UWL: Food, Appetite and Environment (2009)

Citation:
 
Study Design:
Class:
- Click here for explanation of classification scheme.
Quality Rating:
Research Purpose:
  • The aim of the study was to describe eating difficulties and swallowing in patients with dysphagia, nursing interventions and the development of complications over three months
  • The aim was also to explore common characteristics of eating difficulties that influenced the ability to finish meals.
Inclusion Criteria:

All patients consecutively admitted with stroke to either a medical clinic or a geriatric rehabilitation ward were tested for dysphagia using an interview, observations and test swallows.

Exclusion Criteria:
  • Unconscious
  • Terminally ill
  • No previous history of dysphagia.
Description of Study Protocol:
  • Recruitment: Not specified
  • Design: Descriptive study
  • Intervention: Individually designed by the author.

Statistical Analysis

  • Friedman's two-way ANOVA for dependent samples, Kruskall-Wallis one-way ANOVA for three independent samples, Mann-Whitney U-test for two independent samples
  • Wilcoxon signed rank test was used to analyse differences in type of housing before and after hospital stay
  • A P-value of less than 0.05 was used for statistical significance.
Data Collection Summary:
  • Timing of measurements: Baseline assessment was carried out within 48 hours of stroke in 15 cases and after 48 hours in nine cases. Reassessment for complications occurred at three months.   
  • Dependent variables: Eating difficulties and swallowing
  • Independent variables: Individualized interventions.
Description of Actual Data Sample:
  • Initial N: 131 patients were screened and 24 found to have dysphagia
  • Attrition (final N): Not addressed
  • Age: Median of 77 years
  • Ethnicity: Swedish
  • Other relevant demographics: 10 were women, seven living alone, all were living in their own homes and three received home help serivces
  • Location: Lund, Sweden.
Summary of Results:
Variables
Total (N=24)
Not Able to Complete a Meal (N=9)
Completed Meal with Great Difficulty (N=5)
Completed Meal with Minor Difficulty (N=10)
P-Value
Weight Loss, (% Change from Admission) Median (Min-Max) 
2 weeks
-0.9
(-9.3 to +3.0)
-4.0
(-9.3 to +0.4)
+0.0
(-1.3 to +0.5)
+6.0
(-5.5 to +3.0)
<0.23
1 month
-1.2 (-12.4 to +2.6)
-5.7
(-12.4 to +0.0)
+0.5
(-1.9 to +2.0)
-0.8
(-6.6 to +2.6)
<0.05*
3 months
 -3.5
(-20.0 to +3.7)
 -7.1
(-20.0 to -3.5)
-2.2
(-12.3 to +3.7)
-2.0
(-18.3 to +2.9)
 <0.05*
P-value
<0.13
<0.02
<0.77
<0.91
 
Serum-Albumin, Median (Min-Max)
Baseline
40.0
(25.0-44.0)
37.0
(28.0-43.0)
36.0
(25.0-41.0)
42.0
(43.0-44.0)
<0.16
2 weeks
40.0
(21.0-47.0)
38.5
(26.0-45.0)
38.0
(21.0-47.0)
41.0
(35.0-45.0)
 <0.59
1 month
38.0
(24.0-46.0)
38.0
(25.0-40.0)
38.0
(24.0-42.0)
41.0
(36.0-46.0)
<0.21
3 months
42.0
(31.0-52.0)
42.5
(35.0-46.0)
42.0
(31.0-48.0)
42.0
(36.0-52.0)
 
P-value
<0.003
<0.05
<0.26
<0.22
 

 

Kruskal-Wallis test between three groups, Mann-Whitney U-test between two groups, Freidman test for differences over time. Reduced P-value <0.017 used between two groups. Internal drop-out varies between one and four. 
*No significant difference between the two groups when applying reduced P-value limit <0.017.
Author Conclusion:

The findings from this study indicate that the planning and implementation of interventions to improve and adapt eating and swallowing in patients with acute stroke and dysphagia, have to be based not only on the neurological damage but on the overall functional ability of the patient, for instance their alertness and energy and ability to learn and adopt different strategies.

Funding Source:
Reviewer Comments:
  • The authors did not identify a nutrition or weight history or any conditions such as medications or disease that could influence weight or feeding behavior
  • The authors do not report whether weight was reported or measured
  • Clinical significance of weight change was not discussed and likely insignificant
  • At the end of the study, weight change ranged from 2% (likely within the order of magnitude of normal diurnal weight variation) to 7%, which might be clinically relevant.
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) Yes
 
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? No
  1.2. Was (were) the outcome(s) [dependent variable(s)] clearly indicated? No
  1.3. Were the target population and setting specified? Yes
2. Was the selection of study subjects/patients free from bias? ???
  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? No
  2.2. Were criteria applied equally to all study groups? ???
  2.3. Were health, demographics, and other characteristics of subjects described? No
  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) N/A
  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
  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.) N/A
  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? N/A
  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%.) N/A
  4.3. Were all enrolled subjects/patients (in the original sample) accounted for? N/A
  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? No
  5.1. In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate? No
  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.) No
  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? N/A
  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? No
  6.1. In RCT or other intervention trial, were protocols described for all regimens studied? N/A
  6.2. In observational study, were interventions, study settings, and clinicians/provider described? ???
  6.3. Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect? ???
  6.4. Was the amount of exposure and, if relevant, subject/patient compliance measured? ???
  6.5. Were co-interventions (e.g., ancillary treatments, other therapies) described? No
  6.6. Were extra or unplanned treatments described? No
  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? No
  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? Yes
  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? No
  8.1. Were statistical analyses adequately described and the results reported appropriately? No
  8.2. Were correct statistical tests used and assumptions of test not violated? No
  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)? No
  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? No
  8.7. If negative findings, was a power calculation reported to address type 2 error? ???
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