Post-publication research integrity concerns in randomized clinical trials: A scoping review of the literature.

BACKGROUND: Post-publication handling of integrity concerns in randomized clinical trials (RCTs) is a contentious matter. OBJECTIVES: We undertook a scoping systematic review to map the literature regarding post-publication integrity issues in RCTs. SEARCH STRATEGY AND SELECTION CRITERIA: Following prospective registration (https://osf.io/pgxd8) we initially searched PubMed and Scopus but subsequently extended it to include the Cochrane Library, and Google Scholar databases without language, article type or publication time restriction until November 2022. Reviewers independently selected published articles covering any aspect of post-publication research integrity concerns in RCTs. DATA COLLECTION AND ANALYSIS: The study findings grouped within domains relating to issues concerning post-publication integrity were extracted in duplicate, verified by a third reviewer, and then tabulated. MAIN RESULTS: The initial search captured 3159 citations, of which 89 studies were included in the review. Cross-sectional studies constituted the majority of included studies (n = 34, 38.2%), followed by systematic reviews (n = 10, 11.2%), methodology reviews/studies (n = 9, 10.1%) and other types of descriptive studies (n = 8, 9.0%). A total of 21 articles (23.6%) covered the domain on general issues, 25 (28.1%) in the journal's instructions and policies domain, eight (9.0%) in the editorial and peer review domain, one (1.1%) in the correspondence and complaints (post-publication peer review) domain, 12 (13.5%) in the investigation for concerns domain, six (6.7%) in the post-investigation decisions and sanctions domain, none in the critical appraisal guidance domain, five (5.6%) in the integrity assessment in systematic reviews domain, and 26 (29.2%) in the recommendations for future research domain. A total of 12 of the selected articles (13.5%) covered two (n = 9) or three (n = 3) different domains. CONCLUSIONS: Various research integrity domains and issues covering post-publication aspects of RCT integrity were captured and gaps were identified, mostly related with the necessary implications for all stakeholders to improve research transparency. There is an urgent need for a multistakeholder consensus towards creating specific statements for addressing post-publication integrity concerns in RCTs.

Quantifying the association of sperm DNA fragmentation with assisted reproductive technology outcomes: An umbrella review.

BACKGROUND: Systematic reviews and meta-analyses are instrumental in shaping clinical practice. However, their findings can sometimes be marred by discrepancies and potential biases, thereby diluting the strength of the evidence presented. Umbrella reviews serve to comprehensively assess and synthesise these reviews, offering a clearer insight into the quality of the evidence presented. In the context of the relationship between sperm DNA fragmentation (SDF) and assisted conception outcomes, there is a divergence in the literature. Some reviews suggest a clear cause-and-effect linkage, whereas others present conflicting or inconclusive results. OBJECTIVES: In this umbrella review we aimed to synthesise the evidence collated in systematic reviews and meta-analyses summarising the association of SDF with assisted reproductive technology (ART) outcomes. SEARCH STRATEGY: After preregistration (https://doi.org/10.17605/OSF.IO/6JHDP), we performed a comprehensive search of the PubMed, Scopus, Cochrane Library, Web of Science and Embase databases. We conducted a search for systematic reviews on the association between SDF and ART without any restrictions on language or publication date. SELECTION CRITERIA: Systematic reviews and meta-analyses assessing the association between SDF and ART outcomes were eligible. DATA COLLECTION AND ANALYSIS: We assessed the quality of the included reviews using AMSTAR 2 and ROBIS, and determined the degree of overlap of primary studies between reviews estimating the corrected covered area (CCA), adjusted for structural missingness. We evaluated the most recent reviews assessing the association of SDF with live birth, pregnancy, miscarriage, implantation, blastulation and fertilisation. The synthesis of evidence was harmonised across all included quantitative syntheses, re-estimating the odds ratio (eOR) in random-effects meta-analyses with 95% confidence intervals (95% CIs) and 95% prediction intervals (95% PIs). We categorised the evidence strength into convincing, highly suggestive, suggestive, weak or nonsignificant, according to the meta-analysis re-estimated P-value, total sample size, I2 statistic for heterogeneity, small study effect, excess significance bias and the largest study significance. MAIN RESULTS: We initially captured and screened 49 332 records. After excluding duplicate and ineligible articles, 22 systematic reviews, 15 of which were meta-analyses, were selected. The 22 reviews showed a moderate degree of overlap (adjusted CCA 9.2%) in their included studies (overall n = 428, with 180 unique studies). The 15 meta-analyses exhibited a high degree of overlap (adjusted CCA = 13.6%) in their included studies (overall n = 274, with 118 unique studies). AMSTAR 2 categorised the quality of evidence in 18 reviews as critically low and the quality of evidence in four reviews as low. ROBIS categorised all the reviews as having a high risk of bias. The re-estimated results showed that the association of SDF with live birth was weak in one and nonsignificant in four meta-analyses. Similarly, the association of SDF with pregnancy, miscarriage, implantation, blastulation and fertilisation was also weak or nonsignificant. The association of high SDF with different ART outcomes was also weak or nonsignificant for different interventions (IVF, ICSI and IUI) and tests. CONCLUSIONS: This umbrella review did not find convincing or suggestive evidence linking SDF with ART outcomes. Caution should be exercised in making any claims, policies or recommendations concerning SDF.

