Helping Homeless Veterans Find Employment and Pay Child Support: A Program Evaluation of a Pilot Collaboration

Objective: This research evaluates the effectiveness of a pilot collaboration in Georgia (USA) designed to help homeless veterans, with open child support cases,locate employment, find permanent housing, resolve legal issues, and begin making child support payments. Method: The study employed a single group pretest posttest research design (n= 45). Quantitative and qualitative data were collected from all 45 participants enrolled in the study. Results: Between baseline and posttest,mean monthly child support payments increased 47% ($55 to$81). While child support payments improved, they remained well below the $396 mean monthly amount owed. Sixty-nine percent of the sample remained unemployed at posttest and presented with major barriers to employment. Half of focus group respondents reported improved housing conditions over the course of the study. While a few veterans reported progress on resolving legal issues, the majority had extant legal issues at the end of the study. Conclusions: While a majority of focus group participants felt their lives had improved, stronger interventions tailored to help participants overcome multiple, complex barriers to employment will be necessary to help homeless veterans secure living wage employment and make substantial child support payments

When innovation outpaces regulations:The legal challenges for direct-to-patient supply of investigational medicinal products

AIMS: We profile the lack of specific regulation for direct‐to‐patient postal supply (DTP) of clinical trial medications (investigational medicinal products, IMPs) calling for increased efficiency of patient‐centred multi‐country remote clinical trials. METHODS: Questionnaires emailed to 28 European Economic Area (EEA) Medical Product Licensing Authorities (MPLAs) and Swissmedic MPLA were analysed in 2019/2020. The questionnaire asked whether DTP of IMPs was legal, followed by comparative legal analysis profiling relevant national civil and criminal liability provisions in 30 European jurisdictions (including The Netherlands), finally summarising accessible COVID‐19‐related guidance in searches of 30 official MPLA websites in January 2021. RESULTS: Twenty MPLAs responded. Twelve consented to response publication in 2021. DTP was not widely authorised, though different phrases were used to explain this. Our legal review of national laws in 29 EEA jurisdictions and Switzerland did not identify any specific sanctions for DTP of IMPs; however, we identified potential national civil and criminal liability provisions. Switzerland provides legal clarity where DTP of IMPs is conditionally legal. MPLA webpage searches for COVID‐19 guidance noted conditional acceptance by 19 MPLAs. CONCLUSIONS: Specific national legislation authorising DTP of IMPs, defining IMP categories, and conditions permitting the postage and delivery by courier in an EEA‐wide clinical trial, would support innovative patient‐centred research for multi‐country remote clinical trials. Despite it appearing more acceptable to do this between EU Member States, provided each EU MPLA and ethics board authorises it, temporary Covid‐19 restrictions in national Good Clinical Practice (GCP) guidance discourages innovative research into the safety and effectiveness of clinical trial medications

Home blood pressure monitors owned by participants in a large decentralised clinical trial in hypertension:the Treatment In Morning versus Evening (TIME) study

Various home blood pressure monitors (HBPMs) are available to the public for purchase but only some are validated against standardised protocols. This study aimed to assess whether HBPMs owned by participants taking part in a clinical trial were validated models. The TIME study is a decentralised randomised trial investigating the effect of antihypertensive medication dosing time on cardiovascular outcomes in adults with hypertension. No HBPMs were provided to participants in this trial but patients were asked to report if they already owned one. We identified the model of HBPM reported by participants, then cross-referenced this against lists of validated HBPMs produced by dabl Educational Trust and the British and Irish Hypertension Society (BIHS). Of 21,104 participants, 10,464 (49.6%) reported their model of HBPM. 7464 (71.3%) of these participants owned a monitor that could be identified from the participants’ entry. Of these, 6066 (81.3%) participants owned a monitor listed as validated by either dabl (n = 5903) or BIHS (n = 5491). Some were listed as validated by both. 1398 (18.7%) participants owned an identifiable HBPM that lacked clear evidence of validation. 6963 (93.3%) participants owned an upper arm HBPM and 501 (6.7%) owned a wrist HBPM. Validated HBPMs had a higher median online retail price of £45.00 compared to £20.00 for HBPMs lacking clear evidence of validation. A significant number of participants own HBPMs lacking evidence of validation

