Assessing the adherence of intervertebral disc degeneration clinical trial protocols to SPIRIT guidelines
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Introduction
Clinical trials are important for advancing medical knowledge and protocols are the core documents that facilitate their appraisal. The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) checklist offers a framework for standardizing the quality and content of clinical trial protocols. Although there is a high growth in number of clinical trials investigating the efficacy and safety of various therapies, many still exhibit deficiencies in information contained in both their reports and protocols. The main objective for this study were to check the findability of intervertebral disc degeneration (IVD) clinical trial protocols and assessing their adherence to SPIRIT recommendations.
Methods
We included randomized controlled trials (RCTs) that investigated various therapeutic interventions for IVD provided they included a control group and reported at least one relevant clinical outcome. Studies were excluded if they were not recruiting, were observational, case reports, reviews, meta-analyses, editorials, or commentaries, or if they lacked complete data, such as missing results or a protocol. A search was conducted on ClinicalTrials.gov using terms related to IVD, covering the period from January 2013 to the present, aligning with the post-SPIRIT recommendation publication period. Data extraction was performed using a reduced SPIRIT checklist to assess adherence to protocol guidelines, with compliance measured across 64 key items. A narrative synthesis was conducted to summarize study characteristics, adherence levels and patterns by intervention and sponsor type.
Results
Adherence rates vary from 28.13% to 98.44% with a median of 48.44%. Heatmaps revealed heterogeneity, highlighting areas of consistent adherence and regions requiring improvement. High adherence was noted in inclusion criteria and outcome measurement, while lower in research ethics and funding declarations. Industry-sponsored studies demonstrated highest adherence in ‘DRUG’ (79.69%) and ‘DEVICE’ (62.50%) categories, while non-industry sponsors were most adherent in ‘BIOLOGICAL’ (50.00%) and ‘OTHER’ intervention categories.
Discussion
Our findings shows a critical need for findability of clinical trial protocols to assist in appraisal of interventions and enhanced adherence to SPIRIT guidelines among IVD clinical trials, for greater transparency and accuracy. Adherence is essential for ensuring high-quality evidence that can inform clinical practice and patient care in managing IVD.