Efficacy of virtual reality for pain relief in medical procedures: a systematic review and meta-analysis.

BACKGROUND: Effective pain control is crucial to optimise the success of medical procedures. Immersive virtual reality (VR) technology could offer an effective non-invasive, non-pharmacological option to distract patients and reduce their experience of pain. We aimed to evaluate the efficacy of Immersive virtual reality (VR) technology in reducing patient's pain perception during various medical procedures by conducting a systematic review and meta-analysis. METHODS: We searched MEDLINE, EMBASE, CENTRAL, CINAHL, and SIGLE until December 2022 for all randomised clinical trials (RCT) evaluating any type of VR in patients undergoing any medical procedure. We conducted a random effect meta-analysis summarising standardised mean differences (SMD) with 95% confidence intervals (CI). We evaluated heterogeneity using I 2 and explored it using subgroup and meta-regression analyses. RESULTS: In total, we included 92 RCTs (n = 7133 participants). There was a significant reduction in pain scores with VR across all medical procedures (n = 83, SMD - 0.78, 95% CI - 1.00 to - 0.57, I 2 = 93%, p = < 0.01). Subgroup analysis showed varied reduction in pain scores across trial designs [crossover (n = 13, SMD - 0.86, 95% CI - 1.23 to - 0.49, I 2 = 72%, p = < 0.01) vs parallel RCTs (n = 70, SMD - 0.77, 95% CI - 1.01 to - 0.52, I 2 = 90%, p = < 0.01)]; participant age groups [paediatric (n = 43, SMD - 0.91, 95% CI - 1.26 to - 0.56, I 2 = 87%, p = < 0.01) vs adults (n = 40, SMD - 0.66, 95% CI - 0.94 to - 0.39, I 2 = 89%, p = < 0.01)] or procedures [venepuncture (n = 32, SMD - 0.99, 95% CI - 1.52 to - 0.46, I 2 = 90%, p = < 0.01) vs childbirth (n = 7, SMD - 0.99, 95% CI - 1.59 to - 0.38, I 2 = 88%, p = < 0.01) vs minimally invasive medical procedures (n = 25, SMD - 0.51, 95% CI - 0.79 to - 0.23, I 2 = 85%, p = < 0.01) vs dressing changes in burn patients (n = 19, SMD - 0.8, 95% CI - 1.16 to - 0.45, I 2 = 87%, p = < 0.01)]. We explored heterogeneity using meta-regression which showed no significant impact of different covariates including crossover trials (p = 0.53), minimally invasive procedures (p = 0.37), and among paediatric participants (p = 0.27). Cumulative meta-analysis showed no change in overall effect estimates with the additional RCTs since 2018. CONCLUSIONS: Immersive VR technology offers effective pain control across various medical procedures, albeit statistical heterogeneity. Further research is needed to inform the safe adoption of this technology across different medical disciplines.

