Clinical trial NCT02274441: Activity and Quality of Care Indicators' for a Sentinel Network Creation
Official title: Gynaecological Emergencies: Validation of Indicators of Activity and Quality of Care for Creation of a Network Sentinel
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstetrics
Maternal Morbidity
Gynecology
Quality
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2014-10-24
Enrollment: 2000
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Number of centers :

22 French-speaking gynaecological emergencies departments leaned with a public maternity

Number of subjects expected:

2000 consultations for acute pelvic pain, 200 patients hospitalized for data-gathering stage; 408 records for checking data stage

Brief summary: There is no large-scale data in France or internationally, on the quality of care in gynecological emergencies, or the consequences of delay or misdiagnosis of women's health or on determinants of these delays or misdiagnosis. The creation of a sentinel network for gynecological emergencies could help quantify these links and test strategies to avoid the worst effects by implementing simple diagnostic tools from clinical research.

The network will be designed to promote research in women's health and the emergency reception by focusing on:

(i) Assessment of the quality and organization of care and professional practice for the management of gynecological emergencies.

(ii) The study of severe morbidity and its determinants (iii) comparison of organizational practices and health outcomes of women over time within the same department or between services having substantially the same recruitment (iv) Comparison of organization systems gynecological emergencies departement between different high resource francophone countries (France, Switzerland, Belgium).

(v) The assessment of new diagnostic strategies (sorting or diagnostic aid) or therapeutic derived from clinical research.

Detailed description: Objectives :

* To measure the incidence of the potentially life-threatening gynaecological emergencies (G-PLE) and of the Cases of severe morbidity (SM)
* To analyze the determinants of the SM,
* To validate an objective score of quality

Criterias of evaluation:

* Incidence of the G-PLE and SM cases during one month.
* Reliability and validity of measurements of the indicators of quality of care.

Methodology:

Stage 1: Data acquisition (prospective) within 22 gynaecological emergencies departments.

Stage 2: Sampling and checking of files of patients included at stage 1

Calendar of the research project:

18 months:

* 6 months for the phase of preparation,
* 1 month for the investigation of incidence,
* 5 months for the phase of checking data,
* 6 months of statistical analysis

Statistical Analyzes:

Descriptive statistics of the data. Estimation of the incidence rate of the potentially life-threatening gynaecological emergencies (G-PLE) and of the cases of Severe morbidity (SM) among women consulting for acute pelvic pain.

To construct reliable quality indicators, principal components analysis and Cronbach's α statistics will be performed to determine the underlying dimensions. Construct validity of indicators will be assessed by testing predefined hypotheses about relationship between G-PLE and or SM and quality indicators.

Eligibility criteria: Inclusion Criteria:

* French-speaking gynaecological emergencies departments leaned with a public maternity volunteers to take part in the study.
* Sample of files resulting from the principal centers recruiters

Exclusion Criteria:

-

Primary outcomes:
measure: Incidence of the potentially life-threatening gynaecological emergencies (G-PLE )
timeFrame: 1 year
measure: Incidence of severe morbidity (SM) cases
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Poissy
country: France
facility: Poissy Saint Germain Hospital
Study officials:
References: