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Objective To evaluate the effectiveness of a multidisciplinary, nonpharmacological, integrative approach that uses shared medical appointments to improve health-related quality of life and reduce opioid medication use in patients with chronic pain. Design This is a retrospective, pre–post review of “Living Well with Chronic Pain” shared medical appointments (August 2016 through May 2018). Setting The appointments included eight 3-hour-long visits held once per week at an outpatient wellness facility. Subjects Patients with chronic, non–cancer-related pain. Methods Patients received evaluation and evidence-based therapies from a team of integrative and lifestyle medicine professionals, as well as education about nonpharmacological therapeutic approaches, the etiology of pain, and the relationship of pain to lifestyle factors. Experiential elements focused on the relaxation techniques of meditation, yoga, breathing, and hypnotherapy, while patients also received acupuncture, acupressure, massage, cognitive behavioral therapy, and chiropractic education. Patients self-reported data via the Patient-Reported Outcomes Measurement Information System (PROMIS-57) standardized questionnaire. Use of opioid medications was evaluated in morphine milligram equivalents. Results A total of 178 participants completed the PROMIS-57 questionnaire at the first and the last visits. Statistically significant improvements in all domains (Physical Functioning, Anxiety, Depression, Fatigue, Social Roles, Pain Interference, and Sleep Disturbance) were observed (P

Poor lifestyle choices play a significant role in the development and progression of preventable chronic diseases, including cancer. In this study, we evaluate the effectiveness of a comprehensive lifestyle medicine intervention on chronic disease risk factors and quality of life in breast cancer survivors.This is a retrospective review of a clinical program from January 2016 to July 2017.It includes seven 2-h group medical visits held every other week at an outpatient wellness facility.Eligible participants are breast cancer survivors who have completed treatment, including those who remain on hormonal therapy.Patients receive education and experience in nutrition, culinary medicine, physical activity, and stress relief practices.Participants' weight, body mass index (BMI), body fat mass, lean body mass, and percent body fat were measured at visit 1 and visit 7. Standard validated questionnaires were used to measure perceived stress, depression, patient activation, physical and mental quality of life, dietary fat consumption, and dietary fruit, vegetable, and fiber consumption.A total of 31 patients participated in the group visits. Pre-post comparison data were not available for 10 patients. More than three-quarters of the 21 breast cancer survivors who attended 5 or more of the 7 group visits and provided data at the first and the last group visit decreased their body weight. On average, patients lost 4.9 pounds (-2.6%, p 0.01), and their BMI decreased by 0.8 kg/mBreast cancer survivors could employ the prescribed lifestyle modifications to produce clinically relevant health benefits. Interdisciplinary teams of health care professionals may help breast cancer survivors with chronic diseases implement evidence-based, individualized, and effective lifestyle prescription through group medical visits.

Healthy lifestyle modifications, including weight management, regular physical activity, prudent diet, and stress relief, have been identified as key components of tertiary cancer prevention. In this study, we evaluate the effectiveness of a comprehensive, lifestyle medicine intervention, Lifestyle 180Retrospective subgroup analysis of a clinical program.An outpatient medical facility.Lifestyle 180 participants with a diagnosis of past cancer.Sixty-four hours of intensive nutrition, culinary medicine, physical activity, and stress relief practices over a 6-month period, with 9- and 12-month follow-up.Pre-postanalysis (baseline vs. 12 months) included biometrics: weight, body mass index (BMI), waist circumference, and blood pressure; standard laboratory tests: lipids, C-reactive protein, fasting insulin/glucose, and insulin resistance; and empirically validated questionnaires: perceived stress, depression, and quality of life.Fifty-eight cancer survivors participated in Lifestyle 180. Average age was 63 years, roughly 75% of participants were female, and the greatest majority had a diagnosis of breast, prostate, or skin cancer. Diagnosis of hyperlipidemia, hypertension, diabetes, and prediabetes presented in 47%, 57%, 22%, and 50% of patients, respectively. Forty-five percent of patients were obese, 24% were overweight, and 16% were depressed. At 12 months, participants lost an average of 14 pounds (-6.6%, p 0.001) and 2.6 inches off their waist (-5.9%, p 0.001). BMI decreased significantly by an average of 2.4 kg/mCancer survivors participating in a comprehensive intervention could employ the prescribed lifestyle modifications to produce clinically relevant health and quality-of-life benefits. These data support the American Cancer Society (ACS) and American Society of Clinical Oncology (ASCO) recommendations to incorporate healthy lifestyle modifications into long-term cancer survivorship care.

