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Background Body-altering surgery may affect perceptions of one's self. For those with abdominal stoma surgeries, altered perceptions amplified by peristomal skin condition can increase health burdens. Objectives To assess health utility and health-related quality of life in an adult US ostomy sample in the presence of three levels of peristomal skin condition: intact, moderately compromised, and severely compromised. Methods The short form 36 health survey version 2, a generic health survey incorporating the six-dimensional health state short form preference-based utility index, was chosen to assess the sample. Analysis of covariance adjusted for age and time from surgery was used. Results The six-dimensional health state short form utilities for those with intact skin and physical component summary (PCS) levels indicating no physical limitations varied significantly from those with severely compromised skin and indicating the greatest degree of physical limitation (0.833 vs. 0.527). Peristomal skin condition decreases were associated with health utility decreases across all levels of the PCS. Because peristomal skin conditions are intermittent, the analysis presents quality-adjusted life-days (QALDs) per month. Ostomates with intact skin and PCS levels indicating no physical limitations demonstrated significant differences from those with severe skin condition and indicating the greatest degree of physical limitations (26.5 d/mo vs. 15.8 d/mo). As peristomal skin condition worsened, QALDs decreased across all levels of the PCS. A minimally important expected value of health was estimated to be an increase of 2.18 QALDs/mo. Conclusions Successful treatment from a clinical perspective is more than the elimination of conditions—it is also a return of quality time to an individual.

ObjectivesTo evaluate the association between hypoglycemia and health-related quality of life (HRQoL) in the context of a clinical trial using both an objectively confirmed and a patient-reported measure of hypoglycemia.MethodsDuring a phase III, double-arm, randomized study, patients completed the short form 36 health survey (SF-36), a generic HRQoL questionnaire, at baseline and at weeks 24, 52, and 104. The objectively confirmed measure of hypoglycemia was based on a combination of plasma glucose measure and presence of hypoglycemia-related symptoms. The patient-reported frequency of hypoglycemia was defined as the following item: “How often have you felt that your blood sugars have been unacceptably low recently?” The association between hypoglycemia and HRQoL was evaluated in intent-to-treat patients (N = 3059) by using repeated-measurements analyses, with SF-36 scores used as explained variables and baseline SF-36 score, age, sex, country, time, and either number of objectively confirmed hypoglycemic events (0, ≥1) or patient-reported frequency of hypoglycemia (continuous variable 0–6) as explanatory variables.ResultsDuring study duration, less than 6% of patients experienced at least one objectively confirmed hypoglycemic event and about half the patients reported unacceptably low blood sugars “none of the time.” The association between the number of objectively confirmed hypoglycemic events and HRQoL was not statistically significant, while the patient-reported frequency of hypoglycemia was statistically significantly related to all SF-36 scores (P < 0.001), except physical functioning; patients reporting greater perceived frequency of hypoglycemia had worse HRQoL.ConclusionsUsing a patient-reported measure of hypoglycemia in the context of a clinical trial could enable the burden of hypoglycemia for patients to be demonstrated.

Objectives: With a lack of an essential evidence on utilities to support cost-effectiveness analysis of hypertension management in Vietnam, we aimed to gather data on health utilities for hypertensive patients and identify predictors of utility. Methods: Hypertensive patients, from 40 to 80 years old visiting the hospital were invited to take a survey. Short-form 36 version 2 translated into Vietnamese was used to interview patients. We applied a specific published model to measure utilities, that explains a reasonable share of variance, especially in those cases when only relatively small differences in health are expected. Results: 712 patients were included in the study. Mean utility of these patients was 0.72 +/- 0.14. Controlling for age, sex, blood pressure (BP) stage and history of stroke, we found that the utilities in older patients were lower than those of the younger groups, and statistically significantly differing if compared the extremes of youngest and oldest groups were considered (p= 0.03). Utility in males was higher than in females (p= 0.002). Patients with a history of stroke exhibited lower utility than patients without such history, although not statistically significant (p= 0.73). Patients with more than 3 comorbidities had lower utilities than patients without comorbidity (p= 0.01). Statistically in significantly relatively higher BP was associated with lower utility at 0.734, 0.726 or 0.712 in the groups with target BP, stage 1 and 2, respectively (p= 0.422). Conclusions: Mean utility was estimated at 0.72 in hypertensive patients in Vietnam. In contrast to BP staging and history of stroke, gender was found as a statistically significant predictor of utility. In addition, patients who experience more than 3 comorbidities or older than 70 had statistically significant lower utilities.

Objectives: With a lack of an essential evidence on utilities to support cost-effectiveness analysis of hypertension management in Vietnam, we aimed to gather data on health utilities for hypertensive patients and identify predictors of utility. Methods: Hypertensive patients, from 40 to 80 years old visiting the hospital were invited to take a survey. Short-form 36 version 2 translated into Vietnamese was used to interview patients. We applied a specific published model to measure utilities, that explains a reasonable share of variance, especially in those cases when only relatively small differences in health are expected. Results: 712 patients were included in the study. Mean utility of these patients was 0.72 +/- 0.14. Controlling for age, sex, blood pressure (BP) stage and history of stroke, we found that the utilities in older patients were lower than those of the younger groups, and statistically significantly differing if compared the extremes of youngest and oldest groups were considered (p= 0.03). Utility in males was higher than in females (p= 0.002). Patients with a history of stroke exhibited lower utility than patients without such history, although not statistically significant (p= 0.73). Patients with more than 3 comorbidities had lower utilities than patients without comorbidity (p= 0.01). Statistically in significantly relatively higher BP was associated with lower utility at 0.734, 0.726 or 0.712 in the groups with target BP, stage 1 and 2, respectively (p= 0.422). Conclusions: Mean utility was estimated at 0.72 in hypertensive patients in Vietnam. In contrast to BP staging and history of stroke, gender was found as a statistically significant predictor of utility. In addition, patients who experience more than 3 comorbidities or older than 70 had statistically significant lower utilities.

