Health-related quality-of-life in patients after elective surgery for abdominal aortic aneurysm

Abstract

Purpose:

The purpose of this study was to describe the health-related quality-of-life (QoL) in patients after elective surgery for abdominal aortic aneurysm (AAA) compared to a normal population and to study the association between QoL and number of years since surgery.

Methods:

All Danish men who underwent elective surgery for AAA at the age of 65 or more in the period from 1989–2007 in Denmark were invited to participate in the survey. Of 722 patients, 375 were alive and 328 (87%) responded. The instruments EQ-5D (European Quality of life), EQ-VAS and SF-12 (Short Form Health Survey) were applied for measuring health-related QoL. Multiple regression analysis was used to study the association between QoL and number of years since AAA surgery.

Results:

A significantly poorer QoL was found in patients having had AAA surgery compared to the normal population as measured with the SF-12 and the EQ-VAS, but not with EQ-5D. A negative association between QoL and years following surgery was found with EQ-VAS and SF-12 (PCS), but not with the other instruments.

Discussion:

Factors such as selection bias because of mortality and non-response may have resulted in an over-estimate of the QoL in patients having had AAA surgery, thus the difference in QoL compared to the normal population was probably under-estimated. The cross-section design was inefficient for the study of the association between QoL and years since surgery, and EQ-5D may be an insensitive instrument for measuring QoL in AAA patients after surgery.

Limitations:

The main limitation of the study was the cross-sectional design. Males with a higher risk of death were under-represented in the sample.

Conclusion:

A poorer quality-of-life was found in patients having had elective AAA surgery compared to the normal population.     

Utility decrements associated with side effects in schizophrenia

Objective:

Most of the existing studies investigating the impact of schizophrenia on utility have focused on the different stages of the disease. The objective of this study was to describe and quantify the impact of treatment-related side-effects on utility in patients with schizophrenia, using data from an observational study.

Methods:

This study used data from the European Schizophrenia Cohort (EuroSC), a multi-center 2-year cohort study conducted in France, England, and Germany. The EQ-5D questionnaire was completed every 6 months, as well as the Subjective Side Effect Rating Scale, assessing patient distress over extrapyramidal symptoms (EPS), weight gain, sedation, and sexual dysfunction, used to assess whether or not the patient experienced the side-effect. At first a bivariate analysis was conducted to describe utility values with and without side-effects. Then, a random effects regression analysis was performed on utility, where random effects were controlled for repeated measures on the same subjects, with potential confounding factors. Finally, findings were compared with those of previous publications.

Results:

This sample consisted of 1208 patients with schizophrenia. At the baseline visit, the most reported side-effect was EPS (almost 60% of patients), followed by sedation and weight gain (～50% of patients for each), and sexual dysfunction (almost 30% of patients). Significant association with severity of symptoms, functioning abilities, and utility were found. Patients reporting none of the studied side-effects had an average EQ-5D index score of 0.81, found to be higher than scores of patients reporting EPS (0.70), sexual dysfunction (0.67), sedation (0.70), or weight gain (0.72). The random effects model reported a utility decrement of 0.042 for EPS, 0.022 for weight gain, 0.022 for sexual dysfunction, and 0.019 for sedation. Although the external validation was difficult due to the different methods or definitions of the side-effects, as well as the paucity of data for weight gain, sedation and sexual dysfunction, the results were generally consistent with previous studies.

Conclusion:

This study aimed at quantifying the direct impact of main side-effects associated with antipsychotics on patients’ utility. Results suggested a significant direct impact of side-effects, with EPS being the most impactful.     

The association between osteoporosis and patient outcomes in Japan

Objective To quantify the burden of osteoporosis and examine the interplay between osteoporosis and various comorbidities as it relates to patient outcomes.

Methods Data from the 2011 Japan National Health and Wellness Survey (NHWS; n?=?30 000), an internet health survey fielded to a nationally representative sample of the Japanese population were used. Only women between the ages of 50–90 years were included in the analyses (n?=?6950).

Results Compared with matched controls (n?=?404), patients with osteoporosis (n?=?404) had lower MCS scores (48.94 vs 51.63), PCS scores (45.57 vs 49.12) (all p?<?0.05). The presence of osteoporosis was associated with worse patient outcomes among those with hypertension, high cholesterol, and insomnia, among other conditions.

Conclusions The results suggest a significant quality-of-life and economic burden for patients with osteoporosis in Japan. Moreover, in a complex co-morbid environment, the presence of osteoporosis contributes more to patient outcomes than other chronic conditions.     

Assessing the impact of nocturia on health-related quality-of-life and utility: results of an observational survey in adults

Background and aim: The impact of nocturia (getting up at night to void) on health-related quality-of-life (HRQoL) is often under-estimated. This study investigated the relative burden in terms of HRQoL and utilities of nocturia in a real-world setting.

