Reviewing fair subject selection considerations for the unique case of post sequelae COVID-19 translational studies.

Fair inclusion of research subjects is necessary to ensure that post-acute sequelae COVID-19 (PASC) research results benefit all members of society. Scientists should conduct research on a broad sample of individuals who represent clinically relevant factors influencing a disease. Without demographic diversity and sociological and environmental variability, research outputs are less likely to apply to different populations and would thus increase health disparities. The goal of this narrative literature review and ethical analysis is to apply fair selection criteria to PASC research studies. We briefly highlight the importance of fair subject selection in translational research and then identify features of PASC, as well as PASC research, that hinder fair inclusion of research participants. We will demonstrate that determining an adequate and representative sample is not simply a matter of ensuring greater diversity; rather, fairness requires a broader evaluation of risks, burdens, and benefits specific to underrepresented populations. We provide recommendations to ensure fair subject selection in PASC research and promote translation toward positive health outcomes for all individuals, including the most vulnerable.

Evaluation of a single-pass with biphasic intravenous contrast medium injection CT protocol for the assessment of complications post-simultaneous pancreas-kidney transplant.

AIM: To evaluate the use of a single-pass with biphasic intravenous contrast medium injection computed tomography (CT) protocol to provide diagnostic quality CT studies for the assessment of complications post-simultaneous pancreas-kidney transplant (SPK). MATERIALS AND METHODS: This was an audit of practice and the need for informed consent was waived. The protocol was used in consecutive patients undergoing CT to exclude intra-abdominal sepsis post-SPK between June and December 2015. Single CT acquisition of the abdomen and pelvis was initiated 70 seconds after the start of biphasic contrast medium injection (66 ml at 1.2 ml/s, followed by 34 ml at 2.4 ml/s, 370 mg iodine/ml). The named transplant pancreas vessels were identified and the attenuation values of the blood within were measured. Diagnostic quality was confirmed if values were >211 HU and >80 HU in the arteries and veins, respectively. RESULTS: Thirteen CT studies were performed in 10 patients. CT studies were excluded due to complete pancreatic necrosis, and transplant superior mesenteric artery (SMA) thrombus with pancreatic head ischaemia causing effacement of the transplant superior mesenteric vein (SMV). Diagnostic quality of the analysed CT studies were confirmed with mean attenuation value of blood >211 HU in the transplant pancreatic arteries (SMA=259.0±51.4 HU, splenic artery=245.3±37.5 HU), and >80 HU in the pancreatic veins (SMV=195.4±36.2 HU, splenic vein=185.1±54.2 HU). CONCLUSION: Diagnostic quality CT studies were obtained using the single-pass CT protocol. Radiation exposure to patients may be reduced with this protocol, while permitting simultaneous assessment of parenchymal and vascular complications post-SPK.

Evaluation of mammographic surveillance services in women aged 40-49 years with a moderate family history of breast cancer: a single-arm cohort study.