The effectiveness of kangaroo mother care in lowering postpartum depression in mothers of preterm and low birth weight babies: a systematic review and meta-analysis.

Background: Kangaroo mother care (KMC) intervention involves skin-to-skin contact between mother and infant. Some studies have shown a decrease in postpartum depression (PPD) in mothers of preterm and low birth weight (LBW) infants. However, the literature is scattered and of variable quality. Aims: To conduct a systematic review of available literature and provide a comprehensive picture of the effect of KMC on PPD among mothers of preterm and LBW infants. Methods: The study was reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) Guidelines. After PROSPERO registration, a systematic search was conducted using PubMed, Cochrane Central Library, and Google Scholar from the inception of the databases till 14 June 2021. Of the 2944 studies assessed for titles and abstracts, nine studies with 2042 participants were included in the review. Included articles targeted mothers with LBW (<2500 g) or preterm infants (<37 weeks), used an authentic PPD tool, and had standard care or an incubator as the control group. Studies not published in English and in which mothers had a previous psychiatric illness were excluded. The risk of bias was assessed using the Cochrane Risk of Bias Tool for randomized control trials and the Newcastle-Ottawa Scale for observational studies. All the results were converted to standard mean deviation and pooled together using a random-effects model with a 95% CI. A P-value of less than 0.05 is considered significant. Results: KMC Intervention was significantly associated with a lower depression score than control groups. The reduction in depression in the intervention (KMC) group was moderate: SMD=-0.38 (-0.68 to -0.08; 95% CI; I 2=86%; P=0.013). No significant difference was found between the PPD scores of both groups using the Edinburgh Postpartum Depression Scale score. Conclusions: The authors conclude that the negative effects of LBW and preterm birth experience on maternal mental health can be avoided to a moderate degree by KMC. Due to a lack of methodological uniformity, different scales for outcome measurement, and discrepancies in intervention features, significantly high heterogeneity was detected. The authors need further larger-scale studies with a uniform study design to better predict the efficacy of KMC better.

Integrity of randomized clinical trials: Performance of integrity tests and checklists requires assessment.

The integrity of randomized clinical trials (RCT) has become a concern owing to a recent rise in the number of retractions and the repercussions this has for evidence-based patient care. However, there is little research on the subject of RCT integrity assessment. Recent literature reviews have revealed that journals' authors' instructions concerning integrity and their investigation policies concerning allegations of misconduct are heterogeneous. The judicious use of integrity tests applied to RCT manuscripts is hampered by an absence of data concerning misconduct prevalence (pre-test probability), a failure to evaluate test performance (validity) and a lack of consensus over a gold standard (against which test accuracy can be evaluated). These deficiencies hinder the post-publication correction of RCT records, the integrity evaluations in systematic reviews of RCTs and the prospective application of preventive solutions in RCT peer-review and preprint assessment. Dealing with the current controversy about trustworthiness of RCT evidence requires a strong investment in research, reform and education concerning research integrity. The purpose of this review article is to highlight the current limitations in dealing with trial integrity-related concerns and to propose solutions to some of these issues.

Gender bias in shared decision-making among cancer care guidelines: A systematic review.

