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Biomedical subjects

Steven R Feldman

Publications and source records attributed to Steven R Feldman.

At least 127 records · Page 7Linked to original sources
PubMed2003

The design of clinical trials in psoriasis: lessons for clinical practice.

Understanding the process by which drugs are approved gives clinicians a better understanding of the medications they prescribe and how these medications are best used to care for patients. The development of new drugs in the United States proceeds through a series of studies culminating in well-designed, large-scale human trials. These studies result from a coordinated collaboration between industry and the Food and Drug Administration (FDA). The results of these studies determine whether drugs are approved for use or not. They also determine the labeling and marketing of products and guide (but do not fully determine) physicians' use of the drug. This article follows a hypothetical drug for use in psoriasis through the approval process, in order to illustrate the process and its implications for clinical practice.

Clinical Trials as Topic↗
PubMed2003

Efficacy, safety, and cost of office-based surgery: a multidisciplinary perspective.

An increasing number of media reports on patient safety risks arising from office-based surgery procedures, as well as growing concerns about patient safety issues in general, have brought office-based surgery as well as its practitioners into focus and placed this very cost-effective medical practice in the eye of the media and regulators. Concerted efforts are now being made to understand the causes and true incidence of patient safety risk associated with office-based surgery and to find ways to minimize this risk.

Ambulatory Surgical Procedures↗
PubMed2003

Coding multiple diagnoses for patient visits at which procedures were performed: no evidence for abuse by physicians.

BACKGROUND: A problem area in the reimbursement of physicians is the office visit at which both procedures and evaluation/management services are performed. Insurers are concerned that frequent reporting of diagnoses unrelated to procedures may represent an abuse of the claims process. OBJECTIVE: To determine the frequency of secondary diagnoses that are present at visits at which procedures are performed and to compare the frequency with that reported in Medicare claims. METHOD: The 1998 and 1999 National Ambulatory Medical Care Survey (NAMCS) data were used to provide data unrelated to claims for payment. The results were compared with Medicare claims data from the 1998 to 1999 Medicare Current Beneficiary Survey. NAMCS visits were limited to patients who were 65 year old or greater to limit the analysis to the Medicare population. RESULTS: In the NAMCS dataset, 52% of the visits for actinic keratoses at which a procedure was performed were associated with multiple diagnoses. Similarly, in the Medicare Current Beneficiary Survey dataset, 52% of these visits had multiple diagnoses listed. CONCLUSION: The frequency of visits with multiple diagnoses is the same in both administrative claims and epidemiologic survey databases. There is no evidence for widespread abusive coding by physicians. It is incumbent on payers to respect the integrity of the coding system in order to assure fair reimbursement for physician services.

Ambulatory Surgical Procedures↗
PubMed2003

Nonmelanoma skin cancer: an episode of care management approach.

BACKGROUND: The incidence of nonmelanoma skin cancers (NMSCs) was estimated at 1.3-million cases for the year 2000 and is on the rise. It is the most common form of cancer in the United States, more common than all other cancers combined. To determine the contributors to the cost of NMSC care, an episode of care of NMSC needed to be defined. OBJECTIVE: To define and validate an episode of NMSC care. DESIGN: Using survey and Medicare part A and part B claims data of the Medicare Current Beneficiary Survey (MCBS), 1992 to 1995, an algorithm was created to define an episode of care for the diagnosis and treatment of an NMSC. MCBS estimates of the number of episodes occurring in three service settings (physician's office, outpatient/ambulatory surgical center, or hospital) and demographics were compared to data from independent datasets, including the National Ambulatory Medical Care Survey (NAMCS, 1995), the National Survey of Ambulatory Surgery (NSAS, 1994 to 1996), and the National Hospital Discharge Survey (NHDS, 1992 to 1997). RESULTS: Pathology claims for NMSC diagnosis served as the indicator of NMSC episodes. The procedures, office visits, and tests that resulted in and from the pathology specimen were identified. The sum of the associated charges to Medicare or Medicare payments for all identified claims equaled the total cost of the episode of NMSC care. For example, these preliminary results demonstrated significant differences between medical and surgical subspecialties. CONCLUSION: This study defined and validated a model of an episode of NMSC care. This model's initial results serve as preliminary data for the design of further studies addressing the differences between specialties and settings. The use of this model will allow identification of factors that determine the cost of NMSC treatment and that are associated with higher cost of care.

