Opportunities for Regulatory Changes to Promote Pediatric Device Innovation in the United States: Joint Recommendations From Pediatric Innovator Roundtables.

OBJECTIVE: The purpose of this report is to provide insight from pediatric stakeholders with a shared desire to facilitate a revision of the current United States regulatory pathways for the development of pediatric healthcare devices. METHODS: On August 5, 2020, a group of innovators, engineers, professors and clinicians met to discuss challenges and opportunities for the development of new medical devices for pediatric health and the importance of creating a regulatory environment that encourages and accelerates the research and development of such devices. On January 6, 2021, this group joined regulatory experts at a follow-up meeting. RESULTS: One of the primary issues identified was the need to present decision-makers with opportunities that change the return-on-investment balance between adult and pediatric devices to promote investment in pediatric devices. DISCUSSION/CONCLUSION: Several proposed strategies were discussed, and these strategies can be divided into two broad categories: 1. Removal of real and perceived barriers to pediatric device innovation; 2. Increasing incentives for pediatric device innovation.

Utilizing mobile health and community informants to collect real-time health care data in extremely low resource environments.

BACKGROUND: Mobile health provides promising opportunities to perform population surveillance in rural, impoverished, or unstable communities. The objective of this study was to test the efficacy and accuracy of data collected by community informants in extreme low-resource environments using electronic surveys and mobile phones. METHODS: We carried out a population-based, cross-sectional survey between October and November 2017 measuring access to health care and prenatal services for pregnant women in the Northern Region of Malawi. The survey was conducted by members of the community who received one day of training and volunteered to conduct a survey for each live birth that occurred within their predetermined catchment area. A study member audited less than 2% of survey responses, where community informant responses were compared to community member self-reports. RESULTS: A total of 915 survey responses were recorded by 21 community informants. These surveys recorded 621 live births and 4 cases of maternal mortality. This represents a maternal mortality rate of 0.64% (95% confidence interval (CI) = 0.2% to 1.6%), roughly equal to the United Nations Children's Fund (UNICEF) estimate from 2015 of 634 per 100 000 live births, or 0.63%. This survey captured 120 births by adolescent mothers aged 15-19 out of 673 responses about maternal age. This represents 17.8% (95% CI = 15.1% to 20.9%) of all births, slightly higher than the UNICEF estimate of 143 per 1000 live births (14.3%). Finally, 51.7% of women were recorded as attending 4 antenatal care visits (95% CI = 47.8% to 55.7%), consistent with the 2015-2016 Demographic and Health Survey (DHS) value of 51%. CONCLUSIONS: The use of cellular phones and electronic surveys by community informants allowed for the real-time capture of data in an area where access is limited by seasonally impassable roads and unreliable cell reception. The data recorded by the surveys is comparable to accepted statistics in several measures. Community reporting of health care data can provide an efficient method of monitoring extremely rural or hard to reach communities.

Linking Engineering and Medical Training: A USC program seeks to introduce medical and engineering students to medical device development.

Medical students are attracted by the prospect of a meaningful addition to their clinical work. Engineering students are excited by a unique opportunity to learn directly alongside their medical student peers. For both, as well as the scientific community at large, the boutique program at the University of Southern California (USC) linking engineering and medical training at the graduate level is instructive of a new way of approaching engineering education that can potentially provide benefits to both students and society. Students who have grown up in an era of ?mass customization? in the retail and service industries can enjoy that same degree of flexibility also in the realm of education. At the same time, society gains engineers who have developed an increased empathy and awareness of the clinical contexts in which their innovations will be implemented.

Factors associated with poor mental health status among homeless women with and without dependent children.

The purpose of this study was to estimate the prevalence of mental health problems among a representative sample of homeless women with and without dependent children and determine if the effects of risk factors for mental health are modified by the presence of dependent children. Homeless women (n = 522) were recruited in 2004-2005 from shelters and meal programs in Toronto, Canada. Linear and logistic regression was performed to identify factors associated with mental health status. Poor mental health was associated with low perceived access to social support, physical/sexual assault in the past 12 months, presence of a chronic health condition, and presence of a drug use problem in the past month. Efforts to improve mental health in this population will need to address the associated problems of victimization, substance abuse, and lack of social supports.

Understanding the patients' perspective of emotional support to significantly improve overall patient satisfaction.

This article presents the results of a research study that laid out important considerations for organizations to improve their patient satisfaction scores. It addresses a dimension of patient satisfaction that appears to garner little attention in healthcare contexts: emotional support. Though the literature strongly suggests that emotional support is correlated to overall patient satisfaction, few organizations have systematically attempted to understand the elements of outstanding emotional support. Research at a community teaching hospital in Ontario has shed light on the essential components of emotional support. In this article, a typology of emotional support is offered. With a better understanding of the components of emotional support, organizations may be able to undertake actions that could potentially improve patient satisfaction scores and, in turn, the overall quality of patient care.