BACKGROUND: In cancer care, the promotion and implementation of shared decision-making in clinical practice guidelines (CPG) and consensus statements may have potential differences by gender. OBJECTIVE: To systematically analyse recommendations concerning shared decision-making in CPGs and consensus statements for the most frequent cancers exclusively among males (prostate) and females (endometrial). SEARCH STRATEGY: We prospectively registered the protocol at PROSPERO (ID: RD42021241127). MEDLINE, EMBASE, Web of Science, Scopus and online sources (8 guideline databases and 65 professional society websites) were searched independently by two reviewers, without language restrictions. INCLUSION CRITERIA: CPGs and consensus statements about the diagnosis or treatment of prostate and endometrial cancers were included from January 2015 to August 2021. DATA EXTRACTION AND SYNTHESIS: Quality assessment deployed a previously developed 31-item tool and differences between the two cancers analysed. MAIN RESULTS: A total of 176 documents met inclusion criteria, 97 for prostate cancer (84 CPGs and 13 consensus statements) and 79 for endometrial cancer (67 CPGs and 12 consensus statements). Shared decision-making was recommended more often in prostate cancer guidelines compared to endometrial cancer (46/97 vs. 13/79, 47.4% vs. 16.5%; p < .001). Compared to prostate cancer guidelines (mean 2.14 items, standard deviation 3.45), compliance with the shared-decision-making 31-item tool was lower for endometrial cancer guidelines (mean 0.48 items, standard deviation 1.29) (p < .001). Regarding advice on the implementation of shared decision-making, it was only reported in 3 (3.8%) endometrial cancer guidelines and in 16 (16.5%) prostate cancer guidelines (p < .001). DISCUSSION AND CONCLUSIONS: We observed a significant gender bias as shared decision-making was systematically more often recommended in the prostate compared to endometrial cancer guidelines. These findings should encourage new CPGs and consensus statements to consider shared decision-making for improving cancer care regardless of the gender affected. PATIENT OR PUBLIC CONTRIBUTION: The findings may inform future recommendations for professional associations and governments to update and develop high-quality clinical guidelines to consider patients' preferences and shared decision-making in cancer care.

Smartphone Apps for Domestic Violence Prevention: A Systematic Review.

Smartphone applications or apps are increasingly being produced to help with protection against the risk of domestic violence. There is a need to formally evaluate their features. OBJECTIVE: This study systematically reviewed app-based interventions for domestic violence prevention, which will be helpful for app developers. METHODS: We overviewed all apps concerning domestic violence awareness and prevention without language restrictions, collating information about features and limitations. We conducted searches in Google, the Google Play Store, and the App Store (iOS) covering a 10-year time period (2012-2022). We collected data related to the apps from the developers' descriptions, peer reviewed research articles, critical reviews in blogs, news articles, and other online sources. RESULTS: The search identified 621 potentially relevant apps of which 136 were selected for review. There were five app categories: emergency assistance (n = 61, 44.9%), avoidance (n = 29, 21.3%), informative (n = 29, 21.3%), legal information (n = 10, 7.4%), and self-assessment (n = 7, 5.1%). Over half the apps (n = 97, 71%) were released in 2020-22. Around a half were from north-east America (n = 63, 46.3%). Where emergency alerts existed, they required triggering by the potential victim. There was no automation. Content analysis showed 20 apps with unique features, including geo-fences, accelerometer-based alert, shake-based alert, functionality under low resources, alert auto-cancellation, anonymous communication, and data encryption. None of the apps deployed artificial intelligence to assist the potential victims. CONCLUSIONS: Apps currently have many limitations. Future apps should focus on automation, making better use of artificial intelligence deploying multimedia (voice, video, image capture, text and sentiment analysis), speech recognition, and pitch detection to aid in live analysis of the situation and for accurately generating emergency alerts.

Smell Dysfunction in Patients with Primary Sjögren's Syndrome: Impact on Quality of Life.

