English (United Kingdom)

https://curated-unify.zendy.io/wp-json/zendy-region/v1/featured_content/oa?rat=en

https://curated-unify.zendy.io/wp-json/zendy-region/v1/highlighted_journal/

Global: Zendy Plus annual

Presents the access of premium content as premium feature

Premium Content

Presents the keyphrase highlighting as premium feature

Keyphrase Highlighting

Presents the summarisation as premium feature

Summarisation

Insights

Presents the pdf analysis as premium feature

PDF Analysis

Presents the zaia usage as premium feature

ZAIA

Global: Zendy Tools annual

Global: Zendy Free Plan

Global: Zendy Tools monthly

Global: Zendy Plus monthly

Randomized trials provide the most reliable evidence about the safety and effectiveness of interventions to improve health care and patient outcomes. Unfortunately, the potential for trials to inform treatment decisions remains limited because the outcomes reported often do not resonate with what is directly meaningful and relevant to patients and their clinicians [1–3]. Further, inconsistent reporting of outcomes across trials prevents assessment of the comparative effect of interventions [4]. Outcome reporting bias, whereby authors cherry-pick the outcomes they report on the basis of favourable results, may also occur when there is not a standardized list of outcomes measured and reported [5, 6]. Collectively these problems may undermine the reliability of published trials, leading to inefficient use of scarce research and health care resources and unintended harm to patients [6]. Such dissonance in outcomes reported in trials is widespread and evident across all medical specialties. The growing recognition of the problem has prompted large-scale efforts to establish core outcome sets. Core outcome sets are an agreed standardized set of outcomes for a specific clinical area that are to be reported as a minimum in all trials in that area [7]. Outcomes are selected because they are critically important to all stakeholders—namely patients, their clinicians and policymakers— for decision making. Core outcome sets are not designed to be comprehensive or exclusive. Typically they include only three to five outcomes. Other outcomes that are identified to be important (i.e. to some stakeholder groups) may also be recommended for some trials (Figure 1). The designated primary outcome of any given trial may be outside the core outcome set and researchers may also opt to add other, trial-specific outcomes, chosen for reasons including responsiveness to the intervention and feasibility. Attempts to standardize outcomes began 50 years ago when the World Health Organization published recommendations for the minimum requirements for data collection in cancer trials [8]. In the 1990s, the Outcome Measures in Rheumatology (OMERACT) initiative was formed, and is perhaps the most widely recognized and largest initiative in the field of core outcome development. OMERACT engages patients and health professionals to standardize outcome measures for trials in rheumatology [9] and has pioneered methodologies for developing core outcome sets. The uptake of the OMERACT core outcome sets has improved the consistency of outcomes reported in trials [10]. In the past decade, core outcome sets in diverse medical specialties, including cardiology, dermatology, surgery, oncology, women’s health and respiratory disease, have progressively been developed [7, 9–11]. The use of core outcome sets is also increasingly being advocated by funders to ensure the relevance and potential impact of research. In the UK, funding organizations, including the National Institute for Health Research and the Health Research Board (Ireland), advise researchers to include core outcome sets if they are available and highlight the Core Outcome Measures in Effectiveness (COMET) database of core outcomes as a key resource [7]. The COMET initiative was recently launched to facilitate the development, implementation and evaluation of core outcome sets [7]. There has been a long-standing need in nephrology to develop core outcomes [12–14]. More than 14 000 randomized trials are available in the Cochrane Kidney and Transplant Specialised Register [15] and a search of ClinicalTrials.gov trials for ‘kidney disease’ yields >3000 ongoing trials. Despite this considerable investment in trials in nephrology, improvements in outcomes for patients with kidney disease have been modest at best. Across all stages of chronic kidney disease (CKD), patients still have a markedly higher risk of mortality and serious comorbidities, including cardiovascular disease, diabetes, cancer and infection, compared with the general population [16–18]. Patients with CKD have poor quality of life, particularly if they are on dialysis, to the extent that many patients || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || ||

Composing a new song for trials: the Standardized Outcomes in Nephrology (SONG) initiative