Impacts of COVID-19 on Young Children and Families: A Qualitative Study Using Best Starts for Kids Health Survey Data in King County, WA.

OBJECTIVES: To evaluate the impacts of the COVID-19 pandemic on parents and caregivers with young children in King County, Washington using data from a local population-based survey, the Best Starts for Kids Health Survey (BSKHS). METHODS: 7033 parents and caregivers in King County, Washington with children 5th grade and younger participated in the BSKHS in 2021. Three evaluators adopted a framework method approach to thematic analysis for open-ended survey responses regarding the impacts of COVID-19 on families. RESULTS: Children aged 0-5 years missed important social development opportunities, while elementary-school children missed social interactions and felt isolated during remote schooling. Parents were exhausted by the competing demands of work and schooling/childcare, with mothers bearing the brunt of additional responsibilities. Many families faced financial uncertainty and were unable to meet basic needs. Yet, families were grateful for more quality time with family members. CONCLUSIONS FOR PRACTICE: Parents expressed that children aged 0-5 years missed out on social development opportunities with both adults and children their own age and elementary-school children and felt isolated while schools were closed to in-person schooling.

A Good Farewell? Positive Exits from Federal Housing Assistance and Lower Acute Healthcare Utilization.

Little is known regarding the health outcomes of people who exit from housing assistance and if that experience varies by the circumstances under which a person exits. We asked two questions: (1) does the type of exit from housing assistance matter for healthcare utilization? And (2) how does each exit type compare to remaining in housing assistance in terms of healthcare utilization? This retrospective cohort study of 5550 exits between 2012 and 2018 used data from two large, urban public housing authorities in King County, Washington. Exposures were exiting from housing assistance and type of exit (positive, neutral, negative). Outcomes were emergency department visits, hospitalizations, and well-child checks (among those aged < 6) in the year following exit from housing assistance. After adjustment for demographics and baseline healthcare utilization, people with positive exits had 26% (95% confident interval: 6-39%) lower odds of having 1 + ED visits in the year following exit than people with negative exits and 20% (95% CI: 6-31%) lower odds than those who continued receiving housing assistance. Neutral and negative exits did not differ substantially from each other, and both exit types appear to be detrimental to health, with higher levels of ED visits and hospitalizations and lower levels of well-child checks. Why people exit from housing assistance matters. Those with negative exits experience poorer outcomes and efforts should be made to both prevent this kind of exit and mitigate its impact.

Linking Health and Housing Data to Create a Sustainable Cross-Sector Partnership.

In response to the growing regional (and national) focus on health and housing intersections, two public housing authorities (PHAs) in Washington-the King County Housing Authority and the Seattle Housing Authority-joined with Public Health-Seattle & King County to form the Housing and Health (H&H) partnership in 2016. H&H linked Medicaid health claims with PHA administrative data to create a sustainable public-facing dashboard that informs health and housing stakeholders such as an Accountable Community of Health (a governing body that oversees local Medicaid transformation projects), managed care organizations, and PHAs, allowing insights into the low-income communities they serve.

The ICMJE Recommendations and pharmaceutical marketing--strengths, weaknesses and the unsolved problem of attribution in publication ethics.

BACKGROUND: The International Committee of Medical Journal Editors (ICMJE) Recommendations set ethical and editorial standards for article publication in most leading medical journals. Here, I examine the strengths and weaknesses of the Recommendations in the prevention of commercial bias in industry-financed journal literature, on three levels - scholarly discourse, article content, and article attribution. DISCUSSION: With respect to overall discourse, the most important measures in the ICMJE Recommendations are for enforcing clinical trial registration and controlling duplicate publication. With respect to article content, the ICMJE promotes stringent author accountability and adherence to established reporting standards. However, the ICMJE accepts the use of commercial editorial teams to produce manuscripts, which is a potential source of bias, and accepts private company ownership and analysis of clinical trial data. New ICMJE guidance on data sharing will address but not eliminate problems of commercial data access. With respect to attribution, the Recommendations oppose guest authorship and encourage clear documentation of author contributions. However, they exclude writers from coauthorship; provide no specific advice on the attribution of commercial literature, for instance with respect to company authorship, author sequence or prominent commercial labeling; and endorse the use of fine print and euphemism. The ICMJE requires detailed author interest disclosures, but overlooks the interests of non-authors and companies, and does not recommend that interests most salient to the publication are highlighted. Together, these weaknesses facilitate "advocacy"-based marketing, in which literature planned, financed and produced by companies is fronted by academics, enabling commercial messages to be presented to customers by their respected clinical peers rather than companies themselves. CONCLUSIONS: The ICMJE Recommendations set important research and reporting standards, without which commercial bias would likely be a significantly greater problem than it is today. However, they also support practices of commercial data control, content development and attribution that run counter to science's values of openness, objectivity and truthfulness. These weaknesses could be addressed with appropriate modifications to the Recommendations. The ICMJE should also disclose its own commercial interests and funding - not least because publishing organizations that finance it and pay the salaries of some member editors derive substantial revenues from industry.

