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PURPOSE: The purpose of this study was to compare elderly patients' satisfaction and oral health-related quality of life with mandibular two-implant overdentures and conventional dentures. MATERIALS AND METHODS: Sixty edentulous subjects aged 65 to 75 years were randomly assigned to two groups treated with maxillary conventional dentures and either a mandibular conventional denture (n = 30) or an overdenture supported by two implants with ball retainers (n = 30). Subjects rated their general satisfaction, as well as other features of their dentures (comfort, stability, ability to chew, speech, esthetics, and cleaning ability), prior to treatment and 2 months postdelivery. Changes in ratings on the original Oral Health Impact Profile (OHIP) and its short form (OHIP-EDENT) were also used as indicators of oral health-related quality of life. RESULTS: The primary outcome of this study, ratings of general satisfaction 2 months postdelivery, was significantly better in the group treated with mandibular two-implant overdentures (P = .001). In addition, the implant group gave significantly higher ratings on comfort, stability, and ability to chew. Furthermore, using OHIP-EDENT, subjects who received mandibular two-implant overdentures had significantly fewer oral health-related quality of life problems than did the conventional group. CONCLUSION: These short-term results suggest that mandibular two-implant overdentures combined with maxillary conventional dentures provide better function and oral health-related quality of life than conventional dentures. [ABSTRACT FROM AUTHOR]

Abstract Background Previous interventions to increase physical activity and reduce cardiovascular risk factors have been targeted at individuals with established disease; less attention has been given to intervention among individuals with high risk for disease nor has there been determination of the influence of setting in which the intervention is provided. In particular, family practice represents an ideal setting for the provision and long-term maintenance of lifestyle interventions for patients at risk (ie high-normal blood pressure or impaired glucose tolerance). Methods/design The Staged Nutrition and Activity Counseling (SNAC) study is a randomized clustered design clinical trial that will investigate the effectiveness and efficacy of a multi-component lifestyle intervention on cardiovascular disease risk factors and vascular function in patients at risk in primary care. Patients will be randomized by practice to either a standard of care lifestyle intervention or a behaviourally-based, matched prescriptive physical activity and diet change program. The primary goal is to increase physical activity and improve dietary intake according to Canada's Guides to Physical Activity Healthy Eating over 24 months. The primary intention to treat analysis will compare behavioral, physiological and metabolic outcomes at 6, 12 and 24 months post-randomization including estimation of incident hypertension and/or diabetes. Discussion The design features of our trial, and the practical problems (and solutions) associated with implementing these design features, particularly those that result in potential delay between recruitment, baseline data collection, randomization, intervention, and assessment will be discussed. Results of the SNAC trial will provide scientific rationale for the implementation of this lifestyle intervention in primary care. Trial registration ISRCTN: ISRCTN:42921300

Abstract Background Most research pertaining to childhood obesity has assessed the effectiveness of preventative interventions, while relatively little has been done to advance knowledge in the treatment of obesity. Thus, a 4-week family- and group-based intervention utilizing group dynamics strategies designed to increase cohesion was implemented to influence the lifestyles and physical activity levels of obese children. Methods/Design This paper provides an overview of the rationale for and implementation of the intervention for obese children and their families. Objectives of the intervention included the modification of health behaviors and cohesion levels through the use of group dynamics strategies. To date, a total of 15 children (7 boys and 8 girls, mean age = 10.5) and their families have completed the intervention (during the month of August 2008). Physiological and psychological outcomes were assessed throughout the 4-week intervention and at 3-, 6-, and 12-month follow-up periods. Discussion It is believed that the information provided will help researchers and health professionals develop similar obesity treatment interventions through the use of evidence-based group dynamics strategies. There is also a need for continued research in this area, and it is our hope that the Children's Health and Activity Modification Program (C.H.A.M.P.) will provide a strong base from which others may build.

Background: To determine the iatrogenic risk factors for cytomegalovirus (CMV) retinitis in patients with the acquired immunodeficiency syndrome (AIDS)., Methods: The case-control study included 120 patients with CMV retinitis and 159 patients without CMV retinitis, all of whom had AIDS and CD4 counts less than 50 cells/microL at the time of diagnosis of retinitis or at the defined corresponding date in the controls. Iatrogenic risk factors studied were corticosteroid use, treatment with chemotherapy, treatment with radiotherapy, and blood transfusions., Results: Among the risk factors studied, only steroid use was predictive of CMV retinitis (odds ratio 6.41, 95% confidence interval 2.35-17.51). Based on this study, the use of steroids systemically elevated the risk of CMV retinitis.

