Identifying and Exploring the Cognitive Nature of Threshold Concepts in Pharmacology to Improve Medical Students' Learning.

Phenomenon: Pharmacology is a fundamental healthcare discipline, but it can be difficult and counterintuitive for learners to learn. Navigation toward understanding pharmacology can be troublesome, but once the threshold to comprehension is crossed, learners can experience a transformative shift in their ways of thinking and practicing. We conducted an in-depth examination of threshold concepts within pharmacology, aiming to identify and prioritize their learning to improve the medical curriculum and enhance medical treatment and patient safety. Approach: We carried out a consensus generation process using the Nominal Group Technique (NGT) to identify potential threshold concepts in pharmacology. Participant groups of pharmacology experts and medical students considered, identified, reviewed, and ranked potential pharmacology threshold concepts within their own group. Then, using a logical, step-by-step approach, we combined the final ranked data from these multiple NGT sessions. We further analyzed these data using an abductive analysis approach; data were coded, categorized, reorganized, and conceptually mapped after critical evaluation. Conceptual themes were established corresponding to different phases of cognitive schema development. Findings: Six comprehensive conceptual themes were identified: Drug Mechanism of Action; Pharmacotherapeutics; Pharmacokinetics; Drug Receptor Interactions; Drug Terminology and Nomenclature; and Signaling Pathways. These concepts align with many of the key attributes of threshold concepts (e.g., troublesome, integrative and transformative). The cognitive schematic themes generated were (i) acquisition-troublesome; (ii) acquisition-transformative; (iii) automation-troublesome; (iv) automation-transformative. Insights: Transformative learning involves different stages of cognitive schema evolution, including acquisition, elaboration, and automation, and is influenced by both the inherent challenges of the concepts and limitations of human cognition. The high interactivity of these troublesome concepts challenge schema acquisition and automation. Troublesome concepts underpinning procedures or skills, while not easily explained by cognitive rules, can lead to slow, awkward, error-prone performance, creating additional barriers for practice. Integrating concepts into a coherent structure leads to the irreversible assimilation of knowledge and the transferability of both knowledge and skills, influencing learners' epistemological transitions and ontological transformations at theoretical and professional levels. Further work on designing instructional models around assisting and automating schemas around identified troublesome knowledge, while addressing the impact of cognitive load, has the potential to promote transformational learning.

Interventions for Weight Management in Children and Adolescents: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force.

Importance: Body mass index (BMI) of the 95th or greater percentile for age and sex is common among young people, and its prevalence has increased in recent decades. Objective: To examine the benefits and harms of weight management interventions initiated in health care settings among children and adolescents with high BMI. Data Sources: MEDLINE via Ovid, PsycINFO via Ovid, and the Cochrane Central Registry of Controlled Trials through January 12, 2023; ongoing surveillance through January 26, 2024. Study Selection: English-language studies of weight management interventions (behavioral and pharmacologic, including liraglutide, semaglutide, orlistat, and phentermine/topiramate) among children aged 2 to 18 years with high BMI (eg, ≥85th or ≥95th percentile for age and sex) conducted in or recruited from health care settings. Data Extraction and Synthesis: One investigator abstracted data; a second checked for accuracy. Outcomes with sufficient evidence for meta-analysis were pooled using random-effects models. Main Outcomes and Measures: BMI and other weight-related outcomes, cardiometabolic measures, quality of life, physical activity, dietary pattern scores, and harms. Results: Fifty-eight randomized clinical trials (RCTs) were included (N = 10 143). Behavioral interventions were associated with small reductions in BMI and other weight outcomes after 6 to 12 months (28 RCTs [n = 4494]; mean difference in change between groups, -0.7 [95% CI, -1.0 to -0.3]). Larger effects were seen in interventions with higher contact hours and that offered physical activity sessions. Reporting was sparse for outcomes other than BMI, with few significant findings. Semaglutide and phentermine/topiramate had the largest effects on BMI (eg, 1 RCT [n = 201] for semaglutide; mean difference, -6.0 [95% CI, -7.3 to -4.6]). The very few studies that evaluated outcomes after medication discontinuation showed immediate weight regain. Gastrointestinal adverse effects were common with liraglutide, semaglutide, and orlistat. Serious adverse effects were rare, but no studies had follow-up longer than 17 months. Conclusions and Relevance: In the short term, weight management interventions led to lower BMI in children and adolescents, with no evidence of serious harm. Evidence is lacking about how weight management interventions affect BMI beyond 1 year and after medication discontinuation and about longer-term effects on other outcomes.

Anxiety Screening: Evidence Report and Systematic Review for the US Preventive Services Task Force.

