Training non-physicians to do endoscopy: Feasibility, effectiveness and cost-effectiveness.

Colorectal cancer (CRC) is one of the most common cancers in women and men worldwide. Training non-physicians including nurses, nurse practitioners, and physician assistants to perform endoscopy can provide the opportunity to expand access to CRC screening as demand for endoscopic procedures continues to grow. A formal program, incorporating didactic instruction and hands-on practice in addition to oversight, is required to train non-physicians to perform endoscopy as safely and effectively as physicians. Additionally, the context in which the non-physician endoscopy program is organized will dictate key program characteristics including remuneration, participant recruitment and professional and legal considerations. This review explores the evidence in support of non-physician based endoscopy, potential challenges in implementing non-physician endoscopy and requirements for a high-quality program to support training and implementation.

Cancer diagnostic assessment programs: standards for the organization of care in Ontario.

BACKGROUND: Improving access to better, more efficient, and rapid cancer diagnosis is a necessary component of a high-quality cancer system. How diagnostic services ought to be organized, structured, and evaluated is less understood and studied. Our objective was to address this gap. METHODS: As a quality initiative of Cancer Care Ontario's Program in Evidence-Based Care, the Diagnostic Assessment Standards Panel, with representation from clinical oncology experts, institutional and clinical administrative leaders, health service researchers, and methodologists, conducted a systematic review and a targeted environmental scan of the unpublished literature. Standards were developed based on expert consensus opinion informed by the identified evidence. Through external review, clinicians and administrators across Ontario were given the opportunity to provide feedback. RESULTS: The body of evidence consists of thirty-five published studies and fifteen unpublished guidance documents. The evidence and consensus opinion consistently favoured an organized, centralized system with multidisciplinary team membership as the optimal approach for the delivery of diagnostic cancer assessment services. Independent external stakeholders agreed (with higher mean values, maximum 5, indicating stronger agreement) that DAP standards are needed (mean: 4.6), that standards should be formally approved (mean: 4.3), and importantly, that standards reflect an effective approach that will lead to quality improvements in the cancer system (mean: 4.5) and in patient care (mean: 4.3). INTERPRETATION: Based on the best available evidence, standards for the organization of DAPS are offered. There is clear need to integrate formal and comprehensive evaluation strategies with the implementation of the standards to advance this field.

Measuring dyspepsia-related health in randomized trials: the Severity of Dyspepsia Assessment (SODA) and its use in treatment with NSAIDs and COX-2-specific inhibitors.

Dyspepsia is a common problem that is important from the perspectives of both patient health and economics. While there has been variability in the definitions used to describe dyspepsia, there have also been few standardized outcomes tools designed to measure dyspepsia-related health, especially in relation to changes in dyspepsia over time. An evaluative tool was developed, the Severity of Dyspepsia Assessment (SODA), which takes into account the multidimensional nature of dyspepsia using three scales (Pain, Non-pain Symptoms, and Satisfaction with Dyspepsia-related Health) and demonstrates good psychometric properties with respect to validity, reliability and sensitivity to change in the measurement of dyspepsia-related health. Although originally developed for the assessment of uninvestigated dyspepsia, the validation of SODA for use in clinical trials suggested its ability to compare treatment effects of non-specific non-steroidal anti-inflammatory drugs (NSAIDs) and cyclooxygenase (COX)-2-specific inhibitors. In comparative trials of celecoxib or valdecoxib with non-specific NSAIDs, COX-2-specific inhibitors were demonstrated to have superior dyspepsia tolerability than non-specific NSAIDs. These data demonstrate that SODA is an effective instrument for measuring dyspepsia-related health with a broad range of applications.

SODA (severity of dyspepsia assessment): a new effective outcome measure for dyspepsia-related health.

The aim of this research was to develop and evaluate an instrument for measuring dyspepsia-related health to serve as the primary outcome measure for randomized clinical trials. Building on our previous work we developed SODA (Severity of Dyspepsia Assessment), a multidimensional dyspepsia measure. We evaluated SODA by administering it at enrollment and seven follow-up visits to 98 patients with dyspepsia who were randomized to a 6-week course of omeprazole versus placebo and followed over 1 year. The mean age was 53 years, and six patients (6%) were women. Median Cronbach's alpha reliability estimates over the eight visits for the SODA Pain Intensity, Non-Pain Symptoms, and Satisfaction scales were 0.97, 0.90, and 0.92, respectively. The mean change scores for all three scales discriminated between patients who reported they were improved versus those who were unchanged, providing evidence of validity. The effect sizes for the Pain Intensity (.98) and Satisfaction (.87) scales were large, providing evidence for responsiveness. The effect size for the Non-Pain Symptoms scale was small (.24), indicating lower responsiveness in this study sample. SODA is a new, effective instrument for measuring dyspepsia-related health. SODA is multidimensional and responsive to clinically meaningful change with demonstrated reliability and validity.

