Benefits and costs of intensive lifestyle modification programs for symptomatic coronary disease in Medicare beneficiaries.

BACKGROUND: This study reports outcomes of a Medicare-sponsored demonstration of two intensive lifestyle modification programs (LMPs) in patients with symptomatic coronary heart disease: the Cardiac Wellness Program of the Benson-Henry Mind Body Institute (MBMI) and the Dr Dean Ornish Program for Reversing Heart Disease® (Ornish). METHODS: This multisite demonstration, conducted between 2000 and 2008, enrolled Medicare beneficiaries who had had an acute myocardial infarction or a cardiac procedure within the preceding 12 months or had stable angina pectoris. Health and economic outcomes are compared with matched controls who had received either traditional or no cardiac rehabilitation following similar cardiac events. Each program included a 1-year active intervention of exercise, diet, small-group support, and stress reduction. Medicare claims were used to examine 3-year outcomes. The analysis includes 461 elderly, fee-for-service, Medicare participants and 1,795 controls. RESULTS: Cardiac and non-cardiac hospitalization rates were lower in participants than controls in each program and were statistically significant in MBMI (P < .01). Program costs of $3,801 and $4,441 per participant for the MBMI and Ornish Programs, respectively, were offset by reduced health care costs yielding non-significant three-year net savings per participant of about $3,500 in MBMI and $1,000 in Ornish. A trend towards lower mortality compared with controls was observed in MBMI participants (P = .07). CONCLUSIONS: Intensive, year-long LMPs reduced hospitalization rates and suggest reduced Medicare costs in elderly beneficiaries with symptomatic coronary heart disease.

Use of cardiac rehabilitation by Medicare beneficiaries after myocardial infarction or coronary bypass surgery.

BACKGROUND: Cardiac rehabilitation (CR) is effective in prolonging survival and reducing disability in patients with coronary heart disease. However, national use patterns and predictors of CR use have not been evaluated thoroughly. METHODS AND RESULTS: Using Medicare claims, we analyzed outpatient (phase II) CR use after hospitalizations for acute myocardial infarctions or coronary artery bypass graft surgery in 267,427 fee-for-service beneficiaries aged > or = 65 years who survived for at least 30 days after hospital discharge. We used multivariable analyses to identify predictors of CR use and to quantify geographic variations in its use. We obtained unadjusted, adjusted-smoothed, and standardized rates of CR use by state. Overall, CR was used in 13.9% of patients hospitalized for acute myocardial infarction and 31.0% of patients who underwent coronary artery bypass graft surgery. Older individuals, women, nonwhites, and patients with comorbidities (including congestive heart failure, previous stroke, diabetes mellitus, or cancer) were significantly less likely to receive CR. Coronary artery bypass graft surgery during the index hospitalization, higher median household income, higher level of education, and shorter distance to the nearest CR facility were important predictors of higher CR use. Adjusted CR use varied 9-fold among states, ranging from 6.6% in Idaho to 53.5% in Nebraska. The highest CR use rates were clustered in the north central states of the United States. CONCLUSIONS: CR use is relatively low among Medicare beneficiaries despite convincing evidence of its benefits and recommendations for its use by professional organizations. Use is higher after coronary artery bypass graft surgery than with acute myocardial infarctions not treated with revascularization procedures and varies dramatically by state and region of the United States.

Acupuncture for treatment of persistent arm pain due to repetitive use: a randomized controlled clinical trial.

OBJECTIVE: To compare true and sham acupuncture in their abilities to relieve arm pain and improve arm function in individuals with arm pain due to repetitive use. METHODS: Participants with persistent arm pain (N=123) were randomly assigned to true or sham acupuncture groups and received 8 treatments over 4 weeks. The primary outcome was intensity of pain (10-point scale) and secondary outcomes were arm symptoms, arm function, and grip strength. Outcomes were measured during treatment (at 2 and 4 wk) and 1 month after treatment ended. RESULTS: Arm pain scores improved in both groups during the treatment period, but improvements were significantly greater in the sham group than in the true acupuncture group. This difference disappeared by 1 month after treatment ended. The true acupuncture group experienced more side effects, predominantly mild pain at time of treatments. DISCUSSION: Sham acupuncture reduced arm pain more than true acupuncture during treatment, but the difference did not persist after 1 month. Mild side effects from true acupuncture may have blunted any positive treatment effects. Overall, this study did not find evidence to support the effectiveness of true acupuncture in treatment of persistent arm pain due to repetitive use.

