Hip resurfacing as an outpatient procedure: a comparison of overall cost and review of safety.

Recent advancements in arthroplasty surgical techniques and perioperative protocols have reduced the duration of hospitalization and length of recovery, allowing surgeons to perform joint replacement as an outpatient procedure. This study aims to evaluate the cost-effectiveness and safety of outpatient hip resurfacing. Two experienced surgeons performed 485 resurfacing surgeries. We retrospectively compared clinical outcomes and patient satisfaction with published outpatient total hip results. Furthermore, we compared average insurance reimbursement with that of local inpatient hip replacement. No major complications occurred within 6 weeks. Of the 39 patients with previous inpatient experience, 37 (95%) believed their outpatient experience was superior. The average reimbursement for hip arthroplasty at local hospitals was $50,000, while the average payment for outpatient resurfacing at our surgery center was $26,000. We conclude that outpatient hip resurfacing can be accomplished safely, with high patient satisfaction, and at a tremendous financial savings to the insurer/patient. LEVEL OF EVIDENCE: III.

Vertebroplasty and kyphoplasty are associated with an increased risk of secondary vertebral compression fractures: a population-based cohort study.

UNLABELLED: To better understand the risk of secondary vertebral compression fracture (VCF) following a vertebroplasty or kyphoplasty, we compared patients treated with those procedures to patients with a previous VCF. The risk of subsequent fracture was significantly greater among treatment patients, especially within 90 days of the procedure. INTRODUCTION: Predominantly uncontrolled studies suggest a greater risk of subsequent vertebral compression fractures (VCFs) associated with vertebroplasty/kyphoplasty. To further understand this risk, we conducted a population-based retrospective cohort study using data from a large regional health insurer. METHODS: Administrative claims procedure codes were used to identify patients receiving either a vertebroplasty or kyphoplasty (treatment group) and a comparison group of patients with a primary diagnosis of VCF who did not receive treatment during the same time period. The main outcomes of interest, validated by two independent medical record reviewers, were any new VCFs within (1) 90 days, (2) 360 days, and (3) at adjacent vertebral levels. Multivariable logistic regression examined the association of vertebroplasty/kyphoplasty with new VCFs. RESULTS: Among 48 treatment (51% vertebroplasty, 49% kyphoplasty) and 164 comparison patients, treated patients had a significantly greater risk of secondary VCFs than comparison patients for fractures within 90 days of the procedure or comparison group time point [adjusted odds ratio (OR) = 6.8; 95% confidence interval (CI) 1.7-26.9] and within 360 days (adjusted OR = 2.9; 95% CI 1.1-7.9). CONCLUSIONS: Patients who had undergone vertebroplasty/kyphoplasty had a greater risk of new VCFs compared to patients with prior VCFs who did not undergo either procedure.

Deaths due to accidents and violence in two recent trials of cholesterol-lowering drugs.

The Helsinki Heart Study and the Lipid Research Clinics Coronary Primary Prevention Trial both reported higher rates of deaths due to homicides, suicides, and accidents in the groups receiving cholesterol-lowering agents compared with the groups receiving placebos. We examined these deaths in the active treatment arms of the two trials to determine if there were some readily explainable causes or if the cholesterol-lowering agents might be a factor. Our examination showed that the two homicides were victims, not offenders, and one had stopped treatment because of myocardial infarction 1 year before his death. Five of the eight suicides had dropped out of the trials and had not taken the cholesterol-lowering drugs for periods of months to years prior to committing suicide. Of the 10 deaths due to accidents, two were dropouts from the trials, three others had high blood alcohol concentrations detectable at autopsy, and another three reported a history of psychiatric symptoms and/or treatment prior to entry. When dropouts and known risk factors for these deaths such as alcohol intoxication and psychiatric histories are considered, little evidence remains to support the hypothesis that cholesterol-lowering drugs are causally associated with deaths due to homicides, suicides, and accidents in these trials.

Outpatient antiarrhythmic drug use from 1970 through 1986.

Antiarrhythmic drugs have been marketed in the United States for more than three decades. However, little is known about the prevalence of use of these drugs. Using data from the National Prescription Audit, we examined trends in outpatient use of oral antiarrhythmic agent types 1 and 3 from 1970 through 1986. Using the National Disease and Therapeutic Index, we assessed prescribing physician specialty and general demographic and clinical characteristics of recipients. We adjusted the numbers of prescriptions dispensed for broad changes in the US population demographics over the 17-year period. From 1970 through 1986 the number of antiarrhythmic agent prescriptions dispensed increased by 200%, from 3.8 million to 11.5 million. This increase is greater than that expected due to changes in size of the US population, estimated changes in prevalence of heart disease, or estimated changes in the proportion of patients with heart disease who have arrhythmias. The weight of evidence suggests that more persons were receiving antiarrhythmic agents in 1986 than in 1970. Physicians probably recognized and/or treated arrhythmias more frequently in 1986 than in 1970.

