Background: Patient-reported outcomes (PROs) can be defined as any report of a patient's health taken directly from the patient. Routine collection of PRO data has been shown to offer potential benefits to patient-doctor communication. Electronic forms of PRO measures (PROMs) could be more beneficial in comparison to traditional PROMs in obtaining PROs from patients. However, it is currently unclear whether the routine collection of electronic PRO data could result in better outcomes for patients undergoing laparoscopic cholecystectomy (LC).
Objective: This study aims to explore the perspectives of patients and surgeons on the use of electronic PROMs. Based on prior research, technical skill and experience level of the surgeon, long-term quality of life, patient involvement in decision-making, communication skills of the surgeon, cleanliness of the ward environment, and standards of nursing care are identified to be the most important factors for the patients.
Methods: This is a mixed methods prospective study that will collect both quantitative (survey) and qualitative (interview) data. The study has two components. The first involves the distribution of an electronic presurvey to patients who received elective LC within 48 hours of their surgery (n=80). This survey will explore the perspective of patients regarding the procedure, hospital experience, long-term outcomes, and the perceived value of using PROMs. These patients will then be followed up after 1 year and given another survey. The second component involves the distribution of the same survey and the completion of structured interviews with general surgeons (n=10). The survey will ascertain what PROs from the participants are most useful for the surgeons and the interviews will focus on how the surgeons view routine PRO collection. A convenience sampling approach will be used. Surveys will be distributed through Qualtrics and interviews will be completed on Microsoft Teams.
Results: Data collection began on February 14, 2023. As of February 12, 2024, 71 of 80 recruited patients have been given the presurvey. The follow-up with the patients and the general surgeon components of the study have not begun. The expected completion date of this study is in April 2025.
Conclusions: Overall, this study will investigate the potential of electronic PRO collection to offer value for patients and general surgeons. This approach will ensure that patient care is investigated in a multifaceted way, offering patient-centric guidance to surgeons in their approach to care.
International registered report identifier (irrid): DERR1-10.2196/57344.
Background: Feedback is an essential tool for learning and improving performance in any sphere of education, including training of resident physicians. The learner's perception of the feedback they receive is extremely relevant to their learning progress, which must aim at providing qualified care for patients. Studies pertinent to the matter differ substantially with respect to methodology, population, context, and objective, which makes it even more difficult to achieve a clear understanding of the topic. A scoping review on this theme will unequivocally enhance and organize what is already known.
Objective: The aim of this study is to identify and map out data from studies that report surgical residents' perception of the feedback received during their education.
Methods: The review will consider studies on the feedback perception of resident physicians of any surgical specialty and age group, attending any year of residency, regardless of the type of feedback given and the way the perceptions were measured. Primary studies published in English, Spanish, and Portuguese since 2017 will be considered. The search will be carried out in 6 databases and reference lists will also be searched for additional studies. Duplicates will be removed, and 2 independent reviewers will screen the selected studies' titles, abstracts, and full texts. Data extraction will be performed through a tool developed by the researchers. Descriptive statistics and qualitative analysis (content analysis) will be used to analyze the data. A summary of the results will be presented in the form of diagrams, narratives, and tables.
Results: The findings of this scoping review were submitted to an indexed journal in July 2024, currently awaiting reviewer approval. The search was executed on March 15, 2024, and resulted in 588 articles. After the exclusion of the duplicate articles and those that did not meet the eligibility criteria as well as the inclusion of articles through a manual search, 13 articles were included in the review.
Conclusions: Conducting a scoping review is the best way to map what is known about a subject. By focusing on the feedback perception more than the feedback itself, the results of this study will surely contribute to gaining a deeper understanding of how to proceed to enhance internal feedback and surgical residents' learning progress.
Trial registration: Open Science Framework yexb; https://osf.io/yexkb.
International registered report identifier (irrid): PRR1-10.2196/56727.
Background: Sexual violence (SV) is a significant problem for sexual minorities, including men who have sex with men (MSM). The limited research suggests SV is associated with a host of syndemic conditions. These factors tend to cluster and interact to worsen one another. Unfortunately, while much work has been conducted to examine these factors in heterosexual women, there is a lack of research examining MSM, especially their SV risk perception. Further, MSM are active users of dating and sexual networking (DSN) mobile apps, and this technology has demonstrated usefulness for creating safe spaces for MSM to meet and engage partners. However, mounting data demonstrate that DSN app use is associated with an increased risk for SV, especially given the higher likelihood of using alcohol and other drugs before sex. By contrast, some researchers have demonstrated that DSN technology can be harnessed as a prevention tool for HIV; unfortunately, no such work has progressed regarding SV.
