Abstract

BackgroundPoor reporting of medical trials has triggered the development of trial reporting standards within the scientific community. In addition to a description of the proposed intervention, adequate information about the trial setting and the group of health workers (cadre) delivering the intervention would allow a better understanding of the generalizability of the trial findings, facilitate replication of trial interventions and assist with assessment of trials for inclusion in systematic reviews. This study aims to determine the completeness of reporting for trial setting and cadre among trials included in two Cochrane reviews on iron and folic acid supplementation for women during pregnancy.MethodsFrom the 81 trials included in the two Cochrane reviews, we extracted data on the trial setting, including the facility type and geographic location, facility descriptors (i.e. level of care) and population descriptors (i.e. socioeconomic status); and the cadre, including professional qualifications, training and supervision.ResultsAlmost all studies reported the facility type and location (96%). However, only 68% included this information in the “methods” section of the report. Facility descriptors and population descriptors were less commonly reported (26% and 54% respectively). For 34% of the trials, we found some account of the type of health worker that delivered the intervention. Only 4% of the trials reported any training procedures.ConclusionsCurrently, complete reporting of setting and health worker cadre in iron and folic acid supplementation in pregnancy trials remains far from ideal, limiting assessments of the applicability of the trial findings. Trialists and journals need to ensure that this information is included in trial reports by adhering to and improving current reporting standards and by not making assumptions regarding readers’ knowledge of the context and of the intervention delivery mechanism.

Highlights

  • Poor reporting of medical trials has triggered the development of trial reporting standards within the scientific community

  • Better descriptions of setting and health worker cadres are necessary for reproducing the interventions in further trials and for the critical evaluation of trial results when conducting systematic reviews [8]

  • One author (RH) reviewed the full text of each report and of associated studies if cited, and extracted information relating to the setting - - and information about the health worker cadre who delivered the intervention

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Summary

Introduction

Poor reporting of medical trials has triggered the development of trial reporting standards within the scientific community. In addition to a description of the proposed intervention, adequate information about the trial setting and the group of health workers (cadre) delivering the intervention would allow a better understanding of the generalizability of the trial findings, facilitate replication of trial interventions and assist with assessment of trials for inclusion in systematic reviews. Better descriptions of setting and health worker cadres are necessary for reproducing the interventions in further trials and for the critical evaluation of trial results when conducting systematic reviews [8]. Guidelines such as the Consolidated Standards of Reporting Trials (CONSORT) and Transparent Reporting of Evaluations with Nonrandomized Designs (TREND) have been developed to facilitate more complete reporting of trials [9,10]. There have been recent indications of improvement in this area, especially in the decade since the release of the CONSORT statement, but reporting is still not optimal [12]

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