Antihypertensive drug use. Trends in the United States from 1973 to 1985.

Hypertension, a major public health problem, often requires drug therapy. We examined trends in outpatient antihypertensive drug use in the United States from 1973 to 1985. The numbers of prescriptions and the diagnostic and drug treatment information were obtained from the National Prescription Audit (Ambler, Pa, IMS America, 1985) the National Disease and Therapeutic Index (Ambler, Pa, IMS America, 1985), ongoing surveys of pharmacies, and office-based physicians. We adjusted drug-use data for the fact that several antihypertensive drugs also have other uses. During the study period, the annual numbers of prescriptions for treatment of hypertension progressively increased from 128.1 to 208.6 million, an average change of 5% per year. In 1973, the three leading classes of antihypertensive drugs were thiazide diuretic agents, peripheral neuronal inhibitors, and central alpha-adrenergic receptor stimulators. By 1985, the thiazide drugs were still the leader, followed by beta-adrenergic receptor blockers and potassium-sparing diuretic drugs. The use trends presented are consistent with surveys indicating increased drug therapy of hypertension from 1960 to the present.

Pain and cyanosis associated with alpha 1-proteinase inhibitor.

PURPOSE: The purpose of this study was to investigate adverse reaction reports of pain and/or cyanosis attributed to alpha 1-proteinase inhibitor (A1PI), a plasma alpha-globulin protein used to treat A1PI deficiency. PATIENTS AND METHODS: The Food and Drug Administration's (FDA) Spontaneous Reporting System for the collection and analysis of suspected adverse reactions to drugs and biologics was searched for all reports with dates from January 1, 1988, through October 31, 1989, in which A1PI was named as the suspect biologic. A case of pain and/or cyanosis was defined and characteristics of cases were compared with all other reactions. Information about the production of A1PI and results from animal studies conducted by the manufacturer were also gathered. RESULTS: Fourteen cases of acute chest pain, back pain, and/or cyanosis among patients receiving A1PI infusions were reported to the FDA. The clinical aspects of reported cases were consistent with a rapidly acting, nonallergic mechanism and were easily distinguished from other reactions associated with A1PI. The characteristics of reported cases, the epidemic curve, and lot-specific analyses suggested a point source and strongly implicated two A1PI lots. Information about the production of A1PI and results from animal studies further implicated high-molecular-weight polysaccharides associated with sucrose stabilization of the suspect lots. CONCLUSION: These cases resemble adverse reactions attributed to complexes of protamine and heparin (a mucopolysaccharide). Similar vasoactive mechanisms are suggested. Research is needed to further define the pathophysiology associated with polysaccharide moieties.

Vaccine-associated poliomyelitis in a household contact with Netherton's syndrome receiving long-term steroid therapy.

Paralytic poliomyelitis developed in a man 51 days after his two-month-old daughter received her first dose of trivalent live oral poliovirus vaccine. The patient was receiving long-term glucocorticosteroid therapy (tapered to 12.5 mg per day for the eight months prior to his poliomyelitis) for Netherton's syndrome, a congenital syndrome characterized by bamboo-like hair, hyperkeratotic and hyperhidrotic skin, and multiple allergies. The patient was ventilator-dependent and quadriplegic throughout most of his hospital stay and died in the hospital 10 months after the onset of paralysis. "Vaccine-like" type 3 poliovirus was isolated from a stool specimen and his serum showed a significant rise in neutralizing antibody titer against type 3 virus. This case report represents the first documented case of vaccine-associated poliomyelitis in a household contact receiving glucocorticosteroids, although evidence of immunosuppression was not documented. Nevertheless, the case reinforces current recommendations not to administer oral poliovirus vaccine to persons known to be immune deficient or suppressed or to normal persons with close contacts known to be immune deficient or suppressed.

Adverse reactions reported following receipt of Haemophilus influenzae type b vaccine: an analysis after 1 year of marketing.

An analysis of adverse reactions occurring after receipt of Haemophilus influenzae type b vaccine and reported to the Food and Drug Administration during the first year of marketing of the product was performed. During the period April 1985 to May 1986, adverse reaction reports on 152 patients, excluding those of vaccine failure and concurrent infection, were received. Several adverse reactions not previously recognized, including convulsions, allergic reactions such as anaphylactoid-like and serum sickness-like reactions, and vomiting were received. The vast majority of adverse reactions were benign. Because there are many biases that result in the reporting of or failure to report an adverse reaction, it is not possible to derive a rate of reactions from these data. Furthermore, causality cannot be inferred from any single report. The data, however, indicate that, in light of widespread use of the vaccine, its use appears to be safe.

