Pilot Evaluation Research Articles

Abstract 1008: Pilot evaluation of an online course for primary care providers on preparing patients for cancer discussions with their oncologists

Abstract Introduction: Cancer clinical trial (CCT) accrual is only 5-8%, and barriers to participate can be more acute for underserved groups. Enrollment of racial/ethnic minorities, older adults, adolescents, and young adults is not adequate to understand treatment outcomes unique to these populations. Education before seeing an oncologist can increase patients’ willingness to ask and consider receiving treatment through a CCT. Because primary care providers (PCPs) interact with patients during diagnosis, provide ongoing care, and are a trusted source of information, they can educate and normalize inquiries about therapeutic CCTs. The aim of this study was to pilot test an innovative, tailored online CCT course for PCPs. Methods: To participate, PCPs (MD, DO, NP, or PA) had to provide care in an outpatient setting, refer patients to a cancer treatment specialist in the past year, and be an English speaker residing in the U.S. or its territories. PCPs were recruited from Clinical Directors Network, University of Pennsylvania, and University of Florida. The 1-hour online course includes four modules hosted by a PCP and radiation oncologist with video segments of a CCT expert who summarized CCT recruitment research. Participants interact with patient scenarios and learn about the patient’s cancer diagnosis and medical/personal background. Videos of actors playing the roles of patient and doctor demonstrate communication skills taught in the course. PCPs completed short surveys prior to and immediately after completing the course. Results: 28 PCPs participated. PCPs were mainly MDs (88.9%), residents (17, 60.7%), White (46.4%), non-Hispanic/Latino (92.9%), and 50% women. Mean knowledge of CCTs scores (0-100%) increased significantly from pre (M=56.7, SD=17.5) to post (M=82.1, SD=12; p<.001) indicating that PCPs answered more true/false statements about CCTs correctly after training. Using a 1-5 scale with 5=strongly agree, PCPs’ attitudes and beliefs scores also increased significantly from pre (M=4.2, SD=.6) to post (4.7, SD=.4, p<.001) indicating that PCPs were more likely to agree they have a role in their patients’ cancer treatment, including CCTs, after training. Using the same scale, PCPs’ willingness to communicate about CCTs increased significantly from pre (M=4.4, SD= .5) to post (M=4.7, SD=.5, p=.007), indicating that PCPs were more willing to engage with patients diagnosed with cancer before referring them to a cancer specialist after training. Conclusions: Significant pilot findings in knowledge, attitudes and beliefs, and communication scores demonstrate that the online course was effective at educating PCPs about CCTs, and improving PCPs’ attitudes about the CCT referral process, and their willingness to engage in their patients’ cancer care. Future research will include a larger sample and explore the course’s impact on PCP’s referral behavior. Citation Format: Alyssa Crowe, Elisa S. Weiss, Margo Michaels, Domenic Durante, Maria Sae-Hau, Andrea Cassells, Carla L. Fisher, Jason Arnold, Taylor Vasquez, Ana Natale-Pereira, Raymond Mailhot, Zhongyue Zhang, Carma L. Bylund. Pilot evaluation of an online course for primary care providers on preparing patients for cancer discussions with their oncologists [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 1008.

Pilot Evaluation of the POWER Program: Positive Outcomes with Emotion Regulation

The Positive Outcomes With Emotion Regulation (POWER) Program is a transdiagnostic intervention for adolescents at risk of developing emotional disorders. The POWER Program was designed to be implemented in secondary schools, by school personnel with or without specialized mental health training, as a Tier 2 intervention. In this pilot study, the POWER Program was implemented by school psychologists and school psychologists-in-training and evaluated across four focal student participants using a multiple-baseline-across-participants single-case design. Program efficacy was assessed using systematic direct classroom observations of student negative affect and social engagement as well as student and caregiver ratings of emotional and behavioral symptoms. Program usability was assessed through rating scales completed by intervention facilitators and student participants. Overall, results provide evidence of the POWER Program’s small- to large-sized effects on students’ emotional and behavioral functioning as observed in the classroom and self-reported by students. In addition, results suggest implementation facilitators’ and students’ positive impressions of the program, evident in ratings of high understanding, feasibility, and acceptability across groups. Study limitations are highlighted with attention to opportunities to further refine and evaluate the POWER Program.

