Samuel J. Wang

Ten Commandments for Effective Clinical Decision Support: Making the Practice of Evidence-based Medicine a Reality

While evidence-based medicine has increasingly broad-based support in health care, it remains difficult to get physicians to actually practice it. Across most domains in medicine, practice has lagged behind knowledge by at least several years. The authors believe that the key tools for closing this gap will be information systems that provide decision support to users at the time they make decisions, which should result in improved quality of care. Furthermore, providers make many errors, and clinical decision support can be useful for finding and preventing such errors. Over the last eight years the authors have implemented and studied the impact of decision support across a broad array of domains and have found a number of common elements important to success. The goal of this report is to discuss these lessons learned in the interest of informing the efforts of others working to make the practice of evidence-based medicine a reality.

A cost-benefit analysis of electronic medical records in primary care

Electronic medical record systems improve the quality of patient care and decrease medical errors, but their financial effects have not been as well documented. The purpose of this study was to estimate the net financial benefit or cost of implementing electronic medical record systems in primary care. We performed a cost-benefit study to analyze the financial effects of electronic medical record systems in ambulatory primary care settings from the perspective of the health care organization. Data were obtained from studies at our institution and from the published literature. The reference strategy for comparisons was the traditional paper-based medical record. The primary outcome measure was the net financial benefit or cost per primary care physician for a 5-year period. The estimated net benefit from using an electronic medical record for a 5-year period was 86,400 US dollars per provider. Benefits accrue primarily from savings in drug expenditures, improved utilization of radiology tests, better capture of charges, and decreased billing errors. In one-way sensitivity analyses, the model was most sensitive to the proportion of patients whose care was capitated; the net benefit varied from a low of 8400 US dollars to a high of 140,100 US dollars . A five-way sensitivity analysis with the most pessimistic and optimistic assumptions showed results ranging from a 2300 US dollars net cost to a 330,900 US dollars net benefit. Implementation of an electronic medical record system in primary care can result in a positive financial return on investment to the health care organization. The magnitude of the return is sensitive to several key factors.

Design and implementation of a comprehensive outpatient results manager

Prior research has demonstrated that clinicians often fail to review and act upon outpatient test results in a timely and appropriate manner. To address this patient safety and quality of care issue, Partners Healthcare has developed a browser-based, provider-centric, comprehensive results management application to help clinic physicians review and act upon test results in a safe, reliable, and efficient manner. The application, called the Results Manager, incorporates extensive decision support features to classify the degree of abnormality for each result, presents guidelines to help clinicians manage abnormal results, allows clinicians to generate result letters to patients with predefined, context-sensitive templates and prompts physicians to set reminders for future testing. In this paper, we outline the design process and functionality of Results Manager. We also discuss its underlying architectural design, which revolves around a clinical event monitor and a rules engine, and the methodological challenges encountered in designing this application.

Primary care physician attitudes concerning follow-up of abnormal test results and ambulatory decision support systems

OBJECTIVES Failures to follow-up abnormal test results are common in ambulatory care. Information systems could assist providers with abnormal test result tracking, yet little is known about primary care providers attitudes toward outpatient decision support systems. METHODS A cross-sectional survey of 216 primary care physicians (PCPs) that utilize a single electronic medical record (EMR) without computer-based clinical decision support. RESULTS The overall response rate was 65% (140/216). Less than one-third of the respondents were satisfied with their current system to manage abnormal laboratory, radiographs, Pap smear, or mammograms results. Only 15% of providers were satisfied with their system to notify patients of abnormal results. Over 90% of respondents felt automated systems to track abnormal test results would be useful. Seventy-nine percent of our respondents believed that they could comply better with guidelines through electronic clinical reminders. CONCLUSIONS Most PCPs were not satisfied with their methods for tracking abnormal results. Respondents believed that clinical decision support systems (CDSS) would be useful and could improve their ability to track abnormal results.

