[Implementing vascular access protection indicators (VAPI) in dialysis: an innovation in quality of care]. / Mise en place d'indicateurs de protection des abords vasculaires (IPAV) en dialyse : une innovation dans la qualité des soins.

Between 2013 and 2021, indicators of vascular access protection (IPAV) integrating a census of haematomas and multiple punctures were set up on the active file of chronic kidney failure patients with a vascular access dialyzed in Monaco's private haemodialysis center. They could help reduce the occurrence of complications and improve the quality of care offered to patients. This article reports on the results obtained before and after the introduction of this quality approach.

Stability Indicating RP-HPLC-DAD method for simultaneous estimation of tadalafil and macitentan in synthetic mixture for treatment of pulmonary arterial hypertension.

OBJECTIVE: High Performance liquid chromatography is an integral analytical tool in assessing drug product stability. A simple, selective, precise, accurate and stability indicating RP-HPLC method was developed and validated for analysis of Tadalafil and Macitentan in synthetic mixture. MATERIAL AND METHOD: Chromatographic separation was performed using Phenomex Gemini C18 (25cm×4.6nm, 5µm) Column. The mobile phase consists of (10mM Ammonium Acetate in water and [Methanol: ACN 20: 80% v/v]) (40: 60% v/v). The flow rate was set to be 1.0mL/min. The injection volume was 10.00µL. The detection was carried out at 260nm at column temperature 35°C. RESULTS: The method was validating according to ICH Q2R1 guideline for accuracy, precision, reproducibility, specificity, robustness and detection and quantification limits. Stability testing was performed on Tadalafil and Macitentan and it was found that these degraded sufficiently in all applied chemical and physical conditions. Linearity for Tadalafil and Macitentan was observed 0.4-100µg/mL and 0.1-25µg/mL with correlation coefficient at 0.9999. LOD and LOQ 0.008µg/mL and 0.024µg/mL and 0.001µg/mL and 0.0029µg/mL for Tadalafil and Macitentan respectively. CONCLUSION: The developed RP-HPLC method was found to be suitable for the determination of both the drugs.

Validity and Accuracy of the Tilburg Frailty Indicator Part B for Identification of Frailty in Older Adults Consulting a Rural Geriatric Medicine Clinic.

The Tilburg Frailty Indicator (TFI) is a validated tool for determining frailty in older adults. This study examined the validity and accuracy of the TFI Part B (TFI-B) in a North American context. Seventy-two individuals ≥ 65 years of age recruited from a rural geriatric medicine clinic completed a set of self-reported and performance-based measures, including TFI-B. Frailty level was determined using modified Fried's Frailty Phenotype (FFP). Pearson correlation coefficients (r) assessed the concurrent relationships between the TFI-B and other measures. Accuracy of the TFI-B in classifying frailty level was assessed using assessing area under the curve (AUC). The TFI-B scores showed low correlations (r < 0.4) with gait speed and grip, suggesting that the TFI-B did not consider frailty as merely a physical problem. The AUC of 0.82 indicated that the TFI-B scores accurately classified frail versus non-frail individuals. The score of ≥ 5 on the TFI-B scores showed satisfactory sensitivity/specificity (73%/77%) and excellent negative predictive value (91.95%). This indicates that a TFI-B score of < 5 can be used to rule out frailty.

A rapid LC-PDA method for the simultaneous quantification of metformin, empagliflozin and linagliptin in pharmaceutical dosage form.

OBJECTIVE: The objective of the present study is to develop and validate a simple, rapid stability indicating high performance liquid chromatography method for the simultaneous quantification of metformin, empagliflozin, linagliptin in bulk and pharmaceutical dosage form. MATERIALS AND METHODS: The chromatographic separation was achieved on C18 X-bridge phenyl column (250×4.6mm, 5µm particle size). The pharmaceutical analytes were quantified by diode array detector in HPLC, eluted with acetonitrile and triethylamine (70:30) as mobile phase, monitored at 240nm over a runtime of 7min. RESULTS: The method was linear in the range of 50-750µg/mL (r2=0.999) for metformin, 0.5-7.5µg/mL (r2=0.999) for empagliflozin, 0.25-3.75µg/mL (r2=0.999) for linagliptin. The percentage recoveries of these 3 drugs were within acceptable limits (99.2-100.8). The method was found to be precise as % RSD<2. Forced degradation studies were conducted under acidic, basic, oxidative, reductive, photolysis, thermal conditions and showed degradation within (19.4-32.4%). CONCLUSION: The validated (as per ICH guidelines) rapid method can be routinely used in quality control lab for the quantification of metformin, empagliflozin and linagliptin in raw materials as well as in pharmaceutical dosage form.

