Proposing a health-specific organizational impact framework to evaluate organizational impacts in health technology assessments.

OBJECTIVES: Health technology assessments (HTAs) have traditionally included clinical and cost-effectiveness evaluation of new health technologies (HTs). However, new HTs can generate important organizational impacts (OIs) that influence their overall value. OIs are currently not clearly identified and evaluated in HTA procedures and tools are limited. To address this issue, a comprehensive framework that allows to assess OIs of new HTs in HTAs is proposed. METHODS: A working and methodological group identified the Oslo Manual 2018, 4th edition, OECD/Eurostat, on the objectives and outcomes of commercial innovations as the basis for the OIs framework for HTAs. The Oslo Manual was translated to the healthcare sector and adapted to HTA procedures through a three-step process. RESULTS: The framework is composed of three main parts. Part I tackles the context of the evaluation, Part II the categories of impacts and the specific impacts - in total, 16 OIs were identified - and Part III the stakeholders involved. The central part of the framework is Part II, and consists of three categories of impacts: (i) on the care process, (ii) on the stakeholders' capabilities and skills, and (iii) on society or the community. CONCLUSIONS: This framework provides a comprehensive and structured basis to document OIs of new HTs. It thus contributes to the extension of HTA evaluation criteria to other dimensions than clinical and economic aspects, that is, organizational aspects. Some of its intrinsic limitations and the questions they raise in the field for policy-makers, practitioners, and researchers are discussed.

Integrating organizational impacts into health technology assessment (HTA): an analysis of the content and use of existing evaluation frameworks.

OBJECTIVE: The French health technology assessment (HTA) agency initiated a research between 2018 and 2019 with the aim of determining whether other HTA organizations (agencies, bodies, institutes, and expert networks) and researchers had developed an evaluation framework of organizational impacts (OIs). METHODS: Three types of investigation were carried out: (i) an analysis of documents published by selected HTA organizations, (ii) a rapid review on the OI issues, (iii) a questionnaire survey to experts of the International Network of Agencies for Health Technology Assessment. RESULTS: The analyses highlight six key points: (i) there is no explicit conceptual definition of OIs; (ii) OIs are often not included in a specific dimension of the evaluation or in the same dimensions; (iii) three recurring categories emerge from the assessment of OIs: processes, structure, and culture; (iv) despite its limitations, the European Network for Health Technology Assessment framework (Core Model) is the most mature assessment model to date; (v) the question of the scope of OIs to be considered is unresolved (micro-meso-macro); and (vi) the delineation between OI assessment and economic assessment must be addressed. CONCLUSIONS: Although the issue of considering OI in HTA has been raised for many years, it remains largely unresolved. Defining the concept of OI is a prerequisite for taking the next step toward an evaluation framework. As the question of the impact of innovation goes beyond the health sector, extensive research on how to define and take into account these OIs may be relevant.

[CKD care in French nephrology practices]. / Réalité de la prise en charge de la maladie rénale chronique en néphrologie en France : étude de cohorte CKD-REIN.

BACKGROUND: To be able to assess the impact of the bundled payment system on real-life management of patients with chronic kidney disease, an overview of patient-care management before its implementation is needed. PATIENTS AND METHODS: We describe patterns of nephrology care over 3 years in 2835 patients with moderate to severe chronic kidney disease, who were followed-up from 2013 to 2019 in the CKD-REIN cohort study. Compliance with health authority guidelines during this period is also studied. RESULTS: At baseline, patients' mean age was 67 years, 65% were men, and 43% had chronic kidney disease stage 4 or 5. The mean number of nephrology visits increased from 1.1 to 2.7 per year, from chronic kidney disease stage 3A to stage 5. The minimum number of nephrology visits as recommended by health authorities was achieved in 84%, 63%, and 33% of patients with chronic kidney disease stages 3B, 4, and 5, respectively. In chronic kidney disease stages 4 and 5, only 34% and 40% of patients had seen a dietitian, and 33% and 54% had received information about treatment options, respectively. The average waiting time for a first appointment with a nephrologist was longer, 60 days and its duration shorter, 30 vs 38 to 40 minutes, in university hospitals compared with non-university hospitals and private clinics. CONCLUSION: The significant gap between received and recommended care reflects human resources and organizational limits in chronic kidney disease management in the nephrology setting. Improvements with bundled payment are expected.

