Cervical Antibodies to Herpes Simplex Virus Proteins in Pregnancy and Puerperium: A Pilot Study

Objective: This study was undertaken to evaluate the changes in total and anti-herpes simplex virus (HSV)-specific cervical IgA and IgG antibody profiles during and after pregnancy

Uncomfortable yet Necessary: The Impact of PPE on Communication in Emergency Medicine

Background: The efficacy of pre-hospital emergency services is heavily dependent on the effective communication of care providers. This effective communication occurs between providers as part of a team, but also among providers interacting with family members and patients. The COVID-19 pandemic introduced a number of communication challenges to emergency care, which are primarily linked to the increased use of PPE. Methods: We sought to analyze the impacts of the Covid-19 pandemic on Emergency Medical Service (EMS) workers and pre-hospital care delivery. We conducted focus groups and one-on-one interviews with fire-EMS first responders between Sept 2021 and 2022. Interviews included questions about job related stress, EMS skills, work experiences and changes during Covid-19. Interviews were recorded, independently dual coded, and analyzed for themes. Results: 223 first responders participated in 40 focus groups and 40 lead paramedics participated in individual interviews. We found that additional use of personal protective-equipment (PPE) was reported to have significantly impaired efficiency and perceptions of quality of care—among EMS team members and also between EMS workers and patients. EMS personnel also experienced on scene hostility on arrival (from both families and other agencies). Use of extensive PPE muffles voices, obscures facial expressions, and can cause team members to have difficulty recognizing and communicating with one another and can be a barrier to showing empathy and connecting with patients. Creative solutions such as putting a hand on someone’s shoulder, wearing name tags on suits, and explaining rationale for perceived delays were mentioned as methods to transcend these barriers. The appearance of providers in heavy PPE can be unsettling and create barriers to human connection, particularly for pediatric patients. Conclusion: Human connection is an important element of health care delivery and healing. These findings shed light on new skills that are needed to initiate and maintain human connection in these times of PPE use, especially full body PPE. Awareness of the communication and empathy barriers posed by PPE is the first step to improving provider-patient interactions in pre-hospital EMS. Additionally, ‘communication-friendly’ adaptations of PPE equipment may be an important area for future research and development in manufacturing and the healthcare industry

Reporting Discrepancies between the ClinicalTrials.gov Results Database and Peer Reviewed Publications

BACKGROUND: Result summaries are now required to be reported in ClinicalTrials.gov for many 1 trials of drugs and devices. PURPOSE: To evaluate the consistency of reporting in trials that are both registered in the ClinicalTrials.gov results database and published in the literature. DATA SOURCES: ClinicalTrials.gov results database, matched publications identified through both ClinicalTrials.gov and a manual search of two electronic databases. STUDY SELECTION: 10% random sample of Phase III or IV trials with results in the ClinicalTrials.gov results database, completed before January 1, 2009, with two or more arms. DATA EXTRACTION: One reviewer extracted data from ClinicalTrials.gov results database and matching publications. A subsample was independently verified. Basic design features and results were compared between reporting sources and discrepancies were summarized. DATA SYNTHESIS: Of 110 reviewed trials with results, most were industry-sponsored, parallel design, drug studies. The most common inconsistency was the number of secondary outcome measures reported (80%). There were 16 trials (15%) that reported the primary outcome description inconsistently and 22 (20%) in which the primary outcome value was reported inconsistently. A total of 38 trials inconsistently reported the number of individuals with a serious adverse event (SAE), of which 33 (87%) reported more SAEs in ClinicalTrials.gov. Among the 84 trials that reported SAEs in ClinicalTrials.gov, 11 publications did not mention SAEs, 5 reported SAEs as zero or not occurring, and 21 reported a different number of SAEs. In 29 trials that reported deaths in ClinicalTrials.gov, 28% differed with the matched publication. LIMITATIONS: Small sample that includes earliest results posted to the database and therefore may reflect inexperience with the submission process. CONCLUSIONS: Reporting discrepancies between the ClinicalTrials.gov results database and matching publications are common. It is unclear which reporting source contains the most accurate account of trial results. ClinicalTrials.gov may provide a more comprehensive description of trial adverse events than the publication.This is an author's peer-reviewed final manuscript, as accepted by the publisher. The published article is copyrighted by the American College of Physicians and can be found at: http://annals.org/

A systematic review of clinic and community intervention to increase fecal testing for colorectal cancer in rural and low-income populations in the United States – How, what and when?