Home oxygen therapy in Medicare beneficiaries, 1991 and 1992.

STUDY OBJECTIVE: Obtain descriptive data on the use of home oxygen by Medicare beneficiaries and study the impact of certain demographic factors and diagnoses on oxygen use. METHODS: A home oxygen user was defined as any Medicare beneficiary with at least one claim for home oxygen in the Health Care Financing Administration National Claims History 5% Physician Supplier Files for 1991 and 1992. Railroad board beneficiaries, health maintenance organization members, and those without continuous part B coverage were excluded. RESULTS: In 1991, there were 21,489 beneficiaries in the sample who received oxygen therapy. In 1992, there were 8,418 new users. Twenty-six percent of new users died in 1992. Factors significantly associated with death included age 76 years or older (relative risk [RR], 1.3), pneumonia (RR, 1.3), lung cancer (RR, 3.8), male gender (RR, 1.2), heart failure (RR, 1.3), and diagnoses suggestive of COPD (RR, 0.45). Seven percent of new users discontinued therapy within 1 month, 28% within 6 months. Liquid oxygen was used by 19% of current and 14% of new users. Factors significantly associated with liquid oxygen use included portable oxygen claims (odds ratio [OR], 2.4), nonmetropolitan residence (OR, 0.73), and white race (OR, 1.2). CONCLUSIONS: Descriptive information on patterns of home oxygen use, including associated medical conditions, types and duration of therapy, and survival is useful for regulatory purposes. This information supports concerns that current payment policy may discourage suppliers from providing liquid oxygen in underserved areas.

The estimated effect of oral contraceptive use on the cumulative risk of epithelial ovarian cancer.

OBJECTIVE: To determine the effect of oral contraceptive (OC) use on the cumulative incidence of epithelial ovarian cancer from ages 20-40, 20-50, and 20-55 years among four groups of women: positive family history, negative family history, parous, and nulliparous. METHODS: Cancer and Steroid Hormone Study data were combined with data from the Surveillance, Epidemiology, and End Results Network to provide estimates of the age-specific incidence rates of epithelial ovarian cancer among never-users of OCs in the four specified groups of women. These rates provided the basis for calculating cumulative incidences. The rates in women using OCs were estimated from meta-analyses of the epidemiologic literature, using regression equations expressing the log-relative rate of epithelial ovarian cancer as a function of duration of use and recency. RESULTS: In all four groups, the cumulative number of epithelial ovarian cancer cases estimated to occur per 100,000 OC users, compared to never-users, decreased with increasing duration of OC use. Our results suggest that 5 years of OC use by nulliparous women can reduce their ovarian cancer risk to the level seen in parous women who never use OCs, and that 10 years of OC use by women with a positive family history can reduce their risk to a level below that for women whose family history is negative and who never use OCs. CONCLUSION: These data represent the first published estimates of the effect of OC use on the cumulative incidence of epithelial ovarian cancer by family history and by parity. The demonstrated substantial noncontraceptive benefit from OCs justifies their judicious use as a potentially powerful resource for primary prevention in women at high risk of ovarian cancer.

Thyroid hormone use: trends in the United States from 1960 through 1988.

Thyroid hormone preparations comprised over 1% of all prescriptions filled by retail pharmacies during 1988 in the conterminous United States, i.e., the 48 contiguous states. Their large market share gives the patterns of their use substantial public health importance. This article describes prescription thyroid hormone use in the United States from 1960 through 1988, using pharmaceutical marketing research data collected from panels of retail pharmacies and office-based physicians. Although the use of natural products has declined by over 50% since 1960, about one fourth of all thyroid hormone prescriptions were for natural preparations as recently as 1988. Per capita thyroid mentions (i.e., patient-physician contacts during which a thyroid agent of any kind was recommended, prescribed, dispensed, administered, ordered to be given by a hospital, or given as a sample) doubled during this period among those over 59 years old. Per capita mentions for synthetic thyroid products increased fourfold and tenfold among men and women in this age group, respectively. Use for weight loss, despite the label's boxed warning indicating it to be ineffective and potentially dangerous, has diminished but persists. Obesity was second only to hypothyroidism among the diagnoses underlying thyroid product mentions.

The epidemiology of pacemaker implantation in the United States.

