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Biomedical subjects

Joshua Cohen

Publications and source records attributed to Joshua Cohen.

12 recordsLinked to original sources
PubMed2007

The utility of gestures in patients with chest discomfort.

PURPOSE: Patient gestures are thought to be useful in determining the etiology of chest discomfort. We sought to determine the utility of certain patient gestures in the diagnosis of ischemic chest discomfort or myocardial infarction. METHODS: We performed a prospective observational study of 202 patients admitted with chest discomfort. Patients were observed for the Levine Sign (clenched fist to the chest), the Palm Sign (palm of the hand to the chest), the Arm Sign (touching the left arm), and, as an indicator of nonischemic chest discomfort, the Pointing Sign (pointing with 1 finger). RESULTS: Prevalences of the Levine, Palm, Arm, and Pointing Signs were 11%, 35%, 16%, and 4%, respectively. Using troponin levels and results of functional studies and coronary angiograms as reference standards, none of the sensitivities of the signs exceeded 38%. Specificities of the Levine and Arm Signs ranged between 78% and 86%, but the positive predictive values did not exceed 55%. The Pointing Sign had a specificity of 98% for evidence of nonischemic chest discomfort, and the positive predictive value of a negative troponin was 88%. The diameter of discomfort significantly correlated with certain gestures. Larger chest pain diameters were associated with evidence of myocardial ischemia. CONCLUSIONS: Although certain gestures are exhibited by patients presenting with chest discomfort, they generally have poor test characteristics. The Pointing Sign has a high specificity for nonischemic chest discomfort, but a low prevalence. The gestures may communicate the size of the chest discomfort, with larger areas suggestive of ischemia.

Biomarkers↗
PubMed2006

A "grapple hook" technique using a deflectable tip catheter to facilitate complex proximal circumflex interventions.

We present two patients with angulated, proximal left circumflex lesions, one a chronic total occlusion and one an acute subtotal occlusion. In both cases, use of the deflectable tip Venture Catheter (Velocimed, Minneapolis, MN) facilitated guide wire passage and successful percutaneous coronary intervention (PCI) after prior attempts at guide wire passage with standard wires were unsuccessful.

Cardiac Catheterization↗
PubMed2006

Comparing patient access to pharmaceuticals in the UK and US.

BACKGROUND: The debate on access to new drugs has focused on the time lag between applications for approval and granting of marketing authorisation. This delay was identified as the first barrier with respect to patient access to new drugs, encompassing the hurdles of safety, efficacy and quality. Additional barriers have since been identified. These pertain to reimbursement and pricing of approved drugs, the so-called fourth and fifth hurdles. METHODS: We reviewed 38 National Institute for Health and Clinical Excellence (NICE) guidance appraisals carried out between April 1999 and April 2005. These appraisals included 71 recently approved drugs considered to have either high clinical or cost impact. For each drug we first determined its marketing approval date by the British Medicines Healthcare Products Agency (MHRA) or European Medicines Evaluation Agency (EMEA). Secondly, we determined if each drug was approved by the US FDA for marketing and, if so, the date when it was approved. Thirdly, we considered whether and when each drug was recommended for reimbursement and use by NICE, and whether conditions of reimbursement applied. Fourthly, for the subset of FDA-approved drugs, we examined formulary placement, cost sharing and conditions of reimbursement on three-tier formularies used by seven leading US third-party payers serving Medicare beneficiaries. Fifthly, we reviewed each NICE recommendation to determine if cost-effectiveness data were referred to either in the appraisal documentation or in the final recommendation. Sixthly, we asked a spokesperson from each US payer whether cost-effectiveness assessments or rebates played a role in determining formulary placement of drugs in our sample, and whether there was a lag between marketing approval and reimbursement for any of the covered drugs. RESULTS: Of the 71 drugs contained in 38 NICE guidance appraisals, the US FDA approved 64. On average, the subset of 64 drugs received marketing authorisation in the US prior to the UK. On average, US plans covered 87% of the 64 drugs, the same percentage of drugs recommended for NHS reimbursement and use. Cost sharing in the US was significantly higher than in the UK, with wider variation across plans. On average, drugs covered in the US had fewer conditions of reimbursement (15%) than the percentage of drugs given conditions by NICE (46%). US plans were quicker to decide to reimburse drugs following marketing approval than NICE. CONCLUSIONS: The US provides faster, more flexible access to most, but not all, of the UK-approved pharmaceuticals in our sample. However, US patients have higher cost sharing than the UK and coverage is less evenly spread across the population. From a policy perspective, our study findings confirm the need to bolster the NICE fast-track initiative to decrease the amount of time it takes to appraise certain new pharmaceuticals. Also, the study findings point to the need in the US for careful monitoring of plan compliance with regulations pertaining to the Medicare drug benefit, particularly with respect to formulary restrictions and limits on cost sharing.

