Sex-related differences in COPD in five Latin American cities: the PLATINO study.

There is evidence to suggest sex differences exists in chronic obstructive pulmonary disease (COPD) clinical expression. We investigated sex differences in health status perception, dyspnoea and physical activity, and factors that explain these differences using an epidemiological sample of subjects with and without COPD. PLATINO is a cross-sectional, population-based study. We defined COPD as post-bronchodilator forced expiratory volume in 1 s/forced vital capacity ratio <0.70, and evaluated health status perception (Short Form (SF)-12 questionnaire) and dyspnoea (Medical Research Council scale). Among 5,314 subjects, 759 (362 females) had COPD and 4,555 (2,850 females) did not. In general, females reported more dyspnoea and physical limitation than males. 54% of females without COPD reported a dyspnoea score ≥ 2 versus 35% of males. A similar trend was observed in females with COPD (63% versus 44%). In the entire study population, female sex was a factor explaining dyspnoea (OR 1.60, 95%CI 1.40-1.84) and SF-12 physical score (OR -1.13, 95%CI -1.56- -0.71). 40% of females versus 28% of males without COPD reported their general health status as fair-to-poor. Females with COPD showed a similar trend (41% versus 34%). Distribution of COPD severity was similar between sexes, but currently smoking females had more severe COPD than currently smoking males. There are important sex differences in the impact that COPD has on the perception of dyspnoea, health status and physical activity limitation.

Evaluating the adequacy of disease control in patients with rheumatoid arthritis: a RAND appropriateness panel.

OBJECTIVES: There is a lack of agreement on assessing disease activity in patients with RA and determining when the RA treatment should be changed or continued. A panel of rheumatologists was convened to develop guidelines to assess adequacy of disease control, focusing on the use of disease-modifying anti-rheumatic drugs. METHODS: The Research and Development/University of California in Los Angeles (RAND/UCLA) Appropriateness Method was used to evaluate disease control adequacy. After a literature review, 108 scenarios were developed to simulate situations most likely to be encountered in clinical practice and rated on a 9-point scale by a 10-member expert panel. RESULTS: Final appropriateness rankings for the scenarios were as follows: 37% 'appropriate', 48% 'inappropriate', and 16% 'neutral'. The panelists felt that patients with disease control in the 'appropriate' range have adequate control with their current therapy, whereas those in the 'inappropriate' range should be considered for a change in therapy. Those in 'neutral' areas should have their therapy reviewed carefully. The panelists recommended that the clinically active joint count should be considered the most important decision factor. In patients with no clinically active joints, regardless of other factors no change in therapy was felt to be warranted. Patients with five or more active joints should be considered inadequately treated, and in patients with one to four active joints other variables must be considered in the decision to change therapy. CONCLUSION: These preliminary guidelines will assist the clinician in determining when a patient's clinical situation warrants therapy escalation and when continuing the current regimen would be appropriate.

Systematic review and meta-analysis of real-world adherence to drug therapy for osteoporosis.

OBJECTIVE: To quantify the adherence of patients to drug therapy for osteoporosis in real-world settings via a systematic review and meta-analysis of observational studies. METHODS: The PubMed and Cochrane databases were searched for English-language observational studies published from January 1, 1990, to February 15, 2006, that assessed patient adherence to drug therapy for osteoporosis using the following medical subject headings and keywords: drug therapy, medication adherence, medication persistence, medication possession ratio, patient compliance, and osteoporosis. Studies were stratified into 3 groups: persistence (how long a patient continues therapy), compliance (how correctly, in terms of dose and frequency, a patient takes the medication), and adherence (a combination of persistence and compliance). A random-effects model was used to pool results from the selected studies. RESULTS: Twenty-four studies were included in the meta-analysis. The pooled database-derived persistence rate was 52% (95% confidence interval [CI], 44%-59%) for treatment lasting 1 to 6 months, 50% (95% CI, 37%-63%) for treatment lasting 7 to 12 months, 42% (95% CI, 20%-68%) for treatment lasting 13 to 24 months, returning to 52% (95% CI, 45%-58%) for treatment lasting more than 24 months. Pooled adherence rates decreased from 53% (95% CI, 52%-54%) for treatment lasting 1 to 6 months to 43% for treatment lasting 7 to 12 months (95% CI, 38%-49%) or 13 to 24 months (43%; 95% CI, 32%-54%). The pooled refill compliance estimate was 68% (95% CI, 63%-72%) for treatment lasting 7 to 12 months and 68% (95% CI, 67%-69%) for treatment lasting 13 to 24 months. The pooled self-reported compliance rate was 62% (95% CI, 48%-75%) for treatment lasting 1 to 6 months and 66% (95% CI, 45%-81%) for treatment lasting 7 to 12 months. CONCLUSION: One-third to half of patients do not take their medication as directed. Nonadherence occurs shortly after treatment initiation. Terms and definitions need to be standardized to permit comparability of technologies designed to improve patient adherence. Prospective trials are needed to assess the relationship between adherence and patient outcomes.