OBJECTIVES: A recent randomized controlled trial has demonstrated significant reductions in terms of cardiovascular hospitalizations and deaths with a nurse-led integrated chronic care approach in patients with atrial fibrillation compared to usual care. The objective of the present study is to assess cost-effectiveness of this nurse-led care program versus usual care. METHODS: A cost effectiveness analysis was undertaken alongside the randomized controlled trial in which 712 patients were included at the Maastricht University Medical Centre, Maastricht, The Netherlands, and allocated to nurse-led care or usual care. Nurse-led care implied guideline adherent management, steered by dedicated software and supervised by cardiologists. Usual care was regular outpatient care performed by cardiologists. A cost per lifeyear as well as a cost per QALY analysis was performed, both from a hospital perspective. QALYs were based on scores of the Short Form 36 questionnaire (SF-36), converted to utility scores by extracting the Short Form 6D (SF-6D). All unit prices were supplied by the hospital's financial department, except for prices for medication, which were taken from the Dutch Pharmacotherapeutic Compass. Results represented the costs and effects for a 12 months follow-up period. RESULTS: The nurse-led care program was associated with slightly more lifeyears and QALYs at a lower cost. Specifically, the nurse-led program contributed to 0.086 QALY gains with a reduced cost of € 1102.77 per patient and a gain of 0.02 life years with a reduced cost of € 731.62 per patient. Therefore, the nurse-led program would be considered dominant. In fact, for all the possible values of willingness to pay for a QALY the nurse-led program is considered to be more likely cost effective than the care as usual. CONCLUSIONS: The cost-effectiveness analysis in the present study demonstrated that a nurse-led integrated care approach is very likely a costeffective management strategy for patients with atrial fibrillation.

OBJECTIVES: A recent randomized controlled trial has demonstrated significant reductions in terms of cardiovascular hospitalizations and deaths with a nurse-led integrated chronic care approach in patients with atrial fibrillation compared to usual care. The objective of the present study is to assess cost-effectiveness of this nurse-led care program versus usual care. METHODS: A cost effectiveness analysis was undertaken alongside the randomized controlled trial in which 712 patients were included at the Maastricht University Medical Centre, Maastricht, The Netherlands, and allocated to nurse-led care or usual care. Nurse-led care implied guideline adherent management, steered by dedicated software and supervised by cardiologists. Usual care was regular outpatient care performed by cardiologists. A cost per lifeyear as well as a cost per QALY analysis was performed, both from a hospital perspective. QALYs were based on scores of the Short Form 36 questionnaire (SF-36), converted to utility scores by extracting the Short Form 6D (SF-6D). All unit prices were supplied by the hospital's financial department, except for prices for medication, which were taken from the Dutch Pharmacotherapeutic Compass. Results represented the costs and effects for a 12 months follow-up period. RESULTS: The nurse-led care program was associated with slightly more lifeyears and QALYs at a lower cost. Specifically, the nurse-led program contributed to 0.086 QALY gains with a reduced cost of € 1102.77 per patient and a gain of 0.02 life years with a reduced cost of € 731.62 per patient. Therefore, the nurse-led program would be considered dominant. In fact, for all the possible values of willingness to pay for a QALY the nurse-led program is considered to be more likely cost effective than the care as usual. CONCLUSIONS: The cost-effectiveness analysis in the present study demonstrated that a nurse-led integrated care approach is very likely a costeffective management strategy for patients with atrial fibrillation.

OBJECTIVE: To determine if quality of life, as measured by the Short Form-36 (SF-36), improved during the treatment of opiate dependence and to identify which dimensions of the SF-36 were impacted by treatment. METHODS: The SF-36 was administered via computer to 100 patients enrolled in a clinical trial of a new drug for opiate dependence. The trial compared two dosage forms of the drug. The five time points for administration were upon enrollment (T1) and monthly (T2-T5) for the 16-week trial. The study was conducted at a drug abuse treatment clinic in a large metropolitan area. Data were analyzed using paired t-tests. RESULTS: Significant improvement in health-related quality of life (P T1), general health (T2, T3 > T1), mental health (T2, T3, T5 > T1), social function (T2, T3, T4, T5 > T1), and vitality (T3, T4, T5 > T1 and T3 > T2). Changes in measures of physical functioning and role physical dimensions were not affected by addiction treatment. Changes in general health, mental health, and social function occurred between the enrollment assessment and the first month of treatment (T1 versus T2). However, significant improvement in bodily pain and vitality did not occur until the second month and after (T1 versus T3–T5). CONCLUSION: Quality of life measures improved during opiate dependence treatment. Fewer measures of physical dimensions improved than mental dimensions. The SF-36 was sensitive to improvements in quality of life in patients treated for opiate dependence; therefore it was helpful in measuring patient outcomes.