Forensic psychiatric services address the therapeutic needs of mentally disordered offenders in a secure setting. Clinical, ethical, and legal considerations underpinning treatment emphasize that the Quality of Life (QOL) of patients admitted to forensic hospitals should be optimised. This study aims to examine changes in the QOL in Ireland's National Forensic Mental Health Service (NFMHS) following its relocation from the historic 1850 site in Dundrum to a new campus in Portrane, Dublin.

This multisite prospective longitudinal study is part of the Dundrum Forensic Redevelopment Evaluation Study (D-FOREST). Repeated measures were taken for all inpatients in the service at regular 6 monthly intervals. The WHOQOL-BREF questionnaire was offered to all inpatients. An anonymised EssenCES questionnaire was used to measure atmosphere in wards. Data were obtained at 5 time points for each individual patient and ward. WHOQOL-BREF ratings were obtained across 5 time points with comparisons available for 4 time intervals, including immediately before and after relocation. For 101 subjects across 4 time intervals, 215 sets of data were obtained; 140 before and 65 after relocation with 10 community patients who did not move. Using Generalised Estimating Equations (GEE) to correct for multiple comparisons over time, the effect of relocation, with community patients as a control, was analysed by ward cluster and whether patients moved between wards. Observations were categorised according to security level – high dependency, medium secure, rehabilitation, or community – and trichotomised based on positive moves to less secure wards, negative moves to more secure wards, or no moves.

Relocation of the NFMHS was associated with a significant increase in environmental QOL (Wald X2 = 15.9, df = 1, p < 0.001), even when controlling for cluster location, positive and negative moves. When controlling for ward atmosphere, environmental QOL remained significantly increased after the move (Wald X2 = 10.0, df = 1, p = 0.002). EssenCES scores were obtained within the hospital for 3 time points before relocation and 2 time points afterwards. No significant differences were found on the three subscales before and after the move. All three EssenCES subscales progressively improved with decreasing security level (Patient Cohesion: Wald X2 = 958.3, df = 1, p < 0.001; Experiencing Safety: Wald X2 = 152.9, df = 5, p < 0.001; Therapeutic Hold: Wald X2 = 33.6, df = 3, p < 0.001).

The GEE model demonstrated that the move of the NFMHS improved self-reported environmental QOL. The cluster location made significant differences, as expected for a system of stratified therapeutic security, with a steady improvement in scores on all three atmosphere subscales.

Leg ulcers are usually treated with compression therapy unless there is evidence of peripheral arterial disease (PAD). Compression may lead to vascular complications in people with PAD. Timely diagnosis and appropriate treatment are important to ensure the best patient outcomes. PAD is usually assessed using a manual ankle brachial pressure index (ABPI). Automated devices may reduce time to diagnosis and treatment of leg ulcers. This study investigated the diagnostic accuracy, clinical effectiveness, and cost effectiveness of automated ABPI measurement, compared with manual doppler testing, to detect PAD in people with leg ulcers.

We conducted a systematic review of studies of any design assessing automated devices in any population. Meta-analyses were conducted where possible. A decision tree and Markov model was used to capture lifetime costs, quality-adjusted life-years (QALYs), and cost effectiveness from a UK National Health Service perspective. Sensitivity analyses captured the uncertainty surrounding model assumptions and probabilistic sensitivity analyses described parameter uncertainty. Value of information analysis was conducted to identify future research priorities.

A total of 22 studies provided diagnostic accuracy data for five automated devices, but there were no studies in people with leg ulcers. Meta-analysis of 12 studies demonstrated a pooled sensitivity of 64 percent (95% confidence interval [CI]: 57, 71) and a specificity of 96 percent (95% CI: 92, 98) for detecting PAD. Automated devices were cheaper to complete due to shorter test times, but the increased risk of inappropriate or delayed treatment due to inaccurate test results offset the cost savings and reduced the QALYs for automated devices.

Given the current limited evidence base, automated devices would only be cost effective if they can demonstrate substantial reductions in time to diagnosis in clinical practice. Value of information analysis identified the following research priorities: (i) to determine diagnostic accuracy in a population with leg ulcers; (ii) to determine the impact of test results on ulcer healing times, and (iii) to determine the risk of providing inappropriate treatment based on inaccurate test results.