Algorithms↗
PubMed2003

Frequency of seborrheic keratosis biopsies in the United States: a benchmark of skin lesion care quality and cost effectiveness.

BACKGROUND: Most seborrheic keratoses may be readily clinically differentiated from skin cancer, but occasional lesions resemble atypical melanocytic neoplasms. OBJECTIVE: To evaluate the frequency, cost, and intensity of procedures performed that result in the removal and histopathologic evaluation of seborrheic keratoses. METHODS: Episodes of surgical removal of lesions that were identified as seborrheic keratoses by histologic identification were determined using Medicare Current Beneficiary Survey data from 1998 to 1999. These episodes were defined by a histopathology procedure code that is associated with a diagnosis code for seborrheic keratosis. We then identified what procedure(s) generated the histopathology specimen. Biopsy and shave procedures were considered "low intensity," whereas excision and repair procedures were considered "high intensity." RESULTS: Dermatologists managed 85% of all episodes of seborrheic keratoses. Dermatologists managed 89% of seborrheic keratosis episodes using low-intensity procedures compared with 51% by other specialties. For nondermatologists, 46% of the treatment cost (9 million US dollars) to Medicare was generated from high-intensity management compared with 15% by dermatologists (6 million US dollars). CONCLUSION: There is a significant difference in the management of suspicious pigmented lesions between dermatologists and other specialists. This affects both the cost and quality of care.

Benchmarking↗
PubMed2003

No smoking gun: findings from a national survey of office-based cosmetic surgery adverse event reporting.

BACKGROUND: Because of recent press reports of adverse outcomes, office-based cosmetic surgery has come under intense scrutiny and associated legislative regulatory action. OBJECTIVE: To assess the safety of office-based cosmetic surgery through a national survey of state agencies that collect information on adverse patient outcomes. METHODS: Medical boards or other responsible authorities were contacted in 48 states to obtain records on adverse outcomes from cosmetic surgery procedures performed in an office-based setting. RESULTS: Five states were able to provide complete information regarding 13 cases of adverse outcomes that resulted from office-based cosmetic surgery procedures. Thirteen states had incomplete information or were unable to provide information. The remaining states reported no adverse outcomes. Information collected by state agencies varies greatly and is inadequate to define the safety of office-based cosmetic surgery practice. CONCLUSIONS: The need to regulate physician office surgery on the basis of hospital privileges and office certification is not supported by current data. Mandatory reporting of adverse outcomes from office-based surgery is warranted to identify modifiable risk factors and to reduce the risk of adverse outcomes.

Ambulatory Surgical Procedures↗
PubMed2003

Health care utilization in patients with migraine: demographics and patterns of care in the ambulatory setting.

BACKGROUND: Migraine affects people of all races and both sexes. Migraineurs suffer both financial losses and impaired quality of life. Recent progress in the treatment of migraine has not been made readily available to all who suffer the condition. OBJECTIVE: To assess outpatient health care delivery patterns for migraine sufferers in the United States. METHODS: National Ambulatory Medical Care Survey data from 1990 to 1998 was used to assess the demographics of patients seen with a diagnosis of migraine, the types of physicians they saw, and the medications used to treat migraine. RESULTS: Women accounted for 79% of visits for migraines and whites for 91% of the visits. There was a dramatic increase in the number of migraine visits during the study period, from 9.4 visits per 1000 people in 1990 to 18 visits per 1000 in 1998. Primary care physicians saw the majority of patients (72.2%). Butalbital/aspirin/caffeine was the drug most commonly prescribed for migraine treatment, followed by acetaminophen/dichloralphenazone/isometheptene mucate, propranolol, and sumatriptan. CONCLUSION: Perhaps in part due to newer treatment options, the number of visits for the treatment of migraine doubled over the study interval. Even so, most patients with migraine continue to be treated with older and presumably less effective medications.

Adolescent↗
PubMed2003

The economic burden of skin disease in the United States.

