A randomized evaluation of on-site monitoring nested in a multinational randomized trial.

BACKGROUND: Evidence from prospectively designed studies to guide on-site monitoring practices for randomized trials is limited. A cluster randomized study, nested within the Strategic Timing of AntiRetroviral Treatment (START) trial, was conducted to evaluate on-site monitoring. METHODS: Sites were randomized to either annual on-site monitoring or no on-site monitoring. All sites were centrally monitored, and local monitoring was carried out twice each year. Randomization was stratified by country and projected enrollment in START. The primary outcome was a participant-level composite outcome including components for eligibility errors, consent violations, use of antiretroviral treatment not recommended by protocol, late reporting of START primary and secondary clinical endpoints (defined as the event being reported more than 6 months from occurrence), and data alteration and fraud. Logistic regression fixed effect hierarchical models were used to compare on-site versus no on-site monitoring for the primary composite outcome and its components. Odds ratios and 95% confidence intervals comparing on-site monitoring versus no on-site monitoring are cited. RESULTS: In total, 99 sites (2107 participants) were randomized to receive annual on-site monitoring and 97 sites (2264 participants) were randomized to be monitored only centrally and locally. The two monitoring groups were well balanced at entry. In the on-site monitoring group, 469 annual on-site monitoring visits were conducted, and 134 participants (6.4%) in 56 of 99 sites (57%) had a primary monitoring outcome. In the no on-site monitoring group, 85 participants (3.8%) in 34 of 97 sites (35%) had a primary monitoring outcome (odds ratio = 1.7; 95% confidence interval: 1.1-2.7; p = 0.03). Informed consent violations accounted for most outcomes in each group (56 vs 41 participants). The largest odds ratio was for eligibility violations (odds ratio = 12.2; 95% confidence interval: 1.8-85.2; p = 0.01). The number of participants with a late START primary endpoint was similar for each monitoring group (23 vs 16 participants). Late START grade 4 and unscheduled hospitalization events were found for 34 participants in the on-site monitoring group and 19 participants in the no on-site monitoring group (odds ratio = 2.0; 95% confidence interval: 1.1-3.7; p = 0.02). There were no cases of data alteration or fraud. Based on the travel budget for on-site monitoring and the hours spent conducting on-site monitoring, the estimated cost of on-site monitoring was over US$2 million. CONCLUSION: On-site monitoring led to the identification of more eligibility and consent violations and START clinical events being reported more than 6 months from occurrence as compared to no on-site monitoring. Considering the nature of the excess monitoring outcomes identified at sites receiving on-site monitoring, as well as the cost of on-site monitoring, the value to the START study was limited.

Early Antiretroviral Therapy at High CD4 Counts Does Not Improve Arterial Elasticity: A Substudy of the Strategic Timing of AntiRetroviral Treatment (START) Trial.

BACKGROUND: Both human immunodeficiency virus (HIV) infection and antiretroviral therapy (ART) may increase cardiovascular disease (CVD) risk. Vascular function assessments can be used to study CVD pathogenesis. We compared the effect of immediate versus deferred ART initiation at CD4 counts >500 cells/mm3 on small arterial elasticity (SAE) and large artery elasticity (LAE). METHODS: Radial artery blood pressure waveforms were recorded noninvasively. Small arterial elasticity and LAE were derived from analysis of the diastolic pulse waveform. Randomized treatment groups were compared with linear models at each visit and longitudinal mixed models. RESULTS: Study visits involved 332 participants in 8 countries: mean (standard deviation [SD]) age 35 (10), 70% male, 66% nonwhite, 30% smokers, and median CD4 count 625 cells/mm3 and 10-year Framingham risk score for CVD 1.7%. Mean (SD) SAE and LAE values at baseline were 7.3 (2.9) mL/mmHg × 100 and 16.6 (4.1) mL/mmHg × 10, respectively. Median time on ART was 47 and 12 months in the immediate and deferred ART groups, respectively. The treatment groups did not demonstrate significant within-person changes in SAE or LAE during the follow-up period, and there was no difference in mean change from baseline between treatment groups. The lack of significant differences persisted after adjustment, when restricted to early or late changes, after censoring participants in deferred group who started ART, and among subgroups defined by CVD and HIV risk factors. CONCLUSIONS: Among a diverse global population of HIV-positive persons with high CD4 counts, these randomized data suggest that ART treatment does not have a substantial influence on vascular function among younger HIV-positive individuals with preserved immunity.

