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Rates of Downstream Procedures and Complications Associated With Lung Cancer Screening in Routine Clinical Practice: A Retrospective Cohort Study: Annals of Internal Medicine: Vol 177, No 1

Background: Lung cancer screening (LCS) using low-dose computed tomography (LDCT) reduces lung cancer mortality but can lead to downstream procedures, complications, and other potential harms. Estimates of these events outside NLST (National Lung Screening Trial) have been variable and lacked evaluation by screening result, which allows more direct comparison with trials. Objective: To identify rates of downstream procedures and complications associated with LCS. Design: Retrospective cohort study. Setting: 5 U.S. health care systems. Patients: Individuals who completed a baseline LDCT scan for LCS between 2014 and 2018. Measurements: Outcomes included downstream imaging, invasive diagnostic procedures, and procedural complications. For each, absolute rates were calculated overall and stratified by screening result and by lung cancer detection, and positive and negative predictive values were calculated. Results: Among the 9266 screened patients, 1472 (15.9%) had a baseline LDCT scan showing abnormalities, of whom 140 (9.5%) were diagnosed with lung cancer within 12 months (positive predictive value, 9.5% [95% CI, 8.0% to 11.0%]; negative predictive value, 99.8% [CI, 99.7% to 99.9%]; sensitivity, 92.7% [CI, 88.6% to 96.9%]; specificity, 84.4% [CI, 83.7% to 85.2%]). Absolute rates of downstream imaging and invasive procedures in screened patients were 31.9% and 2.8%, respectively. In patients undergoing invasive procedures after abnormal findings, complication rates were substantially higher than those in NLST (30.6% vs. 17.7% for any complication; 20.6% vs. 9.4% for major complications). Limitation: Assessment of outcomes was retrospective and was based on procedural coding. Conclusion: The results indicate substantially higher rates of downstream procedures and complications associated with LCS in practice than observed in NLST. Diagnostic management likely needs to be assessed and improved to ensure that screening benefits outweigh potential harms. Primary Funding Source: National Cancer Institute and Gordon and Betty Moore Foundation.

Effects of Implementation of a Supervised Walking Program in Veterans Affairs Hospitals: A Stepped-Wedge, Cluster Randomized Trial: Annals of Internal Medicine: Vol 176, No 6

Background: In trials, hospital walking programs have been shown to improve functional ability after discharge, but little evidence exists about their effectiveness under routine practice conditions. Objective: To evaluate the effect of implementation of a supervised walking program known as STRIDE (AssiSTed EaRly MobIlity for HospitalizeD VEterans) on discharge to a skilled-nursing facility (SNF), length of stay (LOS), and inpatient falls. Design: Stepped-wedge, cluster randomized trial. (ClinicalTrials.gov: NCT03300336) Setting: 8 Veterans Affairs hospitals from 20 August 2017 to 19 August 2019. Patients: Analyses included hospitalizations involving patients aged 60 years or older who were community dwelling and admitted for 2 or more days to a participating medicine ward. Intervention: Hospitals were randomly assigned in 2 stratified blocks to a launch date for STRIDE. All hospitals received implementation support according to the Replicating Effective Programs framework. Measurements: The prespecified primary outcomes were discharge to a SNF and hospital LOS, and having 1 or more inpatient falls was exploratory. Generalized linear mixed models were fit to account for clustering of patients within hospitals and included patient-level covariates. Results: Patients in pre-STRIDE time periods (n = 6722) were similar to post-STRIDE time periods (n = 6141). The proportion of patients with any documented walk during a potentially eligible hospitalization ranged from 0.6% to 22.7% per hospital. The estimated rates of discharge to a SNF were 13% pre-STRIDE and 8% post-STRIDE. In adjusted models, odds of discharge to a SNF were lower among eligible patients hospitalized in post-STRIDE time periods (odds ratio [OR], 0.6 [95% CI, 0.5 to 0.8]) compared with pre-STRIDE. Findings were robust to sensitivity analyses. There were no differences in LOS (rate ratio, 1.0 [CI, 0.9 to 1.1]) or having an inpatient fall (OR, 0.8 [CI, 0.5 to 1.1]). Limitation: Direct program reach was low. Conclusion: Although the reach was limited and variable, hospitalizations occurring during the STRIDE hospital walking program implementation period had lower odds of discharge to a SNF, with no change in hospital LOS or inpatient falls. Primary Funding Source: U.S. Department of Veterans Affairs Quality Enhancement Research Initiative (Optimizing Function and Independence QUERI).

