Increasing adherence to treatment in epilepsy: what do the strongest trials show?

Patient non-adherence to prescribed anti-epileptic drugs (AEDs) remains a challenge to successful treatment of patients with epilepsy. However, the literature on epilepsy does not document a comprehensive review of interventions to improve adherence as a means to improve clinical outcomes. This study systematically reviews existing literature on interventions to enhance AED adherence and clinical outcomes, and the measures of adherence included in these studies. We selected randomized controlled trials (RCTs) of interventions to enhance adherence with AEDs, which also measured clinical outcomes, with at least 80% follow-up of participants for at least 6 months, from a comprehensive Cochrane review of adherence interventions for medications, complete to January 2013, and updated searches for additional AED studies in multiple bibliographic databases to January 2016. Two review authors independently extracted all data and a third author resolved disagreements. The present update included one trial from the Cochrane review and three RCTs published since, bringing the total number of RCTs on this topic to four. Two types of intervention were tested: educational (e.g., providing information to the patient or carer about treatment characteristics, duration, dosage regime, and how to use the AED) and behavioral (activity in order to remind the patient to take a medicine). Methods of measuring adherence included a combination of direct (plasma AED levels) and indirect measures (prescription refill frequency and appointment keeping) or use alone of self-report adherence on standardized scales. Despite the importance of the problem, evidence is limited concerning enhancement of adherence among people with epilepsy. However, the trials available to date show that medication adherence in epilepsy can be improved, leading to better seizure control.

Efficiency of pragmatic search strategies to update clinical guidelines recommendations.

BACKGROUND: A major challenge in updating clinical guidelines is to efficiently identify new, relevant evidence. We evaluated the efficiency and feasibility of two new approaches: the development of restrictive search strategies using PubMed Clinical Queries for MEDLINE and the use of the PLUS (McMaster Premium Literature Service) database. METHODS: We evaluated a random sample of recommendations from a national guideline development program and identified the references that would potentially trigger an update (key references) using an exhaustive approach. We designed restrictive search strategies using the minimum number of Medical Subject Headings (MeSH) terms and text words required from the original exhaustive search strategies and applying broad and narrow filters. We developed PLUS search strategies, matching Medical Subject Headings (MeSH) and Systematized Nomenclature of Medicine (SNOMED) terms with guideline topics. We compared the number of key references retrieved by these approaches with those retrieved by the exhaustive approach. RESULTS: The restrictive approach retrieved 68.1 % fewer references than the exhaustive approach (12,486 versus 39,136), and identified 89.9 % (62/69) of key references and 88 % (22/25) of recommendation updates. The use of PLUS retrieved 88.5 % fewer references than the exhaustive approach (4,486 versus 39,136) and identified substantially fewer key references (18/69, 26.1 %) and fewer recommendation updates (10/25, 40 %). CONCLUSIONS: The proposed restrictive approach is a highly efficient and feasible method to identify new evidence that triggers a recommendation update. Searching only in the PLUS database proved to be a suboptimal approach and suggests the need for topic-specific tailoring.

A candidate gene approach to searching for low-penetrance breast and prostate cancer genes.

Most cases of breast and prostate cancer are not associated with mutations in known high-penetrance genes, indicating the involvement of multiple low-penetrance risk alleles. Studies that have attempted to identify these genes have met with limited success. The National Cancer Institute Breast and Prostate Cancer Cohort Consortium--a pooled analysis of multiple large cohort studies with a total of more than 5,000 cases of breast cancer and 8,000 cases of prostate cancer--was therefore initiated. The goal of this consortium is to characterize variations in approximately 50 genes that mediate two pathways that are associated with these cancers--the steroid-hormone metabolism pathway and the insulin-like growth factor signalling pathway--and to associate these variations with cancer risk.

Can computerized clinical decision support systems improve diabetes management? A systematic review and meta-analysis.

