Health-related Quality Of Life Consequences Research Articles

Cost-Effectiveness of PHMB & betaine wound bed preparation compared with standard care in venous leg ulcers: A cost-utility analysis in the United Kingdom

BackgroundWounds cost £8.3 billion per year in the United Kingdom (UK) annually. Venous leg ulcers (VLUs) account for 15% of wounds and can be complicated to heal, increasing nurse visits and resource costs. Recent wound bed preparation consensus recommends wound cleansing and biofilm disrupting agents. However, inert cleansers such as tap water or saline are inexpensive, an evaluation of evidence is required to justify the higher upfront costs of treatment with active cleansers. We undertook a cost-effectiveness analysis of the use of a biofilm disrupting and cleansing solution and gel, Prontosan® Solution and Gel X, (PSGX) (B Braun Medical), as compared to the standard practice of using saline solution, for treating VLUs. MethodsA Markov model was parameterised to one-year costs and health-related quality of life consequences of treating chronic VLUs with PSGX versus saline solution. Costs are viewed from a UK healthcare payer perspective, include routine care and management of complications. A systematic literature search was performed to inform the clinical parameters of the economic model. Deterministic univariate sensitivity analysis (DSA) and probabilistic sensitivity analysis (PSA) were undertaken. ResultsFor PSGX an Incremental Net Monetary Benefit (INMB) of £1,129.65 to £1,042.39 per patient (with a Maximum Willingness to Pay of £30k and £20k per QALY respectively), of which cost savings are £867.87 and 0.0087 quality-adjusted life years (QALYs) gain per patient. PSA indicates a 99.3% probability of PSGX being cost-effective over saline. ConclusionsPSGX for the treatment of VLUs is dominant compared with saline solution in the UK with expected cost-savings within a year and improved patient outcomes.

EE641 Economic and Health-Related Quality of Life Consequences of Imaging and Surveillance Schedule in Seminoma Testis

EE641 Economic and Health-Related Quality of Life Consequences of Imaging and Surveillance Schedule in Seminoma Testis

Long-Term Functional Outcomes of Trauma Patients With Facial Injuries.

Facial trauma can have long-lasting consequences on an individual's physical, mental, and social well-being. The authors sought to assess the long-term outcomes of patients with facial injuries. This is a prospective multicenter cohort study of patients with face abbreviated injury scores ≥1 within the Functional Outcomes and Recovery after Trauma Emergencies registry. The Functional Outcomes and Recovery after Trauma Emergencies registry collects patient-reported outcomes data for patients with moderate-severe trauma 6 to 12 months after injury. Outcomes variables included general and trauma-specific quality of life, functional limitations, screening for post-traumatic stress disorder, and postdischarge healthcare utilization. A total of 188 patients with facial trauma were included: 69.1% had an isolated face and/or head injury and 30.9% had a face and/or head injuries as a part of polytrauma injury. After discharge, 11.7% of patients visited the emergency room, and 13.3% were re-admitted to the hospital. Additionally, 36% of patients suffered from functional limitations and 17% of patients developed post-traumatic stress disorder. A total of 34.3% patients reported that their injury scars bothered them, and 49.4% reported that their injuries were hard to deal with emotionally. Patients who sustain facial trauma suffer significant long-term health-related quality of life consequences stemming from their injuries.

Childhood maltreatment among university students in Turkey: prevalence, demographic factors, and health-related quality of life consequences

ABSTRACT Childhood maltreatment (CM) is a global problem with serious life-long consequences. The purpose of the present study was to determine the prevalence of CM among university students and to assess the associations between CM and the health-related quality of life (HRQOL) in adulthood. The present descriptive cross-sectional study involved 626 students who had been selected by means of a cluster sampling method from among all the students studying in Giresun University. CM was assessed with the Childhood Trauma Questionnaire at interview and HRQOL was assessed using the Duke Health Profile. Data were analyzed using descriptive statistics, Pearson chi-square tests, independent samples t-test, and binary logistic regression. About half (43.5%) of the students reported exposure to some form of CM. Logistic regression analysis showed that male gender, parental separation or divorce, poorer familial relationships, lower socioeconomic status, smoking and alcohol consumption were significantly associated with CM. A significant correlation emerged between CM and physical health, general health, perceived health, self-esteem, anxiety, pain and disability. CM is common among university students in Turkey. Students who had experienced CM had significant and sustained losses in HRQOL in adulthood relative to students who had not experienced maltreatment.

