Research Register Research Articles

Investigating innovations in outpatient services: a mixed-methods rapid evaluation.

Within outpatient services, a broad range of innovations are being pursued to better manage care and reduce unnecessary appointments. One of the least-studied innovations is Patient-Initiated Follow-Up, which allows patients to book appointments if and when they need them, rather than follow a standard schedule. To use routine national hospital data to identify innovations in outpatient services implemented, in recent years, within the National Health Service in England. To carry out a rapid mixed-methods evaluation of the implementation and impact of Patient-Initiated Follow-Up. The project was carried out in four sequential workstreams: (1) a rapid scoping review of outpatient innovations; (2) the application of indicator saturation methodology for scanning national patient-level data to identify potentially successful local interventions; (3) interviews with hospitals identified in workstream 2; and (4) a rapid mixed-methods evaluation of Patient-Initiated Follow-Up. The evaluation of Patient-Initiated Follow-Up comprised an evidence review, interviews with 36 clinical and operational staff at 5 National Health Service acute trusts, a workshop with staff from 13 National Health Service acute trusts, interviews with four patients, analysis of national and local data, and development of an evaluation guide. Using indicator saturation, we identified nine services with notable changes in follow-up to first attendance ratios. Of three sites interviewed, two queried the data findings and one attributed the change to a clinical assessment service. Models of Patient-Initiated Follow-Up varied widely between hospital and clinical specialty, with a significant degree of variation in the approach to patient selection, patient monitoring and discharge. The success of implementation was dependent on several factors, for example, clinical condition, staff capacity and information technology systems. From the analysis of national data, we found evidence of an association between greater use of Patient-Initiated Follow-Up and a lower frequency of outpatient attendance within 15 out of 29 specialties and higher frequency of outpatient attendance within 7 specialties. Four specialties had less frequent emergency department visits associated with increasing Patient-Initiated Follow-Up rates. Patient-Initiated Follow-Up was viewed by staff and the few patients we interviewed as a positive intervention, although there was varied impact on individual staff roles and workload. It is important that sites and services undertake their own evaluations of Patient-Initiated Follow-Up. To this end we have developed an evaluation guide to support trusts with data collection and methods. The Patient-Initiated Follow-Up evaluation was affected by a lack of patient-level data showing who is on a Patient-Initiated Follow-Up pathway. Engagement with local services was also challenging, given the pressures facing sites and staff. Patient recruitment was low, which affected the ability to understand experiences of patients directly. The study provides useful insights into the evolving national outpatient transformation policy and for local practice. Patient-Initiated Follow-Up is often perceived as a positive intervention for staff and patients, but the impact on individual outcomes, health inequalities, wider patient experience, workload and capacity is still uncertain. Further research should include patient-level analysis to determine clinical outcomes for individual patients on Patient-Initiated Follow-Up and health inequalities, and more extensive investigation of patient experiences. This study is registered with the Research Registry (UIN: researchregistry8864). This award was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme (NIHR award ref: 16/138/17) and is published in full in Health and Social Care Delivery Research; Vol. 12, No. 38. See the NIHR Funding and Awards website for further award information.

A systematic review and meta-analysis of the association between selenium and osteoarthritis

Introduction: Osteoarthritis is an inflammatory disorder and the most common human joint disease. Considering the anti-inflammatory properties of selenium, we aimed to investigate the relationship between selenium and the risk of osteoarthritis in this study. Materials and Methods: The present study was a systematic review and meta-analysis based on the PRISMA guidelines, conducted in databases including Web of Science, Cochrane, ProQuest, PubMed, and Google Scholar Search Engine for articles published until December 12, 2023. Data was analyzed using STATA 14 software, and tests with p-values lower than 0.05 were considered statistically significant. Results: Seven cross-sectional studies with 412998 participants were combined, and results indicated that selenium intake increased the risk of osteoarthritis (OR: 1.26; 95% CI: 1.06, 1.49). However, the risk of osteoarthritis in individuals with low, moderate, and high serum selenium levels was (OR: 1.03; 95% CI: 0.81, 1.31), (OR: 0.97; 95% CI: 0.83, 1.13), and (OR: 0.99; 95% CI: 0.99, 1), respectively. The relationship between serum selenium level and the risk of osteoarthritis in male and female patients were also (OR: 0.99; 95% CI: 0.98, 0.99) and (OR: 0.99; 95% CI: 0.98, 0.99), respectively. Findings showed the relationship between serum selenium level and knee (OR: 1.11; 95% CI: 0.89, 1.38) and hip (OR: 1.23; 95% CI: 0.86, 1.77) osteoarthritis. Conclusion: Selenium intake increased the risk of osteoarthritis by 26%. However, there was no statistically significant relationship between the serum selenium level and the risk of osteoarthritis. Considering the limited number of reviewed studies, further studies in this field are required. Registration: This study has been compiled based on the PRISMA checklist, and its protocol was registered on the PROSPERO (ID: CRD42023494294) and Research Registry (UIN: reviewregistry1762) website.

