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Importance: Reducing the use of coercion in mental health care is crucial from a human rights and public health perspective. Psychiatric advance directives (PADs) are promising tools that may reduce compulsory admissions. Assessments of PADs have included facilitation by health care agents but not facilitation by peer workers.Objective: To determine the efficacy of PADs facilitated by peer workers (PW-PAD) in people with mental disorders.Design, Setting, and Participants: A multicenter randomized clinical trial was conducted in 7 French mental health facilities. Adults with a DSM-5 diagnosis of schizophrenia, bipolar I disorder, or schizoaffective disorder who had a compulsory admission in the past 12 months and the capacity to consent were enrolled between January 2019 and June 2020 and followed up for 12 months.Interventions: The PW-PAD group was invited to fill out a PAD form and meet a peer worker who was trained to assist in completing and sharing the form with relatives and psychiatrists.Main Outcomes and Measures: The primary outcome was the rate of compulsory admission at 12 months after randomization. The overall psychiatric admission rate, therapeutic alliance, quality of life, mental health symptoms, empowerment, and recovery outcomes were also investigated.Results: Among 394 allocated participants (median age, 39 years; 39.3% female; 45% with schizophrenia, 36% bipolar I disorder, and 19% schizoaffective disorder), 196 were assigned to the PW-PAD group and 198 to the control group. In the PW-PAD group, 27.0% had compulsory admissions compared with 39.9% in the control group (risk difference, -0.13; 95% CI, -0.22 to -0.04; P = .007). No significant differences were found in the rate of overall admissions, therapeutic alliance score, and quality of life. Participants in the PW-PAD group exhibited fewer symptoms (effect size, -0.20; 95% CI, -0.40 to 0.00), greater empowerment (effect size, 0.30; 95% CI, 0.10 to 0.50), and a higher recovery score (effect size, 0.44; 95% CI, 0.24 to 0.65), compared with those in the control group.Conclusions and Relevance: Peer worker-facilitated PADs are effective in decreasing compulsory hospital admissions and increasing some mental health outcomes (self-perceived symptoms, empowerment, and recovery). Involving peer workers in the completion of PADs supports the current shift of mental health care from substitute decision-making to supported decision-making.Trial Registration: ClinicalTrials.gov Identifier: NCT03630822. [ABSTRACT FROM AUTHOR]

Objective: We still don't know if recurrent major depressive disorder (RMDD) may impact the quality of the end-of-life (EOL) cancer care in France. To tackle this knowledge gap, we explored EOL care in RMDD subjects who died from cancer compared to subjects without psychiatric disorder in a 4-year nationwide cohort study.Design: Nationwide cohort study.Setting: National hospital database, France.Participants: All patients aged ≥15 years who died from cancer in hospital: 4070 RMDD subjects and 222,477 controls, 2013-2016, France.Main Outcome Measures: Palliative care in the last 31 days of life and high-intensity EOL care including chemotherapy in the last 14 days of life, artificial nutrition, tracheal intubation, mechanical ventilation, gastrostomy, cardiopulmonary resuscitation, dialysis, transfusion, surgery, endoscopy, imaging, intensive care unit and emergency department admission in the last 31 days of life. Multivariate generalized mixed models with log-normal distribution was used to compare RMDD subjects and controls.Results: Compared to the controls, the RMDD subjects died 3 years younger, had more comorbidities, more thoracic cancers, less metastases and longer time from cancer diagnosis to death. After matching and adjustment, subjects with RMDD were found to receive more palliative care and less high-intensity EOL care, had fewer iterative admissions to acute care unit, and died less often in the intensive care unit and emergency department.Conclusions: RMDD subjects were more likely to receive palliative care associated with less high-intensity EOL care. Yet the interpretation may be discussed, resulting from either patients'/families' wishes or difficulties for providers in offering personalized care to RMDD. [ABSTRACT FROM AUTHOR]