Methods: Patient data were collected from two surveys: a nocturia-specific, cross-sectional survey of physicians and their patients (DSP), and a general UK population health survey (HSFE). Utilities (EQ-5D-5L), productivity (Work Productivity and Activity Index), and the impact of nocturia symptoms (Nocturia Impact Diary and Overactive Bladder Questionnaires) were assessed against the number of voids. A robust linear regression model with propensity score weights was used to control for confounding factors in estimating utilities.

Results: Physician-recorded data were available from 8,738 patients across the US, Germany, Spain, France, and the UK; of these, 5,335 (61%) included patient-reported outcomes. In total, 6,302 controls were drawn from the two surveys and compared to 1,104 nocturia patients. Deterioration of HRQoL was associated with increasing number of night-time voids (p?p?p?Limitations: The cause of nocturia is multifactorial and the mostly elderly patients may have several concomitant diseases. The authors tried to adjust for the most common ones, but there may be diseases or unknown relationships not included.

Conclusions: Nocturia negatively affected HRQoL and patient utility. A clear effect is seen already at two voids per night. Every effort should, therefore, be made to reduce nocturia below the bother threshold of two voids per night.     

Treatment experience,burden and unmet needs (TRIBUNE) in MS study: results from Turkey

Abstract

Objective:

To estimate the economic burden of multiple sclerosis (MS) in Turkey, including the relapses and disease severity, and to evaluate the quality-of-life of MS patients.

Methods:

The Treatment Experience, Burden and Unmet Needs (TRIBUNE) study was a multi-national, cross-sectional, retrospective, burden-of-illness survey. Total costs were calculated using unit costs derived from price lists or published literature, where relevant, and inflated to 2011 TL prices.

Results:

A total of 295 MS patients (74% females) were included in the analysis. The population had a mean age of 36 years; 73% had the relapsing–remitting form. Mean Expanded Disability Status Scale (EDSS) score was 2.2. Twenty-two per cent of the MS patients required hospitalization in the past year and spent an average of 29.2 days/year in hospital. These values were 43% and 5.6 days for the outpatients, respectively. Total cost per patient/year was 18,700 TL (Turkish Lira). Total costs for patients with mild, moderate, and severe disability were 15,418 TL, 26,002 TL, and 44,208 TL per patient/year, respectively. The mean EuroQol 5D scores in the same groups were 0.73, 0.52, and 0.05, respectively.

Conclusions:

Multiple sclerosis imposes a significant economic burden on patients and society in Turkey.     

Adapting the Asthma Life Impact Scale (ALIS) for use in Southern European (Italian) and Eastern European (Russian) cultures

Abstract

Background:

The Asthma Life Impact Scale (ALIS) is a disease-specific measure used to assess the quality-of-life of people with asthma. It was developed in the UK and US and has proven to be acceptable to patients, to have good psychometric properties, and to be unidimensional.

Objective:

This paper reports on the adaptation and validation of the ALIS for use in representative Southern European (Italian) and Eastern European (Russian) languages.

Methods:

The ALIS was translated for both cultures using the dual-panel process. The newly translated versions were then tested with asthma patients to ensure face and content validity. Psychometric properties of the new language versions were assessed via a test–re-test postal survey conducted in both countries.

Limitations:

It is possible that some cultural or language differences still exist between the different language versions. Further research should be undertaken to determine responsiveness. Further studies designed to determine the clinical validity of the Italian ALIS would be valuable.

Results:

Linguistic nuances were easily resolved during the translation process for both language adaptations. Cognitive debriefing interviews (Russia n?=?9, male?=?11.1%, age mean (SD)?=?55.4 (13.2); Italy n?=?15, male?=?66.7%, age mean (SD)?=?63.5 (11.2)) indicated that the ALIS was easy to read and acceptable to patients. Psychometric testing was conducted on the data (Russia n?=?61, age mean (SD)?=?40.7 (15.4); Italy n?=?71, male?=?42.6%, age mean (SD)?=?49.5 (14.1)). The results showed that the new versions of the ALIS were consistent (Russian and Italian Cronbach’s alpha?=?0.92) and reproducible (Russian test–re-test?=?0.86; Italian test–re-test?=?0.94). The Italian adaptation showed the expected correlations with the NHP and the Russian adaptation showed strong correlations with the CASIS and CAFS and weak-to-moderate correlations with %FEV1 and %PEF. In both adaptations the ALIS was able to distinguish between participants based on self-reported general health, self-reported severity, and whether or not they were hospitalized in the previous week.     

Impact of nocturnal hypoglycemic events on diabetes management,sleep quality,and next-day function: results from a four-country survey

Abstract

Objectives:

Non-severe nocturnal hypoglycemic events (NSNHEs) may have a major impact on patients. The objective was to determine how NSNHEs affect diabetes management, sleep quality, functioning, and to assess if these impacts differ by diabetes type or country.

Methods:

An internet survey to adults with diabetes in the US, UK, Germany, and France.

