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Effectiveness of a Sodium Restricted Diet on Reducing Weight Gain and Edema Formation in Adult Patients with Chronic Heart Failure: A Systematic Review Protocol

Abraham, Jessie RN; Merrill, April DNP, APRN, CNS, CCNS, Deputy Director JBIO

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JBI Database of Systematic Reviews and Implementation Reports: April 2013 - Volume 11 - Issue 4 - p 187-196
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Inclusion criteria

Types of participants

The review will consider studies that include all patients 18 years of age and older, females and males, all types and classes of heart failure, in patients that are not hospitalized but are receiving treatment for heart failure via pharmacologic interventions and non-pharmacologic interventions.

Types of interventions

The review will consider studies that evaluate the effectiveness of various sodium restricted diets, low sodium versus high sodium. The average low-sodium diet is defined as a daily intake of two grams of sodium. 17

Types of outcomes

Types of outcomes that will be evaluated will be amount of weight gain in pounds/kilograms associated with various sodium restricted diets and the visible edema noted by physical examination based on patient self-report or clinician exam. Furthermore urinary sodium excretion data will be utilized when available to further quantify the efficacy of the low sodium diet, in terms of physiological utilization of sodium ingested.

Types of studies

The types of studies considered will be any randomized controlled trials (RCTs); in the absence of RCTs, other research designs, such as non-randomized controlled trials and before and after studies, will be considered for inclusion. The search strategy will strive to find both published and unpublished studies in English language only. A three-step search strategy will be utilized.

Search strategy

An initial limited search of MEDLINE and CINAHL will be undertaken followed by analysis of the text words contained in the title and abstract, and of the index terms used to describe the article. A second search using all identified keywords and index terms will be undertaken across all included databases. Thirdly, the reference list of all identified reports and articles will be searched for additional studies.

The databases to be searched include:

AMED, OVID All EBM Reviews (collection includes Cochrane DSR, ACP Journal Club, DARE, CCTR, CMR, HTA, & NHSEED), CINAHL, EMBASE, TRIP, NGC, PubMed, Current Contents, ProQuest, Science Direct, and Expanded Academic ASAP (1955 to Aug. 2012).

The search for unpublished studies will include:

AHRQ (Agency for Healthcare Research and Quality), Evidence Reports, Dissertation Abstracts, Google Scholar, SIGLE (System for Information on Grey Literature in Europe), The New York Academy of Medicine Gray Literature Report, Scirus Networked Digital Library of Theses and Dissertations (NDLTD), and Mednar (the most recent unpublished studies from 1999 to Aug. 2012).

Initial keywords to be used will be: heart failure, sodium restriction, low sodium diet, edema, oedema and weight gain

Assessment of methodological quality

Quantitative papers selected for retrieval will be assessed by two independent reviewers for methodological validity prior to inclusion in the review using standardized critical appraisal instruments from the Joanna Briggs Institute Meta-Analysis of Statistics Assessment and Review Instrument (JBI-MASTARI) (Appendix I). Any disagreements that arise between the reviewers will be resolved through discussion, or with a third reviewer.

Data collection

Quantitative data will be extracted from papers included in the review using the standardized data extraction tool from JBI-MASTARI (Appendix II). The data extracted will include specific details about the interventions, populations, study methods and outcomes of significance to the review question and specific objectives.

Data synthesis

Quantitative papers will, where possible be pooled in statistical meta-analysis using JBI-MAStARI. All results will be subject to double data entry. Odds ratio (for categorical data) and weighted mean differences (for continuous data) and their 95% confidence intervals will be calculated for analysis. Heterogeneity will be assessed using the standard Chi-square. Where statistical pooling is not possible the findings will be presented in narrative form.

Conflicts of interest





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                          Appendix I: Appraisal instruments

                          MAStARI Appraisal instrument

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                          Appendix II: Data extraction instruments

                          MAStARI data extraction instrument

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                          heart failure; sodium restriction; low sodium diet; edema; oedema; weight gain

                          © 2013 by Lippincott williams & Wilkins, Inc.