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Preoperative cardiac risk stratification algorithms typically use a Bayesian approach to identify a low-risk category group for which the outcome is unlikely to be improved by further testing. This report suggests evaluating common carotid intima-media thickness (CCIMT) as measured by ultrasound to determine whether it strengthens and optimizes perioperative Bayesian risk indices. The idea proposes to use CCIMT Z score and vascular age to quantify atherosclerotic burden. CCIMT may be useful as part of shared decision-making for perioperative care. A website (www.suhitam.com/vascularage) designed by one of the authors (S.M.) is a useful resource.).

Asian Indians have a genetic predisposition to atherothrombotic risk. common carotid intima-media thickness (CCIMT) measured by ultrasound is a quantitative marker for atherosclerotic burden and a derived variable, that is, "CCIMT statistical Z-score (Z-score)" is useful for better quantification. The association between vitamin D deficiency and atherosclerosis is inconclusive. Since, vitamin D deficiency is highly prevalent in India, there is a need to study its relative contribution to subclinical atherosclerotic burden.This prospective cross-sectional study (n = 117) in apparently healthy individuals aged 20 to 60 years sought to identify the determinants of CCIMT Z score with CCIMT measured by "echo-tracking" method. A multivariable linear regression analysis was done with CCIMT Z score as dependent variable and the following as independent variables: age, body mass index, waist-to-height ratio, total cholesterol to HDL ratio (TC-HDL ratio), serum vitamin D3 levels (ng/mL), sex, diabetes mellitus, current cigarette smoking status. A diagnostic prediction model was also developed with a threshold value of 1.96 for CCIMT Z score.The mean (SD) for calendar age (y) was 40 (8). There were 26 (22.22%) individuals in sample with CCIMT Z score ≥1.96 (advanced stage) of whom 14 (23.33%) were

Insomnia is a common complaint of individuals presenting to healthcare providers and is associated with decreased quality of life and higher healthcare utilization. In-person cognitive behavioral therapy (CBT) is an effective treatment for insomnia but is hindered by cost and limited access to treatment. Initial research suggests that Web-based CBT may mitigate these obstacles.This study tests the effectiveness of a Web-based program for insomnia based on principles of CBT and stress management.We conducted a randomized trial with wait-list controls among adults with primary insomnia (n = 88). Two hundred sixty-three adults with comorbid insomnia were also included and analyzed separately. The intervention was a 6-week online program, and effectiveness was measured via the Insomnia Severity Index (ISI).Baseline ISI score for the intervention group (n = 43) was 17.0; 16.6 for the control group (n = 45). At first follow-up, the intervention group (n = 25) had a mean change from baseline of -7.3 (95% CI: -9.0, -5.6), sustained through second follow-up, while the control group (n = 35) had a change of -1.3 (-2.7, 0.1). The between-group difference was statistically significant (p 0.001). Participants in the comorbid insomnia group had a baseline ISI score of 16.7 with improvement similar to the primary insomnia group (-6.9; -7.6, -6.2).We observed clinically meaningful improvements in insomnia severity in adults with primary or comorbid insomnia. Sustained improvement over 4 months underscores the effectiveness of a well-constructed online CBT for insomnia program.Go! to Sleep

