Methodology and feasibility of a home-based examination in disabled older women: the Women's Health and Aging Study

BACKGROUND: To ascertain disease and functional capacity in community-resident disabled older women in the Women's Health and Aging Study (WHAS), a prospective investigation of the causes and course of disability, a home-based standardized physical examination and performance test battery were developed. Thirty-nine tests were administered, 9 by a lay interviewer and 30 by a nurse. This scope and intensity of testing had not been performed previously in a home environment or on such a functionally limited population. Thus, substantial developmental work was required. This report describes the administrative procedures and field experience for each exam component, highlighting innovations pertinent to home administration. METHODS: Exclusion criteria, safety issues, administration time, completion rates, and reasons for incomplete data are reported. Administration time is based on 30 exams conducted over a 3-week period 90% of the way through baseline data collection. Completion status was determined using all 1,002 participants and is categorized as follows: complete; partial; not done, health; not done, other; and refused. RESULTS: Seventy-two percent of the screened, eligible respondents completed the 30-min interviewer-administered physical assessment and the 2-hr, 10-min nurse examination. Classifiable data were obtained for 90% of participants on 36 examination items. Lower completion rates were obtained on the other three tests primarily due to exclusions for health-related conditions; environmental constraints and participant refusal were minimal. CONCLUSION: Extensive, research-oriented physical evaluation can be successfully and safely performed in a home setting. In future studies, home-based examination may be preferable, as participation in the WHAS examination substantially exceeded rates for clinic-based exams in similar populations.     

Role of hostility in women's health during midlife: A longitudinal study.

Relationships between hostility at ages 21, 27, 43, and 52 years old and general health at age 52 were investigated in a longitudinal sample of educated midlife women. Hostility was assessed at ages 21 and 27 using the Cook-Medley Hostility Scale (HO), and at all four test sessions using a California Psychological Inventory (CPI) derived hostility scale consisting of 33 CPI items that were either duplicates or close equivalents of HO items. Hostility at each age was negatively correlated with general health at age 52. Further analyses revealed that hostility at each age remained a significant health predictor at age 52 when possible mediator variables at age 43 (cigarette smoking, excessive alcohol intake, body mass index, negative life events, and social role satisfactions) were controlled. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

A study of the services provided by the women's health nurses in a Sydney Area Health Service

OBJECTIVES: To describe the client characteristics and nature of services provided by women's health nurses and to examine whether the goals set for the service are being met. DESIGN: A retrospective study of women's health nurse (WHN) records from 1987 to 1991. SETTING AND SUBJECTS: All women attending the women's health nurse in the Southern Sydney Area Health Service, 1987 to 1991. Older women and women of non English-speaking background are specific targets for this service. OUTCOME MEASURES: Pap test and breast self-examination practices were examined in relation to age and ethnic background. Use of general practitioner services was examined for all women attending the women's health nurse in 1991. RESULTS: Forty-five per cent of clients were aged over 50, and 29 per cent were from a non English-speaking background. Older women were more likely to return for subsequent visits to the women's health nurse. The practice of breast self-examination increased significantly between visits among all women. Forty-one per cent of women had not had a Pap test for at least three years, 93 per cent of these women were screened at their first visit. Eighty-seven per cent of women on their first visit and 86 per cent of women revisiting the women's health nurse had seen their general practitioner within the previous year. CONCLUSION: Women's health nurses are meeting the goals set for their service in relation to health promotion and the screening of women. Their services are perceived by their clients as complementary to those provided by their general practitioners.     

Initial effects of the grounding of the tanker Braer on health in Shetland. The Shetland Health Study Group

OBJECTIVE: To determine if the oil spillage from the tanker Braer had any immediate health effects on the exposed resident population. DESIGN: Cohort study with a comparison against controls, exposure status being assigned on the basis of geographical location. SETTING: Rural Shetland. SUBJECTS: All those resident on or after 5 January 1993 (day 0) within 4.5 km of the site of tanker's grounding. Controls matched for sex and age were drawn from a general practice list 95 km distant. OUTCOME MEASURES: Demographic details; smoking and alcohol consumption; perception of health and reported presence or absence of specific symptoms; peak expiratory flow; results of haematology, liver and renal function tests, and blood and urine toxicology. RESULTS: Of subjects contacted, 420 (66%) exposed people and 92 (68%) controls were studied; 56 non-attenders were surveyed. Principal health effects arose on days 1 and 2 and were headache, throat irritation, and itchy eyes. No significant differences between those exposed and controls were found for any of the biological markers. Toxicological studies did not show any exposures that are known to affect human health. CONCLUSIONS: The study confirmed the anecdotal reports of certain acute symptoms. No evidence of pulmonary, haematological, renal, or hepatic damage was detected at the population level. Toxicological samples from exposed people did not find levels known to affect human health. Further studies are required to ascertain whether there have been any long term effects on the population.     

