Nutrition Screening - Route to a More Practical Method

Observational study. Comparison of existing nutritional screening tools based on questionnaires with blood tests already performed on a routine basis.

No intervention undertaken.

Study Overview

• Status: Completed
• Conditions: Internal Medicine
• Intervention / Treatment: Diagnostic test: Standard nutrition screening tools to be compared with routine blood tests

Detailed Description

Nutrition screening is of established benefit but is difficult to ensure in ordinary clinical practice. It is relatively labour intensive. The investigation aims to determine whether routinely collected laboratory data could provide comparable information without the need for personnel time. It is known that individual blood tests do not provide sufficient sensitivity or specificity but it is hypothesised that combinations of tests could do so.

Included subjects are those admitted to the University Hospital department of internal medicine. All are eligible other than those subject to protective isolation for infection control (COVID, etc). Data collection is in the form of questionnaires to permit the calculation of 3 tools widely used for screening for malnutrition and malnutrition risk, namely the Malnutrition Universal Screening Tool (MUST), the Nutrition Risk Screening 2002 (NRS-2002) and the Subjective Global Assessment (SGA). Nutritional status is documented by the patient's status according to the international definition provided by the Global Leadership Initiative on Malnutrition (GLIM).

The blood tests already performed on a routine basis are captured to go alongside the nutrition screening tools.

Analysis will aim to determine whether combinations of laboratory data can simulate or replicate the information provided by MUST and NRS2002.

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• Estonia
  • Tartumaa
    • Tartu, Tartumaa, Estonia, 50406
      • Tartu Ulikooli Kliinikum

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

In-patient in department of internal medicine

Description

Inclusion Criteria:

In-patient in department of internal medicine

Exclusion Criteria:

Unable to complete questionnaire or in protective isolation

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of new nutrition risk screening tool (devised from 200 patients) by validation in 100 contemporaneous patients in comparison with established screening tools (MUST, NRS-2002 and SGA) and malnutrition defined by GLIM.	Established tools for screening and assessing nutritional status are utilised. These are the Malnutrition Universal Screening Tool (MUST), the Nutrition Risk Screening-2002 (NRS-2002), the Subjective Global Assessment (SGA) and the Global Leadership Initiative on Malnutrition (GLIM). Data from laboratory testing that has already been performed on these patients is extracted from their hospital records. It is hypothesised that multivariate analysis of indicative parameters will identify 6 to 12 tests that can be combined (with appropriate weighting) into a new predictive score. 300 sets of patient data will be divided on a randomised basis into a group of 200 from whom the prospective new scoring system will be devised, and a group of 100 in whom the score will be tested for validity against NRS-2002.	Within 6 months of completion of recruitment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Validation of new score against GLIM	The intended new score will be tested against GLIM. The primary validation is against NRS-2002 as the score is intended as a screening tool for high risk of malnutrition, but it is important to determine whether it is also a test of established malnutrition.	Within 6 months of completion of recruitment

Collaborators and Investigators

• Sponsor: University of Tartu

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2021
• Primary Completion (Actual): March 23, 2022
• Study Completion (Actual): March 23, 2022

Study Registration Dates

• First Submitted: September 8, 2022
• First Submitted That Met QC Criteria: September 14, 2022
• First Posted (Actual): September 19, 2022

Study Record Updates

• Last Update Posted (Actual): September 19, 2022
• Last Update Submitted That Met QC Criteria: September 14, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: PKL-127

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No