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.

Sensitivity-to-change and predictive validity of the Cervantes Short-Form (C-SF) questionnaire in postmenopausal women.

OBJECTIVES: To explore, for the first time, the ability of the Cervantes Short-Form (C-SF) questionnaire to detect and to predict meaningful changes (sensitivity-to-change and predictive validity) in women with menopausal symptoms receiving any therapeutic management under routine medical care. METHODS: Postmenopausal women included in a registry study were the source of data. Sensitivity-to-change was explored by assessing the responses of C-SF to different type of treatment management: no treatment, natural therapies or systemic hormonal therapy (SHT). Predictive validity assessed the ability of baseline score to predict the reduction in the impact of menopausal symptoms in C-SF scoring equal or higher than one time its minimally important difference (MID) of improvement (response rate). RESULTS: A total of 245 women were enrolled. C-SF score was significantly reduced (better QoL) with SHT by 10.62 points versus no change or 2.32 point by natural therapies or no treatment, respectively (p < 0.001 in both cases). Women declaring better improvement after treatment showed higher significant reduction in C-SF score versus those with no self-perceived improvement or impairment: -12.49 point versus +1.06 and +12.71, respectively (p < 0,01 in both cases). Responder rate showed a significant lineal growing trend with higher C-SF scoring at baseline in women who received SHT: higher scoring showed higher response rates (lineal Chi2 = 15.9, p < 0.001), but not in the case of receiving natural therapies or no treatment. CONCLUSIONS: C-SF was shown to be sensitive-to-change when postmenopausal QOL status changes due to mainly systemic hormonal treatment, therefore, supporting the utilization of this instrument to monitor response to treatment. Likewise, pre-treatment scoring in C-SF was able to predict woman's QOL meaningful response with hormonal treatment.

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.

Disability-adjusted life expectancy lost due to pain severity and usual analgesic treatment among older adults with osteoarthritis in Spain.

BACKGROUND: Osteoarthritis (OA) is a seriously debilitating disease, which prevalence is growing in aging population becoming a substantial burden (BoD) to society. AIM: To assess disability-adjusted life expectancy (DALE) lost by pain severity and usual analgesic treatment among OA adults 65 + year in Spain. METHODS: The National Health Survey, a large, nationally representative, cross-sectional general health survey administered to 23,089 individuals was the data source. Data on subjects of 65 + years with a self-reported physician diagnosis of OA were analysed. Records were cross-classified by pain severity (no pain/mild pain, moderate pain and severe pain) and use of usual analgesics. DALE lost was used as a summary measure of BoD and expressed as both number of years of healthy life-expectancy lost due to disability and percentage of life-expectancy lost. RESULTS: 3389 records were analysed [women 73.3%; age 77.4 (SD 7.5) years]. Older OA patients showed a mean (95% CI) DALE loss of 3.5 (3.3-3.7) years, that represented on average a loss of 35.6% (33.8-37.4) as a percentage of life expectancy. Higher pain severity and analgesic treatment was statistically linked to more years of DALE lost; from 2.8 (2.3-3.2), in no/mild, to 9.0 (8.6-9.4) years in severe pain, and from 32.2% (27.5-36.9) to 90.9% (86.5-95.3) of life expectancy, respectively. DISCUSSION: In Spain, older adults with moderate to severe OA pain receiving usual analgesics showed a substantial BoD in terms of years of DALE lost and percentage of life expectancy lost. CONCLUSIONS: Patients with treated moderate to severe pain showed a more significant burden in term of DALE lost despite analgesic treatment, which apparently fails to meet pain management needs.

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.

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.

Cost comparison of adding pregabalin or gabapentin for the first time to the therapy of patients with painful axial radiculopathy treated in Spain.

