Anticoagulation in atrial fibrillation. Does efficacy in clinical trials translate into effectiveness in practice?

BACKGROUND: Several recent randomized clinical trials of anticoagulation in atrial fibrillation have demonstrated significant reduction in stroke rates with a small incidence of bleeding complications. The objective of this study was to determine whether the recommendations resulting from these trials have been implemented into routine practice, and if the anticoagulation control, therapeutic efficacy, and low complication rates achieved in the trials have been matched in community practice. METHODS: We analyzed the anticoagulation practices and outcomes obtained for patients in atrial fibrillation at a large staff model health maintenance organization (HMO). We reviewed the medical records of all patients in atrial fibrillation as of April 1990. We compared demographic characteristics and clinical risk factors between HMO patients and those in the clinical trials. We also compared anticoagulation monitoring, adequacy of anticoagulation control, and clinical outcomes at the HMO with those achieved in the clinical trials. RESULTS: Of 238 HMO patients in atrial fibrillation, 198 were without contraindications and therefore eligible for anticoagulation. Of these, 168 were offered anticoagulation (84.8%) and 156 were receiving anticoagulation therapy (78.8% of those eligible). The HMO patients had a greater prevalence of comorbidities than those in the clinical trials. The routine monitoring interval at the HMO was estimated at between 36.3 and 40.9 days (compared with 21 to 28 days reported in the clinical trials). The prothrombin time ratios at the HMO were in the target range on 50% of days compared with 68% of days in the clinical trials. The annual stroke and major bleeding rates in the HMO patients (1.3% and 0.6%, respectively) were not significantly different from the rates in the clinical trials (1.3% and 1.1%, respectively). The annual minor bleeding rate of 13.6% at the HMO was greater than the 7.8% to 8.4% rates in the two trials with better anticoagulation control (Boston Area Anticoagulation Trial for Atrial Fibrillation and Stroke Prevention in Atrial Fibrillation Study) but was not significantly different than the rates of 12.7% and 13.7% of the two trials with poorer anticoagulation control (Canadian Atrial Fibrillation Anticoagulation Study and Stroke Prevention in Nonrheumatic Atrial Fibrillation Study). CONCLUSIONS: Anticoagulation practices in this community setting appear to be good in that a large majority of patients were receiving anticoagulation therapy, and there were few major adverse outcomes. However, this study illustrates two common problems in attempting to apply the results of randomized clinical trials to routine practice: (1) differences between community patient populations and those on which the conclusions of clinical trials are based, and (2) less successful application of therapeutic interventions in settings other than that of a controlled clinical trial. The greater prevalence of comorbidities in the HMO patient population appears to convey a greater overall risk of thromboembolism and bleeding complications than in the clinical trials. In addition, the suboptimal anticoagulation control achieved at the HMO may increase the risks and decrease the potential benefits compared with those achieved in the clinical trials. Thus, the efficacy demonstrated in the clinical trials of anticoagulation in atrial fibrillation may not be directly translated into effectiveness in practice.

A nationwide survey of financing health-related services for special education students.

The Individuals with Disability Education Act (IDEA) requires state educational systems to provide school-based, health related services (RS). This survey determined the financing arrangements used by states for health-related services for school-aged children with disabilities. A survey was sent to directors of special education, Medicaid, and public health departments in each of the 50 states. Financial patterns for RS were sought at the state level for children ages 3-21 with disabilities for the 1993-1994 school year, the most recent year for which complete financial data were available. Univariate analyses probed the relationship between systems' variables and the extent of Medicaid usage by local education agencies. Respondents reported that schools tapped traditional health resources to supplement educational dollars in paying for related services in schools. Medicaid was by far the most common source with 29 states reporting established mechanisms for recouping Medicaid dollars and 10 states reporting phase-in activities. Seventeen states reported that departments of public health played some role in administration, training, and demonstrations, but only six states provided specific dollars for related services through the department. Use of private insurance was reported sporadically with only one state indicating a specific state-level program. Correlates of increased Medicaid usage were presence of interagency agreements (IAAs) (OR 11.1, p = 0.002), having specific personnel for school-based medical assistance (OR 17.7, p = 0.001), and utilizing school nursing services as a Medicaid optional service (OR 4.2, p = 0.048).

Influence of clinical knowledge, organizational context, and practice style on transfusion decision making. Implications for practice change strategies.