Stroke Care in Brazil and France: National Policies and Healthcare Indicators Comparison.

OBJECTIVE: To identify the commonalities and discrepancies between national health policies to combat stroke in France and Brazil. JUSTIFICATION: Both healthcare systems were structured as universal access and comprehensive care attention, hierarchized by the level of care, politically and administratively decentralized. France is an industrialized, high-income country, with health care involving copayment and reimbursement of expenses, and spontaneous demand for services. Brazil is a member of the BRICs, of upper middle income with totally free health care, with an active search for hypertension and diabetes in the general population. METHODS: Data regarding policies, risk factors, and health indicators about stroke care, from 2010 to 2017, were obtained from both countries (publicly accessible information or on request) from the respective Ministries of Health or international agencies. RESULTS: About acute stroke hospitalizations, on average, Brazil has 0.75 per 1000 annual population hospitalizations versus 1.54 per 1000 in France. Brazil has 0.21 per 1000 population deaths per year versus 0.40 per 1000 in France. The in-hospital mortality rate in Brazil has 139 per 1000 hospitalized people versus 263 in France. The average length of stay of acute hospitalizations was 7.6 days in Brazil versus 12.6 in France. The prevalence of strokes by age group shows from 0 to 39 years old (this rate is stable); 40-59 years (it is increasing in both countries); and 60-79 and 80+ years (this rate has been increasing in France and decreasing in Brazil). CONCLUSION: No major differences were found about the health policies and the National Health Plans related to stroke. However, the data directly linked to the period of hospitalization differed substantially between countries. Subsequent studies can be implemented to identify the explanatory factors, notably among the risk factors and actions in primary care, and the moments after hospital care, such as secondary prevention and palliative care.

Risk profile, quality of life and care of patients with moderate and advanced CKD: The French CKD-REIN Cohort Study.

Background: The French Chronic Kidney Disease-Renal Epidemiology and Information Network (CKD-REIN) cohort study was designed to investigate the determinants of prognosis and care of patients referred to nephrologists with moderate and advanced chronic kidney disease (CKD). We examined their baseline risk profile and experience. Methods: We collected bioclinical and patient-reported information from 3033 outpatients with CKD and estimated glomerular filtration rates (eGFRs) of 15-60 mL/min/1.73 m2 treated at 40 nationally representative public and private facilities. Results: The patients' median age was 69 (60-76) years, 65% were men, their mean eGFR was 33 mL/min/1.73 m2, 43% had diabetes, 24% had a history of acute kidney injury (AKI) and 57% had uncontrolled blood pressure (BP; >140/90 mmHg). Men had worse risk profiles than women and were more likely to be past or current smokers (73% versus 34%) and have cardiovascular disease (59% versus 42%), albuminuria >30 mg/mmol (or proteinuria > 50) (40% versus 30%) (all P < 0.001) and a higher median risk of end-stage renal disease within 5 years, predicted by the kidney failure risk equation {12% [interquartile range (IQR) 3-37%] versus 9% [3-31%], P = 0.008}. During the previous year, 60% of patients reported one-to-two nephrologist visits and four or more general practitioner visits; only 25% saw a dietician and 75% were prescribed five or more medications daily. Physical and mental quality of life (QoL) were poor, with scores <50/100. Conclusions: The CKD-REIN study highlights high-risk profiles of cohort members and identifies several priorities, including improving BP control and dietary counselling and increasing doctors' awareness of AKI, polypharmacy and QoL. Trial registration: ClinicalTrials.gov identifier: NCT03381950.

[The French Chronic Kidney Disease-Renal Epidemiology and Information Network (CKD-REIN) cohort study: To better understand chronic kidney disease]. / Cohorte française Chronic Kidney Disease-Réseau Épidémiologie et Information en Néphrologie (CKD-REIN) : mieux connaître la maladie rénale chronique.

