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JID: JINJ

ARTICLE IN PRESS [m5G;January 9, 2022;9:5]


Injury xxx (xxxx) xxx

Contents lists available at ScienceDirect

Injury
journal homepage: www.elsevier.com/locate/injury

Letter to the Editor

Letter regarding “Open reduction and internal fixation alone Declaration of Competing Interest
versus open reduction and internal fixation plus total hip
arthroplasty for displaced acetabular fractures in patients older None.
than 60 years: A prospective clinical trial”
Acknowledgment

The authors would like to thank Editage (www.editage.jp) for


Dear editor
the English language review.

We read the article by Manson et al. with great interest, and Reference
we appreciate the authors’ great efforts to clarify the best treat-
ment for acetabular fractures in older patients, for which no con- [1] Manson TT, Slobogean GP, Nascone JW, Sciadini MF, LeBrun CT, Boulton CL.
sensus has been reached thus far [1]. However, we would like to Open reduction and internal fixation alone versus open reduction and internal
fixation plus total hip arthroplasty for displaced acetabular fractures in patients
suggest three suggestions that might influence the interpretation older than 60 years: a prospective clinical trial. Injury 2021 in press, available
of this article. online 2 Oct, 202110.1016/j.injury.2021.09.048.
First, not all items set in the protocol were reported, and the [2] ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine(US).
20 0 0 Feb 29 -. Identifier NCT03419182,RCT Determining Best Treatment for
timing of measurement was inconsistent with the protocol [2].
Geriatric Acetabular Fractures (GeriTab); 2017 September 22 [cited 2021 October
Only two of the 10 primary outcomes specified in the protocol 15]. Available from https://www.clinicaltrials.gov/ct2/show/NCT03419182?term=
were selectively reported. In terms of timing, a significant differ- NCT03419182&draw=2&rank=1
[3] Stibolt RD, Patel HA, Huntley SR, Lehtonen EJ, Shah AB, Naranje SM. Total
ence was reported in the reoperation rate at 2 years. However, the
hip arthroplasty for posttraumatic osteoarthritis following acetabular fracture: a
primary outcome measurement was set at 1 year in the protocol. systematic review of characteristics, outcomes, and complications. Chin J Trau-
In a systematic review (SR) and meta-analysis, the median time to matol - English editor 2018;21:176–81 10.1016/j.cjtee.2018.02.004.
total hip arthroplasty (THA) after acetabular fracture was 37 (27– [4] Boutron I, Dutton S, Ravaud P, Altman DG. Reporting and interpretation of ran-
domized controlled trials with statistically nonsignificant results for primary
74) months [3]. The authors might have chosen the 2-year outcome outcomes. JAMA - J Am Med Assoc 2010;303:2058–64 10.1001/jama.2010.651.
as the 1-year reoperation rate might not have shown a significant [5] Walsh M, Srinathan SK, McAuley DF, Mrkobrada M, Levine O, Ribic C,
difference. This may be considered a spin because the results are et al. The statistical significance of randomized controlled trial results is fre-
quently fragile: a case for a Fragility Index. J Clin Epidemiol 2014;67:622–8
based on selective reporting and are emphasized in the results and 10.1016/j.jclinepi.2013.10.019.
abstract [4]. If this result is to be reported, it would have been bet-
ter to report the results as per the protocol at 1 year and the re-
sults at 2 years as additional analysis.
Shiho Oide
In addition, their result concluding that there was a significant
Department of Obstetrics and Gynecology, Kitasato University
reduction in reoperation is fragile. The fragility index indicates how
Medical Center, Arai 6-100, Kitamoto-shi, Saitama 364-8501, Japan
many participants would be required to convert a study from be-
Scientifics Research WorkS Peer Support Group (SRWS-PSG),
ing statistically significant to not significant [5]. The index for out-
Osaka, Japan
comes was 2. It is considered less robust when the number of pa-
tients lost to follow-up is greater than the index value. Therefore, Masahiro Banno
considering their loss to follow-up in the THA group (n = 3), the Scientifics Research WorkS Peer Support Group (SRWS-PSG),
significant result in the reoperation rate is less robust. Osaka, Japan
Finally, because the authors mixed samples from the random- Department of Psychiatry, Seichiryo Hospital, Tsurumai 4-16-27,
ized controlled trial (RCT) and the observational study, the data in Showa-ku, Nagoya 466-0064, Japan
Tables 2 and 3 cannot be used for meta-analysis and SR. To use Department of Psychiatry, Nagoya University Graduate School of
the data in this paper in a future SR of RCTs, we would like to ask Medicine, Tsurumai-cho 65, Showa-ku, Nagoya 466-8560 Japan
the authors to present the data from the RCT and the observational
Akihiro Saitsu
study separately in Table 2 and Table 3.
Scientifics Research WorkS Peer Support Group (SRWS-PSG),
Once again, we thank the authors for providing novel and valu-
Osaka, Japan
able data and analysis findings. However, as discussed above, we
Department of General Medicine, Taragi Municipal Hospital, 4210
think that their statistically significant result should be interpreted
Taragi, Taragi-machi, Kuma-gun, Kumamoto 868-0598, Japan
with caution because this is not a pre-specified outcome and less
robust. In addition, the data from the RCT and observational study Natsumi Saka∗
should be reported separately for future SR. We believe that these Scientifics Research WorkS Peer Support Group (SRWS-PSG),
three suggestions will make future clinical research more valuable. Osaka, Japan

https://doi.org/10.1016/j.injury.2021.11.056
0020-1383/© 2021 Elsevier Ltd. All rights reserved.
JID: JINJ
ARTICLE IN PRESS [m5G;January 9, 2022;9:5]

S. Oide, M. Banno, A. Saitsu et al. Injury xxx (xxxx) xxx

Department of Health Research Methods, Evidence & Impact,


McMaster University, 1280 Main Street West, Hamilton, Ontario, L8S
4K1, Canada
Department of Orthopaedics, Teikyo University School of Medicine,
1-2-11 Kaga, Itabashi-ku, Tokyo 174-0054, Japan
∗ Corresponding
author at: Department of Health Research
Methods, Evidence & Impact, McMaster University, 1280 Main
Street West, Hamilton, Ontario, L8S 4K1, Canada.
E-mail addresses: shihooide@gmail.com (S. Oide),
solvency@med.nagoya-u.ac.jp (M. Banno), m07039as@jichi.ac.jp (A.
Saitsu), natsumi613@gmail.com (N. Saka)

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