Costs of managing Helicobacter pylori-infected ulcer patients after initial therapy.

BACKGROUND: The objective of this research was to evaluate the outcomes and costs of alternative approaches to managing patients previously treated for peptic ulcer disease and Helicobacter pylori infection. MATERIALS AND METHODS: A decision-analytic model was used to compare (1a) urease breath testing (UBT) for assessment of H. pylori status versus (1b) observation without further testing or treatment, among patients who were symptom-free following initial antimicrobial and antisecretory therapy for endoscopically demonstrated ulcer and H. pylori infection; and (2a) UBT versus (2b) repeat endoscopy with H. pylori testing, and versus (2c) repeat antimicrobial and antisecretory therapy without further testing, among patients who remained symptomatic following initial therapy. RESULTS: Among patients who were symptom free after initial therapy, 6.1% receiving UBT had symptomatic ulcer at one year, compared to 18.2% of those simply observed. The expected first-year cost per symptom-free patient following initial therapy was $591 for UBT compared to $480 for observation. Among patients with persistent symptoms after initial therapy, 21% receiving repeat therapy had symptomatic ulcer at one year, compared to 23.8% receiving repeat endoscopy, and 23.3% receiving UBT. Corresponding medical costs per patient were, respectively, $766, $1787 and $1122. CONCLUSIONS: The optimal approach to managing patients following initial treatment for ulcer and H. pylori infection depends on symptom status following initial therapy. For symptomatic patients, the preferred approach is to prescribe a repeat course of antimicrobial and antisecretory therapy. For patients without symptoms following initial therapy, UBT is the preferred approach because it is associated with a threefold lower risk of symptomatic ulcer at one year, although it costs an additional $110 per patient, compared with observation.

Increased numbers of women, older individuals, and Blacks receive health care for dyspepsia in the United States.

GOALS: The objectives of this research were to use a national probability sample of the U.S. population to determine the demographic characteristics of individuals who obtained care for dyspepsia, to compare these demographic characteristics with those of the U.S. population, and to describe the amount of health care that these individuals received. STUDY: We analyzed data from the 1987 National Medical Expenditure Survey, which is based on a national probability sample of the U.S. adult population. RESULTS: Approximately 3.6 million individuals, or 2% of U.S. adults, obtained care for dyspepsia. Compared with the U.S. population, a predominance of women, individuals 65 years or older, and African Americans obtained care for dyspepsia. Expenditures for health care totaled $2.5 billion. CONCLUSIONS: Given the major impact of dyspepsia on U.S. health care resources, a critical issue facing investigators is to identify the most cost-effective approach to managing these patients.

How good are US studies of HIV costs of care?

BACKGROUND: Valid, timely estimates of the costs of HIV care are needed by health planners and policy makers. OBJECTIVE: To perform a methodologic critique of published estimates of resource utilization and costs of HIV care. DATA SOURCES: MEDLINE database for 1990-1998. DATA SELECTION: Included articles focused on adults with a spectrum of HIV disease in which the authors developed their own resource use and cost data. Thirty one articles met these criteria. DATA EXTRACTION: Studies were compared based on: (1) utilization and cost estimates, in 1995 dollars; (2) study period; (3) research design; (4) sampling frame; (5) sample size and patient characteristics; (6) data sources and scope of services; and (7) methods used in the analysis. DATA SYNTHESIS: The most recent estimates pertain to the first half of 1995, before the use of protease inhibitor therapy. We found wide variations in the estimates and identified three major sources for this: (1) patient samples that were restricted to subgroups of the national HIV-infected population; (2) utilization data that were limited in scope (e.g., inpatient care only); and (3) invalid methods for estimating annual or lifetime costs, particularly in dealing with decedents. CONCLUSIONS: To accurately estimate resource use and costs for HIV care nationwide, a nationally representative probability sample of HIV-infected patients is required. Even in research that is not intended to provide national estimates, the scope of utilization data should be broadened and greater attention to methodologic issues in the analysis of annual and lifetime costs is needed.

Evaluation of a multidimensional measure of dyspepsia-related health for use in a randomized clinical trial.

In previous work, we developed a multidimensional measure of dyspepsia-related health. To evaluate the adequacy of this instrument as an outcome measure for a large-scale, multicenter, randomized clinical trial, we used Rasch analysis to address three questions: (1) Are the scales interval-level? (2) Do the scales measure precisely across the entire range of dyspepsia outcomes? (3) Do the scales' items have an optimal number of response categories? We found that the scales were not interval-level and that they did not measure effectively at low or high levels of the dyspepsia-related outcomes. Our results also suggest that patients were capable of discriminating among only four- to seven-item response categories. Further studies are needed to identify items that effectively measure high and low levels of dyspepsia-related outcomes and to validate that decreasing the number of response categories improves the psychometric properties of these scales.

