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A clinical trial of chronic care diabetic clinics in general practice in the United Arab Emirates: a preliminary analysis.

Control of diabetes mellitus is a high priority for primary health care systems. One innovative method of diabetes care delivery is the use of structured diabetes care in primary care. This includes the use of chronic care diabetes clinics or mini-clinics operated by general practitioners in primary care. There is limited experience with this model in non-Western settings. This study sought to evaluate a multi-component structured approach to diabetes care in primary care including chronic care diabetes clinics in a newly developed country in the Arabian Gulf. The study design used was a controlled before-after methodology. Three primary health centers were chosen for the intervention with six of the remaining clinics in a Health District being used as controls. A multifaceted intervention was initiated in the intervention clinics composed of chronic care diabetes clinics, a diabetic flow chart, and educational programs for clinic nurses and doctors and patients. The study intervention took place over a period of 18 months with three diabetic outcomes (fasting blood glucose, blood pressure and cholesterol) and adherence to seven diabetes guidelines being compared for the year prior to the intervention and during the last 12 months of the intervention period. Knowledge and satisfaction questionnaires were also administered to intervention and control subjects at the end of the study. In this study, 219 subjects were enrolled (130 males and 89 females). They had a mean age of 51.6 years and a mean of 3.1 years of formal education. Of these 109 were enrolled in one of three clinics that had a chronic care diabetes clinic and 110 were enrolled in one of the six control clinics. Subjects had diabetes for a mean of 7.8 +/- 4.8 years and the majority was treated with pharmacological therapy. Baseline characteristics in the intervention and the control clinics were similar with the exception of younger age (p = 0.01) and a trend for more males (p = 0.06) in the intervention clinics. There was a statistically insignificant change noted with the intervention in the three clinical outcomes studied (fasting blood glucose, blood pressure and cholesterol) both in comparison to the control group before and after and within the intervention group. However most changes noted were in the expected direction of improvement; six of the seven guidelines were statistically improved in the intervention group when compared with the control group. Within the intervention group, adherence with five of seven guidelines was also statistically significantly increased with the remaining guidelines showing a trend in favor of improvement (fasting blood glucose measurements (p = 0.07) and urine determinations for protein (p = 0.07)). Knowledge questionnaire scores were similar between the intervention and control groups on completion of the study but 2 of 4 items on a satisfaction scale were statistically significantly higher in the intervention group. The intervention described in this setting was successful in improving adherence to diabetes guidelines and increased some aspects of satisfaction with diabetes care. The intervention did not result in a statistically significant improvement in clinical outcomes but changes noted were in the expected direction of improvement. The significant improvement in adherence to diabetes guidelines suggests that this intervention is a promising model for diabetes care for newly developed countries.

Blood Glucose↗

Serotonin transporter polymorphisms affect human blood glucose control.

We measured the effect of nutritional intervention on clinical data, including fasting blood glucose (FBG), and their association with polymorphisms of the serotonin transporter-linked polymorphic region (5-HTTLPR) which might affect adherence. Enrolled in the intervention program were 264 Japanese women not on medication for diabetes, hypercholesterolemia or hypertension. The 5-HTTLPR allele (S and L) frequencies among the subjects differed markedly from those of Caucasians: SS (n = 183), LS (n = 69), and LL (n = 12). The decrease in FBG (DeltaFBG) from the beginning to the end of the program (11 weeks; short-term study), and DeltaFBG from the beginning to a follow-up check performed between 2002 and 2004 (average of 23 years later; long-term study) was calculated. The SS homozygotes of 5-HTTLPR showed larger DeltaFBG (P = 0.01 and P < 0.0001 in the short- and long-term studies, respectively) than DeltaFBG with other genotypes.

Adult↗

Structured nursing intervention versus routine rehabilitation after stroke.

