The efficacy of the M72/AS01(sub E) vaccine tuberculosis to prevent tuberculosis was 49.7% at month 36. An according-to-protocol efficacy cohort has 3,289 participants. There were 13 of the 1626 ...participants in the vaccine group, compared with 26 of the 1663 participants in the placebo group, that had first-case-definition cases of tuberculosis (0.3 vs. 0.6 cases per 100 person-years).
High levels of empathy are associated with healthy relationships and prosocial behavior; in health professionals, high levels of empathy are associated with better therapeutic outcomes. To determine ...whether empathy can be taught, researchers have evaluated empathy training programs. After excluding 1 outlier study that showed a very large effect with few participants, the meta-analysis included 18 randomized controlled trials of empathy training with a total of 1,018 participants. The findings suggest that empathy training programs are effective overall, with a medium effect (g = 0.63), adjusted to 0.51 after trim-and-fill evaluation for estimated publication bias. Moderator analyses indicated that 4 factors were statistically significantly associated with higher effect sizes: (a) training health professionals and university students rather than other types of individuals, (b) compensating trainees for their participation, (c) using empathy measures that focus exclusively on assessing understanding the emotions of others, feeling those emotions, or commenting accurately on the emotions, and (d) using objective measures rather than self-report measures. Number of hours of training and time between preintervention assessment and postintervention assessment were not statistically significantly associated with effect size, with 6 months the longest time period for assessment. The findings indicate that (a) empathy training tends to be effective and (b) experimental research is warranted on the impact of different types of trainees, training conditions, and types of assessment.
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CEKLJ, FFLJ, NUK, ODKLJ, PEFLJ, UPUK
Objective: Differences between therapists (therapist effect) are often larger than differences between treatments (treatment effect) in explaining client outcomes, and thus should be considered ...relevant to providing optimal treatment to clients. However, research on therapist effectiveness has focused largely on global measures of distress as opposed to a multidimensional assessment, and has failed to risk-adjust for client characteristics. The purpose of this study was to examine the stability and predictive validity of therapist effectiveness across multiple outcome domains using risk-adjusted outcomes. Method: Initial and follow-up outcome data on the Treatment Outcome Package (Kraus, Seligman, & Jordan, 2005) were collected on 3,540 clients who were treated in naturalistic settings by a sample of 59 therapists. After risk-adjusting outcomes based on case-mix variables using random forest models, outcome data from the first 30 clients of each therapist were used to classify each therapist's effectiveness on 12 outcome domains. These results were then compared with outcome data from the therapist's next 30 clients. Results: Results demonstrated that therapist effectiveness was relatively stable, although somewhat domain specific. Therapists classified as "exceptional" were significantly more likely to remain above average with future cases, suggesting that a therapist's past performance is an important predictor of their future performance. Conclusions: Clients are likely to experience differential benefit depending on the particular therapist and his or her strengths. Clinical outcomes may be improved by developing the best possible prediction model for each new client and then providing that client with referrals to therapists with well-matched strengths.
What is the public health significance of this article?
Therapist effectiveness in treating different domains of client functioning can be predicted from past performance, and using this actuarial information in clinical decision making holds promise for improving the percentage of clients who experience a positive treatment effect.
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The objectives of this study are to assess the efficacy and safety of peripheral nerve surgery for migraine headaches and to bibliometrically analyze all anatomical studies relevant to migraine ...surgery.
Migraines rank as the second leading cause of disability worldwide. Despite the availability of conservative management options, individuals suffer from refractive migraines which are associated with poor quality of life. Migraine surgery, defined as the peripheral nerve decompression/trigger site deactivation, is a relatively novel treatment strategy for refractory migraines.
EMBASE and the National Library of Medicine (PubMed) were systematically searched for relevant articles according to the PRISMA guidelines. Data was extracted from studies which met the inclusion criteria. Pooled analyses were performed to assess complication rates. Meta-analyses were run using the random effects model for overall effects and within subgroup fixed-effect models were used.
