Comprehensive Lifestyle Improvement Program for Prostate Cancer (CLIPP) is associated with improvement in weight and components of metabolic syndrome in men exposed to androgen deprivation therapy for prostate cancer.

BACKGROUND: Androgen deprivation therapy (ADT) for prostate cancer is associated with adverse effects, such as obesity and metabolic syndrome, which increase cardiovascular risk, the most common cause of non-cancer mortality in men diagnosed with prostate cancer. The Comprehensive Lifestyle Improvement Program for Prostate Cancer (CLIPP) was created to determine the feasibility of conducing a comprehensive lifestyle modification intervention in men on ADT for prostate cancer and determine its early efficacy in reducing obesity and metabolic syndrome. METHODS: A single-arm, open-label clinical trial was conducted by recruiting 31 men diagnosed with prostate cancer and exposed to ADT within the last 5 years. A multicomponent lifestyle modification program was delivered weekly for 16 weeks by a trained health coach. This was followed by 8 weeks of passive follow-up resulting in a total trial duration of 24 weeks. Feasibility was determined by calculating study recruitment, retention, and adherence rates. Weight and components of metabolic syndrome (waist circumference, triglycerides (TG), high-density lipoprotein (HDL), serum glucose, and blood pressure (BP)) were measured at baseline, 12, and 24 weeks. RESULTS: Recruitment, retention, and adherence rates were 47.1%, 90.3%, and 100%, respectively. Statistically significant improvements were noted between baseline and end of study measurements for weight (206.3 vs. 191.3 lbs, p < 0.001), waist (41.3 vs. 38.8 inches, p < 0.001), systolic BP (144.1 vs. 133.4 mm of Hg, p = 0.014), diastolic BP (83.3 vs. 76.2 mm of Hg, p = 0.0056), TG (146.0 vs. 113.8 mg/dl, p = 0.022), HDL (51.1 vs. 55.0 mg/dl, p = 0.012), and serum glucose (114.0 vs. 103.2 mg/dl, p = 0.013). CONCLUSION: CLIPP demonstrates feasibility and early efficacy of a multicomponent lifestyle modification intervention toward addressing obesity as well as components of metabolic syndrome in men on ADT for prostate cancer. This study provides strong preliminary data to develop future clinical trials in this population.

Protocol for a feasibility and early efficacy study of the Comprehensive Lifestyle Improvement Program for Prostate Cancer-2 (CLIPP2).

BACKGROUND: Although androgen deprivation therapy (ADT) for prostate cancer demonstrates improved overall and disease-free survival, it is associated with adverse effects such as obesity and metabolic syndrome that increase risk of cardiometabolic disease and diabetes type 2. ADT also leads to fatigue, depression and erectile dysfunction, which reduce quality of life (QoL). Lifestyle modification has shown promise in reducing obesity, metabolic syndrome and diabetes type 2 in other disease types. However, there is a paucity of data regarding the utility of lifestyle modification in men receiving ADT for prostate cancer. METHODS: The primary aim of the Comprehensive Lifestyle Improvement Program for Prostate Cancer-2 (CLIPP2) is to test the feasibility of conducting a 24-week lifestyle modification intervention in men on ADT for prostate cancer. Additionally, it will also determine the effect of this intervention on weight loss, cardiometabolic markers (secondary aim and markers of interest: serum glucose, insulin resistance, hemoglobin A1C and lipid panel), and QoL (tertiary aim). The intervention will be delivered weekly via telephone for the first 10 weeks and bi-weekly for the remaining 14 weeks. Questionnaires and serum samples will be collected at baseline, week 12, and week 24. Anthropometric measurements will be collected at baseline, week 6, week 12, week 18 and week 24. RESULTS: We hypothesize that the CLIPP2 intervention will produce a 7% weight loss that will result in improved markers associated with cardiometabolic disease and type 2 diabetes in the study population. CONCLUSION: Results will provide insight into the role of lifestyle modification in addressing ADT adverse effects as well as provide preliminary data to inform the development of future lifestyle interventions in this area. TRIAL REGISTRATION: NCT04228055 Clinicaltrials. gov.

Prevalence of pain and association with quality of life, depression and glycaemic control in patients with diabetes.

