Recommendations for a clinical decision support for the management of individuals with chronic kidney disease.

BACKGROUND AND OBJECTIVES: Care for advanced CKD patients is suboptimal. CKD practice guidelines aim to close gaps in care, but making providers aware of guidelines is an ineffective implementation strategy. The Institute of Medicine has endorsed the use of clinical decision support (CDS) for implementing guidelines. The authors' objective was to identify the requirements of an optimal CDS system for CKD management. DESIGN, SETTING, PARTICIPANTS, AND MEASUREMENTS: The aims of this study expanded on those of previous work that used the facilitated process improvement (FPI) methodology. In FPI, an expert workgroup develops a set of quality improvement tools that can subsequently be utilized by practicing physicians. The authors conducted a discussion with a group of multidisciplinary experts to identify requirements for an optimal CDS system. RESULTS: The panel considered the process of patient identification and management, associated barriers, and elements by which CDS could address these barriers. The panel also discussed specific knowledge needs in the context of a typical scenario in which CDS would be used. Finally, the group developed a set of core requirements that will likely facilitate the implementation of a CDS system aimed at improving the management of any chronic medical condition. CONCLUSIONS: Considering the growing burden of CKD and the potential healthcare and resource impact of guideline implementation through CDS, the relevance of this systematic process, consistent with Institute of Medicine recommendations, cannot be understated. The requirements described in this report could serve as a basis for the design of a CKD-specific CDS.

Comorbidity, age, race and stage at diagnosis in colorectal cancer: a retrospective, parallel analysis of two health systems.

BACKGROUND: Stage at diagnosis plays a significant role in colorectal cancer (CRC) survival. Understanding which factors contribute to a more advanced stage at diagnosis is vital to improving overall survival. Comorbidity, race, and age are known to impact receipt of cancer therapy and survival, but the relationship of these factors to stage at diagnosis of CRC is less clear. The objective of this study is to investigate how comorbidity, race and age influence stage of CRC diagnosis. METHODS: Two distinct healthcare populations in the United States (US) were retrospectively studied. Using the Cancer Care Outcomes Research and Surveillance Consortium database, we identified CRC patients treated at 15 Veterans Administration (VA) hospitals from 2003-2007. We assessed metastatic CRC patients treated from 2003-2006 at 10 non-VA, fee-for-service (FFS) practices. Stage at diagnosis was dichotomized (non-metastatic, metastatic). Race was dichotomized (white, non-white). Charlson comorbidity index and age at diagnosis were calculated. Associations between stage, comorbidity, race, and age were determined by logistic regression. RESULTS: 342 VA and 340 FFS patients were included. Populations differed by the proportion of patients with metastatic CRC at diagnosis (VA 27% and FFS 77%) reflecting differences in eligibility criteria for inclusion. VA patients were mean (standard deviation; SD) age 67 (11), Charlson index 2.0 (1.0), and were 63% white. FFS patients were mean age 61 (13), Charlson index 1.6 (1.0), and were 73% white. In the VA cohort, higher comorbidity was associated with earlier stage at diagnosis after adjusting for age and race (odds ratio (OR) 0.76, 95% confidence interval (CI) 0.58-1.00; p = 0.045); no such significant relationship was identified in the FFS cohort (OR 1.09, 95% CI 0.82-1.44; p = 0.57). In both cohorts, no association was found between stage at diagnosis and either age or race. CONCLUSION: Higher comorbidity may lead to earlier stage of CRC diagnosis. Multiple factors, perhaps including increased interactions with the healthcare system due to comorbidity, might contribute to this finding. Such increased interactions are seen among patients within a healthcare system like the VA system in the US versus sporadic interactions which may be seen with FFS healthcare.

Opportunities for improving management of advanced chronic kidney disease.

Evidence suggests that management of advanced chronic kidney disease affects patient outcomes. To identify clinical areas that demand attention from a quality improvement perspective, we sought to examine the extent of conformance to an advanced chronic kidney disease guideline in a range of practices. A total of 237 patient medical records were abstracted from 4 primary care providers and 4 nephrology private practices across the country. In the practices studied, management of advanced chronic kidney disease patients was suboptimal for patients managed by primary care providers as well as those managed by nephrologists (overall conformance 27% and 42%, respectively), specifically for anemia, bone disease, and timing for renal replacement therapy. The current exercise (in conjunction with a literature search and focused and individual interviews with providers and patients) offered valuable information that was used to develop a toolkit for optimizing management of advanced chronic kidney disease.

Utility of the advanced chronic kidney disease patient management tools: case studies.

