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  1. Article ; Online: COVID 19 and the race to publish: an ethical issue.

    Safieddine, Maissa / Kassir, Radwan

    The British journal of surgery

    2020  Volume 107, Issue 11, Page(s) e504

    MeSH term(s) COVID-19/epidemiology ; Humans ; Publishing/statistics & numerical data ; SARS-CoV-2
    Keywords covid19
    Language English
    Publishing date 2020-08-28
    Publishing country England
    Document type Letter
    ZDB-ID 2985-3
    ISSN 1365-2168 ; 0263-1202 ; 0007-1323 ; 1355-7688
    ISSN (online) 1365-2168
    ISSN 0263-1202 ; 0007-1323 ; 1355-7688
    DOI 10.1002/bjs.11966
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  3. Article ; Online: Psychometric properties of a Creole version of Medical Outcome Study - Short Form 36 among type II diabetes patients on Reunion Island.

    Soulaimana, Ibtissame / Bruneau, Léa / Tisseaux, Antoine / Safieddine, Maissa / Debussche, Xavier / Lafarge, Sophie / Falissard, Bruno / Ferdynus, Cyril / Huiart, Laetitia

    Frontiers in public health

    2023  Volume 11, Page(s) 1186153

    Abstract: 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) ... ...

    Abstract 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.
    MeSH term(s) Humans ; Diabetes Mellitus, Type 2 ; Psychometrics ; Quality of Life ; Reproducibility of Results ; Reunion
    Language English
    Publishing date 2023-08-21
    Publishing country Switzerland
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2711781-9
    ISSN 2296-2565 ; 2296-2565
    ISSN (online) 2296-2565
    ISSN 2296-2565
    DOI 10.3389/fpubh.2023.1186153
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  4. Article: Quality of life assessment in diabetic patients: validity of the creole version of the EQ-5D-5L in Reunion Island.

    Safieddine, Maissa / Bruneau, Lea / Soulaimana, Ibtissame / Debussche, Xavier / Lafarge, Sophie / Falissard, Bruno / Ferdynus, Cyril / Huiart, Laetitia

    Frontiers in psychology

    2023  Volume 14, Page(s) 1185316

    Abstract: 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. ... ...

    Abstract 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.
    Language English
    Publishing date 2023-06-15
    Publishing country Switzerland
    Document type Journal Article
    ZDB-ID 2563826-9
    ISSN 1664-1078
    ISSN 1664-1078
    DOI 10.3389/fpsyg.2023.1185316
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  5. Article ; Online: Comparative analysis of robotic versus laparoscopic Roux-en-Y gastric bypass in severely obese patients.

    Lainas, Panagiotis / Kassir, Radwan / Benois, Marine / Derienne, Joseph / Debs, Tarek / Safieddine, Maissa / Gugenheim, Jean / Dagher, Ibrahim / Amor, Imed Ben

    Journal of robotic surgery

    2021  Volume 15, Issue 6, Page(s) 891–898

    Abstract: 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 ... ...

    Abstract 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/m
    MeSH term(s) Gastric Bypass ; Humans ; Laparoscopy ; Obesity ; Obesity, Morbid/surgery ; Prospective Studies ; Retrospective Studies ; Robotic Surgical Procedures/methods ; Treatment Outcome
    Language English
    Publishing date 2021-01-23
    Publishing country England
    Document type Journal Article
    ZDB-ID 2268283-1
    ISSN 1863-2491 ; 1863-2483
    ISSN (online) 1863-2491
    ISSN 1863-2483
    DOI 10.1007/s11701-020-01181-5
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  6. Article ; Online: Laparoscopic Greater Curvature Plication for the Treatment of Obesity: a Systematic Review.

    El Soueidy, Toni / Kassir, Radwan / Nakhoul, Mary / Balian, Axel / Nunziante, Marco / Safieddine, Maissa / Perlemuter, Gabriel / Lainas, Panagiotis / Dagher, Ibrahim

    Obesity surgery

    2020  Volume 31, Issue 3, Page(s) 1168–1182

    Abstract: 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 ... ...

    Abstract 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/m
    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.
    MeSH term(s) Adolescent ; Adult ; Body Mass Index ; Gastrectomy ; Humans ; Laparoscopy ; Middle Aged ; Obesity/surgery ; Obesity, Morbid/surgery ; Postoperative Complications ; Treatment Outcome ; Young Adult
    Language English
    Publishing date 2020-11-19
    Publishing country United States
    Document type Journal Article ; Systematic Review
    ZDB-ID 1070827-3
    ISSN 1708-0428 ; 0960-8923
    ISSN (online) 1708-0428
    ISSN 0960-8923
    DOI 10.1007/s11695-020-05112-z
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    Zs.A 3381: Show issues Location:
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    Jg. 1995 - 2021: Lesesall (2.OG)
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  7. Article ; Online: Compared to randomized studies, observational studies may overestimate the effectiveness of DOACs: a metaepidemiological approach.

    Safieddine, Maissa / Chapelle, Celine / Ollier, Edouard / Ferdynus, Cyril / Bertoletti, Laurent / Mismetti, Patrick / Cucherat, Michel / Laporte, Silvy

    Journal of clinical epidemiology

    2020  Volume 130, Page(s) 49–58

    Abstract: 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 ... ...

    Abstract 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.
    MeSH term(s) Anticoagulants/therapeutic use ; Biomedical Research/standards ; Data Collection/standards ; Female ; Guidelines as Topic ; Humans ; Male ; Middle Aged ; Observational Studies as Topic/standards ; Proportional Hazards Models ; Prospective Studies ; Randomized Controlled Trials as Topic/standards ; Research Design ; Retrospective Studies ; Treatment Outcome ; Venous Thromboembolism/drug therapy ; Venous Thromboembolism/physiopathology
    Chemical Substances Anticoagulants
    Language English
    Publishing date 2020-10-17
    Publishing country United States
    Document type Comparative Study ; Journal Article ; Research Support, Non-U.S. Gov't ; Systematic Review
    ZDB-ID 639306-8
    ISSN 1878-5921 ; 0895-4356
    ISSN (online) 1878-5921
    ISSN 0895-4356
    DOI 10.1016/j.jclinepi.2020.10.013
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  8. Article ; Online: Early detection of the existence or absence of the treatment effect: A cumulative meta-analysis.

    Laporte, Silvy / Chapelle, Céline / Trone, Jane-Chloé / Bertoletti, Laurent / Girard, Philippe / Meyer, Guy / Safieddine, Maissa / Cucherat, Michel / Ollier, Edouard / Mismetti, Patrick

    Journal of clinical epidemiology

    2020  Volume 124, Page(s) 24–33

    Abstract: 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 ... ...

    Abstract 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.
    MeSH term(s) Anticoagulants/therapeutic use ; Heparin, Low-Molecular-Weight/therapeutic use ; Humans ; Neoplasms/complications ; Randomized Controlled Trials as Topic ; Survival Analysis ; Treatment Outcome ; Venous Thromboembolism/complications ; Venous Thromboembolism/prevention & control
    Chemical Substances Anticoagulants ; Heparin, Low-Molecular-Weight
    Language English
    Publishing date 2020-04-13
    Publishing country United States
    Document type Journal Article ; Meta-Analysis ; Review
    ZDB-ID 639306-8
    ISSN 1878-5921 ; 0895-4356
    ISSN (online) 1878-5921
    ISSN 0895-4356
    DOI 10.1016/j.jclinepi.2020.04.006
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