Nonopioid Versus Opioid Analgesics After Thyroid and Parathyroid Surgery: A Systematic Review.

OBJECTIVE: To determine whether nonopioid analgesic regimens, taken after discharge for thyroid and parathyroid surgery have noninferior pain outcomes in comparison to opioid analgesic regimens. Secondarily, we sought to determine if nonopioid analgesic regimens decrease the number of opioid medications taken after thyroid and parathyroid surgery, and to assess adverse events associated with opioid versus nonopioid regimens. DATA SOURCES: PubMed, Embase, Cochrane. REVIEW METHODS: A comprehensive search of the literature was performed according to the PRISMA guidelines, and identified 1299 nonduplicate articles for initial review of which 2 randomized controlled trials (RCTs) were identified as meeting all eligibility criteria. Meta-analysis was not conducted due to heterogeneity in the data and statistical analyses. RESULTS: Both RCTs included in this systematic review found no significant differences in postoperative pain scores between individuals discharged with a nonopioid only analgesic regimen compared to analgesic regimen that included oral opioid medications. One study reported significantly increased number of postoperative calls related specifically to pain in the nonopioid arm compared to the opioid arm (15.6% vs. 3.2%, P = .045). CONCLUSION: This systematic review of RCTs revealed a limited number of studies examining nonopioid versus opioid postoperative pain medications among adults who undergo thyroid and parathyroid surgery. Among the 2 RCTs on this topic, there is a shared finding that nonopioid analgesic regimens are noninferior to opioid analgesic regimens in managing postoperative pain after thyroid and parathyroid surgery, supporting the use of nonopioid pain regimens given the risk of opioid dependence associated with prescription opioid medications.

Serious adverse events after cessation of nucleos(t)ide analogues in individuals with chronic hepatitis B: A systematic review and meta-analysis.

Background & Aims: The risk of serious clinical outcomes following cessation of nucleos(t)ide analogues (NUCs) in individuals with chronic hepatitis B remains poorly characterized. This systematic review and meta-analysis aimed to evaluate current literature on this issue. Methods: We searched PubMed, Embase, and Web of Science for NUC stop studies that noted clinical outcomes published between January 1, 2006 and August 18, 2022. We performed meta-research analyses to examine the relationships of reported outcomes with study designs and characteristics and also pooled studies with non-overlapping populations to provide risk estimates for the proportions of (1) severe hepatitis flares or hepatic decompensation or (2) hepatitis flare-related death or liver transplantation. Results: The meta-research analysis included 50 studies of highly heterogeneous designs and characteristics. We found that reporting of safety outcomes varied widely according to outcome definition, follow-up duration, and sample size. Only ten studies prespecified safety events as the study outcome, and only four had an outcome definition to include hepatic insufficiency, a follow-up duration >12 months, and a sample size >100 patients. We further pooled 15 studies with 4,525 individuals and estimated that severe hepatitis flares or decompensation would occur in 1.21% (95% CI 0.70-2.08%), with significant heterogeneity (I 2 = 54%, p <0.01), while hepatitis flare-related death or liver transplantation would occur in 0.37% (95% CI 0.20-0.67%), without significant heterogeneity (I 2 = 0.00%, p = 1.00). Conclusions: Current literature on the risk of serious clinical outcomes following NUC cessation is very limited and highly heterogeneous. Pooled analyses of available data found approximately 1% of patients who stopped NUCs developed severe flares or hepatic decompensation. Impact and implications: Current literature regarding the safety concerns surrounding NUC cessation for individuals with chronic hepatitis B is limited and heterogeneous in designs and characteristics, and thus should be interpreted with great caution. Based on currently available data, the proportion of patients that develop severe hepatitis flares or hepatic decompensation was estimated at 1.21% and that of flare-related death or liver transplantation at 0.37%. Our findings are important for individuals receiving nucleos(t)ide analogues for hepatitis B virus infection because we not only pooled currently available data to estimate the risk of serious clinical adverse events following treatment cessation but also uncovered critical limitations of existing literature regarding the safety of finite therapy.

