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Biomedical subjects

B S Bloom

Publications and source records attributed to B S Bloom.

At least 19 recordsLinked to original sources

Breast cancer treatment in clinical practice compared to best evidence and practice guidelines.

There is sparse evidence on community practice patterns in treating women with breast cancer. This study compared care of women with breast cancer with evidence from meta-analyses and US National Comprehensive Cancer Network (NCCN) clinical guidelines. Records of 4395 women with breast cancer were abstracted from practices of 19 surgeon oncologists in six specialty practices in the Philadelphia region during 1995-1999. Patients were followed through December 2001. Low-frequency data were obtained on all patients. All other data were from a random sample of 464 women, minimum of 50 patients per practice. Actual care provided was compared to NCCN guidelines and results of meta-analyses. Fewer than half the women received treatments reflecting meta-analysis results or NCCN guidelines, by disease stage/TNM status. Adherence to either standard varied from 0% for LCIS to 87% for stages IIA or IIB node positive. There are multiple interactive reasons for low adherence to guidelines or meta-analyses results, including insufficient health system supports to clinicians, inadequate organisation and delivery systems and ineffective continuing medical education. The paucity of written information from patient records on physician/patient interactions limits the understanding of treatment decisions.

Adult↗

Time trends in cost of caring for people with gastroesophageal reflux disease.

OBJECTIVE: Increasing acceptance of the many permutations of gastroesophageal reflux disease (GERD) has led to diverse study of the disease and its effects. The goal of this study was to estimate medical care costs attributable to a defined GERD population over time. METHODS: A retrospective cohort control design was used. All participants were identified from the database of a managed care organization serving 300,000 people in the northeastern United States. The index population (n = 600) was defined as anyone who obtained medical services during 1997 or 1998, for any International Classification of Diseases (ninth revision, Clinical Modification) codes suggestive of GERD, and/or anyone who received at least one prescription and one refill for antisecretory or GERD medications during at least two 3-month periods in 1997 or 1998. A matched cohort (n = 600) without any diagnosis of GERD was randomly selected as a control group. Both populations were observed restrospectively from January 1, 1990 through December 31, 1998. RESULTS: The cost of treating GERD averaged around $510 per year, about 15% of all medical costs for those with GERD. Treating people with GERD was about 2-fold more costly than treating those without GERD, a marginal cost of $1500 to $2000 per annum. CONCLUSION: Although GERD is a low-cost disease to treat, the cost of treating people with GERD is subtantially greater than that for a comparable population without GERD. Two explanations may account for the large difference of costs between the study populations. First, the GERD group may be sicker than the control group. Disease severity variables and diagnoses associated with GERD were more commonly diagnosed in the GERD group. Second, an additional disease that is not treated appropriately increases the cost of treatment geometrically for all diseases.

Adult↗

Usefulness of US cost-of-illness studies in healthcare decision making.

OBJECTIVE: Cost-of-illness studies have been completed on scores of diseases over the past 30 years. The goal of this study was to review published cost-of-illness studies on US populations in order to evaluate the potential usefulness of the results in decision making. METHODS: Medline and related databases were searched using diagnosis and economic terms. The bibliographies of the articles found were reviewed visually to identify further studies. Inclusion criteria required a specified diagnosis, the study to be published between 1 January 1985 and 30 April 1999 in an English-language peer-reviewed journal, a clearly defined US sample or national population, available and recent epidemiological data on prevalence and incidence of diagnosis, and money estimates of direct and/or indirect costs. Three readers reviewed each study. The senior reviewer settled all differences. RESULTS: Searches found 1725 published studies; only 110 (6.4%) met all inclusion criteria. Main reasons for rejection were insufficient cost data (80%), insufficient information on data sources and aggregation or estimation methods (56%), inadequate sector data e.g. hospitalisations or work loss (48%), study of value, not cost, of illness (44%), not a US population (30%) and insufficient population detail (19%). There were 80 diagnosis categories, 28 of which had more than one study. Only 5 diagnoses had > or = 5 studies--Alzheimer's dementia, depression, diabetes mellitus, mental illness and stroke. Multifold cost variations were found among studies within diagnosis categories, even with the same method and data sources. The more narrowly defined diagnoses, depression and stroke, had the smallest cost variation, 41.7 and 17.2%, respectively. A generalised linear regression model found that a significant portion of total and direct cost variance could be explained only for Alzheimer's dementia. CONCLUSIONS: The wide variation of cost estimates for the same diagnosis raises serious questions of comparability, accuracy, validity and usefulness of all studies. Implementing guidelines to standardise methods and study design for cost-of-illness studies would be a worthwhile first step. The advantages and disadvantages of using money or another metric such as disability-adjusted life-years as the prime outcome measure should also be publicly discussed.

