Factors affecting quality of life of asthma patients in Spain: the importance of patient education.

OBJECTIVES: Assessment of demographic and clinical factors that have an impact on the quality of life (QoL) of patients with asthma in Spain. PATIENTS AND METHODS: Multicenter, prospective, observational, cohort study, conducted in 40 Spanish Pneumology Units during a 12-month period. Data on sociodemographic, clinical variables, asthma treatment and QoL were collected in a case report form. RESULTS: 536 patients (64.6% women, mean age: 54) were recruited. Reported QoL was better for patients from Northern and Central Spain as compared with those from the South and the East (p<0.001), students and employed patients as compared with housewives and unemployed (p<0.01), for those who had received asthma information (p<0.01), for those with milder daytime symptoms (p<0.01) and for patients with higher level of education (p<0.05). CONCLUSIONS: Among the factors that have a significant effect on patients' QoL only symptom control and patient education on asthma control are modifiable. Therefore, all the strategies should be tailored to improve such factors when managing asthma patients.

Chemotherapy-induced nausea and vomiting in clinical practice: impact on patients' quality of life.

BACKGROUND: Chemotherapy-induced nausea and vomiting (CINV) in cancer patients are common symptoms most feared by patients. The aim of this study was to analyze the impact of CINV associated to moderate/highly emetogenous chemotherapy regimens on patients' quality of life (QoL). PATIENTS AND METHODS: Open, multicenter, prospective observational study was performed. Each patient filled out a patient diary for each cycle from the day before chemotherapy and for the next 5 days that included the number of emetic episodes, the intensity of nausea, and QoL evaluation (functional living index-emesis questionnaire). RESULTS: Data from 202 consecutive patients from nine university hospitals were collected, but only data from 160 were analyzed (79.2 %). Most of the participants (70 %) were women with a mean age of 50 years (SD 1.2 years). The most frequent cancer site was breast (44 %) followed by lung (16 %) and 76.3 % were receiving highly emetogenous chemotherapy. Despite the use of antiemetic prophylaxis, patients experienced significant nausea and vomiting during 31 % (3.2 % during acute, 15.0 % during delayed phase, and 13.2 % during both phases) and 45.1 % (5.1 % only during the acute phase, 23.5 % only during the delayed phase and 16.5 % during both phases) of the cycles, respectively, having 44.5 % (nausea) and 39.3 % (emesis) of the cycles an impact on patients' QoL. CONCLUSIONS: The results of the study confirm the detrimental effect of CINV on patients' QoL despite the use of antiemetic prophylaxis (5HT(3) receptor antagonist, steroids, and dopamine receptor antagonists). It is mandatory to intensify the detection of CINV in order to improve the management of these important, albeit frequent, side effects of cancer treatments.

Evaluation of patients' and physicians' expectations and attributes of osteoarthritis treatment using Kano methodology.

PURPOSE: To evaluate expectations regarding osteoarthritis (OA) treatment of patients (PT) and physicians (PH) (Orthopedic Surgeons) in Spain. METHODS: Multicenter, cross-sectional study in adult patients with OA with at least 1 year of disease progression and with at least one prescription of anti-inflammatory drugs within the last year. Sociodemographic, clinical, and treatment characteristics as well as patient-reported outcomes were obtained by phone interview. Using a treatment expectations questionnaire and applying Kano methodology, treatment attributes were classified as: must-be; one-directional; attractive; indifferent; reverse or questionable. RESULTS: A total of 965 adult patients with OA [mean age: 64 years (SD: 11); 75% women] and 383 PH [mean age: 47 years (SD: 10); 14% women] were surveyed. None of the treatment attributes showed a dominant "must-be" characteristic. The attributes that led to a greater dissatisfaction when absent were non-occurrence of long-term adverse effects, no discomfort upon administration, and achievement of symptoms relief. The two attributes that were considered most important by PT were as follows: achievement of both total disappearance of the symptoms and lasting symptom relief. Conversely, for PH, the two most important attributes were related to short- and long-term safety. CONCLUSIONS: A clear different perspective regarding treatment expectation was noted among PT (effectiveness) and PH (safety). Therefore, when selecting the most appropriate treatment for OA, PH should invite PT to participate in the decision making.

Glycaemic control among patients with type 2 diabetes mellitus in seven European countries: findings from the Real-Life Effectiveness and Care Patterns of Diabetes Management (RECAP-DM) study.

