The HI V O pen Call on I nformed C onsent and E thics in Research (VOICE) for Adolescents and Young Adults: A Digital Crowdsourcing Open Call in Low- and Middle-Income Countries.

BACKGROUND: Many adolescents and young adults (AYAs; 10-24 years old) are excluded from HIV research because of social, ethical, and legal challenges with informed consent, resulting in limited AYA-focused data. We use a participatory approach to identify strategies for improving AYA consent processes in HIV research in low- and middle-income countries (LMICs). METHODS: We conducted a digital crowdsourcing open call for ideas to improve AYA consent to HIV research in LMICs. Crowdsourcing involves engaging a group of people in problem-solving, then sharing emergent solutions. Submissions were evaluated by 3 independent judges using predefined criteria, with exceptional strategies receiving prizes. Demographic data were collected, and textual data were qualitatively analyzed for emergent themes in barriers and facilitators for improving AYA consent in HIV research, guided by a socioecological model. RESULTS: We received 110 strategies total; 65 were eligible for evaluation, 25 of which were identified as finalists. Fifty-eight participants from 10 LMICs submitted the 65 eligible submissions, of which 30 (52%) were 18 to 24 years old. Thematic analysis identified 10 barriers to AYA consent, including HIV stigma, limited education, and legal/regulatory barriers. Strategies for improving AYA consent processes revealed 7 potential facilitators: enhancing AYA engagement in research, involving parents/guardians, improving education/awareness, improving institutional practices/policy, making research participation more AYA-friendly, enhancing engagement of other key communities of interest, and empowering AYA. CONCLUSIONS: Diverse communities of interest in LMICs developed compelling strategies to enhance informed consent that may improve AYA inclusion in HIV research. These data will be used to develop practical guidance on improving AYA consent processes.

The International Sexual Health And REproductive Health during COVID-19 (I-SHARE) Study: A Multicountry Analysis of Adults from 30 Countries Prior to and During the Initial Coronavirus Disease 2019 Wave.

BACKGROUND: There is limited evidence to date about changes to sexual and reproductive health (SRH) during the initial wave of coronavirus disease 2019 (COVID-19). To address this gap, our team organized a multicountry, cross-sectional online survey as part of a global consortium. METHODS: Consortium research teams conducted online surveys in 30 countries. Sampling methods included convenience, online panels, and population-representative. Primary outcomes included sexual behaviors, partner violence, and SRH service use, and we compared 3 months prior to and during policy measures to mitigate COVID-19. We conducted meta-analyses for primary outcomes and graded the certainty of the evidence. RESULTS: Among 4546 respondents with casual partners, condom use stayed the same for 3374 (74.4%), and 640 (14.1%) reported a decline. Fewer respondents reported physical or sexual partner violence during COVID-19 measures (1063 of 15 144, 7.0%) compared to before COVID-19 measures (1469 of 15 887, 9.3%). COVID-19 measures impeded access to condoms (933 of 10 790, 8.7%), contraceptives (610 of 8175, 7.5%), and human immunodeficiency virus/sexually transmitted infection (HIV/STI) testing (750 of 1965, 30.7%). Pooled estimates from meta-analysis indicate that during COVID-19 measures, 32.3% (95% confidence interval [CI], 23.9%-42.1%) of people needing HIV/STI testing had hindered access, 4.4% (95% CI, 3.4%-5.4%) experienced partner violence, and 5.8% (95% CI, 5.4%-8.2%) decreased casual partner condom use (moderate certainty of evidence for each outcome). Meta-analysis findings were robust in sensitivity analyses that examined country income level, sample size, and sampling strategy. CONCLUSIONS: Open science methods are feasible to organize research studies as part of emergency responses. The initial COVID-19 wave impacted SRH behaviors and access to services across diverse global settings.

Pediatric systemic lupus erythematosus with lupus anticoagulant hypoprothrombinemia syndrome-A case series with review of literature.