The effectiveness of endoscopy in the management of dyspepsia: a qualitative systematic review.

PURPOSE: Dyspepsia is a common primary care condition, yet its optimal management is poorly defined. We reviewed the literature to answer the following questions about patients with dyspepsia: 1) Does endoscopy result in improved patient outcomes? 2) Does endoscopy result in a reduction in the use of subsequent medical resources? 3) Does endoscopy result in improved medical decision making? 4) Is endoscopy cost effective? METHODS: We performed a systematic review of English-language articles in the MEDLINE, HEALTHSTAR, and EMBASE computerized bibliographic databases from January 1985 to July 1998. We included all studies, including decision analyses, with information about the effectiveness of endoscopy, as measured by its impact on patient outcomes, resource utilization, clinical decision making, or cost effectiveness. Two independent reviewers abstracted data from each study, and assessed its methodologic quality. RESULTS: Twenty-one studies met the inclusion criteria. For 3 of the 4 clinical questions, the weight of evidence does not support the effectiveness of endoscopy. The largest randomized clinical trial comparing endoscopy with empiric therapy demonstrates equivalent symptoms and quality of life at 1 year, with increased patient satisfaction and lower costs for initial endoscopy. Suboptimal study design, including lack of appropriate comparison groups, limit studies measuring the impact of endoscopy on resource utilization and decision-making. Decision analyses indicate that noninvasive H pylori testing followed by anti-H pylori therapy or empiric antisecretory therapy is more cost effective than initial endoscopy. CONCLUSIONS: With the exception of one randomized clinical trial, the preponderance of available data does not support the effectiveness of endoscopy in the management of dyspepsia. Prospective clinical trials that evaluate patient outcomes and resource utilization, and take H pylori status into account, are needed to determine the effectiveness of endoscopy in the management of dyspepsia.

Managing dyspepsia: what do we know and what do we need to know?

OBJECTIVE: The conceptual revolution concerning the role of Helicobacter pylori in the pathogenesis of peptic ulcer disease has raised the larger question of how to integrate this new information into the management of patients with dyspepsia. The aim of this research was to critically evaluate current knowledge about dyspepsia and its management. METHODS: Relevant articles on dyspepsia were identified from MEDLINE searches and from the bibliographies of identified articles. Studies that contained information on the prevalence of dyspepsia, endoscopic findings, and evaluations of alternative management strategies were reviewed. RESULTS: By coupling H. pylori serological testing with clinical factors such as age and nonsteroidal antiinflammatory drug use, strategies have been developed that identify patients with organic disease. Although the use of these strategies can reduce the volume of endoscopies, their effects on dyspepsia symptoms are unknown. Computerized decision analysis models have been used to evaluate the cost-effectiveness of alternative strategies. The indirect evidence obtained from these models suggests that empiric therapy, guided by H. pylori testing, may be the preferred approach. However, the models have been hampered by the lack of information concerning dyspepsia symptoms, the primary health outcome of the majority of patients seen in primary practice settings. CONCLUSIONS: Currently, the knowledge needed to integrate H. pylori tests and antimicrobial therapies into the management of patients with dyspepsia in primary practice settings has not been developed. A pressing need exists for a randomized controlled trial to evaluate alternative management strategies. In conducting such a trial, valid, reliable instruments for measuring dyspepsia will be needed.

Predicting outcomes in HIV-infected veterans: I. Progression to AIDS.

This article and the following article (Parts I and II) report the development of two clinical staging systems for HIV-infected individuals. The objective of the research reported here (Part I) was to construct a clinical staging system to predict progression to AIDS. We analyzed data from VA Cooperative Study Number 298, a multicenter, double-blind, randomized trial that compared immediate versus deferred zidovudine therapy in 338 HIV-infected individuals who did not have AIDS at enrollment. Baseline variables were tested in univariate Cox regression for their relationship to progression to AIDS, and those that appeared predictive were examined in multivariable analysis. Based on these analyses, we constructed a new clinical staging system based on CD4+ cell count, age, hemoglobin, oral hairy leukoplakia or oral thrush, and fever. The stages of the system were significant predictors of progression to AIDS (p = 0.0001, log-rank test). In conclusion, simple, valid, clinical staging systems for HIV-infected patients can be constructed using information that is readily available in clinical practice settings. Such systems provide better prognostic distinction than CD4+ cell count alone by taking into account the known prognostic effects of other variables.

Predicting outcomes in HIV-infected veterans: II. Survival after AIDS.

