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.     

Prevalence and impact of constipation and bowel dysfunction induced by strong opioids: a cross-sectional survey of 520 patients with cancer pain: DYONISOS study

Abstract

Objective:

To describe the prevalence of opioid-induced constipation (OIC) in patients with cancer pain according to the Knowles-Eccersley-Scott symptom score (KESS), the different symptoms of opioid-induced bowel dysfunction (OIBD), and to assess the impact of OIBD on patient’s quality-of-life.

Methods:

A cross-sectional observational study, using the KESS questionnaire and the physician’s subjective assessment of constipation, and other questionnaires and questions on constipation, OIBD, and quality-of-life, carried out on 1 day at oncology day centres and hospitals.

Results:

Five hundred and twenty patients were enrolled at 77 centres in France; 61.7% of patients (n?=?321) showed a degree of constipation that is problematic for the patient according to KESS (between 9–39). Even more patients, 85.7% (n?=?438), were considered constipated according to the physician’s subjective assessment—despite laxative use (84.7% of patients). Quality-of-life was significantly reduced in constipated vs non-constipated patients for both PAC-QoL (p?<?0.0001 for total score and each dimension) and the SF-12 questionnaires (statistically significant for all dimensions except physical state and role physical). OIC and OIBD led to hospitalization (16% of patients), pain (75% of patients), and frequent changes in opioid and laxative treatment.

Key limitations:

This cross-sectional study, in a selected population of cancer patients, has measured prevalence and impact of OIBD. Further confirmation could be sought through the use of longitudinal studies, and larger populations, such as non-cancer pain patients treated with opioids

Conclusions:

Cancer patients taking opioids for pain are very frequently constipated, even if they are prescribed laxatives. This leads to relevant impairments of quality-of-life.     

Converting EORTC QLQ-C30 scores to utility scores in the brigatinib ALTA study

Abstract

Aims: Health utilities summarize a patient’s overall health status. This study estimated utilities based on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (QLQ-C30), a widely used measure of health-related quality-of-life (HRQoL) in oncology, using published mapping algorithms.

Materials and methods: Data were from the Anaplastic Lymphoma Kinase (ALK) in Lung Cancer Trial of brigatinib (ALTA; NCT02094573), an open-label, international, phase 2 study. ALTA evaluated the efficacy and safety of two randomized dosing regimens of brigatinib in patients with locally advanced or metastatic ALK?+?non-small cell lung cancer (NSCLC) that had progressed on prior therapy with crizotinib. QLQ-C30 scores were mapped to European Quality-of-Life-5 Dimensions (EQ-5D) utility scores using two published algorithms (Khan et al. for EQ-5D-5L; Longworth et al. for EQ-5D-3L). The impact of brigatinib treatment on health utilities over time was assessed.

Results: The analysis included 208 subjects. Mean baseline utility scores for both algorithms ranged between 0.60???0.71 and increased to 0.78 by cycle 5. Utility improvements were sustained during most of the treatment, before disease progression. Minor variations were observed between utility scores; Khan et al. estimates were approximately 0.01 or 0.02 points lower than Longworth et al. estimates.

Limitations: Algorithms considered were limited to those available in the published literature at the time of the study. This utility analysis was exploratory, and the ALTA trial did not include an internal control group (i.e. standard of care) and was not powered to detect differences in QoL/utility outcomes between treatment arms.

Conclusions: Converting QLQ-C30 scores into utilities in trials using established mapping algorithms can improve evaluation of medicines from the patient perspective. Both algorithms suggested that brigatinib improved health utility in crizotinib-refractory ALK?+?NSCLC patients, and improvements were maintained during most of the treatment.

Clinicaltrials.gov identifier: NCT02094573     

Mapping AcroQoL scores to EQ-5D to obtain utility values for patients with acromegaly

Aims: To estimate a preference-based single index for the disease-specific instrument (AcroQoL) by mapping it onto the EQ-5D to assist in future economic evaluations.

Materials and methods: A sample of 245 acromegaly patients with AcroQoL and EQ-5D scores was obtained from three previously published European studies. The sample was split into two: one sub-sample to construct the model (algorithm construction sample, n?=?184), and the other one to confirm it (validation sample, n?=?61). Various multiple regression models including two-part model, tobit model, and generalized additive models were tested and/or evaluated for predictive ability, consistency of estimated coefficients, normality of prediction errors, and simplicity.

