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The purpose of this study was to evaluate the efficacy of art electric feeder, a device designed to increase independence in self-feeding tasks for persons with physical disabilities. This study used a single-subject research design across 4 subjects and two settings. Variables measured were the length of the meal, the amount of physical assistance needed, and the percentage of the meal eaten. The subjects also answered a questionnaire concerning their satisfaction with the feeder. The results of the study indicated that the use of the electric feeder increased the length of the meal in some cases and decreased the percentage of food eaten in all cases. Two of the 4 subjects showed a clear decrease in the amount of staff time needed when using the feeder. All subjects stated that the feeder increased independence, but only 2 indicated they would use it on a regular basis.

The influence of SPECT over the detectability of SOL in the liver was evaluated by the Subcommittee on Efficacy Study, which belongs to Medical and Pharmaceutical Committee of Japan Radioisotope Association, under the participation of 9 hospitals including some university hospitals. In this study segmental reading of the SOL was requested. The film reading was performed twice on the different patient-groups and the results from well-experienced doctors (11 doctors) were summarized, indicating a slight increase in sensitivity as a whole although there were some doctors showing a reverse effect in each performance. Sensitivity was determined in the patient-group without SOL, which showed a slight decrease as a whole, indicating that SPECT had some possibility of increasing false positive cases. In the study of SOL detectability based on its segmental location, a marked positive effect of SPECT was noted in the right anterior and right posterior segments whereas a marked negative effect in the left lateral segment. The left medial segment also showed a slight decrease in the detectability of SOL.

Five healthy female volunteers were given the “morning-after” injection intramuscularly 1–4 days after midcycle LH peak. The medication consisted of 12.5 mg of estradiol-benzoate and 10 mg of estradiol-phenylpropionate. In both control and treatment cycles, ovulation was determined according to the pattern of urinary total estrogens and LH as well as the rise in basal body temperature. After the LH peak, daily plasma samples were obtained for protein binding assay of progesterone. Plasma progesterone levels were unchanged in two cases and slightly suppressed in another two, while in one case the effect of the medication was moderate. At the end of treatment cycles, endometrial biopsies were taken and histological evaluation revealed dissociation or pronounced local epithelial proliferation of the secretory endometrium in three of five cases observed. The pattern of postovulatory basal body temperature recordings remained unchanged. The length of the mentrual cycle was shortened by two days in one of the participants and by four days in another one. Menstrual patterns after the treatment cycles were unchanged. No side-effects were recorded. In the efficacy study of 150 volunteers, treated so far, a low frequency of side-effects was reported. Unfortunately, four pregnancies considered to be method-failures, were seen in these 150 cases.

The effectiveness of hospital social work preadmission screening and assessment is compared with postadmission screening and assessment. Outcome variables include length of stay, readmission rates, posthospital home management, resource attainment, and satisfaction with hospital services. The patients screened postadmission were assessed within forty-eight hours of admission, while the patients screened preadmission were assessed one to two weeks prior to admission. Telephone follow-up was conducted with both groups. Preadmission patients reported better home management and attained more resources. Patients' satisfaction with hospital care was inversely related to the need for more resources in the post-hospital period.

The results of studies are described which were designed to assess the efficacy, tolerance, and safety of tioconazole 2% cream administered once daily for 14 days in the treatment of vaginal candidiasis. One study was a double-blind comparison with vehicle cream and the other was an open efficacy study which additionally assessed the systemic absorption of tioconazole in 6 patients. In the double-blind study, 18 patients were treated with tioconazole and 17 with vehicle cream. In the tioconazole group, 12 of 17 patients (71%) were cured (complete clinical and mycologic resolution) at the 7-day review; at the end of treatment, 15 of 16 patients (94%) were cured, and at short-term follow-up (1 week after the end of treatment), 13 of 15 patients (87%) were cured. Of the latter 13 patients, 9 were reviewed at long-term follow-up and all (100%) remained cured. In the vehicle group, 4 of 17 patients (24%) were cured at the 7-day review; at the end of treatment only 3 of 6 patients (50%) were cured. At short-term follow-up, 2 of the 3 patients (67%) cured at the end of treatment remained cured. At long-term follow-up, 1 of the 2 cured at short-term follow-up was reviewed and she remained cured. In all, 13 of the 17 vehicle-treated patients were transferred to tioconazole treatment due to failure of the vehicle. Statistically, tioconazole treatment was significantly more effective than vehicle treatment. In the open part of this study, 11 of 11 patients were cured at the end of treatment. Follow-up reviews were not performed. A total of 6 patients took part in the study in which the systemic absorption of tioconazole was assessed. Bioassay of plasma samples revealed no detectable systemic absorption of tioconazole. No clinically relevant changes in laboratory test results were observed in either study. The creams were found to be generally acceptable in terms of ease of application, leakage from the vagina and staining of clothing.