A total of 68 studies (38 clinical, 30 anatomical) were included in this review. There was a significant overall reduction in migraine intensity (P < 0.001, SE = 0.22, I2 = 97.9), frequency (P < 0.001, SE = 0.17, I2 = 97.7), duration (P < 0.001, SE = 0.15, I2 = 97), and migraine headache index (MHI, P < 0.001, SE = 0.19, I2 = 97.2) at follow-up. A total of 35 studies reported on migraine improvement (range: 68.3%-100% of participants) and migraine elimination (range: 8.3%-86.5% of participants). 32.1% of participants in the clinical studies reported complications for which the most commonly reported complications being paresthesia and numbness, which was mostly transient, (12.11%) and itching (4.89%).
This study demonstrates improved migraine outcomes and an overall decrease in MHI as well as strong evidence for the safety profile and complication rate of migraine surgery.
In this article, we review the history and definition of countertransference, as well as empirical research on countertransference, its management, and the relation of both with psychotherapy ...outcome. Three meta-analyses are presented, as well as studies that illustrate findings from the meta-analyses. The first meta-analysis indicated that countertransference reactions are related inversely and modestly to psychotherapy outcomes (r = −.16, p = .02, 95% CI −.30, −.03, d = −0.33, k = 14 studies, N = 973). A second meta-analysis supported the notion that countertransference management factors attenuate countertransference reactions (r = −.27, p = .001, 95% CI −.43, −.10, d = −0.55, k = 13 studies, N = 1,065). The final meta-analysis revealed that successful countertransference management is related to better therapy outcomes (r = .39, p < .001, 95% CI .17, .60, d = 0.84, k = 9 studies, N = 392 participants). In all meta-analyses, there was significant heterogeneity across studies. We conclude by summarizing the limitations of the research base and highlighting the therapeutic practices predicated on research.
Clinical Impact Statement
Question: What are the potential effects on outcome of psychotherapists' reactions that are based on their unresolved personal conflicts, and how can these reactions be managed effectively? Findings: Psychotherapists' unresolved personal conflicts can give rise to reactions that negatively affect the outcome of therapy, and successfully managing these reactions seems to be an important element in positive therapy outcomes. Meaning: Psychotherapists of all theoretical orientations need to attend to their personal conflicts and monitor their reactions to clients as a routine part of effective clinical practice. Next steps: Additional research would provide insight into various ways that psychotherapists can manage their countertransference reactions, and studies are especially needed across therapeutic modalities and with culturally diverse therapists and clients.
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Cognitive remediation (CR) is a treatment targeting cognitive difficulties in people with schizophrenia. Recent research suggested that CR may also have a positive effect on negative symptoms. This ...meta-analysis investigates the effect of CR on negative symptoms.
A systematic search was used to identify all randomized-controlled trials of CR in people with schizophrenia reporting negative symptoms outcomes. Levels of negative symptoms at baseline, post-therapy and follow-up, sample demographics and treatment length were extracted. Study methodological quality and heterogeneity were addressed. Negative symptoms standardized mean change was calculated using Hedges's g and used as the main outcome.
The search identified 45 studies reporting results for 2511 participants; 15 studies reported follow-up outcomes. CR was associated with a reduction of negative symptoms (most conservative model g=−0.30; 95% CI: −0.36, −0.22) at post-therapy compared with treatment as usual and this effect was larger at follow-up (g=−0.36; 95% CI: −0.51, −0.21). Drop-out rate was comparable between conditions. Network meta-analysis confirmed CR was superior to TAU and TAU plus active control or adjunctive treatment. No evidence of publication bias was found. Studies with more rigorous methodology were associated with larger negative symptom reduction (g=−0.40; 95% CI: −0.51 to −0.30).
Although negative symptoms have not been considered a primary target for CR, this intervention can have small to moderate beneficial effects on this symptom cluster. Future research should explore in detail the active mechanisms responsible for negative symptom reduction and the relationship between cognitive and negative symptoms in schizophrenia.
