Weight change in diabetes and glycemic and blood pressure control

OBJECTIVE—Weight loss in type 2 diabetes is undisputedly important, and data from community settings are limited. We evaluated weight change and resulting glycemic and blood pressure control in type 2 diabetic patients at an HMO.RESEARCH DESIGN AND METHODS—Using electronic medical records, this retrospective cohort study identified 2,574 patients aged 21–75 years who received a new diagnosis of type 2 diabetes between 1997 and 2002. We estimated 3-year weight trajectories using growth curve analyses, grouped similar trajectories into four categories using cluster analysis, compared category characteristics, and predicted year-4 above-goal A1C and blood pressure by group.RESULTS—The weight-trajectory groups were defined as higher stable weight (n = 418; 16.2%), lower stable weight (n = 1,542; 59.9%), weight gain (n = 300; 11.7%), and weight loss (n = 314; 12.2%). The latter had a mean weight loss of 10.7 kg (−9.8%; P < 0.001) by 18 months, with near-complete regain by 36 months. After adjusting for age, sex, baseline control, and related medication use, those with higher stable weight, lower stable weight, or weight-gain patterns were more likely than those who lost weight to have above-goal A1C (odds ratio [OR] 1.66 [95% CI 1.12–2.47], 1.52 [1.08–2.14], and 1.77 [1.15–2.72], respectively). Those with higher stable weight or weight-gain patterns were more likely than those who lost weight to have above-goal blood pressure (1.83 [1.31–2.57] and 1.47 [1.03–2.10], respectively).CONCLUSIONS—A weight-loss pattern after new diagnosis of type 2 diabetes predicted improved glycemic and blood pressure control despite weight regain. The initial period postdiagnosis may be a critical time to apply weight-loss treatments to improve risk factor control.Almost all adults with diabetes are overweight; more than half are obese (1). Obesity is associated with worse blood glucose and other cardiovascular risk factor control (2). Results from the Look AHEAD trial show that weight loss in diabetes improves glycemic control, reduces blood pressure, and improves blood lipids (3). Observational studies also support a likely link between weight loss and reduced mortality in people with diabetes (2).Limited data describe the extent to which weight loss, as well as resulting levels of glycemic and blood pressure control, is achieved in community-living people with type 2 diabetes (4,5). Most weight information on these subjects comes from research volunteers (4,5). Prior studies of health effects of weight change have been plagued by confounding of low weight by disease burden and by difficulty separating intentional from unintentional weight loss (6,7).This study used electronic medical records data to evaluate weight trajectories in the initial years following a new type 2 diabetes diagnosis, associated demographic and comorbidity factors, and resulting glycemic and blood pressure control. The initial period after a diabetes diagnosis is of particular interest because this may be a time of heightened patient and clinician interest in patient behavior change (8).     

Correlates of myalgia in electroconvulsive therapy

Myalgias are common in patients treated with electroconvulsive therapy (ECT). The mechanism of this side effect is unknown. Two commonly postulated etiologies are the motor activity during the convulsion and the fasciculations induced by succinylcholine. If the former phenomenon accounts for most of themyalgias, then the appropriate strategy will be to increase the succinylcholine dose at subsequent treatments. If, on the other hand, the latter phenomenon is more important in inducing myalgias, then the appropriate strategy may be to decrease succinylcholine dosages (on the theory that lower doses result in less fasciculating). On the other hand, if neither of these factors accounts for myalgias, then succinylcholine dose adjustments may be irrelevant to myalgias in the ECT situation. In this study, we assessed the degree of convulsive movements during the seizure as well as strength of fasciculations caused by succinylcholine to see which, if either, correlates with ultimate complaints of myalgias. The results indicated that neither of these factors, nor dose of succinylcholine, correlated with myalgias. We conclude that dose adjustments to succinylcholine are unlikely to affect complaints of myalgias in ECT patients.     

Malingering and uncooperativeness in psychiatric and psychological assessment: prevalence and effects in a German sample of claimants

Effort has repeatedly been shown to have a pervasive effect on performance in psychological tests. The current study evaluates to what degree performance on various psychological tests is affected by lack of effort as compared with brain injury. Psychological and medical data from a sample of 233 patients referred from Workers' Compensation Boards or from claimants in personal injury litigation were retrospectively analyzed. Each patient underwent a battery of psychological tests and a medical examination. Measures of effort were derived from the Word Memory Test (WMT) and the Medical Symptom Validity Test (MSVT). Insufficient effort was shown by 44.6% of the patients. The frequency of patients failing the effort tests was independent of age, sex, referral source, and leading complaint. Effort accounted for up to 35% of the variance of performance in the domains of cognitive speed, memory and intelligence. After controlling for effort, there was no significant effect that could be attributed to substantial brain injury. The findings confirm that there is a general and strong effect of effort on psychological test results, which dwarfs the impact of substantial brain injury. Effort testing should become a standard procedure in psychological testing.     

The FDA process for the evaluation and approval of orthopaedic devices

The US Food and Drug Administration (FDA) is a scientific, regulatory, and public health agency whose authority includes overseeing the marketing of products relevant to medical practice. Devices are classified based on the extent of oversight needed to ensure public safety. Divisions within the FDA provide specific expertise regarding drugs, devices, biologic products, and combinations thereof. Various pathways exist to apply for marketing through the FDA, depending on the nature of the product and its intended use. Expert panels advise the agency on issues related to product safety and efficacy, and clinical studies may be required to provide data based on these parameters. Clinical data are monitored postapproval for potential adverse events not evident in earlier trials. Orthopaedic surgeons are involved in all aspects of the FDA as employees, consultants, product advocates, participants in clinical trials and advisory panels, and experts involved in the appropriate reporting of adverse events.     

Assessment of lung tumor motion and setup uncertainties using implanted fiducials

PURPOSE: The purpose of this work was to assess the magnitude of setup uncertainties and respiratory-induced motion of lung tumors by monitoring the location of fiducials implanted in the vicinity of the tumors. METHODS AND MATERIALS: Gold fiducials were implanted in the periphery of lung tumors in 5 patients who had Stage III non-small-cell lung cancer. Fiducial motion was measured using weekly repeated four-dimensional computed tomography (4DCT) imaging and during gated treatment each day using an electronic portal imaging device (EPID). Setup uncertainties were quantified using both the EPID images and the 4DCT data sets. RESULTS: We observed a reduction in fiducial motion (left/right and superior/inferior directions) during gated treatment; however, large gated motion was present (>1 cm). Systematic and random uncertainties based on patient setup ranged from 4 to 6 mm in all three directions as measured using fiducials on gated EPID images and repeat 4DCTs, and using bony anatomy on repeat 4DCTs. CONCLUSIONS: Respiratory gating may be an effective method of reducing average motion during the course of treatment, but large motion is still possible when delivering gated treatment. Setup uncertainties were on the order of, if not larger than, residual gated motion. We recommend careful consideration of all sources of error before reducing margins on the basis of respiratory motion management alone without a strategy for accurate patient setup on a daily basis.