OBJECTIVES: This paper aims to compare the costs of initiating pregabalin or gabapentin in the therapeutic management of patients with painful axial radiculopathy in routine medical practice. METHODS: A retrospective claim database analysis was carried-out using medical records of patients of both gender aged >18 years with axial painful radiculopathy (ICD-9-CM codes: 353.0 [cervical], 353.3 [thoracic] or 353.1 [lumbar]) who initiated pregabalin or gabapentin therapy between 2006 and 2008. The economic evaluation included healthcare resource utilisation and corresponding costs from a third-payer perspective during 12 months post index date. Estimates of indirect costs due to sick leave were also computed. RESULTS: A total of 571 records were eligible for analysis: 375 (66%) treated with pregabalin and 193 (34%) gabapentin. Time since diagnosis, duration of treatment, prevalence of most co-morbidities and previous use of analgesics were comparable. However, concomitant use of analgesics was higher in the gabapentin cohort; 3.1 (1.7) vs. 2.8 (1.8); p<0.05, mainly due to greater use of opioids (31.1% vs. 21.2%; p<0.05) and non-narcotic drugs (63.7% vs. 52.1%; p<0.01). Adjusted total costs per patient were significantly lower in the pregabalin group; €2.472 (2.101-2.836) vs. €3.346 (2.866-3.825); p=0.005, due to lower absenteeism costs; €1.012 (658-1.365) vs. €1.595 (1.129-2.062); p=0.042, and lower adjusted healthcare costs; €1.460 (1.360-1.560) vs. €1.750 (1.618-1.882); p=0.001. CONCLUSIONS: In a population setting, pregabalin-treated patients with painful radiculopathies were considerably less costly for the healthcare payer than those treated with gabapentin in routine clinical practice. Patients treated with pregabalin had significantly fewer days of sick leave than gabapentin-treated patients.

Development and psychometric properties of a measurement to ascertain the impact of genitourinary symptoms on health-related quality of life in menopausal women: the Cervantes-GSM questionnaire.

OBJECTIVE: The Cervantes-GSM questionnaire is a novel tool currently being developed to examine the impact of genitourinary symptoms on health-related quality of life in adult women with genitourinary syndrome of menopause (GSM). METHODS: A literature review and cognitive debriefing were conducted in women with GSM, which provided the basis for creating a draft questionnaire. This draft version was pilot-tested to check participant comprehension and ease of completion. The initial draft was then refined to obtain a 15-item version with five domains whose initial psychometric properties were analyzed in 130 adult women with GSM. The psychometric properties tested in this study were factorial structure, feasibility, reliability, and construct validity. RESULTS: The Cervantes-GSM 15-item questionnaire consists of five domains: vulvovaginal symptoms, urinary symptoms, psychological (emotions), interference with daily activities, and sexuality. The instrument was shown to be feasible and easy to complete, regardless of age or educational level. Internal consistency was high (Cronbach α = 0.88). Construct validity was supported by convergent-divergent validity showing higher correlation coefficients between items in their own domain (>0.70) than with the other items and domains in the questionnaire. Cervantes-GSM also showed known group validity with significant differences in total score and most domains (13-20 points, P < 0.01) regardless of whether women chose local treatment of their genitourinary symptoms. CONCLUSION: This study presents a novel questionnaire capable of assessing health-related quality of life in menopausal women with GSM. The tool has shown acceptable preliminary psychometric properties, including feasibility, factor structure, construct validity, and internal consistency.

Disease burden and costs for patients with hip and knee osteoarthritis and chronic moderate-to-severe refractory pain on treatment with strong opioids in Spain.

INTRODUCTION AND OBJECTIVES: To determine the disease burden and costs in patients with hip or knee OA and chronic moderate-to-severe refractory pain, receiving strong opioids in Spain. MATERIALS AND METHODS: This was a 36-month longitudinal secondary analysis of the real-word OPIOIDS study. Patients aged ≥18 years with hip or knee OA and chronic moderate-to-severe refractory pain receiving strong opioids were considered. The disease burden included analgesia assessments (NRS scale), cognitive functioning (MMSE scale), basic activities of daily living (Barthel index), and comorbidities (severity and frequency). Costs due to the use of healthcare resources and productivity loss were estimated. RESULTS: 2832 patients were analyzed; age was 72.0 years (SD=14.3), 76.8% were women. Patients had mainly been treated with fentanyl (n=979; 37.6%), tapentadol (n=625; 24.0%), oxycodone (n=572; 22.0%), and buprenorphine (n=425; 16.3%). Pain intensity decreased by 1 point (13.7%), with a 2.6-point decline in the cognitive scale (14.3%, with a 5.3%-increase in patients with cognitive deficit) over a mean treatment period of 384.6 days (SD: 378.8). Barthel scores decreased significantly yielding to a slightly increase in proportion of patients with severe-to-total dependency; 1.2%-2.9%. In the first year of treatment, average healthcare costs were €2013/patient, whereas the average productivity loss cost was €12,227/working-active patient. DISCUSSION AND CONCLUSIONS: Strong opioids resulted in high healthcare costs with a limited reduction in pain, an increase in cognitive deficit, and a slight increase of patients with severe to total dependency over 36 months of treatment.

