The impact of COVID-19 first wave national lockdowns on perinatal outcomes: a rapid review and meta-analysis

Background Since the emergence of COVID-19, preventative public health measures, including lockdown strategies, were declared in most countries to control viral transmission. Recent studies and anecdotes have reported changes in the prevalence of perinatal outcomes during national COVID-19lockdowns.The objective of this rapid review was to evaluate the impact of COVID-19 lockdowns on the incidence of low birth weight (LBW), preterm birth (PTB), and stillbirth. Methods Two reviewers searched EMBASE, CORD-19, LitCovid (PubMed), WHO Global research on corona virus disease (COVID-19), and MedRxiv for studies published in English from the first reports on COVID-19 until 17 July 2021. Perinatal outcomes of interest included LBW (< 2500 g), PTB (< 37 weeks), and stillbirth. Results Of the 1967 screened articles, 17 publications met the inclusion criteria (14 cohort studies, 1 case control and 2 cross-sectional studies). Studies included data from Denmark, UK, Ireland, Nepal, Italy, Israel, Botswana, Australia, China, Netherlands, Saudi Arabia, Austria, Zimbabwe, India, and Spain. The total sample size ranged from 3399 to 1,599,547 pregnant women. Thirteen studies examined PTB with conflicting results, reporting both an increase and a decrease in PTB incidence, with odds ratios [95% CI] ranging from 0.09 [0.01, 0.40] to 1.93 [0.76, 4.79]. Three studies found a decrease in LBW rates during lockdowns, one of which was statistically significant, with a rate ratio of 3.77 [1.21, 11.75]. Ten studies examined stillbirth rates, including four studies reporting a statistically significant increase in stillbirth rates, with adjusted relative risk ranging from 1.46 [1.13, 1.89] to 3.9 [1.83, 12.0]. Fourteen studies contained data that could be combined in a meta-analysis comparing perinatal outcomes before and during lockdown. We found that lockdown measures were associated with a significant risk of stillbirth with RR = 1.33 [95% CI 1.04, 1.69] when compared to before lockdown period. However, lockdown measures were not associated with a significant risk of PTB, LBW and VLBW compared to prepandemic periods. Conclusions This review provides clues about the severity of the indirect influence of COVID-19 lockdown implementation; however, the criteria that lead to unexpected changes in LBW, PTB, and stillbirth remains unclear. Large studies showed conflicting results, reporting both increases and decreases in selected perinatal outcomes. Pooled results show a significant association between lockdown measures and stillbirth rates, but not low birth weight rates. Further studies examining the differences in other countries’ lockdowns and sociodemographic groups from low to middle-income countries are needed. Exploration of perinatal outcomes during COVID-19 lockdown poses an opportunity to learn from and make changes to promote the reduction of the leading causes of childhood mortality worldwide.

Cross-sectional study of preprints and final journal publications from COVID-19 studies: discrepancies in results reporting and spin in interpretation

ObjectiveTo compare results reporting and the presence of spin in COVID-19 study preprints with their finalised journal publications.DesignCross-sectional study.SettingInternational medical literature.ParticipantsPreprints and final journal publications of 67 interventional and observational studies of COVID-19 treatment or prevention from the Cochrane COVID-19 Study Register published between 1 March 2020 and 30 October 2020.Main outcome measuresStudy characteristics and discrepancies in (1) results reporting (number of outcomes, outcome descriptor, measure, metric, assessment time point, data reported, reported statistical significance of result, type of statistical analysis, subgroup analyses (if any), whether outcome was identified as primary or secondary) and (2) spin (reporting practices that distort the interpretation of results so they are viewed more favourably).ResultsOf 67 included studies, 23 (34%) had no discrepancies in results reporting between preprints and journal publications. Fifteen (22%) studies had at least one outcome that was included in the journal publication, but not the preprint; eight (12%) had at least one outcome that was reported in the preprint only. For outcomes that were reported in both preprints and journals, common discrepancies were differences in numerical values and statistical significance, additional statistical tests and subgroup analyses and longer follow-up times for outcome assessment in journal publications.At least one instance of spin occurred in both preprints and journals in 23/67 (34%) studies, the preprint only in 5 (7%), and the journal publications only in 2 (3%). Spin was removed between the preprint and journal publication in 5/67 (7%) studies; but added in 1/67 (1%) study.ConclusionsThe COVID-19 preprints and their subsequent journal publications were largely similar in reporting of study characteristics, outcomes and spin. All COVID-19 studies published as preprints and journal publications should be critically evaluated for discrepancies and spin.

