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2.
Gynecol Obstet Fertil Senol ; 48(1): 3-11, 2020 01.
Artigo em Francês | MEDLINE | ID: mdl-31678506

RESUMO

OBJECTIVES: To revise the organization and the methodology of the Practice Clinical Guidelines (PCG) of the French College of Gynecologists and Obstetricians (CNGOF). METHODS: The different available methods of PCG organization and of scientific evidence grading have been consulted after searching in the Medline database. RESULTS: The PCG group of the CNGOF has decided to adopt the AGREE II (for Appraisal of Guidelines for REsearch and Evaluation) methology for PCG organization and the GRADE (for Grading of Recommendation Assessment, Development, and Evaluation) system for grading scientific evidence. CONCLUSION: By adopting the AGREE II consortium criteria and grading scientific evidence according to the GRADE system, the CNGOF will increase the quality of the overall process, will deliver more targeted and easy to assimilate recommendations, to facilitate professional decision making.

3.
BJOG ; 127(1): 88-97, 2020 01.
Artigo em Inglês | MEDLINE | ID: mdl-31544327

RESUMO

OBJECTIVE: To assess the short-term incidence of serious complications of surgery for urinary incontinence or pelvic organ prolapse. DESIGN: Prospective longitudinal cohort study using a surgical registry. SETTING: Thirteen public hospitals in France. POPULATION: A cohort of 1873 women undergoing surgery between February 2017 and August 2018. METHODS: Preliminary analysis of serious complications after a mean follow-up of 7 months (0-18 months), according to type of surgery. Surgeons reported procedures and complications, which were verified by the hospitals' information systems. MAIN OUTCOME MEASURES: Serious complication requiring discontinuation of the procedure or subsequent surgical intervention, life-threatening complication requiring resuscitation, or death. RESULTS: Fifty-two women (2.8%, 95% CI 2.1-3.6%) experienced a serious complication either during surgery, requiring the discontinuation of the procedure, or during the first months of follow-up, necessitating a subsequent reoperation. One woman also required resuscitation; no women died. Of 811 midurethral slings (MUSs), 11 were removed in part or totally (1.4%, 0.7-2.3%), as were two of 391 transvaginal meshes (0.5%, 0.1-1.6%), and four of 611 laparoscopically placed mesh implants (0.7%, 0.2-1.5%). The incidence of serious complications 6 months after the surgical procedure was estimated to be around 3.5% (2.0-5.0%) after MUS alone, 7.0% (2.8-11.3%) after MUS with prolapse surgery, 1.7% (0.0-3.8%) after vaginal native tissue repair, 2.8% (0.9-4.6%) after transvaginal mesh, and 1.0% (0.1-1.9%) after laparoscopy with mesh. CONCLUSIONS: Early serious complications are relatively rare. Monitoring must be continued and expanded to assess the long-term risk associated with mesh use and to identify its risk factors. TWEETABLE ABSTRACT: Short-term serious complications are rare after surgery for urinary incontinence or pelvic organ prolapse, even with mesh.


Assuntos
Diafragma da Pelve/cirurgia , Prolapso de Órgão Pélvico/cirurgia , Telas Cirúrgicas/efeitos adversos , Adulto , Idoso , Idoso de 80 Anos ou mais , Análise de Variância , Colposcopia/efeitos adversos , Colposcopia/mortalidade , Colposcopia/estatística & dados numéricos , Feminino , França/epidemiologia , Humanos , Incidência , Complicações Intraoperatórias/etiologia , Complicações Intraoperatórias/mortalidade , Pessoa de Meia-Idade , Prolapso de Órgão Pélvico/mortalidade , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/mortalidade , Estudos Prospectivos , Sistema de Registros , Slings Suburetrais/efeitos adversos , Slings Suburetrais/estatística & dados numéricos , Telas Cirúrgicas/estatística & dados numéricos , Centros Cirúrgicos/estatística & dados numéricos , Adulto Jovem
4.
Hum Reprod ; 34(5): 824-833, 2019 May 01.
Artigo em Inglês | MEDLINE | ID: mdl-30989214