Efficacy studies are important for the development of long-term cancer prevention strategies. Recruitment aims for a highly motivated group of participants. The Concerned Smoker Study is aimed at smokers with at least a 15 pack-year history and bronchial atypia on sputum sampling Recruitment has been primarily through use of the media. During the first year of randomization 905 potential participants expressed interest. Of these, 80 were eventually randomized. With over 60 participants having completed the study only one has defaulted and compliance with the study protocol has been high. Participants became aware of the study through the following sources: daily newspaper 36.6%, weekly newspaper 16.2%, television 14.9%, radio 13.8%, community television 1.3%, other sources 13.3%. Over 90% of potential participants who initially express interest in such a chemoprevention project may not ultimately be suitable. The population chosen for such studies may not be very representative of the more general population; however, a high degree of compliance can be obtained which will provide valuable information on treatment efficacy.

Background This study examined the safety, pharmacokinetics, and efficacy of transarterial chemoembolization of hepatocellular carcinoma (HCC) using a newly developed size of a superabsorbent polymer drug-eluting embolic material. Methods Forty-five patients with documented HCC (Child–Pugh score A/B: 55.5 %/44.5 %) were embolized with HepaSphere microspheres 30–60 μm with escalation of lesion, dose, and frequency of re-embolization. Local response was evaluated with modified response evaluation criteria in solid tumors (mRECIST). Plasma levels of doxorubicin were measured in 24 patients at baseline and at 5, 20, 40, 60, and 120 min, at 6, 24, and 48 h, and at 7 days, respectively, to determine doxorubicin in plasma (Cmax) and area under the curve (AUC). Measurements of three patients who underwent lipiodol-based conventional chemoembolization (c-TACE) were also performed. Results TACE with HepaSphere was well tolerated with an acceptable safety profile and no 30-day mortality. Response rates were calculated on intention-to-treat basis with complete response (CR) in 17.8 % reaching 22.2 % for the target lesion. Overall partial response (PR) was seen in 51.1 %, stable disease in 20 %, and progressive disease in 11.1 % of patients. Overall objective response (CR + PR), including patients treated at all dosages of doxorubicin, was seen in 68.9 % of cases. After a median follow-up of 15.6 months, 1-year survival is 100 %. Doxorubicin AUC was significantly lower in patients with HepaSphere 30–60 μm (35,195 ± 27,873 ng × min/ml) than in patients with conventional TACE (103,960 ± 16,652 ng × min/ml; p = 0.009). Cmax was also significantly lower with HepaSphere 30–60 μm (83.9 ± 32.1 ng/ml) compared with c-TACE (761.3 ± 58.8 ng/ml; p = 0.002). Conclusion HepaSphere 30–60 μm is an effective drug-eluting embolic material with a favourable pharmacokinetic profile.

Veterinary vaccines must be safe, pure, potent, and effective. Potency tests help ensure that each consistently manufactured batch of vaccine provides a level of protection as determined in the original efficacy study throughout the products shelf life. Currently approved assays range from host animal vaccination and challenge to the quantification of specific protective antigens using in vitro technology. The development, maintenance, and update of in vitro potency assays continue to be a priority for both the animal health industry and the corresponding regulatory agencies. New assay development emphasis is being placed on assays that currently involve laboratory animal vaccination/challenge such as vaccines containing the Leptospira and Clostridium spp. antigens. This paper provides an overview of various in vitro potency assays available, the factors that can impact the accuracy of these methods, and specific considerations to be taken into account during assay development.

Retrospective analysis of 1,020 conventional antegrade small-bowel examinations revealed that the variable which correlated most highly with abnormal radiographic findings was the clinical complex of history, physical examination, and laboratory data which prompted suspicion of small-bowel disease. Thirty indications of possible small-bowel disease were divided into groups carrying (a) a high suspicion and (b) a low suspicion of disease. Pertinent abnormalities were revealed by 14.2% of examinations in the high-suspicion group, compared with 4.9% in the low-suspicion group. The individual indications covered a spectrum of 0-34% abnormality. Overall, 9.7% of examinations (99/1,020) revealed abnormalities, but only 6.6% (67/1,020) were pertinent to the clinical problems. The authors conclude that the efficacy of the small-bowel series is directly dependent upon the reason(s) for which it is performed.