AIMS: To systematically review randomized trials that assessed the effects of computerized clinical decision support systems in ambulatory diabetes management compared with a non-computerized clinical decision support system control. METHODS: We included all diabetes trials from a comprehensive computerized clinical decision support system overview completed in January 2010, and searched EMBASE, MEDLINE, INSPEC/COMPENDEX and Evidence-Based Medicine Reviews (EBMR) from January 2010 to April 2012. Reference lists of related reviews, included articles and Clinicaltrials.gov were also searched. Randomized controlled trials of patients with diabetes in ambulatory care settings comparing a computerized clinical decision support system intervention with a non-computerized clinical decision support system control, measuring either a process of care or a patient outcome, were included. Screening of studies, data extraction, risk of bias and quality of evidence assessments were carried out independently by two reviewers, and discrepancies were resolved through consensus or third-party arbitration. Authors were contacted for any missing data. RESULTS: Fifteen trials were included (13 from the previous review and two from the current search). Only one study was at low risk of bias, while the others were of moderate to high risk of bias because of methodological limitations. HbA1c (3 months' follow-up), quality of life and hospitalization (12 months' follow-up) were pooled and all favoured the computerized clinical decision support systems over the control, although none were statistically significant. Triglycerides and practitioner performance tended to favour computerized clinical decision support systems although results were too heterogeneous to pool. CONCLUSIONS: Computerized clinical decision support systems in diabetes management may marginally improve clinical outcomes, but confidence in the evidence is low because of risk of bias, inconsistency and imprecision.

Does conventional early life academic excellence predict later life scientific discovery? An assessment of the lives of great medical innovators.

BACKGROUND: Perhaps, as never before, we need innovators. With our growing population numbers, and with increasing pressures on our education systems, are we in danger of becoming more rigid and formulaic and increasingly inhibiting innovation? When young can we predict who will become the great innovators? For example, in medicine, who will change clinical practice? AIMS: We therefore determined to assess whether the current academic excellence approach to medical school entrance would have captured previous great innovators in medicine, assuming that they should all have well fulfilled current entrance requirements. METHODS: The authors assembled a list of 100 great medical innovators which was then approved, rejected or added to by a jury of 12 MD fellows of the Royal Society of Canada. Two reviewers, who had taken both the past and present Medical College Admission Test as part of North American medical school entrance requirements, independently assessed each innovator's early life educational history in order to predict the innovator's likely success at medical school entry, assuming excellence in all entrance requirements. RESULTS: Thirty-one percent of the great medical innovators possessed no medical degree and 24% would likely be denied entry to medical school by today's standards (e.g. had a history of poor performance, failure, dropout or expulsion) with only 24% being guaranteed entry. Even if excellence in only one topic was required, the figure would only rise to 41% certain of medical school entry. CONCLUSION: These data show that today's medical school entry standards would have barred many great innovators and raise questions about whether we are losing medical innovators as a consequence. Our findings have important implications for promoting flexibility and innovation for medical education, and for promoting an environment for innovation in general.

Tackling the growth of the obesity literature: obesity evidence spreads across many journals.

OBJECTIVE: This study identified the journals with the highest yield of clinical obesity research articles and surveyed the scatter of such studies across journals. The study exemplifies an approach to establish a journal collection that is likely to contain most new knowledge about a field. DESIGN AND METHODS: All original studies that were cited in 40 systematic reviews about obesity topics ('included studies') were compiled and journal titles in which they were published were extracted. The journals were ranked by the number of included studies. The highest-yielding journals for clinical obesity and the scatter across journal titles were determined. A subset of these journals was created in MEDLINE (PubMed) to test search recall and precision for high-quality studies of obesity treatment (that is, articles that pass predetermined methodology criteria, including random allocation of participants to comparison groups, assessment of clinical outcomes, and at least 80% follow-up). RESULTS: Articles in 252 journals were cited in the systematic reviews. The three highest-yielding journals specialized in obesity, but they published only 19.2% of the research, leaving 80.8% scattered across 249 non-obesity journals. The MEDLINE journal subset comprised 241 journals (11 journals were not indexed in MEDLINE) and included 82% of the clinical obesity research articles retrieved by a search for high-quality treatment studies ('recall' of 82%). Of the articles retrieved, 11% were about clinical obesity care ('precision' of 11%), compared with precision of 6% for obesity treatment studies in the full MEDLINE database. CONCLUSION: Obesity journals captured only a small proportion of the literature on clinical obesity care. Those wishing to keep up in this field will need to develop more inclusive strategies than reading these specialty journals. A journal subset based on these findings may be useful when searching large electronic databases to increase search precision.

