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Biomedical subjects

Sean D Sullivan

Publications and source records attributed to Sean D Sullivan.

At least 19 recordsLinked to original sources
PubMed2006

Pain, demographics, and clinical characteristics in persons who received hospice care in the United States.

Pain in persons who receive hospice care is not fully understood. The purpose of this study was to describe the demographics, clinical characteristics, and pain intensity of persons who received hospice care in the United States from 2000-2004. Data for this study were obtained from a provider of hospice pharmacy services and included information about the hospice organization, demographics and clinical characteristics, pain intensity, and opioid analgesic prescribing. Worst pain intensity during the previous 24 hours was assessed using a 0-10 numeric rating scale (0=none, 10=worst) periodically during hospice care. During the study period, 347,555 persons received hospice services; 55.2% of these persons were female, 87.4% were Caucasian, and mean age was 75.3 years. At least one pain score was available for 156,887 (45.1%) individuals. Among persons with at least one pain score, pain was reported a mean of 2.9 times per person. Overall, mean pain intensity was mild, but severe pain was reported at least once by 20.3% of persons. Of individuals who reported severe pain at least once, mean age was 68.9 years, 53.7% were female, 78.0% were Caucasian, 7.4% were cared for in long-term care hospices, and 73.9% had a primary diagnosis of cancer. Severe pain was reported at least once by a substantial percentage of persons in this study. These data provide insight into pain reported by persons who received hospice care, and may be useful as process indicators of the quality of care.

Adolescent↗
PubMed2006

Trends and geographic variation of opiate medication use in state Medicaid fee-for-service programs, 1996 to 2002.

BACKGROUND: Although studies have documented hospital and surgical service geographic variability, prescription use geographic variability is largely unknown. Opiate pain medications are widely used, particularly because the promulgation of clinical guidelines promoting aggressive pain treatment. This study describes temporal and interstate variability in aggregate prescription opiate medication use within U.S. Medicaid programs. METHODS: A dataset of 49 states' fee-for-service (FFS) Medicaid prescription drug dispensing records from 1996 to 2002 was compiled and used to quantify medication dispensing examining all opiates, controlled release oxycodone, and methadone. The defined daily dose (DDD) per 1000 FFS Medicaid adult enrollees per day was calculated for all opiate medication categories. A market basket of nonpain prescription medications was constructed for comparison. Rates, trends, and the coefficient of variation were determined overall, by year and for each state. RESULTS: From 1996 to 2002, overall use of opiate pain medications increased 309%. The market basket use increased 170%. Total opiate dispensing varied widely from state to state, with a range of 6.9 to 44.1 DDD/1000/d in 1996, and 7.1 to 165.0 DDD/1000/d (a 23-fold difference) in 2002. The coefficient of variation was 49.6 in 2002. Controlled release oxycodone and methadone had a greater rate of increase compared with all opiates. CONCLUSIONS: The dispensing of opiate medications in Medicaid programs increased at almost twice the rate of nonpain-related medications during the 7-year study period. Large, unexplained geographic variation in aggregate use exists. The impact of Medicaid cost-containment strategies on utilization and outcomes should be investigated.

Analgesics, Opioid↗
PubMed2006

The ATTEMPT cohort: a multi-national longitudinal study of predictors, patterns and consequences of smoking cessation; introduction and evaluation of internet recruitment and data collection methods.

