The perceptions and experience of developing patient (version of) guidelines: a descriptive qualitative study with Chinese guideline developers.

OBJECTIVE: To understand developers' perception of patient (versions of) guidelines (PVGs), and identify challenges during the PVG development, with the aim to inform methodological guidance for future PVG development. METHODS: We used a descriptive qualitative design. Semi-structured interviews were conducted virtually from December 2021 to April 2022, with a purposive sampling of 12 PVG developers from nine teams in China. Conventional and directed content analysis was used for data analysis. RESULTS: The interviews identified PVG developers' understanding of PVGs, their current practice experience, and the challenges of developing PVGs. Participants believed PVGs were a type of health education material for patients; therefore, it should be based on patient needs and be understandable and accessible. Participants suggested that PVGs could be translated/adapted from one or several clinical practice guidelines (CPG), or developed de novo (i.e., the creation of an entirely new PVG with its own set of research questions that are independent of existing CPGs). Participants perceived those existing methodological guidelines for PVG development might not provide clear instructions for PVGs developed from multiple CPGs and from de novo development. Challenges to PVG development include (1) a lack of standardized and native guidance on developing PVGs; (2) a lack of standardized guidance on patient engagement; (3) other challenges: no publicly known and trusted platform that could disseminate PVGs; concerns about the conflicting interests with health professionals. CONCLUSIONS AND PRACTICE IMPLICATIONS: Our study suggests clarifying the concept of PVG is the primary task to develop PVGs and carry out related research. There is a need to make PVG developers realize the roles of PVGs, especially in helping decision-making, to maximize the effect of PVG. It is necessary to develop native consensus-based guidance considering developers' perspectives regarding PVGs.

Investigation of a Severe Acute Respiratory Syndrome Coronavirus 2 Delta (B.1.617.2) Variant Outbreak Among Residents of a Skilled Nursing Facility and Vaccine Effectiveness Analysis: Maricopa County, Arizona, June-July 2021.

BACKGROUND: Short-term rehabilitation units present unique infection control challenges because of high turnover and medically complex residents. In June 2021, the Maricopa County Department of Public Health was notified of a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Delta outbreak in a skilled nursing facility short-term rehabilitation unit. We describe the outbreak and assess vaccine effectiveness (VE). METHODS: Facility electronic medical records were reviewed for residents who spent > 1 night on the affected unit between June 10 and July 23, 2021, to collect demographics, SARS-CoV-2 test results, underlying medical conditions, vaccination status, and clinical outcomes. Coronavirus disease 2019 VE estimates using Cox proportional hazards models were calculated. RESULTS: Forty (37%) of 109 short-stay rehabilitation unit residents who met inclusion criteria tested positive for SARS-CoV-2. SARS-CoV-2-positive case-patients were mostly male (58%) and White (78%) with a median age of 65 (range, 27-92) years; 11 (27%) were immunocompromised. Of residents, 39% (10 cases, 32 noncases) received 2 doses and 9% (4 cases, 6 noncases) received 1 dose of messenger RNA (mRNA) vaccine. Among nonimmunocompromised residents, adjusted 2-dose primary-series mRNA VE against symptomatic infection was 80% (95% confidence interval, 15-95). More cases were hospitalized (33%) or died (38%) than noncases (10% hospitalized; 16% died). CONCLUSIONS: In this large SARS-CoV-2 Delta outbreak in a high-turnover short-term rehabilitation unit, a low vaccination rate and medically complex resident population were noted alongside severe outcomes. VE of 2-dose primary-series mRNA vaccine against symptomatic infection was the highest in nonimmunocompromised residents. Health departments can use vaccine coverage data to prioritize facilities for assistance in preventing outbreaks.

University-Associated SARS-CoV-2 Omicron BA.2 Infections, Maricopa County, Arizona, USA, 2022.

We investigated a university-affiliated cohort of SARS-CoV-2 Omicron BA.2 infections in Arizona, USA. Of 44 cases, 43 were among students; 26 persons were symptomatic, 8 sought medical care, but none were hospitalized. Most (55%) persons had completed a primary vaccine series; 8 received booster vaccines. BA.2 infection was mild in this young cohort.

COVID-19 Outbreaks Associated With Youth Club Sports: Maricopa County, Arizona, September-November 2020.