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.

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.

Sick Leave and Costs in Active Workers with Chronic Osteoarthritis Pain in Spain: Outcomes of the OPIOIDS Real World Study.

Purpose: To estimate the number of sick leave days and productivity costs in active workers with osteoarthritis (OA) who initiated opioid treatment for moderate/severe chronic pain in clinical practice in Spain. Patients and Methods: This is a secondary analysis of the longitudinal, retrospective OPIOIDS study, using electronic medical records (EMR) of patients aged ≥18 years, who started an opioid treatment for moderate/severe chronic OA pain between 2010 and 2015 after treatment failure with ≥1 first-line drugs (acetaminophen, metamizole and/or nonsteroidal anti-inflammatory drugs [NSAIDs]). The number of days of sick leave and productivity costs were analyzed during a follow-up period of 36 months. Results: A total of 5089 patients with moderate/severe chronic OA pain, aged 56.8 years (standard deviation [SD]: 4.6) (56.6% were female), were analyzed: 73.3% of them started a treatment with weak opioids and 26.7% of them were treated with strong opioids. At 36 months, adherence was 21.0% (strong opioids: 15.4%; weak opioids: 23.0%; p<0.001), and 77% of patients had at least one sick leave related with chronic OA pain, with an average of 93 days off work in all working patients (120.5 days in patients with sick leaves). Besides, 16.9% of the study population had sick leave periods that lasted at least 6 months. Pain reduction was modest (-1.2 points; -4.0%, p<0.001). The cost of sick leave was €2594 patient/year, and factors such as older age (ß=0.043), female sex (ß=0.036), comorbidities (ß=0.035) and strong opioid use (ß=0.031) were associated with higher productivity costs (p<0.05 in all associations). Conclusion: Active workers who started opioid treatment for moderate/severe chronic OA pain showed an increased frequency of sick leave and productivity cost, with a modest effect on pain relief. Older age, female sex, comorbidities, and strong opioids were associated with higher costs for society.

Inappropriate overuse of inhaled corticosteroids for COPD patients: impact on health costs and health status.

The aim of this study was to evaluate the relationship between inappropriate overuse of inhaled corticosteroids and self-reported health status and the annual cost of patients with stable chronic obstructive pulmonary disease (COPD) recruited in the primary-care setting. An observational, crossover, descriptive study was conducted. Patients with stable COPD and aged ≥40 years, evaluated in primary care, were included. Data collected were demographic variables, clinical characteristics, self-reported health status (SF-12), the severity of the illness, treatment, and health-care resource utilization in the past year. The patients were recruited during a period of 3 months (from January 1 to March 31, 2003). Use was considered inappropriate when corticosteroids were prescribed by physicians for patients not meeting criteria for its use as recommended in guidelines. A total of 10,711 patients [75.6% males; mean age = 67.1 (SD = 9.66) years] were evaluated. Disease severity was mild in 35.5% of the cases, moderate in 53.4%, and severe in 11.2%. Among them, 3,697 (34.5%) subjects were prescribed inhaled corticosteroids or drug combinations containing such therapies, with a rate of inappropriate use of 18.2%. Physical health status was significantly lower among patients showing inappropriate corticosteroids use: 37.35 (SD = 9.53) vs. 40.7 (SD = 9.80) (p < 0.05). The annual cost per patient of COPD management was significantly higher in the group with inappropriate inhaled corticosteroids use: 1,590 (SD = 1,834) vs. 1,157 (SD = 1,536) (p < 0.05). Factors statistically associated with inappropriate use of corticosteroids were educational attainment [OR: 2.77 (95% CI: 1.36-5.63) for nonuniversity training], a history of heart disease [OR: 1.42 (95% CI: 1.02-1.97)], depression [OR: 1.47 (95% CI: 1.05-2.05)], any allergy [OR 1.69 (95% CI: 1.13-2.54)], and physical health status [OR 0.97 (95% CI: 0.96-0.98)]. Lack of adherence to the recommended criteria for using inhaled corticosteroids therapy in the management of COPD patients was associated with lower self-reported health status and higher costs. Factors statistically associated with inappropriate use of corticosteroids were educational attainment, a history of heart disease, depression, any allergy, and physical health status.