Interventions for enhancing medication adherence.

BACKGROUND: People who are prescribed self-administered medications typically take less than half the prescribed doses. Efforts to assist patients with adherence to medications might improve the benefits of prescribed medications, but also might increase their adverse effects. OBJECTIVES: To update a review summarizing the results of randomized controlled trials (RCTs) of interventions to help patients follow prescriptions for medications for medical problems, including mental disorders but not addictions. SEARCH STRATEGY: We updated searches of The Cochrane Library, MEDLINE, CINAHL, EMBASE, International Pharmaceutical Abstracts (IPA), PsycINFO (all via OVID) and Sociological Abstracts (via CSA) in January 2007 with no language restriction. We also reviewed bibliographies in articles on patient adherence and articles in our personal collections, and contacted authors of relevant original and review articles. SELECTION CRITERIA: Articles were selected if they reported an unconfounded RCT of an intervention to improve adherence with prescribed medications, measuring both medication adherence and treatment outcome, with at least 80% follow-up of each group studied and, for long-term treatments, at least six months follow-up for studies with positive initial findings. DATA COLLECTION AND ANALYSIS: Study design features, interventions and controls, and results were extracted by one review author and confirmed by at least one other review author. We extracted adherence rates and their measures of variance for all methods of measuring adherence in each study, and all outcome rates and their measures of variance for each study group, as well as levels of statistical significance for differences between study groups, consulting authors and verifying or correcting analyses as needed. The studies differed widely according to medical condition, patient population, intervention, measures of adherence, and clinical outcomes. Therefore, we did not feel that quantitative analysis was scientifically justified; rather, we conducted a qualitative analysis. MAIN RESULTS: For short-term treatments, four of ten interventions reported in nine RCTs showed an effect on both adherence and at least one clinical outcome, while one intervention reported in one RCT significantly improved patient adherence, but did not enhance the clinical outcome. For long-term treatments, 36 of 81 interventions reported in 69 RCTs were associated with improvements in adherence, but only 25 interventions led to improvement in at least one treatment outcome. Almost all of the interventions that were effective for long-term care were complex, including combinations of more convenient care, information, reminders, self-monitoring, reinforcement, counseling, family therapy, psychological therapy, crisis intervention, manual telephone follow-up, and supportive care. Even the most effective interventions did not lead to large improvements in adherence and treatment outcomes. AUTHORS' CONCLUSIONS: For short-term treatments several quite simple interventions increased adherence and improved patient outcomes, but the effects were inconsistent from study to study with less than half of studies showing benefits. Current methods of improving adherence for chronic health problems are mostly complex and not very effective, so that the full benefits of treatment cannot be realized. High priority should be given to fundamental and applied research concerning innovations to assist patients to follow medication prescriptions for long-term medical disorders.

WITHDRAWN: Audit and feedback versus alternative strategies: effects on professional practice and health care outcomes.

BACKGROUND: Audit and feedback has been identified as having the potential to change the practice of health care professionals. OBJECTIVES: To assess the effects of audit and feedback compared with other interventions in changing health professional practice and to assess whether the effectiveness of audit and feedback can be improved by modifying how it is done. SEARCH STRATEGY: We searched MEDLINE up to June 1997, the Research and Development Resource Base in Continuing Medical Education, and reference lists of related systematic reviews and articles. SELECTION CRITERIA: Randomised trials of audit and feedback (defined as any summary of clinical performance of health care over a specified period of time) compared with other interventions. The participants were health care providers responsible for patient care. DATA COLLECTION AND ANALYSIS: Two reviewers independently extracted data and assessed study quality. MAIN RESULTS: Twelve studies were included involving more than 2194 physicians. Seven trials with direct comparisons were included. The targeted behaviours were the management of low haemoglobin, the delivery of preventive care services (two studies), the management of high cholesterol, the performance of cervical smears, and the ordering of diagnostic tests (two studies). From the results of four trials, there is little evidence of a measurable effect of adding a complementary intervention such as a local consensus process to audit and feedback compared to audit and feedback alone. Two of three trials that compared audit and feedback to reminders reported that reminders were more effective in improving the delivery of some preventive services. AUTHORS' CONCLUSIONS: It is not possible to recommend a complementary intervention to enhance the effectiveness of audit and feedback. Reminders might be more effective than audit and feedback to improve the delivery of some preventive services but the results are not striking. Few trials have investigated the effect of varying different characteristics of the audit and feedback process. Consideration should be given to testing the effects of modifying important characteristics such as the content, source, timing, recipient and format.