A spark of change: developing an innovative gerontological nursing intervention mapping initiative for training and education (IGNITE)

BackgroundWith an aging global population and advancements in medical technology, there is an urgent need for innovative gerontological nursing education programs. This study aimed to develop and evaluate the Innovative Gerontological Nursing Intervention Mapping Initiative for Training and Education (IGNITE) program. This program is a digital platform-based postgraduate nursing curriculum that employs the Intervention Mapping Approach (IMA) and Transformative Learning Theory to address the evolving needs of gerontological nursing.MethodsThe IGNITE program’s development process encompassed a comprehensive approach, including needs assessment, mapping of course objectives, integration of theory-based methods and strategies, course design, implementation, and rigorous evaluation. The pilot evaluation study involved pre- and post-tests focused on ageism, attitudes towards elder care, knowledge about older adults, transformative behavior change, and program satisfaction. The findings revealed significant improvements across all these dimensions, affirming the effectiveness of the program.ResultsThe program leveraged experiential learning, critical reflection, and rational discourse to facilitate transformative educational experiences. Notably, pre- and post-test comparisons showed marked improvements in attitudes towards older adult care and dementia care knowledge. Participants expressed high satisfaction with the program, with significant reported changes in transformative behaviors. The study also illuminated the initial negative attitudes of clinical nurses towards older adults and underscored the importance of transformative learning experiences in fostering empathy and understanding.ConclusionsThe IGNITE program lays a foundational framework for developing educational materials that promote transformative learning and self-reflection among healthcare professionals. This approach can lead to innovative nursing practices and personal growth. The application of the IMA and Transformative Learning Theory in gerontological nursing education shows significant promise. Future research should focus on exploring the long-term impacts of such programs and their applicability in diverse healthcare settings.

Developing Personalised Learning Support for the Business Forecasting Curriculum: The Forecasting Intelligent Tutoring System

In forecasting research, the focus has largely been on decision support systems for enhancing performance, with fewer studies in learning support systems. As a remedy, Intelligent Tutoring Systems (ITSs) offer an innovative solution in that they provide one-on-one online computer-based learning support affording student modelling, adaptive pedagogical response, and performance tracking. This study provides a detailed description of the design and development of the first Forecasting Intelligent Tutoring System, aptly coined FITS, designed to assist students in developing an understanding of time series forecasting using classical time series decomposition. The system’s impact on learning is assessed through a pilot evaluation study, and its usefulness in understanding how students learn is illustrated through the exploration and statistical analysis of a small sample of student models. Practical reflections on the system’s development are also provided to better understand how such systems can facilitate and improve forecasting performance through training.

Smartphone-Based Virtual and Augmented Reality Implicit Association Training (VARIAT) for Reducing Implicit Biases Toward Patients Among Health Care Providers: App Development and Pilot Testing.

Implicit bias is as prevalent among health care professionals as among the wider population and is significantly associated with lower health care quality. The study goal was to develop and evaluate the preliminary efficacy of an innovative mobile app, VARIAT (Virtual and Augmented Reality Implicit Association Training), to reduce implicit biases among Medicaid providers. An interdisciplinary team developed 2 interactive case-based training modules for Medicaid providers focused on implicit bias related to race and socioeconomic status (SES) and sexual orientation and gender identity (SOGI), respectively. The simulations combine experiential learning, facilitated debriefing, and game-based educational strategies. Medicaid providers (n=18) participated in this pilot study. Outcomes were measured on 3 domains: training reactions, affective knowledge, and skill-based knowledge related to implicit biases in race/SES or SOGI. Participants reported high relevance of training to their job for both the race/SES module (mean score 4.75, SD 0.45) and SOGI module (mean score 4.67, SD 0.50). Significant improvement in skill-based knowledge for minimizing health disparities for lesbian, gay, bisexual, transgender, and queer patients was found after training (Cohen d=0.72; 95% CI -1.38 to -0.04). This study developed an innovative smartphone-based implicit bias training program for Medicaid providers and conducted a pilot evaluation on the user experience and preliminary efficacy. Preliminary evidence showed positive satisfaction and preliminary efficacy of the intervention.

