Impact of the French and International Definitions and the Type of Muscle Assessment Tool on the Prevalence of Undernutrition in Hospitalized Patients
Conditions: Undernutrition
Sponsor: Hopital Forcilles

PROTEIN 
 
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Evaluation of the impact of the French and international 
definitions and the type of the muscle assessment tool on the 
prevalence of undernutrition in hospitalized patients 
 
PROTEIN 
PRevalence and muscle OuTcomEs of undErnutritIoN in hospitalized patients 
 
Version n°2 of 14 /12 /2021 
Protocol code 
number 
RCB ID 
IRB NUMBER 
CNIL or MR 
number 
No. Clinical 
Trial 
2021-07-01 
2021-A02410-41 
2021-94  
MR001 
<...> 
 
Interventional research involving humans with minimal risk and minimal burden 
 
PRINCIPAL INVESTIGATOR 
Ilham BENHARRATS, internist, Gastro-nutrition Department, Forcilles Hospital 
CO-INVESTIGATORS 
Virginie COLELLA, APA teacher, rehabilitation 
department, Forcilles Hospital 
Aymeric LE NEINDRE, physiotherapist, clinical 
research department, Forcilles Hospital 
Carlos DIAZ LOPEZ, physiotherapist, rehabilitation 
department, Forcilles Hospital 
Mohand TAGZIRT, geriatrician, Forcilles Hospital, 
Gastro-nutrition department 
Leïla NAHAL, dietician, dietetics department, 
Forcilles Hospital 
Salima KALLA, Oncologist, Oncology Department, 
Forcilles Hospital 
Cécile SERON, dietician, dietetics department, 
Forcilles Hospital 
Maxime CADORET, dietician, dietetics department, 
Forcilles Hospital 
Tom BARBOSA, APA teacher, Rehabilitation 
Department, Forcilles Hospital 
Caroline O'CONNELL, Respirologist, Department of 
Respirology, Forcilles Hospital 
Sophie VIDAL-JESSEL, diabetologist, obesity-
nutrition service, Forcilles Hospital 
 
METHODOLOGY-STATISTICS 
Philippe AEGERTER, Methodologist, GIRCI Ile-de-France 
 
Promoter : 
Forcilles Hospital-Cognacq-Jay Foundation 
Route de Servon 
77150 Férolles-Attilly 
Contact: 
Aymeric LE NEINDRE, Clinical Research Coordinator 
Tel: 01 60 64 60 93 
Mail: aleneindre@cognacq-jay.fr  

 
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KEY CONTACTS 
FIRST NAME, LAST 
NAME 
ROLE 
FUNCTION 
CONTACT INFORMATION 
Ilham BENHARRATS 
Principal 
investigator 
Internist 
ibenharrats@cognacq-jay.fr 
01.60.64.61.78 
Virginie COLELLA 
Co-investigator 
APA teacher 
vcolella@cognacq-jay.fr 
Aymeric LE NEINDRE 
Co-investigator 
Physiotherapist 
aleneindre@cognacq-jay.fr 
Carlos DIAZ LOPEZ 
Co-investigator 
Physiotherapist 
clopez@cognacq-jay.fr  
Salima KALLA  
Co-investigator 
Oncologist 
skalla@cognacq-jay.fr  
Leïla NAHAL 
Co-investigator 
Dietician 
lnahal@cognacq-jay.fr  
Mohand TAGZIRT  
Co-investigator 
Geriatrician 
mtagzirt@cognacq-jay.fr  
Cécile SERON 
Co-investigator 
Dietician 
cseron@cognacq-jay.fr  
Maxime CADORET 
Co-investigator 
Dietician 
mcadoret@cognacq-jay.fr  
Tom BARBOSA 
Co-investigator 
APA teacher 
tbarbosa@cognacq-jay.fr  
Caroline O'CONNELL  
Co-investigator 
Pneumologist 
coconnell@cognacq-jay.fr  
Sophie VIDAL-JESSEL , 
Co-investigator 
Diabetologist 
svidaljessel@cognacq-jay.fr  
Philippe AEGERTER 
Methodology 
Public health doctor 
philippe.aegerter@uvsq.fr 

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PROTOCOL VERSION HISTORY 
 
Version 
Date 
Reason for the 
amendment 
2 
14/12/2021 
Requests for changes to the 
IRB 
 
 
 
 
 
 
 
 
 

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SUMMARY OF THE RESEARCH 
Manager 
Forcilles Hospital-Cognacq-Jay Foundation 
Person who 
directs and 
monitors the 
research 
Aymeric LE NEINDRE 
Title 
Evaluation of the impact of the French and international definitions and the type 
of the muscle assessment tool on the prevalence of undernutrition in hospitalized 
patients 
Acronym 
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Protocol version 
n°2 of 14 /12 /2021 
Rationale / 
context 
In France, the prevalence of undernutrition among hospitalized patients varies 
from 30 to 50%. Undernutrition is strongly associated with a decrease in the 
patient's functional capacities and an increase in morbidity and mortality and in 
healthcare costs. 
In 2019, both the Global Leadership Initiative on Malnutrition (GLIM) and the 
Haute Autorité de Santé (HAS) published updated diagnostic criteria for 
undernutrition in adults aged <70 years. Aetiological and phenotypic criteria are 
retained: reduced food intake, inflammatory state, weight loss, BMI and reduced 
muscle mass. Reduced muscle mass has become a major diagnostic criterion 
and various measurement tools are suggested, such as bioelectrical 
impedancemetry, grip strength measurement or magnetic resonance imaging. 
Collaboration between dieticians, physiotherapists, nurses, care assistants and 
doctors makes it possible to respond to the need to screen for undernutrition 
according to these new definitions, which involve a multidisciplinary assessment. 
These two definitions are very close but differ on the time period of weight loss, 
on the BMI cut-off values and on the thresholds for muscle mass loss. The GLIM 
definition may be less selective than the HAS definition. 
We hypothesize that the prevalence of undernutrition in a population of adult 
patients hospitalized in diabetology-obesity, pneumology, oncology and gastro-
nutrition, < 70 years old, is different according to the diagnostic criteria 
recommended by the HAS or by the GLIM, and may be associated with a different 
patient morbi-mortality. In addition, the choice of the method of assessment of 
muscle function could impact this prevalence. 
Main objective 
The main objective of this study is to compare the prevalence of global 
undernutrition based on the diagnostic criteria recommended by the HAS with that 
based on the diagnostic criteria recommended by the GLIM, in patients 
hospitalised in short stay and follow-up and rehabilitation care in diabetology-
obesity, pneumology, oncology and gastro-nutrition 
Secondary 
objectives 
The secondary objectives will be, for patients hospitalised in short stay and 
follow-up care and rehabilitation of diabetes-obesity, pneumology, oncology and 
gastro-nutrition: 
 To compare the prevalence of severe undernutrition between the HAS 
and GLIM groups; 
 To compare the morbi-mortality of undernutrition between the HAS and 
GLIM groups on : 
o 
Length of stay ; 
o 
Mortality rate ; 
o 
Autonomy at discharge. 
 To evaluate the impact of the choice of muscle function assessment tool 
on the prevalence of undernutrition in the HAS and GLIM groups. 

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Research scheme 
Prospective, monocentric, interventional cohort study with minimal risks and 
constraints falling within the scope of article L.1121-1 of the Public Health Code. 
Inclusion criteria 
- Admitted to short stay and follow-up care and rehabilitation of diabetes-
obesity, pneumology, oncology and gastro-nutrition; 
- Age between 18 and 70 years at the time of inclusion ; 
- Affiliation with a social security scheme or beneficiary of such a scheme ; 
- Oral, free, informed and express consent of the patient or his/her relative. 
Non-inclusion 
criteria 
- Inability to perform bioelectrical impedance measurement ; 
- Patient's refusal to participate in the study ; 
- Known pregnancy ; 
- Person subject to a legal protection measure ; 
- Patient under guardianship or curatorship ; 
- Patient with limited care ; 
- Randomisation in the ineligible study group. 
Primary endpoint 
Prevalence of global undernutrition in patients hospitalised in short stay and 
follow-up and rehabilitation care for diabetes-obesity, pneumology, oncology and 
gastro-nutrition, according to the diagnostic methods of the HAS and GLIM 
Secondary 
evaluation criteria 
 
Prevalences of severe undernutrition according to the HAS and GLIM 
diagnostic methods; 
 
Morbidity and mortality criteria in the HAS and GLIM moderate and severe 
undernutrition groups: 
o 
Duration of hospital stay (days) ; 
o 
Mortality: proportion and date of occurrence of death among 
patients included during hospitalisation; 
o 
Autonomy at discharge: Activities Daily Living score (ADL, 
Appendix X). 
 
