The Reporting Recommendations Intended for Pharmaceutical Risk Minimization Evaluation Studies: Standards for Reporting of Implementation Studies Extension (RIMES-SE).

INTRODUCTION: The Reporting recommendations Intended for pharmaceutical risk Minimization Evaluation Studies (RIMES) was developed to improve the quality of reporting of risk minimization program evaluations. In light of continued inadequacies in study reporting, and high-profile program implementation failures, we updated the RIMES Checklist to incorporate additional concepts from the Standards for Reporting of Implementation studies (StaRI). METHODS: The development of the updated checklist, the RIMES-StaRI Extension (RIMES-SE), entailed developing a study protocol and drafting an initial pool of items based on a mapping of the RIMES against the StaRI checklist. A modified e-Delphi exercise was then conducted to determine the importance and understandability of items for checklist inclusion. An expert workshop and an online commentary period for additional feedback followed. RESULTS: The RIMES-SE contains 27 items. It includes two signature features of the StaRI Checklist: 1) a dual strand of items (represented in two columns) describing the risk minimization program (the 'intervention') and the corresponding implementation strategy; and 2) applicable to an array of different research methodologies. CONCLUSIONS: The RIMES-SE Statement and Checklist extends the reporting guidelines set forth in the original RIMES Checklist via inclusion of key implementation science concepts. It is intended to improve the quality and transparency of reporting of risk minimization evaluation studies so as to advance drug safety science.

The Evolve to Next-Gen ACT Network: An evolving open-access, real-world data resource primed for real-world evidence research across the Clinical and Translational Science Award Consortium.

The ACT Network was funded by NIH to provide investigators from across the Clinical and Translational Science Award (CTSA) Consortium the ability to directly query national federated electronic health record (EHR) data for cohort discovery and feasibility assessment of multi-site studies. NIH refunded the program for expanded research application to become "Evolve to Next-Gen ACT" (ENACT). In parallel, the US Food and Drug Administration has been evaluating the use of real-world data (RWD), including EHR data, as sources of real-world evidence (RWE) for its regulatory decisions involving drug and biological products. Using insights from implementation science, six lessons learned from ACT for developing and sustaining RWD/RWE infrastructures and networks across the CTSA Consortium are presented in order to inform ENACT's development from the outset. Lessons include intentional institutional relationship management, end-user engagement, beta-testing, and customer-driven adaptation. The ENACT team is also conducting customer discovery interviews with CTSA hub and investigators using Innovation-Corps@NCATS (I-Corps™) methodology for biomedical entrepreneurs to uncover unmet RWD needs. Possible ENACT value proposition hypotheses are presented by stage of research. Developing evidence about methods for sustaining academically derived data infrastructures and support can advance the science of translation and support our nation's RWD/RWE research capacity.

Applying Customer Discovery Method to a Chronic Disease Self-Management Mobile App: Qualitative Study.

BACKGROUND: A significant health challenge is evident in the United States, with 6 in 10 adults having a chronic disease and 4 in 10 adults having 2 or more. Chronic disease self-management aims to prevent or delay disease progression and disability and reduce mortality risk. The evidence to support the use of information technology tools, including mobile apps, web-based portals, and web-based educational interventions, that support disease self-management and improve clinical outcomes is growing. Customer discovery and value proposition design methodology is a form of stakeholder engagement and is based on marketing and lean start-up business methods. As applied in health care, customer discovery and value proposition methodology can be used to understand the clinical problem and articulate the product's hypothesized unique value proposition relative to alternative options that are available to end users. OBJECTIVE: This study aims to describe the experience and findings of academic researchers applying the customer discovery and value proposition methodology to identify stakeholders, needs, adaptability, and sustainability of a chronic disease self-management mobile app (CDapp). The motivation of the work is to make mobile health app interventions accessible and acceptable for all segments of patients' chronic diseases. METHODS: Data were obtained through key informant interviews and analyzed using rapid qualitative analysis techniques. The value proposition framework was used to build the interview guide. The aim was to identify the needs, challenges (pains), and potential benefits (gains) of the CDapp for our stakeholders. RESULTS: Our results showed that the primary consumers (end users) of a CDapp were the patients. The app adopters (decision makers) can be medical center leaders including population health department managers or insurance providers, while the consumer adoption influencers (influencers or saboteurs) are clinicians and patient caregivers. We developed an ecosystem map to visualize the clinical practice workflow and how an app for chronic disease management might integrate within an academic health care center or system. A value proposition for the identified customer segments was generated. Each stakeholder segment was working within a different framework to improve patient self-management. Patients needed help to adhere to self-care activities and they needed tailored health education. Health care leaders aim to improve the quality of care while reducing costs and workload. Clinicians wanted to improve patient education and care while reducing the time burden. Our results also showed that within academic medical centers, there were variations regarding patients' self-reported abilities to manage their diseases. CONCLUSIONS: Customer discovery is a useful form of stakeholder engagement when designing studies that seek to implement, adapt, and sustain an intervention. The customer discovery and value proposition methodology can be used as an alternative or complementary approach to formative research to generate valuable information in a brief period.

