Once-daily topical metronidazole cream formulations in the treatment of the papules and pustules of rosacea.

BACKGROUND: The papules and pustules of rosacea can be effectively treated with topical metronidazole. The optimal concentrations of metronidazole and optimum frequencies of application are uncertain. Traditionally, twice-daily applications have been advised, based on the pharmacokinetic profile of metronidazole. Once-daily applications may be safer and less expensive, and they may enhance patient compliance. OBJECTIVE: We compared the efficacy and safety of 2 commercially available topical metronidazole formulations (0.75% metronidazole cream formulation and 1.0% metronidazole cream formulation) when both were used in a once-daily regimen. METHODS: A multicenter, randomized, investigator-blind, parallel group trial was conducted at 3 separate clinical sites located in 3 US cities. The study enrolled 72 rosacea patients with at least 8 to 50 inflammatory facial lesions (pustules and papules) and moderately severe facial erythema. Patients were randomly assigned to receive either 0.75% metronidazole cream or 1.0% metronidazole cream and instructed to apply the medication once daily for 12 weeks. Patients' lesions were evaluated at baseline and at weeks 3, 6, 9, and 12. RESULTS: There were no significant differences between treatment groups for any of the efficacy parameters evaluated. The overall median percentage change in lesion count at end point for patients in the 0.75% metronidazole cream treatment group was -62% compared with -60% for the 1.0% metronidazole cream treatment group. The overall percentage change in erythema scores at endpoint for patients in the 0.75% metronidazole cream treatment group was -26% compared with -30% for patients in the 1.0% metronidazole cream treatment group. Regarding physician assessment of global severity, 57% of subjects (20/35) in the 0.75% metronidazole cream group compared with 37% of subjects (13/35) in the 1.0% metronidazole cream group were rated as having a clear to mild condition at end point. Both drugs were well tolerated; there was no significant difference in the number of drug-related adverse events between the two agents. CONCLUSION: This controlled trial demonstrates that both 0.75% metronidazole cream and 1.0% metronidazole cream, when used once daily, provide well-tolerated efficacy for moderate to severe rosacea.

Topical metronidazole maintains remissions of rosacea.

BACKGROUND: Rosacea is a chronic skin disease that requires long-term therapy. Oral antibiotics and topical metronidazole successfully treat rosacea. Because long-term use of systemic antibiotics carries risks for systemic complications and adverse reactions, topical treatments are preferred. OBJECTIVE: To determine if the use of topical metronidazole gel (Metrogel) could prevent relapse of moderate to severe rosacea. DESIGN: A combination of oral tetracycline and topical metronidazole gel was used to treat 113 subjects with rosacea (open portion of the study). Successfully treated subjects (n = 88) entered a randomized, double-blind, placebo-controlled study applying either 0.75% topical metronidazole gel (active agent) or topical metronidazole vehicle gel (placebo) twice daily (blinded portion of the study). SETTING: Subjects were enrolled at 6 separate sites in large cities at sites associated with major medical centers. SUBJECTS: One hundred thirteen subjects with at least 6 inflammatory papules and pustules, moderate to severe facial erythema and telangiectasia entered the open phase of the study. Eighty-eight subjects responded to treatment with systemic tetracycline and topical metronidazole gel as measured by at least a 70% reduction in the number of inflammatory lesions. These subjects were randomized to receive 1 of 2 treatments: either 0.75% metronidazole gel or placebo gel. INTERVENTIONS: Subjects were evaluated monthly for up to 6 months to determine relapse rates. MAIN OUTCOME MEASURES: Inflammatory papules and pustules were counted at each visit. Relapse was determined by the appearance of a clinically significant increase in the number of papules and pustules. Prominence of telangiectases and dryness (roughness and scaling) were also observed. RESULTS: In the open phase, treatment with tetracycline and metronidazole gel eliminated all papules and pustules in 67 subjects (59%). The faces of 104 subjects (92%) displayed fewer papules and pustules after treatment, and 82 subjects (73%) exhibited less erythema. In the randomized double-blind phase, the use of topical metronidazole significantly prolonged the disease-free interval and minimized recurrence compared with subjects treated with the vehicle. Eighteen (42%) of 43 subjects applying the vehicle experienced relapse, compared with 9 (23%) of 39 subjects applying metronidazole gel (P<.05). The metronidazole group had fewer papules and/or pustules after 6 months of treatment (P<.01). Relapse of erythema also occurred less often in subjects treated with metronidazole (74% vs 55%). CONCLUSION: In a majority of subjects studied, continued treatment with metronidazole gel alone maintains remission of moderate to severe rosacea induced by treatment with oral tetracycline and topical metronidazole gel.