Endoscopic resection of benign breast tumors via a single axillary incision using the insufflation method: a preliminary summary report.

Clinicopathological data from 62 patients who underwent this procedure from June 2022 to July 2023 were retrospectively collected. The surgical success rate, number of tumors excised, operative time, intraoperative conditions, postoperative complications, and clinical outcomes were analyzed. A total of 144 benign tumors were resected, and the surgical success rate was 100% (62/62). The time required to resect tumors located in the inner quadrant with larger diameters was shorter than the time to resect tumors located in the outer quadrant with smaller tumors. Sixty-two patients experienced reduced intraoperative bleeding and did not experience skin burns, incision infections, or poor healing. However, all patients experienced varying degrees of subcutaneous emphysema during the postoperative period. Fourteen patients experienced minor local effusions, and 3 patients experienced mild upper limb dysfunction, which resolved within one month. During the six-month follow-up period, there were no cases of tumor recurrence or new tumors. The ABNSW score was above 14 points, and patient satisfaction was high. Endoscopic resection of benign breast tumors through a single incision in the axilla via the inflatable method could quickly remove lesions larger than 3.0cm. This method also results in hidden scars and good cosmetic effects on the shape of the breast. This is a new and effective treatment for benign breast tumors. This retrospective study was registered in the National Medical Research Registry filing system ( https://www.medicalresearch.org.cn ) (No. MR-44-22-007981) and recorded in the Medical Research Division of our hospital (No. NYXJS-22-021).

A rapid review of telehealth in women with recent de novo hypertensive disease of pregnancy.

Hypertensive disorders of pregnancy pose significant risks to both maternal and fetal health. Postpartum hypertension, a common complication, often leads to emergency room (ER) visits or hospital readmissions. Despite the prevalence of these complications, there is a paucity of studies that focus on blood pressure monitoring in postpartum patients with de novo hypertensive disorders of pregnancy. This review aimed to address the gap by evaluating available evidence to compare telehealth monitoring with in-person visits in preventing ER visits and hospital readmissions among postpartum patients with de novo hypertensive disorders of pregnancy. The study identified relevant studies by conducting a rigorous search strategy (Medline/OVID, the Cochrane Library, Scopus, and research registries such as the International Clinical Trials Registry Platform [ICTRP] and clinical trials) directed by the clinical information specialist. Two reviewers independently screened titles and abstracts, resolving discrepancies with the assistance of a third reviewer. Data extraction followed standardized protocols, and risk of bias assessments were conducted using appropriate tools. This rapid review synthesized evidence from 11 studies on telehealth for women with recent de novo hypertensive disorders of pregnancy. Findings highlighted that telemonitoring led to earlier blood pressure documentation and intervention, reduced disparities in blood pressure measurement, decreased hypertension-related readmissions, higher rates of postpartum antihypertensive treatment initiation, and increased patient satisfaction. Telehealth emerges as a promising tool for managing postpartum hypertension among women with recent de novo hypertensive disorders of pregnancy.

Exploring the impact of pediatric OCD on family impairment: A consideration of parent, sibling, and affected-child perspectives

BackgroundPrevious studies have examined the perspectives of both affected children/adolescents and their parents on family functioning impacts of obsessive-compulsive disorder (OCD). While siblings play an integral role within the family system, their perspectives have been largely overlooked in the literature. This study examined sibling, parent, and child perspectives of family functioning in pediatric OCD and assessed demographic and clinical factors associated with family functioning. MethodsParticipating families were identified from a larger research registry of 398 patients referred between 2012 and 2020 to the Provincial OCD Program. A total of 185 families who provided data on family functioning from the perspectives of OCD-affected children, siblings and parents were included for study. All family members completed the OCD Family Functioning scale. ResultsThe extent of perceived impairment differed by family member type, with parents reporting the greatest impacts, followed by OCD-affected children, and then siblings. Predictors of OCD-imposed family dysfunction included family accommodation from all perspectives, clinician-reported child OCD severity, and family blame from parent perspectives. LimitationsData are cross-sectional, and we cannot conclude that the observed associations reflect causal effects. Missing data were evident and differed by variable item and family member type. ConclusionsBy providing sibling perspectives within the same family unit, this study expands upon previous findings that accommodation predicts family impairment from parent and child perspectives. Our study highlights factors relevant to family-based interventions in the treatment of pediatric OCD. Clinicians should be aware of the ongoing impacts OCD has on all family members.

Costs of Health Registries: An Exploration for Health Services Research.