Scoring system and clinical application of COPD diagnostic questionnaires.

OBJECTIVES: In most primary care settings, spirometric screening of all patients at risk is not practical. In prior work, we developed questionnaires to help identify COPD in two risk groups: (1) persons with a positive smoking history but no history of obstructive lung disease (case finding), and (2) patients with prior evidence of obstructive lung disease (differential diagnosis). For these questionnaires, we now present a scoring system for use in primary care. METHODS: Scores for individual questions were based on the regression coefficients from logistic regression models using a spirometry-based diagnosis of obstruction as the reference outcome. Receiver operator characteristic analysis was used to determine performance characteristics for each questionnaire. Several simplified scoring systems were developed and tested. RESULTS: For both scenarios, we created a scoring system with two cut points intended to place subjects within one of three zones: persons with a high likelihood of having obstruction (high predictive value of a positive test result); persons with a low likelihood of obstruction (high predictive value of a negative test result); and an intermediate zone. Using these scoring systems, we achieved sensitivities of 54 to 82%, specificities of 58 to 88%, positive predictive values of 30 to 78%, and negative predictive values of 71 to 93%. CONCLUSIONS: These questionnaires can be used to help identify persons likely to have COPD among specific risk groups. The use of a simplified scoring system makes these tools beneficial in the primary care setting. Used in conjunction with spirometry, these tools can help improve the efficiency and accuracy of COPD diagnosis in primary care.

Questions for COPD diagnostic screening in a primary care setting.

OBJECTIVES: To test questions usable in an ambulatory clinic to identify persons likely to have chronic obstructive pulmonary disease (COPD). METHODS: Analyses were performed as part of a study to identify patients with likely COPD in the Glenfield UK primary care clinic. Patients age 40 and older were recruited based on one of the following criteria: (1) respiratory medications in previous 2 years; (2) history of smoking or (3) history of asthma with no current medications based on case notes. Consenting patients reported smoking history, symptoms, and personal and family history of respiratory conditions. Spirometry with reversibility was conducted to ATS standards. Analyses were performed on this database to test questions for identifying patients with COPD from a sample of patients with a positive smoking history. Multivariate logistic regression identified the question set that best discriminated COPD from other conditions using receiver operating characteristic curves. The usefulness of a simple scoring system was assessed. RESULTS: The study sample included 369 current and former smokers. Patients were diagnosed as: COPD=62 (16.8%); asthma=30 (8.1%); or no obstructive lung disease=277 (75.1%). The best questions for discriminating between persons with and without COPD included items on age, dyspnoea on exertion, and wheeze. This set of questions identified COPD patients with a sensitivity of 77.4--87.1% and specificity of 71.3--76.2%. CONCLUSIONS: A simple questionnaire can facilitate the diagnosis of COPD in a primary care setting.

Chronic obstructive pulmonary disease in patients under age 65: utilization and costs from a managed care sample.