Adapalene 0.1% gel for the treatment of acne vulgaris: its superiority compared to tretinoin 0.025% cream in skin tolerance and patient preference.

One hundred patients with acne vulgaris applied adapalene (Differin) 0.1% gel to one side of their face and tretinoin 0.025% cream to the other once a day for 4 weeks; the side of application was determined by randomization code. Patient tolerance (assessed as the side of the face least irritated by drug application) was recorded weekly and patient preference (assessed as the preparation more easily spread, absorbed more quickly, smelled better, felt best on the skin and least greasy to the feel) at completion of the study. The investigator measured skin irritation weekly, scoring erythema, skin dryness, desquamation and burning/stinging on a 10-point scale. After each week of treatment, 64-68% of patients found adapalene 0.1% gel more tolerable than tretinoin 0.025% cream (P < 0.05). At study completion, 65% of patients preferred adapalene 0.1% gel over tretinoin 0.025% cream (P = 0.003). An overall assessment showed adapalene 0.1% gel was significantly less irritating to the skin in terms of producing erythema, dryness, desquamation and burning/stinging, at Visits 2, 3 and 4 (P < 0.02). Thirty-two patients experienced mild to moderately severe adverse events; three had adverse events considered to be drug related (two with skin discomfort; one with skin dryness). One patient stopped using the study drugs because of dry skin. This study showed that a majority of patients preferred adapalene 0.1% gel over tretinoin 0.025% cream and that it caused significantly less skin irritation.

Comparative tolerance of adapalene 0.1% gel and six different tretinoin formulations.

Adapalene 0.1% gel (Differin gel) is a recently introduced topical treatment for mild to moderate acne which has been demonstrated to be much better tolerated and at least as effective as tretinoin 0.025% gel. We compared the tolerance of adapalene 0.1% gel with six different formulations and concentrations of tretinoin. A total of 55 healthy human subjects were enrolled in two controlled, randomized, observer blinded, intraindividual comparison studies. In the first study, adapalene 0.1% gel was evaluated for its 21-day cumulative irritation potential compared with tretinoin 0.025%, 0.05% and 0.1% cream, tretinoin 0.01% and 0.025% gel, and petrolatum (control). In the second study, adapalene 0.1% gel was evaluated for its 21-day cumulative irritation potential compared with tretinoin 0.025%, 0.05% and 0.1% cream, tretinoin 0.1% gel microsphere, and petrolatum (control). In both studies, cumulative irritation scores helped to define three groups of common irritancy potential, with significant differences between each group. In study A, the three groups were in descending order of irritancy: tretinoin 0.1% cream and tretinoin 0.05% cream; tretinoin 0.025% gel, tretinoin 0.01% gel and tretinoin 0.025% cream; adapalene 0.1% gel and petrolatum (control). In study B, the three groups were in descending order of irritancy: tretinoin 0.1% cream; tretinoin 0.05% cream, tretinoin 0.025% cream and tretinoin 0.1% gel microsphere; adapalene 0.1% gel and petrolatum (control). The experimental results show that adapalene 0.1% gel is significantly better tolerated than any of six formulations of tretinoin, including two gels, three creams and a microsphere formulation, ranging in potency from 0.01% to 0.1%.

Effect of desonide ointment, 0.05%, on the hypothalamic-pituitary-adrenal axis of children with atopic dermatitis.