Nomogram for Predicting the Benefit of Adjuvant Chemoradiotherapy for Resected Gallbladder Cancer

PURPOSE Although adjuvant chemoradiotherapy for resected gallbladder cancer may improve survival for some patients, identifying which patients will benefit remains challenging because of the rarity of this disease. The specific aim of this study was to create a decision aid to help make individualized estimates of the potential survival benefit of adjuvant chemoradiotherapy for patients with resected gallbladder cancer. METHODS Patients with resected gallbladder cancer were selected from the Surveillance, Epidemiology, and End Results (SEER) -Medicare database who were diagnosed between 1995 and 2005. Covariates included age, race, sex, stage, and receipt of adjuvant chemotherapy or chemoradiotherapy (CRT). Propensity score weighting was used to balance covariates between treated and untreated groups. Several types of multivariate survival regression models were constructed and compared, including Cox proportional hazards, Weibull, exponential, log-logistic, and lognormal models. Model performance was compared using the Akaike information criterion. The primary end point was overall survival with or without adjuvant chemotherapy or CRT. RESULTS A total of 1,137 patients met the inclusion criteria for the study. The lognormal survival model showed the best performance. A Web browser-based nomogram was built from this model to make individualized estimates of survival. The model predicts that certain subsets of patients with at least T2 or N1 disease will gain a survival benefit from adjuvant CRT, and the magnitude of benefit for an individual patient can vary. CONCLUSION A nomogram built from a parametric survival model from the SEER-Medicare database can be used as a decision aid to predict which gallbladder patients may benefit from adjuvant CRT.

Prediction Model for Estimating the Survival Benefit of Adjuvant Radiotherapy for Gallbladder Cancer

PURPOSE The benefit of adjuvant radiotherapy (RT) for gallbladder cancer remains controversial because most published data are from small, single-institution studies. The purpose of this study was to construct a survival prediction model to enable individualized predictions of the net survival benefit of adjuvant RT for gallbladder cancer patients based on specific tumor and patient characteristics. METHODS A multivariate Cox proportional hazards model was constructed using data from 4,180 patients with resected gallbladder cancer diagnosed from 1988 to 2003 from the Surveillance, Epidemiology, and End Results database. Patient and tumor characteristics were included as covariates and assessed for association with overall survival (OS) with and without adjuvant RT. The model was internally validated for discrimination and calibration using bootstrap resampling. RESULTS On multivariate regression analysis, the model showed that age, sex, papillary histology, stage, and adjuvant RT were significant predictors of OS. The survival prediction model demonstrated good calibration and discrimination, with a bootstrap-corrected concordance index of 0.71. The model predicts that adjuvant RT provides a survival benefit in node-positive or >or= T2 disease. A nomogram and a browser-based software tool were built from the model that can calculate individualized estimates of predicted net survival gain attributable to adjuvant RT, given specific input parameters. CONCLUSION In the absence of large, prospective, randomized, clinical trial data, a regression model can be used to make individualized predictions of the expected survival improvement from the addition of adjuvant RT after gallbladder cancer resection.

Conditional survival in ovarian cancer: Results from the SEER dataset 1988-2001

OBJECTIVES Survival statistics for patients with ovarian cancer are typically reported in terms of survival from time of diagnosis. For patients who have survived a period of time since diagnosis, however, conditional survival (CS) is a more clinically relevant measure, as it accounts for the changes in risk over time. The purpose of this study was to estimate CS for ovarian cancer patients through analysis of large-scale cancer registry data. METHODS Ovarian cancer cases were extracted from the Surveillance, Epidemiology, and End Results (SEER 17) database from the National Cancer Institute (NCI) for patients diagnosed between 1988-2001. Five-year relative CS calculations were performed with stratification by age, race, stage, histology, and grade for patients who had already survived up to 5 years from diagnosis. RESULTS The 5-year overall relative CS improved over time for up to 5 years after diagnosis for ovarian cancer patients. The largest gains in CS over time were seen for patients with advanced stage disease, poor grade, and serous and undifferentiated epithelioid histologies. For patients with stage IV disease, 5-year CS more than tripled over the first 5 years of surveillance (17%-56%). Among histological types, patients with undifferentiated epithelioid histology saw 5-year CS rise from 29% at diagnosis to 84% after 5 years. CONCLUSIONS Prognosis improves over time for almost all groups of ovarian cancer patients. For ovarian cancer survivors, CS provides a more relevant measure of prognosis than conventional survival estimates that are made at the time of diagnosis.