PURPOSE We investigated whether a tool using patient-entered wellness data to generate tailored electronic recommendations improved preventive care delivery. METHODS We conducted a mixed-methods retrospective study of primary care encounters utilizing an Integrated Wellness Tool with a matched-comparison before-and-after study design. Encounters took place at a single clinic within the Cleveland Clinic Health System. The primary outcome was preventive orders placed. Index patients were matched, based on propensity scores, with comparison patients seen in the same clinic several months earlier. RESULTS Five providers conducted 863 patient encounters using the tool during the study period. During encounters using the tool, providers placed more orders for smoking cessation programs (2.4 vs 0.5%, P < .01), lifestyle medicine (2.4 vs 0%, P < .01) and psychology (2.3 vs 1.0%, P = .04) consults, online nutrition (2.4 vs 1.4%, P = .04) and stress management (5.5 vs 0.9%, P < .01) programs, spirometry (5.9 vs 1.7%, P < .01) and polysomnography (6.3 vs 1.3%, P < .01) tests, and antidepressant (7.2 vs 3.9%, P = .01) and hypnotic (2.2 vs 0.7%, P = .01) medications when compared with matched encounters. CONCLUSIONS Patients are willing to enter lifestyle data, and these data influence provider orders.

Objective:The objective of this study is to determine the effectiveness of an 8-week web-based, mindfulness stress management program (WSM) in a corporate call center and added benefit of group support.Methods:One hundred sixty-one participants were randomized to WSM, WSM with group support, WSM wit

Eighty observational association studies and several controlled trials provide strong evidence that exercise, done in appropriate amounts and with appropriate techniques, can dramatically enhance well-being and decrease morbidity and mortality. This chapter summarizes the available evidence so that healthcare providers can write rational prescriptions for physical activity for patients that allow minimal activity for maximum health benefit. In brief, doing four physical activities weekly—(1) any kind, (2) strength building, (3) bone strengthening (jumping), and (4) stamina building—and avoiding prolonged (> 1 hr) inactivity by walking for two minutes every hour—provides maximal morbidity and mortality benefit.

Olympic marathon runners and college football stars chug-a-lug beet juice for a performance boost. This humble edible is now an international superstar with top billing in pricey juices. This juice is proposed to work wonders by increasing levels of artery-relaxing nitric oxide (NO). Relaxed

Docosahexaenoic acid (DHA), a long-chain omega-3 polyunsaturated fatty acid, has been used to treat a range of different conditions, including periodontal disease (PD) and inflammatory bowel disease (IBD). That DHA helps with these oral and gastrointestinal diseases in which inflammation and bacterial dysbiosis play key roles, raises the question of whether DHA may assist in the prevention or treatment of other inflammatory conditions, such as the metabolic syndrome, which have also been linked with inflammation and alterations in normal host microbial populations. Here we review established and investigated associations between DHA, PD, and IBD. We conclude that by beneficially altering cytokine production and macrophage recruitment, the composition of intestinal microbiota and intestinal integrity, lipopolysaccharide- and adipose-induced inflammation, and insulin signaling, DHA may be a key tool in the prevention of metabolic syndrome.

Although yoga may help manage conditions comorbid with overweight and obesity, such as low back pain, whether yoga helps with weight loss or maintenance beyond that which can be achieved with diet and exercise remains unclear. A search of multiple databases through September 2012 was undertaken identifying peer-reviewed studies on yoga, meditation, mindfulness, obesity, and overweight. Studies on yoga and weight loss are challenged by small sample sizes, short durations, and lack of control groups. In addition, there is little consistency in terms of duration of formal group yoga practice sessions, duration of informal practices at home, and frequency of both. Studies do however suggest that yoga may be associated with weight loss or maintenance. Mechanisms by which yoga may assist with weight loss or maintenance include the following: (a) energy expenditure during yoga sessions; (b) allowing for additional exercise outside yoga sessions by reducing back and joint pain; (c) heightening mindfulness, improving mood, and reducing stress, which may help reduce food intake; and (d) allowing individuals to feel more connected to their bodies, leading to enhanced awareness of satiety and the discomfort of overeating. Thus, yoga appears promising as a way to assist with behavioral change, weight loss, and maintenance.