Deconstructing the differences: a comparison of GBD 2010 and CHERG's approach to estimating the mortality burden of diarrhea, pneumonia, and their etiologies.

BACKGROUND: Pneumonia and diarrhea are leading causes of death for children under five (U5). It is challenging to estimate the total number of deaths and cause-specific mortality fractions. Two major efforts, one led by the Institute for Health Metrics and Evaluation (IHME) and the other led by the World Health Organization (WHO)/Child Health Epidemiology Reference Group (CHERG) created estimates for the burden of disease due to these two syndromes, yet their estimates differed greatly for 2010. METHODS: This paper discusses three main drivers of the differences: data sources, data processing, and covariates used for modelling. The paper discusses differences in the model assumptions for etiology-specific estimates and presents recommendations for improving future models. RESULTS: IHME's Global Burden of Disease (GBD) 2010 study estimated 6.8 million U5 deaths compared to 7.6 million U5 deaths from CHERG. The proportional differences between the pneumonia and diarrhea burden estimates from the two groups are much larger; GBD 2010 estimated 0.847 million and CHERG estimated 1.396 million due to pneumonia. Compared to CHERG, GBD 2010 used broader inclusion criteria for verbal autopsy and vital registration data. GBD 2010 and CHERG used different data processing procedures and therefore attributed the causes of neonatal death differently. The major difference in pneumonia etiologies modeling approach was the inclusion of observational study data; GBD 2010 included observational studies. CHERG relied on vaccine efficacy studies. DISCUSSION: Greater transparency in modeling methods and more timely access to data sources are needed. In October 2013, the Bill & Melinda Gates Foundation (BMGF) hosted an expert meeting to examine possible approaches for better estimation. The group recommended examining the impact of data by systematically excluding sources in their models. GBD 2.0 will use a counterfactual approach for estimating mortality from pathogens due to specific etiologies to overcome bias of the methods used in GBD 2010 going forward.

Care-seeking and appropriate treatment for childhood acute respiratory illness: an analysis of Demographic and Health Survey and Multiple Indicators Cluster Survey datasets for high-mortality countries.

BACKGROUND: Acute lower respiratory illness (ALRI) is a major global cause of morbidity and mortality among children under 5. Antibiotic treatment for ALRI is inexpensive and decreases case fatality, but care-seeking patterns and appropriate treatment vary widely across countries. This study sought to examine patterns of appropriate treatment and estimate the burden of cases of untreated ALRI in high mortality countries. METHODS: This study used cross-sectional survey data from the Phase 5/Phase 6 DHS and MIC3/MICS4 for 39 countries. We analyzed care-seeking patterns and antibiotic treatment based on country-level trends, and estimated the burden of untreated cases using country-level predictors in a general linear model. RESULTS: According to this analysis, over 66 million children were not treated with antibiotics for ALRI in 2010. Overall, African countries had a lower proportion of mothers who sought care for a recent episode of ALRI (41% to 86%) relative to Asian countries (75% to 87%). Seeking any care for ALRI was inversely related to seeking public sector care. Treatment with antibiotics ranged from 8% in Nepal to 87% in Jordan, and was significantly associated with urban residence. CONCLUSIONS: Untreated ALRI remains a substantial problem in high mortality countries. In Asia, the large population numbers lead to a high burden of children with untreated ALRI. In Africa, care-seeking behaviors and access to care issues may lead to missed opportunities to treat children with antibiotics.

The "Monsanto papers" and the nature of ghostwriting and related practices in contemporary peer review scientific literature.

The Monsanto company - now acquired by Bayer - has been accused of ghostwriting articles within peer review literature, with the goal of using influential names to front its content in defence of the herbicide Roundup. Here, I conduct a detailed analysis of three Monsanto review articles and a five-article journal supplement for which detailed information from company emails is publicly available following litigation over Roundup. All the articles had external, but not Monsanto authors, and ghostly practices including ghost authorship, corporate ghost authorship and ghost management were evident in their development. There was clear evidence of ghostwriting - that is, drafting of the manuscript by non-authors - in only two cases. I found no evidence of undeserving authorship among the external authors. The articles complied with the disclosure requirements of their journals, save for the journal supplement. While crude ghostwriting did occur, much of the literature involved subtler practices through which Monsanto exercised control over content, while the attribution of the articles downplayed the company's role - and correspondingly aggrandized that of the external authors. Such practices are widespread within industry journal literature and are the responsibility of byline authors and journals as well as corporations. I discuss these cultural problems and consider remedies.

