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Background A recent randomized phase II trial evaluated stereotactic ablative radiotherapy (SABR) in a group of patients with a small burden of oligometastatic disease (mostly with 1–3 metastatic lesions), and found that SABR was associated with a significant improvement in progression-free survival and a trend to an overall survival benefit, supporting progression to phase III randomized trials. Methods Two hundred and ninety-seven patients will be randomized in a 1:2 ratio between the control arm (consisting of standard of care [SOC] palliative-intent treatments), and the SABR arm (consisting of SOC treatment + SABR to all sites of known disease). Randomization will be stratified by two factors: histology (prostate, breast, or renal vs. all others), and disease-free interval (defined as time from diagnosis of primary tumor until first detection of the metastases being treated on this trial; divided as ≤2 vs. > 2 years). The primary endpoint is overall survival, and secondary endpoints include progression-free survival, cost effectiveness, time to development of new metastatic lesions, quality of life (QoL), and toxicity. Translational endpoints include assessment of circulating tumor cells, cell-free DNA, and tumor tissue as prognostic and predictive markers, including assessment of immunological predictors of response and long-term survival. Discussion This study will provide an assessment of the impact of SABR on survival, QoL, and cost effectiveness to determine if long-term survival can be achieved for selected patients with 1–3 oligometastatic lesions. Trial registration Clinicaltrials.gov identifier: NCT03862911 . Date of registration: March 5, 2019,

Background Bone metastases in the lower spine and pelvis are effectively palliated with radiotherapy (RT), though this can come with side effects such as radiation induced nausea and vomiting (RINV). We hypothesize that high rates of RINV occur in part because of the widespread use of inexpensive simple unplanned palliative radiotherapy (SUPR), over more complex and resource intensive 3D conformal RT, such as volumetric modulated arc therapy (VMAT). Methods This is a randomized, multi-centre phase III trial of SUPR versus VMAT. We will accrue 250 patients to assess the difference in patient-reported RINV. This study is powered to detect a difference in quality of life between patients treated with VMAT vs. SUPR. Discussion This trial will determine if VMAT reduces early toxicity compared to SUPR and may provide justification for this more resource-intensive and costly form of RT. Trial registration Clinicaltrials.gov identifier: NCT03694015 . Date of registration: October 3, 2018.

When determining whether a parent of a child requiring special education services should receive private school tuition reimburse- ment because his or her child's proposed individual education program (IEP) does not provide a free appropriate public education (FAPE) under the Individuals with Disabilities Education Act (IDEA), courts must examine the IEP prospectively, at the time the IEP is created, rather than basing a decision entirely on retrospective testimony not included in the IEP. If the parent believes the IEP does not comply with IDEA, he or she may file a due process com- plaint. Because the parents believed their children's proposed IEPs were inadequate, they placed their children in private schools and brought due process claims for tuition reimbursement.

Humor is widely believed to be an adaptive method of regulating emotions; however, the empirical literature remains inconclusive. One potential explanation for inconsistent results is that humor may be a multidimensional construct. Correlational research suggests that “adaptive” humor styles (Self-Enhancing and Affiliative) are more beneficial than “maladaptive” humor styles (Self-Defeating and Aggressive). The current study examined the effects of humor styles on positive and negative emotion in a sample of 146 young adults. In Part I of the study, participants were 1) randomly assigned to three conditions (adaptive humor, maladaptive humor, and distraction), 2) instructed to write about life events that invoked negative emotions, and 3) instructed to generate humorous responses or engage in a distraction task. Repeated measures ANOVAs showed that the humor tasks resulted in significant changes in positive emotion and negative emotion in the expected directions. Contrary to hypotheses, the humor conditions did not show significantly greater increases in positive emotion or decreases in negative emotion than did the distraction condition. In addition, the adaptive humor condition did not show significantly greater increases in positive emotion or decreases in negative emotion than did the maladaptive humor condition. Part II of the study addressed the lack of research comparing humor styles with established emotion-regulation measures. As predicted, participants who endorsed more adaptive forms of humor reported significantly less difficulties in emotion regulation, and participants who endorsed more maladaptive forms of humor reported significantly more difficulties in emotion regulation. These findings provide preliminary contributions to the understanding of humor’s role as an emotion regulatory strategy.