A simple stability indicating RP-HPLC-DAD method for concurrent analysis of Tenofovir Disoproxil Fumarate, Doravirine and Lamivudine in pure blend and their combined film coated tablets.

OBJECTIVES: The main aim of the study was to develop an economical, insightful, accurate and simple RP-HPLC-DAD method with high precision and good sensitivity for concurrent determination of Tenofovir disoproxil fumarate, Doravirine and Lamivudine in blended bulk form and their combined tablet form. MATERIAL AND METHODS: A method with Ascentis C18 (150×4.6mm, 5µm) column, mobile phase ratio of 0.1% ortho phosphoric acid and Acetonitrile in 70:30 (v/v), 1mL/min flow rate and detection wavelength of 260nm was highly proficient in effective separation of all three drugs. The developed method was validated in accordance with ICH specifications. RESULTS: The retention times of Doravirine, Lamivudine and Tenofovir disoproxil fumarate observed were 2.4, 2.9, and 3.6min, respectively. The linear responses were observed for Doravirine, Lamivudine and Tenofovir disoproxil fumarate in the range of 12.5-75µg/mL, 75-225µg/mL and 75-225µg/mL, respectively. The limit of detection and quantification values were calculated to be 0.36µg/mL and 0.11µg/mL for Lamivudine, 0.55µg/mL and 1.66µg/mL for Tenofovir disoproxil fumarate and 0.03µg/mL and 0.09µg/mL for Doravirine. The % RSD values of the intra-day and inter-day precision were calculated in the range of 0.134-1.749. The mean percentage recovery of all three analytes was in the range of 98.85-100.18%. The statistical results of the validation parameters ensured that the method was accurate, specific, and precise with good sensitivity. Investigation of analytes under different stressed conditions ensures the stability of analytes reflecting the stability indication of the method. The developed method has high proficiency in separation of Tenofovir disoproxil fumarate, Doravirine and Lamivudine. The degradation products generated due to stress conditions also separated with good resolution. CONCLUSION: The current method is a stability-indicating assay method consisting of appropriate specificity, accuracy, precision and sensitivity. The developed method has a good potential to be adopted by the pharmaceutical industrial sector.

Chemometrics supported optimization of a multi-attribute monitoring liquid chromatographic method for estimation of palbociclib in its dosage form: Application to a new regulatory paradigm.

OBJECTIVE: The objective of present work was to develop a validated liquid chromatographic method for the estimation of palbociclib in its solid dosage forms by employing a new systematic concept. MATERIAL AND METHOD: Risk assessment and control measures were undertaken along with chemometrics assistance to establish the robust method performance for studied analytical attributes viz. analyte retention, resolution, plate number, and tailing factor. Methanol %, flow rate, and pH were found influential on the performance of studied analytical attributes and optimized using a Box-Behnken experimental design. Monte-Carlo simulation was performed to evaluate the performance of the analytical procedure. A multi-attribute monitoring liquid chromatographic method employing methanol: 0.01M KH2PO4 buffer of pH 3.5 (70:30, v/v) was used with a reversed-phase column. Flow rate at 1.2mL/min and detection at 265nm monitored peak responses. RESULT: The method efficiently separated analyte from the internal standard caffeine (resolution>16). Specificity (resolution>2.0), linearity (2-64µg/mL), accuracy (>99%) and precision (%RSD<1%) were well in accord with regulatory requirements. Further, analyte was detected at 1µg/mL and was stable over applied stress conditions. CONCLUSION: In a nutshell, the novel approach produced an accurate method for estimation of palbociclib in tablets with optimum method performance.

A systematic approach for stability-indicating HPLC method optimization for Nilotinib bulk through design of experiments: Application towards characterization of base degradation products by mass spectrometry.

A novel and reliable stability-indicating high-performance liquid chromatography method was developed using design of experiments. Under forced degradation conditions (hydrolysis, oxidative, photolytic and thermal) Nilotinib produced five major degradation products utilizing sodium hydroxide in base hydrolysis. The degradation products were separated by Hypersil ODS column (150×4.6mm i.d., 5µ) utilizing methanol and 10mM ammonium acetate (pH 3.0, adjusted with acetic acid) as mobile phase in gradient elusion mode at a flow rate of 1.2mL/min column temperature set at 35°C and UV detection at 263nm. Tandem mass spectrometry method was used to characterize the base degradation products by accurate mass measurements. The developed method was found to be linear, accurate, precise and selective for the separation of Nilotinib from its degradation products as per the International Conference on Harmonisation guidelines. The structures of the degradation products have been elucidated, of which three degradation products were reported for the first time.

