Reporting of Observational Studies Explicitly Aiming to Emulate Randomized Trials: A Systematic Review.

Importance: Observational (nonexperimental) studies that aim to emulate a randomized trial (ie, the target trial) are increasingly informing medical and policy decision-making, but it is unclear how these studies are reported in the literature. Consistent reporting is essential for quality appraisal, evidence synthesis, and translation of evidence to policy and practice. Objective: To assess the reporting of observational studies that explicitly aimed to emulate a target trial. Evidence Review: We searched Medline, Embase, PsycINFO, and Web of Science for observational studies published between March 2012 and October 2022 that explicitly aimed to emulate a target trial of a health or medical intervention. Two reviewers double-screened and -extracted data on study characteristics, key predefined components of the target trial protocol and its emulation (eligibility criteria, treatment strategies, treatment assignment, outcome[s], follow-up, causal contrast[s], and analysis plan), and other items related to the target trial emulation. Findings: A total of 200 studies that explicitly aimed to emulate a target trial were included. These studies included 26 subfields of medicine, and 168 (84%) were published from January 2020 to October 2022. The aim to emulate a target trial was explicit in 70 study titles (35%). Forty-three studies (22%) reported use of a published reporting guideline (eg, Strengthening the Reporting of Observational Studies in Epidemiology). Eighty-five studies (43%) did not describe all key items of how the target trial was emulated and 113 (57%) did not describe the protocol of the target trial and its emulation. Conclusion and Relevance: In this systematic review of 200 studies that explicitly aimed to emulate a target trial, reporting of how the target trial was emulated was inconsistent. A reporting guideline for studies explicitly aiming to emulate a target trial may improve the reporting of the target trial protocols and other aspects of these emulation attempts.

Baseline imbalance and heterogeneity are present in meta-analyses of randomized clinical trials examining the effects of exercise and medicines for blood pressure management.

Randomized clinical trials attempt to reduce bias and create similar groups at baseline to infer causal effects. In meta-analyses, baseline imbalance may threaten the validity of the treatment effects. This meta-epidemiological study examined baseline imbalance in comparisons of exercise and antihypertensive medicines. Baseline data for systolic blood pressure, diastolic blood pressure, and age were extracted from a network meta-analysis of 391 randomized trials comparing exercise types and antihypertensive medicines. Fixed-effect meta-analyses were used to determine the presence of baseline imbalance and/or inconsistency. Meta-regression analyses were conducted on sample size, the risk of bias for allocation concealment, and whether data for all randomized participants were presented at baseline. In one exercise comparison, the resistance group was 0.3 years younger than the control group (95% confidence interval 0.6 to 0.1). Substantial inconsistency was observed in other exercise comparisons. Less data were available for medicines, but there were no occurrences of baseline imbalance and only a few instances of inconsistency. Several moderator analyses identified significant associations. We identified baseline imbalance as well as substantial inconsistency in exercise comparisons. Researchers should consider conducting meta-analyses of key prognostic variables at baseline to ensure balance across trials.

Festschrift for Leonard Bickman: Introduction to The Future of Children's Mental Health Services Special Issue.

This introductory article describes the genesis of the Festschrift for Leonard Bickman and of this Festschrift special issue entitled, The Future of Children's Mental Health Services. The special issue includes a collection of 11 original children's mental health services research articles, broadly organized in accordance with three themes (i.e., Improving Precision and Use of Service Data to Guide Policy and Practice, Implementation and Dissemination, and Preparing for Innovation), followed by an interview-style article with Bickman. Then follows a featured manuscript by Bickman himself, three invited commentaries, and a compilation of letters and notes in which colleagues reflect on his career and on their experiences of him. The introduction concludes with a few thoughts about the future of children's mental health services portended by the extraordinary scholarly contributions of Bickman and those who have been inspired by him.

Communication training improves patient-centered provider behavior and screening for soldiers' mental health concerns.

