Project description:BackgroundPosttraumatic Stress Disorder (PTSD) is a commonly occurring mental illness. There are multiple treatments for PTSD that have similar effectiveness, but these treatments differ substantially in other ways. It is desirable to have well-informed patients involved in treatment choices. A patient decision aid (PtDA) is one method to achieve this goal. This manuscript describes the rationale and development of a patient decision aid (PtDA) designed for patients with PTSD.MethodsWe conducted an informational needs assessment of veterans (n = 19) to obtain their baseline information needs prior to the development of the PtDA. We also conducted a literature review of effective PTSD treatments, and we calculated respective effective sizes. A PtDA prototype was developed according to the guidelines from the International Patient Decision Aid Standards. These standards guided our development of both content and format for the PtDA. In accordance with the standards, we gathered feedback from patients (n = 20) and providers (n = 7) to further refine the PtDA. The information obtained from patients and the literature review was used to develop a decision aid for patients with PTSD.ResultsPatients with PTSD reported a strong preference to receive information about treatment options. They expressed interest in also learning about PTSD symptoms. The patients preferred information presented in a booklet format. From our literature review several treatments emerged as effective for PTSD: Cognitive Therapy, Exposure Therapy, Eye Movement Desensitization Therapy, Selective Serotonin Reuptake Inhibitors, venlafaxine, and risperidone.ConclusionIt appears that the criteria set forth to develop decision aids can effectively be applied to PTSD. The resultant PTSD patient decision aid is a booklet that describes the causes, symptoms, and treatments for PTSD. Future work will examine the effects of use of the PTSD decision aid in clinical practice.Trial registrationClinicaltrials.gov identifier NCT00908440. Registered May 20, 2009.
Project description:Complex generics are generic versions of drug products that generally have complex active ingredients, complex formulations, complex routes of delivery, complex dosage forms, are complex drug-device combination products, or have other characteristics that can make it complex to demonstrate bioequivalence or to develop as generics. These complex products (i.e. complex generics) are an important element of the United States (U.S.) Food and Drug Administration's (FDA's) Generic Drug User Fee Amendments (GDUFA) II Commitment Letter. The Center for Research on Complex Generics (CRCG) was formed by a grant from the FDA to address challenges associated with the development of complex generics. To understand these challenges, the CRCG conducted a "Survey of Scientific Challenges in the Development of Complex Generics". The three main areas of questioning were directed toward which (types of) complex products, which methods of analysis to support a demonstration of bioequivalence, and which educational topics the CRCG should prioritize. The survey was open to the public on a website maintained by the CRCG. Regarding complex products, the top three selections were complex injectables, formulations, and nanomaterials; drug-device combination products; and inhalation and nasal products. Regarding methods of analysis, the top three selections were locally-acting physiologically-based pharmacokinetic modeling; oral absorption models and bioequivalence; and data analytics and machine learning. Regarding educational topics, the top three selections were complex injectables, formulations, and nanomaterials; drug-device combination products; and data analytics, including quantitative methods and modeling & simulation. These survey results will help prioritize the CRCG's initial research and educational initiatives.
Project description:BackgroundThe expansion of Medicaid as part of the Affordable Care Act opened new opportunities to provide health coverage to low-income adults who may be involved in other public sectors.ObjectiveThe main objective of this study was to describe cross-sector utilization patterns among urban Medicaid expansion enrollees.Research designWe merged data from 4 public sectors (health care, human services, housing, and criminal justice) for 98,282 Medicaid expansion enrollees in Hennepin County, MN. We fit a latent class model to indicators of cross-sector involvement.MeasuresIndicator variables described involvement levels within each sector from March 2011 through December 2014. Demographic and chronic condition indicators were included post hoc to characterize classes.ResultsWe found 6 archetypes of cross-sector involvement: The "Low Contact" class (33.9%) had little involvement in any public sector; "Primary Care" (26.3%) had moderate, stable health care utilization; "Health and Human Services" (15.3%) had high rates of health care and cash assistance utilization; "Minimal Criminal History" (11.0%) had less serious criminal justice involvement; "Cross-sector" (7.8%) had elevated emergency department use, involvement in all 4 sectors, and the highest prevalence of behavioral health conditions; "Extensive Criminal History" (5.7%) had serious criminal justice involvement. The 3 most expensive classes (Health and Human Services, Cross-sector, and Extensive Criminal History) had the highest rates of behavioral health conditions. Together, they comprised 29% of enrollees and 70% of total public costs.ConclusionsMedicaid expansion enrollees with behavioral health conditions deserve focus due to the high cost-reduction potential across public sectors. Cross-sector collaboration is a plausible path to reduce costs and improve outcomes.
