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1.
Int J Gynaecol Obstet ; 164(2): 499-503, 2024 Feb.
Article in English | MEDLINE | ID: mdl-37431204

ABSTRACT

There is significant variation in practice when managing couples with recurrent miscarriage (RM), with guidelines differing on the definition of RM, recommended investigations, and treatment options. In the absence of evidence-based guidance, and following on from a paper by the authors-FIGO Good Practice Recommendations on the use of progesterone in the management of recurrent first-trimester miscarriage-this narrative review aims to propose a global holistic approach. We present graded recommendations based on best available evidence.


Subject(s)
Abortion, Habitual , Humans , Female , Abortion, Habitual/prevention & control
2.
Eur J Obstet Gynecol Reprod Biol ; 290: 51-59, 2023 Nov.
Article in English | MEDLINE | ID: mdl-37734138

ABSTRACT

OBJECTIVES: Perineal injury occurs in 85% of cases during vaginal childbirth. This study aimed to synthesize qualitative data on women's perceptions of perineal trauma during vaginal childbirth. STUDY DESIGN: Thematic synthesis was applied utilizing a structured three-step framework. First, line-by-line coding strategy was applied to the included studies. Secondly, related codes were grouped together to develop descriptive themes to emphasize what matters most for women suffering from childbirth perineal trauma. Thirdly, analytical themes were developed. The quality of the included studies was high based on the assessment using the Critical Appraisal Skills Programme tool. RESULTS: Ten eligible studies were included in the meta-synthesis. Twenty-three codes encompassing multiple aspects of childbirth trauma from women's perspective were organised into a set of eight descriptive themes: psychosocial effects, communication, recovery, pain, support, knowledge of childbirth perineal trauma, sexuality, and prioritization. CONCLUSIONS: Among the descriptive themes, psychosocial effects, communication, and recovery exhibited the highest prevalence. The findings of this meta-synthesis may serve as a reporting guideline for future studies investigating the consequences of childbirth perineal trauma, ensuring that women's priorities are accurately reflected in reported outcomes.


Subject(s)
Birth Injuries , Parturition , Pregnancy , Female , Humans , Delivery, Obstetric/adverse effects , Qualitative Research , Perineum/injuries , Outcome Assessment, Health Care
3.
Cureus ; 15(7): e42171, 2023 Jul.
Article in English | MEDLINE | ID: mdl-37484789

ABSTRACT

This report presents the case of a 63-year-old woman who developed a vesicovaginal fistula as a complication of a previous total hysterectomy. The fistula was treated with the use of the da Vinci X surgical system by a multi-disciplinary operating team, including senior Robotic Urological and Gynecological Surgeons at St. Luke's Hospital in Thessaloniki, Greece. The patient was monitored up to 12 months post-op at the time of writing and she was asked to evaluate post-op quality of life using the SF-36 and ICIQ-SF-UI questionnaires. The robotic surgical procedure was completed successfully. The total operation duration was 105 minutes, without any intra-operative complications. The patient was hospitalized for two days and made a swift, uneventful recovery. Regarding the quality of life, the patient reported satisfactory improvement in almost every domain assessed compared to her pre-op assessment; an improvement that was maintained throughout the reported follow-up period. At the time of writing, the patient reports no long-term complications and satisfactory urinary continence. Robotic-assisted laparoscopic vesicovaginal fistula repair is an effective and safe treatment option for this rare complication, as indicated by both post-operative data and the patient's own self-evaluation in this report. Further research is warranted, focusing on refining the surgical technique and comparing this to other alternative methods aiming to further improve patient outcomes.