Head trauma is a high-risk presentation to the emergency department (ED). Preventing secondary brain injury through earlier diagnosis and intervention relies on timely access to head CT. Wexford General Hospital (WGH) ED uses NICE guidelines, which recommend specific timeframes for acquiring CT in head trauma. Following an audit demonstrating low compliance to NICE CG176 time standards in 2020 (34%), a quality improvement project was undertaken to optimize imaging pathways for head trauma.

94 head trauma CT scans were analyzed over a two-month period (June 14, 2022-August 14, 2022) from the NIMIS and IPMS databases to establish current time compliance and median wait times for CT.

Following the implementation of a head injury assessment proforma at triage to prompt earlier evaluation of high-risk head injuries, 108 head trauma CT’s were reviewed over a two-month period (August 15, 2022-October 15, 2022) to determine if these parameters improved.

Unpaired, two-tailed Mann-Whitney’s test was used to compare median wait times from triage to CT. Two-tailed Chi-square test was used to compare overall compliance rates.

Overall ED compliance to NICE time standards improved following implementation of the proforma (43% vs. 36%, p=0.401).

For CT scans that were indicated within one hour, there was a statistically significant decrease in median wait time from triage to CT (134mins vs. 186mins, p=0.046). There was also a decrease in median wait time for scans indicated within 8 hours; however, this did not reach the threshold for statistical significance (216mins vs. 275mins, p=0.230).

Although there was an overall reduction in wait times for CT, this did not translate to a significant improvement in compliance rates to NICE CG176 time standards. This suggests that, despite earlier identification of these high-risk head injuries at triage, other systemic barriers to obtaining head CT are present and warrant further investigation.

Many clinical trials leverage real-world data. Typically, these data are manually abstracted from electronic health records (EHRs) and entered into electronic case report forms (CRFs), a time and labor-intensive process that is also error-prone and may miss information. Automated transfer of data from EHRs to eCRFs has the potential to reduce data abstraction and entry burden as well as improve data quality and safety.

We conducted a test of automated EHR-to-CRF data transfer for 40 participants in a clinical trial of hospitalized COVID-19 patients. We determined which coordinator-entered data could be automated from the EHR (coverage), and the frequency with which the values from the automated EHR feed and values entered by study personnel for the actual study matched exactly (concordance).

The automated EHR feed populated 10,081/11,952 (84%) coordinator-completed values. For fields where both the automation and study personnel provided data, the values matched exactly 89% of the time. Highest concordance was for daily lab results (94%), which also required the most personnel resources (30 minutes per participant). In a detailed analysis of 196 instances where personnel and automation entered values differed, both a study coordinator and a data analyst agreed that 152 (78%) instances were a result of data entry error.

An automated EHR feed has the potential to significantly decrease study personnel effort while improving the accuracy of CRF data.

Looked-after children are at risk of suboptimal attachment patterns and reactive attachment disorder (RAD). However, access to interventions varies widely, and there are no evidence-based interventions for RAD.

To modify an existing parenting intervention for children with RAD in the UK foster care setting, and test the feasibility of conducting a randomised controlled trial (RCT) of the modified intervention.

The intervention was modified with expert input and tested on a case series. A feasibility and pilot RCT compared the new intervention with usual care. Foster carers and children in their care aged ≤6 years were recruited across nine local authorities, with 1:1 allocation and blind post-treatment assessments. The modified intervention was delivered in-home by trained mental health professionals over 4–6 months. Children were assessed for RAD symptoms, attachment quality and emotional/behavioural difficulties, and foster carers were assessed for sensitivity and stress.

Minimal changes to the intervention programme were necessary, and focused on improving its suitability for the UK foster care context. Recruitment was challenging, and remained below target despite modifications to the protocol and the inclusion of additional sites. Thirty families were recruited to the RCT; 15 were allocated to each group. Most other feasibility outcomes were favourable, particularly high numbers of data and treatment completeness. The revised intervention was positively received by practitioners and foster carers.

A large-scale trial may be feasible, but only if recruitment barriers can be overcome. Dedicated resources to support recruitment within local authorities and wider inclusion criteria are recommended.

Studying phenotypic and genetic characteristics of age at onset (AAO) and polarity at onset (PAO) in bipolar disorder can provide new insights into disease pathology and facilitate the development of screening tools.

