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Biomedical subjects

W Henderson

Publications and source records attributed to W Henderson.

At least 19 recordsLinked to original sources

Custom CAD/CAM total temporomandibular joint reconstruction system: preliminary multicenter report.

PURPOSE: The purpose was to test the outcome of a custom computer assisted design/computer assisted manufactured (CAD/CAM) total temporomandibular joint (TMJ) reconstruction system. PATIENTS AND METHODS: There were 215 patients (13 males and 202 females); the average age at reconstruction was 40.9 +/- 10.3 years (range, 15 to 77 years). There were 363 joints placed, 296 bilateral and 67 unilateral. The patients had TMJ problems for an average of 10.3 +/- 7.0 years (range, 1 to 44 years), and had undergone a mean of 5.4 +/- 4.8 (range, 0 to 28) prior unsuccessful surgeries. Preoperative and postoperative data were collected for up to 48 months using a standardized data collection format. Subjective data related to pain, function of the lower jaw, and diet, were obtained using a visual analogue scale. Objective measures of mandibular range of motion were made directly on the patient preoperatively and postoperatively. RESULTS: Preliminary analysis of these data reveals a statistically significant decrease in pain, an increase in function, and improvement in diet (P < .0001) from the preoperative measurements to 1 and 2 years postoperatively. There was also improvement in mandibular vertical range of motion. The number of previous surgeries was a strong predictor of postoperative pain, function, and diet scores, as well as of maximal interincisal opening. A life table analysis of failures indicates good durability of the prosthesis over time. CONCLUSION: These preliminary data indicate that this custom CAD/CAM total TMJ reconstruction system seems to be useful in the treatment of the multiply operated, and/or anatomically mutilated TMJ.

Adolescent

Measuring activities in clinical trials using random work sampling: implications for cost-effectiveness analysis and measurement of the intervention.

Determining research-related costs from intervention-related costs is important for both clinical and health services research. Often this task involves estimating what proportion of the workday personnel spend on a variety of activities. We used a portable random reminder beeper to measure the daily work activities and contacts of study nurses within the context of a multi-site randomized trial designed to assess the effectiveness of primary care. Nurses recorded 4920 work activities over 140 consecutive workdays. Research-related activities consumed the largest proportion of the workday, 42.5% (95% CI, 38.1-46.7) followed by patient care, 28.8% (24.1-33.2), personal time 16.4% (12.0-20.7), and time spent in transit 12.5% (9.1-15.9). Because this research-related time is spent performing tasks specific to the enrollment of patients and measurement of outcome variables, we will use an adjusted annual salary for these nurses (from $56,392-$32,425) when attributing costs of the intervention in cost-effectiveness analyses and for future management projections. Work sampling is a flexible, inexpensive method that was well accepted by the nurses in this study. Our results provide important insights into the costs analysis of complex interventions involving health professionals and may allow us to explore why the intervention worked or did not work at individual sites.

Clinical Trials as Topic

Veterans Affairs Cooperative Study on glycemic control and complications in type II diabetes (VA CSDM). Results of the feasibility trial. Veterans Affairs Cooperative Study in Type II Diabetes.