Face masks to prevent transmission of respiratory infections: Systematic review and meta-analysis of randomized controlled trials on face mask use.

OBJECTIVES: To examine the use of face mask intervention in mitigating the risk of spreading respiratory infections and whether the effect of face mask intervention differs in different exposure settings and age groups. DESIGN: Systematic review and meta-analysis. We evaluated the risk of bias using the Cochrane Risk of Bias 2 tool (ROB2). DATA SOURCES: We searched PubMed, Embase, Cochrane Central Register of Controlled Trials, and Web of Science were searched for randomized controlled trials investigating the effect of face masks on respiratory infections published between 1981 and February 9, 2022. We followed the PRISMA 2020 guidelines. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: We included randomized controlled trials investigating the use of face mask intervention in mitigating the risk of spreading respiratory infections across different exposure settings. RESULTS: We identified 2,400 articles for screening. 18 articles passed the inclusion criteria for both evidence synthesis and meta-analysis. There were N = 189,145 individuals in the face mask intervention arm and N = 173,536 in the control arm, and the follow-up times ranged from 4 days to 19 months. Our results showed between-study heterogeneity (p < 0.0001). While there was no statistically significant association over all studies when the covariate unadjusted intervention effect estimates were used (RR = 0.977 [0.858-1.113], p = 0.728), our subgroup analyses revealed that a face mask intervention reduced respiratory infections in the adult subgroup (RR = 0.8795 [0.7861-0.9839], p = 0.0249) and in a community setting (RR = 0.890 [0.812-0.975], p = 0.0125). Furthermore, our leave-one-out analysis found that one study biased the results towards a null effect. Consequently, when using covariate adjusted odds ratio estimates to have a more precise effect estimates of the intervention effect to account for differences at the baseline, the results showed that a face mask intervention did reduce respiratory infections when the biasing study was excluded from the analysis (OR = 0.8892 [0.8061-0.9810], p = 0.0192). CONCLUSION: Our findings support the use of face masks particularly in a community setting and for adults. We also observed substantial between-study heterogeneity and varying adherence to protocol. Notably, many studies were subject to contamination bias thus affecting the efficacy of the intervention, that is when also some controls used masks or when the intervention group did not comply with mask use leading to a downward biased effect of treatment receipt and efficacy. TRIAL REGISTRATION: PROSPERO registration number CRD42020205523.

The Need to Routinely Convert Emergency Cricothyroidotomy to Tracheostomy: A Systematic Review and Meta-Analysis.

BACKGROUND: Traditional surgical teaching advocates converting emergency cricothyroidotomies to tracheostomies to mitigate the risk of subglottic stenosis. A conversion procedure that may risk losing a tenuous airway should have clear benefits over risks. We aimed to evaluate the necessity of routine cricothyroidotomy to tracheostomy conversion by conducting a systematic review and meta-analysis of contemporary literature. STUDY DESIGN: We performed a systematic review of experimental and observational studies (published between January 1, 2008, and March 1, 2021) reporting hospital outcomes of adults aged ≥18 years who underwent emergency cricothyroidotomies or tracheostomies. We followed PRISMA guidelines and assessed quality of data using GRADE methodology. Meta-analysis pooled incidence of procedure-specific complications (bleeding, subglottic stenosis, and others) using Freeman-Tukey double arcsine transformation and sensitivity analysis addressed survival bias. RESULTS: A total of 18 studies including 1246 patients were analyzed. Incidence of bleeding (5 [1 to 11]% vs 3 [1 to 7]%), subglottic stenosis (0 [0 to 3]% vs 0 [0 to 0]%) and other complications (12 [8 to 16]% vs 13 [5 to 23]%) were similar among patients undergoing emergency cricothyroidotomy or tracheostomy. Sensitivity analysis evaluating the incidence of complications among only survivors found similar results. Only one study reported complications attributable to cricothyroidotomy to tracheostomy conversion. CONCLUSIONS: Subglottic stenosis, the main harm conversion seeks to avoid, appears to be a rare complication after cricothyroidotomy. We did not find evidence supporting routine need to convert cricothyroidotomies to tracheostomies; for many patients, conversion is unlikely to rectify complications attributable to emergency cricothyroidotomy. However, our findings cannot be generalized to patients who require prolonged or permanent airway cannulation. Providers should consider performing cricothyroidotomy to tracheostomy selectively when the benefits clearly outweigh the risks of disrupting a secured airway.