Health-related Quality of Life of Bone Marrow versus Peripheral Blood Stem Cell Donors: A Prespecified Subgroup Analysis from a Phase III RCT—BMTCTN Protocol 0201

Hematopoietic stem cells can be procured from unrelated donors via either the bone marrow (BM) aspiration or peripheral blood stem cell (PBSC) collection methods. There is no evidence from prospective randomized trials in the unrelated donor setting about the relative health-related quality-of-life (HRQoL) benefits/costs to donors. The goals of this prospective longitudinal investigation were to describe and compare the donation-related HRQoL experiences of 332 BM and PBSC donors. Donors were interviewed before donation, 48 hours after donation, weekly until fully recovered, and at 6 and 12 months after donation. Before donation, BM donors had lower confusion, fewer concerns, and were more prepared for donation. Shortly after donation, BM donors reported more physical side effects. BM donors also reported more donation-related impact on their social activities. However, BM donors reported somewhat better psychological status and were more likely to indicate that the donation made their lives more meaningful. There were virtually no longer term differences in the experiences of the 2 donor groups, including no recovery time difference beginning 3 weeks after donation. Although BM donors may experience the process as more physically stressful and more psychologically beneficial in the short term, the longer term HRQoL consequences of BM and PBSC donors are similar.

Having a Pap smear, quality of life before and after cervical screening: a questionnaire study

To assess the health-related quality of life (HRQoL) impact of cervical cancer screening in women with normal test results. Questionnaire study. Maastricht, the Netherlands. A cohort of 789 women were followed from screening invitation until after the receipt of screening results. A female age-matched reference group (n=567) was included. Questionnaires were sent to the home address of the women before screening, after screening, and again with the screening results. Generic HRQoL (SF-12, EQ-5D), generic anxiety (STAI-6), screen-specific anxiety (PCQ), and potential symptoms and feelings related to the smear-taking procedure. A total of 60% of screening participants completed questionnaire 1(n=924): 803 of these women granted permission to access their files; 789 of these 803 women had normal test results (Pap 1), and were included in the analyses. Generic HRQoL (SF-12, EQ-5D) and anxiety (STAI-6) scores were similar in the study and reference groups. Before screening, after screening, and also after the receipt of test results, screening participants reported less screen-specific anxiety (PCQ, P<0.001) than the reference group (n=567), with differences indicating clinical relevance. 19% of screening participants were bothered by feelings of shame, pain, inconvenience, or nervousness during smear taking, and 8 and 5% of women experienced lower abdominal pain, vaginal bleeding, discharge, or urinary problems for 2-3 and 4-7 days, respectively, following the Pap smear. The reduced levels of screen-specific anxiety in screening participants, possibly indicating reassurance, are worthwhile addressing in more depth. We conclude that although considerable numbers of women reported unpleasant effects, there were no adverse HRQoL consequences of cervical screening in women with normal test results.

Physical violence and health-related quality of life: Danish cross-sectional analyses

