Population-based norms for the human papillomavirus-quality of life (HPV-QoL) questionnaire: A cross-sectional multicenter study.

INTRODUCTION: Human papillomavirus (HPV) diagnosis has a considerable emotional and psychological impact on women. To evaluate the impairment this infection leads to regarding quality of life (QoL), several scales have been suggested, such as the human-papillomavirus-quality-of-life (HPV-QoL) questionnaire. This has been validated for the Spanish population and measures the impact of HPV on health-related-quality-of-life (HR-QoL). However, normative values are yet to be developed. Thus, the objective was to describe the population-based norms of the HPV-QoL for Spanish women aged 25-65 years and to test the questionnaire's construct validity. MATERIAL AND METHODS: This was a cross-sectional nationwide multicenter study. Women from outpatient clinics in Spain aged 25-65 years, with a diagnosis of past or active HPV infection were recruited. The central tendency, dispersion, and percentiles were calculated for the total score and its dimensions for each age group. Construct validity was tested by analyzing age groups and their correlations with other related scales (12-Item General Health Questionnaire [GHQ-12], Female Sexual Function Index [FSFI], and Hospital Anxiety and Depression Scale [HADS]). RESULTS: A total of 1352 women were included in the study. The norms showed moderate and significant coefficients of correlation with other related scales. Significant differences between age strata groups were found according to educational level, sexual dysfunction, sexual activity, mental deterioration, and severity of anxiety and depression symptoms (p < 0.001 in all cases). The total score differed significantly between the groups (p = 0.006). Significant differences in the contagiousness, health, and sexuality dimensions (p < 0.05) were found among the groups. It was seen that HPV infection impaired women's QoL. Dimensions within all test age groups (p < 0.001 in all cases) were significantly different, with the health dimension being the highest contributor to women's QoL impairment, whereas social well-being was the main determinant of QoL. CONCLUSIONS: Population-based norms for the novel HPV-QoL questionnaire showed adequate validity and could be a useful tool for assessing the impact of QoL among women with HPV in Spain.

Development and psychometric properties of the human papillomavirus-quality of life (HPV-QoL) questionnaire to assess the impact of HPV on women health-related-quality-of-life.

PURPOSE: The HPV-Quality-of-Life (HPV-QoL) questionnaire was developed to determine the impact of Human-Papillomavirus (HPV) infection and related interventions on women health-related quality-of-life. This study provides the development and preliminary psychometric properties of a novel HPV-QoL questionnaire for adult women with HPV. METHODS: After reviewing literature and cognitive debriefing interviews in women who had experienced HPV-related conditions, instrument items and domains were developed. A draft questionnaire was pilot tested for comprehension and ease of completion. Psychometric evaluation of the final HPV-QoL scale was conducted in a psychometric study including 252 adult women derived to our centre by a positive HPV test in the cervical cancer screening program and/or presenting genital warts. RESULTS: The present study reveals that the HPV-QoL questionnaire, structured in four domains: general well-being [including psychological well-being and social well-being subdomains], health, contagiousness and sexuality, showed good metric properties of feasibility irrespective of age or educational level, and time to administer was less than 5 min. Internal consistency and temporal stability (reliability) showed values above the acceptable standards. The instrument showed its concurrent validity by means of a significant correlation with mental and sexual existing instruments; GHQ-12 and FSFI questionnaires, respectively, and also known groups validity showing significant differences among the subgroups regarding either sexual dysfunction or mental deterioration. CONCLUSION: This study provides an HPV-QoL questionnaire with an innovative patient-reported outcomes specific measurement tool to assess HRQoL in women with HPV infection. The present study suggests this questionnaire has satisfactory psychometric properties, including validity and reliability. Results support the use of the HPV-QoL questionnaire as a HRQoL measurement instrument for daily medical practice and clinical research.

Cost-effectiveness analysis of a lung cancer screening programme in Spain.