BACKGROUND: Skin diseases and their complications are a significant burden on the nation, both in terms of acute and chronic morbidities and their related expenditures for care. Because accurately calculating the cost of skin disease has proven difficult in the past, we present here multiple comparative techniques allowing a more expanded approach to estimating the overall economic burden. OBJECTIVES: Our aims were to (1) determine the economic burden of primary diseases falling within the realm of skin disease, as defined by modern clinical disease classification schemes and (2) identify the specific contribution of each component of costs to the overall expense. METHODS: Costs were taken as the sum of several factors, divided into direct and indirect health care costs. The direct costs included inpatient hospital costs, ambulatory visit costs (further divided into physician's office visits, outpatient department visits, and emergency department visits), prescription drug costs, and self-care/over-the-counter drug costs. Indirect costs were calculated as the outlay of days of work lost because of skin diseases. RESULTS: The economic burden of skin disease in the United States is large, estimated at approximately $35.9 billion for 1997, including $19.8 billion (54%) in ambulatory care costs; $7.2 billion (20.2%) in hospital inpatient charges; $3.0 billion (8.2%) in prescription drug costs; $4.3 billion (11.7%) in over-the-counter preparations; and $1.6 billion (6.0%) in indirect costs attributable to lost workdays. CONCLUSIONS: Our determination of the economic burden of skin care in the United States surpasses past estimates several-fold, and the model presented for calculating cost of illness allows for tracking changes in national expenses for skin care in future studies. The amount of estimated resources devoted to skin disease management is far more than required to treat conditions such as urinary incontinence ($16 billion) and hypertension ($23 billion), but far less than required to treat musculoskeletal conditions ($193 billion).

Ambulatory Care↗
PubMed2003

Skin cancer is among the most costly of all cancers to treat for the Medicare population.

BACKGROUND: Compared with other malignancies, nonmelanoma skin cancer (NMSC) is associated with much less morbidity and mortality. NMSC is, however, far more common than other malignancies. The cost of managing NMSC has not been assessed. OBJECTIVE: The purpose of our study was to determine where the cost of NMSC management ranks among other cancers in the Medicare population. DESIGN: Representative Medicare part A and B claims data were obtained from the Medicare current beneficiary survey, 1992 to 1995. Claims associated with cancer costs were identified using the International Classification of Diseases, Ninth Revision, Clinical Modification codes. Weights were applied to obtain nationally representative estimates. RESULTS: Average Medicare expenditure on cancer management was $13 billion per year. The 5 most costly cancers to Medicare were lung and bronchus, prostate, colon and rectum, breast, and NMSC. The mean annual cost per patient using Medicare for all cancers was $17,094. Malignancies of lung and bronchus, colon and rectum, breast, and prostate were 11 to 19 times more costly per affected patient than NMSC. CONCLUSION: In addition to classifying cancers by number of cases and number of deaths, the financial impact of treatment can also be used to prioritize different malignancies. Such a scheme ranks NMSC far higher than would death statistics. In light of its already high and rising incidence, the cost of NMSC care to Medicare is likely to increase. However, to maintain the cost-effective management of NMSC, it is essential to preserve the current low per-patient cost of its management.

Aged↗
PubMed2003

The use of 0.25% zinc pyrithione spray does not enhance the efficacy of clobetasol propionate 0.05% foam in the treatment of psoriasis.

BACKGROUND: It was discovered that Skin Cap (Cheminova Internacional S.A., Madrid, Spain), an over-the-counter psoriasis therapy with zinc pyrithione, contained clobetasol propionate and it was withdrawn from the market by the US Food and Drug Administration review. Some suggested that there might be a synergistic effect of zinc pyrithione with clobetasol propionate. OBJECTIVE: We sought to evaluate the efficacy of clobetasol propionate 0.05% foam with and without the coadministration of a topical 0.25% zinc pyrithione spray in treating psoriasis involving sites other than the scalp. METHODS: We conducted a randomized, double-blind, right/left study of patients with mild to moderate, generally symmetric, plaque-type psoriasis. Patients were assigned to treatment with clobetasol propionate foam on all psoriatic lesions and then randomly assigned to use zinc pyrithione spray to either the right or left side of their body (vehicle spray to be applied to the opposite side). There was a 2-week treatment phase (visits at baseline, week 1, and week 2) and a follow-up phase (visit at week 4), and all treatments were administered twice daily for 2 weeks. The primary outcome measure was the change from baseline to week 2 in the composite score of the signs of psoriasis (erythema, scaling, plaque thickness) for symmetric target lesions. RESULTS: A total of 25 patients were enrolled; 24 completed the trial and 1 was lost to follow up. Of those who completed the study, 63% (15 of 24) were men, and the mean age (+/-SD) was 50 years (+/-12.2). After 2 weeks of therapy, the average decline in the composite score was 3.5 (+/-1.8) for monotherapy (clobetasol propionate foam and vehicle) and, similarly, 3.3 (+/-1.8) for clobetasol propionate foam plus zinc pyrithione spray (P =.5). DISCUSSION: Zinc pyrithione spray does not appear to enhance the efficacy of clobetasol propionate foam after 2 weeks of therapy.