Objective: Quality of life (QoL) is still assessed using paper-based and fixed-length questionnaires, which is one reason why QoL measurements have not been routinely implemented in clinical practice. Providing new QoL measures that combine computer technology with modern measurement theory may enhance their clinical use. The aim of this study was to develop a QoL multidimensional computerized adaptive test (MCAT), the SQoL-MCAT, from the fixed-length SQoL questionnaire for patients with schizophrenia.Methods: In this multicentre cross-sectional study, we collected sociodemographic information, clinical characteristics (i.e., duration of illness, the PANSS, and the Calgary Depression Scale), and quality of life (i.e., SQoL). The development of the SQoL-CAT was divided into three stages: (1) multidimensional item response theory (MIRT) analysis, (2) multidimensional computerized adaptive test (MCAT) simulations with analyses of accuracy and precision, and (3) external validity.Results: Five hundred and seventeen patients participated in this study. The MIRT analysis found that all items displayed good fit with the multidimensional graded response model, with satisfactory reliability for each dimension. The SQoL-MCAT was 39% shorter than the fixed-length SQoL questionnaire and had satisfactory accuracy (levels of correlation >0.9) and precision (standard error of measurement <0.55 and root mean square error <0.3). External validity was confirmed via correlations between the SQoL-MCAT dimension scores and symptomatology scores.Conclusion: The SQoL-MCAT is the first computerized adaptive QoL questionnaire for patients with schizophrenia. Tailored for patient characteristics and significantly shorter than the paper-based version, the SQoL-MCAT may improve the feasibility of assessing QoL in clinical practice. [ABSTRACT FROM AUTHOR]

Objective: Researchers are interested in studying whether the quality of life (QoL) of cancer patients and caregivers is influenced by internal psychobehavioral processes (temporality and coping strategies) and the personality traits that they or their relatives experience. We examined these associations in a sample of patient-caregiver dyads by using the actor-partner interdependence model.Methods: This cross-sectional study involved 156 cancer patient-caregiver dyads. The self-reported data included QoL (Short-Form 36), coping strategies (Brief Coping Orientation to Problems Experienced Scale), time perspectives (Zimbardo Time Perspective Inventory), and personality (Big Five Inventory). The actor-partner interdependence model was used to test the dyadic effect individualizing actor (degree to which the individual's characteristics were associated with their QoL) and partner (degree to which the individual's characteristics were associated with the QoL of the other dyad member) effects.Results: Actor effects were found for patients and caregivers: The use of positive thinking and future/present-hedonistic perspectives were associated with higher QoL; the use of avoidance and past-negative perspective were associated with lower QoL. Partner effects were also found highlighting the specific mechanisms of the interconnections in the patient-caregiver dyad. The patient's QoL was higher when the caregiver used social support and experienced openness. The caregiver's QoL was lower when the patient used social support and avoidance strategies and experienced future perspective.Conclusions: The examination of the relationships between individuals' QoL and their internal psychobehavioral processes and personality traits will have several applications in the routine clinical management. Individual-level and dyad-level interventions should be proposed: cognitive-rehabilitation, emotional and cognitive self-regulation for time perspectives, and personality constructs. [ABSTRACT FROM AUTHOR]

