Pilot Evaluation Research Articles

BabyBreathe trial: protocol for a randomised controlled trial of a complex intervention to prevent postpartum return to smoking

IntroductionMany people quit smoking during pregnancy, but postpartum smoking relapse is common. Maintaining smoking abstinence achieved during pregnancy is key to improving maternal and child health. There are no evidence-based...

Serum BMP-2 and osteocalcin levels, and CT Hounsfield unit post hyperbaric oxygen therapy in patients with cleft lip and palate post alveolar bone graft: A case study

BackgroundThis study investigated the levels of bone morphogenetic protein 2 (BMP-2), osteocalcin, and 3D CT Hounsfield units following hyperbaric oxygen therapy (HBOT) in patients with cleft lip and palate (CLP) undergoing alveolar bone grafts to provide a pilot evaluation of the role of HBOT in osteogenesis. MethodsThis prospective, quasi-experimental, pre–post-intervention study evaluated seven patients with CLP receiving HBOT after single-stage reconstructions with alveolar bone grafts. The outcomes included the serum levels of BMP-2 and osteocalcin and the 3D CT Hounsfield units obtained before and after the surgery, and after the five HBOT sessions, to a total of 12 measurements. The data were analyzed with linear mixed-effects models using the intervention stage (pre-surgery, pre-HBOT, first to fifth HBOT sessions) as covariates and adjusting for several baseline factors. ResultsA significant difference was found in outcome measures across time (ANOVA p < 0.001 for BMP-2 and osteocalcin, p = 0.01 for Hounsfield units), with mean values appearing to steadily increase once HBOT began. Regression analyses indicated that the effect of HBOT was evident in serum osteocalcin after the 1st HBOT session (adjusted b = 1.32; 95% CI 0.39, 2.25) and in serum BMP-2 after the third session (adjusted b = 6.61; 95% CI 1.93, 11.28). After the fifth session, the HBOT effect was fairly pronounced on the two outcomes: the adjusted increase compared to the baseline was 28.06 ng/mL for BMP-2 and 6.27 ng/mL for osteocalcin. Our mixed-effect models also showed a post-HBOT increase in Hounsfield units. ConclusionWe found an increase of BMP-2, osteocalcin, and Hounsfield units following the HBOT intervention. These may suggest an effect of HBOT on osteogenesis.

Effectiveness of telehealth in providing preventive oral health care: A pilot evaluation of patient, carer, and clinician experience.

This pilot study aimed to characterize the experience, satisfaction, and views on feasibility of an oral health primary prevention telehealth service at a public dental hospital's department of pediatric dentistry, from the viewpoint of patients, carers, and clinicians. Data were collected using an anonymous questionnaire for parents/guardians, a focus group for clinicians; and were summarized using descriptive statistics, chi-square tests, analysis of variance, and by thematic analysis for the qualitative data. Thirty-seven parents/guardians and four clinicians were included. The mean patient age was 5 years (SD = 3.3). Over half of the parents (51.4%) were aged 30-39 years. There was high satisfaction (97.3%) and acceptability (81.1%) of the telehealth service. Native English-speakers were significantly more likely to agree that telehealth was an acceptable mode of preventive care and that they would use it again (p = 0.033). Parents reporting difficulty traveling to dental appointments were significantly more likely to score favorably in categories of usefulness, technical quality, and satisfaction relating to telehealth (all p < 0.001). Important themes from the clinician focus group included specific benefits for patients with special needs or who live rurally, reduced stress on families, and an enhanced focus on prevention. The findings suggest ongoing benefits of providing preventive oral health services as an adjunct to face-to-face care, especially to the identified subset of patients who will benefit the most.