OBJECTIVE: To evaluate the cost-effectiveness of the implementation of national lung cancer (LC) screening programme (SP) in a high-risk population from the perspective of the Spanish National Health System (NHS). METHODS: A cost-effectiveness analysis for a LC SP was carried out on a lifetime horizon. A Markov model was designed that assumed two scenarios, one with the implementation of the SP and another one without it. Effectiveness and cost of LC management, diagnosis and screening were included in the different health states. Deterministic and probabilistic sensitivity analyses were conducted to evaluate its robustness. A discount rate was set at 3% both for effectiveness and cost. RESULTS: In the base-case, an increase of 4.80 quality-adjusted life years (QALY) per patient was obtained, resulting in an incremental cost-effectiveness ratio of €2345/QALY. Probabilistic sensitivity analysis showed the national LC SP to be cost-effective in 80% of cases (probability=0.8) for a willingness-to-pay threshold equivalent to the gross domestic product per capita in Spain, which was set at €25 854/QALY in 2018 based on the per capita income of Spain. The sensitivity analysis indicates that the obtained results are robust in terms of changes in the presentation rates and costs, and the cost-effectiveness thresholds. CONCLUSIONS: This analysis suggests that the implementation of a LC SP in the high-risk Spanish population would be a cost-effective strategy for the Spanish NHS.

Economic Evaluation of Combining Pharmaco- and Behavioral Therapies for Smoking Cessation in an Occupational Medicine Setting.

OBJECTIVE: To estimate the budget impact (BI) of funding pharmaco+behavioral therapies for smoking cessation from an employer perspective. METHODS: A hybrid economic model was applied to estimate the BI, which considered up to four cessation attempts over a 3-year horizon. The model estimated the costs of funding a cessation programme, and the mean savings due to avoided loss of productivity and absenteeism because of smoking cessation. RESULTS: 53.8% of smokers quit smoking. The programme, which costs &OV0556;394,468, would generate earnings of &OV0556;1,342,133; with &OV0556;644,974 in incremental net savings. These mean &OV0556;1.64 in return per each euro invested. Results show net benefits from two cigarettes smoked while working every day. CONCLUSIONS: Considering the avoided costs of loss of productivity and absenteeism, funding a smoking cessation programme of pharmaco+behavioral therapies would produce substantial savings for the employer.

Budgetary Impact Analysis of Reimbursement Varenicline for the Smoking-Cessation Treatment in Patients with Cardiovascular Diseases, Chronic Obstructive Pulmonary Disease or Type-2 Diabetes Mellitus: A National Health System Perspective.

AIMS: The study aimed to assess the budgetary impact (BI) of reimbursing varenicline in patients with chronic obstructive pulmonary disease (COPD), type-2 diabetes mellitus (t2-DM) or cardiovascular diseases (CVD). METHODS: The BI was estimated comparing the current non-reimbursed scenario versus a projected reimbursed scenario using the Spanish National Health System (SNHS) perspective. A hybrid model was developed using epidemiological data and Markov chains to estimate smoking cessation rates with varenicline during a 5-year horizon. Costs of cessation were considered in the reimbursement scenario only. Efficacy, expressed as a 1-year continuous abstinence rate, was derived from clinical trials. Cost savings due to smoking cessation were extracted from local cost-of-illness studies. Results are shown as incremental cost savings. Univariate sensitivity analysis was also applied. RESULTS: A total of 68,684 patients stopped smoking in the reimbursed scenario compared with 15,208 without reimbursement. In the reimbursed scenario, total savings accounted for €36.3 million, showing 14.6 million accumulated additional savings compared with the scenario without reimbursement. Sensitivity analyses showed results to be robust with monetary savings starting in the third year of modeling. CONCLUSION: Reimbursement of varenicline in smoking cessation is a cost-effective health policy in the SNHS in COPD, t2-DM or CVD, and could produce cost savings starting in the third year of implementation.

[Smoking impact on mortality in Spain in 2012]. / Impacto del consumo de tabaco sobre la mortalidad en España en el año 2012.