OBJECTIVES: Chronic obstructive pulmonary disease (COPD) affects all adult age groups, not just elderly males. We assessed the health care utilization and cost impact of COPD in different age groups. METHODS: We compared burden of illness, utilization, and charges for younger versus older COPD patients and versus age- and gender-matched controls. RESULTS: A total of 16.9% of patients with COPD were under age 65. Patients with COPD (n=19,338) had higher comorbidity than age-matched controls (n=94,384) across all age groups. Younger patients with COPD had lower comorbidity scores and fewer hospitalizations but more COPD-related emergency services than older patients with COPD. Average COPD-related charges were higher for younger patients. Facility-based care was the cost driver across all age groups. CONCLUSIONS: COPD is a burden to younger individuals in the workforce, who are likely to be enrolled in a commercial health plan.

Effect of multiple patient reminders in improving diabetic retinopathy screening. A randomized trial.

OBJECTIVE: To determine whether multiple mailed patient reminders can produce an increase in the rate of diabetic retinal examinations (DRE) over that seen with a single reminder. RESEARCH DESIGN AND METHODS: All diabetic members > or = 18 years who were enrolled in a large network-based health maintenance organization (HMO) in California from August 1996 to July 1997 were identified using claims and pharmacy databases. Members who had no record of DRE in the HMO's claims database were then randomized into two groups. Both groups received mailed educational materials and a reminder to obtain the examination. Their physician groups also received a letter explaining the program, current guidelines for DRE, and a list of their diabetes patients with their DRE status. The single intervention group received no additional reminders. The multiple intervention group received additional reminders at 3, 6, and 9 months after baseline if they continued with no record of service, as determined from the claims database. RESULTS: The study cohort comprised 19,523 diabetic members, which were randomized into single (n = 9,614) and multiple (n = 9,909) intervention groups. There was an increase in monthly DRE rates after the intervention in August 1996 for both intervention groups. After the second reminder was sent to the multiple intervention group, the percentage of diabetic members receiving DRE was higher than the single intervention group. Rates before and after the third intervention were not significantly different, nor were monthly differences found. There was a significant difference in overall annual DRE rates between the groups (P = 0.023). CONCLUSIONS: Multiple patient reminders are more effective than single reminders in improving DRE rates in a managed care setting. However, the improvement noted was clinically small and appeared only after the second reminder; no incremental improvement was seen with additional reminders. Resources used for multiple reminders aimed at diabetic retinopathy might better be spent on other approaches to reducing complications of diabetes.

Life satisfaction in renal transplant recipients: preliminary results from the transplant learning center.

The Transplant Learning Center (TLC) was designed to improve quality of life (QOL) and preserve graft function in solid-organ transplant recipients. To meet the specific goals of the program, the Life Satisfaction Index and Transplant Care Index were designed to serve as composite measures for measuring transplant-specific QOL and the ability to care for a transplant, respectively. In this study, we analyzed self-reported health information to examine relationships between comorbidities and individual posttransplantation side effects, life satisfaction, and transplant care, defined by renal transplant recipients. Patients entered the TLC through self-referral or referral by a health professional. Included in the analysis were 3,676 TLC enrollees with a mean time since transplantation of 4.8 years. Comorbidities and adverse effects were common, with high blood pressure reported by 89% of respondents and unusual hair growth reported by 70%. Sexual dysfunction and headache had a greater impact on QOL than more common adverse effects, such as changes in body and facial shape, hirsutism, and tremor. Regression modeling was used to identify the most significant associations between QOL indices and structural (nonmedical), medical, and psychosocial factors. Greater life satisfaction was most strongly associated with being in control of one's health and living a normally active life with satisfying emotional relationships. Management of such clinical problems as adverse effects of medication and nonadherence should be informed by the patient's perspective. Clinicians should actively solicit information about physical activity, appearance concerns, side effects of medications, nonadherence, and sexual and relationship issues when evaluating renal transplant recipients.

Interpreting COPD prevalence estimates: what is the true burden of disease?