4.
J Med Syst ; 47(1): 62, 2023 May 12.
Article in English | MEDLINE | ID: mdl-37171621

ABSTRACT

We aimed to assess the feasibility of developing three-dimensional (3D) models of pelvic organs using cross-sectional MRI images of patients with uterine fibroids and urinary symptoms and of obtaining anatomical information unavailable in 2D imaging modalities. We also aimed to compare two image processing applications. We performed a feasibility study analysing MRI scans from three women, aged 30 to 58 years old, with fibroids and urinary symptoms. Cross-sectional images were used to render 3D models of pelvic anatomy, including bladder, uterus and fibroids, using 3D Slicer and OsiriX. Dimensions, volumes and anatomical relationships of the pelvic organs were evaluated. Comparisons between anatomical landmarks and measurements obtained from the two image processing applications were undertaken. Rendered 3D pelvic models yielded detailed anatomical information and data on spatial relationships that were unobtainable from cross-sectional images. Models were rendered in sufficient resolution to aid understanding of spatial relationships between urinary bladder, uterus and fibroid(s). Measurements of fibroid volumes ranged from 5,336 to 418,012 mm3 and distances between the fibroid and urinary bladder ranged from 0.10 to 83.60 mm. Statistical analysis of measurements showed no significant differences in measurements between the two image processing applications. To date, limited data exist on the use of 3D volume reconstructions of routine MRI scans, to investigate pelvic pathologies such as fibroids in women with urinary symptoms. This study suggests that post-MRI image processing can provide additional information over standard MRI. Further studies are required to assess the role of these data in clinical practice, surgical planning and training. Three-dimensional reconstruction of routine two-dimensional magnetic resonance imaging provides additional anatomical information and may improve our understanding of anatomical relationships, their role in clinical presentations and possibly guide clinical and surgical management.


Subject(s)
Leiomyoma , Pelvic Floor , Humans , Female , Adult , Middle Aged , Leiomyoma/diagnostic imaging , Leiomyoma/pathology , Magnetic Resonance Imaging/methods , Uterus , Image Processing, Computer-Assisted , Imaging, Three-Dimensional/methods
7.
Int Urogynecol J ; 34(1): 1-42, 2023 01.
Article in English | MEDLINE | ID: mdl-36443462

ABSTRACT

AIMS: The terminology of obstetric pelvic floor disorders should be defined and reported as part of a wider clinically oriented consensus. METHODS: This Report combines the input of members of two International Organizations, the International Continence Society (ICS) and the International Urogynecological Association (IUGA). The process was supported by external referees. Appropriate clinical categories and a sub-classification were developed to give coding to definitions. An extensive process of 12 main rounds of internal and 2 rounds of external review was involved to exhaustively examine each definition, with decision-making by consensus. RESULTS: A terminology report for obstetric pelvic floor disorders, encompassing 357 separate definitions, has been developed. It is clinically-based with the most common diagnoses defined. Clarity and user-friendliness have been key aims to make it usable by different specialty groups and disciplines involved in the study and management of pregnancy, childbirth and female pelvic floor disorders. Clinical assessment, investigations, diagnosis, conservative and surgical treatments are major components. Illustrations have been included to supplement and clarify the text. Emerging concepts, in use in the literature and offering further research potential but requiring further validation, have been included as an Appendix. As with similar reports, interval (5-10 year) review is anticipated to maintain relevance of the document and ensure it remains as widely applicable as possible. CONCLUSION: A consensus-based Terminology Report for obstetric pelvic floor disorders has been produced to support clinical practice and research.


Subject(s)
Gynecology , Medicine , Pelvic Floor Disorders , Urology , Female , Humans , Pelvic Floor Disorders/diagnosis , Pelvic Floor Disorders/therapy , Societies, Medical
8.
J Obstet Gynaecol ; 42(7): 2634-2642, 2022 Oct.
Article in English | MEDLINE | ID: mdl-36222025

ABSTRACT

New pathways for the management of postpartum voiding dysfunction and postpartum urinary retention should be considered to shorten hospital stays and promote early discharge during the COVID-19 pandemic. This rapid systematic review aimed to identify relevant national and international guidelines, and summarise available recommendations on postpartum bladder care that are relevant to women's care and management at the time of the pandemic. We searched Medline, Embase and Cochrane from inception till September 2021. Hand-searching of national and international specialist societies' websites was performed. We identified one international technical consultation, one international society's report of recommendations and two national guidelines. Guidelines stated that postnatal women should not be left more than 6 hours without voiding and assessed for postpartum urinary retention. As the cut-off of 150 ml for the diagnosis of significant postvoid residual volume is commonly used with no reported adverse outcomes, it could be beneficial to adopt this instead of 100 ml as further unnecessary interventions can be avoided. Such changes can reduce the number of women staying in the hospital. Clean intermittent self-catheterisation for the management of postpartum urinary retention could be considered as an option during the COVID-19 pandemic aiming to shorten hospital stays and avoid further attendances. Optimised bladder care has become more relevant during the coronavirus pandemic by striving towards self-care, community-based and remote care. We propose consideration of intermittent self-catheterisation in cases of postpartum urinary retention enabling self-care and avoidance of hospital visits.


