Prepopulated radiology report templates: a prospective analysis of error rate and turnaround time.

Current speech recognition software allows exam-specific standard reports to be prepopulated into the dictation field based on the radiology information system procedure code. While it is thought that prepopulating reports can decrease the time required to dictate a study and the overall number of errors in the final report, this hypothesis has not been studied in a clinical setting. A prospective study was performed. During the first week, radiologists dictated all studies using prepopulated standard reports. During the second week, all studies were dictated after prepopulated reports had been disabled. Final radiology reports were evaluated for 11 different types of errors. Each error within a report was classified individually. The median time required to dictate an exam was compared between the 2 weeks. There were 12,387 reports dictated during the study, of which, 1,173 randomly distributed reports were analyzed for errors. There was no difference in the number of errors per report between the 2 weeks; however, radiologists overwhelmingly preferred using a standard report both weeks. Grammatical errors were by far the most common error type, followed by missense errors and errors of omission. There was no significant difference in the median dictation time when comparing studies performed each week. The use of prepopulated reports does not alone affect the error rate or dictation time of radiology reports. While it is a useful feature for radiologists, it must be coupled with other strategies in order to decrease errors.

Effect of pravastatin on coronary disease events in subgroups defined by coronary risk factors: the Prospective Pravastatin Pooling Project.

BACKGROUND: Previous trials have had insufficient numbers of coronary events to address definitively the effect of lipid-modifying therapy on coronary heart disease in subgroups of patients with varying baseline characteristics. METHODS AND RESULTS: The data from 3 large randomized trials with pravastatin 40 mg were pooled and analyzed with the use of a prospectively defined protocol. Included were 19 768 patients, 102 559 person-years of follow-up, 2194 primary end points (coronary death or nonfatal myocardial infarction), and 3717 expanded end points (primary end point, CABG, or PTCA). Pravastatin significantly reduced relative risk in younger (<65 years) and older (>/=65 years) patients, men and women, smokers and nonsmokers, and patients with or without diabetes or hypertension. The relative effect was smaller, but absolute risk reduction was similar in patients with hypertension compared with those without hypertension. Relative risk reduction was significant in predefined categories of baseline lipid concentrations. Tests for interaction were not significant between relative risk reduction and baseline total cholesterol (5% to 95% range 177 to 297 mg/dL, 4.6 to 7.7 mmol/L), HDL cholesterol (27 to 58 mg/dL, 0.7 to 1.5 mmol/L), and triglyceride (74 to 302 mg/dL, 0.8 to 3.4 mmol/L) concentrations, analyzed as continuous variables. However, for LDL cholesterol, the probability values for interaction were 0.068 for the prespecified primary end point and 0.019 for the expanded end point. Relative risk reduction was similar throughout most of the baseline LDL cholesterol range (125 to 212 mg/dL, 3.2 to 5.5 mmol/L) with the possible exception of the lowest quintile of CARE/LIPID (<125 mg/dL) (relative risk reduction 5%, 95% CI 19% to -12%). CONCLUSIONS: Pravastatin treatment is effective in reducing coronary heart disease events in patients with high or low risk factor status and across a wide range of pretreatment lipid concentrations.

Training and certification of blood pressure observers.

Accurate, reproducible measurements of blood pressure (BP) were central to the goals and objectives of the Hypertension Detection and Follow-Up Program (HDFP), a multicenter clinical trial on the efficacy of pharmacological treatment of individuals with elevated BP. All potential BP observers with or without previous experience in measuring BP were required to undergo a defined training program and meet set performance criteria to be certified to take HDFP BP. Recertification was required twice a year. Originally an audiotape test was used to measure accuracy of BP readings. This approach was later replaced by a videotape test, which proved more realistic and an equally effective tool for long-term quality control. With this technique of certifications, 75% of the individuals taking the test passed on the first attempt and more than 95% passed with one or two attempts. Although agreement for blinded BP duplicates was generally good, the appearance of sound (systolic BP) was identified with greater reproducibility than was the disappearance (diastolic BP). These recertification procedures were of great value in assuring the continued high quality of our BP data.

Effect of antihypertensive therapy on weight loss. The Trial of Antihypertensive Interventions and Management Research Group.