(1982). Physician/Patient acceptability and efficacy study of quibron-T/SR tablets in adult asthmatics. Journal of Asthma: Vol. 19, No. 3, pp. 163-169.

Selenium sulfide (2.5%) lotion applied daily for 10 minutes for 7 consecutive days was found to be an effective therapeutic agent, significantly superior to the vehicle, in a double-blind study in the treatment of tinea versicolor. Mild transitory contact dermatitis of the primary irritant type occurred in all the treatment groups and was apparently due to the detergent base.

Claims analysis and efficacy study are two new methods of evaluating medical services. In Manitoba, with a 1974 population of 1,053,382, approximately 100,000 patient-physician interfaces resulted in 16,594 barium enema examinations; 1,000 significant abnormalities were discovered, and the referring physician was unusually perceptive in predicting the likelihood of these abnormalities. It is estimated that a 10% reduction in the use of barium enemas could be achieved by referring physicians with no deterioration in the care of patients.

Thirty patients with advanced non-small cell bronchogenic carcinoma were treated with cis-platin, 75 mg/M2 weekly for three weeks, then every three weeks. Eighteen were ambulatory, 22 had distant metastases, 14 had prior irradiation, and none had prior chemotherapy. Ten patients (33%) had objective remissions lasting a median of three months. Responders lived a median of five months, compared to three months for nonresponders. Transient mild azotemia was noted in twelve patients. Cis-platin has definite but modest activity in non-small cell bronchogenic carcinoma.

The chest radiographs of asthmatic patients in an emergency room setting over a four-year period were reviewed. A total of 997 radiographs was reviewed; radiographic findings were compared with history and clinical data. In adults 2.2% of the radiographs were abnormal; in children 13%. It is concluded that a chest radiograph in adults in unnecessary unless the patient is unresponsive to bronchodilators and is being admitted to the hospital. In children, however, if rales and rhonchi are present, in addition to wheezing, a chest radiograph may be useful.

To the Editor.— The article by Fineberg et al (238:224, 1977) on an efficacy type study of computerized cranial tomography prompts me to point out that a large-scale study of the efficacy of diagnostic x-ray examination has been in progress since 1971 as an activity of the American College of Radiology (ACR) Committee on Efficacy Studies. Two of the ideas used by Fineberg were developed and pilot tested during 1971 to 1973 by Thornbury, Edwards, and Fryback at the University of Michigan for the ACR efficacy study: first, that efficacy should be defined as levels in a hierarchy and, second, that the impact of diagnostic test information on the physician's diagnostic opinion could be measured in terms of the physician's probability assessments of diagnoses. A final report on the first phase (efficacy 1, defined as diagnostic thinking efficacy or diagnostic efficacy) of the ACR efficacy study has been completed. Since

This single-subject research study with replication evaluated the effect of daily occupational therapy on the nutritive and nonnutritive sucking behaviors of three high-risk, premature infants. At the time of entrance into the study, the infants were 34 to 35 weeks old and were documented poor feeders. Treatment consisted of individual, multimodal sensory stimulation, with emphasis on proprioceptive and vestibular input, graded to the sensory needs of the infants. Movement components of the jaw and tongue during nutritive and nonnutritive sucking were measured during baseline and intervention phases to assess the infants’ sucking ability. A comparison of testing results revealed that during intervention the total sucking scores improved significantly for two of the three infants and that rapid changes occurred in the oral-motor function of all three infants. The results of the study suggest that occupational therapy can improve the rate of development of sucking in the premature neonate. However, future research needs to be done to isolate the specific techniques of treatment that produce positive changes.

The usefulness of routine overhead views in the double-contrast investigation of the stomach and duodenum was evaluated. In this series, overhead views missed 26% of the lesions diagnosed and diagnosed no lesion not also seen on spot films. The authors could thus find no indication for the routine use of overhead views. It is concluded that overhead projections add no information to the examination, are not cost-effective, and can be eliminated without detriment to the patient.

During the 12-month period primary throat, wound, and skin cultures, tentatively identified as B streptococci, were submitted by 10 different clinical laboratories for evaluation. A total of 692 beta-hemolytic streptococci were isolated from cultures submitted and examined in parallel by the fluorescent-antibody, precipitin, and bacitracin techniques. An evaluation of the specificity and sensitivity in conjunction with basic and personnel costs was determined for each method. The standard Lancefield precipitin method was established as the standard by which the bacitracin and flourescent antibody techniques were compared. With some variation depending on the commerical source of the disc, approximately 7% of the strains examined produced false reactions with the bacitracin disc. False-negative reactions were rarely noted by the group A fluorescent antibody technique (0.5%), but an appreciable number of other Lancefield groups (B, C, and G) were nonreactive with homologous conjugates.

