JORGE MILHEM HADDAD
Projetos de Pesquisa
Unidades Organizacionais
Instituto Central, Hospital das Clínicas, Faculdade de Medicina - Médico
LIM/58 - Laboratório de Ginecologia Estrutural e Molecular, Hospital das Clínicas, Faculdade de Medicina
LIM/58 - Laboratório de Ginecologia Estrutural e Molecular, Hospital das Clínicas, Faculdade de Medicina
16 resultados
Resultados de Busca
Agora exibindo 1 - 10 de 16
- A systematic review and meta-synthesis of qualitative studies on pelvic organ prolapse for the development of core outcome sets(2020) RADA, Maria Patricia; JONES, Stephanie; FALCONI, Gabriele; HADDAD, Jorge Milhem; BETSCHART, Cornelia; PERGIALIOTIS, Vasilios; DOUMOUCHTSIS, Stergios K.Aims In the current climate of evidence-based health care, the aim of this meta-synthesis was to collect and systematically analyse data from primary qualitative studies on pelvic organ prolapse (POP), to identify patient-centered perspectives on the natural course of POP. Information acquired in this study may be useful for ongoing research towards the development of core outcome sets (COS) in pelvic floor disorders. Methods A CHORUS Working Group performed a standardized search of three different databases (Medline, Embase, Scopus), from inception to October 2019. We selected qualitative studies on women's perspectives on POP that were published in the English language. Three reviewers independently evaluated the quality of eligible papers and highlighted recurrent themes based on patient perspectives. Results Eighteen qualitative studies including a total of 497 patients were assessed in this analysis. Our study revealed five superordinate themes, recurrently encountered in qualitative studies on POP: awareness of POP (6 studies), communication (9 studies), treatments (10 studies), effects on quality of life (6 studies), and self-image (3 studies). Five out of 10 quality criteria were met by all the studies included, based on an assessment performed using the critical appraisal skills program. Conclusions This is the first synthesis of qualitative studies that address POP-related experiences of women, highlighting five superordinate themes, of which treatment was the most commonly reported one. This synthesis' findings may guide quantitative research priorities and will hopefully contribute to the development of a COS for POP.
- Management of Apical Compartment Prolapse (Uterine and Vault Prolapse): A FIGO Working Group Report(2017) BETSCHART, Cornelia; CERVIGNI, Mauro; ORTIZ, Oscar Contreras; DOUMOUCHTSIS, Stergios K.; KOYAMA, Masayasu; MEDINA, Carlos; HADDAD, Jorge Milhem; TORRE, Filippo La; ZANNI, GiulianoAim: Apical prolapse includes descent of the uterus, vagina cuff, or rarely solely of the cervix. It is estimated that women have an 11-19% life-time risk of undergoing surgery for POP. This rate is projected to increase over the next 2-3 decades. In this FIGO working group report we address the conservative and surgical treatment options for apical prolapse. Methods: The FIGO working group ""Pelvic Floor Medicine and Reconstructive Surgery"" describes the different treatments for apical prolapse based on the literature evidence, the cost-effectiveness, the degree of difficulty and summed them up with an experts recommendation. Results: Among the conservative treatment options, pessaries are the most successful options since centuries with a low complication rate and low costs. Among the vaginal operative procedures the sacrospinous ligament fixation (SSLF) and the uterosacral ligament suspension (USLS) show comparable outcomes and efficacy with a different, however, rather low complication pattern and a favorable cost-benefit profile. Sacrocolpopexy, independent on the open abdominal, laparoscopic, or robotic-assisted laparoscopic technique has a good durability and quality of life performance. The minimal invasive techniques are as effective as the open abdominal techniques and there is no difference in mesh exposure. Conclusion: Vaginal procedures are well described procedures with favorable outcomes and cost-benefit profiles. Sacral colpopexy has a high-effectivity; data on the route of performance and long-term outcome are awaited. The cost with mesh implants are higher compared to the operations with autologous tissue or any conservative treatment and further studies are recommended to evaluate the cure rates in the span of decades and the possible long-term mesh complications. (C) 2015 Wiley Periodicals, Inc.
