Browsing by Author "Teixeira-Pinto, Armando"

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    Standardised Outcomes in Nephrology—Polycystic Kidney Disease (SONG-PKD): study protocol for establishing a core outcome set in polycystic kidney disease
    (2017-11-23) Cho, Yeoungjee; Sautenet, Benedicte; Rangan, Gopala; Craig, Jonathan C; Ong, Albert C M; Chapman, Arlene; Ahn, Curie; Chen, Dongping; Coolican, Helen; Kao, Juliana T; Gansevoort, Ron; Perrone, Ronald; Harris, Tess; Torres, Vicente; Pei, York; Kerr, Peter G; Ryan, Jessica; Gutman, Talia; Howell, Martin; Ju, Angela; Manera, Karine E; Teixeira-Pinto, Armando; Hamiwka, Lorraine A; Tong, Allison
    Abstract Background Autosomal dominant polycystic kidney disease (ADPKD) is the most common potentially life threatening inherited kidney disease and is responsible for 5–10% of cases of end-stage kidney disease (ESKD). Cystic kidneys may enlarge up to 20 times the weight of a normal kidney due to the growth of renal cysts, and patients with ADPKD have an increased risk of morbidity, premature mortality, and other life-time complications including renal and hepatic cyst and urinary tract infection, intracranial aneurysm, diverticulosis, and kidney pain which impair quality of life. Despite some therapeutic advances and the growing number of clinical trials in ADPKD, the outcomes that are relevant to patients and clinicians, such as symptoms and quality of life, are infrequently and inconsistently reported. This potentially limits the contribution of trials to inform evidence-based decision-making. The Standardised Outcomes in Nephrology—Polycystic Kidney Disease (SONG-PKD) project aims to establish a consensus-based set of core outcomes for trials in PKD (with an initial focus on ADPKD but inclusive of all stages) that patients and health professionals identify as critically important. Methods The five phases of SONG-PKD are: a systematic review to identify outcomes that have been reported in existing PKD trials; focus groups with nominal group technique with patients and caregivers to identify, rank, and describe reasons for their choices; qualitative stakeholder interviews with health professionals to elicit individual values and perspectives on outcomes for trials involving patients with PKD; an international three-round Delphi survey with all stakeholder groups (including patients, caregivers, healthcare providers, policy makers, researchers, and industry) to gain consensus on critically important core outcome domains; and a consensus workshop to review and establish a set of core outcome domains and measures for trials in PKD. Discussion The SONG-PKD core outcome set is aimed at improving the consistency and completeness of outcome reporting across ADPKD trials, leading to improvements in the reliability and relevance of trial-based evidence to inform decisions about treatment and ultimately improve the care and outcomes for people with ADPKD.
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    Study protocol for Vascular Access outcome measure for function: a vaLidation study In hemoDialysis (VALID)
    (2022-11-19) Viecelli, Andrea K.; Teixeira-Pinto, Armando; Valks, Andrea; Baer, Richard; Cherian, Roy; Cippà, Pietro E.; Craig, Jonathan C.; DeSilva, Ranil; Jaure, Allison; Johnson, David W.; Kiriwandeniya, Charani; Kopperschmidt, Pascal; Liu, Wen-J; Lee, Timmy; Lok, Charmaine; Madhan, Krishan; Mallard, Alistair R.; Oliver, Veronica; Polkinghorne, Kevan R.; Quinn, Rob R.; Reidlinger, Donna; Roberts, Matthew; Sautenet, Bénédicte; Hooi, Lai S.; Smith, Rob; Snoeijs, Maarten; Tordoir, Jan; Vachharajani, Tushar J.; Vanholder, Raymond; Vergara, Liza A.; Wilkie, Martin; Yang, Bing; Yuo, Theodore H.; Zou, Li; Hawley, Carmel M.
    Abstract Background A functioning vascular access (VA) is crucial to providing adequate hemodialysis (HD) and considered a critically important outcome by patients and healthcare professionals. A validated, patient-important outcome measure for VA function that can be easily measured in research and practice to harvest reliable and relevant evidence for informing patient-centered HD care is lacking. Vascular Access outcome measure for function: a vaLidation study In hemoDialysis (VALID) aims to assess the accuracy and feasibility of measuring a core outcome for VA function established by the international Standardized Outcomes in Nephrology (SONG) initiative. Methods VALID is a prospective, multi-center, multinational validation study that will assess the accuracy and feasibility of measuring VA function, defined as the need for interventions to enable and maintain the use of a VA for HD. The primary objective is to determine whether VA function can be measured accurately by clinical staff as part of routine clinical practice (Assessor 1) compared to the reference standard of documented VA procedures collected by a VA expert (Assessor 2) during a 6-month follow-up period. Secondary outcomes include feasibility and acceptability of measuring VA function and the time to, rate of, and type of VA interventions. An estimated 612 participants will be recruited from approximately 10 dialysis units of different size, type (home-, in-center and satellite), governance (private versus public), and location (rural versus urban) across Australia, Canada, Europe, and Malaysia. Validity will be measured by the sensitivity and specificity of the data acquisition process. The sensitivity corresponds to the proportion of correctly identified interventions by Assessor 1, among the interventions identified by Assessor 2 (reference standard). The feasibility of measuring VA function will be assessed by the average data collection time, data completeness, feasibility questionnaires and semi-structured interviews on key feasibility aspects with the assessors. Discussion Accuracy, acceptability, and feasibility of measuring VA function as part of routine clinical practice are required to facilitate global implementation of this core outcome across all HD trials. Global use of a standardized, patient-centered outcome measure for VA function in HD research will enhance the consistency and relevance of trial evidence to guide patient-centered care. Trial registration Clinicaltrials.gov: NCT03969225. Registered on 31st May 2019.