PMID- 34730830
OWN - NLM
STAT- MEDLINE
DCOM- 20211227
LR  - 20240214
IS  - 1538-6724 (Electronic)
IS  - 0031-9023 (Print)
IS  - 0031-9023 (Linking)
VI  - 101
IP  - 11
DP  - 2021 Nov 1
TI  - Reporting of Adverse Events in Randomized Controlled Trials of Therapeutic 
      Exercise for Hip Osteoarthritis: A Systematic Review.
LID - 10.1093/ptj/pzab195 [doi]
LID - pzab195
AB  - OBJECTIVE: The purpose of this study was to describe adverse events (AEs) and 
      dropouts (DOs) in randomized controlled trials of therapeutic exercise for hip 
      osteoarthritis (HOA) and to identify whether Consolidated Standards of Reporting 
      Trials (CONSORT) guidelines were followed. METHODS: The Cochrane Library, Embase, 
      PubMed, and CINAHL databases were searched. Randomized controlled trials of 
      therapeutic exercise for HOA published in English from January 1, 1980 to August 
      1, 2020 were included. Studies were excluded if other interventions were 
      provided, if participants had previous hip arthroplasty, or if AEs and DOs for 
      HOA participants were not reported separately. The internal validity of each 
      study (Physiotherapy Evidence Database [PEDro] scoring) was assessed, participant 
      and intervention characteristics were extracted, and the existence of a clear 
      statement and reasons for AEs and DOs was reported. Descriptive statistics 
      characterized results. Data heterogeneity prohibited the use of meta-analysis. 
      RESULTS: Fourteen studies (mean PEDro score = 7.4; range = 6-10) from 10 
      countries were included, with 707 participants exercising. Exercise intensity was 
      unspecified in 72.2% of exercise arms. Six studies (42.9%) included a statement 
      of AEs, and 32 AEs were reported. All studies had a DO statement, but 29.0% of 
      DOs occurred for unknown reasons. Six studies (42.9%) gave reasons for DOs that 
      could be classified as AEs in 9 participants; 41 participants (5.8%) experienced 
      exercise-related AEs. CONCLUSION: Reports of AEs were inconsistent, some DOs were 
      potentially misclassified, and primary components of exercise interventions were 
      frequently unreported. Despite these limitations, the overall low number of 
      nonserious AEs suggests that the exercise-related risk of harm is minimal for 
      individuals with HOA. IMPACT: Understanding the risk of harm associated with 
      exercise for HOA can better inform safe dosing of exercise, clinical 
      implementation, and replicability. Informative, consistent reporting of AEs, DOs, 
      and exercise is needed. Greater use of the CONSORT harms-reporting checklist is 
      warranted.
CI  - (c) The Author(s) 2021. Published by Oxford University Press on behalf of the 
      American Physical Therapy Association. All rights reserved. For permissions, 
      please email: journals.permissions@oup.com.
FAU - James, Khara A
AU  - James KA
AUID- ORCID: 0000-0001-7269-8311
AD  - Department of Physical Therapy, Movement and Rehabilitation Sciences, 
      Northeastern University, Boston, Massachusetts, USA.
FAU - von Heideken, Johan
AU  - von Heideken J
AD  - Department of Women's and Children's Health, Karolinska Intitutet, Stockholm, 
      Sweden.
FAU - Iversen, Maura D
AU  - Iversen MD
AD  - Department of Physical Therapy, Movement and Rehabilitation Sciences, 
      Northeastern University, Boston, Massachusetts, USA.
AD  - Department of Women's and Children's Health, Karolinska Intitutet, Stockholm, 
      Sweden.
AD  - Section of Clinical Sciences, Division of Rheumatology, Immunology & Allergy, 
      Brigham & Women's Hospital, Department of Medicine, Harvard Medical School, 
      Boston, Massachusetts, USA.
AD  - College of Health Professions, Sacred Heart University, Fairfield, Connecticut, 
      USA.
LA  - eng
GR  - R03 AR057133/AR/NIAMS NIH HHS/United States
PT  - Journal Article
PT  - Research Support, N.I.H., Extramural
PT  - Systematic Review
PL  - United States
TA  - Phys Ther
JT  - Physical therapy
JID - 0022623
SB  - IM
MH  - Biomedical Research/*standards
MH  - Exercise Therapy/*methods
MH  - Humans
MH  - Osteoarthritis, Hip/*rehabilitation
MH  - Randomized Controlled Trials as Topic/*standards
MH  - Risk Assessment
PMC - PMC8565302
OTO - NOTNLM
OT  - Adult
OT  - Exercise Therapy
OT  - Hip Osteoarthritis
OT  - Rehabilitation
OT  - Risk Assessment
EDAT- 2021/11/04 06:00
MHDA- 2021/12/28 06:00
PMCR- 2022/11/03
CRDT- 2021/11/03 12:24
PHST- 2020/08/10 00:00 [received]
PHST- 2021/04/13 00:00 [revised]
PHST- 2021/07/05 00:00 [accepted]
PHST- 2021/11/03 12:24 [entrez]
PHST- 2021/11/04 06:00 [pubmed]
PHST- 2021/12/28 06:00 [medline]
PHST- 2022/11/03 00:00 [pmc-release]
AID - 6420118 [pii]
AID - pzab195 [pii]
AID - 10.1093/ptj/pzab195 [doi]
PST - ppublish
SO  - Phys Ther. 2021 Nov 1;101(11):pzab195. doi: 10.1093/ptj/pzab195.