Experiences of acupuncturists in a placebo-controlled, randomized clinical trial.

BACKGROUND: This paper describes the experiences of 8 licensed acupuncturists in a placebo-controlled randomized clinical trial (RCT). This information is important to the design and conduct of high-quality trials. METHODS: We conducted a RCT (N=135) with a 2-week placebo run-in followed by 4 weeks of twice-weekly treatments comparing genuine to sham acupuncture (using the Streitberger placebo needle) in the treatment of arm pain caused by repetitive use. At the end of this study, we conducted written structured interviews with 8 participating acupuncturists. The acupuncturists were not aware of the study's results at the time of these interviews. The questions focused on their experiences in the study, adherence to study protocols, their thoughts about the technical and ethical issues involved in using a sham needling device, and their expectations of trial outcomes. The questions were motivated by expressions of concerns the acupuncturists raised in feedback groups during the course of the study, and our desire to improve further trials. RESULTS: The acupuncturists differed widely in their comfort levels with the research methods used, their adherence to the study protocol, and their expectations of trial outcomes. CONCLUSIONS: We conclude that careful monitoring of acupuncturists, including observation of treatments and frequent meetings to support them throughout the trial, is necessary to maintain a high degree of quality control.

Correlated change in upper limb function and motor cortex activation after verum and sham acupuncture in patients with chronic stroke.

BACKGROUND: Acupuncture may improve motor function in patients with chronic hemiparetic stroke, yet the neural mechanisms underlying such an effect are unknown. As part of a sham-controlled, randomized clinical trial testing the efficacy of a 10-week acupuncture protocol in patients with chronic hemiparetic stroke, we examined the relationship between changes in function of the affected upper limb and brain activation using functional magnetic resonance imaging (fMRI). METHODS: Seven (7) chronic hemiparetic stroke patients underwent fMRI and testing of function of the affected upper limb (spasticity and range-of-motion) before and after a 10-week period of verum (N=4) or sham (N=3) acupuncture. The correlation between changes in function of the affected upper limb and brain activation after treatment was tested across patients. RESULTS: We found a significant positive correlation between changes in function of the affected upper limb (spasticity and range of motion) and activation in a region of the ipsilesional motor cortex. Patients treated with verum acupuncture showed a trend toward a greater maximum activation change in this motor cortical area as compared to those treated with sham acupuncture. CONCLUSIONS: Acupuncture may improve function of the affected upper limb in chronic hemiparetic stroke patients by increasing activity in the ipsilesional motor cortex.

Sham acupuncture devices--practical advice for researchers.

Several validated sham acupuncture devices have recently become available. While some debate exists on whether such needles are the best placebo control for an RCT of acupuncture, practical advice based on research experience is missing from the literature. This paper shares our concrete experience using the most commonly used such sham needle (the 'Streitberger needle' and its paired verum needle) in a large RCT (n=135) which included a two-week run-in period. The placebo run-in gave us an opportunity to use the sham device on all participants, who were then re-randomised to receive genuine acupuncture or to continue treatment with the device. The blinding was successful both at the end of the run-in and at the conclusion of the trial despite the re-randomisation. We also report our experience with the sham needle in neuroimaging experiments where the magnetic machinery poses considerable challenges for acupuncture research.

Effects of Expanded Coverage for Chiropractic Services on Medicare Costs in a CMS Demonstration.