Numerous studies reveal the cardiovascular benefits of consuming dietary fiber and, especially, cereal fiber. Cereal fiber is associated with cardiovascular risk reduction through multiple mechanisms and consuming a variety of cereal fiber sources offers health benefits specific to the source. Certain cereal fibers have been studied more extensively than others and provide greater support for their incorporation into a healthful diet. β-glucan from oats or barley, or a combination of whole oats and barley, and soluble fiber from psyllium reduces the risk of coronary heart disease; inulin-type fructans added to foods and beverages may modestly decrease serum triacylglycerols; arabinoxylan and resistant starch may improve glycemic control. Individuals with low cereal fiber intake should increase their intake of whole grains in order to receive the benefits of whole grains in addition to fiber. For those adjusting to the texture and palatability of whole grains, turning to added-fiber products rich in β-glucan and psyllium may allow them to reach their fiber goals without increasing caloric intake.

Purpose. Describe the specifications of the Smoking Prevalence, Savings, and Treatment (SmokingPaST) Framework and show how it can illustrate the impact of quit attempts, quit method, number of new smokers, smoking rates of immigrants and emigrants, and death rates of smokers and nonsmokers on future smoking prevalence rates, program costs, years of life saved, medical costs saved, cost effectiveness of programs, and return on investment (ROI). Framework Specifications. Mathematical relationships among factors in SmokingPaST are described. Input variables include baseline smoking rates among current adults, new adults, immigrants, and emigrants; population counts for these groups; annual quit attempts; and distribution of quit methods. Assumption variables include success rate by quit method, death rates of smokers and nonsmokers, annual medical costs of smoking, costs per person for four tobacco treatment methods, age distribution of quitters, and distribution of medical cost funding by source. Output variables include year-end adult smoking rates, successful quitters, years of life saved by quitting, medical costs saved by quitting and by not hiring smokers, total costs of smoking treatment programs, cost per quitter, cost per life-year saved, distribution of medical cost savings from quitting, and ROI of treatment costs. Applications. The Framework was applied at the employer, county, state, and national levels. Conclusions. The SmokingPaST Framework provides a conceptually simple framework that can be applied to any population. It illustrates that significant drops in smoking rates can be achieved and significant savings in medical costs can be captured by employers as well as state and federal governments through tobacco treatment and prevention programs. Savings are especially important for reducing state and federal government deficits and enhancing job competitiveness.

How to resolve conflicts between hospital policy and the treatment recommendations for an individual patient. Virtual Mentor is a monthly bioethics journal published by the American Medical Association.

BACKGROUND: Strategies to limit adverse cardiac events after vascular surgery continue to evolve. Early recognition and treatment of myocardial ischemia may be a key to improving postoperative survival rates. Cardiac troponin I (cTnI) screening is an effective means of surveillance for postoperative myocardial ischemic injury and has long-term prognostic value. METHODS: We designed a Markov-based decision analysis model to determine the cost-effectiveness of routine surveillance with cTnI on postoperative Days 0, 1, 2, and 3, with an aim to institute tight heart rate control (60–65 bpm) with close monitoring and coronary care in the intensive care unit for 5 days in patients with cTnI 1.5 ng/mL. The key input variables obtained from published literature were as follows: probability of myocardial infarction, 0.049; cost of cTnI surveillance, $357; cost and efficacy of interventions, $13,145 and 0.55, respectively. The time horizon was lifetime and the target population being individuals aged 65 yr (median) undergoing elective open abdominal aortic surgery. The perspective for analysis was third-party payer. RESULTS: The incremental cost-effectiveness ratio for cTnI surveillance was $12,641 per quality-adjusted life year compared with standard care without cTnI surveillance. During one-way sensitivity analysis, probability of myocardial infarction and efficacy of interventions were found to influence the cost-effectiveness. Multivariate sensitivity analysis with second-order Monte Carlo simulation revealed that cTnI surveillance was favored in 90.75% of simulations at a commonly used threshold of $50,000 per quality-adjusted life year. CONCLUSIONS: In patients presenting for elective open abdominal aortic surgery, intensive surveillance with cTnI and early institution of aggressive -blockade is cost-effective. (Anesth Analg 2007;105:1346‐56)

