Examining how study teams manage different viewpoints and priorities in patient-centered outcomes research: Results of an embedded multiple case study.

Introduction: Limited evidence exists about which patient and stakeholder engagement practices support or hinder study teams as they negotiate different viewpoints in decisions about the design and conduct of patient-centered outcomes research.

Methods: We applied a multiple-embedded descriptive case study design for six studies funded by the Patient-Centered Outcomes Research Institute (PCORI). We interviewed 32 researchers and stakeholder partners, including patients, caregivers and clinicians, and reviewed documents related to each study (e.

Patients' preferences in therapeutic decision-making in digestive oncology: a single centre cross-sectional observational study.

Considering the preferences in Shared Decision Making (SDM) of patients with Digestive Cancer (DC) is crucial to ensure the quality of care. To date, there is limited information on preferences in SDM of patients with DC. The objectives of this study were to describe digestive cancer patients' preference for involvement in therapeutic decision-making and to identify variables associated with these preferences.

Association of urine and plasma ADMA with atherosclerotic risk in DKD cardiovascular disease risk in diabetic kidney disease: findings from the Chronic Renal Insufficiency Cohort (CRIC) study.

Background: Chronic kidney disease (CKD) is associated with atherosclerotic cardiovascular disease (ASCVD) risk, especially among those with diabetes. Altered metabolism of solutes that accumulate in CKD [asymmetric dimethylarginine (ADMA), symmetric dimethylarginine (SDMA) and trimethylamine N-oxide (TMAO)] may reflect pathways linking CKD with ASCVD.

Methods: This case-cohort study included Chronic Renal Insufficiency Cohort participants with baseline diabetes, estimated glomerular filtration rate <60 mL/min/1.

Patient-reported outcomes for people with diabetes: what and how to measure? A narrative review.

Patient-reported outcomes (PROs) are valuable for shared decision making and research. Patient-reported outcome measures (PROMs) are questionnaires used to measure PROs, such as health-related quality of life (HRQL). Although core outcome sets for trials and clinical practice have been developed separately, they, as well as other initiatives, recommend different PROs and PROMs.

Nitrous oxide: a unique official French addictovigilance national survey.

Introduction: Nitrous oxide has become over the last few years a public health problem in many countries. France has a dedicated health monitoring system dedicated to the surveillance of the abuse, dependence and consequences associated with the use of psychoactive substances coordinated by the French National Agency for the Safety of Medicines and Health Products.We present the French national survey of nitrous oxide.

Use of the European Organisation for Research and Treatment of Cancer multiple myeloma module (EORTC QLQ-MY20): a review of the literature 25 years after development.

The European Organisation for Research and Treatment of Cancer Quality of Life Multiple Myeloma Questionnaire (EORTC QLQ-MY20) was developed in 1996 to assess health-related quality of life (HRQoL) in patients with multiple myeloma. Since its development new therapies have prolonged survival in patients with myeloma and new combination agents are likely to impact HRQoL outcomes and its measurement.The aim of this review was to explore the use of the QLQ-MY20 and reported methodological issues.

Return of aggregate results to study participants: Facilitators, barriers, and recommendations.

Background: Most researchers and study participants believe that the summary, or aggregate, results of health research should be returned to study participants. However, researchers often do not return aggregate results. A better understanding of the impediments to results return could support improvements in this practice.

Healthcare resource utilization of maribavir versus investigator-assigned therapy in transplant recipients with cytomegalovirus infection refractory (with or without genotypic resistance) to prior treatment: Exploratory analysis of the Phase 3 SOLSTICE trial.

Background: Cytomegalovirus (CMV), a common post-transplant infection, is associated with increased healthcare resource utilization. In the Phase 3 SOLSTICE trial, maribavir was superior to investigator-assigned therapy (IAT; valganciclovir/ganciclovir, foscarnet, and cidofovir) for CMV viremia clearance at Week 8 in transplant recipients with confirmed refractory CMV infection with/without resistance. This exploratory analysis evaluated hospital admissions of patients during the SOLSTICE trial.

Priority acute and preventive migraine treatment benefits: Results of the Migraine Clinical Outcome Assessment System (MiCOAS) qualitative study of people living with migraine.

Background: There is renewed emphasis on including patients in determining, defining, and prioritizing outcomes for migraine treatment.

Objectives: To obtain insights directly from people living with migraine on their priorities for treatment.

Methods: A total of 40 qualitative interviews were conducted as part of the Migraine Clinical Outcome Assessment System project, a United States Food and Drug Administration grant-funded program to develop a core set of patient-centered outcome measures for migraine clinical trials.

Physical performance tasks were linked to the PROMIS physical function metric in patients undergoing hemodialysis.

Objectives: To investigate whether a multi-item performance outcome measure, the physical performance test (PPT), can be calibrated to a common scale with patient-reported outcome measures, using the Patient-Reported Outcomes Measurement Information System (PROMIS) physical function (PF) metric.

Study Design And Setting: We analyzed baseline data (N = 1,113) from the CONVINCE study, an international trial in end-stage kidney disease patients comparing high-dose hemodiafiltration with high-flux hemodialysis. Assumptions of item response theory (IRT) modelling were investigated for the combined set of the nine-item PPT and a four-item PROMIS PF short form (PROMIS-PF4a).

Frequency of and Factors Associated with the Presence of a History of Probable Attention-Deficit Hyperactivity Disorder in a Population of Patients with Sex Addiction.

Introduction: Since the first description of sex addiction (SA) by Carnes, research on this problematic behaviour has continued to grow, and the association with attention-deficit hyperactivity disorder (ADHD) appears to be frequent. This study aimed to estimate the frequency of a history of probable ADHD in a population of patients with SA and to explore the factors associated with it.

