Bronchiolitis recovery and the use of High Efficiency Particulate Air (HEPA) Filters (The BREATHE Study): study protocol for a multi-center, parallel, double-blind, randomized controlled clinical trial.

BACKGROUND: Acute viral bronchiolitis is the most common reason for hospitalization of infants in the USA. Infants hospitalized for bronchiolitis are at high risk for recurrent respiratory symptoms and wheeze in the subsequent year, and longer-term adverse respiratory outcomes such as persistent childhood asthma. There are no effective secondary prevention strategies. Multiple factors, including air pollutant exposure, contribute to risk of adverse respiratory outcomes in these infants. Improvement in indoor air quality following hospitalization for bronchiolitis may be a prevention opportunity to reduce symptom burden. Use of stand-alone high efficiency particulate air (HEPA) filtration units is a simple method to reduce particulate matter ≤ 2.5 µm in diameter (PM2.5), a common component of household air pollution that is strongly linked to health effects. METHODS: BREATHE is a multi-center, parallel, double-blind, randomized controlled clinical trial. Two hundred twenty-eight children < 12 months of age hospitalized for the first time with bronchiolitis will participate. Children will be randomized 1:1 to receive a 24-week home intervention with filtration units containing HEPA and carbon filters (in the child's sleep space and a common room) or to a control group with units that do not contain HEPA and carbon filters. The primary objective is to determine if use of HEPA filtration units reduces respiratory symptom burden for 24 weeks compared to use of control units. Secondary objectives are to assess the efficacy of the HEPA intervention relative to control on (1) number of unscheduled healthcare visits for respiratory complaints, (2) child quality of life, and (3) average PM2.5 levels in the home. DISCUSSION: We propose to test the use of HEPA filtration to improve indoor air quality as a strategy to reduce post-bronchiolitis respiratory symptom burden in at-risk infants with severe bronchiolitis. If the intervention proves successful, this trial will support use of HEPA filtration for children with bronchiolitis to reduce respiratory symptom burden following hospitalization. TRIAL REGISTRATION: NCT05615870. Registered on November 14, 2022.

Patient-facing job role is associated with SARS-CoV-2 positivity among healthcare workers in long term care facilities in Minnesota, August-December, 2020.

OBJECTIVE: Healthcare workers (HCWs) in long-term care facilities (LTCFs) are disproportionately affected by severe acute respiratory coronavirus virus 2 (SARS-CoV-2), the virus that causes coronavirus disease 2019 (COVID-19). To characterize factors associated with SARS-CoV-2 positivity among LTCF HCWs, we performed a retrospective cohort study among HCWs in 32 LTCFs in the Minneapolis-St Paul region. METHODS: We analyzed the outcome of SARS-CoV-2 polymerase chain reaction (PCR) positivity among LTCF HCWs during weeks 34-52 of 2020. LTCF and HCW-level characteristics, including facility size, facility risk score for resident-HCW contact, and resident-facing job role, were modeled in univariable and multivariable generalized linear regressions to determine their association with SARS-CoV-2 positivity. RESULTS: Between weeks 34 and 52, 440 (20.7%) of 2,130 unique HCWs tested positive for SARS-CoV-2 at least once. In the univariable model, non-resident-facing HCWs had lower odds of infection (odds ratio [OR], 0.50; 95% confidence interval [CI], 0.36-0.70). In the multivariable model, the odds remained lower for non-resident-facing HCW (OR, 0.50; 95% CI, 0.36-0.71), and those in medium- versus low-risk facilities experienced higher odds of testing positive for SARS-CoV-2 (OR, 1.47; 95% CI, 1.08-2.02). CONCLUSIONS: Our findings suggest that COVID-19 cases are related to contact between HCW and residents in LTCFs. This association should be considered when formulating infection prevention and control policies to mitigate the spread of SARS-CoV-2 in LTCFs.

Does tamsulosin decrease postoperative urinary retention in spine surgery? A double-blind, randomized controlled trial.

