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Biomedical subjects

C D Naylor

Publications and source records attributed to C D Naylor.

At least 19 recordsLinked to original sources

Vitamin B12 injections versus oral supplements. How much money could be saved by switching from injections to pills?

OBJECTIVE: To estimate savings, using a third-party payer perspective, if all elderly patients currently receiving vitamin B12 (cobalamin) injections were switched to high-dose oral therapy. DESIGN: We modeled high-dose oral B12 supplement costs to include drugs, pharmacists' fees, and one-time conversion costs consisting of two physician visits and laboratory monitoring. The number of vitamin-injection visits avoided by switching to oral therapy was predicted using a multivariate model that considered covariates for overall patient illness. SETTING: Ontario family physicians' and internists' practices. PARTICIPANTS: Population-based administrative databases for Ontario were used to identify all people between 65 and 100 years who received parenteral vitamin B12 during 1995 and 1996. MAIN OUTCOME MEASURES: The cost of parenteral vitamin B12 for each patient, including drugs, injections, pharmacists' fees, and injection-associated physician visits, was measured directly from the databases. RESULTS: The annual cost of parenteral vitamin B12 therapy averaged $145.88 per person and totaled a maximum $25 million over 5 years. Converting all patients to high-dose oral B12 and treating them for 5 years would cost $7.4 million. Depending on how many vitamin-injection visits are avoided by switching to oral therapy, between $2.9 million and $17.6 million would be saved. Switching to oral B12 administration saved costs as long as 16.3% of injection-associated visits were avoided. CONCLUSION: Switching all patients from B12 injections to oral cobalamin therapy could result in substantial savings.

Administration, Oral↗

Users' Guides to the Medical Literature: XXV. Evidence-based medicine: principles for applying the Users' Guides to patient care. Evidence-Based Medicine Working Group.

This series provides clinicians with strategies and tools to interpret and integrate evidence from published research in their care of patients. The 2 key principles for applying all the articles in this series to patient care relate to the value-laden nature of clinical decisions and to the hierarchy of evidence postulated by evidence-based medicine. Clinicians need to be able to distinguish high from low quality in primary studies, systematic reviews, practice guidelines, and other integrative research focused on management recommendations. An evidence-based practitioner must also understand the patient's circumstances or predicament; identify knowledge gaps and frame questions to fill those gaps; conduct an efficient literature search; critically appraise the research evidence; and apply that evidence to patient care. However, treatment judgments often reflect clinician or societal values concerning whether intervention benefits are worth the cost. Many unanswered questions concerning how to elicit preferences and how to incorporate them in clinical encounters constitute an enormously challenging frontier for evidence-based medicine. Time limitation remains the biggest obstacle to evidence-based practice but clinicians should seek evidence from as high in the appropriate hierarchy of evidence as possible, and every clinical decision should be geared toward the particular circumstances of the patient.

Clinical Competence↗

Rate of heart failure and 1-year survival for older people receiving low-dose beta-blocker therapy after myocardial infarction.

BACKGROUND: Many older people do not receive beta-blocker therapy after myocardial infarction or receive doses lower than those tested in trials, perhaps because physicians fear that beta-blockers may precipitate heart failure. We examined the relation between use of beta-blockers, the dose used, and hospital admission for heart failure and 1-year survival in a cohort of all older patients surviving myocardial infarction in Ontario, Canada. METHODS: We collected data on a cohort of 13,623 patients aged 66 years or older who were discharged from hospital after a myocardial infarction and who did not receive beta-blocker therapy or received low, standard, or high doses. We used Cox's proportional-hazards models to study the association of dose with admission for heart failure and survival with adjustment for factors including age, sex, and comorbidity. FINDINGS: Among 8232 patients with no previous history of heart failure, dispensing of beta-blocker therapy was associated with a 43% reduction in subsequent admission for heart failure (adjusted risk ratio 0.57 [95% CI 0.48-0.69]) compared with patients not dispensed this therapy. Among the 4681 patients prescribed beta-blockers, the risk of admission was greater in the high-dose than in the low-dose group (1.53 [1.01-2.31]). Among all 13,623 patients in the cohort, 2326 (17.1%) died by 1 year. Compared with those not dispensed beta-blocker therapy, the adjusted risk ratio for mortality was lower for all three doses (low 0.40 [0.34-0.47], standard 0.36 [0.31-0.42], high 0.43 [0.33-0.56]). INTERPRETATION: Compared with high-dose beta-blocker therapy, low-dose treatment is associated with a lower rate of hospital admission for heart failure and has a similar 1-year survival benefit. Our findings support the need for a randomised controlled trial comparing doses of beta-blocker therapy in elderly patients.