Attribution and credit bias in publication ethics.

In this article, I argue that many of the ethical problems associated with the authorship of journal literature can usefully be clarified if authorship is placed within the broader concept of attribution, which extends beyond the author byline to encompass everything that readers are told about the work's origination and the parties responsible. I also suggest that as the attribution of literature has grown more complex, and the opportunities for misattribution have become more subtle and multifarious, attribution has become increasingly vulnerable to systematic bias. Accordingly, I define "credit bias" as the systematic distortion of attribution, frequently in the interests of those with influence over the publication. I present a four-step framework for evaluating publications, discuss misattribution in drug industry literature as an illustration of credit bias, and examine the role of editorial standards in mitigating, but also in assisting, credit bias. I also argue for an independent scientific standard to promote ethical conduct in the medical journal sector.

Clinical Trial Endpoints in Metastatic Cancer: Using Individual Participant Data to Inform Future Trials Methodology.

Meta-analysis based on individual participant data (IPD) is a powerful methodology for synthesizing evidence by combining information drawn from multiple trials. Hitherto, its principal application has been in questions of clinical management, but an increasingly important use is in clarifying trials methodology, for instance in the selection of endpoints, as discussed in this review. In oncology, the Aide et Recherche en Cancérologie Digestive (ARCAD) Metastatic Colorectal Cancer Database is a leader in the use of IPD-based meta-analysis in methodological research. The ARCAD database contains IPD from more than 38 000 patients enrolled in 46 studies and continues to collect phase III trial data. Here, we review the principal findings of the ARCAD project in respect of endpoint selection and examine their implications for cancer trials. Analysis of the database has confirmed that progression-free survival (PFS) is no longer a valid surrogate endpoint predictive of overall survival in the first-line treatment of colorectal cancer. Nonetheless, PFS remains an endpoint of choice for most first-line trials in metastatic colorectal cancer and other solid tumors. Only substantial PFS effects are likely to translate into clinically meaningful benefits, and accordingly, we advocate an oncology research model designed to identify highly effective treatments in carefully defined patient groups. We also review the use of the ARCAD database in assessing clinical response including novel response metrics and prognostic markers. These studies demonstrate the value of IPD as a tool for methodological studies and provide a reference point for the expansion of this approach within clinical cancer research.

Five steps for structural reform in clinical cancer research.

Despite advances in the prevention and early detection of cancer and the treatment of some malignancies, clinical research has not yet delivered treatment benefits of the magnitude anticipated after the launch of imatinib, which established highly effective new treatment standards. The primary impediments to progress are scientific, but the efficiency of research is also affected by structural deficiencies relating to where and by whom it is conducted, as well as how it is organized and regulated. To optimize the research environment and maximize the benefits of improved funding, adjustments in the roles of government, industry, the academic community, national research bodies, and regulatory authorities are needed. A patchwork of reforms that are enabling in character and build on existing expertise can deliver substantial progress without the need for radical intervention.

No Evidence of Acute Dengue Virus Infections at a Rural Site in Western Kenya, 2011 and 2013.

The incidence and spread of dengue virus (DENV) have increased rapidly in recent decades. Dengue is underreported in Africa, but recent outbreaks and seroprevalence data suggest that DENV is widespread there. A lack of ongoing surveillance limits knowledge about its spatial reach and hinders disease control planning. We sought to add data on dengue distribution in Kenya through diagnostic testing of serum specimens from persons with an acute febrile illness (AFI) attending an outpatient clinic in rural western Kenya (Asembo) during rainy seasons. Patients with symptoms not likely to be misclassified as dengue (e.g., diarrhea and anemia), those with a positive diagnostic laboratory results which explained their febrile illness, or those with serum collected more than 5 days after fever onset were excluded. However, febrile patients with a positive malaria smear were included in the study. We used reverse transcription polymerase chain reaction (RT-PCR) to test for DENV and IgM anti-DENV to test for recent infection. Of the 615 serum specimens available for testing, none were dengue positive by either RT-PCR or IgM anti-DENV testing. Dengue did not appear to be a cause of febrile illness in this area of western Kenya, although our relatively small sample size may not have identified DENV infections occurring at low incidence. A more widespread AFI surveillance system that includes dengue diagnostic testing by RT-PCR and antibody-based methods is required to more definitively gauge the size and geographic distribution of DENV infection in western Kenya.