Background: Very few studies have investigated risk factors for cytomegalovirus (CMV) retinitis. Identifying these risk factors will have many benefits, including helping establish screening regimens, examination frequency regimens, and targeted prophylaxis with oral therapy with valganciclovir or other anti-CMV agents. The purpose of this study was to determine the laboratory-based risk factors for CMV retinitis in patients with AIDS., Methods: We conducted a case-control study involving 120 patients in whom CMV retinitis had been diagnosed in 1990-99 and 159 patients without CMV retinitis from the same period. The sampling was from a primary study base in eastern Ontario and western Quebec of patients with AIDS and CD4 counts less than 50 cells/microL at the time of diagnosis of retinitis in the case subjects or an analogous date for the control subjects. There were two components to the study. In the first component (n = 279) we examined standard-of-care laboratory tests (hematologic and nutrition variables) done during the study period. In the second component (n = 57), which was a subset of the first, we examined laboratory tests (HLA type, qualitative and quantitative CMV polymerase chain reaction [PCR] and HIV load) on stored blood samples from the eastern Ontario site. Multivariate logistic regression was used to model the data and control for confounding. We developed a systematic model-building strategy, from assumption testing to model building to model checking., Results: A low hemoglobin concentration was a statistically significant predictor of CMV retinitis (odds ratio [OR] 0.96, 95% confidence interval [CI] 0.94-0.98). Both qualitative CMV PCR (OR 21.71, 95% CI 1.80-261.67) and quantitative CMV PCR (OR 33.03,95% CI 2.32-469.39) were strong predictors of CMV retinitis. Among the 80 HLA types tested, HLA-Bw4 (OR 11.68, 95% CI 1.29-105.82) and HLA-DRB115 (OR 9.34, 95% CI 1.14-76.41) were significant predictors of CMV retinitis, whereas HLA-Cw7 was protective against CMV retinitis (OR 0.09, 95% CI 0.01-0.67)., Interpretation: We have identified laboratory variables that elevate (or decrease) the risk of CMV retinitis. These findings may be useful to clinicians and health policy experts in developing rational guidelines for screening, examination frequency and targeted prophylaxis for patients with AIDS.

Purpose: To determine the clinical risk factors for cytomegalovirus (CMV) retinitis in patients with AIDS., Design: A case-control study., Participants: The study included 120 patients in whom CMV retinitis had been diagnosed from 1990 through 1999 (cases) and 159 patients without CMV retinitis from the same period (controls). All individuals had AIDS and CD4 counts less than 50 cells/microl at the time of diagnosis of retinitis in the cases or on the corresponding date for the controls., Methods: Clinical risk factors were determined by history or physical examination. Confounders controlled for included CD4 count, hospital center, and a series of variables to control for confounding by drug treatment. Statistical analysis was performed by multivariate logistic regression. A systematic model-building strategy was developed from assumption testing to model building to model checking. MAIN VARIABLES MEASURED: Presence of visual symptoms, retinal microinfarctions (cotton-wool spots), history of opportunistic infections, and risk factors for human immunodeficiency virus acquisition were determined and compared in both groups., Results: The following clinical risk factors were significant predictors of CMV retinitis: flashing lights or floaters (odds ratio [OR], 11.42; 95% confidence interval [CI], 3.43 to 38.01), cotton-wool spots (OR, 2.90; 95% CI, 1.01 to 8.29), number of previous opportunistic infections (OR, 1.81; 95% CI, 1.24 to 2.64), previous nonocular CMV infection (OR, 82.99; 95% CI, 6.86 to 1004.58), previous Mycobacterium infection (OR, 3.41; 95% CI, 0.99 to 11.85), and homosexuality (OR, 2.83; 95% CI, 1.13 to 7.12)., Conclusions: Based on this study, clinical variables have been identified that elevate the risk of CMV retinitis. These findings may be useful to clinicians and health policy experts in developing rational guidelines for screening, examination frequency, and targeted prophylaxis for CMV retinitis in patients with AIDS.

Objective: To evaluate the effectiveness of a new intensive functional rehabilitation (IFR) program on functional ability and quality of life (QOL) in persons who underwent a first total knee arthroplasty (TKA)., Design: Randomized controlled trial., Setting: Ambulatory care., Participants: Seventy-seven people with knee osteoarthritis., Intervention: Two months after TKA, subjects were randomly assigned to either a group with IFR (n=38), who received 12 supervised rehabilitation sessions combined with exercises at home between months 2 and 4 after TKA, or to a control group (n=39), who received standard care. All participants were evaluated by a blind evaluator at baseline (2mo after TKA), immediately after IFR (2mo later; POST1), and 2 and 8 months later (POST2 and POST3). Main outcome measures The primary outcome measure with respect to effectiveness was the 6-minute walk test (6MWT) at POST2. Secondary outcome measures were the 6MWT at the other evaluations and the Western Ontario and McMaster Universities Osteoarthritis Index and Medical Outcomes Study 36-Item Short-Form Health Survey., Results: Subjects in the IFR group walked longer distances (range, 23-26m) in 6 minutes at the 3 POST evaluations than subjects in the control group. At POST1 and POST2, they also had less pain, stiffness, and difficulty in performing daily activities. Positive changes in QOL in favor of the IFR were found only at POST2., Conclusions: The IFR was effective in improving the short-term and mid-term functional ability after uncomplicated primary TKA. The magnitude of the IFR effect on the primary outcome was modest but consistent. More intensive rehabilitation should be promoted in the subacute recovery period after TKA, to optimize functional outcomes in the first year after surgery.

