Journal of the American Geriatrics SocietyVolume 49, Issue 3 p. 339-339 Free Access IN RE MEGESTROL ACETATE TREATMENT Richard G. Bennett MD, Richard G. Bennett MD Johns Hopkins Geriatrics Center, Johns Hopkins University School of Medicine, Baltimore, MarylandSearch for more papers by this author Richard G. Bennett MD, Richard G. Bennett MD Johns Hopkins Geriatrics Center, Johns Hopkins University School of Medicine, Baltimore, MarylandSearch for more papers by this author First published: 04 February 2003 https://doi.org/10.1046/j.1532-5415.2001.49303347.xCitations: 1About ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL No abstract is available for this article. REFERENCES 1 Yeh S-S, Wu S-Y, Lee T-P, et al. Improvement in quality-of-life measures and stimulation of weight gain after treatment with megestrol acetate oral suspension in geriatric cachexia: Results of a double-blind, placebo-controlled study. J Am Geriatr Soc 2000; 48: 485 – 492. 2 Bolen JC, Bennett RG, Andersen RE. Deep vein thrombosis as a complication of megestrol acetate therapy among nursing home residents. J Am Med Dir Assoc 2000; 48: 248 – 252. 3 Hansson PO, Welin L, Tibblin G et al. Deep vein thrombosis and pulmonary embolism in the general population. Arch Intern Med 1997; 157: 1665 – 1670. 4 Kniffin WD, Baron JA, Barrett J et al. The epidemiology of diagnosed pulmonary embolism and deep vein thrombosis in the elderly. Arch Intern Med 1994; 154: 861 – 866. 5 Nordstrom M, Linblad B, Bergqvist D et al. A prospective study of the incidence of deep vein thrombosis within a defined urban population. J Intern Med 1992; 232: 155 – 160. Citing Literature Volume49, Issue3March 2001Pages 339-339 ReferencesRelatedInformation

The development of pressure ulcers is a common adverse occurrence among hospital patients and nursing home residents. In recent years, there have been media reports of older plaintiffs winning up to $65 million from healthcare providers, related to the development of pressure ulcers. The passage of sweeping nursing home reform legislation as part of the Omnibus Budget Reconciliation Act of 1987 (OBRA‐87) may have influenced this trend. A review of identifiable federal and state legal databases was undertaken to investigate these issues. One hundred seventy‐three lawsuits related to pressure ulcers were identified between 1937 and 1997, with all but 11 (6%) recorded in the last 15 years. Although the majority of cases were related to the development of pressure ulcers among nursing home residents, hospitals were a defendant in almost one‐quarter of the cases. The median (range) number of cases identified annually increased significantly in the 5‐year epochs before and after passage of OBRA‐87 and increased again after publication of OBRA‐87 regulations in 1992 (2 (2–4) vs 9 (5–15) vs 19 (16–23) cases per year, respectively, P < .0001), evidence that this law has had a broad impact on medical malpractice risk. In addition, the median (range) age of patients for whom a suit was brought also increased significantly before compared with after 1987 (48 (2–81) vs 72 (5–96) years, respectively, P = .0009), evidence that the law facilitated the ability of older adults to become plaintiffs in medical malpractice cases. The median (range) monetary settlement or judgment did not change significantly during the three 5‐year epochs ($340,000 ($4000‐$2,000,000) vs $168,000 ($2200‐$2,000,000) vs $279,000 ($25,000‐$65,000,000), respectively, P = .44), evidence that the OBRA‐87 statutes and regulations established both a standard of care that should not be breached and a standard that can be achieved by healthcare providers. This article reviews these trends, provides examples of pressure ulcer cases, discusses the implications of these findings, and provides recommendations for minimizing this medical malpractice risk. J Am Geriatr Soc 48: 73–81, 2000 .