The Maricopa County Department of Public Health in Arizona investigated three COVID-19 outbreaks associated with club sports, two in tournaments and one in a hockey league. During September through November 2020, 195 team-associated and 69 secondary household contact cases were identified among 2093 athletes, coaches, and staff members; the team attack rate ranged from 6% to 72%. Outbreaks occurred during high community transmission periods in Maricopa County. Identification of contacts and characterization of prevention strategies were challenging because of limited cooperation from athletes, families, and staff. (Am J Public Health. 2022;112(2):216-219. https://doi.org/10.2105/AJPH.2021.306579).

The Association Between Weight Gain, Sex, and Immune Activation Following the Initiation of Antiretroviral Therapy.

BACKGROUND: Immune activation persists despite suppressive antiretroviral therapy (ART) and may be affected by sex or body composition. We explored these relationships in a subset of participants who initiated ART in two large randomized trials. METHODS: Purposeful sampling selected participants who achieved virologic suppression on ART and either maintained weight within ± 0.5 kg/m2 or gained 2.6-6.4 kg/m2 from baseline to 96 weeks. We measured 7 markers of inflammation and immune activation at weeks 0 and 96. Multivariable linear regression explored associations of weight gain, sex, and pre-ART BMI with pre-ART and changes in biomarker concentrations. RESULTS: 340 participants were selected; median pre-ART age 42 years, CD4+ cell count 273 cells/mm3, HIV-1 RNA 4.7 log10 copies/mL; 49% were women, 33% white, 42% black, and 24% Hispanic. Among participants with a normal pre-ART BMI, higher pre-ART levels of IL-6, sTNF-RI and RII, CXCL-10, sCD163 and hsCRP were associated with weight gain. Association of weight gain with week 96 changes of these biomarkers differed by sex; women who gained weight had smaller declines in most measured biomarkers compared to men who gained. CONCLUSIONS: Among women, weight gain is associated with attenuated decline in several immune activation markers following ART initiation. Clinical Trials Registration. NCT00811954 and NCT00811954.

Association Between K-12 School Mask Policies and School-Associated COVID-19 Outbreaks - Maricopa and Pima Counties, Arizona, July-August 2021.

CDC recommends universal indoor masking by students, staff members, faculty, and visitors in kindergarten through grade 12 (K-12) schools, regardless of vaccination status, to reduce transmission of SARS-CoV-2, the virus that causes COVID-19 (1). Schools in Maricopa and Pima Counties, which account for >75% of Arizona's population (2), resumed in-person learning for the 2021-22 academic year during late July through early August 2021. In mid-July, county-wide 7-day case rates were 161 and 105 per 100,000 persons in Maricopa and Pima Counties, respectively, and 47.6% of Maricopa County residents and 59.2% of Pima County residents had received at least 1 dose of a COVID-19 vaccine. School districts in both counties implemented variable mask policies at the start of the 2021-22 academic year (Table). The association between school mask policies and school-associated COVID-19 outbreaks in K-12 public noncharter schools open for in-person learning in Maricopa and Pima Counties during July 15-August 31, 2021, was evaluated.

The pro-tumorigenic effects of metabolic alterations in glioblastoma including brain tumor initiating cells.

De-regulated cellular energetics is an emerging hallmark of cancer with alterations to glycolysis, oxidative phosphorylation, the pentose phosphate pathway, lipid oxidation and synthesis and amino acid metabolism. Understanding and targeting of metabolic reprogramming in cancers may yield new treatment options, but metabolic heterogeneity and plasticity complicate this strategy. One highly heterogeneous cancer for which current treatments ultimately fail is the deadly brain tumor glioblastoma. Therapeutic resistance, within glioblastoma and other solid tumors, is thought to be linked to subsets of tumor initiating cells, also known as cancer stem cells. Recent profiling of glioblastoma and brain tumor initiating cells reveals changes in metabolism, as compiled here, that may be more broadly applicable. We will summarize the profound role for metabolism in tumor progression and therapeutic resistance and discuss current approaches to target glioma metabolism to improve standard of care.

Strengthening patient outcome evidence in health technology assessment: a coproduction approach.