Cost of Illness↗

Surgeon predictions on growth of minimal invasive therapy: the difficulty of estimating technologic diffusion.

OBJECTIVE: To compare five-year predictions made in 1992 by academic surgeon leaders in UK, US and Canada, with actual experiences in 1997, of increased rates of minimal invasive therapy (MIT) for surgical operations. METHOD: We compared 1992 predictions of percent of operations done by minimal invasive therapy and length of stay in the US with actual 1997 percents found by literature searches. RESULTS: We found sufficient data on 12 operations done by MIT in 1997 of the original 34 operations predicted in 1992 by surgeon experts to be to be amenable to this technique. These 12 operations were among the top 20 most commonly performed procedures in 1992 and 1997. Of these 12 operations, ten had 40-60% lower 1997 percentages than predicted, one had about 10% lower rate, and two had 18% and 100% higher rates of MIT than predicted. Overall mean length of stay (LOS) for all 34 study operations fell from 6.8 days in 1992 to 5.2 days in 1997. Mean LOS in 1997 was 2.5 days by MIT and 6.7 days by open technique (OT). CONCLUSION: Most of the predictions made in 1992 by surgical leaders in Canada, US and UK were incorrect when examined 5 years later. The rate of MIT diffusion and its effect on length of stay were overestimated for most operations, while for two procedures the predictions underestimated extent of diffusion. Also, much of the declines of LOS for surgical care paralleled declines in length of stay for all care, supplemented by the individual contributions of MIT specifically. Relying on expert opinion alone to predict the acceptability, rapidity, scope and extent of technological change is fraught with uncertainty. Unexpected consequences occur when one or a few parts of complex systems are changed. This is a particular problem when predictions are a main basis for informed decision making in the absence of any supporting data from appropriately designed empirical or controlled study.

Attitude of Health Personnel↗

Evaluation of randomized controlled trials on complementary and alternative medicine.

OBJECTIVES: Use of complementary and alternative medicine (CAM) is growing in all Western countries. The goal of this study was to evaluate quality of randomized controlled trials (RCTs) of CAM interventions for specific diagnoses to inform clinical decision making. METHODS: MEDLINE and related databases were searched for CAM RCTs. Visual review was done of bibliographies, meta-analyses, and CAM journals. Inclusion criteria for review and scoring were blinded RCT, specified diagnosis and intervention, complete study published between January 1, 1966 and July 31, 1998 in an English-language, peer-reviewed journal. Two reviewers independently scored each study. RESULTS: More than 5,000 trials were found, but only 258 met all study inclusion criteria. The main cause for rejection (> 90%) was that the study was not an RCT or had no blinding. Mean score across 95 diagnosis/intervention categories was 44.7 (S.D. +/- 14.3) on a 100-point scale. Ordinary least-squares regression found date of publication, biostatistician as author or consultant, published in one of five widely read English-language medical journals and diagnosis/intervention category of hypertension/relaxation as significant predictors of higher scores. CONCLUSIONS: The overall quality of evidence for CAM RCTs is poor but improving slowly over time, about the same as that of biomedicine. Thus, most services are provided without good evidence of benefit.

Complementary Therapies↗

Patient, physician, and payer perceptions and misperceptions of willingness to pay for diagnostic certainty.