BACKGROUND: Moderately convincing evidence supports the benefits of chiropractic manipulations for low back pain. Its effectiveness in other applications is less well documented, and its cost-effectiveness is not known. These questions led the Centers for Medicaid and Medicare Services (CMS) to conduct a two-year demonstration of expanded Medicare coverage for chiropractic services in the treatment of beneficiaries with neuromusculoskeletal (NMS) conditions affecting the back, limbs, neck, or head. METHODS: The demonstration was conducted in 2005-2007 in selected counties of Illinois, Iowa, and Virginia and the entire states of Maine and New Mexico. Medicare claims were compiled for the preceding year and two demonstration years for the demonstration areas and matched comparison areas. The impact of the demonstration was analyzed through multivariate regression analysis with a difference-in-difference framework. RESULTS: Expanded coverage increased Medicare expenditures by $50 million or 28.5% in users of chiropractic services and by $114 million or 10.4% in all patients treated for NMS conditions in demonstration areas during the two-year period. Results varied widely among demonstration areas ranging from increased costs per user of $485 in Northern Illinois and Chicago counties to decreases in costs per user of $59 in New Mexico and $178 in Scott County, Iowa. CONCLUSION: The demonstration did not assess possible decreases in costs to other insurers, out-of-pocket payments by patients, the need for and costs of pain medications, or longer term clinical benefits such as avoidance of orthopedic surgical procedures beyond the two-year period of the demonstration. It is possible that other payers or beneficiaries saved money during the demonstration while costs to Medicare were increased.

Postoperative Staphylococcus aureus infections in Medicare beneficiaries.

Staphylococcus aureus (S. aureus) infections are important because of their increasing frequency, resistance to antibiotics, and high associated rates of disabilities and deaths. We examined the incidence and correlates of S. aureus infections following 219,958 major surgical procedures in a 5% random sample of fee-for-service Medicare beneficiaries from 2004-2007. Of these surgical patients, 0.3% had S. aureus infections during the hospitalizations when index surgical procedures were performed; and 1.7% and 2.3%, respectively, were hospitalized with infections within 60 days or 180 days following admissions for index surgeries. S. aureus infections occurred within 180 days in 1.9% of patients following coronary artery bypass graft surgery, 2.3% following hip surgery, and 5.9% following gastric or esophageal surgery. Of patients first hospitalized with any major infection reported during the first 180 days after index surgery, 15% of infections were due to S. aureus, 18% to other documented organisms, and no specific organism was reported on claim forms in 67%. Patient-level predictors of S. aureus infections included transfer from skilled nursing facilities or chronic hospitals and comorbid conditions (e.g., diabetes, congestive heart failure, chronic obstructive pulmonary disease, and chronic renal disease). In a logarithmic regression, elective index admissions with S. aureus infection stayed 130% longer than comparable patients without that infection. Within 180 days of the index surgery, 23.9% of patients with S. aureus infection and 10.6% of patients without this infection had died. In a multivariate logistic regression of death within 180 days of admission for the index surgery with adjustment for demographics, co-morbidities, and other risks, S. aureus was associated with a 42% excess risk of death. Due to incomplete documentation of organisms in Medicare claims, these statistics may underestimate the magnitude of S. aureus infection. Nevertheless, this study generated a higher rate of S. aureus infections than previous studies.

Cardiac rehabilitation enrollment among referred patients: patient and organizational factors.

PURPOSE: Cardiac rehabilitation (CR) is underutilized despite well-documented benefits for patients with coronary heart disease. The purpose of this study was to identify organizational and patient factors associated with CR enrollment. METHODS: Facilities of the Wisconsin Cardiac Rehabilitation Outcomes Registry (N = 38) were surveyed, and the records of referred patients were analyzed. Generalized estimating equations were used to account for clustering of patients within facilities. RESULTS: Of the 6874 patients referred to the 38 facilities, 67.6% (n = 4,644) enrolled in CR. Patients receiving coronary artery bypass grafting (adjusted odds ratio [OR], 1.72; 95% CI: 1.36-2.19) and those who possessed health insurance (OR, 3.04; 95% CI: 2.00-4.63) were more likely to enroll. Enrollment was also positively impacted by organizational factors, including promotion of CR program (OR, 2.35; 95% CI: 1.39-4.00), certification by the American Association of Cardiovascular Pulmonary Rehabilitation (OR, 2.63; 95% CI: 1.32-5.35), and a rural location (OR, 3.30; 95% CI: 2.35-4.64). Patients aged ≥65 years (OR, 0.81; 95% CI: 0.74-0.90) and patients with heart failure (OR, 0.40; 95% CI: 0.22-0.72), diabetes (OR, 0.58; 95% CI: 0.37-0.89), myocardial infarction without a cardiac procedure (OR, 0.78; 95% CI: 0.67-0.90), previous coronary artery bypass grafting (OR, 0.72; 95% CI: 0.56-0.92), depression (OR, 0.56; 95% CI: 0.36-0.88), or current smoking (OR, 0.59; 95% CI: 0.44-0.78) were less likely to enroll. CONCLUSIONS: Predictors of patient enrollment in CR following referral included both organizational and personal factors. Modifiable organizational factors that were associated either positively or negatively with enrollment in CR may help directors of CR programs improve enrollment.

