Differences in patient characteristics and external validity of randomized clinical trials on pain management following total hip and knee arthroplasty: A systematic review
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Differences in patient characteristics and external validity of randomized clinical trials on pain management following total hip and knee arthroplasty : A systematic review. / Pedersen, Casper; Troensegaard, Hannibal; Laigaard, Jens; Koyuncu, Seda; Schrøder, Henrik Morville; Overgaard, Søren; Mathiesen, Ole; Karlsen, Anders Peder Højer.
In: Regional Anesthesia and Pain Medicine, Vol. 45, No. 9, 2020, p. 709-715.Research output: Contribution to journal › Review › Research › peer-review
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TY - JOUR
T1 - Differences in patient characteristics and external validity of randomized clinical trials on pain management following total hip and knee arthroplasty
T2 - A systematic review
AU - Pedersen, Casper
AU - Troensegaard, Hannibal
AU - Laigaard, Jens
AU - Koyuncu, Seda
AU - Schrøder, Henrik Morville
AU - Overgaard, Søren
AU - Mathiesen, Ole
AU - Karlsen, Anders Peder Højer
PY - 2020
Y1 - 2020
N2 - 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
AB - 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
KW - acute pain
KW - pain medicine
KW - postoperative pain
U2 - 10.1136/rapm-2020-101459
DO - 10.1136/rapm-2020-101459
M3 - Review
C2 - 32723841
AN - SCOPUS:85089787748
VL - 45
SP - 709
EP - 715
JO - Regional Anesthesia and Pain Medicine
JF - Regional Anesthesia and Pain Medicine
SN - 1098-7339
IS - 9
ER -
ID: 250548192