Item response theory analysis of daytime sleepiness as a symptom of obstructive sleep apnea.

Obstructive sleep apnea (OSA) is a sleep disorder which is linked to many health risks. The gold standard to evaluate OSA in clinical trials is the Apnea-Hypopnea Index (AHI). However, it is time-consuming, costly, and disregards aspects such as quality of life. Therefore, it is of interest to use patient-reported outcomes like the Epworth Sleepiness Scale (ESS), which measures daytime sleepiness, as surrogate end points. We investigate the link between AHI and ESS, via item response theory (IRT) modeling. Through the developed IRT model it was identified that AHI and ESS are not correlated to any high degree and probably not measuring the same sleepiness construct. No covariate relationships of clinical relevance were found. This suggests that ESS is a poor choice as an end point for clinical development if treatment is targeted at improving AHI, and especially so in a mild OSA patient group.

Evaluation of pain relief treatment and timelines in emergency care in six European countries and Australia.

PURPOSE: Inadequate relief of pain is common in prehospital and hospital emergency department (ED) settings. We investigated pain treatments and timelines in patients receiving pre-hospital and hospital ED care to provide insight into potential approaches to reduce the burden of trauma-related pain. PATIENTS AND METHODS: In this observational, retrospective chart review, patients had received emergency care for musculoskeletal trauma injuries and analgesic treatment for moderate-to-severe pain in Belgium, France, Germany, Italy, Spain or Sweden. As inhaled low-dose methoxyflurane (LDM) is used extensively in Australia but was not widely available in Europe at the time of this analysis, data from Australia were collated to provide insight into the potential utility of this analgesic in Europe. The primary endpoint was time to administration of first pain relief treatment following arrival of paramedic/ED care. RESULTS: Randomly selected physicians (n=189) collated data from 856 patients (Europe: n=585; Australia: n=271) via an online survey. Time to first pain relief treatment varied between countries and was significantly longer across Europe versus Australia (mean [SD] 38.1 [34.7] vs 29.9 [35.5] mins; P=0.0017). Patients from Australia who received LDM experience a shorter mean (SD) time to first pain treatment following arrival of emergency care versus patients who received other analgesics (propensity score matched [n=85] per group: 21.7 [24.2] vs 39.1 [43.0] mins; P=0.0013). Across all countries, mean (SD) time to first analgesic was shorter when treatment was administered by paramedics versus hospital ED staff (15.7 [14.7] vs 49.1 [38.4] mins). CONCLUSIONS: While there was a large variation in analgesia timelines across countries, mean times are shorter in Australia compared with Europe overall. In Australia, use of LDM was associated with a significantly shorter time from emergency assistance to first pain treatment compared with non-LDM treatments. Further studies are needed to investigate the utility of LDM in Europe.

Asthma severity in primary care asthma patients: a comparative study of four different approaches to severity classification.

AIMS: To explore the factor structure of asthma severity and asthma control and to compare the results of different approaches to asthma severity classification on the distribution of costs of asthma medication. METHODS: Comparison of four different approaches to asthma severity classification and factor analysis of asthma control descriptors. A correlation analysis between costs and the different approaches to severity classification was performed. RESULTS: The factor analysis suggests that asthma control consists of at least two factors. Four approaches to severity classification were explored and all except the 'GINA EXPANDED' classification tended to place patients in the most severe category. The pharmaceutical costs varied between 0 and 75 SEK per day (0 and 5.31 GBP; 0 and 7.68 EURO). CONCLUSIONS: There is a considerable overlap between asthma control and asthma severity. None of the approaches used in this study present a superior satisfactory solution to the classification problem.

The influence of structured information and monitoring on the outcome of asthma treatment in primary care: a cluster randomized study.

BACKGROUND: In clinical trials of asthma, the outcomes are often good, but when the same treatment regimens are implemented in primary care, equally good results are not obtained. OBJECTIVE: To investigate if addition of structured patient information and monitoring by an asthma diary in primary care improves asthma control. METHODS: 141 patients from 19 primary care centres were studied. The centres were randomised to a standard care group or to an intervention group. The intervention group received structured written and oral information about asthma and asthma medication, and were instructed to keep an asthma diary. The primary outcome was asthma control as assessed by the Asthma Control Questionnaire. Secondary outcomes were costs of asthma medication, the Mini Asthma Quality of Life Questionnaire score and lung function. RESULTS: Asthma Control Questionnaire score changes differed between the study groups (p < 0.05). In the intervention group, these changes (M = -0.45) in asthma control were close to clinical significance (minimal important difference approximately 0.5). Both groups improved in disease-specific quality of life scores. For the intervention group, which changed the most (p < 0.05), the change exceeded the threshold for the minimal important difference (0.5). The costs of medications increased significantly in the intervention group, where adjustments of medication were made more often than in controls. CONCLUSION: Disease-specific quality of life of asthma patients could be improved by adding structured information and monitoring by diary to standard care.

