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Biomedical subjects

S Hilton

Publications and source records attributed to S Hilton.

At least 55 records · Page 3Linked to original sources

Can practice nurses increase physical activity in the over 65s? Methodological considerations from a pilot study.

There is ample evidence of the benefits of exercise for older people. Less is known about the most effective strategies for promoting the participation of older people in exercise regimes. An approach whereby practice nurses used motivational interviewing, based on Prochaska and Di Clemente's model of behaviour change, was piloted in two general practices. The strategy appeared feasible and will be tested further in a large controlled trial.

Aged↗

Randomised trial of Haemophilus influenzae type-b tetanus protein conjugate vaccine [corrected] for prevention of pneumonia and meningitis in Gambian infants.

BACKGROUND: In developing countries, pneumonia and meningitis due to Haemophilus influenzae type b (Hib) are common in children under age 12 months and the mortality from meningitis is high. Protein-polysaccharide conjugate vaccines have brought Hib disease under control in industrialised countries. We did a double-blind randomised trial in The Gambia to assess the efficacy of a Hib conjugate vaccine for the prevention of meningitis, pneumonia, and other invasive diseases due to Hib. METHODS: Between March, 1993, and October, 1995, 42,848 infants were randomly allocated the conjugate vaccine Hib polysaccharide tetanus protein (PRP-T) mixed with diphtheria-tetanus-pertussis vaccine (DTP), or DTP alone at age 2 months, 3 months, and 4 months. Children who presented with signs of invasive Hib were investigated by blood culture and, where appropriate, by lumbar puncture, chest radiograph, or percutaneous lung aspirate. Children were followed up for between 5 and 36 months. FINDINGS: The median ages at which children received the study vaccine were 11 weeks, 18 weeks, and 24 weeks. 83% of children enrolled received all three doses of vaccine. 17 cases of culture-positive Hib pneumonia, 28 of Hib meningitis, and five of other forms of invasive Hib disease were detected amongst the study children. The efficacy of the vaccine for the prevention of all invasive disease after three doses was 95% (PRP-T vaccinees 1, controls 19 [95% CI 67-100]), for the prevention of Hib pneumonia after two or three doses, 100% (vaccinees 0, controls 10 [55-100]), and for the prevention of radiologically defined pneumonia at any time after enrollment, 21.1% (PRP-T vaccinees 198, controls 251 [4.6-34.9]). INTERPRETATION: PRP-T conjugate Hib vaccine prevented most cases of meningitis and pneumonia due to Hib in Gambian infants. The reduction in the overall incidence of radiologically defined pneumonia in PRP-T vaccinees suggests that about 20% of episodes of pneumonia in young Gambian children are due to Hib. The introduction of Hib vaccines into developing countries should substantially reduce childhood mortality due to pneumonia and meningitis.

Age Factors↗

Phase II trial of docetaxel in patients with advanced or metastatic transitional-cell carcinoma.

PURPOSE: A phase II trial of docetaxel was conducted to assess its efficacy and toxicity in patients with advanced transitional-cell carcinoma (TCC) who had failed to respond to prior cisplatin-based therapy. PATIENTS AND METHODS: Thirty assessable patients who had failed to respond to or relapsed after one prior cisplatin-containing regimen were treated with docetaxel 100 mg/m2 over 1 hour, every 21 days. All patients were premedicated with dexamethasone and diphenhydramine to reduce allergic reactions. Reductions of subsequent doses were made for severe hematologic toxicity. Prophylactic hematopoietic growth factors were not used. RESULTS: Four of 30 patients (13.3%; 95% confidence interval [CI], 3.8% to 30.7%) demonstrated a partial response (PR), with durations of response ranging from 3 to 8 months. The estimated median survival duration for all patients is 9 months (95% CI, 6 to 12 months) with a median follow-up time of 14 months (range, 1 to 27). Hematologic toxicity included anemia, thrombocytopenia, neutropenia, and febrile neutropenia. Nonhematologic toxicity included alopecia and mucositis. Fluid retention was not observed and cutaneous toxicity was mild and infrequent. Dose reductions were necessary for adverse events in 18 patients (60%). CONCLUSION: Docetaxel is an active single agent in previously treated patients with TCC of the urothelial tract. Therapy was well tolerated in this patient population but myelosuppression was frequent. Further study in previously untreated patients, both alone and in combination, is warranted.

