Supporting health education policies: translation, cross-cultural adaptation and validation of a health literacy instrument, in French.

Background: Oral health is a fundamental human right and is inseparable and indivisible from overall health and well-being. Oral Health Literacy (OHL) has been proved to be fundamental to promoting oral health and reducing oral health inequalities. To our knowledge, no OHL instrument to evaluate OHL level is currently validated in French language despite the fact it is the fifth most widely spoken languages on the planet. The Oral health literacy Instrument (OHLI) appears to be the most interesting OHL instrument to adapt into French because it is already available in English, Spanish, Russian, Malaysian, and it contains both reading comprehension and numeracy sections. Its psychometric properties have been rated as adequate. Objective: The aim of this study was to translate and adapt cross-culturally the OHLI into French, to evaluate its psychometric properties and to compare its results to oral health knowledge. Method: This study followed and applied well-established processes of translation, cross-cultural adaptation and validation, based on the recommendations of the World Health Organization guidelines and on the Consensus-Based Standards for the Selection of Health Measurement Instruments (COSMIN) study design checklist for patient-reported outcomes. Two psychometric assessments were planned, the comparison of OHLI-F scores according to education level and frequency of dental visits, and the test-retest reliability of the OHLI-F. Results: A total of 284 participants answered the OHLI-F. The OHLI-F scores were significantly different between participants with different levels of education and frequency of dental visits (p < 0.001). Participants with an education level lower than the baccalaureate, and those who never visit the dentist or only in case of pain, had significantly lower OHLI-F scores. Internal consistency was excellent (Cronbach's alpha = 0.881-0.914). Test-retest reliability was very high (intraclass correlation = 0.985 to 0.996). Conclusion: The OHLI-F has demonstrated adequate psychometric properties and can therefore be used to measure oral health literacy in French-speaking populations.

Cost savings using a test-based de-escalation strategy for patients with Crohn's disease in remission on optimized infliximab: A discrete event model study.

BACKGROUND: Drug de-escalation is considered in Crohn's disease patients in sustained remission on optimized infliximab treatment. AIM: We built a model to evaluate the magnitude of cost savings in patients' disease course with or without drug de-escalation guided by infliximab trough levels. METHODS: We designed 4 virtual cohorts (P1-P4) of 10,000 patients in clinical remission on optimized infliximab treatment followed for 2 years. P1: no drug de-escalation - 10 mg/kg/8 weeks; P2: drug de-escalation from 10 mg/kg/8 weeks to 5 mg/kg/8 weeks according to trough levels; P3: no drug de-escalation - 10 mg/kg/6 weeks; and P4: drug de-escalation from 10 mg/kg/6 weeks to 10 mg/kg/8 weeks according to trough levels. For P2 and P4 cohorts, drug de-escalation was decided if trough levels were ≥7 µg/mL and no de-escalation if trough levels were <7 µg/mL. Only costs related to drug administration were considered. RESULTS: The cost differences when comparing P1 versus P2 and P3 versus P4 were 7.6% and 4.6%, respectively, corresponding to costs savings of €30.5 millions and €20.3 million for 10,000 patients. CONCLUSION: Over a 2-year period, infliximab de-escalation according to trough levels led to cost saving of about 6%, corresponding to around €25.4 million.

Cost savings of anti-TNF therapy using a test-based strategy versus an empirical dose escalation in Crohn's disease patients who lose response to infliximab.

BACKGROUND: The use of pharmacokinetics is associated with cost savings in anti-tumor necrosis factor (anti-TNF) therapy, but the long-term cost savings in a large cohort of Crohn's disease (CD) patients are unknown. AIM: The goal of this study was to compare the cost of anti-TNF therapy in two cohorts of CD patients losing response to infliximab, one using a test-based strategy and one an empirical dose escalation. METHODS: We used a selected mathematical model to describe the trajectories of CD patients based on a discrete event system. This design allowed us to track over a given period a double cohort of patients who moved randomly and asynchronously from one state to another, while keeping all the information on their entire trajectory. Both cohorts were modeled using state diagram parameters where transition probabilities from one state to another are derived from literature data. Costs were estimated based on the French health care system. RESULTS: Cost savings among the 10,000 CD patients using a test-based strategy were €131,300,293 at 5 years. At 5 years the mean cost saving was €13,130 per patient. The direct cost of the test had no impact on the results until the cost per test reached €2,000. CONCLUSIONS: A test-based strategy leads to major cost savings related to anti-TNF therapy in CD.

Validation of the underlying assumptions of the quality-adjusted life-years outcome: results from the ECHOUTCOME European project.