Universal health insurance and health care access for homeless persons.

OBJECTIVES: We examined the extent of unmet needs and barriers to accessing health care among homeless people within a universal health insurance system. METHODS: We randomly selected a representative sample of 1169 homeless individuals at shelters and meal programs in Toronto, Ontario. We determined the prevalence of self-reported unmet needs for health care in the past 12 months and used regression analyses to identify factors associated with unmet needs. RESULTS: Unmet health care needs were reported by 17% of participants. Compared with Toronto's general population, unmet needs were significantly more common among homeless individuals, particularly among homeless women with dependent children. Factors independently associated with a greater likelihood of unmet needs were younger age, having been a victim of physical assault in the past 12 months, and lower mental and physical health scores on the 12-Item Short Form Health Survey. CONCLUSIONS: Within a system of universal health insurance, homeless people still encounter barriers to obtaining health care. Strategies to reduce nonfinancial barriers faced by homeless women with children, younger adults, and recent victims of physical assault should be explored.

Drug problems among homeless individuals in Toronto, Canada: prevalence, drugs of choice, and relation to health status.

BACKGROUND: Drug use is believed to be an important factor contributing to the poor health and increased mortality risk that has been widely observed among homeless individuals. The objective of this study was to determine the prevalence and characteristics of drug use among a representative sample of homeless individuals and to examine the association between drug problems and physical and mental health status. METHODS: Recruitment of 603 single men, 304 single women, and 284 adults with dependent children occurred at homeless shelters and meal programs in Toronto, Canada. Information was collected on demographic characteristics and patterns of drug use. The Addiction Severity Index was used to assess whether participants suffered from drug problems. Associations of drug problems with physical and mental health status (measured by the SF-12 scale) were examined using regression analyses. RESULTS: Forty percent of the study sample had drug problems in the last 30 days. These individuals were more likely to be single men and less educated than those without drug problems. They were also more likely to have become homeless at a younger age (mean 24.8 vs. 30.9 years) and for a longer duration (mean 4.8 vs. 2.9 years). Marijuana and cocaine were the most frequently used drugs in the past two years (40% and 27%, respectively). Drug problems within the last 30 days were associated with significantly poorer mental health status (-4.9 points, 95% CI -6.5 to -3.2) but not with poorer physical health status (-0.03 points, 95% CI -1.3 to 1.3)). CONCLUSIONS: Drug use is common among homeless individuals in Toronto. Current drug problems are associated with poorer mental health status but not with poorer physical health status.

Multidimensional social support and the health of homeless individuals.

Homeless individuals often suffer from serious health problems. It has been argued that the homeless are socially isolated, with low levels of social support and social functioning, and that this lack of social resources contributes to their ill health. These observations suggest the need to further explore the relationship between social networks, social support, and health among persons who are homeless. The purpose of this study was to examine the association between multidimensional (cognitive/perceived and behavioral/received) social support and health outcomes, including physical health status, mental health status, and recent victimization, among a representative sample of homeless individuals in Toronto, Canada. Multivariate regression analyses were performed on social support and health outcome data from a subsample of 544 homeless adults, recruited from shelters and meal programs through multistage cluster sampling procedures. Results indicated that participants perceived moderately high levels of access to financial, emotional, and instrumental social support in their social networks. These types of perceived social supports were related to better physical and mental health status and lower likelihood of victimization. These findings highlight a need for more services that encourage the integration of homeless individuals into social networks and the building of specific types of social support within networks, in addition to more research into social support and other social contextual factors (e.g., social capital) and their influence on the health of homeless individuals.

The effect of traumatic brain injury on the health of homeless people.

BACKGROUND: We sought to determine the lifetime prevalence of traumatic brain injury and its association with current health conditions in a representative sample of homeless people in Toronto, Ontario. METHODS: We surveyed 601 men and 303 women at homeless shelters and meal programs in 2004-2005 (response rate 76%). We defined traumatic brain injury as any self-reported head injury that left the person dazed, confused, disoriented or unconscious. Injuries resulting in unconsciousness lasting 30 minutes or longer were defined as moderate or severe. We assessed mental health, alcohol and drug problems in the past 30 days using the Addiction Severity Index. Physical and mental health status was assessed using the SF-12 health survey. We examined associations between traumatic brain injury and health conditions. RESULTS: The lifetime prevalence among homeless participants was 53% for any traumatic brain injury and 12% for moderate or severe traumatic brain injury. For 70% of respondents, their first traumatic brain injury occurred before the onset of homelessness. After adjustment for demographic characteristics and lifetime duration of homelessness, a history of moderate or severe traumatic brain injury was associated with significantly increased likelihood of seizures (odds ratio [OR] 3.2, 95% confidence interval [CI] 1.8 to 5.6), mental health problems (OR 2.5, 95% CI 1.5 to 4.1), drug problems (OR 1.6, 95% CI 1.1 to 2.5), poorer physical health status (-8.3 points, 95% CI -11.1 to -5.5) and poorer mental health status (-6.0 points, 95% CI -8.3 to -3.7). INTERPRETATION: Prior traumatic brain injury is very common among homeless people and is associated with poorer health.