Regional variation and adherence to guidelines for drug treatment of asthma.

AIMS: To describe the utilization of antiasthmatic drugs in Sweden and to explore regional variations in drug utilization and adherence to guidelines for rational drug prescribing of antiasthmatics and their rationale. METHODS: Data on antiasthmatic drugs dispensed between July 2005 and December 2008 to all Swedish citizens aged between 18 and 44 years were obtained from the Swedish National Prescribed Drug Register. The period prevalence was determined by analyzing the number of users/1000 inhabitants, and the incidence by analyzing the number of new users after an 18-month drug-free wash-out period. Three drug-related indicators were used to assess the adherence to guidelines. All measures were analyzed by gender and region. RESULTS: A total of 161,000 patients were dispensed antiasthmatics in 2007, corresponding to a prevalence of 4 and 6% among men and women, respectively; the incidence rates were 2 and 3%, respectively. The total drug utilization and adherence to guidelines varied between regions. The total drug expenditures of antiastmatics were 258 million SEK (28 million euro), with fixed dose combinations accounting for 46% of the expenditure. No relation was found between models for allocating prescribing budgets or clear Drug and Therapeutics Committee recommendations and adherence to guidelines. CONCLUSION: There are large regional variations in the utilization of antiasthmatics between Swedish regions, with substantial room for improvement in the adherence to guidelines. New methods of influencing physician behavior may be needed in the future to enhance adherence.

Validation of the clinical COPD Questionnaire (CCQ) in primary care.

BACKGROUND: Patient centred outcomes, such as health status, are important in Chronic Obstructive Pulmonary Disease (COPD). Extensive questionnaires on health status have good measurement properties, but are not suitable for use in primary care. The newly developed, short Clinical COPD Questionnaire, CCQ, was therefore validated against the St George's Respiratory Questionnaire (SGRQ). METHODS: 111 patients diagnosed by general practitioners as having COPD completed the questionnaires twice, 2-3 months apart, without systematic changes in treatment. Within this sample of patients with "clinical COPD" a subgroup of patients with spirometry verified COPD was identified. All analyses was performed on both groups. RESULTS: The mean FEV1 (% predicted) was 58.1% for all patients with clinical COPD and 52.4% in the group with verified COPD (n = 83). Overall correlations between SGRQ and CCQ were strong for all patients with clinical COPD (0.84) and the verified COPD subgroup (0.82). The concordance intra-class correlation between SGRQ and CCQ was 0.91 (p < 0.05). Correlations between CCQ and SGRQ were moderate to good, regardless of COPD severity. CONCLUSION: The CCQ is a valid and reliable instrument for assessments of health status on the group level in patients treated for COPD in primary care but its reliability may not be sufficient for the monitoring of individual patients.

The relationship between pharmaceutical costs, disease severity, and health-related quality of life in asthmatics in Swedish primary care.

The objective of this study is to explore the relationship between variables that may influence pharmaceutical costs in asthma and to generate a predictive model for these costs in primary health care. The understanding of these relationships is important since costs of drugs may place unnecessary economic burden on patients and society. During 2003, prospective clinical data were collected from 105 patients in 24 primary health care centers located in Stockholm. The relationships between cost of drugs and quality of life, lung function, and asthma severity were analyzed in a regression model. Twenty-three percent of the observed variation in pharmaceutical costs could be explained by asthma severity, disease-specific quality of life, and clinical practice. There was a weak inverse correlation between pharmaceutical costs, generic quality of life, and lung function. Even when severity was accounted for, there were large variations in costs between different primary health care units.

Brief questionnaires for patient-reported outcomes in asthma: validation and usefulness in a primary care setting.

UNLABELLED: STUDY OBJECTIVES AND DESIGN: Health-related quality of life (QoL) instruments are generally used for studies of asthma in specialized settings. For primary care use, there is a need for brief and simple questionnaires for structured patient-reported outcomes. We validated the Mini-Asthma Quality of Life Questionnaire (Mini-AQLQ), using the Asthma Quality of Life Questionnaire with standardized activities (AQLQ[S]) as the "gold standard." The Asthma Control Questionnaire (ACQ) was validated against the symptoms domain of the AQLQ(S). Patients were characterized by the Short Form-36 Health Survey (SF-36). SUBJECTS: One hundred eight patients (68 women) with asthma diagnosed by their physicians from 24 primary care centers completed two visits (2 to 3 months apart). Their mean SF-36 scores were lower than the national norm for all domains. RESULTS: The Mini-AQLQ and ACQ correlated well with the AQLQ(S). Reliability, determined in 57 patients with stable AQLQ(S) scores, was good. Both brief questionnaires detected improvement or deterioration of patients at the group level. Global ratings of disease severity by patients or clinicians correlated poorly with disease-specific QoL scores. CONCLUSIONS: The Mini-AQLQ and ACQ instruments are sufficiently simple and robust to be suitable for research and quality of care monitoring in primary care at the group level. They may, after further validation, even be useful in the management of individual patients.