Abstract:
BACKGROUND:Plasma cell dyscrasias (PCD) are a spectrum of disorders resulting from the clonal expansion of plasma cells, ranging from the pre-malignant condition monoclonal gammopathy of undetermined significance (MGUS) to multiple myeloma (MM). MM generates a significant burden of disease on the community and it is predicted that it will increase in both incidence and prevalence owing to an ageing population and longer survival secondary to new therapeutic options. Robust and comprehensive clinical data are currently lacking but are required to define current diagnostic, investigational and management patterns in Australia and New Zealand (ANZ) for comparison to both local and international guidelines for standards of care. A clinical registry can provide this information and subsequently support development of strategies to address any differences, including providing a platform for clinical trials. The Myeloma and Related Diseases Registry (MRDR) was developed to monitor and explore variations in practices, processes and outcomes in ANZ and provide benchmark outcomes nationally and internationally for PCD. This paper describes the MRDR aims, development and implementation and discusses challenges encountered in the process. METHODS:The MRDR was established in 2012 as an online database for a multi-centre collaboration across ANZ, collecting prospective data on patients with a diagnosis of MGUS, MM, solitary plasmacytoma or plasma cell leukaemia. Development of the MRDR required multi-disciplinary team participation, IT and biostatistical support as well as financial resources. RESULTS:More than 1250 patients have been enrolled at 23 sites to date. Here we describe how database development, data entry and securing ethics approval have been major challenges for participating sites and the coordinating centre, and our approaches to resolving them. Now established, the MRDR will provide clinically relevant and credible monitoring, therapy and 'real world' outcome data, to support the conduction of high quality studies. In addition, the Myeloma 1000 sub-study is establishing a repository of paired peripheral blood specimens from registry patients to study mechanisms underlying disease progression. CONCLUSION:Establishment of the MRDR has been challenging, but it is a valuable investment that will provide a platform for coordinated national and international collaboration for clinical research in PCD in ANZ.
journal_name
BMC Med Res Methodoljournal_title
BMC medical research methodologyauthors
Bergin K,Moore E,McQuilten Z,Wood E,Augustson B,Blacklock H,Ho J,Horvath N,King T,McNeil J,Mollee P,Quach H,Reid CM,Rosengarten B,Walker P,Spencer Adoi
10.1186/s12874-016-0250-zsubject
Has Abstractpub_date
2016-11-09 00:00:00pages
151issue
1issn
1471-2288pii
10.1186/s12874-016-0250-zjournal_volume
16pub_type
杂志文章abstract:BACKGROUND:Nowadays, more and more clinical scales consisting in responses given by the patients to some items (Patient Reported Outcomes - PRO), are validated with models based on Item Response Theory, and more specifically, with a Rasch model. In the validation sample, presence of missing data is frequent. The aim of...
journal_title:BMC medical research methodology
pub_type: 杂志文章
doi:10.1186/1471-2288-11-105
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journal_title:BMC medical research methodology
pub_type: 社论
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pub_type: 杂志文章
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journal_title:BMC medical research methodology
pub_type: 临床试验,杂志文章
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journal_title:BMC medical research methodology
pub_type: 杂志文章,评审
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journal_title:BMC medical research methodology
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更新日期:2018-11-16 00:00:00
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