Introduction Quantify quality of life (QoL) outcomes in gastroschisis children is little assessed. The primary objective was to describe the long-term outcome of newborns with gastroschisis treated in three tertiary care hospitals of France in terms of neurodevelopment and QoL. Materials and Methods The study reported was a cross-sectional, descriptive multicentric retrospective study assessing the outcome of newborns with gastroschisis, born between January 1, 2009, and December 31, 2014, treated at two large and French level III neonatal intensive care units. Long-term outcome data were assessed by questionnaires sent to the infants' parents. Questionnaires explored global health, neurological development, and quality of life (overall assessment including socio-economic and medical), Age & Stages Questionnaire, infants' quality of life (KIDSCREEN), and quality of parents' life (General Questionnaire Short Form-36). Results In this study, 50% of the survivor's families answered the assessment form (n = 33). The average follow-up age was 40 months, ranging from 8 months to 6 years. Cases of simple gastroschisis more often had a normal score for "communication" (p = 0.033), while patients who received morphine for a longer duration had significantly lower scores for the items "communication" and "problem resolving" (p = 0.024 and p = 0.011, respectively). Children's QoL was significantly lower for patients with gestational age younger than 36 weeks (p = 0.023) and for patients born following "fetal cause delivery" (p = 0.022). Parents had a significantly higher physical composite score if their child underwent primary closure (p = 0.012). Conclusion Our analyses confirm the idea that cases of complex gastroschisis and preterm delivery may lead to poorer outcome. Such hindsight (40 months in mean) allowed for an interesting assessment of development long after the patient's initial hospitalization and to confirm these results, a standardized neuropsychological evaluation of patients should be done when at least 6 years old. An accurate assessment of the social environment and its impact on the development and QoL of children will be fundamental to avoid selection bias. [ABSTRACT FROM AUTHOR]

Aim: Individuals with severe and complex disabilities, defined by a combination of profound intellectual impairment and serious motor deficit resulting in extreme dependence, often remain in hospital or at residential facilities. The aim of this study was to identify the determinants of quality of life (QoL) of 238 health care workers (HCWs) caring for individuals with severe and complex disabilities.Method: We conducted a cross-sectional study. The recruitment of the HCWs was performed in five French centres specializing in patients with severe and complex disabilities. The selection criteria were age above 18 years, being an institutional referent HCW (a resource person coordinating various issues for or about the patient), and agreeing to participate. Sociodemographic, health, professional variables, and psycho-behavioural (QoL, burn-out, and coping strategies) data were collected.Results: Of the 362 eligible HCWs, 65.7% returned the questionnaires. The scores of the physical and social dimensions of QoL were significantly lower, and the score of the psychological dimension significantly higher, than those of a comparison group. The main factors modulating QoL were age, financial difficulties, nature of coping strategy, and burn-out.Interpretation: This research provides preliminary evidence that caring for patients with severe and complex disabilities affects the QoL of HCWs. These results support the need for optimization of the work environments for HCWs. [ABSTRACT FROM AUTHOR]

Background: Early hospital readmission of patients after discharge is a public health problem. One major cause of hospital readmission is dysfunctions in integrated pathways between community and hospital care that can cause adverse drug events. Furthermore, the French ENEIS 2 study showed that 1.3% of hospital stays originated from serious adverse drug events in 2009. Pharmacy-led medication reviews at hospital transitions are an effective means of decreasing medication discrepancies when conducted at admission or discharge. However, it is difficult to assess the true impact of pharmacist-led medication reviews in specific high-risk populations, such as pediatric and geriatric populations. In such a context, it is important to demonstrate the effectiveness of medication reconciliation as part of a standardized medication review process-in pediatric and elderly populations-on all-cause readmissions in a large randomized controlled clinical trial. The aim of this study is to assess the impact of the pharmacist-led medication review on the rate of readmissions and/or death after hospital discharge and patient treatment satisfaction.Methods/design: The study is a randomized controlled clinical trial. A total of 1400 hospitalized patients will be randomized in two groups: (1) the experimental group (group receiving a pharmacist-led medication review) and (2) the control group (group receiving usual care). The pharmacist-led medication review process includes medication reconciliation, treatment review and medication liaison service. The primary endpoint will be the rate of readmissions and/or death at 30 days following initial hospitalization discharge. The secondary endpoints will be the rate of hospital readmission, the rate of emergency department visits, the rate of mortality, the number of consultations and patient treatment satisfaction at 30 days following initial hospitalization discharge.Discussion: A randomized controlled trial provides the most extensive evidence on the impact of pharmacist-led medication reviews on early hospital readmission for extreme age populations.Trial Registration: Current Controlled Trials, NCT02734017 . Registered on 4 May 2016. [ABSTRACT FROM AUTHOR]