Educational outreach visits: effects on professional practice and health care outcomes.

BACKGROUND: Educational outreach visits (EOVs) have been identified as an intervention that may improve the practice of healthcare professionals. This type of face-to-face visit has been referred to as university-based educational detailing, academic detailing, and educational visiting. OBJECTIVES: To assess the effects of EOVs on health professional practice or patient outcomes. SEARCH STRATEGY: For this update, we searched the Cochrane EPOC register to March 2007. In the original review, we searched multiple bibliographic databases including MEDLINE and CINAHL. SELECTION CRITERIA: Randomised trials of EOVs that reported an objective measure of professional performance or healthcare outcomes. An EOV was defined as a personal visit by a trained person to healthcare professionals in their own settings. DATA COLLECTION AND ANALYSIS: Two reviewers independently extracted data and assessed study quality. We used bubble plots and box plots to visually inspect the data. We conducted both quantitative and qualitative analyses. We used meta-regression to examine potential sources of heterogeneity determined a priori. We hypothesised eight factors to explain variation across effect estimates. In our primary visual and statistical analyses, we included only studies with dichotomous outcomes, with baseline data and with low or moderate risk of bias, in which the intervention included an EOV and was compared to no intervention. MAIN RESULTS: We included 69 studies involving more than 15,000 health professionals. Twenty-eight studies (34 comparisons) contributed to the calculation of the median and interquartile range for the main comparison. The median adjusted risk difference (RD) in compliance with desired practice was 5.6% (interquartile range 3.0% to 9.0%). The adjusted RDs were highly consistent for prescribing (median 4.8%, interquartile range 3.0% to 6.5% for 17 comparisons), but varied for other types of professional performance (median 6.0%, interquartile range 3.6% to 16.0% for 17 comparisons). Meta-regression was limited by the large number of potential explanatory factors (eight) with only 31 comparisons, and did not provide any compelling explanations for the observed variation in adjusted RDs. There were 18 comparisons with continuous outcomes, with a median adjusted relative improvement of 21% (interquartile range 11% to 41%). There were eight trials (12 comparisons) in which the intervention included an EOV and was compared to another type of intervention, usually audit and feedback. Interventions that included EOVs appeared to be slightly superior to audit and feedback. Only six studies evaluated different types of visits in head-to-head comparisons. When individual visits were compared to group visits (three trials), the results were mixed. AUTHORS' CONCLUSIONS: EOVs alone or when combined with other interventions have effects on prescribing that are relatively consistent and small, but potentially important. Their effects on other types of professional performance vary from small to modest improvements, and it is not possible from this review to explain that variation.

Interventions to enhance medication adherence.