OBJECTIVE: The goal of this study was to examine the effect of a structured, comprehensive nursing intervention on the course of rehabilitation over the first 6 mos after a first-ever stroke. DESIGN: Intervention (experimental) study. The participants were 155 elderly stroke survivors who were admitted to a geriatric rehabilitation department. Stratified random sampling generated intervention and control groups. The intervention was designed to work together with the routine rehabilitation program and consisted of 12 consecutive weekly meetings. The control group received only the routine rehabilitation program. Study variables were measured at entry to study and after 3- and 6-mo intervals. RESULTS: Although there were no significant differences between the two groups at entry to study, at 3 and 6 mos after stroke, the intervention group showed better scores than the control group in functional status (FIM instrument), depression (Geriatric Depression Scale), self-perceived health, self-esteem, and dietary adherence. CONCLUSION: The nursing intervention had both short- and long-term effects on functional, psychological, and emotional variables. Serious consideration should be given to implementing comprehensive nursing interventions during rehabilitation tailored to meet the specific needs of stroke survivors and their caregivers.

Activities of Daily Living↗

Biological and psychological differences in the child and adolescent transplant recipient.

Solid organ transplantation has become accepted therapy for the treatment of end-stage organ dysfunction in children. As early management of the pediatric transplant recipient has improved, important age-related differences in long-term patient outcomes have become apparent. Late morbidity and mortality can, in most cases, be attributed to the consequences of long-term immunosuppression: graft loss from under-immunosuppression or an increased incidence of cancer, hypertension, renal failure or diabetes from over-immunosuppression. Age-related differences in both biological and psychological factors play an important role in the optimization of therapy in the transplanted child. Important age-related differences have been demonstrated in all phases of pharmacokinetics: absorption, distribution, metabolism and elimination. Information regarding specific age-related pharmacokinetic differences is lacking for many immunosuppressive medications. Further study using physiologically based pharmacokinetic (PBPK) models will lead to more specific recommendations for age-based immunosuppression protocols. Non-adherence is common among solid organ transplant recipients of all ages and the consequences of non-adherence include increased rejection, late graft loss and death. The biological and psychological developmental changes that occur during adolescence place the transplanted adolescent at an even higher risk of non-adherence and poor outcome than other age groups. Further studies to elucidate the importance of both age-related pharmacokinetic and behavioral factors are needed to formulate therapeutic interventions that would improve adherence and patient outcomes.

Adolescent↗

Social-cognitive correlates of CPAP adherence in experienced users.

BACKGROUND AND PURPOSES: Obstructive sleep apnea (OSA) is a condition with serious medical and psychosocial consequences. However, poor adherence with nasal continuous positive airway pressure (CPAP) treatment limits the effectiveness of treatment. Behavior change factors offer one avenue of research to better understand the correlates of CPAP adherence. PATIENTS AND METHODS: Fifty-eight participants who had been diagnosed with OSA and prescribed CPAP treatment agreed to complete questionnaires that assessed sleep apnea symptoms, behavior change factors, and CPAP side effects, and to have their CPAP data downloaded. Behavior change factors from both social cognitive theory (SCT) and the transtheoretical model (TM) were assessed. The primary aim of the study was to examine the relationship between these social-cognitive factors and objectively measured CPAP adherence. RESULTS: Participants had been using CPAP for a mean of 2.1 years. SCT variables (adjusted R(2)=0.115, P=.008) and TM variables (adjusted R(2)=0.157, P<.0001) each accounted for a statistically significant amount of variance in CPAP adherence. CONCLUSIONS: The results suggest that social-cognitive factors may be associated with CPAP adherence in experienced CPAP users. The principal advantage to these theory-driven and empirically validated factors is that they are modifiable and can provide the basis for effective interventions to increase CPAP adherence.

Body Mass Index↗

Psychological factors associated with medication nonadherence in asthmatic children.