•This is the first study on the effect of Cognitive Remediation (CR) on negative symptoms in people with schizophrenia.•The results demonstrate a small to moderate effect of CR on negative symptoms (effect size g=−0.30).•Negative symptom reduction is maintained at follow-up (effect size 95% g=−0.36).•Studies with more robust methodology show a larger negative symptom reduction (effect size g=−0.40).•There were no differences in drop-out rates between individuals randomized to CR and the control conditions suggesting that this intervention is acceptable.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK, ZRSKP
High tumor mutation burden (TMB-H) has been proposed as a predictive biomarker for response to immune checkpoint blockade (ICB), largely due to the potential for tumor mutations to generate ...immunogenic neoantigens. Despite recent pan-cancer approval of ICB treatment for any TMB-H tumor, as assessed by the targeted FoundationOne CDx assay in nine tumor types, the utility of this biomarker has not been fully demonstrated across all cancers.
Data from over 10 000 patient tumors included in The Cancer Genome Atlas were used to compare approaches to determine TMB and identify the correlation between predicted neoantigen load and CD8 T cells. Association of TMB with ICB treatment outcomes was analyzed by both objective response rates (ORRs, N = 1551) and overall survival (OS, N = 1936).
In cancer types where CD8 T-cell levels positively correlated with neoantigen load, such as melanoma, lung, and bladder cancers, TMB-H tumors exhibited a 39.8% ORR to ICB 95% confidence interval (CI) 34.9-44.8, which was significantly higher than that observed in low TMB (TMB-L) tumors odds ratio (OR) = 4.1, 95% CI 2.9-5.8, P < 2 × 10−16. In cancer types that showed no relationship between CD8 T-cell levels and neoantigen load, such as breast cancer, prostate cancer, and glioma, TMB-H tumors failed to achieve a 20% ORR (ORR = 15.3%, 95% CI 9.2-23.4, P = 0.95), and exhibited a significantly lower ORR relative to TMB-L tumors (OR = 0.46, 95% CI 0.24-0.88, P = 0.02). Bulk ORRs were not significantly different between the two categories of tumors (P = 0.10) for patient cohorts assessed. Equivalent results were obtained by analyzing OS and by treating TMB as a continuous variable.
Our analysis failed to support application of TMB-H as a biomarker for treatment with ICB in all solid cancer types. Further tumor type-specific studies are warranted.
•TMB-H failed to predict improved or clinically relevant response to ICB in all cancer types.•Cancer types where TMB-H does not predict response generally show no relationship between tumor neoantigen load and CD8 T-cell infiltration.•Further studies should be carried out before application of TMB-H as a biomarker for ICB in all cancer types.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Diabetes was identified as a tuberculosis (TB) risk factor mostly in retrospective studies with limited assessments of metabolic variables. The prospective Effects of Diabetes on Tuberculosis ...Severity study compared adults with pulmonary TB in Chennai, India, who were classified as having either diabetes or a normal glucose tolerance at enrollment.
Baseline TB severity, sputum conversion, and treatment outcomes (cure, failure, death, or loss to follow-up) were compared between groups with respect to glycemic status and body mass index (BMI).
The cohort of 389 participants included 256 with diabetes and 133 with a normal glucose tolerance. Low BMIs (<18.5 kg/m2) were present in 99 (74.4%) of nondiabetic participants and 85 (33.2%) of those with diabetes. Among participants with normal or high BMIs, rates of cure, treatment failure, or death did not vary by glycemic status. Participants with low BMIs had the highest radiographic severity of disease, the longest time to sputum culture conversion, and the highest rates of treatment failure and death. Among participants with low BMIs, poorly controlled diabetes (glycohemoglobin HbA1c ≥8.0%) was unexpectedly associated with better TB treatment outcomes. A high visceral adiposity index was associated with adverse outcomes and, despite an overall correlation with HbA1c, was elevated in some low-BMI individuals with normal glucose tolerance.
In this South Indian cohort, a low BMI was significantly associated with an increased risk for adverse TB treatment outcomes, while comorbid, poorly controlled diabetes lessened that risk. A high visceral adiposity index, either with or without dysglycemia, might reflect a novel TB susceptibility mechanism linked to adipose tissue dysfunction.