Data management and sharing: Practices and perceptions of psychology researchers.

Research data is increasingly viewed as an important scholarly output. While a growing body of studies have investigated researcher practices and perceptions related to data sharing, information about data-related practices throughout the research process (including data collection and analysis) remains largely anecdotal. Building on our previous study of data practices in neuroimaging research, we conducted a survey of data management practices in the field of psychology. Our survey included questions about the type(s) of data collected, the tools used for data analysis, practices related to data organization, maintaining documentation, backup procedures, and long-term archiving of research materials. Our results demonstrate the complexity of managing and sharing data in psychology. Data is collected in multifarious forms from human participants, analyzed using a range of software tools, and archived in formats that may become obsolete. As individuals, our participants demonstrated relatively good data management practices, however they also indicated that there was little standardization within their research group. Participants generally indicated that they were willing to change their current practices in light of new technologies, opportunities, or requirements.

Evaluation of Data Sharing After Implementation of the International Committee of Medical Journal Editors Data Sharing Statement Requirement.

Importance: The benefits of responsible sharing of individual-participant data (IPD) from clinical studies are well recognized, but stakeholders often disagree on how to align those benefits with privacy risks, costs, and incentives for clinical trialists and sponsors. The International Committee of Medical Journal Editors (ICMJE) required a data sharing statement (DSS) from submissions reporting clinical trials effective July 1, 2018. The required DSSs provide a window into current data sharing rates, practices, and norms among trialists and sponsors. Objective: To evaluate the implementation of the ICMJE DSS requirement in 3 leading medical journals: JAMA, Lancet, and New England Journal of Medicine (NEJM). Design, Setting, and Participants: This is a cross-sectional study of clinical trial reports published as articles in JAMA, Lancet, and NEJM between July 1, 2018, and April 4, 2020. Articles not eligible for DSS, including observational studies and letters or correspondence, were excluded. A MEDLINE/PubMed search identified 487 eligible clinical trials in JAMA (112 trials), Lancet (147 trials), and NEJM (228 trials). Two reviewers evaluated each of the 487 articles independently. Exposure: Publication of clinical trial reports in an ICMJE medical journal requiring a DSS. Main Outcomes and Measures: The primary outcomes of the study were declared data availability and actual data availability in repositories. Other captured outcomes were data type, access, and conditions and reasons for data availability or unavailability. Associations with funding sources were examined. Results: A total of 334 of 487 articles (68.6%; 95% CI, 64%-73%) declared data sharing, with nonindustry NIH-funded trials exhibiting the highest rates of declared data sharing (89%; 95% CI, 80%-98%) and industry-funded trials the lowest (61%; 95% CI, 54%-68%). However, only 2 IPD sets (0.6%; 95% CI, 0.0%-1.5%) were actually deidentified and publicly available as of April 10, 2020. The remaining were supposedly accessible via request to authors (143 of 334 articles [42.8%]), repository (89 of 334 articles [26.6%]), and company (78 of 334 articles [23.4%]). Among the 89 articles declaring that IPD would be stored in repositories, only 17 (19.1%) deposited data, mostly because of embargo and regulatory approval. Embargo was set in 47.3% of data-sharing articles (158 of 334), and in half of them the period exceeded 1 year or was unspecified. Conclusions and Relevance: Most trials published in JAMA, Lancet, and NEJM after the implementation of the ICMJE policy declared their intent to make clinical data available. However, a wide gap between declared and actual data sharing exists. To improve transparency and data reuse, journals should promote the use of unique pointers to data set location and standardized choices for embargo periods and access requirements.

Epidemiology of COVID-19: A systematic review and meta-analysis of clinical characteristics, risk factors, and outcomes.

