Tong Allison, Crowe Sally, Gill John S, Harris Tess, Hemmelgarn Brenda R, Manns Braden, Pecoits-Filho Roberto, Tugwell Peter, van Biesen Wim, Wang Angela Yee Moon, Wheeler David C, Winkelmayer Wolfgang C, Gutman Talia, Ju Angela, O'Lone Emma, Sautenet Benedicte, Viecelli Andrea, Craig Jonathan C
Sydney School of Public Health, The University of Sydney, Sydney, New South Wales, Australia.
Centre for Kidney Research, The Children's Hospital at Westmead, Sydney, New South Wales, Australia.
BMJ Open. 2018 Apr 20;8(4):e021198. doi: 10.1136/bmjopen-2017-021198.
To describe the perspectives of clinicians and researchers on identifying, establishing and implementing core outcomes in haemodialysis and their expected impact.
Face-to-face, semistructured interviews; thematic analysis.
Twenty-seven centres across nine countries.
Fifty-eight nephrologists (42 (72%) who were also triallists).
We identified six themes: (survival as the primary goal of dialysis, enabling well-being and functioning, severe consequences of comorbidities and complications, indicators of treatment success, universal relevance, stakeholder consensus); (realistic and possible to intervene on, differentiating between treatments); (clarity and consistency in definition, easily measurable, requiring minimal resources, creating a cultural shift, aversion to intensifying bureaucracy, allowing justifiable exceptions); (endorsement for legitimacy, necessity of buy-in from dialysis providers, incentivising uptake); (explicitly addressing patient-important outcomes, reciprocating trial participation, improving comparability of interventions for decision-making, driving quality improvement and compelling a focus on quality of life).
Nephrologists emphasised that core outcomes should be relevant to patients, amenable to change, feasible to implement and supported by stakeholder organisations. They expected core outcomes would improve patient-centred care and outcomes.
描述临床医生和研究人员对于确定、建立和实施血液透析核心结局指标及其预期影响的看法。
面对面、半结构化访谈;主题分析。
九个国家的27个中心。
58名肾病学家(其中42名(72%)也是试验人员)。
我们确定了六个主题:(生存作为透析的首要目标,促进健康和功能,合并症和并发症的严重后果,治疗成功的指标,普遍相关性,利益相关者共识);(现实且可干预,区分不同治疗方法);(定义清晰一致,易于测量,所需资源最少,促成文化转变,避免加剧官僚作风,允许合理例外);(认可其合法性,透析提供者认可的必要性,激励采用);(明确关注对患者重要的结局,回报试验参与,提高干预措施在决策中的可比性,推动质量改进并促使关注生活质量)。
肾病学家强调核心结局指标应与患者相关,易于改变,实施可行并得到利益相关者组织的支持。他们预计核心结局指标将改善以患者为中心的医疗服务和结局。