Evidence map›Paper›PMID 34180534›Full record

SynthesisPhysical therapy2021

Reporting of Harm in Randomized Controlled Trials of Therapeutic Exercise for Knee Osteoarthritis: A Systematic Review.

Johan von Heideken, Sana Chowdhry, Joanna Borg, Khara James, Maura D Iversen

Abstract readSystematic Review
In one paragraph

Synthesis in Physical therapy, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Guideline
  2. Trial
  3. Article
  4. Article
  5. [DNVF Memorandum: Objectives and Methods of Physical Activity-Related Health Services Research].Gesundheitswesen (Bundesverband der Arzte des Offentlichen Gesundheitsdienstes (Germany)) · 2024
    Article
  6. Article
  7. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Johan von HeidekenDepartment of Women's and Children's Health, Karolinska Intitutet, Stockholm, Sweden.
Sana ChowdhryCollege of Health Professions, Department of Health Sciences, Northeastern University, Boston, Massachusetts, USA.
Joanna BorgCollege of Health Professions, Department of Health Sciences, Northeastern University, Boston, Massachusetts, USA.
Khara JamesDepartment of Rehabilitation and Movement Sciences, Northeastern University, Boston, Massachusetts, USA.ORCID 0000-0001-7269-8311
Maura D IversenDepartment of Women's and Children's Health, Karolinska Intitutet, Stockholm, Sweden.

Funding

Trial of risk mangement for prevention of accelerated atherosclerosis in SLEP60AR047782 · NIAMS · BRIGHAM AND WOMEN'S HOSPITAL · PI KATZ, JEFFREY NEIL · 2001 to 2016
$18.8M
Activity Presciptions in Rheumatoid Arthritis: Toward Personalized CounselingR03AR057133 · NIAMS · BRIGHAM AND WOMEN'S HOSPITAL · PI IVERSEN, MAURA · 2010 to 2011
$175k
NIAMS NIH HHS P60 AR047782NIAMS NIH HHS R03 AR057133
6 · The paper itself

Abstract

objectiveThe 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).

methodsData 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.

resultsOne 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%; $\chi^{2}_{1} = 21.2$).

conclusionsIn 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.

Indexed as

Exercise TherapyRandomized Controlled Trials as TopicExerciseHumansOsteoarthritis, KneeRisk AssessmentAdultExercise TherapyKnee OsteoarthritisRehabilitationRisk Assessment

Identifiers

PMID34180534
PMCPMC8557852

What Socratic holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.