Importance: Anxiety is commonly seen in primary care and associated with substantial burden. Objective: To review the benefits and harms of screening and treatment for anxiety and the accuracy of instruments to detect anxiety among primary care patients. Data Sources: MEDLINE, PsychINFO, Cochrane library through September 7, 2022; references of existing reviews; ongoing surveillance for relevant literature through November 25, 2022. Study Selection: English-language original studies and systematic reviews of screening or treatment compared with control conditions and test accuracy studies of a priori-selected screening instruments were included. Two investigators independently reviewed abstracts and full-text articles for inclusion. Two investigators independently rated study quality. Data Extraction and Synthesis: One investigator abstracted data; a second checked accuracy. Meta-analysis results were included from existing systematic reviews where available; meta-analyses were conducted on original research when evidence was sufficient. Main Outcomes and Measures: Anxiety and depression outcomes; global quality of life and functioning; sensitivity and specificity of screening tools. Results: Of the 59 publications included, 40 were original studies (N = 275 489) and 19 were systematic reviews (including ≈483 studies [N≈81 507]). Two screening studies found no benefit for screening for anxiety. Among test accuracy studies, only the Generalized Anxiety Disorder (GAD) GAD-2 and GAD-7 screening instruments were evaluated by more than 1 study. Both screening instruments had adequate accuracy for detecting generalized anxiety disorder (eg, across 3 studies the GAD-7 at a cutoff of 10 had a pooled sensitivity of 0.79 [95% CI, 0.69 to 0.94] and specificity of 0.89 [95% CI, 0.83 to 0.94]). Evidence was limited for other instruments and other anxiety disorders. A large body of evidence supported the benefit of treatment for anxiety. For example, psychological interventions were associated with a small pooled standardized mean difference of -0.41 in anxiety symptom severity in primary care patients with anxiety (95% CI, -0.58 to -0.23]; 10 RCTs [n = 2075]; I2 = 40.2%); larger effects were found in general adult populations. Conclusions and Relevance: Evidence was insufficient to draw conclusions about the benefits or harms of anxiety screening programs. However, clear evidence exists that treatment for anxiety is beneficial, and more limited evidence indicates that some anxiety screening instruments have acceptable accuracy to detect generalized anxiety disorder.

Depression and Suicide Risk Screening: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force.

Importance: Depression is common and associated with substantial burden. Suicide rates have increased over the past decade, and both suicide attempts and deaths have devastating effects on individuals and families. Objective: To review the benefits and harms of screening and treatment for depression and suicide risk and the accuracy of instruments to detect these conditions among primary care patients. Data Sources: MEDLINE, PsychINFO, Cochrane library through September 7, 2022; references of existing reviews; ongoing surveillance for relevant literature through November 25, 2022. Study Selection: English-language studies of screening or treatment compared with control conditions, or test accuracy of screening instruments (for depression, instruments were selected a priori; for suicide risk, all were included). Existing systematic reviews were used for treatment and test accuracy for depression. Data Extraction and Synthesis: One investigator abstracted data; a second checked accuracy. Two investigators independently rated study quality. Findings were synthesized qualitatively, including reporting of meta-analysis results from existing systematic reviews; meta-analyses were conducted on original research when evidence was sufficient. Main Outcomes and Measures: Depression outcomes; suicidal ideation, attempts, and deaths; sensitivity and specificity of screening tools. Results: For depression, 105 studies were included: 32 original studies (N=385 607) and 73 systematic reviews (including ≈2138 studies [N ≈ 9.8 million]). Depression screening interventions, many of which included additional components beyond screening, were associated with a lower prevalence of depression or clinically important depressive symptomatology after 6 to 12 months (pooled odds ratio, 0.60 [95% CI, 0.50-0.73]; reported in 8 randomized clinical trials [n=10 244]; I2 = 0%). Several instruments demonstrated adequate test accuracy (eg, for the 9-item Patient Health Questionnaire at a cutoff of 10 or greater, the pooled sensitivity was 0.85 [95% CI, 0.79-0.89] and specificity was 0.85 [95% CI, 0.82-0.88]; reported in 47 studies [n = 11 234]). A large body of evidence supported benefits of psychological and pharmacologic treatment of depression. A pooled estimate from trials used for US Food and Drug Administration approval suggested a very small increase in the absolute risk of a suicide attempt with second-generation antidepressants (odds ratio, 1.53 [95% CI, 1.09-2.15]; n = 40 857; 0.7% of antidepressant users had a suicide attempt vs 0.3% of placebo users; median follow-up, 8 weeks). Twenty-seven studies (n = 24 826) addressed suicide risk. One randomized clinical trial (n=443) of a suicide risk screening intervention found no difference in suicidal ideation after 2 weeks between primary care patients who were and were not screened for suicide risk. Three studies of suicide risk test accuracy were included; none included replication of any instrument. The included suicide prevention studies generally did not demonstrate an improvement over usual care, which typically included specialty mental health treatment. Conclusions and Relevance: Evidence supported depression screening in primary care settings, including during pregnancy and postpartum. There are numerous important gaps in the evidence for suicide risk screening in primary care settings.

Pharmacotherapy for Alcohol Use Disorder: A Systematic Review and Meta-Analysis.