RESUMO

STUDY QUESTION: Is the Sexual Activity Questionnaire (SAQ) a valid tool for patients treated for symptomatic endometriosis? SUMMARY ANSWER: For women having surgical treatment for endometriosis, we determined that the SAQ is a valid and responsive tool. WHAT IS KNOWN ALREADY: Endometriosis adversely affects sexual quality of life. Suitable validated sexual quality of life instruments for endometriosis are lacking both in clinical practice and for research. STUDY, DESIGN, SIZE, DURATION: A total of 367 women with proven endometriosis undergoing medical or surgical treatment were included in an observational study conducted between 1 January 2012 and 31 December 2014 in two French tertiary care centers. Both hospitals are reference centers for endometriosis treatment. Of these 367 women, 267 were sexually active and constituted the baseline population. PARTICPANTS/MATERIALS, SETTINGS, METHODS: Women >18 years old with histological or radiological proven endometriosis, consulting for painful symptoms of at least 3 months duration, infertility, or other symptoms (bleeding, cysts) were invited to complete self-administered questionnaires before (T0) and 12 months after treatment (T1). Tests of data quality included descriptive statistics of the data, missing data levels, floor and ceiling effects, structural validity and internal consistency.The construct validity was obtained by testing presupposed relationships between previously established SAQ scores and prespecified characteristics of the patients by comparing different subgroups of patients at T0. Sensitivity to change was subsequently calculated by comparing the SAQ score between T1 and T0 overall and for different subgroups of treatment. Effect sizes (to T1) were calculated according to Cohen's method. The minimally important difference was estimated by a step-wise triangulation approach (including anchor-based method). MAIN RESULTS AND THE ROLE OF CHANCE: In total, 267 sexually active patients (204 surgical and 63 medical treatment) completed the SAQ at T0 and 136 (50.9%) at T1. The SAQ score ranged from 2.0 to 28.0 (mean ± SD: 16.8 ± 5.7).The SAQ score was one-dimensional according to the scree plot with good internal consistency (Cronbach alpha = 0.78, 95% CI 0.74-0.81) and had good discriminative ability according to pain descriptors and quality of life in endometriosis. The SAQ was responsive in patients treated by surgery but the effect size was low (0.3, 95% CI (0.0-0.6), P = 0.01). The minimally important difference was determined at 2.2. LIMITATIONS, REASONS FOR CAUTION: The effect size for medical treatment was non-significant. Other effect sizes were low but statistically significant. This could be explained by lower libido due to progestin intake, which was used for both surgically and medically treated patients. WIDER IMPLICATIONS OF THE FINDINGS: The SAQ is easy to use, valid and effective in assessing sexual quality of life in patients with endometriosis. This patient-reported score could be used as a primary outcome for future clinical studies. The minimally important difference estimation will be useful for future research. We recommend using 2.2 for the minimally important difference of the SAQ. STUDY FUNDING/COMPETING INTEREST(S): This work was funded by the 'Direction à la Recherche Clinique et à l'Innovation' of Versailles, France and the 'Institut de Recherche en Santé de la Femme' (IRSF). The authors have no conflicts of interest to declare.

5.
Hum Reprod Open ; 2019(2): hoz007, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30968062

RESUMO

Study question: Could we construct and validate a preoperative score to predict rectosigmoid involvement in endometriosis (RE)? Summary answer: We developed a simple preoperative score (ENDORECT) to predict RE. What is known already: Accurate preoperative classification is important to optimize the surgical approach for patients with endometriosis but there is currently no reliable first-line examination to determine RE. Study design size duration: This was a single-centre observational study including all women (N = 119) who underwent complete surgery for endometriosis between January 2011 and June 2016 in the Gynaecological Department of the University Hospital of Poissy Saint-Germain en Laye. Participants/materials setting methods: Of the 119 women, 47 had RE and 72 did not. Two-thirds of the patients were randomly selected to derive the predictive score based on multiple logistic regression with internal validation by bootstrap. We used information from a self-assessment questionnaire, digital and speculum examination, transvaginal ultrasound and MRI. The score was then applied to the remaining sample of patients for validation. Main results and the role of chance: Four variables were independently associated with RE: palpation of a posterior nodule on digital examination (aOR=5.6; 95%CI [1.7-21.8]); a UBESS score of 3 on ultrasonography (aOR=4.9; 95%CI [1.4-19.8); RE infiltration on MRI (aOR=6.8; 95%CI [2-25.5]); and presence of blood in the stools during menstruation (aOR=5.2; 95%CI [1.3-24.7]). The ROC-AUC of the model was 0.86 (95%CI [0.77-0.94]) and the bootstrap procedure showed that the model was stable. The ENDORECT score was derived from these four criteria and three risk groups were identified: the high-risk group (score>17) had a probability of RE of 100% with an specificity (Sp) of 100%, postive likelihood ratio (Lr+)>10; the intermediate-risk group (score: 7-17) had a probability of RE of 42%; and the low-risk group (score=0), with a sensitivity (Se) of 97%, negative likelihood ratio (Lr-) of 0.07 and a probability of RE of 5%. In the validation cohort, a score >17 predicted RE with an Sp of 96, Lr+ of 9.2, and probability of RE of 83%. Patients in this sample with a score=0, had an Se of 100%, Lr- of 0 and a probability of RE of 0%. Limitations reasons for caution: The single-centre recruitment and over-representation of RE could constitute a referral bias. Wider implications of the findings: The use of a preoperative predictive score could facilitate patient counselling and guide surgical management. Both MRI and transvaginal ultrasound provide independent information and are useful before surgery for RE. Study funding/competing interests: No financial support was specifically received for this study. The authors declare no conflict of interest. Trial registration number: N/A.