Health registries are an established methodology in health services research. Regarded as cheap bidder for observation studies in earlier times, many registries now benefit from an appropriate funding. However, reference figures for costs of registries in health services research are missing. Based on literature data as well as figures from a German funding initiative, the relationship between costs per newly recruited case and the annual sample size was analyzed. One can assume that a standard multicenter registry in health services research with 1,000 new patients each year will be appropriately financed with 1.1 to 2.2 million Euro in a period of five years. So smaller the sample size, so higher the costs for a newly recruited patient. The cost model of health registries should be further elaborated taking into account specifics of individual registries and differences in the level of case money.

Insights from a 10-year Australasian idiopathic hypersomnia patient data registry study.

Idiopathic hypersomnia (IH) is a disorder of central hypersomnolence that results in excessive daytime sleepiness in the absence of another identifying cause. Case studies from sleep clinic patients may not be a fair representation of the wider IH population. This study aims to better characterize patients diagnosed with IH in Australia and New Zealand using online patient-driven survey data. A retrospective analysis of 686 participants from the Hypersomnolence Australia Patient Data Registry diagnosed with either IH (n = 554), narcolepsy type 1 (NT1, n = 54) or narcolepsy type 2 (NT2, n = 78) between January 2013 and October 2022 was performed. Participants with IH reported additional sleep disorders such as OSA (16.4%) and restless legs syndrome (7.9%) and notable comorbidities included depression (46.2%) and anxiety (50%). There was a mean delay in diagnosis of 10 years in participants with IH, when compared to symptom onset. IH presents with unique but also overlapping symptomatology with NT2, with similar reporting of long daytime naps, unrefreshed sleep and automatic behavior. Modafinil was the most common medication (45.5%) used by participants with IH followed by dexamphetamine (44.2%). Most participants with IH reported receiving physician advice regarding positive lifestyle changes but recommend that newly diagnosed patients be given more advice about medication use. This study demonstrates a delay in IH diagnosis when compared to symptom onset and overlapping features of IH and NT2. It also highlights the heterogeneous presentation of IH and the value of large patient registries in future research.

Suicide Attempt and Suicide Death Among Spouses of Patients With Cancer

Little is known about the risk of suicidal behavior in relation to having a spouse with a cancer diagnosis. To estimate the risk of suicide attempt and suicide death among spouses of patients with cancer. This nationwide cohort study in Denmark collected registry-based data from 1986 through 2016. Analyses were performed from August 8, 2022, to October 30, 2023. Individuals who had a spouse with a cancer diagnosed during 1986 to 2015 were compared with individuals whose spouse did not have a cancer diagnosis during the same period, randomly selected from the general population and matched by birth year and sex. Having a spouse with a cancer diagnosis. Suicide attempt was identified through the Danish National Patient Register and the Danish Psychiatric Central Research Register, whereas suicide death was identified through the Danish Causes of Death Register, through 2016. Flexible parametric and Cox proportional hazards models were used to estimate hazard ratios (HRs) and 95% CIs for suicide attempt and suicide death among spouses of patients with a cancer diagnosis. The study included 409 338 exposed individuals and 2 046 682 unexposed individuals (median [IQR] age at cohort entry for both groups, 63 [54-70] years; 55.4% women). During the follow-up, 2714 incident cases of suicide attempt among exposed individuals (incidence rate [IR], 62.6 per 100 000 person-years) and 9994 among unexposed individuals (IR, 50.5 per 100 000 person-years) were identified, as well as 711 cases of suicide death among the exposed individuals (IR, 16.3 per 100 000 person-years) and 2270 among the unexposed individuals (IR, 11.4 per 100 000 person-years). An increased risk of suicide attempt (HR, 1.28; 95% CI, 1.23-1.34) and suicide death (HR, 1.47; 95% CI, 1.35-1.60) was observed among spouses of patients with cancer throughout the follow-up. The increased risk was particularly notable during the first year after the cancer diagnosis, with an HR of 1.45 (95% CI, 1.27-1.66) for suicide attempt and 2.56 (95% CI, 2.03-3.22) for suicide death. There was a greater risk increase for both suicide attempt and suicide death when the cancer was diagnosed at an advanced stage or when the spouse died after the cancer diagnosis. These findings suggest a need for clinical and societal awareness to prevent suicidal behaviors among spouses of patients with cancer, particularly during the first year following the cancer diagnosis.

Improving the integration of care for trans adults: ICTA a mixed-methods study.