Tools for measuring muscle function : 
o 
Bioelectrical impedance measurement ; 
o 
Handgrip ; 
o 
Walking speed. 
Group 
comparison 
Patients hospitalised in short stay and follow-up and rehabilitation care for 
diabetes-obesity, pneumology, oncology and gastro-nutrition. 
Number of 
subjects needed 
260 
Expected number 
of centres 
1 
Duration of the 
research 
21 months 
Statistical 
analysis of data 
Univariate comparisons will use the usual statistical tests after verification of the 
distribution of the variables (Chi2 or Fisher's test, t-test, anova or their non-
parametric equivalents Wilcoxon and Kruskal-Wallis tests). The variables will be 
compared between the two groups by the appropriate tests according to the type 
of variables (quantitative or qualitative) and their distribution. 
Expected benefits 
The results of this study will make it possible to verify whether the GLIM definition 
increases the prevalence of undernutrition compared to that of the HAS. The use 
of one or other of the definitions could thus have an impact on the medical and 
paramedical management of undernutrition. On the other hand, muscle function 
benefits from different assessment tools, which could lead to a different estimate 
of the reduction in muscle mass and therefore a different prevalence of 
undernutrition. The results of our study will help to evaluate this and guide 
professionals in the choice of tools for assessing muscle function. 
Source of funding 
Forcilles Hospital-Cognacq-Jay Foundation 

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Independent 
Supervisory 
Committee 
planned 
No 
 
 

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Table of contents 
PROTOCOL VERSION HISTORY........................................................................................... 3 
SUMMARY OF THE RESEARCH ........................................................................................... 4 
1 
Rationale for the research ....................................................................................... 10 
1.1 
Epidemiology and morbidity of undernutrition ............................................................ 10 
1.2 
Definitions of undernutrition ....................................................................................... 10 
1.3 
International consensus on the definition of undernutrition ......................................... 11 
1.4 
New definition of undernutrition adopted in France..................................................... 11 
1.5 
Convergences and divergences between the international and French definition .......... 12 
1.6 
Roles of professionals in screening for undernutrition .................................................. 13 
1.7 
Assessment of muscle function .................................................................................... 13 
1.8 
Research hypothesis .................................................................................................... 14 
2 
Originality of the research ....................................................................................... 14 
3 
Objective ................................................................................................................. 15 
3.1 
Main objective ............................................................................................................ 15 
3.2 
Secondary objectives ................................................................................................... 15 
4 
Judging criteria ..................................................................... Erreur ! Signet non défini. 
4.1 
Primary endpoint ........................................................................................................ 15 
4.2 
Secondary endpoint .................................................................................................... 16 
5 
Critères d’éligibilité.................................................................................................. 17 
5.1 
Critères d’inclusion ...................................................................................................... 17 
5.2 
Non-inclusion criteria .................................................................................................. 17 
5.3 
Recruitment procedures .............................................................................................. 17 
6 
Conception de la recherche ...................................................................................... 18 
6.1 
Type d’étude ............................................................................................................... 18 
6.2 
Research outline ......................................................................................................... 18 
6.3 
Provisional research timetable .................................................................................... 18 
6.4 
Lieu de l’étude ............................................................................................................ 19 
7 
Description de la prise en charge habituelle ............................................................. 19 
7.1 
Déroulement habituel de la prise en charge ................................................................. 19 
7.2 
Procédures d’évaluation habituelles ............................................................................ 19 

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7.2.1 
Evaluation nutritionnelle .............................................................................................. 19 
7.2.2 
Mesures anthropométriques ........................................................................................ 20 
7.2.3 
Mesures biologiques ..................................................................................................... 20 
7.2.4 
Mesures de la fonction musculaire ............................................................................... 20 
8 
Procédure d’évaluation rajoutée par la recherche .................................................... 21 
8.1 
Score Mini-Nutritionnal Assessment Short Version (MNA-SF) ....................................... 21 
8.2 
Diagnostic de la dénutrition selon les critères du GLIM ................................................. 21 
8.3 
L’impédancemétrie bio-électrique ............................................................................... 21 
9 
Déroulement de la recherche ................................................................................... 22 
9.1 
Visite de pré-inclusion ................................................................................................. 22 
9.1.1 
Vérification des critères d’inclusion et de non inclusion .............................................. 22 
9.1.2 
Randomisation .............................................................................................................. 22 
9.1.3 
Information et consentement du patient ..................................................................... 23 
9.2 
Visite d’inclusion ......................................................................................................... 23 
9.3 
Visite fin de recherche ................................................................................................. 23 
9.4 
Tableau récapitulatif ................................................................................................... 24 
10 
Définition des critères d’évaluation et techniques de mesure ............................... 25 
10.1 
Prévalence de la dénutrition ........................................................................................ 25 
10.2 
Impédancemétrie bio-électrique .................................................................................. 26 
10.3 
Critères de morbi-mortalité ......................................................................................... 26 
10.3.1 
Durée d’hospitalisation ................................................................................................. 26 
10.3.2 
Mortalité ....................................................................................................................... 27 
10.3.3 
Score Activities Daily Living (ADL) de Katz .................................................................... 27 
11 
Aspects statistiques .............................................................................................. 28 
11.1 
Calcul du nombre de sujet nécessaire .......................................................................... 28 
11.2 
Aspects généraux ........................................................................................................ 28 
11.3 
Objectif principal ......................................................................................................... 29 
11.4 
Objectifs secondaires .................................................................................................. 29 
11.4.1 
Comparaison des prévalences de la dénutrition sévère ............................................... 29 
11.4.2 
Comparaison de la morbi-mortalité.............................................................................. 29 
11.4.3 
Comparaison des outils d’évaluation de la fonction musculaire .................................. 30 
12 
Résultats attendus en termes d’avancées scientifiques et professionnelles ........... 30 

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13 
Bénéfices et risques attendus pour les patients .................................................... 30 
13.1 
Risques et contraintes minimes ajoutés par la recherche .............................................. 30 
13.2 
Bénéfices attendus pour le patient .............................................................................. 31 
14 
Faisabilité............................................................................................................. 31 
15 
Aspects éthiques et réglementaires ...................................................................... 32 
15.1 
Rôle du promoteur ...................................................................................................... 32 
15.2 
Soumission au CPP ...................................................................................................... 32 
15.3 
Protection des données ............................................................................................... 32 
15.4 
Assurance ................................................................................................................... 33 
15.5 
Modification substantielle au protocole ....................................................................... 33 
15.6 
Note d’information et consentement exprès ................................................................ 34 
15.7 
Echéance prévue pour la publication des résultats dans une revue internationale......... 34 
15.8 
Gestion des données ................................................................................................... 35 
15.9 
Moyens humains et financiers ..................................................................................... 35 
15.10 
Propriétés des données ........................................................................................... 35 
16 
Références Bibliographiques ................................................................................ 36 
17 
Annexes ............................................................................................................... 38 
17.1 
Annexe 1 : Echelle ADL (Activities in Daily Living) de Katz (26) ...................................... 39 
17.2 
Annexe 2 : Protocole d’utilisation du Handgrip ............................................................. 40 
17.3 
Annexe 3 : Protocole de réalisation du Gait speed test ................................................. 41 
17.4 
Annexe 4 : Score Mini-Nutritional Assessment Short-Form (MNA-SF) (23) ..................... 42 
17.5 
Annexe 5 : Protocole d’impédancemétrie bio-électrique .............................................. 44 
17.6 
Annexe 6 : Note d’information remise au patient ......................................................... 46 
17.7 
Annexe 7 : Note d’information remise au proche ......................................................... 51 
17.8 
Annexe 8 : Note d’information du patient pour la poursuite de recherche .................... 57 
18 
Liste des investigateurs ........................................................................................ 62 
 
 
 

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1 Rationale for the research 
1.1 Epidemiology and morbidity of undernutrition 
Undernutrition, whether linked to disease, poverty, hunger, war or natural disasters, affects 
more than 1 billion people worldwide (1). In France, an empirical estimate suggests a 
prevalence of undernutrition among hospital patients of about 2 million (2) or 30 to 50%. (3). 
It should be remembered that undernutrition is very common in and out of hospital. It is widely 
accepted that undernutrition can be caused by a deficit in nutrient intake or malabsorption. 
However, it is now known that the inflammatory state present during an illness is associated 
with undernutrition (1). The inflammatory state promotes anorexia and decreased intake but 
also increases basal metabolic rate and muscle catabolism. Undernutrition is marked by a 
decrease in all markers of muscle mass (1). It is thus strongly associated with a reduction in 
the patient's functional capacities and an increase in morbidity and mortality and health costs 
(1,4–6). 
 
1.2 Definitions of undernutrition 
The definition of undernutrition has lacked consensus for many years on the diagnostic criteria 
to be applied in clinical practice (1,7). In France, undernutrition has been the subject of 
numerous definitions as shown by the various publications since 1971 (7). Currently, 
undernutrition is defined as an imbalance in the energy and/or protein balance, producing a 
measurable change in body functions and/or composition, and worsening the prognosis of 
diseases (8,9). In France, undernutrition in patients under the age of 70 has long been defined 
according to the presence of at least one of the following diagnostic criteria (10,11) : 
- 
Weight loss ≥ 10% from previous weight or ≥ 5% in one month; 
- 
BMI ≤ 18.5 kg/m2  ; 
- 
Albumin level (excluding inflammatory syndrome) < 30g/l ; 
- 
Pre-albumin < 110mg/l. 
Undernutrition was qualified as severe if weight loss was greater than 15% in 6 months or ≥ 
10% in one month, or if albuminemia excluding inflammatory syndrome was less than 20g/l 
and pre-albuminemia less than 50 mg/l. This definition did not take into account the impact of 
undernutrition on the patient's body composition and functional capacities, which are 
nevertheless the reflection of a significant clinical impact of undernutrition (9,12). 
 