Supporting social emotional learning and wellbeing of displaced adolescents from the middle east: a pilot evaluation of the ‘forward with peers’ intervention

BackgroundA growing literature points to the critical role schools can play in promoting improved psychosocial wellbeing and resilience among first- and second-generation Arab immigrant and refugee adolescents, but few evaluations have examined the effectiveness of culturally adapted, school-based interventions.MethodsWe conducted a pilot evaluation of a culturally adapted social and emotional learning and life skills program, Forward with Peers (FwP), and examined its potential effectiveness for this population. FwP was evaluated across three high schools in the Detroit Metropolitan Area. Within each school, one Arabic class was randomly assigned to receive FwP programming and another served as a control. The pilot evaluation sought to examine changes in several mental health and psychosocial outcomes of interest.FindingsImprovements in overall perceived social support (P = 0.045) and perceived social support from someone special in one’s life (0.042) were statistically significant in the treatment as compared to the control group. Comparative improvements were also marginally significant for resilience (P = 0.095) and perceived social support from family (P = 0.074).ConclusionsFindings highlight the potential of FwP and support the growing interest in establishing efficacy of school-based, culturally appropriate SEL programming to improve psychosocial wellbeing among Arab refugee and immigrant adolescents. FwP’s demonstrated improvements in resilience and social support have the potential to prevent mental health disorders and bolster coping mechanisms to minimize adverse consequences in this vulnerable population. Employing a strengths-based approach, FwP offers an alternative intervention to traditional treatment-oriented supports for the proliferation of mental health disorders within this vulnerable population.

Integration of the RTS,S/AS01 malaria vaccine into the Essential Programme on Immunisation in western Kenya: a qualitative longitudinal study from the health system perspective

Malaria accounts for over half a million child deaths annually. WHO recommends RTS,S/AS01 to prevent malaria in children living in moderate-to-high malaria transmission regions. We conducted a qualitative longitudinal study to investigate the contextual and dynamic factors shaping vaccine delivery and uptake during a pilot introduction in western Kenya. The study was conducted between Oct 3, 2019, and Mar 24, 2022. We conducted participant and non-participant observations and in-depth interviews with health-care providers, health managers, and national policymakers at three timepoints using an iterative approach and observations of practices and processes of malaria vaccine delivery. Transcripts were coded by content analysis using the consolidated framework for implementation research, to which emerging themes were added deductively and categorised into challenges and opportunities. We conducted 112 in-depth interviews with 60 participants (25 health-care providers, 27 managers, and eight policy makers). Health-care providers highlighted limitations in RTS,S/AS01 integration into routine immunisation services due to the concurrent pilot evaluation and temporary adaptations for health reporting. Initial challenges related to the complexity of the four-dose schedule (up to 24-months); however, self-efficacy increased over time as the health-care providers gained experience in vaccine delivery. Low uptake of the fourth dose remained a challenge. Health managers cited insufficient trained immunisation staff and inadequate funding for supervision. Confidence in the vaccine increased among all participant groups owing to reductions in malaria frequency and severity. Integration of RTS,S/AS01 into immunisation services in western Kenya presented substantial operational challenges most of which were overcome in the first 2 years, providing important lessons for other countries. Programme expansion is feasible with intensive staff training and retention, enhanced supervision, and defaulter-tracing to ensure uptake of all doses. PATH via World Health Organization; Gavi, the Vaccine Alliance; The Global Fund; and Unitaid.