OBJECTIVE: It is not clear whether intensive pharmacological therapy can be effectively sustained in non-insulin-dependent diabetes mellitus (NIDDM). The relative risks and benefits of intensive insulin therapy in NIDDM are not well defined. Accordingly, we designed a feasibility study that compared standard therapy and intensive therapy in a group of NIDDM men who required insulin due to sustained hyperglycemia. RESEARCH DESIGN AND METHODS: A prospective trial was conducted in five medical centers in 153 men of 60 +/- 6 years of age who had a known diagnosis of diabetes for 7.8 +/- 4 years. They were randomly assigned to a standard insulin treatment group (one morning injection per day) or to an intensive therapy group designed to attain near-normal glycemia and a clinically significant separation of glycohemoglobin from the standard arm. A four-step plan was used in the intensive therapy group along with daily self-monitoring of glucose: 1) an evening insulin injection, 2) the same injection adding daytime glipizide, 3) two injections of insulin alone, and 4) multiple daily injections. Patient accrual and adherence, glycohemoglobin (HbA1c), side effects, and measurements of endpoints for a prospective long-term trial were assessed. RESULTS: Accrual goals were met, mean follow-up time was 27 months (range 18-35 months), and patients kept 98.6% of scheduled visits. After 6 months, the mean HbA1c in the intensive therapy group was at or below 7.3% and remained 2% lower than the standard group for the duration of the trial. Most of the decrease in the mean HbA1c in the intensive group was obtained by a single injection of evening intermediate insulin, alone or with daytime glipizide. By the end of the trial, 64% of the patients had advanced to two or more injections of insulin a day, aiming for normal HbA1c. However, only a small additional fall in HbA1c was attained. Severe hypoglycemia was rare (two events per 100 patients per year) and not significantly different between the groups, nor were changes in weight, blood pressure, or plasma lipids. There were 61 new cardiovascular events in 40 patients and 10 deaths (6 due to cardiovascular causes). CONCLUSIONS: Intense stepped insulin therapy in NIDDM patients who have failed glycemic control on pharmacological therapy is effective in maintaining near-normal glycemic control for > 2 years without excessive severe hypoglycemia, weight gain, hypertension, or dyslipidemia. Cardiovascular event rates are high at this stage of NIDDM. A long-term prospective trial is needed to assess the risk-benefit ratio of intensified treatment of hyperglycemia in NIDDM patients requiring insulin.

Aged

The National Veterans Administration Surgical Risk Study: risk adjustment for the comparative assessment of the quality of surgical care.

BACKGROUND: The use of surgical outcome in the comparative assessment of the quality of surgical care is predicted on the development of proper models that adjust for the severity of the preoperative risk factors of the patient. The National Veterans Administration Surgical Risk Study was designed to collect reliable, valid data about patient risk and outcome for major surgery in the Veterans Health Administration (VHA) and to report comparative risk-adjusted surgical morbidity and mortality rates for surgical services in VHA. This study describes the rationale and methods used in the Risk Study and reports on the frequency distribution of the data elements that will be used in the development of risk-adjusted reporting of surgical outcome. STUDY DESIGN: This study was a prospective observational study in which dedicated nurses collected preoperative, intraoperative, and outcome data on patients undergoing noncardiac operations using general, spinal, and epidural anesthesia in 44 Veterans Administration Medical Centers. Outcome measures included all cause mortality within the 30 days after the index procedure and 21 major morbidities. RESULTS: Eighty-three thousand nine hundred fifty-eight cases meeting inclusion criteria were entered in the study between October 1, 1991 and December 31, 1993. Ninety-seven percent of patients were men, with a mean age of 60.1 +/- 13.6 (standard deviation) years. The most common preoperative risk factors were smoking (40.7 percent) and hypertension (36.1 percent). Of the patients, 84.6 percent had one or more risk factors. The most common procedures were transurethral resection of the prostate gland (6.7 percent), total knee replacement (3.1 percent), thromboendarterectomy (2.4 percent), partial colectomy (2.2 percent), and total hip replacement (2 percent). The unadjusted mortality rate was 3.1 percent at 30 days. The most common postoperative morbidities were pneumonia (3.6 percent), urinary tract infection (3.5 percent), and failure to wean from the ventilator at 48 hours postoperatively (3.2 percent). Seventeen percent of the patients have one or more major complications. CONCLUSIONS: The Veterans Health Administration has successfully implemented an outcome reporting system for major surgery that prospectively collects patient risk and outcome information reliably and validly. Risk adjustment models and comparative hospital-specific rates of risk-adjusted outcomes are currently being developed.

Aged

Lack of association between patients' measured burden of disease and risk for hospital readmission.