Retrieving arXiv, SocArXiv, and SSRN metadata for initial review screening

Researchers around the globe invest a lot of time searching the literature for performing reviews (Systematic Literature Review (SLR), Multivocal Literature Review (MLR)). The steps to performing the review includes inclusion of the grey literature, preprints, and quality assessed non-peer reviewed literature (the purpose is to minimize the publication bias). The initial screening of the papers takes time and bibliographic information is only available online for the researcher(s). Objective of our study is to propose, design, and develop a method that will help the research community to download the basic information of the papers (title, abstract, author) for the searched query from arxiv, SSRN, and SocArxiv (Social Science ArXiv). We used Web scraping to extract data from the servers and save it in excel file. To retrieve the desired query from the databases, a Python code is used. Two methods have been discussed in the study to download the metadata of the searched query. We have used different queries (such as “grey literature”, “testing software”, and “python” etc.) to see the results of our proposed method. Furthermore, we cross-verified the results with the online search results of the databases. Initial results from the preliminary pilot evaluations show that it is a viable method to search, download, and shortlist the research articles information (title, abstract etc.) from arXiv,1 SSRN,2 and SocArXiv.3 For external validity more evaluations are needed.

A Serious Game to Self-Regulate Heart Rate Variability as a Technique to Manage Arousal Level Through Cardiorespiratory Biofeedback: Development and Pilot Evaluation Study.

Heart rate variability biofeedback (HRVB) is an established intervention for increasing heart rate variability (HRV) in the clinical context. Using this technique, participants become aware of their HRV through real-time feedback and can self-regulate it. The aim of this study was 2-fold: first, to develop a serious game that applies the HRVB technique to teach participants to self-regulate HRV and, second, to test the app with participants in a pilot study. An HRVB app called the FitLab Game was developed for this study. To play the game, users must move the main character up and down the screen, avoiding collisions with obstacles. The wavelength that users must follow to avoid these obstacles is based on the user's basal heart rate and changes in instantaneous heart rate. To test the FitLab Game, a total of 16 participants (mean age 23, SD 0.69 years) were divided into a control group (n=8) and an experimental group (n=8). A 2 × 2 factorial design was used in each session. Participants in the experimental condition were trained in breathing techniques. Changes in the frequency and time domain parameters of HRV and the game's performance features were evaluated. Significant changes in the average RR intervals and root mean square of differences between adjacent RR intervals (RMSSD) were found between the groups (P=.02 and P=.04, respectively). Regarding performance, both groups showed a tendency to increase the evaluated outcomes from baseline to the test condition. The results may indicate that playing different levels leads to an improvement in the game's final score by repeated training. The tendency of changes in HRV may reflect a higher activation of the mental system of attention and control in the experimental group versus the control group. In this context, learning simple, voluntary strategies through a serious game can aid the improvement of self-control and arousal management. The FitLab Game appears to be a promising serious game owing to its ease of use, high engagement, and enjoyability provided by the instantaneous feedback.

Pilot Evaluation of the Online 'Chaplains-CARE' Program: Enhancing Skills for United States Military Suicide Intervention Practices and Care.

Chaplains frequently serve as first responders for United States military personnel experiencing suicidal thoughts and behaviors. The Chaplains-CARE Program, a self-paced, e-learning course grounded in suicide-focused cognitive behavioral therapy principles, was tailored for United States military chaplains to enhance their suicide intervention skills. A pilot program evaluation gathered 76 Department of Defense (DoD), Veterans Affairs (VA), and international military chaplain learners' responses. Most learners indicated that the course was helpful, easy to use, relevant, applicable, and that they were likely to recommend it to other chaplains. Based on open-ended responses, one-quarter (25.0%) of learners indicated that all content was useful, and over one-quarter (26.3%) of learners highlighted the usefulness of the self-care module. One-third (30.3%) of learners reported the usefulness of the interactive e-learning features, while others (26.3%) highlighted the usefulness of chaplains' role play demonstrations, which portrayed counseling scenarios with service members. Suggested areas of improvement include specific course adaptation for VA chaplains and further incorporation of experiential learning and spiritual care principles. The pilot findings suggest that Chaplains-CARE Online was perceived as a useful suicide intervention training for chaplains. Future training can be enhanced by providing experiential, simulation-based practice of suicide intervention skills.

Supervisor Training: A Promising Approach to Addressing Impairment in the Workplace.