STUDY OBJECTIVES: To summarize the available data on COPD prevalence and assess reasons for conflicting prevalence estimates in the published literature. DESIGN: We reviewed published studies that (1) estimated COPD prevalence for a population, and (2) clearly described the methods used to obtain the estimates. RESULTS: Thirty-two sources of COPD prevalence rates, representing 17 countries and eight World Health Organization-classified regions, were identified and reviewed. Prevalence estimates were based on spirometry (11 studies), respiratory symptoms (14 studies), patient-reported disease (10 studies), or expert opinion. Reported prevalence ranged from 0.23 to 18.3%. The lowest prevalence rates (0.2 to 2.5%) were based on expert opinion. Sixteen studies had measured rates that could reasonably be extrapolated to an entire region or country. All were for Europe or North America, and most fell between 4% and 10%. CONCLUSIONS: There is considerable variation in the reported prevalence of COPD. The overall prevalence in adults appears to lie between 4% and 10% in countries where it has been rigorously measured. Some of the variation attributed to differences in risk exposure or population characteristics may be influenced by the methods and definitions used to measure disease. Spirometry is least influenced by local diagnostic practice, but it is subject to variation based on the lung function parameters selected to define COPD.

Determinants of quality of life changes among long-term cardiac transplant survivors: results from longitudinal data.

BACKGROUND: Cross-sectional analyses have identified significant associations between quality of life (QOL), and comorbidities and adverse effects in cardiac transplant recipients. However, little is known about factors that influence changes in QOL over time. This study examines both cross-sectional and longitudinal data from long-term survivors to identify factors that affect differences in QOL among recipients and individual changes in QOL during a 1-year period. METHODS: Self-selected enrollees completed questionnaires, including QOL scales, at 3-month intervals. Repeated measures multiple regression analysis was used to examine the association between the QOL scales and comorbidities, adverse effects, and compliance measures, controlling for other factors. RESULTS: We included 569 participants in the analysis, with a mean time since transplantation of 8.6 years. Cross-sectional results showed that the number of comorbidities, treatment non-compliance, and several adverse effects were associated with low QOL. In longitudinal results, waiting to take medications and taking less medication because of lifestyle restrictions were associated with decreases in QOL over time. Hair loss, changes in face shape, and decreased sexual interest or ability also had the largest adverse effects on changes in QOL. CONCLUSIONS: These findings provide new opportunities for interventions to address factors related to decreases in QOL. Clinicians should actively solicit information about compliance with medication regimens. In addition, information about the adverse effects of medications should be considered when making therapeutic decisions.

Competencies for population-based clinical managers. A survey of managed care medical directors.

BACKGROUND: The evolution of American health care into integrated systems of delivery and finance requires a specialized set of population-based skills for physicians. The field of preventive medicine represents one source of this expertise. Specific competencies for the emerging area of managerial medicine have not been well delineated. METHODS: Using concept documents from the Residency Review Committee for Preventive Medicine and the American Board of Preventive Medicine, a list of proposed competencies for managerial medicine was identified. Surveys were mailed to medical directors of all members of the American Association of Health Plans and to a random sample of diplomates of the American Board of Preventive Medicine. Respondents were asked to rate the importance of these competencies for a population-oriented clinician manager. RESULTS: Areas rated highly by medical directors included health services research (including outcome research), quality assurance and improvement, health risk assessment and reduction, programmatic skills, and clinical preventive skills. Responses from preventive medicine specialists were similar, but placed lower emphasis on these skills. CONCLUSION: Despite its limited response rate, this survey may be useful in the implementation of specialty training in managerial medicine. Residency training programs may choose to emphasize specific content area that reflect the priorities expressed by physicians actively involved in management.

Traffic-related injury hospitalizations among California elderly, 1994.

Traffic-related injuries among the elderly are a growing concern in most developed and many developing countries. To better understand injuries sustained by the elderly in the traffic environment, hospitalizations for traffic-related injuries among those aged 64 and over in California in 1994 were examined to determine incidence and characterize injuries. Both injury incidence and injury severity increased as age increased over 64. Males were more likely to be injured as drivers of motor vehicles, but females were more likely to be injured as passengers. Fractures and internal injuries represented 72.3% of all primary diagnoses, and total hospital charges exceeded $140 million. Efforts to reduce traffic-related injuries in the elderly and to reduce injury severity will be increasingly important as the elderly comprise a larger proportion of the population.