Results:

Of 6756 screened respondents, 1086 reported an NSNHE in the past month. For this last event, respondents with type 2 required significantly more time than type 1 to recognize and respond to the event (1.5 vs 1.1 hours), 25.7% (T1) and 18.5% (T2) decreased their normal insulin dose due to their most recent NSNHE. All respondents were likely to take 1–2 additional self-monitored blood glucose measurements on the day following. NSNHEs were associated with a high proportion of respondents contacting a healthcare professional (18.6% T1, 27.8% T2) reporting they could not return to sleep at night (13.3% T1, 13.4% T2), and tiredness on the day following the event (71.2% for both). Of the respondents working for pay, 18.4% T1 and 28.1% T2 reported being absent from work due to the NSNHE, and a substantial proportion of respondents (8.7% T1, 14.4% T2) also reported missing a meeting or work appointment or not finishing a task on time. Compared with other countries, respondents from France may experience a more substantial impact on diabetes management and daily functioning following an NSNHE. Potential limitations in this study include recall and selection bias; however, these biases are not believed to have impacted findings in any meaningful way.

Conclusions:

NSNHEs are associated with a substantial impact on diabetes management, sleep quality, and next-day functioning.     

The impact of non-severe hypoglycemic events on daytime function and diabetes management among adults with type 1 and type 2 diabetes

Abstract

Objectives:

To describe daytime non-severe hypoglycemic events (NSHEs), assess their impact on patient functioning and diabetes self-management, and examine if these impacts differ by diabetes type or country.

Methods:

Internet survey to adults with diabetes in the US, UK, Germany, and France.

Results:

Of 6756 screened respondents, 2439 reported a daytime NSHE in the past month. NSHEs occurred while active (e.g., running errands) (45.1%), 29.6% while not active (e.g., watching TV), and 23.8% at work. On average, it took half a day to respond and recover from NSHE. Respondents monitored their glucose 5.7 extra times on average over the following week. On the day of event, type 1 respondents tested significantly more often than type 2 (p?<?0.05). Type 2 were less likely to confirm NSHE with glucose test (p?<?0.001). Following NSHE, 12.6% of respondents reduced total insulin by an average of 7.6 units (SD?=?8.3). Total units and days with reduced dosing was significantly less, whilst number of additional glucose tests and time to recover was significantly longer if NSHE occurred at work (p?<?0.001). Type 1 decreased insulin doses more often (p?<?0.001); however, type 2 decreased a greater number of units (p?<?0.01). Compared with other countries, US respondents were more likely to eat a light or full meal and respondents in France took significantly longer than all other countries to recognize (p?<?0.05), respond to (p?<?0.001), and recover from (p?<?0.001) NSHE, used significantly more monitoring tests the day of (p?<?0.05) and over the subsequent week (p?<?0.001), and decreased their normal insulin dose more (p?<?0.001). Limitations of the study include potential recall bias and selection bias.

Conclusions:

NSHEs are associated with a significant impact on patient functioning and diabetes management.     

A cost-effectiveness analysis of subcutaneous interferon beta-1a 44mcg 3-times a week vs no treatment for patients with clinically isolated syndrome in Sweden

Abstract

Objective:

To assess the cost-effectiveness of subcutaneous interferon (sc IFN) beta-1a 44?mcg 3-times weekly (tiw) vs no treatment at reducing the risk of conversion to multiple sclerosis (MS) in patients with clinically isolated syndrome (CIS) in Sweden.

Methods:

A Markov model was constructed to simulate the clinical course of patients with CIS treated with sc IFN beta-1a 44?mcg tiw or no treatment over a 40-year time horizon. Costs were estimated from a societal perspective in 2012 Swedish kronor (SEK). Treatment efficacy data were derived from the REFLEX trial; resource use and quality-of-life (QoL) data were obtained from the literature. Costs and outcomes were discounted at 3%. Sensitivity analyses explored whether results were robust to changes in input values and use of Poser criteria.

Results:

Using McDonald criteria sc IFN beta-1a was cost-saving and more effective (i.e., dominant) vs no treatment. Gains in progression free life years (PFLYs) and quality-adjusted life-years (QALYs) were 1.63 and 0.53, respectively. Projected cost savings were 270,263 SEK. For Poser criteria cost savings of 823,459 SEK were estimated, with PFLY and QALY gains of 4.12 and 1.38, respectively. Subcutaneous IFN beta-1a remained dominant from a payer perspective. Results were insensitive to key input variation. Probabilistic sensitivity analysis estimated a 99.9% likelihood of cost-effectiveness at a willingness-to-pay threshold of 500,000 SEK/QALY.

Conclusion:

Subcutaneous IFN beta-1a is a cost-effective option for the treatment of patients at high risk of MS conversion. It is associated with lower costs, greater QALY gains, and more time free of MS.

Limitations:

The risk of conversion from CIS to MS was extrapolated from 2-year trial data. Treatment benefit was assumed to persist over the model duration, although long-term data to support this are unavailable. Cost and QoL data from MS patients were assumed applicable to CIS patients.