Project description:OBJECTIVE:To explore whether there is a potential for greater use of research-based information in public health practice in a local setting. Secondly, if research-based information is relevant, to explore the extent to which this generates questioning behaviour. DESIGN:Qualitative study using focus group discussions, observation and interviews. SETTING:Public health practices in Norway. PARTICIPANTS:52 public health practitioners. RESULTS:In general, the public health practitioners had a positive attitude towards research-based information, but believed that they had few cases requiring this type of information. They did say, however, that there might be a potential for greater use. During five focus groups and six observation days we identified 28 questions/cases where it would have been appropriate to seek out research evidence according to our definition. Three of the public health practitioners identified three of these 28 cases as questions for which research-based information could have been relevant. This gap is interpreted as representing unrecognised information needs. CONCLUSIONS:There is an unrealised potential in public health practice for more frequent and extensive use of research-based information. The practitioners did not appear to reflect on the need for scientific information when faced with new cases and few questions of this type were generated.
Project description:BACKGROUND:Mobile health applications are complex interventions that essentially require changes to the behavior of health care professionals who will use them and changes to systems or processes in delivery of care. Our aim has been to meet the technical needs of Health Extension Workers (HEWs) and midwives for maternal health using appropriate mobile technologies tools. METHODS:We have developed and evaluated a set of appropriate smartphone health applications using open source components, including a local language adapted data collection tool, health worker and manager user-friendly dashboard analytics and maternal-newborn protocols. This is an eighteen month follow-up of an ongoing observational research study in the northern of Ethiopia involving two districts, twenty HEWs, and twelve midwives. RESULTS:Most health workers rapidly learned how to use and became comfortable with the touch screen devices so only limited technical support was needed. Unrestricted use of smartphones generated a strong sense of ownership and empowerment among the health workers. Ownership of the phones was a strong motivator for the health workers, who recognised the value and usefulness of the devices, so took care to look after them. A low level of smartphones breakage (8.3%,3 from 36) and loss (2.7%) were reported. Each health worker made an average of 160 mins of voice calls and downloaded 27Mb of data per month, however, we found very low usage of short message service (less than 3 per month). CONCLUSIONS:Although it is too early to show a direct link between mobile technologies and health outcomes, mobile technologies allow health managers to more quickly and reliably have access to data which can help identify where there issues in the service delivery. Achieving a strong sense of ownership and empowerment among health workers is a prerequisite for a successful introduction of any mobile health program.
Project description:ObjectiveMany economically developed countries have seen a decline in publicly funded community programming. Within this context, community-based seniors' service (CBSS) organizations have been increasingly tasked to deliver programs to support the health and wellbeing of older citizens (e.g., home support, physical activity programs, and chronic disease management education). The primary objective of this study was to capture of the current needs of CBSS leaders in British Columbia, Canada, who attended a seminal event in the CBSS sector's development-the inaugural Summit on Aging.ResultsOur evaluation of the Summit included: pre/post Summit surveys (N = 79/76), ethnographic observations, and follow-up interviews (n = 22). Our detailed evaluation plan may inform others undertaking similar data collection; the most informative results were derived from the follow-up interviews and our findings suggest that interviews may be sufficient for similar evaluations. Summit delegates identified key opportunities to strengthen the CBSS as a sector, including enhanced collaboration; improved mechanisms that foster connecting and collaborating; and more resources, including training and qualified staff, to increase their capacity to deliver community-based health services. These findings echo work already completed in the community-based health promotion sector.