Effect of Yoga on Frailty in Older Adults: A Systematic Review: Annals of Internal Medicine: Vol 176, No 4

Background: Yoga, a multicomponent mind–body practice, improves several domains of physical and psychological health and may affect frailty in older adults. Purpose: To evaluate the available trial evidence on the effect of yoga-based interventions on frailty in older adults. Data Sources: MEDLINE, EMBASE, and Cochrane Central from their inception to 12 December 2022. Study Selection: Randomized controlled trials evaluating the effect of yoga-based interventions, including at least 1 session of physical postures, on a validated frailty scale or single-item markers of frailty in adults aged 65 years or older. Data Extraction: Two authors independently screened articles and extracted data; 1 author assessed risk of bias with review from a second author. Disagreements were resolved through consensus and as-needed input from a third author. Data Synthesis: Thirty-three studies (n = 2384 participants) were identified in varied populations, including community dwellers, nursing home residents, and those with chronic disease. Yoga styles were primarily based on Hatha yoga and most often included Iyengar or chair-based methods. Single-item frailty markers included measures of gait speed, handgrip strength, balance, lower-extremity strength and endurance, and multicomponent physical performance measures; no studies included a validated definition of frailty. When compared with education or inactive control, there was moderate-certainty evidence that yoga improved gait speed and lower-extremity strength and endurance, low-certainty evidence for balance and multicomponent physical function measures, and very low-certainty evidence for handgrip strength. Limitation: Heterogeneity in study design and yoga style, small sample sizes, and reporting deficiencies leading to concerns for selection bias. Conclusion: Yoga may affect frailty markers that are associated with clinically meaningful outcomes in older adult populations but may not offer benefit over active interventions (for example, exercise). Primary Funding Source: None. (PROSPERO: CRD42020130303)

Effectiveness of an Intervention to Improve Decision Making for Older Patients With Advanced Chronic Kidney Disease: A Randomized Controlled Trial: Annals of Internal Medicine: Vol 176, No 1

Background: Older patients with advanced chronic kidney disease (CKD) face difficult decisions about managing kidney failure, frequently experiencing decisional conflict, regret, and treatment misaligned with preferences. Objective: To assess whether a decision aid about kidney replacement therapy improved decisional quality compared with usual care. Design: Multicenter, randomized, controlled trial. (ClinicalTrials.gov: NCT03522740) Setting: 8 outpatient nephrology clinics associated with 4 U.S. centers. Participants: English-fluent patients, 70 years and older with nondialysis CKD stages 4 to 5 recruited from 2018 to 2020. Intervention: DART (Decision-Aid for Renal Therapy) is an interactive, web-based decision aid for older adults with CKD. Both groups received written education about treatments. Measurements: Change in the decisional conflict scale (DCS) score from baseline to 3, 6, 12, and 18 months. Secondary outcomes included change in prognostic and treatment knowledge and change in uncertainty. Results: Among 400 participants, 363 were randomly assigned: 180 to usual care, 183 to DART. Decisional quality improved with DART with mean DCS declining compared with control (mean difference, −8.5 [95% CI, −12.0 to −5.0]; P < 0.001), with similar findings at 6 months, attenuating thereafter. At 3 months, knowledge improved with DART versus usual care (mean difference, 7.2 [CI, 3.7 to 10.7]; P < 0.001); similar findings at 6 months were modestly attenuated at 18 months (mean difference, 5.9 [CI, 1.4 to 10.3]; P = 0.010). Treatment preferences changed from 58% “unsure” at baseline to 28%, 20%, 23%, and 14% at 3, 6, 12, and 18 months, respectively, with DART, versus 51% to 38%, 35%, 32%, and 18% with usual care. Limitation: Latinx patients were underrepresented. Conclusion: DART improved decision quality and clarified treatment preferences among older adults with advanced CKD for 6 months after the DART intervention. Primary Funding Source: Patient-Centered Outcomes Research Institute (PCORI).

