TY - JOUR
T1 - Pearls and pitfalls of PROMIS clinically significant outcomes in orthopaedic surgery
AU - Gilat, Ron
AU - Mitchnik, Ilan Y.
AU - Patel, Sumit
AU - Dubin, Jeremy A.
AU - Agar, Gabriel
AU - Tamir, Eran
AU - Lindner, Dror
AU - Beer, Yiftah
N1 - Publisher Copyright:
© 2023, The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.
PY - 2023/11
Y1 - 2023/11
N2 - Introduction: Patient-Reported Outcome Measurement Information System (PROMIS) was developed as a uniform and generalizable PROM system using item response theory and computer adaptive testing. We aimed to assess the utilization of PROMIS for clinically significant outcomes (CSOs) measurements and provide insights into its use in orthopaedic research. Materials and methods: We reviewed PROMIS CSO reports for orthopaedic procedures via PubMed, Cochrane Library, Embase, CINAHL, and Web of Science from inception to 2022, excluding abstracts and missing measurements. Bias was assessed using the Newcastle–Ottawa Scale (NOS) and questionnaire compliance. PROMIS domains, CSO measures, and study populations were described. A meta-analysis compared distribution and anchor-based MCIDs in low-bias (NOS ≥ 7) studies. Results: Overall, 54 publications from 2016 to 2022 were reviewed. PROMIS CSO studies were observational with increasing publication rates. Evidence-level was II in 10/54, bias low in 51/54, and compliance ≥ 86% in 46/54. Most (28/54) analysed lower extremity procedures. PROMIS domains examined Pain Function (PF) in 44/54, Pain Interference (PI) in 36/54, and Depression (D) in 18/54. Minimal clinically important difference (MCID) was reported in 51/54 and calculated based on distribution in 39/51 and anchor in 29/51. Patient acceptable symptom state (PASS), substantial clinical benefit (SCB), and minimal detectable change (MDC) were reported in ≤ 10/54. MCIDs were not significantly greater than MDCs. Anchor-based MCIDs were greater than distribution based MCIDs (standardized mean difference = 0.44, p < 0.001). Conclusions: PROMIS CSOs are increasingly utilized, especially for lower extremity procedures assessing the PF, PI, and D domains using distribution-based MCID. Using more conservative anchor-based MCIDs and reporting MDCs may strengthen results. Researchers should consider unique pearls and pitfalls when assessing PROMIS CSOs.
AB - Introduction: Patient-Reported Outcome Measurement Information System (PROMIS) was developed as a uniform and generalizable PROM system using item response theory and computer adaptive testing. We aimed to assess the utilization of PROMIS for clinically significant outcomes (CSOs) measurements and provide insights into its use in orthopaedic research. Materials and methods: We reviewed PROMIS CSO reports for orthopaedic procedures via PubMed, Cochrane Library, Embase, CINAHL, and Web of Science from inception to 2022, excluding abstracts and missing measurements. Bias was assessed using the Newcastle–Ottawa Scale (NOS) and questionnaire compliance. PROMIS domains, CSO measures, and study populations were described. A meta-analysis compared distribution and anchor-based MCIDs in low-bias (NOS ≥ 7) studies. Results: Overall, 54 publications from 2016 to 2022 were reviewed. PROMIS CSO studies were observational with increasing publication rates. Evidence-level was II in 10/54, bias low in 51/54, and compliance ≥ 86% in 46/54. Most (28/54) analysed lower extremity procedures. PROMIS domains examined Pain Function (PF) in 44/54, Pain Interference (PI) in 36/54, and Depression (D) in 18/54. Minimal clinically important difference (MCID) was reported in 51/54 and calculated based on distribution in 39/51 and anchor in 29/51. Patient acceptable symptom state (PASS), substantial clinical benefit (SCB), and minimal detectable change (MDC) were reported in ≤ 10/54. MCIDs were not significantly greater than MDCs. Anchor-based MCIDs were greater than distribution based MCIDs (standardized mean difference = 0.44, p < 0.001). Conclusions: PROMIS CSOs are increasingly utilized, especially for lower extremity procedures assessing the PF, PI, and D domains using distribution-based MCID. Using more conservative anchor-based MCIDs and reporting MDCs may strengthen results. Researchers should consider unique pearls and pitfalls when assessing PROMIS CSOs.
KW - Clinically significant outcomes
KW - Minimal clinically important difference
KW - PROMIS
KW - Patient outcome assessment
KW - Patient reported outcome measures
UR - http://www.scopus.com/inward/record.url?scp=85164785548&partnerID=8YFLogxK
U2 - 10.1007/s00402-023-04983-y
DO - 10.1007/s00402-023-04983-y
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C2 - 37436494
AN - SCOPUS:85164785548
SN - 0936-8051
VL - 143
SP - 6617
EP - 6629
JO - Archives of Orthopaedic and Trauma Surgery
JF - Archives of Orthopaedic and Trauma Surgery
IS - 11
ER -