Degumming of Yuli Apocynum Fibers Using Hydrogen Peroxide and Biocatalysts Besides Factory Pilot Evaluation

Degumming of Yuli Apocynum Fibers Using Hydrogen Peroxide and Biocatalysts Besides Factory Pilot Evaluation

Pilot Evaluation of the Long-Term Reproducibility of Capillary Zone Electrophoresis-Tandem Mass Spectrometry for Top-Down Proteomics of a Complex Proteome Sample.

Mass spectrometry (MS)-based top-down proteomics (TDP) has revolutionized biological research by measuring intact proteoforms in cells, tissues, and biofluids. Capillary zone electrophoresis-tandem MS (CZE-MS/MS) is a valuable technique for TDP, offering a high peak capacity and sensitivity for proteoform separation and detection. However, the long-term reproducibility of CZE-MS/MS in TDP remains unstudied, which is a crucial aspect for large-scale studies. This work investigated the long-term qualitative and quantitative reproducibility of CZE-MS/MS for TDP for the first time, focusing on a yeast cell lysate. Over 1000 proteoforms were identified per run across 62 runs using one linear polyacrylamide (LPA)-coated separation capillary, highlighting the robustness of the CZE-MS/MS technique. However, substantial decreases in proteoform intensity and identification were observed after some initial runs due to proteoform adsorption onto the capillary inner wall. To address this issue, we developed an efficient capillary cleanup procedure using diluted ammonium hydroxide, achieving high qualitative and quantitative reproducibility for the yeast sample across at least 23 runs. The data underscore the capability of CZE-MS/MS for large-scale quantitative TDP of complex samples, signaling its readiness for deployment in broad biological applications. The MS RAW files were deposited in ProteomeXchange Consortium with the data set identifier of PXD046651.

A mixed-method non-randomized pilot evaluation of a mentalization-informed motivational interviewing group intervention for concerned significant others of adolescents with excessive gaming behaviors

Existing interventions to address gaming disorder or excessive gaming primarily focus on individuals with the disorder. Little research has been undertaken regarding the development and evaluation of interventions tailored for concerned significant others (CSOs), who often feel distressed due to their loved ones’ excessive gaming. This pilot study adopts a mixed-method design to evaluate the impacts of four sessions of a mentalization-informed motivational interviewing group intervention for CSOs. For the quantitative evaluation, a non-randomized controlled design is used. The study involves 38 parents of adolescents who are experiencing excessive gaming in Hong Kong. The intervention group (n = 23) received the CSO intervention; the control group (n = 15) did not. A total of 12 qualitative interviews with the intervention group participants were also conducted to collect their views on the usefulness of the intervention. The quantitative findings show that the intervention group experienced significant improvements in mental health, emotion regulation, and gaming-related parent–child conflict from pre-test to post-test, compared with the control group. The qualitative data corroborates the quantitative findings and provides insights into potential reasons for these improvements. The findings contribute to the knowledge base regarding CSO interventions in the context of gaming disorder—an underexplored area of study.

Pilot evaluation of a prototype online acceptance and commitment therapy program for adults living with a chronic health condition

The purpose of this study was to examine the feasibility of a prototype self-guided, online acceptance and commitment therapy (ACT) program as a transdiagnostic approach to improve health-related quality of life for individuals living with a chronic health condition. Participants consisted of adults with one or more chronic health conditions. A pre-post pilot trial design was used with participants asked to complete the 12-session ACT program over 12 weeks. Of the 38 enrolled participants, only 20 completed the first session and 6 completed all 12 sessions, indicating significant non-adherence to the prototype. Among post-intervention survey completers (n = 20), significant pre- to post-intervention improvements were found for psychological inflexibility and health-related quality of life, but not for anxiety and depression symptoms. Qualitative data is reviewed to further clarify feasibility challenges and potential strategies to improve a transdiagnostic approach to delivering online ACT for chronic health conditions.