In preparation for an electronic mail (e-mail) and web-based health promotion intervention across multiple worksites, secure, regulatory-compliant, user-friendly e-mail and Internet applications were used to recruit potential participants across worksites, to enroll participants, and to collect baseline health assessment data. Specific hardware and software information technology environments were required of the 19 participating worksites. Sequential e-mails introduced the study and invited participation. Twenty-four percent of all employees (1106 of approximately 4600) provided consent. E-mail delivered a web link for the baseline study assessment, and reminder e-mails were sent to prompt completion. Of those who consented, 888 (80%) completed baseline health and behavior data surveys. An HTML-native web survey software was more stable across computing environments. Using e-mail and web assessment, this research recruited, enrolled, and collected data from more than 850 participants. Technical and operational challenges emerged at each step. Solutions and recommendations are discussed. Overall, this experience suggests that the use of e-mail and web software can facilitate recruitment, enrollment, and data acquisition through direct contact with study participants. This experience yields a series of lessons learned for using e-mail and the Internet to support multi-site trials.

Objectives.Inadvertent sleep episodes are a recognizedcomplication of sleep deprivation. Although such events can be lifethreatening, no system currently exists to detect and prevent sleeponset. Because sleep shares electroencephalographic similarities withthe anesthetized state, we hypothesized that the BIS monitor, acurrently available EEG-based monitor of anesthetic depth, would detectthe onset of physiologic sleep. To test our hypothesis, we monitoredvolunteers during the transition from waking to sleep. Methods.Non-medicated volunteers were asked to lie down in a dark room for30-minutes and fall asleep while attached to a BIS monitor locatedoutside the room. A laptop computer was used to generate an audio toneinside the room. Speaker volume was adjusted to the lowest leveldetectable by the awake subject. Testing was begun by activating acomputer to play a tone at random intervals. The subject was instructedto click a mouse connected to the computer upon hearing the tone toverify wakefulness. The session was terminated upon loss of response tothree consecutive tones or after 30 minutes. Subjects were questionedafterwards regarding their perceptions of sleep during testing.Results.11 out of 28 self-described good sleepers could notsleep under testing conditions. BIS values for the remaining 17 fellfrom 96.4 ± 2.1 to 86.5 ± 0.79 (p 90, and were asleep either by subjective or objective report at BISvalues

Plant-based nutrition achieved coronary artery disease (CAD) arrest and reversal in a small study. However, there was skepticism that this approach could succeed in a larger group of patients. The purpose of our follow-up study was to define the degree of adherence and outcomes of 198 consecutive patient volunteers who received counseling to convert from a usual diet to plant-based nutrition.We followed 198 consecutive patients counseled in plant-based nutrition. These patients with established cardiovascular disease (CVD) were interested in transitioning to plant-based nutrition as an adjunct to usual cardiovascular care. We considered participants adherent if they eliminated dairy, fish, and meat, and added oil.Of the 198 patients with CVD, 177 (89%) were adherent. Major cardiac events judged to be recurrent disease totaled one stroke in the adherent cardiovascular participants—a recurrent event rate of .6%, significantly less than reported by other studies of plant-based nutrition therapy. Thirteen of 21 (62%) nonadherent participants experienced adverse events.Most of the volunteer patients with CVD responded to intensive counseling, and those who sustained plant-based nutrition for a mean of 3.7 years experienced a low rate of subsequent cardiac events. This dietary approach to treatment deserves a wider test to see if adherence can be sustained in broader populations. Plant-based nutrition has the potential for a large effect on the CVD epidemic.

Background Purified palmitoleic acid (16-1; omega-7) has shown lipid-lowering and anti-inflammatory benefits in open label, epidemiologic, and animal studies. Objective Our objective was to perform the first randomized controlled trial of purified palmitoleic acid supplementation in humans. Methods Adults with dyslipidemia and evidence of mild systemic inflammation (high-sensitivity C-reactive protein [hs-CRP] between 2 and 5 mg/L) were randomly allocated to receive either 220.5 mg of cis -palmitoleic acid (n = 30) or an identical capsule with placebo (1000 mg of medium chain triglycerides, n = 30) once per day for 30 days. Participants were asked to maintain their current diet. Serum lipids and hs-CRP were drawn at baseline and study completion. Results At 30 days, there were significant mean (95% confidence interval [CI]) reductions in CRP (−1.9 [−2.3 to −1.4] mg/L), triglyceride (−30.2 [−40.2 to −25.3] mg/dL), and low-density lipoprotein (LDL) (−8.9 [−12.0 to −5.8] mg/dL), and a significant increase in high-density lipoprotein (HDL) (2.4 [1.5, 3.3] mg/dL) in the intervention group compared with control. These changes equated to 44%, 15%, and 8% reductions in CRP, triglyceride, and LDL respectively, and a 5% increase in HDL compared with control. Conclusions Purified palmitoleic acid may be useful in the treatment of hypertriglyceridemia with the beneficial added effects of decreasing LDL and hs-CRP and raising HDL. Further study is needed to elucidate mechanisms and establish appropriate human doses.

