EAL

UWL: Screening and Assessment Methods (2009)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

To compare the 24-hour dietary intake of older people consuming a texture modified diet in a clinical setting to older people consuming a normal hospital diet.

Inclusion Criteria:

All cases were on texture modified diets
All controls were considered by the medical teams to be medically stable (no acute or ongoing illnesses and in a rehabilitation phase of their management); they were selected according to which patients were on the ward at the time the weighed food intake occurred

Exclusion Criteria:

Those under 60 years
Those who were NPO, on a tube feed, or on another therapeutic diet such as gluten-free

Description of Study Protocol:

Recruitment

All patients admitted to the medicine for the elderly and neurology wards at Charing Cross Hammersmith Hospital between May and September 2003, and who were on a texture-modified diet, were considered for the study. Controls, who were patients on a normal diet, were also selected from the same wards during the same time period.

Design: Case-Control Study

Blinding used (if applicable): not applicable

Intervention (if applicable)

Weighed food intakes and food record charts were used to quantify the patients' intakes, which were compared to their individual requirements.

Statistical Analysis

Power calculation indicated that to detect a difference of 2000 kJ, with a standard deviation of 2000 kJ, at a power of 90%, a sample size of 22 was required for both groups. Continuous data was compared using a two-sample t test or Mann-Whitney test depending on data distribution. The Kruskal-Wallis test was used to compare the dietary groups.

Data Collection Summary:

Timing of Measurements

Each patient had a 1-day weighed food intake carried out.

Dependent Variables

Food intake: main meals were weighed, and food charts were used to collect the remaining food intake, including nutritional supplements
Patient's energy and protein requirements were calculated using Schofield equation and Elia's estimation of nitrogen requirements
PAL values between 1.15 and 1.25 were used for determining total energy expenditure

Independent Variables

Texture-modified diet or normal hospital diet
Patient data (age, sex, weight and diagnosis) were collected from the notes

Control Variables

Description of Actual Data Sample:

Initial N: 55 patients; 25 on normal diet served as controls (7 males, 18 females); 30 with dysphagia were prescribed a texture-modified diet (16 males, 14 females)

Attrition (final N): as above

Age: mean age cases: 82 years (range 63 - 95 years), mean age controls: 81 years (range 68 - 91)

Ethnicity: not mentioned

Other relevant demographics: mean weight cases: 60 kg (range 39 - 96 kg), mean weight controls: 62 kg (range 46 - 93 kg)

Anthropometrics: No statistically significant differences between groups at baseline, but controls were not matched

Location: United Kingdom

Summary of Results:

	Normal diet	Dysphagia diet	P value
Energy requirements (kJ)	6472 ± 882	6426 ± 1029	0.79
Protein requirements (g)	66 ± 14.2	62 ± 13.1	0.29
Energy consumed (kJ)	6115 ± 2575	3877 ± 1420	<0.0001
Protein consumed (g)	60 ± 27	40 ± 18.6	0.003
Energy deficit (kJ)	-357 ± 2366	-2549 ± 1066	<0.0001
Protein deficit (g)	-6 ± 24.8	-22 ± 16.9	0.013

Other Findings

There were no significant differences in energy or protein requirements between groups.

The texture-modified group had significantly lower intakes of energy (3877 versus 6115 kJ, P < 0.0001) and protein (40 versus 60 g, P < 0.003) compared to those consuming normal diet.

The energy and protein deficit from estimated requirements was significantly greater in the texture-modified group (2549 versus 357 kJ, P < 0.0001); 6 versus 22 g, P = 0.013, respectively).

Patients on a texture-modified diet had a greater contribution of energy from supplements, and that those on supplements consumed more energy than the group average.

Author Conclusion:

Patients on texture-modified diets have a lower intake of energy and protein than patients consuming a normal hospital diet and it is likely that other nutrients will be inadequate too. All patients on texture-modified diets should be seen by the dietitian and assessed for nutritional support. Evidence based strategies for improving overall nutrient intake should be identified. More research needs to be carried out around the effectiveness of fortification of texture-modified diets and additional nursing time and care for patients consuming texture-modified diets. Nursing and medical staff should be educated about the risk of poor nutritional intakes in this patient group.

Funding Source:

University/Hospital:

Northeast Dairy Food Research Center

Reviewer Comments:

Authors note that a 3-day food intake may have been more accurate than the 1-day food intake. Small sample sizes. Caloric and protein needs based on estimation equations. Controls were not matched.

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)	N/A
	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?	Yes
	2.3.	Were health, demographics, and other characteristics of subjects described?	Yes
	2.4.	Were the subjects/patients a representative sample of the relevant population?	Yes
3.	Were study groups comparable?		???
	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?	???
	3.3.	Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.)	Yes
	3.4.	If cohort study or cross-sectional study, were groups comparable on important confounding factors and/or were preexisting differences accounted for by using appropriate adjustments in statistical analysis?	N/A
	3.5.	If case control study, were potential confounding factors comparable for cases and controls? (If case series or trial with subjects serving as own control, this criterion is not applicable.)	???
	3.6.	If diagnostic test, was there an independent blind comparison with an appropriate reference standard (e.g., "gold standard")?	N/A
4.	Was method of handling withdrawals described?		Yes
	4.1.	Were follow-up methods described and the same for all groups?	Yes
	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
	4.5.	If diagnostic test, was decision to perform reference test not dependent on results of test under study?	N/A
5.	Was blinding used to prevent introduction of bias?		Yes
	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.)	N/A
	5.3.	In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded?	N/A
	5.4.	In case control study, was case definition explicit and case ascertainment not influenced by exposure status?	Yes
	5.5.	In diagnostic study, were test results blinded to patient history and other test results?	N/A
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
	6.2.	In observational study, were interventions, study settings, and clinicians/provider described?	N/A
	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?	Yes
	6.8.	In diagnostic study, were details of test administration and replication sufficient?	N/A
7.	Were outcomes clearly defined and the measurements valid and reliable?		???
	7.1.	Were primary and secondary endpoints described and relevant to the question?	N/A
	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?	???
	7.5.	Was the measurement of effect at an appropriate level of precision?	???
	7.6.	Were other factors accounted for (measured) that could affect outcomes?	No
	7.7.	Were the measurements conducted consistently across groups?	Yes
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)?	N/A
	8.5.	Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)?	N/A
	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?	No
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