6.
Gynecol Obstet Fertil Senol ; 47(4): 337-341, 2019 04.
Artigo em Francês | MEDLINE | ID: mdl-30769103

RESUMO

OBJECTIVES: There are no recommendations on the way emergency ultrasound should be performed but there are Standardized Acute Female Echography (SAFE) planes with quality criteria for ultrasound scoring. The objective of this study was to evaluate the impact of the quality of ultrasound on the diagnosis of ectopic pregnancy. METHODS: A retrospective study was conducted in 2016-2017 and included all Ectopic Pregnancies (EP). Clinical, biological and ultrasonographic characteristics were collected, in particular the analysis of ultrasound scans according to the scoring score of standardized planes (total score out of 15). EP diagnosed at first ultrasound and those from Pregnancy of unknown location (PUL) were compared. RESULTS: Hundred and seventeen patients were included: 45 (38.5%) in the group "EP from PLU" and 72 (61.5%) in the group "EP diagnosed directly". The ultrasound images were significantly better in the "directly diagnosed EP" group than in the "EP from PUL" group: 11.9/15 vs. 10.07/15 respectively (P=0.005). Moreover, in the group "EP from PUL", the images were significantly better on the final ultrasound diagnosing the EP compared to the first ultrasound performed: 11.4/15 vs. 10.07/17 (P=0.04). CONCLUSION: The evaluation of quality of ultrasound scan using a standardized scoring system shows an impact in the diagnosis of ectopic pregnancies.


Assuntos
Endossonografia , Gravidez Ectópica/diagnóstico por imagem , Ultrassonografia Pré-Natal , Adulto , Feminino , Humanos , Gravidez , Gravidez Ectópica/terapia , Estudos Retrospectivos
7.
Gynecol Obstet Fertil Senol ; 47(3): 265-272, 2019 03.
Artigo em Francês | MEDLINE | ID: mdl-30691974

RESUMO

OBJECTIVES: Surgical management of endometriosis may require different levels of surgical skill which influences the orientation of the patient. The Ultrasound-Based Endometriosis Staging System (UBESS) is a score developed in 2016 to predict the difficulty of surgery. To study the correlation between UBESS score and two main surgical classifications in the literature. METHODS: Study performed at the center of Poissy, France, between July 2016 and December 2017. Patients who underwent prospective UBESS staging then operated of their endometriosis were included. The patients were classified according to the levels of surgical difficulty of the Royal College of Obstetricians and Gynecologists (RCOG) and the classification created by Chi et al. The criterion of judgment was the correlation between the UBESS stages and RCOG and CHI levels. In a second analysis, we determined the predictive value of the operative plan for items included in the systematic sonographic evaluation described by Menakaya et al. RESULTS: Thirty-three patients were included in the study. Correlation was found to be low between UBESS and RCOG (θ=0.22) and between UBESS and CHI (θ=0.30). The prediction of the operative plan was good for endometrioma, sites specific tenderness, sliding sign, vaginal and digestive tract involvement; but modest for the anterior compartment and uterosacrals ligaments. CONCLUSION: In our study on a small number of patients, the UBESS score does not adequately predict the surgical difficulty. Taken separately, the items of systematic sonographic evaluation based on 5 domains successfully predict the operative plan.


Assuntos
Endometriose/classificação , Endometriose/cirurgia , Procedimentos Cirúrgicos em Ginecologia/métodos , Ultrassonografia , Adulto , Competência Clínica , Endometriose/diagnóstico por imagem , Feminino , França , Humanos , Estudos Retrospectivos
8.
J Gynecol Obstet Hum Reprod ; 48(2): 109-114, 2019 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-29654939

RESUMO

OBJECTIVES: To assess and compare the diagnostic accuracy of transvaginal ultrasonography (TVUS) by trained or untrained ultrasound operators in deep infiltrating endometriosis (DIE) imaging, for diagnosing DIE and bowel involvement. METHODS: This was an observational study of patients with clinically suspected DIE operated in a reference center. TVUS was performed pre-operatively by a trained or/and untrained ultrasound operator to search for DIE and rectal involvement. During surgery, DIE was diagnosed according to macroscopic and histological criteria. Sensitivity (Se), specificity (Sp) and c-index were calculated with 95% confidence intervals for trained and untrained operators, if TVUS results were significantly predictive of DIE and rectal involvement at p<0.05. RESULTS: 115 patients were included: 100 (87%) had DIE and 34 (29.6%) had bowel involvement. TVUS was performed by a trained ultrasound operator for 70 patients and by an untrained one for 56 patients. When performed by a trained operator, TVUS significantly predicted DIE with a Se of 58% (95% CI, 46-70), a Sp of 87.5% (95% CI, 63-100) and a c-index of 0.73 (95% CI, 0.59-0.87). TVUS performed by an untrained operator was not significantly predictive of DIE (p=0.58). Rectal involvement was significantly predicted by TVUS performed by a trained operator with a Se of 40% (95% CI, 23-59), a Sp of 93% (95% CI, 86-100) and a c-index of 0.67 (95% CI, 0.56-0.77). None of the untrained ultrasound operators diagnosed a bowel involvement. CONCLUSION: TVUS is not sufficient to diagnose DIE and bowel involvement, in particular when performed by untrained ultrasound operators.


