O steoporosis-related fractures are a major health concern, affecting a growing number of individuals worldwide. The burden of fracture has largely been assessed by the impact on health-related quality of life and health care costs. 1,2Fractures can also be associated with death. However, trials that have examined the relation between fractures and mortality have had limitations that may influence their results and the generalizability of the studies, including small samples, 3,4 the examination of only 1 type of fracture, 4-10 the inclusion of only wo men, 8,11 the enrolment of participants from specific areas (i.e., hospitals or certain geographic regions), 3,4,7,8,10,12 the nonrandom selection of participants 3-11 and the lack of statistical adjustment for confounding factors that may influence mortality. 3,[5][6][7]12 We evaluated the relation between incident fractures and mortality over a 5-year period in a cohort of men and women 50 years of age and older. In addition, we examined whether other characteristics of participants were risk factors for death. MethodsStudy design and population Details about the purpose and methodology of the Canadian Multicentre Osteoporosis Study have been reported previously. 13 The Canadian Multicentre Osteoporosis Study is a large prospective trial that provides substantial data on fractures
Objective. Decision boards (DBs) help clinicians present options and include patients in the decision-making process. Our objective was to describe the steps to develop a DB to support shared decision making and assess reliability and construct validity. Methods. Systemic lupus erythematosus (SLE) scenarios were designed with the support of experts for disease severity, potential side effects, and outcomes. The DB comprised clinical information, 2 different treatment options (oral and intravenous), a description of the potential to control SLE within 5 years, and a list of potential side effects. Patients selected what they thought would be the 3 worst side effects and were informed of the probability that these would occur. We presented the DB to 172 patients who were asked to select and justify 1 treatment option. Reliability was assessed by kappa statistics. Construct validity was tested by an a priori hypothesis, analyzing the correlation between treatment decision and side effects selected, self-assessment score, educational level, and clinical aspects. Results. Patients favored oral medication, and side effects most often listed were iatrogenic cancer (44.2%), hair loss (21.6%), and severe infection (19.1%). Justifications were risk (48.9%), practicality (36.6%), effectiveness (12.2%), and risk-benefit tradeoff (2.3%). Reliability was similar to that found in the test phase ( ؍ 0.689, P < 0.001). Validity was tested by prediction of treatment decision based on the undesirable side effects selected (P ؍ 0.047). DB content was clear and easy for all patients to understand (P ؍ 0.05). Immunosuppressive drugs influenced patient decisions (P ؍ 0.006). Conclusion. DB is a reliable and valid instrument to assess SLE patient preference.
Economic analyses (i.e., analyses that are concerned primarily with questions of resource allocation) are becoming more common in health care in general and care of cancer patients in particular. The most commonly used measure for the valuation of outcome in such analyses is the QALY (quality-adjusted life-years), which combines qualitative (i.e., quality of life) and quantitative (i.e., survival) aspects of the outcome into one dimension. Using economics (i.e., the discipline) as the mode of thinking to help solve problems of resource allocation in health, this paper describes a framework to evaluate the appropriateness of use of a measure of outcome in the context of an economic evaluation. This framework will be used to critically appraise the use of the QALY measure and of two alternative measures, HYE (healthy years equivalent) and WTP (willingness to pay), in economic evaluations of health care interventions. The paper also describes a practical tool that can be used to measure individuals' WTP in the context of public decision making. This tool involves modifying the decision board, a tool develop (originally in the cancer area) to help clinicians present information to patients. The intent is to show that the use of a theoretically superior measure of outcome need not always be empirically restrictive.
Context.—Although human papillomavirus (HPV) testing may aid in managing low-grade abnormality on screening cervical cytology, patient compliance with repeat testing programs requires consideration. Objectives.—To determine effectiveness and costs of repeated Papanicolaou (Pap) test and oncogenic HPV testing for detecting cervical intraepithelial neoplasia 2 or 3. Design.—We conducted a randomized controlled trial of combined Pap test and cervical HPV testing by Hybrid Capture 1 test compared with Pap test alone; tests were performed every 6 months for up to 2 years. The study end point was colposcopic examination performed on all women at 2 years, or earlier if an HPV test was positive or if a Pap test showed high-grade squamous intraepithelial lesion. Setting.—Sixty-six community family practices. Participants.—Two hundred fifty-seven women with atypical squamous cells of undetermined significance or low-grade squamous intraepithelial lesion on screening cervical cytology. Main Outcome Measures.—Detection of histologically confirmed cervical intraepithelial neoplasia 2 or 3, fully allocated costs, and loss to follow-up. Results.—Combined Pap test and HPV testing detected 11 (100%) of 11 cases of cervical intraepithelial neoplasia 2/3, whereas Pap test alone detected 7 (63.6%) of these 11 cases (P = .14); corresponding specificities were 39 (46.4%) of 84 and 45 (71.4%) of 63 (P = .005). The cost-effectiveness ratio was Can $4456 per additional case of high-grade cervical intraepithelial neoplasia. Sixty-nine (26.8%) of the 257 women (24.6% combined group vs 29.1% Pap test only group, P = .41) defaulted from testing or from colposcopy when referred with an abnormal result. Conclusions.—Combined testing was more costly but may detect more cases of cervical intraepithelial neoplasia 2/3 than Pap test alone. However, poor adherence limits usefulness of a management strategy that requires repeated follow-up.
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