BACKGROUND AND OBJECTIVE: Smoking is an important public health problem, and is one of the main avoidable causes of morbidity and early mortality. The aim was to estimate the mortality attributable to smoking and its impact on premature mortality in Spain in the year 2012. PATIENTS AND METHODS: Descriptive, cross-sectional study, carried out on the Spanish population aged ≥ 18 years in 2012. The prevalence of smoking by age and sex was obtained from the National Health Survey 2011-2012, and the number of deaths by age, sex and cause was obtained from the vital statistics of the National Institute of Statistics. The proportion of deaths attributable to smoking was calculated according to sex and age group, from the etiological fraction of the population. Likewise, loss of potential years of life lost (PYLL) and the mean potential years of life lost (MPYLL) were also calculated. RESULTS: In 2012, smoking caused 60,456 deaths which accounted for 15.23% of all deaths. Trachea-bronchial-lung cancer in men and other cardiopathies in women mostly contributed to this mortality. The PYLL were 184,426, and the MPYLL were 3.25 years in men and 2.42 years in women. CONCLUSIONS: In 2012, every day, 125 men and 40 women die from smoking-related conditions. The smoking prevalence has diminished in comparison with previous years and the number and percentage of deaths attributable to the smoking have increased in the last 20 years.

The effect of quitting smoking on costs and healthcare utilization in patients with chronic obstructive pulmonary disease: a comparison of current smokers versus ex-smokers in routine clinical practice.

PURPOSE: Chronic obstructive pulmonary disease (COPD) is a prevalent condition mainly related to smoking, which is associated with a substantial economic burden. The purpose was to compare healthcare resource utilization and costs according to smoking status in patients with COPD in routine clinical practice. METHODS: A retrospective cohort nested case-control study was designed. The cohort was composed of male and female COPD outpatients, 40 years or older, covered by the Badalona Serveis Assistencials (a health provider) health plan. Cases were current smokers with COPD and controls (two per case) were former smokers with COPD (at least 12 months without smoking), matched for age, sex, duration of COPD, and burden of comorbidity. The index date was the last visit recorded in the database, and the analysis was performed retrospectively on healthcare resource utilization data for the 12 months before the index date. RESULTS: A total of 930 COPD records were analyzed: 310 current and 620 former smokers [mean age 69.4 years (84.6 % male)]. Cases had more exacerbations, physician visits of any type, and drug therapies related to COPD were more common. As a consequence, current smokers had higher average annual healthcare costs: €3,784 (1,888) versus €2,302 (2,451), p < 0.001. This difference persisted after adjusting for severity of COPD. CONCLUSIONS: Current smokers with COPD had significantly higher use of healthcare resources, mainly COPD drugs and physician visits, compared with former smokers who had abstained for at least 12 months. As a consequence, current smokers had higher healthcare costs to the National Health System in Spain than ex-smokers.

Effect of smoking status on healthcare costs and resource utilization in patients with type 2 diabetes in routine clinical practice: a retrospective nested case-control economic study.

AIM: To compare healthcare resource utilization and costs according to smoking status in patients with type 2 diabetes in clinical practice. METHODS: A retrospective cohort nested case-control study was designed. Cases were current smokers, while 2 types of controls (former smokers and never smokers) were matched (2 controls per case) for age, sex, duration of diabetes and burden of comorbidity using data from medical records. Noninstitutionalized diabetics of both genders, aged>18 years and seen consecutively over a 5-year period before the index date, were enrolled. Analysis compared healthcare resource utilization, loss of productivity due to sick leave and corresponding costs. RESULTS: In total, 2,490 medical records were analyzed, i.e. 498 cases, 996 former smokers and 996 never smokers. Mean age was 63.4 years (64.9% male). Smokers had higher glycosylated hemoglobin levels (7.4 vs. 7.2 and 7.2%, respectively; p=0.013) and a lower degree of metabolic control (49.2 vs. 54.7 and 55.8%; p=0.036). Smokers had higher average annual costs (EUR 3,583) than former smokers (EUR 2,885; p<0.001) and never smokers (EUR 2,183; p<0.001). CONCLUSIONS: Diabetic smoker patients had lower metabolic control, higher health resource utilization and more sick leave, resulting in higher healthcare costs and lost productivity compared with both former and never smoker diabetics.

Prospective study of the use of healthcare resources and economic costs in patients with fibromyalgia after treatment in routine medical practice.

