UWL: Association With Outcomes (2009)

Citation:
 
Study Design:
Class:
- Click here for explanation of classification scheme.
Quality Rating:
Research Purpose:
  • The primary aim was to describe the prevalence of malnutrition at admittance and after four weeks in rehabilitation stroke center
  • The secondary aim was to analyze existing eating difficulties and feeding dependence in stroke patients and their relation to malnutrition.
Inclusion Criteria:

Stroke patients older than 18 years.

Exclusion Criteria:
  • Pregnant
  • Used diuretic medication
  • Had edema or ascitis
  • Aphasia.
Description of Study Protocol:

Recruitment

Stroke patients admitted to the Centre for Rehabilitation, University Medical Centre Groningen during the 18-month study period.

Design

Descriptive, before-and-after study. 

Intervention

  • Four weeks of stroke rehabilitation 
  • Nutritional intervention under supervision of a dietitian was given to 74% of malnourished patients, but the intervention was not described.

Statistical Analysis

  • Statistical analyses were performed with Fisher's exact test, chi-square test, McNemmar test, Mann-Whitney U test and Student's T-test for independent observations as appropriate
  • Confidence intervals calculated by using the Wilson method.
Data Collection Summary:

Timing of Measurements

Study period lasted 18 months. Weight measured at admittance and after four weeks of rehabilitation.

Dependent Variables

  • Malnutrition was defined as unintentional weight loss (more than 5% in one month or more than 10% in six months) or low BMI (less than 18 if under age 65, less than 22 if over age 65)
  • Height measured with measuring rod
  • Weight measured in light clothing without shoes 
  • Body composition assessed through bioelectrical impedance analysis
  • Malnutrition was also defined as serum albumin less than 35g per L; fat free mass less than 16kg/m2 for men, less than 15kg/m2 for women; triceps skinfold less than 90% of 12.5mm for men or 16.5mm for women; or mid-arm muscle circumference less than 90% of 25.3cm for men or 23.3cm for women  
  • Structured observations of eating difficulties and feeding dependence were performed at a regular meal, assessed by a speech therapist. 

Independent Variables

Four weeks of stroke rehabilitation and nutritional intervention.

Description of Actual Data Sample:
  • Initial N: 114 admitted stroke patients. 19 were excluded due to severe aphasia, one due to pregnancy; 17 refused to participate. In eight patients, nutritional status could not be assessed due to logistical problems. 69 were included in the study.
  • Attrition (final N): 60 of 69 were reassessed after four weeks (68% male, 32% female)
  • Age: Mean age 56.7±11.0 years
  • Location: The Netherlands.
Summary of Results:

Prevalence of Malnutrition for Separate Criteria

Variables

Malnourished at Admission

Malnourished After Four Weeks

P-value

Weight loss

32% 2% 0.000
BMI 4% 2% 0.500
Serum albumin 10% No data available ---
Fat-free mass 15% 5% 0.031
Triceps skin fold 38% 32% 1.000

Mid-arm muscle circumference

20%

15%

0.453

Other Findings

  • On admittance, malnutrition was present in 35% of the patients and decreased to 3% after four weeks of rehabilitation (P<0.05)
  • In total, 43% of the patients had one or more eating difficulties (19% were leaking food from the mouth, 18% were hoarding food in the mouth, 12% were spilling by transport to the mouth, 12% had aberrant eating speed, 12% had swallowing problems, 10% had reduced alertness, 7% were eating less than three-quarters of served food, 3% had ineffective lip closing, 3% were not sitting upright and 3% had poor retention of dentures) 
  • 16% were dependent in feeding (15% were unable to cut food, 6% were unable to spread, and 2% were unable to swallow)
  • None of the patients were dependent in holding cutlery, transporting food to the mouth, biting and chewing
  • None of the patients was tube fed
  • Feeding dependence was more frequently present in patients with one or more eating difficulties (33%) than in patients with no eating difficulties (7%, P<0.05)
  • Aberrant eating speed was significantly associated with the presence of malnutrition at admission (25% of malnourished, 5% of well-nourished, P<0.05)
  • Eating difficulties or feeding dependencies were not significantly associated with malnourishment at four weeks. 
Author Conclusion:

The prevalence of malnutrition at admittance for stroke rehabilitation is high, and decreases significantly during rehabilitation. Research is needed into constructs of malnutrition, eating difficulties and feeding dependence.

Funding Source:
Industry:
Nutricia
Other:
Reviewer Comments:

Relatively small sample size. Stroke rehabilitation and nutritional intervention for four weeks was not described. Authors note that through excluding patients with severe aphasia, they may have excluded a population with more severe neurological problems, influencing the prevalence of malnutrition.

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? 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? ???
  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? ???
  2.2. Were criteria applied equally to all study groups? N/A
  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? ???
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? 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.) Yes
  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? No
  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? ???
  6.5. Were co-interventions (e.g., ancillary treatments, other therapies) described? No
  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
  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? 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? Yes
  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? ???
  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? ???
  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)? 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