Adrenergic beta-Antagonists↗

Users' guides to the medical literature: XXIV. How to use an article on the clinical manifestations of disease. Evidence-Based Medicine Working Group.

Clinicians rely on knowledge about the clinical manifestations of disease to make clinical diagnoses. Before using research on the frequency of clinical features found in patients with a disease, clinicians should appraise the evidence for its validity, results, and applicability. For validity, 4 issues are important-how the diagnoses were verified, how the study sample relates to all patients with the disease, how the clinical findings were sought, and how the clinical findings were characterized. Ideally, investigators will verify the presence of disease in study patients using credible criteria that are independent of the clinical manifestations under study. Also, ideally the study patients will represent the full spectrum of the disease, undergo a thorough and consistent search for clinical findings, and these findings will be well characterized in nature and timing. The main results of these studies are expressed as the number and percentages of patients with each manifestation. Confidence intervals can describe the precision of these frequencies. Most clinical findings occur with only intermediate frequency, and since these frequencies are equivalent to diagnostic sensitivities, this means that the absence of a single finding is rarely powerful enough to exclude the disease. Before acting on the evidence, clinicians should consider whether it applies to their own patients and whether it has been superseded by new developments. Detailed knowledge of the clinical manifestations of disease should increase clinicians' ability to raise diagnostic hypotheses, select differential diagnoses, and verify final diagnoses. JAMA. 2000;284:869-875

Diagnosis↗

Users' guides to the medical literature: XXII: how to use articles about clinical decision rules. Evidence-Based Medicine Working Group.

Clinical experience provides clinicians with an intuitive sense of which findings on history, physical examination, and investigation are critical in making an accurate diagnosis, or an accurate assessment of a patient's fate. A clinical decision rule (CDR) is a clinical tool that quantifies the individual contributions that various components of the history, physical examination, and basic laboratory results make toward the diagnosis, prognosis, or likely response to treatment in a patient. Clinical decision rules attempt to formally test, simplify, and increase the accuracy of clinicians' diagnostic and prognostic assessments. Existing CDRs guide clinicians, establish pretest probability, provide screening tests for common problems, and estimate risk. Three steps are involved in the development and testing of a CDR: creation of the rule, testing or validating the rule, and assessing the impact of the rule on clinical behavior. Clinicians evaluating CDRs for possible clinical use should assess the following components: the method of derivation; the validation of the CDR to ensure that its repeated use leads to the same results; and its predictive power. We consider CDRs that have been validated in a new clinical setting to be level 1 CDRs and most appropriate for implementation. Level 1 CDRs have the potential to inform clinical judgment, to change clinical behavior, and to reduce unnecessary costs, while maintaining quality of care and patient satisfaction. JAMA. 2000;284:79-84

Decision Support Techniques↗

Postmenopausal estrogen replacement therapy and increased rates of cholecystectomy and appendectomy.