Importance: Alcohol use disorder affects more than 28.3 million people in the United States and is associated with increased rates of morbidity and mortality. Objective: To compare efficacy and comparative efficacy of therapies for alcohol use disorder. Data Sources: PubMed, the Cochrane Library, the Cochrane Central Trials Registry, PsycINFO, CINAHL, and EMBASE were searched from November 2012 to September 9, 2022 Literature was subsequently systematically monitored to identify relevant articles up to August 14, 2023, and the PubMed search was updated on August 14, 2023. Study Selection: For efficacy outcomes, randomized clinical trials of at least 12 weeks' duration were included. For adverse effects, randomized clinical trials and prospective cohort studies that compared drug therapies and reported health outcomes or harms were included. Data Extraction and Synthesis: Two reviewers evaluated each study, assessed risk of bias, and graded strength of evidence. Meta-analyses used random-effects models. Numbers needed to treat were calculated for medications with at least moderate strength of evidence for benefit. Main Outcomes and Measures: The primary outcome was alcohol consumption. Secondary outcomes were motor vehicle crashes, injuries, quality of life, function, mortality, and harms. Results: Data from 118 clinical trials and 20 976 participants were included. The numbers needed to treat to prevent 1 person from returning to any drinking were 11 (95% CI, 1-32) for acamprosate and 18 (95% CI, 4-32) for oral naltrexone at a dose of 50 mg/d. Compared with placebo, oral naltrexone (50 mg/d) was associated with lower rates of return to heavy drinking, with a number needed to treat of 11 (95% CI, 5-41). Injectable naltrexone was associated with fewer drinking days over the 30-day treatment period (weighted mean difference, -4.99 days; 95% CI, -9.49 to -0.49 days) Adverse effects included higher gastrointestinal distress for acamprosate (diarrhea: risk ratio, 1.58; 95% CI, 1.27-1.97) and naltrexone (nausea: risk ratio, 1.73; 95% CI, 1.51-1.98; vomiting: risk ratio, 1.53; 95% CI, 1.23-1.91) compared with placebo. Conclusions and Relevance: In conjunction with psychosocial interventions, these findings support the use of oral naltrexone at 50 mg/d and acamprosate as first-line pharmacotherapies for alcohol use disorder.

Vitamin and Mineral Supplements for the Primary Prevention of Cardiovascular Disease and Cancer: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force.

Importance: Cardiovascular disease and cancer are the 2 leading causes of death in the US, and vitamin and mineral supplementation has been proposed to help prevent these conditions. Objective: To review the benefits and harms of vitamin and mineral supplementation in healthy adults to prevent cardiovascular disease and cancer to inform the US Preventive Services Task Force. Data Sources: MEDLINE, PubMed (publisher-supplied records only), Cochrane Library, and Embase (January 2013 to February 1, 2022); prior reviews. Study Selection: English-language randomized clinical trials (RCTs) of vitamin or mineral use among adults without cardiovascular disease or cancer and with no known vitamin or mineral deficiencies; observational cohort studies examining serious harms. Data Extraction and Synthesis: Single extraction, verified by a second reviewer. Quantitative pooling methods appropriate for rare events were used for most analyses. Main Outcomes and Measures: Mortality, cardiovascular disease events, cancer incidence, serious harms. Results: Eighty-four studies (N=739 803) were included. In pooled analyses, multivitamin use was significantly associated with a lower incidence of any cancer (odds ratio [OR], 0.93 [95% CI, 0.87-0.99]; 4 RCTs [n=48 859]; absolute risk difference [ARD] range among adequately powered trials, -0.2% to -1.2%) and lung cancer (OR, 0.75 [95% CI, 0.58-0.95]; 2 RCTs [n=36 052]; ARD, 0.2%). However, the evidence for multivitamins had important limitations. Beta carotene (with or without vitamin A) was significantly associated with an increased risk of lung cancer (OR, 1.20 [95% CI, 1.01-1.42]; 4 RCTs [n=94 830]; ARD range, -0.1% to 0.6%) and cardiovascular mortality (OR, 1.10 [95% CI, 1.02-1.19]; 5 RCTs [n=94 506] ARD range, -0.8% to 0.8%). Vitamin D use was not significantly associated with all-cause mortality (OR, 0.96 [95% CI, 0.91-1.02]; 27 RCTs [n=117 082]), cardiovascular disease (eg, composite cardiovascular disease event outcome: OR, 1.00 [95% CI, 0.95-1.05]; 7 RCTs [n=74 925]), or cancer outcomes (eg, any cancer incidence: OR, 0.98 [95% CI, 0.92-1.03]; 19 RCTs [n=86 899]). Vitamin E was not significantly associated with all-cause mortality (OR, 1.02 [95% CI, 0.97-1.07]; 9 RCTs [n=107 772]), cardiovascular disease events (OR, 0.96 [95% CI, 0.90-1.04]; 4 RCTs [n=62 136]), or cancer incidence (OR, 1.02 [95% CI, 0.98-1.08]; 5 RCTs [n=76 777]). Evidence for benefit of other supplements was equivocal, minimal, or absent. Limited evidence suggested some supplements may be associated with higher risk of serious harms (hip fracture [vitamin A], hemorrhagic stroke [vitamin E], and kidney stones [vitamin C, calcium]). Conclusions and Relevance: Vitamin and mineral supplementation was associated with little or no benefit in preventing cancer, cardiovascular disease, and death, with the exception of a small benefit for cancer incidence with multivitamin use. Beta carotene was associated with an increased risk of lung cancer and other harmful outcomes in persons at high risk of lung cancer.

Making Narrative Statements to Describe Treatment Effects.

Accurately describing treatment effects using plain language and narrative statements is a critical step in communicating research findings to end users. However, the process of developing these narratives has not been historically guided by a specific framework. The Agency for Healthcare Research and Quality Evidence-based Practice Center Program developed guidance for narrative summaries of treatment effects that identifies five constructs. We explicitly identify these constructs to facilitate developing narrative statements: (1) direction of effect, (2) size of effect, (3) clinical importance, (4) statistical significance, and (5) strength or certainty of evidence. These constructs clearly overlap. It may not always be feasible to address all five constructs. Based on context and intended audience, investigators can determine which constructs will be most important to address in narrative statements.