OBJECTIVE: This study was undertaken to assess glycaemic control as well as changes in glycaemic control over time in patients with type 2 diabetes mellitus (T2DM) who added a sulphonylurea (SU) or thiazolidinedione (TZD) to their metformin monotherapy in typical treatment settings within seven European countries. METHODS: An observational, cross-sectional multicentre study with retrospective medical chart review was conducted in Finland, France, Germany, Norway, Poland, Spain and UK. T2DM patients who added a SU or a TZD to metformin monotherapy between January 2001 and January 2006 (i.e. index date) and who had > or = 1 haemoglobin A1C (HbA1C) measurement within 12 months before the visit date, which occurred from June 2006 to February 2007, were included in the study. Demographic and clinical data were collected from medical records. The main study outcome measure was the proportion of patients with adequate glycaemic control (defined according to the International Diabetes Federation as HbA1C < 6.5%) using the most recent HbA1C measurement before the visit date. In addition, patients were grouped based upon the interval from the index date to the most recent HbA1C measurement to evaluate goal attainment and treatment changes over time. FINDINGS: In this European cohort of 2023 T2DM patients on metformin and either an SU or a TZD (mean age = 60.4 years), 25.5% of patients had adequate glycaemic control. The average HbA1C level was 7.2% after a mean of 2.6 years of treatment with combination oral antihyperglycaemic agent (AHA) therapy. Among the patients (n = 227) with most recent HbA1C measurement within 1 year after first adding an SU or a TZD, 27% had adequate glycaemic control (HbA1C < 6.5%), with a mean (s.d.) HbA1C of 7.1% (1.0); 1.3% of these patients were using some type of insulin therapy. Among the patients (n = 176) with most recent HbA1C measurement occurring > or = 5 years after adding an SU or a TZD, 20% had adequate glycaemic control, with a mean (s.d.) HbA1C of 7.4% (1.17), and 29.6% of these patients were using insulin. Overall, patients with (vs. without) adequate glycaemic control had significantly (p < 0.05) lower HbA1C levels (7.6 vs. 8.2%) at the time of adding an SU or a TZD to ongoing metformin monotherapy, were less likely to report a history of macrovascular complications (20 vs. 26%) and were more often engaged in physical activity three to five times a week (29 vs. 23%). CONCLUSIONS: Approximately one quarter of European out-patients with T2DM had adequate glycaemic control after a mean of 2.6 years following initiation of combination AHA therapy. Overall glycaemic control modestly declined over time, even though more patients were being treated with insulin. These findings highlight the progressive nature of the disease and need for more effective disease management/therapeutic alternatives.

Cost-effectiveness of sitagliptin-based treatment regimens in European patients with type 2 diabetes and haemoglobin A1c above target on metformin monotherapy.

OBJECTIVE: Sitagliptin is a novel oral incretin enhancer that acts by inhibiting the dipeptidyl peptidase 4 enzyme and is indicated in Europe as a treatment adjunct to metformin (MF), sulphonylurea (SU), MF plus SU and diet and exercise, in the management of type 2 diabetes mellitus. The objective of the current analysis was to evaluate the cost-effectiveness of adding sitagliptin to the regimens of patients with haemoglobin A1c (HbA1C) above the International Diabetes Federation goal (6.5%) while on MF in six European countries: Austria, Finland, Portugal, Scotland (United Kingdom), Spain and Sweden. METHODS: A discrete event simulation model, which employed the United Kingdom Prospective Diabetes Study (UKPDS) Outcomes Model risk equations for predicting risks of diabetes-related complication, was used. Lifetime costs and benefits were projected for alternative treatment strategies of adding sitagliptin, compared with adding rosiglitazone or a SU to MF in patients not at HbA1C goal on MF monotherapy. Changes in HbA1C as well as side effects associated with these different treatment strategies were based on clinical trial data. Mean baseline values from local epidemiologic studies involving patients with type 2 diabetes not at HbA1C goal on MF monotherapy were included in the current analysis. Costs of medications, side effects and direct costs of diabetes-related complications were based on country-specific data. UKPDS-based disutility weights associated with diabetes complications were incorporated. Disutilities associated with medication side effects were based on published data. All future costs and benefits were discounted according to local guidelines on cost-effectiveness analysis. One-way sensitivity analyses were conducted by varying key input parameters. FINDINGS: The discounted incremental cost-effectiveness ratios (ICER) associated with the addition of sitagliptin to MF, compared with adding rosiglitazone, in the different countries analysed ranged from treatment with sitagliptin being dominant (cost saving with improved health outcome) to its being cost-effective [4,766 euros per quality-adjusted life year (QALY)]. Treatment with sitagliptin added to MF was cost-effective compared with adding a SU, with discounted ICER values ranging from 5949 euros/QALY to 20,350 euros/QALY across countries. Sensitivity analyses showed that these results were robust to changes in input parameters, including clinical efficacy, costs and utility weights for both diabetes-related complications and hypoglycaemia. CONCLUSIONS: Compared with adding rosiglitazone or a SU to MF, adding sitagliptin to MF is projected to be either cost saving or cost-effective for patients with type 2 diabetes who are not at HbA1C goal on MF.