INTRODUCTION: Lupus anticoagulant hypoprothrombinemia syndrome (LAHPS) is a rare phenomenon that leads to concomitant thrombosis and hemorrhage in children with SLE. LAHPS in pediatric SLE (pSLE) has a protracted course requiring long-term immunosuppressive therapy. Due to the rarity of this syndrome and paucity of reported cases, there is lack of standardized management. We herewith report 5 children with pSLE with LAHPS.Methodology: We retrospectively reviewed clinical features, laboratory features, treatment and outcome for 5 children with lupus anticoagulant hypoprothrombinemia syndrome with SLE and a review of literature of similar cases published. RESULTS: Mean age of presentation was 10.2 ± 2.38 years (mean ± SD) and female to male ratio was 4:1. All children presented with mild to severe bleeding manifestations like gum bleed, epistaxis, hematuria, menorrhagia and subarachnoid bleed. Coagulation profile revealed prolonged PT and aPTT, with low prothrombin levels and positive Lupus anticoagulant in all children. Mixing studies were characteristic in these children. On comparing laboratory parameters majority had low C3, C4 levels, ANA and anti-DsDNA antibody positivity and three children had anticardiolipin positivity. One child had lupus nephritis along with LAHPS at presentation. All responded well to steroids and supportive measures. CONCLUSION: High index of suspicion is needed when child with lupus presents with bleeding manifestations for early diagnosis and treatment.

Three hundred babies born to underhoused mothers in Toronto-understanding the problem and how we can help.

Little is known about pregnancy in underhoused women, possibly because the number of underhoused mothers with babies in Toronto has been significantly underestimated. Using a novel data collection method, it has been found that there are approximately 300 babies being born each year to underhoused women in Toronto. This finding has significant public health implications, as these women are at increased risk of multiple issues related to physical health, mental health, child protection, poverty and safety. This commentary presents a new data collection strategy, highlights the importance of accurate data collection and offers suggestions for supports for this over-looked population.

Selectivity of Pyridone- and Diphenyl Ether-Based Inhibitors for the Yersinia pestis FabV Enoyl-ACP Reductase.

The enoyl-ACP reductase (ENR) catalyzes the last reaction in the elongation cycle of the bacterial type II fatty acid biosynthesis (FAS-II) pathway. While the FabI ENR is a well-validated drug target in organisms such as Mycobacterium tuberculosis and Staphylococcus aureus, alternate ENR isoforms have been discovered in other pathogens, including the FabV enzyme that is the sole ENR in Yersinia pestis (ypFabV). Previously, we showed that the prototypical ENR inhibitor triclosan was a poor inhibitor of ypFabV and that inhibitors based on the 2-pyridone scaffold were more potent [Hirschbeck, M. (2012) Structure 20 (1), 89-100]. These studies were performed with the T276S FabV variant. In the work presented here, we describe a detailed examination of the mechanism and inhibition of wild-type ypFabV and the T276S variant. The T276S mutation significantly reduces the affinity of diphenyl ether inhibitors for ypFabV (20-fold → 100-fold). In addition, while T276S ypFabV generally displays an affinity for 2-pyridone inhibitors higher than that of the wild-type enzyme, the 4-pyridone scaffold yields compounds with similar affinity for both wild-type and T276S ypFabV. T276 is located at the N-terminus of the helical substrate-binding loop, and structural studies coupled with site-directed mutagenesis reveal that alterations in this residue modulate the size of the active site portal. Subsequently, we were able to probe the mechanism of time-dependent inhibition in this enzyme family by extending the inhibition studies to include P142W ypFabV, a mutation that results in a gain of slow-onset inhibition for the 4-pyridone PT156.

Hepatoblastoma in Children With Congenital Portosystemic Shunts.

Two children developed hepatoblastoma concurrent with congenital portosystemic shunts (PSSs) (Abernethy malformations). Both underwent operative ligation of their PSSs. One received concurrent tumor resection, whereas the other was deemed initially unresectable and underwent biopsy followed by neoadjuvant chemotherapy. Although benign hepatic masses, such as focal nodular hyperplasia and nodular regenerative hyperplasia, are common in patients with Abernethy malformations, malignant tumors have also been documented and should always be considered in the differential diagnosis of a patient with a congenital PSS and a hepatic mass.

Rational Modulation of the Induced-Fit Conformational Change for Slow-Onset Inhibition in Mycobacterium tuberculosis InhA.