Background The Limb Girdle Muscular Dystrophies (LGMDs) are characterized by progressive weakness of the shoulder and hip girdle muscles as a result of over 30 different genetic mutations. This study is designed to develop clinical outcome assessments across the group of disorders. Methods/design The primary goal of this study is to evaluate the utility of a set of outcome measures on a wide range of LGMD phenotypes and ability levels to determine if it would be possible to use similar outcomes between individuals with different phenotypes. We will perform a multi-center, 12-month study of 188 LGMD patients within the established Genetic Resolution and Assessments Solving Phenotypes in LGMD (GRASP-LGMD) Research Consortium, which is comprised of 11 sites in the United States and 2 sites in Europe. Enrolled patients will be clinically affected and have mutations in CAPN3 (LGMDR1), ANO5 (LGMDR12), DYSF (LGMDR2), DNAJB6 (LGMDD1), SGCA (LGMDR3), SGCB (LGMDR4), SGCD (LGMDR6), or SGCG (LGMDR5, or FKRP-related (LGMDR9). Discussion To the best of our knowledge, this will be the largest consortium organized to prospectively validate clinical outcome assessments (COAs) in LGMD at its completion. These assessments will help clinical trial readiness by identifying reliable, valid, and responsive outcome measures as well as providing data driven clinical trial decision making for future clinical trials on therapeutic agents for LGMD. The results of this study will permit more efficient clinical trial design. All relevant data will be made available for investigators or companies involved in LGMD therapeutic development upon conclusion of this study as applicable. Trial registration Clinicaltrials.gov NCT03981289; Date of registration: 6/10/2019.

Background Rates of HIV acquisition and sexual violence perpetration are pressing public health issues for adolescents in South Africa. The evidence base around interventions that concomitantly address both HIV risk and prevention of sexual violence perpetration needs development. This protocol describes the design and procedures for a randomized controlled trial that investigates the efficacy of a behavioral intervention to address HIV and sexual violence called Safe South Africa. Methods Safe South Africa is a behavioral intervention. The intervention takes an integrated approach for preventing or reducing risk behavior related to the acquisition of human immunodeficiency virus (HIV) and sexually transmitted infections (STIs) and the perpetration of sexual violence among adolescents in South Africa. The behavioral intervention is gender and developmentally tailored for adolescent boys aged 15–17 years and delivered in the school setting. The trial will compare the experimental intervention—Safe South Africa—with control of practice as usual. In South Africa, the practice as usual consists of no intervention, as there are currently no existing interventions that have been proven to be efficacious for reducing the risk for HIV and perpetration of sexual violence concurrently with adolescent boys in this setting. The study is based on the hypothesis that the behavioral intervention—Safe South Africa—will result in adolescent boys randomized to the intervention showing (a) a lower incidence of any STI (including HIV) and (b) reductions in sexual violence perpetration frequency and decreased endorsement of intimate partner violence supportive attitudes as compared to the control. N  = 836 participants will be randomly assigned to either the intervention group or the control group with an allocation ratio of 1:1. Eligible participants include the following: (1) identification as boys; (2) ages 15–17 years; (3) enrolled at public high schools in South Africa situated in communities with high rates of HIV and violence. Participants must provide informed written assent (following parental consent). We will compare primary outcomes between the two study arms at 4 and 12 months versus baseline to quantify the intervention’s short- and long-term effects using generalized estimating equations to account for repeated measures. Discussion Study findings will allow us to contribute to the evidence base of integrated HIV-violence prevention interventions that meet the needs of adolescents in school settings. Trial registration This study has been registered at ClinicalTrials.gov under protocol ID NCT03231358. Registered on December 27, 2024.

Early in the COVID-19 pandemic, Canadian primary care practices rapidly adapted to provide care virtually. Most family physicians lacked prior training or expertise with virtual care. In the absence of formal guidance, they made individual decisions about in-person versus remote care based on clinical judgement, their longitudinal relationships with patients, and personal risk assessments. Our objective was to explore Canadian family physicians' perspectives on the strengths and limitations of virtual care implementation for their patient populations during the COVID-19 pandemic and implications for the integration of virtual care into broader primary care practice. We conducted semi-structured qualitative interviews with family physicians working in four Canadian jurisdictions (Vancouver Coastal health region, British Columbia; Southwestern Ontario; the province of Nova Scotia; and Eastern Health region, Newfoundland and Labrador). We analyzed interview data using a structured applied thematic approach. We interviewed 68 family physicians and identified four distinct themes during our analysis related to experiences with and perspectives on virtual care: (1) changes in access to primary care; (2) quality and efficacy of care provided virtually; (3) patient and provider comfort with virtual modalities; and (4) necessary supports for virtual care moving forward. The move to virtual care enhanced access to care for select patients and was helpful for family physicians to better manage their panels. However, virtual care also created access challenges for some patients (e.g., people who are underhoused or living in areas without good phone or internet access) and for some types of care (e.g., care that required access to medical devices). Family physicians are optimistic about the ongoing integration of virtual care into broader primary care delivery, but guidance, regulations, and infrastructure investments are needed to ensure equitable access and to maximize quality of care.