Desonide ointment has demonstrated a good safety and efficacy profile during the many years it has been used in treating dermatoses. However, there have been no controlled clinical trials to evaluate its systemic safety when used in treating children. Suppression of the hypothalamic-pituitary-adrenal (HPA) axis can occur after repeated application of topical corticosteroids. In general, the degree of suppression of the HPA axis function is related to the daily dosage of steroid given, the duration of its administration, the extent of body surface covered, and the potency of the corticosteroid. This study sought to determine the comparative effects of 0.05 percent desonide and 2.5 percent hydrocortisone ointments on the HPA axis of children with atopic dermatitis. There was no suppression of early morning cortisol in either treatment group. The ACTH-stimulated mean cortisol values after four weeks of treatment were not significantly different from the baseline values for either treatment group. We conclude that neither 0.05 percent desonide ointment nor 2.5 percent hydrocortisone ointment compromised the HPA axis of children with atopic dermatitis treated topically for four weeks.

Appendicitis: higher risk in Mexican Americans?

OBJECTIVES: Mexican Americans (MAs), compared to white non-Hispanics (WNHs), have higher rates of biliary disease, noninsulin dependent diabetes, and endstage renal disease but lower rates of lung cancer, hip fractures, and mortality from coronary heart disease. Relatively little research has been done to identify other ethnic differences in disease incidence. We used surgical procedure rates to confirm known ethnic differences and to explore our clinical suspicion that MAs have higher rates of appendectomy than WNHs. METHODS: We used a registry of surgical procedures at two teaching hospitals in South Texas to calculate proportional operation ratios (PORs) for MAs versus WNHs. These two hospitals are the primary source of acute hospital care for the indigent in the area. The POR is arithmetically identical to proportional incidence and mortality ratios. RESULTS: MAs underwent appendectomy proportionally more often than WNHs at both hospitals (POR = 1.41 and 1.75, p < 0.0001). Other significant PORs were consistent with known ethnic disease differences in biliary tract operations, vascular access for chronic hemodialysis, lung cancer, and coronary artery bypass. CONCLUSIONS: These findings support the hypothesis that MAs may undergo appendectomy more often than WNHs and so may be at higher risk of appendicitis.

Survival among Mexican-Americans, non-Hispanic whites, and African-Americans with end-stage renal disease: the emergence of a minority pattern of increased incidence and prolonged survival.

We undertook this study to determine whether there is a significant difference in survival on treatment for end-stage renal disease between Mexican-Americans, non-Hispanic whites, and African-Americans. A database covering the years 1975 to 1986 was obtained from the Texas Kidney Health Program. Eight-eight percent to 90% of patients starting renal replacement therapy in Texas were included in this database. The patients were followed until death, for 3 years after successful transplantation, or until they were lost to follow-up. Life table analysis as well as age-adjusted analysis using the Cox proportional hazards model were performed comparing ethnic/racial groups, disease etiology, and treatment type. In life-table analyses, African-Americans and Mexican-Americans had a survival advantage in most age, disease, and treatment groups. With age adjustment, this survival advantage remained for all etiologies combined, for diabetes and hypertension cases, and for patients receiving hemodialysis in a center. Multivariate analysis revealed a persistent survival advantage for Mexican-Americans independent of traditional predictor variables, such as age, disease etiology, treatment type, or size of the center in which they received treatment. In this same analysis, African-Americans showed an advantage in the older age groups. Both African-Americans and Mexican-Americans on renal replacement therapy have an increased survival advantage compared with non-Hispanic whites. Given the additional burden of increased incidence of end-stage renal disease in these groups, the cost of renal replacement therapy for these minorities is disproportionately high. Further study should be aimed at elucidation of the mechanisms by which minorities achieve their survival advantage.

Methods for screening for hearing loss in older adults.