Introduction and Objective: The purpose of this study was to evaluate the cost-effectiveness of surgery versus collagen injection to treat female stress urinary incontinence after the failure of initial surgical treatment. The analysis was conducted from the health care system perspectives of Ontario and Quebec., Materials and Methods: A decision-tree was constructed to compare each of three surgeries (i.e., retropubic suspension, transvaginal suspension, sling procedures) with collagen. An average cost estimate was generated for each intervention, as was an incremental cost-effectiveness ratio for each surgery-collagen comparison., Results: In both Ontario and Quebec, the treatment with the lowest average cost was collagen (Ontario: collagen = 2695 dollars; Quebec: collagen = 2718 dollars). However, the surgeries had higher probabilities of success (defined as 'cure' - no urine leakage during follow-up examinations), with point estimates of at least.79 (.53 for collagen). Incremental cost-effectiveness ratios for the base case analyses of all treatment comparisons indicated that the cost to cure an additional patient with surgery could range from 1824 dollars to 6814 dollars in Ontario and 1388 dollars to 3008 dollars in Quebec. These ratios were sensitive to changes in the mean number of injections for collagen patients and to a reduction in the length of hospital stay for surgery to 1 day., Conclusions: Collagen injection may be cost-effective as a follow-up treatment to initial surgical failure in both Ontario and Quebec when the number of injections is kept to a minimum and hospital stays after surgery are relatively lengthy. Otherwise, surgery may be cost-effective.

Purpose: Eliciting physician efficacy requirements for utilizing medical treatments can be a useful means of helping plan a clinical trial. Efficacy requirements were studied for female stress urinary incontinence, where an experimental treatment (collagen injection) was compared to the standard therapy (surgery)., Methods: A self-administered questionnaire was sent to 223 North American urologists, gynecologists, and urogynecologists. An interviewer also administered a similar questionnaire to 20 other clinician-specialists., Results: The response rate for the self-administered questionnaire was 48.4% (108/223). All 20 clinician-specialists who were approached for an interview consented. On average, respondents to the self-administered questionnaire indicated they would consider using collagen as the first line treatment if the absolute reduction in efficacy of collagen versus surgery was no larger than 23%. The corresponding result for the interview-questionnaire was 22%. Efficacy was measured as patient satisfaction with treatment. In the opinion of the physicians, surgery would remain the standard therapy if the reduction was greater than 34% (self-administered questionnaire), or 37% (interviewer-administered questionnaire)., Conclusions: The elicitation of physician efficacy requirements provides an idea of the treatment effect that would be needed for a clinical trial to have an impact on medical practice. These requirements can be used to calculate a relevant sample size.

Background: The presence of WBCs in RBCs is thought to be associated with a number of significant adverse effects in recipients. In adults, WBC reduction has been shown to reduce the frequency of HLA alloimmunization, CMV and HTLV infections, and febrile nonhemolytic transfusion reactions. However, neonates are unique, given that they have an immature immune system and are frequently transfused with RBCs. Thus, the aims of this systematic review were to determine whether WBC reduction of RBCs transfused to neonates decreases the transmission of CMV, reduces the ability to develop HLA antibodies, or reduces the risk of immunomodulation. In addition, nosocomial infection, mortality, and duration of stay were identified and analyzed., Study Design and Methods: All studies of WBC reduction were identified by a systematic review of the literature. Studies meeting the inclusion criteria were grouped based on study outcome. Where appropriate, studies were pooled to obtain an overall measure of effect., Results: Nine eligible studies were identified from the systematic literature search, and six were deemed evaluable. Two studies evaluated WBC reduction and the development of CMV, with different results. The pooled OR was 0.19 (95% Cl, 0.01-3.41), suggesting a clinical but nonsignificant effect. Two studies evaluated WBC reduction and HLA antibody development. As with CMV, the two studies were not congruent in their results. The pooled OR was 0.17 (95% Cl, 0.01-2.43). As for immunomodulation, two small studies presented evidence of a statistically significant change in lymphocyte subsets. No studies were identified with a primary objective of evaluating the impact of WBC reduction on nosocomial infection, mortality, or duration of stay., Conclusion: Current evidence suggests that WBC reduction may be effective in neonates; however, further studies are needed. The lack of convincing data and the significant cost of WBC reduction mandate evaluations to determine the clinical and economic impact.