The National Institute for Health and Care Excellence (NICE) worked with patients and staff from six patient organizations to review existing health technology assessment (HTA) methods and coproduce proposals to improve the following: patient involvement, how patient evidence is identified and considered by committees, and the support offered to patient stakeholders. This engagement identified important factors that HTA bodies need to understand to enable meaningful patient and public involvement (PPI), such as having clearly documented processes, appropriate evidence submission processes, transparent decisions, and suitable support. This work demonstrated the benefits of HTA bodies working collaboratively with patient stakeholders to improve PPI. By doing so, HTA bodies can increase their knowledge and understanding of the barriers faced by patient stakeholders to develop appropriate solutions to remove them. The coproduction approach improved stakeholder engagement methods, provided a better analysis of data, supported the development of meaningful conclusions, and improved stakeholder relationships.

First Mildly Ill, Nonhospitalized Case of Coronavirus Disease 2019 (COVID-19) Without Viral Transmission in the United States-Maricopa County, Arizona, 2020.

BACKGROUND: Coronavirus disease 2019 (COVID-19) causes a range of illness severity. Mild illness has been reported, but whether illness severity correlates with infectivity is unknown. We describe the public health investigation of a mildly ill, nonhospitalized COVID-19 case who traveled to China. METHODS: The case was a Maricopa County resident with multiple severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-positive specimens collected on 22 January 2020. Contacts were persons exposed to the case on or after the day before case diagnostic specimen collection. Contacts were monitored for 14 days after last known exposure. High-risk contacts had close, prolonged case contact (≥ 10 minutes within 2 m). Medium-risk contacts wore all US Centers for Disease Control and Prevention-recommended personal protective equipment during interactions. Nasopharyngeal and oropharyngeal (NP/OP) specimens were collected from the case and high-risk contacts and tested for SARS-CoV-2. RESULTS: Paired case NP/OP specimens were collected for SARS-CoV-2 testing at 11 time points. In 8 pairs (73%), ≥ 1 specimen tested positive or indeterminate, and in 3 pairs (27%) both tested negative. Specimens collected 18 days after diagnosis tested positive. Sixteen contacts were identified; 11 (69%) had high-risk exposure, including 1 intimate contact, and 5 (31%) had medium-risk exposure. In total, 35 high-risk contact NP/OP specimens were collected for SARS-CoV-2 testing; all 35 pairs (100%) tested negative. CONCLUSIONS: This report demonstrates that SARS-CoV-2 infection can cause mild illness and result in positive tests for up to 18 days after diagnosis, without evidence of transmission to close contacts. These data might inform public health strategies to manage individuals with asymptomatic infection or mild illness.

Economic Abuse and Help-Seeking Intentions Among Adolescents.

Economic adolescent relationship abuse (ARA) includes coercive behaviors leading to interference with education, employment, and finances. To date, no study has examined help seeking among adolescents and young adults if they were to experience economic ARA. The goals of this article include examining: (a) help-seeking intentions of adolescents regarding economic ARA; (b) help-seeking sources and reasons for not seeking help; and (c) differences in help-seeking intentions based on age, race/ethnicity, gender identity, and experiences of economic ARA. We conducted a cross-sectional survey of adolescents ages 13-19 focused on economic ARA experiences and help seeking. We performed descriptive statistics of help-seeking intentions, sources, and barriers. We utilized logistic regression, adjusted for age, race/ethnicity, and gender identity, to explore associations between economic ARA victimization and help-seeking intentions. Of 2,852 participants, 56% said they would seek help for economic ARA. Adolescents with positive help-seeking intentions shared that they would seek help from their parents (43%) or friends (35%). Those less likely to seek help were concerned about others finding out (32%), not being believed (31%), or authority figures being notified (31%). Help-seeking intentions were lower among Black/African American adolescents (aOR = 0.55, CI [0.43, 0.70]) and Multiracial adolescents (aOR = 0.26, CI [0.16, 0.42]) compared to White adolescents. Help-seeking intentions were higher among gender diverse adolescents (aOR = 5.78, CI [2.98, 11.22]) and those ages 15-17 years (aOR = 1.84, CI [1.36, 2.47]) compared to those identifying as female and ages 18-19 years. Help-seeking intentions were lower among adolescents who experienced economic ARA (aOR = 0.61, CI [0.51, 0.72]). While the majority of adolescents reported that they would seek help if they experienced economic ARA, those who had experienced economic ARA were less likely to report intentions to seek help. Supportive interventions for adolescents experiencing economic ARA are needed.