Two common screening tools for detecting hearing loss, the Hearing Handicap Inventory for the Elderly-Screening Version (HHIE-S) and Audioscope, are compared. One hundred eighty-five consecutive patients over age 60 at a primary care clinic received both screening tests followed by pure tone audiometry. Three criteria for hearing loss was considered: Speech Frequency Pure Tone Average > or = 25 dB; High Frequency Pure Tone Average > or = 25 dB; and Ventry and Weinstein's criteria of a 40 dB loss at 1.0 or 2.0 kHz. Ranges of respective operating characteristics for the Audioscope versus the HHIE-S were: sensitivities 0.64 to 0.96 versus 0.29 to 0.63; specificities 0.80 to 0.91 versus 0.75 to 0.93; and positive likelihood ratios 4.86 to 7.52 versus 2.42 to 4.27. Most patients preferred screening with the Audioscope (60%) over the HHIE-S (13%). The Audioscope is preferred by patients, and outperforms the HHIE-S using a variety of reference standard definitions.

Postoperative complications after thoracic and major abdominal surgery in patients with and without obstructive lung disease.

STUDY OBJECTIVE: To determine the risk of thoracic and major abdominal surgery in patients with chronic obstructive pulmonary disease (COPD). DESIGN: Retrospective cohort study with controls. SETTING: A 692-bed teaching hospital. PATIENTS: A cohort of 26 patients with severe COPD (FEV1 < 50 percent predicted) undergoing thoracic and major abdominal surgery was matched by age and type of operation to 52 patients with mild-moderate COPD and 52 patients with no COPD. MEASUREMENTS AND RESULTS: The 26 patients with severe COPD had rates of cardiac, vascular, and minor pulmonary complications similar to patients with mild-moderate COPD and without COPD, but experienced higher rates of serious pulmonary complications (23 percent vs 10 percent vs 4 percent, p = 0.03) and death (19 percent vs 4 percent vs 2 percent, p = 0.02). All deaths and instances of ventilatory failure in the patients with severe COPD occurred in the subset undergoing coronary artery bypass surgery. Logistic regression revealed that increased age, higher American Society of Anesthesiologists class, an abnormal chest radiograph, and perioperative bronchodilator administration were associated with higher cardiac or serious pulmonary complication rates. Spirometry was not an independent predictor of postoperative complications. CONCLUSIONS: Clinical variables appear better than preoperative spirometry in predicting postoperative cardiopulmonary complications. The utility of preoperative spirometry as well as the benefits of perioperative bronchodilators in patients in stable condition remain to be determined.

Medical treatment preferences of nursing home residents: relationship to function and concordance with surrogate decision-makers.

OBJECTIVE: To describe treatment preferences of nursing home residents, concordance with decisions by self-selected proxies and to establish the relationship of sociodemographic and functional measures to decisions. SETTING AND SUBJECTS: 52 patient-proxy pairs at a Veterans Affairs nursing home. METHODS: Treatment preferences were elicited from residents and proxies regarding cardiopulmonary resuscitation, mechanical ventilation, and intensive care unit care. Hospitalization, intravenous antibiotics, intravenous fluid administration, and tube feeding were presented in three separate health scenarios. Concordance was determined for the entire interview and separately for each scenario. Treatment-seeking intensity and decision-making consistency were scored and used to explore associations with sociodemographic variables and function. RESULTS: Subjects were predominantly male (97%) and non-Hispanic white (74%); average age was 70 +/- 12 years, with 4 +/- 2.9 diagnoses. Residents accepted 70% of all treatments. The proportion of subjects accepting interventions declined parallel to health status in each scenario. Only 7/52 (13%) subjects made inconsistent decisions. Resident treatment acceptance was inversely associated with GDS scores but not associated with any other sociodemographic or functional measure. Concordance with proxies was no greater than chance. Proxies' decisions were not systematically biased against resident preferences or influenced by patient characteristics. CONCLUSIONS: Veterans desired most treatments, but adjusted preferences according to health status and were not inconsistent. Depressive symptoms should be addressed prior to advance directive selection. The patient remains the best source of information, but proxies' decisions exhibit no bias and are not affected by patient status.

Screening for diabetic retinopathy. The wide-angle retinal camera.