BACKGROUND: Preserving kidney function and improving the transition from chronic kidney disease to end stage is a research and healthcare challenge. The national Chronic Kidney Disease-Renal Epidemiology and Information Network (CKD-REIN) cohort was established to identify the determinants, biomarkers and practice patterns associated with chronic kidney disease outcomes. METHODS: The study will include more than 3000 adult patients with moderate to advanced chronic kidney disease from a representative sample of 40 nephrology clinics with respect to regions and legal status, public or private. Patients are recruited during a routine visit and followed for 5 years, before and after starting renal replacement therapy. Patient-level clinical, biological, and lifestyle data are collected annually, as well as provider-level data on clinical practices, coordinated with the International Chronic Kidney Disease Outcomes and Practice Pattern Study. Blood and urine samples are stored in a biobank. Major studied outcomes include survival, patient-reported outcomes, disease progression and hospitalizations. RESULTS: More than 13,000 eligible patients with chronic kidney disease were identified, 60% with stage 3 and 40% with stage 4. Their median age is 72 years [interquartile range, 62-80 years], 60% are men and 38% have diabetes. By the end of December 2015, 2885 patients were included. CONCLUSION: The CKD-REIN cohort will serve to improve our understanding of chronic kidney disease and provide evidence to improve patient survival and quality of life as well as health care system performances.

The French Chronic Kidney Disease-Renal Epidemiology and Information Network (CKD-REIN) cohort study.

BACKGROUND: While much has been learned about the epidemiology and treatment of end-stage renal disease (ESRD) in the last 30 years, chronic kidney disease (CKD) before the end-stage has been less investigated. Not enough is known about factors associated with CKD progression and complications, as well as its transition to ESRD. We designed the CKD-renal epidemiology and information network (REIN) cohort to provide a research platform to address these key questions and to assess clinical practices and costs in patients with moderate or advanced CKD. METHODS: A total of 46 clinic sites and 4 renal care networks participate in the cohort. A stratified selection of clinic sites yields a sample that represents a diversity of settings, e.g. geographic region, and public versus for-profit and non-for-profit private clinics. In each site, 60-90 patients with CKD are enrolled at a routine clinic visit during a 12-month enrolment phase: 3600 total, including 1800 with Stage 3 and 1800 with Stage 4 CKD. Follow-up will continue for 5 years, including after initiation of renal replacement therapy. Data will be collected from medical records at inclusion and at yearly intervals, as well as from self-administered patient questionnaires and provider-level questionnaires. Patients will also be interviewed at baseline, and at 1, 3 and 5 years. Healthcare costs will also be determined. Blood and urine samples will be collected and stored for future studies on all patients at enrolment and at study end, and at 1 and 3 years in a subsample of 1200. CONCLUSIONS: The CKD-REIN cohort will serve to improve our understanding of the biological, clinical and healthcare system determinants associated with CKD progression and adverse outcomes as well as of international variations in collaboration with the CKD Outcome and Practice Pattern Study (CKDopps). It will foster CKD epidemiology and outcomes research and provide evidence to improve the health and quality of life of patients with CKD and the performances of the healthcare system in this field.

The context of available options affects health care decisions: a generalization study.

BACKGROUND: When a given option is presented along with 2 alternatives, similar to each other, health care professionals choose it more often than when it is presented with just one of the alternatives. This inconsistent decision pattern may depend on the conflict generated from choosing between 2 highly similar options. OBJECTIVE: To generalize the effect by using realistic scenarios that involve 2 alternatives displaying various degrees of similarity. METHODS: One hundred fifty-five psychiatrists, 149 gynecologists, and 89 nurse managers had to indicate the treatment they would recommend in clinical scenarios containing either 3 options or just 2 of them. The similarity between the 2 alternatives varied across scenarios, ranging from a very high (psychiatric scenario) to an only moderately high (nursing management scenario) to a limited level (gynecological scenario). RESULTS: Professionals chose the focal option more often when both alternatives were available. The paradoxical effect occurred for all scenarios--namely, when the alternatives were medication variants (psychiatric scenario), when most of the features they shared produced their effect at a different extent in the 2 cases (nursing management scenario), and some of their consequences were at variance (gynecological problem). CONCLUSIONS: The context of available options affects professionals' choices when the alternatives are similar but also when they present diverging features. Professionals need to be aware of such a source of practice variability and are encouraged to consider each option per se before they compare the available options.