Heplisav-B in Prior Hepatitis B Vaccine Nonresponders: A Case Series

ABSTRACT Introduction Hepatitis B is a potentially deadly infection that can be acquired by exposure to infectious human blood or body fluids. While service members and others at occupational risk are routinely vaccinated to prevent hepatitis B, non-responders to this vaccine are at continued risk. Heplisav-B is a newer vaccine that may offer additional protection to those at risk. Materials and Methods Cases of hepatitis B vaccine non-responders who were given Heplisav-B after receiving six or more doses of standard hepatitis B vaccine were collected from existing health records within the military health system after Uniformed Services University of the Health Sciences Institutional Review Board review. Results Twelve of thirteen (92%) prior non-responders who were tested at least 1 month after completing the recombinant Heplisav-B vaccine series demonstrated seroprotection against hepatitis B. Conclusions Ideally, all service members and other at-risk workers should be protected from hepatitis B. This case series suggests that prior non-responders are likely to gain protection from hepatitis B with Heplisav-B vaccination. A prospective trial is warranted for further evaluation of this potential indication.

Facilitating Timely Institutional Review Board Review: Common Issues and Recommendations

Review of clinical research by institutional review boards (IRBs) is integral to the protection of human subjects and necessary for the conduct of legal and ethical research. Because such review is time and resource intensive, it is critical to identify common issues that contribute to delayed review and approval of research. Hence, the aim of this quality improvement project was to identify factors associated with long delays in IRB approval and identify potential strategies to streamline the review process. In collaboration with the human subjects research protection program at a large academic health center in the northeastern United States, we conducted a content analysis of minutes of convened IRB meetings for every new protocol (initial submission) approved between January and September 2019 that required greater than or equal to two full board reviews prior to approval ( n = 33). We also examined characteristics of new protocols that were reviewed less than twice at convened meetings during the same time frame ( n = 244). Using χ2 or Fisher's exact tests, the characteristics of protocols with multiple reviews by the convened IRBs were compared with those protocol submissions reviewed by the convened IRBs only once. Three factors significantly associated with increased delays were researcher conflict of interest (30% vs. 12%, respectively, p < .01), need for radiation safety evaluation (36% vs. 20%, respectively, p = .03), and protocols that were clinical trials (73% vs. 60%, respectively, p < .01). Other factors associated with delayed IRB approval were excessive technical jargon (93.94%, n = 31), inadequate description of data security or inability to meet data security requirements of the institution (75.76%, n = 25), protocol design affecting patient safety (57.58%, n = 19), and lack of clarity regarding compensation and payment or study duration ( n = 18, 54.54% each). Approaches to mitigate delays in approval and increase the efficiency and efficacy of the IRB process are recommended.

Developing Quality and Efficiency of Institutional Review Board Review Under a Human Research Protection Program at a Leading Hospital in Central Southern China: A Descriptive Analysis of the First Three Years

This study analyzes the Institutional Review Board (IRB) quality and efficiency at a leading hospital in Central Southern China, under the first three years of a Human Research Protection Program (HRPP). We conducted a descriptive, retrospective analysis from 2015 through 2017. We extracted characteristics from the protocol archive in duplicate. Of 396 protocols submitted, 98% were approved. Mean protocol review time decreased from 23 to 15 calendar days, 344 serious adverse events SAEs were reviewed, and 93 conflicts of interest (COIs) were disclosed. IRB quality and efficiency mechanisms improved. Remaining needs include increased monitoring of COIs and unanticipated problem involving risks to subjects or others, distinctions between research types, and cooperation with specialized committees.

Pathology Laboratory Policies and Procedures for Releasing Diagnostic Tissue for Cancer Research

Context.— The Surveillance, Epidemiology, and End Results (SEER) cancer registry program is currently evaluating the use of archival, diagnostic, formalin-fixed, paraffin-embedded (FFPE) tissue obtained through SEER cancer registries, functioning as honest brokers for deidentified tissue and associated data. To determine the feasibility of this potential program, laboratory policies for sharing tissue for research needed to be assessed. Objective.— To understand the willingness of pathology laboratories to share archival diagnostic tissue for cancer research and related policies. Design.— Seven SEER registries administered a 27-item questionnaire to pathology laboratories within their respective registry catchment areas. Only laboratories that processed diagnostic FFPE specimens and completed the questionnaire were included in the analysis. Results.— Of the 153 responding laboratories, 127 (83%) responded that they process FFPE specimens. Most (n = 88; 69%) were willing to share tissue specimens for research, which was not associated with the number of blocks processed per year by the laboratories. Most laboratories retained the specimens for at least 10 years. Institutional regulatory policies on sharing deidentified tissue varied considerably, ranging from requiring a full Institutional Review Board review to considering such use exempt from Institutional Review Board review, and 43% (55 of 127) of the laboratories did not know their terms for sharing tissue for research. Conclusions.— This project indicated a general willingness of pathology laboratories to participate in research by sharing FFPE tissue. Given the variability of research policies across laboratories, it is critical for each SEER registry to work with laboratories in their catchment area to understand such policies and state legislation regulating tissue retention and guardianship.

