Abstract:Crystal clear RCT protocols are of paramount importance. The reader needs to easily understand the trial methodology and know what is pre-planned. They need to know there are procedures in place if there are, for instance, protocol breaches and protocol amendments are required, there is loss to follow-up and missing data, and how solicited and spontaneous reported adverse events are dealt with. This plan is important for the trial and for the results that will be published when the data is analysed. After all,… Show more
“… 25 , 26 This intervention, however, requires that journals invest in hiring expert reviewers to check adherence to reporting guidelines. The journal Trials has implemented such expert reviewers, 27 and other journals should follow this lead to increase the reporting quality of articles in their journals.…”
ImportanceNumerous studies have shown that adherence to reporting guidelines is suboptimal.ObjectiveTo evaluate whether asking peer reviewers to check if specific reporting guideline items were adequately reported would improve adherence to reporting guidelines in published articles.Design, Setting, and ParticipantsTwo parallel-group, superiority randomized trials were performed using manuscripts submitted to 7 biomedical journals (5 from the BMJ Publishing Group and 2 from the Public Library of Science) as the unit of randomization, with peer reviewers allocated to the intervention or control group.InterventionsThe first trial (CONSORT-PR) focused on manuscripts that presented randomized clinical trial (RCT) results and reported following the Consolidated Standards of Reporting Trials (CONSORT) guideline, and the second trial (SPIRIT-PR) focused on manuscripts that presented RCT protocols and reported following the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guideline. The CONSORT-PR trial included manuscripts that described RCT primary results (submitted July 2019 to July 2021). The SPIRIT-PR trial included manuscripts that contained RCT protocols (submitted June 2020 to May 2021). Manuscripts in both trials were randomized (1:1) to the intervention or control group; the control group received usual journal practice. In the intervention group of both trials, peer reviewers received an email from the journal that asked them to check whether the 10 most important and poorly reported CONSORT (for CONSORT-PR) or SPIRIT (for SPIRIT-PR) items were adequately reported in the manuscript. Peer reviewers and authors were not informed of the purpose of the study, and outcome assessors were blinded.Main Outcomes and MeasuresThe difference in the mean proportion of adequately reported 10 CONSORT or SPIRIT items between the intervention and control groups in published articles.ResultsIn the CONSORT-PR trial, 510 manuscripts were randomized. Of those, 243 were published (122 in the intervention group and 121 in the control group). A mean proportion of 69.3% (95% CI, 66.0%-72.7%) of the 10 CONSORT items were adequately reported in the intervention group and 66.6% (95% CI, 62.5%-70.7%) in the control group (mean difference, 2.7%; 95% CI, −2.6% to 8.0%). In the SPIRIT-PR trial, of the 244 randomized manuscripts, 178 were published (90 in the intervention group and 88 in the control group). A mean proportion of 46.1% (95% CI, 41.8%-50.4%) of the 10 SPIRIT items were adequately reported in the intervention group and 45.6% (95% CI, 41.7% to 49.4%) in the control group (mean difference, 0.5%; 95% CI, −5.2% to 6.3%).Conclusions and RelevanceThese 2 randomized trials found that it was not useful to implement the tested intervention to increase reporting completeness in published articles. Other interventions should be assessed and considered in the future.Trial RegistrationClinicalTrials.gov Identifiers: NCT05820971 (CONSORT-PR) and NCT05820984 (SPIRIT-PR)
“… 25 , 26 This intervention, however, requires that journals invest in hiring expert reviewers to check adherence to reporting guidelines. The journal Trials has implemented such expert reviewers, 27 and other journals should follow this lead to increase the reporting quality of articles in their journals.…”
ImportanceNumerous studies have shown that adherence to reporting guidelines is suboptimal.ObjectiveTo evaluate whether asking peer reviewers to check if specific reporting guideline items were adequately reported would improve adherence to reporting guidelines in published articles.Design, Setting, and ParticipantsTwo parallel-group, superiority randomized trials were performed using manuscripts submitted to 7 biomedical journals (5 from the BMJ Publishing Group and 2 from the Public Library of Science) as the unit of randomization, with peer reviewers allocated to the intervention or control group.InterventionsThe first trial (CONSORT-PR) focused on manuscripts that presented randomized clinical trial (RCT) results and reported following the Consolidated Standards of Reporting Trials (CONSORT) guideline, and the second trial (SPIRIT-PR) focused on manuscripts that presented RCT protocols and reported following the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guideline. The CONSORT-PR trial included manuscripts that described RCT primary results (submitted July 2019 to July 2021). The SPIRIT-PR trial included manuscripts that contained RCT protocols (submitted June 2020 to May 2021). Manuscripts in both trials were randomized (1:1) to the intervention or control group; the control group received usual journal practice. In the intervention group of both trials, peer reviewers received an email from the journal that asked them to check whether the 10 most important and poorly reported CONSORT (for CONSORT-PR) or SPIRIT (for SPIRIT-PR) items were adequately reported