EAL

CKD: Dietary Intake (2018)

Author and Year:

Shapiro B et al, 2015

PubMed ID:

25682334

Article Title:

Self-Reported Interview-Assisted Diet Records Underreport Energy Intake in Maintenance Hemodialysis Patients.

Authors:

Shapiro B, Bross R, Morrison G, Kalantar-Zadeh K, Kopple J

Journal:

Journal of Renal Nutrition : the official journal of the Council on Renal Nutrition of the National Kidney Foundation

Year of publication:

2015

Volume:

Issue:

Page numbers:

357-63

Study Design:

Randomized Crossover Trial

Risk of Bias Assessment Rating:

Neutral

Inclusion Criteria:

Inclusion criteria: (1) ages 25 to 65 years, (2) men and women of all racial and ethnic groups, (3) maintenance hemodialysis (MHD) treatment 3-times weekly for 6 months or greater (at the time that the nitrogen balance studies commenced), (4) serum albumin 3.6 g/dL or greater, (5) serum hemoglobin 11 g/dL or greater, and (6) relative body weight of 90% to 115% of NHANES II median body weights.

Exclusion Criteria:

Exclusion criteria: (1) moderate-or-severe PEW, (2) existing cancer other than basal cell carcinoma, (3) severe heart, lung, or liver disease, (4) poorly controlled hypertension or asthma, chronic systemic infection, active vasculitis, or any systemic inflammatory process, symptomatic musculoskeletal disease or neuropathy, or amputations of the lower extremities, (5) insulin-dependent or insulin-independent diabetes mellitus, (6) pregnancy, (7) history of alcohol or drug abuse, (8) treatment with L-carnitine or anabolic hormones within the previous 6 months, (9) psychosis or inability to give informed consent or to follow the protocol.

Research Purpose:

To introduce a novel approach of assessing underreporting of energy intakes (EI) in maintenance hemodialysis patients: (1) comparing the patients’ reported EI to their resting energy expenditure (REE) measured by indirect calorimetry and to a validated estimate of total energy expenditure (TEE) and (2) comparing the patients’ reported EI to their actual dietary energy requirements (DERs) for weight stability, measured under the strict protocol of a long-term (mean, 89.5 days) classical nitrogen balance study in which constant energy diets were meticulously prepared and fed to MHD patients for relatively long periods of time.

Blinding efforts:

Not Reported

Study Location:

California, USA (Harbor-UCLA Medical Center)

Source(s) of Funding:

Government, University/Hospital

Please specify names of funders:

This study was supported by the UCLA-Clinical and Translational Science Institute at Harbor-UCLA Medical Center and by grants from the National Institute of Health.

Quality Criteria Checklist: Primary Research
Relevance Questions
	1.	Would implementing the studied intervention or procedure (if found successful) result in improved outcomes for the patients/clients/population group? (Not Applicable for some epidemiological studies)	Yes
	2.	Did the authors study an outcome (dependent variable) or topic that the patients/clients/population group would care about?	Yes
	3.	Is the focus of the intervention or procedure (independent variable) or topic of study a common issue of concern to dieteticspractice?	Yes
	4.	Is the intervention or procedure feasible? (NA for some epidemiological studies)	N/A

Validity Questions
1.	Was the research question clearly stated?		Yes
	1.1.	Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified?	Yes
	1.2.	Was (were) the outcome(s) [dependent variable(s)] clearly indicated?	Yes
	1.3.	Were the target population and setting specified?	Yes
2.	Was the selection of study subjects/patients free from bias?		Yes
	2.1.	Were inclusion/exclusion criteria specified (e.g., risk, point in disease progression, diagnostic or prognosis criteria), and with sufficient detail and without omitting criteria critical to the study?	Yes
	2.2.	Were criteria applied equally to all study groups?	N/A
	2.3.	Were health, demographics, and other characteristics of subjects described?	???
	2.4.	Were the subjects/patients a representative sample of the relevant population?	???
3.	Were study groups comparable?		N/A
	3.1.	Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT)	Yes
	3.2.	Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline?	N/A
	3.3.	Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.)	N/A
4.	Was method of handling withdrawals described?		Yes
	4.1.	Were follow-up methods described and the same for all groups?	N/A
	4.2.	Was the number, characteristics of withdrawals (i.e., dropouts, lost to follow up, attrition rate) and/or response rate (cross-sectional studies) described for each group? (Follow up goal for a strong study is 80%.)	Yes
	4.3.	Were all enrolled subjects/patients (in the original sample) accounted for?	Yes
	4.4.	Were reasons for withdrawals similar across groups?	N/A
5.	Was blinding used to prevent introduction of bias?		N/A
	5.1.	In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate?	N/A
	5.2.	Were data collectors blinded for outcomes assessment? (If outcome is measured using an objective test, such as a lab value, this criterion is assumed to be met.)	Yes
6.	Were intervention/therapeutic regimens/exposure factor or procedure and any comparison(s) described in detail? Were interveningfactors described?		Yes
	6.1.	In RCT or other intervention trial, were protocols described for all regimens studied?	Yes
	6.3.	Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect?	Yes
	6.4.	Was the amount of exposure and, if relevant, subject/patient compliance measured?	Yes
	6.5.	Were co-interventions (e.g., ancillary treatments, other therapies) described?	N/A
	6.6.	Were extra or unplanned treatments described?	N/A
	6.7.	Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups?	N/A
7.	Were outcomes clearly defined and the measurements valid and reliable?		Yes
	7.1.	Were primary and secondary endpoints described and relevant to the question?	Yes
	7.2.	Were nutrition measures appropriate to question and outcomes of concern?	Yes
	7.3.	Was the period of follow-up long enough for important outcome(s) to occur?	Yes
	7.4.	Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures?	Yes
	7.5.	Was the measurement of effect at an appropriate level of precision?	Yes
	7.6.	Were other factors accounted for (measured) that could affect outcomes?	N/A
	7.7.	Were the measurements conducted consistently across groups?	N/A
8.	Was the statistical analysis appropriate for the study design and type of outcome indicators?		Yes
	8.1.	Were statistical analyses adequately described and the results reported appropriately?	Yes
	8.2.	Were correct statistical tests used and assumptions of test not violated?	Yes
	8.3.	Were statistics reported with levels of significance and/or confidence intervals?	Yes
	8.4.	Was "intent to treat" analysis of outcomes done (and as appropriate, was there an analysis of outcomes for those maximally exposed or a dose-response analysis)?	Yes
	8.5.	Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)?	No
	8.6.	Was clinical significance as well as statistical significance reported?	Yes
	8.7.	If negative findings, was a power calculation reported to address type 2 error?	N/A
9.	Are conclusions supported by results with biases and limitations taken into consideration?		Yes
	9.1.	Is there a discussion of findings?	Yes
	9.2.	Are biases and study limitations identified and discussed?	Yes
10.	Is bias due to study's funding or sponsorship unlikely?		Yes
	10.1.	Were sources of funding and investigators' affiliations described?	Yes
	10.2.	Was the study free from apparent conflict of interest?	Yes