As a result of the Kefauver-Harris amendments to the Federal Food, Drug, and Cosmetic Act of 1938, a new drug application can now be rejected not only when evidence is insufficient to establish its safety, but also if substantial proof is lacking to show that the drug will have the effect it purports or is represented to have under conditions of use recommended in the proposed labeling. In 1946, Hamilton (1) published a brief report advocating the addition of a table-spoonful of tannic acid to two quarts of barium to enhance the mucosal pattern in postevacuation films of the colon. Since that time tannic acid has been widely utilized by radiologists for this purpose. Numerous laudatory reports have appeared in the radiological literature attesting to the value of tannic acid or tannic acid preparations. In spite of the many reports praising tannic acid, there were, in fact, no statistically valid large-scale objective studies comparing its utilization in enemas with that of a placebo. In considering the d...

Background: The EVIDENCE (EVidence of Interferon Dose-response: European North American Comparative Efficacy) study was an international, randomized, open-label, assessor-blinded, parallel-group study assessing the efficacy and tolerability of interferon (IFN) beta-1a, 44 mcg subcutaneously (sc) three times weekly (tiw), and IFN beta-1a, 30 mcg intramuscularly (im) once weekly (qw), in patients with relapsing-remitting multiple sclerosis (RRMS). The aim of this analysis was to assess whether reductions in T2 burden of disease (BOD) were greater for patients receiving IFN beta-1a, 44 mcg sc tiw, than for those treated with IFN beta-1a, 30 mcg im qw, and to assess the impact of neutralizing antibodies (NAbs). Methods: A post-hoc analysis was performed on magnetic resonance imaging (MRI) data collected prospectively from the EVIDENCE study. The analysis included all patients with evaluable T2 MRI scans at the start of dosing and at week 48, and those who received at least one drug dose (n = 553). Lesions were identified by a radiologist blinded to treatment codes and the total volume of T2 lesions (BOD) was reported in mm3. Results: Both median percentage decreases and absolute reduction in BOD were greater in the IFN beta-1a, 44 mcg sc tiw, treatment group. The adjusted mean treatment difference in percentage change in BOD from baseline to week 48 showed a significant treatment benefit for patients treated with IFN beta-1a, 44 mcg sc tiw, over those treated with IFN beta-1a, 30 mcg im qw (-4.6%; standard error: 2.6%; p = 0.002). The presence of NAbs reduced the effect of IFN beta-1a 44, mcg sc tiw, on BOD, but BOD changes were still similar to those seen with IFN beta-1a, 30 mcg im qw. Conclusion: Patients with RRMS treated with IFN beta-1a, 44 mcg sc tiw, had greater reduction in T2 BOD after 48 weeks than those treated with IFN beta-1a, 30 mcg im qw, which is consistent with other clinical and MRI outcome measures in the EVIDENCE study. In patients testing positive for NAbs (NAb+) to IFN beta-1a 44 mcg sc tiw, changes in BOD were smaller than in NAb negative (NAb-) patients, but similar to those receiving IFN beta-1a, 30 mcg im qw.

Introduction The diagnosis, management, and treatment for hepatitis C virus (HCV) infection (the “HCV care continuum”) have improved in recent years. People who use drugs (PWUD) have a prevalence of HCV infection from 30 to 70 %, yet rates of testing, engagement in care, and treatment for HCV are disproportionately low compared to other populations. Delineating the progression of PWUD through the steps in the HCV care continuum in the USA is important in informing efforts to improve HCV outcomes among PWUD. Methods/design Scientific databases will be searched using a comprehensive automated search strategy; gray literature and reference lists will be manually searched. Eligible reports will provide original research data related to the HCV care continuum in the USA including proportions of PWUD engaging in the following discrete steps: screening/testing, engagement in care (including receiving an HCV clinical assessment), treatment initiation and completion, and rates of those with successful HCV treatment. A quality-rating tool will be developed to ascertain the level of bias (including selection bias) in each report, and a quality score will be assigned to each eligible report. A tool adapted from the Pragmatic Explanatory Continuum Indicator Summary-2 instrument will be developed to assess the extent to which an included report reflects an effectiveness or efficacy study design. Pooled estimates and measures of association will be calculated using random effects models, and heterogeneity will be assessed at each stage of data synthesis. Discussion Through this review, we hope to quantify the proportion of PWUD at each progressive step and to help identify key individual, social, and structural points of leakage in the HCV care continuum for PWUD. In meeting these objectives, we will identify predictors to progress along the HCV care continuum, which can be used to inform policy to directly improve HCV care for PWUD. Systematic review registration PROSPERO CRD42016034113 Electronic supplementary material The online version of this article (doi:10.1186/s13643-016-0293-6) contains supplementary material, which is available to authorized users.

