Volume 16 Supplement 1

Lupus 2014: New Targets, New Approaches

Open Access

Methodological quality of studies of end-stage renal disease risks in lupus nephritis

Arthritis Research & Therapy201416(Suppl 1):A47

https://doi.org/10.1186/ar4663

Published: 18 September 2014

Background

Variations in methodological quality can affect the results of individual studies and of systematic reviews. We examined the adequacy of patient descriptions, representativeness, and follow-up information in studies included in a systematic review of risks of end-stage renal disease (ESRD) in patients with lupus nephritis.

Methods

We search Medline, Embase, and the Cochrane Database from their inceptions to 31 December 2013 for studies that reported on ESRD in adults with lupus nephritis. We included all observational studies and long-term clinical trials with a minimum of 12 months of follow-up and 10 patients that reported specific data on the development of ESRD. Two authors independently assessed study quality using a modification of the Newcastle Ottawa scale, and rated studies on 10 items in three areas: adequacy of description of the cohort (items 1 to 3); representativeness (items 4 to 7); and adequacy of follow-up information (items 8 to 10).

Results

The literature search yielded 1,852 articles, of which 174 articles met our inclusion criteria. These included 132 observational studies and 42 clinical trials. The proportion of studies meeting each quality measure, stratified by study design, is presented in Table 1. Among observational studies, the median number of measures satisfied per study was 5 (range 2 to 9), and among clinical trials was 4 (range 2 to 7). There was no correlation between publication year and number of measures satisfied for observational studies (r = 0.14), but recent trials tended to satisfy more quality measures (r = 0.32; P = 0.04).

Table 1

Quality measure

Observational studies (n= 132)

Clinical trials (n= 42)

1. ACR criteria for SLE used

88.3

88.1

2. Measure of renal function included

77.2

95.2

3. Treatments described

84.1

100

4. Community-based study

11.3

Not applicable

5. Inception cohort

40.1

11.9

6. Renal biopsy not required for inclusion

37.1

35.7

7. Patients with chronic kidney disease not excluded

80.3

23.8

8. Losses to follow-up described

24.2

42.8

9. Losses to follow-up < 20%

18.9

30.9

10. Data reported using Kaplan-Meier curves

36.3

9.5

Conclusions

While both observational studies and clinical trials generally provided good clinical descriptions of the cohorts, few provided adequate data on follow-up. The representativeness of observational studies was low. The improvement in trial quality over time may be due to the development of standardized protocols and the institution of reporting standards, which might also serve to enhance the reporting of observational studies.

Declarations

Acknowledgements

Supported by the Intramural Research Program, NIAMS/NIH.

Authors’ Affiliations

(1)
School of Medicine, University of Athens
(2)
National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institutes of Health

Copyright

© Tektonidou et al.; licensee BioMed Central Ltd. 2014

This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

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