Cost-Benefit Analysis↗
PubMed2006

A low-fat vegan diet improves glycemic control and cardiovascular risk factors in a randomized clinical trial in individuals with type 2 diabetes.

OBJECTIVE: We sought to investigate whether a low-fat vegan diet improves glycemic control and cardiovascular risk factors in individuals with type 2 diabetes. RESEARCH DESIGN AND METHODS: Individuals with type 2 diabetes (n = 99) were randomly assigned to a low-fat vegan diet (n = 49) or a diet following the American Diabetes Association (ADA) guidelines (n = 50). Participants were evaluated at baseline and 22 weeks. RESULTS: Forty-three percent (21 of 49) of the vegan group and 26% (13 of 50) of the ADA group participants reduced diabetes medications. Including all participants, HbA(1c) (A1C) decreased 0.96 percentage points in the vegan group and 0.56 points in the ADA group (P = 0.089). Excluding those who changed medications, A1C fell 1.23 points in the vegan group compared with 0.38 points in the ADA group (P = 0.01). Body weight decreased 6.5 kg in the vegan group and 3.1 kg in the ADA group (P < 0.001). Body weight change correlated with A1C change (r = 0.51, n = 57, P < 0.0001). Among those who did not change lipid-lowering medications, LDL cholesterol fell 21.2% in the vegan group and 10.7% in the ADA group (P = 0.02). After adjustment for baseline values, urinary albumin reductions were greater in the vegan group (15.9 mg/24 h) than in the ADA group (10.9 mg/24 h) (P = 0.013). CONCLUSIONS: Both a low-fat vegan diet and a diet based on ADA guidelines improved glycemic and lipid control in type 2 diabetic patients. These improvements were greater with a low-fat vegan diet.

Adult↗
PubMed2004

Effect of blood collection tubes on total triiodothyronine and other laboratory assays.

BACKGROUND: Increased total triiodothyronine (TT(3)) assay results in apparently euthyroid patients triggered an investigation of the effect of blood collection tubes on serum TT(3) and other laboratory assays. METHODS: We examined potential assay interference for three types of tubes: plastic Greiner Bio-One Vacuette; glass Becton Dickinson (BD) Vacutainer; and plastic BD Vacutainer SST tubes. Serum samples from apparently healthy volunteers (age range, 30-60 years; 15 males and 34 females) were collected in different tube types and analyzed in 17 immunoassays (n = 49), 30 clinical chemistry tests (n = 20), and 33 immunology assays (n = 15). Tube effects were also examined by adding pooled serum to different tube types. RESULTS: TT(3) values, when measured by the IMMULITE 2000 but not the AxSYM analyzer, were significantly higher (P <0.0001) for SST (2.81 nmol/L) than either glass (2.15 nmol/L) or Vacuette (2.24 nmol/L) tubes. The effect was large enough to substantially shift the distribution of patient values, increasing the percentage of values above the reference interval from 11.3% to 35.8%. The degree of interference from SST tubes on TT(3) differed among various tube lots and could be attributed to a tube additive shared by other plastic tubes. Results from several other tests statistically differed among tube types, but differences were not considered to be clinically significant. CONCLUSIONS: Assay interferences from blood collection tubes represent challenges to clinical laboratories because they are not detected by the usual quality-control or proficiency testing programs. Laboratories can, however, address this problem by monitoring distribution of patients' results.

Adult↗
PubMed2004

Anti-inflammatory treatment with acetylsalicylate or rofecoxib is not neuroprotective in Huntington's disease transgenic mice.

