[Guidelines for clinical trial protocols for interventions involving artificial intelligence: the SPIRIT-AI extensionDiretrizes para protocolos de ensaios clínicos com intervenções que utilizam inteligência artificial: a extensão SPIRIT-AI].

Objective.: To determine if there was an association between intrapartum stillbirths and both traveled distance for delivery and delivery care accessibility, assessing periods before and during the COVID-19 pandemic.

Methods.

[Reporting guidelines for clinical trial reports for interventions involving artificial intelligence: the CONSORT-AI extensionDiretrizes para relatórios de ensaios clínicos com intervenções que utilizam inteligência artificial: a extensão CONSORT-AI].

The CONSORT 2010 statement provides minimum guidelines for reporting randomized trials. Its widespread use has been instrumental in ensuring transparency in the evaluation of new interventions. More recently, there has been a growing recognition that interventions involving artificial intelligence (AI) need to undergo rigorous, prospective evaluation to demonstrate impact on health outcomes.

[Guidelines for clinical trial protocols for interventions involving artificial intelligence: the SPIRIT-AI extensionDiretrizes para protocolos de ensaios clínicos com intervenções que utilizam inteligência artificial: a extensão SPIRIT-AI].

The SPIRIT 2013 statement aims to improve the completeness of clinical trial protocol reporting by providing evidence-based recommendations for the minimum set of items to be addressed. This guidance has been instrumental in promoting transparent evaluation of new interventions. More recently, there has been a growing recognition that interventions involving artificial intelligence (AI) need to undergo rigorous, prospective evaluation to demonstrate their impact on health outcomes.

Pediatric-onset multiple sclerosis is associated with reduced parental health-related quality of life and family functioning.

Background: Diagnosis of multiple sclerosis (MS) during childhood has the potential to impact the affected child's self-perception and the health-related quality of life (HRQoL) of the family.

Objective: To evaluate the impact of chronic disease, in children ascertained as having MS and their families, when compared to those with monophasic acquired demyelinating syndrome (monoADS).

Methods: In a national prospective cohort study of pediatric acquired demyelinating syndromes (ADS), the HRQoL of children and their families was captured using the Pediatric Quality of Life Inventory (PedsQL) Modules.

Impact of including or excluding both-armed zero-event studies on using standard meta-analysis methods for rare event outcome: a simulation study.

Objectives: There is no consensus on whether studies with no observed events in the treatment and control arms, the so-called both-armed zero-event studies, should be included in a meta-analysis of randomised controlled trials (RCTs). Current analytic approaches handled them differently depending on the choice of effect measures and authors' discretion. Our objective is to evaluate the impact of including or excluding both-armed zero-event (BA0E) studies in meta-analysis of RCTs with rare outcome events through a simulation study.

Use of heparins in patients with cancer: individual participant data meta-analysis of randomised trials study protocol.

Introduction: Parenteral anticoagulants may improve outcomes in patients with cancer by reducing risk of venous thromboembolic disease and through a direct antitumour effect. Study-level systematic reviews indicate a reduction in venous thromboembolism and provide moderate confidence that a small survival benefit exists. It remains unclear if any patient subgroups experience potential benefits.

Development and Assessment of a Distal Radial Fracture Model as a Clinical Teaching Tool.

Background: Simulation-based learning is increasingly prevalent in the curricula of many surgical training programs. Newly developed simulators must undergo rigorous validity testing before they are used to assess and evaluate surgical trainees. We describe the development of a model that simulates a distal radial fracture requiring closed reduction and cast application and demonstrate its validity.

Subsequent Malignant Neoplasms in a Population-Based Cohort of Pediatric Cancer Patients: A Focus on the First 5 Years.

Background: The purpose was to describe the development of subsequent malignant neoplasms (SMN) among a population-based cohort of pediatric cancer patients, with a focus on SMNs that occurred within the first 5 years from diagnosis.

Methods: The cohort was identified from POGONIS, an active provincial registry. Cohort members were Ontario residents ages 0 to 14.

Offspring of parents with chronic pain: a systematic review and meta-analysis of pain, health, psychological, and family outcomes.

Offspring of parents with chronic pain may be at risk for poorer outcomes than offspring of healthy parents. The objective of this research was to provide a comprehensive mixed-methods systematic synthesis of all available research on outcomes in offspring of parents with chronic pain. A systematic search was conducted for published articles in English examining pain, health, psychological, or family outcomes in offspring of parents with chronic pain.

A Qualitative Investigation of Return to Sport After Arthroscopic Bankart Repair: Beyond Stability.

Background: Arthroscopic shoulder stabilization is known to have excellent functional results, but many patients do not return to their preinjury level of sport, with return to play rates reported between 48% and 100% despite good outcome scores.

Purpose: To understand specific subjective psychosocial factors influencing a patient's decision to return to sport after arthroscopic shoulder stabilization.

Study Design: Case series; Level of evidence, 4.

The design of a multicentre Canadian surveillance study of sedation safety in the paediatric emergency department.

Introduction: Procedural sedation and analgesia have become standard practice in paediatric emergency departments worldwide. Although generally regarded as safe, serious adverse events such as bradycardia, asystole, pulmonary aspiration, permanent neurological injury and death have been reported, but their incidence is unknown due to the infrequency of their occurrence and lack of surveillance of sedation safety. To improve our understanding of the safety, comparative effectiveness and variation in care in paediatric procedural sedation, we are establishing a multicentre patient registry with the goal of conducting regular and ongoing surveillance for adverse events in procedural sedation.

