A self-administered questionnaire to measure the painful symptoms of endometriosis: Results of a modified DELPHI survey of patients and physicians.

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.

The research gap in chronic paediatric pain: A systematic review of randomised controlled trials.

BACKGROUND AND OBJECTIVE: Chronic pain is associated with significant functional and social impairment. The objective of this review was to assess the characteristics and quality of randomized controlled trials (RCTs) evaluating pain management interventions in children and adolescents with chronic pain. METHODS: We performed a systematic search of PubMed, Embase and the Cochrane Library up to July 2017. We included RCTs that involved children and adolescents (3 months-18 years) and evaluated the use of pharmacological or non-pharmacological intervention(s) in the context of pain persisting or re-occurring for more than 3 months. Methodological quality was evaluated using the Cochrane Risk of Bias (ROB) Tool. RESULTS: A total of 58 RCTs were identified and numbers steadily increased over time. The majority were conducted in single hospital institutions, with no information on study funding. Median sample size was 47.5 participants (Q1,Q3: 32, 70). Forty-five percent of RCTs included both adults and children and the median of the mean ages at inclusion was 12.9 years (Q1,Q3: 11, 15). Testing of non-pharmacological interventions was predominant and only 5 RCTs evaluated analgesics or co-analgesics. Abdominal pain, headache/migraine and musculoskeletal pain were the most common types of chronic pain among participants. Methodological quality was poor with 90% of RCTs presenting a high or unclear ROB. CONCLUSIONS: Evaluation of analgesics targeting chronic pain relief in children and adolescents through RCTs is marginal. Infants and children with long-lasting painful conditions are insufficiently represented in RCTs. We discuss possible research constraints and challenges as well as methodologies to circumvent them. SIGNIFICANCE: There is a substantial research gap regarding analgesic interventions for children and adolescents with chronic pain. Most clinical trials in the field focus on the evaluation of non-pharmacological interventions and are of low methodological quality. There is also a specific lack of trials involving infants and children and adolescents with long-lasting diseases.

Visual outcomes and complications of cataract surgery with primary implantation in infants.

PURPOSE: To describe the visual results and postoperative complications of cataract surgery with primary intraocular lens (IOL) implantation performed in infants and to determine possible predictive factors related to poor visual outcome. METHODS: A retrospective consecutive case series of cataract surgeries with primary IOL implantation in infants was performed. Visual outcome and postoperative complications were recorded. A final visual acuity>0.5 logMAR was considered as a poor visual outcome. RESULTS: Sixty-one consecutive procedures were evaluated in 43 infants. Eighteen infants (42%) had bilateral cataract surgery and 25 (58%) had monocular surgery. The median age at primary surgery was 5.7 months (range: 4 weeks-24 months). The median follow-up was 47 months (range: 14-60 months). The median best-corrected visual acuity in logarithm of the minimum angle of resolution (logMAR) at the last follow-up examination was 1.00 in the case of unilateral surgery and 0.40 in the case of bilateral surgery. The overall visual result in all eyes was 0.50 logMAR. A better visual result was achieved when the infants were younger than 6 months or older than 12 months of age when surgery was performed. Opacification in the visual axis requiring secondary surgery occurred in 54% of the eyes (33/61). Postoperative inflammation occurred in 41% of the eyes (25/61) but was not associated with poor visual outcome (P=0.39). Glaucoma affected 11.5% of the eyes (7/61) and was significantly associated with poorer visual function (OR: 15.36, 95% CI 1.02-230.35, P=0.05). Compared with the unilateral cataract group, the OR of poor visual acuity was 0.06 (95% CI 0.01-0.35, P<0.01) in the bilateral cataract group. No statistical association was observed between final visual acuity>0.5 logMAR and leukocoria at time of diagnosis, IOL-related complications and postoperative strabismus. CONCLUSIONS: Primary IOL implantation is associated with an overall satisfactory visual outcome, especially when surgery is performed before 6 months or after 12 months of age and in bilateral cases. Glaucoma is the main complication associated with poor visual outcome.

Methodology used in comparative studies assessing programmes of transition from paediatrics to adult care programmes: a systematic review.

OBJECTIVE: To explore the methodologies employed in studies assessing transition of care interventions, with the aim of defining goals for the improvement of future studies. DESIGN: Systematic review of comparative studies assessing transition to adult care interventions for young people with chronic conditions. DATA SOURCES: MEDLINE, EMBASE, ClinicalTrial.gov. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: 2 reviewers screened comparative studies with experimental and quasi-experimental designs, published or registered before July 2015. Eligible studies evaluate transition interventions at least in part after transfer to adult care of young people with chronic conditions with at least one outcome assessed quantitatively. RESULTS: 39 studies were reviewed, 26/39 (67%) published their final results and 13/39 (33%) were in progress. In 9 studies (9/39, 23%) comparisons were made between preintervention and postintervention in a single group. Randomised control groups were used in 9/39 (23%) studies. 2 (2/39, 5%) reported blinding strategies. Use of validated questionnaires was reported in 28% (11/39) of studies. In terms of reporting in published studies 15/26 (58%) did not report age at transfer, and 6/26 (23%) did not report the time of collection of each outcome. CONCLUSIONS: Few evaluative studies exist and their level of methodological quality is variable. The complexity of interventions, multiplicity of outcomes, difficulty of blinding and the small groups of patients have consequences on concluding on the effectiveness of interventions. The evaluation of the transition interventions requires an appropriate and common methodology which will provide access to a better level of evidence. We identified areas for improvement in terms of randomisation, recruitment and external validity, blinding, measurement validity, standardised assessment and reporting. Improvements will increase our capacity to determine effective interventions for transition care.