In contrast to attempts that have been made to measure the clarity of reporting of the methods of clinical trials in journal articles, we report here an attempt to measure the accuracy of methods reporting. We focus in this article on eligibility criteria as a test case for the reporting of clinical trial methods. We examined the reporting of eligibility criteria in the protocol, methods paper (if applicable), journal article, and Clinical Alert for articles appearing in print between January 1988 and September 1994 for which a Clinical Alert had been issued. Eligibility criteria were further classified into five categories in order to examine the content of information loss, if any. On average, 82% of protocol eligibility criteria were reported in methods papers. Journal articles and Clinical Alerts fared somewhat worse: 63% of criteria were reported in journal articles, 19% in Clinical Alerts. In all three categories of medical communication, the reporting of criteria that defined the study disease tended to be complete; reporting of criteria relating to trial precision, patient safety, legal and ethical concerns, and administrative considerations, was not complete. We found that criteria for clinical trial eligibility are frequently under-reported in medical communications. Moreover, some of the criteria omitted are of considerable clinical importance. We suggest that in the design phase of clinical trials, proposed eligibility criteria be scrutinized closely. Those criteria that survive this scrutiny and that have clinical import must be reported upon fully and accurately when communicating trial results.

Several researchers have suggested that patients' preferences for a particular form of treatment should be taken into account in clinical trials. Preferences may influence the outcome of treatment, especially in trials when patients cannot be blinded to the type of treatment received and the outcome is based on patients' evaluations of therapy. Participants in this study were 136 edentulous patients who took part in a randomised controlled clinical trial comparing two types of treatments for edentulism: conventional dentures and implant-supported prostheses. Prior to receiving treatment, subjects were required to complete a questionnaire regarding their satisfaction with their present prostheses. In addition, they were asked to indicate which treatment they would prefer if given a choice. The objective of this study was to determine whether there are important differences among study participants between patients who have a treatment preference and those who do not. The effects of satisfaction with pre-treatment prostheses, age, gender and level of education on preferences were examined. Level of satisfaction with the original dentures and level of education were significant predictors of preference. Compared to subjects who rated their satisfaction with their current condition as 'low', the odds ratios associated with having a preference for implant treatment were 0.31 (95% CI: 0.09 to 0.96) for subjects who rated their prostheses in the 'medium' range and 0.11 (95% CI: 0.03 to 0.41) for those who rated in the 'high' range. In addition, subjects with high levels of education were significantly less likely to have a preference for either conventional or implant treatments (OR = 0.18, 95% CI: 0.02 to 0.77 and OR = 0.20, 95% CI: 0.05 to 0.76, respectively) compared to those with low education. Neither age nor gender was a significant predictor of preference. We suggest that study designs which incorporate patients' preferences must take into account possible differences between preference groups that might confound the relationship between preference and the outcome of interest.

We studied the relationship between smokers' sociodemographic characteristics, their smoking habit, health status, and the probability of their having been approached for recruitment in the smoking cessation trial performed in Turin, Italy, with the aim of gathering information on the role of selection criteria adopted by general practitioners (GPs) in offering anti-smoking counseling. The 965 smokers who were offered participation in the trial were matched to a sample of eligible smokers (n = 277), selected from the rosters of the 42 GPs collaborating in the trial, who had not been invited to participate. The probability of being offered enrollment, estimated through a multiple conditional logistic regression model, assuming the GP as the matching variable, was significantly increased for intermediate (10-19 cigarettes per day: odds ratio [OR] = 4.13; 95% confidence interval [CI]: 2.63-6.47) and heavy (20 cigarettes per day or more: OR = 10.12; 95% CI: 6.51-15.75) smokers, for smokers diagnosed with chronic cardiovascular (OR = 2.06; 95% CI: 1.19-3.58), or respiratory (OR = 2.50; 95% CI: 1.40-4.48) diseases, and for smokers mentioning an intermediate number (2-4) of past quit attempts (OR = 3.70; 95% CI: 2.18-6.28). General Practitioners focused their recruitment activity on higer-risk smokers or smokers who had tried to quit, to offer more clues for intervention. Assessing the potential public health benefit of preventive interventions requires a more systematic evaluation of the generalizability of the reported findings.

Background: The purpose of this study was, to identify predictors of quitting following general practitioners' (GP) anti-smoking counseling., Methods: We studied determinants (characterized following the Precede framework) of successful quitting (1 year sustained abstinence, biochemically confirmed at 6- and 12-month follow-up) among 861 smokers randomized to the intervention groups based on repeated counseling (RC), RC + spirometric testing, and RC + nicotine gum, in a smoking cessation trial carried out in Turin, Italy., Results: GPs' intervention worked best for male (OR = 2.30; 95% CI, 1.13-4.52) and married (OR = 3.63; 95% CI, 1.37-9.59) smokers, for smokers who had maintained abstinence for at least 1 month in the past (OR = 6.78; 95% CI, 1.56-29.52) or at their first quit attempt (OR = 10.91; 95% CI, 2.37-50.13), and for those who spontaneously reduced their coffee consumption (OR = 3.30; 95% CI, 1.59-6.82); heavy smokers (> = 20 cig/day OR = 0.48; 95% CI, 0.24-0.93) and those living with other smokers (> = 1 smokers in the household: OR = 0.44; 95% CI, 0.22-0.90) were less likely to give up. Previous antismoking advice by the GP represented a strong barrier to success for healthy smokers (OR = 0.19; 95% CI, 0.07-0.52), but not for those reporting symptoms of shortness of breath (OR = 0.63; 95% CI, 0.39-9.20). There were no interactions between predictors and treatment conditions., Conclusions: Assessment of factors influencing quitting would allow GPs to tailor their message to address existing barriers and to help patients utilize their resources for change.

