[Analysis of circumstances of occurrence of contrast media in imaging services]. / Analyse des circonstances de survenue des extravasations de produits de contraste en imagerie.

INTRODUCTION: To prevent extravasations in medical imaging, analyses of organizational and professional circumstances of the occurrence of extravasations have been conducted in the Bordeaux University Hospital (BUH). METHOD: Two parallel studies were conducted: (i) clinical practice evaluation (CPE) including practice analysis groups and development of indicator of extravasation occurrence; (ii) Case-control study analyzing the factors associated with the occurrence of extravasations. Cases were constituted with consecutive series of patients with extravasation occurred in the BUH; controls were constituted of series of patients managed in medical imaging in the BUH without any extravasation. Statistical analysis included univariate and multivariate regression logistic models. RESULTS: CPE identified the following circumstances: patient' characteristics (female gender, low blood vessels) and professional situations (lack of check of: peripheral veinous access, contrast media temperature, injection process and lack of matching between injection amount and veinous access diameter). In the case-control analysis, patients' gender and catheter placement in medical imaging were significantly associated with the occurrence of extravasations. Guidelines have been drafted allowing the decrease of extravasation incidence. CONCLUSION: Adherence to guidelines of contrast media preparation and injection process is very important to prevent extravasation and improve patient safety.

Appropriateness of psychotropic drug prescriptions in the elderly: structuring tools based on data extracted from the hospital information system to understand physician practices.

BACKGROUND: The appropriateness of psychotropic prescriptions in the elderly is a major quality-of-care challenge at hospital. Quality indicators have been developed to prevent inappropriate psychotropic prescriptions. We aimed to select and automatically calculate such indicators, from the Bordeaux University Hospital information system, and to analyze the appropriateness of psychotropic prescription practices, in an observational study. METHODS: Experts selected indicators of the appropriateness of psychotropic prescriptions in hospitalized elderly patients, according to guidelines from the French High Authority for Health. The indicators were reformulated to focus on psychotropic administrations. The automated calculation of indicators was analyzed by comparing their measure to data collected from a clinical audit. In elderly patients hospitalized between 2014 and 2015, we then analyzed the evolution of the appropriateness of psychotropic prescription practices during hospital stay, using methods of visualization, and described practices by considering patients' characteristics. RESULTS: Two indicators were automated to detect overuse and misuse of psychotropic drugs. Indicators identified frequent inappropriate drug administrations, but practices tended to become more appropriate after quality-of-care improvement actions. In the majority of patients (85%), there was no inappropriate administration of psychotropic drugs during hospital stay; for the remaining 15% with at least one inappropriate administration, physicians tended to limit overuse or misuse during hospital stay. Inappropriate administrations were more frequent in patients suffering from psychiatric disorders, dependence and associated complications or morbidities. CONCLUSIONS: The automated indicators are structuring tools for the development of a drug prescription monitoring system. Inappropriate psychotropic administrations were limited by physicians during hospital stay; some inappropriate prescriptions might be explained by clinical characteristics of patients.

Maintenance of occupational therapy (OT) for dementia: protocol of a multi-center, randomized controlled and pragmatic trial.

BACKGROUND: There is a growing interest in developing tailored non-pharmacological strategies to face patients' needs in dementia. Occupational therapy (OT) may contribute to promote self-empowerment of both patients and caregivers. France has implemented nationwide OT over a short-term period of 3/4 months. The main objective of the MathéoAlz study is to measure the impact of maintaining OT over 4 supplementary months on patients' neuropsychiatric symptoms. METHODS/DESIGN: The MatheoAlz trial (Maintenance of Occupational Therapy in Alzheimer's disease) is a multi-center, pragmatic randomized controlled trial testing maintenance of OT over 4 supplementary months compared to routine OT delivered as recommended. This paper describes the study protocol. MatheoAlz plans to enroll 240 dyads, i.e. dementia patients and caregivers, whose main inclusion criteria are: prescription for routine OT, patients with mild or moderate dementia, living at home, receiving support from an informal caregiver. The study will compare a control group of patients benefiting from 12 to 15 initial sessions of OT over 3/4 months and an intervention group of patients benefiting from these initial sessions plus 8 extra home sessions over 4 supplementary months. The main outcome is the patient's neuropsychiatric symptoms assessed by the Neuropsychiatric Inventory at 8 months. Several clinical outcomes and economic consequences are measured at 4, 8 and 12 months. DISCUSSION: This is the first trial designed to assess the specific impact of the maintaining OT on the patients' neuropsychiatric symptoms burden. The results will inform policymakers on strategies to implement in the near future. TRIAL REGISTRATION: This trial was registered at ClinicalTrials.gov on February 16, 2018, identifier: NCT03435705 .