The Treatment In Morning versus Evening (TIME) study:Analysis of recruitment, follow-up and retention rates post-recruitment

Abstract Background The use of information technology (IT) is now the preferred method of capturing and storing clinical research data. The Treatment In Morning versus Evening (TIME) study predominantly uses electronic data capture and IT to compare morning dosing of hypertensive medication against evening dosing. Registration, consent, participant demographics and follow-up data are all captured via the study website. The aim of this article is to assess the success of the TIME methodology compared with similar studies. Methods To assess the TIME study, published literature on similar clinical trials was reviewed and compared against TIME recruitment, follow-up and email interaction data. Results The TIME website registered 31,695 individuals, 21,116 of whom were randomised. Recruitment cost per randomised participant varied by strategy: £17.40 by GP practice, £3.08 by UK Biobank and £58.82 for GoShare. Twelve-month follow-up retention rates were 96%. A total of 1089 participants have withdrawn from their assigned time of dosing, 2% of whom have declined follow-up by record linkage or further contact. When the TIME data are compared with similar study data, study recruitment is very successful. However, TIME suffers difficulties with participant follow-up and withdrawal rates similar to those of conventional studies. Conclusions The TIME study has been successful in recruitment. Follow-up, retention rates and withdrawal rates are all acceptable, but ongoing work is required to ensure participants remain engaged with the study. Various recruitment strategies are necessary, and all viable options should be encouraged to maintain participant engagement throughout the life of studies using IT

Factors influencing home blood pressure monitor ownership in a large clinical trial

Home blood pressure monitor (HBPM) ownership prevalence and the factors that influence it are unclear. This study aimed to investigate factors associated with HBPM ownership among participants in the Treatment in Morning versus Evening (TIME) hypertension study. This study is a sub-analysis of the TIME study, a randomised trial investigating the effect of day-time versus night-time dosing of antihypertensive medication on cardiovascular outcomes in adults with hypertension. As part of the TIME study online registration process, participants were asked to indicate whether they owned an HBPM. A multivariate logistic regression model was constructed to determine factors associated with HBPM ownership. Of 21 104 randomised participants, 11 434 (54.2%) reported owning an HBPM. The mean age of all participants at enrolment was 67.7 ± 9.3 years, 12 134 (57.5%) were male, and 8 892 (42.1%) reported a current or previous history of smoking. Factors associated with an increased likelihood of reporting HBPM owned include being male (OR:1.47; 95% CI 1.39-1.56) or residing in a less deprived socioeconomic region (IMD Decile 6-10) (OR:1.31; 95% CI 1.23-1.40). Participants with a history of diabetes mellitus (OR:0.74; 95% CI:0.64-0.86) or current smokers, compared to non-smokers, (OR:0.71; 95% CI:0.62-0.82) were less likely to report owning an HBPM. This study has identified important patient factors influencing HBPM ownership. Further qualitative research would be valuable to identify and explore potential patient-level barriers to engagement with self-monitoring of blood pressure

Situation Awareness, Workload, and Performance in Midterm Nextgen: Effect of Dynamic Variations in Aircraft Equipage Levels

NextGen changes in air traffic management promise to bring many benefits to the current airspace system, but these changes must be evaluated for their impact on mid-term air traffic management in which mixed-equipage is certain. We examined mixed equipage environments in which the equipage levels changed over the course of the scenario to reflect changes in sector characteristic over the course of a day or controller’s work shift. Six retired ATCs managed mixed-equipage traffic that either began with low levels of NextGen equipped aircraft and increased midway through the scenario or vice-versa. These were compared to a scenario in which the equipage mix was held constant. ATC performance, workload and situation awareness were affected differently by these scenarios