Study Objectives: To compare patients' functional ability in the 24-hour postoperative period following a remifentanil compared to a hypnotic-fentanyl-treated anesthesia regimen using a 24-Hour Functional Ability Questionnaire. Design: Prospective, 1:1 single-blind, randomized, controlled effectiveness study. Setting: Multicenter study including 156 hospitals and ambulatory surgery facilities. Patients: 2438 patients (1496 outpatients and 942 inpatients) 18 years of age or older, scheduled for elective surgeries under general endotracheal anesthesia, with an expected duration of unconsciousness of ≥30 minutes. Interventions: Patients were randomized to receive either intravenous remifentanil (0.5 μg/kg/min for induction and intubation; with the infusion rate decreased to 0.25 μg/kg/min after intubation) or fentanyl (administered according to anesthesiologists' usual practice) as the opioid during surgery. Concomitant hypnotic drugs were propofol and/or isoflurane (with or without nitrous oxide) titrated according to protocol. Transition analgesia with either morphine or fentanyl was given in the remifentanil patients and at the discretion of the anesthesiologists in the fentanyl patients. Measurements: A validated set of measurements of functional ability, rather than more traditional clinical psychological methods, to compare the recovery of patients from remifentanil- and fentanyl-treated anesthetic regimens up to 24 hours after surgery. Main Results: Remifentanil was statistically superior to fentanyl for the four functional assessments evaluated: walking without dizziness, thinking clearly, concentration, and communicating effectively. These differences reflect events occurring within the first 24 hours after anesthesia and surgery. Conclusions: A remifentanil-treated anesthetic demonstrated earlier return to some functions than a fentanyl-treated technique. Although functional assessment is a field that is still in its infancy, a questionnaire to assess functional ability during the 24 hours after anesthesia may provide more practical information about anesthetic recovery than previously used, traditional psychomotor evaluations.

This study prospectively determined whether there was a learning curve with the use of remifentanil, as indicated by decreased hemodynamic variability, improved recovery profile, and decreased incidence of opioid-related adverse events with increasing experience. Patients undergoing diverse surgical procedures (outpatient [n = 1340] and inpatient [n = 560]) were enrolled by investigators (n = 190) who had no previous experience with remifentanil use. Each investigator enrolled 10 patients. A standardized protocol for administration of remifentanil was used. Data were analyzed to determine differences between the first three patients and the last three patients enrolled for each anesthesiologist in the study. There were no differences in hemodynamic variables between the first triad and the last triad in either outpatients or inpatients. Requirements for hypnotic drugs and the doses of remifentanil used were also similar between groups. Analgesic medications administered at the end of surgery and in the postanesthesia care unit (PACU) were similar between groups, except that the last triad in the outpatient group received smaller doses of fentanyl compared with the first triad. Times to response to verbal command, tracheal extubation, and operating room discharge did not differ between groups. However, patients in the last triad undergoing outpatient surgery had shorter times to eligibility for PACU discharge, but times to eligibility for discharge home did not differ. The overall incidence of all adverse events (i.e., hypotension, hypertension, muscle rigidity, respiratory depression, apnea, nausea, and vomiting) was less in the last triad as compared with the first triad. When analyzed separately, only the incidence of vomiting (in the outpatient group) was decreased in the last triad as compared with the first triad. This study suggests that there is a learning curve that aids reduction of minor adverse effects associated with the use of analgesic medications administered at the end of surgery in outpatients, which might have reduced the incidence of postoperative vomiting and the duration of PACU stay.This study demonstrated that anesthesiologists rapidly acquire the ability to use remifentanil with limited experience. However, there is a learning curve that aids reduction of minor adverse effects associated with the use of analgesic medications administered at the end of surgery in outpatients, which might have reduced the incidence of postoperative vomiting and the duration of postanesthesia care unit stay.