We report the clinical outcomes of a randomized trial comparing prophylactic whole-pelvic nodal radiotherapy to prostate-only radiotherapy (PORT) in high-risk prostate cancer.
This phase III, single ...center, randomized controlled trial enrolled eligible patients undergoing radical radiotherapy for node-negative prostate adenocarcinoma, with estimated nodal risk ≥ 20%. Randomization was 1:1 to PORT (68 Gy/25# to prostate) or whole-pelvic radiotherapy (WPRT, 68 Gy/25# to prostate, 50 Gy/25# to pelvic nodes, including common iliac) using computerized stratified block randomization, stratified by Gleason score, type of androgen deprivation, prostate-specific antigen at diagnosis, and prior transurethral resection of the prostate. All patients received image-guided, intensity-modulated radiotherapy and minimum 2 years of androgen deprivation therapy. The primary end point was 5-year biochemical failure-free survival (BFFS), and secondary end points were disease-free survival (DFS) and overall survival (OS).
From November 2011 to August 2017, a total of 224 patients were randomly assigned (PORT = 114, WPRT = 110). At a median follow-up of 68 months, 36 biochemical failures (PORT = 25, WPRT = 7) and 24 deaths (PORT = 13, WPRT = 11) were recorded. Five-year BFFS was 95.0% (95% CI, 88.4 to 97.9) with WPRT versus 81.2% (95% CI, 71.6 to 87.8) with PORT, with an unadjusted hazard ratio (HR) of 0.23 (95% CI, 0.10 to 0.52;
< .0001). WPRT also showed higher 5-year DFS (89.5%
77.2%; HR, 0.40; 95% CI, 0.22 to 0.73;
= .002), but 5-year OS did not appear to differ (92.5%
90.8%; HR, 0.92; 95% CI, 0.41 to 2.05;
= .83). Distant metastasis-free survival was also higher with WPRT (95.9%
89.2%; HR, 0.35; 95% CI, 0.15 to 0.82;
= .01). Benefit in BFFS and DFS was maintained across prognostic subgroups.
Prophylactic pelvic irradiation for high-risk, locally advanced prostate cancer improved BFFS and DFS as compared with PORT, but OS did not appear to differ.
IMPORTANCE: Measurement-based care (MBC) is the systematic evaluation of patient symptoms before or during an encounter to inform behavioral health treatment. Despite MBC’s demonstrated ability to ...enhance usual care by expediting improvements and rapidly detecting patients whose health would otherwise deteriorate, it is underused, with typically less than 20% of behavioral health practitioners integrating it into their practice. This narrative review addresses definitional issues, offers a concrete and evaluable operationalization of MBC fidelity, and summarizes the evidence base and utility of MBC. It also synthesizes the extant literature’s characterization of barriers to and strategies for supporting MBC implementation, sustainment, and scale-up. OBSERVATIONS: Barriers to implementing MBC occur at multiple levels: patient (eg, concerns about confidentiality breach), practitioner (eg, beliefs that measures are no better than clinical judgment), organization (eg, no resources for training), and system (eg, competing requirements). Implementation science—the study of methods to integrate evidence-based practices such as MBC into routine care—offers strategies to address barriers. These strategies include using measurement feedback systems, leveraging local champions, forming learning collaboratives, training leadership, improving expert consultation with clinical staff, and generating incentives. CONCLUSIONS AND RELEVANCE: This narrative review, informed by implementation science, offers a 10-point research agenda to improve the integration of MBC into clinical practice: (1) harmonize terminology and specify MBC’s core components; (2) develop criterion standard methods for monitoring fidelity and reporting quality of implementation; (3) develop algorithms for MBC to guide psychotherapy; (4) test putative mechanisms of change, particularly for psychotherapy; (5) develop brief and psychometrically strong measures for use in combination; (6) assess the critical timing of administration needed to optimize patient outcomes; (7) streamline measurement feedback systems to include only key ingredients and enhance electronic health record interoperability; (8) identify discrete strategies to support implementation; (9) make evidence-based policy decisions; and (10) align reimbursement structures.
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