The surgical oncology clinical trial landscape: A cross-sectional analysis of ClinicalTrials.gov from 2008-2020.

1561 Background: Surgical interventions are studied less often than medical or radiation interventions in oncology clinical trials. We characterized surgical oncology trials registered on ClinicalTrials.gov, analyzed funding sources and identified features associated with early discontinuation and results reporting. Methods: We employed a cross-sectional study design with descriptive, logistic regression, cox regression, time series and survival analyses. We downloaded all 270,172 studies registered on the Aggregate Analysis of the ClinicalTrials.gov database from October 1, 2008 to March 9, 2020. After excluding non-interventional trials, applying cancer/oncology specific Medical Subject Heading terms to the remaining trials and excluding phase 1 trials, 27,915 trials were identified for manual review. Primary exposure variables were trial focus: neoplasia site and treatment modality (surgical interventions included investigations of outcomes from surgical resection or intra-operative/peri-operative changes), and funding: industry, U.S. government, academic. Results: 26,815 trials were found to have true oncology content; 1,661 (6.2%) involved surgical oncology, representing 311,789 patients. Funding sources were: 82.7% by academic institutions, 10.9% by industry, and 6.2% by U.S. government. The most studied neoplasia sites were colorectal (17.4% of trials), breast (10.7%), gastric (10.5%), hepatic (8.6%), lung (7.5%), brain/CNS (6.7%) and cervical (6.6%). U.S. government funded surgical oncology trials had the lowest risk of early discontinuation (adjusted HR 0.65, 95% CI: 0.58-0.73, p<0.001) and the highest odds of results reporting (adjusted OR 1.35, 95% CI: 1.08-1.68, p=0.008) (Table). Conclusions: There is a paucity of surgical oncology clinical trials compared to other treatment modalities, especially in context of surgery’s role in overall cancer care. From 2008-2020 only 6.2% of trials focused on surgical oncology, and U.S. government funded trials displayed the lowest hazard of early discontinuation and highest odds of results reporting. Stakeholders should look to government funded trials as models of improvement, but must increase representation and results dissemination of surgical oncology trials to guide treatment recommendations. Surgical oncology trial features and associated early discontinuation/results reporting.[Table: see text]

Comparison of preprints and final journal publications from COVID-19 Studies: Discrepancies in results reporting and spin in interpretation

Objective: To compare results reporting and the presence of spin in COVID-19 study preprints with their finalized journal publications Design: Cross-sectional Setting: International medical literature Participants: Preprints and final journal publications of 67 interventional and observational studies of COVID-19 treatment or prevention from the Cochrane COVID-19 Study Register published between March 1, 2020 and October 30, 2020 Main outcome measures: Study characteristics and discrepancies in 1) Results reporting (number of outcomes, outcome descriptor, measure (e.g., PCR test), metric (e.g., mean change from baseline), assessment time point (e.g., 1 week post treatment), data reported (e.g., effect estimate and measures of precision), reported statistical significance of result, type of statistical analysis (e.g., chi-squared test), subgroup analyses (if any), whether outcome was identified as primary or secondary and 2) Spin (reporting practices that distort the interpretation of results so that results are viewed more favorably). Results: Of 67 included studies, 23 (34%) had no discrepancies in results reporting between preprints and journal publications. Fifteen (22%) studies had at least one outcome that was included in the journal publication, but not the preprint; 8 (12%) had at least one outcome that was reported in the preprint only. For outcomes that were reported in both preprints and journals, common discrepancies were differences in numerical values and statistical significance, additional statistical tests and subgroup analyses conducted in journal publications, and longer follow-up times for outcome assessment in journal publications. At least one instance of spin occurred in both preprints and journals in 23 / 67 (34%) studies, the preprint only in 5 (7%) studies, and the journal publications only in 2 (3%) of studies. Spin was removed between the preprint and journal publication in 5/67 (7%) studies; but added in 1/67 (1%) study. Conclusions: The COVID-19 preprints and their subsequent journal publications were largely similar in reporting of study characteristics, outcomes and spin. All COVID-19 studies published as preprints and journal publications should be critically evaluated for discrepancies and spin.