Papel ético del estadístico en la experimentación humana

En diferentes ocasiones, desde la Sociedad de Estad´ıstica e Investigaci´on Operativa o desde la Regi´on Espa˜nola de la International Biometry Society, se nos ha pedido a los estad´ısticos aplicados que hablemos de aquellas caracter´ısticas de nuestro trabajo profesional no contempladas en los planes de estudio. En estas l´ıneas pretendemos recordar el relevante papel que el estad´ıstico desempe˜na en la investigaci´on y desarrollo de nuevas pautas terap´euticas. Para ello, expondremos los principios ´eticos b´asicos que gu´ıan la experimentaci´on con seres humanos y sus implicaciones en la tarea profesional del estad´ıstico. Tambi´en esbozaremos aquellas l´ıneas de investigaci´onmetodol´ogica b´asica que podr´ıan aligerar las tensiones entre principios ´eticos e investigaci´on con seres humanos. Finalmente, insistimos en la necesidad de la reincorporaci´on inmediata de estad´ısticos en las comisiones encargadas de valorar la validez cient´ıfica de las propuestas de investigaci´on cl´ınica

Taking advantage of unexpected WebCONSORT results

To estimate treatment effects, trials are initiated by randomising patients to the interventions under study and finish by comparing patient evolution. In order to improve the trial report, the CONSORT statement provides authors and peer reviewers with a guide of the essential items that would allow research replication. Additionally, WebCONSORT aims to facilitate author reporting by providing the items from the different CONSORT extensions that are relevant to the trial being reported. WebCONSORT has been estimated to improve the proportion of reported items by 0.04 (95% CI, –0.02 to 0.10), interpreted as “no important difference”, in accordance with the scheduled desired scenario of a 0.15 effect size improvement. However, in a non-scheduled analysis, it was found that, despite clear instructions, around a third of manuscripts selected for trials by the editorial staff were not actually randomised trials. We argue that surprises benefit science, and that further research should be conducted in order to improve the performance of editorial staff.Peer ReviewedPostprint (published version

Papel ético del estadístico en la experimentación humana

En diferentes ocasiones, desde la Sociedad de Estad´ıstica e Investigaci´on Operativa o desde la Regi´on Espa˜nola de la International Biometry Society, se nos ha pedido a los estad´ısticos aplicados que hablemos de aquellas caracter´ısticas de nuestro trabajo profesional no contempladas en los planes de estudio. En estas l´ıneas pretendemos recordar el relevante papel que el estad´ıstico desempe˜na en la investigaci´on y desarrollo de nuevas pautas terap´euticas. Para ello, expondremos los principios ´eticos b´asicos que gu´ıan la experimentaci´on con seres humanos y sus implicaciones en la tarea profesional del estad´ıstico. Tambi´en esbozaremos aquellas l´ıneas de investigaci´onmetodol´ogica b´asica que podr´ıan aligerar las tensiones entre principios ´eticos e investigaci´on con seres humanos. Finalmente, insistimos en la necesidad de la reincorporaci´on inmediata de estad´ısticos en las comisiones encargadas de valorar la validez cient´ıfica de las propuestas de investigaci´on cl´ınica

Are CONSORT checklists submitted by authors adequately reflecting what information is actually reported in published papers?

BackgroundCompulsory submission of a checklist from the relevant reporting guideline is one of the most widespread journal requirements aiming to improve completeness of reporting. However, the current suboptimal levels of adherence to reporting guidelines observed in the literature may indicate that this journal policy is not having a significant effect.FindingsWe explored whether authors provided the appropriate CONSORT checklist extension for their study and whether there were inconsistencies between what authors claimed on the submitted checklist and what was actually reported in the published paper. We randomly selected 12 randomized trials from three journals that provide the originally submitted checklist and analyzed six core CONSORT items. Only one paper used the appropriate checklist extension and had no inconsistencies between what was claimed in the submitted checklist and what was reported in the published paper.ConclusionJournals should take further actions to take full advantage of the requirement for the submission of fulfilled CONSORT checklists, thus ensuring that these checklists reflect what is reported in the manuscript

The STROBE extensions: protocol for a qualitative assessment of content and a survey of endorsement

