JAMA Network Open最新文献

Importance: Target trial emulation (TTE) is increasingly used to estimate causal effects with observational data, yet its clinical applications and methodologic quality remain unclear.

Objective: To characterize the clinical scenarios where TTE has been applied, assess methodologic limitations in design and implementation, and provide structured recommendations for strengthening future practice.

Design, setting, and participants: This cross-sectional study searched PubMed for TTE studies published from January 1, 2017, to December 15, 2023, in clinical journals in the top Journal Impact Factor quartile, supplemented by studies from 3 prior scoping reviews. Eligible studies explicitly aimed to emulate a target trial using observational data. Data were extracted using a standardized, consensus-based tool.

Main outcomes and measures: Study characteristics, application scenarios, specification of target trials, and adherence to 7 methodologic domains of TTE were evaluated. Recommendations were developed to address observed gaps.

Results: Among 237 included studies, over half (128 [54.0%]) evaluated drug interventions, commonly in infectious diseases, cardiology, and oncology. TTE was applied in 8 recurring clinical scenarios, including randomized clinical trial replication and extending evidence to underrepresented populations or rare outcomes. TTE was most frequently applied to assess treatment effectiveness (165 studies [69.6%]), long-term outcomes (39 [16.5%]), emergency-use medications (42 [17.7%]), and active-treatment comparisons (49 [20.7%]). Major methodologic gaps were evident: only 134 studies (56.5%) developed a prespecified protocol, 127 (53.6%) did not review existing randomized clinical trials, and most that emulated existing trials (20 of 31 [64.5%]) or hypothetical trials (147 of 153 [96.1%]) did not justify the choice of trial to emulate. During implementation, 103 studies (43.5%) did not report all 7 methodologic components, 36 (15.2%) used postbaseline information inappropriately for eligibility, only 40 (16.9%) provided follow-up diagrams to define time zero, and only 73 (30.8%) addressed unmeasured confounding. A 5-step framework for target trial design and practical considerations for implementing methodologic principles was developed.

Conclusions and relevance: This cross-sectional study of TTE identified 8 common clinical scenarios for TTE application and substantial methodologic heterogeneity that threatened the credibility of resulting evidence. The study highlighted common pitfalls and proposed actionable recommendations to complement reporting standards such as the Transparent Reporting of Observational Studies Emulating a Target Trial guideline, which may support the generation of more robust observational evidence for clinical and policy decision-making.

Importance: Although the adenoma detection rate is a key colonoscopy quality metric, benchmarks for serrated polyp removal, specifically the sessile serrated lesion detection rate (SSLDR), are currently lacking.

Objective: To evaluate the physician SSLDR and the risk of postcolonoscopy colorectal cancer (PCCRC) and related mortality.

Design, setting, and participants: This retrospective cohort study was conducted between January 1, 2000, and December 31, 2021, within a large integrated health care system in Northern California and included colonoscopies performed for patients aged 18 years or older, without a diagnosis of colorectal cancer within 6 months of colonoscopy, history of colorectal cancer, or history of inflammatory bowel disease by 50 gastroenterologists. Statistical analysis was performed from January 1, 2000, to December 31, 2021.

Exposure: The primary exposure was the SSLDR, defined as the proportion of screening colonoscopies with at least 1 histologically confirmed sessile serrated adenoma or traditional serrated adenoma, categorized into quartiles.

Main outcomes and measures: The primary outcome was PCCRC diagnosed more than 6 months after negative colonoscopy results. Secondary outcomes included proximal or distal PCCRC, advanced stage colorectal cancer, all-cause mortality, and colorectal cancer-related mortality. Outcomes were ascertained through linked state and institutional cancer registries and vital records.

Results: Among 328 416 colonoscopies performed for 226 695 unique patients (mean [SD] age, 58.6 [10.7] years; 51.7% women), 562 PCCRC cases were identified over 2 038 816 person-years of follow-up. The absolute PCCRC incidence rate decreased with higher SSLDR quartiles, from 3.9 cases per 10 000 person-years in the lowest quartile to 2.4 cases per 10 000 person-years in the highest quartile. Compared with patients in the lowest SSLDR quartile, those in the highest SSLDR quartile had a significantly lower risk of PCCRC (multivariate hazard ratio, 0.69; 95% CI, 0.50-0.94; P = .01 for trend), primarily associated with lower risk of proximal PCCRC. A higher SSLDR was associated with lower all-cause mortality (second quartile, 57.7 deaths per 10 000 person-years; third quartile, 58.0 deaths per 10 000 person-years) and colorectal cancer-related mortality (second quartile, 0.2 deaths per 10 000 person-years; third quartile, 0.2 deaths per 10 000 person-years) in the second and third SSLDR quartiles, but the association was not significant in the highest quartile compared with the lowest quartile.

Conclusions and relevance: In this large community-based cohort study, a higher physician SSLDR was associated with a significantly lower risk of PCCRC in a dose-dependent manner. These findings support using the SSLDR as a crucial quality metric for colonoscopy.

Importance: Current interpretation services for Deaf patients who use sign language are often ineffective or unacceptable. In-person interpretation is frequently unavailable, and while video remote interpreting (VRI) remains underused, its scalability may be a solution given interpreter shortages and cost barriers. Existing research focuses on user and interpreter preferences, leaving a critical gap in understanding how interpretation formats affect communication quality.

Objective: To evaluate the effectiveness of VRI in improving communication outcomes between Deaf patients and physicians compared with usual communication tools, such as self-arranging interpretation, lip-reading, note-taking, and the use of images.

Design, setting, and participants: This randomized clinical trial was conducted in Colombia at a public hospital from August 2023 to October 2024, involving Deaf adults who use Colombian Sign Language as their primary language. Participants were randomly assigned to either the control or intervention group. The data were analyzed between January and May 2025.