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1.3 International consensus on the definition of undernutrition 
In 2019, the Global Leadership Initiative on Malnutrition (GLIM) published an international 
consensus report on diagnostic criteria for undernutrition (1). The diagnostic criteria are 
numerous, and include aetiological criteria such as reduced food intake; an inflammatory 
context; symptoms such as anorexia, fatigue; phenotypic criteria such as weight loss, body 
mass index (BMI), fat to lean mass ratio, fluid retention and muscle function. 
GLIM has chosen to retain the most relevant criteria among the etiological and phenotypic 
criteria: 
- 
Aetiological criteria: reduced food intake and inflammatory state of the patient; 
- 
Phenotypic criteria: weight loss, BMI and reduction in muscle mass. 
Muscle mass is described as a major diagnostic criterion, since it is a direct indicator of protein 
catabolism linked to undernutrition, but also a reflection of functional impairment in the patient, 
since it is directly associated with functional capacities, autonomy and prognosis (1). Various 
measurement tools are suggested, such as bioelectrical impedancemetry, ultrasound or 
magnetic resonance imaging, leaving the choice of tool to the clinicians, depending on 
experience and local resources. Handgrip measurement is considered a complementary 
measure. GLIM advises an assessment of the risk of undernutrition, using validated 
questionnaires such as the NRS (Nutritional Risk Screening) or the MNA-SF (Mini Nutritional 
Assessment-Short Form). The degree of severity of undernutrition is only assessed on the 
basis of phenotypic criteria. 
 
1.4 New definition of undernutrition adopted in France 
The French National Authority for Health (HAS) revised the definition of undernutrition in adults 
(< 70 years) in 2019 (7)This definition is very similar to the GLIM definition, but differs in some 
important respects. It includes the use of aetiological and phenotypic criteria, and now includes 
the assessment of muscle strength, gait speed and bioelectrical impedancemetry. It is 
important to note that albuminemia has disappeared from this new definition, in favour of the 
evaluation of the reduction in food intake and the search for an aggressive situation (acute, 
chronic progressive or malignant pathology). The albumin level is only used in the severity 
criteria. This new definition makes it possible to take into account the consequences in terms 
of body composition and functional capacity of undernutrition, the alteration of which is 
associated with a poor prognosis (13). 
 

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1.5 Convergences and divergences between the international and French 
definition 
In adults under 70 years of age, both the GLIM and the HAS recommend screening for 
undernutrition, but the HAS recommendations do not recommend the use of a precise tool for 
assessing the risk of undernutrition. The presence of at least one aetiological criterion and one 
phenotypic criterion is mandatory to make a diagnosis of undernutrition in both situations. The 
differences between the international consensus and the HAS recommendations concern the 
diagnostic criteria used (Table 1). 
 
Table 1: Comparison of the diagnostic criteria for undernutrition between the GLIM (1) 
and HAS definitions (7). 
 
Phenotypic criteria 
Etiological criteria 
Weight loss (%) 
Low BMI 
(kg/m2 ) 
Reduction in 
muscle mass 
Reduction in food 
intake or 
absorption 
Inflammatory 
situation 
GLIM 
> 5% in the last 6 
months or > 10% 
beyond 6 months 
< 20 
Reduction 
assessed by a 
validated 
measurement 
technique*. 
≤ 50% of food intake 
> 1 week or any 
reduction > 2 
weeks, or any 
gastrointestinal 
conditions or 
symptoms impacting 
assimilation or 
absorption 
Acute or certain 
chronic or 
malignant 
conditions 
HAS 
≥ 5% in 1 month or ≥ 
10% in 6 months or loss 
≥ 10% from usual 
weight before onset of 
disease 
< 18,5 
Quantified 
Reduction** (QR) 
Same as 
Same as 
* Methods of measuring muscle mass proposed by GLIM: Dual X-ray Absorptiometry (DEXA); bioelectrical 
impedancemetry; CT or MRI. In the absence of these tools, anthropometric measurements such as arm or leg 
circumference can be used. Grip strength measurement is considered a complementary measure. The cut-off 
values are those of Cruz et al (14). 
** Methods of measuring muscle mass proposed by the HAS:
 
 
The GLIM and HAS diagnostic criteria differ on the time period of weight loss, on the BMI cut-
off values and on the tools for measuring muscle mass/strength/function. 
 

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The severity of undernutrition can then be determined. It can be moderate or severe. GLIM 
defines severity solely according to phenotypic criteria, whereas the HAS uses both 
phenotypic and aetiological criteria (Table 2): 
 
Table 2: Classification of the severity of undernutrition according to GLIM and HAS 
 
Moderate malnutrition 
Severe undernutrition 
GLIM 
 BMI < 20 kg/m2 
 Weight loss of 5-10% in the last 6 months or 10-
20% beyond 6 months 
 Mild to moderate reduction in muscle mass 
 BMI < 18.5 kg/m2 
 Weight loss of >10% in the last 6 
months or >20% beyond 6 months 
 Severe reduction in muscle mass 
HAS 
 17 < BMI < 18.5 kg/m2 
 Weight loss ≥ 5% in 1 month or ≥ 10% in 6 months 
or loss ≥ 10% from usual weight before onset of 
disease 
 Measurement of albumin by immuno-electrometry or 
immunoturbidimetry > 30 g/L and < 35 g/L. 
 BMI < 17 kg/m2 
 Weight loss ≥ 10% in 1 month or ≥ 
15% in 6 months or loss ≥ 15% 
from usual weight before onset of 
disease 
 Measurement of albumin by 
immuno-electrodelemetry or 
immunoturbidimetry < 30 g/L 
 
1.6 Roles of professionals in screening for undernutrition 
In general, and more particularly in the Forcilles hospital, dieticians have a leading role in the 
detection of undernutrition (15,16). They carry out prospective monitoring on the patient's 
admission to hospital, collecting indicators relating to BMI and weight loss, in collaboration 
with the nurses and care assistants. They also carry out a dietetic consultation to clarify the 
above criteria, to evaluate the reduction in intake and absorption, in collaboration with the 
doctor, and to measure body composition, such as bioelectrical impedance measurement. 
The evolution of the definition of undernutrition, with an important place in the muscular and 
functional evaluation of the patient, involves new actors: the physiotherapist and the Adapted 
Physical Activity Teacher (APAT). Indeed, they have expertise in the evaluation of the patient's 
muscular function and functional capacities. As part of his diagnostic assessment, the 
physiotherapist is used to evaluating muscle function by dynamometry (17)As part of the 
diagnostic assessment, the physiotherapist usually assesses muscle function by 
dynamometry, as well as the patient's functional capacities by field tests or the use of scores. 
The EAPA also participates in the performance of field tests. 
The collaboration between dieticians, physiotherapists, EAPAs, nurses, care assistants and 
doctors thus makes it possible to respond to the need to detect undernutrition according to the 
new definitions. 
 
1.7 Assessment of muscle function 
Physiotherapists and EAPAs use different tools to assess different aspects of muscle function, 
such as strength or walking speed in more functional tests. 

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Isometric grip strength is strongly correlated with lower limb muscle strength, and is a poor 
marker of mobility in case of weakness (14). A linear relationship has been observed between 
grip strength and patient disability as measured by the Katz independence scale (18). In 
addition, grip strength was found to be a good predictor of the patient's clinical condition (19). 
The measurement of grip strength, using a dedicated dynamometer, also has the advantage 
of being simple and reproducible (20) and has reference values adjusted for gender and BMI 
(21). 
Gait speed is another indicator used to assess muscle function. Indeed, it is associated with 
lower limb strength and is predictive of disability and mobility limitation (14). The usual walking 
speed is usually measured over a distance of 4 or 6 m and has reference values adjusted for 
sex and height (19). 
Dietitians are also involved in the assessment of muscle function, by measuring body 
composition in terms of lean and fat mass. They perform bioelectrical impedancemetry, which 
estimates the volumes of fat and lean body mass by measuring the resistance of biological 
tissues to a low-intensity, high-frequency electrical current at a distance of sinusoïdal of low 
intensity and high frequency through electrodes (14). This measurement method is simple to 
use, inexpensive, reproducible and feasible in bedridden patients (14). It also correlates very 
well with MRI and reference values are obtained in a variety of adult populations (12,22). 
 
1.8 Research hypothesis 
We hypothesise that the prevalence of undernutrition in a population of patients hospitalised 
in diabetology-obesity, pneumology, oncology and gastro-nutrition, under 70 years of age is 
different according to the diagnostic criteria recommended by the French National Authority 
for Health or those recommended by the Global Leadership Initiative on Malnutrition. 
Moreover, these two definitions could have a different impact on the patient's morbidity and 
mortality. The choice of the method of assessment of muscle function could impact on this 
prevalence. 
 