Addressing Racism in Preventive Services: Methods Report to Support the US Preventive Services Task Force.

Importance: In January 2021, the US Preventive Services Task Force (USPSTF) issued a values statement that acknowledged systemic racism and included a commitment to address racism and health equity in recommendations for clinical preventive services. Objectives: To articulate the definitional and conceptual issues around racism and health inequity and to describe how racism and health inequities are currently addressed in preventive health. Methods: An audit was conducted assessing (1) published literature on frameworks or policy and position statements addressing racism, (2) a subset of cancer and cardiovascular topics in USPSTF reports, (3) recent systematic reviews on interventions to reduce health inequities in preventive health or to prevent racism in health care, and (4) health care-relevant professional societies, guideline-making organizations, agencies, and funding bodies to gather information about how they are addressing racism and health equity. Findings: Race as a social category does not have biological underpinnings but has biological consequences through racism. Racism is complex and pervasive, operates at multiple interrelated levels, and exerts negative effects on other social determinants and health and well-being through multiple pathways. In its reports, the USPSTF has addressed racial and ethnic disparities, but not racism explicitly. The systematic reviews to support the USPSTF include interventions that may mitigate health disparities through cultural tailoring of behavioral interventions, but reviews have not explicitly addressed other commonly studied interventions to increase the uptake of preventive services or foster the implementation of preventive services. Many organizations have issued recent statements and commitments around racism in health care, but few have provided substantive guidance on operational steps to address the effects of racism. Where guidance is unavailable regarding the proposed actions, it is principally because work to achieve them is in very early stages. The most directly relevant and immediately useful guidance identified is that from the GRADE working group. Conclusions and Relevance: This methods report provides a summary of issues around racism and health inequity, including the status of how these are being addressed in preventive health.

Motivations of assessment item writers in medical programs: a qualitative study.

BACKGROUND: The challenge of generating sufficient quality items for medical student examinations is a common experience for medical program coordinators. Faculty development strategies are commonly used, but there is little research on the factors influencing medical educators to engage in item writing. To assist with designing evidence-based strategies to improve engagement, we conducted an interview study informed by self-determination theory (SDT) to understand educators' motivations to write items. METHODS: We conducted 11 semi-structured interviews with educators in an established medical program. Interviews were transcribed verbatim and underwent open coding and thematic analysis. RESULTS: Major themes included; responsibility for item writing and item writer motivations, barriers and enablers; perceptions of the level of content expertise required to write items; and differences in the writing process between clinicians and non-clinicians. CONCLUSIONS: Our findings suggest that flexible item writing training, strengthening of peer review processes and institutional improvements such as improved communication of expectations, allocation of time for item writing and pairing new writers with experienced writers for mentorship could enhance writer engagement.

Behavioral Counseling to Promote a Healthy Diet and Physical Activity for Cardiovascular Disease Prevention in Adults With Cardiovascular Risk Factors: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force.

Importance: Cardiovascular disease is the leading cause of death in the US, and poor diet and lack of physical activity are major factors contributing to cardiovascular morbidity and mortality. Objective: To review the benefits and harms of behavioral counseling interventions to improve diet and physical activity in adults with cardiovascular risk factors. Data Sources: MEDLINE, PubMed, PsycINFO, and the Cochrane Central Register of Controlled Trials through September 2019; literature surveillance through July 24, 2020. Study Selection: English-language randomized clinical trials (RCTs) of behavioral counseling interventions to help people with elevated blood pressure or lipid levels improve their diet and increase physical activity. Data Extraction and Synthesis: Data were extracted from studies by one reviewer and checked by a second. Random-effects meta-analysis and qualitative synthesis were used. Main Outcomes and Measures: Cardiovascular events, mortality, subjective well-being, cardiovascular risk factors, diet and physical activity measures (eg, minutes of physical activity, meeting physical activity recommendations), and harms. Interventions were categorized according to estimated contact time as low (≤30 minutes), medium (31-360 minutes), and high (>360 minutes). Results: Ninety-four RCTs were included (N = 52 174). Behavioral counseling interventions involved a median of 6 contact hours and 12 sessions over the course of 12 months and varied in format and dietary recommendations; only 5% addressed physical activity alone. Interventions were associated with a lower risk of cardiovascular events (pooled relative risk, 0.80 [95% CI, 0.73-0.87]; 9 RCTs [n = 12 551]; I2 = 0%). Event rates were variable; in the largest trial (Prevención con Dieta Mediterránea [PREDIMED]), 3.6% in the intervention groups experienced a cardiovascular event, compared with 4.4% in the control group. Behavioral counseling interventions were associated with small, statistically significant reductions in continuous measures of blood pressure, low-density lipoprotein cholesterol levels, fasting glucose levels, and adiposity at 12 to 24 months' follow-up. Measurement of diet and physical activity was heterogeneous, and evidence suggested small improvements in diet consistent with the intervention recommendation targets but mixed findings and a more limited evidence base for physical activity. Adverse events were rare, with generally no group differences in serious adverse events, any adverse events, hospitalizations, musculoskeletal injuries, or withdrawals due to adverse events. Conclusions and Relevance: Medium- and high-contact multisession behavioral counseling interventions to improve diet and increase physical activity for people with elevated blood pressure and lipid levels were effective in reducing cardiovascular events, blood pressure, low-density lipoproteins, and adiposity-related outcomes, with little to no risk of serious harm.