AIMS: To determine the prevalence of pain and its association with glycaemic control, mental health and physical functioning in patients with diabetes. METHODS: Cross-sectional data from a multi-site, prospective cohort study of 11 689 participants with diabetes. We analysed the associations of pain severity and interference with glycated haemoglobin (HbA(1c)) measurements and Medical Outcomes Study SF-Mental and Physical Component Summary-12 (MCS-12 and PCS-12) scores. RESULTS: Of participants, 57.8% reported moderate to extreme pain and, compared with those without pain, were somewhat older (60.8 vs. 59.9 years, P < 0.001), more obese (body mass index of 32.1 vs. 29.8 kg/m(2), P < 0.001), more likely to report being depressed or anxious (41.3 vs. 16.2%, P < 0.001) and more likely to report fair or poor health (48.5 vs. 23.1%, P < 0.001). Bivariate comparisons demonstrated that patients with extreme pain had higher HbA(1c) than those without pain (8.3 vs. 8.0%, P = 0.001). In multivariable analyses, pain was not associated with HbA(1c) (P = 0.304) but was strongly associated with worse MCS-12 (P < 0.001), PCS-12 (P < 0.001) and depression (P < 0.001). Depression was 1.3 (95% CI: 1.12, 1.96) times more likely in patients with moderate pain and 2.0 (95% CI: 1.56, 2.46) times more likely in patients with extreme pain. CONCLUSIONS: Moderate to extreme pain was present in 57.8% of diabetic patients. Pain was strongly associated with poorer mental health and physical functioning, but not worse glycaemic control. Recognizing the high prevalence of pain and its strong association with poorer health-related quality of life may be important to improve the comprehensive management of diabetes.

Pharmaceutical care program for patients with reactive airways disease.

A pharmaceutical care program for patients with reactive airways disease (RAD) is described. A pharmaceutical care program for patients with RAD was developed and implemented at 36 CVS pharmacies. The impact on patient outcomes, pharmacist job satisfaction, and other variables is currently being evaluated in a controlled trial with more than 1100 patient enrollees. Guiding the program are the beliefs that pharmacists must have clinically relevant, patient-specific data to provide appropriate care; that pharmacists must have adequate training to provide pharmaceutical care; that the program must be sensitive to organizational barriers, particularly time demands; and that there must be ongoing support for the program. The program has five components: (1) computer display of patient-specific data for patients enrolled in the study, (2) distribution of tailored patient education materials, (3) use of a resource guide to facilitate the implementation of pharmaceutical care, (4) strategies to reinforce and facilitate the program, and (5) pharmacist training. While developed for community pharmacies, the program is applicable to most ambulatory care pharmacy practices. A pharmaceutical care program for patients with RAD was developed for use in community pharmacies.

Report of the health care delivery work group: behavioral research related to the establishment of a chronic disease model for diabetes care.

As one of four work groups for the November 1999 conference on Behavioral Science Research in Diabetes, sponsored by the National Institute on Diabetes and Digestive and Kidney Diseases, the health care delivery work group evaluated the status of research on quality of care, patient-provider interactions, and health care systems' innovations related to improved diabetes outcomes. In addition, we made recommendations for future research. In this article, which was developed and modified at the November conference by experts in health care delivery, diabetes and behavioral science, we summarize the literature on patient-provider interactions, diabetes care and self-management support among underserved and minority populations, and implementation of chronic care management systems for diabetes. We conclude that, although the quality of care provided to the vast majority of diabetic patients is problematic, this is principally not the fault of either individual patients or health care professionals. Rather, it is a systems issue emanating from the acute illness model of care, which still predominates. Examples of proactive population-based chronic care management programs incorporating behavioral principles are discussed. The article concludes by identifying barriers to the establishment of a chronic care model (e.g., lack of supportive policies, understanding of population-based management, and information systems) and priorities for future research in this area needed to overcome these barriers.

Pharmaceutical care in chain pharmacies: beliefs and attitudes of pharmacists and patients.