Perinatal Economic Abuse: Experiences, Impacts, and Needed Resources.

Introduction: Economic abuse is one form of intimate partner violence (IPV) intended to control a survivor's ability to make, save, or spend money to gain power over them. Perinatal people may be more vulnerable to economic abuse due to changes in employment and finances. This study's aims were to explore how economic abuse manifests among pregnant and parenting survivors and how best to support pregnant and parenting survivors of economic abuse. Methods: We conducted virtual semistructured interviews with IPV survivors and IPV advocates. Participants were recruited through an online recruitment registry, national IPV organizations, and local domestic violence agencies. Interview audiorecordings were transcribed. We used a deductive-inductive thematic analysis approach. Two research team members individually coded each transcript and met to resolve discrepancies in coding. Results: We completed interviews with 18 advocates and 20 survivors. Participants described experiences of financial control, exploitation, and employment sabotage. Partners leveraged the criminal-legal, child welfare, and health care systems and cultural norms about pregnancy, including those related to gender and religion to financially harm survivors. Advocates described how economic abuse impacts marginalized survivors. Dream resources described include cash assistance, healthy relationship and financial education, and employer policies. Discussion: Survivors and advocates reported a variety of experiences with economic abuse during the perinatal period. Future interventions should focus on providing unrestricted cash transfers to survivors, developing education on economic abuse, and creating supportive policies in health care and employment settings. This study highlights the ways that economic abuse specifically impacts perinatal survivors and their children.

Creating Healing-Centered Spaces for Intimate Partner Violence Survivors in the Postpartum Unit: Examining Current Practices and Desired Resources Among Health Care Providers and Postpartum People.

Background: Intimate partner violence (IPV) has negative health impacts for pregnant people and their infants. Although inpatient postpartum units offer an opportunity to provide support and resources for IPV survivors and their families, to our knowledge, such interventions exist. The goal of this study is to explore (1) how IPV is currently discussed with postpartum people in the postpartum unit; (2) what content should be included and how an IPV intervention should be delivered; (3) how best to support survivors who disclose IPV; and (4) implementation barriers and facilitators. Materials and Methods: We used individual, semistructured interviews with postpartum people and health care providers (HCPs). Interview transcripts were coded and analyzed using an inductive-deductive thematic analysis. Results: While HCPs reported using a variety of practices to support survivors, postpartum people reported that they did not recall receiving resources or education related to IPV while in the inpatient postpartum unit. While HCPs identified a need for screening and disclosure-driven resource provision, postpartum people identified a need for universal IPV resource provision in the postpartum unit to postpartum people and their partners. Participants identified several barriers (i.e., staff capacity, education already provided in the postpartum unit, and COVID-19 pandemic) and facilitators (i.e., continuity of care, various HCPs) to supporting survivors in the postpartum unit. Conclusion: The inpatient postpartum unit is a promising setting to implement an intervention to support IPV survivors and their infants. Future research and intervention development should focus on facilitating universal education and promoting resource provision to IPV survivors.

Policy and Systems Change in Intimate Partner Violence and Human Trafficking: Evaluation of a Federal Cross-Sector Initiative.

Objectives: This study evaluates Project Catalyst's impact on policies related to Intimate Partner Violence (IV) and Human Trafficking (HT), which contribute to negative health outcomes for survivors. Methods: We utilized continuous evaluation using data from policy assessment tools and interviews with participating state leadership team (SLT) members. Results: Five SLTs reported integration of IPV into state-level initiatives. All implemented clinical practice and organizational policy recommendations. SLTs reported that Project Catalyst increased awareness of IPV/HT and health impacts and established ongoing partnerships between the three organizations. Conclusions: Funding, training, and technical assistance to encourage cross-sector collaboration at the state level can promote policy changes that support comprehensive health center responses to IPV/HT.

Using Automation, Prioritization, and Collaboration to Manage a COVID-19 Case Surge in Maricopa County, Arizona, 2020.