Interventions to Prevent Illicit and Nonmedical Drug Use in Children, Adolescents, and Young Adults: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force.

Importance: Illicit and nonmedical (use in ways other than instructed) drug use is common in adolescents and young adults and increases the risk of harmful outcomes such as injuries, violence, and poorer academic performance. Objective: To review the benefits and harms of interventions to prevent illicit and nonmedical drug use in children, adolescents, and young adults to inform the US Preventive Services Task Force. Data Sources: MEDLINE, PubMED, PsycINFO, and the Cochrane Central Register of Controlled Trials (January 1, 2013, to January 31, 2019 [children and adolescents]; January 1, 1992, to January 31, 2019 [young adults <25 years]); surveillance through March 20, 2020. Study Selection: Clinical trials of behavioral counseling interventions to prevent initiation of illicit and nonmedical drug use among young people. Data Extraction and Synthesis: Critical appraisal was completed independently by 2 investigators. Data were extracted by 1 reviewer and checked by a second. Random-effects meta-analysis was used to estimate the effect sizes associated with the interventions. Main Outcomes and Measures: Number of times illicit drugs were used; any illicit drug or any cannabis use. Results: Twenty-nine trials (N = 18 353) met inclusion criteria. Health, social, or legal outcomes such as mental health symptoms, family functioning, consequences of drug use, and arrests were reported in 19 trials and most showed no group differences. The effects on illicit drug use in 26 trials among nonpregnant youth (n = 17 811) were highly variable; the pooled result did not show a clinically important or statistically significant association with illicit drug use (standardized mean difference, -0.08 [95% CI, -0.16 to 0.001]; 24 effects [from 23 studies]; n = 12 801; I2 = 57.0%). The percentage of participants using illicit drugs ranged from 2.3% to 38.6% in the control groups and 2.4% to 33.7% in the intervention groups at 3 to 32 months' follow-up. The median absolute risk difference between groups was -2.8%, favoring the intervention group (range, -11.5% to 14.8%). The remaining 3 trials provided a perinatal home-visiting intervention to pregnant Native American youth. One trial (n=322) found a reduction in illicit drug use at 38 months (eg, cannabis use in the previous month, 10.7% in the intervention group and 15.6% in the control group) but not at earlier follow-up assessments. Across all 29 trials, only 1 trial reported on harms and found no statistically significant group differences. Conclusions and Relevance: The evidence for behavioral counseling interventions to prevent initiation of illicit and nonmedical drug use among adolescents and young adults was inconsistent and imprecise, with some interventions associated with reduction in use and others associated with no benefit or increased use. Health, social, and legal outcomes were sparsely reported, and few showed improvements.

Behavioral Counseling Interventions to Prevent Sexually Transmitted Infections: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force.

Importance: Increasing rates of preventable sexually transmitted infections (STIs) in the US pose substantial burdens to health and well-being. Objective: To update evidence for the US Preventive Services Task Force (USPSTF) on effectiveness of behavioral counseling interventions for preventing STIs. Data Sources: Studies from the previous USPSTF review (2014); literature published January 2013 through May 31, 2019, in MEDLINE, PubMed (for publisher-supplied records only), PsycINFO, and Cochrane Central Register of Controlled Trials. Ongoing surveillance through May 22, 2020. Study Selection: Good- and fair-quality randomized and nonrandomized controlled intervention studies of behavioral counseling interventions for adolescents and adults conducted in primary care settings were included. Studies with active comparators only or limited to individuals requiring specialist care for STI risk-related comorbidities were excluded. Data Extraction and Synthesis: Dual risk of bias assessment, with inconsistent ratings adjudicated by a third team member. Study data were abstracted into prespecified forms. Pooled odds ratios (ORs) were estimated using the DerSimonian and Laird method or the restricted maximum likelihood method with Knapp-Hartung adjustment. Main Outcomes and Measures: Differences in STI diagnoses, self-reported condom use, and self-reported unprotected sex at 3 months or more after baseline. Results: The review included 37 randomized trials and 2 nonrandomized controlled intervention studies (N = 65 888; 13 good-quality, 26 fair-quality) recruited from primary care settings in the US. Study populations were composed predominantly of heterosexual adolescents and young adults (12 to 25 years), females, and racial and ethnic minorities at increased risk for STIs. Nineteen trials (n = 52 072) reported STI diagnoses as outcomes (3 to 17 months' follow-up); intervention was associated with reduced STI incidence (OR, 0.66 [95% CI, 0.54-0.81; I2 = 74%]). Absolute differences in STI acquisition between groups varied widely depending on baseline population STI risk and intervention effectiveness, ranging from 19% fewer to 4% more people acquiring STI. Thirty-four trials (n = 21 417) reported behavioral change outcomes. Interventions were associated with self-reported behavioral change (eg, increased condom use) that reduce STI risk (OR, 1.31 [95% CI, 1.10-1.56; I2 = 40%, n = 5253). There was limited evidence on persistence of intervention effects beyond 1 year. No harms were identified in 7 studies (n = 3458) reporting adverse outcomes. Conclusions and Relevance: Behavioral counseling interventions for individuals seeking primary health care were associated with reduced incidence of STIs. Group or individual counseling sessions lasting more than 2 hours were associated with larger reductions in STI incidence, and interventions of shorter duration also were associated with STI prevention, although evidence was limited on whether the STI reductions associated with these interventions persisted beyond 1 year.

