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Malnutrition, specifically protein-energy wasting (PEW), is common in patients with chronic kidney disease (CKD), and its prevalence increases as CKD progresses. Oral nutritional supplementation (ONS) with complete formulas specific to this pathology, is a strategy aimed at meeting energy and protein requirements that are not possible with dietary recommendations and advice alone. This study systematically reviewed the available scientific literature on the safety and effectiveness of nutritional therapy with complete formulas specially designed for adults with CKD who have PEW that is not reversible through ordinary food consumption.
We systematically searched for articles published up to May 2018 in several electronic databases. We included comparative studies that evaluated the safety and effectiveness of complete nutritional formulas for malnourished adults with CKD. Relevant outcomes included rates of death, hospitalization, and adverse effects, and changes in nutritional status, anthropometrics, and health-related quality of life (HRQoL).
Three systematic reviews and 22 primary studies were identified. The primary studies comprised nine randomized controlled trials, nine non-randomized comparative studies, and four before-after studies (the latter were only included in the safety review). The majority of studies were conducted in patients on hemodialysis. The studies exhibited methodological heterogeneity in terms of the methods used to measure nutritional status and the interventions and comparators evaluated. There was also inconsistency among the results. Adherence to ONS, especially in the long term, can be affected by taste fatigue produced by repeatedly taking the same formula. Some studies recommend supplementation during hemodialysis sessions.
The studies with less risk of bias indicated a trend toward improvements in rates of death and hospitalization, HRQoL and, to a lesser extent, some anthropometric variables and serum markers, such as albumin, when ONS was given to patients with CKD. High quality comparative studies are needed to make conclusive statements about the effectiveness of this intervention.
Transparent evidence-based decision making has been promoted worldwide to engender trust in science and policy making. Yet, little attention has been given to transparency implementation. The degree of transparency (focused on how uncertain evidence was handled) during the development of folate and vitamin D Dietary Reference Values was explored in three a priori defined areas: (i) value request; (ii) evidence evaluation; and (iii) final values.
Qualitative case studies (semi-structured interviews and desk research). A common protocol was used for data collection, interview thematic analysis and reporting. Results were coordinated via cross-case synthesis.
Australia and New Zealand, Netherlands, Nordic countries, Poland, Spain and UK.
Twenty-one interviews were conducted in six case studies.
Transparency of process was not universally observed across countries or areas of the recommendation setting process. Transparency practices were most commonly seen surrounding the request to develop reference values (e.g. access to risk manager/assessor problem formulation discussions) and evidence evaluation (e.g. disclosure of risk assessor data sourcing/evaluation protocols). Fewer transparency practices were observed to assist with handling uncertainty in the evidence base during the development of quantitative reference values.
Implementation of transparency policies may be limited by a lack of dedicated resources and best practice procedures, particularly to assist with the latter stages of reference value development. Challenges remain regarding the best practice for transparently communicating the influence of uncertain evidence on the final reference values. Resolving this issue may assist the evolution of nutrition risk assessment and better inform the recommendation setting process.
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