BACKGROUND: Women with a significant family history of breast cancer are often offered more intensive and earlier surveillance than is offered to the general population in the National Breast Screening Programme. Up to now, this strategy has not been fully evaluated. OBJECTIVE: To evaluate the benefit of mammographic surveillance for women aged 40-49 years at moderate risk of breast cancer due to family history. The study is referred to as FH01. DESIGN: This was a single-arm cohort study with recruitment taking place between January 2003 and February 2007. Recruits were women aged < 50 years with a family history of breast or ovarian cancer conferring at least a 3% risk of breast cancer between ages 40 and 49 years. The women were offered annual mammography for at least 5 years and observed for the occurrence of breast cancer during the surveillance period. The age group 40-44 years was targeted so that they would still be aged < 50 years after 5 years of surveillance. SETTING: Seventy-four surveillance centres in England, Wales, Scotland and Northern Ireland. PARTICIPANTS: A total of 6710 women, 94% of whom were aged < 45 years at recruitment, with a family history of breast cancer estimated to imply at least a 3% risk of the disease between the ages of 40 and 50 years. INTERVENTIONS: Annual mammography for at least 5 years. MAIN OUTCOME MEASURES: The primary study end point was the predicted risk of death from breast cancer as estimated from the size, lymph node status and grade of the tumours diagnosed. This was compared with the control group from the UK Breast Screening Age Trial (Age Trial), adjusting for the different underlying incidence in the two populations. RESULTS: As of December 2010, there were 165 breast cancers diagnosed in 37,025 person-years of observation and 30,556 mammographic screening episodes. Of these, 122 (74%) were diagnosed at screening. The cancers included 44 (27%) cases of ductal carcinoma in situ. There were 19 predicted deaths in 37,025 person-years in FH01, with an estimated incidence of 6.3 per 1000 per year. The corresponding figures for the Age Trial control group were 204 predicted deaths in 622,127 person-years and an incidence of 2.4 per 1000 per year. This gave an estimated 40% reduction in breast cancer mortality (relative risk = 0.60; 95% confidence interval 0.37 to 0.98; p = 0.04). CONCLUSIONS: Annual mammography in women aged 40-49 years with a significant family history of breast or ovarian cancer is both clinically effective in reducing breast cancer mortality and cost-effective. There is a need to further standardise familial risk assessment, to research the impact of digital mammography and to clarify the role of breast density in this population. TRIAL REGISTRATION: National Research Register N0484114809. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 17, No. 11. See the HTA programme website for further project information.

Cost effectiveness of strategies to combat chronic obstructive pulmonary disease and asthma in sub-Saharan Africa and South East Asia: mathematical modelling study.

OBJECTIVES: To determine the population level costs, effects, and cost effectiveness of selected, individual based interventions to combat chronic obstructive pulmonary disease (COPD) and asthma in the context of low and middle income countries. DESIGN: Sectoral cost effectiveness analysis using a lifetime population model. SETTING: Two World Health Organization sub-regions of the world: countries in sub-Saharan Africa with very high adult and high child mortality (AfrE); and countries in South East Asia with high adult and high child mortality (SearD). DATA SOURCES: Disease rates and profiles were taken from the WHO Global Burden of Disease study; estimates of intervention effects and resource needs were drawn from clinical trials, observational studies, and treatment guidelines. Unit costs were taken from a WHO price database. MAIN OUTCOME MEASURES: Cost per disability adjusted life year (DALY) averted, expressed in international dollars ($Int) for the year 2005. RESULTS: In both regions low dose inhaled corticosteroids for mild persistent asthma was considered the most cost effective intervention, with average cost per DALY averted about $Int2500. The next best value strategies were influenza vaccine for COPD in Sear-D (incremental cost $Int4950 per DALY averted) and low dose inhaled corticosteroids plus long acting ß agonists for moderate persistent asthma in Afr-E (incremental cost $Int9112 per DALY averted). CONCLUSIONS: COPD is irreversible and progressive, and current treatment options produce relatively little gains relative to the cost. The treatment options available for asthma, however, generally decrease chronic respiratory disease burden at a relatively low cost.

Selection against small males in utero: a test of the Wells hypothesis.

BACKGROUND: The argument that women in stressful environments spontaneously abort their least fit fetuses enjoys wide dissemination despite the fact that several of its most intuitive predictions remain untested. The literature includes no tests, for example, of the hypothesis that these mechanisms select against small for gestational age (SGA) males. METHODS: We apply time-series modeling to 4.9 million California male term births to test the hypothesis that the rate of SGA infants in 1096 weekly birth cohorts varies inversely with labor market contraction, a known stressor of contemporary populations. RESULTS: We find support for the hypothesis that small size becomes less frequent among term male infants when the labor market contracts. CONCLUSIONS: Our findings contribute to the evidence supporting selection in utero. They also suggest that research into the association between maternal stress and adverse birth outcomes should acknowledge the possibility that fetal loss may affect findings and their interpretation. Strengths of our analyses include the large number and size of our birth cohorts and our control for autocorrelation. Weaknesses include that we, like nearly all researchers in the field, have no direct measure of fetal loss.

Evidence-based design for a safer environment without construction.