BACKGROUND Methylnaltrexone is the first peripheral opioid receptor antagonist. It has the potential to prevent or reverse the peripherally mediated gastrointestinal effects of opioids. In previous human volunteer trials, we demonstrated that oral uncoated methylnaltrexone prevented morphine-induced delay in gastrointestinal transit time. METHODS This trial consisted of two studies: a pilot study and a controlled study. The lactulose hydrogen breath test was used to measure the oral-cecal transit time. RESULTS In the pilot study with three subjects, an oral dose of 6.4 mg/kg enteric-coated methylnaltrexone effectively reversed the effects of morphine, producing transit times shorter than baseline levels. Subsequently, in the controlled study with another nine subjects, the transit time increased after intravenous morphine administration in all nine subjects, and the lower dose (3.2 mg/kg) of enteric-coated methylnaltrexone completely prevented the morphine-induced change in oral-cecal transit time in all nine subjects. Morphine significantly increased oral-cecal transit time from baseline level of 96.7 +/- 54.1 minutes (mean +/- SD) to 155.0 +/- 53.6 minutes (P = .014). After enteric-coated methylnaltrexone and morphine, the transit time returned to the baseline level (93.3 +/- 56.0 minutes; P = .55 compared with placebo). Plasma concentrations after 6.4 mg/kg and 3.2 mg/kg enteric-coated methylnaltrexone were substantially lower compared with those after 6.4 mg/kg of the uncoated formulation. CONCLUSION Our results suggest that there is a prevailing direct and local luminal effect of enteric-coated methylnaltrexone and that the enteric-coated formulation exerts its gut pharmacologic actions more efficiently than the uncoated formulation.

In this era of medical technology assessment and evidence-based medicine, evaluating new methods to measure physiologic variables is facilitated by standardization of reporting results. It has been proposed that assessing repeatability be followed by assessing agreement with an established technique. If the “limits of agreement” (mean bias 6 2sd) are not clinically important, then one could use two measurements interchangeably. Generalizability to larger populations is facilitated by reporting confidence intervals. We identified 44 studies that compared methods of clinical measurement published during 1996 to 1998 in seven anesthesia journals. Although 42 of 44 (95.4%) used the limits of agreement methodology for analysis, several inadequacies and inconsistencies in reporting the results were noted. Limits of agreement were defined a priori in 7.1%, repeatability was evaluated in 21.4%, and relationship (pattern) between difference and average was evaluated in 7.1%. Only one of the articles reported confidence intervals. A computer macro for the Minitab statistical package (State College, PA) is described to facilitate reporting of Bland and Altman analysis with confidence intervals. We propose standardization of nomenclature in clinical measurement comparison studies. Implications: A literature review of anesthesia journals revealed several inadequacies and inconsistencies in statistical reports of results of comparison studies with regard to interchangeability of measurement methods. We encourage journal editors to evaluate submissions on this subject carefully to ensure that their readers can draw valid conclusions about the value of new technologies.