2 Originality of the research 
The definitions used in the scientific literature to diagnose undernutrition in hospitalised 
patients are heterogeneous and make it difficult to compare populations within different 
studies. The international consensus on the definition of undernutrition could provide a solution 
to these limitations. The recommendation of a new definition of undernutrition in France, which 
differs on certain criteria from that of the international consensus, could lead to a different 
prevalence of undernutrition. To our knowledge, no study has assessed whether the 

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prevalence of undernutrition according to these two definitions is different in hospitalized 
patients. Furthermore, no study has assessed the prognostic character of undernutrition 
according to these two definitions on the morbidity and mortality of these patients. Muscle 
function plays an important role in these two definitions and different measurement tools are 
proposed. The predictive capacity of these different tools on undernutrition has never been 
evaluated or compared. 
 
3 Objective 
3.1 Main objective 
The main objective of this study is to compare the prevalence of global undernutrition based 
on the diagnostic criteria recommended by the French National Authority for Health with that 
based on the diagnostic criteria recommended by the Global Leadership Initiative on 
Malnutrition , in patients hospitalised in short-stay and follow-up care and rehabilitation in 
diabetes-obesity, pneumology, oncology and gastro-nutrition. 
 
3.2 Secondary objectives 
The secondary objectives will be, for patients hospitalised in short stay and follow-up care and 
rehabilitation of diabetes-obesity, pneumology, oncology and gastro-nutrition: 
- To compare the prevalence of severe undernutrition according to the HAS and GLIM 
diagnostic criteria ; 
- To compare the morbidity and mortality of moderate and severe undernutrition 
according to the HAS and GLIM diagnostic criteria : 
 
Length of stay ; 
 
Mortality rate ; 
 
Autonomy at discharge. 
- To compare the predictive capacity of muscle function assessment tools on 
undernutrition according to the HAS and GLIM diagnostic criteria . 
 
4 Outcome 
4.1 Primary outcome 
The main outcome is the prevalence of global undernutrition in patients hospitalised in short 
stay and follow-up and rehabilitation care for diabetes-obesity, pneumology, oncology and 
gastro-nutrition, according to the diagnostic methods of the HAS and GLIM. 

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4.2 Secondary outcomes 
The secondary outcomes will be : 
- 
Prevalences of severe undernutrition according to the HAS and GLIM diagnostic methods; 
- 
Morbidity and mortality criteria related to moderate and severe undernutrition according to 
the HAS and GLIM diagnostic criteria : 
 
Duration of hospital stay (days) ; 
 
Mortality: proportion and date of occurrence of death among patients included 
during hospitalisation; 
 
Autonomy at discharge: Activities Daily Living score (ADL, Appendix 1). 
- 
Measures of muscle function : 
 
Bioelectrical impedance measurement ; 
 
Handgrip ; 
 
Walking speed. 
 
 
 

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5 Eligibility criteria 
5.1 Inclusion criteria 
Patients with the following criteria will be included:  
- Admitted to short-stay and follow-up care and rehabilitation of diabetes-obesity, 
pneumology, oncology and gastro-nutrition; 
- Age between 18 and 70 years at the time of inclusion ; 
- Affiliation with a social security scheme or beneficiary of such a scheme ; 
- Oral, free, informed and express consent of the patient. 
5.2 Non-inclusion criteria 
Patients with the following criteria will not be included:  
- Inability to perform bioelectrical impedance measurement ; 
- Incapacity to consent ; 
- Patient's refusal to participate in the study ; 
- Known pregnancy ; 
- Person subject to a legal protection measure ; 
- Patient under guardianship or curatorship ; 
- Patient with limited care ; 
- Randomisation in the ineligible study group. 
 
5.3 Recruitment procedures 
Patients will be recruited prospectively and consecutively from the departments of diabetes-
obesity, pneumology, oncology and gastro-nutrition at the Forcilles Hospital. The dietician of 
the unit identifies the patients on admission to the department. 
In 2020, according to PMSI data, 1128 patients under 70 years of age were hospitalised in 
diabetes-obesity, pneumology, oncology and gastro-nutrition. The monthly recruitment target 
is 13 patients, with a potential of 94 patients per month. 
 
 
 

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6 Research design 
6.1 Type of study 
This is a prospective, monocentric, interventional cohort study with minimal risks and 
constraints falling within the scope of article L.1121-1 of the Public Health Code. 
The research will be conducted in accordance with the protocol. 
 
6.2 Research scheme 
 
 
6.3 Provisional research timeline 
The duration of recruitment will be 20 months with follow-up of patients during their entire 
hospital stay in the care unit, i.e. approximately 30 days (average length of stay), for a total 
estimated study duration of 21 months. 
 
- 
Submission to PPC: November 2021 
- 
Start of inclusions: February 2021 
- 
Duration of the inclusion period: 20 months 
- 
Duration of participation of each patient: 30 days 
- 
End of inclusions: October 2023 
- 
Total duration of the research: 21 months 
- 
Conference papers: congresses of medical societies of oncology, surgery, pneumology, 
nutrition and gastroenterology 
- 
Publication: February 2024 
 

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6.4 Location of the study 
The study will take place at the Forcilles Hospital, in the short stay and follow-up care and 
rehabilitation departments of diabetology-obesity, pneumology, oncology and gastro-nutrition. 
 
7 Description of the usual care 
7.1 Usual course of treatment 
Patients admitted to short stay and follow-up and rehabilitation care for diabetes-obesity, 
pneumology, oncology and gastro-nutrition benefit from medical, nursing and rehabilitation 
examinations and care. All of this care will not be modified in the framework of this protocol. 
Physiotherapists and dieticians carry out their diagnostic assessment and rehabilitation on 
medical prescription. The EAPAs participate in the functional evaluation of the patient and 
carry out physical activities adapted to the patient, also on medical prescription. 
As part of the screening for undernutrition in our establishment, the dieticians carry out a 
prospective and systematic collection of the patient's weight and its evolution over the last few 
months, their BMI and an evaluation of their food intake, within 48 hours of the patient's 
admission to the department. The estimation of the patient's intake is carried out in 
collaboration with the nursing assistant. 
The nurse's aide carries out a systematic measurement of grip strength when the patient is 
admitted to the ward (Appendix 2). A plan to train the nursing assistants to carry out this 
measurement has been put in place by the physiotherapists. 
The physiotherapist or EAPA carries out the measurement of the patient's walking speed 
systematically on admission to one of these services (Appendix 3). 
 
7.2 Standard assessment procedures 
7.2.1 Nutritional assessment 
At the time of the patient's admission, a dietary assessment is carried out by the dietician in 
accordance with the recommendations issued by the French Association of Dieticians-
Nutritionists (AFDN) and the HAS. The dietician collects all the data required to detect 
malnutrition, such as weight, height, BMI, albumin levels, as well as grip strength and walking 
speed (carried out by the care assistant and the physiotherapist or the EAPA). The dietician 
also looks for possible barriers to feeding such as dental condition, swallowing problems or 
digestive discomfort. 
The doctor looks for various pathologies impacting on digestive absorption such as short stool 
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such as cancers, chronic progressive diseases, infections etc. He also looks for factors of 
aggression such as cancers, chronic progressive diseases, infections etc. 
All of these data make it possible to estimate the theoretical nutritional needs of the patient 
and to adapt the nutritional management. A follow-up of the ingestations is carried out by the 
dietician in collaboration with the nurses' aides. 
 
7.2.2 Anthropometric measurements 
On admission, the ward's nurses and orderlies measure the patient's weight and height. When 
the patient can maintain an upright position, a conventional scale and a measuring rod are 
used for the measurements. If the patient cannot maintain this position, a weighing chair and 
a laser meter are used. 
In order to assess weight loss prior to hospitalisation, the previous weight is sought in a 
hospital report or other recent medical document. Contact with the attending physician is also 
made in order to obtain information about the patient's weight monitoring. When this 
information is not available, the previous weight given by the patient is collected. 
 
7.2.3 Biological measurements 
On admission, a biological sample is usually taken from patients at risk of undernutrition in 
order to measure pre-albumin, albumin and C-reactive protein (CRP). These elements make 
it possible to determine the severity of undernutrition when it is present, according to the 
diagnostic criteria of the HAS. 
 
7.2.4 Measures of muscle function 
Handgrip force measurement ("Handgrip ") 
The grip strength is assessed with the Jamar® hydraulic dynamometer by the caregiver. 
The patient is in a seated position, on a chair with a backrest, with the feet on the floor. The 
device is placed in the patient's hand. The patient is instructed to squeeze the dynamometer 
as hard as possible. 
The measurement is taken on the dominant side of the patient. The homolateral shoulder is 
in adduction (elbow to body), without extension or flexion and in neutral rotation. The elbow is 
bent to 90° and in neutral pronation. The wrist is in neutral position. Three trials will be carried 
out, and the best value (in Kg) of the different trials is retained (see measurement procedure 
in Appendix 2). 
 
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Walking speed (m/s) is measured on a 4-metre course in a corridor by the EAPA or 
physiotherapist. The course is marked out on the ground. There are also 1 metre run-up and 
deceleration zones. The patient is instructed to walk the course at a normal speed and not to 
complete the distance as quickly as possible. The course is completed 3 times and the best 
time (in seconds) is recorded (see procedure in Annex 3). 
 