- A multicenter, randomized trial comparing pelvic organ prolapse surgical treatment with native tissue and synthetic mesh: A 5-year follow-up study(2020) SILVEIRA, Simone dos Reis B. da; AUGE, Antomio P. F.; JARMY-DIBELLA, Zsuzsanna I. K.; MARGARIDO, Paulo F. R.; CARRAMAO, Silvia; RODRIGUES, Claudinei Alves; DOUMOUCHTSIS, Stergios K.; BARACAT, Edmund Chada; HADDAD, Jorge MilhemIntroduction The aim of this study was to compare long-term outcomes in patients who underwent either native tissue repair or monofilament macroporous polypropylene mesh. Methods This multicenter, randomized trial included-at the end of 5 years follow-up-122 women with severe pelvic organ prolapse, who were randomly assigned to undergo surgical treatment using native tissue repair (native tissue group, n = 59) or synthetic mesh repair (mesh group, n = 63). Cure criterion was when pelvic organ prolapse-quantification (POP-Q) point was <= 0. Quality of life was assessed using the prolapse quality-of-life questionnaire and sexual function with the quality of sexual function. Results Groups were homogeneous preoperatively with the exception of the previous pelvic surgery variable, which was higher in mesh (P = .019). Cure rate was significantly better for mesh group in the anterior compartment (P = .002) and in the combination of all compartments (P = .001). Native tissue group was significantly better when there was prolapse in the posterior and apical compartment (P = .031). In the quality of life analysis, mesh group showed a significant improvement compared with native tissue group (P = .004). Complications were significantly higher in mesh and recurrence in native tissue. Regarding the reoperation rate, there was no difference between groups, but native tissue had a higher reoperation rate due to recurrence (P = .031). Conclusions Outcomes in women with severe POP were better with mesh use than native tissue repair, both in the anterior compartment and in the multicompartmental prolapse after 5-year follow-up. Complications were more common in the mesh group and recurrences were more frequent in the native tissue group.
- Biomarkers in the diagnosis and symptom assessment of patients with bladder pain syndrome: a systematic review(2019) MAGALHAES, Thais F.; BARACAT, Edmund C.; DOUMOUCHTSIS, Stergios K.; HADDAD, Jorge M.Introduction and hypothesisBladder pain syndrome (BPS) is a disease of unknown etiology defined as an unpleasant sensation related to the bladder, associated with lower urinary tract symptoms of more than 6 weeks' duration, in the absence of any identifiable causes. Despite its impact on quality of life (QoL) and socioeconomic burden, there are no objective methods for the diagnosis or assessment of therapeutic response. We systematically reviewed biomarkers associated with BPS to update the current knowledge on this issue.MethodsA systematic review of the Cochrane Library, Embase, PubMed/MEDLINE, LILACS, SCOPUS, and ClinicalTrials.gov databases was conducted following the PRISMA statement. Original articles investigating biomarkers for the diagnosis or symptom assessment of patients with BPS were assessed; no language restrictions were applied. Animal or post-mortem studies were excluded.ResultsOf the 478 records retrieved, 11 articles were included. MIF, NGF, Etio-S, APF, and a combined methylhistamine/Il-6 model were increased in BPS urine samples versus controls. Also increased were glyceraldehyde in stool, in addition to the expression of some genes (ARID1A, ARF, CHAT, eNOS, GLI-1, iNOS, MCP-1, NGF, WNT-8A, WNT-10A), nerve density, IL-16, VCAM-1, and ICAM-1 in bladder tissue specimens. In contrast, some fecal bacteria, expression of other genes (CHT, HB-EGF, OCT-1, SMRT-1, WNT11) in the bladder urothelium, and urinary DNA methylation in CpG-sites, MCP-3, G5P1, and HB-EGF were decreased in BPS. As none of the biomarkers was studied more than once, a Forest plot could not be constructed. Only 4 articles reported the relation of biomarkers to symptom scores.ConclusionsPotential biomarkers for BPS in urine, stool, and bladder biopsy specimens are described. Further research is needed before their use in clinical practice.