Little is known about the value patients, physicians, and payers place on intangible attributes of care. Differences in valuations among these groups and misperceptions of value of intangible attributes to other groups can contribute to conflicts about treatment recommendations or coverage decisions. We surveyed patients, physicians, and managed care executives to assess their willingness to pay (WTP) for diagnostic certainty for peptic ulcer disease (PUD) and gastroesophageal reflux disease (GERD). To determine if patients, physicians, and payers accurately perceive each other's valuations of diagnostic certainty, participants were also asked to estimate the WTP of each of the other types of respondents. Patients were most likely, and executives least likely, to value diagnostic certainty. For PUD, 84% of patients, 61% of physicians, and 43% of executives expressed a positive WTP. Median WTP was low for all three groups ($1-9 for patients and physicians; $0 for payers). Physicians and executives both correctly predicted patient WTP. For GERD, 87% of patients, 52% of physicians, and 29% of executives expressed a positive WTP. Executives underestimated patient WTP. For both diseases, physicians' WTP was overestimated by patients and underestimated by executives. The inconsistency in the value that patients, physicians, and managed care executives place on diagnostic certainty indicates the potential for conflict over practice guidelines or access to services. WTP surveys can provide information to aid in anticipating and addressing areas of disagreement.

Cost-Benefit Analysis↗

Internet availability of prescription pharmaceuticals to the public.

BACKGROUND: The Internet holds great but uncertain promise for increased access and cost control in health care. OBJECTIVE: To determine access to and cost of prescription pharmaceuticals over the Internet. DESIGN: An Internet search conducted during February and March 1999. SETTING: The Philadelphia region. MEASUREMENTS: Data were collected on availability and cost of medications and physician Internet visits, requirements for physician prescriptions, and geographic location of Web-based companies and consulting physicians. Costs of comparable physician visits were obtained from Medicare and managed care organizations in the Philadelphia region. Costs of medications came from five Philadelphia community pharmacies. RESULTS: Forty-six Web sites were identified. Thirty-seven sites (33 based in the United States and 4 based outside the United States) required a prescription from a personal physician or from an Internet physician consultation. Nine sites based outside of the United States did not require a prescription or physician consultation. The median cost of an Internet physician visit was $70 (range, $20 to $90), more than 15% higher than that for a general practice visit in the Philadelphia region. Quality of physician consultation, physician qualifications and specialty, and geographic location were unknown. Median price per pill of the two most commonly offered medications was 10% higher on the Internet (before shipping charges) than at Philadelphia pharmacies ($5.49 and $4.50 for sildenafil; $1.94 and $1.83 for finasteride). CONCLUSIONS: The Internet may expand patient access to health-related services but at overall increased cost. In addition, the quality of physician Internet care is uncertain, and potential for serious abuse exists. Patients can easily provide incorrect or false information to obtain medications. Furthermore, conflict of interest exists for Web-based firms because they profit from selling medications and physician consultations.

Conflict of Interest↗

Clinical and economic effects of population-based Helicobacter pylori screening to prevent gastric cancer.

BACKGROUND: Helicobacter pylori infection has been identified as a risk factor for certain types of gastric cancer. However, the extent to which H. pylori eradication decreases the risk of gastric cancer is unknown, raising the question of whether population-based H. pylori screening should be undertaken. OBJECTIVE: To compare clinical and economic effects of H. pylori screening, with and without confirmatory testing, with no screening to prevent gastric cancer. DESIGN: Decision analysis incorporating a Markov simulation. PATIENTS: Simulated cohorts of men and women with varying risk of gastric cancer. INTERVENTION: Three strategies were evaluated: (1) no screening; (2) H. pylori serologic testing, treat those positive for H. pylori, no follow-up testing; and (3) H. pylori serologic testing, treat those positive for H. pylori, followed by a test to confirm H. pylori eradication, retreat those who test positive. In the principal analysis, the risk of gastric cancer after H. pylori eradication was assumed to be similar to that for those without H. pylori infection. Scenarios with less optimistic assumptions regarding risk reduction of cancer were evaluated. MAIN OUTCOME MEASURES: Gastric cancer rates, discounted cost per life-year saved. RESULTS: If H. pylori eradication reduced the risk of cancer to that of people never infected, both H. pylori intervention strategies reduced gastric cancer rates so that each yielded at least 12 additional life-years per 1000 40-year-old white men screened when compared with no screening. Helicobacter pylori serologic testing without posttreatment confirmatory testing resulted in the lowest cost per additional life-year saved (S6264). The cost-effectiveness of the H. pylori screening strategies varied substantially as the level of risk reduction of cancer was varied, but remained cost-effective even at moderate rates (<30%) of excess risk reduction of cancer in all cohorts evaluated. CONCLUSIONS: Population-based H. pylori screening has the potential to produce important health benefits at a reasonable cost at moderate rates of excess risk reduction of cancer. Controlled studies are necessary to confirm and quantify the impact of H. pylori eradication on the risk of gastric cancer.