Asthma-related resource use and cost by GINA classification of severity in three European countries.

BACKGROUND: This study assessed the relationship between asthma burden and asthma severity in France, Italy, and Spain. METHODS: Adult asthmatics, 18-55 years of age, completed a questionnaire while visiting a respiratory physician in 1998 and 1999. Asthma severity was categorized by physicians as intermittent, mild persistent, moderate persistent, or severe persistent according to Global Initiative for Asthma (GINA) guidelines. RESULTS: Totals of 282 patients in France, 500 in Italy, and 296 in Spain entered the study. There were few differences between the three countries in the asthma symptom burden. Most patients with persistent asthma had used inhaled corticosteroids in the previous 14 days. Unexpectedly, 35% (Italy) to 83% (Spain) of patients with intermittent asthma also had used inhaled corticosteroids. In Spain, visits to the emergency department were more frequent (OR 7.0, 95% CI 4.9-10.0 with Italy as reference) and the costs of emergency care in all asthma severity categories were up to 10 times higher than in Italy and France. The frequency of hospitalizations did not differ systematically between the three countries. CONCLUSIONS: Inadequate control of asthma symptoms among patients with severe persistent asthma could not be entirely explained by under-prescribing of asthma medications. The use of inhaled corticosteroids by patients with intermittent asthma might reflect misclassification of asthma severity, possibly due to difficulty in interpreting the GINA guidelines. The relatively high cost of emergency care in Spain does not appear to be related to greater asthma severity or poorer symptom control, but may be a feature of the Spanish health care system.

Differences in the methodology and data of economic evaluations of a health programme. The case of hepatitis B vaccination programmes in Spain.

Economic evaluations of hepatitis B vaccination programmes in Spain or particular regions of Spain were identified and analysed, and their methodologies and data were compared. The results revealed important differences in methodology and the way in which different parameters, such as duration of immunity, costs and sources of cost data, were defined and measured. Some of these variations could be justified by the need to adapt studies to specific contexts, while others appeared arbitrary. Although it is understandable that there should be a substantial amount of heterogeneity between studies, greater efforts need to be made to reduce unnecessary variations in the way in which different parameters are measured. Increasing standardisation in methodology, which nevertheless takes into account inevitable variations due to changing circumstances and perspectives, will help to make economic evaluation a more attractive proposition for decision makers.

Current lipid management and low cholesterol goal attainment in common daily practice in Spain. The REALITY Study.

OBJECTIVE: To evaluate prescribing patterns of lipid-lowering drugs used in management of patients at risk of coronary heart disease (CHD) in usual clinical practice in Spain and to assess low-density lipoprotein cholesterol (LDL-C) goal attainment among CHD and CHD equivalent patients (< 100 mg/dL) and non-CHD patients with two or more risk factors (< 130 mg/dL) who were prescribed lipid-lowering drugs. METHODS: Cohort study with retrospective chart review at 23 primary care centres and 16 lipid treatment centres across Spain (59% primary care; 41% outpatient lipid centres). Physicians consecutively identified eligible patients. Adults (aged > or = 18 years) with CHD/CHD equivalent or two or more major risk factors prior to first prescription of lipid-lowering drugs were eligible. Medical records were reviewed by physicians to collect patient characteristics, baseline and follow-up laboratory values and lipid-lowering drug treatment data. RESULTS: 619 patients (45.5% CHD and CHD equivalent patients and 54.5% non-CHD with two or more major risk factors) were included in the study with an average study follow-up of 3.6 years. Mean age was 60.1 years (SD 10.2), and 47.8% were female. Mean baseline LDL-C was 178 mg/dL (SD 45.0) for the CHD/CHD equivalent patients and 191 mg/dL (SD 56.95) for patients with two or more risk factors. Statins were the initial lipid-lowering drugs in 90.2% of patients; 52.5% of patients were initiated on low-dose (simvastatin 10mg or lower potency) statins. Overall 20.2% of CHD/CHD equivalent and 31.4% of patients with two or more risk factors attained LDL-C goal during the study period; of patients not attaining goal, 28.7% required an additional LDL-C reduction of > 30% to attain goal. In a logistic regression model for goal attainment, CHD/CHD equivalent patients (odds ratio [OR] 0.47; 95% confidence interval [CI] 0.31, 0.72) and patients with baseline LDL-C > 190 mg/dL (OR 0.53; 95% CI 0.35, 0.80) were least likely to reach cholesterol goal when compared with patients having baseline LDL-C > 100 mg/dL and < 130 mg/dL. CONCLUSION: Only 12.9% of patients attained LDL-C goal on their initial lipid-lowering drugs, and an additional 13.4% achieved goal after a change in their lipid-lowering therapy, resulting in 73.7% of patients not attaining goal after at least 3 years of follow-up, after initiation of lipid-lowering therapy. Patients who would gain the most from aggressive lipid lowering (CHD patients and patients with high baseline LDL-C) were least likely to achieve goal. More effective lipid management is needed to help these patients lower their cholesterol to goal levels or even lower.