Subject(s)
COVID-19 , Urinary Retention , Female , Humans , COVID-19/epidemiology , Pandemics/prevention & control , Postpartum Period , Urinary Bladder , Urinary Retention/therapy
9.
J Obstet Gynaecol Res ; 48(8): 2112-2121, 2022 Aug.
Article in English | MEDLINE | ID: mdl-35699223

ABSTRACT

AIM: This review aimed to evaluate the quality of medicalinformation online for patients relating to vulvodynia. To our knowledge no evaluation of online patient information exists regarding vulvodynia and, at present, there is no standardized or validated method of evaluating medical information on the internet. METHODS: A clearly defined protocol was developed to generate keywords relating to vulvodynia. The three most popular search engines worldwide; google.com, yahoo.com, and bing.com, were searched in September 2020. Three assessors evaluated eligible webpages for accuracy, credibility, readability, and reliability. RESULTS: Forty-five webpages were eligible with 38% given HON certification or Information Standard approval. Only one webpage achieved a DISCERN score of ≥63 indicating excellent reliability. No webpages scored a maximum 10 points for credibility. Eleven percent of webpages were rated "accurate" with score 17 or above. The modal Flesch Kincaid Grade Level was 9 with only 15.6% having a readability grade level of 8 or less. CONCLUSIONS: It has been shown in previous studies that patient information available online pertaining to gynecological conditions is frequently inaccurate, with limited regulation and low reliability, and our findings are in agreement with this. As patients increasingly look to the internet for medical information and education, we as clinicians, need to ensure the resources available are of a high standard and regulated. Without ensuring safe and effective healthcare resources, we risk misinformation which can negatively impact clinical care.


Subject(s)
Consumer Health Information , Vulvodynia , Comprehension , Female , Humans , Internet , Reproducibility of Results , Vulvodynia/therapy
10.
J Clin Epidemiol ; 149: 1-11, 2022 09.
Article in English | MEDLINE | ID: mdl-35452795

ABSTRACT

OBJECTIVES: To evaluate the content validity of 19 patient-reported outcome measures (PROMs) used to measure quality of life (QoL) in women with chronic pelvic pain (CPP). STUDY DESIGN AND SETTING: We searched Embase, MEDLINE, PsycINFO databases and Google Scholar from inception to August 2020. We included records describing the development or studies assessing content validity of PROMs. Two reviewers independently assessed the methodological quality of PROMs using the Consensus-based Standards for the Selection of Health Measurement Instruments checklist. Evidence was synthesized for relevance, comprehensiveness, and comprehensibility. Quality of evidence was rated using a modified Grading of Recommendations, Assessment, Development, and Evaluations approach. RESULTS: PROM development was inadequate for all instruments included in this review. No high-quality evidence ratings were found for relevance, comprehensiveness, and comprehensibility. QoL was measured using generic instruments (68.42%, 13/19) rather than those specific to chronic pain (21.04%, 4/19) or pelvic pain (10.53%, 2/19). Quality of concept elicitation was inadequate for 90% of PROMs. Half of PROMs did not include patients in their development and only 40% were devised using a sample representative of the target population for which the PROM was developed. Cognitive interviews were conducted in one-fifth of PROMs and were mostly of inadequate/doubtful quality. CONCLUSION: There is poor quality of evidence for content validity of PROMs used to measure QoL in women with CPP.


Subject(s)
Chronic Pain , Quality of Life , Female , Humans , Quality of Life/psychology , Patient Reported Outcome Measures , Chronic Pain/therapy , Checklist , Pelvic Pain/therapy
11.
Int J Gynaecol Obstet ; 159(3): 757-763, 2022 Dec.
Article in English | MEDLINE | ID: mdl-35426118

