scholarly journals Standardised Outcomes in Nephrology – Chronic Kidney Disease (SONG-CKD): a protocol for establishing a core outcome set for adults with chronic kidney disease who do not require kidney replacement therapy

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Nicole Evangelidis ◽  
Benedicte Sautenet ◽  
Magdalena Madero ◽  
Allison Tong ◽  
Gloria Ashuntantang ◽  
...  
Keyword(s):  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Replacement Therapy ◽  
Health Professionals ◽  
Core Outcome Set ◽  
Core Outcome ◽  
Outcome Set ◽  
Kidney Replacement Therapy ◽  
Randomised Controlled ◽  
Stakeholder Consensus

Abstract 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.

scholarly journals A protocol for developing a core outcome set for ectopic pregnancy

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Krystle Y. Chong ◽  
Sarah Solangon ◽  
James Kemper ◽  
Kurt Barnhart ◽  
Pamela Causa Andrieu ◽  
...  
Keyword(s):  
Ectopic Pregnancy ◽  
Randomised Controlled Trials ◽  
Core Outcome Set ◽  
Future Research ◽  
Controlled Trials ◽  
Core Outcome ◽  
Key Stakeholders ◽  
Outcome Set ◽  
Core Outcomes ◽  
Randomised Controlled

Abstract Background Randomised controlled trials (RCTs) evaluating ectopic pregnancy have reported many different outcomes, which are themselves often defined and measured in distinct ways. This level of variation results in an inability to compare results of individual RCTs. The development of a core outcome set to ensure outcomes important to key stakeholders are collected consistently will guide future research in ectopic pregnancy. Study aim To develop and implement a core outcome set to guide future research in ectopic pregnancy. Methods and analysis We have established an international steering group of key stakeholders, including healthcare professionals, researchers, and individuals with lived experience of ectopic pregnancy. We will identify potential outcomes from ectopic pregnancy from a comprehensive literature review of published randomised controlled trials. We will then utilise a modified Delphi method to prioritise outcomes. Subsequently, key stakeholders will be invited to score potential core outcomes on a nine-point Likert scale, ranging from 1 (not important) to 9 (critical). Repeated reflection and rescoring should promote whole and individual stakeholder group convergence towards consensus ‘core’ outcomes. We will also establish standardised definitions and recommend high-quality measurements for individual core outcomes. Trial registration COMET 1492. Registered in November 2019.

scholarly journals Core outcome set measurement for future clinical trials in acute myeloid leukemia: the HARMONY study protocol using a multi-stakeholder consensus-based Delphi process and a final consensus meeting

2020 ◽  
Author(s):  
Katharina M Lang ◽  
Kathryn L. Harrison ◽  
Paula R. Williamson ◽  
Brian J.P. Huntly ◽  
Gert Ossenkoppele ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Acute Myeloid Leukemia ◽  
Myeloid Leukemia ◽  
Core Outcome Set ◽  
Core Outcome ◽  
Face To Face ◽  
Outcome Set ◽  
Multi Stakeholder ◽  
Stakeholder Consensus ◽  
Acute Myeloid

Abstract Background Acute myeloid leukemia is the most common acute leukemia in adults with an unacceptably low cure rate. In recent years a number of new treatment strategies and compounds were developed for the treatment of acute myeloid leukemia. There were several randomized, controlled clinical trials with the objective to improve patients’ management and patients’ outcome in acute myeloid leukemia. Unfortunately, these trials are not always directly comparable, as they do not measure the same outcomes and currently there are no core outcome sets that can be utilized to guide outcome selection and harmonization in this disease area. The HARMONY Alliance is a public-private European Network established in 2017, which currently includes 53 partners and 32 associated members from 22 countries. Amongst many other goals of the HARMONY Alliance, Work Package 2 focuses on defining outcomes that are relevant to each hematological malignancy. In accordance, a pilot study will be performed to define core outcome set in acute myeloid leukemia. Methods The pilot study will use a three-round Delphi survey and a final consensus meeting to define a core outcome set. Participants will be recruited from different stakeholder groups, including patients, clinicians, regulators and members of the European Federation of Pharmaceutical Industries and Associations (EFPIA). At the pre-Delphi stage a literature research was conducted followed by several semi-structured interviews of clinical public and private key opinion leaders. Subsequently the preliminary outcome list was discussed in several multi-stakeholder face-to-face meetings. The Delphi survey will reduce the preliminary outcome list to essential core outcomes. After completing the last Delphi round a final face-to-face meeting is planned to achieve consensus about core outcome set in acute myeloid leukemia. Discussion The pilot Delphi as part of HARMONY Alliance aims to define a core outcome set in acute myeloid leukemia based on a multi-stakeholder consensus. Such a core outcome set will help to allow consistent comparison of future clinical trials and real world evidence research and ensures that appropriate outcomes valued by a range of stakeholders are measured within future trials.