During summer 2020, the Maricopa County Department of Public Health (MCDPH) responded to a surge in COVID-19 cases. We used internet-based platforms to automate case notifications, prioritized investigation of cases more likely to have onward transmission or severe COVID-19 based on available preinvestigation information, and partnered with Arizona State University (ASU) to scale investigation capacity. We assessed the speed of automated case notifications and accuracy of our investigation prioritization criteria. Timeliness of case notification-the median time between receipt of a case report at MCDPH and first case contact-improved from 11 days to <1 day after implementation of automated case notification. We calculated the sensitivity and positive predictive value (PPV) of the investigation prioritization system by applying our high-risk prioritization criteria separately to data available pre- and postinvestigation to determine whether a case met these criteria preinvestigation, postinvestigation, or both. We calculated the sensitivity as the percentage of cases classified postinvestigation as high risk that had also been classified as high risk preinvestigation. We calculated PPV as the percentage of all cases deemed high risk preinvestigation that remained so postinvestigation. During June 30 to July 31, 2020, a total of 55 056 COVID-19 cases with an associated telephone number (94% of 58 570 total cases) were reported. Preinvestigation, 8799 (16%) cases met high-risk criteria. Postinvestigation, 17 037 (31%) cases met high-risk criteria. Sensitivity was 52% and PPV was 98%. Automating case notifications, prioritizing investigations, and collaborating with ASU improved the timeliness of case contact, focused public health resources toward high-priority cases, and increased investigation capacity. Establishing partnerships between health departments and academia might be a helpful strategy for future surge capacity planning.

Electronic Patient Portal Access, Retention in Care, and Viral Suppression Among People Living With HIV in Southeastern United States: Observational Study.

BACKGROUND: Approximately 1.1 million people living with HIV live in the United States, and the incidence is highest in Southeastern United States. Electronic patient portal prevalence is increasing and can improve engagement in primary medical care. Retention in care and viral suppression-measures of engagement in HIV care-are associated with decreased HIV transmission, morbidity, and mortality. OBJECTIVE: We aimed to determine if patient portal access among people living with HIV was associated with retention and viral suppression. METHODS: We conducted an observational cohort study among people living with HIV in care at the Vanderbilt Comprehensive Care Clinic (Nashville, Tennessee) from 2011-2016. Individual access was defined as patient portal account registration at any point in the year prior. Retention was defined as ≥2 kept appointments or HIV lab measurements ≥3 months apart within a 12-month period. Viral suppression was defined as the last viral load in the calendar year <200 copies/mL. We calculated adjusted prevalence ratios (aPRs) and 95% CIs using modified Poisson regression with generalized estimating equations to estimate the association of portal access with retention and viral suppression. RESULTS: We included 4237 people living with HIV contributing 16,951 person-years of follow-up (median 5, IQR 3-5 person-years). The median age was 43 (IQR 33-50) years. Of the 4237 people living with HIV, 78.1% (n=4237) were male, 40.8% (n=1727) were Black non-Hispanic, and 56.5% (n=2395) had access. Access was independently associated with retention (aPR 1.13, 95% CI 1.10-1.17) and viral suppression (aPR 1.18, 95% CI 1.14-1.22). CONCLUSIONS: In this population, patient portal access was associated with retention and viral suppression. Future prospective studies should assess the impact of increasing portal access among people living with HIV on these HIV outcomes.

Development of patient versions of guidelines in Chinese mainland: A systematic survey of current practices and methods.

OBJECTIVES: To review current practices and methods underlying the development of patient versions of guidelines (PVGs) in Chinese mainland. METHODS: We systematically searched for PVGs created or published between January 2010 and February 2022. We conducted a framework analysis for the development process and assessed the compliance of PVGs using the Reporting Checklist for Public Versions of Guidelines (RIGHT-PVG). RESULTS: We identified 26 PVGs developed by 16 PVG-working teams. In accordance with the Guidelines International Network (GIN), only two PVGs were translated using one clinical practice guideline (CPG) provided by the CPG-working group source. Several CPGs and other information sources were integrated and translated into a single PVG by other PVG teams. Moreover, we identified various practices described by different PVG teams that could be structured into six steps. Out of the 17 RIGHT-PVG items, five items were fully reported in all PVGs, while two items ("Provide a summary of the PVG" and "Provide a list of terms and abbreviations") were not reported in any of the PVGs. CONCLUSIONS AND PRACTICAL IMPLICATIONS: A relatively small number of PVGs were developed in Chinese mainland. The development of a PVG requires comprehensive methodological guidance based on several CPGs and other sources of information as opposed to only using one.