Cost-Benefit Analysis↗

Willingness to pay for diagnostic certainty: comparing patients, physicians, and managed care executives.

Cost-effectiveness analyses routinely ignore the value of diagnostic certainty. Moreover, no previous study has compared this value among different stakeholders. We surveyed 25 patients, 28 physicians, and 23 managed care executives to compare their willingness to pay for diagnostic information for peptic ulcer disease. Patients (84%) were most likely, and executives (43%) least likely, to be willing to pay at least $1 (median willingness to pay < $50). Differences in willingness to pay among stakeholders indicate potential for conflicts over access to tests. Although nearly all patients valued diagnostic certainty, its value was generally small and insufficient to change the cost-effectiveness ranking of treatment alternatives.

Administrative Personnel↗

Decision analytic modeling in health care decision making. Oversimplifying a complex world?

The need to choose among alternatives instead of allowing the market to make choices has led health care professionals to rely on scientific information as an aid in decision making. Mathematical modeling is one of the increasingly common tools used over the past three decades to produce new information. But we have used almost exclusively noncomplex models to help analyze complex systems problems. The need to integrate the complexity of the interactions of clinical, quality of life, and economic attributes into such models can no longer be ignored. The opportunity is available to use existing complex systems modeling techniques for health care questions to improve the quality of study outputs, which can, in turn, help produce more rational decisions.

Decision Support Techniques↗

Cost savings in duodenal ulcer therapy through Helicobacter pylori eradication compared with conventional therapies: results of a randomized, double-blind, multicenter trial. Gastrointestinal Utilization Trial Study Group.

BACKGROUND: We hypothesized that treatment of duodenal ulcer disease with antibiotic therapy directed toward Helicobacter pylori infection is more cost-effective than therapy with antisecretory agents. METHODS: A randomized, double-blind, multicenter clinical trial of adult patients with active duodenal ulcer and H. pylori infection was conducted. Patients were randomized to receive 500 mg of clarithromycin 3 times a day plus 40 mg of omeprazole daily for 14 days followed by 20 mg of omeprazole daily for an additional 14 days (group 1), 20 mg of omeprazole daily for 28 days (group 2), or 150 mg of ranitidine hydrochloride twice a day for 28 days (group 3). The use of ulcer-related health care resources was documented during monthly interviews for 1 year after the initial therapy. Clinical success was evaluated 4 to 6 weeks and 1 year after the end of therapy. RESULTS: Of the 819 patients enrolled, 727 completed the study. Group 1 included 243 patients; group 2, 248 patients; and group 3, 236 patients. Patients in group 1 used fewer ulcer-related health care resources during the 1 year after therapy compared with groups 2 and 3 (comparisons are given as group 1 vs group 2 and group 1 vs group 3, respectively): the number of endoscopies performed, 28 vs 76 (P<.001) and vs 71 (P<.001); patients receiving drugs to treat an ulcer, 118 vs 180 (P<.001) and vs 168 (P<.001); clinic visits, 83 vs 135 (P=.05) and vs 161 (P<.001); hospitalizations, 0 vs 5 (P=.045) and vs 6 (P=.02); and length of hospital stay, 0 vs 24 days (P=.04) and vs 37 (P=.04). When ulcer-related costs were defined as the outcome variable in a multivariate linear regression analysis, therapy was determined to have a significant influence on costs (group 1 vs group 2, P<.001; group 1 vs group 3, P=.008). Clinical success rates at the end of the study and cure of H. pylori infection were significantly greater in group 1 compared with groups 2 and 3 (P<.001). Therapy with clarithromycin plus omeprazole provided savings of $1.94 and $2.96 (compared with therapy with omeprazole and with ranitidine hydrochloride, respectively) per dollar spent within the first year after therapy. This incremental cost-benefit translates to savings of $547 or $835 per patient in group 1 (compared with patients in group 2 or group 3, respectively) during the first year after therapy. CONCLUSIONS: Combination therapy with clarithromycin and omeprazole resulted in significantly fewer uses of ulcer-related health care resources than conventional antisecretory therapy during a 1-year follow-up and significant savings in associated costs during the same period. Patients who received clarithromycin plus omeprazole also showed a significantly improved clinical outcome compared with patients who received only omeprazole or ranitidine.