Screening for Unhealthy Drug Use: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force.

Importance: Illicit drug use is among the most common causes of preventable morbidity and mortality in the US. Objective: To systematically review the literature on screening and interventions for drug use to inform the US Preventive Services Task Force. Data Sources: MEDLINE, PubMed, PsycINFO, Embase, and Cochrane Central Register of Controlled Trials through September 18, 2018; literature surveillance through September 21, 2019. Study Selection: Test accuracy studies to detect drug misuse and randomized clinical trials of screening and interventions to reduce drug use. Data Extraction and Synthesis: Critical appraisal and data abstraction by 2 reviewers and random-effects meta-analyses. Main Outcomes and Measures: Sensitivity, specificity, drug use and other health, social, and legal outcomes. Results: Ninety-nine studies (N = 84 206) were included. Twenty-eight studies (n = 65 720) addressed drug screening accuracy. Among adults, sensitivity and specificity of screening tools for detecting unhealthy drug use ranged from 0.71 to 0.94 and 0.87 to 0.97, respectively. Interventions to reduce drug use were evaluated in 52 trials (n = 15 659) of psychosocial interventions, 7 trials (n = 1109) of opioid agonist therapy, and 13 trials (n = 1718) of naltrexone. Psychosocial interventions were associated with increased likelihood of drug use abstinence (15 trials, n = 3636; relative risk [RR], 1.60 [95% CI, 1.24 to 2.13]; absolute risk difference [ARD], 9% [95% CI, 5% to 15%]) and reduced number of drug use days (19 trials, n = 5085; mean difference, -0.49 day in the last 7 days [95% CI, -0.85 to -0.13]) vs no psychosocial intervention at 3- to 4-month follow-up. In treatment-seeking populations, opioid agonist therapy and naltrexone were associated with decreased risk of drug use relapse (4 trials, n = 567; RR, 0.75 [95% CI, 0.59 to 0.82]; ARD, -35% [95% CI, -67% to -3%] and 12 trials, n = 1599; RR, 0.73 [95% CI, 0.62 to 0.85]; ARD, -18% [95% CI, -26% to -10%], respectively) vs placebo or no medication. While evidence on harms was limited, it indicated no increased risk of serious adverse events. Conclusions and Relevance: Several screening instruments with acceptable sensitivity and specificity are available to screen for drug use, although there is no direct evidence on the benefits or harms of screening. Pharmacotherapy and psychosocial interventions are effective at improving drug use outcomes, but evidence of effectiveness remains primarily derived from trials conducted in treatment-seeking populations.

National and rural-urban prevalence and determinants of early initiation of breastfeeding in India.

BACKGROUND: Early initiation of breastfeeding (EIBF) reduces the risk of neonatal mortality. Previous studies from India have documented some factors associated with EIBF. However, those studies used data with limited sample size that potentially affect the application of the evidence. Additionally, the effectiveness of national breastfeeding programmes requires up-to-date analysis of new and robust EIBF data. The present study aimed to investigate the prevalence and determinants of EIBF in India and determine to what extent these factors differ by a mother's residence in the rural or urban area. METHODS: This study used information from a total weighted sample of 94,401 mothers from the 2015-2016 India National Family Health Survey. Multivariate logistic regression was used to investigate the association between the study factors and EIBF in India and rural-urban populations, after adjusting for confounders and sampling weight. RESULTS: Our analysis indicated that 41.5% (95% confidence interval (CI): 40.9-42.5, P < 0.001) of Indian mothers initiated breastfeeding within 1-h post-birth, with similar but significant different proportions estimated for those who resided in rural (41.0, 95% CI: 40.3-41.6, P < 0.001) and urban (42.9, 95% CI: 41.7-44.2, P < 0.001) areas. Mothers who had frequent health service contacts and those with higher educational attainment reported higher EIBF practice. Multivariate analyses revealed that higher educational achievement, frequent antenatal care visits and birthing in a health facility were associated with EIBF in India and rural populations (only health facility birthing for urban mothers). Similarly, residing in the North-Eastern, Southern, Eastern and Western regions were also associated with EIBF. Birthing through caesarean, receiving delivery assistance from non-health professionals and residing in rural areas of the Central region were associated with delayed EIBF in all populations. CONCLUSION: We estimated that more than half of Indian mothers delayed breastfeeding initiation, with different rural-urban prevalence. Key modifiable factors (higher maternal education and frequent health service contacts) were associated with EIBF in India, with notable difference in rural-urban populations. Our study suggests that targeted and well-coordinated infant feeding policies and interventions will improve EIBF for all Indian mothers.

Barriers and facilitators to writing quality items for medical school assessments - a scoping review.

BACKGROUND: Producing a sufficient quantity of quality items for use in medical school examinations is a continuing challenge in medical education. We conducted this scoping review to identify barriers and facilitators to writing good quality items and note gaps in the literature that are yet to be addressed. METHODS: We conducted searches of three databases (ERIC, Medline and Scopus) as well as Google Scholar for empirical studies on the barriers and facilitators for writing good quality items for medical school examinations. RESULTS: The initial search yielded 1997 articles. After applying pre-determined criteria, 13 articles were selected for the scoping review. Included studies could be broadly categorised into studies that attempted to directly investigate the barriers and facilitators and studies that provided implicit evidence. Key findings were that faculty development and quality assurance were facilitators of good quality item writing while barriers at both an individual and institutional level include motivation, time constraints and scheduling. CONCLUSIONS: Although studies identified factors that may improve or negatively impact on the quality of items written by faculty and clinicians, there was limited research investigating the barriers and facilitators for individual item writers. Investigating these challenges could lead to more targeted and effective interventions to improve both the quality and quantity of assessment items.

