Systematic reviews and quality assessment of patient-reported outcome measures for physical function in comparative effectiveness studies regarding acute postoperative pain after total knee arthroplasty-Do we need to start all over again?

BACKGROUND AND OBJECTIVE: Recently, a consensus process specified a core outcome set (COS) of domains to be assessed in each comparative effectiveness research and clinical practice related to acute postoperative pain. Physical function (PF) was one of these domains. The aim of this review was to investigate which patient-reported outcome measures (PROMs) are used to assess PF after total knee arthroplasty (TKA) in clinical trials and if they fulfil basic requirements for a COS of PROMs based on their psychometric properties. METHODS: A systematic review of randomized controlled trials and observational studies based on a search in MEDLINE, EMBASE and CENTRAL was undertaken. PROMs and performance measures were extracted and investigated, including evaluation of psychometric properties of PROMs based on COSMIN recommendations. RESULTS: From initially 2896 identified records, 479 studies were included in the qualitative synthesis. Only 87 of these trials (18%) assessed PF using PROMs, whereas especially performance outcome measures were used in 470 studies (98%). Application of the 'COSMIN Risk-of-Bias-Box 1' to 13 of the 14 identified PROMs resulted in insufficient content validity of the included PROMs regarding the target population based on the inauguration or development articles. CONCLUSION: Our data indicate that a patient-centred postoperative assessment of PF in pain-related clinical trials early after TKA is not common, even though patient-reported assessment is widely recommended. In addition, none of the applied PROMs shows content validity based on their inauguration or development articles for the assessment of postoperative pain-related PF after TKA. SIGNIFICANCE: A systematic search for patient-reported outcome measures assessing postoperative, pain-related physical function after total knee arthroplasty in clinical trials and assessment of their content validity revealed none that fulfilled requirements based on COSMIN recommendations.

Systematic Review on Pain-Related Outcome Domains After Sternotomy: A First Step Toward the Development of a Core Outcome Set.

OBJECTIVES: Pain after surgery has a major impact on acute and long-term recovery and quality of life, but its management is often insufficient. To enhance the quality of research and to allow for better comparability between studies, it is important to harmonize outcomes for assessing the efficacy and effectiveness of pain management interventions after surgery. As a first step in developing a core outcome set, this study aimed to systematically search for outcome domains assessed in research regarding acute pain management after sternotomy as an example of a typically painful surgical procedure. METHODS: A systematic literature review was performed using MEDLINE, Embase, and CENTRAL. Eligibility criteria consisted of randomized controlled trials and observational trials targeting pain management after sternotomy in adults in the acute postoperative setting (≤2 weeks). After duplicate removal and title and abstract screening by 2 independent reviewers, study characteristics and outcome domains were identified, which were extracted from full texts and summarized qualitatively. RESULTS: Of 1350 studies retrieved by database searching, 156 studies were included for full-text extraction. A total of 80 different outcome domains were identified: pain intensity, analgesic consumption, physiological function, and adverse events were the most frequent ones. Outcome domains were often not explicitly reported, and the combination of domains and assessment tools was heterogeneous. The choice of outcomes is commonly made within clinicians; patients' perspectives are not considered. CONCLUSIONS: The wide variety of commonly applied outcome domains, the nonexplicit wording, and the heterogeneous combination of the domains indicating treatment benefit demonstrate the need for harmonization of outcomes assessing perioperative pain management after surgery.

Safety of tapentadol compared with other opioids in chronic pain treatment: network meta-analysis of randomized controlled and withdrawal trials.

OBJECTIVE: To assess the relative safety of oral tapentadol PR and other opioid analgesics for moderate or severe chronic pain in adults, we conducted a systematic review and network meta-analysis (NMA). METHODS: A systematic review was conducted to identify randomized controlled trials (RCTs) and randomized withdrawal trials of tapentadol with other WHO stage II and III opioid analgesics in patients with moderate or severe chronic pain. Searches were conducted in MEDLINE, EMBASE, PubMed, Cochrane databases and trial registries. Feasibility assessment evaluated the trials' suitability for NMA. Outcomes assessed were overall AEs, overall serious adverse events, constipation, nausea, dizziness, somnolence, headache, and discontinuation due to AEs. Randomized withdrawal trials were analyzed separately to other RCTs. RESULTS: Searches conducted in April 2019 identified 16,604 records. Following screening and feasibility assessment, 29 RCTs and 19 randomized withdrawal trials were identified and included in the NMA. Consistent with existing research, evidence from RCTs suggested that tapentadol is associated with relatively lower odds of adverse events occurring than most active comparators. The withdrawal trial data were less clear, with higher uncertainty around the results, and results that appear to contradict the RCT evidence. There are a number of trial design factors that may be affecting these results. CONCLUSIONS: RCT evidence suggests that tapentadol can be a useful treatment option for patients suffering from chronic pain and in need of an opioid analgesic. Opioids should be prescribed by a qualified physician only after other analgesics have been considered, taking side effects and misuse risk into account.