OBJECTIVE: To evaluate the effectiveness of patient-centered communication training for military providers who conduct post-deployment health screening. The half-day interactive workshop included simulated Soldier patients using video technology. METHODS: Using a quasi-experimental design, all health care providers at four military treatment facilities were recruited for data collection during a four- to nine-day site visit (23 trained providers, 28 providers in the control group, and one provider declined to participate). All Soldiers were eligible to participate and were blinded to provider training status. Immediately after screening encounters, providers reported on their identification of mental health concerns and Soldiers reported on provider communication behaviors resulting in 1,400 matched pairs. Electronic health records were also available for 26,005 Soldiers. RESULTS: The workshop was found to increase (1) providers' patient-centered communication behaviors as evaluated by Soldiers; (2) provider identification of Soldier mental health concerns; and (3), related health outcomes including provision of education and referral to a confidential counseling resource. CONCLUSION: Results are promising, but with small effect sizes and study limitations, further research is warranted. PRACTICE IMPLICATIONS: A brief intensive workshop on patient-centered communication tailored to the military screening context is feasible and may improve key outcomes.

Implementing a Measurement Feedback System: A Tale of Two Sites.

A randomized experiment was conducted in two outpatient clinics evaluating a measurement feedback system called contextualized feedback systems. The clinicians of 257 Youth 11-18 received feedback on progress in mental health symptoms and functioning either every 6 months or as soon as the youth's, clinician's or caregiver's data were entered into the system. The ITT analysis showed that only one of the two participating clinics (Clinic R) had an enhanced outcome because of feedback, and only for the clinicians' ratings of youth symptom severity on the SFSS. A dose-response effect was found only for Clinic R for both the client and clinician ratings. Implementation analyses showed that Clinic R had better implementation of the feedback intervention. Clinicians' questionnaire completion rate and feedback viewing at Clinic R were 50 % higher than clinicians at Clinic U. The discussion focused on the differences in implementation at each site and how these differences may have contributed to the different outcomes of the experiment.

Feedback mechanisms of change: How problem alerts reported by youth clients and their caregivers impact clinician-reported session content.

OBJECTIVE: This study explored how clinician-reported content addressed in treatment sessions was predicted by clinician feedback group and multi-informant cumulative problem alerts that appeared in computerized feedback reports for 299 clients aged 11-18 years receiving home-based community mental health treatment. METHOD: Measures included a clinician report of content addressed in sessions and additional measures of treatment progress and process (e.g., therapeutic alliance) completed by clinicians, clients, and their caregivers. Item responses in the top 25th percentile in severity from these measures appeared as "problem alerts" on corresponding computerized feedback reports. Clinicians randomized to the feedback group received feedback weekly while the control group did not. Analyses were conducted using the Cox proportional hazards regression for recurrent events. RESULTS: For all content domains, the results of the survival analyses indicated a robust effect of the feedback group on addressing specific content in sessions, with feedback associated with shorter duration to first occurrence and increased likelihood of addressing or focusing on a topic compared to the non-feedback group. CONCLUSION: There appears to be an important relationship between feedback and cumulative problem alerts reported by multiple informants as they influence session content.

Overview of depression, post-traumatic stress disorder, and alcohol misuse among active duty service members returning from Iraq and Afghanistan, self-report and diagnosis.

Previous studies have found deployment to combat areas to be associated with an increased risk of post-traumatic stress disorder (PTSD), depression, and alcohol abuse, but many previous studies were limited by samples that were not representative of the deployed military as a whole. This study presents an overview of these three mental health problems associated with deployment among Air Force, Army, Marine Corp, and Navy service members returning from deployment to Iraq and Afghanistan between January 2007 and March 2008. With postdeployment health data on over 50,000 service men and women, including diagnostic information, we were able to estimate prevalence of those who screened positive for risk of each disorder in self-report data at two time points, as well as prevalence of diagnoses received during health care encounters within the military health care system. The prevalence ranges of the three disorders were consistent with previous studies using similar measures, but service members in the Navy had higher rates of screening positive for all three disorders and higher prevalence of depression and PTSD diagnoses compared to the other branches. Further, PTSD risk was higher for service members returning from Afghanistan compared to Iraq, in contrast to previous findings.