Heterogeneity and gaps in reporting primary outcomes from neonatal trials

OBJECTIVES: Clear outcome reporting in clinical trials facilitates accurate interpretation and applica- tion of findings and improves evidence-informed decision-making. Standardized core outcomes for reporting neonatal trials have been developed, but little is known about how primary out- comes are reported in neonatal trials. Our aim was to identify strengths and weaknesses of pri- mary outcome reporting in recent neonatal trials. METHODS: Neonatal trials including $100 participants/arm published between 2015 and 2020 with at least 1 primary outcome from a neonatal core outcome set were eligible. Raters recruited from Cochrane Neonatal were trained to evaluate the trials’ primary outcome reporting completeness using relevant items from Consolidated Standards of Reporting Trials 2010 and Consolidated Standards of Reporting Trials-Outcomes 2022 pertaining to the reporting of the definition, selec- tion, measurement, analysis, and interpretation of primary trial outcomes. All trial reports were assessed by 3 raters. Assessments and discrepancies between raters were analyzed. RESULTS: Outcome-reporting evaluations were completed for 36 included neonatal trials by 39 raters. Levels of outcome reporting completeness were highly variable. All trials fully reported the primary outcome measurement domain, statistical methods used to compare treatment groups, and participant flow. Yet, only 28% of trials fully reported on minimal important difference, 24% on outcome data missingness, 66% on blinding of the outcome assessor, and 42% on handling of outcome multiplicity. CONCLUSIONS: Primary outcome reporting in neonatal trials often lacks key information needed for interpretability of results, knowledge synthesis, and evidence-informed decision-making in neona- tology. Use of existing outcome-reporting guidelines by trialists, journals, and peer reviewers will enhance transparent reporting of neonatal trials

Manuscript Pre-Print_Stallwood et al., 2021 CDRS-R adolescents

The Children’s Depression Rating Scale-Revised (CDRS-R) is the most commonly used method to measure depression in treatment studies of teens with depression, but it is unknown whether the CDRS-R is appropriate for the purpose of measuring depression in adolescents. This study aimed to identify all existing evidence of the key measurement properties of the CDRS-R (for example, how well the scale measures what it is supposed to measure) in teens with depression, and to evaluate these properties using a well-established method developed by the COSMIN Initiative (https://www.cosmin.nl/). The study concludes that it is unclear whether the CDRS-R can appropriately measure depression symptom severity in treatment studies of teens with depression based on current available evidence. It is important that the best methods are used to measure outcomes to ensure that results from clinical research studies in teens with depression are meaningful and useful to relevant stakeholders, including patients, caregivers, health care providers, researchers, and policymakers

Systematic Review: The Measurement Properties of the Children's Depression Rating Scale−Revised in Adolescents With Major Depressive Disorder

Objective: To systematically appraise existing evidence of the measurement properties of the Children's Depression Rating Scale−Revised (CDRS-R) in adolescents with major depressive disorder (MDD). The CDRS-R is the most commonly used scale in adolescent depression research, yet was originally designed for use in children 6 to 12 years old. Method: Seven databases were searched for studies that evaluated the measurement properties of the CDRS-R in adolescents (ages 12−18 years). Of 65 studies screened by full-text, 6 were included. Measurement properties were appraised using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) guidelines. The COSMIN minimum requirements for recommending the use of an outcome measurement instrument are (1) evidence for sufficient content validity (any level of evidence), and (2) at least low-quality evidence for sufficient internal consistency. Results: Four studies assessed an English-language version of the CDRS-R; the other 2 assessed German and Korean versions, respectively. No study assessed content validity, cross-cultural validity/measurement invariance, or measurement error of the CDRS-R in adolescents with MDD. Low-quality evidence was found for sufficient construct validity (n = 4 studies) and responsiveness (n = 2 studies) assessed via comparator instruments. Very-low−quality evidence was found for sufficient interrater reliability (n = 2 studies). The results for structural validity (n = 3 studies) and internal consistency (n = 5 studies) were inconclusive. Conclusion: It remains unclear whether the CDRS-R appropriately measures depressive symptom severity in adolescent MDD. Before use of the CDRS-R in adolescent MDD research can be recommended, evidence of sufficient psychometric properties in adolescents with MDD is needed

The measurement properties of the Adolescent Depression Rating Scale (ADRS) and the Quick Inventory of Depressive Symptomatology (QIDS) in youth with major depressive disorder (MDD): a systematic review protocol

The objectives of this review are to determine if the ADRS and the QIDS have sufficient measurement properties according to the COSMIN guidelines, to evaluate the quality of this evidence, and to determine whether these OMIs meet at least minimum COSMIN criteria to support their use in youth with MDD and consideration for inclusion in a COS for this population (i.e., sufficient content validity (any level) AND at least low quality evidence for sufficient internal consistency)