BACKGROUND: Several studies have indicated that estrogen may prime inflammatory and nociceptive pathways, leading to symptoms that mimic cholecystitis. We set out to confirm the relation between recent estrogen use and cholecystectomy in postmenopausal women and to test the novel hypothesis that a similar relation exists for appendectomy. METHODS: We developed a retrospective cohort using prescribing and surgical procedure information from health administrative databases for approximately 800,000 female residents of Ontario who were over 65 years of age between July 1, 1993, and Mar. 31, 1998. We compared the incidence of cholecystectomy and appendectomy among women recently prescribed estrogen replacement therapy, levothyroxine and dihydropyridine calcium-channel antagonists (DCCA) using age-adjusted Cox proportional hazards models. Patients were followed for a mean of 540 (standard deviation [SD] 449) days. RESULTS: Compared with women taking DCCA, those who had recently begun taking estrogen were significantly more likely to undergo cholecystectomy (age-adjusted risk ratio [aRR] 1.9, 95% confidence interval [CI] 1.6-2.2) and appendectomy (aRR 1.8, 95% CI 1.1-3.0). No significant difference in either outcome measure was found between the levothyroxine users and the DCCA users. INTERPRETATION: This study identifies an increased risk of cholecystectomy and appendectomy among postmenopausal women who have recently begun estrogen replacement therapy.

Aged↗

Benchmarking the vital risk of waiting for coronary artery bypass surgery in Ontario.

BACKGROUND: Deaths among patients awaiting coronary artery bypass grafting (CABG) are a source of private grief and public concern in Canada. However, some deaths are expected over time among patients with coronary artery disease. Methods of benchmarking the burden of delayed care may be useful in understanding and managing waiting lists for CABG and other health services. The authors therefore determined the vital risk among people waiting for CABG in Ontario and compared it with the risk in the general population and among people living with coronary artery disease. METHODS: Patients registered to undergo CABG in Ontario between 1991 and 1995 were followed to ascertain numbers and dates of preoperative deaths or completed operations. Linking hospital discharge abstract data to vital statistics for 1991 to 1994, the authors defined a cohort of people who had survived 6 months after an acute myocardial infarction (AMI) and followed them for an additional 6 months to determine numbers and dates of deaths. They matched patients by age and sex and then calculated the standardized mortality ratio for each cohort (i.e., the ratio of observed deaths to those expected based on age- and sex-specific daily probabilities of death for the provincial population). RESULTS: Among 21,220 patients awaiting CABG, there were 82 preoperative deaths over a median follow-up of 18 days; the standardized mortality ratio was 2.92 (95% confidence limit [CL] 2.29-3.55). Among 21,220 matched 6-month survivors of an AMI, there were 663 deaths over a median follow up of 185 days; the standardized mortality ratio was 3.84 (95% CI 3.54-4.14). INTERPRETATION: Patients awaiting CABG in Ontario are at a much greater risk of death than the general population. However, when compared with thousands of other patients living with coronary artery disease, they are at similar or decreased vital risk.

Aged↗

Prognostic significance of diabetes as a predictor of survival after cardiac catheterization. APPROACH Investigators. Alberta Provincial Program for Outcome Assessment in Coronary Heart Disease.

PURPOSE: Diabetes is a recognized risk factor for the development of cardiac disease, but its importance as a prognostic factor among patients with known cardiovascular disease is less clear. We evaluated survival in patients with and without diabetes who underwent cardiac catheterization for presumed coronary artery disease. SUBJECTS AND METHODS: We analyzed data from a prospective cohort study that captures detailed clinical information and longitudinal outcomes for all patients who undergo cardiac catheterization in Alberta, Canada. We studied 11,468 patients, 1959 (17%) of whom had diabetes. Logistic regression was used to model predictors of 1-year mortality, and proportional hazards analysis was used to model predictors of survival up to 3 years after cardiac catheterization. RESULTS: One-year mortality was 7.6% for patients with diabetes versus 4.1% for those without diabetes (odds ratio = 1.9, 95% confidence interval [CI]: 1.6 to 2.3). After adjusting for other characteristics of the patients, including comorbid conditions, previous cardiac history, coronary anatomy, and renal function, the odds ratio for 1-year mortality was 1.1 (95% CI: 0.8 to 1.3). Similarly, the adjusted hazard ratio for longer term mortality was 1. 2 (95% CI: 1.0 to 1.4, mean follow-up of 702 days). CONCLUSIONS: These results suggest that there is little or no independent association between diabetes and mortality for up to 3 years after cardiac catheterization. Estimates of short- to intermediate-term prognosis for diabetic patients with coronary artery disease should be based on the presence of other prognostic factors associated with diabetes.

