Necessity of using intermediate outcome to proxy long term effects. The example of thrombolytics.
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Outcomes assessment describes a variety of activities, including classic clinical trials with quality of life and cost end points, observational studies examining the outcomes of treatment in the course of routine clinical care, and the process of managing patterns of care in clinical practice. These activities share important common features, including an emphasis on quality of life and economic outcomes, an explicit consideration of the importance of patient characteristics in determining outcomes, and a broad definition of what constitutes cancer care. The primary uses of outcomes data are to evaluate treatments and to assess the quality of care provided by physicians, health care institutions, and health insurance plans. Outcomes management integrates these activities through the implementation of guidelines, ideally based on empiric data on the relationship between medical interventions and outcomes; and the measurement of performance against a set of quality indicators derived from those guidelines. One of the biggest challenges facing clinicians today is how to reconcile the need to do what is best for patients with the need to practice cost-conscious medicine. High-quality outcomes data are at the heart of the solution. This presentation is a brief overview of outcomes research and management and its role in oncology practice.
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Sheway is a single-access comprehensive street-front service to pregnant and parenting women with a history of alcohol and/or drug abuse that is located in one of Canada's poorest neighbourhoods, the Downtown Eastside of Vancouver. This investigation assesses the concurrent health and social problems clients report upon entry into the program, service utilization, and the impact of services on neonate and infant well-being. Data were collected through the review of files from the 9 1/2 years of the agency's service. Findings suggest that the clients' concurrent health and social problems have increased over the years of operation while indicators of infant health have either improved or maintained steady rates.
Health care systems throughout the world are faced with continuously rising health care expenditure. In Germany, a fee per capita system will be introduced by 2003 to keep the budgets for hospital care within limits. As a result, numbers of hospital beds and hospitals will be cut in the coming years. On the other hand, more and more patients and health care providers are asking if they are really receiving an adequate value for their money in the treatment they receive. All this will have a strong impact on the anaesthesiologist's work and her/his perception of the different facets of quality. Quality has various aspects for the anaesthesiologist. The patient as a customer should not incur any detrimental effects after a surgical procedure, and is accompanied by the anaesthesiologist throughout the perioperative setting. The surgeon needs optimal conditions to perform a procedure. The hospital must balance equally costs and income; this requires optimal operating room utilization. Finally, health insurance companies and the government are responsible for covering the cost of treatment according to the quality of the care delivered. Quality assessment concerning structure, process and outcome has to take these demands into account. Continuous quality improvement in the spirit of Deming's 'plan-do-check-act cycle' has to be part of anaesthesiologist's everyday routine. In future, the traditional barriers between the specialities treating a patient will be disrupted when reimbursement for treatment is made according to quality and efficacy of treatment.
PURPOSE: Mounting evidence suggests a relationship between hospital volume and outcomes after major cancer surgery; however, the absolute benefits of volume-based referral on a national basis are unclear. PATIENTS AND METHODS: Data from the Nationwide Inpatient Sample were used to measure the likelihood of operative mortality and a prolonged length of stay (LOS) after six cancer surgeries (prostatectomy, cystectomy, esophagectomy, pancreatectomy, pneumonectomy, and liver resection) between 1993 and 2003. Using sampling weights, the adjusted likelihood of the outcomes was used to calculate the number of lives saved (or prolonged LOS avoided) in the United States. RESULTS: The magnitude of the volume-operative mortality effect varied from an adjusted odds ratio (OR) of 1.3 (95% CI, 0.8 to 2.3) for cystectomy to 4.9 (95% CI, 2.4 to 10.1) for pancreatectomy. After accounting for varying rates of procedure utilization, the lives saved per 100 surgeries regionalized ranged from 0.2 (95% CI, 0.12 to 0.24 lives saved) for prostatectomy to 9.2 (95% CI, 6.7 to 10.4 lives saved) for pancreatectomy. The volume-prolonged LOS effect varied from an adjusted OR of 0.9 (95% CI, 0.5 to 1.6) for liver resection to 4.8 (95% CI, 3.5 to 6.7) for prostatectomy. After accounting for procedure use, the number of prolonged hospitalizations avoided ranged from -1.7 (95% CI, -11.3 to 3.6 hospitalizations) to 14.3 (95% CI, 12.9 to 15.4 hospitalizations) per 100 surgeries regionalized for liver resection and prostatectomy, respectively. CONCLUSION: For patients undergoing major cancer surgery, the benefits of volume-based referral depend on the interplay between procedure utilization, the magnitude of effect, and the outcome chosen.