OBJECTIVES: To estimate the burden and to prospectively analyse resources utilisation and costs in a cohort of treated patients with fibromyalgia (FM) in daily practice. METHODS: Prospective, observational, multicentre, 3-month study in 232 patients with FM according to the ACR criteria (98% women, 47 years), with no concomitant systemic diseases, followed in rheumatology units. The control group consisted of 110 subjects without FM or any other systemic condition, paired by age and gender. Clinical assessment, use of healthcare resources and treatments, out-of-pocket expenses, occupational status, days off work, and calculation of lost workdays equivalents were recorded. RESULTS: Patients had worse clinical status, four times the control group's healthcare costs, twelve times its indirect costs and six times its total costs. After the treatment, there was significant clinical improvement in the patient group, the healthcare costs were significantly reduced in all components except for drugs costs, which increased (p<0.001), and out-of-pocket expenses, which remained unaltered. Indirect costs were reduced (p<0.05) in the FM group only, mainly due to fewer days off work. The patient group presented a significantly greater variation in montly total costs than the controls; -€193.75 ± 781.9 vs. -€26.22 ± 402.7, p=0.006. The patients who most reduced their healthcare costs were actively employed. CONCLUSIONS: Treated patients with FM in daily practice improved their clinical status and were accompanied by a significant reduction in the cost of the illness. The extra cost of drugs is substantially compensated for by less use of other healthcare resources and fewer days off work.

Health, treatment and health care resources consumption profile among Spanish adults with diabetes and chronic obstructive pulmonary disease.

AIMS: To describe the health, treatment and health care resources consumption profile among Spanish adults with diabetes and chronic obstructive pulmonary disease (COPD), and compare it with that of non-diabetic COPD patients. PATIENTS AND METHODS: An observational and descriptive epidemiological study (EPIDEPOC study). The study included patients with stable COPD and aged > or =40 years, evaluated in primary care. Data were collected relating to sociodemographic variables, health profile, quality of life (SF-12), treatment and health care resources consumption. The results corresponding to diabetic and non-diabetic patients were compared. RESULTS: A total of 10,711 patients (75.6% males) with COPD were evaluated. The prevalence of diabetes was 16.9%. The diabetic patients were significantly older, with a larger percentage of women, and a lesser educational level compared with the non-diabetic patients. In addition, the diabetics were more sedentary, smoked less, and presented a higher percentage of obesity (33.6% versus 19.7%) than the non-diabetic patients. The severity of airways obstruction was greater among the diabetics than in the non-diabetic patients (54.57+/-13.37% versus 57.92+/-13.39%, respectively, p<0.05). As to co-morbidity, the diabetics showed a greater frequency of arterial hypertension, hypercholesterolemia, heart disease, depression and anxiety. Both the physical and the mental component as measured by the SF-12 yielded significantly poorer results among the diabetics. On the other hand, the diabetic subjects showed a higher consumption of drugs for COPD. In addition, they consumed significantly more health care (and thus economical) resources than the non-diabetic patients. The results of the multivariate logistic regression analysis showed that the variables that were independently associated to COPD among diabetic patients were: higher age, higher BMI, concomitant chronic heart disease, use of inhaled corticoids, SF-12 mental component, SF-12 physical component and total cost of COPD. CONCLUSIONS: The presence of diabetes in patients with COPD shows in the bivariate analysis a more severe lung disease, greater co-morbidity, poorer quality of life, and a greater consumption of resources, as well as a less favorable course in the previous year. However, the multivariate logistic regression shows that the variables that are independently associated to COPD among diabetic patients are higher age, higher BMI, concomitant chronic heart disease, use of inhaled corticoids, physical and mental component of quality of life questionnaire and total cost of COPD.

[Use of resources and costs profile in patients with fibromyalgia or generalized anxiety disorder in primary care settings]. / Perfil de uso de recursos y costes en pacientes que demandan atención por fibromialgia o trastorno de ansiedad generalizada en el ámbito de la atención primaria de salud.