Effects of lifestyle modification programs on cardiac risk factors.

Medicare conducted a payment demonstration to evaluate the effectiveness of two intensive lifestyle modification programs in patients with symptomatic coronary artery disease: the Dr. Dean Ornish Program for Reversing Heart Disease (Ornish) and Cardiac Wellness Program of the Benson-Henry Mind Body Institute. This report describes the changes in cardiac risk factors achieved by each program during the active intervention year and subsequent year of follow-up. The demonstration enrolled 580 participants who had had an acute myocardial infarction, had undergone coronary artery bypass graft surgery or percutaneous coronary intervention within 12 months, or had documented stable angina pectoris. Of these, 98% completed the intense 3-month intervention, 71% the 12-month intervention, and 56% an additional follow-up year. Most cardiac risk factors improved significantly during the intense intervention period in both programs. Favorable changes in cardiac risk factors and functional cardiac capacity were maintained or improved further at 12 and 24 months in participants with active follow-up. Multivariable regressions found that risk-factor improvements were positively associated with abnormal baseline values, Ornish program participation for body mass index and systolic blood pressure, and with coronary artery bypass graft surgery. Expressed levels of motivation to lose weight and maintain weight loss were significant independent predictors of sustained weight loss (p = 0.006). Both lifestyle modification programs achieved well-sustained reductions in cardiac risk factors.

Beyond spinal manipulation: should Medicare expand coverage for chiropractic services? A review and commentary on the challenges for policy makers.

OBJECTIVES: Private insurance plans typically reimburse doctors of chiropractic for a range of clinical services, but Medicare reimbursements are restricted to spinal manipulation procedures. Medicare pays for evaluations performed by medical and osteopathic physicians, nurse practitioners, physician assistants, podiatrists, physical therapists, and occupational therapists; however, it does not reimburse the same services provided by chiropractic physicians. Advocates for expanded coverage of chiropractic services under Medicare cite clinical effectiveness and patient satisfaction, whereas critics point to unnecessary services, inadequate clinical documentation, and projected cost increases. To further inform this debate, the purpose of this commentary is to address the following questions: (1) What are the barriers to expand coverage for chiropractic services? (2) What could potentially be done to address these issues? (3) Is there a rationale for Centers for Medicare and Medicaid Services to expand coverage for chiropractic services? METHODS: A literature search was conducted of Google and PubMed for peer-reviewed articles and US government reports relevant to the provision of chiropractic care under Medicare. We reviewed relevant articles and reports to identify key issues concerning the expansion of coverage for chiropractic under Medicare, including identification of barriers and rationale for expanded coverage. RESULTS: The literature search yielded 29 peer-reviewed articles and 7 federal government reports. Our review of these documents revealed 3 key barriers to full coverage of chiropractic services under Medicare: inadequate documentation of chiropractic claims, possible provision of unnecessary preventive care services, and the uncertain costs of expanded coverage. Our recommendations to address these barriers include the following: individual chiropractic physicians, as well as state and national chiropractic organizations, should continue to strengthen efforts to improve claims and documentation practices; and additional rigorous efficacy/effectiveness research and clinical studies for chiropractic services need to be performed. Research of chiropractic services should target the triple aim of high-quality care, affordability, and improved health. CONCLUSIONS: The barriers that were identified in this study can be addressed. To overcome these barriers, the chiropractic profession and individual physicians must assume responsibility for correcting deficiencies in compliance and documentation; further research needs to be done to evaluate chiropractic services; and effectiveness of extended episodes of preventive chiropractic care should be rigorously evaluated. Centers for Medicare and Medicaid Services policies related to chiropractic reimbursement should be reexamined using the same standards applicable to other health care providers. The integration of chiropractic physicians as fully engaged Medicare providers has the potential to enhance the capacity of the Medicare workforce to care for the growing population. We recommend that Medicare policy makers consider limited expansion of Medicare coverage to include, at a minimum, reimbursement for evaluation and management services by chiropractic physicians.