OBJECTIVES To describe a cluster of cases of proximal deep vein thrombosis among nursing home residents treated with megestrol acetate, to identify other risk factors for deep vein thrombosis development among these patients, and to alert physicians to this potential complication of megestrol acetate therapy. DESIGN Retrospective review. SETTING A 129-bed Maryland nursing home. PARTICIPANTS Nineteen residents prescribed megestrol acetate between November 1997 July 1998, identified by computerized pharmacy records. MEASUREMENTS Demographic data (including identification of known risk factors for deep vein thrombosis development) were collected along with information on the indications for megestrol acetate therapy and its duration, diagnostic studies related to detection of deep vein thrombosis and their results, and patient outcomes following diagnosis of deep vein thrombosis. RESULTS Megestrol acetate was prescribed for 18 nutritionally at-risk patients and one with uterine cancer. Six (32%) patients developed deep vein thrombosis signs and symptoms, and all diagnoses were confirmed as proximal deep vein thromboses with Doppler studies. (No diagnosis of deep vein thrombosis were made among any nursing home patients not being treated with megestrol acetate during the observation period.) All patients diagnosed with deep vein thrombosis were hospitalized and anticoagulated, but none were diagnosed with pulmonary embolus or died. The length [median (range)] of megestrol acetate treatment was similar regardless of whether deep vein thrombosis developed [117 (57-244) versus 143 (2-294) days, respectively, P = 0.83]. Stratification by length of treatment in 50-day increments revealed that most patients who developed deep vein thrombosis did so after 50 days of treatment (P = 0.046). CONCLUSION A high incidence of deep vein thrombosis was identified among nursing home residents treated with megestrol acetate, even among ambulatory individuals with no other known risk factors. Because the efficacy of megestrol acetate treatment in nursing home residents with weight loss is unproven, the risk of deep vein thrombosis must be considered when prescribing megestrol acetate, and its use to treat nutritionally at-risk nursing home residents should be limited.

OBJECTIVE: To determine whether low airless hydrotherapy reduces the incidence of new skin lesions associated with incontinence in hospitalized patients and results in more rapid healing of existing pressure sores compared with standard care. To assess subjectively patient and nursing satisfaction related to using low airless hydrotherapy beds.DESIGN: Randomized, prospective, unblinded study.SETTING: Acute and chronic hospital wards.PARTICIPANTS: A total of 116 newly admitted, incontinent, hospitalized patients with and without existing pressure sores.INTERVENTION: Low airless hydrotherapy compared with treatment on hospital beds and mattresses ordered by the patient's attending physician.MEASUREMENTS: Incidence rates of new skin lesion development, e.g., pressure sores, candidiasis, and chemical irritation; improvement in existing pressure sore size, volume, and status; subjective assessment of patient and nursing satisfaction.RESULTS: Possible hypothermia was identified in two patients during the first week of the study, and patient and nursing dissatisfaction with low airless hydrotherapy remained high throughout the first months of the study. Therefore, two major modifications in the initial protocol were made: (1) increased patient temperature monitoring for hypothermia was initiated in Week 2 of the study and (2) increased staff resources for in-service training on bed use began in Week 18 of the study. After the latter change, 58 subjects were randomized to low airless hydrotherapy and 58 to standard care. Subjects were old (median age greater than or equal to 80 years), and almost all were bedbound or nonambulatory. The median (range) length of follow-up for subjects in the treatment group was significantly shorter than for those in the control group (4 (1-60) days versus 6 (1-62) days, respectively, P = .017) because there were more dropouts from the treatment group (24 (36%) of 58 versus 2 (3%) of 58, P = .0001). The major reasons dropout occurred were patient or family dissatisfaction (12 (21%)), new or worsened skin lesions thought to be related to bed use (4 (7%)), and hypothermia < 97 degrees F (4 (7%)). The total cumulative incidence of new truncal skin lesions within 9 days of enrollment was greater in the treatment than in the control group (48% versus 14%, respectively, P < 0.01). Too few patients with existing pressure sores were treated for too short a period of time to assess the effect df low airless hydrotherapy on pressure sore healing. Because only 10 patients treated on low airless hydrotherapy beds were able to complete satisfaction surveys meaningfully, interpretation of these data is difficult. Only nine (21%) of 44 nurses subjectively reported overall satisfaction using the low airless hydrotherapy bed.CONCLUSIONS: This study shows the value of a rigorously designed clinically based evaluation of a new product developed for older patients. The results of the study led to re-engineering of the prototype low airless hydrotherapy bed as well as a change in marketing strategy. Studies of products targeted to the prevention and treatment of pressure sores in older patients should be undertaken before generalized marketing begins.