Aged↗

Predictive accuracy study: comparing a statistical model to clinicians' estimates of outcomes after coronary bypass surgery.

BACKGROUND: The purpose of this study was to compare clinicians' prior probability estimates of operative mortality (OM) and prolonged intensive care unit stay (ICU) length of stay greater than 48 hours after coronary artery bypass graft surgery (CABG) with estimates derived from statistical models alone. METHODS: Nine clinicians estimated the predicted probability of OM and ICU stay greater than 48 hours from an abstract of information for each of 100 patients selected from the 1996 to 1997 database of 1,904 patients who underwent isolated CABG. Logistic regression models were used to calculate the predicted probability of OM and ICU stay greater than 48 hours for each patient. The study sample was split into two parts; clinicians were randomly given access to a predictive rule to guide their judgements for one part of the study. RESULTS: Clinicians' estimates were similar with or without access to the rule, and both parts of the study were therefore pooled. Clinicians significantly overestimated the probability of OM (model 6.3% +/- 1%, clinicians 7.6% +/- 3%, p = 0.0001) and ICU stay greater than 48 hours (model 25% +/- 2%, clinicians 28% +/- 1%, p = 0.0012). Clinicians' estimates of OM were not significantly higher than the model's for nonsurvivors (0.8% +/- 0.7%, p = 0.2), but were significantly higher for survivors (1.4% +/- 0.3%, p = 0.039). CONCLUSIONS: Clinicians trusted their own empiric estimates rather than a predictive rule and overestimated the probability of OM and ICU stay greater than 48 hours.

Aged↗

Dealing with missing data in observational health care outcome analyses.

Observational outcome analyses appear frequently in the health research literature. For such analyses, clinical registries are preferred to administrative databases. Missing data are a common problem in any clinical registry, and pose a threat to the validity of observational outcomes analyses. Faced with missing data in a new clinical registry, we compared three possible responses: exclude cases with missing data; assume that the missing data indicated absence of risk; or merge the clinical database with an existing administrative database. The predictive model derived using the merged data showed a higher C statistic (C = 0.770), better model goodness-of-fit as measured in a decile-of-risk analysis, the largest gradient of risk across deciles (46.3), and the largest decrease in deviance (-2 log likelihood = 406.2). The superior performance of the enhanced data model supports the use of this "enhancement" methodology and bears consideration when researchers are faced with nonrandom missing data.

Adult↗

Subgroups, treatment effects, and baseline risks: some lessons from major cardiovascular trials.

BACKGROUND: The objective of this study was to determine how subgroup analyses are performed in large randomized trials of cardiovascular pharmacotherapy. METHODS AND RESULTS: We reviewed 67 randomized, double-blind, controlled trials involving pharmacotherapy in at least 1000 patients with unstable angina, myocardial infarction, left ventricular dysfunction, or heart failure with clinical outcomes as primary end points, published between 1980 and 1997. Nine had no subgroup analyses but 43 reported on 5 or more subgroups and 31 reported subgroups without formal statistical tests for treatment-subgroup interactions. In most trials, a rationale for subgroup selection was missing. All but 6 focused on single-factor subgroups. CONCLUSIONS: Trial subgroups should ideally be defined a priori on 2 bases: single-factor subgroups with a strong rationale for biological response modification and multifactorial prognostic subgroups defined from baseline risks. However, single-factor subgroup analyses are often reported without a supporting rationale or formal statistical tests for interactions. We suggest that clinicians should interpret published subgroup-specific variations in treatment effects skeptically unless there is a prespecified rationale and a significant treatment-subgroup interaction.

Angina, Unstable↗

Temporal changes in the outcomes of acute myocardial infarction in Ontario, 1992-1996.

