Access to medical records for research purposes: varying perceptions across research ethics boards.

INTRODUCTION: Variation across research ethics boards (REBs) in conditions placed on access to medical records for research purposes raises concerns around negative impacts on research quality and on human subject protection, including privacy. AIM: To study variation in REB consent requirements for retrospective chart review and who may have access to the medical record for data abstraction. METHODS: Thirty 90-min face-to-face interviews were conducted with REB chairs and administrators affiliated with faculties of medicine in Canadian universities, using structured questions around a case study with open-ended responses. Interviews were recorded, transcribed and coded manually. RESULTS: Fourteen sites (47%) required individual patient consent for the study to proceed as proposed. Three (10%) indicated that their response would depend on how potentially identifying variables would be managed. Eleven sites (38%) did not require consent. Two (7%) suggested a notification and opt-out process. Most stated that consent would be required if identifiable information was being abstracted from the record. Among those not requiring consent, there was substantial variation in recognising that the abstracted information could potentially indirectly re-identify individuals. Concern over access to medical records by an outside individual was also associated with requirement for consent. Eighteen sites (60%) required full committee review. Sixteen (53%) allowed an external research assistant to abstract information from the health record. CONCLUSIONS: Large variation was found across sites in the requirement for consent for research involving access to medical records. REBs need training in best practices for protecting privacy and confidentiality in health research. A forum for REB chairs to confidentially share concerns and decisions about specific studies could also reduce variation in decisions.

Association of physician and hospital volume with use of aspirin and reperfusion therapy in acute myocardial infarction.

BACKGROUND: The association between volume of patients treated and quality of care has important implications for patient referral policies and approaches to quality improvement. Most studies have focused on hospital volume alone and health outcomes. OBJECTIVES: The objective of this work was to examine the association of hospital and physician volume with use of aspirin and reperfusion therapy in the management of acute myocardial infarction (AMI) in eligible patients. METHODS: We reviewed charts of 2,215 patients treated at 35 Minnesota hospitals for AMI between October 1, 1992, and July 31, 1993, comparing use of aspirin and reperfusion therapy in eligible patients across different physician and hospital volume categories through multiple logistic regression. RESULTS: Aspirin use did not vary significantly with physician volume. Use of reperfusion therapy was reduced among the lowest-volume physicians only (adjusted OR, 0.38; 95% CI, 0.15-0.94). Compared with the highest volume hospitals (treating >200 patients), aspirin use among lower-volume hospitals was lower. This was statistically significant only in the hospitals treating <30 patients (adjusted OR, 0.54; 95% CI, 0.30-0.97). These same hospitals had increased odds of using thrombolytics (adjusted OR, 3.02; 95% CI, 1.40-6.53). CONCLUSIONS: Differences in use of aspirin and reperfusion therapy occur at the extremes of hospital and physician volume. These observed differences are in the anticipated direction, except for the increased use of thrombolytics at very-low-volume hospitals. This may be a "desperation reaction" with a perceived lack of other alternatives, such as cardiac catheterization labs and cardiologists.

Delayed thrombolytic treatment of older patients with acute myocardial infarction.

OBJECTIVE: To determine demographic and clinical factors associated with delayed thrombolysis in patients with acute myocardial infarction. DESIGN: A retrospective cohort. SETTING: 37 Minnesota hospitals during the time periods October 1992-July 1993 and July 1995-April 1996. PATIENTS: We reviewed the medical records of 776 older patients aged 65 or older hospitalized with an admission diagnosis of acute myocardial infarction, suspected acute myocardial infarction, or rule-out acute myocardial infarction, who were treated with a thrombolytic agent. MEASUREMENT: We used multivariate logistic regression models to examine the association between selected study characteristics and time between hospital presentation and administration of thrombolytic treatment. Early thrombolysis was defined as less than 60 minutes after hospital presentation and late thrombolysis as 60+ minutes. RESULTS: Of 776 study patients, 57.5% (n = 446) received early thrombolysis. Of the remaining 330 patients receiving late treatment, 12.1% (n = 94) were thrombolyzed more than 2 hours after hospital presentation. After controlling for other factors, the odds of delayed thrombolysis among patients aged 75 or older were 1.48 compared with younger individuals (95% CI, 1.17-1.88). The odds of delayed thrombolysis among patients with severe comorbidity were 1.46 (95% CI, 1.10-1.94) compared with individuals without severe comorbidity. Predictors of early thrombolytic treatment included hospital arrival via emergency transport (ORdelay = 0.46; 95% CI, 0.34-0.63) and chest discomfort at admission (ORdelay = 0.40; 95% CI, 0.18-0.86). CONCLUSIONS: The present study indicates that patients of advanced age and with severe comorbidity are more likely to experience delayed thrombolytic treatment after hospital presentation. These are the patients who suffer the highest morbidity from acute myocardial infarction and for whom expeditious treatment may enhance therapeutic benefit.