Results: Across these studies, mean age was 50–60 years and the proportion of males was 36–59%. At overall level the percentage of patients with controlled disease was 37.4%. Mean (SD) scores for AcroQoL Global Score and EQ-5D utility were 62.3 (18.5) and 0.71 (0.28), respectively. The best model for predicting EQ-5D was a generalized regression model that included the Physical Dimension summary score and categories from questions 9 and 14 as independent variables (Adj. R²?=?0.56, with mean absolute error of 0.0128 in the confirmatory sample). Observed and predicted utilities were strongly correlated (Spearman r?=?0.73, p?<?.001) and paired t-Student test revealed non-significant differences between means (p?>?.05). Estimated utility scores showed a minimum error of ≤10% in 45% of patients; however, error increased in patients with an observed utility score under 0.2. The model’s predictive ability was confirmed in the validation cohort.

Limitations and conclusions: A mapping algorithm was developed for mapping of AcroQoL to EQ-5D, using patient level data from three previously published studies, and including validation in the confirmatory sub-sample. Mean (SD) utilities index in this study population was estimated as 0.71 (0.28). Additional research may be needed to test this mapping algorithm in other acromegaly populations.     

Understanding the effects on HR-QoL of treatment for overactive bladder: a detailed analysis of EQ-5D clinical trial data for mirabegron

Abstract

Background:

Analysis of EQ-5D data often focuses on changes in utility, ignoring valuable information from other parts of the instrument. The objective was to explore how the utility index, EQ-5D profile, and EQ-VAS captured change in clinical trials of mirabegron, a new treatment for overactive bladder (OAB).

Data:

Data were pooled from three phase III clinical trials that investigated the efficacy and safety of mirabegron vs placebo. Tolterodine ER 4?mg was included as an active control in one study: (1) placebo, mirabegron 50?mg and 100?mg, and tolterodine 4?mg ER; (2) placebo, mirabegron 50?mg and 100?mg; (3) placebo, and mirabegron 25?mg and 50?mg. Data were collected at baseline, week 4, 8, and 12.

Methods:

Analyses were performed on full analysis and modified intention to treat (ITT) data sets using UK utilities. Analysis controlled for relevant patient characteristics. Analysis of Covariance identified changes from baseline at each time point in utilities and EQ-VAS. Areas Under the Curve were estimated to summarize inter-temporal differences in effect. EQ-5D profile data were analysed using the Paretian Classification of Health Change.

Results:

In modified ITT analyses, mirabegron 50?mg was superior to tolterodine 4?mg in changes from baseline utilities after 12 weeks (p?<?0.05); similarly, AUC results showed mirabegron 50?mg to be superior to tolterodine (p?<?0.05) and placebo (p?<?0.05) with the benefit already apparent at 4 weeks (p?<?0.05). EQ-VAS more consistently indicated superior outcomes: all three mirabegron doses showed statistically significant greater effectiveness compared to tolterodine at 12 weeks. Individual EQ-5D dimensions and the overall profile showed no significant differences between study arms.

Conclusion:

Mirabegron showed quicker and superior improvement in HR-QoL compared to tolterodine 4?mg ER. A limitation of the study is that EQ-5D was a secondary outcome in the pivotal trials, which were not powered to measure differences on EQ-5D.     

EQ-5D health utilities: exploring ways to improve upon responsiveness in psoriasis

Aims: To determine if EuroQoL 5-Dimension Health Questionnaire (EQ-5D) health utility scores were able to discriminate among different levels of improvement in psoriasis severity following therapy.

Materials and methods: Data were from three placebo-controlled phase 3 ixekizumab studies (UNCOVER-1, UNCOVER-2, and UNCOVER-3) with patients who had baseline Dermatology Life Quality Index scores >10 (DLQI >10). Psoriasis severity (Psoriasis Area and Severity Index [PASI]), general health utility (EQ-5D), and psoriasis-specific utility (EQ-PSO, UNCOVER-3 only) were assessed. EQ-5D-5L utility scores were generated using the England EQ-5D-5L value set, a crosswalk applied to the EQ-5D-3L United States (US) and United Kingdom (UK) value sets, and a regression-based exploratory scoring function for the EQ-PSO (UK). Analysis of variance was used to estimate change in EQ-5D-5L from baseline to Week 12 per PASI improvement level: PASI <50, PASI 50 to <75, PASI 75 to <90, PASI 90 to <100, and PASI 100. Missing data were imputed using the last observation carried forward method. Value sets for the UK, England, and the US were applied.