Comparison of methodologies used to define the protein quality of human foods and support regulatory claims.

Protein quality (PQ) is the capacity of a protein to meet the amino acid (AA) requirements of an individual. There are several methodologies for determining the PQ of foods. The protein efficiency ratio is an animal growth bioassay. The protein-digestibility-corrected AA score considers the AA requirements of a reference population, and the true nitrogen digestibility coefficient for each ingredient. The digestible indispensable AA score is based on true ileal AA digestibility and better represents bioavailability of AAs. In vitro techniques for assessment of PQ are available but require validation against a greater range of protein sources. Isotopic methods, such as the indicator AA oxidation and dual tracer techniques measure AA relative bioavailability and digestibility, respectively, but require sophisticated equipment, and may not be cost nor time effective for the industry to adopt. The present review discusses advantages and disadvantages of methodologies for determining PQ of food for humans focused on methods that are or could be adopted by regulatory agencies. Understanding the framework and resources available for PQ determination will help in the selection of appropriate methods depending on the application. Novelty Understanding the framework and resources available for PQ determination will help in the selection of appropriate methods depending on the application.

Use of consumer monitors for estimating energy expenditure in youth.

The purpose of this study was to compare energy expenditure (EE) estimates from 5 consumer physical activity monitors (PAMs) to indirect calorimetry in a sample of youth. Eighty-nine youth (mean (SD); age, 12.3 (3.4) years; 50% female) performed 16 semi-structured activities. Activities were performed in duplicate across 2 visits. Participants wore a Cosmed K4b2 (criterion for EE), an Apple Watch 2 (left wrist), Mymo Tracker (right hip), and Misfit Shine 2 devices (right hip; right shoe). Participants were randomized to wear a Samsung Gear Fit 2 or a Fitbit Charge 2 on the right wrist. Oxygen consumption was converted to EE by subtracting estimated basal EE (Schofield's equation) from the measured gross EE. EE from each visit was summed across the 2 visit days for comparison with the total EE recorded from the PAMs. All consumer PAMs estimated gross EE, except for the Apple Watch 2 (net Active EE). Paired t tests were used to assess differences between estimated (PAM) and measured (K4b2) EE. Mean absolute percent error (MAPE) was used to assess individual-level error. The Mymo Tracker was not significantly different from measured EE and was within 15.9 kcal of measured kilocalories (p = 0.764). Mean percent errors ranged from 3.5% (Mymo Tracker) to 48.2% (Apple Watch 2). MAPE ranged from 16.8% (Misfit Shine 2 - right hip) to 49.9% (Mymo Tracker). Novelty Only the Mymo Tracker was not significantly different from measured EE but had the greatest individual error. The Misfit Shine 2 - right hip had the lowest individual error. Caution is warranted when using consumer PAMs in youth for tracking EE.

[Assessing the contribution of the advanced practice nurse]. / Évaluer la contribution de l'infirmier en pratique avancée.

An assessment of the impact of advanced practice will be presented to the French parliament in 2021. Advanced practice nurses must make use of this opportunity. Indeed, this assessment is likely to come with major challenges in terms of the reorganisation of the healthcare provision following the implementation of this new function. The definition of adapted indicators is essential.

[How can accessibility measures be improved to better target underserved areas?] / Comment améliorer les mesures d'accessibilité aux soins pour mieux cibler les zones sous-denses ?

INTRODUCTION: Compared to the other countries of the Organization for Economic Cooperation and Development (OECD), France now enjoys an average level of medical staffing. Yet accessibility to healthcare is a major public policy issue because of the unequal distribution of health professionals throughout the French territories; the authorities are trying to fight the problem by deploying a set of measures favoring the installation and maintenance of healthcare services in areas identified as underserved. OBJECTIVES: The identification of underserved zones raises the question of what healthcare accessibility measures exist for clarifying the situation in the territories. Localized potential accessibility calculated at the municipal level has been used since 2017 as a criterion for the national selection of underserved areas. We show how this indicator represents an advance in the measurement of accessibility to care, but we also discuss the limits. Proposals for improvement are put forward. METHODOLOGY: Taking advantage of the availability of new databases, we propose for the Île-de-France region an infra-communal APL indicator that is calculated at a more appropriate geographical level, integrates better consideration of mobility practices linked to the use of care, and takes into account the social aspect of healthcare needs. RESULTS: This type of indicator represents an important step forward in measuring territorial disparities in access to care. As in other countries, and in France for other fields, its use as an instrument of public policy raises questions related to the derivation of an operational indicator for delineating areas of action.