OBJECTIVES: Patients with primary Sjögren's syndrome (pSS) often report smell and taste disturbances. However, the correlation between smell impairment and mucosal dryness is not well understood. The objectives of this study were to investigate the following: (1) the prevalence of smell hypofunction in patients with SS; (2) the impact of smell hypofunction on their quality of life (QoL); (3) whether the patients' smell is correlated with xerostomia; and (4) whether the patients' smell is affected by taste hypofunction, disease duration, age, smoking or self-reported neuropathy. METHODOLOGY: An ethically approved cross-sectional study was conducted on 65 female patients with SS and 62 sex-matched healthy controls. Their smell was assessed using the University of Pennsylvania Smell Identification Test. Their taste acuity was assessed using the Taste Strips Test. A visual analogue scale was used for the self-assessment of smell and taste functions. Xerostomia was assessed by the salivary flow rate, clinical oral dryness score and the Xerostomia Inventory. The patients' QoL and mental health well-being were assessed using validated questionnaires. RESULTS: In the SS group, the patients' smell function was impaired in 27/65 patients compared with the controls (15/62, p < 0.05), and it did not correlate with the severity of xerostomia, taste acuity (r = 0.05, p = 0.6) or self-reported nasal dryness (r = -0.02, p = 0.7). In the patients' group, smell hypofunction was not correlated with disease duration (ß = 0.1, 95% CI = -0.07-0.1) or smoking (ß = -0.02, 95% CI = -8-7). Age was not correlated with the smell function in the patients' group (ß = -0.1, p = 0.5) but was correlated significantly with smell in the healthy participants' group (ß = -0.3, p = 0.02). Neuropathy affected 81.2% of the patients' group. Their QoL and mental health well-being were not affected by smell hypofunction. CONCLUSION: Smell hypofunction appears to be a clinical manifestation in patients with SS, but it does not seem to be associated with the severity of mucosal dryness or with taste disturbance.

Research integrity in randomized clinical trials: A scoping umbrella review.

BACKGROUND: Randomized clinical trials (RCTs) are experiencing a crisis of confidence in their trustworthiness. Although a comprehensive literature search yielded several reviews on RCT integrity, an overarching overview is lacking. OBJECTIVES: The authors undertook a scoping umbrella review of the research integrity literature concerning RCTs. SEARCH STRATEGY AND SELECTION CRITERIA: Following prospective registration (https://osf.io/3ursn), two reviewers independently searched PubMed, Scopus, The Cochrane Library, and Google Scholar, without language or time restrictions, until November 2021. The authors included systematic reviews covering any aspect of research integrity throughout the RCT lifecycle. DATA COLLECTION AND ANALYSIS: The authors assessed methodological quality using a modified AMSTAR 2 (A Measurement Tool to Assess Systematic Reviews) tool and collated the main findings. MAIN RESULTS: A total of 55 relevant reviews, summarizing 6001 studies (median per review, 63; range, 8-1106) from 1964 to 2021, had an overall critically low quality of 96% (53 reviews). Topics covered included general aspects (15%), design and approval (22%), conduct and monitoring (11%), reporting (38%), postpublication concerns (2%), and future research (13%). The most common integrity issues covered were ethics (18%) and transparency (18%). CONCLUSIONS: Low-quality reviews identified various integrity issues across the RCT lifecycle, emphasizing the importance of high ethical standards and professionalism while highlighting gaps in the integrity landscape. Multistakeholder consensus is needed to develop specific RCT integrity standards.

Systematic Review Reporting - Writing concisely and precisely.

Systematic reviews rank at the top of the evidence hierarchy. Concise writing implies drafting the systematic review article succinctly, i.e. using as few words to express as full an extent of the research effort as possible. Precise writing means drafting the text with accuracy especially with respect to the methodological and statistical aspects. The Abstract ought to be succinct and structured to allow for editors, peer reviewers and readers to get the gist of the key aspects of the systematic review with a quick read. The readership needs to be able to critically appraisal systematic reviews for their internal and external validity rapidly. The Abstract also needs to be standalone, representing an independent summary that can be fully understood without the need for reading the full paper. The standard structure of the main text of a scientific article called IMRaD (Introduction, Methods, Results and Discussion) applies equally to systematic reviews in the same way as it does to any other kinds of research manuscripts whether related to laboratory experiments or clinical trials. Restricting the word count limits to those imposed by journals may at first seem difficult, even unfair, to systematic reviewers. However, with the availability of online appendices to transparently and fully report the details of the methods, results and other aspects of the work undertaken allows for a succinct print or PDF article. Writing a shorter manuscript is more effortful than writing a longer report. This commentary is aimed at novice systematic reviewers to help them learn the written and unwritten writing rules in order to assist them in producing impactful publications to support evidence-based medicine.