Incidence and cost of pneumonia in older adults with COPD in the United States.

OBJECTIVES: To estimate the incidence of pneumonia by COPD status and the excess cost of inpatient primary pneumonia in elders with COPD. STUDY DESIGN: A retrospective, longitudinal study using claims linked to eligibility/demographic data for a 5% sample of fee-for-service Medicare beneficiaries from 2005 through 2007. METHODS: Incidence rates of pneumonia were calculated for elders with and without COPD and for elders with COPD and coexistent congestive heart failure (CHF). Propensity-score matching with multivariate generalized linear regression was used to estimate the excess direct medical cost of inpatient primary pneumonia in elders with COPD as compared with elders with COPD but without a pneumonia hospitalization. RESULTS: Elders with COPD had nearly six-times the incidence of pneumonia compared with elders without COPD (167.6/1000 person-years versus 29.5/1000 person-years; RR=5.7, p <0 .01); RR increased to 8.1 for elders with COPD and CHF compared with elders without COPD. The incidence of inpatient primary pneumonia among elders with COPD was 54.2/1000 person-years compared with 7/1000 person-years for elders without COPD; RR=7.7, p<0.01); RR increased to 11.0 for elders with COPD and CHF compared with elders without COPD. The one-year excess direct medical cost of inpatient pneumonia in COPD patients was $ 22,697 ($45,456 in cases vs. $ 22,759 in controls (p <0.01)); 70.2% of this cost was accrued during the quarter of the index hospitalization. During months 13 through 24 following the index hospitalization, the excess direct medical cost was $ 5,941 ($23,215 in cases vs. $ 17,274 in controls, p<0.01). CONCLUSIONS: Pneumonia occurs more frequently in elders with COPD than without COPD. The excess direct medical cost in elders with inpatient pneumonia extends up to 24 months following the index hospitalization and represents $28,638 in 2010 dollars.

Cardiac rehabilitation patient and organizational factors: what keeps patients in programs?

BACKGROUND: Despite documented benefits of cardiac rehabilitation, adherence to programs is suboptimal with an average dropout rate of between 24% and 50%. The goal of this study was to identify organizational and patient factors associated with cardiac rehabilitation adherence. METHODS AND RESULTS: Facilities of the Wisconsin Cardiac Rehabilitation Outcomes Registry Project (N = 38) were surveyed and records of 4412 enrolled patients were analyzed. Generalized estimating equations were used to account for clustering of patients within facilities. The results show that organizational factors associated with significantly increased adherence were relaxation training and diet classes (group and individual formats) and group-based psychological counseling, medication counseling, and lifestyle modification, the medical director's presence in the cardiac rehabilitation activity area for ≥ 15 min/week, assessment of patient satisfaction, adequate space, and adequate equipment. Patient factors associated with significantly increased adherence were aged ≥ 65 years, the American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR) high-risk category, having received coronary artery bypass grafting, and diabetes disease. Non-white race was negatively associated with adherence. There was no significant gender difference in adherence. None of the baseline patient clinical profiles were associated with adherence including body mass index, total cholesterol, low-density lipoprotein, high-density lipoprotein, triglycerides, and blood pressure. CONCLUSIONS: Factors associated with adherence to cardiac rehabilitation included both organizational and patient factors. Modifiable organizational factors may help directors of cardiac rehabilitation programs improve patient adherence to this beneficial program.