AIMS: The ATTEMPT study was designed to chart the natural history of smoking cessation and associated short-term health outcomes and effects on medical resource utilization among a cohort recruited across multiple countries. This paper describes the methods for recruitment and follow-up, the baseline population characteristics of the enrolled population and 1-year response rates. DESIGN: ATTEMPT is a multi-national prospective cohort study that used the internet for subject recruitment and online assessments every 3 months for 2.5 years. SETTING: Subjects were recruited via e-mail from existing internet panels [Canada (n = 208), France (n = 201), the United Kingdom (n = 200) and the United States (n = 1400]. SUBJECTS: Panel members who were aged 35-65 years, smoked at least five cigarettes per day and at initiation stated an intention to quit smoking within the next 3 months were eligible for this study. MEASUREMENTS: Measures included: attempts to quit, smoking status, smoking history, nicotine dependence and craving, methods used to quit smoking, reasons for quitting or failing to quit smoking, short-term health effects, health resource utilization, wellbeing, concern over weight gain, confidence in preventing weight gain, body weight and demographics. In addition, in-home assessments of weight were undertaken by field staff for a random sample of US participants. FINDINGS: Country-specific recruitment was completed within 17 days. The recruitment method produced a sample with characteristics broadly similar to those found in national surveys of smokers except for higher prevalence of obesity in the US and Canadian samples and higher educational level. At the end of 1 year the response rate was 52%, and there was little evidence of differential loss to follow-up by key subject characteristics. Weight reported in the survey was found to correlate highly with weight measured during in-home visits. CONCLUSION: This paper demonstrates the feasibility of enrolling and following a diverse cohort of smokers for self-reported health and behaviour measures via the internet.

Adult↗
PubMed2006

Cost-effectiveness of early intervention with once-daily budesonide in children with mild persistent asthma: results from the START study.

The inhaled Steroid Treatment As Regular Therapy in early asthma (START) study has shown that early intervention with inhaled budesonide in mild persistent asthma improves clinical outcomes in both adults and children. The aim of this study was to estimate the incremental cost-effectiveness of early treatment with budesonide Turbuhaler in children aged 5-10 yr who participated in START. Direct and indirect costs associated with asthma were determined for 1974 children participating in the double-blind, 3-year part of the study. Randomization was to placebo or to budesonide 200 microg once daily in each case in addition to usual asthma care. Cost-effectiveness ratios were calculated from the healthcare payer's and societal perspectives (using US prices). The addition of once-daily budesonide therapy to usual asthma care was associated with 16 additional symptom-free days (SFDs) per child over the 3-yr period (p < 0.001), with a substantial reduction (50%) in the mean number of days spent in hospital, and with reduced frequency of emergency room visits and missed school and caregiver work days. From the healthcare payer's perspective (direct costs), the increase in mean direct cost over 3 yr with budesonide was 169 dollars, which translated into an incremental cost of early intervention with budesonide in children of 10.50 dollars (95% CI 1.20-33.30 dollars) per SFD gained. From the societal perspective, there was a cost reduction over 3 yr of 192 dollars with budesonide relative to placebo. From a societal perspective, budesonide was therefore dominant. In conclusion, early intervention with once-daily budesonide added to usual asthma care in children with mild persistent asthma is cost-saving from a societal perspective and is acceptably cost-effective when viewed from a healthcare payer perspective.

Administration, Inhalation↗
PubMed2006

Economic evaluation in the US: what is the missing link?

In this paper we consider the evolving American healthcare landscape and what it means for the use of economic evaluation of health interventions. We emphasise that use of economic evaluation in the US is unlikely to follow the European, Canadian or Australian models, which use cost effectiveness openly and explicitly, given the decentralised manner in which American healthcare is organised, financed and delivered, as well as different political systems and traditions, and cultural expectations and attitudes surrounding healthcare. However, this does not mean that considerations of value are absent. On the contrary, measurement of value remains near the top of the agenda among US policy makers. With a few exceptions, it just isn't playing out explicitly. In the American context, it means in part heightened debate over clinical evidence, and cost sharing. In some cases, payers are also considering economic evaluation more directly in coverage and reimbursement decisions and indirectly for clinical practice guidelines and best practice recommendations. A dramatic shift in policy towards cost effectiveness seems unlikely in the near future. Change will likely come in incremental fashion through experimentation, and perhaps in selected circumstances with public and private leaders willing to take the political risks. Conceivably, more substantial change will occur with a major shift in the political leadership in Washington, DC in the legislative or executive branches, and/or with an economic downturn and severe pressures on federal and state health budgets. However, a more likely outcome is the ongoing indirect use of cost-effectiveness information.