Identifying patients at increased risk for hospital readmission is important for clinicians, health policy-makers, hospital administrators, and researchers. We used a retrospective case-control design to compare the clinimetric properties of five validated indices that measure a patient's disease burden. The study was conducted on a random sample of patients discharged from the general medicine service at the Durham Department of Veterans Affairs Medical Center. Trained observers (two research assistants, one nurse, and two physicians) blinded to readmission status abstracted the required data elements from the medical record for three indices (Charlson, Kaplan-Feinstein, Index of Coexistent Disease). The hospital's computer provided data elements for two indices (Smith, adapted Charlson). Indices varied in the time required to complete, the ability to capture individual heterogeneity, and inter-observer variability. However, none of the indices discriminated among patients who did and those who did not have 6-month hospital readmissions. Factors other than summary scores derived from these indices should be used to identify patients at high risk for readmission.

Aged

Long-term graft patency (3 years) after coronary artery surgery. Effects of aspirin: results of a VA Cooperative study.

BACKGROUND: The long-term success of coronary bypass surgery is dependent on graft patency after surgery. This trial was designed to determine if aspirin improved saphenous vein graft or internal mammary artery (IMA) graft patency between 1 and 3 years after coronary artery bypass grafting (CABG). METHODS AND RESULTS: After receiving aspirin 325 mg/d for 1 year after CABG and undergoing a 1-year postoperative cardiac catheterization, patients were randomized to receive either aspirin (325 mg) or placebo for 2 additional years. Angiography was performed 3 years after surgery to determine the primary end point-saphenous vein graft patency in 288 patients and IMA graft patency in 167 patients. At 3 years after CABG, the saphenous vein graft occlusion rate was 17.0% (62 of 365) for patients treated with aspirin compared with 19.7% (74 of 376) for those who received placebo (P = .404). For saphenous vein grafts that were patent at 1 year, the occlusion rate at 3 years was 4.8% (15 of 313) for patients treated with aspirin compared with 4.2% (13 of 310) for patients who received placebo (P = .757). At 3 years, the IMA graft occlusion rate was 10.3% (8 of 78) for patients treated with aspirin compared with 7.9% (7 of 89) for patients who received placebo (P = .594). For IMA grafts that were patent at 1 year, the occlusion rate was 4.3% (3 of 70) for patients treated with aspirin compared with 2.5% (2 of 81) for patients who received placebo (P = .541). CONCLUSIONS: These data suggest that aspirin treatment does not improve saphenous vein graft or IMA graft patency between 1 and 3 years after CABG.

Aspirin

Glycemic control and complications in type II diabetes. Design of a feasibility trial. VA CS Group (CSDM)

OBJECTIVE: To determine, after 1 yr of follow-up in type II diabetes patients, whether a statistically and clinically significant difference can be achieved in HbA1c between a standard therapy group and an intensively treated group, while maintaining HbA1c levels in both groups within ranges acceptable in regular community practice. Secondary objectives include assessment of patient adherence to protocol, side effects, and accuracy of data collection. RESEARCH DESIGN AND METHODS: This is a prospective, randomized, controlled VA CS conducted with 151 patients at five VAMCs. Patients are males, age 40-69 yr, treated at entry with a maximum dose of sulfonylurea or with insulin, exhibiting an HbA1c level > 3 SDs above the normal mean (5.05 + 3 x 0.50 = > 6.55%). Standard control is achieved with insulin and intensive control with a step-up regimen including insulin alone or insulin/glipizide combinations. Education and management of cardiovascular risk factors are handled similarly in both groups. Primary macrovascular end points are nonfatal myocardial infarction, congestive heart failure, stroke, amputation, and cardiovascular death. Primary microvascular end points are appearance and progression of retinopathy, documented by centrally read seven-field-stereo fundus photographs. Other measured indicators include resting and ambulatory ECGs, ventricular function (MUGA scan), serum lipid and apolipoprotein levels, plasma fibrinogen, nonsymptomatic peripheral vasculopathy, neuroautonomic status by heart-beat variation on Valsalva maneuver, and microalbuminuria. CONCLUSIONS: This study may be the basis for a long-term trial, involving 1400 patients, to assess the long-term effects of metabolic control on macro- and microvascular end points.