The completeness of medical records to assess quality of hospital care: the case of acute myocardial infarction in a district-level general hospital in Iran.

BACKGROUND: Quantifying the quality of care in high-cost and fatal conditions such as acute myocardial infarction (AMI) is a crucial step toward improving clinical outcomes in these patients. The main objective of this pilot study is to show whether abstraction of medical charts would be a useful method to systematically assess quality of care in patients hospitalized for AMI in a general hospital that has no interventional cardiac technology. METHODS: A general physician and a cardiologist working with Shahid Gholipour Hospital in Bukan, Northwest Iran, retrospectively abstracted medical records of all patients with verified diagnoses of myocardial infarction who were hospitalized between April 1, 2010 and March 31, 2011. The targeted outcome variables were risk-adjusted mortality and risk-adjusted length of hospital stay. Process quality indicators were selected from those developed by the National Quality Forum (NQF) of the United States. We reported completeness of selected variables used to build and calculate quality indicators in this study. RESULTS: For most variables, missing values were negligible. However, missing data on fields related to contraindications for prescribed medications were common. CONCLUSIONS: Medical chart abstractions provide useful first steps in assessing differences in the quality of hospital care for patients with AMI. Extension of our pilot study is highly recommended and may help trigger policy decisions to promote hospital quality in Iran.

Incidence and cost of pneumonia in medicare beneficiaries.

BACKGROUND: Pneumonia is a frequent and serious illness in elderly people, with a significant impact on mortality and health-care costs. Lingering effects may influence clinical outcomes and medical service use beyond the acute hospitalization. This study describes the incidence and mortality of pneumonia in elderly Medicare beneficiaries based on treatment setting (outpatient, inpatient) and location of origin (health-care associated, community acquired) and estimates short- and long-term direct medical costs and mortality associated with an inpatient episode of pneumonia. METHODS: Administrative claims from a 5% sample of fee-for-service Medicare beneficiaries aged ≥ 65 years from 2005 through 2007 were used. Total direct medical costs for patients during and after hospitalization for pneumonia compared with similar patients without pneumonia (the excess cost of pneumonia) were estimated using propensity score matching. RESULTS: The age-adjusted annual cumulative incidence of any pneumonia was 47.4 per 1,000 beneficiaries (13.3 per 1,000 inpatient primary pneumonia), increasing with age; one-half of pneumonia cases were treated in the hospital. Thirty-day mortality was twice as high among beneficiaries with health-care-associated pneumonia than among those hospitalized with community-acquired pneumonia (13.4% vs 6.4%). Total medical costs for beneficiaries during and 1 year following a pneumonia hospitalization were $15,682 higher than matched control patients without pneumonia. The total annual excess cost of hospital-treated pneumonia as a primary diagnosis in the elderly fee-for-service Medicare population in 2010 is estimated conservatively at > $7 billion. CONCLUSIONS: Pneumonia in elderly people is associated with high acute-care costs and an overall impact on total direct medical costs and mortality during and after an acute episode.

Effects of complementary therapies on clinical outcomes in patients being treated with radiation therapy for prostate cancer.

BACKGROUND: This pilot randomized controlled trial (RCT) examined the clinical effects of 2 complementary (CAM) therapies, relaxation response therapy (RRT) and Reiki therapy, in men being treated with external beam radiotherapy (EBRx) for prostate cancer. METHODS: Study participants were randomly assigned to weekly RRT, Reiki therapy twice weekly, or wait-list control. Well-validated instruments measured anxiety (STAI), depression (CES-D), and quality of life in cancer patients (FACT-G) at randomization and 3 subsequent time points. RESULTS: Fifty-four men were randomized, and 16 of 18 (89%) of RRT and 15 of 18 (83%) of Reiki patients completed the intervention protocol. No statistically significant difference was found between the RRT, Reiki, and control groups on total scores for the STAI, CES-D, or FACT-G instruments at any time point. However, at the end of the intervention, significant improvement was found on the emotional well-being subscale of the FACT-G quality of life scale in the RRT group compared with the Reiki and control groups (P = .01). In participants who were classified as "anxious" at baseline, statistically significant improvement occurred in the RRT group (P = .02), and a positive trend was found in the Reiki group (P = .10). CONCLUSIONS: This pilot study documented the feasibility of conducting a RCT of CAM therapies in men undergoing EBRx for prostate cancer. Relaxation response therapy improved emotional well being and eased anxiety in participants. Reiki therapy also had a positive effect in anxious patients. A larger study to verify and better define the benefits of these therapies in men with prostate cancer is warranted.