Slow-onset enzyme inhibitors are the subject of considerable interest as an approach to increasing the potency of pharmaceutical compounds by extending the residence time of the inhibitor on the target (the lifetime of the drug-receptor complex). However, rational modulation of residence time presents significant challenges because it requires additional mechanistic insight, such as the nature of the transition state for postbinding isomerization. Our previous work, based on X-ray crystallography, enzyme kinetics, and molecular dynamics simulation, suggested that the slow step in inhibition of the Mycobacterium tuberculosis enoyl-ACP reductase InhA involves a change in the conformation of the substrate binding loop from an open state in the initial enzyme-inhibitor complex to a closed state in the final enzyme-inhibitor complex. Here, we use multidimensional free energy landscapes for loop isomerization to obtain a computational model for the transition state. The results suggest that slow-onset inhibitors crowd key side chains on helices that slide past each other during isomerization, resulting in a steric clash. The landscapes become significantly flatter when residues involved in the steric clash are replaced with alanine. Importantly, this lower barrier can be increased by rational inhibitor redesign to restore the steric clash. Crystallographic studies and enzyme kinetics confirm the predicted effects on loop structure and flexibility, as well as inhibitor residence time. These loss and regain of function studies validate our mechanistic hypothesis for interactions controlling substrate binding loop isomerization, providing a platform for the future design of inhibitors with longer residence times and better in vivo potency. Similar opportunities for slow-onset inhibition via the same mechanism are identified in other pathogens.

Rational design of broad spectrum antibacterial activity based on a clinically relevant enoyl-acyl carrier protein (ACP) reductase inhibitor.

Determining the molecular basis for target selectivity is of particular importance in drug discovery. The ideal antibiotic should be active against a broad spectrum of pathogenic organisms with a minimal effect on human targets. CG400549, a Staphylococcus-specific 2-pyridone compound that inhibits the enoyl-acyl carrier protein reductase (FabI), has recently been shown to possess human efficacy for the treatment of methicillin-resistant Staphylococcus aureus infections, which constitute a serious threat to human health. In this study, we solved the structures of three different FabI homologues in complex with several pyridone inhibitors, including CG400549. Based on these structures, we rationalize the 65-fold reduced affinity of CG400549 toward Escherichia coli versus S. aureus FabI and implement concepts to improve the spectrum of antibacterial activity. The identification of different conformational states along the reaction coordinate of the enzymatic hydride transfer provides an elegant visual depiction of the relationship between catalysis and inhibition, which facilitates rational inhibitor design. Ultimately, we developed the novel 4-pyridone-based FabI inhibitor PT166 that retained favorable pharmacokinetics and efficacy in a mouse model of S. aureus infection with extended activity against Gram-negative and mycobacterial organisms.

Myosteatosis for Early Detection of Muscle Disorder in Patients With Liver Cirrhosis.

Background and aims: Muscle disorders in cirrhosis are associated with poor outcome and need early identification. Anthropometric measures lack sensitivity, and CT-based L3-skeletal muscle Index (L3-SMI) may miss early sarcopenia. The study aimed to find if SM-RA can identify more patients with muscle disorder than L3-SMI and anthropometry. Methods: 388 patients with cirrhosis underwent nutritional assessment by anthropometry, short-physical-performance-battery (SPPB) < 9, L3-SMI (<36.5 cm2/m2 (males); <30.2 cm2/m2 (females), and myosteatosis assessment by skeletal muscle radiation attenuation (SM-RA) (<41 HU for body mass index [BMI] <24.9 kg/m2 and <33 HU for ≥25 kg/m2) and results were compared. Results: Sarcopenia based on SPPB was 38.9 % with scores (9 ± 1.48 vs. 10.74 ± 1.25, P = 0.001 in males; and 8.43 ± 1.59 vs. 9.89 ± 1.57, P = 0.001 in females). Mid-arm muscle circumference was lower in sarcopenic males [20.5 ± 2.42 vs. 22.9 ± 2.19 cm, P = 0.001] but not in females [19.4 ± 2.73 vs. 21.1 ± 2.51, P = 0.18]. L3-SMI-based sarcopenia was found in 44.8 % (additional 5.92 %) compared to SPPB, mostly in cryptogenic cirrhosis (19.2 % vs. 35.08 %, δ change +15.9 %). Myosteatosis (71.64 %) identified an additional 26.85 % and 32.74 % of patients with muscle disorder compared to L3SMI and SPPB, respectively, with the majority of new detection in non-alcoholic fatty liver disease (NAFLD) 39.4 % vs. 77.06 %, δ change +37.66 %) CTP-A patients (16.6 % vs. 36.8 %, δ change +20.2 %). Myosteatosis was found in 48.3 % of patients with normal L3-SMI. Conclusion: SM-RA can identify more patients with muscle disorder than L3-SMI and SPPB.

Pharmacists' role in detection and evaluation of adverse drug reactions: Developing proactive systems for pharmacosurveillance.