Assuming that a drug is active and different from placebo, a patient's gain or loss is likely to depend on how much of the drug is taken and when. The present paper motivates the ethical imperative of statistical compliance analysis by considering important clinical questions, the advent of more precise compliance measuring instruments and new statistical efforts towards well understood analyses that seek to preserve scientific integrity. An extension of Efron and Feldman's approach is developed which exploits the randomization assumption in combination with structural models. It also generates more promising designs and alternative statistical approaches.

The role of nutritional status in the prognosis of subjects with severe chronic obstructive pulmonary disease was studied in a cohort of Canadian men and women followed for 3 to 5 yr. A total of 348 subjects who were recruited for a study of negative pressure ventilation were evaluated for lung function and body weight, and a subset who entered hospital for the study (n=184) had baseline measures of diffusing capacity, maximal inspiratory and expiratory mouth pressure (PImax and PEmax), and blood gases. Predictors of survival were analyzed using Cox regression models. In the total cohort, low body mass index (BMI) and use of home oxygen were independently associated with reduced survival. In the hospitalized group, predictors of respiratory mortality were elevated PaCO2 and low BMI, PImax, and diffusing capacity. PaO2 (measured on oxygen therapy), FEV1, PEmax, age, smoking behavior, and gender were not associated with survival. The predictors of total mortality were similar, except that BMI was no longer significant. In conclusion, low body weight, a potentially modifiable factor, was associated with respiratory mortality, but whether it has a casual effect or is a marker of declining health can only be resolved through an intervention trial.

The cytoplasm of hepatocytes in a liver biopsy from a patient with acquired immunodeficiency syndrome (AIDS) treated with sulfamethazole-trimethoprim contained concentric membranous bodies (CMB) and giant mitochondria. By light microscopy the general architecture of the liver was unaltered. By electron microscopy one to three CMB were present in random distribution within several cells in equal periportal and centrilobular localization. CMB were irregularly rounded or ovoid, loosely ribosome-studded lamellar whorls. Some were agranular or in parallel arrangement. Giant mitochondria often with paracrystalline inclusions were frequently in close association with CMB. Tubuloreticular inclusions were noted in Kupffer cell cytoplasm. Since CMB have been infrequently observed in human hepatocytes, are rare in nonneoplastic human liver, and have not been previously reported in association with AIDS, their appearance may relate to regenerative changes and/or sulfamethazole-trimethoprim therapy.

The renal glomerular mesangium in male, Swiss Webster mice, fed a diet containing 2.5 percent griseofulvin (GF), showed hypercellularity and mesangial thickening within three weeks. These changes gradually increased, peaking in prominence at 11 to 16 weeks and persisted up to 22 weeks. The tubular epithelium showed minimal light microscopic changes. There was focal hyperplasia of parietal cells of the Bowman's capsule. Ultrastructurally, the changes in the mesangial region of the glomeruli included increase in mesangial cells and mesangial matrix. The renal tubular epithelial cells showed dilatation of mitochondria and smooth endoplasmic reticulum. These changes, in addition to diverse cellular alterations in other organs previously reported, constitute the morphologic features of GF-induced renal disease.

The hypothesis that patients with chronic obstructive pulmonary disease (COPD) have chronic inspiratory muscle fatigue was tested in an effectiveness trial in which negative pressure ventilation (NPV) was used to produce inspiratory muscle rest. In a double-blind study 184 patients with severe COPD were randomly allocated active or sham NPV treatment for a 12-week period of home use. The distance walked in a 6 min walk test was the primary outcome variable. Secondary outcome measures were cycle exercise endurance time, severity of dyspnoea, quality of life, arterial blood gas tensions, and respiratory muscle strength. The percentage reduction in amplitude of the diaphragmatic electromyographic signal multiplied by hours of NPV was used to reflect the dose of NPV so we could examine dose-response relations. Analysis was based on intention to treat. We found no evidence of a clinically or statistically significant difference in any outcome measure between active and sham groups. No dose-response relation was observed. Moreover, the intervention was poorly accepted despite substantial clinical support. We conclude that NPV as used in this study is difficult to apply and ineffective when used with the aim of resting the respiratory muscles in patients with stable COPD.