OBJECTIVE: To discuss with pharmacists and patients with reactive airways disease their beliefs about pharmaceutical care and the pharmacist's role in health care, obstacles to providing pharmaceutical care in community pharmacies, and strategies to overcome these obstacles. DESIGN: Two focus groups of patients, two focus groups of pharmacists. PARTICIPANTS: Thirteen patients with reactive airways disease and 11 chain pharmacists. MAIN OUTCOME MEASURES: Qualitative reports on the pharmacist's role in health care delivery and obstacles to implementing pharmaceutical care programs. RESULTS: Pharmacists wished to provide pharmaceutical care, and patients were supportive of pharmacists' involvement in their health care. Both viewed counseling as an important role for pharmacists and believed that pharmacists should work with patients' physicians. Reported obstacles included lack of time, inadequate privacy, and pharmacists' lack of direct access to patients' physicians. Pharmacists and patients believed pharmacists should have access to patient-specific clinical data. CONCLUSION: Focus groups provided valuable information for designing pragmatic pharmaceutical care. The obstacles and possible solutions identified through the discussions represent fertile ground for designing innovative pharmaceutical care programs.

Sequencing diet and exercise programs for African American women with diabetes.

PURPOSE: This study was designed to compare the effects of 2 programs that present diet and exercise components in a different sequence. METHODS: At an urban YMCA, African American women with type 2 diabetes, aged 30 to 65, were randomly assigned to either 10 weekly sessions about healthy eating followed by 6 weekly sessions about exercise or to the reverse sequence. Sessions consisted of small group discussions and physical activity or food tasting. Primary outcomes were attendance, percent of calories consumed from fat, fruit and vegetable intake, and minutes of exercise per week. Measures were taken at baseline, and 4 and 12 months after the program. RESULTS: The only group difference found at the 12-month follow-up was in diastolic blood pressure. Time effects for both groups combined included an increase in minutes of activity, an increase in vegetable intake, and a decrease in percent of calories consumed from fat. CONCLUSIONS: This study does not provide definitive evidence of which sequence may be best to bring about behavior change. The effects of sequencing difficult behavioral changes such as diet modification and establishing an exercise habit deserve further study.

Nutrition management of type 2 diabetes by primary care physicians: reported use and barriers.

A survey was mailed to a probability sample of primary care physicians in Indiana to assess their use of and barriers to nutritional therapy for patients with type 2 diabetes. Most (62%) primary care physicians reported referring their type 2 diabetes patients for nutrition counseling, while 38% reported providing counseling themselves. Patient-centered barriers were most frequently cited as reasons for poor effectiveness of nutrition therapy. This differs from previous research that cites system-level factors as barriers.

The Diabetes Empowerment Scale: a measure of psychosocial self-efficacy.

OBJECTIVE: The purpose of this study was to assess the validity, reliability, and utility of the Diabetes Empowerment Scale (DES), which is a measure of diabetes-related psychosocial self-efficacy. RESEARCH DESIGN AND METHODS: In this study (n = 375), the psychometric properties of the DES were calculated. To establish validity, DES subscales were compared with 2 previously validated subscales of the Diabetes Care Profile (DCP). Factor and item analyses were conducted to develop subscales that were coherent, meaningful, and had an acceptable coefficient alpha. RESULTS: The psychometric analyses resulted in a 28-item DES (alpha = 0.96) with 3 subscales: Managing the Psychosocial Aspects of Diabetes (alpha = 0.93), Assessing Dissatisfaction and Readiness To Change (alpha = 0.81), and Setting and Achieving Diabetes Goals (alpha = 0.91). Consistent correlations in the expected direction between DES subscales and DCP subscales provided evidence of concurrent validity. CONCLUSIONS: This study provides preliminary evidence that the DES is a valid and reliable measure of diabetes-related psychosocial self-efficacy. The DES should be a useful outcome measure for various educational and psychosocial interventions related to diabetes.

Screening and treatment of diabetic nephropathy by primary care physicians.

OBJECTIVE: To describe the practices of Indiana primary care physicians related to diabetic nephropathy screening and management. DESIGN: Cross-sectional, observational. SETTING: The state of Indiana. PARTICIPANTS: Active primary care physicians (defined as general internists, family practitioners, and general practitioners) in Indiana who provided care for diabetic patients at the time of the survey (n = 1,018) MEASUREMENTS AND MAIN RESULTS: Practice patterns relevant to microalbuminuria and overt albuminuria screening and management were assessed along two dimensions: the percentage of patients to whom the practices were applied and the frequency with which the practices were performed. Of 1,141 physicians who responded to the survey, 1,018 were eligible for analysis. Eighty-six percent of physicians reported screening more than half of their patients with type 1 diabetes for overt albuminuria, as did 82% of physicians for their patients with type 2 diabetes. Only 17% of physicians indicated performing microalbuminuria testing on more than half of their type 1 patients. Angiotensin-converting enzyme inhibitor agents were used frequently to treat abnormal urinary albumin excretion when hypertension was present, but less often when hypertension was absent. Physician specialty, year of graduation from medical school, practice location, and familiarity with the results of the Diabetes Control and Complications Trial were significant predictors of screening and treatment practice patterns. CONCLUSIONS: Primary care physicians report practices that allow them to detect overt albuminuria but not microalbuminuria. Angiotensin-converting enzyme inhibitors are frequently used by physicians who test for microalbuminuria, but efforts to increase the detection of early renal damage are needed so that these agents and other therapeutic strategies may be employed at the earliest opportunity.