Assuntos
Endometriose/diagnóstico por imagem , Endometriose/patologia , Pessoal de Saúde/educação , Intestinos/diagnóstico por imagem , Intestinos/patologia , Ultrassonografia , Adulto , Competência Clínica , Endometriose/cirurgia , Feminino , Humanos , Reto/diagnóstico por imagem , Reto/patologia , Sensibilidade e Especificidade , Ultrassonografia/métodos
9.
J Gynecol Obstet Hum Reprod ; 47(7): 265-274, 2018 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-29920379

RESUMO

First-line diagnostic investigations for endometriosis are physical examination and pelvic ultrasound. The second-line investigations are: targeted pelvic examination performed by an expert clinician, transvaginal ultrasound performed by an expert physician sonographer (radiologist or gynaecologist), and pelvic MRI. Management of endometriosis is recommended when the disease has a functional impact. Recommended first-line hormonal therapies for the management of endometriosis-related pain are combined hormonal contraceptives (CHCs) or the 52mg levonorgestrel-releasing intrauterine system (IUS). There is no evidence base on which to recommend systematic preoperative hormonal therapy solely to prevent surgical complications or facilitate surgery. After surgery for endometriosis, a CHC or 52mg levonorgestrel-releasing IUS is recommended as first-line treatment when pregnancy is not desired. In the event of failure of the initial treatment, recurrence, or multiorgan involvement, a multidisciplinary team meeting is recommended, involving physicians, surgeons and other professionals. A laparoscopic approach is recommended for surgical treatment of endometriosis. HRT can be offered to postmenopausal women who have undergone surgical treatment for endometriosis. Antigonadotrophic hormonal therapy is not recommended for patients with endometriosis and infertility to increase the chances of spontaneous pregnancy, including postoperatively. Fertility preservation options must be discussed with patients undergoing surgery for ovarian endometriomas.


Assuntos
Endometriose/tratamento farmacológico , Ginecologia , Obstetrícia , Guias de Prática Clínica como Assunto , Sociedades Médicas , Endometriose/diagnóstico , Endometriose/cirurgia , Feminino , França , Ginecologia/normas , Humanos , Obstetrícia/normas , Guias de Prática Clínica como Assunto/normas , Sociedades Médicas/normas
11.
Gynecol Obstet Fertil Senol ; 46(3): 223-230, 2018 03.
Artigo em Francês | MEDLINE | ID: mdl-29548620

RESUMO

Based on the best evidence available, we have provided guidelines for clinical practice to target the nature of endometriosis as a disease, the consequences of its natural history on management, and the clinical and imaging evaluation of the disease according to the level of care (primary care, specialized or referral). The frequency of endometriosis is unknown in the general population; endometriosis requires management when it causes symptoms (pain, infertility) or when it affect the function of an organ. In the absence of symptom, there is no need for follow-up or screening of the disease. Endometriosis may be responsible for various pain symptoms such as severe dysmenorrhea, deep dyspareunia, painful bowel movements or low urinary tract signs increasing with menstruation, or infertility. A careful evaluation of the symptoms and their impact on the quality of life should be made. The first-line examinations for the diagnosis of endometriosis are: digital examination and pelvic ultrasound. The second-line examinations are: the pelvic exam by an expert clinician, the pelvic MRI and/or the transvaginal ultrasound by an expert. MRI and ultrasound carrying different and complementary information. Other examinations may be considered as part of the pre-therapeutic assessment of the disease in case of specialized care. Diagnostic laparoscopy may be suggested in case of clinical suspicion of endometriosis whereas preoperative examinations have not proved the disease, it must be part of a management plan of endometriosis-related pain or infertility. During management, it is recommended to give comprehensive information on the different therapeutic alternatives, the benefits and risks expected from each treatment, the risk of recurrence, fertility, especially before surgery. The information must be personalized and take into account the expectations and preferences of the patient, and accompanied by an information notice given to the patient.