Evidence shows that blood products, like other health care resources, are often used inappropriately, but the reasons for this have not been well studied. We conducted a face-to-face survey of 122 general surgeons, orthopedic surgeons, and anesthesiologists in three hospitals to evaluate the influence of several clinical and nonclinical factors on transfusion decision making. We found widespread deficiencies in physicians' knowledge of transfusion risks and indications. Each transfusion risk was estimated correctly by fewer than half of the physicians surveyed, and only 31% responded correctly to a set of four questions regarding transfusion indications. Attending physicians routinely had lower knowledge scores than did residents, yet they exhibited more confidence in their knowledge. Residents' transfusion decisions, however, were strongly influenced by the desires of their attending physicians, resulting in their ordering potentially inappropriate transfusions. Of the residents surveyed, 61% indicated that they ordered transfusions that they judged unnecessary at least once a month because a more senior physician suggested that they do so. These findings provide insights for the development of strategies to improve transfusion practices, which would address the dual concerns of quality of care and cost containment.

Influence of knowledge and attitudes on the quality of physicians' transfusion practice.

Studies evaluating relationships between physician background characteristics (e.g. years of practice and medical training) and quality of care have found few consistent associations. Site of practice variables have been better predictors of quality than have characteristics of individual physicians. This study explores the relationship between physicians' knowledge and attitudes regarding the use of blood products, and the quality of their transfusion practice, based on in-depth physician interviews and medical record reviews. The sample includes 296 transfusion episodes ordered by 17 physicians in 2 teaching hospitals. The physicians had participated in a larger survey of staff surgeons and anesthesiologists in these hospitals. The quality of transfusion practice was defined as the proportion of a physicians' transfusion episodes scored as justified, as determined by explicit chart audit plus implicit physician review. Large baseline differences were observed between the 2 hospitals; 48% of transfusions in hospital A were justified compared with 81% in hospital B. At the physician level, knowledge of transfusion indications and receptivity to input from colleagues were significantly associated with higher quality transfusion practice (standardized betas = 0.41 (P = 0.01), and 0.40 (P = 0.02), respectively). These findings suggest that in addition to organizational context, physician characteristics may be associated with the quality of care related to a specific clinical practice.

Attitudes about clinical practice guidelines in a mixed model HMO: the influence of physician and organizational characteristics.

OBJECTIVE: This study assesses physician attitudes toward clinical practice guidelines, in an organization where guidelines have long been incorporated into the clinical practice. Attitudes toward institutional guidelines and guidelines in general are explored, and are compared to a published study describing attitudes among a sample of American College of Physician (ACP) members. DESIGN: Descriptive study. SETTING: A large, mixed model HMO. SAMPLE: Two hundred and three internists and family practice physicians. MEASURES: Attitudes toward perceived compliance with clinical practice guidelines were assessed. Summary measures of attitudes and anticipated impact of guidelines were created. RESULTS: Overall, attitudes toward practice guidelines among HMO physicians were very positive. Differences were observed by gender, practice model, years in practice and residency training. HMO physicians on average held more favorable attitudes toward guidelines compared with published results of an ACP survey. While HMO physicians in independent group practices viewed the concept of guidelines less favorably than staff model physicians, they were more likely to view the impact of guidelines positively than were the ACP physicians. CONCLUSIONS: Exposure to practice guidelines in the context of clinical practice can lead to positive attitudes about those guidelines. While resentment toward a system which relies on practice supports such as guidelines may remain among some physicians, this need not be inconsistent with an appreciation of the potential value of guidelines for improving clinical quality.

The case for case-mix adjustment in practice profiling. When good apples look bad.

OBJECTIVE: To assess the influence of patient characteristics on practice profiling. Using the example of specialty referrals by primary care physicians, we evaluated the impact of adjusting for patient characteristics (age/sex vs case mix) on the estimation of practice variation, the identification of outlier practices, and the evaluation of potential predictors of variation. DESIGN AND SETTING: We applied several measurement strategies to a retrospective cohort of patients (N = 37,830) within 52 physician practices in a large staff-model health maintenance organization during a 1-year period. OUTCOME MEASURES: We calculated unadjusted referral rates and adjusted standardized referral ratios for each physician. Using these, we determined coefficients of variation and statistical "outlier status." RESULTS: Adjustment for patient characteristics decreased the observed variation in referral profiles, with a decrease of more than 50% in the coefficient of variation. Three quarters of the physicians identified as statistical outliers with use of an age/sex-adjusted measure were no longer identified as such with use of an case-mix-adjusted measure. Several key predictors of unadjusted referral rate (including physician age, practice tenure, site of practice, and extent of laboratory test ordering) dropped out of regression models when the outcome variable was adjusted for patient characteristics. CONCLUSION: Failure to adjust for case mix in physician practice profiles may lead to overestimates of variation and misidentification of outliers. To the extent that unadjusted practice profiles are used for decisions about education, sanctions, or employment, physicians may be subject to inequitable decisions and actions. Misinformation about the causes and extent of practice variation may also lead to misdirection of scarce resources for quality improvement efforts.