PURPOSE: To identify current challenges in detection of medication-related symptoms, and review technology-based opportunities to increase the patient-centeredness of postmarketing pharmacosurveillance to promote more accountable, safer, patient-friendly, and equitable medication prescribing. SUMMARY: Pharmacists have an important role to play in detection and evaluation of adverse drug reactions (ADRs). The pharmacist's role in medication management should extend beyond simply dispensing drugs, and this article delineates the rationale and proactive approaches for pharmacist detection and assessment of ADRs. We describe a stepwise approach for assessment, best practices, and lessons learned from a pharmacist-led randomized trial, the CEDAR (Calling for Detection of Adverse Drug Reactions) project. CONCLUSION: Health systems need to be redesigned to more fully utilize health information technologies and pharmacists in detecting and responding to ADRs.

Association Between Hypoglycemia and the Occurrence of Early Onset Sepsis in Premature Infants.

BACKGROUND: We examined the association between hypoglycemia and the occurrence of early onset sepsis (EOS) in premature infants admitted to the neonatal intensive care unit (NICU). METHODS: We included infants discharged from 358 NICUs between 1997 and 2020 with gestational age <34 weeks, ≥1 culture collected in the first 3 days of life, and ≥1 serum glucose value recorded on the day of or day prior to culture collection. We used multivariable logistic regression and inverse probability weighting (IPW) and constructed models for three definitions of hypoglycemia: American Academy of Pediatrics (AAP), Pediatric Endocrine Society, and a definition based on neurodevelopmental studies. We performed subgroup analysis in EOS episodes caused by Gram-negative and Gram-positive organisms. RESULTS: Of the 62,178 infants and 64,559 cultures that met study inclusion criteria, 739 (1%) cultures were positive. The median (25th, 75th percentile) glucose value was 75 mg/dL (50, 106) on the day of or day prior to a positive culture versus 70 mg/dL (50, 95) on the day of or day prior to a negative culture. We found that hypoglycemia was not associated with the occurrence of EOS for all organisms and Gram-positive organisms, whereas there was a small but significant association between the lower AAP glucose cutoff value and EOS due to Gram-negative organisms (logistic regression: risk difference [RD] 0.24% [95% CI, 0.01-0.47]; IPW: RD 0.22% [95% CI, 0.00-0.43]). CONCLUSIONS: Hypoglycemia may be an early marker of EOS, particularly in episodes caused by Gram-negative organisms and when using a stricter definition of hypoglycemia.

Stevens-Johnson syndrome and toxic epidermal necrolysis: A systematic review of PubMed/MEDLINE case reports from 1980 to 2020.

Background: Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are rare, life-threatening immunologic reactions. Prior studies using electronic health records, registries or reporting databases are often limited in sample size or lack clinical details. We reviewed diverse detailed case reports published over four decades. Methods: Stevens-Johnson syndrome and toxic epidermal necrolysis-related case reports were identified from the MEDLINE database between 1980 and 2020. Each report was classified by severity (i.e., SJS, TEN, or SJS-TEN overlap) after being considered a "probable" or "definite" SJS/TEN case. The demographics, preconditions, culprit agents, clinical course, and mortality of the cases were analyzed across the disease severity. Results: Among 1,059 "probable" or "definite" cases, there were 381 (36.0%) SJS, 602 (56.8%) TEN, and 76 (7.2%) SJS-TEN overlap cases, with a mortality rate of 6.3%, 24.4%, and 21.1%, respectively. Over one-third of cases had immunocompromised conditions preceding onset, including cancer (n = 194,18.3%), autoimmune diseases (n = 97, 9.2%), and human immunodeficiency virus (HIV) (n = 52, 4.9%). During the acute phase of the reaction, 843 (79.5%) cases reported mucous membrane involvement and 210 (19.8%) involved visceral organs. Most cases were drug-induced (n = 957, 90.3%). A total of 379 drug culprits were reported; the most frequently reported drug were antibiotics (n = 285, 26.9%), followed by anticonvulsants (n = 196, 18.5%), analgesics/anesthetics (n = 126, 11.9%), and antineoplastics (n = 120, 11.3%). 127 (12.0%) cases reported non-drug culprits, including infections (n = 68, 6.4%), of which 44 were associated with a mycoplasma pneumoniae infection and radiotherapy (n = 27, 2.5%). Conclusion: An expansive list of potential causative agents were identified from a large set of literature-reported SJS/TEN cases, which warrant future investigation to understand risk factors and clinical manifestations of SJS/TEN in different populations.