BACKGROUND: People who are prescribed self-administered medications typically take less than half the prescribed doses. Efforts to assist patients with adherence to medications might improve the benefits of prescribed medications, but also might increase their adverse effects. OBJECTIVES: To update a review summarizing the results of randomized controlled trials (RCTs) of interventions to help patients follow prescriptions for medications for medical problems, including mental disorders but not addictions. SEARCH STRATEGY: Computerized searches were updated to September 2004 without language restriction in MEDLINE, EMBASE, CINAHL, The Cochrane Library, International Pharmaceutical Abstracts (IPA), PsycINFO and SOCIOFILE. We also reviewed bibliographies in articles on patient adherence and articles in our personal collections, and contacted authors of original and review articles on the topic. SELECTION CRITERIA: Articles were selected if they reported an unconfounded RCT of an intervention to improve adherence with prescribed medications, measuring both medication adherence and treatment outcome, with at least 80% follow-up of each group studied and, for long-term treatments, at least six months follow-up for studies with positive initial findings. DATA COLLECTION AND ANALYSIS: Study design features, interventions and controls, and results were extracted by one reviewer and confirmed by at least one other reviewer. We extracted adherence rates and their measures of variance for all methods of measuring adherence in each study, and all outcome rates and their measures of variance for each study group, as well as levels of statistical significance for differences between study groups, consulting authors and verifying or correcting analyses as needed. MAIN RESULTS: For short-term treatments, four of nine interventions reported in eight RCTs showed an effect on both adherence and at least one clinical outcome, while one intervention reported in one RCT significantly improved patient compliance, but did not enhance the clinical outcome. For long-term treatments, 26 of 58 interventions reported in 49 RCTs were associated with improvements in adherence, but only 18 interventions led to improvement in at least one treatment outcome. Almost all of the interventions that were effective for long-term care were complex, including combinations of more convenient care, information, reminders, self-monitoring, reinforcement, counseling, family therapy, psychological therapy, crisis intervention, manual telephone follow-up, and supportive care. Even the most effective interventions did not lead to large improvements in adherence and treatment outcomes. Six studies showed that telling patients about adverse effects of treatment did not affect their adherence. AUTHORS' CONCLUSIONS: Improving short-term adherence is relatively successful with a variety of simple interventions. Current methods of improving adherence for chronic health problems are mostly complex and not very effective, so that the full benefits of treatment cannot be realized. High priority should be given to fundamental and applied research concerning innovations to assist patients to follow medication prescriptions for long-term medical disorders.

Computer-aided quality assurance. A critical appraisal.

Computerized information systems hold the promise of overcoming problems in the management of clinical information Many of the claims of the creators and promoters of these systems, however, are not based on sound clinical studies. To determine the ability of computer information systems to improve the quality of medical care, we applied methodologic criteria to published articles in the field. Only 30 (22%) of 135 articles reported preplanned investigations, and only half of these met minimal criteria for scientific investigations. Fourteen studies were well designed and executed. All studies reported improvements in the process of care. However, patient outcomes were not measured, not affected, or only minimally influenced. While computer information systems show increasing potential, more work is required to enhance their effect on the quality of care and thus on patient outcomes.

Problems in the handling of clinical and research evidence by medical practitioners.

There are important problems in the accuracy with which we collect, interpret, communicate, and apply clinical and relevant research evidence in the care of our patients. Many of these problems can be avoided or ameliorated by applying some specific measurement principles and information tools. The collection of clinical evidence can be improved by adhering to strategies that reduce observer error. The interpretation of clinical and paraclinical information can be improved by harnessing the predictive value of this information to estimates of the diagnosis, prognosis, and therapeutic responsiveness of patients. Communication can be improved by replacing the ambiguous argot of clinical equivocation with a more precise terminology. The detection of both valid and useful new knowledge can be facilitated by applying some straightforward guidelines to the rapid critical appraisal of the medical literature. Finally, we can look to advances in information technology to help us become more consistent in providing the best possible care for our patients.

A critical appraisal of ticlopidine, a new antiplatelet agent. Effectiveness and clinical indications for prophylaxis of atherosclerotic events.

BACKGROUND: Recommendations are broadening for the prophylaxis of atherosclerotic disorders, but aspirin is the only widely used agent. Ticlopidine hydrochloride, a new antiplatelet medication, has recently been approved for prescription in North America. We reviewed the major clinical trials of ticlopidine and derived guidelines for its use. METHODS: Studies of ticlopidine were sought through MEDLINE for 1980 to 1990 and through bibliographies of retrieved articles. All published, randomized trials of ticlopidine were appraised if they reported major morbidity and mortality as primary end points. All eligible studies were formally reviewed by an expert panel according to published principles for critical appraisal of the medical literature. Both benefits and risks were quantified. RESULTS: Four randomized trials reported major clinical end points. In these, ticlopidine was more effective than placebo for preventing recurrences after completed stroke; was more effective than aspirin for patients with transient ischemic attacks and partial strokes; and reduced vascular death and nonfatal myocardial infarction in an open trial among patients with unstable angina. For patients with intermittent claudication ticlopidine, was not significantly better than placebo for preventing myocardial infarction or stroke. Side effects were more common with ticlopidine than with aspirin or placebo. CONCLUSIONS: Ticlopidine should be prescribed in place of aspirin for stroke prophylaxis or unstable angina if the patient is unable to tolerate aspirin. Ticlopidine may also benefit patients who experience new ischemic events while taking aspirin or, probably, patients with peripheral vascular disease. A complete blood cell count should be performed every 2 weeks during the first 3 months of therapy to check for leukopenia.