Adult

Starting aspirin therapy after operation. Effects on early graft patency. Department of Veterans Affairs Cooperative Study Group.

BACKGROUND: Although aspirin therapy started before operation improves vein graft patency after coronary artery bypass grafting, it also causes bleeding. The objective of this prospective, centrally directed, randomized, double-blind, placebo-controlled trial was to compare the effects of aspirin therapy started before operation with aspirin started 6 hours after operation on early (7-10-day) graft patency. METHODS AND RESULTS: Patients were randomized to receive either aspirin 325 mg or placebo the night before surgery; after operation, all patients received aspirin 325 mg daily, with the first dose administered through the nasogastric tube 6 hours after operation. Angiography was performed in 72% of the analyzed patients an average of 8 days after operation, and the primary end point was saphenous vein graft patency in 351 patients. Internal mammary artery graft patency was also assessed in 246 patients because many individuals received both internal mammary artery and vein grafts. In the patients given preoperative aspirin, the vein graft occlusion rate was 7.4 +/- 1.3% compared with 7.8 +/- 1.5% in those who received preoperative placebo (p = 0.871). In the subgroup of patients receiving Y grafts, 0.0% of the grafts were occluded in the preoperative aspirin group compared with 7.0 +/- 3.6% in the preoperative placebo group (p = 0.066). The internal mammary artery occlusion rate was 0.0% (0 of 131) in the aspirin group compared with 2.4 +/- 1.4% (three of 125) in the placebo group (p = 0.081). Patients in the aspirin group received more transfusions than those in the placebo group (median, 900 versus 725 ml, p = 0.006). The reoperation rate for bleeding in the aspirin group was 6.3% compared with 2.4% in the placebo group (p = 0.036). Median chest tube drainage within the first 6 hours after operation was 500 ml in the aspirin group compared with 448 ml in the placebo group (p = 0.011). CONCLUSIONS: Thus, preoperative aspirin is associated with increased bleeding complications and offers no additional benefit in early vein graft patency compared with starting aspirin therapy 6 hours after operation. There was a trend, although not significant, toward improved early patency for Y grafts and internal mammary artery grafts with preoperative aspirin.

Aged

Comparison of postoperative complications between saphenous vein and IMA grafts to left anterior descending coronary artery.

Considerable controversy exists regarding relative morbidity associated with the saphenous vein graft (SVG) and internal mammary artery (IMA) graft in patients undergoing myocardial revascularization. As a part of the cooperative study on use of antiplatelet drugs for graft patency, operative and postoperative data were prospectively collected on 1,150 patients who underwent either SVG (n = 656) or IMA anastomosis (n = 494) to the left anterior descending coronary artery. There were no differences in baseline characteristics of patients, distribution of randomization among treatment groups, and total number of distal anastomoses performed between the two groups. The aortic cross-clamp time, cardiopulmonary bypass duration, operative time, and chest tube drainage were greater (p = 0.0001) in the patients with IMA grafts compared with SVG. However, there was no difference in the operative mortality rate, the amount of blood and blood products received, the reoperation rate for control of postoperative bleeding, and incidence of wound complications between the two groups. The early and 1-year patency rates for the IMA were slightly but not significantly better than the SVG patency rates (92.8% versus 90.1% for 1-year patency; p = 0.309). In conclusion, use of IMA is associated with a longer operative time as well as increased postoperative bleeding compared with the SVG. It, however, does not increase operative mortality or postoperative morbidity.