OBJECTIVE: Quality improvement programs for depression can improve outcomes, but the utility of including patients with subthreshold depression in quality improvement programs is unclear. The authors examined 57-month effects of quality improvement on clinical outcomes and mental health care utilization of primary care patients with depressive disorder and subthreshold depression. METHOD: In a group-level, randomized, controlled trial, 46 primary care clinics were randomly assigned to provide usual care or care with a quality improvement intervention that included provider training and other resources for either medication management (medications quality improvement) or evidence-based psychotherapy (therapy quality improvement). Among 1,356 enrolled depressed patients, 991 completed the 57-month follow-up interview (604 patients with depressive disorder and 387 with subthreshold depression). Outcomes measured at 57 months were presence of probable depressive disorder, unmet need for appropriate care (untreated probable disorder), and mental health care utilization in the prior 6 months. RESULTS: Among patients with subthreshold depression at baseline, those seen in clinics with quality improvement programs with special resources for therapy were less likely to have probable depressive disorder and unmet need for care at follow-up, compared with those seen in clinics that provided usual care. Among patients with depressive disorder at baseline, those seen in clinics with quality improvement programs with special resources for medication management were less likely to have unmet need for care at follow-up, compared with those seen in clinics that provided usual care. Patients with subthreshold depression at baseline seen in clinics with a quality improvement intervention were less likely at follow-up to have had a mental health visit (in primary care or specialty care, depending on the intervention) in the prior 6 months. CONCLUSIONS: Relative to usual care, quality improvement interventions improved 57-month outcomes (probable depression, unmet need, or both) for primary care patients with depressive disorder and subthreshold depression and lowered use of mental health visits for those with subthreshold depression. The results highlight the feasibility and utility of including patients with subthreshold depression in such programs.
Evaluation of the impact of clinical nurse specialist (CNS) practice in today's health care environment is currently one of the most important issues facing these advanced practitioners and nursing administrators. The unique contributions of CNS practice can be demonstrated through use of sophisticated evaluation methods. This paper begins with a discussion of types of evaluation (structure, process, and outcome) that have been utilized in the past and then describes the structure, developmental process, and function of an evaluation instrument recently implemented by a group of CNSs. The evaluation instrument is a step towards the ultimate goal of process-outcome evaluation, the most sophisticated method of evaluating the impact of the CNS. The benefits of utilization of this tool are presented from the perspective of CNSs and nurse administrators.
BACKGROUND: Improving clinical outcomes requires that physicians examine and change their clinical practice. Sustaining outcome improvements requires a dedicated and dynamic program of analyzing and improving patient care. In 1992 North Mississippi Health Services (NMHS) implemented a program to improve physicians' clinical efficiency. CLINICAL PRACTICE ANALYSIS ( CPA): CPA uses evidenced-based guidelines and examines each physician's resource utilization, processes, and outcomes for a diagnosis or procedure. Clinical practice profiles are developed, and individual performance is compared to local and national benchmarks and presented to physicians. The CPA process is used on its own or as a component of more comprehensive performance improvements projects. Physicians have been engaged in outcome improvement by more than 55 CPA projects. RESULTS: NHMS has progressively reduced its Medicare loss and its length of stay (LOS) to 4.9 days. Mortality and readmission rates have been reduced in specific diagnoses. The community-acquired pneumonia project reduced the LOS from 7.7 to 5.1 days, decreaesed the mortality rate from 8.9% to 5.0%, and decreased the cost of care from $4,269 to $3,834. The ischemic stroke project reduced the aspiration pneumonia rate from 6.4% to 0% and mortality from 11.0% to 4.6%. Patients' average LOS decreased from 10.7 days to 6.5 days, and their cost of care was reduced by $1,100 per patient. DISCUSSION: Providing individualized data has engaged physicians in improving outcomes. The program has evolved from improving efficiency to managing outcomes and from simple CPA projects to integrated performance improvement projects; however, the CPA process remains the cornerstone of the current process.