scholarly journals The Difference of Potassium Level in Stage 5 Kidney Chronic Disease Patients Whose Using New and Re-use Hemodialyzer in RSD dr. Soebandi Jember

2019 ◽  
Vol 5 (3) ◽  
pp. 148
Author(s):  
Yuli Hermansyah ◽  
Dinda Ayu Wanodya Supriatiningsih ◽  
Bagus Hermansyah
Keyword(s):  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Replacement Therapy ◽  
Potassium Level ◽  
Good Condition ◽  
Total Sample ◽  
Kidney Replacement Therapy ◽  
Quasi Experimental ◽  
The Difference ◽  
The Cost

Stage 5 chronic kidney disease (CKD) is a condition where the renal function decrease, marked by the GFR value < 15/ml/minute/1,73 m2 with or without kidney damage history for 3 months or more that needs kidney replacement therapy, including hemodialysis. In Indonesia, hemodialysis was chosen for 82% from all the cases that needs kidney replacement therapy. However, the cost for hemodialysis therapy is considered as too expensive and burdens The National Health Insurance, Badan Penyelenggara Jaminan Sosial (BPJS), allowing the reuse of hemodialyzer as an alternative for cost-effectiveness. Re-use hemodialyzer is a term for using the same hemodialyzer for the same patient but on different therapy session. The main purpose of this research is to investigate the difference of Potassium level in stage 5 chronic kidney disease patients whose using new and re-use hemodialyzer in RSD dr. Soebandi Jember. This research used quasi experimental design by using blood sample that will be measured for the potassium level after using new hemodialyzer and re-use hemodialyzer for the 4th time in Hemodialysis Installation of RSD dr. Soebandi Jember on December 2018. Total sample of 19 patients chosen using inclusion and exclusion criteria. Collected data were analyzed using paired t-test. The result of statistical test shows that there is no significance potassium level difference in stage 5 chronic kidney disease whose using new and re-use hemodialyzer for the 4th time (p=0,094). The effectivity of hemodialyzer that still has a good condition and hemodialysis therapy that has been done in accordance with the procedure until the 4th reuse is the main factor of this result.   Keywords: CKD, potassium, re-use hemodialyzer

scholarly journals The importance of stakeholder selection in core outcome set development: how surveying different health professionals may influence outcome selection

Trials ◽  
2015 ◽  
Vol 16 (S2) ◽  
Author(s):  
Kerry Avery ◽  
Katy Chalmers ◽  
Katie Whale ◽  
Natalie Blencowe ◽  
Rhiannon Macefield ◽  
...  
Keyword(s):  
Health Professionals ◽  
Core Outcome Set ◽  
Core Outcome ◽  
Outcome Set ◽  
Outcome Selection

scholarly journals Systematic review of clinical outcome reporting in randomised controlled trials of burn care

BMJ Open ◽  
2019 ◽  
Vol 9 (2) ◽  
pp. e025135 ◽  
Author(s):  
Amber E Young ◽  
Anna Davies ◽  
Sophie Bland ◽  
Sara Brookes ◽  
Jane M Blazeby
Keyword(s):  
Randomised Controlled Trials ◽  
Core Outcome Set ◽  
Controlled Trials ◽  
Free Text ◽  
Core Outcome ◽  
Care Research ◽  
Burn Care ◽  
Outcome Reporting ◽  
Outcome Set ◽  
Randomised Controlled