Assuntos
Endometriose/diagnóstico , Técnicas de Apoio para a Decisão , Diagnóstico por Imagem , Dispareunia/etiologia , Endometriose/epidemiologia , Feminino , Exame Ginecológico , Humanos , Laparoscopia , Dor Pélvica/etiologia
12.
Gynecol Obstet Fertil Senol ; 46(3): 214-222, 2018 Mar.
Artigo em Francês | MEDLINE | ID: mdl-29530554

RESUMO

Women with endometriosis often say that the information doctors give them should be improved. Patient support groups can provide missing information but may lack objectivity, or reliability, and may even generate anxiety or even harm their health. Clear unbiased medical information is the ideal. New patients with endometriosis wish to be taken seriously by primary care physicians, and be referred quickly to a specialist without further unnecessary investigation or delay. The diagnosis of endometriosis should ideally be made quickly, and should clearly specify the nature of the disease, its evolution, and its consequences on quality of life, relationships, and fertility. When choosing a treatment, information should state the risks of each treatment, the risks of recurrence long term, and the therapeutic alternatives. These should include conventional medical treatment, lifestyle adaptation, or alternative therapies. In case of surgery, prior written information should be provided, the likely scar appearance, the short and long term consequences in terms of pain, postoperative recovery time and complication rates. Once the surgery is performed, the degree of endometriotic involvement and the treatment undertaken should be explained. At discharge, patients should be told the expected recovery time, and the consequences of the operation on daily life.


Assuntos
Endometriose/diagnóstico , Endometriose/terapia , Educação de Pacientes como Assunto , Tomada de Decisões , Feminino , Humanos , Relações Médico-Paciente
13.
Gynecol Obstet Fertil Senol ; 46(3): 168-176, 2018 Mar.
Artigo em Francês | MEDLINE | ID: mdl-29530559

RESUMO

In case of consultation for chronic pelvic pain or suspicion of endometriosis, it is recommended to evaluate the pain (intensity, resonance) and to search out the evocative and localizing symptoms of endometriosis (Grade B). The main symptoms suggestive of endometriosis are: severe dysmenorrhea (NP2), deep dyspareunia (NP2), painful defecation during menstruation (NP2), urinary tract symptoms during menstruation (NP2) and infertility (NP2). In patients with chronic pelvic pain, it is recommended to search deep infiltrating endometriosis in patients with painful defecation during menstruation or severe deep dyspareunia (Grade B). It is recommended to search symptoms suggestive of sensitization in painful patients with endometriosis (Grade B). When suggestive symptoms of endometriosis are present, a directed gynecological examination is recommended, where possible, including examination of the posterior vaginal cul-de-sac (Grade C). In assessing pain intensity or evaluating analgesic effectiveness of a treatment, it is recommended to use a scale to measure the intensity of pain (Grade A). In the management of symptomatic endometriosis, it is recommended to evaluate the quality of life (Grade C).


Assuntos
Dispareunia/etiologia , Endometriose/diagnóstico , Dor Pélvica/etiologia , Qualidade de Vida , Inquéritos e Questionários , Feminino , Exame Ginecológico , Humanos , Fatores de Risco
14.
Gynecol Obstet Fertil Senol ; 46(3): 144-155, 2018 Mar.
Artigo em Francês | MEDLINE | ID: mdl-29550339

RESUMO

First-line investigations to diagnose endometriosis are clinical examination and pelvic ultrasound. Second-line investigations include pelvic examination performed by a referent clinician, transvaginal ultrasound performed by a referent echographist, and pelvic MRI. It is recommended to treat endometriosis when it is symptomatic. First-line hormonal treatments recommended for the management of painful endometriosis are combined with hormonal contraceptives or levonorgestrel 52mg IUD. There is no evidence to recommend systematic preoperative hormonal therapy for the unique purpose of preventing the risk of surgical complications or facilitating surgery. After endometriosis surgery, combined hormonal contraceptives or levonorgestrel SIU 52mg are recommended as first-line therapy in the absence of desire of pregnancy. In case of initial treatment failure, recurrence, or multiple organ involvement by endometriosis, medico-surgical and multidisciplinary discussion is recommended. The laparoscopic approach is recommended for the surgical treatment of endometriosis. HRT may be offered in postmenopausal women operated for endometriosis. In case of infertility related to endometriosis, it is not recommended to prescribe anti-gonadotropic hormone therapy to increase the rate of spontaneous pregnancy, including postoperatively. The possibilities of fertility preservation should be discussed with the patient in case of surgery for ovarian endometrioma.