Health stresses and depressive symptomatology in the elderly: The importance of health engagement control strategies.

The study presents cross-sectional (N=127) and longitudinal (n=111) analyses examining relations between health engagement control strategies (HECSs), depressive symptoms, and health stresses in elderly individuals. HECS was measured as people's behavioral and cognitive investments toward attaining health goals. HECS was related to low levels of depressive symptoms, particularly among people experiencing acute physical symptoms. Moreover, HECS predicted reduction of depressive symptoms over time, and depressive symptomatology predicted negative change in HECS. The findings show that active investments of HECSs significantly moderate the negative affective consequences of health threats. Individuals who are characterized by low levels of HECS and high levels of depressive symptoms may be at increased risk of accelerated decline in their physical and mental health. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Systemic lupus erythematosus in three ethnic groups: II. Features predictive of disease activity early in its course. LUMINA Study Group. Lupus in minority populations, nature versus nurture

OBJECTIVE: To determine the factors associated with disease activity in patients with recent-onset (< or =5 years) systemic lupus erythematosus (SLE) who were of Hispanic, African-American, or Caucasian ethnicity. METHODS: Incident and prevalent cases of SLE, as defined by the American College of Rheumatology criteria for SLE, among the 3 ethnic groups were identified in Alabama (The University of Alabama at Birmingham) and Texas (The University of Texas-Houston Health Science Center and The University of Texas Medical Branch at Galveston). Variables from the sociodemographic, clinical, immunologic, immunogenetic, behavioral, and psychological domains were obtained using validated instruments. Disease activity was ascertained with the Systemic Lupus Activity Measure (SLAM). Stepwise domain regressions with SLAM score as the dependent variable were performed. Final ethnic-specific and overall regression models were obtained by entering variables that were retained in the domain regressions. RESULTS: SLAM scores at study entry were higher in the African Americans (mean +/- SD 12.6 +/- 6.9) and Hispanics (11.0 +/- 6.2) than in the Caucasians (8.5 +/- 3.7) (P < or = 0.001). The final overall regression model (R2 = 28%) for higher SLAM score included the following variables: African-American ethnicity, lack of private health insurance, abrupt disease onset, presence of anti-Ro antibodies, absence of HLA-DRB1*0301, higher levels of helplessness, and abnormal illness-related behaviors. CONCLUSION: Socioeconomic, immunologic, immunogenetic, behavioral, and psychological variables were all predictive of disease activity early in the course of SLE, irrespective of ethnic group. However, there remain ethnic group differences in disease activity that were not explained by these factors.     

Use of low molecular weight heparin (dalteparin), once daily, for the treatment of deep vein thrombosis. A feasibility and health economic study in an outpatient setting. Swedish Venous Thrombosis Dalteparin Trial Group

OBJECTIVES: To test the safety and feasibility of treating deep vein thrombosis (DVT) in an outpatient setting, using the low molecular weight heparin dalteparin, to calculate the potential and actual cost reductions achievable as a result of such a treatment regimen. DESIGN: An open, nonrandomized, multicentre trial. SETTING: Fourteen hospitals in central Sweden. SUBJECTS: Ambulant patients, aged 18 years or older. with symptomatic DVT in the leg, diagnosed using phlebography or ultrasound (Duplex-Doppler). INTERVENTIONS: Dalteparin (Fragmin) at a fixed dose of 200 i.u. kg-1 body weight, was administered once daily subcutaneously for at least 4 consecutive days. Treatment with warfarin was initiated from the first day of dalteparin administration. Outpatient treatment was encouraged whenever possible Financial calculations were performed independently at two hospitals, giving an average cost for all actions. OUTCOME MEASURES: Increasing severity of symptoms (or thromboembolic recurrences during the 3-months follow-up period), pulmonary embolism (PE), bleeding events, and death during the initial phase and follow-up period. RESULTS: Of 434 patients, 35% and 64% were treated in hospital within 24 and 72 h, respectively, and thereafter as outpatients. The overall frequency of serious complications was 0.92% (exact 95% confidence interval, 0.25-2.35%) during the initial phase and one patient suffered a PE and three patients had a recurrent DVT during the follow-up period. A cost reduction of 2705529 Swedish crowns (34.5%) was achieved in this study compared with traditional in-patient treatment. CONCLUSIONS: Dalteparin, administered subcutaneously, once daily, for the initial treatment of DVT yields large cost reductions and is well tolerated and effective in an outpatient setting.     