The role of research evidence in pharmaceutical policy making: evidence when necessary but not necessarily evidence.

The use of research evidence in policy making at the legislative and administrative levels would appear to be very selective. Focusing on pharmaceutical policy, this paper argues that research evidence is only one ingredient leading to a policy decision and that any examination of research transfer into policy must take into account the many other factors which impact on decision making. The paper describes the policy making process, barriers to the uptake of research evidence into policy and ways of improving research uptake into policy making. Examples are given from drug licensing, remuneration policies, post-marketing surveillance and product withdrawal from the market.

Consultation between cardiologists and generalists in the management of acute myocardial infarction: implications for quality of care.

BACKGROUND: The rapid expansion of managed care in the United States has increased debate regarding the appropriate mix of generalist and specialist involvement in medical care. OBJECTIVE: To compare the quality of medical care when generalists and cardiologists work separately or together in the management of patients with acute myocardial infarction (AMI). METHODS: We reviewed the charts of 1716 patients with AMI treated at 22 Minnesota hospitals between 1992 and 1993. Patients eligible for thrombolytic aspirin, beta-blockers, and lidocaine therapy were identified using criteria from the 1991 American College of Cardiology guidelines for the management of AMI. We compared the use of these drugs among eligible patients whose attending physician was a generalist with no cardiologist input, a generalist with a cardiologist consultation, and a cardiologist alone. RESULTS: Patients cared for by a cardiologist alone were younger, presented earlier to the hospital, were more likely to be male, had less severe comorbidity, and were more likely to have an ST elevation of 1 mm or more than generalists' patients. Controlling for these differences, there was no variation in the use of effective agents between patients cared for by a cardiologist attending physician and a generalist with a consultation by a cardiologist. However, there was a consistent trend toward increased use of aspirin, thrombolytics, and beta-blockers in these patients compared with those with a generalist attending physician only (P<.05 for beta-blockers only). Differences between groups in the use of lidocaine were not statistically significant. The adjusted probabilities of use of thrombolytics for consultative care and cardiologist attending physicians were 0.73 for both. Corresponding probabilities were 0.86 and 0.85 for aspirin and 0.59 and 0.57 for beta-blockers, respectively. CONCLUSIONS: For patients with AMI, consultation between generalists and specialists may improve the quality of care. Recent policy debates that have focused solely on access to specialists have ignored the important issue of coordination of care between generalist and specialist physicians. In hospitals where cardiology services are available, generalists may be caring for patients with AMI who are older and more frail. Future research and policy analyses should examine whether this pattern of selective referral is true for other medical conditions.

Effect of local medical opinion leaders on quality of care for acute myocardial infarction: a randomized controlled trial.

CONTEXT: The effectiveness of recruiting local medical opinion leaders to improve quality of care is poorly understood. OBJECTIVE: To evaluate a guideline-implementation intervention of clinician education by local opinion leaders and performance feedback to (1) increase use of lifesaving drugs (aspirin and thrombolytics in eligible elderly patients, beta-blockers in all eligible patients) for acute myocardial infarction (AMI), and (2) decrease use of a potentially harmful therapy (prophylactic lidocaine). DESIGN: Randomized controlled trial with hospital as the unit of randomization, intervention, and analysis. SETTING: Thirty-seven community hospitals in Minnesota. PATIENTS: All patients with AMI admitted to study hospitals over 10 months before (1992-1993, N=2409) or after (1995-1996, N=2938) the intervention. INTERVENTION: Using a validated survey, we identified opinion leaders at 20 experimental hospitals who influenced peers through small and large group discussions, informal consultations, and revisions of protocols and clinical pathways. They focused on (1) evidence (drug efficacy), (2) comparative performance, and (3) barriers to change. Control hospitals received mailed performance feedback. MAIN OUTCOME MEASURES: Hospital-specific changes before and after the intervention in the proportion of eligible patients receiving each study drug. RESULTS: Among experimental hospitals, the median change in the proportion of eligible elderly patients receiving aspirin was +0.13 (17% increase from 0.77 at baseline), compared with a change of -0.03 at control hospitals (P=.04). For beta-blockers, the respective changes were +0.31 (63% increase from 0.49 at baseline) vs +0.18 (30% increase from baseline) for controls (P=.02). Lidocaine use declined by about 50% in both groups. The intervention did not increase thrombolysis in the elderly (from 0.73 at baseline), but nearly two thirds of eligible nonrecipients were older than 85 years, had severe comorbidities, or presented after at least 6 hours. CONCLUSIONS: Working with opinion leaders and providing performance feedback can accelerate adoption of some beneficial AMI therapies (eg, aspirin, beta-blockers). Secular changes in knowledge and hospital protocols may extinguish outdated practices (eg, prophylactic lidocaine). However, it is more difficult to increase use of effective but riskier treatments (eg, thrombolysis) for frail elderly patients.