This research concerns improving the National Health Service health services trans adults need. These include the national specialist Gender Identity Clinics that support people making a medical transition. Not all trans people need to make a medical transition, and transition can take many different paths. Waits to be seen by Gender Identity Clinics are, however, several years long, and there may be significant problems of co-ordination between different aspects of transition-related care, and between transition-related care and general health care. The main objectives were to understand: Which factors make services more or less accessible and acceptable to the variety of trans adults? How initiatives for providing more person-centred and integrated care can be successfully implemented and further improved? An online and paper screening survey was used to gather data on demographics and service use of trans people across the United Kingdom, with 2056 responses. Researchers used survey data to construct five purposive subsamples for individual qualitative interviews, identifying groups of people more likely to experience social exclusion or stigma. There were 65 online interviews. In addition, 23 trans Black people and people of colour attended focus groups. Six case studies were completed: four on initiatives to improve care and two on experiences of particular trans populations. Fifty-five service provider staff and 45 service users were interviewed. The following undermine person-centred co-ordinated care and can lead to experiences of harm: lack of respectful treatment of trans people by general practitioner practices; inadequate funding of services; lack of support during waiting; the extended and challenging nature of Gender Identity Clinic diagnostic assessments, sometimes experienced as adversarial; breakdowns in collaboration between Gender Identity Clinics and general practitioner practices over hormone therapy; lack of National Health Service psychological support for trans people. Case studies indicated ways to improve care, although each has significant unresolved issues: training in trans health care for general practitioners; third-sector peer-support workers for trans people who come to National Health Services; gender services taking a collaborative approach to assessing what people need, clarifying treatment options, benefits and risks; regional general practitioner-led hormone therapy clinics, bringing trans health care into the mainstream; psychology services that support trans people rather than assess them. Some contexts of care and experiences of particular groups of trans people were not addressed sufficiently within the scope of the project. While efforts were made to recruit people subject to multiple forms of stigma, there remained gaps in representation. The findings have significant implications for commissioners and providers of existing National Health Services gender services, including recently established pilot services in primary care. In particular they point to the need for assessments for access to transition care to be more collaborative and culturally aware, implying the value of exploring informed consent models for accessing transition-related care. Further research is needed to investigate how far the findings apply with particular subpopulations. This study is registered as Research Registry, no. 5235. This award was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme (NIHR award ref: 17/51/08) and is published in full in Health and Social Care Delivery Research; Vol. 12, No. 28. See the NIHR Funding and Awards website for further award information.

Feasibility of in-home monitoring for people with glaucoma: the I-TRAC mixed-methods study.

Glaucoma is a chronic disease of the optic nerve and a leading cause of severe visual loss in the UK. Once patients have been diagnosed, they need regular monitoring at hospital eye services. Recent advances in technology mean patients with glaucoma can now monitor their disease at home. This could be more convenient for patients and potentially reduce costs and increase capacity for the NHS. However, it is uncertain whether self-monitoring would be acceptable or possible for patients with glaucoma. The objectives were to: identify which patients are most appropriate for home monitoring; understand views of key stakeholders (patients, clinicians, researchers) on whether home glaucoma monitoring is feasible and acceptable; develop a conceptual framework for the economic evaluation of home glaucoma monitoring; and explore the need for and provide evidence on the design of a future study to evaluate the clinical and cost-effectiveness of digital technologies for home monitoring of glaucoma. In-home Tracking of glaucoma: Reliability, Acceptability, and Cost (I-TRAC) was a multiphase mixed-methods feasibility study with key components informed by theoretical and conceptual frameworks. Expert glaucoma specialists in the UK recruited through professional glaucoma societies; study site staff and patient participants recruited through three UK hospital eye services (England, Scotland, Northern Ireland); and UK research teams recruited though existing networks. Home tonometer that measures intraocular pressure and a tablet computer with a visual function application. Patients were asked to use the technology weekly for 12 weeks. Forty-two patients were recruited. Retention and completion of follow-up procedures was successful, with 95% (n = 40) completing the 3-month follow-up clinic visits. Adherence to the interventions was generally high [adherence to both devices (i.e. ≥80% adherence) was 55%]. Overall, patients and healthcare professionals were cautiously optimistic about the acceptability of digital technologies for home monitoring of patients with glaucoma. While most clinicians were supportive of the potential advantages glaucoma home monitoring could offer, concerns about the technologies (e.g. reliability and potential to miss disease progression) and how they would fit into routine care need to be addressed. Additionally, clarity is required on defining the ideal population for this intervention. Plans for how to evaluate value for money in a future study were also identified. However, the study also highlighted several unknowns relating to core components of a future evaluative study that require addressing before progression to a definitive effectiveness trial. The main limitation relates to our sample and its generalisability, for example, the over-representation of educated persons of white ethnicity who were generally experienced with technology and research motivated. The In-home Tracking of glaucoma: Reliability, Acceptability, and Cost study has demonstrated 'cautious optimism' when considering patients' and healthcare professionals' views on the acceptability of digital technologies for home monitoring of patients with glaucoma. However, the study also highlighted several unknowns relating to the research question and design of a future evaluative study that require addressing before progression to a randomised controlled trial. Further research is required to determine the appropriate population (i.e. low vs. high risk of progression) and further refine the intervention components and delivery for planning of future evaluation studies. This study is registered as Research Registry #6213. This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: NIHR129248) and is published in full in Health Technology Assessment; Vol. 28, No. 44. See the NIHR Funding and Awards website for further award information.