Results: In total, 2085 patients across UNCOVER-1, UNCOVER-2, and UNCOVER-3 had baseline DLQI >10 and available utility scores. At Week 12, mean EQ-5D utility scores increased with increasing PASI improvement levels (p?n?=?645; PASI 90 to <100: 0.141, PASI 100: 0.200; adjusted p?=?0.043).

Limitations: EQ-5D-5L index-based scores have limited ability to differentiate among psoriasis patients at the highest PASI improvement levels.

ConclusionsL Adding psoriasis-specific EQ-PSO dimensions to the EQ-5D may enhance responsiveness to improvement in skin clarity at the highest PASI levels, and, therefore, generate utility scores that better reflect treatment benefit in cost-utility models.     

Costs and quality of life effects of the first year of renal replacement therapy in one Finnish treatment centre

Abstract

Objective: The main objective of the study was to assess the cost and quality of life (QoL) effects of elective dialysis patients during the first year of end-stage renal disease (ESRD) treatment in one Finnish treatment centre.

Methods: A prospective case-series study was performed involving all elective dialysis patients (n=29) in a Finnish dialysis unit during 2003–2004. Direct costs of ESRD treatment were obtained from the hospital database and the Social Insurance Institution. The QoL effects were measured at the initiation of treatment, at 6 and at 12 months using 15D, a generic QoL instrument.

Results: The average cost of ESRD treatment was €69,085. The improvement in the patients' QoL score was statistically and clinically significant during the first treatment year. The most significant changes were seen in the dimensions of breathing and vitality. The condition of patients commencing haemodialysis (HD) was more severe than that of patients commencing peritoneal dialysis (PD) as indicated by worse residual kidney function and poorer quality of life at the initiation.

Conclusions: In this small patient population, treatment of ESRD during the first year seemed to improve or maintain the QoL of the patients.     

Quality of life benefits and cost impact of prolonged release oxycodone/naloxone versus prolonged release oxycodone in patients with moderate-to-severe non-malignant pain and opioid-induced constipation: a UK cost-utility analysis

Abstract

Objective:

To compare the cost effectiveness of prolonged release oxycodone/naloxone (OXN) tablets (Targinact) and prolonged release oxycodone (OXY) tablets (OxyContin) in patients with moderate-to-severe non-malignant pain and opioid-induced constipation (OIC) from the perspective of the UK healthcare system.

Methods:

A cohort model used data from a phase III randomised, controlled trial (RCT). It calculated the cost difference between treatments by combining the cost of pain therapy with costs of laxatives and other resources used to manage constipated patients. SF-36 scores were converted into EQ-5D utility values to calculate the quality-adjusted life-year (QALY) gains. Deterministic and probabilistic sensitivity analyses were performed.

Results:

The incremental cost of OXN versus OXY was £159.68 for the average treatment duration of 301 days. OXN gave an incremental QALY gain of 0.0273. The estimated incremental cost-effectiveness ratio (ICER) was £5841.56 per QALY. Sensitivity analyses gave a maximum ICER of £10,347.03. In some scenarios, OXN dominated with a cost saving of up to £4254.70. Probabilistic sensitivity analysis showed that OXN had approximately 96.6% probability of cost effectiveness at the £20,000 threshold.

Limitations:

The model was conservative in predicting the probability of constipation beyond the 12-week RCT period. UK cost of constipation data were limited and based on primary care physician opinion.

Conclusions:

In the base case, direct treatment costs were slightly higher for patients treated with OXN than for those treated with OXY. However, patients treated with OXN experienced a quality of life gain, and had an ICER considerably below thresholds commonly applied in the UK. The model was most sensitive to the estimated cost of constipation with a number of realistic scenarios in the sensitivity analysis demonstrating a cost saving with OXN (OXN dominant). OXN is therefore estimated to be a cost-effective option for treating patients with severe non-malignant pain and OIC.     

