Clinical Management Program Research Articles

Comparison of a low carbohydrate and low fat diet for weight maintenance in overweight or obese adults enrolled in a clinical weight management program

BackgroundRecent evidence suggests that a low carbohydrate (LC) diet may be equally or more effective for short-term weight loss than a traditional low fat (LF) diet; however, less is known about how they compare for weight maintenance. The purpose of this study was to compare body weight (BW) for participants in a clinical weight management program, consuming a LC or LF weight maintenance diet for 6 months following weight loss.MethodsFifty-five (29 low carbohydrate diet; 26 low fat diet) overweight/obese middle-aged adults completed a 9 month weight management program that included instruction for behavior, physical activity (PA), and nutrition. For 3 months all participants consumed an identical liquid diet (2177 kJ/day) followed by 1 month of re-feeding with solid foods either low in carbohydrate or low in fat. For the remaining 5 months, participants were prescribed a meal plan low in dietary carbohydrate (~20%) or fat (~30%). BW and carbohydrate or fat grams were collected at each group meeting. Energy and macronutrient intake were assessed at baseline, 3, 6, and 9 months.ResultsThe LC group increased BW from 89.2 ± 14.4 kg at 3 months to 89.3 ± 16.1 kg at 9 months (P = 0.84). The LF group decreased BW from 86.3 ± 12.0 kg at 3 months to 86.0 ± 14.0 kg at 9 months (P = 0.96). BW was not different between groups during weight maintenance (P = 0.87). Fifty-five percent (16/29) and 50% (13/26) of participants for the LC and LF groups, respectively, continued to decrease their body weight during weight maintenance.ConclusionFollowing a 3 month liquid diet, the LC and LF diet groups were equally effective for BW maintenance over 6 months; however, there was significant variation in weight change within each group.

SMARThivPack: a complexity free and cost effective "three tests" combo kit model for improving HIV patients monitoring standards in resource poor settings.

We propose a second method at an implementation level with cost and complexity reductions for monitoring HIV patients in resource-limited settings. The model is SMARThivPack, a "three tests" combo kit. Cost and complexity reductions of HIV patient monitoring technologies were described in a first model (at a technology development stage) proposed earlier. In developed countries, HIV patient clinical management programs comport three laboratory tests containing CD4 count, viral load measurement and pharmaco-resistance testing. In most developing countries only CD4 count is performed without the other two tests. Cost and complexity of required technologies are the major challenges to the developing world to meeting the "three tests" standard. SMARThivPack model achieves the "three tests" standard in the developing world by optimizing technology choice as to favour cross-use of equipments, thereby reducing equipment cost at the laboratory implementation level. Equipment cross use also reduces complexity by reducing training time, promoting specialization and substantiating experience in equipment use. The second level cost and complexity reductions model sets the grounds for a third level, global coordination cost and complexity reductions model.

FMECA methodology applied to two pathways in an orthopaedic hospital in Milan.

Adverse events pose a challenge to medical management: they can produce mild or transient disabilities or lead to permanent disabilities or even death; preventable adverse events result from error or equipment failure. IRCCS Istituto Ortopedico Galeazzi implemented a clinical risk management program in order to study the epidemiology of adverse events and to improve new pathways for preventing clinical errors: a risk management FMECA-FMEA pro-active analysis was applied either to an existing clinical support pathway or to a new process before its implementation. The application of FMEA-FMECA allowed the clinical risk unit of our hospital to undertake corrective actions in order to reduce the adverse events and errors on high-risk procedure used inside the hospitals.

Feasibility of the Use of Phosphodiesterase Type 5 Inhibitors in a Pharmacologic Prevention Program for Recurrent Priapism

