EAL

UWL: Screening and Assessment Methods (2009)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

To describe the Individual Nutrition Rx (INRx) assessment process and report preliminary findings on baseline nutritional status, common nutrition problems identified by the INRx protocol and specific individualized interventions.

Inclusion Criteria:

At least 65 years of age
One or more risk factors for malnutrition
Lived within the nursing home for at least three weeks
Exhibited normal to moderately impaired cognitive abilities (measured by Mini-Mental State Examination [MMSE] more than 11)
Did not have an end-stage terminal diagnosis (renal disease, cancer, primary diagnosis of COPD).

Exclusion Criteria:

Excluded if not included above.

Description of Study Protocol:

Recruitment

Residents from two 250-bed for-profit southwest nursing homes were invited to participate.

Design

Non-randomized clinical trial.

Intervention

Participants in the intervention group received the six-month INRx protocol, which utilizes a predictive model for participant identification, a systematic assessment process and evidence-based interventions to improve nutritional status of at-risk residents. An extensive, weekly RN assessment process and chart review by a licensed dietitian and registered pharmacist was used to identify nutritional problems in the intervention group.
Participants in the comparison group received care routine to their nursing home.

Statistical Analysis

Descriptive statistics. Statistical methods not reported.

Data Collection Summary:

Timing of Measurements

Measurements taken at baseline and at six months.

Dependent Variables

Nutritional status measured using BMI, and serum albumin and prealbumin
Common nutritional problems
Specific individualized interventions.

Independent Variables

INRx protocol
Routine care.

Description of Actual Data Sample:

Initial N: 80 residents (60 females, 20 males)
Attrition (final N): 80, unclear as to how many in each group
Age: Mean 81.13±8.62 years (range 65 to 98 years)
Anthropometrics: Similarity of groups at baseline not discussed
Location: Two southwest nursing homes in the US.

Summary of Results:

Participant BMI ranged from 17.09 to a high of 43.98. Of those, 23% were underweight (BMI less than 22, indicating malnutrition), 18% had normal weight and 59% were either overweight or obese
19% of participants had abnormal serum albumin levels and 32.8% had abnormal serum prealbumin levels, indicating diminished protein stores and protein calorie malnutrition
Frequent nutritional problems identified through the INRx assessment process were appetite change (due to chronic pain, depression or weight loss), poor positioning while eating (table too high, wheelchair uncomfortable, wheelchair legs up, resident always reclined) and oral status concerns (due to sore gums and mouth pain, difficulty swallowing, difficulty chewing and poor fitting dentures)
25% of all intervention group residents had one or more of these modifiable problems
Other problems identified included difficulty feeding self (due to poor hand-to-mouth coordination, poor vision or inability to reach items on tray), poor nutritional status (abnormal serum potassium, albumin or prealbumin levels), environment not conducive to eating (noisy dining room, non-supportive dining room staff) and personal preferences not honored
Intervention most commonly identified included proper positioning when eating, the use of antidepressant medications and the repair of dentures.

Author Conclusion:

At the conclusion of this research study, the INRx protocol will have been tested to determine whether it improves resident outcomes in the areas of nutritional status, quality of life, morbidity and health care utilization. Successes demonstrated with the INRx protocol should be incorporated into evidence-based nursing practice and interdisciplinary approaches within the nursing homes.

Funding Source:

Government:

NIH/NINR 1 R15 NR008382-01A1

Reviewer Comments:

Assignment to groups and similarities between groups were not discussed. Statistical methods were not reported.

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?		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)	No
	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.)	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?		???
	4.1.	Were follow-up methods described and the same for all groups?	No
	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%.)	???
	4.3.	Were all enrolled subjects/patients (in the original sample) accounted for?	???
	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?		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?	Yes
	6.6.	Were extra or unplanned treatments described?	Yes
	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?		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?	Yes
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?	No
	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)?	???
	8.6.	Was clinical significance as well as statistical significance reported?	???
	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