Adherence with inhaled beta-agonists and corticosteroids in 24 asthmatic children was tracked over 3 months utilizing the metered-dose inhaler chronolog (MDIC). Patients seldom took all of their medications as prescribed, and failed to take any inhaled corticosteroid doses on a median of 41.8% of days or inhaled beta-agonists on 28.1% of days despite prescribed daily use. Medication nonadherence was correlated with lower levels of asthma knowledge (Asthma Knowledge Questionnaire) and family dysfunction (Family Assessment Device), but not child behavior disorder (Child Behavior Checklist). Patients tended to dramatically over-report medication use. Improved identification of the markers of nonadherence can directly facilitate more efficient targeting of behavioral interventions, resulting in improved adherence, better illness control, and less requirement of urgent medication intervention.

Anti-Asthmatic Agents↗

Adherence to heroin dependence therapies and human immunodeficiency virus/acquired immunodeficiency syndrome infection rates among drug abusers.

Adherence is a primary determinant of treatment effectiveness; thus, poor adherence attenuates optimum clinical benefit. A bibliographic review was conducted to evaluate the impact of adherence to heroin dependence treatment on human immunodeficiency virus (HIV) transmission and to identify interventions proven to be effective in improving adherence. The best adherence rates were achieved by methadone and diacetylmorphine, both of which are comparable in promoting significant reduction in heroin use. Methadone adjusted-dose studies with daily doses ranging from 100 to 200 mg and multiple support interventions achieved the highest adherence rates. Studies of methadone maintenance that examined changes in HIV prevalence of infection have found that higher treatment adherence is correlated with a reduction in HIV transmission. These data suggest that patients who adhere continuously to methadone treatment are less likely to continue injecting illicit drugs and sharing contaminated injection equipment than are those who interrupt treatment, thus preventing the spread of HIV via drug injection.

Acquired Immunodeficiency Syndrome↗

Dietary trial in prostate cancer: Early experience and implications for clinical trial design.

Much epidemiologic and case-controlled evidence suggests that diet may be a modifier of prostate cancer risk. However, the role of dietary modification in men known to have prostate cancer is a matter of some debate. To elucidate the effect of diet and comprehensive lifestyle changes on cancer risk, we are conducting a randomized, prospective clinical trial on men with clinically localized prostate cancer who have selected "watchful waiting" as primary therapy. Since its inception in April 1997, 93 men have been randomized to control (n = 47) or dietary and lifestyle intervention (n = 46). Patients in the intervention group are asked to eat a low-fat, soy-supplemented vegan diet and take part in stress management, psychosocial group support, and exercise programs. After 1 year, adherence to all four interventions was greater than 80%, and no deaths or adverse outcomes have occurred. To date, we have collected prostate-specific antigen and endorectal magnetic resonance imaging and spectroscopy data on 63 patients (34 control and 29 intervention). This study demonstrates that a randomized, prospective dietary trial for men with localized prostate cancer is safe and feasible. The methodologies used provide insights into practical aspects of diet design and compliance assessment that may be useful templates for future dietary trials.

Diet, Vegetarian↗

Pillboxes and antiretroviral adherence: prevalence of use, perceived benefits, and implications for electronic medication monitoring devices.

HIV treatment adherence is improved by behavioral interventions, including medication organizers such as pillboxes, which can also interfere with adherence electronic monitoring devices (EMD). This study examined the characteristics of pillbox users and the implications of pillbox use for research using EMD adherence research. Men and women (n = 160) currently taking antiretroviral medications (ARVs) completed anonymous surveys in a community research setting. Sixty-three (39%) of individuals taking ARVs were currently using a pillbox. Pillbox users were significantly more likely to have an undetectable viral load and less likely to have missed their medications within a day of the assessment. Pillbox users indicated feeling that they benefited from using their pillbox and 76% reported they would likely stop using their pillbox if required to participate in a research study that paid them. Adherence EMD pose methodological limitations to research when pillbox users are excluded and ethical implications when pillbox users stop using their pillbox to participate.

Adult↗

Bridging community intervention and mental health services research.