The purpose of this study was to examine the effectiveness of different practice-based approaches to assist patients of primary care physicians to quit smoking and sustain cessation. Forty-four nonsmoking general practitioners volunteered for the study. After a period of training, they randomized 923 smoking clients, unselected for motivation toward quitting, to four different intervention groups: (i) minimal intervention, consisting of one single counselling session and a brief handout on quitting techniques; (ii) repeated counselling including reinforcing sessions at Months 1, 3, 6, and 9; (iii) repeated counselling and use of nicotine gum; and (iv) repeated counselling and spirometry. Biochemically validated smoking status was assessed at six and 12 months after recruitment. The proportion of verified quitters at 12 months was 4.8 percent among subjects randomized to the minimal intervention group, compared to 5.5 percent, 7.5 percent, and 6.5 percent among those randomized to the three repeated-counselling groups. In no treatment group was the outcome significantly different from that for one-time counselling at the (P less than 0.05) level. Lack of power, contamination, and low attendance at reinforcing sessions should be taken into account in interpreting the results.

This report documents the design and methods of a randomized clinical trial designed to test the effectiveness of home negative pressure ventilation in patients with severe chronic obstructive pulmonary disease. Active negative pressure ventilation was compared with a sham version of the treatment after a pre-trial assessment had indicated the feasibility of the latter. Over 1200 patients in the metropolitan Montreal area were screened. Of these, 348 patients were recruited to enter a 4-week stabilization period, and 184 were subsequently randomized to receive either active or sham negative pressure ventilation. A 5-day in-hospital period was used to train patients in ventilator use and obtain baseline measures of exercise capacity, lung function, respiratory symptoms, and quality of life. Home ventilation treatment took place during a following 12-week period. Respirator use was recorded both from patient logs and from concealed meters installed in the units. Patients received four home visits by physiotherapists during the 12-week period and returned for follow-up to the hospital 4 and 12 weeks post-discharge for reassessment.

We investigated the relation between outcome and sample size for six selected stroke outcome measures to assist investigators in selecting end points for stroke studies. Data from a clinical trial of 167 stroke patients assessed shortly after admission to the hospital and 5 weeks later provided information on clinical, motor, and functional outcomes measured using a neurologic status scale, a stroke severity scale, the Fugl-Meyer Scale, the Barthel Index, and the activities of daily living and cognition subscales of the Level of Rehabilitation Scale. Data were examined using Pearson correlation coefficients and power analyses. All measures were significantly correlated. There was also substantial congruency between the subscales of a measure and its total score. The measures had variable efficiencies; the Barthel Index was the most efficient and therefore required the fewest subjects to identify a significant effect. These data suggest that careful consideration must be given to the choice of stroke outcome measures in terms of their numbers, interrelationships, and statistical properties, as these factors have important implications for the design, analysis, and conduct of clinical stroke studies.

A randomized double-blind study was carried out comparing single daily dose phenobarbital plus antipyretic instruction to a placebo plus antipyretic instruction to prevent a recurrent seizure following an initial simple febrile seizure. Parents of 138 consecutive children presenting to an emergency room with a first simple febrile convulsion received verbal and written instructions about fever control. Seventy-nine then agreed to participate in this study. Children were randomized to receive either placebo with riboflavin tracer (n = 40) or phenobarbital 5 mg/kg in a single daily dose with a riboflavin tracer (n = 39) for 12 months or until another seizure occurred. Urine fluorescence for riboflavin was used to monitor compliance in all patients. Serum phenobarbital levels were obtained at each follow-up visit and averaged 1.4 mg/dl throughout the study. The significant difference (P less than 0.02) in the incidence of recurrent seizures between patients receiving phenobarbital (2/39) and those receiving placebo (10/40) suggests that a single daily dose of phenobarbital is more effective than counseling parents about antipyretic therapy in preventing recurrent seizures following an initial febrile seizure.

Rhodamine B fluorescence is presented as a simple, rapid, highly sensitive, permanent method for the histologic detection of squames in maternal amniotic fluid emboli and fetal lungs in cases of intrauterine asphyxia. The method may be used on alcohol fixed smears or formalin fixed paraffin sections. The application of this procedure allows for identification of sparsely distributed fetal squames which otherwise may be overlooked by less sensitive tinctorial methods which may also be more tedious in technical preparation and screening.