BackgroundThe aim of this study was to evaluate the association between experienced physical violence and health-related quality of life (HRQoL) by comparing self-reported health status for individuals with and without experience of physical violence. Our hypothesis was that individuals exposed to violence would experience worse HRQoL than non-exposed individuals. We tested whether men and women and different age groups experience similar reductions in HRQoL, and the extent to which such differences might be associated with social circumstances and lifestyle conditions. Finally, we explored the HRQoL consequences of exposure to violence in a longer time perspective.MethodsWe used data from self-completed questionnaires in two Danish nationally representative, cross-sectional health interview surveys. Exposure to violence was indicated through specific survey questions (Straus’ conflict tactics scale) enquiring about different types of violence during the last 12 months. Health status of respondents was elicited by the EQ-5D and SF-36 questionnaires. The health status profiles were converted to health score indexes using the Danish algorithm for EQ-5D and the revised Brazier algorithm for SF-6D. Differences in score indexes between the exposed and non-exposed individuals were explored separately for men and women using ordinary least square regression with four age categories as explanatory variables.ResultsIn the 2000 and 2005 surveys, respectively, 4.9% and 5.7% of respondents indicated that they had been exposed to physical violence within the last 12 months. Exposure to violence was more prevalent in the younger age groups and more prevalent for men than women. Respondents exposed to violence had lower score indexes on both the EQ-5D and the SF-6D compared with the non-exposed. Respondents who reported exposure to violence in both 2000 and 2005 reported lower HRQoL than individuals who only reported exposure in one of the surveys.ConclusionsThe results of this study provide evidence for an association between exposure to physical violence and reduction in health-related quality of life.

Urinary Obstructive Problems Exposed But Hormonal Health-Related Quality-of-Life Concerns Eschewed in Prostate Cancer Quality-of-Life Study

Urinary Obstructive Problems Exposed But Hormonal Health-Related Quality-of-Life Concerns Eschewed in Prostate Cancer Quality-of-Life Study

Short-term health-related quality of life consequences in a lung cancer CT screening trial (NELSON)

Background:In lung cancer CT screening, participants often have an indeterminate screening result at baseline requiring a follow-up CT. In subjects with either an indeterminate or a negative result after screening, we investigated whether health-related quality of life (HRQoL) changed over time and differed between groups in the short term.Methods:A total of 733 participants in the NELSON trial received four questionnaires: T0, before randomisation; T1, 1 week before the baseline screening; T2, 1 day after the screening; and T3, 2 months after the screening results but before the 3-month follow-up CT. HRQoL was measured as generic HRQoL (the 12-item Short Form, SF-12; the EuroQol questionnaire, EQ-5D), anxiety (the Spielberger State-Trait Anxiety Inventory, STAI-6), and lung-cancer-specific distress (the Impact of Event Scale, IES). For analyses, repeated-measures analysis of variance was used, adjusted for covariates.Results:Response to each questionnaire was 88% or higher. Scores on SF-12, EQ-5D, and STAI-6 showed no clinically relevant changes over time. At T3, IES scores that were clinically relevant increased after an indeterminate result, whereas these scores showed a significant decrease after a negative result. At T3, differences in IES scores between the two baseline result groups were both significant and clinically relevant (P<0.01).Conclusion:This longitudinal study among participants of a lung cancer screening programme showed that in the short term recipients of an indeterminate result experienced increased lung-cancer-specific distress, whereas the HRQoL changes after a negative baseline screening result may be interpreted as a relief.

Measuring Health-Related Quality of Life Consequences From Primary Treatment for Early-Stage Prostate Cancer

Radical prostatectomy, external radiation therapy, and brachytherapy are all mainstay treatment options for clinically localized prostate cancer. Over time, each of these treatments has been modified so as to maximize percent cancer-free survival while minimizing health-related risks such as urinary incontinence, bowel incontinence, and sexual dysfunction. With these efforts, there is still not one superior single treatment that is devoid of side effects. Concurrently, efforts have been made to generate validated health-related quality of life (HRQOL) measurement scales to aid in the decision making by both physician and patient. HRQOL measurement scales enable physicians to have informed discussions with patients about potential likelihood of a given set of side effects with the various prostate cancer treatment options. This review will highlight prostate cancer HRQOL outcomes and delineate further areas of study necessary to optimize evidence-based decision making for prostate cancer patients.