Maintenance motives for physical activity among older adults: a protocol for a systematic review and meta-analysis

IntroductionPhysical activity (PA) is an important aspect for health and well-being, yet many older adults do not maintain their PA long term. The identification of key factors that are associated with, and likely causally related to, older adults’ PA maintenance is a crucial first step towards developing programmes that are effective at promoting long-term PA behaviour change. The purpose of this protocol is to outline a systematic review that will examine the relationship between four motives (ie, satisfaction, enjoyment, self-determination and identity) and older adults’ PA maintenance.Methods and analysisStudies that investigated PA maintenance with a sample mean age ≥55 years will be included. Five electronic databases (PubMed, Cumulative Index to Nursing and Allied Health Literature, SPORTDiscus, PsycINFO and ProQuest Dissertations and Theses) were searched on 6 April 2018 with no publication date limit (ie, from inception). One reviewer screened 100% of titles and abstracts (k=21 470) while a random subsample (20%) was screened independently by two reviewers. An update of the search was run on 1 October 2019. All studies for which the full text was retrieved will be independently screened by two reviewers. Data pertaining to study sample, design, motives, PA (eg, measurement validity evidence, study definition of maintenance) and essential bias domains (eg, bias due to missing data) will be extracted. Study-level effect sizes will be calculated, and if the number of studies is ≥5, a random-effects meta-analysis will be performed using inverse-variance methods; a narrative synthesis will be performed otherwise.Ethics and disseminationThe university’s Human Research Protection Program determined that the proposed study qualifies as exempt from the Institutional Review Board review under Exemption Category 4 (PROPEL #: 80047007). Results will be published in a peer-review journal, and the findings will help inform future interventions with older adults.PROSPERO registration numberCRD42018088161.

Implementing Common Metrics across the NIH Clinical and Translational Science Awards (CTSA) consortium

The Clinical and Translational Science Award (CTSA) Consortium and the National Center for Advancing Translational Science (NCATS) undertook a Common Metrics Initiative to improve research processes across the national CTSA Consortium. This was implemented by Tufts Clinical and Translational Science Institute at the 64 CTSA academic medical centers. Three metrics were collaboratively developed by NCATS staff, CTSA Consortium teams, and outside consultants for Institutional Review Board Review Duration, Careers in Clinical and Translational Research, and Pilot Award Publications and Subsequent Funding. The implementation program included training on the metric operational guidelines, data collection, data reporting system, and performance improvement framework. The implementation team provided small-group coaching and technical assistance. Collaborative learning sessions, driver diagrams, and change packages were used to disseminate best and promising practices. After 14 weeks, 84% of hubs had produced a value for one metric and about half had produced an initial improvement plan. Overall, hubs reported that the implementation activities facilitated their Common Metrics performance improvement process. Experiences implementing the first three metrics can inform future directions of the Common Metrics Initiative and other research groups implementing standardized metrics and performance improvement processes, potentially including other National Institutes of Health institutes and centers.

Development of health-system inpatient pharmacy clinical metrics

Purpose To describe a process to identify metrics that represent the impact of inpatient pharmacy services on patient outcomes across a health system. Summary The authors describe a systematic process of identifying inpatient clinical outcome measures that could represent pharmacists’ impact on patient outcomes and eventually be displayed in a dashboard within the electronic medical record (EMR). A list was generated through literature review, assessment of practices at other sites, evaluation of current pharmacy services, and collaboration with the quality department and System Pharmacy Clinical User Group. The project team narrowed the list through assessment against standardized criteria. An assessment tool was designed and distributed to stakeholders to prioritize clinical outcome measures for inclusion on the dashboard. The clinical outcome measures were transformed into metrics by determining measurement criteria, inclusion and exclusion parameters, and review time frame. After validation, the metrics are planned to be displayed on an inpatient pharmacy EMR dashboard. Exemption from institutional review board review was granted for this project. Conclusion A systematic process was developed and used to identify inpatient clinical outcome metrics.

Surveys

Surveys collect descriptive data about the behaviors or opinions of a population. The power of surveys comes from applying the same questions and the same response choices to a large number of people. In the health humanities, surveys have most often been used for course or program evaluations, to learn about patient experiences, and to collect data on opinions. A good survey has a defined research question and respondent population, and it asks carefully crafted questions including yes/no, multiple choice, ratings, rankings, sliders, pull-downs, and text entry. Surveys require Institutional Review Board review and a knowledge of basic statistics. While a good survey can provide generalizable perspectives, one of their main limitations is that they do not explain why people answer as they do.

Reconstructing the Face of War

Introduction Ongoing combat operations in Iraq, Afghanistan, and other theaters have led to an increase in high energy craniomaxillofacial (CMF) wounds. These challenging injuries are typically associated with complex tissue deficiencies, evolving areas of necrosis, and bony comminution with bone and ballistic fragment sequestrum. Restoring form and function in these combat-sustained CMF injuries is challenging, and frequently requires local and distant tissue transfers. War injuries are different than the isolated trauma seen in the civilian sector. Donor sites are limited on patients with blast injuries and they may have preferences or functional reasons for the decisions to choose flaps from the available donor sites. Methods A case series of patients who sustained severe combat-related CMF injury and were treated at Walter Reed National Military Medical Center (WRNMMC) is presented. Our study was exempt from Institutional Review Board review, and appropriate written consent was obtained from all patients included in the study for the use of representative clinical images. Results Four patients treated by the CMF team at Walter Reed National Military Medical Center are presented. In this study, we highlight their surgical management by the CMF team at WRNMMC, detail their postoperative course, and illustrate the outcomes achieved using representative patient clinical images. We also supplement this case series demonstrating military approaches to complex CMF injuries with CMF reconstructive algorithms utilized by the senior author (EDR) in the management of civilian complex avulsive injuries of the upper, mid, and lower face are thoroughly reviewed. Conclusion While the epidemiology and characteristics of military CMF injuries have been well described, their management remains poorly defined and creates an opportunity for reconstructive principles proven in the civilian sector to be applied in the care of severely wounded service members. The War on Terror marks the first time that microsurgery has been used extensively to reconstruct combat sustained wounds of the CMF region. Our manuscript reviews various options to reconstruct these devastating CMF injuries and emphasizes the need for steady communication between the civilian and military surgical communities to establish the best care for these complex patients.