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Supplemental Material, sj-docx-1-ptd-10.1177_08968608221087794 for Survival study and factors associated with mortality in Chilean patients on peritoneal dialysis infected with SARS-CoV-2 by Ana M Ortiz, Rodrigo A Sepúlveda, Rubén Torres, René Clavero, Luis Toro, Miguel Albornoz, Tatiana Aldunate, Ingrid Arce, Juan Arévalo, Andrés Arriagada, Julieta Becker, Sonia C González, Waldo Bernales, Eduardo Briones, Álvaro Castillo, Agustín Fuentes, Esteban Gómez, Hernán Jaramillo, Mario Lillo, Eduardo Lorca, Eduardo Machuca, Rodrigo Mansilla, Serwin Menéndez, Carlos Moya, Carolina Muñoz, William Neilson, Rodrigo Orozco, María Padrino, Edgard Pais, Gonzalo Ramírez, María E Sanhueza, Herman Schneider, Ruth Solís, Jaime Troncoso, Marcela Ursu and Marcela Valenzuela in Peritoneal Dialysis International

OBJECTIVES: Respiratory failure, multiple organ failure, shortness of breath, recovery, and mortality have been identified as critically important core outcomes by more than 9300 patients, health professionals, and the public from 111 countries in the global coronavirus disease 2019 core outcome set initiative. The aim of this project was to establish the core outcome measures for these domains for trials in coronavirus disease 2019. DESIGN: Three online consensus workshops were convened to establish outcome measures for the four core domains of respiratory failure, multiple organ failure, shortness of breath, and recovery. SETTING: International. PATIENTS: About 130 participants (patients, public, and health professionals) from 17 countries attended the three workshops. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Respiratory failure, assessed by the need for respiratory support based on the World Health Organization Clinical Progression Scale, was considered pragmatic, objective, and with broad applicability to various clinical scenarios. The Sequential Organ Failure Assessment was recommended for multiple organ failure, because it was routinely used in trials and clinical care, well validated, and feasible. The Modified Medical Research Council measure for shortness of breath, with minor adaptations (recall period of 24 hr to capture daily fluctuations and inclusion of activities to ensure relevance and to capture the extreme severity of shortness of breath in people with coronavirus disease 2019), was regarded as fit for purpose for this indication. The recovery measure was developed de novo and defined as the absence of symptoms, resumption of usual daily activities, and return to the previous state of health prior to the illness, using a 5-point Likert scale, and was endorsed. CONCLUSIONS: The coronavirus disease 2019 core outcome set recommended core outcome measures have content validity and are considered the most feasible and acceptable among existing measures. Implementation of the core outcome measures in trials in coronavirus disease 2019 will ensure consistency and relevance of the evidence to inform decision-making and care of patients with coronavirus disease 2019.

Background: protein restriction is the mainstay of dietary management of chronic kidney disease. Aim: to assess the usefulness of urine urea nitrogen measurement as a marker of protein restriction. Methods: healthy young participants were randomly divided in two groups. During 14 days, one group received a diet containing 30 kcal/kg body weight and 1 g protein/kg body weight and the other group received a diet with the same amount of calories and 0.6 g/kg of proteins. At baseline, seven days and 14 days, 24 h dietary recalls were answered by the participants. They collected 24 hour urine and provided spot urine samples at baseline and at the end of the intervention, to measure creatinine and urea nitrogen. Results: forty-one participants aged 29 ± 5 years completed the follow-up. According to 24h dietary recalls, the group receiving 0.6 g/kg protein reduced significantly the protein intake during the intervention from 0.88 ± 0.06 to 0.59 ± 0.05 g/kg/day. A significant reduction in 24 h urea nitrogen excretion was also observed in this group. In the group receiving 1 g/kg of protein, no significant changes in 24 h urea nitrogen excretion were observed. Among all participants, the odds ratio of observing a reduction in protein intake in the dietary survey was 5.75 (95% confidence intervals 1.29-25.55, p = 0.02), when a reduction in 24 h urea nitrogen excretion corrected by creatinine was observed. No changes were observed in urea nitrogen excretion in spot urine samples. Conclusions: repeated urea nitrogen excretion measured in 24 h urine samples can be a reliable indicator of dietary protein restriction. Resumen Introducción: la restricción proteica es fundamental en el manejo de la enfermedad renal crónica. Objetivo: valuamos la utilidad de la medición de nitrógeno ureico urinario como marcador de restricción proteica. Métodos: participantes jóvenes sanos fueron divididos aleatoriamente en dos grupos. Un grupo recibió una dieta con 30 kcal/día/kg peso corporal y 1 g/proteína/día/kg peso corporal y el otro recibió una dieta con la misma cantidad de calorías pero con 0,6 g/kg peso corporal de proteína. Al inicio, a los siete y a los 14 días, los participantes respondieron una encuesta dietaria de recordatorio de 24 horas. Además, recolectaron orina de 24 horas y se les tomó una muestra aislada de orina al comienzo y a los 14 días de la intervención para medir creatinina y nitrógeno ureico. Resultados: cuarenta y un participantes de 29 ± 5 años completaron el estudio. El grupo que consumió 0,6 g/kg de proteínas redujo su ingesta proteica de 0,88 ± 0,06 a 0,59 ± 0,05 g/kg/día durante la intervención. En este grupo se observó una reducción significativa en la excreción urinaria de nitrógeno ureico en 24 horas. No se observó tal reducción en el grupo que consumió 1 g/kg de proteínas. La tasa de probabilidad de detectar una reducción en la ingesta proteica en las encuestas dietarias, cuando se observaba una disminución en la excreción urinaria de nitrógeno ureico/mg creatinina de 24 horas, fue de 5,75 (intervalos de confianza de 95% = 1,29-25,55, p = 0,02). No hubo cambios significativos en la excreción de nitrógeno ureico en las muestras aisladas de orina. Conclusión: las mediciones repetidas de nitrógeno ureico urinario en 24 horas son un marcador de restricción dietaria de proteínas.