Angiographic Features of Meningiomas Predicting Extent of Preoperative Embolization.

Preoperative embolization is used as an endovascular adjunct to surgical resection of meningiomas. However, there is no standardized system to assess the efficacy or extent of embolization during the embolization procedure. We sought to establish a purely angiographic grading system to facilitate consistent reporting of the outcome of meningioma embolization and to characterize the anatomic and other features of meningiomas that predict the degree of devascularization achieved through preoperative embolization. We identified patients with meningiomas who underwent preoperative cerebral angiography and subsequent resection between 2015 and 2021. Demographic, clinical, and imaging data were collected in a research registry. We defined an angiographic devascularization grading scale as follows: grade 0 for no embolization, 1 for partial embolization, 2 for majority embolization, 3 for complete external carotid artery embolization, and 4 for complete embolization. Eighty consecutive patients were included, 60 of whom underwent preoperative tumor embolization (20 underwent angiography with an intention to treat but ultimately not embolization). Embolized tumors were larger (59.0 vs 35.9 cc; P = .03). Gross total resection, length of stay, and complication rates did not differ among groups. The distribution of arterial feeders differed significantly across tumors in a location-specific manner. Both the tumor location and the identity of arterial feeders were predictive of the extent of embolization. Anterior midline meningiomas were associated with internal carotid (ophthalmic, ethmoidal) supply and lower devascularization grades (P = .03). Tumors fed by meningeal feeders (convexity, falcine, lateral sphenoid wing) were associated with higher devascularization grades (P < .01). The procedural complication rate for tumor embolization was 2.5%. Angiographic outcomes can be graded to indicate the extent of tumor embolization. This system may facilitate consistency of reported angiographic results. In addition, arterial feeders vary in a manner predicted by tumor location, and these patterns correlate with typical degrees of devascularization achieved in those tumor locations.

Communication and Counseling Preferences of Women Who Chose Abortion During Adolescence: A Qualitative Study

Study ObjectiveAs part of a larger study about pregnancy options counseling with adolescents, we interviewed women in the United States who chose abortion during adolescence about preferences and experiences regarding communication from healthcare professionals during abortion care. Design, Setting, and ParticipantsWe conducted individual semi-structured interviews with women ages 18-35 years old who were pregnant before age 20 years old and chose abortion. We recruited participants through social media, a research registry, and flyers in healthcare facilities. We recorded and transcribed interviews. Two investigators coded interview transcripts using thematic analysis. ResultsWe conducted interviews with 17 US women (median age 32 years old, range 20-35 years old) from 11/2020-4/2021. The median age at time of abortion was 18 years old (range 14-19 years). The sample was 58% (n = 10) Caucasian and 65% (n = 11) heterosexual. Themes included: 1) Participants perceived options counseling before abortion as important and necessary but did not always feel they personally needed it. 2) Participants reported that clinicians including nurses, physicians, and other staff sometimes had poor bedside manner, which was not aligned with their perceived need for gentleness due to their adolescence. 3) Participants valued nonjudgmental communication including normalization of abortion care. 4) Participants desired privacy and confidentiality throughout their clinic appointment, but clinic logistics led to concerns about limited privacy. 5) Participants appreciated medically accurate information about abortion in plain language balancing safety and risk information for reducing fear before the procedure. ConclusionResponses suggested specific best practices that healthcare providers can adopt to improve care for youth considering abortion.

Menopause and Traumatic Brain Injury: A NIDILRR Collaborative Traumatic Brain Injury Model Systems Study