Can self-regulation deliver an ethical commercial literature? A critical reading of the "Good Publication Practice" (GPP3) guidelines for industry-financed medical journal articles.

Much medical journal literature is developed by the pharmaceutical and device industries, sometimes with assistance from marketing agencies, writers, and academics. This literature is vulnerable to commercial bias. The publications trade issues self-regulatory ethical guidelines for its production, called "Good Publication Practice" (GPP). I evaluated the most recent iteration, GPP3. The most progressive recommendations in GPP3 call for complete publication of all clinical trials, and full data sharing. GPP3 makes numerous further recommendations more directly concerning the publications trade. Many of these repeat existing editorial requirements, chiefly those of the International Committee of Medical Journal Editors, but readers are not adequately advised of this. Despite its emphasis on ethical and transparent reporting, the detail of GPP3 enables continued use of academic medical literature for drug marketing, on the basis of commercial steerage of content, coupled with the attribution of published articles to collaborating academic authors. As such, GPP3 provides a de facto manual for how marketing through academic journal content can be conducted in compliance with contemporary editorial standards. Consequently, the self-regulatory GPP3 guidelines are not a sound basis for the production of unbiased industry-financed medical journal literature. I suggest improvements for future iterations of these influential guidelines.

Marketing trials, marketing tricks - how to spot them and how to stop them.

BACKGROUND: Last this year in this journal, Barbour and colleagues reported a study of "marketing trials" in leading medical journals (Trials 2016;17:31). In this commentary I discuss their research, describe new analyses of the study cohort and consider measures to address marketing within academic medical literature. DISCUSSION: Barbour et al. sought to identify a subgroup of "marketing trials" within leading medical journals, but in reality, nearly all industry-financed trials serve marketing functions, and many exhibit marketing-related features, including biases, in their framing, methodology or reporting. I conducted new analyses of the cohort of Barbour et al., showing that most trials funded exclusively by drug manufacturers had direct involvement of the manufacturer in design, analysis and reporting, and features supportive of product seeding. However, these commercial enterprises were without exception presented to journal readers as academic-led projects, using attributional spin, which should itself be considered an important form of marketing bias. Barbour et al. correctly conclude that commercial bias in industry clinical trials articles often requires expertise to recognize, and in many cases cannot be identified from the published journal report. Several potential remedies are discussed, including independent clinical research, data sharing, improved reporting guidance, improved tools for assessing research quality, reforms to article attribution, submission checklists and new editorial standards. CONCLUSION: Medicine's journals have a responsibility to uphold rigorous scientific and reporting standards, require ready trials data access and ensure the commercial dimensions of research are brought prominently to their readers' attention. Failure to meet these responsibilities constitutes an enduring threat to the integrity of biomedical literature.

The Disposable Author: How Pharmaceutical Marketing Is Embraced within Medicine's Scholarly Literature.

The best studies on the relationship between pharmaceutical corporations and medicine have recognized that it is an ambiguous one. Yet most scholarship has pursued a simpler, more saleable narrative in which pharma is a scheming villain and medicine its maidenly victim. In this article, I argue that such crude moral framing blunts understanding of the murky realities of medicine's relationship with pharma and, in consequence, holds back reform. My goal is to put matters right in respect to one critical area of scholarly interest, the medical journal publication. Pharma relies on peer advocacy to sell its wares to prescribing doctors. This is an arrangement in which clinicians' qualified colleagues, including "key opinion leaders," are recruited by pharmaceutical corporations and marketing agencies to deliver commercially expedient content to their professional fellows. Precisely how this practice works in the setting of publications is not well understood because ethicists studying the problem have made too much of the narrative of corporate villainy and medical victimhood. Accordingly, criticism of industry publications has been preoccupied with the crudely dishonest practices of ghostwriting, ghost authorship, and "ghost management," vices condemned as "dirty little secrets" perpetrated from "behind the scenes" with the connivance of academic "shills" or "guest authors," in contempt of standards set by the International Committee of Medical Journal Editors. This account is appealing, and yet it is wrong or, at the very least, seriously incomplete, with only limited relevance to the actualities of contemporary industry practices. In truth, many commercial publications are not developed in secret but fashioned within a culture of open collaboration, where academic authors make substantial, independent contributions; pharmaceutical companies are showcased rather than hidden; and medicine's editorial standards assist rather than impede the workings of commerce.