- Developing Core Outcome Sets (COS) and Core Outcome Measures Sets (COMS) in Cosmetic Gynecological Interventions: Protocol for a Development and Usability Study(2021) DOUMOUCHTSIS, Stergios K.; NAMA, Vivek; FALCONI, Gabriele; RADA, Maria Patricia; MANONAI, Jittima; IANCU, George; HADDAD, Jorge Milhem; BETSCHART, CorneliaBackground: Studies evaluating cosmetic gynecological interventions have followed variable methodology and reported a diversity of outcomes. Such variations limit the comparability of studies and the value of research-based evidence. The development of core outcome sets (COS) and core outcome measures sets (COMS) would help address these issues, ensuring a minimum of outcomes important to all stakeholders, primarily women requesting or having experienced cosmetic gynecological interventions. Objective: This protocol describes the methods used in developing a COS and COMS for cosmetic gynecological interventions. Methods: An international steering group within CHORUS, including health care professionals, researchers, and women with experience in cosmetic gynecological interventions from 4 continents, will guide the development of COS and COMS. Potential outcome measures and outcomes will be identified through comprehensive literature reviews. These potential COS and COMS will be entered into an international, multi-perspective web-based Delphi survey where Delphi participants judge which domains will be core. A priori thresholds for consensus will get established before each Delphi round. The Delphi survey results will be evaluated quantitatively and qualitatively in subsequent stakeholder group consensus meetings in the process of establishing ""core"" outcomes. Results: Dissemination and implementation of the resulting COS and COMS within an international context will be promoted and reviewed. Conclusions: This protocol presents the steps in developing a COS and COMS for cosmetic gynecological interventions. Embedding the COS and COMS for cosmetic gynecological interventions within future clinical trials, systematic reviews, and practice guidelines could contribute to enhancing the value of research and improving overall patient care.
- Outcome reporting in randomized controlled trials (RCTs) on the pharmacological management of idiopathic overactive bladder (OAB) in women; a systematic review for the development of core outcome sets (COS)(2022) MOUSSA, Reem; RADA, Maria Patricia; DURNEA, Constantin; FALCONI, Gabriele; BETSCHART, Cornelia; HADDAD, Jorge Milhem; SEDGWICK, Philip; DOUMOUCHTSIS, Stergios K.Introduction and hypothesis Evidence on OAB management remains suboptimal and methodological limitations in randomized control trials (RCTs) affect their comparability. High quality meta-analyses are lacking. This study aimed to compare selection and reporting of outcomes and outcome measures across RCTs as well as evaluate methodological quality and outcome reporting quality as a first stage in the process of developing core outcome sets (COS). Methods RCTs were searched using Pubmed, EMBASE, Medline, Cochrane, ICTRP and from inception to January 2020, in English language, on adult women. Pharmacological management, interventions, sample size, journal type and commercial funding were documented. Methodological and outcome reporting quality were evaluated using JADAD and MOMENT scores. Results Thirty-eight trials (18,316 women) were included. Sixty-nine outcomes were reported, using 62 outcome measures. The most commonly reported outcome domains were efficacy (86.8%), safety (73.7%) and QoL (60.5%). The most commonly reported outcomes in each domain were urgency urinary incontinence episodes (UUI) (52.6%), antimuscarinic side effects (76.3%) and change in validated questionnaire scores (36.8%). A statistically significant correlation was found between JADAD and MOMENT (Spearman's rho = 0.548, p < 0.05) scores. This indicates that higher methodological quality is associated with higher outcome reporting quality. Conclusions Development of COS and core outcome measure sets will address variations and lead to higher quality evidence. We recommend the most commonly reported outcomes in each domain, as interim COS. For efficacy we recommend: UUI episodes, urgency and nocturia episodes; for safety: antimuscarinic adverse events, other adverse events and discontinuation rates; for QoL: OAB-q, PPBC and IIQ scores.