Conditional survival in head and neck squamous cell carcinoma: results from the SEER dataset 1973-1998.

Survival statistics for patients with head and neck squamous cell carcinomas (HNSCC) are commonly calculated from the time of diagnosis. The less commonly employed conditional survival (CS) analyzes survival for patients who have survived a period of time after diagnosis. Useful prognostic information for cancer survivors is provided by CS analysis. Estimated baseline CS parameters for HNSCC were sought using large‐scale cancer registry data.

Conditional survival in gastric cancer: a SEER database analysis

BackgroundGastric cancer survival is typically reported in terms of survival from the time of diagnosis. Conditional survival is a more relevant measure of prognosis for patients who have already survived 1 or more years since diagnosis.MethodsUsing the Surveillance, Epidemiology, and End Results (SEER 17) database from the National Cancer Institute, we analyzed data from 20 018 gastric cancer patients diagnosed between 1988 and 1998. Using the life-table method, we computed 5-year relative conditional survival, grouped by summary stage, age, sex, and ethnicity, for patients who had already survived up to 5 years from diagnosis.ResultsRelative conditional survival improves over time for all groups of gastric cancer patients who survive a period of time after diagnosis. The largest gains in conditional survival were seen in patients with advanced stage disease. In general, females showed better survival than males. When grouped by ethnicity, Asians continued to have improved survival compared to other ethnic categories, even at 5 years out from diagnosis.ConclusionFor gastric cancer patients who survive a period of time after diagnosis, the largest increases in conditional survival are seen for patients with advanced stage disease and for those less than 65 years old. Conditional survival can provide more relevant prognostic information than survival from the time of diagnosis for gastric cancer patients who survive a period of time after diagnosis.

Prospective randomized double-blind pilot study of site-specific consensus atlas implementation for rectal cancer target volume delineation in the cooperative group setting

PURPOSE Variations in target volume delineation represent a significant hurdle in clinical trials involving conformal radiotherapy. We sought to determine the effect of a consensus guideline-based visual atlas on contouring the target volumes. METHODS AND MATERIALS A representative case was contoured (Scan 1) by 14 physician observers and a reference expert with and without target volume delineation instructions derived from a proposed rectal cancer clinical trial involving conformal radiotherapy. The gross tumor volume (GTV), and two clinical target volumes (CTVA, including the internal iliac, presacral, and perirectal nodes, and CTVB, which included the external iliac nodes) were contoured. The observers were randomly assigned to receipt (Group A) or nonreceipt (Group B) of a consensus guideline and atlas for anorectal cancers and then instructed to recontour the same case/images (Scan 2). Observer variation was analyzed volumetrically using the conformation number (CN, where CN = 1 equals total agreement). RESULTS Of 14 evaluable contour sets (1 expert and 7 Group A and 6 Group B observers), greater agreement was found for the GTV (mean CN, 0.75) than for the CTVs (mean CN, 0.46-0.65). Atlas exposure for Group A led to significantly increased interobserver agreement for CTVA (mean initial CN, 0.68, after atlas use, 0.76; p = .03) and increased agreement with the expert reference (initial mean CN, 0.58; after atlas use, 0.69; p = .02). For the GTV and CTVB, neither the interobserver nor the expert agreement was altered after atlas exposure. CONCLUSION Consensus guideline atlas implementation resulted in a detectable difference in interobserver agreement and a greater approximation of expert volumes for the CTVA but not for the GTV or CTVB in the specified case. Visual atlas inclusion should be considered as a feature in future clinical trials incorporating conformal RT.