Recurrent ischemic priapism is an enigmatic erectile disorder in need of improved clinical interventions to avert its known, potentially serious complications. To evaluate the use of a long-term, continuous phosphodiesterase type 5 (PDE5) inhibitor therapeutic regimen in controlling recurrent ischemic priapism and its feasibility in a clinical management program for the disorder. The main outcome measure was reduction in frequency or duration of priapism episodes. A secondary outcome measure was preservation of erectile ability. We retrospectively evaluated the clinical progress of seven patients (age 22-37 years) with sickle cell disease-associated "stuttering" priapism (N = 4) and idiopathic recurrent priapism (N = 3), who were counseled and consented to the "off-label" use of the PDE5 inhibitors sildenafil citrate and tadalafil. The medications were administered according to a specified therapeutic regimen based on scientific evidence that chronic PDE5 inhibitor administration in priapism contexts effectively reconditions PDE5 regulatory function in the penis. The duration of clinical follow-up extended through 2 years. All seven patients were confirmed to have recurrent ischemic priapism without identifiable pharmacologic, traumatic, or neoplastic disease associations based on clinical history, physical examination, laboratory testing, and penile diagnostics. PDE5 inhibitor treatment was successful in alleviating or resolving priapism recurrences in six of the seven patients. Erectile function was unchanged in six patients and improved in one patient at last follow-up compared with baseline status. All the patients reported that PDE5 inhibitor therapy was well tolerated and did not cause any adverse effects limiting their continued use of the medication. Because of their efficacy, safety, and tolerability as shown in this case series, PDE5 inhibitors would appear to have a possible role in a rigorously implemented clinical management program to control recurrent priapism. However, completion of a controlled clinical trial is necessary to confirm the utility of this treatment.

Validity of the leg-to-leg bioimpedance to estimate changes in body fat during weight loss and regain in overweight women: a comparison with multi-compartment models

To investigate changes in body composition and the validity of the leg-to-leg bioimpedance (LTL) method to measure body fat during active weight loss (WL) and weight regain (WR). Longitudinal, 12-week weight loss intervention (3.3-3.8 MJ/day) and subsequent follow-up at 1 year. Fifty-eight adult women aged between 24 and 65 years (mean age: 46.8+/-8.9 years) and with a body mass index (BMI) > or =25 kg/m(2) (mean BMI: 31.6+/-2.5 kg/m(2), range=26.0-48.2 kg/m(2)) participated in the study. Fat mass (FM) was measured at baseline, 12 weeks, 24 weeks and 52 weeks using three- and four-compartment (4-C) models, air displacement plethysmography (ADP), deuterium dilution - total body water (TBW), dual-energy X-ray absorptiometry (DXA), skinfold thickness (SFT), tetrapolar bioelectrical impedance analysis (T-BIA) and LTL. At the end of the weight loss programme, subjects lost 9.9+/-3.5 kg weight (P<0.001) and 7.6+/-0.5 kg fat (P<0.001) but after 1 year they had regained 4.9+/-3.7 kg of weight and 3.7+/-2.9 kg of fat. The 4-C model showed that FM and TBW accounted for 76.2 and 23.6% of the loss in body mass and 81.8 and 17.7% of the tissue accrued during weight regain, respectively. The estimate of body fat change by LTL relative to multi-compartment models (WL(bias+/-2s.d.)=0.51+/-3.26 kg; WR(bias+/-2s.d.)=-0.25+/-2.30 kg) was similar to ADP, DXA and TBW in both phases but it was better than T-BIA (WL(bias+/-2s.d.)=0.17+/-7.90 kg; WR(bias+/-2s.d.)=-0.29+/-7.59 kg) and skinfold thickness (WL(bias+/-2s.d.)=2.68+/-6.68 kg; WR(bias+/-2s.d.)=-0.84+/-3.80 kg). Weight loss and regain were associated with minimal changes in lean tissue as measured using multi-compartment models. The LTL system is a useful method to measure body composition changes during clinical weight management programmes.

Health-related quality of life following a clinical weight loss intervention among overweight and obese adults: intervention and 24 month follow-up effects