Family Involvement Training for Staff and Family Caregivers: Case Report on Program Design and Mixed Methods Evaluation.

The COVID-19 pandemic underscored the imperative for meaningful family involvement in long-term care, aligning with policy and safety standards while enhancing outcomes for caregivers, residents, and staff. The objectives of this article are as follows: (1) a case study report on implementing a family involvement intervention designed to facilitate the formal and safe engagement of family caregivers in resident care and (2) the pilot evaluation of the intervention. We used Knapp's six-step implementation science model to guide and describe intervention development to provide insight for others planning family involvement projects. We employed sequential mixed methods, including surveys with quantitative and qualitative questions before and after program implementation for providers, and surveys and interviews with family caregivers a year after. We used the Mann-Whitney U test (p < 0.05) to assess differences in health providers' perceptions pre- and post-education. Families and staff perceived that the Family Involvement Program was important for improving the quality of care, residents' quality of life and family/staff relationships. Providers' perceptions of the program's positive impact on residents' quality of life (p = 0.020) and quality of care (p = 0.010), along with their satisfaction with working relationships with families (p = 0.039), improved significantly after the program. Qualitative data confirmed improvements in family-staff relationships. In conclusion, we documented the design of this family involvement initiative to encourage family caregivers and staff to work together in residents' care. Youville's Family Involvement Program gives families and family caregivers an explicit role as partners in long-term care. The mixed methods pilot evaluation documented improvements in staff and family relationships.

Group eye movement desensitization and reprocessing (EMDR) in chronic pain patients.

The prevalence of chronic pain is increasing, and conventional pain therapies often have limited efficacy in individuals with high levels of psychological distress and a history of trauma. In this context, the use of Eye Movement Desensitization and Reprocessing (EMDR), an evidence-based psychotherapy approach for the treatment of posttraumatic stress disorder, is becoming increasingly important. EMDR shows promising results, particularly for patients with pain and high levels of emotional distress. Although group therapy is becoming increasingly popular in pain management, EMDR has mainly been studied as an individual treatment. However, a systematic review suggests that group therapy can be an effective tool for improving mental health outcomes, especially when trauma is addressed together. Based on these findings, an outpatient EMDR group program was developed for patients with chronic pain. The program consists of a total of four treatment days with 5-5.5 h therapy sessions each day and provides patients with a supportive environment in which they can learn effective pain management strategies and interact with other patients with similar experiences. Initial pilot evaluations indicate high efficacy and adequate safety for patients with chronic pain.

Ovarian Morphology in Girls Longitudinal Cohort Study: Pilot Evaluation of Ovarian Morphology as a Biomarker of Reproductive and Metabolic Features during the First Gynecological Year

The objective was to establish whether aspects of ovarian morphology correlate with reproductive and metabolic features during the first postmenarcheal year using data from the Ovarian Morphology in Girls (OMG!) cohort study. The feasibility of transabdominal ultrasonography to assess ovarian features was also determined. Healthy adolescent females enrolled in a prospective cohort study. Study visits occurred at 6-10, 11-13, 17-19, and 23-25 months postmenarche and entailed a physical exam, transabdominal ultrasound, and fasting blood draw. Participants maintained menstrual diaries throughout the study. The present analysis reflects participants who completed the study visit at 6-10 months postmenarche. Associations between ovarian morphology or average cycle length with reproductive and metabolic features were assessed by Spearman correlations and linear regression. Forty participants enrolled in the OMG! Thirty-one participants initiated study procedures at 6-10 months postmenarche, and data were available for analysis for 29 participants. Image quality was judged as partially visible or excellent in 90% of the left and 78% of the right ovaries assessed, with all images collected having sufficient image quality to provide measurements of at least 1 ovarian marker. The follicle number per ovary and ovarian volume were positively associated with anti-Müllerian hormone levels and negatively associated with fasting insulin. The average cycle length was only associated negatively with triglycerides. Transabdominal ultrasonography in the early postmenarcheal period provides sufficient resolution to enable estimations of antral follicle count and ovarian size. Ovarian features in early gynecological life may correspond with measures of reproductive and metabolic function.