We report the effect of weight changes of the type of antihypertensive medication prescribed in a trial of the relative efficacy of drug and dietary measures in mild hypertension. The Trial of Antihypertensive Interventions and Management studied 878 mildly hypertensive individuals randomly assigned, in a 3 x 3 design, to no diet change, weight loss, or a low sodium-high potassium diet and to placebo, 25 mg chlorthalidone, or 50 mg atenolol. The type of drug prescribed affected weight change with all diets. The drug effect on weight change, present in all groups at 6 months, was most pronounced in those randomly assigned to the weight loss diet, where the placebo group lost 4.4 kg, the atenolol group lost 3.0 kg, and the chlorthalidone group lost 6.9 kg. The group differences were attenuated but persisted at 24 months. We suggest that the antihypertensive drug prescribed affects the success of a conjoint weight loss program and speculate that the difference between the drugs may be due to their intrinsic effects on the sympathetic nervous system and related metabolic changes.

Systolic Hypertension of the Elderly Program (SHEP). Part 10: Analysis.

The SHEP is a randomized, placebo-controlled trial that will follow standard clinical trial principles in analyzing data relating to its proposed hypotheses. The protocol has stated a priori the main objective as well as the secondary subgroup hypotheses. Sample size calculations for SHEP have accounted for dropins to and drop-outs from active therapy as well as for the risk of nonstroke death. The sample size achieved (4,736 participants) should be adequate to address the proposed questions. Monitoring procedures have been described and established. A data and safety monitoring board that uses these procedures is closely following the data from the trial. The board will periodically examine the data to determine whether termination of the study is warranted.

Quality of life on antihypertensive therapy: a randomized double-blind controlled trial of captopril and atenolol.

A randomized double-blind study lasting 2 months was performed with either 25 mg captopril twice a day or 50 mg atenolol once a day in 125 patients with established diastolic hypertension (diastolic blood pressure greater than 95 mmHg) identified during a population screening programme of subjects aged less than 65 years. Quality of life was assessed from self-completed questionnaires. A significant fall in diastolic blood pressure occurred with both captopril (106.7 +/- 7.0 to 98.6 +/- 8.6 mmHg) and atenolol (107.4 +/- 7.5 to 98.2 +/- 8.1 mmHg) but there was no difference between the two drugs in the size of the fall. A measure of the number of symptomatic complaints, the symptom complaint rate, decreased with both drugs, by 1.3% for captopril and 3.1% for atenolol, but the difference between the drugs was not significant [1.8%; 95% confidence interval (Cl) - 1.3%, 4.9%]. There was a significant increase in the reporting of cough and runny nose in those on captopril compared with atenolol. A health index increased by 1.1% with captopril in comparison with no change on atenolol (difference 1.1%; 95% Cl - 2.0%, 4.2%). Psychological well-being was measured using the Symptom Rating Test. The improvement in total score was 1.4% with captopril and 2.3% with atenolol. The difference of 0.9% was not statistically significant (95% Cl - 1.2%, 3.0%).(ABSTRACT TRUNCATED AT 250 WORDS)

Rationale and design of a secondary prevention trial of lowering normal plasma cholesterol levels after acute myocardial infarction: the Cholesterol and Recurrent Events trial (CARE)

Recent clinical trials of primary and secondary prevention of cardiovascular disease have demonstrated that lowering plasma cholesterol decreases the incidence of coronary heart disease in patients with elevated plasma cholesterol. However, it is not known whether patients with established coronary artery disease and normal plasma cholesterol can be benefited. Several previous prevention trials reviewed in this report found that patients who had plasma cholesterol levels at baseline in the upper portion of the eligibility range (e.g., greater than 240 mg/dl) received greater benefit from hypolipidemic diet or drug therapy than patients who had lower plasma cholesterol levels at baseline. The recent availability of drugs that are more potent and less prone to cause adverse reactions than previous regimens permits this important question to be addressed. The Cholesterol and Recurrent Events trial is testing whether pravastatin, a hydroxymethylglutaryl coenzyme A reductase inhibitor, will decrease the sum of fatal coronary heart disease and nonfatal myocardial infarction (MI) in patients who have recovered from a MI and who have normal total cholesterol levels. Fatal cardiovascular disease and total mortality are important secondary end points. The trial is enrolling 4,000 men and women from 80 centers throughout North America, age 21 to 75 years, who have survived MI for 3 to 20 months, who have plasma total cholesterol less than 240 mg/dl (6.2 mmol/liter) and low-density cholesterol of 115 to 174 mg/dl (3.0 to 4.5 mmol/liter), and who are representative of the general population of patients with MI. Patients are randomized to either active or inactive drug therapy. Active therapy consists of pravastatin, 40 mg/day, designed to achieve an average decrease in low-density lipoprotein cholesterol of approximately 30%, and an increase in high-density lipoprotein of 5%. The average duration of follow-up will be greater than or equal to 5 years. To protect against a lower than expected rate of recurrent events, the trial will be continued until a predetermined fixed number of coronary heart disease events occurs in the entire cohort so that the original sensitivity of the trial will be maintained.