Methods: One hundred 85 patients referred to the Nantes University Hospital for SA between 2011 and 2020 were included.

Qualitative concept elicitation and cognitive debriefing interviews of symptoms, impacts and selected customized PROMIS Short Forms: a study in patients with axial spondyloarthritis.

Background: Sleep disturbance, pain, and fatigue are key symptoms/impacts of axial spondyloarthritis (axSpA). Three customized Patient-Reported Outcomes Measurement Information System (PROMIS) Short Forms (Sleep Disturbance, Pain Interference, and Fatigue) have been proposed for use in axSpA to assess these key disease concepts. This study was designed to further understand the patient experience of axSpA and evaluate the content validity of the three customized PROMIS Short Forms to support their use in axSpA clinical trials.

Suitability of the animated activity questionnaire for use as computer adaptive test: establishing the AAQ-CAT.

Purpose: The animated activity questionnaire (AAQ) is a computer-based measure of activity limitations. To answer a question, patients choose the animation of a person performing an activity that matches their own level of limitation. The AAQ has not yet been tested for suitability to be applied as computer-adaptive test (CAT).

Breast Cancer Survivors' Experiences of Managers' Actions During the Return to Work Process: A Scoping Review of Qualitative Studies.

Purpose: Managers' actions can facilitate the return to work (RTW) process for breast cancer survivors (BCS). However, data on BCS' experiences of managers' actions regarding RTW are dispersed across multiple qualitative studies and do not offer useful insights for managers to support employees returning to work. This study aimed to summarize and map managers' actions experienced by BCS over three RTW phases (before, during, after) and categorize them as facilitating or hindering RTW.

Content Validation of Patient-Reported Sleep Measures and Development of a Conceptual Model of Sleep Disturbance in Patients with Moderate-to-Severe, Uncontrolled Asthma.

Purpose: Sleep disturbance is common in patients with asthma and can lead to subsequent impacts on health-related quality of life (HRQOL). Fit-for-purpose patient-reported outcome measures (PROMs) assessing asthma-related sleep disturbance and next-day HRQOL impact (next-day impact) are needed to evaluate disease burden and treatment effects.

Patients And Methods: Adults (18-65 years) from three US clinics were recruited for semistructured interviews.

Development and testing of an alternative responder definition for EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI).

Objectives: Dryness, fatigue and joint/muscle pain are typically assessed in Sjögren's trials using European Alliance of Associations for Rheumatology Sjögren's Syndrome Patient Reported Index (ESSPRI). A Patient Acceptable Symptom State of <5 and a Minimal Clinically Important Improvement (MCII)/responder definition (RD) of ≥1 point or 15% on ESSPRI have previously been defined. This study explored alternative RDs to better discriminate between active treatment and placebo in trials.

Patient-reported experiences with migraine-related cognitive symptoms: Results of the MiCOAS qualitative study.

Objectives: To capture patients' perspectives on migraine-related cognitive symptoms during pre-headache, headache, post-headache, and interictal periods.

Background: Migraine-related cognitive symptoms are reported by people with migraine both during and between attacks. Associated with disability, they are increasingly viewed as a priority target for treatment.

Feasibility of a virtual reality intervention targeting distress and anxiety symptoms in patients with primary brain tumors: Interim analysis of a phase 2 clinical trial.

Purpose: Cancer patients experience distress and anxiety when undergoing imaging studies to monitor disease status, yet these symptoms are not always appropriately identified or well-managed. This interim analysis of a phase 2 clinical trial explored feasibility and acceptability of a virtual reality relaxation (VR) intervention for primary brain tumor (PBT) patients at the time of clinical evaluation.

Methods: English speaking, adult PBT patients with previous reports of distress and upcoming neuroimaging were recruited between March of 2021 and March 2022.

Liberation from Mechanical Ventilation and Tracheostomy Practice in Traumatic Brain Injury.

Liberating patients with severe traumatic brain injury (TBI) from mechanical ventilation is often a challenging task. These patients frequently require prolonged ventilation and have persistent alterations in the level and content of consciousness. Questions about their ability to protect their airway are common.

Different prognostic role of EGFR mutation according to the IASLC histological grade in patients with resected early-stage lung adenocarcinoma.

Aims: The prognostic role of EGFR mutations remains controversial. We aimed to evaluate the prognostic role of EGFR mutation in consideration of the IASLC histological grade in patients with resected early-stage lung adenocarcinoma.

Methods And Results: A total of 3297 patients with stages I-IIA resected lung adenocarcinoma who had had EGFR mutation tests between January 2014 and December 2019 at the Samsung Medical Center, Seoul, Korea were included.

Multicenter randomized trial comparing diagnostic sensitivity and cellular abundance with aggressive versus standard biliary brushing for bile duct stenosis without mass syndrome.

BACKGROUND : The diagnosis of cholangiocarcinoma in patients with a biliary stricture without mass syndrome can be obtained by biliary brushing with a sensitivity of ~50 %. We performed a multicenter randomized crossover trial comparing the aggressive Infinity brush with the standard RX Cytology Brush. The aims were to compare sensitivity for cholangiocarcinoma diagnosis and cellularity obtained.

Physical Activity Patterns According to the Type of Physical Education Classes by Sex and Obesity among Korean Adolescents.

This study aimed to compare physical activity patterns according to the type of physical education by sex and body mass index categories among Korean adolescents. We analyzed physical activity using an accelerator in a physical education class among Korean middle school students (1305 boys and 1328 girls). An independent -test and regression analysis were conducted to compare differences between the obesity groups by sex.