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Association of Incident Dialysis Modality with Mortality: a Protocol for Systematic Review and Meta-Analysis of Randomized Controlled Trials and Cohort Studies Mark R

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Association of Incident Dialysis Modality with Mortality: a Protocol for Systematic Review and Meta-Analysis of Randomized Controlled Trials and Cohort Studies Mark R Marshall et al. Systematic Reviews (2019) 8:55 https://doi.org/10.1186/s13643-019-0972-1 PROTOCOL Open Access Association of incident dialysis modality with mortality: a protocol for systematic review and meta-analysis of randomized controlled trials and cohort studies Mark R. Marshall1,2,3* , Chun-Yuan Hsiao2, Philip K. Li4, Masaaki Nakayama5,6, S. Rabindranath7, Rachael C. Walker8, Xueqing Yu9,10 and Suetonia C. Palmer11 Abstract Background: At least 2.6 million adults and children receive dialysis treatment for end-stage kidney disease (ESKD) worldwide. The large majority of these receive hemodialysis (HD), while the remaining receive peritoneal dialysis (PD). Peritoneal dialysis may be associated with similar mortality outcomes as HD, and patient-reported outcomes are potentially increased with PD. Existing evidence for the mortality associated with PD was summarized over 20 years ago, and there has been greater marginal improvement in survival with PD relative to HD since that time. It is therefore timely to reexamine the question of differential mortality by modality and summarize evidence from more contemporary practice settings. Methods/design: Electronic databases will be systematically searched for publications that report the association between dialysis modality (HD or PD) with death from any cause and cause-specific death in incident patients with end-stage kidney disease. The database searches will be supplemented by searching through citations and references and consultation with experts. Studies published before 1995 will be excluded. Screening of both titles and abstracts will be done by two independent reviewers. All disagreements will be resolved by an independent third reviewer. A quantitative meta-analysis of effect sizes and standard errors will be applied. Discussion: Our systematic review will update previous evidence summaries and provide a quantitative and standardized assessment of the contemporary literature comparing HD and PD including published and unpublished non-English studies from greater China, Taiwan, and Japan. This review will inform shared decision- making around initial dialysis modality choice and jurisdiction-level considerations of dialysis practice. Systematic review registration: PROSPERO CRD42018111829 Keywords: Hemodialysis, Systematic review, Peritoneal dialysis, Mortality, Cause-specific mortality * Correspondence: [email protected]; [email protected]; [email protected]; [email protected] 1School of Medicine, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand 2Department of Renal Medicine, Middlemore Hospital, Counties Manukau Health, Auckland, New Zealand Full list of author information is available at the end of the article © The Author(s). 2019 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. 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. Marshall et al. Systematic Reviews (2019) 8:55 Page 2 of 6 Introduction identification of eligible studies, data extraction, and bias Rationale assessment will be undertaken independently by at least At least 2.6 million adults and children receive dialysis two researchers. treatment for end-stage kidney disease (ESKD) worldwide, and a substantial number remain without access to dialysis PICO tables and eligibility criteria care [1]. Globally, close to 90% of long-term dialysis pa- The PICO criteria were agreed by the review researchers tients receive hemodialysis (HD) with the remaining receive and defined as follows. Participants of eligible trials and peritoneal dialysis (PD). The distribution of dialysis modal- studies will be adults and children with incidence of end- ity, however, varies widely by health jurisdiction and coun- stage kidney disease starting long-term dialysis treatment. try. Peritoneal dialysis may be associated with similar The intervention will consider any type of PD and its vari- mortality outcomes as compared to HD [2–4], al- ants (continuous ambulatory PD (CAPD), automated PD though patient-reported outcomes are potentially increased (APD)/continuous cyclic PD (CCPD), (nocturnal) inter- with PD (e.g., patient satisfaction [5–7], life participation mittent PD (IPD/NIPD), tidal PD (TPD), or continuous [8], treatment flexibility and intrusiveness [9], flow PD (CFPD)). The comparison will consider HD and self-management [7], some domains of health-related qual- its variants (hemofiltration, hemodiafiltration, acid-free ity of life [10, 11], and health utility [12–14]). Importantly, biofiltration). We will exclude studies evaluating com- for most health care systems, PD is less expensive to pro- bined HD and PD strategies, or where the hemodialysis vide than HD, and economic evaluations suggest improved comprises intensive dialysis (i.e., greater than 3.5 times productivity and societal outcomes with greater use of PD per week, or greater than 6 h per treatment [44]). The [15–20]. primary outcome will be death from any cause. There are several potential barriers to the adoption of Eligible studies and trials will include published or PD, some of which relate to clinician attitudes towards its unpublished reports in any language that assess asso- safety and efficacy relative to HD. Where there is strong ciations between PD and HD with the outcome of clinical belief, adoption of PD is higher irrespective of fi- interest. We will include randomized controlled trials nancial or infrastructure constraints [21–24]. When there and quasi-RCTs and prospectively or retrospectively is equipoise, the addressing of barriers becomes critical to recruited longitudinal cohort studies. We will exclude increased adoption [25]. Clinician uptake of PD may of studies published before 1995. Narrative reviews and course depend on non-medical factors, such as financial health technology assessments related to the topic will incentives [26], clinical culture and disposition among be retained to investigate their references for further peers [27], and familiarity and confidence in achieving the eligible studies. outcomes that are seen in centers of excellence [28, 29]. Existing evidence for the mortality associated with PD was summarized over 20 years ago, when outcomes associ- Literature search ated with PD were accepted to be inferior to HD [30, 31]. We will identify studies and trials from a highly sensitive Since those reviews, new evidence has emerged on out- literature search to identify all published and unpub- comes from Australia and New Zealand [32], Canada [33, lished studies (Appendix in Table 1). The following data- 34], the USA [35, 36], the Netherlands [37], Denmark [38], bases will be searched from inception to present: Taiwan [39], and Korea [40]. These studies indicate a MEDLINE; Embase; CENTRAL; Ichushi-Web; clinical greater marginal improvement in survival with PD rela- trials registries (ClinicalTrials.gov, International Clinical tive to HD over the last two decades, with recent health Trials Registry Platform Search Portal (ICTRP), EU Clin- technology assessments suggesting that the conclusions ical Trials Register, Japan Primary Registries Network from the older studies may no longer be valid [16, 41, (JPRN), China’s Clinical Trial Registry (ChiCTR)); China 42]. It is therefore timely to re-examine the question of National Knowledge Infrastructure (www.cnki.net); differential mortality by modality and summarize evi- Chongqing VIP Information Co., Ltd., formerly known dence from more contemporary practice settings. as Database Research Center under Chongqing Branch We will conduct a systematic review to evaluate the of Institute of Scientific & Technical information of association between dialysis modality (HD or PD) with China (CB-ISTIC, www.wanfangdata.com.cn); HK gov- death from any cause and cause-specific death in inci- ernment library (https://www.hkpl.gov.hk/en/e-re- dent patients with end-stage kidney disease. The pri- sources/e-databases/keyword/e-database/all/1); Hyread mary outcome will be death from any cause. full-text database of Taiwan (http://www.hyread.com.tw/ hyreadnew/); Ericdata Higher Education Knowledge Base Methods (http://www.ericdata.com/); Taiwan Journal Papers We will conduct a systematic review with meta-analysis ac- Index System (http://readopac.ncl.edu.tw/nclJournal/ cording to reporting standards [43]. Literature searchers, index.htm); TAO Taiwan Academic Online (http:// Marshall et al. Systematic Reviews (2019) 8:55 Page 3 of 6 tao.wordpedia.com/); and Ariti library (http://www.air- representativeness of exposed cohort, ascertainment of ex- itilibrary.com/). posure, statistical methods, outcomes of interest defined a We will search manually for additional studies by priori (outcomes reporting bias), assessment of outcomes, cross-checking the reference lists of all included primary and follow-up times for outcomes and attrition [45]. Any studies and lists of relevant systematic reviews. In disagreements will be resolved through discussion and addition, study authors and experts will be contacted for consensus. If necessary,
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