Assuntos
Endometriose/diagnóstico , Endometriose/terapia , Terapias Complementares , Anticoncepcionais Orais Hormonais , Diagnóstico por Imagem , Feminino , Exame Ginecológico , Humanos , Infertilidade Feminina/etiologia , Infertilidade Feminina/terapia , Educação de Pacientes como Assunto , Dor Pélvica/tratamento farmacológico , Dor Pélvica/etiologia
15.
J Gynecol Obstet Hum Reprod ; 47(2): 69-79, 2018 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-29133195

RESUMO

PURPOSE: To develop a questionnaire based on patients' verbal descriptors, to measure the painful symptoms of endometriosis. METHODS: We performed a two-round modified DELPHI procedure mixing endometriosis patients and physicians to select a set of statements to describe the painful symptoms of endometriosis. Each panelist rated each statement based on diagnosis validity and clarity. The clinicians were experts in endometriosis management selected from various geographic regions in France. Patients were women with surgically confirmed endometriosis who volunteered from a patient association and from the recruitment of the participating physicians. The first round questions were derived from words and phrases in narratives of pain by endometriosis patients. RESULTS: Overall, 76 experts were invited, and of these 56 (74%), comprising 33 patients and 23 gynecologists, responded to the first round questionnaire, and 40 (71.4%) to the second round. Among the 48 statements assessed in the first-round questionnaire, 11 were selected after completion of the two round DELPHI procedure. After discussion and rewording of some items, a total of 21 questions were selected during a final face-to-face meeting. The content of the final questionnaire is organized according to four dimensions: (i) spontaneous pelvic pain and dysmenorrhea, (ii) dyspareunia, (iii) painful bowel symptoms, (iv) and other symptoms. We also provide an English (UK) version produced using several steps of translation and back-translation. CONCLUSIONS: The questionnaire has content validity to measure the subjective experiences of patients with painful endometriosis and can provide a solid basis on which to develop an efficient patient-centered outcome to measure the painful symptoms in therapeutic or in diagnostic studies of endometriosis.


Assuntos
Dispareunia/diagnóstico , Endometriose/complicações , Medição da Dor/métodos , Dor Pélvica/diagnóstico , Psicometria/métodos , Inquéritos e Questionários , Adulto , Técnica Delfos , Dismenorreia/diagnóstico , Dismenorreia/etiologia , Dispareunia/etiologia , Feminino , Humanos , Pessoa de Meia-Idade , Medição da Dor/instrumentação , Dor Pélvica/etiologia , Narrativas Pessoais como Assunto , Médicos , Psicometria/instrumentação
16.
Prog Urol ; 27(11): 576-584, 2017 Sep.
Artigo em Francês | MEDLINE | ID: mdl-28461041

RESUMO

AIMS: The Female Pelvic Floor Questionnaire (FPFQ) is a self-administered tool on pelvic floor function. Our aim was to carry out a cultural adaptation of the FPFQ into French and to assess its psychometric properties. METHODS: After cross-cultural adaptation into French, acceptability and reliability of the questionnaire were assessed through a sample of 56 women in a test-retest. Discriminative construct validity was evaluated by comparing the results obtained by the FPFQ to those of other validated questionnaires. Longitudinal follow-up of the 282 pregnant women included in the PreNatal Pelvic floor Prevention trial (3PN) was used to analyze responsiveness. RESULTS: The proportion of missing data did not exceed 4 % for questions about bladder function, bowel function and pelvic organ prolapse; 10 % for issues related to sexual function. Question 9 was considered difficult to understand by 14 % of women. After rewriting, this issue was retested in a new sample of 52 women and presented no further problems. The intra-class correlation coefficient was greater than or equal to 0.7 for all domains during the test-retest. The FPFQ was strongly and significantly correlated (Spearman r>0.5) with the other validated questionnaires. The French version of FPFQ recorded changes in urinary and sexual symptoms for the women involved in 3PN trial with a standardized response mean equal to 0.83 and 0.44, respectively. CONCLUSION: The French version of the FPFQ is self-administered, reliable, valid, and can detect a change in symptoms during follow-up. LEVEL OF EVIDENCE: Level 4.


Assuntos
Características Culturais , Autoavaliação Diagnóstica , Distúrbios do Assoalho Pélvico/diagnóstico , Adulto , Feminino , Humanos , Psicometria , Traduções
17.
Hum Reprod ; 32(6): 1258-1269, 2017 06 01.
Artigo em Inglês | MEDLINE | ID: mdl-28383700