OBJECTIVE: The authors' objective was to determine whether preoperative administration of tamsulosin decreases postoperative urinary retention after spine surgery. METHODS: In this randomized, double-blind, placebo-controlled clinical trial performed at a single institution between 2016 and 2019, eligible males aged 50 to 85 years were administered tamsulosin or placebo for 5 days prior to elective spine surgery. Patients were excluded if they were taking alpha adrenergic blocking drugs; were allergic to tamsulosin, lactose, or sulfa drugs; had a preexisting indwelling urinary catheter, orthostatic hypotension, history of urological surgery, or renal failure; or were scheduled for cataract surgery within 2 weeks. Screening identified 1051 eligible patients (140 declined participation, 150 did not meet the inclusion criteria, and 151 did not enroll for other reasons). A total of 610 patients were randomly assigned to receive 0.4 mg oral tamsulosin or an identical placebo capsule for 5 days preoperatively and 2 days postoperatively. RESULTS: A total of 497 patients were included in the final statistical analysis. The overall rate of postoperative urinary retention was 9.7%, and tamsulosin had no observed effect on reducing the rate of postoperative urinary retention as compared with placebo (9.4% vs 9.9%, p = 0.96). There were no significant differences in the reported adverse events between groups. Multivariate logistic regression was performed to model the effects of patient, surgical, and anesthetic factors on postoperative urinary retention, and the study drug remained an insignificant factor. CONCLUSIONS: This study did not detect an effect of perioperative tamsulosin on reducing the rate of postoperative urinary retention in male patients aged 50 to 85 years who underwent elective spine surgery. This study does not support the routine use of tamsulosin to reduce postoperative urinary retention in patients without a previous prescription. It is unknown if subpopulations exist for which prophylactic tamsulosin may reduce postoperative urinary retention.

Capacity Building for a New Multicenter Network Within the ECHO IDeA States Pediatric Clinical Trials Network.

Introduction: Research capacity building is a critical component of professional development for pediatrician scientists, yet this process has been elusive in the literature. The ECHO IDeA States Pediatric Clinical Trials Network (ISPCTN) seeks to implement pediatric trials across medically underserved and rural populations. A key component of achieving this objective is building pediatric research capacity, including enhancement of infrastructure and faculty development. This article presents findings from a site assessment inventory completed during the initial year of the ISPCTN. Methods: An assessment inventory was developed for surveying ISPCTN sites. The inventory captured site-level activities designed to increase clinical trial research capacity for pediatrician scientists and team members. The inventory findings were utilized by the ISPCTN Data Coordinating and Operations Center to construct training modules covering 3 broad domains: Faculty/coordinator development; Infrastructure; Trials/Research concept development. Results: Key lessons learned reveal substantial participation in the training modules, the importance of an inventory to guide the development of trainings, and recognizing local barriers to clinical trials research. Conclusions: Research networks that seek to implement successfully completed trials need to build capacity across and within the sites engaged. Our findings indicate that building research capacity is a multi-faceted endeavor, but likely necessary for sustainability of a unique network addressing high impact pediatric health problems. The ISPCTN emphasis on building and enhancing site capacity, including pediatrician scientists and team members, is critical to successful trial implementation/completion and the production of findings that enhance the lives of children and families.

Team Science Process Builds Research Coordinators' Voices in a National Pediatric Clinical Trials Network.