Cost effectiveness of multi-therapy treatment strategies in the prevention of vertebral fractures in postmenopausal women with osteoporosis.

OBJECTIVE: The aim of this study was to evaluate the cost effectiveness of multi-therapy treatment strategies in the prevention of vertebral fractures in postmenopausal women with osteoporosis. DESIGN: A retrospective, incremental cost-effectiveness analysis was conducted from a societal perspective. It compared 9 treatment strategies over 3 years and incorporated the willingness of patients to initiate and continue each therapy. MAIN OUTCOME MEASURES AND RESULTS: Four nondominated strategies formed the efficient frontier in the following order: (i) calcium-->no therapy; (ii) ovarian hormone therapy (OHT)-->calcium-->no therapy [166 Canadian dollars ($Can)]; (iii) OHT-->etidronate-->calcium-->no therapy ($Can2331); and (iv) OHT-->alendronate-->calcium-->no therapy ($Can40,965). The figures in parentheses are the incremental costs per vertebral fracture averted to move to that strategy from the previous strategy for patients who had undergone a hysterectomy. CONCLUSIONS: We identified 4 efficient multi-therapy strategies for the treatment of vertebral osteoporosis in postmenopausal women, 2 of which were consistent with the practice guidelines of the Osteoporosis Society of Canada. Decision-makers may select from among these efficient strategies on the basis of incremental cost effectiveness.

Delayed hospital presentation in patients who have had acute myocardial infarction.

BACKGROUND: In patients who have had acute myocardial infarction, the delay between the onset of symptoms and hospital presentation is a critical factor in determining the initial management strategy and outcomes of treatment. OBJECTIVE: To examine the determinants of delayed hospital presentation in patients who have had acute myocardial infarction. DESIGN: Retrospective chart review. SETTING: 37 hospitals in Minnesota. PATIENTS: 2409 persons hospitalized with acute myocardial infarction between October 1992 and July 1993. MAIN OUTCOME MEASURE: Hospital presentation delayed more than 6 hours after the onset of symptoms of acute myocardial infarction. RESULTS: Information on length of delay was available for 2404 patients. Of these patients, 969 (40%) delayed presentation to the hospital for more than 6 hours after the onset of symptoms. Factors associated with prolonged delay included advanced age and female sex. The presence of chest discomfort and a history of mechanical revascularization significantly reduced the risk for prolonged delay. Risk for delay was greatest during the evening and early morning hours (6:00 p.m. to 6:00 a.m.) Patients with a history of hypertension were more likely to delay presentation. Only 42% of all patients hospitalized with acute myocardial infarction had used emergency medical transport services. CONCLUSIONS: Patients who have had acute myocardial infarction often delay hospital presentation. Educational interventions that encourage the prompt use of emergency medical transport services and target specific patient populations, such as elderly persons, women, and persons with cardiac risk factors, may be most successful in reducing the length of delay and improving the outcomes of patients with acute myocardial infarction.

The effect of comorbidity on use of thrombolysis or aspirin in patients with acute myocardial infarction eligible for treatment.

OBJECTIVE: Growing evidence indicates that life-sustaining therapies for the treatment of acute myocardial infarction (AMI) are underused among patients eligible for therapy, including the elderly and women. We examined the effect of a patient's comorbidity burden on use of these highly effective therapies in eligible populations of individuals with AMI. DESIGN: Retrospective cohort design. SETTING AND PATIENTS: We reviewed the medical records of 2,409 individuals at 37 Minnesota hospitals from October 1992 through July 1993 with an admission diagnosis of AMI, suspected AMI, or rule-out AMI, who met electrocardiographic, laboratory, and clinical criteria for AMI. MEASUREMENTS AND MAIN RESULTS: Using multivariate logistic regression models, we determined the association between a validated comorbidity measure and the proportion of eligible patients who received thrombolysis or aspirin. Controlling for other factors previously reported to influence rates of study treatment, the odds of receipt of thrombolysis among patients with severe comorbidity was 0.49 (95% confidence interval [CI] 0.27, 0.88) when compared with individuals without such limitation. Similarly, the odds of aspirin treatment among study patients with severe comorbidity was 0.46 (95% CI 0.30 0.72), compared with individuals without severe comorbidity. We did not distinguish any differences in patterns of treatment with either study treatment among patients with mild or moderate comorbidity when compared with individuals without any concomitant comorbidity. CONCLUSIONS: This study indicates that patients with severe mental and physical comorbidities are less likely to receive standard therapies for AMI recommended in national treatment guidelines.