Filling the gaps: A community case study in using an interprofessional approach and community-academic partnerships to address COVID-19-related inequities.

Public health challenges rapidly escalated during the COVID-19 pandemic. In response to a severe lack of resources and support in the near western suburbs of Chicago, the COVID Equity Response Collaborative: Loyola (CERCL) was established by an interprofessional team of Loyola University Chicago students, staff, and faculty. CERCL sought to minimize the negative impact of COVID-19 on vulnerable communities, those that are largely Black, Hispanic, or low-income. From April 2020 to the present, the collaborative utilized community-academic partnerships and interdisciplinary collaborations to conduct programming. CERCL's programming included free community-based testing, screening for and assistance with social determinants of health, dissemination of relevant and reliable COVID-related information, provision of personal protective equipment, and facilitation of access to vaccines. With partners, the collaborative conducted 1,500 COVID-19 tests, trained 80 individuals in contact tracing, provided over 100 individuals with specifically tailored resources to address social and legal needs, distributed 5,000 resource bags, held 20 community conversations, canvassed 3,735 homes, and hosted 19 vaccine clinics. Community-academic partnerships with the health system, community and governmental agencies, and the local public health department have been critical to CERCL efforts. The interdisciplinary and interprofessional successes demonstrated in this case study lends the example of a relevant, sustainable, and practical intervention to address nuanced public health issues.

Impact of COVID-19 on hospital acquired infections.

While there are established and effective guidelines for prevention of hospital-acquired infections (HAIs), the impact of the COVID-19 pandemic on those implemented practices and policies have not been thoroughly investigated. This report examines the impact of COVID-19 on HAI rates at 2 hospitals within the same healthcare system. HAIs significantly increased during the COVID-19 pandemic which correlated with the use of overtime and agency nursing hours.

Family-based lifestyle interventions: What makes them successful? A systematic literature review.

Nearly one in five young people in the United States has obesity, putting one-fifth of America's children at higher risk of having chronic health conditions and of having obesity into adulthood. Family-based lifestyle interventions (FBLI) have been proposed as effective mechanisms to improve the health through health education and the adoption of healthier behaviors. The aim of this review is to identify and summarize effective intervention activities and lessons learned that organizations can adopt when planning health promotion interventions for families, and to assess the effect of family-based lifestyle interventions on BMI z-score. A systematic review on lifestyle health-promotion interventions for families was conducted following PRISMA (Preferred Reporting Items for Systematic reviews and Meta-analyses) statements. Inclusion criteria were: duration ≥12 weeks and inclusion of family members. Summary data about the assessment tools, intervention strategies, and outcomes in parents and children were extracted and compared for all studies. A meta-analysis of BMI z-score change was conducted. Thirty-four articles were included in this review. Frequent strategies used were delivering education and training on healthy habits and well-being (94%), engaging community in the planning and implementation phases (80.6%) and providing reminders and feedback (47.2%). BMI z-score mean differences were reported in 40 cohorts and included in a meta-analysis, with no statistically significant differences between groups. The findings of this systematic review and meta-analysis indicate that components of a successful family lifestyle intervention program include duration between six to twelve months and delivery in a community setting. Other key factors include constructing a multidisciplinary team, using a mentor/role model approach, and reinforcing messaging with technology.

A Synthesis of Hepatitis C prevalence estimates in Sub-Saharan Africa: 2000-2013.