E-health psychological intervention in pregnant women exposed to intimate partner violence (eIPV): A protocol for a pilot randomised controlled trial.

Intimate partner violence (IPV) during pregnancy, a condition as common as obstetrics conditions like gestational diabetes, is associated with maternal and neonatal complications. Systematic detection of IPV is not well established in antenatal screening probably because the effectiveness of protective interventions has not been evaluated. E-health interventions may be beneficial among mothers exposed to IPV. Prior to performing a full-scale effectiveness trial for such an intervention, a pilot study is required to assess the feasibility of randomising a sufficiently large number of women exposed to IPV during pregnancy. The eIPV trial is a randomised pilot study nested within a cohort of consenting mothers who screen positive for IPV in the first antenatal visit at <12 weeks' gestation and accept an e-health package (psychological counselling by videoconference) in Spain and Denmark. Twenty eligible mothers from the above cohort will be randomised to either intervention or control. The intervention group will receive the e-health package as part of the cohort. The control group will be invited to accept a delay in the intervention (e-health package eight weeks later). After consenting to delay, the control group will provide comparative data without losing the opportunity of obtaining the intervention. We will determine estimates of rates of informed consent to randomization, and the rates of adherence and dropout following randomization. Qualitative interviews will be conducted to examine the women's perception about the benefit of the intervention, reasons for acceptability and non-adherence, and obstacles to recruitment, randomisation and consent. The results will inform the trial feasibility and variance of key clinical outcome measures for estimation of sample size of the full-scale effectiveness trial.

Prevalence of pelvic floor disorders in the Eastern Mediterranean region: A meta-analysis.

OBJECTIVES: High prevalence of risk factors for pelvic floor disorders (PFD) in the Eastern Mediterranean may result in higher rates of prevalence of PFD in comparison to other regions. Despite individual studies, there are no clear statistics on the cumulative prevalence of PFDs in the East Mediterranean region. The aim of this study was to investigate the prevalence of PFDs in the Eastern Mediterranean region. METHODS: A literature search without language restriction was conducted in PubMed, Cochrane database and Web of Science from 2016 to 01 June 2022. Cross-sectional and cohort studies that reported prevalence of urinary incontinence (UI), constipation, fecal incontinence (FI) and pelvic organ prolapse (POP) among women in the Eastern Mediterranean region were included. Study quality was assessed according to the Joanna Briggs Institute critical appraisal tool. Data were pooled and meta-analysed using a random effects model. PROSPERO: CRD42021283127 RESULTS: The search yielded 390 articles, from which 12 studies containing 9905 patients were included. Five studies were high quality and seven were low quality. The prevalence of POP (12 studies, 9905 participants), UI (5 studies, 2340 participants), constipation (4 studies, 2045 participants) and FI (1 study, 166 participants) was 39% (95% CI 21-57; I2 99.8%), 48% (95% CI 16-80; I2 99.7%), 39% (CI 17-60; I2 99.1%) and 14% (95% CI 9-20) respectively. CONCLUSION: In meta-analysis pooling studies of mixed quality, a high prevalence of PFDs was seen in the Eastern Mediterranean region.PROSPERO No.: CRD42021283127.

Cow bone-derived biochar enhances microbial biomass and alters bacterial community composition and diversity in a smelter contaminated soil.