BackgroundDespite a growing literature on the efficacy of behavioral weight loss interventions, we still know relatively little about the long terms effects they have on HRQL. Therefore, we conducted a study to investigate the immediate post-intervention (6 months) and long-term (12 and 24 months) effects of clinically based weight management programs on HRQL.MethodsWe conducted a randomized clinical trial in which all participants completed a 6 month clinical weight loss program and were randomized into two 6-month extended care groups. Participants then returned at 12 and 24 months for follow-up assessments. A total of 144 individuals (78% women, M age = 50.2 (9.2) yrs, M BMI = 32.5 (3.8) kg/m2) completed the 6 month intervention and 104 returned at 24 months. Primary outcomes of weight and HRQL using the SF-36 were analyzed using multivariate repeated measures analyses.ResultsThere was complete data on 91 participants through the 24 months of the study. At baseline the participants scored lower than U.S. age-specific population norms for bodily pain, vitality, and mental health. At the completion of the 6 month clinical intervention there were increases in the physical and mental composite measures as well as physical functioning, general health, vitality, and mental health subscales of the SF-36. Despite some weight regain, the improvements in the mental composite scale as well as the physical functioning, vitality, and mental health subscales were maintained at 24 months. There were no significant main effects or interactions by extended care treatment group or weight loss group (whether or not they maintained 5% loss at 24 months).ConclusionA clinical weight management program focused on behavior change was successful in improving several factors of HRQL at the completion of the program and many of those improvements were maintained at 24 months. Maintaining a significant weight loss (> 5%) was not necessary to have and maintain improvements in HRQL.

Improvements in Overweight Youth with Participation in a Clinical Weight Management Program

Improvements in Overweight Youth with Participation in a Clinical Weight Management Program

Response to Comment on “Tumor Progression Can Occur despite the Induction of Very High Levels of Self/Tumor Antigen-Specific CD8+ T Cells in Patients with Melanoma”

Health information technology (health IT) has potential to improve patient safety but its implementation and use has led to unintended consequences and new safety concerns. A key challenge to improving safety in health IT-enabled healthcare systems is to develop valid, feasible strategies to measure safety concerns at the intersection of health IT and patient safety. In response to the fundamental conceptual and methodological gaps related to both defining and measuring health IT-related patient safety, we propose a new framework, the Health IT Safety (HITS) measurement framework, to provide a conceptual foundation for health IT-related patient safety measurement, monitoring, and improvement. The HITS framework follows both Continuous Quality Improvement (CQI) and sociotechnical approaches and calls for new measures and measurement activities to address safety concerns in three related domains: 1) concerns that are unique and specific to technology (e.g., to address unsafe health IT related to unavailable or malfunctioning hardware or software); 2) concerns created by the failure to use health IT appropriately or by misuse of health IT (e.g. to reduce nuisance alerts in the electronic health record (EHR)), and 3) the use of health IT to monitor risks, health care processes and outcomes and identify potential safety concerns before they can harm patients (e.g. use EHR-based algorithms to identify patients at risk for medication errors or care delays). The framework proposes to integrate both retrospective and prospective measurement of HIT safety with an organization9s existing clinical risk management and safety programs. It aims to facilitate organizational learning, comprehensive 360 degree assessment of HIT safety that includes vendor involvement, refinement of measurement tools and strategies, and shared responsibility to identify problems and implement solutions. A long term framework goal is to enable rigorous measurement that helps achieve the safety benefits of health IT in real-world clinical settings.

Clinical Waste Generation from Renal Units: Implications and Solutions

The treatment of end-stage renal disease (ESRD) makes extensive use of presterilized disposable items which, after use, are contaminated by blood. The preferred route of disposal of such items is by incineration. Disposal costs have risen and this increase in costs has not been matched by waste management programs in renal units. Many of the waste items generated also contain polyvinyl chloride (PVC) whose incineration is environmentally sensitive. Furthermore blood tubing sets contain plasticizers such as di(2-ethylhexyl) phthalate (DEHP), which is known to pose health risks to specific groups of patients. The generation of clinical waste in a dialysis unit is analyzed, issues associated with disposal are discussed, and approaches toward a cost-effective, environmentally sustainable clinical waste management program are reviewed.