Background: The Brief Coping Orientation to Problems Experienced (Brief COPE) inventory is the most usual measure to identify the nature of coping strategies implemented by individuals and explore 14 coping strategies. The availability of a structure with fewer factors rather than the initial 14-factor structure may be of interest for both healthcare professionals and researchers. We report the validation process of a 4-factor structure of the French version of the Brief COPE in a French sample of individuals facing a singular life event, such as cancer, including patients and their caregivers.Methods: The cross-sectional study included cancer patients and their caregivers. Self-administered data were collected including: socio-demographic (age, gender, marital status, employment status, and education level), coping strategies using the French version of the Brief COPE, quality of life (QoL) using the French version of the short form health survey questionnaire (SF36). Construct validity, internal consistency, reliability, and external validity were tested.Results: The sample included 398 individuals. The principal component factor analysis identified a 4-factor structure. The dimensions were labeled according to their constitutive items: social support (8 items), problem solving (4), avoidance (10), and positive thinking (6). The 4-factor structure was supported by different theoretical models of coping and showed satisfactory psychometric properties.Conclusion: The 4-factor structure of the French version of the Brief COPE, validated in a sample of individuals facing a singular stressful event, including cancer patients and their caregivers, makes the instrument easier to use both in clinical practice and clinical research. [ABSTRACT FROM AUTHOR]

Background: The CareGiver Oncology Quality of Life (CarGOQoL) questionnaire, a 29-item, multidimensional, self-administered questionnaire, was validated using a large French sample. We reported the linguistic validation process and the metric validity of the English version of CarGOQoL in the United- States.Methods: The translation process consisted of 3 consecutive steps: forward-backward translation, acceptability testing, and cognitive interviews. The psychometric testing was applied to caregivers of consecutive patients with representative cancers who were recruited from the Regional Cancer Center in northwestern Pennsylvania. All individuals completed the CarGOQoL at baseline, day- 30, and day- 90. Internal consistency, reliability, external validity, reproducibility, and sensitivity to change were tested.Results: The translated version was validated on a total of 87 American cancer caregivers. The dimensions of the CarGOQoL generally demonstrated a high internal consistency (Cronbach's alpha > 0.70 for all but four domain scores). External validity testing revealed that the CarGOQoL index score correlated significantly with all SF-36 dimension scores except the physical composite score (Pearson's correlation: 0.28-0.70). Reproducibility was satisfactory at day- 30 (intraclass correlation coefficient: 0.46-0.94) and day- 90 (0.43-0.92). Four specific dimensions of CarGOQoL showed responsiveness: the Psychological well-being, the Relationships with health care system, the Social support and the Finances.Conclusions: The American version of the CarGOQoL constitutes a useful instrument to measure QoL in caregivers of cancer patients in the United- States. [ABSTRACT FROM AUTHOR]

Background: Successful interventions have been developed for smoking cessation, but the success of smoking relapse prevention interventions has been limited. In particular, cognitive behavioural therapy (CBT) has been hampered by a high relapse rate. Because relapses can be due to the presence of conditions associated with tobacco consumption (such as drinking in bars with friends), virtual reality exposure therapy (VRET) can generate synthetic environments that represent risk situations for the patient in the context of relapse prevention. The primary objective of this study is to evaluate the effectiveness of CBT coupled with VRET, in comparison to CBT alone, in the prevention of smoking relapse. The secondary objectives are to assess the impact of CBT coupled with VRET on anxiety, depression, quality of life, self-esteem and addictive comorbidities (such as alcohol, cannabis, and gambling). A third objective examines the feasibility and acceptability of VR use considering elements such as presence, cybersickness and number of patients who complete the VRET program.Method/design: The present study is a 14-month (2 months of therapy followed by 12 months of follow-up), prospective, comparative, randomized and open clinical trial, involving two parallel groups (CBT coupled with VRET versus CBT alone). The primary outcome is the proportion of individuals with tobacco abstinence at 6 months after the end of the therapy. Abstinence is defined by the total absence of tobacco consumption assessed during a post-test interview and with an apparatus that measures the carbon monoxide levels expired. A total of 60 individuals per group will be included.Discussion: This study is the first to examine the efficacy of CBT coupled with VRET in the prevention of smoking relapse. Because VRET is simple to use and has a low cost, this interactive therapeutic method might be easily implemented in clinical practice if the study confirms its efficacy.Trial Registration: ClinicalTrials.gov Identifier: NCT02205060 (registered 25 July 2014). [ABSTRACT FROM AUTHOR]

