Current Medical Research and Opinion最新文献

Objective: Patients with schizophrenia value improved life engagement, a term that describes positive health aspects across emotional, physical, social, and cognitive domains. This post hoc analysis of clinical trial data aimed to investigate the effect of brexpiprazole on patient life engagement in schizophrenia over the short and long term.

Methods: Data were pooled from three 6-week, randomized, double-blind, placebo-controlled clinical trials (ClinicalTrials.gov identifiers: NCT01396421, NCT01393613, NCT01810380; N = 1385) and two 52-week, open-label extension studies (NCT01397786, NCT01810783; N = 408) of brexpiprazole in adults with schizophrenia. Patient life engagement was measured using a subset of 14 Positive and Negative Syndrome Scale items (score range: 14 [best] to 98 [worst]) that has previously demonstrated content validity. Mean score changes and response rates (based on minimal clinically important difference estimates of ≥5 and ≥10 points) were calculated.

Results: Greater improvement in patient life engagement from baseline to Week 6 was observed for brexpiprazole 2-4 mg/day (least squares mean [standard error] change: -8.3 [0.3]; n = 868) versus placebo (-5.7 [0.4]; n = 517), with a least squares mean difference of -2.58 (95% confidence interval: -3.57 to -1.58; p < 0.001; Cohen's d effect size: 0.28). These improvements were maintained over 58 weeks on brexpiprazole 1-4 mg/day (n = 399). At Week 6, response rates among patients treated with brexpiprazole versus placebo were 71.6% versus 58.0% (≥5-point improvement; p < 0.001) and 43.5% versus 32.8% (≥10-point improvement; p < 0.001). At Week 58 (n = 179), response rates among patients treated with brexpiprazole were 90.5% (≥5-point improvement) and 78.2% (≥10-point improvement).

Conclusion: Beyond its efficacy on psychotic symptoms, brexpiprazole has the potential to improve patient life engagement - an important patient-centered outcome in schizophrenia.

Background: The number of systematic reviews is increasing rapidly. Several methodologies exist for systematic reviews. Cochrane Reviews follow distinct methods to ensure they provide the most reliable and robust evidence, ideally based on rigorous evaluations of randomized controlled trials and other high-quality studies. We aimed to examine the difference in citation patterns of Cochrane Reviews and other systematic reviews.

Methods: We conducted a bibliometric analysis of systematic reviews indexed in PubMed from 1993 to 2022. We collected data on citations from The Lens from 1993 to 2023, thus having at least 1-year follow-up on citations. The reviews were linked through their PubMed identifier. Comparisons between the Cochrane Reviews and other systematic reviews included total citations per review, reviews with zero citations, and the time window within which they receive citations.

Results: We included 10,086 Cochrane Reviews and 231,074 other systematic reviews. Other systematic reviews received significantly more citations than Cochrane Reviews from 1993 to 2007. From 1993 to 1997, the median difference was 80 citations (95% CI = 79.6-80.4). From 2008 and forward, the overall number of citations was similar between Cochrane Reviews and other systematic reviews (2018-2022: median difference = 5 [95% CI = 4.9-5.1] in favor of Cochrane Reviews; p = 0.83). Systematic reviews with zero citations were rare in both groups, but it was observed more often among other systematic reviews than Cochrane Reviews. Over the last 30 years, the time window in which all reviews received citations narrowed.

Conclusion: In recent years, Cochrane Reviews and other systematic reviews had similar citation patterns, but other systematic reviews received more citations from 1993 to 2007. Other systematic reviews were more often never cited than Cochrane Reviews, and potentially wasted. The time window in which systematic reviews received citations has been progressively decreasing, possibly indicating a trend toward quicker recognition and uptake of these reviews within the academic community. Cochrane reviews aim to provide robust evidence, but this is not reflected in the citation metrics compared to other systematic reviews.

Objective: The recent outbreak of monkeypox (mpox) poses significant public health challenges, particularly for immunocompromised populations such as patients with cancer. However, misinformation poses a significant challenge during new outbreaks for patients with chronic diseases, as observed during the COVID-19 pandemic. Therefore, we aimed to assess perspectives and knowledge of patients with cancer on mpox and their willingness to receive mpox vaccination.

Methods: A cross-sectional study was conducted among patients with cancer using a structured questionnaire. The survey encompassed sociodemographic data, mpox knowledge, attitudes towards vaccination, and willingness to mpox vaccination. Multivariate logistic regression analyses were performed to identify independent predictors of vaccination willingness.

