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      Cost-effectiveness of enhancing adherence with oral bisphosphonates treatment in osteoporotic women: an empirical approach based on healthcare utilisation databases

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          Abstract

          Objective

          Adherence with bisphosphonates therapy is generally low. Enhancing adherence with bisphosphonates would be effective in achieving the full benefits of therapy albeit a growth in the expenditure for supporting incremented drug use is expected. The cost-effectiveness of enhancing adherence with oral bisphosphonates in a large population of osteoporotic women has been assessed in the current study.

          Design

          Retrospective cohort study.

          Setting

          Healthcare utilisation databases of Lombardy Region, Italy.

          Participants

          A cohort of 28 558 women aged 45 years or more, resident in the Italian Region of Lombardy, who were newly treated with oral bisphosphonates during 2003–2004, was followed for 6 years after index prescription.

          Outcome measures

          Fracture-free survival time, healthcare cost and incremental cost-effectiveness ratio (ICER) of enhancing adherence, that is, the additional cost that would be spent every year for gaining one fracture-free year as a consequence of enhancing adherence at a certain level.

          Results

          Enhanced adherence from 33% (baseline) to 80%, increased both fracture-free survivals from 970 to 973 years and healthcare costs from €118 000 to €265 000 every 1000 woman-years, with ICER value of €53 000 (95% CI €49 000 to €58 000). ICER values were lower for older women (€50 000; 95% CI €42 000 to €58 000) and for those suffering from at least a chronic comorbidity (€25000; 95% CI 95% CI €7000 to €47 000).

          Conclusions

          Enhancing adherence with oral bisphosphonates offers important benefits in reducing the risk of fracture, although at a substantial cost.

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          Most cited references32

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          Osteoporosis prevention, diagnosis, and therapy.

          (2001)
          To clarify the factors associated with prevention, diagnosis, and treatment of osteoporosis, and to present the most recent information available in these areas. From March 27-29, 2000, a nonfederal, nonadvocate, 13-member panel was convened, representing the fields of internal medicine, family and community medicine, endocrinology, epidemiology, orthopedic surgery, gerontology, rheumatology, obstetrics and gynecology, preventive medicine, and cell biology. Thirty-two experts from these fields presented data to the panel and an audience of 699. Primary sponsors were the National Institute of Arthritis and Musculoskeletal and Skin Diseases and the National Institutes of Health Office of Medical Applications of Research. MEDLINE was searched for January 1995 through December 1999, and a bibliography of 2449 references provided to the panel. Experts prepared abstracts for presentations with relevant literature citations. Scientific evidence was given precedence over anecdotal experience. The panel, answering predefined questions, developed conclusions based on evidence presented in open forum and the literature. The panel composed a draft statement, which was read and circulated to the experts and the audience for public discussion. The panel resolved conflicts and released a revised statement at the end of the conference. The draft statement was posted on the Web on March 30, 2000, and updated with the panel's final revisions within a few weeks. Though prevalent in white postmenopausal women, osteoporosis occurs in all populations and at all ages and has significant physical, psychosocial, and financial consequences. Risks for osteoporosis (reflected by low bone mineral density [BMD]) and for fracture overlap but are not identical. More attention should be paid to skeletal health in persons with conditions associated with secondary osteoporosis. Clinical risk factors have an important but poorly validated role in determining who should have BMD measurement, in assessing fracture risk, and in determining who should be treated. Adequate calcium and vitamin D intake is crucial to develop optimal peak bone mass and to preserve bone mass throughout life. Supplementation with these 2 nutrients may be necessary in persons not achieving recommended dietary intake. Gonadal steroids are important determinants of peak and lifetime bone mass in men, women, and children. Regular exercise, especially resistance and high-impact activities, contributes to development of high peak bone mass and may reduce risk of falls in older persons. Assessment of bone mass, identification of fracture risk, and determination of who should be treated are the optimal goals when evaluating patients for osteoporosis. Fracture prevention is the primary treatment goal for patients with osteoporosis. Several treatments have been shown to reduce the risk of osteoporotic fractures, including those that enhance bone mass and reduce the risk or consequences of falls. Adults with vertebral, rib, hip, or distal forearm fractures should be evaluated for osteoporosis and given appropriate therapy.
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            A checklist for medication compliance and persistence studies using retrospective databases.

            The increasing number of retrospective database studies related to medication compliance and persistence (C&P), and the inherent variability within each, has created a need for improvement in the quality and consistency of medication C&P research. This article stems from the International Society of Pharmacoeconomics and Outcomes Research (ISPOR) efforts to develop a checklist of items that should be either included, or at least considered, when a retrospective database analysis of medication compliance or persistence is undertaken. This consensus document outlines a systematic approach to designing or reviewing retrospective database studies of medication C&P. Included in this article are discussions on data sources, measures of C&P, results reporting, and even conflict of interests. If followed, this checklist should improve the consistency and quality of C&P analyses, which in turn will help providers and payers understand the impact of C&P on health outcomes.
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              Bias due to misclassification in the estimation of relative risk.

              Lack of bias in the estimation of relative effect in epidemiologic studies depends on the internal validity of the study. This paper conveys in graphic and tabular form the direction and magnitude of bias due to misclassification of study subjects. A series of computer-generated graphs shows that the departure of the estimate of effect (relative risk or odds ratio) from its true value is a function of sensitivity and specificity (measures of classification validity), disease frequency, and exposure frequency. The discussion of bias emphasizes misclassification of the "outcome" variable; i.e., disease occurrence in a cohort study and exposure rate in a case-control study. Examples are used to illustrate that the magnitude of the bias can be large under circumstances which occur readily in epidemiologic research. When misclassification is equal for the two compared groups, the estimate is biased toward the null value, and in some instances beyond; when differential misclassification occurs (as in selective recall in case-control studies) the bias can be in either direction, and may be great. Formulas are derived to estimate the underlying true value of the relative risk or odds ratio using the investigator's observations together with the estimated sensitivity and specificity of the classification procedure.
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                Author and article information

                Journal
                BMJ Open
                BMJ Open
                bmjopen
                bmjopen
                BMJ Open
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                2044-6055
                2014
                24 March 2014
                : 4
                : 3
                : e003758
                Affiliations
                [1 ]Department of Statistics and Quantitative Methods, Unit of Biostatistics, Epidemiology and Public Health, University of Milano-Bicocca , Milan, Italy
                [2 ]Operative Unit of Territorial Health Services, Lombardia Regional Council , Milan, Italy
                Author notes
                [Correspondence to ] Professor Antonella Zambon; antonella.zambon@ 123456unimib.it
                Article
                bmjopen-2013-003758
                10.1136/bmjopen-2013-003758
                3975742
                24662445
                9e9507b7-e54a-4325-9775-4ae2ef05bcc8
                Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions

                This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 3.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/3.0/

                History
                : 7 August 2013
                : 10 February 2014
                : 13 February 2014
                Categories
                Health Economics
                Research
                1506
                1701
                1724
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                Medicine
                health economics,public health,epidemiology
                Medicine
                health economics, public health, epidemiology

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