Cost of managing constipation among terminally ill cancer patients treated with transdermal fentanyl and 12 hour sustained-release morphine in Canada

Summary

This study examined the cost of treating constipation among terminally ill cancer patients receiving transdermal fentanyl and 12 hour sustained-release morphine in Ontario, Canada. A decision tree was constructed that modelled the treatment paths and associated resource use attributable to managing constipation among patients receiving both opioids using a randomised clinical trial and information on patient management obtained from a panel of eight physicians and two community nurses who specialise in palliative care in Ontario. The cost to the Ontario Ministry of Health of managing constipation in a patient receiving transdermal fentanyl and 12 hour sustained-release morphine was estimated to be $31.77 and $52.76 respectively during the first two weeks of treatment. When the opioids' acquisition costs were included, the two-weekly cost of managing a patient with transdermal fentanyl and 12 hour sustained-release morphine was $123.24 and $119.70 respectively. The results were sensitive to the incidence of constipation attributable to each opioid, the rate and length of hospital admission and the efficacy of various treatments for constipation. We conclude that opioid acquisition costs alone should not dictate treatment choice for palliative care, but attention should also be paid to the costs of managing opioid-related adverse events and care should always be tailored to the needs and preferences of individual patients.     

A systematic literature review of utility weights in wet age-related macular degeneration

Abstract

Objective:

The objective of the study was to conduct a systematic review of utility weight estimates relevant to economic models for wet age-related macular degeneration (wAMD).

Methods:

A systematic literature search of PubMed, Embase, the Cochrane Library, and EconLit was performed (January 1995–December 2010) and then updated (October 2010–May 2012; February 2012–July 2013) identifying articles reporting utilities in patients with wAMD and visual impairment. Extracted studies were also assessed for compliance with the NICE reference case.

Results:

Of 2415 articles identified from the searches, 212 articles were reviewed in full, and 17 selected for data extraction. Most studies used time trade-off (TTO) techniques to estimate utilities; other methods included standard gamble, EuroQoL Health Questionnaire 5 Dimensions (EQ-5D); Short-Form 6D Health Status Questionnaire (SF-6D); and Health Utilities Index Mark III (HUI3). Correlation between utility estimates and visual acuity (VA) differed between the instruments. Time trade-off methods were more sensitive to VA changes than standard gamble methods. HUI3 estimates were most highly correlated with VA changes, followed by TTO; no trend was observed between VA and EQ-5D or SF-6D utility weights. Six of the 17 studies complied with the NICE reference case.

Conclusions:

Several instruments have been used to elicit utilities from patients with wAMD. Because TTO methods were more sensitive to VA changes than standard gamble and HUI3 estimates were most highly correlated with VA changes, TTO and HUI3 may be suitable methods for economic evaluations in these patients. The EQ-5D and SF-6D were poor indicators of the impact of VA on HRQL.     

Further validation of the psychometric properties of the Bowel Function Index for evaluating opioid-induced constipation (OIC)

Abstract

Objective:

The BFI (Bowel Function Index) is a 3-item questionnaire for assessing opioid-induced constipation (OIC). The aim of this study was to contribute to the validation of the psychometric properties of the BFI by confirming a constipation threshold, and through correlation with other validated tools: KESS (Knowles Eccersley Scott Symptom) score and generic (12-Item Short Form Health Survey, SF-12) and specific (Patient Assessment of Constipation–Quality of Life, PAC-QoL) quality-of-life scores.

Methods:

A survey on opioid-requiring cancer-patients was carried out in France. A questionnaire was filled out for all patients that recorded their demographic characteristics, an assessment of their constipation using BFI and KESS scores, and included a self-assessment of quality-of-life using PAC-QoL and SF-12. Correlation of BFI with KESS, PAC-QoL, and SF-12 was investigated.

Results:

Five hundred and twenty patients participated in the entire data collection with no loss. BFI was shown to be statistically correlated (r?=?0.571; p?<?0.0001) with the KESS score and matches up with PAC-QoL and to a lesser extent with the SF-12 generic quality-of-life questionnaire. A BFI threshold of 27–29 to discriminate constipated from non-constipated patients was confirmed.

Key limitations:

This cross-sectional study in a selected population of cancer pain patients has validated the psychometric properties of the BFI. Further confirmation of the validity of the BFI could be sought through the use of longitudinal studies, and larger populations, such as non-cancer pain patients treated with opioids.

Conclusion:

This study contributes to the validation of the psychometric properties of the BFI. It confirms the BFI as an easy-to-use tool to assess constipation and its impact on quality-of-life in chronic pain patients.     