Evolving Practice Choices by Newly Certified and More Senior General Internists: A Cross-Sectional and Panel Comparison: Annals of Internal Medicine: Vol 175, No 7

Background: Hospital medicine has grown as a field. However, no study has examined trends in career choices by internists over the past decade. Objective: To measure changes in practice setting for general internists. Design: Using Medicare fee-for-service claims (2008 to 2018) and data from the American Board of Internal Medicine, practice setting types were measured annually for general internists initially certifying between 1990 and 2017. Setting: General internists (non-subspecializing) treating Medicare fee-for-service beneficiaries. Patients: Medicare fee-for-service beneficiaries aged 65 years and older with at least 20 evaluation and management (E&M) visits annually. Measurements: Practice setting types were defined as hospitalist (>95% inpatient E&M), outpatient only (100% outpatient E&M), or mixed. Results: 67 902 general internists, comprising 80% of all general internists initially certified from 1990 to 2017 (n = 84 581), were studied. From 2008 to 2018, both hospitalists and outpatient-only physicians increased as percentages of general internists (25% to 40% and 23% to 38%, respectively). This was accompanied by a 56% decline in the percentage of mixed-practice physicians (52% to 23%) as these physicians largely migrated to outpatient-only practice. By 2018, 71% of newly certified general internists practiced as hospitalists compared with only 8% practicing as outpatient-only physicians. Most (86% of hospitalists in 2013) had the same practice type 5 years later. This retention rate was similar across early career and more senior physicians (86% and 85% for the 1999 and 2012 initial certification cohorts, respectively) and for the outpatient-only practice type (95%) but was only 57% for the mixed practice type. Limitation: Practice setting measurement relied only on Medicare fee-for-service claims. Conclusion: Newly certified general internists are largely choosing hospital medicine as their career choice whereas more senior physicians increasingly see patients only in the outpatient setting. Primary Funding Source: This study did not receive direct funding.

Effectiveness of Motivational Interviewing in Managing Overweight and Obesity: A Systematic Review and Meta-analysis: Annals of Internal Medicine: Vol 175, No 6

Background: Motivational interviewing (MI) is potentially useful in management of overweight and obesity, but staff training and increased delivery time are barriers, and its effectiveness independent of other behavioral components is unclear. Purpose: To assess the independent contribution of MI as part of a behavioral weight management program (BWMP) in controlling weight and improving psychological well-being. Data Sources: 6 electronic databases and 2 trial registries, searched from database inception through 24 September 2021. Study Selection: Randomized controlled trials in adults or adolescents aimed at weight loss or maintenance and comparing programs incorporating MI versus interventions without MI. Data Extraction: Two reviewers independently screened studies, extracted data, and assessed risk of bias. Outcomes included weight, anxiety, depression, quality of life, and other aspects of psychological well-being. Pooled mean differences or standardized mean differences were obtained using random- and fixed-effects meta-analyses. Data Synthesis: Forty-six studies involving 11 077 participants, predominantly with obesity, were included. At 6 months, BWMPs using MI were more effective than no/minimal intervention (−0.88 [95% CI, −1.27 to −0.48] kg; I 2 = 0%) but were not statistically significantly more effective than lower-intensity (−0.88 [CI, −2.39 to 0.62] kg; I 2 = 55.8%) or similar-intensity (−1.36 [CI, −2.80 to 0.07] kg; I 2 = 18.8%) BWMPs. At 1 year, data were too sparse to pool comparisons with no/minimal intervention, but MI did not produce statistically significantly greater weight change compared with lower-intensity (−1.16 [CI, −2.49 to 0.17] kg; I 2 = 88.7%) or similar-intensity (−0.18 [CI, −2.40 to 2.04] kg; I 2 = 72.7%) BWMPs without MI. Studies with 18-month follow-up were also sparse; MI did not produce statistically significant benefit in any of the comparator categories. There was no evidence of subgroup differences based on study, participant, or intervention characteristics. Too few studies assessed effects on psychological well-being to pool, but data did not suggest that MI was independently effective. Limitations: High statistical heterogeneity among studies, largely unexplained by sensitivity and subgroup analyses; stratification by comparator intensity and follow-up duration resulted in pooling of few studies. Conclusion: There is no evidence that MI increases effectiveness of BWMPs in controlling weight. Given the intensive training required for its delivery, MI may not be a worthwhile addition to BWMPs. Primary Funding Source: National Institute for Health Research Biomedical Research Centre. (PROSPERO: CRD42020177259)