Health-Related Quality of Life Consequences of Implantable Cardioverter Defibrillators

Implantable cardioverter defibrillators (ICDs) improve survival and extend lives of patients with severe heart disease. We sought to evaluate the impact of ICDs on health-related quality of life (HRQOL) during the first 3 years after implantation. A total of 1089 patients from the Multicenter Automatic Defibrillator Implantation Trial II (MADIT II) were randomized to an ICD or medical treatment only. Health Utility Index (HUI3) at baseline, 3, 12, 24, and 36 months following randomization; survival data. We constructed mean profiles of HRQOL for living patients, estimated overall quality-adjusted life years (QALYs), separately by treatment arm, and calculated cumulative QALY gains/losses as the difference between the areas under the treatment specific HRQOL profiles. Multivariate fixed effect regression models were developed to impute the missing HRQOL data using baseline patient characteristics (age, gender, treatment, HUI3 score, diabetes, diuretics use, and NYHA class). Bootstrapped standard errors were calculated for the estimated differences in HRQOL gains/losses between treatment arms. Similarly, we performed subgroup analyses (by gender, age, and baseline NYHA class, blood urine nitrogen, ejection fraction, and QRS). There were no differences in QALYs loss for living patients by treatment group (-0.037, P = 0.64) or in overall QALYs loss by treatment group (0.043, P = 0.37) over 3 years. In subgroup analysis, female subjects demonstrated a trend towards greater survival benefit (0.298, P = 0.07) and overall QALYs (0.261, P = 0.14). Adverse effects of the ICD on HRQOL together with lower HRQOL among survivors may offset the 3-year survival benefits of ICDs.

Implantable Cardioverter-Defibrillators for Primary Prevention of Sudden Death in Heart Failure

The demonstrated efficacy of implantable cardioverter-defibrillators (ICDs) for reducing sudden death in heart failure trial populations presents a critical challenge to those responsible for the allocation of healthcare resources.1–3 The current cost, multiplied by the prevalence of heart failure deemed high-risk, threatens to make this one enterprise the highest priced intervention for the Medicare population. The elegant cost-effectiveness analysis contributed by Dr Mark and colleagues from the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) in this issue of Circulation provides an exemplary insight into this challenge.4 These investigators’ favorable conclusions are consistent with those from a meta-analysis by Sanders et al5 and with the slightly more conservative implications from the recent cost-effectiveness analysis of the Multicenter Automatic Defibrillator Implantation Trial (MADIT)-II by Zwanziger et al.6 Article p 135 This editorial will offer an alternative conclusion based on both back-of-the-envelope estimations and scrutiny of model assumptions regarding different phases of survival for heart failure populations. ICDs for primary prevention of sudden death in the heart failure population may be less cost-effective than other recommended heart failure therapies, which are prescribed to modify disease progression and symptoms, decreasing costly hospitalizations as well as mortality. Formal cost-effectiveness analysis is complex, but it may be illustrative to begin from simple considerations. A reasonable threshold for cost-effective intervention is often assigned as $40 000 per life-year saved, in line with the present article4 suggesting a cost of $38 389 per life-year saved and $41 530 per quality-adjusted life-year saved. This is approximately equal to the cost of the defibrillator device and implantation, as currently assessed for reimbursement. (The costs would be lower for the simpler device used in SCD-HeFT, which is not available now, and for outpatient implantation, which was common in SCD-HeFT but not the current standard.) This …

Epidemiology of Immune Thrombocytopenic Purpura in the United Kingdom, Germany, and the Netherlands.