ABSTRACT

OBJECTIVE: To evaluate the impact of a previous pregnancy and delivery on perineal trauma rates in the subsequent vaginal birth. METHODS: Retrospective cohort study. The perineal outcomes of secundiparous women with history of previous (first) delivery in one of three categories: failed operative vaginal delivery (FOVD) and second-stage emergency cesarean section (EmCS); elective cesarean section (ElCS), and vaginal delivery (VD) with intact perineum, were compared with a control primiparous group. RESULTS: The percentage obstetric anal sphincter injuries (OASIS)at first vaginal delivery was 17.3% (n = 9) after previous FOVD+EmCS, 12.9% (n = 18) after previous ElCS, and 0.6% (n = 9) after previous VD maintaining an intact perineum, compared with 6% (n = 1193) in the control primiparous group of women. Multivariate regression analysis demonstrated that previous FOVD+EmCS and ElCS were associated with a statistically significant increased risk of OASIS of 180% and 110% when compared with control (odds ratio [OR] 2.80; 95% confidence interval [CI] 1.35-5.78 and OR 2.10; 95% CI 1.27-3.48, respectively). Previous VD with intact perineum was associated with a statistically significantly reduced risk of OASIS (OR 0.09; 95% CI 0.04-0.17). CONCLUSIONS: Previous FOVD+EmCS and ElCS were associated with increased risk of OASIS in subsequent vaginal delivery compared with control, whereas previous VD with intact perineum was associated with decreased risk.


Subject(s)
Lacerations , Obstetric Labor Complications , Female , Pregnancy , Humans , Perineum/injuries , Cesarean Section/adverse effects , Anal Canal/injuries , Retrospective Studies , Delivery, Obstetric/adverse effects , Risk Factors , Obstetric Labor Complications/epidemiology , Obstetric Labor Complications/etiology , Lacerations/epidemiology , Lacerations/etiology
12.
Int Urogynecol J ; 33(11): 2941-2949, 2022 11.
Article in English | MEDLINE | ID: mdl-35254471

ABSTRACT

INTRODUCTION AND HYPOTHESIS: The mesh controversy has highlighted the need for robust evidence of treatment safety and efficacy, particularly in the surgical treatment of stress urinary incontinence (SUI). Current trials demonstrate heterogeneity in outcomes reported as well as outcome measures used, restricting the ability to synthesize data and produce robust research evidence (Doumouchtsis et al. 5). Patient-reported outcomes (PROs) should be a focus when evaluating SUI surgery given the quality-of-life nature of this condition affecting 25-45% women worldwide (Milsom and Gyhagen 1). As part of the first step in developing a core outcome set (COS) and measures set (COMS), we aimed to systematically review RCTs evaluating SUI surgery and extract PROs and outcome measures (PROMs) used. MATERIALS AND METHODS: We searched databases including MEDLINE and Cochrane for RCTs evaluating SUI surgical treatments from inception to January 2020. Eligibility criteria included English language and female-only subjects. PROs and PROMs were extracted and grouped into a structured inventory. PROMs were assigned to domains based on predominant theme. RESULTS: Of 123 eligible RCTs, 116 (94%) included PROs. Forty-four different PROMs were utilized; most frequent was Patient Global Impression of Improvement (PGI-I). Fifteen PROMs were used once. The top five PROMs have evidence of validity and are highly recommended. CONCLUSIONS: There is no consensus amongst relevant stakeholders regarding PROs or PROMs used in SUI surgery research. We propose that this consensus is required to standardize measurements and reporting and promote use of validated and reliable outcome measures. This systematic review forms the first step in the development process.


Subject(s)
Urinary Incontinence, Stress , Female , Humans , Male , Outcome Assessment, Health Care , Patient Reported Outcome Measures , Quality of Life , Urinary Incontinence, Stress/surgery
13.
J Perinat Med ; 50(4): 446-456, 2022 May 25.
Article in English | MEDLINE | ID: mdl-35119802

ABSTRACT

OBJECTIVES: Late first-stage or second-stage cesarean section is commonly associated with fetal head impaction, leading to maternal and neonatal complications. This situation requires safe delivery techniques, but the optimal management remains controversial. The aim of this meta-analysis was to compare maternal and neonatal outcomes associated with delivery techniques via cesarean section. METHODS: An electronic search of three databases, from inception to June 2021, was conducted. Cohort and randomised comparative studies on maternal and neonatal outcomes associated with techniques to deliver an impacted fetal head during cesarean section were included. The methodological quality of the primary studies was assessed. Review Manager 5.4 was used for statistical analyses. RESULTS: Nineteen articles, including 2,345 women were analyzed. Three fetal extraction techniques were identified. Meta-analyses showed that the "pull" technique carries lower risks as compared to the "push" technique and the "Patwardhan" technique is safer compared to the "push" or the "push and pull" technique. CONCLUSIONS: In the absence of robust evidence to support the use of a specific technique, the choice of the obstetrician should be based on best available evidence. Our study suggests that the "pull", as well as the "Patwardhan" technique represent safe options to deliver an impacted fetal head.


