Impact of the economic crisis and drug shortage on Lebanese cancer patients' care.

BACKGROUND: As a consequence of the economic crisis, the sociopolitical instability and the advent of the coronavirus disease-19 pandemic, nested challenges faced the Lebanese healthcare system. These have resulted in critical shortages of essential resources, including medications vital for oncologic patients. AIM: To assess the ramifications of the ongoing economic crisis on oncology patient care focusing on our outpatient oncology department. METHODS: A questionnaire was distributed during the month of February 2022 to oncology patients in Hôtel Dieu de France University Hospital in Beirut during their outpatient therapy. The primary objective was to assess the far-reaching impact of the economic crisis on patient care and the resulting psychological implications. RESULTS: Among 182 interviewed patients, 31.87% experienced treatment interruption mainly due to acute drug shortages. Despite 87.91% of the patients benefiting from third-party coverage, 69.60% had to self-pay for their medications leading to 69.78% of patients perceiving that healthcare was more difficult to access after 2020. Psychologically, one-third of the patients exhibited symptoms of anxiety and/or depression, with 7 patients reporting suicidal ideations. Notably, 37.93% of patients who interrupted cancer treatment reported a history of comorbidities, and 89.66% who altered their treatment cited financial difficulties. CONCLUSION: Lebanese cancer patients face complex challenges spanning economic, healthcare, and psychological realms. Income inequalities exacerbated by the economic crisis hindered healthcare access.

Quality of life assessment in diabetic patients: validity of the creole version of the EQ-5D-5L in Reunion Island.

Introduction: Due to the high prevalence of diabetes and its complications, evaluating the patient's quality of life is critical. EQ-5D-5L is a valid tool for assessing health-related quality of life (HRQOL) in chronic diseases, including diabetes. However, no psychometric measures have been validated in a Creole-speaking population. Therefore, this study aimed for the first time to validate and cross-culturally adapt Creole and French versions of EQ-5D-5L on Type II diabetes patients in Reunion Island. Materials and methods: The Creole translation and cross-cultural adaptation process were based on the EUROQOL methods. Internal consistency and construct validity were determined using confirmatory factor analysis (CFA) of EQ-5D-5L for both versions. CFA model for HRQOL and global fit measures were calculated based on the EQ-5D-5L items using the maximum likelihood (ML) method. Results: From November 2016 to October 2017, 148 patients were included in the Creole group and 152 in the French group. EQ-5D-5L measures were unidimensional for both versions. Cronbach's coefficient alpha was 0.76 for the Creole version and 0.81 for the French version in CFA models. The root mean square error of approximation (RMSEA) was 0.06 for the Creole version and 0.02 for the French version. The Comparative Fit Index (CFI) was closer to 1 for both versions. CFA models for both the Creole and French versions fit the data adequately. Discussion: Overall, our findings provided evidence that both the Creole and French versions of EQ-5D-5L are suitable for assessing HRQOL in diabetes patients in Reunion Island. However, further research could be done to investigate French-Creole differences concerning the perception of health status, and a cultural adaptation of the French version will be considered.

Psychometric properties of a Creole version of Medical Outcome Study - Short Form 36 among type II diabetes patients on Reunion Island.

Introduction: Health quality of life assessment is particularly important to measure the impact of chronic diseases. The aims of this study were to provide a cross-culturally adapted Creole-translation of the Medical Outcome Study Short-Form 36 (SF-36) and to assess psychometric performance of the Creole and French versions of the SF-36 among patients with type II diabetes in Reunion Island. Materials and methods: The Creole translation and cross-cultural adaptation processes were based on the International Quality Of Life Assessment (IQOLA) methods. Internal consistency, test-retest reliability, convergent and discriminant validity using Multi-Trait-Multi-Method analysis and structural validity using exploratory factor analysis of the SF-36 for both versions were performed. Results: In the Creole version of the SF-36, Cronbach's alpha exceeded 0.70 for all subscales except general health. In the French SF-36, Cronbach's alpha exceeded 0.70 on all subscales except general health and bodily pain. In the Creole SF-36, intraclass correlation coefficient (ICC) for reproducibility was suboptimal. Multi-trait multi-method analysis showed that item-scale correlation exceeded 0.4 for all items except two general health items of the Creole SF-36 and one of the French SF-36. Factor analysis of 2 versions showed that the physical functioning, vitality, and mental health were each divided into two subscales. Discussion: Overall, our findings provided evidence that the SF-36 is adapted to Reunion Island in both Creole and French versions. However, further research could be conducted to investigate French-Creole differences in perceived health status and a cultural adaptation of the French version will be considered.

Comparative analysis of robotic versus laparoscopic Roux-en-Y gastric bypass in severely obese patients.