Delivery of Health Care↗
PubMed2006

Toward evidence-based assessment for coverage and reimbursement of laboratory-based diagnostic and genetic tests.

Despite the pervasiveness of laboratory tests and their importance to medicine, evidence for their appropriate use often is very limited. In this article, we argue for a fundamental restructuring of the process by which laboratory tests are evaluated and reimbursed. We present an approach that would promote more evidence- based appraisals for laboratory tests. In addition, we urge that coverage and reimbursement for laboratory tests move toward an evidence- and value-based approach, using the tools that largely have been adopted for pharmaceuticals by many US healthcare payers. To address this information gap for laboratory tests, we note several potential strategies to encourage manufacturers, laboratory service providers, and payers to collect outcome and cost data that will better support effective use of new laboratory tests. Integral to increasing appropriate use and reimbursement will be the development of a common language and format for dialogue--facilitating the development, review, and delivery of evidence-based tests by manufacturers, clinical laboratories, and healthcare payers.

Clinical Laboratory Techniques↗
PubMed2005

Daily versus as-needed corticosteroids for mild persistent asthma.

BACKGROUND: Although guidelines recommend daily therapy for patients with mild persistent asthma, prescription patterns suggest that most such patients use these so-called controller therapies intermittently. In patients with mild persistent asthma, we evaluated the efficacy of intermittent short-course corticosteroid treatment guided by a symptom-based action plan alone or in addition to daily treatment with either inhaled budesonide or oral zafirlukast over a one-year period. METHODS: In a double-blind trial, 225 adults underwent randomization. The primary outcome was morning peak expiratory flow (PEF). Other outcomes included the forced expiratory volume in one second (FEV1) before and after bronchodilator treatment, the frequency of exacerbations, the degree of asthma control, the number of symptom-free days, and the quality of life. RESULTS: The three treatments produced similar increases in morning PEF (7.1 to 8.3 percent; approximately 32 liters per minute; P=0.90) and similar rates of asthma exacerbations (P=0.24), even though the intermittent-treatment group took budesonide, on average, for only 0.5 week of the year. As compared with intermittent therapy or daily zafirlukast therapy, daily budesonide therapy produced greater improvements in pre-bronchodilator FEV1 (P=0.005), bronchial reactivity (P<0.001), the percentage of eosinophils in sputum (P=0.007), exhaled nitric oxide levels (P=0.006), scores for asthma control (P<0.001), and the number of symptom-free days (P=0.03), but not in post-bronchodilator FEV1 (P=0.29) or in the quality of life (P=0.18). Daily zafirlukast therapy did not differ significantly from intermittent treatment in any outcome measured. CONCLUSIONS: It may be possible to treat mild persistent asthma with short, intermittent courses of inhaled or oral corticosteroids taken when symptoms worsen. Further studies are required to determine whether this novel approach to treatment should be recommended.

Administration, Inhalation↗
PubMed2005

A multisite randomized trial of the effects of physician education and organizational change in chronic asthma care: cost-effectiveness analysis of the Pediatric Asthma Care Patient Outcomes Research Team II (PAC-PORT II).

BACKGROUND: A decision to implement innovative disease management interventions in health plans often requires evidence of clinical benefit and financial impact. The Pediatric Asthma Care Patient Outcomes Research Team II trial evaluated 2 asthma care strategies: a peer leader-based physician behavior change intervention (PLE) and a practice-based redesign called the planned asthma care intervention (PACI). OBJECTIVE: To estimate the cost-effectiveness of the interventions. METHODS: This was a 3-arm, cluster randomized trial conducted in 42 primary care practices. A total of 638 children (age range, 3-17 years) with mild to moderate persistent asthma were followed up for 2 years. Practices were randomized to PLE (n = 226), PACI (n = 213), or usual care (n = 199). The primary outcome was symptom-free days (SFDs). Costs included asthma-related health care utilization and intervention costs. RESULTS: Annual costs per patient were as follows: PACI, USD 1292; PLE, USD 504; and usual care, USD 385. The difference in annual SFDs was 6.5 days (95% confidence interval [CI], -3.6 to 16.9 days) for PLE vs usual care and 13.3 days (95% CI, 2.1-24.7 days) for PACI vs usual care. Compared with usual care, the incremental cost-effectiveness ratio was USD 18 per SFD gained for PLE (95% CI, USD 5.21-dominated) and USD 68 per SFD gained for PACI (95% CI, USD 37.36-361.16). CONCLUSIONS: Results of this study show that it is possible to increase SFDs in children and move organizations toward guideline recommendations on asthma control in settings where most children are receiving controller medications at baseline. However, the improvements were realized with an increase in the costs associated with asthma care.