Motion correction of 3D dynamic contrast-enhanced ultrasound imaging without anatomical B-Mode images: Pilot evaluation in eight patients.

Dynamic contrast-enhanced ultrasound (DCE-US) is highly susceptible to motion artifacts arising from patient movement, respiration, and operator handling and experience. Motion artifacts can be especially problematic in the context of perfusion quantification. In conventional 2D DCE-US, motion correction (MC) algorithms take advantage of accompanying side-by-side anatomical B-Mode images that contain time-stable features. However, current commercial models of 3D DCE-US do not provide side-by-side B-Mode images, which makes MC challenging. This work introduces a novel MC algorithm for 3D DCE-US and assesses its efficacy when handling clinical data sets. In brief, the algorithm uses a pyramidal approach whereby short temporal windows consisting of three consecutive frames are created to perform local registrations, which are then registered to a master reference derived from a weighted average of all frames. We applied the algorithm to imaging studies from eight patients with metastatic lesions in the liver and assessed improvements in original versus motion corrected 3D DCE-US cine using: (i) frame-to-frame volumetric overlap of segmented lesions, (ii) normalized correlation coefficient (NCC) between frames (similarity analysis), and (iii) sum of squared errors (SSE), root-mean-squared error (RMSE), and r-squared (R2) quality-of-fit from fitted time-intensity curves (TIC) extracted from a segmented lesion. We noted improvements in frame-to-frame lesion overlap across all patients, from 68%±13% without correction to 83%±3% with MC (p=0.023). Frame-to-frame similarity as assessed by NCC also improved on two different sets of time points from 0.694±0.057 (original cine) to 0.862±0.049 (corresponding MC cine) and 0.723±0.066 to 0.886±0.036 (p ≤ 0.001 for both). TIC analysis displayed a significant decrease in RMSE (p=0.018) and a significant increase in R2 goodness-of-fit (p=0.029) for the patient cohort. Overall, results suggest decreases in 3D DCE-US motion after applying the proposed algorithm.

Resident perceptions of learning challenges in concussion care education

Background: Resident-focused curricula that support competency acquisition in concussion care are currently lacking. We sought to fill this gap by developing and evaluating Spiral Integrated Curricula (SIC) using the cognitive constructivism paradigm and the Utilization-Focused Evaluation (UFE) framework. The evidence-based curricula consisted of academic half-days (AHDs) and clinics for first- and second-year family medicine residents. Our first pilot evaluation had quantitatively demonstrated effectiveness and acceptability but identified ongoing challenges. Here we aimed to better describe how concussion learning is experienced from the learners’ perspective to understand why learning challenges occurred. Methods: A qualitative interpretative cohort study was utilized to explore resident perceptions of concussion learning challenges. Participants completed six monthly longitudinal case logs to reflect on their concussion experience. Semi-structured interviews were conducted. Results: Residents' beliefs and perceptions of their roles influenced their learning organization and approaches. Challenges were related to knowledge gaps in both declarative knowledge and knowledge interconnections. Through reflection, residents identified their concussion competency acquisition gaps, leading to transformative learning. Conclusion: This Spiral Integrated Design created vigorous processes to interrogate “concussion” competency gaps. We discussed resident mindsets and factors that hindered “concussion” learning and potentially unintentional negative impacts on the continuity of patient care. Future studies could explore how to leverage humanistic adaptive expertise, cross-disciplines for curriculum development, and evaluation to overcome the hidden curriculum and to promote integrated education and patient care.

"ReachOut": Pilot Evaluation of a Help-Seeking Intervention for Common Mental Health Concerns Among Distressed Non-Treatment-Seeking Young Adults.