Interventions to Prevent Perinatal Depression: Evidence Report and Systematic Review for the US Preventive Services Task Force.

Importance: Depression during pregnancy and the postpartum period is relatively common and can have adverse effects on both mother and child. Objective: To systematically review benefits and harms of primary care-relevant interventions to prevent perinatal depression, a major or minor depressive episode during pregnancy or up to 1 year after childbirth, to inform the US Preventive Services Task Force. Data Sources: MEDLINE, PubMED (for publisher-supplied records only), PsycINFO, and the Cochrane Central Register of Controlled Trials; surveillance through December 5, 2018. Study Selection: Randomized clinical trials (RCTs) and nonrandomized controlled intervention studies of interventions (eg, behavior-based, antidepressants, dietary supplements) to prevent perinatal depression in general populations of pregnant and postpartum individuals or in those at increased risk of perinatal depression. Large cohort studies were considered for harms of antidepressant use only. Data Extraction and Synthesis: Two investigators independently reviewed abstracts and full-text articles and quality rated included studies. Random-effects meta-analysis was used to estimate the benefits of the interventions. Main Outcomes and Measures: Depression status; depression symptoms; maternal, infant, and child health outcomes. Results: Fifty studies (N = 22 385) that met inclusion criteria were identified. Counseling interventions were the most widely studied interventions. Compared with controls, counseling interventions were associated with a lower likelihood of onset of perinatal depression (pooled risk ratio [RR], 0.61 [95% CI, 0.47-0.78]; 17 RCTs [n = 3094]; I2 = 39.0%). The absolute difference in the risk of perinatal depression ranged from 1.3% greater reduction in the control group to 31.8% greater reduction in the intervention group. Health system interventions showed a benefit in 3 studies (n = 5321) and had a pooled effect size similar to that of the counseling interventions, but the pooled effect was not statistically significant using a method appropriate for pooling a small number of studies (restricted maximum likelihood RR, 0.58 [95% CI, 0.22-1.53]; n = 4738; I2 = 66.3%; absolute risk reduction range, -3.1% to -13.1%). None of the behavior-based interventions reported on harms directly. A smaller percentage of participants prescribed sertraline had a depression recurrence compared with those prescribed placebo (7% vs 50%, P = .04) at 20 weeks postpartum in 1 very small RCT (n = 22 analyzed) but with an increased risk of adverse effects to the mother. Conclusions and Relevance: Counseling interventions can be effective in preventing perinatal depression, although most evidence was limited to women at increased risk for perinatal depression. A variety of other intervention approaches provided some evidence of effectiveness but lacked a robust evidence base and need further research.

Behavioral and Pharmacotherapy Weight Loss Interventions to Prevent Obesity-Related Morbidity and Mortality in Adults: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force.

Importance: Overweight and obesity have been associated with adverse health effects. Objective: To systematically review evidence on benefits and harms of behavioral and pharmacotherapy weight loss and weight loss maintenance interventions in adults to inform the US Preventive Services Task Force. Data Sources: MEDLINE, PubMed Publisher-Supplied Records, PsycINFO, and the Cochrane Central Register of Controlled Trials for studies published through June 6, 2017; ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform for ongoing trials through August 2017; and ongoing surveillance in targeted publications through March 23, 2018. Studies from previous reviews were reevaluated for inclusion. Study Selection: Randomized clinical trials (RCTs) focusing on weight loss or weight loss maintenance in adults. Data Extraction and Synthesis: Data were abstracted by one reviewer and confirmed by another. Random-effects meta-analyses were conducted for weight loss outcomes in behavior-based interventions. Main Outcomes and Measures: Health outcomes, weight loss or weight loss maintenance, reduction in obesity-related conditions, and adverse events. Results: A total of 122 RCTs (N = 62 533) and 2 observational studies (N = 209 993) were identified. Compared with controls, participants in behavior-based interventions had greater mean weight loss at 12 to 18 months (-2.39 kg [95% CI, -2.86 to -1.93]; 67 studies [n = 22065]) and less weight regain (-1.59 kg [95% CI, -2.38 to -0.79]; 8 studies [n = 1408]). Studies of medication-based weight loss and maintenance interventions also reported greater weight loss or less weight regain in intervention compared with placebo groups at 12 to 18 months (range, -0.6 to -5.8 kg; no meta-analysis). Participants with prediabetes in weight loss interventions had a lower risk of developing diabetes compared with controls (relative risk, 0.67 [95% CI, 0.51 to 0.89]). There was no evidence of other benefits, but most health outcomes such as mortality, cardiovascular disease, and cancer were infrequently reported. Small improvements in quality of life in some medication trials were noted but were of unclear clinical significance. There was no evidence of harm such as cardiovascular disease from behavior-based interventions; higher rates of adverse events were associated with higher dropout rates in medication groups than in placebo groups. Conclusions and Relevance: Behavior-based weight loss interventions with or without weight loss medications were associated with more weight loss and a lower risk of developing diabetes than control conditions. Weight loss medications, but not behavior-based interventions, were associated with higher rates of harms. Long-term weight and health outcomes data, as well as data on important subgroups, were limited.

