Motivation for participating in phase 1 vaccine trials: Comparison of an influenza and an Ebola randomized controlled trial

Introduction/Hypothesis

Recruitment of participants into phase 1 vaccine clinical trials can be challenging since these vaccines have not been used in humans and there is no perceived benefit to the participant. Occasionally, as was the case with a phase 1 clinical trial of an Ebola vaccine in Halifax, Canada, during the 2014–2016 West African Ebola virus outbreak, recruitment is less difficult. In this study, we explored the motivations of participants in two phase 1 vaccine trials that were concurrently enrolling at the same centre and compared the motivations of participants in a high-profile phase 1 Ebola vaccine trial to those in a less high-profile phase 1 adjuvanted seasonal influenza vaccine study.

Safety profile of the adjuvanted recombinant zoster vaccine: Pooled analysis of two large randomised phase 3 trials

Background

The ZOE-50 (NCT01165177) and ZOE-70 (NCT01165229) phase 3 clinical trials showed that the adjuvanted recombinant zoster vaccine (RZV) was ≥90% efficacious in preventing herpes zoster in adults. Here we present a comprehensive overview of the safety data from these studies.

Variations in length of stay and outcomes for six medical and surgical conditions in Massachusetts and California

OBJECTIVES.--To determine the extent to which interinstitutional variations in length of stay are explained by differences in patient characteristics and to determine whether patients in hospitals with shorter lengths of stay had worse outcomes. DESIGN.--We reviewed patients' medical records and surveyed patients between 3 and 12 months after hospital discharge using a questionnaire. SETTING.--Six teaching hospitals in California and Massachusetts. PATIENTS.--A cohort of 2484 selected patients who had been hospitalized for acute myocardial infarction or to rule out acute myocardial infarction, coronary artery bypass graft surgery, total hip replacement, cholecystectomy, or transurethral prostatectomy. Between 73% and 84% of the patients with each condition completed a follow-up questionnaire. OUTCOME MEASURES.--In-hospital complications, deaths, length of stay, functional status after hospital discharge, readmission, and patient satisfaction with hospital care were analyzed. RESULTS.--Significant interinstitutional differences in length of stay were noted for all conditions except rule-out acute myocardial infarction. Statistical adjustment for case-mix differences accounted for most of the interinstitutional differences in length of stay for total hip replacement but explained little of the differences in the other conditions. When we controlled statistically for other predictors, length of stay did not have a significant impact on deaths, functional status after hospital discharge, the probability of readmission, or patient satisfaction with hospital care. CONCLUSION.--More research is needed to determine the medical practices that are related to variations in lengths of stay. Routinely available outcome data may help preserve quality in the face of efforts to decrease costs by effecting more standardized practices of care.     

FEASIBILITY OF CONDUCTING CARDIOVASCULAR OUTCOME RESEARCH IN AUSTRALIAN GENERAL PRACTICE: RESULTS FROM THE ANBP2 PILOT STUDY

1. The present study aimed to determine the feasibility of conducting a 5 year cardiovascular outcome trial of the treatment of 6000 elderly hypertensive patients in Australian general practices. 2. General practitioners (GPs) were invited to participate by mail and personal follow-up. Patient records were reviewed to identify subjects for a blood pressure (BP) screening programme. Blood pressure was measured on three occasions and eligible subjects were included if the average BP was 160 mmHg systolic or 90 mmHg diastolic if systolic BP was 140 mmHg. 3. Seven hundred and forty-one GPs were approached and 89 were enrolled in the study (12% of mail invites and 75% of those receiving a personal contact). In 16 practices where screening was completed, 82 000 records were reviewed to identify 4% patients eligible for screening. Twenty-two per cent of eligible subjects attended screening. Of 1938 subjects screened, 180 (9%) had BP 5=160/90 mmHg. Forty-seven percent of subjects (n = 916) were receiving antihypertensive therapy and 184 (20%) were withdrawn from therapy. One hundred and sixteen (63%) of these subjects had BP return to study entry levels within 6 weeks. Fifty-seven newly diagnosed and 81 previously treated subjects were randomized (7% of the screened population). 4. Based on the high participation rate of GPs, the response rate of patients to attend a BP screening programme and the 7% randomization to screening ratio for entry into the study, the ANBP2 pilot study has demonstrated that it is feasible to recruit subjects from Australian general practices to a cardiovascular outcome trial.