8 Evaluation procedure added by the research 
8.1 Mini-Nutritional Assessment Short Version (MNA-SF) score 
The MNA-SF is a validated nutritional risk screening tool that can be applied by health 
professionals (see Appendix 4). It was developed by Rubenstein (23)based on the MNA. 
Completed in less than five minutes, it can identify a decrease in food intake, acute pathology 
or stress and a drop in BMI. It also includes two questions related to the frailty of the elderly, 
mobility and neuropsychological problems (dementia, depression). 
The MNA-SF classifies people as "undernourished" with a score between 0 and 7 points, "at 
risk of undernutrition" with a score between 8 and 11 points and "satisfactory nutritional status" 
with a score between 12 and 14 points. Patients considered "undernourished" and "at risk of 
undernutrition" should have their nutritional status assessed. 
 
8.2 Diagnosis of undernutrition according to the GLIM criteria 
The diagnosis of undernutrition will also be carried out in the framework of this research 
according to the GLIM criteria. It will be based on the search for at least 1 phenotypic criterion 
and 1 etiological criterion. Severe undernutrition will be based solely on phenotypic criteria. 
See detailed description in section 10.1. 
This diagnosis according to the GLIM definition will be made by one of the investigators not 
involved in the management of the patient. The patient's team will be blinded to these results 
so as not to influence the management of the patient. 
 
8.3 Impedance measurement bio-electrical 
Bioelectrical impedance measurement is carried out in the patient's room using the Z-Metrix 
impedance meter from Bioparhom. The test is carried out when the patient is admitted to the 
ward. 
The patient is positioned in the supine position, inclined at 30 degrees. The patient must rest 
for at least 15 minutes before the measurement. Four electrodes are placed: 
- 
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- 
In the wrist at the level of the head of the ulna, in the intertendinous hollow; 
- 
At the ankle, above the lateral malleolus ; 
- 
Above the previous electrode, spaced about 4 fingerbreadths apart. 
This non-invasive test quantifies muscle, lean and fat mass as well as bone and water mass. 
Values are expressed in kilograms and as a percentage of body weight (see measurement 
procedure in Appendix 5). 
The following clues will be collected: 
- 
Muscle mass index (in kg/m2 ); 
- 
Non-fat mass index (in kg/m2 ). 
 
9 Conduct of the research 
9.1 Pre-inclusion visit 
9.1.1 Checking inclusion and non-inclusion criteria 
When a patient is admitted to short-stay and follow-up care and rehabilitation in diabetes-
obesity, pneumology, oncology and gastro-nutrition, one of the investigators checks the 
presence of the inclusion criteria and the absence of the non-inclusion criteria in the 
institution's computerised medical record. 
 
9.1.2 Sampling of the population 
A potential of 94 patients per month eligible for this study are admitted in the short stay and 
follow-up care and rehabilitation of diabetology-obesity, pneumology, oncology and gastro-
nutrition. We anticipate a maximum inclusion of 13 patients per month for logistical reasons. 
In order to obtain a representative sample of this patient population in the study, we will sample 
the patient population on admission , if they meet the eligibility criteria and before the patient 
is informed and consents are obtained. The patient will be randomly assigned to either the 
eligible or the ineligible group of the study. Patients in the ineligible group will therefore not be 
included in the study, but the number of such patients will be collected. 
Patients will be sampled via a centralised randomisation system available via the internet, 
according to a pre-determined randomisation list. The randomisation list will be scheduled in 
advance by the study statistician. The sampling will be stratified on the care service, and 
unbalanced using random blocks in order to obtain a number of eligible patients of 15 patients 
per month (in order to take into account possible refusals of participation). Only the hospital 
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9.1.3 Patient information and consent 
When all the criteria allow the inclusion of the patient, the investigator informs the patient of 
the purpose of the study during a visit to the room. The investigator provides the patient with 
all the information described in the information note (Appendix 6) and, if necessary, obtains 
the patient's free, informed and express oral consent. This consent will be recorded in the 
patient's computerised medical record. 
The state of consciousness of certain patients (confusion, cognitive disorders) at the time of 
their admission will not allow them to receive information related to the research and the 
collection of consent and the information will be given to the person close to them who has 
been declared a trusted person (Appendix 7). At any time, if the patient's neurological or 
cognitive state permits, he or she will be informed of this research and asked to give express 
oral consent for the possible continuation of the research (Appendix 8). 
In the event of a new ban on visits to hospital wards due to the health crisis, information and 
oral consent from the trusted support person will be given by telephone or video conference. 
 
9.2 Inclusion visit 
The inclusion visit will take place within 48 hours of the patient or relative consenting to 
participate in the study. The following data will be collected:  
- 
Age, weight, height, BMI, gender (male/female) ; 
- 
Hospitalization service ; 
- 
Reason for hospitalisation ; 
- 
Background; 
- 
Reduction in food intake or absorption ; 
- 
Inflammatory situation ; 
- 
Biological markers (albumin, pre-albumin, CRP) if applicable;  
- 
Nutritional data (weight evolution over the last months, theoretical needs, ingestas) ; 
- 
Mini-Nutritional Assessment Short-Form (MNA-SF); 
- 
Autonomy score (Katz ADL) ; 
- 
Bioelectrical impedance data ; 
- 
Grip force (Handgrip) ; 
- 
Walking speed. 
 
9.3 End of research visit 
The end-of-research visit will take place when the patient is discharged from hospital or dies. 
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- 
Duration of hospital stay (in days) ; 
- 
Vital status (death yes/no) ; 
- 
Autonomy score (Katz ADL). 
 
9.4 Summary table 
 
Pre-inclusion 
Inclusion visit 
End of research 
visit 
Informing the patient and obtaining 
consent 
 
 
 
Collection of basic data (age, weight, 
sex, BMI, medical history)  
 
 
 
Collection of service and reason for 
hospitalisation 
 
 
 
Associated diseases 
 
 
 
Biomarkers 
 
 
 
Nutritional data 
 
 
 
MNA-SF 
 
 
 
Bioelectrical impedance 
measurement  
 
 
 
Handgrip, Walking speed 
 
 
 
Katz ADL 
 
 
 
Vital status 
 
 
 
Length of stay in hospital 
 
 
 
 
 

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10 Definition of evaluation criteria and measurement 
techniques 
10.1 Prevalence of undernutrition 
Undernutrition is defined according to the diagnostic methods of the HAS and GLIM: 
 
Phenotypic criteria 
Etiological criteria 
Weight loss (%) 
Low BMI 
(kg/m2 ) 
Reduction in 
muscle mass 
Reduction in food 
intake or 
absorption 
Inflammatory 
situation 
GLIM 
> 5% in the last 6 
months or > 10% 
beyond 6 months 
< 20 
Reduction 
assessed by a 
validated 
measurement 
technique*. 
≤ 50% of food intake 
> 1 week or any 
reduction > 2 
weeks, or any 
gastrointestinal 
conditions or 
symptoms impacting 
assimilation or 
absorption 
Acute or certain 
chronic or 
malignant 
conditions 
HAS 
≥ 5% in 1 month or ≥ 
10% in 6 months or loss 
≥ 10% from usual 
weight before onset of 
disease 
< 18,5 
Quantified 
Reduction** (QR) 
Same as 
Same as 
 
For the GLIM and HAS diagnostic method, the diagnosis of undernutrition is positive if an 
etiological criterion and a phenotypic criterion are present. The assessment of undernutrition 
according to GLIM will be preceded by a MNA-SF (Appendix 4). The methods for measuring 
the reduction in muscle mass are described in section "7.2.4. Measurement of muscle 
function". 
 
Among patients with undernutrition, severe undernutrition is defined by : 
 
Moderate undernutrition 
Severe undernutrition 
GLIM 
 BMI < 20 kg/m2 
 Weight loss of 5-10% in the last 6 months or 10-
20% beyond 6 months 
 Mild to moderate reduction in muscle mass 
 BMI < 18.5 kg/m2 
 Weight loss of >10% in the last 6 
months or >20% beyond 6 months 
 Severe reduction in muscle mass 
HAS 
 17 < BMI < 18.5 kg/m2 
 Weight loss ≥ 5% in 1 month or ≥ 10% in 6 months 
or loss ≥ 10% from usual weight before onset of 
disease 
 Measurement of albumin by immuno-electrometry or 
immunoturbidimetry > 30 g/L and < 35 g/L. 
 BMI < 17 kg/m2 
 Weight loss ≥ 10% in 1 month or ≥ 
15% in 6 months or loss ≥ 15% 
from usual weight before onset of 
disease 
 Measurement of albumin by 
immuno-electrodelemetry or 
immunoturbidimetry < 30 g/L 
 
The prevalence of undernutrition is defined as the proportion of patients with moderate and/or 
severe undernutrition among the patients included in the study. 
 
 

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10.2 Bioelectrical impedance measurement 
According to the physiological model of body composition, 5 compartments are defined (24) : 
- 
Lean mass is the sum of water, bones and organs, excluding the fatty part. It is 
composed of : 
- 
The active cell mass (all the cells of the various organs and muscles); 
- 
Extracellular water (all interstitial fluids and plasma) ; 
- 
Bone mineral mass (tricalcium phosphate crystals in the skeleton) ; 
- 
The fat mass corresponds to the triglycerides stored in the adipocytes, whatever their 
anatomical location; this compartment is virtually devoid of water. 
 