Clinical trial enrollers vs. nonenrollers: the Cardiac Arrhythmia Suppression Trial (CAST) Recruitment and Enrollment Assessment in Clinical Trials (REACT) project

The Recruitment and Enrollment Assessment in Clinical Trials (REACT) was a National Heart, Lung, and Blood Institute (NHLBI)-sponsored substudy to the Cardiac Arrhythmia Suppression Trial (CAST). Two-hundred-sixty (260) patients who enrolled in CAST and 140 partially or fully eligible patients who did not enroll were compared across several parameters, including demographic variables, disease severity, psychosocial functioning, health beliefs, recruitment experience, and understanding of informed consent procedures used in CAST. Significant predictors of enrollment included several demographic variables (e.g., being male, not having medical insurance), episodes of ventricular tachycardia, and health beliefs (e.g., extra beats are harmful, a higher degree of general health concern). Enrollment was higher for those who read and understood the informed consent and those who were initially recruited after hospital discharge, particularly nondepressed patients. In the multivariate model, the key variables that emerged were the patient's reading of the informed consent form and the patient's lack of medical insurance. These results suggest that (1) the clinical trial staff's interaction with the patient and the time when recruitment is initiated contribute significantly to the decision to enroll; and (2) it may be a greater challenge to motivate patients to enroll in future clinical trials if health care reform improves access to medical insurance coverage. Some of the significant variables are modifiable, suggesting interventions that may increase enrollment rates in future trials.     

The Study of Health Assessment and Risk in Ethnic groups (SHARE): rationale and design. The SHARE Investigators

The Study of Health Assessment and Risk in Ethnic groups (SHARE) is a study to determine the risk factors for atherosclerosis among three ethnic populations in Canada. Three hundred and thirty South Asian Canadian, 320 Chinese Canadian and 320 European Canadian men and women between 35 and 75 years of age are being randomly sampled from communities in Hamilton and Toronto, Ontario and Edmonton, Alberta for assessment of conventional (i.e., smoking, dyslipidemia, diabetes and hypertension) and emerging (i.e., candidate genes for atherosclerosis, homocysteine, fibrinolytic parameters, neurohormones, glucose intolerance, markers of infection, socioeconomic status, psychosocial status and diet) cardiovascular disease risk factors. Subclinical atherosclerosis is measured by quantitative B-mode ultrasonography of the carotid arteries, and other objective measures of vascular disease are a 12-lead electrocardiogram, a two-dimensional echocardiogram, ankle to arm blood pressure ratio and urine microalbumin concentration. The relationship between the conventional and emerging risk factors, and atherosclerosis, vascular disease and markers of end-organ damage will be evaluated between and within ethnic groups.     

Significance of the BTA test in bladder cancer: a multicenter trial. BTA Study Group Japan

Complex regional pain syndrome (CRPS) is a progressive, chronic illness that is enigmatic because the mechanisms for its pathogenesis have yet to be determined. Syndromes synonymous with CRPS are reflex sympathetic dystrophy, reflex neurovascular dystrophy, causalgia, algoneurodystrophy, sympathetically maintained pain, clenched fist syndrome, and Sudek's syndrome. The diagnosis of CRPS is categorized into three stages: acute, dystrophic, and atrophic. CRPS is most often precipitated by peripheral trauma (crushing injuries, lacerations, fractures, sprains, burns, or surgery) to soft tissue or nerve complexes. The pathogenesis for CRPS has been speculated as being either a disease process of the peripheral nerves, a disease process of peripheral soft tissue, or a disease process of the spinal cord. Patients suffering from CRPS may be limited in their ability to function in a self-directed, independent fashion. A longitudinal study of CRPS on 1,348 patients revealed that 96% of the study subjects still suffer some pain and disability regardless of the duration of the disease or course of treatment. Although the primary etiology for CRPS is not clearly understood, key progress has been made in terms of establishing a psychological as well as therapeutic treatment plan once the diagnosis has been made.     