Background: It is now well documented that critically ill patients are exposed to stressful conditions and experience discomforts from multiple sources. Improved identification of the discomforts of patients in intensive care units (ICUs) may have implications for managing their care, including consideration of ethical issues, and may assist clinicians in choosing the most appropriate interventions. The primary objective of this study was to assess the effectiveness of a multicomponent program of discomfort reduction in critically ill patients. The secondary objectives were to assess the sustainability of the impact of the program and the potential seasonality effect.Methods/design: We conducted a multicenter, cluster-randomized, controlled, single (patient)-blind study involving 34 French adult ICUs. The experimental intervention was a 6-month period during which the multicomponent program was implemented in the ICU and included the following steps: identification of discomforts, immediate feedback to the healthcare team, and implementation of targeted interventions. The control intervention was a 6-month period during which any program was implemented. The primary endpoint was the monthly overall score of self-reported discomfort from the French questionnaire on discomforts in ICU patients (IPREA). The secondary endpoints were the scores of the discomfort items of IPREA. The sample size was 660 individuals to obtain 80% power to detect a 25% difference in the overall discomfort score of IPREA between the two groups (design effect: 2.9).Discussion: The results of this cluster-randomized controlled study are expected to confirm that a multicomponent program of discomfort reduction may be a new strategy in the management of care for critically ill patients.Trial Registration: ClinicalTrials.gov NCT02442934, registered 11 May 2015. [ABSTRACT FROM AUTHOR]

Background: International recommendations in favor of screening for vaginal infection in pregnancy are based on heterogeneous criteria. In most developed countries, the diagnosis of bacterial vaginosis is only recommended for women with high-risk of preterm birth. The Nugent score is currently used, but molecular quantification tools have recently been reported with a high sensitivity and specificity. Their value for reducing preterm birth rates and related complications remains unexplored. This trial was designed to assess the cost-effectiveness of a systematic screen-and-treat program based on a point-of-care technique for rapid molecular diagnosis, immediately followed by an appropriate antibiotic treatment, to detect the presence of abnormal vaginal flora (specifically, Atopobium vaginae and Gardnerella vaginalis) before 20 weeks of gestation in pregnant women in France. We hypothesized that this program would translate into significant reductions in both the rate of preterm births and the medical costs associated with preterm birth.Methods/design: A multicenter, open-label randomized controlled trial (RCT) will be conducted in which 20 French obstetrics and gynecology centers will recruit eligible pregnant women at less than 20 weeks gestation with singleton pregnancy and with a low-risk factor for preterm birth. Interventions will include a) an experimental group that will receive a systematic rapid screen-and-treat program from a point-of-care analysis using a molecular quantification method and b) a control group that will receive usual care management. Randomization will be in a 1:1 allocation ratio. The primary endpoint that will be assessed over a period of 12 months will be the incremental cost-effectiveness ratio (ICER) expressed as cost per avoided preterm birth before 37 weeks. Secondary endpoints will include ICER per avoided preterm birth before 24, 28 and 32 weeks, obstetrical outcomes, neonatal outcomes, rates of treatment failure and recurrence episodes for positive women. Uncertainty surrounding these estimates will be addressed using nonparametric bootstrapping and represented using cost-effectiveness acceptability curves. A total of 6,800 pregnant women will be included.Discussion: This appropriate randomized controlled design will provide insight into the cost-effectiveness and therefore the potential cost savings of a rapid screen-and-treat strategy for molecular abnormal vaginal flora in pregnant women. National and international recommendations could be updated based on the findings of this study.Trial Registration: ClinicalTrials.gov: NCT02288832 (registration date: 30 October 2014); Eudract: 2014-001559-22. [ABSTRACT FROM AUTHOR]

