Institutional Review Boards and post-approval monitoring (PAM) of human research: content analysis of select university (academic health center) web pages across the USA.

OBJECTIVE: To conduct a content analysis of IRB webpages of select universities (academic health centers) in the USA that describe post IRB- approval monitoring activities. METHOD: This was a qualitative study. Thematic analysis was the method to review the webpage content of selected academic health centers (AHC) within the USA. RESULTS: Some US academic health "centers" IRB administrative or research compliance offices conduct post- approval monitoring (PAM) of human subjects' research including clinical trials. The goals of this PAM programmes are to (a) ensure compliance to approved protocols, (b) preserve research integrity, (c) manage institutional risks, d) provide advisory/educational support to researchers, (e) recommend corrective actions for identified issues, and most importantly, (f) to protect the safety, rights, and well-being of research participants. Although not a requirement by law, the PAM program has legislative support in the US Code of Federal Regulations as part of the US Office for Human Research Protection's (OHRP) Federal Wide Assurance (FWA). This is especially for institutions that conduct studies funded by the Federal government. PAM on-site checks reveal various incidents of protocol deviations and violations. This includes issues with recruitment processes, informed consent discrepancies, and incidents of non-compliance. When a study protocol is identified as non-compliant, the principal investigator works with the PAM monitor to develop a corrective action plan that would allow the study to become compliant and avoid sanctions from the IRB or the regulatory authority. CONCLUSIONS: REC/IRB post-approval monitoring of clinical trials is a valuable mechanism of protection for research participants while giving educational and quality assurance support to researchers. The program enables early detection and resolution of non-compliance to approved protocols. The impact of the program in the USA requires further exploration.

Digital and virtual strategies to advance community stakeholder engagement in research during COVID-19 pandemic.

Despite the adversity presented by COVID-19 pandemic, it also pushed for experimenting with innovative strategies for community engagement. The Community Research Advisory Council (C-RAC) at Johns Hopkins University (JHU), is an initiative to promote community engagement in research. COVID-19 rendered it impossible for C-RAC to conduct its meetings all of which have historically been in person. We describe the experience of advancing the work of the C-RAC during COVID-19 using digital and virtual strategies. Since March 2020, C-RAC transitioned from in person to virtual meetings. The needs assessment was conducted among C-RAC members, and individualized solutions provided for a successful virtual engagement. The usual working schedule was altered to respond to COVID-19 and promote community engaged research. Attendance to C-RAC meetings before and after the transition to virtual operation increased from 69% to 76% among C-RAC members from the community. In addition, the C-RAC launched new initiatives and in eighteen months since January 2020, it conducted 50 highly rated research reviews for 20 research teams. The experience of the C-RAC demonstrates that when community needs are assessed and addressed, and technical support is provided, digital strategies can lead to greater community collaborations.

Comparison of conscious sedation for oocyte retrieval between low-anxiety and high-anxiety patients.

STUDY OBJECTIVE: To investigate the correlation among the level of anxiety, the intravenous propofol requirement for conscious sedation, and recovery profile in in vitro fertilization patients. DESIGN: Prospective, randomized, double-blinded study. SETTING: Operating room of tertiary-care university hospital. PATIENTS: One hundred fifty consecutive women scheduled for oocyte retrieval under conscious sedation. INTERVENTIONS: Anxiety scores were separately measured by an anesthesiologist who was not involved in sedation. The patients were divided into 2 groups, high-anxiety and low-anxiety, as determined by using the median of anxiety VAS scoring for assessment of preoperative anxiety (4.0 cm). The subjects were collected, 76 in high-anxiety group and 74 in low-anxiety group. MEASUREMENTS: An infusion of propofol with a preset target concentration of 2.5 microg/mL(-1) was started until the patient had reached and maintained a sedation level of 3 on a 5-point sedation scale. Hemodynamic variables were recorded by using standard monitors. The scorings of sedation, operability, and satisfaction were assessed by one of the investigator-anesthesiologists. Data of induction quality and concentration of propofol were obtained from Target-Controlled Infusion system that runs on a microcomputer connected to an infusion pump (Becton-Dickinson infusion system, Le Grande chemin, France). Recovery data were measured in the recovery room. MAIN RESULTS: The high-anxiety group required more for the induction of sedation and a larger amount of total dosage of propofol for sedation, as compared with the low-anxiety group. The concentrations of propofol on the Target-Controlled Infusion at sedation level 3 of the high-anxiety group were significantly higher than those of the low-anxiety group. Context-sensitive half time of high-anxiety group was also longer than that of the low-anxiety group. The postoperative pain score of the high-anxiety group was higher than that of the low-anxiety group. Increased preoperative anxiety was significantly correlated with postoperative wound pain (r = 0.240, P = 0.009) and previously experienced pain on same procedure (r = 0.252, P = 0.031), but not with pain on propofol injection (r = -0.05, P = 0.58). CONCLUSIONS: The high-anxiety group needs more sedative requirement of propofol for conscious sedation than the low-anxiety group. Thus, we suggest that propofol dose for such sedation must take into account the individual patient's anxiety level when propofol is administered by an anesthesiologist for oocyte retrieval.

Outcome after induction chemotherapy for older patients with acute myeloid leukemia is not improved with mitoxantrone and etoposide compared to cytarabine and daunorubicin: a Southwest Oncology Group study.

Complete remission and long-term survival rates are low for older adults treated for acute myeloid leukemia (AML). Because of favorable phase 2 data using mitoxantrone and etoposide, we conducted a phase 3 study (SWOG-9333) in which patients over 55 years of age with previously untreated AML were randomized to receive mitoxantrone (10 mg/m(2) per day x 5) and etoposide (100 mg/m(2) per day x 5) [ME], or cytarabine (200 mg/m(2) per day x 7) and daunorubicin (45 mg/m(2) per day x 3) [AD] as induction therapy. The randomization was stratified by age, onset of leukemia, and multidrug resistance phenotype. Over a 4-year period, 328 eligible patients from 66 institutions were enrolled. The complete remission rate was 34% (95% confidence interval [CI] 26%-41%) for patients in the ME and 43% (CI 35%-51%) for patients in the AD treatment arm (one-tailed P value.96). The rates of resistant disease were 43% (CI 35%-51%) and 34% (CI 27%-42%), respectively, for the 2 treatment arms (one-tailed P value.95). The estimated overall survival at 2 years was 11% (CI 6%-15%) and 19% (CI 12%-25%) for patients randomized to ME and to AD induction therapy, respectively (one-tailed P value.99). After accounting for the independent prognostic factors associated with survival (karyotype, performance status, age, white blood cell count), exploratory analysis suggested there was a worse survival for patients who received ME compared with AD induction therapy (2-tailed P value.0066). We conclude that the results of our study do not demonstrate any benefit to the use of ME induction chemotherapy instead of AD in older patients with AML.