Project description:A Teratology Information Service (TIS) does not exist in Belgium yet but will hopefully be established soon. To prepare for this, we aimed to provide insight into the information needs and counseling preferences of the Belgian public and healthcare professionals (HCPs) regarding medication use in pregnancy and breastfeeding. A cross-sectional study using two anonymous, online surveys disseminated via social media, websites, and newsletters addressing Dutch and French-speaking individuals (≥18 years) and licensed HCPs was performed between June and September 2020. Ethics approval and informed consent were obtained. In total, 1508 public survey respondents (98% women) and 702 HCPs participated. Information needs on perinatal medication use were ubiquitous among both groups, and for which they often relied on patient information leaflets or the product information and online fora. Conflicting information on this topic regularly occurs and complicates HCPs' duties. Women and HCPs assigned an important role to a TIS, both in terms of providing evidence-based information (via a website or app) and being accessible to be contacted in case of questions (by phone or via e-mail or chat). In conclusion, a TIS would be warmly welcomed by women and HCPs in Belgium and should ideally be established soon to address current information needs regarding perinatal medication use and to contribute to research in this field.
Project description:Addressing psychosocial and quality of life needs is central to provision of excellent care for people with advanced cancer. This study tested a brief nurse-delivered intervention to address the needs of urban women with advanced breast cancer. This study was conducted at four large urban hospitals in Australia. One hundred and five women with advanced breast cancer were recruited and randomised to receive the intervention or usual care, then asked to complete the European Organisation of Research and Treatment of Quality of life Q-C30 version (2.0) (EORTC Q-C30) (version 2) and Supportive Care Needs Survey (SCNS) at 1 month and 3 months postrecruitment. No significant differences were detected between intervention and usual care groups in the SCNS or the EORTC Q-C30 subscale scores. However, when the groups were divided into high needs (score of above 50) and low baseline needs (score of 50 or below) for each SCNS subscale, a significant difference between intervention and usual care groups was found in the psychological/emotional subscale among women with high baseline needs. In conclusions, this study demonstrated that a face-to-face session and follow-up phone call with a breast care nurse significantly reduced the psychological and emotional needs of those with high initial needs. There was no evidence of the intervention influencing the quality of life; or perceived needs of women with low initial psychological/emotional needs or perceived needs in other domains. Possibly, the intervention was not sufficiently intense to achieve an effect.
Project description:BackgroundThe poor in low and middle income countries have limited access to health services due to limited purchasing power, residence in underserved areas, and inadequate health literacy. This produces significant gaps in health care delivery among a population that has a disproportionately large burden of disease. They frequently use the private health sector, due to perceived or actual gaps in public services. A subset of private health organizations, some called social enterprises, have developed novel approaches to increase the availability, affordability and quality of health care services to the poor through innovative health service delivery models. This study aims to characterize these models and identify areas of innovation that have led to effective provision of care for the poor.MethodsAn environmental scan of peer-reviewed and grey literature was conducted to select exemplars of innovation. A case series of organizations was then purposively sampled to maximize variation. These cases were examined using content analysis and constant comparison to characterize their strategies, focusing on business processes.ResultsAfter an initial sample of 46 studies, 10 case studies of exemplars were developed spanning different geography, disease areas and health service delivery models. These ten organizations had innovations in their marketing, financing, and operating strategies. These included approaches such a social marketing, cross-subsidy, high-volume, low cost models, and process reengineering. They tended to have a narrow clinical focus, which facilitates standardizing processes of care, and experimentation with novel delivery models. Despite being well-known, information on the social impact of these organizations was variable, with more data on availability and affordability and less on quality of care.ConclusionsThese private sector organizations demonstrate a range of innovations in health service delivery that have the potential to better serve the poor's health needs and be replicated. There is a growing interest in investing in social enterprises, like the ones profiled here. However, more rigorous evaluations are needed to investigate the impact and quality of the health services provided and determine the effectiveness of particular strategies.