PMID- 35571970
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220716
IS  - 2325-9671 (Print)
IS  - 2325-9671 (Electronic)
IS  - 2325-9671 (Linking)
VI  - 10
IP  - 5
DP  - 2022 May
TI  - Statistical Fragility of Single-Row Versus Double-Row Anchoring for Rotator Cuff 
      Repair: A Systematic Review of Comparative Studies.
PG  - 23259671221093391
LID - 10.1177/23259671221093391 [doi]
LID - 23259671221093391
AB  - BACKGROUND: Comparative studies and randomized controlled trials (RCTs) often use 
      the P (probability) value to convey the statistical significance of their 
      findings. P values are an imperfect measure, however, and are vulnerable to a 
      small number of outcome reversals to alter statistical significance. The 
      inclusion of a fragility index (FI) and fragility quotient (FQ) may aid in the 
      interpretation of a study's statistical strength. PURPOSE/HYPOTHESIS: The purpose 
      of this study was to examine the statistical stability of studies comparing 
      single-row to double-row rotator cuff repair. It was hypothesized that the 
      findings of these studies would be vulnerable to a small number of outcome event 
      reversals, often fewer than the number of patients lost to follow-up. STUDY 
      DESIGN: Systematic review; Level of evidence, 3. METHODS: We analyzed comparative 
      studies and RCTs on primary single-row versus double-row rotator cuff repair that 
      were published between 2000 and 2021 in 10 leading orthopaedic journals. 
      Statistical significance was defined as a P < .05. The FI for each outcome was 
      determined by the number of event reversals necessary to alter significance. The 
      FQ was calculated by dividing the FI by the respective sample size. RESULTS: Of 
      4896 studies screened, 22 comparative studies, 10 of which were RCTs, were 
      ultimately included for analysis. A total of 74 outcomes were examined. Overall, 
      the median FI was 2 (interquartile range [IQR], 1-3), and the median FQ was 0.035 
      (IQR, 0.020-0.057). The mean FI was 2.55 +/- 1.29, and the mean FQ was 0.043 +/- 
      0.027. In 64% of outcomes, the FI was less than the number of patients lost to 
      follow-up.) Additionally, 81% of significant outcomes needed just a single 
      outcome reversal to lose their significance. CONCLUSION: Over half of the studies 
      currently used to guide clinical practice have a number of patients lost to 
      follow-up greater than their FI. The results of these studies should be 
      interpreted within the context of these limitations. Future analyses may benefit 
      from the inclusion of the FI and the FQ in their statistical analyses.
CI  - (c) The Author(s) 2022.
FAU - Fackler, Nathan P
AU  - Fackler NP
AD  - Department of Orthopaedic Surgery, University of California, Irvine, Irvine, 
      California, USA.
AD  - Georgetown University School of Medicine, Washington, DC, USA.
FAU - Ehlers, Cooper B
AU  - Ehlers CB
AD  - Department of Orthopaedic Surgery, University of California, San Diego, San 
      Diego, California, USA.
FAU - Callan, Kylie T
AU  - Callan KT
AD  - Department of Orthopaedic Surgery, University of California, Irvine, Irvine, 
      California, USA.
FAU - Amirhekmat, Arya
AU  - Amirhekmat A
AD  - Department of Orthopaedic Surgery, University of California, Irvine, Irvine, 
      California, USA.
FAU - Smith, Eric J
AU  - Smith EJ
AD  - Department of Orthopaedic Surgery, University of California, Irvine, Irvine, 
      California, USA.
FAU - Parisien, Robert L
AU  - Parisien RL
AD  - Department of Orthopaedic Surgery, Mount Sinai, New York, New York, USA.
FAU - Wang, Dean
AU  - Wang D
AD  - Department of Orthopaedic Surgery, University of California, Irvine, Irvine, 
      California, USA.
LA  - eng
PT  - Journal Article
PT  - Review
DEP - 20220510
PL  - United States
TA  - Orthop J Sports Med
JT  - Orthopaedic journal of sports medicine
JID - 101620522
PMC - PMC9096204
OTO - NOTNLM
OT  - P value
OT  - double row
OT  - fragility index
OT  - fragility quotient
OT  - rotator cuff
OT  - single row
OT  - statistical significance
COIS- One or more of the authors has declared the following potential conflict of 
      interest or source of funding: R.L.P. has received grant support and education 
      payments from Arthrex. D.W. has received education payments from Arthrex and 
      Smith & Nephew; consulting fees from Newclip, Ipsen Biosciences, DePuy/Medical 
      Device Business Services, and Vericel; and hospitality payments from Linvatec and 
      Stryker. AOSSM checks author disclosures against the Open Payments Database 
      (OPD). AOSSM has not conducted an independent investigation on the OPD and 
      disclaims any liability or responsibility relating thereto.
EDAT- 2022/05/17 06:00
MHDA- 2022/05/17 06:01
PMCR- 2022/05/10
CRDT- 2022/05/16 04:05
PHST- 2022/01/06 00:00 [received]
PHST- 2022/02/17 00:00 [accepted]
PHST- 2022/05/16 04:05 [entrez]
PHST- 2022/05/17 06:00 [pubmed]
PHST- 2022/05/17 06:01 [medline]
PHST- 2022/05/10 00:00 [pmc-release]
AID - 10.1177_23259671221093391 [pii]
AID - 10.1177/23259671221093391 [doi]
PST - epublish
SO  - Orthop J Sports Med. 2022 May 10;10(5):23259671221093391. doi: 
      10.1177/23259671221093391. eCollection 2022 May.