OBJECTIVE: To define the test characteristics of four methods of screening for diabetic retinopathy. RESEARCH DESIGN AND METHODS: Four screening methods (an exam by an ophthalmologist through dilated pupils using direct and indirect ophthalmoscopy, an exam by a physician's assistant through dilated pupils using direct ophthalmoscopy, a single 45 degrees retinal photograph without pharmacological dilation, and a set of three dilated 45 degrees retinal photographs) were compared with a reference standard of stereoscopic 30 degrees retinal photographs of seven standard fields read by a central reading center. Sensitivity, specificity, and positive and negative likelihood ratios were calculated after dichotomizing the retinopathy levels into none and mild nonproliferative versus moderate to severe nonproliferative and proliferative. Two sites were used. All patients with diabetes in a VA hospital outpatient clinic between June 1988 and May 1989 were asked to participate. Patients with diabetes identified from a laboratory list of elevated serum glucose values were recruited from a DOD medical center. RESULTS: The subjects (352) had complete exams excluding the exam by the physician's assistant that was added later. The sensitivities, specificities, and positive and negative likelihood ratios are as follows: ophthalmologist 0.33, 0.99, 72, 0.67; photographs without pharmacological dilation 0.61, 0.85, 4.1, 0.46; dilated photographs 0.81, 0.97, 24, 0.19; and physician's assistant 0.14, 0.99, 12, 0.87. CONCLUSIONS: Fundus photographs taken by the 45 degrees camera through pharmacologically dilated pupils and read by trained readers perform as well as ophthalmologists for detecting diabetic retinopathy. Physician extenders can effectively perform the photography with minimal training but would require more training to perform adequate eye exams. In this older population, many patients did not obtain adequate nonpharmacological dilation for use of the 45 degrees camera.

Anterior ischemic optic neuropathy is not associated with carotid artery atherosclerosis.

BACKGROUND AND PURPOSE: The relation between anterior ischemic optic neuropathy and carotid artery atherosclerotic disease is unclear. We studied patients with anterior ischemic optic neuropathy to determine if they had an increased occurrence of carotid artery stenosis. METHODS: Fifteen consecutive patients with anterior ischemic optic neuropathy were evaluated prospectively for cervical carotid artery stenosis and compared with 30 age- and sex-matched asymptomatic patients and also with 11 age- and sex-matched patients experiencing transient monocular blindness. RESULTS: There was no difference in the mean stenosis of the internal carotid artery between patients with anterior ischemic optic neuropathy (mean carotid stenosis, 19%) and asymptomatic patients (mean carotid stenosis, 9%; p > 0.05), whereas patients with transient monocular blindness had significantly more stenosis (mean, 77%) in the cervical carotid arteries than both control subjects (p < 0.0001) and patients with anterior ischemic optic neuropathy (p < 0.0001). There was also no difference in the percentage of patients with stenosis > or = 30% in anterior ischemic optic neuropathy (two of 15) and asymptomatic patients (five of 30), whereas 10 of 11 patients with transient monocular blindness had stenoses > or = 30%, significantly more than patients with anterior ischemic optic neuropathy (p < 0.0001) and asymptomatic patients (p < 0.0001). CONCLUSIONS: Anterior ischemic optic neuropathy is not a marker for atherosclerotic carotid artery stenosis. The pathogenesis of nonarteritic anterior ischemic optic neuropathy does not involve carotid artery stenosis in most patients.

Development and validation of a physical performance instrument for the functionally impaired elderly: the Physical Disability Index (PDI).

Article describes development of the Physical Disability Index (PDI), an observer-administered, performance-based instrument measuring physical disability in frail-elderly persons without severe cognitive impairment. Sixty-five items in four subscales encompassing Range of Motion (ROM), Strength (STR), Balance (BAL), and Mobility (MOB) were measured. Subjects were randomly selected frail nursing home residents (N = 103) with a Folstein Mini-Mental State Exam (MMSE) score of > or = 11. Using correlation matrices, cluster analysis, and regression techniques, the scale was reduced to 54 items. All individual item values were standardized and aggregated into subscale and summary PDI scores, each with a range of 0-100. Test-retest and interrater reliability were evaluated. Discriminant and convergent validity were established using MMSE, Physical Self-Maintenance Scale (PSMS), and Sickness Impact Profile-Physical Dimension (SIP-PD). PDI is a performance-based instrument that appears to discriminate among frail individuals with differing levels of physical function. Further testing is warranted in other populations of frail-elderly persons to ascertain its applicability and generalizability.