Objective: This study aims to (1) use qualitative and quantitative methods to tailor an existing laboratory paradigm of SV risk perception in women for MSM using a DSN mobile app framework and (2) subject this novel paradigm to a rigorous validation study to confirm its usefulness in predicting SV, with the potential for use in future prevention endeavors.
Methods: To tailor the paradigm for MSM, a team of computer scientists created an initial DSN app (G-Date) and incorporated ongoing feedback about the usability, feasibility, and realism of this tool from a representative sample of MSM. We used focus groups and interviews to assist in the development of G-Date, including by identifying relevant stimuli, developing the cover story, and establishing the appropriate study language. To confirm the paradigm's usefulness, we are conducting an experimental study with web-based and face-to-face participants to determine the content, concurrent, and predictive validities of G-Date. We will evaluate whether certain correlates of SV informed by syndemics and minority stress theories (eg, history of SV and alcohol and drug use) affect the ability of MSM to detect SV risk within G-Date and how paradigm engagement influences behavior in actual DSN app use contexts.
Results: This study received funding from the National Institute on Alcohol Abuse and Alcoholism on September 10, 2020, and ethics approval on October 19, 2020, and we began app development for aim 1 immediately thereafter. We began data collection for the aim 2 validation study in December 2022. Initial results from the validation study are expected to be available after December 2025.
Conclusions: We hope that G-Date will enhance our understanding of factors associated with SV risk and serve as a useful step in creating prevention programs for this susceptible population.
Background: Postacute sequelae of COVID-19 (PASC) remain understudied in nonhospitalized patients. Digital wearables allow for a continuous collection of physiological parameters such as respiratory rate and oxygen saturation that have been predictive of disease trajectories in hospitalized patients.
Objective: This protocol outlines the design and procedures of a prospective, longitudinal, observational study of PASC that aims to identify wearables-collected physiological parameters that are associated with PASC in patients with a positive diagnosis.
Methods: This is a single-arm, prospective, observational study of a cohort of 550 patients, aged 18 to 65 years, male or female, who own a smartphone or a tablet that meets predetermined Bluetooth version and operating system requirements, speak English, and provide documentation of a positive COVID-19 test issued by a health care professional within 5 days before enrollment. The primary end point is long COVID-19, defined as ≥1 symptom at 3 weeks beyond the first symptom onset or positive diagnosis, whichever comes first. The secondary end point is chronic COVID-19, defined as ≥1 symptom at 12 weeks beyond the first symptom onset or positive diagnosis. Participants must be willing and able to consent to participate in the study and adhere to study procedures for 6 months.
Results: The first patient was enrolled in October 2021. The estimated year for publishing the study results is 2025.
Conclusions: This is a fully decentralized study investigating PASC using wearable devices to collect physiological parameters and patient-reported outcomes. The study will shed light on the duration and symptom manifestation of PASC in nonhospitalized patient subgroups and is an exemplar of the use of wearables as population-level monitoring health tools for communicable diseases.
Trial registration: ClinicalTrials.gov NCT04927442; https://clinicaltrials.gov/study/NCT04927442.
International registered report identifier (irrid): DERR1-10.2196/57382.
Background: Gaming disorder (GD) is a new official diagnosis in the International Classification of Diseases, 11th Revision, and with its recognition, the need to offer treatment for the condition has become apparent. More knowledge is needed about the type of treatment needed for this group of patients.
Objective: This study aims to evaluate the effectiveness and acceptability of a novel module-based psychological treatment for GD based on cognitive behavioral therapy and family therapy.
Methods: This study is a nonrandomized intervention study, with a pretest, posttest, and 3-month follow-up design. It will assess changes in GD symptoms, psychological distress, and gaming time, alongside treatment satisfaction, working alliance, and a qualitative exploration of patients' and relatives' experiences of the treatment.
Results: This study started in March 2022 and the recruitment is expected to close in August 2024.
Conclusions: This study evaluates the effectiveness and acceptability of a psychological treatment for patients with problematic gaming behavior and GD. It is an effectiveness trial and will be conducted in routine care. This study will have high external validity and ensure that the results are relevant for a diverse clinical population with psychiatric comorbidity.
Trial registration: ClinicalTrials.gov NCT06018922; https://clinicaltrials.gov/study/NCT06018922.
International registered report identifier (irrid): DERR1-10.2196/56315.
Background: The responsibility of care for Veterans and Service Members (V/SMs) with traumatic brain injury (TBI) often defaults to informal family caregivers. Caregiving demands considerable knowledge, skill, and support to facilitate the health and well-being of V/SMs and themselves. Persistent and common TBI caregiver issues include strain, depression, and anxiety. While evidence-based, brief interventions have been developed and implemented for family caregivers in Veteran neurodegenerative populations, few interventions have been developed, adapted, or tested to support the unique needs of caregivers of V/SMs with TBI.