Documenting assistive technology outcomes has grown in importance, but outcome measurement remains problematic. A new approach uses natural science measures and a model (selectionism) from the field of Behavior Analysis. Selectionism defines behaviors by their effects (functional performance) and the environment (including technology) within which they occur, and explicitly treats variation in patterns of behavior over time for individuals (intervention effects). Its basic metric is frequency of behaviors (count per unit time) which is similar to robust engineering measures like centimeters, grams, and seconds. This approach eliminates many of the problems inherent to more traditional psychometrics. Selectionism based on frequencies also provides an empirical structure or taxonomy to organize efforts and outcomes, unified by the notion of fluency. Composite behaviors are combinations of smaller component behaviors that are required for performance of the composite. A frequency above which a component behavior is readily retained, generalized, and recruited into the more complex composite behavior is called fluency; thus individuals fluent on the critical components easily and efficiently demonstrate the composite. This model suggests that when assistive technology interventions raise component behavior frequencies to fluent levels, they will be integrated usefully into an individual's life. This selectionistic approach has been used successfully in the field of education. It has the added benefit of not only empirically defining measurable outcomes, but also of providing useful ongoing measurement of change during treatment. This paper briefly describes this "Precision Measurement" strategy and its data-driven feedback process and makes suggestions for further research and development efforts. The method provides a basis for better documentation, control, and outcomes of assistive technology and related interventions.
Despite a number of potential benefits to both the clinician and the patient, patient-based measures of health have not been routinely or systematically used within routine practice by clinicians in the care of individual patients. There are a number of practical, methodological and attitudinal barriers which have so far limited the use of patient-based measures of health within routine practice. The extent to which these barriers are overcome is likely to influence the effectiveness of such instruments in improving the process and outcomes of patient care. This study reviewed the evidence for the effectiveness of this intervention and identified some of the factors that may influence its effectiveness. Thirteen relevant studies were located using search strategies on three computerized databases for 1987-97. The study found that clinicians see information from patient-based measures of health as valuable in the overall assessment of the patient and that its feedback to clinicians increases the detection of psychological and, to a lesser extent, functional problems. However, there was little evidence to suggest their use substantially changed patient management or improved patient outcomes. Our findings suggest that the ways in which patient based measures of health are implemented in routine practice may have an impact on their effectiveness. It is recommended that implementation strategies that are guided by theories of individual and organizational change might allow the barriers to using patient-based measures of health in routine practice to be identified and overcome more effectively.
Shift report is a multifaceted process that serves to provide nurses with vital patient information to facilitate clinical decisions and patient care planning. A shift report also provides nurses with a forum for functions, such as patient problem solving and collaboration. The authors conducted a literature review, which indicates that current methodologies used to collect and convey patient information are ineffective and may contribute to negative patient outcomes. Data incongruence, legal implications, time constraints augmented by the nursing shortage, and the financial impact of shift report are also addressed. The literature reveals significant rationale for pioneering new and innovative methods of shift-to-shift communication. In the report To Err is Human: Building a Safe Health System, the Institute of Medicine attributes the deaths of up to 98,000 hospitalized Americans to medical errors, including communication failures [Institute of Medicine. (1999). To err is human: Building a safe health system. Report by the Committee on Quality of Health Care in America. Washington, DC: National Academy Press]. As a result, government policy makers and health care agencies have focused their attention on determining the root cause of errors to identify preventative measures, including the use of information technology [Institute of Medicine. (2004). Keeping patients safe: Transforming the work environment of nurses. Report by the Committee on Quality of Health Care in America. Washington, DC: National Academy Press]. Under these premises, the authors examined the process of nursing shift report and how it impacts patient outcomes. The use of computer technology and wireless modes of communication is explored as a means of improving the shift report process and, subsequently, health care outcomes and patient safety.