Heterogeneity of Drug Allergies and Reaction Lists in Two U.S. Health Care Systems' Electronic Health Records.

BACKGROUND: Health care institutions have their own "picklist" for clinicians to document adverse drug reactions (ADRs) into the electronic health record (EHR) allergy list. Whether the lack of a nationally standardized picklist impacts clinician data entries is unknown. OBJECTIVES: The objective of this study was to assess the impact of defined reaction picklists on clinical documentation and, therefore, downstream analytics and clinical research using these data at two institutions. METHODS: ADR data were obtained from the EHRs of patients who visited the emergency department or outpatient clinics at Brigham and Women's Hospital (BWH) and University of Colorado Hospital (UCH) from 2013 to 2018. Reported drug class ADR prevalences were calculated. We investigated the reactions on each picklist and compared the top 40 reactions at each institution, as well as the top 10 reactions within each drug class. RESULTS: Of 2,160,116 patients, 640,444 (30%) had 928,973 active drug allergies. The most commonly reported drug class allergens were similar between BWH and UCH. BWH's picklist had 48 reactions, and UCH's had 160 reactions; 29 reactions were shared by both picklists. While the top four reactions overall (rash, GI upset/nausea/vomiting, hives, itching) were identical between sites, reactions by drug class exhibited greater documentation diversity. For example, while the summed prevalence of swelling-related reactions to angiotensin-converting-enzyme inhibitors was comparable across sites, swelling was represented by two terms ("swelling," "angioedema") at BWH but 11 terms at UCH (e.g., "swelling," "edema," by body locality). CONCLUSION: The availability and granularity of reaction picklists impact ADR documentation in the EHR by health care providers; picklists may partially explain variations in reported ADRs across health care systems.

Renal medication-related clinical decision support (CDS) alerts and overrides in the inpatient setting following implementation of a commercial electronic health record: implications for designing more effective alerts.

OBJECTIVE: To assess the appropriateness of medication-related clinical decision support (CDS) alerts associated with renal insufficiency and the potential/actual harm from overriding the alerts. MATERIALS AND METHODS: Override rate frequency was recorded for all inpatients who had a renal CDS alert trigger between 05/2017 and 04/2018. Two random samples of 300 for each of 2 types of medication-related CDS alerts associated with renal insufficiency-"dose change" and "avoid medication"-were evaluated by 2 independent reviewers using predetermined criteria for appropriateness of alert trigger, appropriateness of override, and patient harm. RESULTS: We identified 37 100 "dose change" and 5095 "avoid medication" alerts in the population evaluated, and 100% of each were overridden. Dose change triggers were classified as 12.5% appropriate and overrides of these alerts classified as 90.5% appropriate. Avoid medication triggers were classified as 29.6% appropriate and overrides 76.5% appropriate. We identified 5 adverse drug events, and, of these, 4 of the 5 were due to inappropriately overridden alerts. CONCLUSION: Alerts were nearly always presented inappropriately and were all overridden during the 1-year period studied. Alert fatigue resulting from receiving too many poor-quality alerts may result in failure to recognize errors that could lead to patient harm. Although medication-related CDS alerts associated with renal insufficiency had previously been found to be the most clinically beneficial alerts in a legacy system, in this system they were ineffective. These findings underscore the need for improvements in alert design, implementation, and monitoring of alert performance to make alerts more patient-specific and clinically appropriate.

Comparison of Medication Alerts from Two Commercial Applications in the USA.