OBJECTIVE: To determine the use of services and costs in patients with Fibromyalgia (FM) or Generalized Anxiety Disorder (GAD) followed up in Primary Care (PC). DESIGN: A retrospective multicenter population-based study. SETTING: Five primary care clinics managed by Badalona Health Service. PARTICIPANTS: Patients over 18 years seen in the 5 PC centers during the year 2006. Patients with and without GAD/FM were compared. MEASUREMENTS: Main outcomes measures were general, case/co-morbidity, health care use and primary care cost (visits, diagnostic/therapeutic tests and drugs). STATISTICAL ANALYSIS: logistic regression and ANCOVA (P<.05). RESULTS: There was a total of 63,349 patients, 1.4% (95% CI, 0.6%-2.2%) had a diagnosis of FM, and 5.3% (95% CI, 4.5%-6.1%) GAD. The average episodes/year and visits /year was higher in FM group compared to GAD group, with a marked difference observed vs. the reference group (8.3 vs. 7.2 and 4.6 episodes/year; and 12.9 vs. 12.1 and 7.4 visits/year; P <.001). FM was shown to be related to female gender (odds ratio [OR] = 16.8), dyslipidemia (OR = 1.5), and depressive syndrome (OR = 3.9) (P <.001 in all cases). GAD was related to age (OR = 1.1), female gender (OR = 2.2), high blood pressure (OR = 1.3), dyslipidemia (OR=1.2), smoking (OR = 1.4), depressive syndrome (OR = 1.2), and cardiovascular events (OR = 1.3) (P<.02 in all cases). After adjusting for age, gender and co-morbidities, mean annual direct ambulatory cost was 555.58 Euro for the reference group, 817.37 Euro for GAD, and 908.67 Euro for FM (P<.001). CONCLUSIONS: Compared with reference group, a considerable use of health resources and costs was observed in patients with FM or TAG in medical practice in PC settings.

Characteristics of chronic obstructive pulmonary disease in Spain from a gender perspective.

BACKGROUND: The objective of this study was to analyze the clinical and management characteristics of chronic obstructive pulmonary disease (COPD) in men and women, to determine possible gender-associated differences between the two groups of patients. METHODS: An observational and descriptive epidemiological study (EPIDEPOC study). The study included patients with stable COPD and aged >or= 40 years, evaluated in primary care. Data were collected relating to sociodemographic variables, clinical characteristics, quality of life (SF-12), severity of disease and treatment. The results obtained in men and women were compared. RESULTS: A total of 10,711 patients (75.6% males and 24.4% females) were evaluated. Significant differences were found between males and females in relation to the following parameters: age (67.4 +/- 9.2 years in men vs 66.1 +/- 10.8 in women, p < 0.05), smoking (91.9% of the men were smokers or ex-smokers vs 30% of the women), comorbidity (the frequency of hypertension, diabetes, anxiety and depression was greater in women, while ischemic heart disease was more common in men), mental component of quality of life (49.4 +/- 10.3 in men vs 44.6 +/- 11.9 in women, p < 0.05) and severity of disease (56.5 +/- 13.3% in men vs 60.7 +/- 3.2 in women, p < 0.05). As regards treatment, the percentage use of long-acting b2-adrenergic agonists, anticholinergic agents, theophyllines and mucolytic agents was significant greater in men. The total annual cost of COPD was greater in males than in females (1989.20 +/- 2364.47 euro vs 1724.53 +/- 2106.90, p < 0.05). CONCLUSION: The women with COPD evaluated in this study were younger, smoked less and have more comorbidity, a poorer quality of life, and lesser disease severity than men with COPD. However, they generated a lesser total annual cost of COPD than men.

Metabolic syndrome in outpatients receiving antipsychotic therapy in routine clinical practice: a cross-sectional assessment of a primary health care database.

OBJECTIVE: To determine the prevalence of metabolic syndrome (MS) in outpatients treated with antipsychotics included in a primary-health-care database. METHODS: A cross-sectional study was carried out assessing an administrative outpatients claim-database from 5 primary-health-centers. Subjects on antipsychotics for more than 3 months were included. The control group was formed by the outpatients included in the database without exposition to any antipsychotic drugs. MS was defined according to the modified NCEP-ATP III criteria, and required confirmation of at least 3 of the 5 following components: body mass index >28.8 kg/m(2), triglycerides >150 mg/ml, HDL-cholesterol <40 mg/ml (men)/<50mg/ml (women), blood pressure >130/85 mmHg, and fasting serum glucose >110 mg/dl. RESULTS: We identified 742 patients [51.5% women, aged 55.1 (20.7) years] treated with first- or second-generation antipsychotics during 27.6 (20.3) months. Controls were 85.286 outpatients [50.5% women, aged 45.5 (17.7) years]. MS prevalence was significantly higher in subjects on antipsychotics: 27.0% (95% CI, 23.8-30.1%) vs. 14.4% (14.1-14.6%); age- and sex-adjusted OR=1.38 (1.16-1.65, P<0.001). All MS components, except high blood pressure, were significantly more prevalent in the antipsychotic group, particularly body mass index >28.8 kg/m(2): 33.0% (29.6-36.4%) vs. 17.8% (17.6-18.1%), adjusted OR=1.63 (1.39-1.92, P<0.001), and low HDL-cholesterol levels: 48.4% (44.8-52.0%) vs. 29.3% (29.0-29.6%); adjusted OR=1.65 (1.42-1.93, P<0.001). Compared with the reference population, subjects with schizophrenia or bipolar disorder (BD), but not dementia, showed a higher prevalence of MS. CONCLUSIONS: Compared with the general outpatient population, the prevalence of MS was significantly higher in patients with schizophrenia or BD treated with antipsychotics.