BACKGROUND: Audit of diabetic care is becoming common in general practice. Most of this audit is concerned with structure and process; outcome audit is much more difficult to achieve. AIM: To determine whether the structure of general practice diabetic care influenced the process or outcome and whether efficiency of process predicted improved outcome. METHOD: Cross-sectional survey, by questionnaire and review of notes, among general practices in the East Dorset district, involving diabetic patients identified from general practitioner (GP) disease registers or from a hospital diabetic register. The main outcome measures were the proportion of process and outcome measurements, related to selected structure criteria and the proportion of outcome measurements, related to appropriate process measurements. All associations were tested using the practice as the unit of analysis. RESULTS: Practices with a detailed diabetic register showed a positive association with a higher proportion of some process, but no outcome, measurements compared to those practices without such a registrar. A high proportion of process measurements did not correlate with improved outcome. CONCLUSION: Assessment of the follow-up of diabetic patients in general practice by measurement of the structure or process of care does not allow the prediction of an improved outcome for those patients when summarized on a practice basis. There is no shortcut to the collection of data on outcome as a measure of the benefit of follow-up for diabetic patients.
Using a local cross-cultural health service program as a framework, the authors describe the process of an evaluability assessment (EA) and illustrate how it can be a catalyst for program change. An EA is a process that improves evaluation. The key product was a logic model, which traces the links between objectives, activities, and outcomes. Four key insights emerged. First, the distinction of who was included and excluded in the target population, originally ambiguous, was clearly defined. Second, through the development of the logic model, staff members were able to analyze their goals and assumptions and critically explore possible gaps between expected outcomes and activities. Third, the EA enabled reflection on and clarification of both process and outcome measures. Finally, global goals were pared down to better match the project capacity. Developing an evaluability assessment was a cost-effective way to collaborate with staff to develop a clearer, more evaluable project.
BACKGROUND: The Queen Elizabeth II Health Sciences Centre uses a weekly peer-review conference of cardiovascular experts to prioritize each surgical case to 1 of 4 queues with the use of standardized criteria of coronary anatomy, stress test result, and symptoms. We examined the hazard of waiting as well as the impact of waiting on surgical outcomes. METHODS AND RESULTS: Analysis was performed for 2102 consecutive patients queued for CABG, aortic valve replacement, or CABG+aortic valve replacement between January 1, 1998, and December 31, 1999. Among 1854 patients undergoing surgery, median waiting times on the respective queues were as follows: in-house urgent group, 8 days; semiurgent A group, 37 days; semiurgent B group, 64 days; and elective group, 113 days. There were 13 deaths (12 cardiac) that occurred during the waiting period (0.7% of the patients). Of the 8.7% patients upgraded to a more urgent queue, 86.1% required hospitalization before surgery. Although female sex was not associated with prolonged waiting time, it was predictive of urgent status (P=0.001). The incidence of postoperative complications was 25.0%, and operative mortality was 2.86%. Both were more frequent among patients undergoing surgery early (P=0.01); however, this difference was attributable to the in-house urgent queue. The median length of stay was 7 days for all patients and was not affected by waiting time. CONCLUSIONS: Death and upgrades while the patients were waiting tended to occur early in the queuing process, and prolonged waiting was not associated with worse surgical outcomes. The cost of reducing waiting times could in part be offset by prevention of hospital admissions among upgraded patients.
