PMID- 34101690
OWN - NLM
STAT- MEDLINE
DCOM- 20211223
LR  - 20211223
IS  - 1535-1386 (Electronic)
IS  - 0021-9355 (Linking)
VI  - 103
IP  - 22
DP  - 2021 Nov 17
TI  - A Call for a Standardized Approach to Reporting Patient-Reported Outcome 
      Measures: Clinical Relevance Ratio.
PG  - e91
LID - 10.2106/JBJS.21.00030 [doi]
AB  - A shift toward a value-driven health-care model has made prospective collection 
      of patient-reported outcome measures (PROMs) inextricably tied to measuring the 
      success of orthopaedic surgery and patient satisfaction. While progress has been 
      made in optimizing the utilization of PROM data, including establishing 
      appropriate PROMs for a procedure and determining the clinical importance of 
      unique tools, if these PROMs are not accurately analyzed and reported, a 
      proportion of patients who do not reach the clinical thresholds may go unnoticed. 
      Furthermore, parameters are unclear for setting a statistically and clinically 
      important PROM threshold along with a minimum period for follow-up data 
      collection.In this forum, we walk through simulated data sets modeling PROMs with 
      the example of total joint arthroplasty. We discuss how the commonly used method 
      of reporting PROMs by mean change can overestimate the treatment effects for the 
      cohort as a whole and fail to capture distinct populations that are below a 
      clinically relevant threshold. We demonstrate that when a study's outcome is 
      PROMs, clinical importance should be reported using clinical thresholds such as 
      the minimum clinically important difference (MCID), the smallest change in the 
      treatment outcome that a patient perceives as beneficial, and the patient 
      acceptable symptom state (PASS), the highest level of symptoms beyond which a 
      patient considers himself or herself well. Finally, we propose a standardized 
      reporting of PROMs that incorporates both the MCID and the PASS, and introduce a 
      "clinical relevance ratio," which relies on a clinically relevant threshold to 
      dichotomize outcomes and reports the number of patients achieving clinical 
      importance at a given time point divided by the total number of patients included 
      in the study. Unlike other common PROM-reporting approaches, the clinical 
      relevance ratio is not skewed by patients who are lost to follow-up with 
      increased time.
CI  - Copyright (c) 2021 by The Journal of Bone and Joint Surgery, Incorporated.
FAU - Orr, Melissa N
AU  - Orr MN
AUID- ORCID: 0000-0003-3281-7907
AD  - Department of Orthopaedic Surgery, Cleveland Clinic, Cleveland, Ohio.
FAU - Klika, Alison K
AU  - Klika AK
AUID- ORCID: 0000-0003-2755-0742
AD  - Department of Orthopaedic Surgery, Cleveland Clinic, Cleveland, Ohio.
FAU - Gagnier, Joel J
AU  - Gagnier JJ
AUID- ORCID: 0000-0002-3162-3935
AD  - Department of Orthopaedic Surgery, University of Michigan, Ann Arbor, Michigan.
AD  - Department of Epidemiology, School of Public Health, University of Michigan, Ann 
      Arbor, Michigan.
FAU - Bhandari, Mohit
AU  - Bhandari M
AUID- ORCID: 0000-0003-3556-9179
AD  - Division of Orthopaedic Surgery, Department of Surgery, McMaster University, 
      Hamilton, Ontario, Canada.
FAU - Piuzzi, Nicolas S
AU  - Piuzzi NS
AUID- ORCID: 0000-0003-3007-7538
AD  - Department of Orthopaedic Surgery, Cleveland Clinic, Cleveland, Ohio.
LA  - eng
PT  - Journal Article
PL  - United States
TA  - J Bone Joint Surg Am
JT  - The Journal of bone and joint surgery. American volume
JID - 0014030
SB  - IM
MH  - Humans
MH  - Lost to Follow-Up
MH  - *Minimal Clinically Important Difference
MH  - Orthopedic Procedures/*standards
MH  - *Patient Reported Outcome Measures
MH  - Patient Satisfaction
MH  - Prospective Studies
COIS- Disclosure: The Disclosure of Potential Conflicts of Interest forms are provided 
      with the online version of the article (http://links.lww.com/JBJS/G532).
EDAT- 2021/06/09 06:00
MHDA- 2021/12/24 06:00
CRDT- 2021/06/08 17:31
PHST- 2021/06/09 06:00 [pubmed]
PHST- 2021/12/24 06:00 [medline]
PHST- 2021/06/08 17:31 [entrez]
AID - 00004623-202111170-00016 [pii]
AID - 10.2106/JBJS.21.00030 [doi]
PST - ppublish
SO  - J Bone Joint Surg Am. 2021 Nov 17;103(22):e91. doi: 10.2106/JBJS.21.00030.