Administration, Topical↗
PubMed2003

Electronic monitoring of medication adherence in skin disease: results of a pilot study.

BACKGROUND: Traditional medication adherence monitoring for topical medication use in dermatology relies heavily on measures of self-reporting and ointment tube weight, which are susceptible to various biases. METHODS: We first assessed the feasibility of using medication electronic monitoring system caps with cream, ointment, and gel formulations. We then performed a pilot study using 10 patients given a diagnosis of psoriasis with a weekly follow-up visit. Topical salicylic acid 6% was supplied to patients in medication jars with caps that recorded the opening and closing of the bottles, without patient knowledge. RESULTS: Medication electronic monitoring system cap monitors accurately recorded the opening and closing of bottles of topical agents. Patients overreported adherence in patient logs, and there was greater detection of missed doses using electronic monitors than self-reporting through patient log (relative risk = 6.2, 95% confidence interval: 1.13, 34.09). CONCLUSION: Electronic monitoring shows promise as a more accurate form of measuring treatment adherence to topical medication regimens.

Administration, Topical↗
PubMed2003

Patients with palmoplantar psoriasis have more physical disability and discomfort than patients with other forms of psoriasis: implications for clinical practice.

BACKGROUND: Psoriasis is a chronic, unpredictable, and incurable disease that has a negative impact on patients' quality of life. Palm and sole psoriasis can add to this negative impact as it directly affects activities of daily living. OBJECTIVE: We sought to estimate the prevalence of palmoplantar psoriasis in a patient population and to explore associations with patient outcomes. METHODS: In all, 317 individuals with psoriasis completed a comprehensive assessment battery. Patients with palmoplantar psoriasis (n = 124, 39%) were compared with patients without palmoplantar involvement with respect to functional disability, psychiatric symptoms, physical and social discomfort, self-reported psoriasis severity, and health-related quality of life. RESULTS: Patients with palmoplantar involvement reported significantly greater physical disability and physical discomfort than patients without palmoplantar involvement (both P <.01). There were no differences between the 2 groups with respect to psychosocial outcomes. CONCLUSION: Patients with palmoplantar psoriasis are affected to a greater degree by the physical aspects of the disease than patients without palmoplantar involvement.

Adult↗
PubMed2003

Are there racial and sex differences in the use of oral isotretinoin for acne management in the United States?

BACKGROUND: Treatment of various diseases has been noted to vary by patient demographics. There is reason to suspect that there may be sex and racial differences in the treatment of severe acne. OBJECTIVE: We sought to determine if treatment of severe acne with oral isotretinoin varied with patient sex, race, or both. METHODS: We analyzed the demographics of patients with acne and patients using oral isotretinoin, minocycline, and tetracycline recorded in the 1990 to 1997 National Ambulatory Medical Care Survey. RESULTS: There were 35 million visits to physicians for the treatment of acne between 1990 and 1997, and isotretinoin was prescribed at 5.8 million (17%) of these visits. Per capita visit rates for acne among whites was 2.3 times that of blacks, and whites were 1.8 times more likely to receive isotretinoin at acne visits. Per capita, women had 1.4 times as many visits for acne as men, but men were 1.7 times more likely than women to receive isotretinoin at an acne visit. Dermatologists managed 83% of all isotretinoin visits. Dermatologists accounted for 100% of isotretinoin visits for which pregnancy prevention education and counseling was reported. CONCLUSIONS: Patients who are black receive less oral isotretinoin than those who are white, and the expense of isotretinoin appears to be one factor in this difference. Women are less likely than men to receive isotretinoin at acne visits. Expense does not appear to be a factor in this difference. Dermatologists have more experience than nondermatologists managing acne, prescribing isotretinoin, and counseling women treated with isotretinoin concerning pregnancy prevention. Pregnancy prevention is an essential component of isotretinoin use in women that must not be ignored.

Acne Vulgaris↗
PubMed2003

Surgical treatment of nonmelanoma skin cancer in the Medicare population.