Community-acquired pneumonia (CAP) is a key target for research and quality improvement in acute medicine. However, many of the outcome measures used in prognostic and antibiotic studies are not validated and do not capture features of outcome that are important to patients. Substitutes for traditional outcome measures include a recently validated patient-based symptom questionnaire (the CAP-Sym) and process-of-care measures. The interpretation of outcomes also depends on the quality of the study design and methods used. This paper discusses the advantages and disadvantages of outcome, process-of-care, and economic measures in CAP and the interpretation of these measures in randomised and observational studies. A core set of measures for use in clinical CAP research and performance measurement is proposed.
BACKGROUND: Previous research has identified 2 styles of family physicians' focus on the patient's family: (1) using the family history as the context of care of the patient; and (2) maintaining a family orientation with the family as the unit of care. The purpose of our study was to determine whether these styles affect patient outcomes and time use during outpatient visits. METHODS: In a cross-sectional study, data on 4454 outpatient visits to 138 community family physicians were collected using direct observation, patient and physician questionnaires, and medical record review. We computed partial correlations between the physician's family practice style score and patient outcomes for delivery of preventive services, patient visit satisfaction, and patient-reported delivery of specific components of primary care. We controlled for relevant patient characteristics. RESULTS: The patients of the physicians using either practice style had similar levels of satisfaction with coordination of care and interpersonal communication, and their value of continuity of care was comparable. Patients of physicians with a family-history style, however, rated their physicians lower on a measure of in-depth knowledge of the patient and family but higher on preventive services delivery. Differences in time use during the visit reflected how these styles were manifested during the outpatient visit. CONCLUSIONS: The different styles physicians use to focus on the family affect the process and outcomes of patient care. This difference may be explained by the developmental life cycle of family physicians, as younger physicians may be more focused on family history and older physicians may have a more family-oriented focus. Physicians may need to find alternate ways of meeting those patient needs not well met by their predominant practice style.
PURPOSE: The purpose of this study was to (1) conduct a systematic review of the literature to identify interventions that improve patient outcomes in the intensive care unit (ICU); (2) evaluate potential measures of quality based on the impact, feasibility, variability, and the strength of evidence to support each measure and to categorize these measures as outcome, process, access, or complication measures; and (3) select a list of candidate quality measures that can be broadly applied to improve ICU care. METHODS: We identified and independently reviewed all studies in Medline (1965-2000) and The Cochrane Library (Issue 3, 2001) that met the following criteria: design: observational studies, experimental trials, or systematic reviews; population: critically ill adults; and intervention: process or structure measure that was associated with improved patient outcomes: morbidity, mortality, complications, errors, costs, length of stay (LOS), and patient reported outcomes. Studies were grouped into categories by the type of outcome that was improved by the intervention. Potential quality measures were evaluated for: impact on morbidity, mortality, and costs; feasibility of the measure; and variability in the measure. We evaluated the strength of evidence for each intervention used to improve outcomes and using the Delphi method, assigned an over-all recommendation for each quality measure. RESULTS: A total of 3,014 citations were identified. Sixty-six studies that met selection criteria reported on a variety of interventions that were associated with improved patient outcomes. We identified 6 outcome measures: ICU mortality rate, ICU LOS greater than 7 days, average ICU LOS, average days on mechanical ventilation, suboptimal management of pain, and patient/family satisfaction; 6 process measures: effective assessment of pain, appropriate use of blood transfusions, prevention of ventilator-associated pneumonia, appropriate sedation, appropriate peptic ulcer disease prophylaxis, and appropriate deep venous thrombosis prophylaxis; 4 access measures: rate of delayed admissions, rate of delayed discharges, cancelled surgical cases, and emergency department by-pass hours; and 3 complication measures: rate of unplanned ICU readmission, rate of catheter-related blood stream infections, and rate of resistant infections. CONCLUSIONS: Further work is needed to create operational definitions and to pilot test the selected measures. The value of these measures will be determined by our ability to evaluate our current performance and implement interventions designed to improve the quality of ICU care.