This study presents a pilot evaluation of a new online training program created to improve supervisors' ability to protect worker safety by recognizing and responding to signs of impairment from diverse causes. The study design relied on a mixed-methods approach with two waves of surveys and interviews immediately after training completion and after 3 months to gauge changes in participants' perceived knowledge and competencies. Participants had a positive reaction to training and found it relevant to their job responsibilities and aligned with existing organizational safety programs, practices, and policies. There was statistically significant improvement in perceived impairment knowledge and competencies. The study also provided early indications of training transfer. The study offers encouraging results that may be used to improve the impairment recognition and response training for supervisors and support future investigations of its impact.

Supporting Relational, Trauma-Informed Social Care Work with Autistic Adults: Evaluation of a Reflective Supervision Group Pilot

Abstract There is a growing body of literature highlighting the need for reflective supervision to support the often complex and challenging practice of social care workers. The current study aimed to explore an Irish social care team’s experience of a pilot reflective supervision group. The study participants were six male social care workers supporting autistic adults in the community. The team met for four one-monthly group supervision sessions, facilitated by an external supervisor. A reflective, relational approach was taken to the supervisory work, using role-play, free association and the Seven-Eyed model of supervision. At the end of the four-month pilot, participants completed a brief questionnaire to evaluate the supervision group experience. Thematic analysis of the participants’ open responses revealed the following themes: (i) increased insight/empathy; (ii) experiential learning; (iii) enhanced awareness/skills in relational practice; (iv) personal resilience; (v) team resilience; and (vi) emotional challenges. The study results suggest the potential importance of reflective supervision in boosting resilience, motivation and emotional insight when supporting people with unique relational needs.

PENGEMBANGAN JURNAL ILMIAH ONLINE PADA SEKOLAN TINGGI TEOLOGIA BETHEL MEDAN

This community service aims to document the process of developing an online scientific journal as an effort to expand the impact of academic knowledge from Bethel College of Theology (STT) in Medan. Through a collaborative approach, this research involved faculty members and administrative staff in developing an effective and accessible online scientific journal platform. The development process included needs analysis, interface design, technical development, and pilot testing and evaluation. The outcome of this service was the launch of a scientific journal platform that facilitates publication, peer-review, and knowledge exchange digitally. It is hoped that this initiative will enrich the quality of research and scientific understanding among students, lecturers, as well as the academic community, while making a sustainable contribution to the development of knowledge in the field of theology and religion.

A framework to assess resilience attributes based on local knowledge

New coexistence scenarios have been imposed on fishermen in the Santos Estuarine System region, a coastal city located 75 km from the largest city in Latin America (São Paulo). Whether due to the expansion of port and industrial activities, or due to the environmental liabilities associated with other human activities, thousands of workers from fishing communities are compelled to seek new forms of subsistence in the face of the gradual reduction of their fishing territories. The objective of this investigation was to develop a methodological framework to assess, based on local knowledge, ecological and social attributes of resilience in socio-ecological systems of small-scale fisheries over the last decades. To experimentally test the application of the framework, pilot interviews with fishermen, master craftsman and local leaders of the Santos Estuarine System were carried out with questions on aspects concerning eleven attributes of resilience, for three different time periods (currently, 25 years ago, and 50 years ago). Scores were assigned to the responses according to the contribution of the aspect addressed to the resilience of small-scale fisheries in the face of the various disturbances suffered over the years. The attribute scores in each period were then compared in a multivariate manner and the results of this pilot evaluation showed a decrease in overall resilience in recent decades, according to the perceptions of interviewees. Ecological attributes showed a significant decrease in the same period associated with anthropic pressures with losses in the attributes diversity, modularity and variability. Social resilience attributes did not show significant variation, although there was an increase in the attributes recognition of slow variables, tight feedbacks and overlap in governance. Although the use of the framework proposed requires its application on a broader scale for the characterization of resilience of small-scale fishing communities, the present study demonstrated that the methodological framework is applicable and provides useful information on attributes of socio-ecological resilience based on local knowledge.

A pilot evaluation of an 8-week mindfulness-based stress reduction program for people with pre-symptomatic Huntington's disease.

