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Table 5 Overview of study outcomes, instruments, and assessment details

From: Design of the DYNAMO study: a multi-center randomized controlled trial to investigate the effect of pre-thickened oral nutritional supplements in nursing home residents with dysphagia and malnutrition (risk)

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Outcome

Instruments

Score

Assessment details

Primary

Body Weight

Calibrated lift with integrated scale, mobile chair with integrated scale or wheelchair platform with integrated scale

Body weight weighed to the nearest gram

The resident is in fasting state and preferably dressed in light clothing and without shoes

Secondary

Nutritional intake

Standardized three-day food diary and a kitchen scale

Food products weighed to the nearest gram

Food products, leftovers and napkins with spit out food pieces will be weighed by a member of the trained study team

HRQoL and OD-specific QoL

Standardized questionnaire EQ-5D-5L [33] and VAS: EQ VAS, DSS, DHRQoL [34, 35] and DAS

EQ-5D descriptive system [no problems/slight problems/moderate problems/severe problems/extreme problems]

EQ VAS [0ā€“100 score], DSS [0ā€“10 score], DHRQoL [0ā€“10 score], DAS [0ā€“10 score]

Self-assessment or proxy-assessment

Compliance to test product

Standardized compliance log

Amount of product leftover [no leftover/quarter/half/three quarters/complete leftover]

Filled out by nursing staff

Exploratory

ADL

Validated Barthel Index (BI) [36]

0 [dependent] - 20 [independent]

Conducted by a member of the trained study team

Activity

Activity monitor activPAL3ā„¢ (PAL Technologies Ltd., Glasgow, UK) [37, 38] with activity log

Steps [count], upright/sitting/lying position [hours], stepping/standing position [hours]

Applied and completed by a member of the trained study team

Anthropometrics

Measuring tape

Upper-arm and calf-circumference [cm]

Conducted by a member of the trained study team

Blood nutritional- and hydration parameters

Laboratory analysis

Osmolality [mOsmol/kg], sodium [mmol/L], vitamin D [nmol/L], vitamin B12 [pmol/L], folate [nmol/L], magnesium [mmol/L], albumin (g/L) and calcium [mmol/L]

Clinical chemical and hematological laboratory of the Zuyderland Hospital (Heerlen-Sittard, the Netherlands)

Vital signs

Electronic blood pressure monitor

Heart rate [bpm] and systolic and diastolic blood pressure [mmHg]

Conducted by a member of the trained study team

Oxygen saturation

Oximeter

Oxygen saturation level [%]

Conducted by a member of the trained study team

Dysphagia severity: swallowing assessment

3-oz WST [26], swallow observation, water thickness test, Modified version of the MISA [27]

Swallow of 3ā€‰oz water [positive/negative], descriptive report summary of swallow observation, safest thickness level of liquids for swallowing, completed modified MISA

Conducted by the trained SLT

More details in Table 3

Palatability of the test product

Standardized questionnaire

Taste [1 (poor taste) - 10 (very tasty)], viscosity [too thick/good/too thin], sweetness [too sweet/good/not sweet enough] and swallowing ability [1 (very difficult) - 10 (very easy)]

Self-assessment

Safety

(S)AEs

(S) AE forms

MedDRA Medical Coding

Coding will be done by the data manager

  1. Abbreviations: EuroQol 5-dimensions 5-level (EQ-5D-5L), Visual Analog Scale (VAS), EUROQoL-VAS (EQ-VAS), Dysphagia Severity Scale (DSS), Dysphagia HRQoL (DHRQoL), Dysphagia-related Anxiety Scale (DAS), 3ā€‰oz Water Swallow Test (3-oz WST), McGill Ingestive Skills Assessment (MISA), (Serious) Adverse Event ((S)AE)