Symptom Manifestation and Impairments in College Students With ADHD.

To better understand the nature of impairment resulting from attention-deficit/hyperactivity disorder (ADHD) for students in a post-secondary education (PSE) setting, the authors analyzed the symptoms and associated impairment of 135 students with a diagnosis of ADHD who were recruited via Student Disability Services in Canadian post-secondary institutions. The authors (a) developed a novel semistructured telephone interview based on the 6-item Adult ADHD Self-Report Scale Screener-Telephone Interview With Probes (ASRS-TIPS) to elicit students' descriptions of their behavior for each symptom they endorsed, (b) administered standardized tests of executive functioning (EF) and academic fluency, and (c) obtained self-reports of grade point averages (GPAs), EF, cognitive failures, psychopathology, distress, and resilience. Qualitative analysis of the ASRS-TIPS revealed significant impairment relating to symptoms of ADHD in the PSE setting.

Multiple influenza A (H3N2) mutations conferring resistance to neuraminidase inhibitors in a bone marrow transplant recipient.

Immunocompromised patients are predisposed to infections caused by influenza virus. Influenza virus may produce considerable morbidity, including protracted illness and prolonged viral shedding in these patients, thus prompting higher doses and prolonged courses of antiviral therapy. This approach may promote the emergence of resistant strains.

Ceftriaxone-induced immune hemolytic anemia.

Objectives: To describe a case of ceftriaxone-induced immune hemolytic anemia (CIIHA) in a 6 year-old boy with sickle cell disease (SCD) and perform a systematic literature review to delineate the clinical and laboratory features of this condition.

Data Sources: EMBASE (1947-January 2014), MEDLINE (1946-January 2014), and databases from the US Food and Drug Administration and Health Canada were searched, using anemia, hemolytic anemia, hemolysis, and ceftriaxone as search terms. Additional references were identified from a review of literature citations.

Quantifying comorbidity in individuals with COPD: a population study.

Chronic obstructive pulmonary disease (COPD) has been associated with many types of comorbidity. We aimed to quantify the real world impact of COPD on lower respiratory tract infection, cardiovascular disease, diabetes, psychiatric disease, musculoskeletal disease and cancer, and their impact on COPD through health services. A population study using health administrative data from Ontario, Canada, in 2008-2012 was conducted.

Procedural pain in neonatal units in Kenya.

Objectives: To determine the nature and frequency of painful procedures and procedural pain management practices in neonatal units in Kenya.

Design: Cross-sectional survey.

Setting: Level I and level II neonatal units in Kenya.

A.S.P.E.N. clinical guidelines: support of pediatric patients with intestinal failure at risk of parenteral nutrition-associated liver disease.

Background: Children with severe intestinal failure and prolonged dependence on parenteral nutrition are susceptible to the development of parenteral nutrition-associated liver disease (PNALD). The purpose of this clinical guideline is to develop recommendations for the care of children with PN-dependent intestinal failure that have the potential to prevent PNALD or improve its treatment.

Method: A systematic review of the best available evidence to answer a series of questions regarding clinical management of children with intestinal failure receiving parenteral or enteral nutrition was undertaken and evaluated using concepts adopted from the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) Working Group.

A randomized controlled trial of clinician-led tactile stimulation to reduce pain during vaccination in infants.

Background: Clinician-led tactile stimulation (rubbing the skin adjacent to the injection site or applying pressure) has been demonstrated to reduce pain in children and adults undergoing vaccination.

Objective: To evaluate the analgesic effectiveness of clinician-led tactile stimulation in infants undergoing vaccination.

Methods: This was a partially blinded randomized controlled trial that included infants undergoing vaccination in a private clinic in Toronto.

Parent behaviors moderate the relationship between neonatal pain and internalizing behaviors at 18 months corrected age in children born very prematurely.

Children born very preterm (≤ 32 weeks gestation) exhibit greater internalizing (anxious/depressed) behaviors compared to term-born peers as early as 2 years corrected age (CA); however, the role of early stress in the etiology of internalizing problems in preterm children remains unknown. Therefore, we examined the relationship between neonatal pain and internalizing behavior at 18 months CA in children born very preterm and examined whether parent behavior and stress moderated this relationship. Participants were 145 children (96 very preterm, 49 full term) assessed at 18 months CA.

Variability in infant acute pain responding meaningfully obscured by averaging pain responses.

Given the inherent variability in pain responding, using an "average" pain score may pose serious threats to internal and external validity. Using growth mixture modeling (GMM), this article first examines whether infants can be differentiated into stable groups based on their pain response patterns over a 2-minute post-needle period. Secondary analyses, to specifically address the issue of averaging pain scores to represent a sample, qualitatively described clinically meaningful differences between pain scores of the discerned groups and the overall mean (irrespective of groups).

Construct validity of a multidimensional electronic pain diary for adolescents with arthritis.

The aim of this study was to evaluate the construct validity and feasibility of a multidimensional electronic pain diary (e-Ouch(c)) in adolescents with juvenile idiopathic arthritis (JIA). Two descriptive studies with repeated measures were conducted between January and December 2005. Participants were drawn from a large metropolitan rheumatology clinic in a university affiliated pediatric tertiary care centre.