[Consensus validation of a tool to identify inappropriate prescribing in pediatrics (POPI)]. / Validation par consensus d'un outil d'identification de prescriptions inappropriées en pédiatrie (POPI).

OBJECTIVE: Medication errors including inappropriate prescriptions and drug omissions are one of the causes of adverse drug events in children. Our aim was to develop a preliminary screening tool to detect omissions and inappropriate prescriptions in pediatrics based on French and international guidelines. MATERIEL AND METHODS: Disease classification was based on the prevalence rate of pathology and hospital statistics. The criteria were obtained by reviewing many French and international references. The Delphi consensus technique was used to establish the content validity of POPI. The level of agreement and the proposals of healthcare professionals was noted on a nine-point Likert scale. RESULTS: The criteria were categorized according to the main physiological systems (gastroenterology, respiratory infections, pain, neurology, dermatology, and miscellaneous). They were distributed to 16 French pediatric panelists (eight pharmacists, eight pediatricians who were hospital-based [50%] or working in the community [50%]). After two rounds of the Delphi process, 101 of 108 criteria were chosen with strong consensus (76 inappropriate prescriptions and 25 omissions). CONCLUSIONS: POPI is the first screening tool to detect inappropriate prescriptions and omissions in pediatrics. It is now necessary to conduct a prospective study to determine inter-rater reliability and the tool's detection capacity.

Development of a consensus-base list of criteria for prescribing medication in a pediatric population.

BACKGROUND: Although many people are involved in the optimal use of a medication within this process, the use of medications carries risks of adverse events, which are greater in the pediatric population because of many factors. OBJECTIVE: In this context, our aim was to develop a consensus-based list of criteria for the safety of the pediatric medication-use process or circuit (referred to from now on as the CIRCUS tool: CIRcuit-of-Child-drug-USe). SETTING: Multicenter with a trio of experts from eight university hospitals. METHODS: A literature search (1998-2013) was conducted in order to identify the different safety practice domains for the pediatric medication use process. Twenty-six safety practice domains were identified and 48 compliance criteria were formulated. In order to reach a consensus on the most relevant compliance criteria for safety practices, an international 24 French-speaking multidisciplinary panelists (8 doctors, 8 pharmacists and 8 nurses) selected to represent a broad range of experience levels and specialties took part in a two round Delphi survey which was conducted between March and July 2013. Each panelist was asked to rate each proposed criterion on a 1-9 Likert scale in order to show their level of agreement (i.e. 1 reflects strong disagreement and 9 reflects strong agreement). MAIN OUTCOME MEASURE: Development of a consensus-base list for safety practices in pediatrics. RESULTS: Twenty-two of the 24 professionals invited to take part in this survey (92% participation rate) completed the two Delphi rounds. At the end of the two Delphi rounds, a total of 38/48 (79%) safety practice compliance criteria achieved consensus by the panelists. The criteria were grouped into 23 domains. CONCLUSION: This study presents the development of a self-assessment tool for safety practices in the pediatric drug-use process using a Delphi method. This tool may be used in order to record and compare the prevalence of best safety practices in the pediatric drug-use process.

Monitoring healthcare quality in an obstetrics and gynaecology department using a CUSUM chart.

OBJECTIVE: To use cumulative sum (CUSUM) charts for the early detection of variations in quality of care in a maternity department. DESIGN: Retrospective analysis of prospectively collected data. SETTING: Maternity department of a teaching hospital in Paris (France). POPULATION: Data from 20 519 women and 21 448 infants were collected between January 2000 and December 2007. METHODS: CUSUM charts were used to monitor the rate of 19 pre-selected quality indicators over 3 years (2005-2007), against standards developed by department obstetrician gynaecologists. Periods with adverse event rates that did not meet the standards were identified. MAIN OUTCOME MEASURES: Quality indicator rates. RESULTS: Indicators fell into three groups based on the number of periods with unacceptable rates: less than one per year [e.g. the rate of intensive care unit (ICU) admission of mothers and rate of third- or fourth-degree perineal tears]; one every 2-12 months on average (e.g. blood transfusion and sulprostone use in the overall population of women); and at least one per month (insufficient availability of epidural analgesia). CONCLUSION: CUSUM charts for a broad range of quality indicators can be used to monitor the quality of care in an obstetrics department. A prospective study investigating the ability of CUSUM-based monitoring to improve maternal and neonatal outcomes would be of interest.