To examine the genetic architecture of AAO and PAO and their association with bipolar disorder disease characteristics.

Genome-wide association studies (GWASs) and polygenic score (PGS) analyses of AAO (n = 12 977) and PAO (n = 6773) were conducted in patients with bipolar disorder from 34 cohorts and a replication sample (n = 2237). The association of onset with disease characteristics was investigated in two of these cohorts.

Earlier AAO was associated with a higher probability of psychotic symptoms, suicidality, lower educational attainment, not living together and fewer episodes. Depressive onset correlated with suicidality and manic onset correlated with delusions and manic episodes. Systematic differences in AAO between cohorts and continents of origin were observed. This was also reflected in single-nucleotide variant-based heritability estimates, with higher heritabilities for stricter onset definitions. Increased PGS for autism spectrum disorder (β = −0.34 years, s.e. = 0.08), major depression (β = −0.34 years, s.e. = 0.08), schizophrenia (β = −0.39 years, s.e. = 0.08), and educational attainment (β = −0.31 years, s.e. = 0.08) were associated with an earlier AAO. The AAO GWAS identified one significant locus, but this finding did not replicate. Neither GWAS nor PGS analyses yielded significant associations with PAO.

AAO and PAO are associated with indicators of bipolar disorder severity. Individuals with an earlier onset show an increased polygenic liability for a broad spectrum of psychiatric traits. Systematic differences in AAO across cohorts, continents and phenotype definitions introduce significant heterogeneity, affecting analyses.

The use of online platforms for pediatric healthcare research is timely, given the current pandemic. These platforms facilitate trial efficiency integration including electronic consent, randomization, collection of patient/family survey data, delivery of an intervention, and basic data analysis.

We created an online digital platform for a multicenter study that delivered an intervention for sleep disorders to parents of children with autism spectrum disorder (ASD). An advisory parent group provided input. Participants were randomized to receive either a sleep education pamphlet only or the sleep education pamphlet plus three quick-tips sheets and two videos that reinforced the material in the pamphlet (multimedia materials). Three measures – Family Inventory of Sleep Habits (FISH), Children’s Sleep Habits Questionnaire modified for ASD (CSHQ-ASD), and Parenting Sense of Competence (PSOC) – were completed before and after 12 weeks of sleep education.

Enrollment exceeded recruitment goals. Trial efficiency was improved, especially in data entry and automatic notification of participants related to survey completion. Most families commented favorably on the study. While study measures did not improve with treatment in either group (pamphlet or multimedia materials), parents reporting an improvement of ≥3 points in the FISH score showed a significantly improved change in the total CSHQ (P = 0.038).

Our study demonstrates the feasibility of using online research delivery platforms to support studies in ASD, and more broadly, pediatric clinical and translational research. Online platforms may increase participant inclusion in enrollment and increase convenience and safety for participants and study personnel.

Clinical trial participation among US Hispanics remains low, despite a significant effort by research institutions nationwide. ResearchMatch, a national online platform, has matched 113,372 individuals interested in participating in research with studies conducted by 8778 researchers. To increase accessibility to Spanish speakers, we translated the ResearchMatch platform into Spanish by implementing tenets of health literacy and respecting linguistic and cultural diversity across the US Hispanic population. We describe this multiphase process, preliminary results, and lessons learned.

Translation of the ResearchMatch site consisted of several activities including: (1) improving the English language site’s reading level, removing jargon, and using plain language; (2) obtaining a professional Spanish translation of the site and incorporating iterative revisions by a panel of bilingual community members from diverse Hispanic backgrounds; (3) technical development and launch; and (4) initial promotion.

The Spanish language version was launched in August 2018, after 11 months of development. Community input improved the initial translation, and early registration and use by researchers demonstrate the utility of Spanish ResearchMatch in engaging Hispanics. Over 12,500 volunteers in ResearchMatch self-identify as Hispanic (8.5%). From August 2018 to March 2020, 162 volunteers registered through the Spanish language version of ResearchMatch, and over 500 new and existing volunteers have registered a preference to receive messages about studies in Spanish.

By applying the principles of health literacy and cultural competence, we developed a Spanish language translation of ResearchMatch. Our multiphase approach to translation included key principles of community engagement that should prove informative to other multilingual web-based platforms.