in the manuscript. Peer reviewers and authors were not informed of the purpose of the study, and outcome assessors were blinded.Main Outcomes and MeasuresThe difference in the mean proportion of adequately reported 10 CONSORT or SPIRIT items between the intervention and control groups in published articles.ResultsIn the CONSORT-PR trial, 510 manuscripts were randomized. Of those, 243 were published (122 in the intervention group and 121 in the control group). A mean proportion of 69.3% (95% CI, 66.0%-72.7%) of the 10 CONSORT items were adequately reported in the intervention group and 66.6% (95% CI, 62.5%-70.7%) in the control group (mean difference, 2.7%; 95% CI, −2.6% to 8.0%). In the SPIRIT-PR trial, of the 244 randomized manuscripts, 178 were published (90 in the intervention group and 88 in the control group). A mean proportion of 46.1% (95% CI, 41.8%-50.4%) of the 10 SPIRIT items were adequately reported in the intervention group and 45.6% (95% CI, 41.7% to 49.4%) in the control group (mean difference, 0.5%; 95% CI, −5.2% to 6.3%).Conclusions and RelevanceThese 2 randomized trials found that it was not useful to implement the tested intervention to increase reporting completeness in published articles. Other interventions should be assessed and considered in the future.Trial RegistrationClinicalTrials.gov Identifiers: NCT05820971 (CONSORT-PR) and NCT05820984 (SPIRIT-PR)
“…However, if the application of such technologies results in unfair and unjust outcomes, they can propagate inequality and discrimination in our society, especially against women and other underserved communities, having a severe impact on the health system and the lives of women and men ( 46 – 48 ). The emergence of sex and gender bias in AI and health is linked to several unresolved issues, such as the diversity gap in clinical trials ( 49 , 50 ), poor data management ( 51 , 52 ), the lack of data collection accountability ( 53 , 54 ), among many others. Thus, different strategies need to be defined to help the society and the experts understand and address these issues, especially in high-stakes AI applications ( 55 , 56 ).…”
Historically, biomedical research has been led by and focused on men. The recent introduction of Artificial Intelligence (AI) in this area has further proven this practice to be discriminatory for other sexes and genders, more noticeably for women. To move towards a fair AI development, it is essential to include sex and gender diversity both in research practices and in the workplace. In this context, the Bioinfo4women (B4W) program of the Barcelona Supercomputing Center (i) promotes the participation of women scientists by improving their visibility, (ii) fosters international collaborations between institutions and programs and (iii) advances research on sex and gender bias in AI and health. In this article, we discuss methodology and results of a series of conferences, titled “Sex and Gender Bias in Artificial Intelligence and Health, organized by B4W and La Caixa Foundation from March to June 2021 in Barcelona, Spain. The series consisted of nine hybrid events, composed of keynote sessions and seminars open to the general audience, and two working groups with invited experts from different professional backgrounds (academic fields such as biology, engineering, and sociology, as well as NGOs, journalists, lawyers, policymakers, industry). Based on this awareness-raising action, we distilled key recommendations to facilitate the inclusion of sex and gender perspective into public policies, educational programs, industry, and biomedical research, among other sectors, and help overcome sex and gender biases in AI and health.
Background
Pancreaticoduodenectomy (PD) nowadays serves as a standard treatment for patients with disorders of the pancreas, intestine, and bile duct. Although the mortality rate of patients undergoing PD has decreased significantly, postoperative complication rates remain high. Dexamethasone, a synthetic glucocorticoid with potent anti-inflammatory and metabolic effects, has been proven to have a favorable effect on certain complications. However, the role it plays in post-pancreatectomy patients has not been systematically evaluated. The aim of this study is to assess the effect of dexamethasone on postoperative complications after PD.
Methods
The PANDEX trial is an investigator-initiated, multicentric, prospective, randomized, double-blinded, placebo-control, pragmatic study. The trial is designed to enroll 300 patients who are going to receive elective PD. Patients will be randomized to receive 0.2 mg/kg dexamethasone or saline placebo, administered as an intravenous bolus within 5 min after induction of anesthesia. The primary outcome is the Comprehensive Complication Index (CCI) score within 30 days after the operation. The secondary outcomes include postoperative major complications (Clavien-Dindo≥3), postoperative pancreatic fistula (POPF), post-pancreatectomy acute pancreatitis (PPAP), infection, and unexpected relaparotomy, as well as postoperative length of stay, 30-day mortality, and 90-day mortality.
Discussion
The PANDEX trial is the first randomized controlled trial concerning the effect of dexamethasone on postoperative complications of patients undergoing PD, with the hypothesis that the intraoperative use of dexamethasone can reduce the incidence of postoperative complications and improve short-term outcomes after PD. The results of the present study will guide the perioperative use of dexamethasone and help improve the clinical management of post-pancreatectomy patients.
Trial registration
ClinicalTrials.gov NCT05567094. Registered on 30 September 30 2022
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