BACKGROUND: There is relatively little information available on recent population-based trends in the outcomes of patients who have had an acute myocardial infarction (AMI). We, therefore, conducted a study of temporal trends in the outcomes of AMI patients in Ontario, Canada, between the 1992 and 1996 fiscal years. METHODS: 114,618 AMI patients were discharged from hospitals in Ontario between Apr. 1, 1992, and Mar. 31, 1997. After specific exclusion criteria were applied the final sample of 89,456 patients was divided into 5 cohorts according to the fiscal year of discharge. As part of the Ontario Myocardial Infarction Database project the linked administrative data pertaining to these patients were used to examine cohort characteristics, cardiac procedures used and mortality rates for each of the 5 cohorts over time. RESULTS: There was a significant increase in the percentage of patients in Ontario receiving coronary angiography, percutaneous transluminal coronary angioplasty and coronary artery bypass grafting surgery (p < 0.001) after an AMI between 1992 and 1996. In addition, the overall 30-day risk-adjusted mortality rate declined from 15.5% in 1992 to 14.0% in 1996 (p = 0.001) and the 1-year risk-adjusted mortality rate declined from 23.7% in 1992 to 22.3% in 1996 (p = 0.017). Virtually all of the improvement occurred within 30 days of admission. The absolute decline in 1-year mortality rates was significant for patients under the age of 65 (2.3%, 95% confidence interval [CI] 1.4% to 3.2%) and for males (1.2%, 95% CI 0.2% to 2.2%); absolute declines were not significant for patients 65 years of age or older (0.7%, 95% CI -0.6% to 2.0%) and for female patients (-0.1%, 95% CI -1.7% to 1.5%). Interestingly, post-infarction coronary angiography and coronary artery bypass grafting rates were consistently lower in the older and the female patients throughout the study period. INTERPRETATION: There was a modest improvement in the short- and long-term survival of patients in Ontario after an AMI between 1992 and 1996. The Ontario experience suggests that recent advances in AMI management have been of more benefit to younger and male AMI patients.

Age Factors↗

Effects of socioeconomic status on access to invasive cardiac procedures and on mortality after acute myocardial infarction.

BACKGROUND: Universal health care systems seek to ensure access to care on the basis of need rather than income and to improve the health status of all citizens. We examined the performance of the Canadian health system with respect to these goals in the province of Ontario by assessing the effects of neighborhood income on access to invasive cardiac procedures and on mortality one year after acute myocardial infarction. METHODS: We linked claims for payment for physicians' services, hospital-discharge abstracts, and vital-status data for all patients with acute myocardial infarction who were admitted to hospitals in Ontario between April 1994 and March 1997. Patients' income levels were imputed from the median incomes of their residential neighborhoods as determined in Canada's 1996 census. We determined rates of use and waiting times for coronary angiography and revascularization procedures after the index admission for acute myocardial infarction and determined death rates at one year. In multivariate analyses, we controlled for the patient's age, sex, and severity of disease; the specialty of the attending physician; the volume of cases, teaching status, and on-site facilities for cardiac procedures at the admitting hospital; and the geographic proximity of the admitting hospital to tertiary care centers. RESULTS: The study cohort consisted of 51,591 patients. With respect to coronary angiography, increases in neighborhood income from the lowest to the highest quintile were associated with a 23 percent increase in rates of use and a 45 percent decrease in waiting times. There was a strong inverse relation between income and mortality at one year (P<0.001). Each $10,000 increase in the neighborhood median income was associated with a 10 percent reduction in the risk of death within one year (adjusted hazard ratio, 0.90; 95 percent confidence interval, 0.86 to 0.94). CONCLUSIONS: In the province of Ontario, despite Canada's universal health care system, socioeconomic status had pronounced effects on access to specialized cardiac services as well as on mortality one year after acute myocardial infarction.

Coronary Angiography↗

Fairness in the coronary angiography queue.