The authors tried to determine whether housestaff are systematically assigned clinic patients who are more "difficult": the elderly, the poor, those with many problems, and those who cannot speak English. This cross-sectional study was carried out in the outpatient department of a university health care insurance. A systematic sample of 1,870 patient visits to the medical clinic from 1980 to 1986 was studied. Housestaff were more likely to see patients who did not speak English, who had four or more medical problems, who had visited the clinic five or more times, who had been admitted to the hospital or emergency ward, or who had a skin problem. Multivariate analysis of these individual factors, allowing for the effect of each upon the others, showed that only previous hospital or emergency ward admission, native language, and skin disease retained a significant association with housestaff physicians. None of these factors was strongly associated with physician status, as shown by poor predictive accuracy when the multivariate models were used to predict accuracy when the multivariate models were used to predict physician status in 105 patient visits in 1987. While some factors were statistically associated with physician status, the magnitude of the effect of each was small. An explantation, other than bias in patient assignment, was usually apparent. It is possible to organize an outpatient clinic where housestaff care for patients who are similar to those seen by faculty.

Utilization of physician services by initial subscribers to a Canadian consumer-sponsored medical care plan was examined for the period 1965-1979. After stratification by sex and age, 1,046 individuals aged 18-44 years were sampled and their records abstracted to yield the annual number of in-plan physician visits. The most frequently attending 10% of patients generated almost 30% of all visits. Moreover, those who initially made most frequent use of physician services persisted in doing so over the 15-year period. Utilization patterns differed between the sexes. Women, with a median of 40 visits, made more frequent use of services than men, with a median of 27 visits. Among men, the group that was oldest at enrollment utilized services more heavily than their younger counterparts, and this increased relative utilization became more pronounced with time. Corresponding effects were not seen in women, even after adjustment for prenatal visits. Adjustment for prenatal visits also had only a minimal effect on the frequency and duration of nonattendance. Ascertainment of out-of-plan utilization indicated that for the most recent year of follow-up, 20% of the patients made at least one out-of-plan visit. Although this had little effect on patients' relative utilization status, it had a substantial effect on the identification of nonattenders.

Male Swiss Webster mice were fed a diet containing 2.5 percent griseofulvin (GF). Serially progressive light and electron microscopic hepatic altertions were present from one day on and grossly visible hepatomegaly from two weeks until termination at 22 weeks. GF induced liver changes included hepatocyte nuclear and cytoplasmic hypertrophy, increased incidence of necrosis and mitosis, Kupffer cell activation, bile duct proliferation and portal fibrosis. Protoporphyrin crystals were present in hepatocyte cytoplasm as early as one day after GF feeding. Hepatocellular hyalin was initially noted at seven weeks. Thereafter, the hyalin increased in prominence and frequency of occurrence. Ultrastructurally, three types of hyalin have been presently demonstrated to correspond to Mallory bodies (MB) reported in human liver disease. Forms intermediate in appearance between various MB types suggested transition from one to another. Areas of organelle free cytosol with abundant, loosely scattered filamentous elements as well as vesicular, smooth surfaced endoplasmic reticulum and ribosomes appeared preceding and closely associated with MB formation. Similarities of hepatocellular MB observed in GF fed mice and reported earlier in human alcoholic liver disease suggest a common pathway in its formation as a response to divergent noxious insults.

Soaking the exposed face of routine paraffin-processed tissue blocks from human autopsies in solutions containing either 60% ethyl alcohol-glycerol 9:1; glycerol-aniline 9:1; 5% aqueous phenol; 5% aqueous Photo-flo, or 10% aqueous ammonium hydroxide for 2--4 hours at 0--4 C resulted in greater ease of ribboning and overall improvement of slide quality in the majority of sections compared to the results with the same blocks soaked only in water at 0--4 C. The use of postembedding adjuvants, especially 10% aqueous ammonium hydroxide, presents a simple, convenient, inexpensive means of increasing section quality with routine as well as refractory paraffin-embedded tissue without sacrificing tissue adhesion, staining qualities or cellular detail.

The ultrastructure of hypertrophic nucleoli in large cells from each of 5 successive cases of non-Hodgkin's lymphoma (regardless of predominant cell type) showed irregularly rounded or ovoid, mostly compact forms with few scattered light spaces. Occasional nucleolonemal forms were noted. Few ring forms or transitional forms between ring and compact or nucleolonemal types were present. Granular components occupied 78.5 +/- 1.0% of the mean total area of 132 lymphoma large cell nucleoli of all configurations studied. Hypertrophic nucleoli in 27 phytohemagglutinin (PHA)-stimulated lymphocytes were predominantly nucleolonemal with 74.2 +/- 10.6% granular composition. The qualitative and quantitative distribution of nucleolar granular moieties did not vary significantly between individual cases of lymphoma nor quantitatively between these and nucleoli in PHA-stimulated lymphocytes. These observations lend further credence to the suggestion of the lymphocyte as a common progenitor cell type for the large B and T cell of malignant lymphomas. Some functional similarity of their nucleoli and those of PHA-stimulated lymphocytes in their participation in ribonucleic acid synthesis is implied. Generally compact nucleoli of lymphomas in contrast to nucleolonemal forms of PHA-stimulated lymphocytes may be pathognomonic for large lymphocytic cells undergoing neoplasia.