Geographically-dispersed teams have become the norm in clinical research collaborations. The Institutional Development Awards (IDeA) Program, first authorized by Congress in 1993 and managed by the National Institute of General Medical Sciences, has been developed for the purpose of broadening the geographic distribution of National Institutes of Health (NIH) funding for biomedical and behavioral research by enhancing the competitiveness for research funding of institutions located in states in which the aggregate success rate for grant applications to the NIH has historically been low. The IDeA States are composed of the Commonwealth of Puerto Rico and the following 23 states: Alaska, Arkansas, Delaware, Hawaii, Idaho, Kansas, Kentucky, Louisiana, Maine, Mississippi, Montana, Nebraska, Nevada, New Hampshire, New Mexico, North Dakota, Oklahoma, Rhode Island, South Carolina, South Dakota, Vermont, West Virginia, Wyoming. The Environmental influences on Child Health Outcomes (ECHO) research program's IDeA States Pediatric Clinical Trials Network (ISPCTN) was formed in 2016 with 24 sites within the IDeA states to provide clinical trial access to children in rural and underserved communities while building research capacity and infrastructure. In order to become effective, the network research coordinators used many methods to become more cohesive and productive. One of those methods was the use of Team Science.

Training as an Intervention to Decrease Medical Record Abstraction Errors Multicenter Studies.

Studies often rely on medical record abstraction as a major source of data. However, data quality from medical record abstraction has long been questioned. Electronic Health Records (EHRs) potentially add variability to the abstraction process due to the complexity of navigating and locating study data within these systems. We report training for and initial quality assessment of medical record abstraction for a clinical study conducted by the IDeA States Pediatric Clinical Trials Network (ISPCTN) and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Neonatal Research Network (NRN) using medical record abstraction as the primary data source. As part of overall quality assurance, study-specific training for medical record abstractors was developed and deployed during study start-up. The training consisted of a didactic session with an example case abstraction and an independent abstraction of two standardized cases. Sixty-nine site abstractors from thirty sites were trained. The training was designed to achieve an error rate for each abstractor of no greater than 4.93% with a mean of 2.53%, at study initiation. Twenty-three percent of the trainees exceeded the acceptance limit on one or both of the training test cases, supporting the need for such training. We describe lessons learned in the design and operationalization of the study-specific, medical record abstraction training program.

Low workplace social capital as a predictor of depression: the Finnish Public Sector Study.

In a prospective cohort study of Finnish public sector employees, the authors examined the association between workplace social capital and depression. Data were obtained from 33,577 employees, who had no recent history of antidepressant treatment and who reported no history of physician-diagnosed depression at baseline in 2000-2002. Their risk of depression was measured with two indicators: recorded purchases of antidepressants until December 31, 2005, and self-reports of new-onset depression diagnosed by a physician in the follow-up survey in 2004-2005. Multilevel logistic regression analysis was used to explore whether self-reported and aggregate-level workplace social capital predicted indicators of depression at follow-up. The odds for antidepressant treatment and physician-diagnosed depression were 20-50% higher for employees with low self-reported social capital than for those reporting high social capital. These associations were not accounted for by sex, age, marital status, socioeconomic position, place of work, smoking, alcohol use, physical activity, and body mass index. The association between social capital and self-reported depression attenuated but remained significant after further adjustment for baseline psychological distress (a proxy for undiagnosed mental health problems). Aggregate-level social capital was not associated with subsequent depression.

Outcomes of DATA 2000 certification trainings for the provision of buprenorphine treatment in the Veterans Health Administration.

Despite the high numbers of veterans with opioid dependence, few receive pharmacologic treatment for this disorder. The adoption of buprenorphine treatment within the Veterans Health Administration (VHA) has been slow. To expand capacity for buprenorphine treatment, the VHA sponsored two eight-hour credentialing courses for the Drug Addiction Treatment Act of 2000. We sought to describe the outcomes of such training. Following the training sessions, 29 participants (18 physicians) were highly satisfied with course content and affirmed their intention to prescribe buprenorphine; after nine-month follow-up, two physicians were prescribing. We conclude that providing credentialing courses, while popular, did not markedly promote the prescription of buprenorphine.

Organisational justice and smoking: the Finnish Public Sector Study.