Abstract Background Interventions to improve fecal testing for colorectal cancer (CRC) exist, but are not yet routine practice. We conducted this systematic review to determine how implementation strategies and contextual factors influenced the uptake of interventions to increase Fecal Immunochemical Tests (FIT) and Fecal Occult Blood Testing (FOBT) for CRC in rural and low-income populations in the United States. Methods We searched Medline and the Cochrane Library from January 1998 through July 2016, and Scopus and clinicaltrials.gov through March 2015, for original articles of interventions to increase fecal testing for CRC. Two reviewers independently screened abstracts, reviewed full-text articles, extracted data and performed quality assessments. A qualitative synthesis described the relationship between changes in fecal testing rates for CRC, intervention components, implementation strategies, and contextual factors. A technical expert panel of primary care professionals, health system leaders, and academicians guided this work. Results Of 4218 citations initially identified, 27 unique studies reported in 29 publications met inclusion criteria. Studies were conducted in primary care (n = 20, 74.1%), community (n = 5, 18.5%), or both (n = 2, 7.4%) settings. All studies (n = 27, 100.0%) described multicomponent interventions. In clinic based studies, components that occurred most frequently among the highly effective/effective study arms were provision of kits by direct mail, use of a pre-addressed stamped envelope, client reminders, and provider ordered in-clinic distribution. Interventions were delivered by clinic staff/community members (n = 10, 37.0%), research staff (n = 6, 22.2%), both (n = 10, 37.0%), or it was unclear (n = 1, 3.7%). Over half of the studies lacked information on training or monitoring intervention fidelity (n = 15, 55.6%). Conclusions Studies to improve FIT/FOBT in rural and low-income populations utilized multicomponent interventions. The provision of kits through the mail, use of pre-addressed stamped envelopes, client reminders and in-clinic distribution appeared most frequently in the highly effective/effective clinic-based study arms. Few studies described contextual factors or implementation strategies. More robust application of guidelines to support reporting on methods to select, adapt and implement interventions can help end users determine not just which interventions work to improve CRC screening, but which interventions would work best in their setting given specific patient populations, clinical settings, and community characteristics. Trial registration In accordance with PRISMA guidelines, our systematic review protocol was registered with PROSPERO, the international prospective register of systematic reviews, on April 16, 2015 (registration number CRD42015019557 )

Protocol: Conflict of interest issues when engaging stakeholders in health and healthcare guideline development: a systematic review

This is the protocol for a Campbell systematic review. The overall objective of this study is to gather and summarize the existing literature on conflict of interest issues when engaging stakeholders in guideline development

A National Strategy to Develop Pragmatic Clinical Trials Infrastructure

An important challenge in comparative effectiveness research is the lack of infrastructure to support pragmatic clinical trials, which compare interventions in usual practice settings and subjects. These trials present challenges that differ from those of classical efficacy trials, which are conducted under ideal circumstances, in patients selected for their suitability, and with highly controlled protocols

Protocol for the development of guidance for stakeholder engagement in health and healthcare guideline development and implementation

Stakeholder engagement has become widely accepted as a necessary component of guideline development and implementation. While frameworks for developing guidelines express the need for those potentially affected by guideline recommendations to be involved in their development, there is a lack of consensus on how this should be done in practice. Further, there is a lack of guidance on how to equitably and meaningfully engage multiple stakeholders. We aim to develop guidance for the meaningful and equitable engagement of multiple stakeholders in guideline development and implementation. METHODS: This will be a multi-stage project. The first stage is to conduct a series of four systematic reviews. These will (1) describe existing guidance and methods for stakeholder engagement in guideline development and implementation, (2) characterize barriers and facilitators to stakeholder engagement in guideline development and implementation, (3) explore the impact of stakeholder engagement on guideline development and implementation, and (4) identify issues related to conflicts of interest when engaging multiple stakeholders in guideline development and implementation. DISCUSSION: We will collaborate with our multiple and diverse stakeholders to develop guidance for multi-stakeholder engagement in guideline development and implementation. We will use the results of the systematic reviews to develop a candidate list of draft guidance recommendations and will seek broad feedback on the draft guidance via an online survey of guideline developers and external stakeholders. An invited group of representatives from all stakeholder groups will discuss the results of the survey at a consensus meeting which will inform the development of the final guidance papers. Our overall goal is to improve the development of guidelines through meaningful and equitable multi-stakeholder engagement, and subsequently to improve health outcomes and reduce inequities in health