This article explores the implementation of evidence-based design elements in the renovation of 1 patient room on a budget of $3500. The functional mock-up was evaluated through survey and focus groups by staff, visitors, and physicians to identify problematic features. Overall, participants perceived that design elements were effective with only minor modification needed before replication. Suggestions are provided for ways to implement evidence-based design with limited funds.

Linking economics and quality: developing an evidence-based nurse staffing tool.

The evidence linking nurse staffing with patient outcomes has been established; however, incorporating the evidence into practice is lagging. This article describes a practice/academic collaborative initiated to promote the translation of staffing research into decision-making through the development of an evidence-based staffing tool. Reports of previous research on nurse staffing and patient and financial outcomes are summarized, and aspects of the 2 phases of the collaborative to date are discussed. In the initial phase, a pilot research study on nurse staffing and patient outcomes in medical-surgical units support previous findings that higher nurse staffing results in positive patient outcomes. The focus in the current phase is expansion of the pilot research and the development of a decision-making staffing tool based on the additional staffing research. Identifying the critical data elements and sources of the data are major challenges to achieving the project objectives. Other challenges are maintaining interest and creating wide-spread understanding of the importance of nurse managers having access to timely, useable information. The success of the collaborative is due to the commitment and participation of leaders from various disciplines in both organizations.

Inequalities in access to education and healthcare.

The burden of disease is borne by those who suffer as patients but also by society at large, including health service providers. That burden is felt most severely in parts of the world where there is no infrastructure, or foreseeable prospects of any, to change the status quo without external support. Poverty, disease and inequality pervade all the activities of daily living in low-income regions and are inextricably linked. External interventions may not be the most appropriate way to impact on this positively in all circumstances, but targeted programmes to build social capital, within and by countries, are more likely to be sustainable. By these means, basic oral healthcare, underpinned by the primary healthcare approach, can be delivered to more equitably address needs and demands. Education is fundamental to building knowledge-based economies but is often lacking in such regions even at primary and secondary level. Provision of private education at tertiary level may also introduce its own inequities. Access to distance learning and community-based practice opens opportunities and is more likely to encourage graduates to work in similar areas. Recruitment of faculty from minority groups provides role models for students from similar backgrounds but all faculty staff must be involved in supporting and mentoring students from marginalized groups to ensure their retention. The developed world has to act responsibly in two crucial areas: first, not to exacerbate the shortage of skilled educators and healthcare workers in emerging economies by recruiting their staff; second, they must offer educational opportunities at an economic rate. Governments need to lead on developing initiatives to attract, support and retain a competent workforce.

The economic impact of chronic diseases: how do households respond to shocks? Evidence from Russia.

The epidemiological burden of chronic diseases is increasing worldwide and there is very little empirical evidence regarding the economic impact of chronic diseases on individuals and households. The primary objective of this paper is to explore the evidence on how chronic diseases affect household healthcare expenditure, non-health consumption, labour (earned) income, and to demonstrate how transfers may provide some insurance against shocks from chronic diseases. We have explicated a two-part Heckit model on household level data obtained from the Living Standard Measurement Surveys (LSMS) from Russia to control for nontrivial proportion of zeros in the dependent variables, skewed distribution of expenditure data and endogeneity. The results indicate that chronic diseases are significantly associated with higher levels of household healthcare expenditure in Russia and productivity losses reflected by reduced labour supply and reduced household labour income. Non-healthcare expenditure also increased. Results suggest that households are able to insure non-health consumption against chronic diseases, possibly from transfers, which also increased. In addition, socioeconomic status indicators significantly explained the impact of chronic diseases on households. Insurance and higher average education in households were associated with higher healthcare expenditure. Household transfers were significant in Russia despite an appreciable level of insurance cover. We conclude that households depend on informal coping mechanisms in the face of chronic diseases, irrespective of insurance cover. These results have implications for policies regarding the financing of treatment and control of chronic diseases in the country studied.

Pathways of decision making among Yucatan Mayan traditional birth attendants.