Understanding of prognosis among parents of children who died of cancer: impact on treatment goals and integration of palliative care.

CONTEXT: Parents' understanding of prognosis or decision making about palliative care for children who die of cancer is largely unknown. However, a more accurate understanding of prognosis could alter treatment goals and expectations and lead to more effective care. OBJECTIVES: To evaluate parental understanding of prognosis in children who die of cancer and to assess the association of this factor with treatment goals and the palliative care received by children. DESIGN, SETTING, AND PARTICIPANTS: Survey, conducted between September 1997 and August 1998, of 103 parents of children who received treatment at the Dana-Farber Cancer Institute and Children's Hospital, Boston, Mass, and who died of cancer between 1990 and 1997 (72% of those eligible and those located) and 42 pediatric oncologists. MAIN OUTCOME MEASURE: Timing of parental understanding that the child had no realistic chance for cure compared with the timing of physician understanding of this prognosis, as documented in the medical record. RESULTS: Parents first recognized that the child had no realistic chance for cure a mean (SD) of 106 (150) days before the child's death, while physician recognition occurred earlier at 206 (330) days before death. Among children who died of progressive disease, the group characterized by earlier recognition of this prognosis by both parents and physicians had earlier discussions of hospice care (odds ratio [OR], 1.03; 95% confidence interval [CI], 1.01-1.06; P =.01), better parental ratings of the quality of home care (OR, 3.31; 95% CI, 1.15-9.54; P =.03), earlier institution of a do-not-resuscitate order (OR, 1.03; 95% CI, 1.00-1.06; P =.02), less use of cancer-directed therapy during the last month of life (OR, 2.80; 95% CI, 1.05-7.50; P =.04), and higher likelihood that the goal of cancer-directed therapy identified by both physician and parent was to lessen suffering (OR, 5.17; 95% CI, 1.86-14.4; P =.002 for physician and OR, 6.56; 95% CI, 1.54-27.86; P =.01 for parents). CONCLUSION: Considerable delay exists in parental recognition that children have no realistic chance for cure, but earlier recognition of this prognosis by both physicians and parents is associated with a stronger emphasis on treatment directed at lessening suffering and greater integration of palliative care. JAMA. 2000;284:2469-2475.

A controlled trial of educational outreach to improve blood transfusion practice.

OBJECTIVE: To determine whether brief, face-to-face educational outreach visits can improve the appropriateness of blood product utilization. DESIGN: Randomized, controlled multicenter trial with 6-month follow-up. SETTING: Surgical and medical services of two pairs of matched community and teaching hospitals in Massachusetts. PARTICIPANTS: One hundred one transfusing staff surgeons and attending medical physicians. INTERVENTION: A professionally based transfusion specialist presented one surgical- or medical-service-wide lecture emphasizing appropriate indications, risks, and benefits of red blood cell transfusions; brief, graphic, printed educational guidelines; and one 30-minute visit with each transfusing physician. No data feedback was provided. Educational messages emphasized the lack of utility of the traditional threshold for red blood cell transfusions (hematocrit, 30%) and transfusion risks (eg, viral hepatitis). MEASURES: Proportion of red blood cell transfusions classified as compliant or noncompliant with blood transfusion guidelines, or indeterminate 6 months before and 6 months after an experimental educational intervention. RESULTS: Based on analyses of 1449 medical record audits of red blood cell transfusions that occurred 6 months before and 6 months after the educational intervention, the average proportion of transfusions not in compliance with criteria declined from 0.40 to 0.24 among study surgeons (-40%) compared with an increase from 0.40 to 0.44 (+9%) among control surgeons (P = .006). These effects were consistent across procedure type and specialty. On average, study surgeons in the postintervention period performed transfusions when hematocrits were 2.0 percentage points lower than before the intervention (28.3% preintervention vs 26.3% postintervention), and lower than in the control group (28.3% preintervention and postintervention; P = .04). Likely savings in blood use for surgical services probably exceeded program costs, even without considering reduced risks of infection. No effects were observed among transfusions occurring in medical services, possibly because of substantially lower transfusion rates and lower pretransfusion hematocrits. CONCLUSIONS: Brief, focused educational outreach visits by transfusion specialists can substantially improve the appropriateness and cost-effectiveness of blood product use in surgery. More data are needed regarding the durability of changes in practice patterns and the health and economic benefits of such interventions.

A randomized trial of a program to reduce the use of psychoactive drugs in nursing homes.