Introduction The STrengthening the Reporting of OBservational studies in Epidemiology (STROBE) Statement was developed in response to inadequate reporting of observational studies. In recent years, several extensions to STROBE have been created to provide more nuanced field-specific guidance for authors. The content and the prevalence of extension endorsement have not yet been assessed. Accordingly, there are two aims: (1) to classify changes made in the extensions to identify strengths and weaknesses of the original STROBE checklist and (2) to determine the prevalence and typology of endorsement by journals in fields related to extensions. Methods and analysis Two independent researchers will assess additions in each extension. Additions will be coded as â field specific' (FS) or â not field specific' (NFS). FS is defined as particularly relevant information for a single field and guidance provided generally cannot be extrapolated beyond that field. NFS is defined as information that reflects epidemiological or methodological tenets and can be generalised to most, if not all, types of observational research studies. Intraclass correlation will be calculated to measure reviewers' concordance. On disagreement, consensus will be sought. Individual additions will be grouped by STROBE checklist items to identify the frequency and distribution of changes. Journals in fields related to extensions will be identified through National Library of Medicine PubMed Broad Subject Terms, screened for eligibility and further distilled via Ovid MEDLINE® search strategies for observational studies. Text describing endorsement will be extracted from each journal's website. A classification scheme will be created for endorsement types and the prevalence of endorsement will be estimated. Analyses will use NVivo V.11 and SAS University Edition. Ethics and dissemination This study does not require ethical approval as it does not involve human participants. This study has been preregistered on Open Science Framework.Peer ReviewedPostprint (author's final draft

Scoping review on interventions to improve adherence to reporting guidelines in health research

Objectives The goal of this study is to identify, analyse and classify interventions to improve adherence to reporting guidelines in order to obtain a wide picture of how the problem of enhancing the completeness of reporting of biomedical literature has been tackled so far. Design Scoping review. Search strategy We searched the MEDLINE, EMBASE and Cochrane Library databases and conducted a grey literature search for (1) studies evaluating interventions to improve adherence to reporting guidelines in health research and (2) other types of references describing interventions that have been performed or suggested but never evaluated. The characteristics and effect of the evaluated interventions were analysed. Moreover, we explored the rationale of the interventions identified and determined the existing gaps in research on the evaluation of interventions to improve adherence to reporting guidelines. Results 109 references containing 31 interventions (11 evaluated) were included. These were grouped into five categories: (1) training on the use of reporting guidelines, (2) improving understanding, (3) encouraging adherence, (4) checking adherence and providing feedback, and (5) involvement of experts. Additionally, we identified lack of evaluated interventions (1) on training on the use of reporting guidelines and improving their understanding, (2) at early stages of research and (3) after the final acceptance of the manuscript. Conclusions This scoping review identified a wide range of strategies to improve adherence to reporting guidelines that can be taken by different stakeholders. Additional research is needed to assess the effectiveness of many of these interventionsPeer ReviewedPostprint (author's final draft

Effect of an editorial intervention to improve the completeness of reporting of randomised trials: a randomised controlled trial

Objective To evaluate the impact of an editorial intervention to improve completeness of reporting of reports of randomised trials. Design Randomised controlled trial (RCT). Setting BMJ Open’s quality improvement programme. Participants 24 manuscripts describing RCTs. Interventions We used an R Shiny application to randomise manuscripts (1:1 allocation ratio, blocks of 4) to the intervention (n=12) or control (n=12) group. The intervention was performed by a researcher with expertise in the content of the Consolidated Standards of Reporting Trials (CONSORT) and consisted of an evaluation of completeness of reporting of eight core CONSORT items using the submitted checklist to locate information, and the production of a report containing specific requests for authors based on the reporting issues found, provided alongside the peer review reports. The control group underwent the usual peer review. Outcomes The primary outcome is the number of adequately reported items (0–8 scale) in the revised manuscript after the first round of peer review. The main analysis was intention-to-treat (n=24), and we imputed the scores of lost to follow-up manuscripts (rejected after peer review and not resubmitted). The secondary outcome is the proportion of manuscripts where each item was adequately reported. Two blinded reviewers assessed the outcomes independently and in duplicate and solved disagreements by consensus. We also recorded the amount of time to perform the intervention. Results Manuscripts in the intervention group (mean: 7.01; SD: 1.47) were more completely reported than those in the control group (mean: 5.68; SD: 1.43) (mean difference 1.43, 95% CI 0.31 to 2.58). We observed the main differences in items 6a (outcomes), 9 (allocation concealment mechanism), 11a (blinding) and 17a (outcomes and estimation). The mean time to perform the intervention was 87 (SD 42) min. Conclusions We demonstrated the benefit of involving a reporting guideline expert in the editorial process. Improving the completeness of RCTs is essential to enhance their usability. Trial registration number NCT03751878.Peer ReviewedPostprint (published version