Understanding sex differences among persons with moderate-to-severe traumatic brain injury (TBI) is critical to addressing the unique needs of both males and females from acute care through to rehabilitation. Epidemiological studies suggest that 7 of every 10 persons with moderate-to-severe TBI are male, with females representing about 30%–33%.

To examine the proportion of female and male individuals included in randomized controlled trials (RCTs) of interventions for moderate-to-severe TBI.

A systematic review was conducted in line with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines up to and including December 2022 using MEDLINE, PubMed, Scopus, CINAHL, EMBASE and PsycINFO databases. Studies were included if they met the following criteria: (1) human participants with a mean age ≥18 years, (2) ≥50% of the sample had moderate-to-severe TBI and (3) the study design was a RCT. Data extracted included author, year, country, sample size, number of female/male participants and time post-injury.

595 RCTs met the criteria for inclusion, published between 1978 and 2022, totaling 86,662 participants. The average proportion of female participants was 23.14%, and the percentage increased a small but significant amount over time. There was a significantly lower percentage of female participants in RCTs initiated in the acute phase (≤ 1 month) when compared with RCTs conducted in the chronic phase (≥ 6 months) post-injury (p < 0.001).

Female participants are underrepresented in RCTs of moderate-to-severe TBI. Addressing this underrepresentation is critical to establish effective treatments for all persons with TBI.

There is considerable evidence that waiting list (WL) control groups overestimate the effect sizes of psychotherapies for depression. It is not clear, however, what are the exact causes for this overestimation. We decided to conduct a meta-analytic study to compare trials on psychotherapy for depression with a WL control group against trials with a care-as-usual (CAU) control group.

We used an existing meta-analytic database of randomized trials comparing psychological treatments of adult depression with control groups and selected trials using a WL or a CAU control group. We used subgroup and meta-regression analyses to examine differences in effect sizes between WL and CAU controlled trials.

We included 333 randomized controlled trials (472 comparisons; total number participants: 41,480), 141 with a WL and 195 with a CAU control group (3 included both). We found several significant differences between WL and CAU controlled trials (in type of therapy examined, treatment format, recency, target group, recruitment strategy, number of treatment arms and number of depression outcome measures). The overall effect size indicating the difference between treatment and control at post-test for all comparisons was g = 0.77 (95% confidence interval [CI]: 0.71; 0.84) with high heterogeneity (I2 = 84; 95% CI: 82; 85). A highly significant difference was observed between studies with a CAU control group (g = 0.63; 95% CI: 0.55; 0.71; I2 = 85; 95% CI: 83; 86) and studies with a WL (g = 0.95; 95% CI: 0.85; 1.04; I2 = 80; 95% CI: 78; 82; p for difference < 0.001). This difference remained significant in all sensitivity analyses, including a meta-regression analysis in which we adjusted for all differences in characteristics of studies with a WL versus CAU control group. We also found that pre-post effect sizes in WL control conditions (g = 0.37; 95% CI: 0.28; 0.46) were significantly smaller than change within CAU conditions (g = 0.64; 95% CI: 0.50; 0.78). We found few indications that pre-post effect sizes within therapy conditions differed between WL and CAU controlled trials.

WL control conditions considerably overestimate the effect sizes of psychological treatments, compared to trials using CAU control conditions. This overestimation is probably caused by a smaller improvement within the WL condition compared to the improvement in the CAU condition. WL control conditions should be avoided in randomized trials examining psychological treatments of adult depression.

To test for publication bias with alprazolam, the most widely prescribed benzodiazepine, by comparing its efficacy for panic disorder using trial results from (1) the published literature and (2) the US Food and Drug Administration (FDA).

From FDA reviews, we included data from all phase 2/3 efficacy trials of alprazolam extended-release (Xanax XR) for the treatment of panic disorder. A search for matching publications was performed using PubMed and Google Scholar. Publication bias was examined by comparing: (1) overall trial results (positive or not) according to the FDA v. corresponding publications; (2) effect size (Hedges's g) based on FDA data v. published data.

The FDA review showed that five trials were conducted, only one of which (20%) was positive. Of the four not-positive trials, two were published conveying a positive outcome; the other two were not published. Thus, according to the published literature, three trials were conducted and all (100%) were positive. Alprazolam's effect size calculated using FDA data was 0.33 (CI95% 0.07–0.60) v. 0.47 (CI95% 0.30–0.65) using published data, an increase of 0.14, or 42%.

Publication bias substantially inflates the apparent efficacy of alprazolam XR.

We aimed to assess the cost-effectiveness of psychiatric advance directives (PAD) facilitated by peer workers (PW-PAD) in the management of patients with mental disorders in France.

In a prospective multicentre randomized controlled trial, we randomly assigned adults with a Diagnostic and Statistical Manual of Mental Disorders, fifth edition diagnosis of schizophrenia, bipolar I disorder or schizoaffective disorders, who were compulsorily hospitalized in the past 12 months, to either fill out a PAD form and meet a peer worker for facilitation or receive usual care. We assessed differences in societal costs in euros (€) and quality-adjusted life-years (QALYs) over a year-long follow-up to estimate the incremental cost-effectiveness ratio of the PW-PAD strategy. We conducted multiple sensitivity analyses to assess the robustness of our results.