ObjectiveTo examine the experience of menopause symptoms in women with traumatic brain injury (TBI). DesignCross-sectional descriptive study. SettingFive sites of the TBI Model Systems (TBIMS) program. ParticipantsParticipants were 210 women, aged 40-60 years, who were not taking systemic hormones and did not have both ovaries removed: 61 participants were enrolled in the TBIMS, who were at least 2 years post-TBI and living in the community. One hundred forty-nine participants without TBI were recruited from a research registry and the metropolitan Detroit community. InterventionsNot applicable. Main Outcome MeasuresA checklist comprised of 21 menopause symptoms assessing 4 symptom clusters (vasomotor, somatic, psychological, and cognitive). ResultsTBI and non-TBI groups did not significantly differ and showed small effect sizes on vasomotor symptoms. On the remaining symptom clusters, women with TBI showed greater presence and severity of symptoms than women without TBI, as well as fewer differences between premenopausal and postmenopausal women on those symptoms. A profile indicating an additive or potentiating effect of TBI on menopause symptoms was not observed. ConclusionsFindings support a conceptual model of menopause and TBI indicating that symptoms most closely associated with estrogen decline are similar for women with and without TBI, whereas symptoms that overlap with common TBI sequelae are generally more frequent and severe among these women. Likely because of lower baseline of symptoms premenopause, postmenopausal women without TBI reported more numerous and severe symptoms relative to their premenopausal counterparts without TBI. Overall, it may be that women without TBI experience menopause as more of a “change” of life, whereas women with TBI chronically face significantly more of these symptoms than women without TBI.

Informing a Future Clinician-Led Virtual Reality Experience Through Oncology Caregivers' Pre-Treatment Preparation Experiences.

The purpose of this study was to 1) describe oncology caregivers' pre-treatment preparation experiences, 2) elicit their feedback about approaches to improve the pre-treatment preparation experience, and 3) explore the potential use of visual aids into the pre-treatment education experience that will inform future clinician-led VR experiences. Using a qualitative descriptive design and convenience sampling technique, adult oncology caregivers were recruited to complete anonymous demographic and qualitative surveys posted on social media sites (i.e. American Cancer Society, Facebook, and LinkedIn) and a university supported community research registry (i.e. Pitt + Me). Demographic data were calculated using descriptive analyses (frequency and percentage) and qualitative data were analyzed using an inductive coding approach. Participants (N=18) were mostly female (n=13, 72%), white (n=14, 78%), married (n=14, 78%), and had a college degree or higher (n=16, 89%). They categorically ranged in age from 26 years to above 65 years, with the majority (n=11, 61%) between 36-55 years of age. Caregivers described the cancer information as overwhelming and in need of additional side effect information and emotional support. To meet their unmet needs, participants suggested providing additional resources, different approaches to learning, better explanation of processes and procedures, diverse emotional support, and more interactions with the oncology team. Clinician created VR experiences designed for and informed by oncology caregivers do not exist yet. VR could provide an alternative pediogogical approach to complement standard oncology treatment preparation. These study findings begin the exploration into innovative preparation approaches that could meet oncology caregivers' unmet emotional and educational needs during a stressful period. There is a dearth of clinicians creating and testing VR experiences for patients, let alone caregivers. Oncology caregivers are the unseen 'backbone' supporting their loved one and providing an innovative modality to support them could improve outcomes. VR has the potential improve outcomes for caregivers, which may improve outcomes for patients.

Enhancing the Meaning of Psychological Research Through Trend Research and Research Registries

The relentless development of research in various fields of science, including psychology, has the potential to cause redundancy and reduce relevance. To overcome this, the discourse and efforts of Trend Research and Research Registries were developed. The integration of Trend Research and Research Registry is expected to be implemented and utilized by researchers in the field of science, to not only maintain the quality of research conducted, but to further improve the quality so that it can be more meaningful.

Epidemiology of Diffuse Alveolar Hemorrhage in Pediatric Allogeneic Hematopoietic Cell Transplantation Recipients

Diffuse alveolar hemorrhage (DAH) is a life-threatening pulmonary toxicity that can arise after hematopoietic cell transplantation (HCT). Risk factors and outcomes are not well understood owing to a sparsity of cases spread across multiple centers. The objectives of this epidemiologic study were to characterize the incidence, outcomes, transplantation-related risk factors and comorbid critical care diagnoses associated with post-HCT DAH. Retrospective analysis was performed in a multicenter cohort of 6995 patients age ≤21 years who underwent allogeneic HCT between 2008 and 2014 identified through the Center for International Blood and Marrow Transplant Research registry and cross-matched with the Virtual Pediatric Systems database to obtain critical care characteristics. A multivariable Cox proportional hazard model was used to determine risk factors for DAH. Logistic regression models were used to determine critical care diagnoses associated with DAH. Survival outcomes were analyzed using both a landmark approach and Cox regression, with DAH as a time-varying covariate. DAH occurred in 81 patients at a median of 54 days post-HCT (interquartile range, 23 to 160 days), with a 1-year post-transplantation cumulative incidence probability of 1.0% (95% confidence interval [CI], .81% to 1.3%) and was noted in 7.6% of all pediatric intensive care unit patients. Risk factors included receipt of transplantation for nonmalignant hematologic disease (reference: malignant hematologic disease; hazard ratio [HR], 1.98; 95% CI, 1.22 to 3.22; P = .006), use of a calcineurin inhibitor (CNI) plus mycophenolate mofetil (MMF) as graft-versus-host disease (GVHD) prophylaxis (referent: CNI plus methotrexate; HR, 1.89; 95% CI, 1.07 to 3.34; P = .029), and grade III-IV acute GVHD (HR, 2.67; 95% CI, 1.53-4.66; P < .001). Critical care admitted patients with DAH had significantly higher rates of systemic hypertension, pulmonary hypertension, pericardial disease, renal failure, and bacterial/viral/fungal infections (P < .05) than those without DAH. From the time of DAH, median survival was 2.2 months, and 1-year overall survival was 26% (95% CI, 17% to 36%). Among all HCT recipients, the development of DAH when considered was associated with a 7-fold increase in unadjusted all-cause post-HCT mortality (HR, 6.96; 95% CI, 5.42 to 8.94; P < .001). In a landmark analysis of patients alive at 2 months post-HCT, patients who developed DAH had a 1-year overall survival of 33% (95% CI, 18% to 49%), compared to 82% (95% CI, 81% to 83%) for patients without DAH (P < .001). Although DAH is rare, it is associated with high mortality in the post-HCT setting. Our data suggest that clinicians should have a heightened index of suspicion of DAH in patients with pulmonary symptoms in the context of nonmalignant hematologic indication for HCT, use of CNI + MMF as GVHD prophylaxis, and severe acute GVHD. Further investigations and validation of modifiable risk factors are warranted given poor outcomes.