Subject(s)
Cesarean Section , Fetus , Cesarean Section/adverse effects , Cesarean Section/methods , Female , Head/diagnostic imaging , Humans , Infant, Newborn , Male , Pregnancy
14.
Int Urogynecol J ; 33(5): 1243-1250, 2022 05.
Article in English | MEDLINE | ID: mdl-35006311

ABSTRACT

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 Clinicaltrials.gov 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.


Subject(s)
Urinary Bladder, Overactive , Urinary Incontinence , Adult , Female , Humans , Muscarinic Antagonists/therapeutic use , Outcome Assessment, Health Care , Randomized Controlled Trials as Topic , Treatment Outcome , Urinary Bladder, Overactive/complications , Urinary Bladder, Overactive/drug therapy , Urinary Incontinence/complications
15.
Int J Gynaecol Obstet ; 158(1): 3-12, 2022 Jul.
Article in English | MEDLINE | ID: mdl-34534366

ABSTRACT

OBJECTIVE: Given the high variation of perceptions of women with stress urinary incontinence (SUI), qualitative meta-synthesis in this field appears warranted. We aimed to synthesize evidence on women's experiences of SUI by analyzing qualitative data. METHODS: A literature search of Medline, Embase, Scopus, PsycInfo, and CINAHL databases was performed by a CHORUS Working Group, from inception to August 2020. Qualitative studies on women's perspectives on SUI were included. Thematic analysis was used as a conceptual approach to analyze the data and develop a set of overarching themes. The quality of studies was assessed based on the Critical Appraisal Skills Program tool. RESULTS: Seven studies were included. Six themes encompassing women's perspectives on SUI emerged: experiencing SUI, awareness of SUI, treatments for SUI, sexuality, communication, and psychosocial effects. The quality appraisal of the studies showed good coherence. CONCLUSION: This study revealed six overarching themes, of which treatment had the highest prevalence. Assessment of women's perceptions of SUI in the context of a qualitative meta-synthesis may inform policy and practice around this condition, may guide and help set research priorities, and will ideally contribute to the development of a Core Outcome Set for SUI.


Subject(s)
Urinary Incontinence, Stress , Female , Humans , Outcome Assessment, Health Care , Prevalence , Qualitative Research , Quality of Life/psychology , Urinary Incontinence, Stress/therapy
16.
Arch Gynecol Obstet ; 305(3): 555-565, 2022 03.
Article in English | MEDLINE | ID: mdl-34729631

ABSTRACT

PURPOSE: Synthesis of available evidence on clinical practice in gynaecological oncology during the COVID-19 pandemic is highly warranted, as women with cancer are at increased risk due to their systemic immunosuppressed state and changes in their care are inevitable. Rapid review of available data is a quick way of providing useful information and insight into the way medical practice has been affected by the COVID pandemic. METHODS: We conducted a systematic rapid review, based on a literature search of MEDLINE/PubMed, Embase, and Cochrane CENTRAL. We considered all studies on gynaecological oncology care during the COVID-19 pandemic using relevant keywords and MeSH terms. Selection criteria were English language, studies with more than five cases and publication in peer-review journal. RESULTS: Nine retrospective studies, one systematic review and five questionnaire surveys were included. Quality of the studies has been assessed. Development of higher quality evidence is warranted. Mortality of COVID-19 infection is higher in patients with gynaecological cancer than in non-cancer patients. Reported delays in diagnosis and management of cancer and changes in treatments, may affect the natural history of cancer and increase patients' anxiety and fear of disease progression while causing concerns to healthcare professionals affecting their clinical practice. The number of new diagnoses has declined. Prioritization is important, face-to-face interactions should be limited, and appropriate protective measures are essential. Cancer surgery, chemotherapy, and radiotherapy should continue as high priority practices. CONCLUSION: The COVID-19 pandemic has affected clinical practice significantly. Adaptations in clinical practice may improve mortality and complication rates.


