Minimal clinically important differences in randomised clinical trials on pain management after total hip and knee arthroplasty: a systematic review.
Analgesics
/ administration & dosage
Analgesics, Opioid
/ administration & dosage
Arthroplasty, Replacement, Hip
/ methods
Arthroplasty, Replacement, Knee
/ methods
Humans
Minimal Clinically Important Difference
Pain Measurement
Pain, Postoperative
/ drug therapy
Randomized Controlled Trials as Topic
attrition
minimal clinically important difference
numerical analogue scale
patient-controlled analgesia
postoperative morphine consumption
postoperative pain treatment
power calculation
visual analogue scale
Journal
British journal of anaesthesia
ISSN: 1471-6771
Titre abrégé: Br J Anaesth
Pays: England
ID NLM: 0372541
Informations de publication
Date de publication:
May 2021
May 2021
Historique:
received:
28
08
2020
revised:
19
12
2020
accepted:
10
01
2021
pubmed:
9
3
2021
medline:
12
5
2021
entrez:
8
3
2021
Statut:
ppublish
Résumé
Sample size determination is essential for reliable hypothesis testing in clinical trials and should rely on adequate sample size calculations with alpha, beta, variance, and an effect size being the minimal clinically important difference (MCID). This facilitates interpretation of the clinical relevance of statistically significant results. No gold standard for MCIDs exists in postoperative pain research. We searched Cochrane Central Register of Controlled Trials, MEDLINE, and Embase for English language articles on randomised trials investigating analgesic interventions after total hip or knee arthroplasty. Primary outcomes were the reported MCIDs for pain score and cumulated rescue opioid consumption. Secondary outcomes included reported sample size calculations and propensity to report statistical significance without reaching MCID. Trend analyses were conducted using statistical process control. We included 570 trials. Median MCID for 0-24 h opioid consumption was 10 mg i.v. morphine equivalents for absolute reductions (interquartile range [IQR]: 6.8-14.5) and relative 40% (IQR: 30-50%). Median MCIDs for pain scores were absolute 15 mm at rest (IQR: 10-20) and 18 mm during movement (IQR: 10-20) on a 0-100 mm VAS and relative 30% (IQR: 20-30%). No trends were demonstrated for MCIDs. Adequate sample size calculations were reported in 34% of trials. In 46% of trials with statistically significant primary outcomes, the differences did not reach the predetermined MCID. We provide clinician-perceived MCID estimates for rescue opioid consumption and pain scores that can be used for sample size calculations until reliable evidence-based patient-rated MCIDs emerge. Nearly half of the trials with significant findings did not reach the predetermined MCID.
Sections du résumé
BACKGROUND
BACKGROUND
Sample size determination is essential for reliable hypothesis testing in clinical trials and should rely on adequate sample size calculations with alpha, beta, variance, and an effect size being the minimal clinically important difference (MCID). This facilitates interpretation of the clinical relevance of statistically significant results. No gold standard for MCIDs exists in postoperative pain research.
METHODS
METHODS
We searched Cochrane Central Register of Controlled Trials, MEDLINE, and Embase for English language articles on randomised trials investigating analgesic interventions after total hip or knee arthroplasty. Primary outcomes were the reported MCIDs for pain score and cumulated rescue opioid consumption. Secondary outcomes included reported sample size calculations and propensity to report statistical significance without reaching MCID. Trend analyses were conducted using statistical process control.
RESULTS
RESULTS
We included 570 trials. Median MCID for 0-24 h opioid consumption was 10 mg i.v. morphine equivalents for absolute reductions (interquartile range [IQR]: 6.8-14.5) and relative 40% (IQR: 30-50%). Median MCIDs for pain scores were absolute 15 mm at rest (IQR: 10-20) and 18 mm during movement (IQR: 10-20) on a 0-100 mm VAS and relative 30% (IQR: 20-30%). No trends were demonstrated for MCIDs. Adequate sample size calculations were reported in 34% of trials. In 46% of trials with statistically significant primary outcomes, the differences did not reach the predetermined MCID.
CONCLUSIONS
CONCLUSIONS
We provide clinician-perceived MCID estimates for rescue opioid consumption and pain scores that can be used for sample size calculations until reliable evidence-based patient-rated MCIDs emerge. Nearly half of the trials with significant findings did not reach the predetermined MCID.
Identifiants
pubmed: 33678402
pii: S0007-0912(21)00046-5
doi: 10.1016/j.bja.2021.01.021
pii:
doi:
Substances chimiques
Analgesics
0
Analgesics, Opioid
0
Types de publication
Journal Article
Systematic Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
1029-1037Commentaires et corrections
Type : CommentIn
Type : CommentIn
Informations de copyright
Copyright © 2021 British Journal of Anaesthesia. Published by Elsevier Ltd. All rights reserved.