Inflammatory mechanisms have been implicated in the pathogenesis of Huntington's disease (HD). Possible benefits of anti-inflammatory treatments include improved folding of mutant huntingtin mediated through chaperones, reduction of destructive cellular and humoral inflammatory pathways, and reduction of proapoptotic signaling mediated by NF-kappaB or other transcription factors. This study was performed to investigate the therapeutic potential of anti-inflammatory drugs as treatments for Huntington's disease by examining whether two compounds in widespread human use can ameliorate the phenotype of HD transgenic mouse models. We examined the effectiveness of acetylsalicylate and rofecoxib as treatments for the R6/2 and N171-82Q transgenic mouse models of Huntington's disease. Both drugs were administered from weaning. To monitor the effectiveness of the treatment, we analyzed the mice for weight loss, behavioral changes, and gross cerebral and striatal atrophy. The studies showed that neither drug benefited the animals at doses comparable to those tolerated by humans.

Acoustic Stimulation↗
PubMed2004

Are clinical practice guidelines impartial?

In A Theory of Justice, John Rawls demands from citizens who decide upon principles of justice and the rules derived from such principles that they abstract from all particularities that constitute their identity as unique individuals. This demand is unrealistic in policy settings where actual policy-makers convene to provide guidance, establish rules regarding public good, and enact legislation. In practice, I argue, policy-makers, legislators, and others involved in developing social rules that pertain to distributive justice formulate such rules as reasonably partial spectators. To illustrate, I show how clinical practice guidelines are established and mediated by a reasonably partial expert panel whose partial action is publicly justifiable, yet whose claims to impartiality are not.

Costs and Cost Analysis↗
PubMed2003

On the possibility of a positive-sum game in the distribution of health care resources.

Health care resource distribution is a subject of debate among health policy analysts, economists, and philosophers. In the United States, there is a widening gap between the more- and less-advantaged socioeconomic sub-populations in terms of both health care resource distribution and outcomes. Conventional wisdom suggests that there is a tradeoff, a zero-sum game, between efficiency and fairness in the distribution of health care resources. Promoting fairness in the distribution of health care resources and outcomes is not efficient in terms of maximization of a health outcome production function. On the other side of the coin, improving efficiency comes at the expense of fairness. Such conventional wisdom is supported in part by standard static Paretian welfare analysis. However, in this paper it is shown that in a dynamic setting in which there are efficiency gains in the health production function, fairness in distribution of health care resources can improve simultaneously.

Efficiency, Organizational↗
PubMed2003

State-based versus federal-based approaches to reducing the Medicare pharmaceutical coverage gap.

A state-based approach, such as the Immediate Helping Hand proposal put forward by the Bush administration, is likely to be less effective than a federal-based approach at reducing the Medicare pharmaceutical coverage gap. In addition, the voluntary nature of a state-based approach, coupled with variations across states in existing coverage benefits and the limited reach of state pharmacy assistance programs, would likely lead to a perpetuation of uneven coverage. This article argues in favor of adding a federal-based universal prescription drug benefit to Medicare on the grounds of both equity and empirical evidence. Adding a universal drug benefit to the currently existing Medicare program would extend application of the social insurance concept across hospital care, physician service, and prescription drug coverage components of Medicare. As a result, a more equitable distribution of prescription drug coverage would be promoted while mitigating the effects of selection risk.

Aged↗
PubMedDate not supplied

Switching omeprazole in Sweden and the United States.

This article compares the Swedish Medical Products Agency's (MPA) decision to switch omeprazole from prescription (Rx) to over-the-counter (OTC) status with the US Food and Drug Administration (FDA) advisory panel's decision not to authorize the switch. The agencies' differing perspectives on efficacy, safety, labeling, and clinical trial requirements are evaluated with regard to the Rx-to-OTC switch process in general and omeprazole's case in particular. The FDA and MPA regulatory policies on switches are substantially divergent. The FDA maintains a stricter set of switch guidelines and requirements than the MPA. One could infer from this that the FDA is more risk-averse than the MPA. Nevertheless, the omeprazole switch in Sweden appears to be an exception in that it contrasts with the MPA's historical reluctance to switch the Rx status of medications. Cost considerations appear to have triggered the omeprazole switch, making it a special case. The lessons to be drawn from this case study are both specific and general. At the specific level, this case study suggests the MPA's decision to switch omeprazole was prompted by economic considerations, whereas the FDA's mandate did not allow cost to affect its decision on omeprazole. At a general level, this case study indicates that the differences between the FDA and MPA with respect to their regulatory policies on switches and their mandates apply not only to omeprazole but also to the dozens of switches currently under consideration by the respective regulatory agencies.

Anti-Ulcer Agents↗