The Erectile Function Visual Analog Scale (EF-VAS): a disease-specific utility instrument for the assessment of erectile function.

UNLABELLED: This article presents the responsiveness results of the Erectile Function Visual Analog Scale (EF-VAS) and reports, for the first time, utilities associated with erectile dysfunction (ED), as calculated by a disease-specific utility assessment. The EF-VAS is a new quality of life (QoL) instrument specific to ED that combines the strengths of the disease-specific approach to measuring QoL (greater disease relevance and responsiveness, with relevance to clinicians and patients) with those of preference-based assessments (generalizability and relevance to decision makers). The EF-VAS has demonstrated feasibility, reliability, and validity as reported in a recent publication. METHODS: Standard instrument development methodology was utilized and the finalized content was integrated into a preference based scoring instrument comprised of two visual analogue scales (VAS). The EF-VAS was implemented in a clinical trial and data from the trial was subjected to validation analysis. Three methods were used to evaluate the responsiveness of the EF-VAS: Spearman correlations, effect size and standardized response means. VAS scores were converted to von Neumann-Morgenstern (vNM) utilities through a conversion curve. RESULTS: The EF-VAS was established to be responsive to changes in disease state within and between patients with ED. The EF-VAS allowed the calculation of vNM utility values and a significant increase in utility was observed in the sildenafil group compared to placebo at study end. CONCLUSION: The EF-VAS represents an important advance in the understanding of the impact of ED on patients' QoL and in providing a mechanism to allow the quantification of the health status that patients associate with ED. Based on its responsiveness, the EF-VAS will provide an important clinical tool to assess and contribute to the understanding of the impact of treatment for ED. The EF-VAS represents a major advance in the science of health-related quality of life (HRQol) assessment, as it is the first validated ED-specific utility assessment reported in the literature.

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.

Drug utilization review of celecoxib in Ontario.

Cyclooxygenase (COX)-2-specific inhibitors were developed to circumvent the gastrointestinal toxicity of non-specific non-steroidal anti-inflammatory drugs while maintaining efficacy. However, the higher acquisition cost of COX-2-specific inhibitors has resulted in the implementation of a programme for cost containment in the Ontario public drug program. This programme consists of limited use (LU) criteria that need to be met for drug reimbursement of patients with osteoarthritis (OA) or rheumatoid arthritis (RA). Determining the proportion of patients eligible for reimbursement for celecoxib according to the LU criteria (based on prior treatment failure and the presence or history of serious ulcer-related gastrointestinal complications) can provide an indication of the extent of adherence to suggested guidelines. Using a patient-based survey and an analysis of the Ontario Drug Benefit Program database, the proportion of patients prescribed celecoxib who met rigorous or pragmatic definitions of the LU criteria was determined. The extent of coprescription of gastroprotective agents among patients taking celecoxib was also determined. Using the pragmatic definition, the majority of patients in the patient-based survey (53% for OA and 81% for RA) met the LU criteria. Similarly, in the database analysis, the majority of patients (76% for OA and 78% for RA) met the LU criteria. These data suggest that physician prescribing of celecoxib is consistent with the LU criteria. Concomitant prescription of gastroprotective agents in patients taking celecoxib was approximately 40%. It is recommended that further investigations be performed to determine the long-term impact of LU criteria on clinical and economic outcomes, since these criteria may also serve to restrict use in patients who may benefit from taking COX-2-specific inhibitors.

Pulmonary complications in inhalation injuries with associated cutaneous burn.

This retrospective study of 100 consecutive patients with inhalation injury documents that adult respiratory distress syndrome (ARDS) and pneumonia are common complications. Pulmonary complications cause or directly contribute to death in 77% of patients with combined inhalation and cutaneous burn injury. Additionally, the high fluid requirements of these patients worsens their pulmonary injury and is associated with adverse outcome. Independent factors predictive of death include ARDS and expected fluid requirements as well as age and percentage of total body surface area burned. An abnormal chest roentgenogram in the first 48 hours after injury is also associated with death. The development of ARDS is predicted by the actual volume of fluid resuscitation, despite normal pulmonary wedge pressure or normal central venous pressure reflecting increased microvascular permeability. These findings indicate a need for reevaluation of fluid resuscitation of patients with inhalation injury.