TIDIER checklist of PA in HTN studies
September 28, 2018
Treating hypertension with exercise made harder by poor trial reporting
The reporting quality of exercise interventions was poor and insufficient to allow for their replication. This makes it harder to translate research findings into clinical practice and ultimately impacts on the potential benefits to patients.
David Nunan, Director, Certificate in Teaching Evidence-Based Health Care
Hypertension is the most common modifiable risk factor for cardiovascular diseases and has been estimated to cause 13% of deaths worldwide.
Several systematic reviews and meta-analyses support the beneficial effects of exercise and are incorporated into numerous guidelines. However, the reporting quality of non-pharmacological therapeutic interventions has been questioned, resulting in a lack of replicability which may impact translation of research findings to clinical practice.
We therefore conducted an assessment of the reporting quality of randomised controlled trials (RCTs) assessing the effect of exercise therapy in patients with hypertension using the TIDieR (Template for Intervention Description and Replication) and CERT (Consensus on Exercise Reporting Template) guidelines.
What did we find?
Using the most up-to-date systematic review as our source, we assessed the reporting quality of 24 RCTs investigating the effect of endurance training in a total of 1,195 patients.
We found that on average 61% of core items of the TIDieR guidelines required for replication were reported across the 24 trials. The figure for the CERT guidelines was 57% on average.
The most frequent issues were with the reporting of adherence, intervention provider, and adverse events. Details about exercise dosage were missing in 22% of trials and information as to whether the intervention was delivered as planned was reported in less than half (48%).
Only 13% of included trials reported adequate information on adverse events
What does this mean?
Our study showed that reporting of interventions in trials of endurance exercise for the management of hypertension was poor and insufficient to allow for their replication regardless of whether TIDieR or CERT guidelines were applied.
None of the original trials provided complete information for all essential intervention elements, making accurate replication of the included interventions difficult.
We also highlighted an improvement in the quality of reporting of exercise-based interventions across the timeframe of included studies for TIDieR but not CERT guidelines.
There was a clear lack of reporting of adverse events and harms, which makes it almost impossible to estimate the potential risk of the exercise interventions with any degree of certainty.
Our findings have important implications for research and practice as they are based on trials from a systematic review that underpins the evidence-base in numerous publications and guideline recommendations. Given the quality of reporting, it is not possible to offer specific exercise prescriptions in accordance with the evidence-base supporting such recommendations.
We recommend all agents involved in the exercise-therapy evidence pipeline including trial researchers, systematic review authors, journal editors and reviewers, and health care professionals, to familiarize themselves with available reporting guidelines and ensure adherence throughout planning to publication.
Hacke C, Nunan D, Weisser B.
Do Exercise Trials for Hypertension Adequately Report Interventions? A Reporting Quality Study. Int J Sports Med. 2018 Aug 21. doi: 10.1055/a-0649-1040.
David Nunan is a Senior Researcher in the Centre for Evidence-Based Medicine, University of Oxford, and Course Director of the Certificate in Teaching Evidence-based Health Care
Competing interests: DN reports grants from NIHR School of Primary Care Research and grants from the Royal College of General Practitioners, during the conduct of the study; and occasionally receives expenses for teaching Evidence-Based Medicine.
Funding: This article was not funded. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR, or the Department of Health.