BACKGROUND: Hepatitis C (HCV) is a deleterious virus that can be cured with new, highly effective anti-viral treatments, yet more than 185 million individuals worldwide remain HCV positive (with the vast majority un-diagnosed or untreated). Of importance, HCV is a leading cause of chronic liver disease and liver cancer, especially in Sub-Saharan Africa (SSA) where the prevalence remains high but uncertain due to little population-based evidence of the epidemic. We aimed to synthesize available data to calculate and highlight the HCV disease burden in SSA. METHODS: Weighted random-effects generalized linear mixed models were used to estimate prevalence by risk cohort, African region (Southern, Eastern, Western, and Central Africa), type of assay used, publication year, and whether the estimate included children. A pooled prevalence estimate was also calculated. Multi-variable analyses were limited to cohort and region specific prevalence estimates in the adult population due to limited studies including children. Prevalence estimates were additionally weighted using the known adult population size within each region. RESULTS: We included more than 10 years of data. Almost half of the studies on HCV prevalence in SSA were from the Western region (49 %), and over half of all studies were from either blood donor (25 %) or general population cohorts (31 %). In uni-variable analyses, prevalence was lowest in Southern Africa (0.72 %), followed by Eastern Africa at 3.00 %, Western Africa at 4.14 %, and Central Africa at 7.82 %. Blood donors consistently had the lowest prevalence (1.78 %), followed by pregnant women (2.51 %), individuals with comorbid HIV (3.57 %), individuals from the general population (5.41 %), those with a chronic illness (7.99 %), and those at high risk for infection (10.18 %). After adjusting for the population size in each region, the overall adult prevalence of HCV in SSA rose from 3.82 to 3.94 %. CONCLUSION: This meta-analysis offers a timely update to the HCV disease burden in SSA and offers additional evidence of the burgeoning epidemic. The study highlights the need to account for type of cohort and region variation when describing the HCV epidemic in SSA, the need for more studies that include children, as well as the need to factor in such variations when planning public health interventions.

Next-Generation Sequencing Reveals Frequent Opportunities for Exposure to Hepatitis C Virus in Ghana.

Globally, hepatitis C Virus (HCV) infection is responsible for a large proportion of persons with liver disease, including cancer. The infection is highly prevalent in sub-Saharan Africa. West Africa was identified as a geographic origin of two HCV genotypes. However, little is known about the genetic composition of HCV populations in many countries of the region. Using conventional and next-generation sequencing (NGS), we identified and genetically characterized 65 HCV strains circulating among HCV-positive blood donors in Kumasi, Ghana. Phylogenetic analysis using consensus sequences derived from 3 genomic regions of the HCV genome, 5'-untranslated region, hypervariable region 1 (HVR1) and NS5B gene, consistently classified the HCV variants (n = 65) into genotypes 1 (HCV-1, 15%) and genotype 2 (HCV-2, 85%). The Ghanaian and West African HCV-2 NS5B sequences were found completely intermixed in the phylogenetic tree, indicating a substantial genetic heterogeneity of HCV-2 in Ghana. Analysis of HVR1 sequences from intra-host HCV variants obtained by NGS showed that three donors were infected with >1 HCV strain, including infections with 2 genotypes. Two other donors share an HCV strain, indicating HCV transmission between them. The HCV-2 strain sampled from one donor was replaced with another HCV-2 strain after only 2 months of observation, indicating rapid strain switching. Bayesian analysis estimated that the HCV-2 strains in Ghana were expanding since the 16th century. The blood donors in Kumasi, Ghana, are infected with a very heterogeneous HCV population of HCV-1 and HCV-2, with HCV-2 being prevalent. The detection of three cases of co- or super-infections and transmission linkage between 2 cases suggests frequent opportunities for HCV exposure among the blood donors and is consistent with the reported high HCV prevalence. The conditions for effective HCV-2 transmission existed for ~ 3-4 centuries, indicating a long epidemic history of HCV-2 in Ghana.

High frequency of active HCV infection among seropositive cases in west Africa and evidence for multiple transmission pathways.