Data on pacemaker implantation were obtained from the Medical Device Implant Supplement to the 1988 National Health Interview Survey, a nationally representative, population-based survey of 47,485 households (122,310 persons). The survey yielded an estimate of 456,482 noninstitutionalized adults with pacemakers (prevalence, 2.6 per 1,000). Prevalence rose significantly with age, from 0.4 per 1,000 among persons ages 18-64 to 26 per 1,000 among those ages 75 or older. Age-adjusted prevalence in males was 1.5 times that in females, and in whites 1.6 times that in nonwhites, although these differences were of borderline statistical significance. Prevalence did not vary significantly by region of residence, educational level, or income, but was significantly increased (more than threefold) in those reporting any activity limitation compared with those with no limitation. Fifteen percent of pacemakers in use were replacements; about one-fifth of these had been replaced more than twice. Sixty percent of previous pacemakers had been in place for at least 5 years. These data provide the first nationwide, population-based estimates of the epidemiology of pacemaker implantation, focusing particularly on the demographics of U.S. pacemaker recipients.

An outbreak of acute infectious nonbacterial gastroenteritis in a high school in Maryland.

An outbreak of acute infectious nonbacterial gastroenteritis (AING) occurred in a high school in Maryland in 1984. Thirty-six percent of students surveyed met the case definition of gastroenteritis, as did 24 percent of school employees. Eating lunch in the cafeteria on January 30 was significantly associated with illness. After controlling for other food items consumed during the January 30 lunch, only the sandwiches were significantly associated with illness, but the source of the contamination was not identified. Four of 17 serum pairs from sick students and none of the 8 serum pairs from exposed controls (a nonsignificant difference) showed at least a 4-fold rise in antibody titre to Norwalk virus between acute- and convalescent-phase specimens. This outbreak of AING is believed to be the first to implicate epidemiologically sandwiches as vehicles of transmission. The outbreak highlights the need for investigators to look for a viral etiology in gastroenteritis outbreaks.

The epidemiology of prosthetic heart valves in the United States.

The Center for Devices and Radiological Health of the Food and Drug Administration, in collaboration with the National Center for Health Statistics, conducted the Medical Device Implant Supplement to the 1988 National Health Interview Survey, generating the 1st available population-based estimates of the use of prosthetic heart valves in the United States. The 1988 National Health Interview Survey was a massive, nationally representative cross-sectional survey that encompassed 47,485 households and 122,310 individuals. Data from the Medical Device Implant Supplement indicate that an estimated 253,283 persons with 279,175 heart valves were present in the civilian, non-institutionalized US population (population prevalence of 1.1/1,000, 95% CI 0.8-1.3). Prevalence of valve prostheses ranged from 0.2 per 1,000 in those age 44 and under to 5.3 per 1,000 in those 75 years of age and older. Age-adjusted prevalence of valve prostheses did not differ significantly according to sex, race, region of residence, education, or income of recipients. Two thirds of aortic valve recipients identified by the survey were male, compared with only one third of mitral valve recipients. Approximately two thirds of both aortic and mitral valve implants were reported as mechanical. Reported use of anticoagulative agents was significantly more common in recipients of mechanical than of bioprosthetic valves. The single most common reported reason for prosthetic valve implantation was rheumatic heart disease. These data provide useful epidemiologic and public health planning information on prosthetic heart valve use.

Medical device vigilance at FDA.

This overview of medical device vigilance at the U.S. Food and Drug Administration (FDA) discusses the basic reporting regulation and program at FDA. The FDA program has grown to the point where we now receive over 100,000 reports per year. How FDA examines the data patterns in overall reporting, to identify signals in the database, and the potential actions FDA takes to respond to these problems are also presented. New initiatives include, for example, new methods to triage reports and the move developing an internationally harmonised nomenclature.

Use and effectiveness of condoms during anal intercourse. A review.

BACKGROUND AND OBJECTIVES: Anal intercourse has been associated with a high risk of human immunodeficiency virus transmission. Survey data suggest that unprotected anal intercourse is practiced by a substantial proportion of the sexually active population, regardless of sexual orientation. GOAL: To review the literature related to the use and effectiveness of condoms during anal intercourse, with emphasis on prevention of human immunodeficiency virus transmission. STUDY DESIGN: Literature review. RESULTS: Epidemiologic studies have shown that consistent, correct condom use reduces the overall risk of sexual transmission of human immunodeficiency virus. Evidence for the effectiveness of condoms used during anal intercourse is less definitive. Survey and clinical trials data indicate that condom breakage and slippage rates vary during anal intercourse and may be considerably higher than during vaginal intercourse. Although condoms designed for anal intercourse have been studied and marketed in Europe, data on their actual performance are scarce. In addition, no information exists on the effectiveness of polyurethane or other nonlatex condoms for use during anal intercourse. CONCLUSIONS: Development of newer and more effective condoms for use during anal intercourse requires consideration of the ethical issues involved in testing and marketing devices used during an activity that carries with it the potential for a substantial risk to health.