Twelve-Month Follow-up of Early COVID-19 Cases in the United States: Cellular and Humoral Immune Longevity.

We quantify antibody and memory B-cell responses to severe acute respiratory syndrome coronavirus 2 at 6 and 12 months postinfection among 7 unvaccinated US coronavirus disease 2019 cases. All had detectable S-specific memory B cells and immunoglobulin G at both time points, with geometric mean titers of 117.2 BAU/mL and 84.0 BAU/mL at 6 and 12 months, respectively.

Novel serum proteomic signatures in a non-human primate model of retinal injury.

PURPOSE: To identify candidate protein biomarkers in sera indicative of acute retinal injury. METHODS: We used laser photocoagulation as a model of acute retinal injury in Rhesus macaques. In a paired-control study design, we collected serum from each animal (n=6) at 4 h, 1 day, and 3 days following a mock procedure and then again following retinal laser treatment that produced mild lesions. Samples were fractionated by isoelectric focusing, digested with trypsin, and analyzed by liquid chromatography/tandem mass spectrometry (LC-MS/MS). Spectral counting was used to determine relative protein abundances and identify proteins with statistically significant differences between control and treated sera. RESULTS: Mild retinal injury was confirmed by fundus photography and histological examination. The average number of total proteins detected by LC-MS/MS was 908±82 among samples from all three time points. Following statistical analysis and employing stringent filtering criteria, a total of 19 proteins were identified as being significantly more abundant in sera following laser-induced retinal injury, relative to control sera. Many of the proteins detected were unique to one time point. However, four proteins (phosphoglycerate kinase 1, keratin 18, Lewis alpha-3-fucosyltransferase, and ephrin receptor A2) showed differences that were significant at both 4 h and 1 day after laser treatment, followed by a decrease to baseline levels by day 3. CONCLUSIONS: A serum biomarker response to mild retinal laser injury was demonstrated in a primate model. Among the proteins detected with highest significant differences, most are upregulated within 24 h, and their appearance in the serum is transient. It is conceivable that a panel of these proteins could provide a means for detecting the acute-phase response to retinal injury. Further investigation of these candidate biomarkers and their correlation to retinal damage is warranted.

Fecal Calprotectin Is Elevated in HIV and Related to Systemic Inflammation.

BACKGROUND: Fecal calprotectin (FC), a biomarker of gastrointestinal (GI) inflammation, is used in the diagnosis and management of inflammatory bowel disease. HIV infection severely damages gut-associated lymphoid and epithelial tissues leading to GI inflammation that drives systemic inflammation and increases subsequent risk of comorbidities. For the first time, we compared FC concentrations by HIV and antiretroviral therapy (ART) status and determined the relationship to systemic inflammation. METHODS: People with and without HIV were enrolled and underwent a comprehensive clinical and laboratory assessment. Stool samples were collected, and FC was measured by enzyme-linked immunosorbent assay ELISA. Plasma biomarkers of inflammation were also measured. RESULTS: One hundred one participants with HIV (83 ART-treated and 18 ART-naive) and 89 uninfected controls were enrolled. There were no significant differences between ART-naive and ART-treated participants, but both HIV groups had significantly higher FC concentrations than controls when FC was considered as a continuous variable or by cut-offs used in inflammatory bowel disease. The highest median and largest proportion of participants with FC >100 µg/g were seen in ART-naive, followed by ART-treated and then controls. Among HIV participants, FC concentrations were positively associated with high-sensitivity C-reactive protein, soluble tumor necrosis factor receptor II, and soluble vascular cellular adhesion molecule and inversely associated with CD4 counts. CONCLUSIONS: FC concentrations are elevated in HIV regardless of ART status. ART and immune reconstitution seem to reduce FC but not to concentrations seen in uninfected controls. Our results suggest a role for FC as a noninvasive surrogate measurement of GI inflammation and associated systemic inflammation in HIV.