Sustained benefits of hearing aids.

This study was designed to evaluate long-term benefits of hearing aids in elderly individuals with hearing loss. A primary care cohort of 192 elderly, hearing-impaired veterans (mean age 72 +/- 6, 97% White, 94% retired) were assessed at baseline and at 4, 8, and 12 months after hearing aid fitting. Drop-out rates at 4, 8, and 12 months were 5%, 13%, and 16%, respectively. Outcome assessments included several quality-of-life scales: Hearing Handicap Inventory in the Elderly (HHIE), Quantified Denver Scale of Communication Function (QDS), Geriatric Depression Scale (GDS), and the Short Portable Mental Status Questionnaire (SPMSQ). All quality-of-life areas improved significantly from baseline to 4-month post-hearing aid fittings (p < 0.05). Social and emotional (HHIE), communication (QDS), and depression (GDS) benefits were sustained at 8 and 12 months, whereas cognitive changes (SPMSQ) reverted to baseline at 12 months. We conclude that hearing aids provide sustained benefits for at least a year in these elderly individuals with hearing impairment.

The influence of outpatient insurance coverage on the microvascular complications of non-insulin-dependent diabetes in Mexican Americans.

Does poor health insurance coverage contribute to increased microvascular complications (nephropathy and retinopathy) in Mexican Americans with non-insulin-dependent diabetes? Mexican-American subjects with diabetes were identified in a population-based cardiovascular risk factor survey, the San Antonio Heart Study. Retinopathy, nephropathy, source of health care, and type and extent of health insurance coverage were assessed in a special diabetes complications exam. Among Mexican-American subjects with non-insulin-dependent diabetes diagnosed prior to their participation in the survey (n = 255), 26% (n = 67) lacked any type of health insurance, and 28% relied on county- or federal-funded clinics rather than private doctors as their primary source of care. Among those with health insurance (188 of 255), only 68% (127 of 188) or 24% of the total sample had private health insurance, and, of those with private insurance, 48% (35 of 73) received reimbursement for outpatient doctor visits and 57% for outpatient medications. Microvascular complications were more common among those who received their health care from a clinic versus a private doctor, and among those who lacked health insurance coverage for outpatient doctor visits and medications. Thus, poor health insurance coverage in the outpatient setting correlates with higher rates of microvascular complications among Mexican Americans with non-insulin-dependent diabetes mellitus.

Operative risk in patients with severe obstructive pulmonary disease.

BACKGROUND: We wanted to determine the risk of postoperative pulmonary complications and mortality in patients with severe chronic obstructive pulmonary disease. METHODS: We reviewed 107 consecutive operations performed in 89 patients with severe chronic obstructive pulmonary disease (forced expiratory volume in 1 second, less than 50% of predicted). RESULTS: Postoperative pulmonary complications occurred in 31 operations (29%) and were significantly related to the type and duration of surgery. Also, American Society of Anesthesiologists class approached significance as a predictor. Postoperative pulmonary complications occurred at higher rates in coronary artery bypass grafting and major abdominal procedures (60% and 56%) than in other operations involving general or spinal anesthesia (27%) or in procedures performed with the patient under regional or local anesthesia (16%). When the durations of the operations were classified as less than 1 hour, 1 to 2 hours, 2 to 4 hours, and more than 4 hours, the rates of postoperative pulmonary complications were 4%, 23%, 38%, and 73%, respectively. Regarding American Society of Anesthesiologists class, postoperative pulmonary complications occurred in 10% of patients in class II, 28% of those in class III, and 46% of those in class IV. In terms of life-threatening complications, there were six deaths and only two cases of nonfatal ventilatory failure. Notably, mortality clustered primarily in coronary artery bypass graft procedures. Five of 10 patients receiving coronary artery bypass grafts died, compared with one death after 97 non-coronary artery bypass graft operations (50% vs 1%). CONCLUSIONS: Although the risk of coronary artery bypass grafting deserves further study, noncardiac surgery carries an acceptable operative risk in patients with severe chronic obstructive pulmonary disease.