Benefits of robotic surgery for Roux-en-Y gastric bypass (RYGB) are still debated. We aimed to compare conventional laparoscopic (L-RYGB) to robotic RYGB (R-RYGB) and evaluate safety, efficacy, advantages and drawbacks of each procedure. A prospective cohort study with a retrospective review approach was conducted to analyze results of L-RYGB and R-RYGB performed at a bariatric center of excellence. Patient demographics, perioperative data, weight loss, comorbidities evolution and cost were assessed. One hundred and sixty-one severely obese patients underwent R-RYGB and L-RYGB, respectively. Patient's characteristics were similar between groups. Intraoperative blood loss was similar (p = 0.91), with no requirement for blood transfusion. Median operative time was significantly reduced for R-RYGB (127 vs 160 min; p < 0.001). Seven patients (11.4%) in the L-RYGB group and 15 patients (15%) in the R-RYGB group had early postoperative complications (p = 0.63), with more anastomotic leaks and stenosis for R-RYGB during initial learning curve (p = NS). Mortality was null. Median length of hospital stay was similar (6 days; p = 0.20). Mean hospital cost was non-significantly increased for R-RYGB ($5730 vs. $4879; p = 0.34). Two years after surgery, median BMI and mean EWL% were similar for both groups (26.1 vs 26.5 kg/m2 and 89.9% vs 90.9% for L-RYGB and R-RYGB groups, respectively; p = 0.71 and 0.85, respectively), with no statistically significant difference in comorbidities between the two groups (p = 0.80). R-RYGB is feasible and safe within the reach of every laparoscopic surgeon. In our series, it was associated with shorter operative time and equivalent length of stay and weight loss outcomes compared to L-RYGB. Further well-designed randomized studies are necessary to draw safe conclusions.

Laparoscopic Greater Curvature Plication for the Treatment of Obesity: a Systematic Review.

BACKGROUND: During the last decade, laparoscopic greater curvature plication (LGCP) has been used as a bariatric procedure for the treatment of obesity, regarded as less invasive and less expensive than other surgical bariatric procedures. We aimed to systematically review the literature and highlight recent clinical data regarding outcomes of LGCP in the treatment of obesity. METHODS: A comprehensive research of Pubmed database on LGCP was performed. The search was conducted on the first of May 2020 and was not limited to any date range. Outcomes of interest were surgical technique, postoperative complications, weight loss outcomes, comorbidities improvement or resolution, and revisional surgeries after technical failure or weight regain. RESULTS: Fifty-three articles were eligible for inclusion, with 3103 patients undergoing LGCP (mean age: 13.8-55 years). Mean preoperative body mass index (BMI) ranged from 31.2 to 47.8 kg/m2. Mean operative time ranged from 48 to 193 min. Length of hospital stay ranged from 0.75 to 7.2 days. Most studies provided postoperative follow-up up to 12 months. Mean percentage of excess weight loss (%EWL) ranged from 30.2 to 71.1% and 35 to 77.1% at 6 and 12 months post-LGCP, respectively. Only one study followed patients for more than 10 years and mean %EWL at 1, 5, and 10 years was 67%, 55%, and 42%, respectively. CONCLUSION: LGCP seems to be an acceptable surgical procedure for the treatment of obesity, especially in centers having a low medical budget. However, most existing comparative studies report superiority of LSG regarding weight loss.

Compared to randomized studies, observational studies may overestimate the effectiveness of DOACs: a metaepidemiological approach.

BACKGROUND AND OBJECTIVES: Randomized controlled trials (RCTs) are criticized for including patients who are overselected. Health authorities consequently encourage "real-world" postmarketing cohort studies. Our objective was to determine the differences between RCTs and observational studies as regards their populations and efficacy/safety results. METHODS: A systematic review was conducted to identify RCTs and observational studies including patients with venous thromboembolism receiving direct oral anticoagulants or conventional treatment. Ratios of hazard ratio (RHR) comparing epidemiological studies (prospective and retrospective cohort studies and studies using living databases) with RCTs were computed. RESULTS: Six RCTs (27,121 patients) and twenty observational studies (248,971 patients) were identified and analyzed. Prospective cohort studies seemed to recruit patients who were no less selected than those of RCTs whereas other types of observational studies may reflect the population treated in real life. Among observational studies, prospective cohort studies yielded the most favorable estimates of treatment effect compared with RCTs. These studies were associated with a nonsignificant 33% increase in efficacy estimate (RHR 0.67, [95% CI, 0.39-1.18]) but no effect on safety estimate. Studies using living databases were associated with nonsignificant trends toward a greater effect on efficacy (RHR 0.82, [0.66-1.01]) and a smaller effect on safety (RHR 1.33, [0.96-1.84]). DISCUSSION: Overall, in this clinical setting, an exaggeration of the treatment efficacy estimate was seen with observational studies compared with RCTs. CONCLUSIONS: As the presence of residual confounding cannot be excluded, these results should be interpreted cautiously.

Early detection of the existence or absence of the treatment effect: A cumulative meta-analysis.

OBJECTIVES: An unexpected promising effect of low molecular weight heparins (LMWHs) on survival in patients with cancer was observed in early trials in post hoc subgroup analyses but not found in more recent trials. To highlight a possible regression over time toward the lack of the antitumoral effect of LMWHs, we performed a cumulative meta-analysis of survival data from randomized controlled trials (RCTs). STUDY DESIGN AND SETTING: Medical databases were searched to identify RCTs comparing, in patients with cancer, LMWHs with placebo or no treatment in patients free of venous thromboembolism (VTE), or to vitamin K antagonists in patients who experienced an acute VTE in overall survival. The cumulative hazard ratio (HR) was estimated after each study inclusion in chronological order. RESULTS: Twenty-three studies (12,970 patients) were included. The cumulative meta-analysis of the earlier trials showed a significant improvement in overall survival with LMWHs. This apparent benefit then gradually regressed over time toward an absence of the effect of LMWHs on survival (HR: 0.98 [95% confidence interval, 0.93; 1.03]). CONCLUSION: Despite supportive experimental data and early clinical findings, the promising antitumoral effect of LMWHs in patients with cancer gradually vanished over time toward a lack of impact on overall survival. This result suggests 'p-hacking' and selective reporting of the positive results from post hoc subgroup analyses in the early studies.