This article (Part II) and the preceding article (Part I) report the development of two clinical staging systems for HIV-infected individuals. The objective of the research reported here (Part II) was to construct a clinical staging system to predict survival in patients with AIDS. We analyzed data from VA Cooperative Study Number 298, a multicenter, double-blind, randomized trial that compared immediate versus deferred zidovudine therapy in HIV-infected individuals. Baseline variables obtained at the onset of AIDS in 204 individuals were tested in univariate Cox regression for their relationship to survival, and those that appeared predictive were examined in multivariable analysis. Based on these analyses, we constructed a new AIDS Clinical Staging System. The system is based on age, CD4+ cell count, type of first AIDS-defining condition, and functional status. The stages of the system were significant predictors of survival (p = 0.0001, log-rank test). In conclusion, valid, simple clinical staging systems for patients with AIDS can be developed based on a few variables that are readily available in clinical settings.

Gastric ulcers at endoscopy: brush, biopsy, or both?

OBJECTIVES: All gastric ulcers discovered at endoscopy are potentially malignant. Concurrent use of both histological biopsy and cytological brushing has been advocated as a means of increasing the diagnostic yield for neoplasia at the time of initial endoscopy. The purpose of this analysis was to determine the impact of these diagnostic strategies on the cost-effectiveness of detecting malignancy in patients with a gastric ulcer. METHODS: The diagnostic performance of biopsy and brushings in detecting gastric malignancy was estimated from a meta-analysis of published reports. Nondiscounted direct costs were determined from patient resource consumer profiles from the perspective of a Canadian hospital. A decision tree was used to compare diagnostic strategies (biopsy alone, brushing alone, or biopsy and brushing) in a hypothetical cohort of patients found to have a gastric ulcer at endoscopy. Effectiveness was expressed as diagnostic days saved. RESULTS: No strategy achieved dominance. The brushing strategy was the most cost-effective, but its cost-effectiveness ratio was only slightly lower than that of biopsy. Cost differences between the biopsy and brushing strategies were small (less than $6 per case). Performing both biopsy and brushing slightly improved the true-positive rate but resulted in a doubling of the false-positive rate, which in turn led to unnecessary laparotomies. The impact of the high false-positive rate was also seen in the incremental cost of performing both brushings and biopsy ($168-$423 per case). CONCLUSIONS: For gastric ulcers discovered at endoscopy, the preferred strategy is to perform either cytological brushing or histological biopsy. The previously recommended strategy of performing both cytological brushing and histological biopsy should be reconsidered.

Esophageal candidiasis in patients infected with the human immunodeficiency virus. A decision analysis to assess cost-effectiveness of alternative management strategies.

BACKGROUND: Currently no consensus exists concerning the timing of upper endoscopy and the choice of antifungal therapy for patients infected with the human immunodeficiency virus who also have esophageal candidiasis. The objective of this research was to determine the clinical and economic effects of alternative management strategies for these patients. METHODS: Decision analysis was used to evaluate the outcomes, costs, and cost-effectiveness of two strategies for the diagnostic workup and treatment of patients infected with the human immunodeficiency virus with dysphagia and/or odynophagia: (1) empiric--a strategy to treat all patients empirically with an oral antifungal agent for up to 4 weeks; and (2) initial esophagogastroduodenoscopy (EGD)--a strategy to perform EGD on all patients and to treat only those with esophageal candidiasis with an oral antifungal agent for up to 4 weeks. Within each strategy, three antifungal regimens were evaluated: ketoconazole, 200 mg daily; fluconazole, 100 mg daily; and ketoconazole, 200 mg daily, for 2 weeks followed by fluconazole, 200 mg daily, for 2 weeks in nonresponders. Information on the probability of esophageal candidiasis in patients with esophageal symptoms and the efficacy of antifungal therapy was obtained from the literature. The costs for diagnostic workup were estimated using both teaching hospital charges and Medicare reimbursement payments. The costs of antifungal therapy were estimated from local pharmacy charges. The average cost per complete response and incremental cost-effectiveness were calculated and subjected to sensitivity analysis. RESULTS: Using the best available evidence for antifungal efficacy, empiric fluconazole was the most cost-effective strategy for all probabilities of esophageal candidiasis that were more than 0.55. Using teaching hospital charges in our base-case analysis, the average costs per complete response for empiric fluconazole and initial EGD and fluconazole were $2706 and $3141, respectively. The incremental cost-effectiveness of initial EGD and fluconazole compared with empiric fluconazole was $3792 per additional complete response. When the cost-effectiveness of the two strategies was compared as the cost of diagnostic workup was varied, initial EGD and fluconazole became the dominant strategy when the diagnostic workup cost fell below $710, a figure that is less than the current Medicare reimbursement payment. CONCLUSIONS: From the perspective of the payer of medical care, empiric fluconazole is the most cost-effective strategy for the initial management of patients infected with the human immunodeficiency virus with esophageal symptoms.