OBJECTIVE: To examine the extent to which the justice of decision-making procedures and interpersonal relationships is associated with smoking. SETTING: 10 municipalities and 21 hospitals in Finland. DESIGN AND PARTICIPANTS: Cross-sectional data derived from the Finnish Public Sector Study were analysed with logistic regression analysis models with generalised estimating equations. Analyses of smoking status were based on data provided by 34,021 employees. Separate models for heavy smoking (> or = 20 cigarettes/day) were calculated for 6295 current smokers. RESULTS: After adjustment for age, education, socioeconomic position, marital status, job contract and negative affectivity, smokers who reported low procedural justice were about 1.4 times more likely to smoke > or = 20 cigarettes/day compared with their counterparts who reported high levels of justice. In a similar way, after adjustments, low levels of justice in interpersonal treatment was significantly associated with an increased prevalence of heavy smoking (OR 1.35, 95% CI 1.03 to 1.77 for men and OR 1.41, 95% CI 1.09 to 1.83 for women). Further adjustment for job strain and effort-reward imbalance had little effect on these results. No associations were observed between justice components and smoking status or ex-smoking. CONCLUSIONS: The extent to which employees are treated with justice in the workplace seems to be associated with smoking intensity independently of established stressors at work.

Psychometric evaluation of a short measure of social capital at work.

BACKGROUND: Prior studies on social capital and health have assessed social capital in residential neighbourhoods and communities, but the question whether the concept should also be applicable in workplaces has been raised. The present study reports on the psychometric properties of an 8-item measure of social capital at work. METHODS: Data were derived from the Finnish Public Sector Study (N = 48,592) collected in 2000-2002. Based on face validity, an expert unfamiliar with the data selected 8 questionnaire items from the available items for a scale of social capital. Reliability analysis included tests of internal consistency, item-total correlations, and within-unit (interrater) agreement by rwg index. The associations with theoretically related and unrelated constructs were examined to assess convergent and divergent validity (construct validity). Criterion-related validity was explored with respect to self-rated health using multilevel logistic regression models. The effects of individual level and work unit level social capital were modelled on self-rated health. RESULTS: The internal consistency of the scale was good (Cronbach's alpha = 0.88). The rwg index was 0.88, which indicates a significant within-unit agreement. The scale was associated with, but not redundant to, conceptually close constructs such as procedural justice, job control, and effort-reward imbalance. Its associations with conceptually more distant concepts, such as trait anxiety and magnitude of change in work, were weaker. In multilevel models, significantly elevated age adjusted odds ratios (ORs) of poor self-rated health (OR = 2.42, 95% confidence interval (CI): 2.24-2.61 for the women and OR = 2.99, 95% CI: 2.56-3.50 for the men) were observed for the employees in the lowest vs. highest quartile of individual level social capital. In addition, low social capital at the work unit level was associated with a higher likelihood of poor self-rated health. CONCLUSION: Psychometric techniques show our 8-item measure of social capital to be a valid tool reflecting the construct and displaying the postulated links with other variables.

Relationship between work stress and body mass index among 45,810 female and male employees.

OBJECTIVE: The proportion of overweight and obese people has grown rapidly, and obesity has now been widely recognized as an important public health problem. At the same time, stress has increased in working life. The 2 problems could be connected if work stress promotes unhealthy eating habits and sedentary behavior and thereby contributes to weight gain. This study explored the association between work stress and body mass index (BMI; kg/m2). METHODS: We used cross-sectional questionnaire data obtained from 45,810 female and male employees participating in the ongoing Finnish Public Sector Cohort Study. We constructed individual-level scores, as well as occupational- and organizational-level aggregated scores for work stress, as indicated by the demand/control model and the effort-reward imbalance model. Linear regression analyses were stratified by sex and socioeconomic status (SES) and adjusted for age, marital status, job contract, smoking, alcohol consumption, physical activity, and negative affectivity. RESULTS: The results with the aggregated scores showed that lower job control, higher job strain, and higher effort-reward imbalance were associated with a higher BMI. In men, lower job demands were also associated with a higher BMI. These associations were not accounted for by SES, although an additional adjustment for SES attenuated the associations. The results obtained with the individual-level scores were in the same direction, but the relationships were weaker than those obtained with the aggregated scores. CONCLUSIONS: This study shows a weak association between work stress and BMI.