Objective: The aim of this study was to identify potential socio-demographic and socio-economic determinants associated with quality of life (QoL) in impoverished individuals admitted in emergency departments (EDs) using a self-administered multidimensional poverty-related QoL questionnaire (PQoL) and a generic QoL questionnaire (Duke).Design: cross-sectional study.Setting: Ten EDs in France.Participants: All participants included in this study lived in impoverished conditions.Intervention and Outcome Measures: We collected socio-demographic information, economic data, and data related to the ED visit. Multiple linear regressions were performed to determine which variables were linked to QoL scores.Results: Three-hundred and eighty-seven individuals were enrolled, and 378 (98%) responded to the QoL questionnaires. PQoL was significantly lower for single individuals (β from -0.15 to -0.23), without a stable home (β from -0.17 to -0.34) and individuals without general health coverage (β = 0.20). Compared with men, women reported lower scores in the psychological well-being dimension (β = -0.19) and higher scores in the relationships with friends dimension (β = 0.17).Conclusions: Not having stable housing was the most important factor associated with low QoL in impoverished people. This finding demonstrates the need for support from policymakers at the national and local levels for these vulnerable populations. [ABSTRACT FROM AUTHOR]

Background: The prevalence of chronic constipation is about 15 % in Western countries with a significant impact on quality of life and health care costs. The first-line therapy, based on medical treatment combined with laxatives and dietary rules, is often disappointing. Interferential therapy is a new treatment that has demonstrated its efficiency in the treatment of chronic constipation in children and encouraging results in adults. The primary objective of this study is to assess the efficacy of interferential therapy during 8 weeks in adult patients. The secondary objectives are to assess this new and noninvasive therapy in terms of persistence of the clinical efficacy, colonic transit time, ano-rectal manometry, patient satisfaction and quality of life (QoL), and tolerance.Methods/design: Design: multicenter, prospective, randomized, placebo-controlled, double blind, two-parallel groups study.Setting: nine French adult gastroenterology centers.Inclusion Criteria: adult patients with a history of chronic constipation refractory to medical treatment for at least 3 months. Treatment groups: (1) interferential-experimental group (effective stimulation); (2) placebo-control group (sham stimulation).Randomization: 1:1 allocation ratio. Evaluation times: inclusion (T0, randomization), baseline assessment (T1), start of stimulation (T2), intermediary assessment (T3, 4 weeks), end of stimulation (T4, 8 weeks), follow-up (T5 and T6, 1- and 6-month).Endpoints: (1) primary: short-term efficacy at T4 (treatment response defined as three or more spontaneous, complete bowel movements per week); (2) secondary: efficacy at T5 and T6, symptoms (Patient Assessment of Constipation Symptoms questionnaire), colonic transit time, anorectal manometry, patient satisfaction (analogical visual scale), patient QoL (Patient Assessment of Constipation Quality of Life Questionnaire), side/unexpected effects.Sample Size: 200 individuals to obtain 80 % power to detect a 20 % difference in treatment response at T4 between the two groups (15 % of lost to follow-up patients expected).Discussion: The randomized, double-blind, placebo-controlled design is the most appropriate to demonstrate the efficacy of a new experimental therapeutic (Evidence-Based Medicine Working Group classification). National and international recommendations could be updated based on the findings of this study.Trial Registration: Current controlled trials NCT02381665 (registration date: February 13, 2015). [ABSTRACT FROM AUTHOR]