Compliance with US asthma management guidelines and specialty care: a regional variation or national concern?

The objective of this study was to examine the compliance with the National Asthma Education Program (NAEP) guidelines among asthmatic members of eight health plans (regions) in seven states, as well as the factors related to the compliance. Information was gathered by means of a cross-sectional survey in a managed care environment. The participants were 6703 respondents (ages 14-65) with moderate or severe asthma. The main outcome measures were compliance with the NAEP guidelines on the use of inhaled steroids, inhaled beta2-agonists, peak flow measurement, and allergy evaluations. Among the results of this survey we found that although these health plans are located from the West Coast to the East Coast and the socioeconomic status of their members varied greatly, compliance with the NAEP guidelines was low among asthmatic members across all geographical regions. The major areas of low compliance identified were inappropriate pharmacological therapy, lack of objective measurement of lung function through peak flow meter, and insufficient environmental trigger control. The regression analyses indicated that the effect of the health plan explained little of the variation in compliance across these regions (only 0.3% at maximum). Low compliance was associated with young age, smoking, moderate asthma, being asthmatic for a few years, currently working, and being treated by a generalist rather than a specialist. In conclusion, this study showed that the compliance with the national guidelines for asthma care was consistently low across different geographical regions in the nation. Improvement in care for asthmatics will require greater commitment and involvement by all stakeholders including physicians, patients, health plans, and employers. We suggest a need for a national strategy to disseminate clinical guidelines not only to the medical community but also to patients themselves.

Life satisfaction among kidney transplant recipients: demographic and biological factors.

PURPOSE: The Transplant Learning Center is a program providing education and support for solid-organ transplant recipients taking cyclosporine (Neoral or Sandimmune). One goal of the program is to improve patients' quality of life, which may be influenced by demographic and biological factors, and in turn influences adherence to prescribed medication regimens. We analyzed the results from the initial survey of enrollees to better understand life satisfaction and to test the validity and reliability of the satisfaction scale used in the program. METHOD: Patients enter the program through self-selection: all enrollees who received a kidney transplant were included in this analysis. Satisfaction was measured using the Life Satisfaction Index, which includes 8 questions about aspects of satisfaction with the patient's life. Associations between the Life Satisfaction Index and demographic factors, comorbid medical conditions, adverse effects of immunosuppressants, and medication compliance were examined. RESULTS: All 3676 kidney transplant recipients who completed the initial survey were included. Mean satisfaction scores were highest in persons who were older than 64 years, men, and those who were married. Satisfaction scores were positively correlated with education and income. Mean satisfaction score was significantly lower among persons with medical comorbidities, persons who reported that adverse effects of medications were more frequent, and persons who reported noncompliance with their medication regimen. CONCLUSION: The Life Satisfaction Index is a transplant-specific measure of health-related quality of life that can be used to help detect areas of potential concern in the clinical management of kidney transplant recipients.

The cost of chronic obstructive pulmonary disease and its effects on managed care.

Chronic obstructive pulmonary disease (COPD) designates respiratory disorders characterized by airway obstruction that is not fully reversible. An estimated 10 million adult Americans have COPD, and the prevalence is rising. Direct and indirect costs of managing COPD exceed dollars 32 billion annually, and this health care burden has provoked vigorous efforts by major public health organizations to evaluate and improve quality of care for COPD. The authors review the substantial effects of COPD on managed care and discuss evidence-based strategies for its effective management.