The Relationship of Health Outcomes to Improvement in BMI in Children and Adolescents

To evaluate the clinical outcomes of patients participating in an outpatient program for managing childhood and adolescent obesity. Based on a retrospective chart review, 394 physician-referred obese youth (BMI > 95th percentile), 5 to 19 years of age, were treated in an interdisciplinary, family-centered, behavioral weight management program in a hospital-based outpatient setting. Treatment included group exercise, parent education, and behavioral intervention therapies to improve diet and physical activity. A total of 177 (45%) completed the initial phase of treatment (mean duration = 5.6 months). For the completion group, there were significant improvements (all p < 0.001) in weight (-2.0 +/- 4.9 kg), BMI (-1.7 +/- 1.9 kg/m(2)), and BMI z score (-0.15 +/- 0.15), without interfering with growth (height, 2.2 +/- 1.3 cm; p < 0.001). Significant improvement was also found for blood pressure, total cholesterol, low-density lipoprotein (LDL)-cholesterol, triglycerides, insulin, and aerobic fitness. At onset of treatment, 134 (84%) patients had abnormal fasting insulin concentration, 88 (50%) had abnormal total cholesterol, 14 (8%) had abnormal diastolic blood pressure, and 69 (40%) had abnormal LDL-cholesterol. At the end of treatment, a significant proportion of patients with baseline abnormal blood pressure, total cholesterol, and LDL-cholesterol had normal values (p < 0.001). A decrease in BMI z score was associated with significant improvements in insulin and lipid values (all p < 0.05). We have demonstrated that a modest decrease in BMI in an ongoing clinical pediatric weight management program is accompanied by significant improvements in related health measures. These results may be helpful in counseling families with overweight children and adolescents.

Lebensqualität und Stimmbeeinträchtigung Laryngektomierter mit Stimmventilprothesen

Health-related quality of life (QoL) and subjective health have become popular constructs for the evaluation of both efficacy and efficiency of diagnostic and therapeutic procedures in medicine. QoL is considered a multidimensional construct encompassing physical, mental and social facets of life. It is an accepted outcome parameter not only in international classification systems such as ICIDH and ICF, but as well in clinical guidelines and disease management programs. Measuring quality of life allows for comparison of different diseases though it certainly lacks disease specific aspects. Thus, it has to be assumed that in patients with distinct functional deficits QoL cannot cover all aspects that are important for the individual patient. This study focuses on laryngectomies and their self-evaluation of post-laryngectomy speech. It is well known that these patients experience a decreased QoL compared to patients after partial laryngectomy or healthy persons. In this study, the impact of voice restoration on the laryngectomies' QoL was evaluated. In 20 male laryngectomies aged 62 +/- 8 years, relations between QoL and voice handicap were evaluated using two instruments as proposed in the international literature, i. e. the Short-Form Health Survey (SF-36) and the Voice Handicap Index (VHI). All patients had successfully been using tracheoesophageal substitute voice for at least one year. Complete data sets were available from all patients. Data were analysed using Microsoft Excel and Sigma Plot, Jandel Corp. software packages. Results of both the SF-36 and the VHI reveal wide interindividual ranges. There are statistically significant correlations (p < 0.05) between the SF-36's scales General Health and Vitality and the VHI, whereas no correlations were found between social and psychological scales and the voice handicap. Wide ranges of the data obtained reveal that obviously both health related quality of life and voice handicap are not affected in a group specific way. So, both tests are of clinical value to depict individual aspects of wellbeing after laryngectomy. The combination of VHI and SF-36 illuminates correlations between general and special subjective aspects. Strikingly, the laryngectomies' social and psychological status is not related to their voice handicap. Data allow for conclusion that laryngectomies' substitute voice problems do not affect social aspects of quality of life in a disease specific way, at least as long as voice restoration was successful at all.

Clinical treatment of obesity: are drugs and surgery the answer?

Obesity treatment remains a 'Cinderella' of all clinical management programmes, but generally without a happy ending. The great expectation for new therapeutic agents has not been fulfilled in clinical practice, whilst the restriction of eating through surgical division of the upper bowel seems strange in an age of advanced and sophisticated technology. The better understanding of the neuro-regulation of appetite, and its application as part of evidence-based clinical interventions, could lead to a more coherent approach to obesity treatment. Nevertheless, investigation of potential neuroendocrine targets for appetite suppression suggests redundancy in the systems, which make development of effective agents against single receptors impractical. Importantly, the progressive rise in the prevalence of obesity will inevitably mean that only a small proportion of afflicted patients will actually be treated by long-term drugs and surgery. Drugs and surgery are not currently the answer for the majority of obese individuals. What is required is a better way of identifying patients who may particularly benefit from such approaches. However, the major emphasis must be the development of effective population-wide interventions that halt the increase in fatness and ensure that future generations maintain and enjoy a healthy body weight.