Aged

Impact of resident training on postoperative morbidity in patients undergoing single valve replacement. Department of Veterans Affairs Cooperative Study on Valvular Heart Disease.

As one of the requirements of the Department of Veterans Affairs cooperative study on valvular heart disease, operative and postoperative data were prospectively collected in 964 patients undergoing single valve replacement. The procedure was performed either by a resident under the direct supervision of an attending surgeon (49.5%) or by an attending surgeon (50.5%). There was no difference in operative mortality between the two groups of surgeons when adjusted for patient-related and disease-related risk factors. The proportion of patients who had at least one postoperative complication was slightly but not significantly higher in the attending group (35.8% versus 30.4% for aortic valve replacement, 38% versus 28% for mitral valve replacement, and 36% versus 30% for all single valve replacement procedures). As the significance of each complication varies, we weighted each complication to the associated operative mortality to formulate the morbidity score. An expected complication rate for each group was derived from a multivariate logistic model, and the ratio of observed to expected morbidity was calculated to adjust observed morbidity according to the risk of patients. There was no difference in the observed/expected morbidity ratio between the two groups of surgeons. We conclude that currently used teaching techniques and philosophy to educate cardiac surgical residents, which allow them to take progressive responsibility for cardiac surgical procedures, are well justified, and patient care does not suffer when resident training is enhanced.

Aortic Valve

Internal mammary artery and saphenous vein graft patency. Effects of aspirin.

As part of two Department of Veterans Affairs Cooperative Trials, we obtained angiographic patency data for internal mammary artery (IMA) and saphenous vein grafts to the left anterior descending (LAD) coronary artery at 1 year after coronary artery bypass surgery. Patients received either aspirin 325 mg q.d., aspirin 325 mg t.i.d., aspirin 325 mg and dipyridamole 75 mg t.i.d., or placebo. Aspirin was initiated either 12 hours before or 6 hours after operation. Patients were stratified preoperatively for extent of disease and randomized to the therapies outlined above. There was no randomization to IMA versus saphenous vein grafts to the LAD. When the patients taking placebo were compared with those taking aspirin, there were no differences in the IMA (100.0% versus 92.1%, p = 0.385) or vein graft (88.8% versus 90.4%, p = 0.675) patency rates. The patency rate, irrespective of treatment, for all IMA grafts was 92.8% (220 of 237) versus 90.1% (345 of 383) for all vein grafts to the LAD (p = 0.309). Thus, both the IMA and vein grafts had excellent patency rates at 1 year. Aspirin did not alter this at 1 year, and there were no differences between IMA and vein graft patency to the LAD.

Aspirin

Saphenous vein graft patency 1 year after coronary artery bypass surgery and effects of antiplatelet therapy. Results of a Veterans Administration Cooperative Study.

To determine whether antiplatelet therapies improve saphenous vein graft patency after coronary artery bypass grafting, we compared 1) aspirin (325 mg once daily), 2) aspirin (325 mg three times daily), 3) aspirin and dipyridamole (325 mg and 75 mg, respectively, three times daily), 4) sulfinpyrazone (267 mg three times daily), and 5) placebo (three times daily). Therapy with dipyridamole and sulfinpyrazone was started 48 hours before bypass graft surgery, and aspirin treatment was begun 12 hours before surgery as a single 325-mg dose. Postoperative treatment was started 6 hours after surgery and continued for 1 year. Graft patency data were obtained early (median, 9 days) and late (median, 367 days) after surgery. The early graft occlusion rate was decreased with all aspirin treatment regimens compared with that of the placebo regimen. At 1 year, in 406 patients with 1,315 grafts, the graft occlusion rate in all of the aspirin groups combined was 15.8% compared with 22.6% for the placebo group (p = 0.029). The patients taking aspirin once daily had a lower occlusion rate (13.2%) compared with the patients receiving placebo (p = 0.050). At 1 year, in the vein grafts placed to vessels less than or equal to 2.0 mm in diameter (804 distal sites), the graft occlusion rate in all of the aspirin groups was 20.1% compared with 32.3% for the placebo group (p = 0.008). In the vein grafts placed to vessels greater than 2.0 mm in diameter (511 distal sites), there was no difference in the occlusion rates between aspirin and the placebo group at 1 year (8.7% vs. 9.0%, p = 0.918).(ABSTRACT TRUNCATED AT 250 WORDS)