[Indicators of research impact: Tools for measuring journals, researchers and published articles in health - Pharmaceutical perspective]. / Indicateurs de notoriété des revues scientifiques, des chercheurs et des articles publiés en santé : perspective pharmaceutique.

There are several indicators to evaluate the impact of the scientific publication in pharmacy. Given their number, complexity, heterogeneity, strengths and weaknesses, we believe that pharmacists are not sufficiently familiar with these indicators. The main objective is to present an inventory of available indicator to measure the research impact. PubMed, GoogleScholar and Google were interviewed in October 2017 from the following terms: bibliométrique/bibliometrics, facteur d'impact/impact factor, impact de citations/citation impact, revue/journal, chercheur/researcher, article, indicateur/indicator, score. For each identified indicator, the following variables were extracted: name, calculation method, calculation time window, data sources considered, access conditions, inclusion of self-citation, strengths and weaknesses. A total of 15 indicators were included: seven for journals, four for researchers and four for articles. Among them two are non-bibliometric indicators: the Altmetric attention score, the RGscore and one other indicator deriving from the impact factor: the SIGAPS indicator developed to finance the research activity of French hospitals. Of the 12 bibliometric indicators, nine include self-citation. All involve forces (e.g. exclusion of editorials, letters, free access) and weaknesses (e.g. self-citations included, time window too short, disciplinary indistinction). There is no indicator with no weaknesses and pharmacists should be able to understand their strengths and weaknesses.

La politique nationale des indicateurs de qualité et de sécurité des soins.

THE NATIONAL POLICY OF CARE QUALITY AND SAFETY INDICATORS: Care quality and safety indicators, piloted by the national health authority, are tools forming part of a global programme of improvement of quality and safety of care. The national scheme for measuring the quality and safety of care provides, for all healthcare facilities, dashboards for managing care quality and safety. Currently focused on the public and private hospital sector, it needs to evolve to widen its scope to include community care and the medical-social sector.

La certification V2014 et les équipes de soins.

V2014 CERTIFICATION AND NURSING TEAMS.: V2014 certification focuses on the management of care-related risks. During the certification visit, the caregiver sometimes has to explain to the experts from the French National Health Authority their understanding of the approaches undertaken in their department, as well as their own contribution to their implementation. Users' representatives are also consulted. The next version of the certification, in 2020, will aim to give even more meaning to nursing practices through the analysis and the relevance of the care provided.

[Emergency departments faced with social inequalities in healthcare]. / Les urgences face aux inégalités sociales de santé.

Emergency departments play an essential role with regard to social inequalities. However, in the current context, this role is not evident in the studies carried out into this sector of activity. This is due to the lack of relevance of the indicators used, such as the waiting time, which serve the hidden objective of increasing the productivity of emergency departments.

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.

[Impact of pharmaceutical interventions on antibiotic therapy of urinary tract infections in rehabilitation center]. / Impact des interventions pharmaceutiques sur l'antibiothérapie des infections urinaires en service de soins de suite et de réadaptation.

BACKGROUND: The aim of this study was to assess the impact of medico-pharmaceutical partnership on the quality of antibiotic treatment in urinary tract infection (UTI) within rehabilitation center. MATERIAL: All antibiotic prescriptions were validated by the pharmacist at the start of treatment and twice a week. All patients with symptomatic urinary tract infection between January 1, 2014 to December 31, 2015 were included in this study. Addition to awareness among specifiers to promoting the appropriate use of antibiotics, the pharmacist suggested pharmaceutical interventions (PI) in order to improve the quality of antibiotic treatments. At the same time, 3 quality indicators (QI) were followed: duration, dosage, antibiotic susceptibility. The compliance rates of this 3 QI allowed to assess the quality of the antibiotic treatment in urinary tract infection. RESULTS: The study population included 154 patients corresponding to 252 UTI. Sixty-eight PI were made by pharmacist about urinary tract infection treatment (overdosage or under-dosing, duration unknown, inadequate route of administration). These QI achieved 96.4% compliance with duration, 98.8% compliance with dosage and 99.2% with the antibiotic susceptibility. CONCLUSION: This study allowed showing the medico-pharmaceutical impact on the quality of antibiotic treatments in UTI. The awareness among specifiers with a daily validation of prescription by the pharmacist allowed to improve urinary tract infections care in rehabilitation center. LEVEL OF EVIDENCE: 4.