OBJECTIVES: To determine the accuracy of patient care staff estimates and documentation of food intake of residents in nursing homes.DESIGN: Prospective, observed, unblinded cohort study.SETTING: Three urban nursing home facilities.SUBJECTS: Staff estimation and documentation of 27 nursing home residents' meal intake.MEASUREMENTS: Actual amount consumed by 27 nursing home residents was ascertained by weighing food and caloric fluids on resident trays before and after one lunch time meal. Staff estimates and documentation of percent of meal consumed was compared with actual intake.RESULTS: Patient care staff estimates differed from actual intake by approximately 20%, and in most instances intake was overestimated. Almost one-third of the residents at risk for nutritional problems were not identified correctly by staff. Chart documentation of meal intake frequently did not reflect either actual amount of meal consumed or the staff's estimation of what was eaten.CONCLUSION: Study findings indicate that the present system used to document nursing home residents' intake is inadequate and that a more accurate mechanism or an entirely different process for identifying residents at risk for nutritional problems should be developed and implemented.

OBJECTIVE: To compare in adults more than 50 years old the tolerability and immunogenicity of vaccination with recombinant hepatitis B surface antigen (HBs) compared with vaccination with recombinant hepatitis B protein PreS2+S, and to investigate the safety and immunogenicity of a fourth vaccine dose in poor and non‐responders.DESIGN: Randomized, double‐blind prospective study.SETTING: General clinical research center for outpatient evaluation and vaccination.SUBJECTS: Adults older than age 50 who were in general good health and with no known risk factors for acquiring or serologic evidence of hepatitis B virus infection.INTERVENTION: Subjects were randomized to receive 10 mcg HBs (Recombivax®, Merck, Sharp and Dohme), 12 mcg PreS2+S, or 24 mcg PreS2+S vaccine at 0, 1, and 6 months. Poor and non‐responders (anti‐Hbs < 10 mIU/mL at month 9 and/or 12) were encouraged to receive a fourth vaccine injection.MEASUREMENTS: Diary records of temperature and local and systemic reactions following each vaccination were maintained by all subjects. Anti‐HBs levels were measured by radioimmunoassay before the first injection, at 1, 2, 3, 6, 7, 9, and 12 months after for all subjects, and 1 month after the fourth injection for the group of poor and non‐responders.MAIN RESULTS: Twenty men and nine women (mean age ± SD, 66 ± 8.0 years) were enrolled. Ten subjects received HBs vaccine, nine received 12 mcg PreS2+S vaccine, and 10 received 24 mcg PreS2 + S vaccine. One subject in the HBs group dropped out, and data were analyzed for the remaining 28 subjects. There were no differences in rates of side effects reported by each of the three groups. Overall, minor local adverse reactions occurred in 12 (40%) after at least one of the first three vaccinations. Systemic side effects occurred in five (17%) after the first vaccination, in one after the second, but in none after the third. The 24‐mcg PreS2+S vaccine was not more immunogenic than the HBs vaccine, and the 12‐mcg PreS2+S vaccine was judged inadequate. Nineteen of 22 (86%) poor and non‐responders received a fourth vaccination. Minor local adverse reactions were reported by six (32%), and none reported a systemic side effect. For the 12 subjects receiving a fourth injection of HBs or 24 mcg PreS2 + S vaccine, the proportion of responders 1 month following the fourth injection was greater than for 1 month following the third injection (11 of 12 [92%] versus 12 of 19 [63%], respectively, P < .05).CONCLUSION: For adults more than 50 years of age who have low anti‐HBs levels after three vaccine injections, a fourth injection is well tolerated and results in improved immunogenic response.