Linguistic adaptation and validation of the Spanish version of the Benign Prostatic Hyperplasia-Patient Impact Measure (BPH-PIM).

BACKGROUND: The Benign Prostatic Hyperplasia-Patient Impact Measure (BPH-PIM) is a self-reported quality-of-life questionnaire for measuring the impact of urinary/prostate symptoms on the quality of life of patients with BPH. The aim of the present study was to adapt the original instrument to Spanish (for use in Spain) and to assess the psychometric properties of the new version. METHODS: Linguistic adaptation was performed using the standard processes for establishing conceptual equivalence, and was partially conducted in parallel with original instrument development. Psychometric properties were assessed on a sample of 131 patients with BPH who were receiving treatment with doxazosin gastrointestinal therapeutic system (GITS). RESULTS: All the standardised items had response rates > 99%; there were no floor or ceiling effects. Reliability in terms of Cronbach's alpha was 0.96 and the intraclass correlation coefficient was 0.97. Construct validity was confirmed by factor analysis. Convergent validity was confirmed in terms of the relationship to the 12-Item Short-Form Health Survey (SF-12) [p < 0.001], Health Utilities Index Mark III (HUI-3) [p < 0.001] and the International Prostate Symptom Score (IPSS) QOL item (p < 0.001). The instrument showed discriminant validity, in terms of IPSS groups (p < 0.001). The instrument was sensitive to change in terms of the correlation of the domain scores of the PIM to improvements in symptom scores (p < 0.001). Significant differences were observed for those who improved > or = 3 points in the IPSS scale (p < 0.001). CONCLUSION: A psychometrically valid and conceptually equivalent version of the BPH-PIM questionnaire has been produced in Spanish to be used in Spain in patients with BPH.

Negative impact of chronic obstructive pulmonary disease on the health-related quality of life of patients. Results of the EPIDEPOC study.

BACKGROUND: COPD is currently the fourth cause of morbidity and mortality in the developed world. Patients with COPD experience a progressive deterioration and disability, which lead to a worsening in their health-related quality of life (HRQoL). The aim of this work is to assess the Health-Related Quality of Life (HRQoL) of patients with stable COPD followed in primary care and to identify possible predictors of disease. METHODS: It is a multicenter, epidemiological, observational, descriptive study. Subjects of both sexes, older than 40 years and diagnosed of COPD at least 12 months before starting the study were included. Sociodemographic data, severity of disease, comorbidity, and use of health resources in the previous 12 months were collected. All patients were administered a generic quality-of-life questionnaire, the SF-12, that enables to calculate two scores, the physical (PCS-12) and the mental (MCS-12) component summary scores. RESULTS: 10,711 patients were evaluated (75.6% men, 24.4% women), with a mean age of 67.1 years (SD 9.66). The mean value of FEV1 was 35.9 +/- 10.0%. Mean PCS-12 and MCS-12 scores were 36.0 +/- 9.9 and 48.3 +/- 10.9, respectively. Compared to the reference population, patients with COPD had a reduction of PCS-12, even in mild stages of the disease. The correlation with FEV1 was higher for PCS-12 (r = 0.38) than for MCS-12 (r = 0.12). Predictors for both HRQoL components were sex, FEV1, use of oxygen therapy, and number of visits to emergency rooms and hospital admissions. Other independent predictors of PCS-12 were age, body mass index and educational level. CONCLUSION: Patients with stable COPD show a reduction of their HRQoL, even in mild stages of the disease. The factors determining the HRQoL include sex, FEV1, use of oxygen therapy, and number of visits to emergency rooms and hospital admissions.