A randomized trial of improved weight loss with a prepared meal plan in overweight and obese patients: impact on cardiovascular risk reduction.

OBJECTIVE: To assess the long-term effects of a prepackaged, nutritionally complete, prepared meal plan compared with a usual-care diet (UCD) on weight loss and cardiovascular risk factors in overweight and obese persons. DESIGN: In this randomized multicenter study, 302 persons with hypertension and dyslipidemia (n = 183) or with type 2 diabetes mellitus (n = 119) were randomized to the nutrient-fortified prepared meal plan (approximately 22% energy from fat, 58% from carbohydrate, and 20% from protein) or to a macronutrient-equivalent UCD. MAIN OUTCOME MEASURES: The primary outcome measure was weight change. Secondary measures were changes in blood pressure or plasma lipid, lipoprotein, glucose, or glycosylated hemoglobin levels; quality of life; nutrient intake; and dietary compliance. RESULTS: After 1 year, weight change in the hypertension/dyslipidemia group was -5.8+/-6.8 kg with the prepared meal plan vs -1.7+/-6.5 kg with the UCD plan (P<.001); for the type 2 diabetes mellitus group, the change was -3.0+/-5.4 kg with the prepared meal plan vs -1.0+/-3.8 kg with the UCD plan (P<.001) (data given as mean +/- SD). In both groups, both interventions improved blood pressure, total and low-density lipoprotein cholesterol levels, glycosylated hemoglobin level, and quality of life (P<.02); in the diabetic group, the glucose level was reduced (P<.001). Compared with those in the UCD group, participants with hypertension/dyslipidemia in the prepared meal plan group showed greater improvements in total (P<.01) and high-density lipoprotein (P<.03) cholesterol levels, systolic blood pressure (P<.03), and glucose level (P<.03); in participants with type 2 diabetes mellitus, there were greater improvements in glucose (P =.046) and glycosylated hemoglobin (P<.02) levels. The prepared meal plan group also showed greater improvements in quality of life (P<.05) and compliance (P<.001) than the UCD group. CONCLUSIONS: Long-term dietary interventions induced significant weight loss and improved cardiovascular risk in high-risk patients. The prepared meal plan simultaneously provided the simplicity and nutrient composition necessary to maintain long-term compliance and to reduce cardiovascular risk.

Nutritional management of cardiovascular risk factors. A randomized clinical trial.