Adherence to national guidelines for drug treatment of suspected acute myocardial infarction: evidence for undertreatment in women and the elderly.

BACKGROUND: Evidence-based guidelines for the treatment of patients with acute myocardial infarction (AMI) have been published and disseminated by the American College of Cardiology and the American Heart Association. Few studies have examined the rates of adherence to these guidelines in eligible populations and the influence of age and gender on highly effective AMI treatments in community hospital settings. METHODS: Medical records of 2409 individuals admitted to 37 Minnesota hospitals between October 1992 and July 1993 for AMI, suspected AMI, or rule-out AMI, and meeting electrocardiographic, laboratory, and clinical criteria suggestive of AMI were reviewed to determine the proportion of eligible patients who received thrombolytic, beta-blocker, aspirin, and lidocaine hydrochloride therapy. The effects of patient age, gender, and hospital teaching status on the use of these treatments were estimated using logistic regression models. RESULTS: Eligibility for treatment ranged from 68% (n=1627) for aspirin therapy, 38% (n=906) for lidocaine therapy, and 30% (n=734) for thrombolytic therapy to 19% (n=447) for beta-blocker therapy. Seventy-two percent of patients eligible to receive a thrombolytic agent received this therapy; 53% received beta-blockers; 81% received aspirin; and 88% received lidocaine. Among patients ineligible for lidocaine therapy (n=1503), 20% received this agent. Use of study drugs was lower among eligible elderly patients, especially those older than 74 years (thrombolytic agent: odds ratio, 0.2; 95% confidence interval, 0.1 to 0.4; aspirin: odds ratio, 0.4, 95% confidence interval, 0.3 to 0.6; beta-blocker: odds ratio, 0.4; 95% confidence interval, 0.2 to 0.8). Female gender was associated with lower levels of aspirin use among eligible patients (odds ratio, 0.7; 95% confidence interval, 0.6 to 0.9); and there was a trend toward lower levels of beta-blocker and thrombolytic use among eligible women. CONCLUSIONS: Use of lifesaving therapies for eligible patients with AMI is higher than previously reported, particularly for aspirin and thrombolytic use in nonelderly patients. Lidocaine is still used inappropriately in a substantial proportion of patients with AMI. Increased adherence to AMI treatment guidelines is required for elderly patients and women.

Experience in the development of a postmarketing surveillance network: the pharmacy medication monitoring program.

OBJECTIVE: To describe the pilot and early implementation phase of a system for assembling and recruiting cohorts of patients taking selected prescription medications and prospectively monitoring them for new health events. DESIGN: Prospective observational study, based on telephone interviews, of 1475 patients filling prescriptions for a nonsteroidal antiinflammatory drug (NSAID). Patients were interviewed by telephone using trained interviewers at a central site. Hospitalizations and deaths were followed up and reviewed by an independently physician. SETTING: Community setting in a region of Hamilton, Ontario, Canada. PARTICIPANTS: All consenting patients filling new or repeat prescriptions for NSAIDs at participating pharmacies. MAIN OUTCOME MEASURES: The authors report on the development and assessment of systems for: (1) ongoing recruitment of patients through community pharmacies; (2) data transfer from pharmacies to the coordinating center; (3) surveying patients; (4) classifying, coding, and evaluating new health events; and (5) following up on new serious adverse events. RESULTS: Fifty-one percent of patients approached were recruited, and 83% of these provided completed interviews. For patients picking up their own medications, pharmacy workload varied from 4 to 10 minutes per patient approached. Nineteen percent of patients reported having a new health problem or unusual symptom at the initial telephone interview. Reported health-related events were similar to those described in other studies of NSAIDs. CONCLUSIONS: Most aspects of the monitoring system performed well. One limitation was the low recruitment rate for patients who did not directly drop off or pick up their own prescriptions. Even so, this method of patient accrual may complement alternative monitoring programs.