Effect of atenolol and reserpine on selected events in the systolic hypertension in the elderly program (SHEP).

The effect of atenolol and reserpine on incidence of strokes, coronary heart disease (CHD), cardiovascular disease (CVD), and mortality was assessed in 4736 persons aged 60 years and older with isolated systolic hypertension. Participants were randomized to either chlorthalidone (2371), with step-up to atenolol, or reserpine if needed, or placebo (2365). The average baseline SBP/DBP was 170/77 mm Hg. In the active treatment group, step 1, dose 1 was chlorthalidone, 12.5 mg/day; dose 2 was 25 mg/day. For step 2, dose 1 was atenolol 25 mg/day (or reserpine 0.05 mg/day if atenolol was contraindicated); dose 2 was 50 mg/day (reserpine, 0.10 mg/day). During 4.5 years average follow-up, 32% (757) of the active treatment group were on atenolol, with an average exposure of two years and 8% (193) were on reserpine with an average exposure of 1.7 years. Overall there were 96 strokes, 140 CHD events and 289 CVD events among the 2365 active group participants. Using time-dependent lifetable regression with adjustment for several variables, the addition of either atenolol or reserpine to chlorthalidone did not substantially alter the risk ratios for chlorthalidone alone. The relative risk for CHD events for atenolol versus no atenolol was 1.04 (95% confidence interval: 0.58, 1.86) and for reserpine versus no reserpine was 0.93 (95% confidence interval: 0.29, 2.96). The relative risk for atenolol were 0.84 (95% confidence interval: 0.54, 1.30) for death, 1.34 (95% confidence interval: 0.80, 2.28) for stroke, and 1.07 (95% confidence interval: 0.71, 1.61) for CVD. For reserpine, the corresponding relative risks and confidence intervals were 0.65 (0.26, 1.59) for death, 0.27 (0.04, 2.26) for stroke, and 0.55 (0.20, 1.49) for CVD. Thus, the beneficial effects in several outcomes in Systolic Hypertension in the Elderly Program (SHEP) were due to the treatment regimen of lowering blood pressure based on low-dose chlorthalidone (plus atenolol or reserpine as required to meet blood pressure criteria). Additional (independent) benefits attributable to atenolol or to reserpine were not identified. However, a greater number of patients might have been necessary to adequately evaluate potential differential effects of these drugs, especially for reserpine.

Rationale and design for the Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). ALLHAT Research Group.

Are newer types of antihypertensive agents, which are currently more costly to purchase on average, as good or better than diuretics in reducing coronary heart disease incidence and progression? Will lowering LDL cholesterol in moderately hypercholesterolemic older individuals reduce the incidence of cardiovascular disease and total mortality? These important medical practice and public health questions are to be addressed by the Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial (ALLHAT), a randomized, double-blind trial in 40,000 high-risk hypertensive patients. ALLHAT is designed to determine whether the combined incidence of fatal coronary heart disease (CHD) and nonfatal myocardial infarction differs between persons randomized to diuretic (chlorthalidone) treatment and each of three alternative treatments--a calcium antagonist (amlodipine), an angiotensin converting enzyme inhibitor (lisinopril), and an alpha-adrenergic blocker (doxazosin). ALLHAT also contains a randomized, open-label, lipid-lowering trial designed to determine whether lowering LDL cholesterol in 20,000 moderately hypercholesterolemic patients (a subset of the 40,000) with a 3-hydroxymethylglutaryl coenzyme A (HMG CoA) reductase inhibitor, pravastatin, will reduce all-cause mortality compared to a control group receiving "usual care." ALLHAT's main eligibility criteria are: 1) age 55 or older; 2) systolic or diastolic hypertension; and 3) one or more additional risk factors for heart attack (eg, evidence of atherosclerotic disease or type II diabetes). For the lipid-lowering trial, participants must have an LDL cholesterol of 120 to 189 mg/dL (100 to 129 mg/dL for those with known CHD) and a triglyceride level below 350 mg/dL. The mean duration of treatment and follow-up is planned to be 6 years. Further features of the rationale, design, objectives, treatment program, and study organization of ALLHAT are described in this article.