Appropriate management of advanced chronic kidney disease (CKD) delays or limits its progression. The Advanced CKD Patient Management Toolkit was developed using a process-improvement technique to assist patient management and address CKD-specific management issues. We pilot tested the toolkit in 2 community nephrology practices, assessed the utility of individual tools, and evaluated the impact on conformance to an advanced CKD guideline through patient chart abstraction. Tool use was distinct in the 2 sites and depended on the site champion's involvement, the extent of process reconfiguration demanded by a tool, and its perceived value. Baseline conformance varied across guideline recommendations (averaged 54%). Posttrial conformance increased in all clinical areas (averaged 59%). Valuable features of the toolkit in real-world settings were its ability to: facilitate tool selection, direct implementation efforts in response to a baseline performance audit, and allow selection of tool versions and customizing them. Our results suggest that systematically created, multifaceted, and customizable tools can promote guideline conformance.

Systematic review: comparative effectiveness of angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers for treating essential hypertension.

BACKGROUND: The relative effectiveness of angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs) for lowering blood pressure is unknown. PURPOSE: To compare the benefits and harms of ACE inhibitors versus ARBs for treating essential hypertension in adults. DATA SOURCES: MEDLINE (1966 to May 2006), the Cochrane Central Register of Controlled Trials (Issue 2, 2006), and selected reference lists were searched for relevant English-language trials. The MEDLINE search was updated to August 2007 to identify head-to-head trials that reported blood pressure outcomes and major cardiovascular events. STUDY SELECTION: 61 clinical studies that directly compared ACE inhibitors versus ARBs in adult patients with essential hypertension, reported an outcome of interest, lasted at least 12 weeks, and included at least 20 patients. DATA EXTRACTION: A standardized protocol with predefined criteria was used to extract data on study design, interventions, population characteristics, and outcomes; evaluate study quality and applicability; and assess the strength of the body of evidence for key outcomes. DATA SYNTHESIS: ACE inhibitors and ARBs had similar long-term effects on blood pressure (50 studies; strength of evidence, high). No consistent differential effects were observed for other outcomes (few studies reported long-term outcomes), including death, cardiovascular events, quality of life, rate of single antihypertensive agent use, lipid levels, progression to diabetes, left ventricular mass or function, and kidney disease. Consistent fair- to good-quality evidence showed that ACE inhibitors were associated with a greater risk for cough. There were fewer withdrawals due to adverse events and greater persistence with therapy for ARBs than for ACE inhibitors, although this evidence was not definitive. Patient subgroups for whom ACE inhibitors or ARBs were more effective, associated with fewer adverse events, or better tolerated were not identified. LIMITATIONS: Few studies involved a representative sample treated in a typical clinical setting over a long duration, treatment protocols had marked heterogeneity, and substantive amounts of data about important outcomes and patient subgroups were missing. CONCLUSION: Available evidence shows that ACE inhibitors and ARBs have similar effects on blood pressure control, and that ACE inhibitors have higher rates of cough than ARBs. Data regarding other outcomes are limited.

Advanced chronic kidney disease practice patterns among nephrologists and non-nephrologists: a database analysis.

Chronic kidney disease (CKD) outcomes, including progression to end stage, is influenced by patient treatment and is known to be suboptimal. A commercial database was analyzed to assess practice patterns and conformance to clinical practice guidelines among nephrologists and non-nephrologists who care for patients with advanced CKD (estimated GFR [eGFR] < or = 30 ml/min per 1.73 m2). Data from 1933 adults with advanced CKD on the basis of prestipulated inclusion criteria were analyzed. Individuals were designated as in a nephrologist or non-nephrologist group depending on whether a nephrologist was involved in their care. With the use of published guidelines, conformance to 10 recommendations was assessed for all patients and separately for the nephrologist and non-nephrologist groups. The average eGFR of included individuals was 23.6 ml/min per 1.73 m2. A majority were female and older than 65 yr. Non-nephrologists treated approximately half of all patients and a greater number of women and patients who were older than 65 yr. Nephrologists treated patients with a lower eGFR, equal numbers of men and women, and an equal number of individuals younger and older than 65 yr. Nephrologist conformance to guidelines was systematically better than that of non-nephrologists. These analyses reveal that a large number of patients with advanced CKD are being treated solely by non-nephrologists and that nephrologists treat patients with more advanced disease. Management of advanced CKD is suboptimal for all patients but is particularly poor for patients who are treated solely by non-nephrologists.

Quality measures for the use of adjuvant chemotherapy and radiation therapy in patients with colorectal cancer: a systematic review.