INTRODUCTION: Medication organizations across the USA have adopted electronic health records, and one of the most anticipated benefits of these was improved medication safety, but alert fatigue has been a major issue. OBJECTIVE: We compared the appropriateness of medication-related clinical decision support alerts triggered by two commercial applications: EPIC and Seegnal's platform. METHODS: This was a retrospective comparison of two commercial applications. We provided Seegnal with deidentified inpatient, outpatient, and inpatient genetic electronic medical record (EMR)-extracted datasets for 657, 2731, and 413 patients, respectively. Seegnal then provided the alerts that would have triggered, which we compared with those triggered by EPIC in clinical care. A random sample of the alerts triggered were reviewed for appropriateness, and the positive predictive value (PPV) and negative predictive value (NPV) were calculated. We also reviewed all the inpatient and outpatient charts for patients within our cohort who were receiving ten or more concomitant medications with alerts we found to be appropriate to assess whether any adverse events had occurred and whether Seegnal's platform could have prevented them. RESULTS: Results from EPIC and the Seegnal platform were compared based on alert load, PPV, NPV, and potential adverse events. Overall, compared with EPIC, the Seegnal platform triggered fewer alerts in the inpatient (1697 vs. 27,540), outpatient (2341 vs. 35,134), and inpatient genetic (1493 vs. 20,975) cohorts. The Seegnal platform had higher specificity in the inpatient (99 vs. 0.3%; p < 0.0001), outpatient (99 vs. 0.3%; p < 0.0001), and inpatient genetic (97.9 vs. 1.2%; p < 0.0001) groups and higher sensitivity in the inpatient (100 vs. 68.8%; p < 0.0001) and outpatient (88.6 vs.78.3%; p < 0.0001) groups but not in the inpatient genetic cohort (81 vs. 78.5%; p = 0.11). We identified 16 adverse events that occurred in the inpatient setting, 11 (69%) of which potentially could have been prevented with the Seegnal platform. CONCLUSIONS: Overall, the Seegnal platform triggered 94% fewer alerts than EPIC in the inpatient setting and 93% fewer in the outpatient setting, with much higher sensitivity and specificity. This application could substantially reduce alert fatigue and improve medication safety at the same time.

Clinical Utility of Pharmacogenomic Data Collected by a Health-System Biobank to Predict and Prevent Adverse Drug Events.

INTRODUCTION: Medication-related harm represents a significant issue for patient safety and quality of care. One strategy to avoid preventable adverse drug events is to utilize patient-specific factors such as pharmacogenomics (PGx) to individualize therapy. OBJECTIVE: We measured the number of patients enrolled in a health-system biobank with actionable PGx results who received relevant medications and assessed the incidence of adverse drug events (ADEs) that might have been prevented had the PGx results been used to inform prescribing. METHODS: Patients with actionable PGx results in the following four genes with Clinical Pharmacogenetics Implementation Consortium (CPIC) guidelines were identified: HLA-A*31:01, HLA-B*15:02, TPMT, and VKORC1. The patients who received interacting medications (carbamazepine, oxcarbazepine, thiopurines, or warfarin) were identified, and electronic health records were reviewed to determine the incidence of potentially preventable ADEs. RESULTS: Of 36,424 patients with PGx results, 2327 (6.4%) were HLA-A*31:01 positive; 3543 (9.7%) were HLA-B*15:02 positive; 2893 (7.9%) were TPMT intermediate metabolizers; and 4249 (11.7%) were homozygous for the VKORC1 c.1639 G>A variant. Among patients positive for one of the HLA variants who received carbamazepine or oxcarbazepine (n = 92), four (4.3%) experienced a rash that warranted drug discontinuation. Among the TPMT intermediate metabolizers who received a thiopurine (n = 56), 11 (19.6%) experienced severe myelosuppression that warranted drug discontinuation. Among patients homozygous for the VKORC1 c.1639 G>A variant who received warfarin (n = 379), 85 (22.4%) experienced active bleeding and/or international normalized ratio (INR) > 5 that warranted drug discontinuation or dose reduction. CONCLUSION: Patients with actionable PGx results from a health-system biobank who received relevant medications experienced predictable ADEs. These ADEs may have been prevented if the patients' PGx results were available in the electronic health record with clinical decision support prior to prescribing.

The International Sexual Health And Reproductive Health Survey (I-SHARE-1): A Multi-Country Analysis of Adults from 30 Countries Prior to and During the Initial COVID-19 Wave.