BACKGROUND: Sub-Saharan Africa (SSA) has one of the highest global hepatitis C virus (HCV) prevalence estimates. However, reports that suggest high rates of serologic false positives and low levels of viremia have led to uncertainty regarding the burden of active infection in this region. Additionally, little is known about the predominant transmission risk factors in SSA. METHODS: We prospectively recalled 363 past blood donors (180 who were rapid screen assay [RSA] positive and 183 who were RSA negative at time of donation) to identify the level of active infection and risk factors for infection at a teaching hospital in Kumasi, Ghana. Participants had repeat blood testing and were administered a questionnaire on risk factors. RESULTS: The frequency of HCV active infection ranged from 74.4% to 88% depending on the criteria used to define serologically positive cases. Individuals with active disease had biochemical evidence of liver inflammation and median viral loads of 5.7 log copies/mL. Individuals from the northern and upper regions of Ghana had greater risks of infection compared with participants from other areas. Additional risk factors included traditional circumcision, home birth, tribal scarring, and hepatitis B virus coinfection. CONCLUSIONS: Viremic infection was common among serologically confirmed cases. Attention to testing algorithms is needed in order to define the true HCV burden in SSA. These data also suggest that several transmission modes are likely contributing to the current HCV epidemic in Ghana and that the distribution of these practices may result in substantial regional variation in prevalence.

Bisphenol A (BPA) Found in Humans and Water in Three Geographic Regions with Distinctly Different Levels of Economic Development.

The suspected endocrine disruptor bisphenol A (BPA) is associated with the manufacture, distribution, and use of epoxy resins and polycarbonate plastics; thus, studies of this compound have focused primarily on urban areas in developed countries. This small study investigating urinary BPA of 109 people was conducted in the urban United States, urban Jamaica, and rural Ghana. Additionally, local drinking and surface water samples were collected and analyzed from areas near study participants. Levels of BPA in both urine and water were comparable among all three sites. Thus, future studies of BPA should consider expanding investigations to rural areas not typically associated with the compound.

Curvature inversion technique: a novel tuboplastic technique for patulous Eustachian tube--a preliminary report.

OBJECTIVE: To assess the laser-assisted curvature inversion technique for the treatment of patients with patulous Eustachian tube (PET). STUDY DESIGN: Case series with planned data collection. SETTING: Tertiary care medical center. SUBJECTS AND METHODS: Eleven patients with Eustachian tube dysfunction underwent laser-assisted curvature inversion technique (CIT) of the medial and lateral lamina of the Eustachian tube. A KTP laser is used to cross-hatch the medial and lateral lamina of the tube to modify the curvature and to alter the spring of the posterior cushion. A change in the direction of the cartilaginous structure curvature is created to promote full closure of the patulous gap without interfering with the tube's muscular activity. None of the patients had any concurrent disease or additional surgical procedure. RESULTS: There were no surgical complications. Following CIT, subjective symptoms of autophony on nasal breathing improved in 9 of 11 patients (81.8%), while voice autophony improved in 8 patients (72.7%); posterior cushion curvature became inverted and less wide, and the valve was seen more closed postoperatively on simple endoscopy and slow-motion video-endoscopic analysis. On otoscopy, abnormal tympanic membrane excursions disappeared in 10 of 11 patients (90.9%). Mean immittance changes in tympanometric measurements for the forced respiration conditions improved postoperatively at least 0.05 mmhos in 9 of 11 patients (81.1%; P = .015). The follow-up period was 24 months. CONCLUSION: CIT appears to be a promising and relatively feasible technique for the treatment of PET.

Inferior turbinate debriding technique: ten-year results.

OBJECTIVES: To evaluate the efficacy and long-term outcomes (10 years) of the submucous stroma debriding technique (SSD) in nonallergic chronic hyperthrophy of the inferior turbinates (N/A-ChITOHD). STUDY DESIGN: Prospective cohort study. METHODS: From June 1994 to October 1996, a group of 350 nonallergic patients with chronic obstructive hypertrophy of the inferior turbinates were followed-up after SSD and compared with a group of 323 normal patients. None of them exhibited obstructive septal deviation or sinus disease. Preoperative and postoperative evaluations were obtained from visual analog scale graded questionnaire, endoscopy, acoustic rhinometry, and mucociliary saccharin transit time. End results were obtained at 6 months, 1, 5, and 10 years intervals. Biopsies from 35 volunteer SSD patients were obtained. RESULTS: Symptom-free patients were observed in 91.3%, partial symptoms in 5.2%; 3.5% of the patients had recurrence of nasal obstruction 10 years postoperatively. Endoscopy, anterior rhinometry, and mucociliary transit time revealed long-term improvements. Few complications were observed. CONCLUSION: SSD has long-lasting effects and it is the only sparing ciliated epithelium technique.