BACKGROUND: The external validity of randomized controlled trials (RCTs) is critical for the relevance of trial results in a clinical setting. We aimed to assess the external validity of RCTs investigating postoperative pain treatment after total hip and knee arthroplasty (THA and TKA) by comparing patient characteristics in these trials with a clinical cohort. Further, we assessed the use of exclusion criteria of the included RCTs.
METHODS: We searched PubMed, Embase, and Cochrane Central Register of Controlled Trials for relevant RCTs up to June 2019. Data on patient characteristics from this research population were compared with an unselected clinical cohort from the Danish Hip and Knee Arthroplasty Registries in the period 2005-2019. Trends in patient characteristics and the use of exclusion criteria were assessed with control charts.
RESULTS: In total, 550 RCTs with 48 962 participants were included in the research cohort. The clinical cohort included 101 439 THA patients and 90 505 TKA patients. Patient characteristics (age, body mass index (BMI), American Society of Anesthesiologists (ASA) score and sex distribution) in the research cohort resembled those of the clinical cohort. Age, BMI and ASA scores did not change over time in the research cohort. In the clinical cohort, age increased among both THA and TKA patients, and BMI and ASA scores increased among TKA patients. Most commonly used exclusion criteria in the RCTs were high ASA score (62%), older age (45%), obesity (32%) and chronic opioid use (41%). Exclusion of chronic opioid users and individuals with obesity increased over time.
CONCLUSION: Patient characteristics in research trials investigating postoperative pain management after THA and TKA currently resemble those of a clinical cohort. However, individuals in the clinical cohort are getting older, and TKA patients more obese with increasing ASA scores. Concomitantly, RCTs increase the tendency to exclude patients with older age, obesity, chronic pain and/or opioid use. This trending discrepancy can hinder the generalizability of future research results, and therefore increased focus on pragmatic trials resembling real-world conditions are needed.
PROSPERO REGISTRATION NUMBER: CRD42019125691.