Adult↗

Phase II randomized trial of gallium nitrate plus fluorouracil versus methotrexate, vinblastine, doxorubicin, and cisplatin in patients with advanced transitional-cell carcinoma.

PURPOSE: A phase II randomized trial of gallium nitrate/fluorouracil (5-FU) versus dose-intense methotrexate, vinblastine, doxorubicin, and cisplatin (M-VAC) was performed in poor-risk patients with advanced urothelial tract tumors. The efficacy and toxicity of these regimens were compared. Assessment of dose-intense M-VAC as salvage treatment in patients who failed to respond to the gallium nitrate/5-FU regimen was also performed. PATIENTS AND METHODS: Thirty-four patients who had not received prior systemic chemotherapy were randomized to either arm of the study. All patients had one or more clinical features predicting a low likelihood of durable complete response to standard chemotherapy, ie, weight loss, visceral metastases, and low performance status. Gallium nitrate and 5-FU were each administered by continuous 5-day infusions every 28 days. M-VAC was recycled every 21 days, with prophylactic recombinant human granulocyte colony-stimulating factor (rh-G-CSF). RESULTS: Two of 17 patients (12%; 95% confidence interval [CI], 1.4% to 36.4%) had a major response to gallium nitrate/5-FU. Sixteen of 17 patients treated with M-VAC (94%; 95% CI, 71.3% to 99.8%) demonstrated a major response. Five of 12 patients who failed to respond to the gallium nitrate/5-FU combination responded to M-VAC as second-line therapy (42%; 95% CI, 15.2% to 72.3%). Median survival for the gallium nitrate and 5-FU arm was 19 versus 17 months for the M-VAC arm, with a median follow-up duration of 35 months (range, 2 to 51) for all patients. Dose-intense M-VAC was associated with a greater incidence of neutropenia and thrombocytopenia. CONCLUSION: Dose-intense M-VAC is superior to gallium nitrate/5-FU in poor-risk patients (P < .0001). Despite the overall high response rate, the median survival for patients with M-VAC remained unsatisfactory. Similar survival distributions were observed for patients who received investigational therapy followed by cisplatin-based therapy and patients treated with initial cisplatin-based therapy.

Adult↗

CT detection of retroperitoneal lymph node metastases in patients with clinical stage I testicular nonseminomatous germ cell cancer: assessment of size and distribution criteria.

OBJECTIVE: Patients with nonseminomatous germ cell cancer of the testis with no evidence of metastatic disease after orchiectomy may be managed with either retroperitoneal lymph node dissection or surveillance. The present retrospective study was undertaken to determine the accuracy of CT for revealing retroperitoneal lymph node metastases in patients with newly diagnosed clinical stage 1 testicular nonseminomatous germ cell cancer of the testis when smaller size criteria (smaller than 10 mm) are applied and to test the hypothesis that CT-revealed anterior retroperitoneal lymph nodes are more likely to correlate with metastases than are posterior lymph nodes. MATERIALS AND METHODS: Abdominal CT scans obtained before surgery in 70 patients were reviewed by three observers who were unaware of the results of retroperitoneal lymphadenectomy. The sizes and sites of all lymph nodes measuring larger than or equal to 4 mm were recorded. Each CT scan was judged as positive or negative for retroperitoneal metastasis on the basis of the size of the largest measured lymph node at the expected metastatic site. Diameters of 4, 6, 8, and 10 mm were successively applied to each case as the criteria for a positive scan. RESULTS: Using a criterion of 10 mm or larger for metastases, we calculated a sensitivity of 37% and a specificity of 100%; with a 4-mm criterion, the sensitivity was 93% and the specificity was 58%. Receiver operating characteristic curves comparing the accuracy of CT for revealing similar-sized lymph nodes located anterior or posterior to a line bisecting the aorta differed significantly (p = .04) when the same criteria were applied to lymph nodes in both regions. CONCLUSION: False-negative rates were decreased from 63% using a size criterion of 10 mm to as low as 7% using a size criterion of 4 mm, with a corresponding decrease in specificity. Lymph nodes measuring larger than or equal to 4 mm, especially those located anterior to the mid portion of the aorta, should raise a suspicion of metastases.