Background: Immune thrombocytopenic purpura (ITP) is an autoimmune disorder that is associated with serious clinical and health-related quality of life consequences. However, the true burden of ITP is not known because there is limited published data on its incidence and prevalence.Aims: To describe the incidence and prevalence of ITP over time among adults in selected European countries (United Kingdom, Germany, and the Netherlands) and to ascertain whether ITP incidence and prevalence differ by age or sex.Methods: ITP incidence and prevalence rates were calculated from three healthcare databases: the General Practitioners Research Database (UK), the IMS Disease Analyzer (UK and Germany), and the PHARMO Database (the Netherlands). These databases contain longitudinal patient medical record information from selected general practitioners and specialists, using samples designed to be representative of the countries of interest. Patient information is acquired through electronic linkages to providers' practices in the GPRD and IMS Disease Analyzer, and through the Dutch National Medical Registry in PHARMO. The study periods were 1990–2000 (GPRD), 1994–2003 (IMS Disease Analyzer), and 1991–2003 (PHARMO); analyses were restricted to persons 19 years and older. ITP diagnoses were identified using the ICD-9-CM 287.3 and ICD-I0-CM D69.3 codes. Incidence rates as calculated include only first-time diagnoses whereas prevalence rates include all new and existing cases during a given year.Results: As shown in the table, average ITP incidence and prevalence rates during the study periods (10 years or more) were generally similar in the UK, Germany, and the Netherlands; for example, average incidence rates ranged from 0.6–3.0 per 100,000 persons/year. Although the differences were relatively minor, in general, incidence and prevalence appeared to be highest in Germany and lowest in the Netherlands. From all databases and years of study, persons 60 years and older had the highest age/sex-specific incidence and prevalence. Incidence and prevalence rates were also generally higher (7–36%) among women than men.ITP Incidence and Prevalence Among Adults in the UK, Germany, and the NetherlandsCountryRates per 100,000 **UKIncidencePrevalenceGPRD: 1990–2000Average3.0N/A***Lowest2.12.1Highest4.38.1Most recent year of data availability2.23.2IMS Disease Analyzer: 1994–2003Average0.6N/A***Lowest0.10.1Highest2.03.2Most recent year of data availability (2003)2.03.2GermanyIMS Disease Analyzer: 1994–2003Average2.7N/A***Lowest1.72.8Highest5.17.3Most recent year of data availability (2003)2.03.5The NetherlandsPHARMO Database: 1992–2003Average1.9Lowest1.6N/A***Highest2.11.9Most recent year of data availability (2003)2.12.42.4** Lowest and highest incidence and prevalence rates not necessarily for the same year; *** N/A = Not applicableSummary/Conclusions: During all study years, the incidence and prevalence of ITP in the UK, Germany, and the Netherlands was less than 10 per 100,000 persons/year and was relatively stable over time. ITP was more frequent among women and persons over 60 years of age. While studies derived from databases of medical records have potential limitations, such as disease misclassification, selection bias, or omissions/recording errors, our findings are consistent with other published investigations showing that ITP incidence and prevalence is fairly low in European countries.

Short-term health-related quality of life with epirubicin and cyclophosphamide versus 5-fluorouracil, epirubicin and cyclophosphamide as adjuvant chemotherapy in Turkish patients with operable breast cancer

877 Background: Although adjuvant treatments improve disease free and overall survival in early breast cancer, one of the key issues is ensuring that patients have a worthwhile health-related quality of life (HRQOL). Our purpose is to compare short-term HRQOL in Turkish patients with operable breast cancer receiving the combination of epirubicin and cyclophosphamide (EC) or 5-fluorouracil, epirubicin and cyclophosphamide (FEC) as adjuvant chemotherapy. Methods: Between July 2001 and June 2003, eligible patients (n=60) with Stage I-II and Stage III breast cancer were assigned to EC (epirubicin 90 mg/m2 plus cyclophosphamide 600 mg/m2) every three weeks for four cycles and FEC (5-fluorouracil 600 mg/m2, epirubicin 100 mg/m2 plus cyclophosphamide 600 mg/m2) every three weeks for six cycles respectively. HRQOL was assessed with WHOQOL-BREF, Beck Depression Inventory and State-Trait Anxiety Inventory at baseline and the start of cycles 2, 4 and 3 months after the last cycle. Treatment comparisons and scores changes between baselines were performed using statistical analysis software (SPSS 11.0 for Windows). All the scales were analyzed by using a two-sided t-test at the 5% significance level. Results: All the patients (n=60) completed baseline and subsequent measures. However, there were no statistically significant differences in global HRQOL between the two treatment groups. In both groups, selected aspects of HRQOL were impaired over time significantly, with decreased physical and social/family activities and impaired psychology; although significant improvements in emotional and physical functioning were seen after the end of both treatments except for continuous impaired social activity in FEC group. Conclusions: This information is important when advising women patients of the expected HRQOL consequences of treatment regimens and should help clinicians and their patients make informed treatment decisions. No significant financial relationships to disclose.