Dataset Information

Predictors of treatment with dialysis modalities in observational studies for comparative effectiveness research.

ABSTRACT:

Background

The Institute of Medicine has identified the comparative effectiveness of renal replacement therapies as a kidney-related topic among the top 100 national priorities. Given the importance of ensuring internal and external validity, the goal of this study was to identify potential sources of bias in observational studies that compare outcomes with different dialysis modalities.

Methods

This observational cohort study used data from the electronic medical records of all patients that started maintenance dialysis in the calendar years 2007-2011 and underwent treatment for at least 60 days in any of the 2217 facilities operated by DaVita Inc. Each patient was assigned one of six dialysis modalities for each 91-day period from the date of first dialysis (thrice weekly in-center hemodialysis (HD), peritoneal dialysis (PD), less-frequent HD, home HD, frequent HD and nocturnal in-center HD).

Results

Of the 162 644 patients, 18% underwent treatment with a modality other than HD for at least one 91-day period. Except for PD, patients started treatment with alternative modalities after variable lengths of treatment with HD; the time until a change in modality was shortest for less-frequent HD (median time = 6 months) and longest for frequent HD (median time = 15 months). Between 30 and 78% of patients transferred to another dialysis facility prior to change in modality. Finally, there were significant differences in baseline and time-varying clinical characteristics associated with dialysis modality.

Conclusions

This analysis identified numerous potential sources of bias in studies of the comparative effectiveness of dialysis modalities.

SUBMITTER: Kuttykrishnan S

PROVIDER: S-EPMC4560036 | biostudies-literature | 2015 Jul

REPOSITORIES: biostudies-literature

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Publications

Predictors of treatment with dialysis modalities in observational studies for comparative effectiveness research.

Kuttykrishnan Sooraj S Kalantar-Zadeh Kamyar K Arah Onyebuchi A OA Cheung Alfred K AK Brunelli Steve S Heagerty Patrick J PJ Katz Ronit R Molnar Miklos Z MZ Nissenson Allen A Ravel Vanessa V Streja Elani E Himmelfarb Jonathan J Mehrotra Rajnish R

Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association 20150416 7

<h4>Background</h4>The Institute of Medicine has identified the comparative effectiveness of renal replacement therapies as a kidney-related topic among the top 100 national priorities. Given the importance of ensuring internal and external validity, the goal of this study was to identify potential sources of bias in observational studies that compare outcomes with different dialysis modalities.<h4>Methods</h4>This observational cohort study used data from the electronic medical records of all p ...[more]

PMID: 25883196

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Project description:BackgroundEvidence from observational comparative effectiveness research (CER) is ranked below that from randomized controlled trials in traditional evidence hierarchies. However, asthma observational CER studies represent an important complementary evidence source answering different research questions and are particularly valuable in guiding clinical decision making in real-life patient and practice settings. Tools are required to assist in quality appraisal of observational CER to enable identification of and confidence in high-quality CER evidence to inform guideline development.MethodsThe REal Life EVidence AssessmeNt Tool (RELEVANT) was developed through a step-wise approach. We conducted an iterative refinement of the tool based on Task Force member expertise and feedback from pilot testing the tool until reaching adequate inter-rater agreement percentages. Two distinct pilots were conducted-the first involving six members of the Respiratory Effectiveness Group (REG) and European Academy of Allergy and Clinical Immunology (EAACI) joint Task Force for quality appraisal of observational asthma CER; the second involving 22 members of REG and EAACI membership. The final tool consists of 21 quality sub-items distributed across seven methodology domains: Background, Design, Measures, Analysis, Results, Discussion/Interpretation, and Conflict of Interest. Eleven of these sub-items are considered critical and named "primary sub-items".ResultsFollowing the second pilot, RELEVANT showed inter-rater agreement ??70% for 94% of all primary and 93% for all secondary sub-items tested across three rater groups. For observational CER to be classified as sufficiently high quality for future guideline consideration, all RELEVANT primary sub-items must be fulfilled. The ten secondary sub-items further qualify the relative strengths and weaknesses of the published CER evidence. RELEVANT could also be applicable to general quality appraisal of observational CER across other medical specialties.ConclusionsRELEVANT is the first quality checklist to assist in the appraisal of published observational CER developed through iterative feedback derived from pilot implementation and inter-rater agreement evaluation. Developed for a REG-EAACI Task Force quality appraisal of recent asthma CER, RELEVANT also has wider utility to support appraisal of CER literature in general (including pre-publication). It may also assist in manuscript development and in educating relevant stakeholders about key quality markers in observational CER.

Dataset Information

Predictors of treatment with dialysis modalities in observational studies for comparative effectiveness research.

Background

Methods

Results

Conclusions

Publications

Predictors of treatment with dialysis modalities in observational studies for comparative effectiveness research.

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