Subject(s)
COVID-19 , Genital Neoplasms, Female , Female , Genital Neoplasms, Female/complications , Genital Neoplasms, Female/diagnosis , Genital Neoplasms, Female/therapy , Humans , Pandemics , Phobic Disorders , Retrospective Studies , SARS-CoV-2
17.
J Obstet Gynaecol Res ; 48(1): 275-279, 2022 Jan.
Article in English | MEDLINE | ID: mdl-34879442

ABSTRACT

Given the rarity of recurrent pelvic organ prolapse after obliterative procedures and the paucity of data in the literature on this topic, optimal management is challenging. We describe a technique of reversal of colpocleisis in an 81-year-old woman with recurrent prolapse as the first step in a staged, reconstructive procedure. Basic principles underlying our approach include multidisciplinary team involvement, detailed preoperative planning, and a series of investigations including different imaging modalities and a meticulous stepwise surgical technique. The distortion of anatomical planes, anticipated scarring, and close proximity of pelvic organs specifically bladder and rectum are important considerations. In our case, the multidisciplinary surgical team included urogynecologists, a urologist, and a colorectal surgeon. Detailed preoperative planning was agreed following multiple patient and team consultations. Preoperative investigations included ultrasound and videourodynamics. Intraoperatively, cystoscopy and sigmoidoscopy were performed to identify anatomical landmarks and planes, rule out fistulae, and evaluate for anatomical distortions involving pelvic organs. Subsequently, reversal of the colpocleisis was undertaken and uneventful. Postoperative recovery was uncomplicated and a sacrospinous fixation, anterior vaginal repair, and perineorrhaphy were performed as a secondary restorative procedure for the correction of recurrent prolapse.


Subject(s)
Pelvic Organ Prolapse , Plastic Surgery Procedures , Aged, 80 and over , Colpotomy , Female , Gynecologic Surgical Procedures , Humans , Pelvic Organ Prolapse/surgery , Pregnancy , Recurrence , Treatment Outcome , Vagina/surgery
18.
Eur J Obstet Gynecol Reprod Biol ; 268: 100-109, 2022 Jan.
Article in English | MEDLINE | ID: mdl-34894536

ABSTRACT

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).


Subject(s)
Pelvic Organ Prolapse , Female , Humans , Outcome Assessment, Health Care , Patient Reported Outcome Measures , Pelvic Floor , Pelvic Organ Prolapse/therapy , Quality of Life , Surveys and Questionnaires
19.
JMIR Res Protoc ; 10(11): e28032, 2021 Nov 15.
Article in English | MEDLINE | ID: mdl-34779787

ABSTRACT

BACKGROUND: 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. TRIAL REGISTRATION: Core Outcome Measures in Effectiveness Trials (COMET) 1592; https://tinyurl.com/n8faysuh. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/28032.

20.
Neurourol Urodyn ; 40(6): 1402-1413, 2021 08.
Article in English | MEDLINE | ID: mdl-34350610

ABSTRACT

AIMS: To systematically evaluate the content and quality of national and international clinical guidelines on pelvic organ prolapse (POP). METHODS: We searched medical databases and organizations websites, to identify national and international guidelines on diagnosis and management of POP. Five authors independently assessed guidelines using the validated AGREE II tool. Its six domains include (1) scope and purpose, (2) stakeholder involvement, (3) rigor of development, (4) clarity of presentation, (5) applicability, and (6) editorial independence. RESULTS: Eight guidelines met the inclusion criteria. Three hundred and thirteen different recommendations were identified. One hundred and ninety-nine recommendations were comparable across guidelines. Thirty-one recommendations were not supported by research evidence. Assessment by history and physical examination using the POP quantification system and consideration of imaging were recommendations featuring in all guidelines. Conservative treatment recommendations namely pelvic floor muscle training and vaginal pessaries were also found in all guidelines. Regarding surgical management, patient counseling, treating only symptomatic POP, consideration of apical fixation during surgical treatment, and use of biological or synthetic implants in recurrent cases were recommendations in all guidelines. Overall, the highest median scores were in the domains "scope and purpose" and "rigor of development". The lowest median score was for applicability (28.3%). Although the median score of "editorial independence" was high (85.4%), variability was also substantial (interquartile range: 12.5-100). CONCLUSION: We identified variations in quality and deficiencies in certain areas, especially "applicability" and "editorial independence." Improvements in these key domains may enhance the quality and clinical impact of clinical practice guidelines.


Subject(s)
Pelvic Organ Prolapse , Practice Guidelines as Topic , Female , Humans , Databases, Factual , Pelvic Organ Prolapse/diagnosis , Pelvic Organ Prolapse/therapy
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