OBJECTIVE: This article explores the potential of community intervention perspectives for increasing the relevance, reach, and public health impact of mental health services research. METHOD: The authors reviewed community intervention strategies, including public health and community development and empowerment interventions, and contrast community intervention with practice-based quality improvement and policy research. RESULTS: A model was proposed to integrate health services and community intervention research, building on the evidence-based strength of quality improvement and participatory methods of community intervention to produce complementary functions, such as linking community-based case finding and referral with practice-based quality improvement, enhanced by community-based social support for treatment adherence. CONCLUSIONS: The community intervention approach is a major paradigm for affecting public health or addressing health disparities. Despite challenges in implementation and evaluation, it represents a promising approach for extending the reach of mental health services interventions into diverse communities.

Community Health Planning↗

Medication nonadherence in older people with serious mental illness: prevalence and correlates.

Medication nonadherence in people with schizophrenia and other serious mental illnesses (SMI) is multidetermined and has been consistently associated with relapse and rehospitalization, but little is known about the prevalence and correlates of nonadherence in older people with SMI. This study evaluated the interrelationships between different measures of medication adherence (including pill counts, self-report, informant report, and attitudes toward medications), and their associations with demographic characteristics, and clinical, functional, skill, and cognitive measures in a group of 72 older people with SMI living in the community. Pill counts of adherence to psychotropic medications were highly correlated with pill counts for nonpsychiatric medications. However, pill counts were weakly correlated with self-report and informant ratings, which tended to overestimate adherence. Lower medication adherence was associated with: mood disorder (compared to schizophrenia), lack of supervision, fewer prescription medications, less insight, more severe negative symptoms, and worse community functioning. Among individuals with little or no supervision of their medications, higher adherence was related to better performance on the Medication Management Administration Assessment (MMAA) role-play, which was highly correlated with several domains of cognitive functioning, suggesting that the MMAA may be a more ecologically valid measure of cognitive functioning related to medication adherence. This study highlights the importance of using multiple measures for the assessment of medication adherence in older people with SMI, including pill counts, and suggests that interventions are needed to improve adherence in this population.

Attitude to Health↗

Effects of a moderate intensity exercise intervention on estrogen metabolism in postmenopausal women.

Physical activity has been associated with reduced breast cancer risk, potentially via hormonal pathways, and high urinary excretion of 2-hydroxyestrone (2-OH E(1)) relative to 16alpha-hydroxyestrone (16alpha-OH E(1)) also has been associated with reduced breast cancer risk. Studies suggest that body composition and exercise can influence estrogen metabolism. We determined the effects of a 12-month moderate intensity aerobic exercise intervention on urinary 2-OH E(1), 16alpha-OH E(1), and their ratio in overweight and obese, previously sedentary, postmenopausal women, ages 50-75 years. Women were randomized to a 12-month exercise intervention (n = 87) or stretching control group (n = 86); 170 completed the study. Urinary 2- and 16alpha-OH E(1) were measured in spot urines collected at baseline, 3, and 12 months. Body composition was measured at baseline and 12 months. Differences between exercisers and controls for excretion of estrogen metabolites were determined using general estimating equations. Further analyses assessed change in estrogen metabolites and their ratio by subgroups of change in body composition. Overall, there were no significant effects of the exercise intervention on 2-OH E(1), 16alpha-OH E(1), or their ratio (P > 0.05). There appeared to be an effect of change in intra-abdominal fat and adherence to the exercise intervention on change in the estrogen metabolites or their ratio. However, this did not reflect a potentially desirable change in estrogen metabolites associated with the exercise intervention. Thus, this 12-month moderate intensity exercise intervention did not significantly alter urinary excretion of 2-OH E(1), 16alpha-OH E(1), or their ratio in this population of women.

Aged↗

Enterococci resistant to multiple antimicrobial agents, including vancomycin. Establishment of endemicity in a university medical center.