Monitoring and evaluation of sport-based HIV/AIDS awareness programmes: Strengthening outcome indicators.

There are number of Non-Governmental Organisations (NGOs) in South Africa that use sport as a tool to respond to Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome (HIV/AIDS), however, little is reported about the outcomes and impact of these programmes. The aim of this study is to contribute to a generic monitoring and evaluation framework by improving the options for the use of outcome indicators of sport-based HIV/AIDS awareness programmes of selected NGOs in South Africa. A qualitative method study was carried out with seven employees of five selected NGOs that integrate sport to deliver HIV/AIDS programmes in South Africa. The study further involved six specialists/experts involved in the field of HIV/AIDS and an official from Sport Recreation South Africa (SRSA). Multiple data collection instruments including desktop review, narrative systematic review, document analysis, one-on-one interviews and focus group interview were used to collect information on outcomes and indicators for sport-based HIV/AIDS awareness programmes. The information was classified according to the determinants of HIV/AIDS. The overall findings revealed that the sport-based HIV/AIDS awareness programmes of five selected NGOs examined in this study focus on similar HIV prevention messages within the key priorities highlighted in the current National Strategic Plan for HIV/AIDS, STIs and TB of South Africa. However, monitoring and evaluating outcomes of sport-based HIV/AIDS programmes of the selected NGOs remains a challenge. A need exists for the improvement of the outcome statements and indicators for their sport-based HIV/AIDS awareness programmes. This study proposed a total of 51 generic outcome indicators focusing on measuring change in the knowledge of HIV/AIDS and change in attitude and intention towards HIV risk behaviours. In addition, this study further proposed a total of eight generic outcome indicators to measure predictors of HIV risk behaviour. The selected NGOs can adapt the proposed generic outcomes and indicators based on the settings of their programmes. A collaborative approach by all stakeholders is required, from international organisations, funders, governments, NGOs and communities to strengthening monitoring and evaluation of sport-based HIV/AIDS awareness programmes including other development programmes. This will assist the NGOs that use sport for development to be able to reflect accurately the information about their HIV/AIDS activities and also be able to contribute to on-going monitoring activities at a national and global level as well as to the Sustainable Development Goals.

Staphylococcus aureus healthcare associated bacteraemia: An indicator of catheter related infections.

PURPOSE: Surveillance of preventable healthcare associated infections and feedback of the results to clinicians is central in the efforts to improve performance. We assessed Staphylococcus aureus healthcare associated bloodstream infection (HA-BSI) as an indicator of healthcare quality. PATIENTS AND METHOD: Between 2002 and 2012, we carried out a ten-year prospective bedside surveillance of S. aureus healthcare associated bacteraemia in a 940-bed university hospital using standard definitions. RESULTS: Overall, 2784 HA-BSI were identified during the study period, among which 573 (18%) were due to S. aureus. Among these 573 S. aureus bacteraemias, 189 originated from intravascular catheters (32.8%) of which 84% (158/189) in patients outside intensive care units. The proportion of catheter related HA-BSI due to S. aureus was 56% (61/109) in PVC-related HA-BSI and 34% (103/301) in CVC-related HA-BSI. A sharp decrease of PVC-related HA-BSI from 20 to 7 per year was obtained during the same period. CONCLUSION: In our experience, S. aureus HA-BSI is a simple and useful indicator of catheter associated infections, and therefore of healthcare quality, especially in units not covered by other type of surveillance.

[Avoidable hospitalizations: the sole responsibility of primary care?]. / Hospitalisations potentiellement évitables: une responsabilité des seuls soins de premier recours?

BACKGROUND: Avoidable hospitalizations are used as a performance indicator of primary care in many countries. We investigate here the validity and usefulness of this measure both at a global scale and for the French healthcare system. METHODS: A scoping study was performed to take a critical look at this concept. The different uses of avoidable hospitalizations as an indicator have already been reported in two recent systematic literature reviews. RESULTS: Rates of avoidable hospitalizations seem to be far more correlated with the socioeconomic attributes of patients than with primary care supply. The few studies conducted in France confirm this international trend. Several weaknesses have been spotted in the building of this indicator: the choice of conditions that can be considered as sources of avoidable hospitalizations, their identification among hospitalization disease codes, the quality of hospital coding procedures, the ecological bias in the data collection of illustrative variables. CONCLUSION: Guidelines for improvement of this indicator are provided. In particular, we discuss the possibility of its use at the scale of the whole healthcare system.