Reproducibility of drug efficacy predictions by Holter monitoring in the electrophysiologic study versus electrocardiographic monitoring (ESVEM) trial. ESVEM Investigators

The effect of a newly developed free radical scavenger (OPC-15161) on the progression of nephrotoxic serum (NTS) nephritis was evaluated. NTS nephritis rats were sacrificed immediately before and 1, 2, 3, 6, and 24 h and 13 and 19 days after intravenous injection of NTS. The tissue content of phosphatidylcholine hydroperoxide, the activity of superoxide, the activity of superoxide dismutase in the renal cortex, and the serum malondialdehyde levels were measured. The phosphatidylcholine hydroperoxide content in the renal cortex of OPC-15161-treated NTS nephritis rats was lower than that in the control rats 24 h after NTS injection. The activity of superoxide dismutase in OPC-15161-treated rats was sustained in contrast to the decrease in this activity in the control rats 6 h after injection of NTS. The effects of OPC-15161, dipyridamole, and prednisolone on NTS nephritis rats were investigated. OPC-15161 (20 mg/kg p.o.) showed a potent inhibitory effect on the urinary protein excretion, whereas dipyridamole (30 and 100 mg/kg p.o.) and prednisolone (2 mg/kg p.o.) had less suppressive effects. In view of these results, we conclude that OPC-15161 notably ameliorated the urinary protein excretion by way of the suppression of lipid peroxidation in the renal tissue of NTS nephritis rats.     

Five-year followup of a prospective trial of radical cystectomy and neoadjuvant chemotherapy: Nordic Cystectomy Trial I. The Nordic Cooperative Bladder Cancer Study Group

PURPOSE: Chemotherapy is widely used in patients with locally advanced bladder cancer but until now there has been no conclusive evidence that this therapy improves survival. The Nordic Cooperative Bladder Cancer Study Group conducted a randomized phase III study to assess the possible benefit of neoadjuvant chemotherapy in patients with bladder cancer undergoing radical cystectomy after short-term radiotherapy. MATERIALS AND METHODS: Our trial included 325 patients with locally advanced stage T1 grade 3 or stages T2 to T4aNXM0 bladder cancer allocated randomly into a chemotherapy or no chemotherapy group (control). The chemotherapy schedule consisted of 2 cycles of 70 mg./m.2 cisplatin and 30 mg./m.2 doxorubicin with a 3-week interval between the cycles. RESULTS: After 5 years the overall survival rate was 59% in the chemotherapy group and 51% in the control group (p = 0.1). The corresponding cancer specific survival rate was 64 and 54%, respectively. In regard to treatment, no difference was observed for stages T1 and T2 disease, while there was a 15% difference in overall survival for patients with stages T3 to T4a disease (p = 0.03). In a multivariate analysis only chemotherapy and T category emerged as independent prognostic factors. The relative death risk for patients who received chemotherapy was 0.69 (95% confidence interval 0.49 to 0.98) compared to the control group after adjustment for the other tested factors. CONCLUSIONS: Neoadjuvant chemotherapy seems to improve long-term survival after cystectomy in patients with stages T3 to T4a bladder carcinoma, while no survival benefit was found for stages T1 to T2 disease.     

Overview of the Activity Counseling Trial (ACT) intervention for promoting physical activity in primary health care settings. Activity Counseling Trial Research Group

Counseling by health care providers has the potential to increase physical activity in sedentary patients, yet few studies have tested interventions for physical activity counseling delivered in health care settings. The Activity Counseling Trial (ACT) is a 5-yr randomized clinical trial to evaluate the efficacy of two primary care, practice-based physical activity behavioral interventions relative to a standard care control condition. A total of 874 sedentary men and women, 35-75 yr of age, have been recruited from primary care physician offices at three clinical centers for 2 yr of participation. They were randomly assigned to one of three experimental conditions that vary, in a hierarchical fashion, by level of counseling intensity and resource requirements. The interventions, which are based on social cognitive theory and the transtheoretical model, are designed to alter empirically based psychosocial mediators that are known to be associated with physical activity. The present paper describes the theoretical background of the intervention, the intervention methods, and intervention training and quality control procedures.     