People with Huntington's disease (HD) face difficult emotional and practical challenges throughout their illness, including in the pre-symptomatic stage. There are, however, extremely limited psychosocial interventions adapted to or researched for HD. We adapted and piloted an 8-week mindfulness-based stress reduction (MBSR) program in people with pre-symptomatic HD to determine if the program (i) was feasible and acceptable to participants, (ii) resulted in increased mindfulness understanding and skills, and (iii) led to improved psychological adjustment. Quantitative measures of mindfulness, emotion regulation, mood, and quality of life were administered pre and post the MBSR program and at 3-month follow-up. Measures of mindfulness practice and session clarity were administered weekly. Qualitative participant feedback was collected with a post-program interview conducted by independent clinicians. Seven participants completed the 8-week course. The program's feasibility and acceptability was supported by excellent retention and participation rates and acceptable rates of home practice completion. In addition, qualitative feedback indicated participant satisfaction with the program structure and content. Two core mindfulness skills (observing and non-judgment) showed significant improvement from pre- to post-assessment. Participant qualitative feedback indicated increased confidence and capacity to use mindfulness techniques, particularly in emotionally challenging situations. Participant questionnaire data showed good psychological adjustment at baseline, which did not change after treatment. Psychological benefits of the program identified in qualitative data included fewer ruminations about HD, reduced isolation and stigma, and being seen by others as calmer. These findings justify expansion of the program to determine its efficacy in a larger, controlled study.

A trauma-informed intervention for foster caregivers in Central Massachusetts: A mixed methods pilot evaluation

The Encompass program trains and supports foster, kinship, and pre-adoptive caregivers to recognize trauma in children, attend to foster children’s behavioral health needs, and ease the stress of caregiving. We used a caregiver survey at two time points to evaluate the preliminary efficacy of the Encompass program on foster parent (n = 17) and child (n = 25) outcomes, and conducted qualitative interviews with caretakers (n = 15). We observed significant positive changes in caretakers’ perceived knowledge about trauma, confidence in trauma-informed fostering, and use of external support care providers. Qualitative data suggest that participants found the Encompass program to be helpful and enjoyable, but that systemic issues in the child welfare system, which were beyond the scope of this program to impact, contribute to caregiver dissatisfaction and fostering difficulties. Findings suggest that Encompass has a positive impact on caregiver perceptions of knowledge about trauma and confidence in their capacity to provide trauma-informed foster care. Continued evaluation of the Encompass program using an experimental design will be informative about program impact.

Evaluation of Salivary Opiorphin, pH and Flow Rate in Oral Submucous Fibrosis - A Case - Control Observational Study.

The aim of the study was to evaluate the salivary pH, flow rate and opiorphin in Oral submucous fibrosis patients and to compare them with healthy individuals. A comparative study was conducted to evaluate the salivary opiorphin levels, pH and flow rate among 78 patients (39 Oral submucous fibrosis + 39 control). Burning sensation was assessed using VAS score. Opiorphin levels were assessed using Cusabio Human Salivary Opiorphin ELISA kit. Salivary flow rate was assessed using graduated syringes and salivary pH was assessed using Hydrion salivary pH strips. Kolmogorov-Smirnov and Shapiro Wilk test were assessed for normality testing and distribution. Inferential statistics was done by using Unpaired t test/Independent sample t test to compare the mean values of variables included in the study among the OSMF and healthy patients. There was statistically significant difference in pH and flow rate with a reduction in the mean pH (p=0.024) and flow rate (p<0.01) among the oral submucous fibrosis patients compared to the control group. A statistically significant increase (p<0.01) in salivary opiorphin levels was noted in the oral submucous fibrosis patients. Majority of the study participants had mild to moderate burning sensation. This study was a pilot evaluation of salivary opiorphin in OSMF. Salivary opiorphin could be used as an objective marker for chronic subjective conditions The pre-treatment and post treatment evaluation of salivary opiorphin could provide more insight on its role.

Feasibility of a text-mediated recall system to increase cardiovascular disease risk assessment in general practice: Mixed-methods pilot evaluation.

The uptake of formal cardiovascular disease risk assessment in the primary prevention setting is low. We tested the feasibility of an SMS recall system to invite eligible patients for a Heart Health Check in Australian general practice. Of 332 general practices that expressed interest in the study, 231 were randomised to either an intervention orwait list control group. Intervention general practices sent SMS invitations linked to digital information to eligible patients via general practice software. Deidentified baseline and two-month data were extracted via clinical audit software. Asurvey was administered to 35intervention general practices. General practice visits were similar between the control and intervention groups, but Heart Health Check billing increased 14-fold in the intervention group. This study showed that an SMS recall system for Heart Health Checks can beeffective and acceptable in general practice. The findings will inform a broader implementation trial over 2022-23.