Correlates of successful hearing aid use in older adults.

OBJECTIVE: To evaluate whether age, education, functional handicap, degree of hearing loss, amount of hearing and speech recognition gain achieved with hearing aid, locus of control, visual acuity, manual dexterity, number of comorbid diseases, and number of medications predict which elderly individuals with hearing loss are likely to benefit from hearing aids. DESIGN: A logistic regression prediction model for hearing aid benefit was developed on a training set of 89 individuals and verified in a test set of 87 individuals. Hearing aid success was assessed 4 mo after hearing aid adminstration. It was defined by assessing hearing aid satisfaction, functional handicap change post-hearing aid, and number of hours of weekly hearing aid use. SETTING: All patients were elderly male veterans from the Audie L. Murphy Memorial Veterans Hospital. There were no differences in demographic or clinical characteristics in training versus test set individuals. RESULTS: Several variables, including baseline perceived functional handicap, education, number of medications, and age correlated with individual success measures. However, no variables consistently correlated with all success measures. The accuracy of prediction rules for success utilizing the variables ranged from 75 to 88% in the training set, and 54 to 84% in the test set. CONCLUSION: Although certain baseline factors were statistically significantly related to individual measures of successful hearing aid use, no factors were good enough to consistently differentiate successful from unsuccessful hearing aid candidates.

The impact of physical therapy on nursing home patient outcomes.

The objective of this retrospective study was to assess the intensity and outcome of individual components of interdisciplinary care, including physical therapy, in a teaching nursing home. Two independent reviewers abstracted records from 90 consecutive patients admitted to the nursing home. They rated intensity and outcome of each program component using a structured, standardized data-abstraction form. Program components were physical therapy, speech therapy, psychosocial therapy, medication adjustment, and other medical and nursing care. Physical therapy and medication adjustment were the most frequently received therapies. Eighty-eight percent of the patients receiving high-intensity physical therapy and 33% of the patients receiving moderate-intensity physical therapy improved. For medication adjustment, 93% and 72% of the high- and moderate-intensity groups, respectively, improved. In univariate analyses, physical therapy intensity and age were associated with improvement. Baseline function in activities of daily living and cognitive function were not associated with physical therapy outcome. A stepwise multiple logistic regression analysis revealed that only therapy intensity was associated with improved outcome. We conclude that physical therapy was efficacious for patients receiving high-intensity treatment. Advanced age, activities-of-daily-living status, and cognitive impairment were not associated with poor physical therapy outcome.

Estimating and testing an index of responsiveness and the relationship of the index to power.

Responsiveness has been proposed as a criterion, in addition to reliability and validity, to evaluate instruments that measure quality of life or functional status. The responsiveness index measures the change in a quality of life score due to a treatment relative to the variability of changes in that score within a stable control group. We derive the expected value, variance and distribution of the responsiveness index and give a large sample distribution for comparing the responsiveness of two different instruments. We also give the relationship between the responsiveness index and the power of a test of treatment effect.

The J-curve phenomenon and the treatment of hypertension. Is there a point beyond which pressure reduction is dangerous?

We critically appraised the medical literature to evaluate whether there is a point beyond which blood pressure reduction in hypertensive subjects is no longer beneficial and possibly even deleterious. Thirteen studies that stratified cardiovascular outcomes by level of achieved blood pressure in treated hypertensive subjects who had been followed up for at least 1 year were critiqued by four independent reviewers. Data addressing population, protocol, and methodological characteristics were evaluated. Studies did not show a consistent J-shaped relationship between treated blood pressure and stroke, but they did demonstrate a consistent J-shaped relationship for cardiac events and diastolic blood pressure. The beneficial therapeutic threshold point was 85 mm Hg. We conclude that low treated diastolic blood pressure levels, ie, below 85 mm Hg, are associated with increased risk of cardiac events.