Intention-to-treat vs. on-treatment analyses of clinical trial data: experience from a study of pyrimethamine in the primary prophylaxis of toxoplasmosis in HIV-infected patients. ANRS 005/ACTG 154 Trial Group

Major advances have recently been made in photodynamic therapy (PDT) for clinical application, including the development of more powerful photosensitizers and light sources and suitable light applicators. PDT is emerging as an attractive new form of cancer therapy, suitable for treating superficial lesions (less than 1 cm in depth) and carcinoma in situ, or as an adjuvant to surgery for more bulky disease. PDT is therefore complementary to radiotherapy which is better suited to treating larger tumours. There are some qualitative similarities between light distribution in tissue during superficial illumination and ionizing radiation dose distributions during external beam irradiation, or between interstitial PDT and brachytherapy, although the geometric scale is very different (visible light penetrates a maximum of 5-10 mm in tissue). The contribution of scattered light to tissue irradiance is much greater than for ionizing radiation and in situ light dosimetry is very important (although rather complicated) to ensure adequate illumination without over-treating. Dosimetry and treatment planning are highly advanced for ionizing radiation and are routine in all radiotherapy departments. Proper in situ light dosimetry and dose distribution calculation for PDT is in its infancy. Physicists have an important role to play in the further optimization of clinical PDT and much of the infrastructure and expertise present in the radiotherapy department is ideally suited to accommodate PDT. In this review, parallels and contrasts are made between PDT and ionizing radiation for both mechanistic and dosimetric aspects of the therapies. A summary of the most interesting clinical applications is also given.     

SHould we emergently revascularize Occluded Coronaries for cardiogenic shocK: an international randomized trial of emergency PTCA/CABG-trial design. The SHOCK Trial Study Group

BACKGROUND: Cardiogenic shock (CS) is the leading cause of death in patients hospitalized with acute myocardial infarction (MI). Nonrandomized studies suggest reduced mortality rate with revascularization. TRIAL DESIGN: The SHOCK trial is a multicenter, randomized, and unblinded study with a Registry for trial-eligible and ineligible nonrandomized patients. The trial is testing the hypothesis that a direct invasive strategy of emergency revascularization for patients with cardiogenic shock complicating acute MI will reduce 30-day all-cause mortality rate by 20 absolute percentage points compared with initial medical stabilization. Eligibility criteria include development of CS within 36 hours of an acute transmural MI as evidenced by ST elevation or new left bundle branch block MI; clinical criteria for CS with hemodynamic confirmation; absence of a mechanical, iatrogenic, or other cause of shock; and enrollment within 12 hours of CS diagnosis. Patients randomly assigned to emergency revascularization immediately undergo coronary angiography, with percutaneous transluminal coronary angioplasty or coronary artery bypass grafting depending on the coronary anatomy. Patients assigned to initial medical stabilization may undergo revascularization >/=54 hours after randomization. END POINTS: The primary end point is all-cause 30-day mortality after randomization. Secondary end points include death at trial termination, changes in left ventricular dimensions and function measured by echocardiography at randomization and 2 weeks later, and changes in quality of life and physical functioning from 2 weeks after discharge to 6 months after MI.     

Short report: ramipril and hydrochlorothiazide combination therapy in hypertension: a clinical trial of factorial design. The East Germany Collaborative Trial Group

OBJECTIVE: To identify appropriate dosages of ramipril and hydrochlorothiazide (HCT) when given in combination once a day for the treatment of essential hypertension. DESIGN: A 2- or 4-week placebo run-in followed by 6-week, double-blind, parallel-group phase: 4 x 3 factorial (2.5, 5 and 10 mg ramipril; 12.5 and 25 mg HCT; all six combinations; placebo). SETTING: Office practice (21 centres). PATIENTS AND PARTICIPANTS: Patients with mild-to-moderate essential hypertension (World Health Organization stage I-II; supine diastolic blood pressure 100-115 mmHg in last 2 weeks of run-in): 581 enrolled, 534 randomly assigned to double-blind therapy and 517 completed. MAIN OUTCOME MEASURES: Reduction in supine and standing blood pressure. RESULTS: In pairwise comparisons, the combinations of 5 mg ramipril with 12.5 and 25 mg HCT and 10 mg ramipril with 12.5 mg HCT consistently produced significantly greater blood pressure reductions than their respective components. Response surface analyses were performed, and a stairstep model was constructed to characterize the shape of the dose-response surface. The combinations involving 5 and 10 mg ramipril with 12.5 and 25 mg HCT were again more effective than their components. Withdrawals and adverse effects were minimal for all treatments. A large drop in serum potassium was observed on 25 mg HCT, but not on combination therapy. Addition of ramipril appeared to reduce the hyperuricaemic effect of HCT. CONCLUSIONS: Several dosage combinations of ramipril plus HCT produced significantly greater blood pressure reductions than the monotherapies at the same dosages. Overall, the combination of 5 mg ramipril and 25 mg HCT gave the best mean reduction. Combination therapy with ramipril plus HCT was safe and effective for patients with mild-to-moderate essential hypertension.     