Results: A total of 275 patients were included. A significant majority (73.1%) of respondents wanted to learn more about mpox, and 33.8% were confident in global efforts to control the outbreak. 69.1% of the patients were unwilling to receive the mpox vaccine, mainly due to safety concerns and the interference with the anti-cancer treatment. In multivariable analysis, younger age (<65 years) (OR = 1.836, 95% CI:1.030-3.271, p = 0.039), information about mpox before (OR = 1.899, 95% CI:1.104-3.268, p = 0.021) and good knowledge about mpox (OR = 1.968, 95% CI:1.118-3.465, p = 0.019) were significant predictors of willingness to vaccinate against mpox.

Conclusion: A substantial proportion of cancer patients in Turkey are hesitant to receive the mpox vaccine, primarily due to concerns about safety and its implications for cancer treatment. Targeted educational interventions that address these specific concerns and enhance understanding of the benefits of vaccination are critical to improving vaccine uptake in this vulnerable population.

Background: White coat effect (WCE) is a phenomenon linked to increased cardiovascular risk, where office blood pressure readings exceed home or ambulatory measurements. Excess weight and elevated blood pressure or glucose are associated with WCE in type 2 diabetes (T2D). This study compared dapagliflozin and glibenclamide on WCE in T2D patients under equivalent blood pressure and glucose control.

Methods: This post-hoc analysis of the ADDENDA-BHS2 trial enrolled T2D patients with high cardiovascular risk, defined by stable coronary artery disease or subclinical carotid atherosclerosis. This single-center, open-label, randomized trial included 98 participants, randomized to 12 weeks of dapagliflozin or glibenclamide, in addition to metformin. Baseline blood pressure and glucose control were adjusted to maintain equivalence. This analysis focused on 85 participants with pre- and post-treatment 24-h ambulatory blood pressure data.

Results: Despite blood pressure and glucose control, WCE was present in 28% of participants at baseline. Baseline-adjusted change in WCE on systolic BP showed median changes of -8.6 and 1.7 mmHg for dapagliflozin and glibenclamide groups, respectively (p = 0.048). This effect was not observed on diastolic blood pressure.

Conclusion: Dapagliflozin reduces WCE on systolic blood pressure compared to glibenclamide, even under equivalent blood pressure and glucose control.

Clinical trial registration: The trial was registered at the Clinicaltrials.gov (NCT: 02919345).

Objective: This study aimed to describe clinical characteristics-including blood counts and pharmacologic cytoreductive treatment patterns-and outcomes after 6 months of hydroxyurea (HU) treatment among patients with polycythemia vera (PV) in US community practices.

Methods: This retrospective observational study included adult patients with a PV diagnosis (1JAN2008-31JAN2020) and ≥2 postdiagnosis visits in the iKnowMed electronic health record database (US Oncology Network and non-Network clinics). Suboptimal HU response required ≥1 criterion after ≥3 months of treatment: white blood cell count (WBC) >10 × 10⁹/L, platelet count >400 × 10⁹/L, and/or hematocrit >45%. Patient characteristics were summarized from structured data using descriptive statistics; overall survival was assessed by Kaplan-Meier method.

Results: Among 5871 patients, mean age at diagnosis was 66.1 years (69.8% ≥60 years); 67.2, 59.4, 38.2, and 33.9% of patients had elevated hematocrit, hemoglobin, WBC, and platelets, respectively; 6.1% had a previous thrombotic event. Of 4185 (71.3%) high-risk and 1675 low-risk patients, 55.0 and 32.0% received pharmacologic cytoreductive treatment, most commonly HU (89.8 and 88.9%). After 6 months of pharmacologic cytoreductive treatment, 56.9% had a suboptimal response. Five-year survival probability was 81.5 and 84.3% among patients with suboptimal and optimal responses to HU, respectively, which was not statistically different but suggests potential for survival benefits with longer follow-up.

Conclusion: Nearly half of high-risk patients with PV did not receive pharmacologic cytoreductive treatment. Of those who did, over half had suboptimal response, suggesting these patients may need dose adjustments, improved adverse effect management, or alternative treatments. Longer follow-up may be needed to assess an association between HU response and survival.

Peripheral Neuropathy (PN) can significantly impair quality of life, but often remains undiagnosed due to limited clinic time, lack of specialist expertise and lack of patient awareness. There are several validated questionnaires for diagnosing PN, but the time taken to administer them in busy primary care clinics limits their utilization. A new, simpler questionnaire was developed following an advisory board meeting in Southeast Asia and was further refined and translated to Portuguese and Spanish following a second advisory board meeting in Latin America. We consider current hurdles and propose a quick and reliable questionnaire that can be widely adopted to enable earlier diagnosis and improved management of PN in resource-limited settings in Latin America.