BACKGROUND: Chemotherapy (CT) and radiation therapy (RT) are essential components of adjuvant (preoperative or postoperative) therapy for many patients with colorectal cancer (CRC); however, quality measures (QMs) of these critical aspects of CRC treatment have not been characterized well. Therefore, the authors conducted a systematic review of the literature to determine the available QMs for adjuvant CT and RT in patients with CRC and rated their usefulness for assessing the delivery of quality care. METHODS: The MEDLINE and Cochrane data bases were searched for all publications that contained potential/actual QMs pertaining to adjuvant therapy for CRC. Identified QMs were rated by using criteria developed by the National Quality Forum. RESULTS: Thirty-two articles met the established inclusion/exclusion criteria. Those 32 articles contained 12 potential or actual QMs, 6 of which had major flaws that limited their applicability. The most useful QMs identified were 1) the percentage of patients with AJCC Stage III colon cancer who received postoperative CT and 2) the percentage of patients with Stage II or III rectal cancer who received chemoradiotherapy. CONCLUSIONS: To the authors' knowledge, very few QMs pertaining to adjuvant CT or RT for CRC have been published to date, and only half of those measures were rated as useful, acceptable, and valid in the current literature review. Future research should focus on refining existing QMs and on developing new QMs that target important leverage points with respect to the provision of adjuvant therapy for patients with CRC.

Improving the process of developing technical reports for health care decision makers: using the theory of constraints in the evidence-based practice centers.

OBJECTIVES: To apply the Theory of Constraints (TOC) to the Evidence-based Practice Center (EPC) process. METHODS: Participants in the EPC process were interviewed, and the technical contracting literature was reviewed. Undesirable effects (UDEs) that might occur in the EPC process were identified and, in a TOC Current Reality Tree (CRT), a fundamental UDE was selected and tracked back to potential root causes, focusing on the core "constraint". The resulting draft CRT was presented at an EPC directors' meeting and finalized. From possible solutions obtained from interviews and literature, a Future Reality Tree (FRT) was constructed. RESULTS: Three UDEs were identified and that a report is not used was deemed fundamentally undesirable. Nine root causes were identified, and using the CRT, a core constraint emerged: EPC partner does not know how to conceptualize and articulate needs, objectives, and specifications. Two change strategies ("injections") appeared to address the core constraint: establish an ongoing relationship between partners, EPC, and Agency for Healthcare Research and Quality early in the process, and use a changes clause; in a FRT the injections lead to the positive outcome-the production of a successful EPC report that meets partner needs and, therefore, will be used. CONCLUSIONS: As with any complex enterprise, the EPC needs to engage in self-reflection and active improvement to maximize its value. The development of technical reports intended to inform decision making represents a complicated area, involving a network of interrelated processes. Using the TOC permitted us to understand process failures; results serve as a guide to improvement.

Evidence-based practice center network and health technology assessment in the United States: bridging the cultural gap.

OBJECTIVES: The purpose of this study was to identify the Evidence-Based Practice Center (EPC) network participants' perceptions of the characteristics of the EPC process and the relationship of the process to the success of EPC reports. METHODS: Semistructured interviews were conducted with the three groups involved in the EPC: EPC staff, Agency for Healthcare Research and Quality (AHRQ) staff, and representatives of partner organizations. RESULTS: The analysis of the coded transcripts revealed three related major themes, which form the conceptual basis for the interpretation presented here: the definition of a successful report, the determinants of a successful report, and the role of AHRQ in the process. CONCLUSIONS: A successful report is a report that is used. The ultimate success of the core health technology assessment objective, moving from research to policy, depends on balancing two values: excellence and relevance. Our findings are consistent with the "two communities thesis," which postulates the existence of two camps that confer different values to excellence and relevance, with resulting tension. A promising model for approaching this tension is integration or collaboration, which requires linking researchers and policy makers, promoting productive dialogues about the formulation and timing of analysis, and early consideration of how the resulting analysis will be used. This effort suggests that actively blurring the frontiers between these two groups will enhance their interaction. Furthermore, enhancing the role of the AHRQ as scientific broker will maximize the potential of the EPC network.

Changing physician knowledge, attitudes, and beliefs about migraine: evaluation of a new educational intervention.