BACKGROUND: Nonmelanoma skin cancer (NMSC) is the most common malignancy of white populations. Different surgical treatment options can be used to treat these tumors, depending on the tumor characteristics and setting. OBJECTIVE: To determine how frequently different specialists use the different types of surgical options available for the treatment of NMSC using a 1998-1999 sample of Medicare claims data. METHODS: Episodes of care of NMSC were identified by pathology claims with a diagnosis of NMSC. The surgical interventions performed within 7 days before the pathologic diagnosis of NMSC were then analyzed. The numbers of patients and the variety of surgical treatments were categorized by specialty to include dermatology, general surgery, and plastic surgery. RESULTS: Dermatologists managed 82% of the NMSC episodes. Dermatologists used a wider range of different treatment options than other specialists and performed 90% of the biopsies, 56% of the excisions, 95% of the destructions, and 100% of the Mohs micrographic surgeries for NMSC. CONCLUSIONS: Dermatologists identify and manage most of the NMSC in the United States and offer patients a broad range of surgical options. The use by dermatologists of office-based surgical methods not commonly used by other specialists may partially explain previous findings of better NMSC outcome by dermatologists. The low level of use of specific surgical options by some specialists may indicate the need for greater training/exposure to these methods.

Humans↗
PubMed2003

Strategy to manage the treatment of severe psoriasis: considerations of efficacy, safety and cost.

Psoriasis is a common, unpredictable, chronic immune-mediated disease characterised by skin lesions and frequently associated with arthritis. Although rarely fatal, psoriasis has a tremendous impact on a patients' quality of life. Traditional therapies for severe psoriasis include phototherapy, methotrexate, oral retinoids and cyclosporin. New biological agents add to the treatment options for psoriasis; however, they raise the already considerable cost of managing the disease. In considering efficacy, safety and cost-effectiveness, ultraviolet Type B (UVB) phototherapy appears to be the best first-line agent for the control of psoriasis. Methotrexate, psoralen plus UVA, alefacept, etanercept and infliximab are appropriate second-line agents, the choice of which requires considerable patient input and physician judgement. Developing rational, effective and acceptable strategies to manage psoriasis treatments would encourage cost-effective psoriasis management.

Combined Modality Therapy↗
PubMed2003

Patients' vehicle preference for corticosteroid treatments of scalp psoriasis.

Topical therapy is one of the foundations of dermatology. The vehicles used to deliver topical therapy have considerable impact on efficacy. The vehicle can have direct effects on disease; it can impact the delivery of the active drug, and its characteristics affect patient compliance. While the physical chemistry of vehicles has been studied in great detail, there has been very little study of patients' preferences for different vehicles and even less on the effect of these preferences on patient compliance. Such study is essential, as noncompliance with topical therapy is very common, and likely impacts the response to topical therapy observed in clinical practice. This manuscript discusses information on patients' preferences for different vehicles, focussing on the treatment of scalp psoriasis. Significant vehicle characteristics such as ease or difficulty of use, messiness, odors, and staining are recognized to affect patients' preferences. An instrument based on these characteristics has been used to compare patients' preferences for different vehicles. Patients with psoriasis generally prefer less messy vehicles, such as foam and solution preparations, to traditional cream and ointment vehicles. These preferences have the potential to impact patient compliance. Studies directly measuring patient compliance have not yet been performed. In conclusion, the choice of vehicles impacts both the potency of the medication and patients' acceptance of the treatment. Actual effects of different vehicles on compliance are important but have not yet been adequately studied.

Administration, Topical↗
PubMed2003

A systematic review of adverse effects associated with topical treatments for psoriasis.

Mild to moderate psoriasis is a disease that can often be treated with topical medications. The diversity of topical therapies and their disparate side effects complicates treatment planning. Our purpose is to compare the rates of adverse events associated with different topical psoriasis treatments. A review of medical literature from 1996 to March, 2002 was conducted using guidelines set by QUORUM statement criteria. In monotherapy studies, corticosteriods caused fewer adverse reactions compared to vitamin D analogues and tazarotene. In combination studies adverse event rates were higher than in monotherapy studies, except for the combination of topical steroid and calcipotriene which decreased irritation. Irritant contact dermatitis was the main side effect with vitamin D analogues, tazarotene, dithranol or coal tar, while side effects of topical corticosteriods included headache, viral infection and skin atrophy. Topical agents for psoriasis are usually well-tolerated without severe side effects. Formulating a patient's medication regimen should take into account the needs for short-term management and long-term control of psoriasis. Since clearance is not a realistic expectation, reasonable goals should be set as excessive use of topical treatments may increase the risk of both cutaneous and systemic side effects.

Administration, Topical↗