Bioelectrical impedance measurement is based on the ability of hydrated tissue to conduct 
electrical energy. Impedance is a function of the volume of the hydro-electrolyte compartment 
in the body. The impedance (Z) of a body is related to the specific resistance (r), the length 
(L), and the conductive volume (V): V = r L2/Z 
According to the physiological model, fat mass is waterless and lean mass contains a fixed 
proportion (73%). From the estimated total body water, it is therefore easy to calculate the 
lean mass. 
Water volumes (total body, extracellular, and intracellular) can be determined. Due to the 
characteristics of the current, the measurement is completely painless. When the current 
frequency is higher than 50 kHz, the measured volume is equal to the total body water. When 
the frequency is lower than 5 kHz, the volume is extracellular water. Measurements with 
several current frequencies allow an approach to the different water sectors. 
Non-fat mass index and muscle mass index in kg/m2 will be measured (see normal values in 
Appendix 5). 
 
10.3 Morbidity and mortality criteria 
10.3.1 Length of stay in hospital 
The duration of hospitalisation is defined as the number of days of presence in the inclusion 
ward, from the patient's admission to the final discharge. Temporary transfers to another 
hospital department for an examination or an intervention are not considered as discharges. 
A special statistical treatment (described in section 11.4) will be carried out on the length of 
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10.3.2 Mortality 
Number of deaths out of the total number of patients included. A special statistical treatment 
(described in section 11.4) will be performed on the mortality rate. 
 
10.3.3 Katz Activities Daily Living (ADL) score 
The Katz ADL score (Appendix 1) is completed within 48 hours prior to (scheduled) discharge 
from hospital by the patient's nurse or nurse's aide. The total score is out of 6. A score of less 
than 3 indicates major dependence, a score of 0 indicates total dependence. 
The Katz ADL score will be treated as a discrete numerical variable. 
 
 

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11 Statistical aspects 
11.1 Calculation of the number of subjects needed 
According to PMSI data, the prevalence of undernutrition according to HAS recommendations 
was 34%. Taking into account the wider period of weight loss and the higher BMI threshold 
used by GLIM in its definition of undernutrition, we estimate a higher prevalence of 
undernutrition. In the absence of data in the literature, we estimate a prevalence of 
undernutrition according to the GLIM definition at 49%, a difference of at least 15%. We wish 
to highlight this discrepancy. With a risk α = 0.05 and a power of 80%, it will be necessary to 
include 260 patients. 
 
11.2 General aspects 
Descriptive statistics will be based on means (+/- standard deviation) or medians [interquartile 
range] depending on the distribution of quantitative variables. Qualitative variables will be 
described in terms of numbers and percentages. Univariate comparisons will use the usual 
statistical tests after checking the distribution of the variables (Chi2 or Fisher's test, t-test, 
anova or their non-parametric equivalents Wilcoxon and Kruskal-Wallis tests). Paired sample 
tests will be used if necessary. 
The tests will be performed at the 5% significance level. The 95% confidence intervals will be 
provided for each estimate. 
The calculations will be done using SPSS v21 IBM and R software (version 3.6.1, 
http://www.R-project.org ). 
 
 

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11.3 Main objective 
The difference between the prevalences of global undernutrition between the HAS and GLIM 
groups will be compared using the McNemar test, designed for the comparison of proportions 
in matched samples. 
 
11.4 Secondary objectives 
11.4.1 Comparison of the prevalence of severe undernutrition 
The difference between the prevalences of severe undernutrition between the HAS and GLIM 
groups will be compared using the test described in the main objective. 
 
11.4.2 Comparison of morbidity and mortality 
Morbidity and mortality will be compared between the HAS and GLIM groups, for moderate 
and severe undernutrition, by comparing the length of hospital stay, mortality and autonomy 
at discharge. 
 
Length of stay in hospital 
There is a relationship between the incidence of mortality and all length of stay variables. 
Length of stay will therefore be analysed using a competitive risk method, which takes into 
account the fact that patients who die are no longer eligible for length of stay analysis (25). 
The estimator also provides the probability of in-hospital death, so that the probability of 
hospital discharge versus death at any time after inclusion in the study can be assessed 
simultaneously. 
 
Mortality rate 
The estimation of mortality rates will be carried out by the Kaplan and Meier method. The 
comparison of the 2 curves will be performed by a Logrank test. The mortality rates in the 2 
groups will be estimated via the survival curves. 
 
ADL 
The ADL score will be compared between the 2 groups using the discrete numerical variable 
comparison tests described in the general aspects. 
 
 

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11.4.3 Comparison of muscle function assessment tools 
The impact of the choice of muscle function assessment tool will be assessed by comparing 
the prevalence of undernutrition diagnosed with each tool and by comparing the presence of 
reduced muscle mass with each tool. 
 
12 Expected results in terms of scientific and professional 
advances 
The results of this study will make it possible to verify whether the GLIM definition increases 
the prevalence of undernutrition compared to that of the HAS. The use of one or other of the 
definitions could thus have an impact on the medical and paramedical management of 
undernutrition. On the other hand, muscle function benefits from various assessment tools. 
These tools assess different aspects of the muscle, such as strength, functional performance 
or quantity. Muscle function has an important place in the new definitions of undernutrition, 
thus involving physiotherapists and EAPAs in addition to dieticians, nurses, care assistants 
and physicians in the screening for undernutrition. The different tools could lead to a different 
estimation of the reduction of muscle mass and thus a different prevalence of undernutrition. 
The results of our study will help to evaluate this and guide professionals in the choice of tools 
for assessing muscle function. 
 
13 Expected benefits and risks for patients 
13.1 Minimal risks and constraints added by the research 
All medical and paramedical examinations and management are usually carried out with the 
exception of the MNA-SF questionnaire and bioelectrical impedancemetry, which will be 
carried out systematically in the patients included. The MNA-SF questionnaire is very quick 
(less than 5 minutes) and therefore causes very little inconvenience to the patient apart from 
an additional visit by a carer. Bioelectrical impedancemetry is a tool for assessing body 
composition using electrodes applied to the skin surface. The examination takes an average 
of 15 minutes, and is non-invasive and painless. The minimal stress is related to the placement 
of the electrode and the duration of the examination. 
 
 

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13.2 Expected benefits for the patient 
This study could highlight a difference in the prevalence of undernutrition according to the 
definitions and tools used. The results of this study will not provide direct benefits for the 
patient, but could allow the clinician to be more vigilant if undernutrition is underestimated, 
according to the criteria used in France. The benefit would then be a broader screening of 
undernutrition and would allow the adaptation of the patient's nutritional and rehabilitation 
management. 
 
14 Feasibility 
Taking into account the inclusion and non-inclusion criteria, possible refusals of patients to 
participate in the research, potential exclusions and recruitment experience, we estimate a 
minimum recruitment capacity of 50% of patients admitted to short-stay and follow-up and 
rehabilitation care for diabetes-obesity, pneumology, oncology and gastro-nutrition, i.e. 47 
patients per month, with a monthly recruitment target of 13 patients over 20 months. 
In addition, screening for undernutrition is usually carried out on all patients admitted to these 
wards within our establishment. Dieticians, nursing assistants, nurses and doctors are 
therefore trained and used to carrying out this screening. Bioelectrical impedance 
measurement by dieticians is already performed on some patients, and takes no more than 
15 minutes. The addition of this test to the research framework is therefore feasible. 
In addition, the teams have experience in clinical research, as they are already involved in 
other research projects as promoters and investigating centres. The medical and rehabilitation 
teams 
are 
involved 
in 
other 
ongoing 
research 
projects 
(https://clinicaltrials.gov/ct2/show/NCT02881814https://clinicaltrials.gov/ct2/show/NCT02474797 
and https://clinicaltrials.gov/ct2/show/NCT04373811). 
 

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15 Ethical and regulatory aspects 
The Forcilles-Fondation Cognacq-Jay hospital promoter and the person(s) directing and 
supervising the research undertake to ensure that this research is carried out in accordance 
with law n°2004-806 of 9 August 2004 relating to public health policy and the regulatory 
provisions in force (articles L.1121-1, L.1121-2 and L.1121-3 of the Public Health Code. The 
data recorded during this research will be subject to computerised processing in compliance 
with law n°78-17 of 6 January 1978 relating to information technology, files and freedoms, 
amended by law n° 2018-493 of 20 June 2018 (decree n° 2018-687 of 1° August 2018) and 
order n° 2018-1125 of 12 December 2018. 
The research will be conducted in accordance with this protocol. 
 
15.1 Role of the promoter 
The research commission of the Forcilles-Fondation Cognacq-Jay hospital, promoter of this 
research, submits the file to the opinion of the relevant Comité de Protection des Personnes 
(CPP) (CPP Ile de France 2) whose opinion will be notified in the information note intended 
for the persons concerned. 
The natural or legal person who initiates the research, manages it and ensures that it is 
financed is called the sponsor. 
 