Environmental Transmission of Typhoid Fever in an Urban Slum.

BACKGROUND: Enteric fever due to Salmonella Typhi (typhoid fever) occurs in urban areas with poor sanitation. While direct fecal-oral transmission is thought to be the predominant mode of transmission, recent evidence suggests that indirect environmental transmission may also contribute to disease spread. METHODS: Data from a population-based infectious disease surveillance system (28,000 individuals followed biweekly) were used to map the spatial pattern of typhoid fever in Kibera, an urban informal settlement in Nairobi Kenya, between 2010-2011. Spatial modeling was used to test whether variations in topography and accumulation of surface water explain the geographic patterns of risk. RESULTS: Among children less than ten years of age, risk of typhoid fever was geographically heterogeneous across the study area (p = 0.016) and was positively associated with lower elevation, OR = 1.87, 95% CI (1.36-2.57), p <0.001. In contrast, the risk of typhoid fever did not vary geographically or with elevation among individuals more than ten years of age [corrected]. CONCLUSIONS: Our results provide evidence of indirect, environmental transmission of typhoid fever among children, a group with high exposure to fecal pathogens in the environment. Spatially targeting sanitation interventions may decrease enteric fever transmission.

Integrated disease prevention campaigns: assessing country opportunity for implementation via an index approach.

OBJECTIVES: To help stakeholders identify and prioritise countries with the best opportunities for implementation of an integrated prevention campaign (IPC) focused on diarrhoea, malaria and HIV prevention. DESIGN: Cross-sectional analysis of country-specific epidemiological data using an index tool developed for this purpose. SETTING: We calculated the total disability-adjusted life years (DALYs) attributed to diarrhoea, malaria and HIV for 214 World Bank economies. Criteria for inclusion were: low-income and middle-income countries, and total annual DALY burden in the top tertile (≥87 000 DALYs). 70 countries met inclusion criteria and were included in our opportunity analysis. OUTCOME MEASURES: We synthesised data on 10 indicators related to the potential reduction in burden and new coverage achievable by an IPC. We scored and ranked countries based on three summary opportunity metrics: DALYs per capita across the diseases, a composite score of tertile rankings of burden for each disease, and a score combining burden and intervention opportunity. RESULTS: We estimated the total annual global burden attributable to diarrhoea, malaria and HIV at 135 million DALYs. All of the countries with the highest opportunity for implementation of a diarrhoea, malaria and HIV IPC are in sub-Saharan Africa, regardless of opportunity metric used. Although the overall rank order changes, 16 countries rank among the top 23 highest opportunity countries for all three metrics. CONCLUSIONS: Stakeholders can use this objective metric-based approach to prioritise countries for IPC scale-up. Priority countries are largely robust to the opportunity metric chosen.

Prioritizing countries for interventions to reduce child mortality: tools for maximizing the impact of mass drug administration of azithromycin.

BACKGROUND: As new interventions to reduce childhood mortality are identified, careful consideration must be given to identifying populations that could benefit most from them. Promising reductions in childhood mortality reported in a large cluster randomized trial of mass drug administration (MDA) of azithromycin (AZM) prompted the development of visually compelling, easy-to-use tools that synthesize country-specific data on factors that would influence both potential AZM benefit and MDA implementation success. METHODOLOGY/PRINCIPAL FINDINGS: We assessed the opportunity to reduce mortality and the feasibility of implementing such a program, creating Opportunity and Feasibility Indices, respectively. Countries with high childhood mortality were included. A Country Ranking Index combined key variables from the previous two Indices and applied a scoring system to identify high-priority countries. We compared four scenarios with varying weights given to each variable. Twenty-five countries met inclusion criteria. We created easily visualized tools to display the results of the Opportunity and Feasibility Indices. The Opportunity Index revealed substantial variation in the opportunity for an MDA of AZM program to reduce mortality, even among countries with high overall childhood mortality. The Feasibility Index demonstrated that implementing such a program would be most challenging in the countries that could see greatest benefit. Based on the Country Ranking Index, Equatorial Guinea would benefit the most from the MZA of AZM in three of the four scenarios we tested. CONCLUSIONS/SIGNIFICANCE: These visually accessible tools can be adapted or refined to include other metrics deemed important by stakeholders, and provide a quantitative approach to prioritization for intervention implementation. The need to explicitly state metrics and their weighting encourages thoughtful and transparent decision making. The objective and data-driven approach promoted by the three Indices may foster more efficient use of resources.