Interventions to improve the health of the homeless: a systematic review.

BACKGROUND: Homelessness is a widespread problem in the United States. The primary goal of this systematic review is to provide guidance in the development and organization of programs to improve the health of homeless people. METHODS: MEDLINE, CINAHL, HealthStar, PsycINFO, Sociological Abstracts, and Social Services Abstracts databases were searched from their inception through July 2004 using the following terms: homeless, homeless persons, and homelessness. References of key articles were also searched. 4564 abstracts were screened, and 258 articles underwent full review. Seventy-three studies conducted from 1988 to 2004 met inclusion criteria (use of an intervention, use of a comparison group, and the reporting of health-related outcomes). Two authors independently abstracted data from studies and assigned quality ratings using explicit criteria. RESULTS: Forty-five studies were rated good or fair quality. For homeless people with mental illness, case management linked to other services was effective in improving psychiatric symptoms, and assertive case management was effective in decreasing psychiatric hospitalizations and increasing outpatient contacts. For homeless people with substance abuse problems, case management resulted in greater decreases in substance use than did usual care. For homeless people with latent tuberculosis, monetary incentives improved adherence rates. Although a number of studies comparing an intervention to usual care were positive, studies comparing two interventions frequently found no significant difference in outcomes. CONCLUSIONS: Coordinated treatment programs for homeless adults with mental illness or substance abuse usually result in better health outcomes than usual care. Health care for homeless people should be provided through such programs whenever possible. Research is lacking on interventions for youths, families, and conditions other than mental illness or substance abuse.

SARS: coping with the impact at a community hospital.

AIM: This paper presents the findings of a staff survey conducted at a 350-bed acute care facility located on the periphery of Toronto, Canada. BACKGROUND: Toronto's severe acute respiratory syndrome (SARS) crisis resulted in trauma-like effects at hospitals hardest hit by the disease. A systematic examination of the impact on staff working in hospitals that saw relatively few cases, while maintaining the precautions associated with elevated alert levels, has not been undertaken. METHODS: A questionnaire was distributed for 1 month commencing 17 April 2003 and 300 completed responses were obtained (approximately one in six staff members). The data collected included demographic and occupational information, in addition to perceptions of SARS' impact on patient care, factors contributing to adverse impacts on patient care, working conditions, decision-making, communication and relations, sources of support, and the impact on workers' lives outside work. Items for these sections were developed by a multi-disciplinary team of health care workers and hospital administrators. RESULTS: In the absence of pre-SARS normative data for the survey, demographic and occupational variables were used to look for patterns of differences between relevant subgroups of respondents. Statistically significant differences were found for gender (73.9% women), nurses (24.7%) vs. others, doctors (20.3%) vs. others, older (40 years or older, 60.0%) vs. younger persons, emergency or intensive care unit workers (8.0%) vs. others, and those employed fewer years at the hospital (less than 5 years: 46.2%) vs. five or more years. These differences varied across the following domains: factors adversely affecting patients, communications, support, working conditions, decision-making and, to a lesser extent, impact on life outside work. While all groups found SARS stressful, nurses reported a greater impact on morale and job satisfaction. Nurses relied more on peer support than doctors, felt less informed and less involved in decision-making than doctors felt, and were more likely to report that infection control procedures were not strict enough. CONCLUSIONS: The between-group differences and the pattern of these differences clearly illustrate the polarizing and stressful impact SARS had at a hospital with only a small number of probable or suspect cases. The clear differences between groups defined by demographics, professions and clinical roles suggest a subtle and pervasive secondary impact of the SARS outbreak, with repercussions health care facilities must contend with while maintaining increased levels of vigilance in the wake of SARS.

Effect of training and other influences on the development of career interest in geriatric psychiatry.