Diabetes disease management in managed care organizations.

Recent clinical trials and disease management programs sponsored by managed care organizations have demonstrated achievements in limiting complications, improving health measures, reducing costs, and enhancing the quality of life of the person with diabetes. In one managed care organization, Group Health, Inc., persons with diabetes received discounted supplies and educational material as encouragement to participate in a diabetes disease management program [Disease Management Solutions (DMS)]. Health risk appraisals (HRAs) were provided at enrollment, and at 6-month intervals thereafter. Over 8,000 persons with diabetes participated in the DMS program over a 2 and 1/2-year period. Claims data over a 3-year period (pre- and post-enrollment) for 1,368 persons with diabetes demonstrated that participation in DMS resulted in greater utilization of primary care services by enrolled persons than by non-enrolled, but a lower increase in costs for those enrolled. In addition to evaluating the program impact through changes in services and costs, HRAs provided self-reported scores on (1) several compliance measures and (2) general health impressions and productivity. In the DMS population, self-reported compliance with physician-recommended office visits and tests (eg, cholesterol screening) improved for persons with diabetes once they enrolled in the program. Participants also reported greater productivity (eg, fewer missed work days) once enrolled in the program. To validate self-reported results, medical claims were used to verify compliance with general office, ophthalmologic, and emergency room visits and hospital admissions. A high level of validity between self-reported results and claims data recording office and emergency room visits and hospital admissions was found.

Improving physician documentation through a clinical documentation management program.

Improving physician documentation ensures that the patient's clinical course is clearly recorded. North Carolina Baptist Hospital implemented interventions addressing physician documentation to ensure the assignment of the most appropriate diagnosis-related group (DRG) when it launched the Clinical Documentation Management Program (CDMP). Collaboration between registered nurses trained as clinical documentation consultants (CDC) and certified coding specialists as well as ongoing physician education has resulted in more accurate and complete documentation in the medical record.

Using Personal Selling Skills to Promote Pharmacy Services: Everyday encounters with patients offer valuable opportunities to build demand for pharmacy services and impart the value of pharmaceutical care

In recent years, pharmacists have made significant progress in building the supply of pharmaceutical care services. Pharmacists in a variety of practice settings are developing new clinical services and disease management programs to help patients achieve desired health outcomes. These services range from blood lipid management and diabetes education to smoking cessation programs and cancer risk assessment.2–5 As pharmaceutical care pioneer Charles D. Hepler has noted, however, the pharmacy profession has put far less focus on building demand for these same services. Because many patients and physicians may not yet recognize the value of pharmacy-based patient services, the demand for pharmaceutical care remains limited. Although some pharmacies have developed and implemented effective marketing strategies to build demand for new services, many others have experienced difficulty in this regard.6 Creating and maintaining mutually beneficial relationships with patients, physicians, and other stakeholders is essential for successful marketing of pharmacy-based services. This approach, known as relationship marketing, depends on effective use of personal (one-on-one) selling skills.6 By combining personal selling skills with a sound marketing plan, pharmacists can more effectively promote and generate demand for their patient services. This article reviews techniques that help pharmacists become more comfortable and proficient with personal selling activities. These strategies have been used by one of the authors (McDonough) in promoting pharmacy services at Main at Locust Pharmacy in Davenport, Iowa.

Establishing an on-site pharmacy in a community health center to help indigent patients access medications and to improve care.