The only fluralaner-related conclusion presented in a study comparing the efficacy of fluralaner and sarolaner for control of the tick Amblyomma americanum on dogs is based on study times that are outside the label administration recommendations. Label recommendations for fluralaner treatment of A. americanum on dogs in the USA require re-administration at 56 days. This 56 day re-administration was not conducted in the study; therefore, all assessed time points following 56 days post-treatment in the study present comparisons that are not consistent with fluralaner administration recommendations. The only comparative time point assessed prior to 56 days showing a difference between treatments was at 42 days post-administration, a time point when methodological problems were identified by the investigators. Therefore, the only comparative study conclusion that a difference was shown between fluralaner and sarolaner beyond 6 weeks (42 days) after treatment is not based on recommended product use. Furthermore, if the study does not show that there is a difference between the treatments at times when the products are used as recommended, then there also can be no comparative discussion of the risk of tick-borne pathogen transmission risk between treatments.

To the Editor. —Hartman and Landau 1 compared "formal language therapy" with "supportive counseling" for aphasia. They did not test the efficacy of language treatment for aphasia. However, their comments and conclusions imply the authors believe they conducted an efficacy study, and, unfortunately, readers may infer that they did. Like most clinical trials, the Hartman and Landau effort contains some flaws. More importantly, their review of the literature contains major errors, and their conclusions are not supported by the results of the study they conducted. First, random assignment of "referred" patients to formal language therapy or supportive counseling does not yield "two randomly selected groups." The authors acknowledge that over 100 of the referred patients were rejected for a variety of reasons, and there were "at least as many very sick and very mildly affected patients who were not referred to us at all." It is appropriate to obtain samples from

The addition of 5 g of Clysodrast to a barium-enema mixture results in a higher yield of satisfactory postevacuation films than that obtained without it. Good or intermediate colonic emptying occurred in 95% of the patients, and most of the mucosa could be seen in 72%. However, there were still a significant number of cases in which a satisfactory postevacuation film was not obtained.

To the Editor.— Several aspects of the SPECIAL COMMUNICATION on "Drug Combinations: A Critique of Proposed New Federal Regulations," by F. Gilbert McMahon, MD, deserve comment, especially the statement at the end of the article ( 216 :1008, 1971) that regulations involving clinicians ought to be made with the advice of clinicians and not simply with that of armchair MDs on blue-ribbon committees. As a member of one of the three dermatology Panels of the Food and Drug Administration—Drug Efficacy Study, not only do I take exception to his statement about "armchair" MDs, but I really wonder where he got the information. The inference that private practitioners were not involved in the judgements regarding these hundreds of drugs studied by the Drug Efficacy Study would be refuted by a careful study of the committee members and their positions. The accurate way to determine the exact amount of time that each one

Background Imaging patients with a pacemaker (PM) or AICD has been mostly taboo in the MRI environment. However, with current improvements in PMlead and generator development along with very vigilant and knowledgeable personnel in pacemaker safety, MRI procedures can be implemented successfully. However, safe performance, not withstanding the risks, leads one to question if the results from the scans provide additional valuable clinical information to warrant such risk. Hypothesis: We propose that MRI imaging patients with a pacemaker can be crucial to establish clinical diagnosis. Methods A total of 25 patients were imaged on a GE CV/i Excite Version 12, 1.5 T system (GE, Milwaukee, WI). Three patients had an AICD, 4 patients had an AICD/PM 2 pts had a single PM lead and the remaining 16 pts had a dualchamber PM implantation. Each pt was performed in the dedicated Cardiac MRI Imaging Suite under the strict supervision of the Cardiologist. EP Lab personnel were present and reconfigured the PMor AICD into an appropriate asynchronous mode and/or with therapies under the guidance of the Cardiologist. The MRI scan sequences were selected such that the SAR level

s / Biol Blood Marrow Transplant 21 (2015) S185eS205 S199 or 4-hour pre-exposure to SAHA followed by washing then addition of [Clad+Gem+Bu] resulted in 40%, and 46% inhibition, respectively (P 1⁄4 0.005). These results underscore the importance of optimizing the sequence of drug exposure. Our results provide a basis for using [Clad+Gem+Bu] as a pre-transplant conditioning regimen for lymphoma patients undergoing HSCT, and further addition of an epigenetic modifier, such as SAHA, may play a role as a sensitizer to optimize the efficacy of the chemotherapy regimen.