[Validity of the Spanish version of the Pediatric Quality of Life Questionnaire for evaluating quality of life in asthmatic children]. / Validación de la versión española del Pediatric Quality of Life Questionnaire en la valoración de la calidad de vida del niño asmático.

BACKGROUND: To analyze the clinical utility of the quality of life questionnaire for asthmatic children (PAQLQ) and to validate it for use in clinical practice. PATIENTS AND METHOD: 1,012 children between 6 and 14 years of age, with a diagnosis of mild to moderate asthma attending 48 Spanish hospitals were included in the study. The patients' socio-demographic and clinical characteristics were recorded and all patients were administered the PAQLQ and EQ-5D questionnaires on two occasions: at the baseline visit and at 2-3 months from baseline in patients with uncontrolled asthma(group A) and at baseline and 15 days from baseline in patients with controlled asthma (group B). The feasibility, validity, reliability and sensitivity to change of the PAQLQ were assessed. RESULTS: The PAQLQ proved to be feasible for use in children over 7 years of age with mild or moderate asthma. The PAQLQ did not show a statistically significant relationship with socio-demographic variables, nor with the majority of clinical variables, with the exception of asthma severity, number of exacerbations, symptoms and use ofon- demand short-term beta2 agonist drugs. Correlations between PAQLQ and EQ-5D dimensions were strongest between dimensions measuring similar attributes. Cronbach's *coefficients for the PAQLQ ranged from 0.88 for the limitations in activities dimension to 0.96 for the overall score. The intraclass correlation coefficient for PAQLQscores in group B ranged from 0.71 (limitation of activities)to 0.83 (overall score). The effect size between both visits ranged from 0.49 to 0.69. CONCLUSIONS: The Spanish version of the PAQLQ proved to be valid for use in children with mild to moderate asthma.

Comparison of expected outcomes between patients and neurologists using Kano's methodology in symptomatic migraine treatment.

OBJECTIVES: Our objective was to evaluate the potential usefulness of the Kano conceptual model to assess expectations of patients and neurologists in Spain regarding symptomatic migraine treatment. METHODS: We performed a multicenter, cross-sectional study in adult migraine patients with at least 1 year of disease evolution and at least one prescription of anti-migraine drugs within the last year. Data collection was performed using questionnaires that included sociodemographic and treatment expectations. Using Kano's methodology, treatment attributes were classified as the following: Must-be; One-dimensional; Attractive; Indifferent; Reverse; or Questionable. RESULTS: A total of 204 migraine patients (mean age 39.2 years [SD 11.9]; 84.6% women) and 68 neurologists (mean age 44 years [SD 8.8]; 63.2% men) were surveyed. None of the treatment attributes evaluated by the patients showed a dominant Must-be feature. Among patients and neurologists, the attributes that led to a greater dissatisfaction when absent and that were ranked as the three most important attributes were those related to treatment safety (absence of long-term adverse effects), efficacy (pain relief achievement), and quality of life (possibility of resuming occupational or academic activities). Differences in attributes' classification were noted among patients and neurologists. The attribute that was considered most important by the patients was achievement of total disappearance of pain, whereas for neurologists the most important attribute was absence of long-term adverse effects. CONCLUSIONS: Kano's methodology is a useful tool to analyze differences in migraine treatment expectations among patients and neurologists. The main difference between patients and neurologists related to basic priorities. Therefore, when selecting treatment for migraine, physicians should invite the patient to participate in the decision making of which treatment is more appropriate.