Coronavirus disease 2019 (COVID-19) has become a pandemic, but its reported characteristics and outcomes vary greatly amongst studies. We determined pooled estimates for clinical characteristics and outcomes in COVID-19 patients including subgroups by disease severity (based on World Health Organization Interim Guidance Report or Infectious Disease Society of America/American Thoracic Society criteria) and by country/region. We searched Pubmed, Embase, Scopus, Cochrane, Chinese Medical Journal, and preprint databases from 1 January 2020 to 6 April 2020. Studies of laboratory-confirmed COVID-19 patients with relevant data were included. Two reviewers independently performed study selection and data extraction. From 6007 articles, 212 studies from 11 countries/regions involving 281 461 individuals were analyzed. Overall, mean age was 46.7 years, 51.8% were male, 22.9% had severe disease, and mortality was 5.6%. Underlying immunosuppression, diabetes, and malignancy were most strongly associated with severe COVID-19 (coefficient = 53.9, 23.4, 23.4, respectively, all P < .0007), while older age, male gender, diabetes, and hypertension were also associated with higher mortality (coefficient = 0.05 per year, 5.1, 8.2, 6.99, respectively; P = .006-.0002). Gastrointestinal (nausea, vomiting, abdominal pain) and respiratory symptoms (shortness of breath, chest pain) were associated with severe COVID-19, while pneumonia and end-organ failure were associated with mortality. COVID-19 is associated with a severe disease course in about 23% and mortality in about 6% of infected persons. Individuals with comorbidities and clinical features associated with severity should be monitored closely, and preventive efforts should especially target those with diabetes, malignancy, and immunosuppression.

Hepatocellular carcinoma incidence with tenofovir versus entecavir in chronic hepatitis B: a systematic review and meta-analysis.

BACKGROUND: It is unclear whether tenofovir disoproxil fumarate and entecavir differ in their association with risk of hepatocellular carcinoma in patients with chronic hepatitis B, and previous meta-analyses have shown conflicting conclusions with substantial heterogeneity. We aimed to analyse the updated data and elucidate the source of heterogeneity. METHODS: We searched PubMed, Embase, Web of Science, and the Cochrane library for relevant studies with time-to-event data for incident hepatocellular carcinoma occurring in patients with chronic hepatitis B who received tenofovir disoproxil fumarate or entecavir monotherapy with follow-up of at least 1 year. Studies published between Jan 1, 2006, and April 17, 2020, and abstracts from international conferences in 2018 and 2019 were included. We pooled covariate adjusted hazard ratios (HRs) for hepatocellular carcinoma using a random-effects model, assessed heterogeneity among included studies using the I2 statistic and Cochran's Q test, and identified the source of heterogeneity using prespecified subgroup analyses. This study is registered with PROSPERO, ID CRD42020176513. FINDINGS: 31 studies involving 119 053 patients were analysed. The 5-year cumulative incidence of hepatocellular carcinoma was 5·97% (95% CI 5·81-6·13, 28 studies) for entecavir and 3·06% (2·86-3·26, 13 studies) for tenofovir disoproxil fumarate in studies with unmatched populations (p<0·0001). For all eight studies matched by propensity score, the 5-year cumulative incidence was 3·44% (95% CI 3·08-3·80) for entecavir and 3·39% (2·94-3·83) for tenofovir disoproxil fumarate (p=0·87). Analysis of 14 comparative studies with covariate adjustment found that tenofovir disoproxil fumarate and entecavir had similar risk of hepatocellular carcinoma (primary outcome); adjusted HR 0·88, 95% CI 0·73-1·07; p=0·20), although heterogeneity was significant (I2=56·4%, p=0·0038). In a subgroup analysis for hospital-based clinical cohorts, there was no difference in hepatocellular carcinoma incidence between the two regimens (adjusted HR 1·03, 95% CI 0·88-1·21; I2=0%). However, tenofovir disoproxil fumarate was associated with a lower risk of hepatocellular carcinoma compared with entecavir in administrative database research (adjusted HR 0·67, 0·59-0·76; I2=0%). INTERPRETATION: Our study found no significant difference between tenofovir disoproxil fumarate and entecavir in their association with incident hepatocellular carcinoma. We suggest that treatment should be guided by patient tolerability and affordability rather than whether one drug is more effective than the other. FUNDING: Supported in part by E-DA Hospital (EDAHP 106008; EDAHP 103046).