CD19-directed CART therapy for T-cell/histiocyte–rich large B-cell lymphoma

AbstractT-cell/histiocyte–rich large B-cell lymphoma (THRLBCL) is a rare histologic variant of LBCL. Limited data regarding CD19–directed chimeric antigen receptor T-cell (CART) therapy in relapsed/refractory (R/R) THRLBCL suggest poor efficacy. We investigated CART outcomes for R/R THRLBCL through the Center for International Blood and Marrow Transplant Research registry. A total of 58 adult patients with R/R THRLBCL who received commercial CD19-CART therapy between 2018 and 2022 were identified. Most patients (67%) had early relapse of disease (45% primary refractory) with a median of 3 (range, 1-7) prior therapies and were treated with axicabtagene ciloleucel (69%). At median follow-up of 23 months after CART therapy, 2-year overall and progression-free survival were 42% (95% confidence interval [CI], 27-57) and 29% (95% CI, 17-43), respectively. In univariable analysis, poor performance status before CART therapy was associated with higher mortality (hazard ratio, 2.35; 95%CI, 1.02-5.5). The 2-year cumulative incidences of relapse/progression and nonrelapse mortality were 69% and 2%, respectively. Grade ≥3 cytokine release syndrome and immune effector cell–associated neurologic syndrome occurred in 7% and 15% of patients, respectively. In this largest analysis of CD19-CART therapy for R/R THRLBCL, ∼30% of patients were alive and progression free 2 years after CART therapy. Despite a high incidence of progression (69% at 2 years), these results suggest a subset of patients with R/R THRLBCL may have durable responses with CARTs.

Antibiotic use attenuates response to immune checkpoint blockade in urothelial carcinoma via inhibiting CD74-MIF/COPA: revealing cross-talk between anti-bacterial immunity and anti-tumor immunity through a tumor marker prognostic study.

Immune checkpoint blockade (ICB) has emerged as a promising therapy for both resectable urothelial carcinoma (UC) patients preparing for radical surgery and unresectable UC patients, whereas the objective response rate of ICB remains unsatisfactory due to various factors. Antibiotic (ATB) use can influence intra-tumoral bacteria, which may further reduce ICB efficacy. The study aims to evaluate the effects of ATB use on prognosis and response in UC patients undergoing ICB, and explore potential molecular mechanisms of ATBs and intra-tumoral bacteria impacting UC immune microenvironment. Pooled analyses, synthesizing evidence from 12 studies and 3496 UC patients with ICB treatment, was conducted via a meta-analysis. In addition, single-cell RNA and single-cell microbiome data were analyzed based on eight UC samples and 63185 single cells. Bulk RNA sequencing and clinical data from a single-arm, multi-center, atezolizumab-treated, phase 2 trial, IMvigor210, were used for validation. The study is registered at PROSPERO (XXX) and at Research Registry (XXX). ATB use exhibited worse overall survival (HR=1.46, 95%CI=[1.20, 1.77], P<0.001, heterogeneity I²=51%) and lower objective response (OR=0.43, 95%CI=[0.27, 0.68], P<0.001, heterogeneity I²=0%) in UC patients receiving ICB. Single-cell transcriptome and single-cell microbiome analyses identified the presence of intra-tumoral bacteria was obviously related to elevated anti-bacterial immune functions; and anti-bacterial immunity was positively correlated to anti-tumor immunity in UC immune microenvironment. Intra-tumoral bacteria could up-regulate CD74-MIF/COPA signaling of immune cells and activation of CD74-MIF/COPA mediated the promotion of T cell anti-tumor function induced by anti-bacterial immune cells. UC patients with higher CD74-MIF/COPA signaling carried better overall survival (HR=1.60, 95%CI=[1.19, 2.15], P=0.002) in IMvigor210 immunotherapy cohort. ATB use reduces overall survival and objective response to ICB in UC patients. Anti-bacterial immune cell functions induced by intra-cellular bacteria in UC microenvironment might up-regulate the function of anti-tumor T immune cells via activating CD74-MIF/COPA, whereas ATB could inhibit the above process through killing intra-cellular bacteria and result in poorer clinical benefit of ICB. The use of ATB should be considered carefully during neoadjuvant immunotherapy period for resectable UC patients preparing for radical surgery and during immunotherapy period for unresectable UC patients.

