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Quality of reporting of randomized, controlled trials in cerebral palsy
Heidi Anttila1, Antti Malmivaara, Regina Kunz
1Finnish Office for Health Technology Assessment, National Research and Development Centre for Welfare and Health, Helsinki, Finland. heidi.anttila@stakes.fi
Insights
Reporting quality in physiotherapy trials for children with cerebral palsy is poor. Adhering to Consolidated Standards of Reporting Trials (CONSORT) guidelines is crucial for accurate clinical implications.
Area of Science:
- Pediatric Rehabilitation
- Clinical Trial Methodology
Background:
- Assessing physiotherapy interventions for pediatric cerebral palsy is hindered by inconsistent trial reporting.
- The Consolidated Standards of Reporting Trials (CONSORT) statement offers guidelines for improving trial transparency.
Purpose of the Study:
- To evaluate the quality of reporting in randomized controlled trials (RCTs) of physiotherapy for children with cerebral palsy.
- To assess adherence to CONSORT statement recommendations in this specific research area.
Main Methods:
- Literature search for RCTs on physiotherapy for pediatric cerebral palsy published since 1990.
- Evaluation of 15 identified RCTs using a modified 33-item CONSORT checklist by two independent reviewers.
Main Results:
- Only 48% of applicable CONSORT items were adequately reported across the 15 RCTs.
- Key areas of inadequate reporting included outcome measures, sample size, randomization details, blinding, and intention-to-treat analysis.
Conclusions:
- A significant number of RCTs in pediatric cerebral palsy physiotherapy suffer from poor reporting.
- High-quality reporting is feasible, as most items have been described in at least one study.
- Improved adherence to CONSORT guidelines is essential for reliable clinical decision-making.
Objectives:
In conducting reviews on the effectiveness of physiotherapy interventions on children with cerebral palsy, the assessment of trials can be hampered by problems in reporting. Therefore, we set out to evaluate trial reporting by using the Consolidated Standards of Reporting Trials (CONSORT) statement recommendations.
Methods:
Randomized, controlled trials published in 1990 or later were identified in literature searches for reviews on the effectiveness of physiotherapy interventions on children with cerebral palsy. Two independent reviewers evaluated the trial reporting by using a modified 33-item Consolidated Standards of Reporting Trials checklist.
Results:
We identified 15 randomized, controlled trials. Almost half (48%) of the applicable items were reported adequately. Inadequate reporting was found in the following items: outcome measures, sample-size determination, details of the sequence generation, allocation concealment and implementation of the randomization, success of assessor blinding, recruitment and follow-up dates, intention-to-treat analysis, precision of the effect size, co-interventions, and adverse events.
Conclusions:
Only a small number of sufficiently reported trials were found. Because nearly all items had been described in at least 1 article, high-quality reporting seems feasible. Assessment of trials depends on appropriate reporting, and poor reporting jeopardizes judgments on the clinical implications. Authors of randomized, controlled trials are encouraged to follow the Consolidated Standards of Reporting Trials criteria. There is a clear need to improve the quality of reporting of trials in this field.
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