To describe the establishment of an on-site pharmacy in a community health center (CHC) to improve access to medications for indigent patients, the implementation of pharmaceutical care programs and clinical pharmacy services to improve patient care and therapeutic outcomes, and the development of an ambulatory care site for training pharmacy students. Partnership Health Center (PHC), a federally funded CHC in Missoula, Mont. Establishment of an on-site pharmacy and strategies for accessing medications for indigent patients, including participation in the U.S. Public Health Service pricing program, pharmaceutical manufacturers' assistance programs, and drug sampling, are described. The clinical pharmacy, disease management, and pharmaceutical care programs developed at the site to improve medication use and therapeutic outcomes are discussed. Development of an ambulatory care clerkship site at the CHC for training University of Montana pharmacy students is reviewed. Partnership between PHC and the University of Montana School of Pharmacy and Allied Health Sciences (SPAHS) to establish an on-site pharmacy to help medically indigent patients access medications and to improve care. Programs to help indigent patients access, adhere, and appropriately use needed medications while decreasing clinic expenditures for medications. Number of prescriptions dispensed per month, clinic expenditures on medications per month, and number of clinical services and pharmaceutical care programs developed. Between November 1, 1999, and April 30, 2000, the average number of prescriptions filled for PHC clients increased from 219/month to 838/month and the average expenditure per prescription decreased from $16.55/month to $0.51/month. A pharmacist-assisted refill program was implemented. Programs in diabetes, hypertension, dyslipidemia, asthma, anticoagulation, and peptic ulcer disease were developed. Establishing an on-site pharmacy in a CHC in collaboration with a school of pharmacy significantly improved indigent patients' access to medications while decreasing clinic expenditures. Pharmaceutical care programs improved therapeutic outcomes, and clinical pharmacy services complemented the clinical activities of other health care providers in managing chronic diseases and resolving drug-related problems. The CHC provided an excellent setting for training pharmacy students in ambulatory care.

Detecting and reducing hospital adverse events: outcomes of the Wimmera clinical risk management program

To determine if an integrated clinical risk management program that detects adverse patient events in a hospital, analyses their risk and takes action can alter the rate of adverse events. Longitudinal survey of adverse patient events over eight years of progressive implementation of the risk management program. 49,834 inpatients (July 1991 to September 1999) and 20,050 emergency department patients (October 1997 to September 1999) at a rural base hospital in the Wimmera region of Victoria. Rates of adverse events detected by medical record review and clinical incident and general practitioner reporting. The annual rate of inpatient adverse events decreased between the first and eighth years of the study from 1.35% of all patient discharges (69 events) to 0.74% (49 events) (P<0.001). Absolute risk reduction was 0.61% (95% CI, 0.23%-0.99%), and relative risk reduction was 44.9% (95% CI, 16.9%-72.9%). The quarterly rate of emergency department adverse events decreased between the first and eighth quarters of monitoring from 3.26% of all attendances (84 events) to 0.48% (12 events) (P< 0.001). Absolute risk reduction was 2.78% (95% CI, 2.04%-3.52%), and relative risk reduction was 85.3% (95% CI, 62.7%-100%). Adverse patient events can be detected, and their frequency reduced, using multiple detection methods and clinical improvement strategies as part of an integrated clinical risk management program.

Customizing a relational database to support a clinical case management program.

Customizing a relational database to support a clinical case management program.

Satisfaction with clinical case management services of patients with long-term psychoses.

Outpatients with long-term psychotic disorders from two clinical case management programs were interviewed one-on-one to determine their satisfaction with specific aspects of such services. Patients answered standardized questionnaires and two open-ended satisfaction questions. The close follow-up provided by these programs led us to expect high patient satisfaction, and most patients were very satisfied with their clinical case managers. Lower functioning patients, followed by more intensive clinical case management, were equally satisfied to those followed by a less intensive program. However, many patients revealed dissatisfaction with explanations about clinical treatment and services.

Violence among comorbid and noncomorbid severely mentally ill adults: A pilot study

This pilot study examined the relationship between substance dependence and violence in a sample of severely mentally ill adults. Subjects were 42 psychiatric outpatients enrolled in a clinical case management program in San Francisco, California. Almost 40% of the participants reported perpetrating at least one violent act in the past 12 months. Comorbid participants were over 4% times more likely to commit a violent act in the past 12 months than noncomorbid participants. Substance dependence was also more frequently associated with perpetration of a violent act by female than by male participants and by Caucasian than by African American participants. Comorbid mentally ill participants appear more likely to perpetrate violent acts than those with mental illness alone. The dangers of substance dependence in terms of the perpetration of violence may not be in mental illness or substance dependence alone but in their co‐occurrence. Further investigation is needed to assess risk factors for violence and victimization in multiple environmental and situational domains. It will be important to explore the moderating effects of gender and race on the co‐occurrence of mental illness, substance dependence, and the perpetration of violent acts.