Background: The effects of glucagon-like peptide-1 receptor agonists (GLP-1RAs) on lipid components are unclear. We aim to quantify the lipid lowering effects of GLP1-RAs.

Methods: A comprehensive database search for placebo-controlled randomized controlled trials (RCTs) on GLP-1RA treatment was conducted until January 2023. Data extraction and quality assessment were performed, and outcomes were analyzed using a random-effects model to calculate weighted mean differences (MDs) in milligrams per deciliter (mg/dl) and 95% confidence intervals (CIs). The primary endpoint was the mean difference in low-density lipoprotein cholesterol (LDL-C). Secondary endpoints included total cholesterol (TC), triglycerides, high density lipoprotein-C (HLD-C), and very low-density lipoprotein-C (VLDL-C). Subgroup analyses and meta-regression accounted for covariates.

Results: GLP-1RAs modestly reduced LDL-C (MD -2.93, 95% CI (-5.01, -0.85), p = 0.01), consistent across treatment durations: ≤12 weeks (MD: -5.39, 95% CI (-10.36, -0.42), p = 0.03) and >12 weeks (MD: -2.39, 95% CI (-4.70, -0.007), p = 0.04). GLP-1RA reduced TC by ∼7 mg/dl. There was no significant reduction in triglycerides (MD = -7.19, 95% CI (-15.01, 0.62), p = 0.07) or VLDL-C (MD = -3.99, 95%, CI (-8.73, 0.75), p = 0.10). GLP-1RA did not increase HDL-C (MD = -0.12, 95% CI (-0.73, 0.49), p = 0.69). Weight change did not influence LDL-C (tau2 = 28.38, I2 = 99.83, R2 = 0.0, p = 0.67) or TC (tau2 = 93.6, I2 = 99.86, R2 = 0.0, p = 0.92).

Conclusion: GLP-1RA treatment modestly decreased LDL-C and TC but did not significantly affect triglycerides, VLDL-C, or HDL-C.

Biomedical research cannot function without the trust of peers and society. The truthfulness of claims made by knowledge-producing agents, such as authors of research, is a prerequisite for their trustworthiness, and violations of truthfulness are rightly seen as a threat to the existence and validity of such research. While most reflection on the lack of truthfulness has focused on fake research, little attention has been paid to how sting operations and hoaxes arguably pose an equally great risk to the ethical integrity of publishing. This paper posits that sting operations, like fake research, are examples of breaches of truthfulness. We also argue that for both fake research, as well as stings and hoaxes, the lack of respect for the ethical criterion of truthfulness makes those researchers who engage in them untrustworthy. Sting operations are akin to fighting fire with fire, further undermining trust in biomedical research. From a deontological perspective, we also argue that the reliance on anonymity in sting operations makes them just as bad, if not worse, than fake research. We advocate for critical scholarship as an alternative to hoaxes and sting operations to expose fake research, in order to promote truthfulness rather than violate it. Finally, we argue that journalists reporting on sting operations should insist less on their entertainment and sensationalist value, and focus more on their unethical nature.

Objective: To estimate the cost and healthcare resource utilization (HRU) associated with the prevalence of comorbidities in people living with HIV (PLWH) in a Spanish cohort over ten years.

Methods: A cohort study carried out at the HIV outpatient clinic of the University Hospital Virgen del Rocío based on data collected during 2007-2016. PLWH with at least one follow-up visit were included. Comorbidities were determined by examining diagnostic codes in the electronic medical records. Costs were estimated from hospitalizations, emergency and non-HIV visits, laboratory tests for conditions unrelated to HIV infection, HIV antiretroviral therapy, and other non-HIV diagnostic tests. A linear regression was performed with non-ART costs as the dependent variable and patient characteristics (sex, HIV transmission route, age, CD4, comorbidities, and infection duration) as independent variables.

Results: The study included 2,798 PLWH; 83% were men with a mean age of 38.6 years. Overall, 52.5% of PLWH had at least one non-HIV comorbidity and 21.2% had ≥3 comorbidities. The most prevalent comorbidities were hepatitis C (25.3%) and hypertension (22.9%). The presence of comorbidities increased the total healthcare cost up to 80% in PLWH with ≥3 comorbidities compared with those without comorbidities (over a 10-year period (115,867.3€ vs 64,290.7€, p < .001). The number of comorbidities was linked to higher healthcare costs in PLWH in the adjusted model.

Conclusion: Comorbidities raised the total healthcare costs for PLWH, with a greater impact on those with multiple comorbidities compared to those with few or none. Both clinical and economic decision-makers must consider and assess the cost of comorbidities when evaluating HIV treatment guidelines or recommendations.