Objective: This study will adapt and test an evidence-based, personalized, 6-session telehealth caregiver intervention, "Resources for Enhancing All Caregivers' Health" (REACH), to meet the unique needs of caregivers of V/SMs with TBI. If successful, a community-based participatory research team will develop an implementation plan to roll out REACH TBI across the national Veterans Affairs Polytrauma System of Care.
Methods: This mixed methods, crossover waitlist control clinical trial will use a Type 1 Hybrid Effectiveness-Implementation approach to adapt and then test the effects of REACH TBI on key TBI caregiver outcomes.
Results: This study was funded by the Department of Defense in September 2023. Participant enrollment and data collection will begin in 2024.
Conclusions: If effective, REACH TBI will be the first evidence-based intervention for caregivers of V/SMs with TBI that can be scaled to implement across the Veterans Affairs Polytrauma System of Care and fill a notable gap in clinical services.
International registered report identifier (irrid): PRR1-10.2196/57692.
Background: In attention-deficit/hyperactivity disorder (ADHD), poor inhibitory control is one of the main characteristics, with oculomotor inhibition impairments being considered a potential biomarker of the disorder. While auditory white noise has demonstrated the ability to enhance working memory in this group, visual white noise is still unexplored and so are the effects of both types of white noise stimulation on oculomotor inhibition.
Objective: This crossover study aims to explore the impact of auditory and visual white noise on oculomotor inhibition in children with ADHD and typically developing (TD) children. The study will investigate the impact of different noise levels (25% and 50% visual, 78 dB auditory), and performance will be evaluated both with and without noise stimulation. We hypothesize that exposure to white noise will improve performance in children with ADHD and impair the performance for TD children.
Methods: Memory-guided saccades and prolonged fixations, known for their sensitivity in detecting oculomotor disinhibition in ADHD, will be used to assess performance. Children diagnosed with ADHD, withdrawing from medication for 24 hours, and TD children without psychiatric disorders were recruited for the study.
Results: Data collection was initiated in October 2023 and ended in February 2024. A total of 97 participants were enrolled, and the first results are expected between September and November 2024.
Conclusions: This study will examine whether cross-modal sensory stimulation can enhance executive function, specifically eye movement control, in children with ADHD. In addition, the study will explore potential differences between auditory and visual noise effects in both groups. Our goal is to identify implications for understanding how noise can be used to improve cognitive performance.
Trial registration: ClinicalTrials.gov NCT06057441; https://clinicaltrials.gov/study/NCT06057441.
International registered report identifier (irrid): DERR1-10.2196/56388.
Background: Advanced cancer significantly impacts patients' and family caregivers' quality of life. When patients and caregivers are supported concurrently as a dyad, the well-being of each person is optimized. Family, Outlook, Communication, Uncertainty, Symptom management (FOCUS) is a dyadic, psychoeducational intervention developed in the United States, shown to improve the well-being and quality of life of patients with advanced cancer and their primary caregivers. Originally, a nurse-delivered in-person intervention, FOCUS has been adapted into a self-administered web-based intervention for European delivery.
Objective: The aims of this study are to (1) adapt FOCUS to the Australian context (FOCUSau); (2) evaluate the effectiveness of FOCUSau in improving the emotional well-being and self-efficacy of patients with advanced cancer and their primary caregiver relative to usual care control group; (3) compare health care use between the intervention and control groups; and (4) assess the acceptability, feasibility, and scalability of FOCUSau in order to inform future maintainable implementation of the intervention within the Australian health care system.
Methods: FOCUS will be adapted prior to trial commencement, using an iterative stakeholder feedback process to create FOCUSau. To examine the efficacy and cost-effectiveness of FOCUSau and assess its acceptability, feasibility, and scalability, we will undertake a hybrid type 1 implementation study consisting of a phase 3 (clinical effectiveness) trial along with an observational implementation study. Participants will include patients with cancer who are older than 18 years, able to access the internet, and able to identify a primary support person or caregiver who can also be approached for participation. The sample size consists of 173 dyads in each arm (ie, 346 dyads in total). Patient-caregiver dyad data will be collected at 3 time points-baseline (T0) completed prerandomization; first follow-up (T1; N=346) at 12 weeks post baseline; and second follow-up (T2) at 24 weeks post baseline.
Results: The study was funded in March 2022. Recruitment commenced in July 2024.
Conclusions: If shown to be effective, this intervention will improve the well-being of patients with advanced cancer and their family caregivers, regardless of their location or current level of health care support.
Trial registration: ClinicalTrials.gov NCT06082128; https://clinicaltrials.gov/study/NCT06082128.
International registered report identifier (irrid): PRR1-10.2196/55252.
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