Bone waste could be utilized as a potential amendment for remediation of smelter-contaminated soils. Nevertheless, the influences of cow bone-derived biochar (CB) on soil microbial biomass and microbial community composition in multi-metal contaminated mining soils are still not clearly documented. Hence, the cow bone was used as feedstock material for biochar preparation and pyrolyzed at two temperatures such as 500 °C (CB500) and 800 °C (CB800), and added to a smelter soil at the dosage of 0 (unamended control), 2.5, 5, and 10% (w/w); then, the soil treatments were cultivated by maize. The CB effect on soil biochemical attributes and response of soil microbial biomass, bacterial communities, and diversity indices were examined after harvesting maize. Addition of CB enhanced total nutrient contents (i.e., total nitrogen up to 26% and total phosphorus P up to 27%) and the nutrients availability (i.e., NH4 up to 50%; NO3 up to 31%; Olsen P up to 48%; extractable K up to 18%; dissolved organic carbon up to 74%) in the treated soil, as compared to the control. The CB500 application revealed higher microbial biomass C (up to 66%), P (up to 41%), and bacterial gene abundance (up to 76%) than the control. However, comparatively a lower microbial biomass nitrogen and diversity indices were observed in the biochar (both with CB500 and CB800) treated soils than in the unamended soils. At the phylum level, the highest dose (10% of CB500 and CB800 resulted in contrasting effects on the Proteobacteria diversity. The CB50010 favored the Pseudomonas abundance (up to 793%), Saccharibacteria (583%), Parcubacteria (138%), Actinobacteria (65%), and Firmicutes (48%) microbial communities, while CB80010 favored the Saccharibacteria (386%), Proteobacteria (12%) and Acidobacteria (11%), as compared to the control. These results imply that CB500 and CB800 have a remarkable impact on microbial biomass and bacterial diversity in smelter contaminated soils. Particularly, CB500 was found to be suitable for enhancing microbial biomass, bacterial growth of specific phylum, and diversity, which can be useful for bioremediation of mining soils.

Predicting major complications in patients undergoing laparoscopic and open hysterectomy for benign indications.

BACKGROUND: Hysterectomy, the most common gynecological operation, requires surgeons to counsel women about their operative risks. We aimed to develop and validate multivariable logistic regression models to predict major complications of laparoscopic or abdominal hysterectomy for benign conditions. METHODS: We obtained routinely collected health administrative data from the English National Health Service (NHS) from 2011 to 2018. We defined major complications based on core outcomes for postoperative complications including ureteric, gastrointestinal and vascular injury, and wound complications. We specified 11 predictors a priori. We used internal-external cross-validation to evaluate discrimination and calibration across 7 NHS regions in the development cohort. We validated the final models using data from an additional NHS region. RESULTS: We found that major complications occurred in 4.4% (3037/68 599) of laparoscopic and 4.9% (6201/125 971) of abdominal hysterectomies. Our models showed consistent discrimination in the development cohort (laparoscopic, C-statistic 0.61, 95% confidence interval [CI] 0.60 to 0.62; abdominal, C-statistic 0.67, 95% CI 0.64 to 0.70) and similar or better discrimination in the validation cohort (laparoscopic, C-statistic 0.67, 95% CI 0.65 to 0.69; abdominal, C-statistic 0.67, 95% CI 0.65 to 0.69). Adhesions were most predictive of complications in both models (laparoscopic, odds ratio [OR] 1.92, 95% CI 1.73 to 2.13; abdominal, OR 2.46, 95% CI 2.27 to 2.66). Other factors predictive of complications included adenomyosis in the laparoscopic model, and Asian ethnicity and diabetes in the abdominal model. Protective factors included age and diagnoses of menstrual disorders or benign adnexal mass in both models and diagnosis of fibroids in the abdominal model. INTERPRETATION: Personalized risk estimates from these models, which showed moderate discrimination, can inform clinical decision-making for people with benign conditions who may require hysterectomy.

Outcomes among participants vs nonparticipants of randomized trials during pregnancy: a systematic review and meta-analysis.