Paid employment in subjects with and without chronic obstructive pulmonary disease in five Latin American cities: the PLATINO study.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is a costly condition that frequently causes permanent work disabilities. Little information exists regarding the impact of COPD on work force participation and the indirect costs of the disease in developing countries. OBJECTIVE: To examine the frequency of paid employment and factors influencing it in a Latin-American population-based study. METHODS: Post-bronchodilator FEV(1)/FVC < 0.70 (forced expiratory volume in 1 s/forced vital capacity) was used to define COPD. Information regarding paid work was assessed by the question 'At any time in the past year, have you worked for payment?' RESULTS: Interviews were conducted with 5571 subjects; 5314 (759 COPD and 4554 non-COPD) subjects underwent spirometry. Among the COPD subjects, 41.8% reported having paid work vs. 57.1% of non-COPD (P < 0.0001). The number of months with paid work was reduced in COPD patients (10.5 ± 0.17 vs. 10.9 ± 0.06, P < 0.05). The main factors associated with having paid work in COPD patients were male sex (OR 0.33, 95%CI 0.23-0.47), higher education level (OR 1.05, 95%CI 1.01-1.09) and younger age (OR 0.90, 95%CI 0.88-0.92). COPD was not a significant contributor to employment (OR 0.83, 95%CI 0.69-1.00, P = 0.054) in the entire population. CONCLUSIONS: Although the proportion of persons with paid work is lower in COPD, having COPD appears not to have a significant impact on obtaining paid employment in the overall population of developing countries.

Value of biologic therapy: a forecasting model in three disease areas.

OBJECTIVE: Forecast the return on investment (ROI) for advances in biologic therapies in years 2015 and 2030, based upon impact on disease prevalence, morbidity, and mortality for asthma, diabetes, and colorectal cancer. METHODS: A deterministic, spreadsheet-based, forecasting model was developed based on trends in demographics and disease epidemiology. 'Return' was defined as reductions in disease burden (prevalence, morbidity, mortality) translated into monetary terms; 'investment' was defined as the incremental costs of biologic therapy advances. Data on disease prevalence, morbidity, mortality, and associated costs were obtained from government survey statistics or published literature. Expected impact of advances in biologic therapies was based on expert opinion. Gains in quality-adjusted life years (QALYs) were valued at $100,000 per QALY. RESULTS: The base case analysis, in which reductions in disease prevalence and mortality predicted by the expert panel are not considered, shows the resulting ROIs remain positive for asthma and diabetes but fall below $1 for colorectal cancer. Analysis involving expert panel predictions indicated positive ROI results for all three diseases at both time points, ranging from $207 for each incremental dollar spent on biologic therapies to treat asthma in 2030, to $4 for each incremental dollar spent on biologic therapies to treat colorectal cancer in 2015. If QALYs are not considered, the resulting ROIs remain positive for all three diseases at both time points. CONCLUSIONS: Society may expect substantial returns from investments in innovative biologic therapies. These benefits are most likely to be realized in an environment of appropriate use of new molecules. LIMITATIONS: The potential variance between forecasted (from expert opinion) and actual future health outcomes could be significant. Similarly, the forecasted growth in use of biologic therapies relied upon unvalidated market forecasts.

Global burden of COPD: systematic review and meta-analysis.

The aim of this study was to quantify the global prevalence of chronic obstructive pulmonary disease (COPD) by means of a systematic review and random effects meta-analysis. PubMed was searched for population-based prevalence estimates published during the period 1990-2004. Articles were included if they: 1) provided total population or sex-specific estimates for COPD, chronic bronchitis and/or emphysema; and 2) gave method details sufficiently clearly to establish the sampling strategy, approach to diagnosis and diagnostic criteria. Of 67 accepted articles, 62 unique entries yielded 101 overall prevalence estimates from 28 different counties. The pooled prevalence of COPD was 7.6% from 37 studies, of chronic bronchitis alone (38 studies) was 6.4% and of emphysema alone (eight studies) was 1.8%. The pooled prevalence from 26 spirometric estimates was 8.9%. The most common spirometric definitions used were those of the Global Initiative for Chronic Obstructive Lung Disease (13 estimates). There was significant heterogeneity, which was incompletely explained by subgroup analysis (e.g. age and smoking status). The prevalence of physiologically defined chronic obstructive pulmonary disease in adults aged > or =40 yrs is approximately 9-10%. There are important regional gaps, and methodological differences hinder interpretation of the available data. The efforts of the Global Initiative for Chronic Obstructive Lung Disease and similar groups should help to standardise chronic obstructive pulmonary disease prevalence measurement.