Background The authors hypothesized that myoclonus after etomidate is dose-related, could be suppressed when small doses of etomidate were administered before induction, and is unassociated with seizure-like activity on electroencephalogram (EEG). Methods Three studies were performed. In the first study, 36 men were randomly assigned to receive 0.025, 0.050, 0.075, 0.100, 0.200, or 0.300 mg/kg of etomidate. In a second crossover study, eight men were randomly allocated to receive either a pretreatment dose of 0.050 mg/kg etomidate or placebo 50 s before 0.300 mg/kg etomidate was injected. EEG was recorded for subjects in the first two studies. In a third study, 60 patients were randomly allocated to one of three pretreatment doses of etomidate: 0.030, 0.050, or 0.075 mg/kg before 0.300 mg/kg was given. Results In Study 1, myoclonus was not observed after 0.025 or 0.050 mg/kg etomidate. One volunteer had myoclonus after 0.075 mg/kg and another after 0.100 mg/kg etomidate; three had myoclonus after 0.200 mg/kg; and five after 0.300 mg/kg. Incidence of myoclonus was dose-related (P < or = 0.01). In Study 2, two volunteers (25%) with etomidate pretreatment had mild myoclonus compared to six (75%) with placebo pretreatment (P < or = 0.05). EEG changes, other than delta waves, were not seen during myoclonic epochs. In Study 3, myoclonus was less likely after the small pretreatment doses (0.030 or 0.050 mg/kg) than after the large dose (0.075 mg/kg, P < or = 0.01). Conclusions Incidence and intensity of myoclonus after induction with etomidate are dose-related, suppressed by pretreatment, and unassociated with seizure-like EEG activity.

I n attempting to address the issue of medical technology assessment, it is important to define technology. There are numerous definitions of technology. From the broadest perspective, John Kenneth Galbraith defined it as organized knowledge. The United States Congress Office of Technology Assessment defines medical technology as “the techniques, drugs, equipment, and procedures used by healthcare professionals in delivering medical care to individuals, and the systems within which such care is delivered.” Assessment of medical technology therefore is the process of examining and reporting properties of a medical technology, such as safety, efficacy, feasibility, effectiveness, and indications for use. The past century has witnessed an explosion of new medical technologies. Once, medical care was relatively inexpensive because interventions were rare and personnel costs were low. As treatments became effective, new drugs and operations were integrated into routine medical practice, increasing the costs of medical care. Increased usefulness and cost led to the development of medical insurance to pay for new technologies. Payment of traditional medical insurance was retrospective; i.e., physicians and hospitals were reimbursed for procedures that had already been performed. Retrospective payment fueled the development of technology because increased use of technology led to increased reimbursement (Fig. l), and technology, especially in the surgical arena, was left to develop unfettered by scientific proof. Every innovative procedure that could be conceived and tried was reimbursed in the 1960s and 1970s. Recently, there have been dramatic ch.mges in the method of medical reimbursement. IncrepFingly, medical bills are reimbursed on a prospective payment system, involving disease-related groups (DiagnosisRelated Groups [DRG]), accepted procedure codes

Opioid compounds are commonly used analgesics. After opioid administration, troublesome subjective effects, such as dysphoria, dizziness, nausea, and pruritus, have been reported. While some if not all of these are believed to occur due to central nervous system effects of opioids, the anecdotal reports heard from volunteers in our other studies suggest that a peripheral opioid antagonist reduced some of these effects. In this double-blind randomized placebo-controlled study, we evaluated the efficacy of oral methylnaltrexone, a selective peripheral opioid receptor antagonist, to decrease subjective effects after administering morphine to normal human volunteers. After intravenous morphine injection (0.05 mg/kg), significant increases in subjective ratings were obtained on 'nauseous', 'skin itch', 'stimulated', and 'flushing'. Oral methylnaltrexone 19.2 mg/kg significantly decreased these four ratings. Plasma methylnaltrexone concentrations at two different oral doses were also measured to correlate between pharmacological effects of the compound and its plasma levels. Our results suggested that methylnaltrexone has a potential therapeutic value in decreasing some undesirable subjective effects associated with opioid medications.

This study was conducted to survey gut motility and transit in 19 volunteers receiving methadone maintenance who were opioid-dependent, and to measure the oral-cecal transit time in these individuals using the lactulose hydrogen breath test. None of these patients reported constipation problems before use of illicit drugs. During current long-term methadone therapy, 58% of patients experienced some degree of constipation, and two of these 19 patients reported that constipation was a very serious problem. Mean +/- standard deviation (SD) oral-cecal transit time in these individuals was 159+/-49.2 minutes, which is significantly longer than the transit time recorded in two previous studies of healthy volunteers (P < 0.01). These results indicate that tolerance to opioids does not appear to extend to gastrointestinal motility and transit. It seems that patients receiving long-term methadone therapy are a good model for use in evaluating gastrointestinal effects of opioid antagonists.