15.2 Submission to the PPC 
This research will be submitted to a Committee for the Protection of Individuals, which will be 
drawn by lot within the framework of the "Jardé law" (article L.1121-4 of the Public Health 
Code, decree no. 2016-1537 of 16 November 2016, which came into force on 18 November 
2016). 
The opinion of the above-mentioned committee is notified in the information note intended for 
the persons concerned. A copy of this opinion and a summary of the research will be sent to 
the ANSM. 
 
15.3 Data protection 
This research is subject to law n°78-17 of 6 January 1978 relating to information technology, 
files and freedoms as amended by law n° 2018-493 of 20 June 2018 (decree n° 2018-687 of 
1 August 2018). Information on the rights of persons participating in this research (right of 
access and rectification, right to object to the transmission of data covered by professional 
secrecy likely to be used in the context of this research) is included in the information note 
intended for the patient. 

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A reference methodology specific to the processing of personal data carried out in the context 
of biomedical research defined by Law 2004-806 of 9 August 2004 as falling within the scope 
of Articles L.1121-1 et seq. of the Public Health Code was updated by the CNIL in May 2018 
(Deliberation No. 2018-153 of 3 May 2018) following the publication of European Regulation 
No. 2016/679 (General Data Protection Regulation). This methodology allows a simplified 
declaration procedure when the nature of the data collected in the research is compatible with 
the list provided by the CNIL in its reference document. This study is part of the MR001 
reference methodology to which the Forcilles-Fondation Cognacq-Jay hospital has committed 
to comply. 
 
15.4 Insurance 
The Sponsor takes out insurance covering its own civil liability and that of any person involved 
in the performance of the research for the entire duration of the research, regardless of the 
nature of the links between the participants and the Sponsor (Article L.1121-10 of the Public 
Health Code). The sponsor is also responsible for the compensation of the harmful 
consequences of the research for the person who undergoes it and for that of his or her 
dependents, unless it can be proved that the damage is not attributable to its fault or to that of 
any other party involved, without the possibility of invoking the act of a third party or the 
voluntary withdrawal of the person who initially agreed to undergo the research. Where the 
sponsor is not liable, the victims may be compensated under the conditions set out in Article 
L.1142-3. 
The Forcilles-Fondation Cognacq-Jay hospital has taken out insurance under contract no. 
163607 guaranteeing its civil liability as well as that of any intervening party with the company 
SHAM for the entire duration of the research, in accordance with article L.1121-10 of the Public 
Health Code. 
 
15.5 Substantial amendment to the protocol 
The investigator or coordinator informs the research commission of the Forcilles-Fondation 
Cogacq-Jay hospital of any proposed modification of the protocol. Any substantial modification 
will be submitted by the sponsor of this research to the CPP for its opinion. 
 

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15.6 Information note and express consent 
In accordance with Article L.1122-1 of the Public Health Code, the information provided to the 
persons who are to be involved in the research is the subject of a written document submitted 
in advance to the personal protection committee. The ethical opinion of the CPP Ile de France 
2 was sought. 
The investigator at the centre offers the patient, or a relative if the patient is incapacitated, to 
participate in the study. The investigator informs the patient orally of the study procedures and 
gives him/her the information note. If the patient gives free, informed and express oral consent 
to participate in the protocol, the information given orally and in writing, as well as the collection 
of oral consent, will be recorded in the patient's medical record. 
In the event that a relative of the patient has given consent, as soon as possible, the patient 
will be informed of the research and asked for oral consent for the possible continuation of the 
research. 
Patients are free to participate or withdraw from the study at any time in accordance with 
Article 21 of the GDPR. Data collected until the patient withdraws consent will be used unless 
the patient expressly requests otherwise. The withdrawal of consent by the patient and the 
agreement to use or not the data previously collected will be traced in the patient's medical 
file. 
When the research is completed, the person who has undergone the research may be 
informed of the overall results of the research in the manner specified in the information 
document. 
 
15.7 Expected deadline for publication of results in an international journal 
The deadline for the publication of the results is 30 months. 
 

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15.8 Data management 
For each subject, an identification code (corresponding to the centre number-inclusion 
number-Initial Surname-Initial First Name) will be assigned. The data collected will be 
confidential and coded (only the identification code will appear). The concordance table linking 
the assigned identification code and the participant's name will be kept by the principal 
investigator at each participating centre in a file with computer restricted access rights. The 
data will be entered into a password-protected Excel® file. Data processing and statistical 
analysis will be carried out at the Forcilles-Fondation Cognacq-Jay hospital. 
The promoter is responsible for the data and no use or transmission to a third party may be 
made without his prior agreement. 
The specific documents of a type 2 interventional research ("Loi Jardé", decree n° 2016-1537 
of 16 November 2016, which came into force on 18 November 2016) with minimal risks and 
constraints will be archived by all parties for a period of 15 years after the end of the research. 
This indexed archiving includes: 
- 
successive versions of the protocol (identified by version number and date); 
- 
correspondence; 
- 
the inclusion list or register ; 
- 
the data collection document ; 
- 
research-specific annexes ; 
- 
the final report of the research. 
The database that gave rise to the statistical analysis must also be archived by the person 
responsible for the analysis (paper or computer). 
 
15.9 Human and financial resources 
The Forcilles-Fondation Cognacq-Jay hospital is equipped with human, material and technical 
resources to carry out this research project. 
 
15.10 Data properties 
The Forcilles-Fondation Cognacq-Jay hospital is responsible for the data and no use or 
transmission to a third party may be made without its prior agreement. 
 
 

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16 Bibliographic References 
1.  
Cederholm T, Jensen GL, Correia MITD, Gonzalez MC, Fukushima R, Higashiguchi T, et al. GLIM 
criteria for the diagnosis of malnutrition - A consensus report from the global clinical nutrition 
community. Clin Nutr Edinb Scotl. Feb 2019;38(1):1-9.  
2.  
Fontaine E. The president's letter: one train may hide another. Nutr Clin Metabolism. 1 May 
2015;29(2):65-6.  
3.  
Grey D. Retrospective study simulating the impact of an evolution of the recommendations of the 
French National Authority for Health (HAS) towards the criteria proposed by the Global Leadership 
Initiative on Malnutrition (GLIM) on the prevalence of undernutrition in a French public hospital. 
Nutr Clin Metabolism. Sep 1, 2019;33(3):205-11.  
4.  
Kyle UG, Genton L, Pichard C. Hospital length of stay and nutritional status. Curr Opin Clin Nutr 
Metab Care. July 2005;8(4):397-402.  
5.  
Correia MITD, Waitzberg DL. The impact of malnutrition on morbidity, mortality, length of hospital 
stay and costs evaluated through a multivariate model analysis. Clin Nutr Edinb Scotl. June 
2003;22(3):235-9.  
6.  
Kyle UG, Unger P, Mensi N, Genton L, Pichard C. Nutrition status in patients younger and older 
than 60 y at hospital admission: a controlled population study in 995 subjects. Nutr Burbank Los 
Angel Cty Calif. June 2002;18(6):463-9.  
7.  
High Authority for Health. Diagnosis of undernutrition in children and adults. Recommendations 
for clinical practice method. 2019;25.  
8.  
Lochs H, Allison SP, Meier R, Pirlich M, Kondrup J, Schneider S, et al. Introductory to the ESPEN 
Guidelines on Enteral Nutrition: Terminology, definitions and general topics. Clin Nutr Edinb Scotl. 
Apr 2006;25(2):180-6.  
9.  
Schlienger J-L. Practical clinical nutrition [Internet]. 2nd ed. Elsevier Masson; 2014 [cited 5 Feb 
2021]. 
352 
p. 
Available 
from: 
https://www.elsevier.com/books/nutrition-clinique-
pratique/9782294739767 
10.  ANAES. Diagnostic evaluation of protein-energy undernutrition in hospitalized adults;  
11.  Haute Autorité de Santé. Management strategy for protein-energy undernutrition in the elderly. 
Médecine Mal Métaboliques. Nov 2007;1(4):92-6.  
12.  Cederholm T, Barazzoni R, Austin P, Ballmer P, Biolo G, Bischoff SC, et al. ESPEN guidelines 
on definitions and terminology of clinical nutrition. Clin Nutr Edinb Scotl. Feb 2017;36(1):49-64.  
13.  Hofbauer KG. Pharmacotherapy of Cachexia [Internet]. CRC Press; 2005 [cited 5 Feb 2021]. 608 
p. Available from: https://www.routledge.com/Pharmacotherapy-of-Cachexia/Hofbauer-Anker-
Inui-Nicholson/p/book/9780849333798 
14.  Cruz-Jentoft AJ, Baeyens JP, Bauer JM, Boirie Y, Cederholm T, Landi F, et al. Sarcopenia: 
European consensus on definition and diagnosis: Report of the European Working Group on 
Sarcopenia in Older People. Age Ageing. Jul 2010;39(4):412-23.  
15.  Quilliot D, Rossi F. Organisation, levels of management of undernutrition and the place of health 
care providers in the nutrition care pathway in hospitals and towns. Nutr Clin Metabolism. 1 Dec 
2016;30(4):316-25.  
16.  Thibault R, Bachmann P, Caldari D, Coti P, Guex E, Zeanandin G, et al. Professional practice 
guidelines: screening for undernutrition in hospitalized adults. Nutr Clin Métabolisme. Feb 
2014;28(1):38-45.  