Future projections of opioid use and cost in patients with chronic osteoarthritis pain in Spain.

BACKGROUND: Opioids are widely used in moderate-to-severe chronic pain which is non-responsive to standard analgesics. Prescriptions have increased in Europe in the last decade, although remain lower than in USA. This work projected the future utilization and costs of opioids in chronic osteoarthritis (OA) pain in the Spanish National Health System (NHS). METHODS: An epidemiological model was populated with the opioid dispensing trends from 2010 to 2019 using Spanish Medicinal Agency rates of opioid utilization in subjects over 18 years of age and the real-world OPIOIDS study to estimate chronic-OA-pain patients receiving opioids. A best-fitted trend analysis model was applied estimating the likely number of DHD (defined daily dose/1000 inhabitants per day) to calculate projected opioid utilization and costs for the period 2020-2029. RESULTS: In 2010, an estimated 5.67 DHD were dispensed for the equivalent of 217,076 chronic OA pain patients per day [1.99 DHD, 76,084 refractory to non-steroidal anti-inflammatory drugs (NSAIDs)]. From these trends and OA prevalence, the projected number of DHDs is expected to increase more than threefold to 17.98 DHDs by the year 2029 for the equivalent of 727,356 chronic OA pain patients per day (8.18 DHD, 330,720 refractory to NSAIDs); 41.8% on strong opioids. The estimated cost was €116.9m (€45.0m in NSAID-refractory OA) in 2010 rising by 222% to €376.1m (€199.7m refractory to NSAIDs) by 2029. CONCLUSION: Chronic-OA-pain-related opioid dispensing and costs to the NHS are set to increase more than threefold from 2010 to 2029 in Spain. Using opioids for OA pain is concerning given disease chronicity and other related costs not computed in these projections. PLAIN LANGUAGE SUMMARY: • Opioids are widely used in chronic pain which is non-responsive to standard analgesics. Prescriptions have increased in Europe, although remain lower than in USA. Osteoarthritis (OA) is a degenerative joint disease usually accompanied by pain. Despite not recommended, opioids use in OA have been expanded because this health condition is increasing with ageing and, also, because physicians both primary and specialist boosted their use.• This study aimed to quantify the current burden of opioids used for chronic moderate-to-severe OA pain by estimating the number of defined daily doses per 1000 inhabitants per day (DHD) and associated costs, and to forecast the likely burden on the National Health System (NHS) in Spain for the years 2020-2029.• In 2010, an estimated 5.67 DHDs were dispensed for the equivalent of 217,076 chronic OA pain patients per day. From these trends, the projected number of DHDs is expected to increase more than threefold to 17.98 DHDs by the year 2029 for the equivalent of 727,356 chronic OA pain patients per day; 41.8% on strong opioids. The estimated cost was €116.9m in 2010 rising by 222% to €376.1m by 2029.• Chronic OA-pain-related opioid dispensing and costs to the NHS are set to increase substantially (threefold to more than fourfold) from 2010 to 2029 in Spain. Thus, using opioids for OA pain is concerning given disease chronicity, aging population and other related costs not computed in these projections. Our findings can inform payors and clinicians about ongoing discussions on appropriate analgesic management for longer-term OA pain, including resource requirements at a national level. Clinicians who prescribe opioids for OA pain should consider the potential implications of side effects such as sedation, cognitive deterioration, incremental need of caregivers, particularly in older people, and carefully consider the risk-benefit balance.

Disease burden on health care by pain severity and usual analgesic treatment in patients with symptomatic osteoarthritis: a Spanish nationwide health survey.