BACKGROUND: Adherence to dietary recommendations for disease management is often hindered by the complexity of incorporating them into the daily diet. Nutrition and cardiovascular scientists and food technologists collaborated to develop a prepared meal plan that meets national dietary guidelines for cardiovascular risk reduction. OBJECTIVE: To assess the clinical effects of this plan, which incorporates all National Academy of Sciences National Research Council recommended dietary allowances for vitamins, minerals, and macronutrients, compared with a patient-selected American Heart Association Step I and Step II diet plan. METHODS: This multicenter, randomized, parallel-intervention trial was conducted at 10 medical centers in the United States and Canada and involved 560 men and women with hypertension, dyslipidemia, or diabetes. Following calculation of prescriptions to meet individual nutritional requirements based on the Harris-Benedict equation, participants were randomized to the Campbell's Center for Nutrition and Wellness (CCNW) plan, which is composed of prepackaged breakfast, lunch, and dinner meals provided to participants, or a nutritionist-guided American Heart Association Step I and Step II diet, in which participants self-selected foods to meet their nutrition prescription for 10 weeks. MAIN OUTCOME MEASURES: Blood pressure (BP); lipid, glucose, glycosylated hemoglobin (HbA1c), and insulin levels; body weight; dietary intake; and quality of life. RESULTS: Patients' BP, lipid levels, carbohydrate metabolism, weight, and quality of life (P < or = .001 for all findings except low-density lipoprotein-high-density lipoprotein ratio, P = .25) all improved on both nutrition plans. Mean differences (+/-SD) between baseline and treatment clinical values for the CCNW and the self-selected diet groups (between-group P values), respectively, were as follows: systolic BP, -6.4 +/- 9.2 mm Hg and -4.6 +/- 9.0 mm Hg (P = .02); diastolic BP, -4.2 +/- 5.7 mm Hg and -3.0 +/- 5.1 mm Hg (P = .006); cholesterol, -0.32 +/- 0.58 mmol/L and -0.27 +/- 0.56 mmol/L (-12.4 +/- 22.5 mg/dL and -10.4 +/- 21.9 mg/dL) (P = .30); glucose, -0.65 +/- 1.88 mmol/L and -0.75 +/- 2.03 mmol/L (-11.7 +/- 34.0 mg/dL and -13.5 +/- 36.6 mg/dL) (P = .10); and HbA1c, -0.4% +/- 0.8% and -0.3% +/- 0.7% (P = .66). Weight loss with the CCNW and self-selected plans, respectively, was as follows: men, -4.5 +/- 3.6 kg and -3.5 +/- 3.3 kg; and women, -4.8 +/- 3.0 kg and -2.8 +/- 2.8 kg. Quality of life was significantly improved for daily and work activities (P < .05) and nutritional health perceptions (P < .05) with the CCNW plan relative to the self-selected group. Overall nutrient intake and compliance were both significantly (P < .001) better with the CCNW plan. CONCLUSIONS: Nutritionally balanced meals that meet the recommendations of national health organizations improved multiple risk factors for patients with cardiovascular disease. The CCNW plan resulted in greater clinical benefits, nutritional completeness, and compliance than the self-selected diet. The CCNW is a comprehensive nutrition plan, convenient for both prescription and practice, and appears viable for effecting favorable dietary changes in patients at high risk for cardiovascular disease.

Multicenter randomized trial of a comprehensive prepared meal program in type 2 diabetes.

OBJECTIVE: To evaluate the clinical effects of a comprehensive prepackaged meal plan, incorporating the overall dietary guidelines of the American Diabetes Association and other national health organizations, relative to those of a self-selected diet based on exchange lists in free-living individuals with type 2 diabetes. RESEARCH DESIGN AND METHODS: A total of 202 women and men (BMI < or = 42 kg/m2) whose diabetes was treated with diet alone or an oral hypoglycemic agent were enrolled at 10 medical centers. After a 4-week baseline period, participants were randomized to a nutrient-fortified prepared meal plan or a self-selected exchange-list diet for 10 weeks. On a caloric basis, both interventions were designed to provide 55-60% carbohydrate, 20-30% fat, and 15-20% protein. At intervals, 3-day food records were completed, and body weight, glycemic control, plasma lipids, and blood pressure were assessed. RESULTS: Food records showed that multiple nutritional improvements were achieved with both diet plans. There were significant overall reductions in body weight and BMI, fasting plasma glucose and serum insulin, fructosamine, HbA1c, total and LDL cholesterol, and blood pressure (P < 0.001 or better for all). In general, differences in major end points between the diet plans were not statistically significant. CONCLUSIONS: Glycemic control and cardiovascular risk factors improve in individuals with type 2 diabetes who consume diets in accordance with the American Diabetes Association guidelines. The prepared meal program was as clinically effective as the exchange-list diet. The prepared meal plan has the additional advantages of being easily prescribed and eliminating the complexities of meeting the multiple dietary recommendations for type 2 diabetes management.

Clinical effectiveness and cost-effectiveness of monitoring blood pressure of hypertensive employees at work.

