PMID- 34180534
OWN - NLM
STAT- MEDLINE
DCOM- 20211215
LR  - 20240214
IS  - 1538-6724 (Electronic)
IS  - 0031-9023 (Print)
IS  - 0031-9023 (Linking)
VI  - 101
IP  - 10
DP  - 2021 Oct 1
TI  - Reporting of Harm in Randomized Controlled Trials of Therapeutic Exercise for 
      Knee Osteoarthritis: A Systematic Review.
LID - 10.1093/ptj/pzab161 [doi]
LID - pzab161
AB  - OBJECTIVE: The Consolidated Standards of Reporting Trials (CONSORT) recommends 
      reporting adverse events (AEs) and dropouts (DOs) with their definitions. The 
      purpose of this study was to identify how AEs and DOs were reported in randomized 
      controlled trials of therapeutic exercise for knee osteoarthritis (OA). METHODS: 
      Data sources were the Cochrane Library, Embase, PubMed, and CINAHL. Databases 
      were searched to identify randomized controlled trials of therapeutic exercise 
      for knee OA published from January 1, 1980, through July 23, 2020. Researchers 
      independently extracted participant and intervention characteristics and 
      determined whether a clear statement of and reasons for AEs and DOs existed. The 
      primary outcome was exercise-related harm. Physiotherapy Evidence Database 
      (PEDro) scoring described study quality and risk of bias. Descriptive and 
      inferential statistics characterized results. Meta-analysis was not performed due 
      to data heterogeneity. RESULTS: One hundred and thirteen studies (152 arms) from 
      25 countries were included, with 5909 participants exercising. PEDro scores 
      ranged from 4 to 9. Exercise intensity was not specified in 57.9% of exercise 
      arms. Fifty studies (44.2%) included an AE statement and 24 (21.2%) reported AEs, 
      yielding 297 patients. One hundred and three studies (91.2%) had a DO statement. 
      Sixteen studies (15.5%) provided reasons for DOs that could be classified as AEs 
      among 39 patients, yielding a 13.1% increase in AEs. Thus, 336 patients (6.0%) 
      experienced exercise-related harm among studies with a clear statement of AEs and 
      DOs. A significant difference existed in misclassification of DOs pre- and 
      post-CONSORT-2010 (12.2% vs 3.1%; $\chi;2_1 = 21.2$). CONCLUSIONS: In some 
      studies, the reason for DOs could be considered AEs, leading to potential 
      underreporting of harm. Improvements in reporting of harm were found pre- and 
      post-CONSORT-2010. Greater clarity regarding AE and DO definitions and 
      therapeutic exercise intensity are needed to determine safe dosing and mode of 
      therapeutic exercise for knee OA. IMPACT: More adherence to the CONSORT statement 
      is needed regarding reporting of and defining of AEs, DOs, and therapeutic 
      exercise intensity; however, despite this, therapeutic exercise seems to be 
      associated with minimal risk of harm.
CI  - 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 - von Heideken, Johan
AU  - von Heideken J
AD  - Department of Women's and Children's Health, Karolinska Intitutet, Stockholm, 
      Sweden.
FAU - Chowdhry, Sana
AU  - Chowdhry S
AD  - College of Health Professions, Department of Health Sciences, Northeastern 
      University, Boston, Massachusetts, USA.
FAU - Borg, Joanna
AU  - Borg J
AD  - College of Health Professions, Department of Health Sciences, Northeastern 
      University, Boston, Massachusetts, USA.
FAU - James, Khara
AU  - James K
AUID- ORCID: 0000-0001-7269-8311
AD  - Department of Rehabilitation and Movement Sciences, Northeastern University, 
      Boston, Massachusetts, USA.
FAU - Iversen, Maura D
AU  - Iversen MD
AD  - Department of Women's and Children's Health, Karolinska Intitutet, Stockholm, 
      Sweden.
AD  - Department of Rehabilitation and Movement Sciences, Northeastern University, 
      Boston, Massachusetts, USA.
AD  - College of Health Professions, Departments of Public Health and Physical Therapy 
      and Movement Sciences, Sacred Heart University, Fairfield, Connecticut, USA.
AD  - Section of Clinical Sciences, Division of Rheumatology, Inflammation and 
      Immunity, Brigham and Women's Hospital, Department of Medicine, Harvard Medical 
      School, Boston, Massachusetts, USA.
LA  - eng
GR  - P60 AR047782/AR/NIAMS NIH HHS/United States
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  - Exercise
MH  - *Exercise Therapy
MH  - Humans
MH  - Osteoarthritis, Knee/*rehabilitation/therapy
MH  - *Randomized Controlled Trials as Topic
MH  - Risk Assessment
PMC - PMC8557852
OTO - NOTNLM
OT  - Adult
OT  - Exercise Therapy
OT  - Knee Osteoarthritis
OT  - Rehabilitation
OT  - Risk Assessment
EDAT- 2021/06/29 06:00
MHDA- 2021/12/16 06:00
PMCR- 2022/06/26
CRDT- 2021/06/28 09:13
PHST- 2020/04/16 00:00 [received]
PHST- 2021/03/19 00:00 [revised]
PHST- 2021/05/19 00:00 [accepted]
PHST- 2021/06/29 06:00 [pubmed]
PHST- 2021/12/16 06:00 [medline]
PHST- 2021/06/28 09:13 [entrez]
PHST- 2022/06/26 00:00 [pmc-release]
AID - 6310001 [pii]
AID - pzab161 [pii]
AID - 10.1093/ptj/pzab161 [doi]
PST - ppublish
SO  - Phys Ther. 2021 Oct 1;101(10):pzab161. doi: 10.1093/ptj/pzab161.