In rural, developing world communities, women are often isolated from biomedical services. Frequently, traditional birth attendants (TBAs) are the only caregivers during childbirth, both normal and complicated. Women trust their TBAs to manage their births. Globally, government and non-governmental organizations (NGOs) have sought to upgrade TBAs' skills and to encourage them to refer complications. However, most training programs have failed to change TBAs' practice substantially. Logistical barriers in reaching biomedical services in a timely manner are a key issue. Another is the difference between biomedical and traditional practitioners in the cognitive frameworks that shape decision making and management behaviors. The purpose of this study, conducted in Quintana Roo State, Mexico, was to listen to the voices of practicing Yucatec Maya TBAs (parteras) as they described decision making and management of complicated births. In-depth interviews with six practicing parteras in rural, isolated communities revealed that the parteras used traditional Maya ethnomedicine while valuing biomedical approaches. We isolated themes in decision making and mapped management of birth complications. Integrating TBAs' traditional knowledge into biomedical training programs is one way to honor their knowledge and make training relevant.

Patient satisfaction with two different models of cancer genetic services in south-east Scotland.

There is a need to integrate primary- and secondary-care cancer genetic services, but the most appropriate model of service delivery remains unclear. This study reports patients' expectations of breast cancer genetic services and a comparison of their satisfaction with two service models. In the first model, risk assessment was carried out using mailed family history data. Women estimated as being at high/moderate risk were offered an appointment at the familial breast cancer clinic, and those at low risk were sent a letter of reassurance. In the second model, all women were seen by a genetic nurse specialist, who assessed risk, referred high/moderate-risk women to the above clinic and discharged those at low risk. Over 60% of all women in the study regarded access to breast screening by mammogram and regular check-ups as very important. This underlines the demand for a multidisciplinary service providing both clinical genetic and surgical services. Satisfaction was high with both models of service, although significantly lower among women not at increased cancer risk and thus not offered a clinical check-up and mammography. Increased cancer worry was associated with a greater expressed need for information and for reassurance through follow-up clinical checks and mammography. Better targeting of counselling to the expressed concerns and needs of these women is required to improve the service offered. GPs and patients expressed no clear preference for any specific service location or staffing configuration. The novel community service was less expensive in terms of both staff and patient costs. The potential to decrease health staff/patient contact time and to employ nurse practitioners with both clinical genetic and oncology training should be explored further. The rapidly rising demand for these services suggests that the evaluation of further new models needs to continue to be given priority to guide the development of cancer genetic services.

Child care decisions: parental choice or chance?

AIM: A study of the context of child care decision making by inner city and suburban mothers, using parents to help develop and administer a semi-structured questionnaire. METHODS: A total of 131 mothers were interviewed (73 inner city and 58 suburban) at home. RESULTS: Inner city mothers were more likely to bottle feed, smoke and adopt risky infant sleeping positions, for example the settee. Virtually all babies (98%) were fully vaccinated and placed prone (95%) to sleep at night. Inner city mothers smoked (71%) despite the known health risks and continued postnatally (55%), mainly as a means of relieving stress. In total, 30% of inner city mothers wanted to breast feed; 19% had succeeded to 6-8 weeks postnatally. Bottle feeding helped both mother and baby to have uninterrupted nights of sleep. Suburban mothers (59%) succeeded in breast feeding, with others choosing bottle feeding mostly because of returning to work. The average weekly alcohol consumption, 32 units inner city and 15 units suburban, was taken in weekend binges by inner city parents, but in daily small amounts by suburban mothers. CONCLUSIONS: The well-being of the baby was the prime concern of all mothers, irrespective of social background. However, inner city mothers made rational decisions to smoke and bottle feed to reduce the impact of stress and allow the mother much needed respite for the good of the entire family.

A model-based method for identifying species hybrids using multilocus genetic data.