- A systematic review of reported outcomes and outcome measures in randomized controlled trials on apical prolapse surgery(2019) LOURENCO, Thais Regina de Mattos; PERGIALIOTIS, Vasilis; DURNEA, Constantin; ELFITURI, Abdullatif; HADDAD, Jorge Milhem; BETSCHART, Cornelia; FALCONI, Gabriele; DOUMOUCHTSIS, Stergios K.Background Evidence on efficacy and safety of pelvic organ prolapse interventions is variable, and methodological flaws preclude meaningful synthesis of primary research data. Objective To evaluate variations in reported outcomes and outcome measures in randomized controlled trials (RCTs) on apical prolapse surgical interventions. Search strategy We searched Cochrane, EMBASE, MEDLINE, and Scopus for English-language articles published from inception to September 30, 2017, using the terms ""management"", ""repair"", ""operation"", and ""pelvic organ prolapse"". Selection criteria RCTs on apical prolapse surgical treatment. Data collection and analysis Outcomes and outcome measures were identified and categorized into domains. Studies were evaluated for quality of outcomes. Descriptive statistics were used to calculate frequencies. Main results Forty-three RCTs were included. Seventy-six outcomes and 66 outcome measures were identified. Bladder and ureteric injury were the most commonly reported intraoperative complications (19/31 studies; 61%). Quality of life was assessed by 19 different instruments and questionnaires. Fourteen (45%) of 31 studies used recurrence of prolapse as a postoperative anatomical outcome. Conclusions Substantial variation in reported outcomes and outcome measures was confirmed, precluding comparisons across trials and synthesis of the results. Development of a core outcome set will enable high-quality meta-analyses to be performed in the future.
- A protocol for developing, disseminating, and implementing a core outcome set (COS) for childbirth pelvic floor trauma research(2020) DOUMOUCHTSIS, Stergios K.; RADA, Maria Patricia; PERGIALIOTIS, Vasilios; FALCONI, Gabriele; HADDAD, Jorge Milhem; BETSCHART, CorneliaBackground More than 85% of women sustain different degrees of trauma during vaginal birth. Randomized controlled trials on childbirth pelvic floor trauma have reported a wide range of outcomes and used different outcome measures. This variation restricts effective data synthesis, impairing the ability of research to inform clinical practice. The development and use of a core outcome set (COS) for childbirth pelvic floor trauma aims to ensure consistent use of outcome measures and reporting of outcomes. Methods An international steering group, within CHORUS, an International Collaboration for Harmonising Outcomes, Research and Standards in Urogynaecology and Women's Health, including academic community members, researchers, healthcare professionals, policy makers and women with childbirth pelvic floor trauma will lead the development of this COS. Relevant outcome parameters will be identified through comprehensive literature reviews. The selected outcomes will be entered into an international, multi-perspective online Delphi survey. Subsequently and based on the results of the Delphi surveys consensus will be sought on 'core' outcomes. Discussion Dissemination and implementation of the resulting COS within an international context will be supported and promoted. Embedding the COS for childbirth pelvic floor trauma within future clinical trials, systematic reviews, and clinical practice guidelines is expected to enrich opportunities for comparison of future clinical trials and allow better synthesis of outcomes, and will enhance mother and child care. The infrastructure created by developing a COS for childbirth pelvic floor trauma could be leveraged in other settings, for example, advancing research priorities and clinical practice guideline development.