In this randomized controlled trial, the value of using occupational health nurses (OHNs) to monitor the care of hypertensive employees at work was compared with regular care (RC) delivered in the community. One year after entry, the blood pressure level, medication history, compliance with treatment, and cost of hypertensive care of the participants were determined by independent evaluators. The reduction in diastolic blood pressure (DBP), the measure of effectiveness, was 10.5 +/- 1.1 mm Hg (mean +/- SEM) in the OHN group and 7.7 +/- 1.1 mm Hg in the RC group, and the proportion under good blood pressure control was 41.8% and 31.0% respectively. These between-group differences were not statistically significant. Although the employees in the OHN group were more medicated and had a lower treatment dropout rate, neither difference was statistically significant. In addition, the proportion of employees who were compliant with prescribed medication was virtually identical in both groups. The cost of the care received by employees in the OHN group of $ 404.14 for the year was substantially higher than that of $ 250.15 in the RC group with the difference principally related to the cost of visiting the OHNs and a significant difference in drug cost (p less than 0.006). The incremental cost-effectiveness (C/E) ratio of $ 53.67 per mm Hg DBP reduction per year for onsite blood pressure monitoring was higher than the base C/E ratio of $ 32.65 per mm Hg for regular care. Our findings indicate that monitoring the blood pressure of hypertensive employees at work is neither clinically effective nor cost-effective.(ABSTRACT TRUNCATED AT 250 WORDS)

Cost-effectiveness of a worksite hypertension treatment program.

The cost-effectiveness of treating hypertension at the patient's place of work was compared in a randomized controlled trial with care delivered in a community. The average total cost per patient for worksite care in this 12-month study was not significantly different from that for regular care ($242.86 +/- 6.94 vs $211.34 +/- 18.66, mean +/- SEM). The worksite health system cost was significantly more expensive ($197.36 +/- 4.99 vs $129.33 +/- 13.34, p less than 0.001) but the patient cost was significantly less ($45.40 +/- 3.23 vs $82.00 +/- 6.20, p less than 0.01). The mean reduction in diastolic blood pressure (BP) at the year-end assessment was significantly greater in the worksite group (12.1 +/- 0.6 vs 6.5 +/- 0.6 mm Hg, p less than 0.001). The incremental cost-effectiveness ratio of $5.63 per mm Hg for worksite care was less than the base cost-effectiveness ratio of $32.51 per mm Hg for regular care, indicating that the worksite program was substantially more cost-effective. Our findings support health policies that favor allocating resources to work-based hypertension treatment programs for the target group identified in this study.

Can simple clinical measurements detect patient noncompliance?

Measurement of patient compliance is essential if management of low compliance is to be performed efficiently. We assessed the value of several easily obtained clinical assessments compared to quantitative pill counts among 134 newly treated hypertensive male steelworkers during the first 6 months of their treatment with antihypertensive medication. Patient's self-reports obtained on structured interview correlated best with pill count compliance (r = 0.74, p less than 0.0001). Patients overestimated their compliance by an average of 17% but 90% of those who admitted to being noncompliant were found so. Qualitative urinary chlorthalidone and hydrochlorothiazide levels and changes in serum potassium, uric acid, and blood pressure also correlated with pill count compliance but were less accurate than interviews. Assessment of the patient's "health beliefs" and a variety of sociodemographic and health traits and perceptions did not provide useful information on compliance. Interviewing the patient is a simple and useful approach in assessing compliance with antihypertensive therapy.

Nature and role of observational studies in public health policy concerning the effects of dietary salt intake on blood pressure.

Does dietary sodium in excess of a specified daily consumption substantively elevate blood pressure in normotensive people? Does lowering the daily consumption of sodium reduce blood pressure in normotensive people? Sound observational and interventional studies can address these questions, but there are substantial differences in the ability of various research designs to provide clear, bias-free answers. I summarize established scientific principles for addressing issues of causation and the effects of interventions and compare observational and interventional designs. Observational studies are important in exploring the possible determinants of health problems but are subject to bias and cannot directly assess the effects of interventions. They are superseded by sound interventional studies, particularly randomized controlled trials, in answering the key questions concerning causes and benefits of intervention.