We present a statistical method for identifying species hybrids using data on multiple, unlinked markers. The method does not require that allele frequencies be known in the parental species nor that separate, pure samples of the parental species be available. The method is suitable for both markers with fixed allelic differences between the species and markers without fixed differences. The probability model used is one in which parentals and various classes of hybrids (F(1)'s, F(2)'s, and various backcrosses) form a mixture from which the sample is drawn. Using the framework of Bayesian model-based clustering allows us to compute, by Markov chain Monte Carlo, the posterior probability that each individual belongs to each of the distinct hybrid classes. We demonstrate the method on allozyme data from two species of hybridizing trout, as well as on two simulated data sets.

A computerized social cognitive intervention for nutrition behavior: direct and mediated effects on fat, fiber, fruits, and vegetables, self-efficacy, and outcome expectations among food shoppers.

This study examined the direct and mediated impact of a self-administered, computer-based intervention on nutrition behavior self-efficacy, and outcome expectations among supermarket food shoppers. The intervention, housed in kiosks in supermarkets and based on social cognitive theory, used tailored information and self-regulation strategies delivered in 15 brief weekly segments. The study sample (N = 277), stratified and randomly assigned to treatment or control, was 96% female, was 92% White, had a median annual income of about $35,000, and had a mean education of 14. 78 +/- 2.11 years. About 12% of the sample reported incomes of $20,000 or less, and about 20% reported 12 years or fewer of education. Analysis of covariance immediately after intervention and at a 4- to 6-month follow-up found that treatment led to improved levels of fat, fiber, and fruits and vegetables. Treatment also led to higher levels of nutrition-related self-efficacy, physical outcome expectations, and social outcome expectations. Logistic regression analysis determined that the treatment group was more likely than the control group to attain goals for fat, fiber, and fruits and vegetables at posttest and to attain goals for fat at follow-up. Latent variable structural equation analysis revealed self-efficacy and physical outcome expectations mediated treatment effects on nutrition. In addition, physical outcome expectations mediated the effect of self-efficacy on nutrition outcomes. Implications for future computer-based health promotion interventions are discussed.

Use of consumer ratings for quality improvement in behavioral health insurance plans.

BACKGROUND: The Consumer Assessment of Behavioral Healthcare Services (CABHS) survey collects consumers' reports about their health care plans and treatment. The use of the CABHS to identify opportunities for improvement, with specific attention to how organizations have used the survey information for quality improvement, is described. METHODS: In 1998 and 1999, data were collected from five groups of adult patients in commercial health plans and five groups of adult patients in public assistance health plans with services received through four organizations (one of three managed behavioral health care organizations or a health system). Patients who received behavioral health care services during the previous year were mailed the CABHS survey. Non-respondents were contacted by telephone to complete the survey. RESULTS: Response rates ranged from 49% to 65% for commercial patient groups and from 36% to 51% for public assistance patients. Promptly getting treatment from clinicians and aspects of care most influenced by health plan policies and operations, such as access to treatment and plan administrative services, received the least positive responses, whereas questions about communication received the most positive responses. In addition, questions about access- and plan-related aspects of quality showed the most interplan variability. Three of the organizations in this study focused quality improvement efforts on access to treatment. DISCUSSION: Surveys such as the CABHS can identify aspects of the plan and treatment that are improvement priorities. Use of these data is likely to extend beyond the behavioral health plan to consumers, purchasers, regulators, and policymakers, particularly because the National Committee for Quality Assurance is encouraging behavioral health plans to use a similar survey for accreditation purposes.

Monte Carlo evaluation of the likelihood for N(e) from temporally spaced samples.

A population's effective size is an important quantity for conservation and management. The effective size may be estimated from the change of allele frequencies observed in temporally spaced genetic samples taken from the population. Though moment-based estimators exist, recently Williamson and Slatkin demonstrated the advantages of a maximum-likelihood approach that they applied to data on diallelic genetic markers. Their computational methods, however, do not extend to data on multiallelic markers, because in such cases exact evaluation of the likelihood is impossible, requiring an intractable sum over latent variables. We present a Monte Carlo approach to compute the likelihood with data on multiallelic markers. So as to be computationally efficient, our approach relies on an importance-sampling distribution constructed by a forward-backward method. We describe the Monte Carlo formulation and the importance-sampling function and then demonstrate their use on both simulated and real datasets.