Job strain, effort-reward imbalance, and heavy drinking: a study in 40,851 employees.

OBJECTIVE: The objective of this study was to examine the relationship of the job strain model and the effort-reward imbalance model with heavy drinking. METHODS: Questionnaire survey data were obtained from 32,352 women and 8499 men employed in the Finnish public sector (participation 67%). Logistic regression analyses for all employees and for separate subgroups were undertaken by sex, adjusted for age, education, occupational position, marital status, job contract, smoking, and negative affectivity. Different cutoff points of heavy drinking were used for men and women. RESULTS: High job strain and high effort-reward imbalance as global constructs were not associated with heavy drinking. However, some components of these models were associated with heavy drinking but the relationships were not all in the expected direction and they varied by sex, age, and occupational position. CONCLUSIONS: Stressful work conditions are not consistently associated with heavy drinking.

Parenting stress in first-time mothers of twins and triplets conceived after in vitro fertilization.

OBJECTIVE: To examine psychosocial and obstetric outcomes at 1 year postpartum in first-time mothers who conceived after IVF. DESIGN: Prospective cohort study. SETTING: University medical center in the United Kingdom. PATIENT(S): One hundred twenty-nine mothers with a single naturally conceived birth, 95 mothers with a single IVF birth, and 36 mothers with a twin or triplet IVF birth. MAIN OUTCOME MEASURE(S): General Health Questionnaire and Parenting Stress Index. RESULT(S): Twenty-two percent of mothers of multiples had Parenting Stress Index scores indicating severe parenting stress, compared with 5% of mothers of IVF singletons (odds ratio, 5.14 [95% confidence interval (CI), 1.55-16.99]) and 9% of mothers of naturally conceived singletons (odds ratio, 2.76 [95% CI, 1.03-7.4]). Mothers of multiple children conceived by IVF did not have poorer mental health but were less likely to be in paid employment at follow-up than were mothers of singletons conceived by IVF (odds ratio, 0.3 [95% CI, 0.13-0.67]) or naturally (odds ratio, 0.27 [95% CI, 0.12-0.59]). Multiple births were more premature, had lower birth weights, and had more medical complications. They were more likely to have been admitted to special care than were singletons conceived by IVF (odds ratio, 14.6 [95% CI, 5.1-42.0)] or those conceived naturally (odds ratio, 10.59 [95% CI, 3.67-30.57]) CONCLUSION(S): Clinicians should ensure that couples making decisions about embryo transfer have considered the potential psychosocial burden of a multiple birth.

Sense of coherence and psychiatric morbidity: a 19-year register-based prospective study.

BACKGROUND: Most prospective studies on the relationship between sense of coherence (SOC) and mental health have been conducted using subjective health indicators and short-term follow-ups. The objective of this prospective occupational cohort study was to examine whether a strong sense of coherence is a protective factor against psychiatric disorders over a long period of time. METHODS: The study was conducted in a multinational forest industry corporation with domicile in Finland. Participants were 8029 Finnish industrial employees aged 18-65 at baseline (1986). Questionnaire survey data on SOC and other factors were collected at baseline; records of hospital admissions for psychiatric disorders and suicide attempt were derived from the National Hospital Discharge Register, while records of deaths due to suicide were derived from the National Death Registry up until 2006. RESULTS: During the 19-year follow-up, 406 participants with no prior admissions were admitted to hospital for psychiatric disorders (n=351) or suicide attempt (n=25) or committed a suicide (n=30). A strong SOC was associated with about 40% decreased risk of psychiatric disorder. This association was not accounted for by mental health-related baseline characteristics, such as sex, age, marital status, education, occupational status, work environment, risk behaviours or psychological distress. The result was replicated in a subcohort of participants who did not report an elevated level of psychological distress at baseline (hazard ratio=0.59, 95% CI 0.40 to 0.86). CONCLUSIONS: A strong SOC is associated with reduced risk of psychiatric disorders during a long time period.