Same eyes, different doctors: differences in primary care physician referrals for diabetic retinopathy screening.

OBJECTIVE: To analyze eye care specialist referral patterns for the diabetic patients of primary care physicians. RESEARCH DESIGN AND METHODS: In 1993, we conducted a census of primary care physicians to evaluate practice patterns relating to diabetes care in the state of Indiana. Using a logistic regression model and data from this census, we compared 1) physicians' odds of referring type II diabetic patients to an optometrist, as opposed to an ophthalmologist, with those of type I diabetic patients and 2) the referral odds ratios of type II to type I diabetic patients between metropolitan and nonmetropolitan counties. RESULTS: Overall, 10% of the physicians in our study most often refer some patients to an optometrist. Physicians are more likely to refer their type II diabetic patients to an optometrist, as opposed to an ophthalmologist, than they are to refer type I diabetic patients, both before and after adjustment for covariates. Physicians who practice in metropolitan counties are 1.55 times more likely to refer their type II diabetic patients than their type I diabetic patients to an optometrist. In nonmetropolitan counties, physicians are 2.5 times more likely to refer their type II diabetic patients to an optometrist. The difference between metropolitan and nonmetropolitan physicians is significant (P = 0.027). CONCLUSIONS: Some physicians mostly refer their diabetic patients to optometrists, instead of ophthalmologists, for eye examinations intended to discover early signs of diabetic eye disease. Type II diabetic patients are more likely to be referred to an optometrist, instead of an ophthalmologist, than are type I diabetic patients. In nonmetropolitan areas, the difference in referral patterns becomes even more marked.

Fear of hypoglycemia in the parents of children and adolescents with diabetes: maladaptive or healthy response?

Sixty-one parents of children with insulin-dependent diabetes mellitus completed modified versions of the Hypoglycemic Fear Survey (HFS) and the Diabetes Quality of Life (DQOL) scale. They also indicated their child's history of hypoglycemic-related seizures or loss of consciousness (SLC) events. Parental HFS scores were significantly greater if their child had ever experienced a SLC event or experienced a SLC event within the past year. Parental HFS scores were positively correlated with general parental worry about their child having diabetes. Adolescent children who experienced a SLC event during the past year reported greater HFS scores, greater general worry about diabetes, and a greater negative impact of having diabetes compared with adolescents with no such history. Despite the greater fear of hypoglycemia in parents and adolescents, there was no significant difference in HbA1 values between children with or without any history of SLC events or children with or without a SLC event within the past year.

Primary care physicians' practice patterns and diabetic retinopathy. Current levels of care.

BACKGROUND: Diabetic retinopathy is a costly and prevalent complication of diabetes mellitus. OBJECTIVE: To assess primary care physicians' self-reported practice patterns for the screening and detection of diabetic retinopathy relative to published guidelines. PARTICIPANTS AND METHODS: All primary care physicians (defined as general internists, family practitioners, and general practitioners) in Indiana were identified and surveyed using a mailed questionnaire. Of 2390 physicians, 1508 (63%) responded and were determined to be eligible. Of these 1508 physicians, 1058 (70%) completed all or some of the eye care-related questions. For each eye care practice, physicians were asked to specify the proportion of patients to which the practice was applied and the frequency (eg, every 3 months) with which the behavior was performed, if appropriate. Physicians were also asked to distinguish between patients with type I (insulin-dependent) and type II (non-insulin-dependent) diabetes mellitus for each practice behavior. RESULTS: Physicians' responses were classified as "high," "moderate," or "low" based on the American Diabetes Association guidelines. Forty-five percent of the physicians' responses were classified as high for referring all of their patients with type I diabetes mellitus to an eye care specialist annually as were 35% of the physicians' responses for referring their patients with type II diabetes mellitus. Fewer physicians reported high levels of routine in-office funduscopic examination. No relationship was found between the extent to which physicians performed an in-office funduscopic examination and patterns of referral to eye care specialists. Logistic regression analysis suggested that recent graduates and general internists are most likely to report behavior that is considered high (P < .05). CONCLUSION: The diabetic retinopathy-related practice patterns of primary care physicians in Indiana differ significantly from published guidelines.