Adolescent↗
PubMed2005

Gastrointestinal symptoms associated with orthostatic intolerance.

BACKGROUND: The term orthostatic intolerance is used to describe symptoms of hemodynamic instability such as lightheadedness, fatigue, impaired cognition and syncope that develop on assuming an upright posture. Common forms of orthostatic intolerance in childhood include postural tachycardia syndrome and neurally mediated hypotension. OBJECTIVE: A descriptive report of the clinical characteristics of patients presenting with gastrointestinal symptoms who are ultimately found to have orthostatic intolerance. METHODS: A medical record review of all patients referred to the pediatric gastroenterology service at the Johns Hopkins Children's Center who had an abnormal tilt table test between June 1996 and December 2000. RESULTS: Of 24 eligible subjects aged 9-17 years (mean, 14.3 years), four had postural tachycardia syndrome, eight had both postural tachycardia and neurally mediated hypotension, and 12 had neurally mediated hypotension alone. The most common presenting gastrointestinal symptoms were abdominal pain, nausea and vomiting. Median number of gastrointestinal symptoms per patient was 3 (range, 1-7), and 87% of the patients experienced gastrointestinal symptoms for more than 1 year and 48% experienced gastrointestinal symptoms for more than 3 years. Follow-up information was available on 18 patients. Seventy-eight percent of patients (14 of 18) had complete resolution of symptoms with treatment of orthostatic intolerance. CONCLUSION: Pediatric patients with chronic upper gastrointestinal symptoms may have underlying orthostatic intolerance. In patients with upper gastrointestinal symptoms and orthostatic intolerance, treatment of orthostatic intolerance may result in resolution of gastrointestinal symptoms.

Abdominal Pain↗
PubMed2005

Practice-level effects of interventions to improve asthma care in primary care settings: the Pediatric Asthma Care Patient Outcomes Research Team.

OBJECTIVE: To assess the practice-level effects of (1) a physician peer leader intervention and (2) peer leaders in combination with the introduction of asthma education nurses to facilitate care improvement. And, to compare findings with previously reported patient-level outcomes of trial enrollees. STUDY SETTING: Data were included on children 5-17 years old with asthma in 40 primary care practices, affiliated with managed health care plans enrolled in the Pediatric Asthma Care Patient Outcomes Research Team (PORT) randomized trial. STUDY DESIGN: Primary care practices were randomly assigned to one of two care improvement arms or to usual care. Automated claims data were analyzed for 12-month periods using a repeated cross-sectional design. The primary outcome was evidence of at least one controller medication dispensed among patients with persistent asthma. Secondary outcomes included controller dispensing among all identified asthmatics, evidence of chronic controller use, and the dispensing of oral steroids. Health service utilization outcomes included numbers of ambulatory visits and hospital-based events. PRINCIPAL FINDINGS: The proportion of children with persistent asthma prescribed controllers increased in all study arms. No effect of the interventions on the proportion receiving controllers was detected (peer leader intervention effect 0.01, 95 percent confidence interval [CI]: -0.07, 0.08; planned care intervention effect -0.03, 95 percent CI: -0.09, 0.02). A statistical trend was seen toward an increased number of oral corticosteroid bursts dispensed in intervention practices. Significant adjusted increases in ambulatory visits of 0.08-0.10 visits per child per year were seen in the first intervention year, but only a statistical trend in these outcomes persisted into the second year of follow-up. No differences in hospital-based events were detected. CONCLUSIONS: This analysis showed a slight increase in ambulatory asthma visits as a result of asthma care improvement interventions, using automated data. The absence of detectable impact on medication use at the practice level differs from the positive intervention effect observed in patient self-reported data from trial enrollees. Analysis of automated data on nonenrollees adds information about practice-level impact of care improvement strategies. Benefits of practice-level interventions may accrue disproportionately to the subgroup of trial enrollees. The effect of such interventions may be less apparent at the level of practices or health plans.

