain after cardiac surgery via median sternotomy using analgesic, anaesthetic or surgical interventions. DATA SOURCES: PubMed, Embase and Cochrane Databases. RESULTS: Of 319 eligible studies, 209 randomised controlled trials and three systematic reviews were included in the final analysis. Pre-operative, intra-operative and postoperative interventions that reduced postoperative pain included paracetamol, non-steroidal anti-inflammatory drugs (NSAIDs), intravenous magnesium, intravenous dexmedetomidine and parasternal block/infiltration. CONCLUSIONS: The analgesic regimen for cardiac surgery via sternotomy should include paracetamol and NSAIDs, unless contraindicated, administered intra-operatively and continued postoperatively. Intra-operative magnesium and dexmedetomidine infusions may be considered as adjuncts particularly when basic analgesics are not administered. It is not clear if combining dexmedetomidine and magnesium would provide superior pain relief compared with either drug alone. Parasternal block/surgical site infiltration is also recommended. However, no basic analgesics were used in the studies assessing these interventions. Opioids should be reserved for rescue analgesia. Other interventions, including cyclo-oxygenase-2 specific inhibitors, are not recommended because there was insufficient, inconsistent or no evidence to support their use and/or due to safety concerns.

Assessing outcome in postoperative pain trials: are we missing the point? A systematic review of pain-related outcome domains reported in studies early after total knee arthroplasty.

ABSTRACT: The management of acute postoperative pain remains suboptimal. Systematic reviews and Cochrane analysis can assist with collating evidence about treatment efficacy, but the results are limited in part by heterogeneity of endpoints in clinical trials. In addition, the chosen endpoints may not be entirely clinically relevant. To investigate the endpoints assessed in perioperative pain trials, we performed a systematic literature review on outcome domains assessing effectiveness of acute pain interventions in trials after total knee arthroplasty. We followed the Cochrane recommendations for systematic reviews, searching PubMed, Cochrane, and Embase, resulting in the screening of 1590 potentially eligible studies. After final inclusion of 295 studies, we identified 11 outcome domains and 45 subdomains/descriptors with the domain "pain"/"pain intensity" most commonly assessed (98.3%), followed by "analgesic consumption" (88.8%) and "side effects" (75.3%). By contrast, "physical function" (53.5%), "satisfaction" (28.8%), and "psychological function" (11.9%) were given much less consideration. The combinations of outcome domains were inhomogeneous throughout the studies, regardless of the type of pain management investigated. In conclusion, we found that there was high variability in outcome domains and inhomogeneous combinations, as well as inconsistent subdomain descriptions and utilization in trials comparing for effectiveness of pain interventions after total knee arthroplasty. This points towards the need for harmonizing outcome domains, eg, by consenting on a core outcome set of domains which are relevant for both stakeholders and patients. Such a core outcome set should include at least 3 domains from 3 different health core areas such as pain intensity, physical function, and one psychological domain.