Quality of cares, management of obstetrical risk and mode of delivery in Quebec (QUARISMA)- English version

RATIONAL: The caesarean section rate continues to rise in industrialized countries. In Quebec, the rate increased from 18.5% in 2000 to over 22.6% in 2004.  The World Health Organization (WHO) recommends that not more than 15% of births should be delivered by caesarean section. The rising caesarean rate and the growing perception of caesarean births as routine raise important public health issue. Morbidity and the long-term complications resulting from caesarean births are not well understood, in particular among low-risk patients of obstetric complications. Since the mid-1990s a number of studies have raised concerns about the risk of materno-foetal morbidity associated with caesarean births compared to vaginal delivery. This study has been developed to provide an adapted solution to this problematic, especially when the elective primary caesarean section rate without medical justification increases. QUARISMA is a multifaceted evidence medicine program based on audit and feedback, local opinion leader and educative activities, according to WHO guidelines for the evaluation of quality of care in obstetrics. This program focuses on the active participation of local health professionals in the intervention process.

HYPOTHESIS:  Primary - The QUARISMA program will result in a 20% reduction in the rate of caesarean section among the hospitals following the intervention compared to control hospitals. Secondary - This program will result in: 1) a reduction in materno-foetal morbidity, including a reduction in severe morbidity among low risk patients; and 2) no augmentation in materno-foetal morbidity among high risk patients.

STUDY DESIGN: This is a cluster randomized controlled trial in Quebec, multi-centered, stratified and non-blinded, to evaluate the effectiveness of the QUARISMA program between an intervention group and a control group. Randomisation and intervention unit is the reference hospital, and the unit of analysis is the patient.

POPULATION: Hospitals will be recruited in Quebec. Public hospitals with functional surgical rooms, more than 300 deliveries per year, a caesarean rate ≥ 17%, and written agreement to participate in the study from the directors of maternity services and professional services, will be included in the trial. In order to participate in the study patients must meet the following criteria: Inclusion - Patients carrying a viable foetus during the course of the study. Exclusion - Patients that give birth or abort before 24 weeks of gestation; patients that die prior to giving birth; patients that give birth to a baby weighing less than 500 grams.

METHODS: 26 hospitals will be stratified according to the level of care offered with 13 randomized to the QUARISMA program and 13 to the control group. A minimum of 7,800 patients per year will be recruited during the 3.5 years of the program, with a mean expected recruitment of 25,000 patients per year. A one year pre-intervention period, during which time baseline data will be collected, will be followed by a year and a half intervention phase, and a subsequent one year post-intervention phase. Four types of data will be analysed during the audit sessions: 1) a situational analysis; 2) the medical files of low-risk patients delivered by cesarean section; 3) statistics of the department; and 4) Satisfaction investigations for the patients included in the audit sessions. The trial data will be obtained from hospital registries and patient medical files before, during and after the intervention period, using standardized procedures. The caesarean section rate during the post-intervention period will be the primary outcome for judging the efficacy of intervention, and will be estimated by the Odds Ratio given by the GEE method and tested by the unilateral Wald's test. This study will also examine the health economic questions. The study will be managed by a multi-disciplinary committee with expertise in clinical research. An independent committee will follow the progress of the study and monitor the quality of data and the analysis.

RESULTS:  This study will provide strong evidence to promote an approach in which the health professionals are actively implicated in the analysis and the modification of health care processes to improve the quality of the obstetric care services. The results of this study will help health care professionals to improve the quality of the obstetric services, institute standards of quality control, meet the information needs of patients with regard to childbirth options, and significantly reducing the rates of caesareans section rate.

QUESTIONS 1: What is your opinion about the design of the study and the description of the intervention ?

QUESTION 2: In your opinion, is this program is a transdisciplinary program ? and why ?