Purpose There is a pressing need for interventions with the potential for scalability to enhance help-seeking inclination and behavior among individuals experiencing common mental health concerns. These interventions are important for addressing the widespread treatment gap. This study aimed to test the effectiveness, feasibility, and acceptability of a newly developed simple technology-based multi-component help-seeking intervention ("ReachOut") for common mental health concerns among distressed, non-treatment-seeking young adults. Methods "ReachOut" was delivered to 172 young adults aged 20-35 years, scoring above the cut-off on the Kessler Psychological Distress scale. Effectiveness was studied using a single-group short-term prospective study design to examine changes in help-seeking barriers, inclination, and behavior. We assessed intervention feasibility in terms of demand, implementation, practicality, and limited efficacyand acceptability was determinedbased on the rate of participation consent, the extent of pro-active initiation of contact with the facilitatorduring the intervention, feedback obtained on various "ReachOut" componentsand ratings on the likelihood of recommendingthe interventiontoa person in distress. Results Significant reductions in the mean barriers and improvement in mean help-seeking inclination from mental health professionals (MHPs) were observed on the Friedman test from baseline to the two-month follow-up period after the intervention. Thirty-eight percent of participants (N=41) reported seeking help from MHPs by two-month follow-up. Feedback from participants, assessments, and observations indicated that "ReachOut" was feasible and acceptable among the target sample. Conclusions The study provides preliminary evidence of the effectiveness, feasibility, and acceptability of the help-seeking intervention "ReachOut" in reducing barriers and improving help-seeking inclination and behavior for common mental health concerns among distressed non-treatment-seeking young adults.

Dolutegravir based therapy showed CD4+ T cell count recovery and viral load suppression among ART naïve people living with HIV AIDS: a pilot evaluation

Recently, dolutegravir (DTG)-based combined therapy, a more effective and safer first-line antiretroviral therapy (ART), has been recommended by the World Health Organization for the treatment of Human Immunodeficiency Virus (HIV) since July 2018. However, its effectiveness in CD4+ T-cells count recovery and viral load suppression has not been studied yet in Ethiopia, where HIV is endemic. Therefore, we aimed to conduct a pilot assessment on the effect of DTG-based therapy on CD4+ T-cell count and viral load count among people living with HIV (PLWH) in Ethiopia. A longitudinal prospective cohort study was conducted from July 2020 to February 2021. 109 PLWH who are ART naive but plan to initiate DTG-based therapy were recruited. HIV viral ribonucleic acid (RNA) copies were determined using polymerase chain reaction. To compute the difference in viral load and CD4+ T-cell counts between the baseline, 3rd, and 6th months, a Friedman test was used. The study included 109 PLWH who had never received antiretroviral medication. Participants taking DTG-based treatment showed significantly decreasing median (IQR) values of viral load count (copies/mL) from 446,812 (237649.5–732994.5) at baseline to 34 (23.5–46) at 3 months and 0.0 (0–19) at 6 months of treatment follow-up. Although the treatment increases the proportion of participants with HIV-1 RNA 50 copies/mL from 0 (0% at baseline) to 87 (79.8%) and 100 (91.7%) at the 3rd and 6th months of treatment, respectively, On the other hand, the CD4+ T-cell count increased significantly during treatment: median (IQR): 209 (81.5–417.5) versus 291 (132–522) versus 378 (181–632.5) cells/L at baseline, the 3rd and 6th months of the treatment follow-up period, respectively. We found dolutegravir-based therapy was a promising option with high virological suppression rates and CD4+ T-cell count recovery, demonstrating a restoration of cellular immunity. Moreover, Viral load suppression rates were high after the initiation of the treatment. We recommend further research should be conducted with a larger number of participants to acquire greater awareness of the treatment outcomes.