Background Prior to the pandemic, Canada lagged behind other Organisation for Economic Cooperation and Development countries in the uptake of virtual care. The onset of COVID-19, however, resulted in a near-universal shift to virtual primary care to minimise exposure risks. As jurisdictions enter a pandemic recovery phase, the balance between virtual and in-person visits is reverting, though it is unlikely to return to pre-pandemic levels. Our objective was to explore Canadian family physicians’ perspectives on the rapid move to virtual care during the COVID-19 pandemic, to inform both future pandemic planning for primary care and the optimal integration of virtual care into the broader primary care context beyond the pandemic. Methods We conducted semi-structured interviews with 68 family physicians from four regions in Canada between October 2020 and June 2021. We used a purposeful, maximum variation sampling approach, continuing recruitment in each region until we reached saturation. Interviews with family physicians explored their roles and experiences during the pandemic, and the facilitators and barriers they encountered in continuing to support their patients through the pandemic. Interviews were audio-recorded, transcribed, and thematically analysed for recurrent themes. Results We identified three prominent themes throughout participants’ reflections on implementing virtual care: implementation and evolution of virtual modalities during the pandemic; facilitators and barriers to implementing virtual care; and virtual care in the future. While some family physicians had prior experience conducting remote assessments, most had to implement and adapt to virtual care abruptly as provinces limited in-person visits to essential and urgent care. As the pandemic progressed, initial forays into video-based consultations were frequently replaced by phone-based visits, while physicians also rebalanced the ratio of virtual to in-person visits. Medical record systems with integrated capacity for virtual visits, billing codes, supportive clinic teams, and longitudinal relationships with patients were facilitators in this rapid transition for family physicians, while the absence of these factors often posed barriers. Conclusion Despite varied experiences and preferences related to virtual primary care, physicians felt that virtual visits should continue to be available beyond the pandemic but require clearer regulation and guidelines for its appropriate future use.

Previous studies have shown that mild traumatic brain injury (mTBI) can cause abnormalities in clinically relevant magnetic resonance imaging (MRI) sequences. No large-scale study, however, has prospectively assessed this in athletes with sport-related concussion (SRC). The aim of the current study was to characterize and compare the prevalence of acute, trauma-related MRI findings and clinically significant, non-specific MRI findings in athletes with and without SRC. College and high-school athletes were prospectively enrolled and participated in scanning sessions between January 2015 through August 2017. Concussed contact sport athletes (n = 138; 14 female [F]; 19.5 ± 1.6 years) completed up to four scanning sessions after SRC. Non-concussed contact (n = 135; 15 F; 19.7 ± 1.6) and non-contact athletes (n = 96; 15 F; 20.0 ± 1.7) completed similar scanning sessions and served as controls. Board-certified neuroradiologists, blinded to SRC status, reviewed T1-weighted and T2-weighted fluid-attenuated inversion recovery and T2*-weighted and T2-weighted images for acute (i.e., injury-related) or non-acute findings that prompted recommendation for clinical follow-up. Concussed athletes were more likely to have MRI findings relative to contact (30.4% vs. 15.6%; odds ratio [OR] = 2.32; p = 0.01) and non-contact control athletes (19.8%; OR = 2.11; p = 0.04). Female athletes were more likely to have MRI findings than males (43.2% vs. 19.4%; OR = 2.62; p = 0.01). One athlete with SRC had an acute, injury-related finding; group differences were largely driven by increased rate of non-specific white matter hyperintensities in concussed athletes. This prospective, large-scale study demonstrates that <1% of SRCs are associated with acute injury findings on qualitative structural MRI, providing empirical support for clinical guidelines that do not recommend use of MRI after SRC.

IntroductionSince the onset of the COVID-19 pandemic, virtual care has gained increased attention, particularly in primary care for the ongoing delivery of routine services. Nurses have had an increased presence in virtual care and have contributed meaningfully to the delivery of team-based care in primary care; however, their exact contributions in virtual models of primary care remain unclear. The Nursing Role Effectiveness Model, applied in a virtual care and primary care context, outlines the association between structural variables, nursing roles and patient outcomes. The aim of this scoping review is to identify and synthesise the international literature surrounding nurse contributions to virtual models of primary care.Methods and analysisThe Joanna Briggs Institute scoping review methodology will guide this review. We performed preliminary searches in April 2022 and will use CINAHL, MEDLINE, Embase and APA PsycInfo for the collection of sources for this review. We will also consider grey literature, such as dissertations/theses and organisational reports, for inclusion. Studies will include nurses across all designations (ie, nurse practitioners, registered nurses, practical nurses). To ensure studies capture roles, nurses should be actively involved in healthcare delivery. Sources require a virtual care and primary care context; studies involving the use of digital technology without patient–provider interaction will be excluded. Following a pilot test, trained reviewers will independently screen titles/abstracts for inclusion and extract relevant data. Data will be organised using the Nursing Role Effectiveness Model, outlining the virtual care and primary care context (structure component) and the nursing role concept (process component).Ethics and disseminationThis review will involve the collection and analysis of secondary sources that have been published and/or are publicly available. Therefore, ethics approval is not required. Scoping review findings will be published in a peer-reviewed journal and presented at relevant conferences, targeting international primary care stakeholders.