The cost-effectiveness and budget impact of stepwise addition of bolus insulin in the treatment of type 2 diabetes: evaluation of the FullSTEP trial

Background and aims:

Intensification of basal insulin-only therapy in type 2 diabetes is often achieved through addition of bolus insulin 3-times daily. The FullSTEP trial demonstrated that stepwise addition (SWA) of bolus insulin aspart was non-inferior to full basal-bolus (FBB) therapy and reduced the rate of hypoglycemia. Here the cost-effectiveness and budget impact of SWA is evaluated.

Methods:

Cost-effectiveness and budget impact models were developed to assess the cost and quality-of-life (QoL) implications of intensification using SWA compared with FBB in the US setting. At assessment, SWA patients added one bolus dose to their current regimen if the HbA1c target was not met. SWA patients reaching three bolus doses used FBB event rates. Outcomes were evaluated at trial end and projected annually up to 5 years. Models captured hypoglycemic events, the proportion meeting HbA1c target, and self-measured blood glucose. Event rates and QoL utilities were taken from trial data and published literature. Costs were evaluated from a healthcare-payer perspective, reported in 2013 USD, and discounted (like clinical outcomes) at 3.5% annually. This analysis applies to patients with HbA1c 7.0–9.0% and body mass index <40?kg/m².

Results:

SWA was associated with improved QoL and reduced costs compared with FBB. Improvement in QoL and cost reduction were driven by lower rates of hypoglycemia. Sensitivity analyses showed that outcomes were most influenced by the cost of bolus insulin and QoL impact of symptomatic hypoglycemia. Budget impact analysis estimated that, by moving from FBB to SWA, a health plan with 77,000 patients with type 2 diabetes, of whom 7.8% annually intensified to basal-bolus therapy, would save USD 1304 per intensifying patient over the trial period.

Conclusions:

SWA of bolus insulin should be considered a beneficial and cost-saving alternative to FBB therapy for the intensification of treatment in type 2 diabetes.     

Relationship between patient-reported disease severity and other clinical outcomes in osteoarthritis: a European perspective

Abstract

Objective:

To determine how patient-rated osteoarthritis (OA) severity correlates with other patient-reported and clinical outcomes in the European clinical setting.

Methods:

We used the Adelphi Arthritis VII (2008) Disease Specific Program (DSP). OA severity was patient-rated using the question ‘How bad would you say your arthritis is now?’ with responses of ‘mild,’ ‘moderate,’ and ‘severe.’ Patient-reported outcomes included a 0–100?mm pain visual analogue scale (VAS); questions on daily functioning; Work Productivity and Activity Impairment (WPAI) scale; and EuroQoL (EQ-5D). Regression models and chi-square analyses evaluated relationships between self-rated OA severity and other outcomes.

Results:

Patient-reported data were available from 1739 individuals (63.1% female, mean age 64.4 [standard deviation 11.9] years) from France, Germany, Italy, Spain, and the UK. With increasing OA severity; mild (24.5%), moderate (56.3%), severe (19.2%), statistically significant differences (p?<?0.05) were observed with higher pain VAS scores (28.3, 49.9, 69.2, respectively), reduced function, and greater overall work impairment due to OA (24.3%, 38.5%, 68.6%, respectively). Significant associations of patient-reported OA severity with function and health status were indicated, including the EQ-5D health state index; 0.77 (mild), 0.62 (moderate), 0.30 (severe) (p?<?0.0001). Physicians tended to overestimate patients who rated their OA as mild, and underrate patients who rated their OA as severe.

Conclusions:

In five European countries, patient-rated OA severity was associated with other patient-reported outcomes, and may be of benefit in the clinical setting when choosing treatment options aimed at improving pain, function and productivity, providing an accurate and tangible assessment of patient’s perceptions of their disease.     

The impact of different scenarios for intermittent bladder catheterization on health state utilities: results from an internet-based time trade-off survey

Aims: Intermittent catheterization (IC) is the gold standard for bladder management in patients with chronic urinary retention. Despite its medical benefits, IC users experience a negative impact on their quality of life (QoL). For health economics based decision making, this impact is normally measured using generic QoL measures (such as EQ-5D) that estimate a single utility score which can be used to calculate quality-adjusted life years (QALYs). But these generic measures may not be sensitive to all relevant aspects of QoL affected by intermittent catheters. This study used alternative methods to estimate the health state utilities associated with different scenarios: using a multiple-use catheter, one-time-use catheter, pre-lubricated one-time-use catheter and pre-lubricated one-time-use catheter with one less urinary tract infection (UTI) per year.