OBJECTIVES: To determine the distribution of and risk factors for colonization and infection with vancomycin-resistant enterococci; to evaluate the molecular epidemiology of these strains; and to assess the effect of interventions, including 1) strict adherence to infection control procedures and 2) restricted use of vancomycin. DESIGN: Problem identification based on descriptive studies, point-prevalence surveys, and case-control studies and followed by specific interventions and evaluation of the response to these interventions. SETTING: University medical center. PARTICIPANTS: All patients hospitalized between May 1992 and June 1994 (59,196 admissions). MAIN RESULTS: 75 active infections attributed to vancomycin-resistant enterococci were identified. Thirty-one patients (41%) had bloodstream infections and 6 (8%) died. The incidence of active infection was highest in the organ transplantation unit (13.2 infections/1000 admissions). In the point-prevalence studies, vancomycin-resistant enterococci were isolated from 20% of a random sample of hospitalized patients in July, August, and September 1993 (adjusted prevalence, 16.9%). Case-control studies showed significant associations between colonization and infection and 1) receipt of antimicrobial agents, particularly vancomycin, and 2) severity of illness. Although several small case clusters had isolates with identical banding patterns on pulsed field gel electrophoresis, at least 45 different banding patterns were noted among medical center isolates. Interventions took place in November and December 1993. Vancomycin restriction policies resulted in a 59% decrease in intravenous vancomycin use and an 85% decrease in oral vancomycin use. Point-prevalence surveys done in April, May, and June 1994 showed a consistent 20% level of colonization with vancomycin-resistant enterococci strains (adjusted prevalence, 18.7%). No significant changes were seen in rates of vancomycin-resistant enterococci infection. CONCLUSIONS: Vancomycin-resistant enterococci are an important cause of illness and death in the study institution, particularly among organ transplant recipients and other seriously ill persons; they have also become a common intestinal colonizer among hospitalized patients. The diversity of isolates (based on molecular typing studies) suggests that resistant organisms have been introduced from multiple sources. Interventions that effectively lower the overall level of colonization with vancomycin-resistant enterococci must still be identified.

Case-Control Studies↗

Methodology of an ongoing, randomized, controlled trial to improve drug use for elderly patients with chronic heart failure.

BACKGROUND: Medications can improve the functioning and health-related quality of life of patients with chronic heart failure (CHF) and reduce morbidity, mortality, and costs of treatment. However, patients may not adhere to therapy. Patients with complex medication regimens and low health literacy are at risk for nonadherence. OBJECTIVE: The primary goal of this project is to develop and assess a multilevel pharmacy-based program to improve patient medication adherence and health outcomes for elderly CHF patients with low health literacy. METHODS: In this 4-year, controlled trial, patients aged 50 years with a diagnosis of CHF who are being treated at Wishard Health Services (Indianapolis, Indiana) are randomly assigned to pharmacist intervention or usual care. Intervention patients receive 9 months of pharmacist support and 3 months of postintervention follow-up. The intervention involves a pharmacist providing verbal and written education, icon-based labeling of medication containers, and therapeutic monitoring. The pharmacist identifies patients' barriers to appropriate drug use, coaches them on overcoming these barriers, and coordinates medication use issues with their primary care providers. Daily updates of relevant monitoring data are delivered via an electronic medical record system and stored in a personal computer system designed to support pharmacist monitoring and facilitate documentation of interventions. To measure medication adherence objectively, electronic monitoring lids are used on all CHF medications for patients in both study groups. Other assessments include self-reported medication adherence, results of echocardiography (eg, ejection fraction), brain natriuretic peptide concentrations, and health-related quality of life. Health services utilization, refill adherence, and cost data derive from electronic medical records. After completion of this study, the data can be used to assess the effectiveness and cost-effectiveness of our intervention. RESULTS: One hundred twenty-two patients have been assigned to receive the intervention and 192 to receive usual care. CONCLUSIONS: Our study aims to improve patients' knowledge and self-management of their medication and to improve medication monitoring in a multilevel pharmacy-based intervention. By doing so, we intend that the intervention will improve the health outcomes of elderly patients with CHF.