BACKGROUND: Quality-adjusted life-years (QALYs) have been used since the 1980s as a standard health outcome measure for conducting cost-utility analyses, which are often inadequately labeled as 'cost-effectiveness analyses'. This synthetic outcome, which combines the quantity of life lived with its quality expressed as a preference score, is currently recommended as reference case by some health technology assessment (HTA) agencies. While critics of the QALY approach have expressed concerns about equity and ethical issues, surprisingly, very few have tested the basic methodological assumptions supporting the QALY equation so as to establish its scientific validity. OBJECTIVES: The main objective of the ECHOUTCOME European project was to test the validity of the underlying assumptions of the QALY outcome and its relevance in health decision making. METHODS: An experiment has been conducted with 1,361 subjects from Belgium, France, Italy, and the UK. The subjects were asked to express their preferences regarding various hypothetical health states derived from combining different health states with time durations in order to compare observed utility values of the couples (health state, time) and calculated utility values using the QALY formula. RESULTS: Observed and calculated utility values of the couples (health state, time) were significantly different, confirming that preferences expressed by the respondents were not consistent with the QALY theoretical assumptions. CONCLUSIONS: This European study contributes to establishing that the QALY multiplicative model is an invalid measure. This explains why costs/QALY estimates may vary greatly, leading to inconsistent recommendations relevant to providing access to innovative medicines and health technologies. HTA agencies should consider other more robust methodological approaches to guide reimbursement decisions.

Comparison of informal care time and costs in different age-related dementias: a review.

OBJECTIVES: Age-related dementia is a progressive degenerative brain syndrome whose prevalence increases with age. Dementias cause a substantial burden on society and on families who provide informal care. This study aims to review the relevant papers to compare informal care time and costs in different dementias. METHODS: A bibliographic search was performed on an international medical literature database (MEDLINE). All studies which assessed the social economic burden of different dementias were selected. Informal care time and costs were analyzed in three care settings by disease stages. RESULTS: 21 studies met our criteria. Mean informal care time was 55.73 h per week for Alzheimer disease and 15.8 h per week for Parkinson disease (P = 0.0076), and the associated mean annual informal costs were $17,492 versus $3,284, respectively (P = 0.0393). CONCLUSION: There is a lack of data about informal care time and costs among other dementias than AD or PD. Globally, AD is the most costly in terms of informal care costs than PD, $17,492 versus $3,284, respectively.

Methodological considerations in cost of illness studies on Alzheimer disease.

Cost-of-illness studies (COI) can identify and measure all the costs of a particular disease, including the direct, indirect and intangible dimensions. They are intended to provide estimates about the economic impact of costly disease. Alzheimer disease (AD) is a relevant example to review cost of illness studies because of its costliness.The aim of this study was to review relevant published cost studies of AD to analyze the method used and to identify which dimension had to be improved from a methodological perspective. First, we described the key points of cost study methodology. Secondly, cost studies relating to AD were systematically reviewed, focussing on an analysis of the different methods used. The methodological choices of the studies were analysed using an analytical grid which contains the main methodological items of COI studies. Seventeen articles were retained. Depending on the studies, annual total costs per patient vary from $2,935 to $52, 954. The methods, data sources, and estimated cost categories in each study varied widely. The review showed that cost studies adopted different approaches to estimate costs of AD, reflecting a lack of consensus on the methodology of cost studies. To increase its credibility, closer agreement among researchers on the methodological principles of cost studies would be desirable.

Prescription patterns of antidepressants: findings from a US claims database.

BACKGROUND: Introduction of serotonin reuptake inhibitors in the 1990s has increased the use of antidepressants and modified their prescription patterns. OBJECTIVE: To identify reasons for prescriptions of antidepressants and factors associated with absence of a labelled indication on the prescription patterns of antidepressants and healthcare costs in a claims database. METHODS: Antidepressant users with a new treatment episode with bupropion, citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline or venlafaxine in 2003 and 2004 were identified in the PharMetrics database. Any ICD-9 code for an approved or clinically-accepted diagnosis for antidepressant treatments ('diagnosis of interest') occurring within the month before or after the index claim was considered as a reason for prescription. Socio-demographic and medical characteristics were described between users with and without a diagnosis of interest and analysed using logistic regression. RESULTS: A total of 392 409 antidepressant users were identified. Diagnoses of interest were recorded for 46.7% of users, the most frequent diagnosis being depressive disorders (29% of the patients), anxiety disorders (17%) and abuse and dependence (5%). There were no major differences in patterns of diagnoses of interest between the antidepressants except for fluvoxamine and bupropion. Users without a diagnosis of interest had similar somatic comorbidities and overall baseline costs to users with a diagnosis of interest. However, they used specialised care less often (4.3 vs. 17.8%, OR = 0.50 [0.48; 0.51]), received psychotherapies less frequently (2.7 vs. 26.6%, OR = 0.12 [0.12; 0.12]), and had a shorter duration of use of antidepressants more often (36.9 vs. 28.5%, OR = 1.18 [1.17; 1.20]). CONCLUSIONS: The reason for prescribing antidepressants was often not reported in claims databases, and although antidepressant users with or without a diagnosis of interest can have similar somatic medical profiles and overall costs, they do not follow the same trajectory in the mental healthcare system. Depending on the research question to be answered, it is therefore important to specify which users are being targeted.