BACKGROUND: Osteoarthritis (OA) pain is a health care highly demanding and costing condition. OBJECTIVE: To estimate disease burden on health care in OA in Spain, determining whether burden differs by pain severity and usual analgesic treatment. METHODS: A cross-sectional design using the 2017-Spanish-National-Health-Survey was used to abstract data of 5,234 adult patients (women 70.8%; 69.9 years) with a self-reported physician OA diagnosis. Patients were assembled according to pain severity (no/mild, moderate, severe) and use of usual analgesia (treated [66.5%]/untreated). Healthcare resource utilization (HRU) and corresponding costs were expressed Per-Patient-Per-Year (PPPY) and adjusted for covariates. RESULTS: Average (SD) healthcare cost was €2,274 (5,461) PPPY, with costs linked to outpatient medical visits being the major driver; ~43%. Adjusted PPPY medical visits, days of hospitalization, other healthcare visits, and corresponding costs were significantly higher in severe pain OA patients, compared to moderate or mild/no pain regardless of being currently treated with usual analgesics or not (p < 0.001). Treated OA patients showed higher HRU and costs than untreated patients. CONCLUSIONS: Severity of pain was the main driver of HRU and costs in OA patients from a nationwide representative survey in Spain. These findings seem to be more consistent in treated versus not treated patients with usual analgesics.

Patient self-reported functioning by pain severity and usual analgesic treatment among older adults with osteoarthritis: analysis of the 2017 Spanish National Health Survey.

PURPOSE: Osteoarthritis (OA) pain is among the leading causes of disability worldwide in older people. Since its prevalence is growing in aging, a significant burden for society is expected. This work ascertained whether level of disability in self-reported functioning differs by pain severity and usual analgesic treatment among older OA patients in Spain. METHODS: The Spanish-National-Health-Survey, a large, nationally representative, cross-sectional general health survey including 23,089 persons, was analyzed. Patients aged 65 + years with a self-reported physician OA diagnosis were classified according to severity of pain (no/mild, moderate or severe pain) and treated or untreated with analgesia. Assessment of function included basic and instrumental activities-of-daily-living (BADL, IADL), mental, social, and cognitive functions, scored on a 0% (no limitation) to 100% (complete limitation) standardized metric. Caregiver need for BADL and IADL was also recorded. RESULTS: A total of 3526 patients were analyzed (women 73.3%; age 77.4 [SD: 7.5]). Adjusted functioning scores showed significant association with pain severity, and for BADL, IADL and social function. Patients with severe pain and treated with analgesia had higher limitation scores, ranging on average between 31.5% on BADL, 34.1% on IADL, 45.0% on mental, 42.2% on social, and 23.4% in cognitive domain. The proportions of patients needing a caregiver for BADL (43.4%) and IADL (56.2%) were also the highest in patients with severe pain and treated with analgesia. CONCLUSIONS: Regardless of usual utilization of analgesics, the severity of pain seemed to be the major determinant of functional impairment, and caregiving need, in all domains of functioning in older OA patients in Spain. Existing treatment strategies are analgesics based and do not meet patient needs for adequate pain management.

Disease Burden and Costs in Moderate-to-Severe Chronic Osteoarthritis Pain Refractory to Standard of Care: Ancillary Analysis of the OPIOIDS Real-World Study.

INTRODUCTION: To determine the disease burden and costs in moderate-to-severe chronic osteoarthritis (OA) pain refractory to standard-of-care treatment in the Spanish National Health System (NHS). METHODS: Ancillary analysis of the OPIOIDS real-world, non-interventional, retrospective, 4-year longitudinal study including patients aged at least 18 years with moderate-to-severe chronic OA pain refractory to standard-of-care with sequential NSAIDs plus opioids. Burden assessment included measurement of analgesia, cognitive functioning, basic activities of daily living, severity and frequency of comorbidities, and all-cause mortality. Costs accounted for healthcare resource utilization and related costs (year 2018). RESULTS: Records of 13,317 patients were analyzed; 68.9 (14.7) years old, 71.3% (70.5-72.1%) women, 58.1% refractory to NSAID plus weak opioid and 41.9% to NSAID plus strong opioid, accounting for 10.7% (10.5-10.8%) of patients with chronic OA pain. Mean number of comorbidities was 2.9 (1.8) and its severity was 1.8 (1.7). Pain decreased by 0.9 points (12.2%) and cognitive declined by 2.3 points (9.1%, with 4.3% more patients with cognitive deficit) and dependency worsened by 0.4 points (0.5%, with 2.3% more patients with severe-to-total dependence) over a mean treatment period of 188.6 (185.4-191.8) days on NSAIDs followed by 400.6 (393.7-407.5) days on opioids. The adjusted mortality rate was higher in patients with OA taking NSAID plus strong opioids; hazard ratio 1.44 (1.26-1.65; p < 0.001). The 4-year healthcare cost was €7350/patient (€7193-7507 or €1838/year) and was higher in those taking strong versus weak opioids; €9886 (€9608-10,164, €2472/year) vs. €5519 (€5349-5689, €1380/year), p < 0.001. Analgesia cost (16.0% of total cost, 70.2% opioids) was higher with strong versus weak opioids, 19.6% vs. 11.3%, p < 0.001. CONCLUSIONS: In routine clinical practice in Spain, patients with moderate-to-severe chronic OA pain refractory to standard analgesic treatment with NSAIDs plus opioids reported modest reductions in pain, while presenting a considerable burden of comorbidities, cognitive impairment, and dependency. Healthcare costs significantly increased for the NHS particularly with NSAIDs plus strong opioids.