[Association between arthritis, functional disability and quality of life using a structural equation]. / Vinculación de la afectación artrósica, la discapacidad funcional y la calidad de vida mediante un modelo de ecuación estructural.

OBJECTIVES: To establish a conceptual model that links arthritis, functional disability in activities of daily living, and quality of life (QoL). METHODS: A multicentre, cross-sectional, observation study was performed. The location of the arthritis (presence/absence) was recorded. Disability was measured using the Health Assessment Questionnaire Disability Index and the QoL determined using the EQ-5D-3 Level questionnaire. The relationship between the arthritis, disability, and the QoL was evaluated using the structural equation model (SEM). PATIENTS: 965 patients with arthritis (mean age=64 years, with 75% females). Arthritis: mean areas affected: 2.8. Areas most frequently affected: knees (67%); lumbar spine (60%) and cervical spine (45%). QoL: The majority of patients did not mention serious problems in the five domains assessed. Disability: «other activities¼ (mean=1.2); «reach¼ (mean=1.1) and «walking¼ (mean=1.0) were the categories that demonstrated greater disability. The SEM showed arthritis, disability and QoL as associated latent variables. Although 92% of the QoL explained the disability, only 5% of the disability was due to the presence/absence of arthritis. The global model that describes arthritis as a cause of disability, and disability was affecting the QoL, had a reasonable goodness of fit (CMIN/DF=5.42; RMR=0.026; RMSEA=0.069). CONCLUSIONS: Functional disability can explain the decrease in QoL. In theory, arthritis is closely related with disability and QoL, but the model did not mange to fully explain this link. As statistical techniques required good measurement models to correctly determine relationships, conventional medical records seem to be insufficient for this purpose. Other valid measurements of arthritis are needed to provide tests of its direct effect on disability and QoL.

Use of a structured migraine diary improves patient and physician communication about migraine disability and treatment outcomes.

Migraine is frequently undertreated, perhaps because impaired communication between patients and physicians underestimate the disability associated with migraine attacks. The purpose of this study was to evaluate the benefits of a structured migraine diary used during a prospective open-label study of triptan-naive patients in Spain for recording information on response to therapy for a pre-study migraine attack and three consecutive migraine attacks, the first and third treated with rizatriptan 10-mg wafer and the second with usual non-triptan therapy. Of 97 patients (83% women; mean age, 39 years) who completed the study, all reported moderate to severe pain, and two-thirds reported severe to total impairment during migraine attacks. At study end, 72% of patients reported that the migraine diary helped communication with their doctor about migraine, and 70% were more or much more satisfied than before the study with level of overall medical care provided by their doctor. Patients who reported the diary to be useful also reported higher overall satisfaction with medical care (p < 0.001). Most of the 22 physicians (91%) reported that the diary enabled them to better communicate with their patients about migraine, and all reported that it enabled them to assess differences in pain intensity and disability across patients. We conclude that a structured migraine diary can be a valuable aid for improving communication between physicians and patients regarding migraine disability and treatment outcomes.

Patient-reported benefits of rizatriptan compared with usual non-triptan therapy for migraine in a primary care setting.

The purpose of this open-label study was to compare rizatriptan with usual non-triptan therapy for migraine in patients who had never received a triptan. Patient-reported outcomes were examined for a prestudy migraine attack and after three consecutive study attacks, the first and third treated with rizatriptan 10 mg wafer and the second with usual non-triptan therapy. A total of 97 patients (83% women; mean age 39 years) completed the study. Two-thirds of patients reported severe or total disability during migraine attacks. All comparisons between rizatriptan therapy and usual non-triptan therapy significantly favoured rizatriptan (p < or = 0.01). Headache relief by 2 hours was reported by 78-83% of patients after rizatriptan and by 46-48% of patients after usual therapy; 41-47% and 12-18%, respectively, were pain free at 2 hours. Patient satisfaction and migraine-specific quality-of-life scores were also significantly better for attacks treated with rizatriptan. At study end, 62% and 17% of patients were very or completely satisfied with rizatriptan and usual non-triptan therapy, respectively. Among those patients who worked for pay, therapy with rizatriptan significantly reduced absenteeism and improved the amount and quality of time at work compared with usual non-triptan therapy. Allowing patients to have experience with rizatriptan may improve the level of medical care for migraine attacks.