Assessing the quality of randomized controlled trials examining psychological interventions for pediatric procedural pain: recommendations for quality improvement.

OBJECTIVE Systematic reviews of randomized controlled trials (RCTs) support the efficacy of psychological interventions for procedural pain management. However, methodological limitations (e.g., inadequate randomization) have affected the quality of this research, thereby weakening RCT findings. METHODS Detailed quality coding was conducted on 28 RCTs included in a systematic review of psychological interventions for pediatric procedural pain. RESULTS The majority of RCTs were of poor to low quality (criteria reported in <50% of RCTs). Commonly reported criteria addressed study background, conditions, statistical analyses, and interpretation of results. Commonly nonreported criteria included treatment administration, evaluation of treatment efficacy (effect sizes, summary statistics, intention-to-treat analyses), caregiver demographics, follow-up, and participant flow. Quality was greater in more recent trials, and did not vary by journal type (psychology vs. medical). CONCLUSION Despite poor quality ratings, quality reporting in psychological RCTs for pediatric procedural pain has improved over time. Recommendations for quality enhancement are provided.