INVESTIGATING THE EFFICACY OF CLINICAL TRIAL MONITORING STRATEGIES: Design and Implementation of the Cluster Randomized START Monitoring Substudy.

BACKGROUND: Trial monitoring protects participant safety and study integrity. While monitors commonly go on-site to verify source data, there is little evidence that this practice is efficient or effective. An ongoing international HIV treatment trial (START) provides an opportunity to explore the usefulness of different monitoring approaches. METHODS: All START sites are centrally monitored and required to follow a local monitoring plan requiring specific quality assurance activities. Additionally, sites were randomized (1:1) to receive, or not receive, annual on-site monitoring. The study will determine if on-site monitoring increases the identification of major protocol deviations (eligibility or consent violations, improper study drug use, primary or serious event underreporting, data alteration or fraud). RESULTS: The START study completed enrollment in December 2013, with planned follow-up through December 2016. The monitoring study is ongoing at 196 sites in 34 countries. Results are expected when the START study concludes in December 2016.

Interaction of Radio Frequency and LAMBDA-DNA.

With the prevalence of wireless radio frequency (RF) devices, interest is growing to more fully understand the effect of RF on biological tissue. This research explores how ?DNA interacts with RF energy. By sweeping a radio frequency range from 1 GHz to 8.5 GHz we hope to observe if specific frequencies show significantly elevated RF energy-?DNA interaction (e.g. either absorbed and/or reflected). Our procedure is as follows: 1) Set up RF equipment (horn antennas and network analyzer), 2) vary frequency from 1- 8.5GHz at a RF power level of 0 dBm, 3) vary same frequency sweep with buffer in the cell culture wells, and next with DNA and buffer in the cell-culture wells, and 4) the frequency sweep was repeated 100 times with a duration of 1.0 second per sweep. The results indicate regions of RF- ?DNA interaction around 3 and 3.5 GHz.

Gerogogy in patient education--revisited.

Gerogogy in Patient Education was first printed in Home Healthcare Nurse, Volume 14, Number 8, (1996), Lippincott. Writers Mary Pearson, M.Ed, RN- BC and Joan Wessman, MA. have revisited and updated the material to meet the needs of a new generation of health care professionals. Baby Boomers are retiring; they will reach their peak in 2030, with an estimated 72 million drawing social security. With these numbers comes an increase in services to the elderly, mostly in the form of medical expenditure. The problem will not only impact the financial system of Medicare but will have a great toll on families. How will the retirees remain independent in their homes? How will they learn new medical information? Will new health care professions be able to teach them while taking into consideration the physical and psychological alterations that occur with aging and illness? Gerogogy takes into account the person's disease process, age-related changes, educational level and motivation. Then incorporates these factors into practice, utilizing the same foundations found within the nursing process: assessment, planning, implementation, and evaluation. As stated, the methods for teaching the elderly are unique and require modifications. Gerogogy meets these needs so individuals can remain at home while also reducing unnecessary medical costs.

Medication reconciliation: a necessity in promoting a safe hospital discharge.

Medication errors are among the most common type of patient-safety error and therefore are a priority for organizational performance-improvement efforts. Medication reconciliation has been found to greatly reduce adverse drug and medication events. At one facility, a computer-generated Physician Discharge Medication Worksheet (PDMW) was developed to aid medication reconciliation. Use of this tool led to a reduction in discrepancies in drug frequency and dose, as well as therapeutic duplication, at the time of discharge. Through the use of the PDMW, medication reconciliation has been dramatically improved.

Self-perceived health among Canadian opiate users: a comparison to the general population and to other chronic disease populations.

BACKGROUND: There are an estimated 40,000 to 90,000 injection opiate users in Canada. The social, economic and health consequences of opiate addiction have been well documented. However, there are no data on the self-perceived health status of opiate users in Canada. Therefore, the goal of this research is to gain an understanding of the self-perceived health status of opiate users by comparing the health-related quality of life of opiate users to chronic disease populations and to the general population. METHODS: The SF-36 was administered to a nonrandom sample of 143 opiate users entering low-threshold methadone treatment. Two sample t-tests were performed to assess statistical differences, at a 5% level of significance, between population scores across SF-36 dimensions. RESULTS: Opiate users perceived both their mental and physical health as worse than the general population and individuals with minor and serious medical problems, but comparable to those with diagnosed psychiatric illnesses. CONCLUSIONS: Methadone treatment services should incorporate both primary care and psychiatric care into their programs, or at the very least secure appropriate referral mechanisms to ancillary services to ensure that the health concerns of opiate users are dealt with in the context of their treatment program.