BACKGROUND: The COVID-19 pandemic forced billions of people to shelter in place, altering social and sexual relationships worldwide. In many settings, COVID-19 threatened already precarious health services. However, there is limited evidence to date about changes to sexual and reproductive health (SRH) during the initial wave of COVID-19 disease. To address this gap, our team organized a multi-country, cross-sectional online survey as part of a global consortium. METHODS: Consortium research teams conducted online surveys in 30 countries. Sampling methods included convenience, online panels, and population-representative. Primary outcomes included sexual behaviors, partner violence, and SRH service utilization, and we compared three months prior to and three months after policy measures to mitigate COVID-19. We used established indicators and analyses pre-specified in our protocol. We conducted meta-analyses for primary outcomes and graded the certainty of the evidence using Cochrane methods. Descriptive analyses included 22,724 individuals in 25 countries. Five additional countries with sample sizes <200 were included in descriptive meta-analyses. RESULTS: Respondents were mean age 34 years; most identified as women (15160; 66.7%), cis-gender (19432; 86.6%) and heterosexual (16592; 77.9%). Among 4546 respondents with casual partners, condom use stayed the same for 3374 (74.4%) people and 640 (14.1%) people reported a decline. Fewer respondents reported physical or sexual partner violence during COVID-19 measures (1063/15144, 7.0%) compared to the period before COVID-19 measures (1469/15887, 9.3%). COVID-19 measures impeded access to condoms (933/10790, 8.7%), contraceptives (610/8175, 7.5%), and HIV/STI testing (750/1965, 30.7%). Pooled estimates from meta-analysis indicate during COVID-19 measures, 32.3% (95% CI 23.9-42.1) of people needing HIV/STI testing had hindered access, 4.4% (95% CI 3.4-5.4) experienced partner violence, and 5.8% (95% CI 5.4-8.2) decreased casual partner condom use (moderate certainty of evidence for each outcome). Meta-analysis findings were robust in sensitivity analyses that examined country income level, sample size, and sampling strategy. CONCLUSION: Open science methods are feasible to organize research studies as part of emergency responses. The initial COVID-19 wave impacted SRH behaviors and access to services across diverse global settings.

Providing Data-Driven Equitable Palliative and End-of-Life Care for Structurally Vulnerable Populations: A Pilot Survey of Information Management Strategies.

BACKGROUND: Considerable gains are being made in data-driven efforts to advance quality improvement in health care. However, organizations providing hospice-oriented palliative care for structurally vulnerable persons with terminal illnesses may not have the enabling data infrastructure or framework to derive such benefits. METHODS: We conducted a pilot cross-sectional qualitative study involving a convenience sample of hospice organizations across North America providing palliative care services for structurally vulnerable patients. Through semistructured interviews, we surveyed organizations on the types of data collected, the information systems used, and the challenges they faced. RESULTS: We contacted 13 organizations across North America and interviewed 9. All organizations served structurally vulnerable populations, including the homeless and vulnerably housed, socially isolated, and HIV-positive patients. Common examples of collected data included the number of referrals, the number of admissions, length of stay, and diagnosis. More than half of the organizations (n = 5) used an electronic medical record, although none of the record systems were specifically designed for palliative care. All (n = 9) the organizations used the built-in reporting capacity of their information management systems and more than half (n = 6) augmented this capacity with chart reviews. DISCUSSION: A number of themes emerged from our discussions. Present data collection is heterogeneous, and storage of these data is highly fragmented within and across organizations. Funding appeared to be a key enabler of more robust data collection and use. Future work should address these gaps and examine opportunities for innovative ways of analysis and reporting to improve care for structurally vulnerable populations.

A dynamic reaction picklist for improving allergy reaction documentation in the electronic health record.

OBJECTIVE: Incomplete and static reaction picklists in the allergy module led to free-text and missing entries that inhibit the clinical decision support intended to prevent adverse drug reactions. We developed a novel, data-driven, "dynamic" reaction picklist to improve allergy documentation in the electronic health record (EHR). MATERIALS AND METHODS: We split 3 decades of allergy entries in the EHR of a large Massachusetts healthcare system into development and validation datasets. We consolidated duplicate allergens and those with the same ingredients or allergen groups. We created a reaction value set via expert review of a previously developed value set and then applied natural language processing to reconcile reactions from structured and free-text entries. Three association rule-mining measures were used to develop a comprehensive reaction picklist dynamically ranked by allergen. The dynamic picklist was assessed using recall at top k suggested reactions, comparing performance to the static picklist. RESULTS: The modified reaction value set contained 490 reaction concepts. Among 4 234 327 allergy entries collected, 7463 unique consolidated allergens and 469 unique reactions were identified. Of the 3 dynamic reaction picklists developed, the 1 with the optimal ranking achieved recalls of 0.632, 0.763, and 0.822 at the top 5, 10, and 15, respectively, significantly outperforming the static reaction picklist ranked by reaction frequency. CONCLUSION: The dynamic reaction picklist developed using EHR data and a statistical measure was superior to the static picklist and suggested proper reactions for allergy documentation. Further studies might evaluate the usability and impact on allergy documentation in the EHR.