IntroductionSystematic reviews collate trial data to provide evidence to support clinical decision-making. For effective synthesis, there must be consistency in outcome reporting. There is no agreed set of outcomes for reporting the effect of burn care interventions. Issues with outcome reporting have been identified, although not systematically investigated. This study gathers empirical evidence on any variation in outcome reporting and assesses the need for a core outcome set for burn care research.MethodsElectronic searches of four search engines were undertaken from January 2012 to December 2016 for randomised controlled trials (RCTs), using medical subject headings and free text terms including ‘burn’, ‘scald’ ‘thermal injury’ and ‘RCT’. Two authors independently screened papers, extracted outcomes verbatim and recorded the timing of outcome measurement. Duplicate outcomes (exact wording ± different spelling), similar outcomes (albumin in blood, serum albumin) and identical outcomes measured at different times were removed. Variation in outcome reporting was determined by assessing the number of unique outcomes reported across all included trials. Outcomes were classified into domains. Bias was reduced using five researchers and a patient working independently and together.Results147 trials were included, of which 127 (86.4%) were RCTs, 13 (8.8%) pilot studies and 7 (4.8%) RCT protocols. 1494 verbatim clinical outcomes were reported; 955 were unique. 76.8% of outcomes were measured within 6 months of injury. Commonly reported outcomes were defined differently. Numbers of unique outcomes per trial varied from one to 37 (median 9; IQR 5,13). No single outcome was reported across all studies demonstrating inconsistency of reporting. Outcomes were classified into 54 domains. Numbers of outcomes per domain ranged from 1 to 166 (median 11; IQR 3,24).ConclusionsThis review has demonstrated heterogeneity in outcome reporting in burn care research which will hinder amalgamation of study data. We recommend the development of a Core Outcome Set.PROSPERO registration numberCRD42017060908.

scholarly journals Outcomes reported on the management of COPD exacerbations: a systematic survey of randomised controlled trials

2019 ◽  
Vol 5 (2) ◽  
pp. 00072-2019 ◽  
Author(s):  
Alexander G. Mathioudakis ◽  
Mia Moberg ◽  
Julie Janner ◽  
Pablo Alonso-Coello ◽  
Jørgen Vestbo
Keyword(s):  
Outcome Measures ◽  
Systematic Reviews ◽  
Randomised Controlled Trials ◽  
Core Outcome Set ◽  
Controlled Trials ◽  
Significant Heterogeneity ◽  
Core Outcome ◽  
Copd Exacerbations ◽  
Outcome Set ◽  
Randomised Controlled

Randomised controlled trials (RCTs) evaluating the management of acute exacerbations of chronic obstructive pulmonary disease (COPD) report heterogeneous outcome measures, thus rendering their results incomparable, complicating their translation into clinical practice. As a first step in the development of a core outcome set that will aim to homogenise outcome measures in future RCTs, we assessed the outcomes reported in recent relevant RCTs and systematic reviews.We conducted a methodological systematic review (https://www.crd.york.ac.uk/prospero/ registration number CRD42016052437) of RCTs and systematic reviews on COPD exacerbation management indexed on Medline and PubMed during the last decade. We evaluated their methodology, specifically focusing on the reported outcome measures.Based on 123 RCTs and 38 systematic reviews, we found significant variability in the outcomes reported and in their definition. Mortality, which was assessed in 82% of the included trials, was the most frequently assessed outcome, followed by the rate of treatment success or failure (63%), adverse events (59%), health status, symptoms and quality of life (59%), lung function (47%), and duration of exacerbations (42%).The significant heterogeneity in the selection and definition of outcome measures in RCTs and systematic reviews limits the interpretability and comparability of their results, and warrants the development of a core outcome set for COPD exacerbations management.

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