OBJECTIVE: This study aimed to evaluate the outcomes among individuals who were eligible and approached for participation in a randomized controlled trial during pregnancy, comparing those who enrolled with those who declined participation. DATA SOURCES: MEDLINE, Scopus, CINAHL, the Cochrane Library, and Ovid were searched from study inception to May 2022. STUDY ELIGIBILITY CRITERIA: This study included all obstetrical randomized controlled trials that reported clinical outcomes for both participants and nonparticipants. METHODS: The primary outcome captured the presence of morbidity. It was a composite of the primary outcome of each study comparing the participant arm with the nonparticipant arm. If a primary outcome was not clearly defined, a surrogate was developed on the basis of the core outcomes for the clinical condition studied. The risk of bias was assessed with the Newcastle-Ottawa Scale. Subgroup analyses for relevant obstetrical and neonatal outcomes were performed. The summary comparisons were reported as odds ratios with 95% confidence intervals computed using random-effects meta-analysis with heterogeneity evaluated using the I2 statistic. A funnel plot was used to examine publication bias, and there was no asymmetry. RESULTS: After reviewing more than 1100 abstracts, 17 obstetrical randomized controlled trials (103,610, with 26,293 participants and 77,317 nonparticipants) met our inclusion criteria and were analyzed. Of note, 9 studies were not rated as high quality, primarily for failing to control for confounding factors. Trial interventions were categorized as antepartum (n=11), intrapartum (n=5), or postpartum (n=1). Overall, participants in obstetrical randomized controlled trials had no difference in outcomes compared with nonparticipants (n=17: odds ratio, 0.88; 95% confidence interval, 0.52-1.49; I2=90%). Moreover, there was no difference seen when only randomized controlled trials that reported a primary outcome were included (n=12: odds ratio, 0.76; 95% confidence interval, 0.38-0.1.49; I2=93%). In addition, there was no difference noted in the subgroup where the randomized controlled trial intervention was not available to nonparticipants (n=7: odds ratio, 0.91; 95% confidence interval, 0.45-1.85; I2=68%). CONCLUSION: Pregnant individuals who agreed to participate in randomized controlled trials had no difference in outcomes compared with those who decline participation. Pregnant individuals should be provided with this reassuring information when offered to participate in a randomized controlled trial. Moreover, this information may improve patient recruitment into randomized controlled trials.

Artificial intelligence in COVID-19 evidence syntheses was underutilized, but impactful: a methodological study.

OBJECTIVES: A rapidly developing scenario like a pandemic requires the prompt production of high-quality systematic reviews, which can be automated using artificial intelligence (AI) techniques. We evaluated the application of AI tools in COVID-19 evidence syntheses. STUDY DESIGN: After prospective registration of the review protocol, we automated the download of all open-access COVID-19 systematic reviews in the COVID-19 Living Overview of Evidence database, indexed them for AI-related keywords, and located those that used AI tools. We compared their journals' JCR Impact Factor, citations per month, screening workloads, completion times (from pre-registration to preprint or submission to a journal) and AMSTAR-2 methodology assessments (maximum score 13 points) with a set of publication date matched control reviews without AI. RESULTS: Of the 3,999 COVID-19 reviews, 28 (0.7%, 95% CI 0.47-1.03%) made use of AI. On average, compared to controls (n = 64), AI reviews were published in journals with higher Impact Factors (median 8.9 vs. 3.5, P < 0.001), and screened more abstracts per author (302.2 vs. 140.3, P = 0.009) and per included study (189.0 vs. 365.8, P < 0.001) while inspecting less full texts per author (5.3 vs. 14.0, P = 0.005). No differences were found in citation counts (0.5 vs. 0.6, P = 0.600), inspected full texts per included study (3.8 vs. 3.4, P = 0.481), completion times (74.0 vs. 123.0, P = 0.205) or AMSTAR-2 (7.5 vs. 6.3, P = 0.119). CONCLUSION: AI was an underutilized tool in COVID-19 systematic reviews. Its usage, compared to reviews without AI, was associated with more efficient screening of literature and higher publication impact. There is scope for the application of AI in automating systematic reviews.