Work factors related to psychological and health-related distress among employees with chronic illnesses.

OBJECTIVE: This study examined specific psychosocial factors associated with psychological and health-related distress amongst employees reporting different chronic illnesses. METHODS: The sample consisted of 1029 employees managing either musculoskeletal pain (n=324), arthritis and rheumatism (n=192), asthma (n=174), depression and anxiety (n=152), heart disease (n=96) or diabetes (n=91). Information on psychological distress, work limitations, illness management, disclosure, absence, presenteeism, support and demographic factors were obtained through self-administered questionnaires. RESULTS: Both low psychological well-being and high health-related distress were associated with an increase in work limitations (beta=0.20, SE=.03; and beta=0.19, SE=.01, respectively), poorer management of illness symptoms at work (beta=-0.17, SE=.12; and beta=-0.13, SE=.02), high presentieesm (beta=0.19, SE=.25; and beta=0.14, SE=.05) and low workplace support (beta=-0.05, SE=.22; and beta=-0.12, SE=.05). Health-related distress was additionally associated with disclosure of illness at work (beta=0.18, SE=.08) and long-term sickness absence (beta=0.10, SE=.06). CONCLUSIONS: To enable individuals to effectively manage both their illness and their work without serious repercussions, it is important for both healthcare professionals and employers alike, to improve the well-being of workers with chronic illness by supporting and facilitating their efforts to over-come health-related limitations at work.

Maternal self-esteem after successful treatment for infertility.

OBJECTIVE: To [1] investigate self-esteem during pregnancy after previous infertility and [2] establish the relationship among self-esteem, anxiety during pregnancy, and parenting self-efficacy. DESIGN: Limited prospective study. SETTING: A regional infertility clinic and antenatal clinic. PATIENT(S): Seventy women who had conceived through assisted reproductive technology and 111 women who had conceived naturally. INTERVENTION(S): Measures of self-esteem, anxiety, and parenting self-efficacy. MAIN OUTCOME MEASURE(S): Self-esteem, anxiety, and parenting self-efficacy. RESULT(S): Women who had conceived through IVF treatment did not differ in terms of self-esteem during pregnancy from those who had conceived naturally. All of the women in the present study displayed levels of self-esteem that were within the normal range. Self-esteem increased as pregnancy progressed. Self-esteem was negatively correlated with anxiety during pregnancy. As self-esteem increased, anxiety decreased. Self-esteem at the start of pregnancy (18 weeks) and anxiety in the early stages of parenthood (6 weeks postpartum) predicted parenting self-efficacy. CONCLUSION(S): Self-esteem in the early stages of pregnancy, for both women who conceived through IVF and women who conceived naturally, is related to self-reported levels of parenting efficacy. Coaching and mentoring through antenatal clinics in the early stages of pregnancy should be tailored to incorporate advice regarding self-esteem in addition to management of pregnancy and psychological well-being.

Rehabilitation during alcohol detoxication in comorbid neuropsychiatric patients.

For this study, we evaluated the effectiveness of a cognitive training program in improving cognitive function in patients with alcoholism comorbid with another neuropsychiatric disorder and going through the subacute phase of detoxication. We employed a randomized clinical trial design in which 20 subjects were assigned to a five-session cognitive rehabilitation program and 20 subjects were assigned to an attention placebo control condition. All subjects received a battery of cognitive tests for reasoning, attention, and visual-spatial abilities. These tests were repeated at the completion of the study. The training consisted of a number of component tasks designed to improve attention, speed of information processing, perceptual analysis, and visual-spatial cognition. We plotted performance on training results across sessions to detect evidence of learning effects. Comparisons of the cognitive tests revealed greater improvement in the training as compared to the attention placebo group on measures of attention and conceptual flexibility. We concluded that the training produced significant improvement over and above natural recovery during detoxication.