Definition of indicators of the appropriateness of oral anticoagulant prescriptions in hospitalized adults: Literature review and consensus (PACHA study).

BACKGROUND: Indicators of the appropriateness of oral anticoagulant prescriptions are lacking, despite the major contribution they could make to improve quality of care. AIM: To identify and select such indicators according to their utility and operational implementation. METHODS: A literature review was conducted to identify indicators of the appropriateness of oral anticoagulant prescriptions according to the guidelines of health authorities and European learned societies. A first list of indicators was identified from guidelines related to general or targeted clinical situations. A two-round Delphi consensus process, completed by a synthesis meeting, was then set up to ask European experts to rate the utility and operational implementation of the indicators on a qualitative binary scale. An indicator was selected if ≥80% of the experts judged it both useful and implementable (strong consensus). RESULTS: We selected 32 references, from which 84 indicators were identified. Nineteen indicators were short-listed for submission to expert judgment. Twenty-two experts participated in the Delphi process. Sixteen indicators obtained strong consensus for selection; three indicators did not achieve consensus. Two-thirds of the selected indicators focused on the appropriateness of oral anticoagulant prescriptions in general or in patients with atrial fibrillation; the other third focused on the appropriateness of prescriptions in patients with a prosthetic heart valve, venous thromboembolism or trauma. CONCLUSION: This work addresses the current lack of indicators of the appropriateness of oral anticoagulant prescriptions. The selected indicators will be implemented from the hospital information system to assess their metrological properties to detect inappropriate prescriptions.

Development and validation of hospital information system-generated indicators of the appropriateness of oral anticoagulant prescriptions in hospitalised adults: the PACHA study protocol.

INTRODUCTION: The appropriateness of oral anticoagulant prescriptions is a major challenge to improve quality and safety of care. As indicators of the appropriateness of oral anticoagulant prescriptions are lacking, the aim of the study is to develop and validate a panel of such indicators, in hospitalised adults, from the hospital information system of two university hospitals in France. METHODS AND ANALYSIS: The study will be carried out in four steps: (1) a literature review to identify indicators of the appropriateness of oral anticoagulant prescriptions and their conditions of appropriateness; (2) a Delphi consensus method to assess the potential utility and operational implementation of the selected indicators; (3) techniques of medical data search to implement indicators from the hospital information system and; (4) a cross-sectional study to assess the ability of indicators to detect inappropriate oral anticoagulant prescriptions, performance of medical data search techniques for tracking or retrieving information and the ability of tools to be transferred into other institutions. The fourth step will include up to 80 patient hospital stays for each indicator, depending on the prevalence of inappropriate prescriptions estimated in interim analyses. ETHICS AND DISSEMINATION: This work addresses the current lack of quality indicators of the appropriateness of oral anticoagulant prescriptions. We aim to develop and validate such indicators for integrating them into hospital clinical practice, as part of a structured approach to improve quality and safety of care. As each hospital information system is different, we will propose tools transferable to other healthcare institutions to allow an automated construction of these indicators. The PACHA study protocol was approved by institutional review boards and ethics committees (CPP Sud-Ouest et Outre Mer III-DC 2016/119; CPP Ile-de-France II-CDW_2016_0014). REGISTRATION DETAILS: Clinical Trial.gov registration: NCT02898090.

Comparing Graphical Formats for Feedback of Clinical Practice Data. A Multicenter Study among Anesthesiologists in France.