Association Between SARS-CoV-2 Messenger RNA Vaccines and Lower Infection Rates in Kidney Transplant Recipients: A Registry-Based Report: Annals of Internal Medicine: Vol 175, No 7

Background: The real-world protection provided by SARS-CoV-2 messenger RNA (mRNA) vaccines to kidney transplant recipients (KTRs) remains uncertain. Objective: To study the association between mRNA vaccination and SARS-CoV-2 infection rate in KTRs. Design: Retrospective observational cohort study. Setting: The Czech Republic (17 February to 16 May 2021). Patients: 2101 KTRs followed in the Department of Nephrology at the Institute for Clinical and Experimental Medicine. Measurements: Positive result for SARS-CoV-2 on polymerase chain reaction test and vaccination status of KTRs. Results: The incidence rate in the vaccinated group was 0.474 per 1000 person-days (33 cases in 69 672 days at risk). The incidence rate in the unvaccinated group was 1.370 per 1000 person-days (79 cases in 57 658 days at risk). The unadjusted incidence rate ratio (IRR; incidence rate of vaccinated/incidence rate of unvaccinated) for KTRs was 0.346 (95% CI, 0.227 to 0.514). The multivariable adjusted IRR for KTRs was 0.544 (CI, 0.324 to 0.876). Limitation: Retrospective observational design, uneven follow-up of patient groups, and different exposition to SARS-CoV-2 stemming from strong temporal trends and differences in clinical and probably behavioral characteristics. Conclusion: Vaccination of KTRs is associated with lower risk for SARS-CoV-2 infection. Primary Funding Source: The Ministry of Health of the Czech Republic.

Efficacy of Acupuncture for Chronic Prostatitis/Chronic Pelvic Pain Syndrome: A Randomized Trial: Annals of Internal Medicine: Vol 174, No 10

Background: Acupuncture has promising effects on chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS), but high-quality evidence is scarce. Objective: To assess the long-term efficacy of acupuncture for CP/CPPS. Design: Multicenter, randomized, sham-controlled trial. (ClinicalTrials.gov: NCT03213938) Setting: Ten tertiary hospitals in China. Participants: Men with moderate to severe CP/CPPS, regardless of prior exposure to acupuncture. Intervention: Twenty sessions of acupuncture or sham acupuncture over 8 weeks, with 24-week follow-up after treatment. Measurements: The primary outcome was the proportion of responders, defined as participants who achieved a clinically important reduction of at least 6 points from baseline on the National Institutes of Health Chronic Prostatitis Symptom Index at weeks 8 and 32. Ascertainment of sustained efficacy required the between-group difference to be statistically significant at both time points. Results: A total of 440 men (220 in each group) were recruited. At week 8, the proportions of responders were 60.6% (95% CI, 53.7% to 67.1%) in the acupuncture group and 36.8% (CI, 30.4% to 43.7%) in the sham acupuncture group (adjusted difference, 21.6 percentage points [CI, 12.8 to 30.4 percentage points]; adjusted odds ratio, 2.6 [CI, 1.8 to 4.0]; P < 0.001). At week 32, the proportions were 61.5% (CI, 54.5% to 68.1%) in the acupuncture group and 38.3% (CI, 31.7% to 45.4%) in the sham acupuncture group (adjusted difference, 21.1 percentage points [CI, 12.2 to 30.1 percentage points]; adjusted odds ratio, 2.6 [CI, 1.7 to 3.9]; P < 0.001). Twenty (9.1%) and 14 (6.4%) adverse events were reported in the acupuncture and sham acupuncture groups, respectively. No serious adverse events were reported. Limitation: Sham acupuncture might have had certain physiologic effects. Conclusion: Compared with sham therapy, 20 sessions of acupuncture over 8 weeks resulted in greater improvement in symptoms of moderate to severe CP/CPPS, with durable effects 24 weeks after treatment. Primary Funding Source: China Academy of Chinese Medical Sciences and the National Administration of Traditional Chinese Medicine.