BACKGROUND: Although psychoactive medications have substantial side effects in the elderly, these drugs are used frequently in nursing homes. Few interventions have succeeded in changing this situation, and little is known about the clinical effects of such interventions. METHODS: We studied six matched pairs of nursing homes; at one randomly selected nursing home in each pair, physicians, nurses, and aides participated in an educational program in geriatric psychopharmacology. At base line we determined the type and quantity of drugs received by all residents (n = 823), and a blinded observer performed standardized clinical assessments of the residents who were taking psychoactive medications. After the five-month program, drug use and patient status were reassessed. RESULTS: Scores on an index of psychoactive-drug use, measuring both the magnitude and the probable inappropriateness of medication use, declined significantly more in the nursing homes in which the program was carried out (experimental nursing homes) than in the control nursing homes (decrease, 27 percent vs. 8 percent; P = 0.02). The use of antipsychotic drugs was discontinued in more residents in the experimental nursing homes than in the control nursing homes (32 percent vs. 14 percent); the comparable figures for the discontinuation of long-acting benzodiazepines were 20 percent vs. 9 percent, and for antihistamine hypnotics, 45 percent vs. 21 percent. In the experimental nursing homes residents who were initially taking antipsychotic drugs showed less deterioration on several measures of cognitive function than similar residents in the control facilities, but they were more likely to report depression. Those who were initially taking benzodiazepines or antihistamine hypnotic agents reported less anxiety than controls but had more loss of memory. Most other measures of clinical status remained unchanged in both groups. CONCLUSIONS: An educational program targeted to physicians, nurses, and aides can reduce the use of psychoactive drugs in nursing homes without adversely affecting the overall behavior and level of functioning of the residents.

Linking multiple heterogeneous data sources to practice guidelines.

The BiliLIGHT system is a World Wide Web (Web) based system that integrates an interactive clinical practice guideline with real-time patient-data retrieval from remote heterogeneous data sources to help clinicians manage newborn jaundice at the point of care in three clinical settings. We briefly describe the system, how actual information exchange of medical data across institutional boundaries was achieved, and how the data were connected to a CPG. In particular, we examine the requirements for patient identification, exchange protocols, authentication, and a standard vocabulary.

The challenges of automating a real-time clinical practice guideline.

OBJECTIVE: To elucidate the types of problems encountered during implementation of a World Wide Web-based clinical practice guideline to manage hyperbilirubinemia in newborn infants. DESIGN: Formative assessment of an automated clinical-practice guideline in a large-scale implementation. SETTING: Primary-care clinics and offices, inpatient clinics, and emergency department affiliated with an academic children's hospital. PARTICIPANTS: General pediatricians, neonatologists, pediatric nurses, and computer scientists. RESULTS: Existing guidelines for hyperbilirubinemia management could not be translated directly into web pages. Modifications of the original guidelines were required to represent the clinical intent of the guidelines accurately. In addition, the automated guideline was augmented to incorporate a mechanism for generating clinical encounter forms in order for the system to be accepted into the clinical work flow. Other clinical considerations that influenced the final form of the automated guideline included limitations of computer resources and time constraints during patient encounters. CONCLUSIONS: Many existing guidelines are not amenable to straightforward implementation in automated systems. Strategies to increase the efficacy of the automated guidelines included guideline modifications, as well as careful consideration of the flow of clinical work. Repeated cycles of development and pilot testing are needed to design methods to accommodate the constraints imposed by clinical use.

Symptoms and suffering at the end of life in children with cancer.

BACKGROUND: Cancer is the second leading cause of death in children, after accidents. Little is known, however, about the symptoms and suffering at the end of life in children with cancer. METHODS: In 1997 and 1998, we interviewed the parents of children who had died of cancer between 1990 and 1997 and who were cared for at Children's Hospital, the Dana-Farber Cancer Institute, or both. Additional data were obtained by reviewing medical records. RESULTS: Of 165 eligible parents, we interviewed 103 (62 percent), 98 by telephone and 5 in person. The interviews were conducted a mean (+/-SD) of 3.1+/-1.6 years after the death of the child. Almost 80 percent died of progressive disease, and the rest died of treatment-related complications. Forty-nine percent of the children died in the hospital; nearly half of these deaths occurred in the intensive care unit. According to the parents, 89 percent of the children suffered "a lot" or "a great deal" from at least one symptom in their last month of life, most commonly pain, fatigue, or dyspnea. Of the children who were treated for specific symptoms, treatment was successful in 27 percent of those with pain and 16 percent of those with dyspnea. On the basis of a review of the medical records, parents were significantly more likely than physicians to report that their child had fatigue, poor appetite, constipation, and diarrhea. Suffering from pain was more likely in children whose parents reported that the physician was not actively involved in providing end-of-life care (odds ratio, 2.6; 95 percent confidence interval, 1.0 to 6.7). CONCLUSIONS: Children who die of cancer receive aggressive treatment at the end of life. Many have substantial suffering in the last month of life, and attempts to control their symptoms are often unsuccessful. Greater attention must be paid to palliative care for children who are dying of cancer.