Aged↗

Association between CBE, FOBT, and Pap smear adherence and mammography adherence among older low-income women.

BACKGROUND: Adherence to regular and timely mammography screening, especially in older low-income women, continues to fall below objectives. The primary aim of this study was to examine whether engaging in other cancer screenings was associated with mammography adherence for older women. METHODS: Women, ages 52 and over, without a self-reported history of breast cancer (N = 862) were selected from a larger sample of women residing in Washington, DC, census tracts with >/=30% of households below 200% of the federal poverty threshold. A computer-assisted telephone survey was used to collect data on health care system factors, demographics, cultural beliefs, clinical breast exam (CBE), Pap smear, fecal occult blood testing (FOBT), and mammography. Adherence was defined as receipt of the last two screening tests within recommended intervals for age. RESULTS: After controlling for other variables, adherence to CBE (OR = 4.15; 95% CI, 2.55-6.73) and Pap smear (OR = 1.82; 95% CI, 1.07-3.12) were highly predictive of mammography adherence. Adherence to FOBT (OR = 1.66; 95% CI, 0.97-2.84) was marginally predictive. CONCLUSIONS: Results of this study indicate that nonadherence to other cancer screenings can help identify women in need of additional interventions to improve mammography adherence.

Aged↗

Effect of a physician-directed educational campaign on performance of proper diabetic foot exams in an outpatient setting.

BACKGROUND: The established guidelines for a diabetes foot examination include assessing circulatory, skin, and neurological status to detect problems early and reduce the likelihood of amputation. Physician adherence to the guidelines for proper examination is less than optimal. OBJECTIVE: Our objective was to increase compliance with the performance of a proper foot examination through a predominantly physician-directed interventional campaign. METHODS: The study consisted of 3 parts: a retrospective chart review to estimate background compliance, an educational intervention, and prospective chart review at 3 and 6 months. A properly documented foot examination was defined as assessing at least 2 of the 3 necessary components. The educational intervention consisted of 2 lectures directed at resident physicians and a quality assurance announcement at a general internal medicine staff meeting. Clinic support staff were instructed to remove the shoes and socks of all diabetic patients when they were placed in exam rooms, and signs reminding diabetics were placed in each exam room. RESULTS: There was a significant increase in the performance of proper foot examination over the course of the study (baseline 14.0%, 3 months 58.0%, 6 months 62.1%; P <.001). Documentation of any component of a proper foot examination also increased substantially (32.6%, 67.3%, 72.5%; P <.001). Additionally, performance of each component of a proper exam increased dramatically during the study: neurological (13.5%, 35.8%, 38.5%; P <.001), skin (23.0%, 64.2%, 69.2%; P <.001), and vascular (14.0%, 51.2%, 50.5%; P <.001). CONCLUSIONS: Patients with diabetes are unlikely to have foot examinations in their primary medical care. A simple, low-cost educational intervention significantly improved the adherence to foot examination guidelines for patients with diabetes.

Adult↗

Strategies to enhance patient adherence: making it simple.

The problem of poor patient adherence has been extensively researched, but the rates of nonadherence have not changed much in the past 3 decades. Healthcare providers play a unique and important role in assisting patients' healthy behavior changes. We conducted a narrative review of the current literature to help providers become more familiar with proven interventions that can enhance patient adherence. We then grouped the interventions into categories that can be remembered by the mnemonic "SIMPLE":1. Simplifying regimen characteristics; 2. Imparting knowledge; 3. Modifying patient beliefs; 4. Leaving the bias; and 6. Evaluating adherence. Chronic lifestyle behavior change often requires a combination of all the aforementioned strategies. We suggest a conceptual framework, which calls for a multidisciplinary approach with the above strategies in the context of a healthcare team and system-related factors. We hope that this framework would not only help design scientifically proven interventions, but also reduce the time and cost involved with implementing these strategies in a healthcare setting.

Behavior Therapy↗