Effect of the STAMP (Sharing and Talking About My Preferences) Intervention on Completing Multiple Advance Care Planning Activities in Ambulatory Care: A Cluster Randomized Controlled Trial: Annals of Internal Medicine: Vol 174, No 11

Background: Interventions with the potential for broad reach in ambulatory settings are necessary to achieve a life course approach to advance care planning. Objective: To examine the effect of a computer-tailored, behavioral health model–based intervention on the engagement of adults in advance care planning recruited from ambulatory care settings. Design: Cluster randomized controlled trial with participant-level analysis. (ClinicalTrials.gov: NCT03137459) Setting: 10 pairs of primary and selected specialty care practices matched on patient sociodemographic information. Participants: English-speaking adults aged 55 years or older; 454 adults at practices randomly assigned to usual care and 455 at practices randomly assigned to intervention. Intervention: Brief telephone or web-based assessment generating a mailed, individually tailored feedback report with a stage-matched brochure at baseline, 2 months, and 4 months. Measurements: The primary outcome was completion of the following 4 advance care planning activities at 6 months: identifying and communicating with a trusted person about views on quality versus quantity of life, assignment of a health care agent, completion of a living will, and ensuring that the documents are in the medical record—assessed by a blinded interviewer. Secondary outcomes were completion of individual advance care planning activities. Results: Participants were 64% women and 76% White. The mean age was 68.3 years (SD, 8.3). The predicted probability of completing all advance care planning activities in usual care sites was 8.2% (95% CI, 4.9% to 11.4%) versus 14.1% (CI, 11.0% to 17.2%) in intervention sites (adjusted risk difference, 5.2 percentage points [CI, 1.6 to 8.8 percentage points]). Prespecified subgroup analysis found no statistically significant interactions between the intervention and age, education, or race. Limitations: The study was done in a single region and excluded non–English speaking participants. No information was collected about nonparticipants. Conclusion: A brief, easily delivered, tailored print intervention increased participation in advance care planning in ambulatory care settings. Primary Funding Source: National Institute of Nursing Research and National Institute of Aging.

Use of Hydroxychloroquine, Remdesivir, and Dexamethasone Among Adults Hospitalized With COVID-19 in the United States: A Retrospective Cohort Study: Annals of Internal Medicine: Vol 174, No 10

Background: Relatively little is known about the use patterns of potential pharmacologic treatments of COVID-19 in the United States. Objective: To use the National COVID Cohort Collaborative (N3C), a large, multicenter, longitudinal cohort, to characterize the use of hydroxychloroquine, remdesivir, and dexamethasone, overall as well as across individuals, health systems, and time. Design: Retrospective cohort study. Setting: 43 health systems in the United States. Participants: 137 870 adults hospitalized with COVID-19 between 1 February 2020 and 28 February 2021. Measurements: Inpatient use of hydroxychloroquine, remdesivir, or dexamethasone. Results: Among 137 870 persons hospitalized with confirmed or suspected COVID-19, 8754 (6.3%) received hydroxychloroquine, 29 272 (21.2%) remdesivir, and 53 909 (39.1%) dexamethasone during the study period. Since the release of results from the RECOVERY (Randomised Evaluation of COVID-19 Therapy) trial in mid-June, approximately 78% to 84% of people who have had invasive mechanical ventilation have received dexamethasone or other glucocorticoids. The use of hydroxychloroquine increased during March 2020, peaking at 42%, and started declining by April 2020. By contrast, remdesivir and dexamethasone use gradually increased over the study period. Dexamethasone and remdesivir use varied substantially across health centers (intraclass correlation coefficient, 14.2% for dexamethasone and 84.6% for remdesivir). Limitation: Because most N3C data contributors are academic medical centers, findings may not reflect the experience of community hospitals. Conclusion: Dexamethasone, an evidence-based treatment of COVID-19, may be underused among persons who are mechanically ventilated. The use of remdesivir and dexamethasone varied across health systems, suggesting variation in patient case mix, drug access, treatment protocols, and quality of care. Primary Funding Source: National Center for Advancing Translational Sciences; National Heart, Lung, and Blood Institute; and National Institute on Aging.

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