OBJECTIVE: The authors examined the relationship between the timing and nature of educational exposure to geriatric psychiatry and other potential influences and subsequent development of career interest in geriatric psychiatry. METHODS: A 46-item survey was distributed to residents and fellows who attended one of the two sponsored programs for residents at the three American Association of Geriatric Psychiatry (AAGP) annual meetings held between 2000 and 2002, inclusive. RESULTS: Ninety-three percent of attendees responded (N=184). Sixty-five percent first developed interest in geriatric psychiatry during their residency years (the majority during their PGY1 or PGY2 year). The timing of individualized teaching exposure, as well as lectures in geriatric psychiatry, was associated with the development of first interest in the field. The most important influences on the development of interest in the field included specific teacher attributes, training experiences, personal experiences with seniors, and characteristics cited as unique to geriatric psychiatry, such as the medical, neuropsychiatric, and multifactorial nature of the field. Patient personal histories and outcomes, as well as non-educational experiences with seniors and cultural attitudes, also contributed to interest. CONCLUSION: It behooves geriatric psychiatry programs to create exemplary educators and commit them to teaching in the early years of general psychiatry programs as well as in medical school. These educators should be identifying potential recruits by enquiring about trainees' previous experiences with older persons as well as emphasizing the unique aspects of geriatric psychiatry that are attractive to trainees.

The effect of housing interventions on neuropsychological functioning among homeless persons with mental illness.

The authors tested the hypotheses that neuropsychological functioning would improve after homeless persons with severe and persistent mental illness were provided with housing and that executive functioning would improve more among those placed in group homes than among those placed in independent apartments. A total of 114 persons with serious and persistent mental illness who were stable residents of homeless shelters completed neuropsychological testing and were randomly assigned to group homes or independent apartments; 91 participants (52 assigned to group homes and 39 assigned to independent apartments) were retested after 18 months. Overall neuropsychological functioning improved significantly across the full study sample. Executive performance, measured by the Wisconsin Card Sorting Test, decreased significantly among persons assigned to independent apartments and increased, but not significantly, among those assigned to group homes. The findings suggest that providing housing for persons who have severe and persistent mental illness improves cognitive functioning but that independent living may diminish executive functioning.

The relationship between housing conditions and health status of rooming house residents in Toronto.

BACKGROUND: Rooming houses are an important source of housing for low-income Canadians. Little information is available on the relationship between housing conditions and health status in this vulnerable population. METHODS: Interviews were conducted with a representative sample of 295 residents in 171 rooming houses in Toronto. Health status was assessed using the SF-36. The physical attractiveness of each rooming house was rated using the Multiphasic Environmental Assessment Procedure. Associations between the health status of residents and the physical attractiveness and organizational characteristics of rooming houses were examined. RESULTS: Rooming house residents aged 35 years and older had significantly poorer health status than their counterparts in the Canadian general population. Eight of the ten dimensions of individual health status assessed by the SF-36 were significantly correlated with the physical attractiveness of the rooming house in which the individual lived. However, there was no significant association between residents' health status and the rooming house's non-profit status, provision of meals, or the presence of an on-site landlord. CONCLUSIONS: Rooming house residents suffer from a high prevalence of ill health. Residents reporting worst health are concentrated in rooming houses in the poorest physical condition. This relationship may be mediated by selection processes that place the sickest individuals in the lowest-quality rooming houses, and/or by a direct effect of adverse housing conditions on health status. Further research is needed to elucidate these processes and to improve the health of this vulnerable population.

The association between homelessness and suicidal ideation and behaviors: results of a cross-sectional survey.

This study was carried out with three goals: (1) to determine the prevalence of suicidal ideation and suicide attempts among the homeless; (2) to determine what aspects of homelessness predict suicidality, and (3) to determine which aspects remain predictive after controlling for key covariates, such as mental illness. A sample of 330 homeless adults were interviewed. Sixty-one percent of the study sample reported suicidal ideation and 34% had attempted suicide. Fifty-six percent of the men and 78% of the women reported prior suicidal ideation, while 28 percent of the men and 57% of the women had attempted suicide. Childhood homelessness of at least 1 week without family members and periods of homelessness longer than 6 months were found to be associated with suicidal ideation. Psychiatric diagnoses were also associated with suicidality in this sample.

Characteristics of persons who are homeless for the first time.

The Pathways Into Homelessness project in Toronto interviewed 300 unaccompanied adult users of homeless shelters to identify characteristics of individuals who are homeless for the first time. The sample reflected the total population of homeless shelter users in terms of age, sex, level of use, and type of shelter. Two fifths of the sample were homeless for the first time. There were more similarities than differences between those who were homeless for the first time and those who had been homeless previously. The prevalence of psychiatric and substance use disorders and the rate of previous hospitalization did not differ between first-time homeless persons and those who had been homeless before. The two groups were distinguished by some childhood experiences related to housing. Both groups had multiple indicators of serious problems, suggesting that the need for intervention is as pressing for persons who are homeless for the first time as it is for the larger population of homeless persons.