Accurate localisation of target position is crucial when using techniques with sharp dose fall off such as volumetric modulated arc therapy (VMAT). Gold seed fiducial markers have been used for target localisation in image-guided radiation therapy for various tumors including intact prostate cancers. However, their role for target localisation in post-prostatectomy radiotherapy is unclear. This study was undertaken to determine the feasibility and effectiveness of gold seed fiducial markers in patients undergoing prostate bed VMAT.

The institutional radiation oncology database was used to analyse the treatment data of 18 post-prostatectomy patients with implanted gold seed fiducial markers. The shifts of the fiducial markers were reviewed, tabulated and statistically analysed.

Three hundred and eighty-six orthogonal pair images for 18 patients were reviewed. Specifically, the average gold seed fiducial shifts were 0·34 cm in the superior–inferior (S/I) axis (0·31 SD), 0·31 cm (0·29 SD) in the anterior–posterior (A/P) axis and 0·28 cm (0·25 SD) in the lateral axis (R/L). As a result, the 95% probability of fiducial marker displacement was 0·96 cm in the S/I, 0·89 cm in the A/P and 0·78 cm in the R/L axes. The most frequent shifts occurred in the inferior, left and posterior directions. The percentage of shifts more than 0·5 cm were 19·74, 21·56 and 12·47% for the S/I, A/P and R/L axes, respectively.

In the absence of fiducial markers, non-uniform planning target volume (PTV) margins of 1 cm for S/I, 9 mm for A/P and 8 mm for the lateral direction are necessary for target localisation in post-prostatectomy radiotherapy. By improving prostate bed localisation, gold seed fiducial markers can decrease PTV margins, reduce normal tissue radiation exposure and allow for dose-escalated and/or hypofractionated radiotherapy to be considered in appropriate clinical scenarios.

Individuals experiencing different medical conditions, as well as healthy volunteers, may often be interested in trial participation, and researchers similarly need to find participants to advance medical knowledge. The ResearchMatch (RM) Trials Today clinical trial searching tool leverages clinicaltrials.gov data to enable potential participants to look for trial opportunities relevant to their situation. To facilitate expanded use of this tool, we undertook a national digital public awareness campaign to increase awareness of Trials Today among members of the general public.

The awareness campaign promoted Trials Today using Facebook and digital banner messages in 2017, encompassing nine cities across the USA. The digital strategy was complemented by print media in several outlets. We employed descriptive statistics to summarize campaign metrics and site usage data during the campaign.

The campaign was successful in increasing visits to Trials Today, with 142,303 sessions logged during its run, as compared to pre-campaign data indicating 104,688 total sessions during the entire 2-year period since the site’s inception. The city-specific click-through rate for all digital impressions, combining Facebook and banner messaging, ranged from 0.50% to 1.09%, resulting in a cost-per-click range of $0.69–$1.15. In addition, visitors conducted 29,697 searches and viewed individual trial records 173,512 times.

The public awareness campaign was successful in increasing use of the RM Trials Today clinical trial searching tool. Our findings support the value of digital media messaging as a cost-effective vehicle for promoting clinical trial awareness, especially for chronic ailments.

Delays in triage processes in the emergency department (ED) can compromise patient safety. The aim of this study was to provide proof-of-concept that a self-check-in kiosk could decrease the time needed to identify ambulatory patients arriving in the ED. We compared the use of a novel automated self-check-in kiosk to identify patients on ED arrival to routine nurse-initiated patient identification.

We performed a prospective trail with random weekly allocation to intervention or control processes during a 10-week study period. During intervention weeks, patients used a self-check-in kiosk to self-identify on arrival. This electronically alerted triage nurses to patient arrival times and primary complaint before triage. During control weeks, kiosks were unavailable and patients were identified using routine nurse-initiated triage. The primary outcome was time-to-first-identification, defined as the interval between ED arrival and identification in the hospital system.

Median (interquartile range) time-to-first-identification was 1.4 minutes (1.0–2.08) for intervention patients and 9 minutes (5–18) for control patients. Regression analysis revealed that the adjusted time-to-first-identification was 13.6 minutes (95% confidence interval 12.8–14.5) faster for the intervention group.

A self-check-in kiosk significantly reduced the time-to-first-identification for ambulatory patients arriving in the ED.