Germinoma↗

Laparoscopic sonography of peripancreatic tumors: preliminary experience.

OBJECTIVE: This study was performed to evaluate the use of laparoscopic sonography in patients with suspected peripancreatic tumors and to assess the impact of laparoscopic sonography on patient management. SUBJECTS AND METHODS: In a prospective study, 24 patients with suspected pancreatic malignancy underwent CT, laparoscopy, and laparoscopic sonography. The pancreas, peripancreatic vasculature, liver, and porta hepatis were evaluated in each patient. Metastases (hepatic, peritoneal, or nodal), extrapancreatic extension of tumor, or vascular encasement was considered evidence of unresectable disease. Histopathology was the standard of reference; unresectable disease was confirmed by biopsy. At the completion of the laparoscopic sonography, each examination was scored according to impact analysis categories that had been prospectively established. RESULTS: Peripancreatic vasculature was adequately shown by laparoscopic sonography in 22 patients (92%), of whom 12 patients had histopathologic evidence of vascular encasement. All 12 cases of vascular encasement were revealed by laparoscopic sonography, and 10 of 12 cases of vascular encasement were revealed by CT. Liver lesions were seen in eight patients (33%). One hemangioma was shown solely by laparoscopic sonography; the other seven liver lesions were revealed by CT, laparoscopy, or both. In six patients (25%), laparoscopic sonography was used to guide biopsy of lesions that were not seen by laparoscopy. Impact analysis showed that laparoscopic sonography provided additional information in eight patients (33%) and altered management in four patients (17%). Of those patients for whom laparoscopic sonography altered management, three patients underwent successful resection after laparoscopic sonography two of these patients had suspected vascular encasement on CT but laparoscopic sonography revealed normal vessels, and the third patient had CT evidence of a liver lesion that was shown to be a cyst on laparoscopic sonography. A fourth patient was spared laparotomy when laparoscopic sonography revealed unsuspected vascular encasement. CONCLUSION: Preliminary experience suggests that laparoscopic sonography may aid diagnosis and alter management in patients with suspected pancreatic neoplasms.

Adenocarcinoma↗

Data management for an efficacy trial of a vaccine in the Gambia.

An individually randomised double-blind trial of PRP-T Hib conjugate vaccine was conducted in the Gambia between 1993 and 1995, in which 42,848 children were randomised into one of 10 groups, five corresponding to vaccine and five to placebo. Basic demographic data were collected on all children, and administration details of all doses of EPI vaccines were recorded. In addition, details on all doses of vaccines were recorded on each child's home-based health card; 2,681 episodes of possible Hib disease were investigated and for each episode detailed clinical data were collected. These investigations yielded 50 cases of confirmed Hib disease, which formed the basis of the final efficacy results. In all 50 cases, the data on the children's health card, describing the doses of study vaccine received exactly, matched the vaccination database which was filled with data returned from the clinics. The data-management procedures are described in detail in this paper.

Child, Preschool↗

Classifying visual field data.

We develop a prediction model for classifying an eye according to glaucoma status based on its visual field. We develop measures of both diffuse and localized defects in the visual field as potential predictors of glaucoma. To identify predictors of abnormal fields, we must describe the variability in the fields of normal eyes, hence we first model the mean, variance and correlation structures of normal fields with use of generalized estimating equations. The best measures of diffuse loss include a field's mean level, contrasts of the upper and lower halves, and contrasts of the nasal and temporal halves. Local loss is measured by the depth, area, volume and location of the field's largest defect. We develop logistic regression models to classify eyes as having glaucoma or not. We present ROC curves of the results that are highly competitive with current clinical methods of classification.

Adult↗

Vocational training for general practice in inner London. Is there a dearth? And if so what's to be done?

OBJECTIVE: To identify the nature and extent of any vocational training deficit within the London initiative zone and investigate the reasons. DESIGN: Collation of statistics and postal questionnaire surveys. SETTING: Thames regions inside and outside the London initiative zone. SUBJECTS: General practice registrars, trainers, principals from non-training practices, and vocational training course organisers. MAIN OUTCOME MEASURES: Trends in numbers of general practice registrars, proportions of trainers, views on current vocational training in inner London. RESULTS: Numbers of general practice registrars fell significantly between 1988 and 1993 within the London initiative zone and in England overall. The number of registrars within the zone fell by more than in the rest of the Thames regions, where the decline was not statistically significant. A lower proportion of principals were approved as trainers within the zone than in the rest of the Thames regions and England overall. In their responses to the survey (88% of inner London registrars responded and 81% of outer Thames registrars) registrars suggested that improving remuneration and personal safety would make training in London more attractive. Trainers and non-trainers (response rates 89% and 66% respectively) also suggested increasing remuneration for trainers together with more protected time for training. CONCLUSIONS: Less vocational training takes place within the London initiative zone than in the rest of the Thames regions and England overall, although there are discrepancies in official statistics. As well as specific recommendations for improving recruitment to vocational training in inner London, measures to tackle inner city deprivation should also remain high on the political agenda.

Adult↗

Non-Hodgkin lymphoma: contribution of chest CT in the initial staging evaluation.

PURPOSE: To analyze incremental information derived from routinely obtained chest computed tomographic (CT) scans compared with chest radiographs in newly diagnosed non-Hodgkin lymphoma and the effect of this information on staging and therapy. MATERIALS AND METHODS: Abnormalities on chest radiographs and CT scans obtained at specific sites were prospectively identified in 181 consecutive patients with no previous treatment. When discrepant information was found, the effect on staging and treatment was determined. RESULTS: CT and chest radiographic findings were negative in 99 (55%) patients. CT findings were positive and chest radiograph findings were negative in 17 (9%). Both chest radiograph and CT findings were positive in 65 (36%) patients, 16 with identical sites of disease and 49 with more extensive intrathoracic disease at CT. Most stage changes occurred in the diffuse large cell histologic subtype. CONCLUSION: Although routine chest CT findings increased stage of disease in some patients, it had no effect on initial treatment of newly diagnosed non-Hodgkin lymphoma at this institution.

Female↗

Moclobemide safety: monitoring a newly developed product in the 1990s.

Moclobemide is a reversible and selective inhibitor of monoamine oxidase subtype A with a wide spectrum of antidepressant activity. To fully evaluate product safety, Roche Drug Safety has collected data on adverse events (AEs), regardless of causality, from all sources worldwide through the product development phase and after launch. This effort has included analyses of reports from clinical trials, regulatory authorities, the literature, observational studies, and the marketplace. Roche Drug Safety has also carefully examined all cases where moclobemide was taken in overdose, whether with or without other substances. This article presents the safety profile of the product after 3 years on world markets. In clinical trials, moclobemide appeared only slightly less well tolerated than placebo. In comparative trials, moclobemide was largely devoid of the anticholinergic effects associated with tricyclic antidepressants. To the end of June 1993, with an estimated 780,000 subjects exposed, AEs had been reported by less than 0.2% of users. The most frequently reported AEs were psychiatric, neurologic, and gastrointestinal disorders. Hepatobiliary AEs were rare, suggesting that moclobemide is largely devoid of hepatotoxic potential. Cardiovascular AEs reflected the prevalence of cardiovascular disease in the population treated. This safety profile is largely unchanged from those observed at 1 and 2 years postlaunch, when the estimated exposed populations were 168,000 and 328,000, respectively. It is of great significance that the fatal toxicity index of moclobemide is zero. A review of single-drug intoxications with moclobemide at doses of up to 20.55 g revealed no deaths due solely to moclobemide overdose. All patients recovered fully within 1 to 7 days without residual hepatic or cardiovascular toxicity.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