OBJECTIVE: Use a presurvey of primary care providers (PCPs) enrolled in a continuing medical education (CME) program on headache management to ascertain their existing knowledge, attitudes, and beliefs regarding migraine and use a postsurvey to determine the extent to which the CME program has brought participant knowledge, attitudes, and skills closer to conformance with best evidence. BACKGROUND: Migraine is a common and debilitating condition, which PCPs may not always manage satisfactorily. In an effort to improve management, the American Headache Society has developed a CME program called BRAINSTORM that encourages PCPs to adopt the US Headache Consortium Guidelines for headache care. METHODS: A 20-item questionnaire was developed that covered the essential elements of migraine care. The questionnaire was administered before and after a BRAINSTORM presentation to 254 consenting primary care clinicians attending a medical meeting at 1 of 6 sites. A control group of 112 comparable physicians who did not attend the presentation completed the same questionnaire. Prepresentation scores of attendees were compared to scores of nonattendees to assess the generalizability of results. Prepresentation scores on selected questions were used to assess participant baseline knowledge, attitudes, and beliefs. Pre- and postpresentation scores for attendees at all sites were compared using the Mantel-Haenszel statistic to assess the effectiveness of the BRAINSTORM CME. Pre- and postpresentation scores were compared by site using the Breslow-Day test to evaluate any differential impact based on CME location. RESULTS: Prepresentation scores of attendees and nonattendees were found to be similar. No significant difference in performance was noted across sites. A chi-square analysis revealed a statistically significant difference between pre- and postpresentation scores for 16 of the test's 20 questions. In the pretest, all participants scored <66% on 2 questions related to prevalence, impact, and pathophysiology of migraine, 2 questions pertaining to history taking/physical examination, and 3 migraine management questions. Attendee scores improved to >66% posttest on all except 2 questions related to prevalence, impact, and pathophysiology of migraine. CONCLUSION: Our results indicate that PCPs need to acquire greater understanding about the epidemiology and pathophysiology of migraine and may require guidance in history taking and physical examination of migraine patients. Improvement in scores posttest confirms that the BRAINSTORM program has a significant immediate impact on the knowledge, beliefs, and attitudes of participants. The program could be strengthened to improve emphasis in some areas where posttest scores showed no improvement.

Facilitated process improvement: an approach to the seamless linkage between evidence and practice in CKD.

BACKGROUND: Two common strategies for guideline implementation are preformed practice improvement tools, such as flowcharts, and process reengineering by total quality management (TQM) teams. Prespecified tools fail to accommodate local circumstances, TQM requires an unrealistic level of local commitment, and neither has a proven track record for success. METHODS: We describe an alternative approach termed facilitated process improvement (FPI), a systematic exploration of potential modifications to systems of care, and its application to the implementation of an evidence-based chronic kidney disease (CKD) guideline, focusing on individuals not yet requiring renal replacement therapy. The FPI steps followed by the implementation work group to develop a set of implementation tools for the Renal Physicians Association Advanced CKD Guideline included: (1) developing functional specifications of processes, including actions and prerequisites required; (2) investigating processes of care in a variety of site types to understand processes and reasons for failures; (3) developing practical tools corresponding to root causes of failures of processes and subprocesses; and (4) developing a meta-tool to tailor local selection of tools. RESULTS: Formal needs assessment identified processes of care related to 3 major tasks: identify patients, develop and communicate patient-specific management plan, and implement plan. Subtasks were identified to address root causes of failures, and, for each, tools were modified from existing or developed de novo by the work group, which further developed an organized management approach that uses 4 categories of tools: (1) assessment tools identify opportunities for improvements; (2) tailoring tools, a unique feature of this approach, determine which tools are applicable; (3) implementation tools identify patients and communicate and implement management plan; and (4) evaluation tools assess the impact of implementation. CONCLUSION: The work group, in collaboration with community clinicians, patients, and CKD and tool experts, developed and used FPI to provide a range of tools in a fashion that supports and simplifies local assessment, tailoring, implementation, and evaluation. With the formative work completed, practitioners whose practice improvement experience level and other resources may be limited will find it more feasible and practical to provide optimal advanced CKD management without the demands of conventional TQM or continuous quality improvement.

Cancer care quality measures: diagnosis and treatment of colorectal cancer.