Adult↗

The diagnostic and treatment approach to two common conditions by the physician members of a community health maintenance organization.

We retrospectively collected data from one community managed care organization on all ambulatory care patients initially diagnosed with pneumonia or acute bronchitis from October, 1, 1992, to March 31, 1993, and from November 1, 1993, to January 31, 1994. We considered treatment to be successful when patients did not return for any related service within 15 days of initial diagnosis. We identified 2,490 episodes of illness, 85.7% which were acute bronchitis and 14.3% which were pneumonia. Overwhelmingly, physicians approached these conditions empirically (no diagnostic test); just 8.6% of patients had a diagnostic test during the 15-day episode of illness. Two-hundred twenty-nine of the episodes (9.2%) were apparently related to initial diagnoses, as they occurred during the 15-day period. More branded prescriptions (vs. generic) were dispensed during these related episodes. One patient was hospitalized and 19 patients used the emergency room either for first or subsequent visits. Empiric treatment is associated with effective diagnosis and therapy in ambulatory care patients with acute bronchitis and pneumonia. It remains unclear, however, if this strategy is the most cost-effective or if it leads to the most effective utilization of services.

Acute Disease↗

Immediate eradication of Helicobacter pylori in patients with previously documented peptic ulcer disease: clinical and economic effects.

OBJECTIVES: The clinical and economic benefits of Helicobacter pylori eradication for patients with newly diagnosed peptic ulcer disease are widely accepted. The objective of this study was to estimate the cost-effectiveness of H. pylori eradication in the large cohort of asymptomatic patients receiving maintenance antisecretory therapy for a previously documented peptic ulcer disease. METHODS: A decision analytic model estimated the clinical and economic effects of two management strategies for asymptomatic patients receiving maintenance antisecretory therapy for a previously documented peptic ulcer: strategy 1-immediate H. pylori eradication therapy and cessation of maintenance therapy, and strategy 2-continued-maintenance antisecretory therapy, with H. pylori eradication therapy reserved for the first symptom recurrence. RESULTS: At 1 yr, the model estimated that immediate H. pylori eradication therapy (strategy 1) led to 22% fewer months with ulcers (28.7 vs. 36.8 ulcer months/100 patient years), 10% fewer months with ulcer symptoms (21.0 vs. 23.1 symptom months/100 patient years), and 24% lower per-patient expenditures ($587 vs. $767/patient year) than maintenance antisecretory therapy and symptom-based H. pylori eradication (strategy 2). Immediate H. pylori eradication, however, resulted in 14% more months with upper gastrointestinal symptoms from all causes (37.9 vs. 33.2 symptom months/100 patient years) than strategy 2, because maintenance antisecretory therapy was effective in treating symptoms due to causes other than peptic ulcer disease. CONCLUSIONS: Ulcer-related outcomes of asymptomatic patients receiving maintenance antisecretory agents for peptic ulcer disease can be improved with immediate H. pylori eradication at reduced cost. Therefore, H. pylori eradication should be aggressively pursued in all patients-symptomatic or not-with previously documented peptic ulcers, who are receiving maintenance antisecretory therapy.

Anti-Ulcer Agents↗