Recommendations and evidence for reporting items in pediatric clinical trial protocols and reports: two systematic reviews

Abstract

Background: Complete and transparent reporting of clinical trial protocols and reports ensures that these documents are useful to all stakeholders, that bias is minimized, and that the research is not wasted. However, current studies repeatedly conclude that pediatric trial protocols and reports are not appropriately reported. Guidelines like SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) and CONSORT (Consolidated Standards of Reporting Trials) may improve reporting, but do not offer guidance on issues unique to pediatric trials. This paper reports two systematic reviews conducted to build the evidence base for the development of pediatric reporting guideline extensions: 1) SPIRIT-Children (SPIRIT-C) for pediatric trial protocols, and 2) CONSORT-Children (CONSORT-C) for pediatric trial reports. Method: MEDLINE, the Cochrane Methodology Register, and reference lists of included studies were searched. Publications of any type were eligible if they included explicit recommendations or empirical evidence for the reporting of potential items in a pediatric protocol (SPIRIT-C systematic review) or trial report (CONSORT-C systematic review). Study characteristics, recommendations and evidence for pediatric extension items were extracted. Recurrent themes in the recommendations and evidence were identified and synthesized. All steps were conducted by two reviewers. Results: For the SPIRIT-C and CONSORT-C systematic reviews 366 and 429 publications were included, respectively. Recommendations were identified for 48 of 50 original reporting items and sub-items from SPIRIT, 15 of 20 potential SPIRIT-C reporting items, all 37 original CONSORT items and sub-items, and 16 of 22 potential CONSORT-C reporting items. The following overarching themes of evidence to support or refute the utility of reporting items were identified:

Are child-centric aspects in newborn and child health systematic review and meta-analysis protocols and reports adequately reported?—two systematic reviews

“…The dearth of quality reporting in research in children has been observed numerous times, yielding repeated calls for child-centric reporting guidelines in the literature [3, 18, 19, 29]. A similar conclusion was reached in a SR assessing issues in the design, reporting, and conduct of clinical trials in children [29].…”

Completeness of protocols for clinical trials in children submitted to ethics committees

“…Two recent systematic reviews gathered evidence and recommendations for including child‐specific items in protocols, SPIRIT‐C, and reporting of trials in children, CONSORT‐C . The development and use of a standardised protocol template including child‐specific domains and the other deficient domains could be expected to improve paediatric trial design, conduct and reporting practices …”

“…A compilation of other protocol elements of importance, particularly child‐specific domains, informed by the current International Conference on Harmonisation Guideline for Good Clinical Practice guidelines (E6R1) and WHO Paediatric Clinical Trials guidance for assessors were also included . Some of these protocol items were, for example, reporting disease prevalence and long‐term safety monitoring, which now appear on Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) and proposals for CONSORT‐Children (CONSORT‐C) and SPIRIT‐Children (SPIRIT‐C) . SPIRIT‐C is an initiative which recognises that trials in children need additional and modified domains to better address the complexities of paediatric trials.…”

“…11 Some of these protocol items were, for example, reporting disease prevalence and long-term safety monitoring, which now appear on Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 12 and proposals for CONSORT-Children (CONSORT-C) and SPIRIT-Children (SPIRIT-C). 13 SPIRIT-C is an initiative which recognises that trials in children need additional and modified domains to better address the complexities of paediatric trials. The Cochrane Collaboration's Risk of Bias Tool contains seven domains, and we assessed the five domains relevant for a protocol: selection bias (random sequence generation, allocation concealment), performance bias (blinding of participants and personnel), detection bias (blinding of outcome assessment) and attrition bias (specified intention-totreat analysis).…”

Feasibility of an online intervention (STAK-D) to promote physical activity in children with type 1 diabetes: protocol for a randomised controlled trial

“…The protocol has been prepared according to Standard Protocol Items: Recommendations for Interventional Trials-Extension for Newborns, Children, and Adolescents (SPIRIT-C) [40]. For the completed checklist, see Additional file 1.…”