Among the 394 randomized participants, 196 were assigned to the PW-PAD group and 198 to the control group. Psychiatric inpatient costs were lower in the PW-PAD group than the control group (relative risk, −0.22; 95% confidence interval, [−0.33 to −0.11]; P < 0.001), and 1-year cumulative savings were obtained for the PW-PAD group (mean difference, −€4,286 [−4,711 to −4,020]). Twelve months after PW-PAD implementation, we observed improved health utilities (difference, 0.040 [0.003–0.077]; P = 0.032). Three deaths occurred. QALYs were higher in the PW-PAD group (difference, 0.045 [0.040–0.046]). In all sensitivity analyses, taking into account sampling uncertainty and unit variable variation, PW-PAD was likely to remain a cost-effective use of resources.

PW-PAD was strictly dominant, that is, less expensive and more effective compared with usual care for people living with mental illness.

The body of evidence regarding self-management programs (SMPs) for adult chronic non-cancer pain (CNCP) is steadily growing, and regular updates are needed for effective decision-making.

To systematically identify, critically appraise, and summarize the findings from randomized controlled trials (RCTs) of SMPs for CNCP.

We searched relevant databases from 2009 to August 2021 and included English-language RCT publications of SMPs compared with usual care for CNCP among adults (18+ years old). The primary outcome was health-related quality of life (HR-QoL). We conducted meta-analysis using an inverse variance, random-effects model and calculated the standardized mean difference (SMD) and associated 95% confidence interval (CI) and statistical heterogeneity using the I 2 statistic.

From 8538 citations, we included 28 RCTs with varying patient populations, standards for SMPs, and usual care. No RCTs were classified as having a low risk of bias. There was no evidence of a significant improvement in overall HR-QoL, irrespective of pain type, immediately post-intervention (SMD 0.01, 95%CI −0.21 to 0.24; I 2 57%; 11 RCTs; 979 participants), 1–4 months post-intervention (SMD 0.02, 95%CI −0.16 to 0.20; I 2 48.7%; 12 RCTs; 1160 participants), and 6–12 months post-intervention (SMD 0.07, 95%CI −0.06 to 0.21; I 2 26.1%; 9 RCTs; 1404 participants). Similar findings were made for physical and mental HR-QoL, and for specific QoL assessment scales (e.g., SF-36).

There is a lack of evidence that SMPs are efficacious for CNCP compared with usual care. Standardization of SMPs for CNCP and better planned/conducted RCTs are needed to confirm these conclusions.

Depression during pregnancy and after the birth of a child is highly prevalent and an important public health problem. Psychological interventions are the first-line treatment and, although a considerable number of randomized trials have been conducted, no recent comprehensive meta-analysis has evaluated treatment effects.

We used an existing database of randomized controlled trials of psychotherapies for adult depression and included studies aimed at perinatal depression. Random effects models were used in all analyses. We examined the effects of the interventions in the short and long term, and also examined secondary outcomes.

Forty-three studies with 49 comparisons and 6270 participants between an intervention and control group were included. The overall effect size was g = 0.67 [95% confidence interval (CI) 0.45~0.89; numbers needed-to-be-treated = 4.39] with high heterogeneity (I2 = 80%; 95% CI 75~85). This effect size remained largely unchanged and significant in a series of sensitivity analyses, although some publication bias was found. The effects remained significant at 6–12 months follow-up. Significant effects were also found for social support, anxiety, functional limitations, parental stress and marital stress, although the number of studies for each outcome was low. All results should be considered with caution because of the high levels of heterogeneity in most analyses.

Psychological interventions are probably effective in the treatment of perinatal depression, with effects that last at least up to 6–12 months and probably also have effects on social support, anxiety, functional impairment, parental stress, and marital stress.

Advance care planning is vital for ensuring individuals receive end-of-life care that is consistent with their care preferences and improves patient quality of life and satisfaction with care; however, only 11% of Americans have discussed advance care planning with a healthcare provider. Individuals with limited health literacy are even less likely to participate in advance care planning due to difficulty comprehending complex health information. The purpose of this review was to identify randomized controlled trials designed to address the effects of limited health literacy on advance care planning, evaluate the quality of these studies, and summarize evaluation data to inform future studies.

This systematic review examined randomized controlled trials published from January 1997 to July 2020 using the PubMed, CINAHL, PsycINFO, and Scopus databases. Data were extracted and two reviewers independently evaluated the quality of studies using the Joanna Briggs Institute Critical Appraisal Tool.

The database search yielded 253 studies and five studies were included in the final review. Studies were conducted in mostly White patients in outpatient clinics in the United States. Researchers wrote text at lower reading levels, added images to materials, and created videos to enhance communication. Health literacy interventions increased participant knowledge, preference for comfort care, engagement, and care documentation; however, several methodological issues were identified, including baseline differences in treatment and control groups, issues with blinding, lack of valid and reliable outcome measures, and inappropriate statistical analyses.

More high-quality intervention studies that address the effects of limited health literacy on advance care planning in diverse populations and settings are needed. Future intervention studies should use reliable and valid instruments to measure advance care planning outcomes. Clinicians should use materials appropriate for their patients’ health literacy levels to address their advance care planning needs.