The SOCRATES curriculum: an innovative integration of technology and theory in medical education.

This article describes the pilot study of an innovative medical school curriculum module that utilizes a modified problem-based learning (PBL) approach to teach medical students about management of diabetes mellitus. The PBL-based curriculum incorporated computer simulations and analysis of videotaped patient encounters in addition to independent study and group discussion. At the conclusion of the study, student knowledge and clinical decision-making skills were evaluated via questionnaires and examinations. Twenty-three students completed the workshop and all evaluation assessments. Students performed well on the case-study examinations (mean score of 3.39 out of 4) but not on the short answer essay examination, which assessed basic knowledge. Students rated the quality and appeal of the activities using Likert-type scales. In general, students perceived the activities as very worthwhile, with reasonable complexity and adequate time devoted to each activity. Students were very positive about the workshop and preceptor; 15 of the 16 items used to rate workshop appeal yielded mean scores greater than 4 (on a scale of 1 to 5, with 5 being the highest). The results of the pilot study suggest future enhancements that would further improve the outcomes of the training.

Prevention of IDDM: a public health perspective.

Insulin dependent diabetes mellitus (IDDM) poses a large social and economic burden on society. There are now methods for identifying persons at risk for IDDM and increasing evidence suggest that it may be possible to delay or even prevent the clinical presentation of the disease. This raises the question of whether a prevention program for IDDM should be initiated through public health channels. Review of the literature suggests that in spite of the considerable societal burden associated with diabetes, there are currently no broadly applicable, effective methods for identifying persons at increased risk of developing IDDM nor are there proven strategies for its prevention when risk is established. Until strategies to identify persons at risk of IDDM and methods to prevent the onset of disease are established, a better use of limited resources may be the secondary and tertiary prevention of complications of the disease.

Using telecommunication technology to manage children with diabetes: the Computer-Linked Outpatient Clinic (CLOC) Study.

The purpose of this study was to evaluate the efficacy of using a telecommunication system to assist in the outpatient management of pediatric patients with insulin-dependent diabetes. Metabolic control, patients' psychosocial status, family functioning, perceived quality of life, patterns of parental/child responsibility for daily diabetes maintenance, and nursing time-on-task were evaluated. One hundred six pediatric patients (mean age = 13.3 years) were randomly assigned to an experimental or control outpatient clinic for 1 year. Experimental subjects transmitted self-monitoring blood glucose data by modem to the hospital every 2 weeks. Transmitted data were reviewed by nurse practitioners who telephoned subjects to discuss regimen adjustments. Control subjects received standard care with regimen adjustments made by physicians. There were no significant between-group differences for metabolic control, rates of hospitalization or emergency-room visits, psychological status, general family functioning, quality of life, or parent-child responsibility. A significant decrease was noted in nursing time-on-task for experimental subjects.

Patterns of diabetic eye care by primary care physicians in the state of Indiana.

Diabetic retinopathy is the leading cause of new blindness in the 20 to 74-age group in the United States. The American Academy of Ophthalmology (AAO) and American Diabetes Association (ADA) have recommended guidelines for eye examination to assist primary care physicians in managing these patients. The purpose of this study is to investigate the patterns of diabetic eye care offered by primary care physicians in the State of Indiana. A survey questionnaire was sent to 1279 primary care physicians in central Indiana. Of those surveyed, 259 (20%) responded. Thirty-five percent of respondents stated that they never refer patients for ocular examination while 26% refer all patients. The remainder refer on a case-by-case basis. Patients who are not referred have their fundus examined only 70% of the time by the primary care physician and 96% of these examinations are performed with an undilated pupil. When referred, 20% of Type I patients are referred at the time of diagnosis and 50% by one year. Of the Type II patients, only 2% are referred at the time of diagnosis and 70% by one year. Ophthalmologists receive 75% of the referrals while optometrists receive 20%. Our results show that a significant number of primary care physicians in the State of Indiana do not follow the recommended guidelines set forth for diabetic eye care.