BACKGROUND: Since waiting lists for coronary angiography are generally managed without explicit queuing criteria, patients may not receive priority on the basis of clinical acuity. The objective of this study was to examine clinical and nonclinical determinants of the length of time patients wait for coronary angiography. METHODS: In this single-centre prospective cohort study conducted in the autumn of 1997, 357 consecutive patients were followed from initial triage until a coronary angiography was performed or an adverse cardiac event occurred. The referring physicians' hospital affiliation (physicians at Sunnybrook & Women's College Health Sciences Centre, those who practice at another centre but perform angiography at Sunnybrook and those with no previous association with Sunnybrook) was used to compare processes of care. A clinical urgency rating scale was used to assign a recommended maximum waiting time (RMWT) to each patient retrospectively, but this was not used in the queuing process. RMWTs and actual waiting times for patients in the 3 referral groups were compared; the influence clinical and nonclinical variables had on the actual length of time patients waited for coronary angiography was assessed; and possible predictors of adverse events were examined. RESULTS: Of 357 patients referred to Sunnybrook, 22 (6.2%) experienced adverse events while in the queue. Among those who remained, 308 (91.9%) were in need of coronary angiography; 201 (60.0%) of those patients received one within the RMWT. The length of time to angiography was influenced by clinical characteristics similar to those specified on the urgency rating scale, leading to a moderate agreement between actual waiting times and RMWTs (kappa = 0.53). However, physician affiliation was a highly significant (p < 0.001) and independent predictor of waiting time. Whereas 45.6% of the variation in waiting time was explained by all clinical factors combined, 9.3% of the variation was explained by physician affiliation alone. INTERPRETATION: Informal queuing practices for coronary angiography do reflect clinical acuity, but they are also influenced by nonclinical factors, such as the nature of the physicians' association with the catheterization facility.

Adult↗

Will elderly patients stand aside for younger patients in the queue for cardiac services?

BACKGROUND: Fair management of queues for hospital-based services requires consideration of clinical need, but there is no information on public attitudes towards non-clinical factors such as age or work status as determinants of priority. METHODS: We asked elderly residents of Padova, Italy, whether, if they were awaiting cardiac surgery or an outpatient cardiology consultant, they would give up their place in line for a younger or self-employed individual. We also elicited responses from a convenience sample of younger health workers asked to imagine themselves as elderly persons facing the same choices. FINDINGS: The eligible response rate was 72% (443/616). About half deemed it right to give up their place in line for cardiac surgery to a 45-year-old (51%, 95% CI 46-56) or self-employed person (47%, 95% CI 42-51) Proportions were significantly higher for an outpatient consultation (68%, 95% CI 63-72). In multivariate analyses, married respondents, those closer to age 65, university graduates, and those who were formerly self-employed were significantly less likely to respond affirmatively. In significant contrast for all four scenarios (p<0.0001), the overwhelming majority of non-elderly respondents refused to give up their places in line. INTERPRETATION: The majority of elderly citizens were hypothetically willing to cede priority in accessing cardiac care to younger or self-employed persons, but this willingness was attenuated among the "young" elderly and more privileged respondents. Non-elderly respondents were much less self-sacrificing, suggesting that ageing baby-boomers may be more assertive about their continuing rights to health care.

Age Factors↗

Use of vitamin B12 injections among elderly patients by primary care practitioners in Ontario.

BACKGROUND: Excess use of parenteral vitamin B12 has been reported from audits of clinical practices. The authors assessed the use of vitamin B12 injections in patients aged 65 years and over in Ontario. METHODS: A cross-sectional analysis was conducted that included all elderly people covered by the Ontario Health Insurance Plan who received insured services from general practitioners or family physicians (GP/FPs). For each practice the proportion of elderly patients who received regular vitamin B12 injections between July 1996 and June 1997 was calculated. The frequency of injections was determined for each patient receiving regular B12 replacement. RESULTS: Of the 1,196,748 elderly patients (mean age 74.8 [standard deviation 6.8], 58.0% female) treated by 14,177 GP/FPs, 23,651 (2.0%) received regular B12 injections. The rate of B12 injections per patient, standardized for age and sex, varied between practices (range 0%-48.6%). Although no authoritative sources support the practice, 3303 (19.8%) of the 16,707 patients receiving long-term parenteral therapy had, on average, overly frequent injections (more than 1 injection every 4 weeks). For 76 (12.3%) of the 617 practices with 10 or more patients receiving regular vitamin B12 injections, the mean injection frequency was greater than once every 4 weeks. The proportion of patients in these 617 practices who received overly frequent injections varied extensively (0%-100%). INTERPRETATION: Our findings indicate that some primary care physicians in Ontario administer unnecessary vitamin B12 injections to elderly patients.

Aged↗