Background: Type 2 Diabetes Mellitus is not always treated successfully, in part due to the difficulties perceived by the medical community about the use of insulin. Aim: To identify the constraints perceived by primary care physicians (PCPs) in the prescription and use of insulin. Material and Methods: Six PCPs were subjected to a semi-structured interview about self-perceived management difficulties, behaviors and beliefs on the use of insulin among diabetics. According to their responses a questionnaire about the subject was devised and PCPs were invited by e-mail to answer it. Results: There were 88 replies and 48% of respondents recognized to have management deficiencies in at least one aspect of insulin prescription. The most common deficiencies were determining the type of insulin and treatment of complications. The perceived difficulties were lack of training (58.0%), lack of medical hours (46.6%), lack of communication with specialists (46.6%), lack of reactive strips for capillary blood glucose determination (43.2%) and rotation of doctors (40.9%). The most common behaviors towards patients reluctant to use insulin were persuasion (83.0%), education and supervisión (63.6%) and signature ofan ad-hoc document (38.6%). Ninety percent considered that timely use of insulin is more beneficial than its prescription as a last resort and 94.3% did not consider that insulin should be prescribed by a specialist. Conclusions: A significant percentage of physicians do not trust their own knowledge about insulin prescription. These professionals should receive training in not only technical aspects of prescribing insulin, but also in the psychological and persuasión strategies. There is willingness among PCPs to prescribe insulin.

Background Globally, over 1.2 million people die from chronic kidney disease (CKD) every year. Patients with CKD are up to 10 times more likely to die prematurely than progress to kidney failure requiring kidney replacement therapy. The burden of symptoms and impaired quality of life in CKD may be compounded by comorbidities and treatment side effects. However, patient-important outcomes remain inconsistently and infrequently reported in trials in patients with CKD, which can limit evidence-informed decision-making. The Standardised Outcomes in Nephrology – Chronic Kidney Disease (SONG-CKD) aims to establish a consensus-based core outcome set for trials in patients with CKD not yet requiring kidney replacement therapy to ensure outcomes of relevance to patients, caregivers and health professionals are consistently reported in trials. Methods SONG-CKD involves four phases: a systematic review to identify outcomes (domains and measures) that have been reported in randomised controlled trials involving adults with CKD who do not require kidney replacement therapy; stakeholder key informant interviews with health professionals involved in the care of adults with CKD to ascertain their views on establishing core outcomes in CKD; an international two-round online Delphi survey with patients, caregivers, clinicians, researchers, policy makers and industry representatives to obtain consensus on critically important outcome domains; and stakeholder consensus workshops to review and finalise the set of core outcome domains for trials in CKD. Discussion Establishing a core outcome set to be reported in trials in patients with CKD will enhance the relevance, transparency and impact of research to improve the lives of people with CKD. Trial registration Not applicable. This study is registered with the Core Outcome Measures in Effectiveness Trials (COMET) database: http://www.comet-initiative.org/Studies/Details/1653 .

Objective: The outcomes reported in trials in COVID-19 are extremely heterogeneous and of uncertain patient relevance, limiting their applicability for clinical decision-making. The aim of this workshop was to establish a core outcomes set for trials in people with suspected or confirmed COVID-19. Design: Four international online multi-stakeholder consensus workshops were convened to discuss proposed core outcomes for trials in people with suspected or confirmed COVID-19, informed by a survey involving 9289 respondents from 111 countries. The transcripts were analyzed thematically. The workshop recommendations were used to finalize the core outcomes set Setting: International Participants: Adults aged 18 years and over with confirmed or suspected COVID-19, their family members, members of the general public and health professionals (including clinicians, policy makers, regulators, funders, researchers). Main Results: Six themes were identified. Responding to the critical and acute health crisis reflected the immediate focus on saving lives and preventing life-threatening complications that underpinned the high prioritization of mortality, respiratory failure, and multiorgan failure. Capturing different settings of care highlighted the need to minimize the burden on hospitals and to acknowledge outcomes in community settings. Encompassing the full trajectory and severity of disease was addressing longer-term impacts and the full spectrum of illness (e.g. shortness of breath and recovery). Distinguishing overlap, correlation and collinearity meant recognizing that symptoms such as shortness of breath had distinct value, and minimizing overlap (e.g. lung function and pneumonia were on the continuum toward respiratory failure). Recognizing adverse events refers to the potential harms of new and evolving interventions. Being cognizant of family and psychosocial wellbeing reflected the pervasive impacts of COVID-19. Conclusions: Mortality, respiratory failure, multiorgan failure, shortness of breath, and recovery are critically important outcomes to be consistently reported in COVID-19 trials., The project is funded by the Flinders University and the National COVID-19 Clinical Evidence Taskforce, convened by the Australian Living Evidence Consortium, hosted by Cochrane Australia, School of Public Health and Preventive Medicine, Monash University supported by the Australian Government, Victorian Department of Health and Human Services, Ian Potter Foundation, Walter Cottman Endowment Fund (managed by Equity Trustees) and the Lord Mayor's Charitable Foundation). AT is supported by The University of Sydney Robinson Fellowship. ACM is supported by a Clinical Research Career Development Fellowship from the Wellcome Trust (WT 2055214/Z/16/Z)