Background: Persistent occiput posterior and occiput transverse positions are the most common malpositions of the fetal head during labor and are associated with prolonged second stage of labor, cesarean deliveries, instrumental deliveries, severe perineal tears, postpartum hemorrhage, and chorioamnionitis. Manual rotation is one of several strategies described to deal with these malpositions.Objective: This study aimed to determine if the trial of prophylactic manual rotation at the early second stage of labor is associated with a decrease in operative deliveries (instrumental and/or cesarean deliveries).Study Design: We conducted a multicenter, open-label, randomized controlled trial in 4 French hospitals. Women with singleton term pregnancy and occiput posterior or occiput transverse position confirmed by ultrasound at the early second stage of labor and with epidural analgesia were eligible. Women were randomly assigned (1:1) to either undergo a trial of prophylactic manual rotation of occiput posterior or occiput transverse position (intervention group) or no trial of prophylactic manual rotation (standard group). The primary outcome was operative delivery (instrumental and/or cesarean deliveries). The secondary outcomes were length of the second stage of labor, maternal complications (postpartum hemorrhage, operative complications during cesarean delivery, episiotomy and perineal tears), and neonatal complications (Apgar score of <5 at 10 minutes, arterial umbilical pH of <7.10, neonatal injuries, neonatal intensive care unit admission). The main analysis was focused on intention-to-treat analysis.Results: From December 2015 to December 2019, a total of 257 women (mean age, 30.4 years; mean gestational age, 40.1 weeks) were randomized: 126 were assigned to the intervention group and 131 were assigned to the standard group. Operative delivery was significantly less frequent in the intervention group compared with the standard group (29.4% [37 of 126] vs 41.2% [54 of 131]; P=.047; differential [intervention-standard] [95% confidence interval] = -11.8 [-15.7 to -7.9]; unadjusted odds ratio [95% confidence interval] = 0.593 [0.353-0.995]). Women in the intervention group were more likely to have a significantly shorter second stage of labor.Conclusion: Trial of prophylactic manual rotation of occiput posterior or occiput transverse positions during the early second stage of labor was statistically associated with a reduced risk of operative delivery. This maneuver could be a safe strategy to prevention operative delivery. [ABSTRACT FROM AUTHOR]

A response from the authors of the article "Evaluating the Impact of a Quality of Life Assessment With Feedback to Clinicians in Patients With Schizophrenia: Randomised Controlled Trial" published in the journal in 2013 is presented.

Objective: To compare the effect of cervical priming with mifepristone with that of misoprostol on pain perception during surgical induced abortion under paracervical block.Methods: We conducted a randomized, single-blind, two-center study of women undergoing surgical induced abortion at less than 14 weeks of gestation under paracervical block. Participants were randomized to receive cervical priming with 200 mg of oral mifepristone 36 hours or 400 micrograms buccal misoprostol 3 hours before surgery. The primary outcome was pain during mechanical cervical dilation evaluated by a 100-mm visual analog scale (VAS). Secondary outcomes were pain during aspiration, preoperative and postoperative pain, participant satisfaction, duration of the procedure, occurrence of complications, and ease of performing the procedure (assessed by a 100-mm VAS). We estimated that 110 women would have to be included to have 90% power to detect a 13mm-difference of VAS for pain.Results: Between June 2017 and May 2019, 314 women were eligible and 110 were randomized (55 in each group). Patient characteristics were similar in the two groups. The mean VAS score during mechanical cervical dilation was lower in the mifepristone group (35.6±21 vs 43.5±21, P=.04) as was the mean VAS during aspiration (34±24 vs 47.8±23, P=.003). The preoperative and postoperative mean VAS, satisfaction and duration of procedures were similar between groups. The procedure was significantly easier to perform in the mifepristone group (88±16 vs 80±23, P=.004).Conclusion: Cervical priming with mifepristone for surgical induced abortion under paracervical block up to 14 weeks of gestation is more effective than misoprostol in reducing pain perception.Clinical Trial Registration: ClinicalTrials.gov, NCT03043014. [ABSTRACT FROM AUTHOR]