Adolescent↗
PubMed2005

Development of a quantifiable symptom assessment tool for patients with chronic bronchitis: the Chronic Bronchitis Symptoms Assessment Scale.

Clinical trials that rely solely on physiologic outcomes may underestimate effects of interventions on patients' symptoms and well-being. We sought to develop and validate an instrument to reliably assess symptom severity and frequency in therapeutic trials for patients with chronic bronchitis. We performed a series of psychometric studies that determined instrument content and assessed validity and reliability. The final version of the Chronic Bronchitis Symptoms Assessment Scale (CBSAS) comprised 15 scored items (16 items total). The instrument demonstrated strong reliability with moderate to high item correlations with total scores (0.41-0.80) and an overall Cronbach's alpha of 0.91. As expected, scores were at the bottom of the range for patients without a history of previous lung disease, and no ceiling effect was seen in the most severely obstructed patients. The CBSAS demonstrated statistically significant and moderate to strong association with spirometry, (post bronchodilator, % pred FEV1, r = -0.42, % pred FVC, r = -0.50), SGRQ (total, r = 0.67) and SOBQ (r = 0.50). The Chronic Bronchitis Symptoms Assessment Scale is an easy to administer, once daily or once weekly, valid and reliable outcome measure for assessing symptom severity among patients with chronic bronchitis.

Adult↗
PubMed2005

The Burden of Obstructive Lung Disease Initiative (BOLD): rationale and design.

Quantifying COPD prevalence worldwide is needed to document COPD's effect on disability, health care costs, and impaired quality of life and to inform governments and health planners. As an adjunct to data obtained from population-based studies, and for countries where a fully powered prevalence survey cannot be done, modeling of COPD prevalence and its economic burdens can help estimate potential health care needs and costs. For comparability, standardized methods for prevalence surveys are needed that can be used in countries at all levels of economic development. The Burden of Obstructive Lung Disease (BOLD) Initiative has developed a set of methods for estimating COPD prevalence and a model for assessing its economic impact, and piloted these methods in China and Turkey. The methods were revised to reflect the findings in the pilot studies, and BOLD is now making the standardized methods available worldwide. The BOLD Operations Center provides training, materials, quality control, and data analysis. BOLD emphasizes data quality control at every stage of the process. Data from paper forms completed in the field are entered electronically to a specially designed secure Web platform. Pre- and post-bronchodilator spirometry testing is done on all participants, and all spirometry data are reviewed for quality. Questionnaires are used to obtain information about respiratory symptoms, health status, exposure to risk factors, and economic data about the burden of COPD. BOLD's standardized methods will provide a uniform way to compare COPD burden within and between countries, and where differences are found, to explore explanations for these differences.

Cost of Illness↗
PubMed2004

Chronic obstructive pulmonary disease: is there a case for early intervention?

Chronic obstructive pulmonary disease (COPD) is a highly prevalent condition that represents a significant economic burden to society. Early diagnosis of COPD offers the best opportunity to slow the progression of the disease through smoking cessation. Aggressive medical management of COPD for patients diagnosed at a moderate or severe stage is likely to be attractive from an economic standpoint, although prospective studies are needed to validate current evidence. Poor adherence to smoking cessation and pharmacologic therapy suggests that patient education is critical to successful intervention at all stages of illness. The economic value of aggressive pharmacotherapy for early-stage COPD is less certain, but the burden of illness and potential pharmacoeconomic benefits in such patients is a strong rationale for combined clinical and economic trials.