The influence of heart disease on characteristics, quality of life, use of health resources, and costs of COPD in primary care settings.

BACKGROUND: To evaluate the influence of heart disease on clinical characteristics, quality of life, use of health resources, and costs of patients with COPD followed at primary care settings under common clinical practice conditions. METHODS: Epidemiologic, observational, and descriptive study (EPIDEPOC study). Patients > or = 40 years of age with stable COPD attending primary care settings were included. Demographic, clinical characteristics, quality of life (SF-12), seriousness of the disease, and treatment data were collected. Results were compared between patients with or without associated heart disease. RESULTS: A total of 9,390 patients with COPD were examined of whom 1,770 (18.8%) had heart disease and 78% were males. When comparing both patient groups, significant differences were found in the socio-demographic characteristics, health profile, comorbidities, and severity of the airway obstruction, which was greater in patients with heart disease. Differences were also found in both components of quality of life, physical and mental, with lower scores among those patients with heart disease. Higher frequency of primary care and pneumologist visits, emergency-room visits and number of hospital admissions were observed among patients with heart diseases. The annual total cost per patient was significantly higher in patients with heart disease; 2,937 +/- 2,957 vs. 1,749 +/- 2,120, p < 0.05. Variables that were showed to be independently associated to COPD in subjects with hearth conditions were age, being inactive, ex-smokers, moderate physical exercise, body mass index, concomitant blood hypertension, diabetes, anxiety, the SF-12 physical and mental components and per patient per year total cost. CONCLUSION: Patients with COPD plus heart disease had greater disease severity and worse quality of life, used more healthcare resources and were associated with greater costs compared to COPD patients without known hearth disease.

[All-cause mortality and incidence of major cardiovascular events in hypertensive patients with ASCOT-type profile in a Spanish population setting]. / Mortalidad por cualquier causa e incidencia de enfermedad cardiovascular en hipertensos con perfil tipo Anglo-Scandinavian Cardiac Outcomes Trial en un ámbito poblacional español.

OBJECTIVES: Mediterranean populations are traditionally considered to be associated with lower incidence of cardiovascular events (CVE). However, this might not be homogeneous throughout different patient strata. The goal was to compare the incidence of CVE and all-causes mortality in hypertensive patients with an ASCOT-type profile with that of the rest hypertensive subjects. METHODS: A retrospective analysis was carried out using a claim database. Hypertensive patients without known cardiovascular disease on antihypertensive therapy included during year 2006 were followed up for two consecutive years to ascertain the incidence of all-causes mortality and any CVE. CVE included any of the following: coronary heart disease, acute myocardial infarction (AMI), angina, stroke, transient ischemic attack (TIA) and peripheral artery disease. Patients with ASCOT and ASCOT-LLA type profiles were identified and compared with non-ASCOT-type profile hypertensive subjects. RESULTS: A total of 11,104 were included in the analysis; 68.0+/-11.4 years, 41.6% males. More than 73% of subjects fulfilled criteria for ASCOT-type profile. All-causes mortality were numerically higher in ASCOT and ASCOT-LLA subjects compared with non-ASCOT-type; hazard ratio (95% CI)=1.3 (0.8-1.9) and 1.6 (0.9-2.8), respectively. However, any-coronary event rate was significantly higher in ASCOT-type [2.3 (1.8-2.8), p<0.001], as well as in ASCOT-LLA subjects [1.8 (1.3-2.4), p<0.001]. CONCLUSIONS: Hypertensive patients on treatment with ASCOT-type profile are more likely to have any cardiovascular event than those hypertensive patients without ASCOT profile in a Mediterranean setting in Spain.