Annals of Internal Medicine最新文献

Despite published guidance by the GRADE (Grading of Recommendations Assessment, Development and Evaluation) Working Group on the use of good practice statements (GPSs), their appropriate development remains challenging. This article provides updated guidance with nuanced operationalization. The updated guidance was developed on the basis of examples and iterative discussions. The lead authors refined the approach according to the feedback from GRADE Working Group meetings and presented the summary of the results to all attendees of the GRADE Working Group meeting for feedback in September 2023 and for final approval in September 2024. The 5 signaling questions from the original guidance were leveraged, and the authors recommend that guideline developers select relevant Evidence to Decision criteria to assess the potential downstream consequences of implementing the statement. They have updated the definition of a GPS, classifying GPSs into the following 3 categories: those grounded in ethics and human rights; those grounded in essential principles, practices, and protocols; and those grounded in established scientific evidence. Practical examples accompany the steps as they relate to each type of GPS. In addition, the authors introduce a tool to streamline GPS development and enhance the reporting process. This GRADE guidance article provides an update on when and how to develop a GPS. Adherence to the guidance will add to the trustworthiness of guidelines and may facilitate reducing the inappropriate use or overuse of the GPS.

Background: Social determinants of health (SDOH) can affect metabolic health.

Objective: To determine the effect of social vulnerability on the comparative effectiveness of metabolic bariatric surgery or medical and lifestyle intervention on glycemia and weight outcomes in people with type 2 diabetes (T2D).

Design: Analysis of the effect modification of baseline Area Deprivation Index (ADI; a metric of social vulnerability) on longitudinal outcomes between randomized treatment groups using linear mixed-effects models. (ClinicalTrials.gov: NCT02328599).

Setting: 4 U.S. academic centers.

Participants: 258 participants with T2D enrolled in 4 randomized controlled trials of surgical versus medical management and a longitudinal observational follow-up study.

Measurements: ADI linked to ZIP code data at randomization; weight loss and hemoglobin A_1c (HbA_1c) level at the end of the active intervention period (7 to 12 years).

Results: Baseline characteristics were well balanced between the surgical and medical therapy groups after adjustment for study site and stratification by high versus low ADI. Surgery was more effective than medical therapy in reducing HbA_1c level among persons with high ADI (net difference, -1.29% [95% CI, -1.95% to -0.63%]) and those with low ADI (net difference, -0.95% [CI, -1.29% to -0.62%]). Surgery was also more effective than medical therapy at producing weight loss across ADIs, with respective net differences of -10.6% (CI, -15.2% to -5.9%) for high ADI and -13.3% (CI, -15.7% to -10.9%) for low ADI. The interaction between ADI and intervention group was not significant for either HbA_1c (P = 0.37) or weight loss (P = 0.31).

Limitations: Small sample size; parent trials were not designed to address effect modification by ADI.

Conclusion: Surgery was superior to medical therapy for people with T2D regardless of social deprivation. This study did not detect statistically significant differences in the comparative advantage of surgery over medical therapy by ADI.

Primary funding source: National Institutes of Health.

Background: Despite the scale of prostate-specific antigen (PSA) testing for prostate cancer (PCa) screening, prediction models do not predict time-to-event end points or adjust for patient life expectancy.

Objective: To develop, externally validate, and compare to existing tools a novel prognostic model for risk for prostate cancer-specific mortality (PCSM) after a PSA test.

Design: Prognostic model development in the PCa screening group of the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial; external validation in a Veterans Affairs (VA) population of patients undergoing PSA testing.

Setting: United States. PLCO patients were enrolled from 1993 to 2001, and VA patients underwent PSA testing from 2002 to 2006. Survival follow-up was updated through 2022 in both cohorts.

Patients: Male patients aged 55 to 74 years in the PLCO PCa screening group (n = 33 339) and the VA Healthcare System (n = 174 787).

Measurements: The model's predicted outcome is PCSM at a specified time point; predictors included PSA level, family history of PCa, and race. Predictors of other-cause mortality included age; body mass index; smoking status; and presence of hypertension, diabetes, or stroke.

Results: In the model development cohort, the area under the receiver operating characteristic curve (AUC) at 29.5 years from screening was 0.666 compared with 0.643 for a previously validated prostate biopsy risk model (Prostate Biopsy Collaborative Group [PBCG]) (P < 0.001). In the external validation cohort, the AUC at 20 years from screening was 0.776 for the PLCO model versus 0.749 for the PBCG model (P = 0.031).

Limitation: The model may not be generalizable to more contemporary PSA screening practices given the periods studied.

Conclusion: This PCSM prognostic model was developed from long-term clinical trial data, was externally validated in a large national cohort, and may be used to improve interpretation of PSA results.

Primary funding source: None.

Background: Patients are sometimes experienced as difficult by their providers.

Purpose: To estimate the prevalence of difficult patient encounters among adults being seen in nonpsychiatric settings. Secondary goals were to assess patient and provider characteristics associated with difficulty as well as patient outcomes.

Data sources: MEDLINE, Web of Science, SciELO, ProQuest, Theses, Scopus, PsychInfo, Cochrane Central Register of Controlled Trials, Global Index Medicus, and EMBASE (inception through 7 July 2025).

Study selection: In duplicate and independently.

Data extraction: Prevalence, patient characteristics (sex, mental health diagnosis, somatization, personality disorders, and chronic pain), provider characteristics (type of provider, encounter setting, burnout, years of experience, and sex), and encounter outcomes (patient unmet expectations and satisfaction) were extracted in duplicate.

Data synthesis: The prevalence of difficult encounters among clinic patients was 0.17 (95% CI, 0.15 to 0.19). Patient characteristics that increased difficulty included personality disorders (relative risk [RR], 2.2 [CI, 1.5 to 3.1]), depression (RR, 1.9 [CI, 1.7 to 2.2]), anxiety (RR, 2.1 [CI, 1.7 to 2.6]), and chronic pain (RR, 1.9 [CI, 1.5 to 2.4]). Providers with less experience (weighted mean difference, -3.5 years [CI, -5.0 to -1.9 years]) rated more encounters as difficult. Patients perceived as difficult were more likely to have unmet visit expectations (RR, 1.9 [CI, 1.4 to 2.5]) and lower satisfaction (RR, 0.76 [CI, 0.65 to 0.88]).

Limitation: Limited data and heterogeneity for many secondary analyses.

Conclusion: Providers perceived 17% of clinic patients as difficult. Patients perceived as difficult were more likely to have depression, anxiety, a greater number of symptoms, personality disorders, or chronic pain. Less experienced providers were more likely to judge patients as difficult. Patients from difficult encounters had more unmet visit expectations and less satisfaction.

Primary funding source: None. (PROSPERO: CRD42024583715).