In assessing the quality of medical care, techniques were needed which can predict which patients are likely to have good or poor health outcomes. This study describes one way of identifying a subgroup of hypertensive patients whose diastolic blood pressures (DBP) are at high risk of remaining uncontrolled while under treatment. Medical care and patient variables were measured for 123 hypertensive medical clinic patients. Stepwise discriminant analysis identified a set of six variables which best distinguished between patients with well-controlled and uncontrolled DBP. When measurements of these variables were divided into high and low risk responses for uncontrolled DBP, the number of high risk variables was directly related to the proportion of patients with uncontrolled DBP. The variables also predicted DBP control among 63 patients in an entirely different medical care setting.

Using the format of a continuous case conference, the authors demonstrate that the therapist-presenter develops unconscious identifications with the patient which are especially intense when difficulties (resistances) arise which he cannot resolve. The presenter then enacts these identifications in the seminar giving rise to responses from the seminar members which repeat the difficulties of the therapy. These parallel processes can be made explicit by eliciting the empathic responses of the seminar participants. By interpreting these parallelisms the authors have evolved a teaching methodology which, like therapy itself, provides an emotionally based learning experience for the participants.

Cognitive and behavioral effects of phenobarbital in toddlers were assessed in a randomized, placebo-controlled study of patients who had had a febrile seizure. There were no significant differences in IQ (Binet or Bayley Scales) between placebo and phenobarbital groups after eight to 12 months of therapy. However, detrimental effects of phenobarbital were found in memory, for which serum level influenced scores, and in comprehension, in that length of treatment time affected performance. Hyperactivity was not seen. Behavioral changes, reported by parents, were increased fussiness and a characteristic disturbance of sleep. These changes varied in severity and were classified as transient, dose related, or unacceptable. After 12 months in the study, most parents could not distinguish between phenobarbital and placebo. Our data suggest that although most toddlers do not have major side effects from phenobarbital therapy when treated for a year, serum levels and length of time on phenobarbital should be kept at a minimum to reduce negative cognitive and behavioral effects.

Concentric membranous bodies (CMB) are described in the cytoplasm of hepatocytes in a liver biopsy from a patient with systemic lupus erythematosus (SLE). Histologically, the biopsy showed binucleated hepatocytes and rosette formation with lymphocytic infiltrates in portal fields. Hepatocyte cytoplasm showed focal fatty metamorphosis, focal staining for RNA with azure B at pH 4.0 (which was perchloric acid labile), diffuse alloxan-Schiff staining for protein, and PAS-positive, diastase-sensitive glycogen. By electron microscopy one to three CMB were present in 10-15% of hepatocytes. CMB appeared as concentric, "fingerprint" or parallel arrays of particle-studded, membranous profiles. Other membranous configurations included mazelike forms. The space of Disse was dilated. Bile ductular changes included basement membrane thickening and redoubling and luminal bulging of ductular epithelium devoid of microvilli. CMB have been rarely reported in human hepatoma and have not heretofore been observed in non-neoplastic human liver. Their appearance in hepatocytes in a patient with SLE may reflect an increase in protein synthesis during regeneration.

Intrahepatic bile ductules in male Swiss Webster mice, fed a diet containing 2.5 percent griseofulvin (GF), showed marked hypertrophy and hyperplasia within two weeks. Thereafter, this reaction gradually increased in prominence until nine weeks. Cytoplasmic acid phosphatase and succinic dehydrogenase deposits were more prominent and abundant after 12 to 14 weeks. Ultrastructural changes in ductular epithelial cells included enlargement of nuclei and nucleoli and increased abundance of cytoplasmic rough surfaced endoplasmic reticulum (RER), ribosomes and mitochondria until nine to 12 weeks. At this interval, duct lumina appeared widely dilated with small clumps of electron dense material at the periphery adjoining apical cell membranes with severely flattened or absent microvilli. Electron dense needle-like crystals resembling protoporphyrin were clustered centrally in the lumina. After twelve weeks occasional mitochondria were markedly swollen and contained vacuolated areas. Numerous multivesicular bodies were noted. Mallory bodies were seen in a few duct cells. The spectrum of duct cell changes just noted gives further evidence of extensive liver injury after GF feeding. These changes, in addition to diverse hepatocyte alterations previously reported, constitute morphologic features of GF induced murine porphyria, also common to human porphyria and human alcoholic liver disease.

During the winter of 1981-82 the City of Philadelphia operated an adult emergency shelter for two months. After reviewing the available records, the authors compiled a psychiatric profile of the 193 residents admitted to the shelter. They grouped the residents into three classes: habitual street people, the episodic homeless, and those who did not usually live on the street but were undergoing an acute crisis. Although a large number of the street people who suffered from diagnosable mental illness improved with adequate treatment, the authors found it was extremely difficult to relocate many of the shelter residents. They discuss other problems such as the need for psychiatric expertise in treating the homeless and the lack of coordinated effort among several city government departments.