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. Key words adolescents; children; CONSORT; pain; randomized controlled trial. Medical procedures involving needles are a considerable source of pain and anxiety for children and adolescents (e.g., Although there is no standard definition for study 'quality', it generally refers to the methodology of a study (usually an RCT), including whether it has sufficient internal validity, addresses the generalizability of findings, provides adequate study details, and adheres to strong study implementation, design, and analyses. Poor quality trials limit our understanding of whether an intervention is efficacious, as poor study designs and implementation can lead to spurious findings (either supporting or failing to support the intervention). There are various quality rating scales available; however, some of the most commonly used measures were developed for assessing RCTs evaluating pharmacological interventions (e.g., The most widely adopted criteria currently used to evaluate the quality of RCTs are the Consolidated Standards of Reporting Trials (i.e., CONSORT Statement; Despite the CONSORT Statement being adopted as recommended criteria by many biomedical journals; psychology journals have been slower to adopt these criteria for psychological or nonpharmacological intervention trials In a commentary accompanying the study by Since the publication of the CONSORT Statement, additional quality measures have been developed. For example, Yates and colleagues developed and validated a 13-criteria (or 26 sub-criteria) measure to assess the quality of psychological interventions for pain management In addition, regularly assessing the quality of RCTs is important for determining whether quality reporting has improved since the development of guidelines such as the CONSORT Statement, and to identify areas in need of further improvement. A study evaluating the reporting of methodological information in four journals of pediatric and child psychology found that although overall quality scores were low, improvements in the reporting of quality in more recently published trials were note