OR09-02-23 Pilot Evaluation of Whether an Interviewer Administered Dietary Recall Method Augmented With a Photo-Based Mobile Food Record Improves Reporting of Food Intake

OR09-02-23 Pilot Evaluation of Whether an Interviewer Administered Dietary Recall Method Augmented With a Photo-Based Mobile Food Record Improves Reporting of Food Intake

Recommendations on the Selection, Development, and Modification of Performance Outcome Assessments: A Good Practices Report of an ISPOR Task Force

In evaluating the clinical benefit of new therapeutic interventions, it is critical that the treatment outcomes assessed reflect aspects of health that are clinically important and meaningful to patients. Performance outcome (PerfO) assessments are measurements based on standardized tasks actively undertaken by a patient that reflect physical, cognitive, sensory, and other functional skills that bring meaning to people’s lives. PerfO assessments can have substantial value as drug development tools when the concepts of interest being measured best suit task performance and in cases where patients may be limited in their capacity for self-report. In their development, selection, and modification, including the evaluation and documentation of validity, reliability, usability, and interpretability, the good practice recommendations established for other clinical outcome assessment types should continue to be followed, with concept elicitation as a critical foundation. In addition, the importance of standardization, and the need to ensure feasibility and safety, as well as their utility in patient groups, such as pediatric populations, or those with cognitive and psychiatric challenges, may enhance the need for structured pilot evaluations, additional cognitive interviewing, and evaluation of quantitative data, such as that which would support concept confirmation or provide ecological evidence and other forms of construct evidence within a unitary approach to validity. The opportunity for PerfO assessments to inform key areas of clinical benefit is substantial and establishing good practices in their selection or development, validation, and implementation, as well as how they reflect meaningful aspects of health is critical to ensuring high standards and in furthering patient-focused drug development.

Working to Improve Youth-Police Interactions: A Pilot Evaluation of a Program for Young People.

In addition to training law enforcement personnel in strategies to promote positive youth-police interactions, equipping youth with similar knowledge is critical in ensuring safe and effective youth-police encounters. The classroom-based Juvenile Justice Curriculum was designed to equip young people with knowledge about the law and their rights and to empower them to have safer interactions with police. In the current study, we conducted the first evaluation of Strategies for Youth's nationally recognized classroom-based intervention. Cross-sectional data were collected from 155 youth (M age = 15.3; 43% White, 23% Black; 61% boys) after they completed the Juvenile Justice Curriculum. Results from our study indicated young people learned new information regarding what leads to arrest and multiple ways they might consider changing their behaviors when interacting with police. Young people's negative experiences with police officers were significantly associated with reduced views that police respect them and reports that they respect police, and with increased views of police as ethnoracially biased after completing the program. Altogether, our pilot program evaluation of this program demonstrated increased awareness of what constitutes illegal behavior, program engagement, and learned strategies to improve future interactions with police. Findings highlight the importance of policy makers supporting programming like the Juvenile Justice Curriculum as one means of preventing juvenile legal system involvement. While the onus to ensure safe and effective interactions with police should not be on young people, empowering young people to understand the law and their rights may help improve the social climate surrounding community responses to police and police interactions.

Pilot Evaluation of the Family Bridge Program: A Communication- and Culture-Focused Inpatient Patient Navigation Program