Screening and Behavioral Counseling Interventions to Reduce Unhealthy Alcohol Use in Adolescents and Adults: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force.

Importance: Unhealthy alcohol use is common, increasing, and a leading cause of premature mortality. Objective: To review literature on the effectiveness and harms of screening and counseling for unhealthy alcohol use to inform the US Preventive Services Task Force. Data Sources: MEDLINE, PubMed, PsycINFO, and the Cochrane Central Register of Controlled Trials through October 12, 2017; literature surveillance through August 1, 2018. Study Selection: Test accuracy studies and randomized clinical trials of screening and counseling to reduce unhealthy alcohol use. Data Extraction and Synthesis: Independent critical appraisal and data abstraction by 2 reviewers. Counseling trials were pooled using random-effects meta-analyses. Main Outcomes and Measures: Sensitivity, specificity, drinks per week, exceeding recommended limits, heavy use episodes, abstinence (for pregnant women), and other health, family, social, and legal outcomes. Results: One hundred thirteen studies (N = 314 466) were included. No studies examined benefits or harms of screening programs to reduce unhealthy alcohol use. For adolescents (10 studies [n = 171 363]), 1 study (n = 225) reported a sensitivity of 0.73 (95% CI, 0.60 to 0.83) and specificity of 0.81 (95% CI, 0.74 to 0.86) using the AUDIT-C (Alcohol Use Disorders Identification Test-Consumption) to detect the full spectrum of unhealthy alcohol use. For adults (35 studies [n = 114 182]), brief screening instruments commonly reported sensitivity and specificity between 0.70 and 0.85. Two trials of the effects of interventions to reduce unhealthy alcohol use in adolescents (n = 588) found mixed results: one reported a benefit in high-risk but not moderate-risk drinkers, and the other reported a statistically significant reduction in drinking frequency for boys but not girls; neither reported health or related outcomes. Across all populations (68 studies [n = 36 528]), counseling interventions were associated with a decrease in drinks per week (weighted mean difference, -1.6 [95% CI, -2.2 to -1.0]; 32 studies [37 effects; n = 15 974]), the proportion exceeding recommended drinking limits (odds ratio [OR], 0.60 [95% CI, 0.53 to 0.67]; 15 studies [16 effects; n = 9760]), and the proportion reporting a heavy use episode (OR, 0.67 [95% CI, 0.58 to 0.77]; 12 studies [14 effects; n = 8108]), and an increase in the proportion of pregnant women reporting abstinence (OR, 2.26 [95% CI, 1.43 to 3.56]; 5 studies [n = 796]) after 6 to 12 months. Health outcomes were sparsely reported and generally did not demonstrate group differences in effect. There was no evidence that these interventions could be harmful. Conclusions and Relevance: Among adults, screening instruments feasible for use in primary care are available that can effectively identify people with unhealthy alcohol use, and counseling interventions in those who screen positive are associated with reductions in unhealthy alcohol use. There was no evidence that these interventions have unintended harmful effects.

Aspirin for the Primary Prevention of Cardiovascular Events: A Systematic Evidence Review for the U.S. Preventive Services Task Force.

BACKGROUND: Cardiovascular disease (CVD) is the leading cause of death in the United States. PURPOSE: To update a systematic review about the benefits of aspirin for the primary prevention of cardiovascular events in adults aged 40 years or older and to evaluate effect modification in subpopulations. DATA SOURCES: MEDLINE, PubMed, Cochrane Central Register of Controlled Trials (January 2008 to January 2015), and Cochrane Database of Systematic Reviews. STUDY SELECTION: Two investigators independently reviewed 3396 abstracts and 65 articles according to prespecified criteria. All included trials evaluated aspirin for the primary prevention of cardiovascular events. DATA EXTRACTION: Two investigators assessed study quality; data were abstracted by 1 reviewer and checked by a second. DATA SYNTHESIS: Two good-quality and 9 fair-quality randomized, controlled trials were identified. In analyses of all doses, aspirin reduced the risk for nonfatal myocardial infarction (MI) (relative risk [RR], 0.78 [95% CI, 0.71 to 0.87]) but not nonfatal stroke; aspirin showed little or no benefit for all-cause or cardiovascular mortality. Benefits began within the first 5 years. Older adults achieved greater relative MI reduction, but no other effect modifications were found in analyzed subpopulations. In trials with aspirin doses of 100 mg or less per day, the reduction in nonfatal MI benefit persisted (absolute risk reduction, 0.15 to 1.43 events per 1000 person-years) and a 14% reduction in nonfatal stroke benefit was noted, but no benefit was found for all-cause mortality (RR, 0.95 [CI, 0.89 to 1.01]) or cardiovascular mortality (RR, 0.97 [CI, 0.85 to 1.10]). LIMITATION: Evidence for aspirin in primary prevention is heterogeneous and limited by rare events and few credible subgroup analyses. CONCLUSION: The beneficial effect of aspirin for the primary prevention of CVD is modest and occurs at doses of 100 mg or less per day. Older adults seem to achieve a greater relative MI benefit. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality.