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Sequential Groups (sequential + groups)
Selected AbstractsUsing disease risk estimates to guide risk factor interventions: field test of a patient workbook for self-assessing coronary riskHEALTH EXPECTATIONS, Issue 1 2002J. Michael Paterson MSc Objective,To assess the feasibility and acceptability of a patient workbook for self-assessing coronary risk. Design,Pilot study, with post-study physician and patient interviews. Setting and subjects,Twenty southern Ontario family doctors and 40 patients for whom they would have used the workbook under normal practice conditions. Interventions,The study involved convening two sequential groups of family physicians: the first (n=10) attended focus group meetings to help develop the workbook (using algorithms from the Framingham Heart Study); the second (n=20) used the workbook in practice with 40 patients. Follow-up interviews were by interviewer-administered questionnaire. Main outcome measures,Physicians' and patients' opinions of the workbook's format, content, helpfulness, feasibility, and potential for broad application, as well as patients' perceived 10-year risk of a coronary event measured before and after using the workbook. Results,It took an average of 18 minutes of physician time to use the workbook: roughly 7 minutes to introduce it to patients, and about 11 minutes to discuss the results. Assessments of the workbook were generally favourable. Most patients were able to complete it on their own (78%), felt they had learned something (80%) and were willing to recommend it to someone else (98%). Similarly, 19 of 20 physicians found it helpful and would use it in practice with an average of 18% of their patients (range: 1,80%). The workbook helped to correct misperceptions patients had about their personal risk of a coronary event over the next 10 years (pre-workbook (mean (SD) %): 35.2 (16.9) vs. post-workbook: 17.3 (13.5), P < 0.0001; estimate according to algorithm: 10.6 (7.6)). Conclusions,Given a simple tool, patients can and will assess their own risk of CHD. Such tools could help inform otherwise healthy individuals that their risk is increased, allowing them to make more informed decisions about their behaviours and treatment. [source] Safety and Immunogenicity Profile of the Concomitant Administration of ZOSTAVAX and Inactivated Influenza Vaccine in Adults Aged 50 and OlderJOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 10 2007Boris Kerzner MD OBJECTIVES: To evaluate the safety and immunogenicity of ZOSTAVAX administered concomitantly with inactivated influenza vaccine or sequentially in adults aged 50 and older. DESIGN: Randomized, blinded, placebo-controlled study. SETTING: Thirteen U.S. and seven European study sites. PARTICIPANTS: Three hundred eighty-two concomitantly, 380 sequentially vaccinated subjects. INTERVENTION: The concomitant vaccination group received influenza vaccine and ZOSTAVAX at separate injection sites on Day 1 and placebo at Week 4. The nonconcomitant vaccination group received influenza vaccine and placebo at separate injection sites on Day 1 and ZOSTAVAX at Week 4. MEASUREMENTS: Primary safety endpoints: vaccine-related serious adverse experiences (AEs) within 28 days postvaccination (PV); and diary card,prompted local and systemic AEs. Primary immunogenicity endpoints: geometric mean titer (GMT) and geometric mean fold rise (GMFR) from baseline of varicella-zoster virus (VZV) antibody (Ab) at 4 weeks PV according to glycoprotein enzyme-linked immunosorbent assay (gpELISA) and GMT of influenza Ab for the three vaccine strains (2005,2006 influenza season) at 4 weeks PV according to hemagglutination inhibition assay. Secondary immunogenicity endpoint: influenza seroconversion rates (SCRs). RESULTS: No serious AEs related to ZOSTAVAX were observed during the study. VZV Ab GMTs 4 weeks PV for the concomitant and sequential groups were 554 and 597 gpELISA U/mL, respectively. The estimated VZV Ab GMT ratio was 0.9 (95% confidence interval (CI)=0.8,1.0), indicating noninferior (P<.001 for the null hypothesis of GMT ratio <0.67) responses. Estimated VZV Ab GMFR from baseline in the concomitant group was 2.1 (95% CI=2.0,2.3), indicating acceptable fold rise. Estimated GMT ratios (concomitant/sequential) for influenza strains A(H1N1), A(H3N2), and B were 0.9 (95% CI=0.8,1.1), 1.1 (95% CI=0.9,1.3), and 0.9 (95% CI=0.8,1.1), respectively, and SCRs were comparable across both groups, with more than 85% achieving titers of 1:40 or greater, meeting regulatory criteria. CONCLUSION: ZOSTAVAX and influenza vaccine given concomitantly are generally well tolerated in adults aged 50 and older. Ab responses were similar whether ZOSTAVAX and influenza vaccine were given concomitantly or sequentially. [source] Observer experience improves reproducibility of color doppler sonography of orbital blood vesselsJOURNAL OF CLINICAL ULTRASOUND, Issue 6 2002János Németh MD Abstract Purpose. The study investigated the reproducibility of orbital blood flow measurements with color Doppler imaging (CDI) at different stages of observer experience. Methods. The subjects were 31 healthy volunteers and 2 sequential groups of 25 glaucoma patients each. Repeated blood flow measurements (usually 3 sets) in orbital vessels (ophthalmic artery, short posterior ciliary arteries, central retinal artery, and central retinal vein) were performed by the same observer in a single session in each subject. Results. The parameters with the best reproducibility were the resistance index (mean coefficient of variation [COV], 3.3,8.8%), the peak systolic velocity (mean COV, 6.9,13.7%), the time-averaged velocity (mean COV, 7.2,16.0%), and the systolic acceleration time (mean COV, 8.8,12.3%). The mean COV was greater (9.9,20.3%) for the other arterial flow parameters (end-diastolic velocity and systolic acceleration) and for the venous flow velocities (maximum and minimum). The COVs of the parameters were improved by 20,40% as the observer became more experienced in ophthalmic CDI. Conclusions. We confirm the general reliability of CDI measurements in orbital vessels and show that observer experience improves reproducibility. It appears, however, that observer performance in these measurements is vessel specific. © 2002 Wiley Periodicals, Inc. J Clin Ultrasound 30:332,335, 2002; Published online in Wiley InterScience (www.interscience.wiley.com). DOI: 10.1002/jcu.10079 [source] The Surgical Learning Curve in Aural Atresia SurgeryTHE LARYNGOSCOPE, Issue 1 2007FRACS, Nirmal Patel MBBS (Hons) Abstract Objective: The objective of this retrospective case review is to examine the effect of surgical learning on hearing outcomes and complications in congenital aural atresia surgery. Patients: Sixty-four consecutive ears (in 60 patients) operated on during the period of 1994 to 2004 at a tertiary referral center were studied. Intervention)s): Intervention consisted of aural atresiaplasty through an anterior approach by the same surgeon (C.S.). Main Outcome Measure)s): Hearing outcomes and complication rates were compared between four temporally sequential groups of 16 ears. Acceptable hearing and complication rate outcomes were defined as results comparable to larger series in the literature. Results: Hearing results, in the short term, comparable to larger series were achieved during the first group of ears (nos. 1,16). A plateau in the learning curve for short-term hearing outcomes was achieved after the first two groups, that is, after 32 ears. Hearing outcomes, in the long term (>1 year) comparable to larger series, were achieved in the second group of ears (nos. 16,32). The learning curve for long-term hearing demonstrated a significant improvement in outcomes in the final group of 16 ears compared with the first 48 ears. Long-term hearing results for the final group show closure of the postoperative air-bone gap to less than 30 dB in 94% of cases. Postoperative complication rates were equivalent to larger series in the first group of 16 ears and showed no statistically significant difference between the four groups. There was one patient with sensorineural hearing loss after surgery; there were no anacoustic ears and no facial palsies in the study group. Conclusions: A learning curve of at least 32 ears was required to achieve stable short-term hearing results. To achieve stable long-term hearing results required a learning curve of at least 48 patients in our series. Complication rates remained stable throughout the study period. [source] A retrospective comparison of three sequential groups of patients with Recurrent/Refractory chronic lymphocytic leukemia treated with fludarabine-based regimensCANCER, Issue 2 2006Ph.D., William Wierda M.D. Abstract BACKGROUND Combining therapeutics with single-agent activity has improved treatment for patients with many malignancies. Debate continues about the impact of treatment on survival in patients with chronic lymphocytic leukemia (CLL). Purine analogues are the most active agents for treatment of patients with CLL. Recently, it was shown that a chemoimmunotherapy regimen combining fludarabine (F), cyclophosphamide (C), and rituximab (R) (FCR) was very effective in treating patients with recurrent and/or refractory CLL. The objective of the current analysis was to determine whether improvements in treatment have had an impact on survival for patients with CLL. METHODS Three nonoverlapping, sequential groups of patients enrolled on Phase II studies who received treatment with F (n = 251 patients), FC (n = 111 patients), or FCR (n = 143 patients) were analyzed. Pretreatment characteristics, responses to treatment, and overall survival were compared. RESULTS Patients who were treated with FCR had a higher complete remission rate compared with patients who were treated with combined F and C or with F alone. Statistically significantly longer estimated median survival was noted for patients who received FCR. A Cox proportional hazards, multivariable model for overall survival that included all patients (n = 505) showed that patients who received FCR had longer survival (P < 0.0001) after adjusting for other significant (P < 0.05) pretreatment characteristics, including age, hemoglobin, ,-2 microglobulin, and the number of prior treatments. CONCLUSIONS The results of this retrospective comparison of patients with recurrent and refractory CLL indicated a higher complete remission rate and the longest estimated survival for patients who were treated with FCR, providing the basis for randomized clinical trials of this regimen. Cancer 2006. © 2005 American Cancer Society. [source] | ||||||||||