RESUMO

STUDY QUESTION: Which of the Endometriosis Health Profile-5 (EHP-5) and the EuroQol-5D (EQ-5D) is the most efficient to assess quality of life in women suffering from endometriosis? SUMMARY ANSWER: Although EHP-5 and EQ-5D instruments had an excellent responsiveness, EHP-5 has a better discriminative ability than EQ-5 to measure health-related quality of life (HrQoL). WHAT IS KNOWN ALREADY: Proper measurement of HrQoL is important in endometriosis. While many quality of life instruments are available, few have been completely validated in endometriosis. The EHP-5 and the EQ-5D are short and practical scales, which may be useful. Literature is lacking to determine which one is the most suitable in clinical practice or in clinical research. STUDY DESIGN, SIZE, DURATION: This prospective and observational study conducted between 1 January 2012 and 31 December 2013 included a total of 253 consecutive women with proven endometriosis, undergoing medical or surgical treatment, in 2 French tertiary care centers. PARTICIPANTS/MATERIALS, SETTINGS, METHODS: Women over 18 years consulting for painful symptoms of at least 3 months' duration or for infertility, with endometriosis proven histologically or radiologically, were requested to fill in the 2 scales before (T0) and 12 months after treatment (T1). Construct validity consisted in testing presupposed relationships between the scales and the characteristics of the patients or the endometriosis. Responsiveness to change was calculated for all patients and in each treatment group. Effect sizes were used according to Cohen's d method. MAIN RESULTS AND THE ROLE OF CHANCE: A total of 216 women filled in completely all the questionnaires at T0 and 133 (61.6%) at T1. EHP-5 and EQ-5D had good discriminative abilities regarding the patients' symptoms, with significant superiority of EHP-5 concerning three of the nine hypotheses. The largest difference was that calculated for the 'intensity of dysmenorrhea' using the Visual Analogic Scale, with respectively effect size from Cohen's d (ES) = 0.86 95% CI (0.54-1.17) for EHP-5 versus 0.48 95% CI (0.16-0.79) for EQ-5D. There were no differences in EHP-5 or in EQ-5D scores between subgroups according to the characteristics of endometriosis. Overall responsiveness was excellent and equivalent for EHP-5 and for EQ-5D, with, respectively, ES = 0.81 95% CI (0.56-1.56) versus ES = 0.95 95% CI (0.68-1.20). In subgroup analyses, EHP-5 was responsive in case of medical treatment with ES = 0.93 95% CI (0.07-1.70), whereas EQ-5D was not, ES = 0.73 95% CI (-0.06-1.47). LIMITATIONS, REASONS FOR CAUTION: Our study population included patients with symptomatic and mainly severe forms of endometriosis, which may suggest a spectrum bias. The evaluation of responsiveness in case of medical treatment was based on a small number of patients, which limits the interpretation of the difference found between the two scales in this subgroup. WIDER IMPLICATIONS OF THE FINDINGS: EHP-5 is a simple, efficient and valid tool for evaluating quality of life in daily practice and also valuable to provide a primary outcome in clinical studies evaluating treatment efficacy. STUDY FUNDING/COMPETING INTEREST(S): This work was funded by the Direction à la Recherche Clinique et à l'Innovation of Versailles, France. The authors have no conflicts of interest. TRIAL REGISTER NUMBER: None.


Assuntos
Ansiedade/diagnóstico , Efeitos Psicossociais da Doença , Depressão/diagnóstico , Endometriose/fisiopatologia , Qualidade de Vida , Estresse Psicológico/diagnóstico , Adolescente , Adulto , Ansiedade/etiologia , Ansiedade/psicologia , Estudos de Coortes , Terapia Combinada/efeitos adversos , Terapia Combinada/psicologia , Depressão/etiologia , Depressão/psicologia , Endometriose/psicologia , Endometriose/terapia , Feminino , Seguimentos , França , Humanos , Infertilidade Feminina/etiologia , Infertilidade Feminina/prevenção & controle , Pessoa de Meia-Idade , Dor Pélvica/etiologia , Dor Pélvica/prevenção & controle , Prognóstico , Estudos Prospectivos , Escalas de Graduação Psiquiátrica , Estresse Psicológico/etiologia , Estresse Psicológico/fisiopatologia , Estresse Psicológico/psicologia , Centros de Atenção Terciária , Adulto Jovem
18.
Acta Anaesthesiol Scand ; 60(9): 1222-9, 2016 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-27345429

RESUMO

BACKGROUND: The need to preserve operating room (OR) scheduling flexibility can challenge adherence to the 2-h pre-operative fasting period recommendation before elective surgery. Our primary objective was to assess the feasibility of a pre-operative carbohydrate (CHO) drink delivery strategy preserving OR scheduling flexibility. METHODS: During the 1st study phase, patients admitted for elective surgery fasted overnight (Control group); during the 2nd phase, patients fasted overnight and received a pre-operative CHO drink (CHO group). CHO delivery time was set to allow any patient to be ready for surgery 30 min ahead of the scheduled time and any patient with an operation scheduled in the afternoon to be ready at 13:00 hours; patients admitted the morning of an early morning operation would not be allowed to take a CHO drink. RESULTS: We included 194 patients in the Control group and 199 in the CHO group. In the CHO group, the morning CHO dose was delivered to 66.3% of the patients (95% CI 59.3-72.9%), with a median pre-operative fasting time period of 4 h 57 min. After excluding patients admitted the morning of an operation scheduled before 10:00 hours, the delivery rate was 77.2% (70.2-83.3%). Patients in the CHO group experienced significantly less pre-operative thirst (median 2 vs. 5 on a 0-10 scale, P < 0.0001) and hunger (0 vs. 2, P < 0.0001) than those in the Control group. CONCLUSION: Although preservation of OR scheduling flexibility resulted in a longer fasting time than recommended, CHO drink can be made available to a large proportion of patients with significantly reduced perioperative discomfort.