- Outcome reporting in trials on conservative interventions for pelvic organ prolapse: A systematic review for the development of a core outcome set(2022) KHAN, Kimmee; RADA, Maria; ELFITURI, Abdullatif; BETSCHART, Cornelia; FALCONI, Gabriele; HADDAD, Jorge Milhem; DOUMOUCHTSIS, Stergios K.Background: Significant risk of bias and limitations in outcome selections in trials evaluating conservative treatments for the management of Pelvic Organ Prolapse (POP) have been highlighted and preclude comparability of outcomes, synthesis of primary studies and high quality evidence. Objectives: As systematic review of the reported outcomes is the first step in the process of development of a Core Outcome Set (COS), we aimed to systematically review reporting of outcomes and outcome measures in Randomised Control Trials (RCTs) on conservative treatments for POP and develop an inventory of them for consideration as core outcome and outcome measures sets. We evaluated methodological quality, outcome reporting quality and publication characteristics and their associations among published RCTs. Study design: Systematic review of RCTs identified from the following databases: Cochrane Central Register of Controlled Trials (CENTRAL), EMBASE and MEDLINE (Pubmed). RCTs evaluating the effectiveness of conservative interventions for the management of POP were considered for inclusion. Outcomes and outcome measures were obtained from the RCTs and an inventory was created. Outcomes were grouped in domains and themes. Methodological quality, outcome reporting quality and publication characteristics were evaluated and statistically analysed. Results: Twenty-five trials (3179 women) were included and reported 31 outcomes and 50 outcome measures. Reporting rates of the outcomes investigated ranged between 4% and 56%. The most commonly reported outcome domains were patient reported symptoms, stage of POP expressed as POP-Q stage, and quality of life. Univariate analysis demonstrated no significant correlations of methodological and outcome reporting parameters. Conclusions: There is a need to increase comparability of RCTs. Reporting standardized outcomes included in a COS for conservative interventions for POP will facilitate the comparability across RCTs. While the process of developing COS is in progress, we propose the interim use of the three most commonly reported outcomes in each domain: patient-reported outcomes (symptom distress including bowel and urinary symptoms, sexual function), stage of prolapse and quality of life parameters using validated questionnaires (Pelvic Floor Distress Inventory 20 (PFDI-20), Pelvic Floor Impact Questionnaire/ Health related quality of life (PFIQ-7/HRQOL) and Pelvic Organ Prolapse Impact Questionnaire (POPIQ-7).
- An update of a former FIGO Working Group Report on Management of Posterior Compartment Prolapse(2020) DOUMOUCHTSIS, Stergios K.; RAHEEM, Ali Abdel; HADDAD, Jorge Milhem; BETSCHART, Cornelia; ORTIZ, Oscar Contreras; NYGAARD, Christiana C.; MEDINA, Carlos A.; TORRE, Fillippo La; IANCU, George; CERVIGNI, Mauro; ZANNI, GiulianoBackground The FIGO Working Group (FWG) in Pelvic Floor Medicine and Reconstructive Surgery (2012-2015) established a consensus among international opinion leaders in evaluating current evidence and providing practice recommendations. Objectives To provide an update of the previous clinical opinion report on conservative and surgical treatment of posterior compartment prolapse. Search strategy Search of evidence was performed using Pubmed, Embase, and Cochrane Library databases up to August 2018. Selection criteria Controlled trials on posterior colporrhaphy, site-specific defect, transanal, abdominal, laparoscopic, and mesh repair. Data collection and analysis Collective consensus on surgical outcomes was based on a decision-making process during meetings and multiple group consultations. Main results Basic evaluation and conservative treatment precede surgical management. Surgical techniques are performed by vaginal, transperineal, transanal, abdominal, or laparoscopic approach. The transvaginal surgical route without mesh appears superior to the transanal route. No conclusions can be drawn based on clinical studies or randomized controlled trials of posterior colporrhaphy and laparoscopic rectopexy. Conclusions Management of rectocele should include patients' history, quality of life questionnaires, and, in case of complex anorectal symptoms, imaging and functional studies. Evidence on the best type of posterior vaginal wall repair is still scarce. Randomized controlled trials are needed to determine the best approach to achieve safe, effective, and long-term anatomical and functional outcomes.