Aspirin

Preoperative identification of patients likely to have left ventricular dysfunction after aortic valve replacement. Participants in the Veterans Administration Cooperative Study on Valvular Heart Disease.

The purpose of this study was to identify preoperative and intraoperative variables predictive of left ventricular dysfunction 6 months after aortic valve replacement. Patients were considered to have postoperative left ventricular dysfunction if the end-diastolic-volume index was greater than or equal to 101 ml/m2 or if the ejection fraction was less than or equal to 0.50. Data from 180 patients entered into the Veterans Administration Cooperative Study on Valvular Heart Disease who had technically satisfactory cardiac catheterizations 6 months postoperatively were analyzed by a series of univariate and multivariate analyses. For the 88 patients with preoperative aortic stenosis, the most powerful predictor of postoperative left ventricular dysfunction in the final multivariate model was preoperative left ventricular ejection fraction (p = 0.0001), followed by preoperative myocardial infarction (p = 0.012), aortic valve gradient (p = 0.020), and incomplete coronary revascularization (p = 0.059). Abnormal preoperative left ventricular ejection fraction had a sensitivity of 72% and a specificity of 82% in identifying patients with postoperative left ventricular dysfunction. Preoperative left ventricular systolic-volume index greater than or equal to 40 ml/m2 had a similar sensitivity and specificity (79% and 84%, respectively). For the 36 patients with aortic regurgitation, preoperative left ventricular ejection fraction was again the most powerful predictor of postoperative left ventricular dysfunction (p = 0.013), followed by left ventricular systolic pressure (p = 0.038) and arteriovenous oxygen difference (p = 0.054). For the 56 patients with mixed aortic stenosis and regurgitation, left ventricular systolic pressure (p = 0.007) and preoperative myocardial infarction (p = 0.022) were the variables predictive of postoperative left ventricular dysfunction. Although many patients with preoperative left ventricular dysfunction experience improved left ventricular performance after aortic valve replacement, performance does not always return to normal. For patients with either aortic stenosis or regurgitation, the strongest predictor of postoperative left ventricular dysfunction is preoperative dysfunction. These data support the concept that patients with moderate or severe aortic stenosis or regurgitation should be operated on before the onset of significant left ventricular dysfunction.

Aortic Valve

Improvement in early saphenous vein graft patency after coronary artery bypass surgery with antiplatelet therapy: results of a Veterans Administration Cooperative Study.

To determine whether specific antiplatelet therapies improved vein graft patency after coronary artery bypass grafting (CABG) we compared (1) aspirin, 325 mg daily, (2) aspirin, 325 mg three times daily, (3) aspirin plus dipyridamole (325 mg and 75 mg, respectively, three times daily), (4) sulfinpyrazone (267 mg three times daily), and (5) placebo (three times daily). Therapy, except aspirin, was started 48 hr before CABG. When aspirin was a treatment, one 325 mg dose was given 12 hr before surgery and therapy was maintained thereafter according to the assigned regimen. Angiographic graft patency data were obtained within 60 days of surgery. Analysis of early graft patency in 555 patients (1781 grafts), revealed the following graft patency rates: aspirin daily, 93.5%; aspirin three times daily, 92.3%; aspirin and dipyridamole, 91.9%; and sulfinpyrazone, 90.2%. All aspirin-containing therapeutic regimens improved (p less than .05) graft patency compared with placebo (85.2%). Chest tube drainage measured within the first 35 hr after CABG revealed that the median loss with aspirin daily (965 ml), aspirin three times daily (1175 ml), and aspirin plus dipyridamole (1000 ml) exceeded (p less than .02) that with placebo (805 ml), while median loss with sulfinpyrazone (775 ml) did not. The reoperation rate was greater (p less than .01) in all the treatment groups that received aspirin (6.5%) compared with the two nonaspirin groups (1.7%). Overall operative mortality was 2.3%, without significant differences among treatment groups. Transient renal insufficiency occurred in 5.3% of patients taking sulfinpyrazone. Thus, early vein graft patency was improved after CABG with all aspirin-containing drug regimens.(ABSTRACT TRUNCATED AT 250 WORDS)