Auto-Occlusive Lidocaine 7% and Tetracaine 7% Cream has Greater Pain Reduction Effects in Comparison with Lidocaine 4% Cream during Laser CO2 Dermabrasion Procedure in Preparation of Non-Cultured Autologous Epidermal Cell Grafting for Repigmentation in Vitiligo Subjects. An Intrasubject Pilot Evaluation Study

Introduction: Autologous non-cultured epidermal cell graft is a complex but promising technique in the treatment of vitiligo. Affected vitiligo areas should be de-epithelialized using an ablative Laser CO2 prior healthy epidermal cell inoculation. The dermabrasion (DA) procedure could be painful for the patient. To reduce the discomfort of this step topical anaesthesia is very often required. Topical anaesthetics available differ for composition, concentration of active anaesthetic molecules and methods of application (occlusion or not). An auto occlusive film-forming cream containing Lidocaine 7% and Tetracaine 7% (Pl-C) has shown in previous trials to be very effective in reducing discomfort during dermatological painful procedures like phototherapy, laser-conducted tattoo removal and laser resurfacing for skin ageing. Study Aim: To compare the clinical efficacy of Pl-C with Lidocaine 4% cream (As-C) in reducing the pain during Laser DA procedures in vitiligo subjects in preparation of autologous non-cultured epidermal transplantation. Subjects and Methods: We performed a prospective intra-subject randomized cases series in 7 subjects (4 men and 3 women) with segmental vitiligo with symmetrical lesions suitable for autologous non-cultured epidermal transplantation. Before the DA procedures the Pl-C or As-C were applied in a randomized fashion over the vitiligo areas to be treated. Pl-C was applied for 20 min without occlusion. The product was removed before the Laser procedure. As-C cream was applied for 30 min with occlusive band and then removed before the procedure. The treated skin regions had a mean area of 72±50 cm2; (range: 10 to 150 cm2). The primary outcome was the 100-mm Visual Analogue Scale (VAS) for patient-assessed pain evaluation with 0 mm value means no pain at all and 100 mm representing the worst possible pain. Results: Just after the Laser CO2 DA procedure the VAS score in PL-C area was 32±7 mm and 58±8 mm in As-C treated areas. This difference (-25±4 mm; 95% CI: from -16 to -35 mm) was highly statistically significant (p=0.0001) and clinically relevant (higher than the minimum clinically significant difference). Conclusion: The Lidocaine 7% and Tetracaine 7% auto occlusive cream is more effective than lidocaine 4% cream in reducing the pain associated with Laser CO2 DA procedures in preparation of skin autologous transplantation in vitiligo subjects.

The Fondazione Toscana Gabriele Monasterio app: a digital health system to improve wellbeing of inpatients with heart or lung disease.

An app providing material for education and entertaining is a possible way to support patients and healthcare providers in achieving person-centered care. An app tailored on the Fondazione Toscana Gabriele Monasterio (FTGM), a research hospital treating cardiac and lung disorders, was created. A pilot evaluation project was conducted on consecutive patients hospitalized for heart or lung disorders. Patients were asked to complete an assessment questionnaire. The FTGM app provides information on diagnostic and therapeutic investigations, hospital and healthcare personnel, and includes content for entertainment and learning. It was tested on 215 consecutive patients (75% men, 66% aged >60 years, and 40% with a primary or middle school degree). Sixty-nine percentage of patients used the FTGM app, including 67% of patients aged >80 years and 65% of those with an elementary education (65%). Patients gave positive feedback on the app layout. Many (76%) looked for information on doctors and nurses in the 'People' section. Sixty-five percent of responders had used at least one of the sections called 'Music' and 'Museum visits'. The app helped many patients perceive the hospital as a more liveable place (68%), and to feel less anxious (76%), and more engaged in the diagnostic and therapeutic workup (65%). Overall, the majority of responders (87%) rated the app as 'excellent' or 'good', and almost all (95%) would have recommended other patients to use the app. The FTGM app is a possible tool to improve patient wellbeing during hospitalization.