The Diabetes Atherosclerosis Intervention Study (DAIS): a study conducted in cooperation with the World Health Organization. The DAIS Project Group

The incidence of coronary artery disease is greatly increased in those with diabetes mellitus. The largest number of those who have coronary artery disease have non-insulin-dependent diabetes (NIDDM). Lipoprotein abnormalities have been identified among the several risk factors that could account for this increase in atherosclerosis. There have been many studies demonstrating that correction of dyslipoproteinaemias will reduce the risk of coronary disease in non-diabetic populations. Current advice to those with diabetes is based on extrapolations from such studies. However, the justification for this, and the treatment targets are unclear as there has been no direct test of the lipid hypothesis in diabetes. This paper describes the protocol of the first intervention trial designed to examine directly whether correcting dyslipoproteinaemia in men and women with NIDDM will reduce their coronary artery disease. The Diabetes Atherosclerosis Intervention Study (DAIS), is a multinational angiographic study using the 200 mg micronized form of fenofibrate in a double-blind, placebo-controlled protocol.     

Health and mental health in older adults: First steps in the study of a pedestrian complaint.

Investigated the relationship of self-reported foot problems to health, mental health, and functional mobility in 111 50–87 yr olds living in a multiethnic urban area. One-third of the respondents reported having problems with their feet. Analyses supported the prediction that foot complaints were significantly related to greater psychological distress and that for most individuals, this relationship was mediated by limited mobility. Specific psychological correlates were congruent with a picture of diminished sense of self-efficacy among those with foot problems. Results have implications for prevention and rehabilitation. (18 ref) (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Adjunctive daunorubicin in the treatment of proliferative vitreoretinopathy: results of a multicenter clinical trial. Daunomycin Study Group

PURPOSE: To assess the efficacy and safety of adjunctive daunorubicin during vitrectomy surgery in eyes with idiopathic proliferative vitreoretinopathy (PVR). METHODS: Two hundred eighty-six eyes (286 patients) with stage C2 (Retina Society Classification, 1983) or more advanced preoperative PVR in which surgery with silicone oil was planned were enrolled in a multicenter, prospective, randomized, controlled clinical trial. Standardized surgery plus adjunctive daunorubicin perfusion was compared with surgery alone. Outcomes assessed were retinal attachment without additional vitreoretinal surgery 6 months after standardized surgery, number of and time until vitreoretinal reoperations within 1 year of standardized surgery, and change in visual acuity 1 year after standardized surgery, evaluated by photodocumentation, number of reoperations, and measurement of best-corrected visual function. Outcomes were determined 6 months after operation and reevaluated after 1 year of follow-up. RESULTS: Six months after standardized surgery, complete retinal reattachment without additional vitreoretinal surgery was achieved in 62.7% (89/142) of eyes in the daunorubicin group vs 54.1% (73/135) in the control group (P = .07, one-sided). However, in the daunorubicin group, significantly fewer vitreoretinal reoperations were performed within 1 year postoperatively (P = .005, one-sided) to achieve the same overall 1-year retinal reattachment rate (80.2% [105/131] vs 81.8% [103/126]). The rate of patients with no vitreoretinal reoperations was 65.5% (95/145) in the daunorubicin group vs 53.9% (76/141) in the control group. There was no difference in the best-corrected visual acuity. No severe adverse effect related to daunorubicin was identified. CONCLUSIONS: Although the rate of anatomic success after 6 months failed to show significance, some benefit of the adjunctive treatment exists, especially a tendency toward increased rate of reattachment and a significant reduction in the number of reoperations. This shows that human PVR is amenable to pharmacologic treatment.