Data management and sharing in neuroimaging: Practices and perceptions of MRI researchers.

Neuroimaging methods such as magnetic resonance imaging (MRI) involve complex data collection and analysis protocols, which necessitate the establishment of good research data management (RDM). Despite efforts within the field to address issues related to rigor and reproducibility, information about the RDM-related practices and perceptions of neuroimaging researchers remains largely anecdotal. To inform such efforts, we conducted an online survey of active MRI researchers that covered a range of RDM-related topics. Survey questions addressed the type(s) of data collected, tools used for data storage, organization, and analysis, and the degree to which practices are defined and standardized within a research group. Our results demonstrate that neuroimaging data is acquired in multifarious forms, transformed and analyzed using a wide variety of software tools, and that RDM practices and perceptions vary considerably both within and between research groups, with trainees reporting less consistency than faculty. Ratings of the maturity of RDM practices from ad-hoc to refined were relatively high during the data collection and analysis phases of a project and significantly lower during the data sharing phase. Perceptions of emerging practices including open access publishing and preregistration were largely positive, but demonstrated little adoption into current practice.

Towards computational reproducibility: researcher perspectives on the use and sharing of software.

Research software, which includes both source code and executables used as part of the research process, presents a significant challenge for efforts aimed at ensuring reproducibility. In order to inform such efforts, we conducted a survey to better understand the characteristics of research software as well as how it is created, used, and shared by researchers. Based on the responses of 215 participants, representing a range of research disciplines, we found that researchers create, use, and share software in a wide variety of forms for a wide variety of purposes, including data collection, data analysis, data visualization, data cleaning and organization, and automation. More participants indicated that they use open source software than commercial software. While a relatively small number of programming languages (e.g., Python, R, JavaScript, C++, MATLAB) are used by a large number, there is a long tail of languages used by relatively few. Between-group comparisons revealed that significantly more participants from computer science write source code and create executables than participants from other disciplines. Differences between researchers from computer science and other disciplines related to the knowledge of best practices of software creation and sharing were not statistically significant. While many participants indicated that they draw a distinction between the sharing and preservation of software, related practices and perceptions were often not aligned with those of the broader scholarly communications community.

Alterations in visual cortical activation and connectivity with prefrontal cortex during working memory updating in major depressive disorder.

The present study examined the impacts of major depressive disorder (MDD) on visual and prefrontal cortical activity as well as their connectivity during visual working memory updating and related them to the core clinical features of the disorder. Impairment in working memory updating is typically associated with the retention of irrelevant negative information which can lead to persistent depressive mood and abnormal affect. However, performance deficits have been observed in MDD on tasks involving little or no demand on emotion processing, suggesting dysfunctions may also occur at the more basic level of information processing. Yet, it is unclear how various regions in the visual working memory circuit contribute to behavioral changes in MDD. We acquired functional magnetic resonance imaging data from 18 unmedicated participants with MDD and 21 age-matched healthy controls (CTL) while they performed a visual delayed recognition task with neutral faces and scenes as task stimuli. Selective working memory updating was manipulated by inserting a cue in the delay period to indicate which one or both of the two memorized stimuli (a face and a scene) would remain relevant for the recognition test. Our results revealed several key findings. Relative to the CTL group, the MDD group showed weaker postcue activations in visual association areas during selective maintenance of face and scene working memory. Across the MDD subjects, greater rumination and depressive symptoms were associated with more persistent activation and connectivity related to no-longer-relevant task information. Classification of postcue spatial activation patterns of the scene-related areas was also less consistent in the MDD subjects compared to the healthy controls. Such abnormalities appeared to result from a lack of updating effects in postcue functional connectivity between prefrontal and scene-related areas in the MDD group. In sum, disrupted working memory updating in MDD was revealed by alterations in activity patterns of the visual association areas, their connectivity with the prefrontal cortex, and their relationship with core clinical characteristics. These results highlight the role of information updating deficits in the cognitive control and symptomatology of depression.