Assuntos
Procedimentos Cirúrgicos Eletivos , Jejum , Salas Cirúrgicas , Cuidados Pré-Operatórios , Adulto , Idoso , Ingestão de Líquidos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Admissão e Escalonamento de Pessoal , Fatores de Tempo
19.
J Gynecol Obstet Biol Reprod (Paris) ; 45(9): 1054-1059, 2016 Nov.
Artigo em Francês | MEDLINE | ID: mdl-27114064

RESUMO

INTRODUCTION: Randomized controlled trials (RCT) in surgery are often subject to difficulties inherent in the study design and recruitment of patients. Women's participation rate to RCTs in surgery is relatively low and varies from 30 to 70%. These recruitment problems might induce a weak scientific value and even stop the study. Thus, optimizing recruitment is a challenge for surgical research. In contemporary literature, we lack data on motivations and profile of women who refuse to participate in a RCT in surgery. OBJECTIVE: To explore the potentially influential factors affecting women's decision to decline participation in PROSPERE trial, comparing laparoscopic sacrocolpopexy (LSCP) to vaginal mesh for cystocele repair. PATIENT AND METHOD: Retrospective, observational, qualitative, bicentric study conducted in the department of gynecology of Poissy and Lille hospitals. Patients included were those who refused to participate to PROSPERE trial in both centers. Factors of non-participation in the trial were recorded at the time of the first visit. A control group consisted of women who agreed to participate in the trial was also analyzed. RESULTS: In both centers, 139 were eligible to participate in the trial but 35 of them (25%) refused. Thirty-two women agreed to declare their refusal motivations. Vaginal mesh was finally performed in 18 (56,2%) patients and LSCP in 14 patients (43,8%). The control group consisted of 20 women, including 9 operated by vaginal mesh and 11 by LSCP. Patient's characteristics were similar in the both groups. Most influencing factor in refusal for participation was "previous choice of technique" in 50% cases (16/32), followed by "geographical remoteness and difficulties for additional visits" in 40.6% cases (13/32), and finally by "do not accept the concept of randomization" in 21.8% cases (7/32). The most influencing factor in women's acceptance was interest in helping others by "supporting medical research" in 100% cases (20/20), followed by "potential personal benefits and close follow-up" in 60% (12/20). CONCLUSION: Our study identified the most influential factors relevant to women decision-making whether or not to participate in RCT in surgery. A number of factors leading to refusal of participation are potentially correctable leading to better recruitment rates in future RCTs. Optimization of information on the principle of randomization, limiting the number of additional visits could help researchers improve participation rates.


Assuntos
Comportamento de Escolha , Procedimentos Cirúrgicos em Ginecologia/psicologia , Motivação , Seleção de Pacientes , Ensaios Clínicos Controlados Aleatórios como Assunto , Idoso , Feminino , Humanos , Pessoa de Meia-Idade , Pesquisa Qualitativa , Estudos Retrospectivos
20.
Prog Urol ; 25(9): 530-5, 2015 Jul.
Artigo em Francês | MEDLINE | ID: mdl-26032455

RESUMO

AIMS: To assess the prevalence of anal (AI) and urinary (UI) incontinence at medium term after 3rd and 4th degree anal sphincter tears and their impact on sexuality and women's quality of life. MATERIAL: It is a case-control, single center study. Sixty-eight primiparous women delivered with severe anal sphincter tear (exposed group) were compared to 136 women without (control group). Questionnaires on anal and urinary incontinence, sexual function and quality of life, using validated scores, were sent between two and five years after the first delivery. Maternal and obstetric data were collected retrospectively on the medical files. RESULTS: The answer rate was 22.5% (46/204) of which 30.9% (21/68) in the exposed group and 18.4% (25/136) in the unexposed group. In case of severe anal sphincter tear, 57.1% of women reported an AI vs 48% in the control group (P=0.76). The rate of AI for liquid stool was significantly higher in the exposed group (P=0.05). Patients with severe perineal tears reported a greater impact of symptoms on their quality of life but the difference with the control group was not significant. CONCLUSIONS: The severity of symptoms related to anal sphincter tears is common and underestimated. Preventive measures must be improved in order to maintain women's quality of life. LEVEL OF EVIDENCE: 4.


Assuntos
Canal Anal/lesões , Parto Obstétrico/efeitos adversos , Incontinência Fecal/etiologia , Períneo/lesões , Qualidade de Vida , Incontinência Urinária/etiologia , Adulto , Estudos de Casos e Controles , Feminino , Humanos , Gravidez , Sexualidade
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