OBJECTIVES: To identify measures that are currently available to assess the quality of care provided to patients with colorectal cancer (CRC), and to assess the extent to which these measures have been developed and tested. DATA SOURCES: Published and unpublished measures identified through a computerized search of English-language citations in MEDLINE (1966-January 2005), the Cochrane Database of Systematic Reviews, and the National Guideline Clearinghouse; through review of reference lists contained in seed articles, all included articles, and relevant review articles; and through searches of the grey literature (institutional or government reports, professional society documents, research papers, and other literature, in print or electronic format, not controlled by commercial publishing interests). Sources for grey literature included professional organization websites and the Internet. REVIEW METHODS: Measures were selected by reviewers according to standardized criteria relating to each question, and were then rated according to their importance and usability, scientific acceptability, and extent of testing; each domain was rated from 1 (poor) to 5 (ideal). RESULTS: We identified a number of well-developed and well-tested CRC-related quality-of-care measures, both general process-of-care measures (on a broader scale) and technical measures (pertaining to specific details of a procedure). At least some process measures are available for diagnostic imaging, staging, surgical therapy, adjuvant chemotherapy, adjuvant radiation therapy, and colonoscopic surveillance. Various technical measures were identified for quality of colonoscopy (e.g., cecal intubation rate, complications) and staging (adequate lymph node retrieval and evaluation). These technical measures were guideline-based and well developed, but less well tested, and the linkage between them and patient outcomes, although intuitive, was not always explicitly provided. For some elements of the care pathway, such as operative reports and chemotherapy reports, no technical measures were found. CONCLUSIONS: Some general process measures have a stronger evidence base than others. Those based on guidelines have the strongest evidence base; those derived from basic first principles supported by some research findings are relatively weaker, but are often sufficient for the task at hand. A consistent source of tension is the distinction between the clinically derived fine-tuning of the definition of a quality measure and the limitations of available data sources (which often do not contain sufficient information to act on such distinctions). Although some excellent technical measures were found, the overall development of technical measures seems less advanced than that of the general process measures.

Alzheimer disease: operating characteristics of PET--a meta-analysis.

PURPOSE: To assess the operating characteristics of positron emission tomography (PET) by using fluorine 18 fluorodeoxyglucose (FDG) in the diagnosis of Alzheimer disease. MATERIALS AND METHODS: Articles published between 1989 and 2003 were identified in the MEDLINE, CINAHL, and HealthSTAR databases. Articles were selected if FDG PET was performed with a dedicated scanner and the resolution was specified, if standard criteria were used for the diagnosis of Alzheimer disease, if at least 12 human subjects with Alzheimer disease were enrolled in the study, if clinical diagnosis or histopathologic findings were used as the reference standard, and if sufficient data were provided to construct a 2 x 2 table. Two reviewers independently abstracted data regarding the operating characteristics (sensitivity and specificity) of PET and evaluated the study quality. A meta-analysis was performed by constructing a summary receiver operating characteristic curve and by combining the sensitivity and specificity values by using a random-effects model. RESULTS: Fifteen articles that met the inclusion criteria showed heterogeneity in sensitivity and specificity estimates that were not related to quality features with no plausible explanations. The summary sensitivity of PET was 86% (95% CI: 76%, 93%), and the summary specificity was 86% (95% CI: 72%, 93%). CONCLUSION: The specificity and sensitivity of FDG PET are limited by both study design and patient characteristics. Therefore, the clinical value of these parameters is uncertain; future research on the use of PET in the diagnosis of Alzheimer disease needs to focus on current limitations to be of practical relevance in clinical settings.

When should functional neuroimaging techniques be used in the diagnosis and management of Alzheimer's dementia? A decision analysis.

BACKGROUND: Functional neuroimaging, including positron emission tomography (PET), has been proposed for use in diagnosing Alzheimer's disease-related dementia (AD). OBJECTIVE: The objective of this study was identify the circumstances under which PET scanning for the diagnosis of AD maximizes health outcomes. METHODS: A Markov-model-based decision analysis was conducted using estimates derived from the literature on AD epidemiology, the accuracy of PET, and donepezil treatment efficacy. The target population for the analysis was assumed to be US men and women who either have mild AD or are asymptomatic but at an elevated risk of developing AD owing to disease in a first-degree relative (parent or sibling). The time horizon was the patient lifetime. We compared treatment 1) based on an American Academy of Neurology (AAN) clinical evaluation either alone; 2) in combination with PET scanning; or 3) empirically based on a family history. Outcomes measures were life expectancy, quality-adjusted life-years (QALYs), and (severe) dementia-free life expectancy (SDFLE). RESULTS: For both patient populations, treating all patients based on an AAN evaluation without further testing using PET resulted in the greatest gains in life expectancy, QALYs, and SDFLEs. PET-based testing was the second preferred strategy compared to no intervention. The rankings of the strategies were sensitive to severity of treatment complications: analyses of hypothetical treatments with the potential for severe complications indicated that testing was preferred if the treatment was effective but had moderate complications. CONCLUSIONS: These results suggest that current treatments, which are relatively benign and may slow progression of disease, should be offered to patients who are identified as having AD based solely on an AAN clinical evaluation. A clinical evaluation that includes functional neuroimaging based testing will be warranted, however, when new treatments that are effective at slowing disease progression but have the potential for moderate to severe complications become available.