ObjectiveChildren with low income and minority race and ethnicity have worse hospital outcomes due partly to systemic and interpersonal racism causing communication and system barriers. We tested the feasibility and acceptability of a novel inpatient communication-focused navigation program. MethodsMultilingual design workshops with parents, providers, and staff created the Family Bridge Program. Delivered by a trained navigator, it included 1) hospital orientation; 2) social needs screening and response; 3) communication preference assessment; 4) communication coaching; 5) emotional support; and 6) a post-discharge phone call. We enrolled families of hospitalized children with public or no insurance, minority race or ethnicity, and preferred language of English, Spanish, or Somali in a single-arm trial. We surveyed parents at enrollment and 2 to 4 weeks post-discharge, and providers 2 to 3 days post-discharge. Survey measures were analyzed with paired t tests. ResultsOf 60 families enrolled, 57 (95%) completed the follow-up survey. Most parents were born outside the United States (60%) with a high school degree or less (60%). Also, 63% preferred English, 33% Spanish, and 3% Somali. The program was feasible: families received an average of 5.3 of 6 components; all received >2. Most caregivers (92%) and providers (81% [30/37]) were "very satisfied." Parent-reported system navigation improved from enrollment to follow-up (+8.2 [95% confidence interval 2.9, 13.6], P = .003; scale 0–100). Spanish-speaking parents reported decreased skills-related barriers (−18.4 [95% confidence interval −1.8, −34.9], P = .03; scale 0–100). ConclusionsThe Family Bridge Program was feasible, acceptable, and may have potential for overcoming barriers for hospitalized children at risk for disparities.

OUTC-09. PEDIATRIC LOW GRADE GLIOMA SURVIVORS’ NEED FOR SURVIVORSHIP CARE: ‘ENGAGE’ A MULTIDISCIPLINARY, E-HEALTH INTERVENTION

Abstract Higher survival rates for children diagnosed with low-grade gliomas (LGG), compared to other brain cancers, often limit the survivorship resources afforded this cohort, despite potential long-term physical, functional and psychological impacts. We conducted a two-phase program of research, first evaluating LGG survivors’ need for support during the survivorship phase, followed by the development and pilot evaluation of a multidisciplinary, telehealth, survivorship program. Phase 1: We conducted a retrospective cohort study of children aged 0-16 years at diagnosis, diagnosed between 2000-2015, assessing psychosocial impact and quality of life. Phase 2: We developed ‘Engage Brain’, a multidisciplinary, telehealth program, designed to improve medical and psychosocial outcomes for childhood cancer survivors throughout their lifespan. Key components of Engage’s design include distance-delivered care to ensure access for all survivors irrespective of whether they live close to a tertiary, survivorship center; hospital-based expertise integrated with local, primary care services to ensure a model of care which is sustainable long-term; nurse-led care providing tailored education to encourage adoption of a prevention-focused healthy lifestyle to mitigate survivors’ personal risk and reduce ongoing costs to the individual and healthcare system; psychosocial focus, incorporating allied health staff (psychologist/social worker) as an integral aspect of care. Phase 1: 45 survivors participated (36% female, mean age 14.8 years, average 7.5 years post-treatment). Survivors reported high levels of anxiety (23%), depression (14%), fatigue (62%). Phase 2: 30 LGG survivors completed Engage Brain intervention (50% female, mean age 21 years, average 11.5 years post-treatment). 64% uptake, 10% attrition. Most (78%) of participants ‘agree’-‘greatly agree’ that Engage Brain provides ‘high-quality survivorship care’ and ‘help accessing survivorship care’. This program of research illustrates the long-term needs of LGG survivors, despite their lower risk status compared to other brain cancers, and the feasibility of providing a multidisciplinary, telehealth intervention to support them.

Solution-Focused Body-Mind-Spirit (SF-BMS) Group Therapy for Mental Health and Trauma Symptoms Among Asian American Youth: A Mixed Methods Pilot Evaluation

Solution-focused and body-mind-spirit practices have shown promising evidence for addressing various mental health and trauma-related problems, though there is limited research regarding their joint application. In addition, Asian American youth are often underrepresented in social work intervention literature despite increasing risk of negative effects from anti-Asian hate and violence since the start of the coronavirus pandemic. Solution-Focused Body-Mind-Spirit (SF-BMS) group therapy is a novel intervention approach with roots in traditional Eastern and postmodern Western philosophies that may be particularly applicable for the cross-cultural experience of second-generation immigrants from Southeast Asian countries. This study conducted a mixed methods pilot evaluation of SF-BMS group therapy with Asian American youth and found modest pre–post improvements in overall problems and qualitative evidence of the intervention’s acceptability.