Clinical Trials as Topic

The Vietnam Era Twin (VET) Registry: method of construction.

A Vietnam Era (1964-1975) Twin Registry of American male-male veterans born between 1939 and 1955 has been developed to provide a study sample for research evaluating the impact of Vietnam service on the medical and psychosocial aspects of health. In preparation for developing the Registry, several alternative sources of twins and methods for identifying twins were investigated. A computerized database of veterans discharged from the military after 1967 was selected as the source because it contains about 50% of the total Vietnam era veteran population, is reasonably unbiased, and provides a feasible method for identifying twins. Twins were identified using an algorithm which involved matching entries on the database for same last name, different first name, same date of birth, and similar social security number. Twin status was confirmed by review of military records. The registry, now complete, is composed of 7,400 twin pairs. It will be an important resource for future research projects.

Adult

The Vietnam Era Twin (VET) Registry: ascertainment bias.

An examination of ascertainment bias in identification of twin pairs in the Vietnam Era Twin Registry has been conducted. A complete listing of all male-male Vietnam era veteran twin pairs born in Connecticut between 1939 and 1955 was obtained (N = 150). An attempt was made to match these pairs with a listing of Vietnam era veteran twin pairs derived from the United States Department of Defense's Defense Manpower Data Center (DMDC) computer files. The results indicate that the DMDC files identified only 46.7% of the 150 Connecticut born Vietnam era veteran pairs. Statistically significant differences (P less than 0.05) between pairs found on the DMDC files and Connecticut veteran pairs missing from the DMDC files are observed for the following variables: a) year of discharge from military service, b) total length of active military service, c) branch of service, and d) foreign service. No consistent pattern of bias is observed for factors related to the physical and psychosocial health of veteran pairs. The implications of the ascertainment biases in the Vietnam Era Twin Registry are discussed.

Adult

Dietary patterns and metabolic control in diabetic diets: a prospective study of 51 outpatient men on unmeasured and exchange diets.

In a prospective, single blind study, 51 adult diabetic, male outpatients at or below ideal body weight (IBW), all but four of whom were insulin-treated, were randomly assigned to a calorically defined exchange diet (EXCH) or an unmeasured diet avoiding refined sugars (UNMEAS). Fasting chemistries, weights and 48-hr dietary recalls were obtained every 3 months for 3 years. There was no difference between groups in mean body weight, mean caloric intake, percentages of carbohydrate or fat intake, day to day consistency of caloric intake, or fasting chemistries. The patients whose actual weight tended to be less than IBW consumed more calories than their theoretical calculated needs (p = 0.002) without effect on glycemic control or stability of weight. Patients with low carbohydrate intake (less than 30%) had significantly higher triglyceride levels (p = 0.015). Otherwise, variations in dietary patterns were not reflected in fasting clinical chemistries. Individual fasting serum glucose levels were not related to consistency of carbohydrate intake, caloric distribution throughout the day or composition of diets. These results suggest that actual dietary patterns of subjects following exchange diabetic diets with precise caloric prescriptions are similar to those resulting from unmeasured diets with restriction of simple sugars. Other than correlation between carbohydrate intake and triglycerides, there was no detectable effect of variations in dietary patterns upon conventional chemical metabolic levels.

Adult