Economics, Pharmaceutical↗
PubMed2004

Randomized trial of pharmacist interventions to improve depression care and outcomes in primary care.

PURPOSE: The impact of pharmacist interventions on the care and outcomes of patients with depression in a primary care setting was evaluated. METHODS: Patients diagnosed with a new episode of depression and started on anti-depressant medications were randomized to enhanced care (EC) or usual care (UC) for one year. EC consisted of a pharmacist collaborating with primary care providers to facilitate patient education, the initiation and adjustment of antidepressant dosages, the monitoring of patient adherence to the regimen, the management of adverse reactions, and the prevention of relapse. The patients in the UC group served as controls. Outcomes were measured by the Hopkins Symptom Checklist, Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, criteria for major depression, health-related quality of life, medication adherence, patient satisfaction, and use of depression-related health care services. An intent-to-treat analysis was used. RESULTS: Seventy-four patients were randomized to EC or UC. At baseline, the EC group included more patients diagnosed with major depression than did the UC group (p = 0.04). All analyses were adjusted for this difference. In both groups, mean scores significantly improved from baseline for symptoms of depression and quality of life at three months and were maintained for one year. There were no statistically significant differences between treatment groups in depression symptoms, quality of life, medication adherence, provider visits, or patient satisfaction. CONCLUSION: Frequent telephone contacts and interventions by pharmacists and UC in a primary care setting resulted in similar rates of adherence to antidepressant regimens and improvements in the outcomes of depression at one year.

Adult↗
PubMed2004

A multisite randomized trial of the effects of physician education and organizational change in chronic-asthma care: health outcomes of the Pediatric Asthma Care Patient Outcomes Research Team II Study.

BACKGROUND: Traditional primary care practice change approaches have not led to full implementation of national asthma guidelines. OBJECTIVE: To evaluate the effectiveness of 2 asthma care improvement strategies in primary care. DESIGN: Two-year randomized controlled clinical trial. SETTING: Forty-two primary care pediatric practices affiliated with 4 managed care organizations. PARTICIPANTS: Children aged 3 to 17 years with mild to moderate persistent asthma enrolled in primary care practices affiliated with managed care organizations. INTERVENTIONS: Peer leader education consisted of training 1 physician per practice in asthma guidelines and peer teaching methods. Planned care combined the peer leader program with nurse-mediated organizational change through planned visits with assessments, care planning, and self-management support, in collaboration with physicians. Analyses compared each intervention with usual care. MAIN OUTCOME MEASURES: Annualized asthma symptom days, asthma-specific functional health status (Children's Health Survey for Asthma), and frequency of brief oral steroid courses (bursts). RESULTS: Six hundred thirty-eight children completed baseline evaluations, representing 64% of those screened and eligible. Mean +/- SD age was 9.4 +/- 3.5 years; 60% were boys. Three hundred fifty (55%) were taking controller medication. Mean +/- SD annualized asthma symptom days was 107.4 +/- 122 days. Children in the peer leader arm had 6.5 fewer symptom days per year (95% confidence interval [CI], - 16.9 to 3.6), a nonsignificant difference, but had a 36% (95% CI, 11% to 54%) lower oral steroid burst rate per year compared with children receiving usual care. Children in the planned care arm had 13.3 (95% CI, - 24.7 to -2.1) fewer symptom days annually (-12% from baseline; P =.02) and a 39% (95% CI, 11% to 58%) lower oral steroid burst rate per year relative to usual care. Both interventions showed small, statistically significant effects for 2 of 5 Children's Health Survey for Asthma scales. Planned care subjects had greater controller adherence (parent report) compared with usual care subjects (rate ratio, 1.05 [95% CI, 1.00 to 1.09]). CONCLUSIONS: Planned care (nurse-mediated organizational change plus peer leader education) is an effective model for improving asthma care in the primary care setting. Peer leader education on its own may also serve as a useful model for improving asthma care, although it is less comprehensive and the treatment effect less pronounced.

Administration, Oral↗