The Prognostic Role of Perineural Invasion for Survival in Head and Neck Squamous Cell Carcinoma: A Systematic Review and Meta-Analysis.

The aim of this study was to conduct a comprehensive review of the predictive significance of PNI in HNSCC survival outcomes. A systematic search was conducted across multiple databases, and all studies published in the last decade were screened (Research Registry ID: reviewregistry1853). The included studies were assessed using the Quality in Prognosis Studies tool. Survival outcome data were extracted, combined, and presented as hazard ratios (HR) with a 95% confidence interval (CI). Totally, 74 studies encompassing 27,559 patients were analyzed and revealed a cumulative occurrent rate of 30% for PNI in HNSCC. PNI+ HNSCC patients had a worse overall survival (HR: 1.91, 95% CI: 1.71-2.13), disease-specific survival (HR: 1.79, 95% CI: 1.55-2.07), disease-free survival (HR: 1.82, 95% CI: 1.69-1.96), local recurrence (HR: 2.54, 95% CI: 1.93-3.33), locoregional recurrence (HR: 2.27, 95% CI: 1.82-2.82), locoregional relapse free survival (HR: 1.77, 95% CI: 1.28-2.45), distant metastasis (HR: 1.82, 95% CI: 1.34-2.48), and distant metastasis-free survival (HR: 2.97, 95% CI: 1.82-4.85) compared to those PNI- patients. The available evidence unequivocally establishes PNI as a critical prognostic factor for worse survival in HNSCC patients.

A Novel mHealth App for Smokers Living With HIV Who Are Ambivalent About Quitting Smoking: Formative Research and Randomized Feasibility Study.

More people who smoke and are living with HIV now die from tobacco-related diseases than HIV itself. Most people are ambivalent about quitting smoking and want to quit someday but not yet. Scalable, effective interventions are needed to motivate and support smoking cessation among people ambivalent about quitting smoking (PAQS) who are living with HIV. This study aims to develop an app-based intervention for PAQS who are living with HIV and assess its feasibility, acceptability, and potential impact. Results of this study will inform plans for future research and development. In phase 1, PAQS living with HIV (n=8) participated in user-centered design interviews to inform the final intervention app design and recruitment plan for a subsequent randomized pilot study. In phase 2, PAQS living with HIV were randomized to either a standard care control app or a similar experimental app with additional content tailored for PAQS and those with HIV. Participants were followed for 3 months. Feasibility focused on recruitment, retention, and participants' willingness to install the app. The study was not powered for statistical significance. Indices of acceptability (satisfaction and use) and impact (smoking behavior change and treatment uptake) were assessed via automated data and self-report among those who installed and used the app (n=19). Recruitment for both study phases was a challenge, particularly via web-based and social media platforms. Enrollment success was greater among people living with HIV recruited from a health care provider and research registry. Once enrolled, retention for the phase 2 randomized study was good; 74% (14/19) of the participants completed the 3-month follow-up. Phase 1 findings suggested that PAQS living with HIV were receptive to using an app-based intervention to help them decide whether, when, and how to stop smoking, despite not being ready to quit smoking. Phase 2 findings further supported this conclusion based on feedback from people who agreed to use an app, but group differences were observed. Indices of acceptability favored the experimental arm, including a descriptively higher mean number of sessions and utilization badges. Similarly, indices of potential impact were descriptively higher in the experimental arm (proportion reducing smoking, making a quit attempt, or calling free tobacco quitline). No participants in either arm quit smoking at the 3-month follow-up. On the basis of this formative work, PAQS living with HIV may be receptive to using a mobile health-based app intervention to help them decide whether, when, or how to stop using tobacco. Indices of acceptability and impact indicate that additional research and development are warranted. ClinicalTrials.gov NCT05339659; https://clinicaltrials.gov/study/NCT05339659.