OBJECTIVES: Although graphical formats used to feedback clinical practice data may have an important impact, the most effective formats remain unknown. Using prevention of postoperative nausea and vomiting by anesthesiologists as an application, the objective of this study was to assess which graphical formats for feedback of clinical practice data are the most incentive to change practice. METHODS: We conducted a multicenter cross-sectional study among anesthesiologists randomized in two groups between March and June 2014. Each anesthesiologist assessed 15 graphical formats displaying an indicator of either prescription conformity or prescription effectiveness. Graphical formats varied by: type of graph (bar charts, linear sliders, or pictographs), presence or not of a target to reach, presence or not of a contrast between a hypothetical physician and his / her team, direction of the difference between the physician and his / her team, and restitution or not of the quality indicator evolution over the previous six months. The primary outcome was a numerical scale score expressing the anesthesiologists' motivation to change his / her practice (ranging from 1 to 10 points). A linear mixed model was fitted to explain variation in motivation. RESULTS: Sixty-six anesthesiologists assessed the conformity indicator and 67 assessed the effectiveness indicator. Factors associated with an increased motivation to change practice were: (i) presence of a clearly defined target to reach (conformity: ß = 0.24 points, p = 0.0046; effectiveness: ß = 1.11 points, p < 0.0001); (ii) contrast between the physician and his / her team (conformity: ß = 0.38 points, p < 0.0001; effectiveness: ß = 0.33 points, p = 0.0021); (iii) better results for the team than for the physician (conformity: ß = 0.65 points, p < 0.0001; effectiveness ß = 1.16 points, p < 0.0001). For the effectiveness indicator, anesthesiologists were more motivated to change practice with bar charts (ß = 0.24 points, p = 0.0447) and pictographs (ß = 0.45 points, p = 0.0001) than with linear sliders. CONCLUSIONS: Graphs associated with a defined target to reach should be preferred to deliver feedback, especially bar graphs or pictographs for indicators which are more complex to represent such as effectiveness indicators. Anesthesiologists are also more motivated to change practice when graphs report contrasted data between the physician and his / her team and a lower conformity or effectiveness for the physician than for his / her team.

Detection of frailty in elderly cancer patients: Improvement of the G8 screening test.

OBJECTIVE: The G8 is a screening test to identify frail elderly patients with cancer. Objectives were to design and evaluate the performance of alternative tests taking into account other predictive domains for frailty. METHODS: We conducted a literature review to identify predictive factors of frailty. Using a Delphi consensus, we collected 24 European experts' opinions to validate the most relevant items to improve the G8. Alternative tests were created and performance assessed on a development population (ONCODAGE cohort). The highest performing test was compared to the G8, and validated through both an internal and an external population validation (Aquitaine Geriatric Oncology cohort). RESULTS: The study population consisted of 1435 patients (ONCODAGE cohort) and 364 patients (Aquitaine Geriatric Oncology cohort). Twenty-three experts validated two items with a strong consensus (>75%): modification of the threshold for the G8 polypharmacy item to six drugs per day and replacement of the G8 item on neuropsychological problems by four Instrumental Activities of Daily Living (IADL) items predictive of incident dementia, creating three modified G8 tests (addition of either item, or both). Only the G8 IADL-modified test had better performance than the G8 when tested on the ONCODAGE cohort: sensitivity=77%, specificity=67%. This test was validated on the internal (sensitivity=78%, specificity=71%) and external (sensitivity=88%, specificity=69%) validation populations. CONCLUSION: Adding the four IADL items improves the performance of the G8. We have developed and validated a G8-modified test that is more specific than the G8 to detect frail elderly, while still sensitive and feasible in less than 10 min.

Barriers to inclusion of older adults in randomised controlled clinical trials on Non-Hodgkin's lymphoma: a systematic review.

BACKGROUND: The majority of Non-Hodgkin's lymphoma (NHL) patients are over 65 years. Management is challenging, especially for aggressive lymphoma, and appropriate assessment of efficacy and tolerance specific to this population is crucial. OBJECTIVES: To assess the representation of older patients in randomised controlled trials (RCT) in NHL, examining whether trial eligibility criteria prevent participation, and whether appropriate primary endpoints such as toxicity, quality of life, or geriatric assessment scores are used. METHODS: We searched Medline for articles published in English or French between 1 January 2005 and 31 December 2011 reporting on phase II/III RCT evaluating therapeutic strategies for NHL. Articles were categorised as including or excluding (directly or indirectly) older adults, and features of RCT that included or excluded older patients are compared. RESULTS: We identified 87 relevant RCT: 9 (10.3%) focussed exclusively on patients >65 years, 22 (25.3%) directly excluded patients >65 years, 47 (54.0%) indirectly excluded older adults through selective inclusion criteria (ECOG status, liver or kidney function, and comorbidities), and 9 (10.3%) did not directly or indirectly exclude patients >65 years (although two excluded patients >70 years). Proportions of older patients included do not reflect incidence. Trials including older adults were published in journals with lower impact factors and few RCT used appropriate endpoints for older adults. CONCLUSIONS: Older adults are poorly represented in NHL RCT both due to direct age-based exclusion and restrictive inclusion criteria. This situation needs rapid correction to better represent older patients and thus improve cancer management in this highly prevalent population.