Low-dose amitriptyline for treatment of persistent arm pain due to repetitive use.

Amitriptyline is sometimes used to treat arm pain related to repetitive use, but rigorous evidence of its benefit is lacking. This randomized controlled trial investigated whether amitriptyline provided greater pain relief or improved arm function than a placebo pill in adults with arm pain associated with repetitive use that had persisted for at least 3 months. Participants (N=118) were randomly assigned to receive 25mg of amitriptyline or a placebo pill for 6 weeks. The primary outcome was intensity of pain (10-point numerical rating scale) and secondary outcomes were arm symptoms, arm function, grip strength, mood, and sleep. Assessments were done at baseline, 3 and 6 weeks of treatment, and 1 month after the treatment ended. Changes in arm pain were not statistically significant. However, the amitriptyline group improved more than the placebo group in arm function (p=0.023) and sense of well being (p=0.034). In a longitudinal analysis, the amitriptyline group's arm function score improved 0.45 points per week faster than placebo after adjusting for subject characteristics (p=0.015). At the treatment's midpoint, the amitriptyline group reported more "troublesome side-effects" than the placebo group (52.5% vs. 27.1%, p=0.005), but this difference decreased by the end of the treatment (30.5% vs. 22.0%, p=0.30). The most frequent side effect was drowsiness. In conclusion, this study found that low-dose amitriptyline did not significantly decrease arm pain among these participants but did significantly improve arm function and well being. Future research is needed to explore the effects of higher doses and longer duration of treatment.

Clinical benefits of the Boston Ocular Surface Prosthesis.

PURPOSE: To evaluate the effects of the Boston Ocular Surface Prosthesis (Boston Foundation for Sight, Needham, Massachusetts, USA) on visual acuity (VA) and visual functioning in patients with severe corneal ectasia, irregular astigmatism, or ocular surface disease. DESIGN: Prospective, interventional case series. METHODS: The study examined the effects of this prosthesis on VA and visual functioning in consecutive patients with corneal ectasia, irregular astigmatism, or ocular surface disease who had failed conventional therapies and were seen at the Boston Foundation for Sight between January 1 and June 30, 2006. Outcomes were best-corrected VA using Snellen charts and visual functioning using the National Eye Institute Visual Functioning Questionnaire (NEI VFQ-25) at 6 months. Clinical data were abstracted from medical records. RESULTS: Of the 101 patients, 80 were fitted with a prosthesis in one or both eyes, and follow-up Visual Functioning Questionnaire data were obtained in 69 eyes. Best-corrected VA improved by a change in mean logarithm of the minimal angle of resolution (logMAR) units of -0.39 (converted from Snellen) with a change of -0.54 logMAR units in patients with ectasia or astigmatism and -0.22 logMAR units in patients with ocular surface disease. Mean composite visual functioning scores increased from 57.0 to 77.8 (P < .0001). Improvements in composite Visual Functioning Questionnaire scores were similar in patients with ectasia or ocular surface disease; but vision-related subscores improved more in patients with ectasia, whereas subscores for ocular pain, role difficulties, and dependency improved more in patients with ocular surface disease. CONCLUSIONS: The Boston Ocular Surface Prosthesis significantly improved VA and visual functioning in patients with corneal ectasia, irregular astigmatism, and ocular surface disease who had failed conventional therapies.

Hypertension: a policy perspective, 1976-2008.

Hypertension has important public health, clinical, and economic consequences for the health care system and for society. This report summarizes key issues pertaining to the global economics of hypertension; describes findings from recent cost-effectiveness analyses; and raises key policy issues with respect to insurance coverage and opportunities to increase the value of efforts to treat hypertension.