Interventions: Patients were divided into 2 groups: an intervention group that received a medical appointment via VRI and a control group that received one via the current standard of communication. Both the Deaf participants and the health care professionals were blinded to the allocation.

Main outcomes and measures: An assessment of communication using the Doctor-Patient Communication scale.

Results: Data were collected from 210 Deaf participants, including 123 (58.6%) women and 87 (41.4%) men, with a mean (SD) age of 42 (13) years (range, 18-84 years). Overall, 108 participants (51.4%) reported using VRI. The intervention revealed that having VRI did not always result in improved communication between Deaf individuals and physicians. While those using VRI were more likely to report positive outcomes in certain areas, such as being encouraged to express themselves (odds ratio, 1.90; 95% CI, 1.13-3.18; P = .02), there was no difference in other areas, such as understanding the doctor (OR, 1.33; 95% CI, 0.79-2.23; P = .28).

Conclusions and relevance: In this randomized clinical trial of VRI in the health care context, some aspects of clinical communication were improved, but others were not. This suggests that critical preconditions have to be met for this technology to achieve its intended impact.

Trial registration: ClinicalTrials.gov Identifier: NCT05966623.

Importance: Predischarge car seat tolerance screening (CSTS) has been recommended by the American Academy of Pediatrics since 1991 for preterm and at-risk full-term-born infants. However, it remains unclear whether routine CSTS prevents adverse outcomes after discharge.

Objective: To estimate the frequency of failed CSTS and its association with adverse postdischarge outcomes.

Data sources: PubMed, Embase, and Web of Science were searched for English-language studies published before June 2025.

Study selection: Randomized trials, nonrandomized intervention studies (utilizing a comparison group discharged without CSTS), and single-group observational studies were eligible.

Data extraction and synthesis: Data were extracted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses reporting guideline by 2 reviewers. Study quality was assessed using the Risk of Bias in Nonrandomized Studies tool.

Main outcomes and measures: Outcomes were 30-day readmission, mortality, and predischarge length of stay for intervention studies, and first and subsequent CSTS failure rates for single-group studies. Random-effects models were used to pool data, and generalized linear mixed models were used to estimate pooled treatment effects from 2-group studies and CSTS failure event rates from all included studies.

Results: A total of 21 studies were included. No randomized trials were identified. Three nonrandomized intervention studies (54 358 participants; 27 786 participants without CSTS) reported postdischarge outcomes. There was no difference in 30-day mortality (2 studies; not pooled due to 0 events), 30-day readmissions (odds ratio, 1.05; 95% CI, 0.86-1.28; 3 studies; 54 559 participants), or combined 30-day mortality or readmission (odds ratio, 1.17; 95% CI, 0.95-1.43; 2 studies; 49 420 participants) among infants receiving predischarge CSTS compared with those that did not. Pooled analysis estimated 8.62 (95% CI, 6.42-11.47) first-test failures per 100 patients (21 studies; 39 052 participants) and 24.40 (95% CI, 6.44-34.64) repeat-test failures per 100 patients (11 studies; 912 participants).

Conclusions and relevance: In this systematic review and meta-analysis of predischarge CSTS for preterm and at-risk full-term-born infants, CSTS was not associated with a reduction in postdischarge readmission or mortality. These findings call into question whether routine CSTS before discharge improves outcomes in preterm or at-risk full-term infants.

Importance: Rates of posttraumatic stress disorder (PTSD) and major depressive disorder (MDD) are high among paramedics.

Objective: To evaluate the efficacy of a cognitive resilience training program for reducing the development of PTSD and MDD among early career paramedics compared with psychoeducation and standard practice.

Design, setting, and participants: This randomized clinical trial of paramedics training at 15 universities across England was conducted between October 2017 to October 2022 with 12-month follow-up. Data were analyzed from December 2023 to July 2025.

Intervention: Participants were randomized to receive internet-delivered cognitive training in resilience (iCT-R), psychoeducation, or standard practice. iCT-R, a guided online intervention that utilizes cognitive therapy tools to target predictors of PTSD and MDD identified in prospective research with paramedics, consisted of 6 modules delivered over 6 weeks with 6-monthly top-up sessions delivered by email. Internet-delivered psychoeducation, a supported online psychoeducation intervention, consisted of 6 topics (1 topic per week) with 6-monthly top-up sessions delivered by email. Standard practice was training as usual.

Main outcomes and measures: The primary outcome was rate of PTSD and MDD at 1-year follow-up, assessed by independent assessors blinded to intervention using the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition). Secondary outcomes included measures of PTSD and depression symptom severity, resilience, rumination, anxiety, psychological distress, and well-being. Intent-to-treat analyses were conducted, with the primary outcome analyzed using mixed-effects logistic regression.

Results: Of 570 student paramedics enrolled (372 female [65.3%]; mean [SD] age, 23.67 [6.88] years), 195 were randomized to iCT-R, 197 to psychoeducation, and 178 to standard practice. For participants randomized to iCT-R, the odds of meeting criteria for PTSD or MDD at 12 months were significantly lower compared with psychoeducation (odds ratio [OR], 0.20; 95% CI, 0.05-0.73) and standard practice (OR, 0.25; 95% CI, 0.07-0.97). Providing iCT-R training to 18 to 24 paramedic trainees (number needed to treat) would prevent 1 case of PTSD or MDD.

Conclusions and relevance: In this randomized clinical trial, participants receiving iCT-R were approximately 5 times less likely to develop PTSD or MDD at 1-year follow-up compared with psychoeducation and 4 times less likely when compared with standard practice. These findings suggest that iCT-R appears to decrease the likelihood of developing PTSD and MDD in early career paramedics.

Trial registration: isrctn.org Identifier: ISRCTN16493616.