Methods: Health state utilities were elicited through an internet-based time trade-off (TTO) survey in adult volunteers representing the general population in Canada and the UK. Health states were developed to represent the catheters based on the following four attributes: steps and time needed for IC process, pain and the frequency of UTIs.

Results: The survey was completed by 956 respondents. One-time-use catheters, pre-lubricated one-time-use catheters and ready-to-use catheters were preferred to multiple-use catheters. The utility gains were associated with the following features: one time use (Canada: +0.013, UK: +0.021), ready to use (all: +0.017) and one less UTI/year (all: +0.011).

Limitations: Internet-based survey responders may have valued health states differently from the rest of the population: this might be a source of bias.

Conclusion: Steps and time needed for the IC process, pain related to IC and the frequency of UTIs have a significant impact on IC related utilities. These values could be incorporated into a cost utility analysis.     

Predictors of government subsidized pharmaceutical use in patients with diabetes or cardiovascular disease in a primary care setting: evidence from a prospective randomized trial

Abstract

Objectives:

This study uses data from a prospective randomized controlled trial to estimate predictors of pharmaceutical expenditure in diabetes (DM) or cardiovascular disease (CVD) patients. Identifying drivers of pharmaceutical use and the extent to which they are modifiable may inform cost-effective policy-making.

Methods:

The trial followed 260 patients aged >18 years (mean 68) from three general practices for 12 months. Patients had type 2 diabetes (90 patients) or cardiovascular disease (170 patients). Costs for pharmaceuticals prescribed on the Pharmaceutical Benefits Scheme (PBS) were obtained retrospectively at 12 months. Sociodemographic data and health-related quality-of-life (QoL) were recorded from questionnaires. Clinical measures (including body mass index (BMI), blood pressure, high and low density lipoprotein (LDL), and HbA1c) were also collected.

Results:

Mean pharmaceutical costs for DM patients (AU$4119) was greater than CVD patients (AU$2424). The largest contributor to costs in both groups was pharmaceuticals used for management of conditions other than CVD or DM. QoL (EQ5D) and BMI were significant predictors of costs in both groups. A history of cardiac events, HbA1c, age, and unemployment were significant predictors of costs in the DM group. A diagnosis of heart failure, frequency of hospital admissions, and LDL levels were significant predictors of costs in the CVD group. Roughly one third of total variation of costs can be explained by the regressors in both models.

Limitations:

Generalizability will be limited as data was derived from a trial and the study was not powered for this post-hoc analysis. Missing data imputation and self-reporting bias may also impact on results.

Conclusions:

Factors such as QoL BMI, HbA1c levels, and a history of cardiac events are significant predictors of costs. The results suggest there may be a place for interventions that improve quality-of-life and concurrently reduce pharmaceutical costs in patients with CVD or DM.     

A systematic literature review identifying associations between outcomes and quality of life (QoL) or healthcare resource utilization (HCRU) in schizophrenia

Aims: There have been no systematic literature reviews (SLRs) evaluating the identified association between outcomes (e.g. clinical, functional, adherence, societal burden) and Quality-of-Life (QoL) or Healthcare Resource Utilization (HCRU) in schizophrenia. The objective of this study was to conduct a SLR of published data on the relationship between outcomes and QoL or HCRU.

Materials and methods: Electronic searches were conducted in Embase and Medline, for articles which reported on the association between outcomes and QoL or HCRU. Inclusion and exclusion criteria were applied to identify the most relevant articles and studies and extract their data. A summary table was developed to illustrate the strength of associations, based on p-values and correlations.

Results: One thousand and two abstracts were retrieved; five duplicates were excluded; 997 abstracts were screened and 95 references were retained for full-text screening. Thrirty-one references were included in the review. The most commonly used questionnaire, which also demonstrated the strongest associations (defined as a p?Limitations: This study included data from an 11-year period, and other instruments less frequently used may be further investigated.

Conclusions: The evidence suggests that the PANSS is the clinical outcome that currently provides the most frequent and systematic associations with HCRU and QoL endpoints in schizophrenia.