Development and initial validation of a new preference-based disease-specific health-related quality of life instrument for erectile function.

UNLABELLED: Health-related quality of life instruments may be generic or specific. In general, only generic instruments use preference-based scoring. We report on a novel approach to combine in one instrument the strengths of the specific approach, greater disease relevance and responsiveness, with those of preference-based scoring, generalizability through utilities. OBJECTIVES: The primary objective was to develop a self-administered, preference-based instrument capable of measuring utilities in the disease-specific context of erectile dysfunction (ED). METHODS: Content derivation/validation began with a literature review. Eight attributes (domains) were selected to provide clinical experts structure for focus group discussion. Four levels describing a continuum of dysfunction-function were defined for each domain. Each domain, including functional levels, was reviewed and modified until consensus was achieved regarding content. This content was then integrated into a preference based scoring instrument using two visual analogue scales (VAS) with which patients rated three 'marker' health states (representing mild, moderate and severe ED), their self-state and a previously validated external marker state. The instrument was pilot tested, and implemented in a clinical trial. Initial validation analyses have been performed. RESULTS: A self-administered, preference-based, VAS instrument was developed for use in the ED population, and the instrument was feasible to complete, was reliable beyond the threshold of acceptability established a priori and demonstrated good validity. Evidence of these properties accumulates over time and this study begins that process with this instrument. Responsiveness is being assessed in the context of a clinical trial.

Cost and health related quality of life consequences of multiple sclerosis.

OBJECTIVES: To (i) quantify the cost of multiple sclerosis (MS) to the Canadian health care system and society; (ii) measure health utility in MS patients, and (iii) examine the influence of disability on patient utility and health care costs. MATERIALS AND METHODS: A comprehensive patient survey and chart review of relapsing MS patients in remission, relapse and recalling a relapse. RESULTS: Annual remission costs increased with EDSS level ($7596 at EDSS 1, $33 206 at EDSS 6). At all EDSS levels the largest costs were due to inability to work, which increased with EDSS. The average relapse cost for all EDSS levels was $1367. An inverse correlation was found between EDSS level and patient utility for patients in remission and relapse. The decrease in remission health utility from EDSS 1 to 6 was 0.24, which is 25% greater than the difference in health status between an average 25 and 85 year-old. CONCLUSIONS: This study demonstrates that MS produces substantial health care costs and reductions in patient quality of life and ability to work, losses that can be avoided or delayed if disease progression is slowed. These data provide health-care decision-makers with the opportunity to consider the full impact of MS when faced with budget allocation decisions.

Cost effectiveness of multi-therapy treatment strategies in the prevention of vertebral fractures in postmenopausal women with osteoporosis.

OBJECTIVE: The aim of this study was to evaluate the cost effectiveness of multi-therapy treatment strategies in the prevention of vertebral fractures in postmenopausal women with osteoporosis. DESIGN: A retrospective, incremental cost-effectiveness analysis was conducted from a societal perspective. It compared 9 treatment strategies over 3 years and incorporated the willingness of patients to initiate and continue each therapy. MAIN OUTCOME MEASURES AND RESULTS: Four nondominated strategies formed the efficient frontier in the following order: (i) calcium-->no therapy; (ii) ovarian hormone therapy (OHT)-->calcium-->no therapy [166 Canadian dollars ($Can)]; (iii) OHT-->etidronate-->calcium-->no therapy ($Can2331); and (iv) OHT-->alendronate-->calcium-->no therapy ($Can40,965). The figures in parentheses are the incremental costs per vertebral fracture averted to move to that strategy from the previous strategy for patients who had undergone a hysterectomy. CONCLUSIONS: We identified 4 efficient multi-therapy strategies for the treatment of vertebral osteoporosis in postmenopausal women, 2 of which were consistent with the practice guidelines of the Osteoporosis Society of Canada. Decision-makers may select from among these efficient strategies on the basis of incremental cost effectiveness.

Demonstration of M cells in the specialized follicle-associated epithelium overlying isolated lymphoid follicles in the gut.

Within the epithelium that overlies the dome regions of Peyer's patches, exist specialized surface epithelial cells (M) which function to take up macromolecules from the gut lumen. These cells may be of great importance in processing antigenic material in the gut. The predominant lymphoid structures of the small intestine are isolated lymphoid follicles, by virtue of their frequency. These follicles are difficult to study because they are not grossly visible. In the present study, three guinea pigs drank India ink mixed into their water for 1, 3, and 5 months. Two hours prior to sacrifice, animals were given an intraintestinal injection of ferritin or India ink. Using a hand lens, the Peyer's patches and isolated follicles were clearly identified among the villi of the intestine. Light microscopy revealed ink in the surface epithelium covering the isolated follicles and within the substance of the follicles. Transmission electron microscopy demonstrated M cells over isolated follicles and Peyer's patches. These cells had lighter staining cytoplasm, while the mitochrondria stained darker with prominent cristae, and the microvilli were shorter. Therefore, M cells do exist within isolated follicles and structurally appear the same as those found in Peyer's patches. This implicates the isolated follicles in the overall antigen processing role of gut-associated lymphoid tissues. The present method facilitates identification of isolated lymphoid follicles which will allow functional studies to be performed on these structures.