Systolic blood pressure as an independent predictor of mortality in the Hypertension Detection and Follow-up Program.

The Hypertension Detection and Follow-up Program (HDFP) findings demonstrate the predictive value of baseline systolic blood pressure (SBP) and of pulse pressure (PB) in five-year mortality from all causes. Grouping participants into four SBP strata revealed an approximately two-fold increase in age-adjusted mortality rate from SBP stratum I to SBP stratum IV. This effect remained after the contributions of other risk factors were controlled by multivariate analysis. In contrast, baseline diastolic blood pressure (DBP) had little demonstrable effect on mortality in this particular population. The predictive power of pulse pressure was similar to that of SBP. The group mean SBP of every stratum fell progressively during the trial, the change being of greater magnitude in the stepped care (SC) group than in the referred care (RC) group. Also, the reduction in all-cause mortality associated with SC treatment was observed at all levels of baseline SBP. An analysis using life table regression with SBP as a time-dependent variable showed that the postrandomization reduction in SBP was a significant factor in reducing mortality. Similarly, reduced DBP was also contributory. Prospective studies are required to answer definitively the question of the efficacy of treatment of systolic hypertension. Nevertheless, the present analysis of the HDFP data, despite design limitations, supports the advisability of reducing elevated systolic blood pressure.

The effects of verapamil and propranolol on quality of life in hypertension.

Quality of life was evaluated in a four-month randomised double-blind trial of verapamil compared with propranolol in the treatment of hypertension in 94 patients in the UK. Scores on a health status index, measuring activity and perceived health, increased in verapamil patients compared to a decrease in propranolol patients (P = 0.01). Measures of psychiatric morbidity also tended to improve with verapamil and deteriorate with propranolol. Propranolol patients reported more symptoms overall compared with verapamil (P less than 0.05). The prevalence of certain symptoms--headaches, weak limbs and slower walking pace, increased significantly with propranolol compared with verapamil, but constipation was more common in verapamil patients (P less than 0.05). After four months, diastolic blood pressure averaged 86.2 mmHg with verapamil and 90.3 mmHg with propranolol (P = 0.02). However, this difference in final blood pressure did not explain the more favourable quality of life scores with verapamil, and the data suggest that health-related well-being is higher with this drug.

A computer program for an illness-death process with time-dependent covariates.

This paper presents a computer program for estimating transition probabilities between states in a stochastic model for an illness-death process which incorporates time-dependent covariates. Parameters are estimated by the method of maximum likelihood using the Newton-Raphson iterative procedure. The program provides the standard normal deviate statistics as well as the value of the maximum of the likelihood function which can be used on repeated applications to test hypotheses concerning coefficients associated with covariates. Although this program is demonstrated by using a model with two 'illness' states and two 'death' states, it is also suitable for analyzing data with models involving fewer states, such as the analysis of survival time with covariates assuming a proportional hazard model.

Effect of dietary change on the return of hypertension after withdrawal of prolonged antihypertensive therapy (DISH). Dietary Intervention Study of Hypertension.

The possibility exists that dietary modification may increase the number of patients who remain normotensive after drug withdrawal. In an effort to resolve this question, former Hypertension Detection and Follow-up Program Stepped Care participants (n = 496) were randomized into four major groups at the end of the programme (greater than 5 years antihypertensive therapy): controls (continue medication); discontinue medication, no dietary intervention; discontinue medication and weight loss; discontinue medication and reduce sodium. Groups 1, 2 and 4 were further divided into obese (greater than or equal to 120% ideal weight, and non-obese groups). The weight reduction group (greater than or equal to 120% ideal weight) lost 10.1 +/- 11 lbs without changing dietary sodium (n = 87). The sodium restriction group reduced urine sodium excretion from 145 to 97 mEq per day (n = 169). Sixty per cent of the weight loss group were normotensive at 56 weeks compared to 35% withdrawn from medication without dietary intervention. The highest 56 weeks success rates were in the mild non-overweight hypertensives on sodium restriction (78%), and the mild overweight hypertensives on weight reduction (72%). Randomization to either weight loss group or sodium restriction group increased the likelihood of remaining off drugs (adjusted odds ratio of 3.43 for the weight group and 2.17 for the sodium group (P less than 0.05). Age, severe hypertension greater than 5 years previous to entry into Dietary Intervention Study of Hypertension (DISH) or need for several drugs increased the chance of failure.