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17.  Le Neindre A, Fossat G. Interest of thoracic and muscular ultrasound in intensive care 
physiotherapy. Intensive Care Medicine. 1 Sep 2017;26(5):425-34.  
18.  Al Snih S, Markides KS, Ottenbacher KJ, Raji MA. Hand grip strength and incident ADL disability 
in elderly Mexican Americans over a seven-year period. Aging Clin Exp Res. Dec 2004;16(6):481-
6.  
19.  Lauretani F, Russo CR, Bandinelli S, Bartali B, Cavazzini C, Di Iorio A, et al. Age-associated 
changes in skeletal muscles and their effect on mobility: an operational diagnosis of sarcopenia. 
J Appl Physiol Bethesda Md 1985. Nov 2003;95(5):1851-60.  
20.  Peolsson A, Hedlund R, Oberg B. Intra- and inter-tester reliability and reference values for hand 
strength. J Rehabil Med. Jan 2001;33(1):36-41.  
21.  Biolo G, Cederholm T, Muscaritoli M. Muscle contractile and metabolic dysfunction is a common 
feature of sarcopenia of aging and chronic diseases: from sarcopenic obesity to cachexia. Clin 
Nutr Edinb Scotl. Oct 2014;33(5):737-48.  
22.  Boshier PR, Heneghan R, Markar SR, Baracos VE, Low DE. Assessment of body composition 
and sarcopenia in patients with esophageal cancer: a systematic review and meta-analysis. Dis 
Esophagus Off J Int Soc Dis Esophagus. 1 August 2018;31(8).  
23.  Rubenstein LZ, Harker JO, Salvà A, Guigoz Y, Vellas B. Screening for undernutrition in geriatric 
practice: developing the short-form mini-nutritional assessment (MNA-SF). J Gerontol A Biol Sci 
Med Sci. June 2001;56(6):M366-372.  
24.  Moreno MV. Study of body composition by impedancemetry on healthy and pathological adults 
and children [Engineering sciences [physics]]. Université de Technologie de Compiègne; 2007.  
25.  Brock GN, Barnes C, Ramirez JA, Myers J. How to handle mortality when investigating length of 
hospital stay and time to clinical stability. BMC Med Res Methodol. 26 Oct 2011;11:144.  
26.  Katz S, Ford AB, Moskowitz RW, Jackson BA, Jaffe MW. STUDIES OF ILLNESS IN THE AGED. 
THE INDEX OF ADL: A STANDARDIZED MEASURE OF BIOLOGICAL AND PSYCHOSOCIAL 
FUNCTION. JAMA. 21 Sep 1963;185:914-9.  
 
 
 

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17 Annexes 
 
 

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17.1 Appendix 1: Katz ADL (Activities in Daily Living) Scale (26) 
 
 
 
 
 

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17.2 Appendix 2: Handgrip Usage Protocol 
 
The patient will be in a seated position, on a chair with a backrest, with the feet on the floor. 
The shoulder shall be in adduction (elbow to body), without extension or flexion, and in neutral 
rotation. The elbow shall be placed at 90° of flexion and in neutral pronation-supination. The 
wrist should also be in neutral position. The practitioner should hold the elbow and the base 
of the JAMAR force gauge® lightly to avoid changes in positioning. The grip force 
measurement will consist of 3 measurements on each limb, alternating with a rest (1 minute: 
time to note the score of the measurement and to quietly settle the person in the position for 
the next measurement). 
 
The dominant hand will be chosen by the participant by answering the following question: "Are 
you right or left handed? 
 
The instructions are: "Lean back against the backrest. Take the handle in your hand, keep 
your elbow close to your body and your forearm straight in front of you" and gradually tighten 
the handle over 2 to 3 seconds to reach a maximum tightening which must also be maintained 
for 2 to 3 seconds, without moving the other joints (wrist, elbow and shoulder). 
Encouragement will be given to the person during the clamping seconds to motivate the 
patient as much as possible: "Go ahead and clamp, clamp... hard, HARD! TIGHT! ...and you 
release". It will be noted if pain appears and limits the grip.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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17.3 Appendix 3: Protocol for conducting the Gait speed test 
Walking speed (m/s) is measured on a 4-metre course in a corridor. The course is marked out 
with ground markings. The course is marked out with markings on the floor. 1 metre run-up 
and run-down zones are also marked out. The patient is instructed to walk the course at a 
normal speed and not to complete the distance as quickly as possible. The course is 
completed 3 times and the best time (in seconds) is recorded. 
The examiner runs the course at a usual speed and at a maximum speed without running to 
ensure that the usual speed instruction is well integrated by the patient. 
The examiner starts the stopwatch when the first foot crosses the end of the run-up line and 
stops it when the first foot crosses the 4m line. (See figure below). 
The walking speed is determined by dividing the distance by the time taken to walk that 
distance, giving a result in m/s. 
 
 
 
Zone 
d'accélération 1 
mètre
Zone de marche 
4 mètres
Zone de 
décélération
1 mètre

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17.4 Annex 4: Mini-Nutritional Assessment Short-Form (MNA-SF) Score (23) 
 
A. Does the patient have a loss of appetite? 
Has he/she eaten less in the last 3 months due to lack of appetite, digestive problems, chewing 
or swallowing difficulties? 
 
0: severe anorexia ; 
1: moderate anorexia; 
2: no anorexia 
 
B. Recent weight loss (< 3 months) 
 
0: loss > 3 kg ; 
1: don't know ; 
2: weight loss between 1 and 3 kg; 
3: no weight loss 
 
C. Motricity 
 
0: from bed to chair ; 
1: stand-alone indoors ; 
2: leaving the home 
 
D. Acute illness or psychological stress in the last 3 months? 
 
0: yes ; 
2: no 
 
E. Neuropsychological problems 
 
0: severe dementia or depression; 
1: moderate dementia or depression; 
2: no psychological problems 
 
 
 

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F. Body Mass Index (BMI) = weight/(height)² in kg/m². 
 
0: BMI < 19 ; 
1: 19 < CGI < 21 ; 
2: 21 < IMC < 23 ; 
3: BMI > 23 
 
Screening score (maximum subtotal = 14 points) 
 
Between 0 and 7 points: malnourished 
 
Between 8 and 11 points: at risk of undernutrition 
 
Between 12 and 14 points: satisfactory nutritional status 
 
 
 

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17.5 Appendix 5: Impedance measurement protocol bio-electrical 
 
The placement of the electrodes is important for optimal results. For a hemi-body 
measurement, four electrodes will be placed as shown in Figures 1 and 2.  
Figure 1: Placement of electrodes 1 and 2 corresponding to cables 1 and 2. 
 
Be careful, never place the electrode on a bone. The first electrode is placed on the flat of the 
back of the hand. It is easier to place it if your patient's spot is tight. The second electrode is 
placed on the wrist at the level of the head of the ulna, in the intertendinous hollow. Figure 1 
shows how to place these two electrodes  
Figure 2: Placement of electrodes 3 and 4 corresponding to cables 3 and 4. 
 
The third electrode is placed on the ankle above the outer malleolus. Finally, to place the last 
electrode, simply take your hand, put it over the malleolar electrode, count 4 finger crosses 
and place the fourth electrode. Figure 2 shows how to place these two electrodes.  
 
It is advisable that the patient has removed any jewellery (watch, bracelet) as well as any 
objects they may have in their pockets. If your connection, the positioning of the device or the 
quality of the subject's skin cause measurement errors, pop-ups will alert you and advise you 
to check your connection. Please note that the patient's or user's body should not be in contact 
with the case or connectors 1 to 4 during the measurement. This can lead to short circuits or 
parallel currents and thus distort the measurement. The device should not be positioned on 
the patient. No contact should be made between the hand and the subject's thigh, or between 

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the thighs. If the thighs of your undressed subject are touching and it cannot be done 
otherwise, you can put a cloth in contact with the thighs. 
 
Example of results (Figure 3): 
The 3 clues will highlight: 
- 
Fat mass, reflects the nutritional status of the patient: Normal if between the gauges, 
underweight or thin below, overweight between the high and high mark +5%, obese 
above the high mark +5%; 
- 
Bone content, will reflect bone fragility if the value is below the bottom of the gauge; 
- 
Muscle mass: will reflect the amount of muscle in the body, allows the impact of 
physical activity and protein intake to be assessed and undernutrition to be detected. 
 
 
Figure 3: Indices measured with the bio-electrical impedance meter (example of a 
clinical case) 
 
 
 

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17.6 Appendix 6: Patient information note 
 
PROTEIN 
"Evaluation of the impact of the French and international 
definitions and of the muscle function measurement tool on the 
prevalence of undernutrition in hospitalized patients 
 
RCB ID: 2021-A02410-41 
 
PRINCIPAL INVESTIGATOR 
Dr Ilham BENHARRATS, internist 
Forcilles Hospital 
Gastro-Nutrition Service 
Route de Servon 77150 Férolles-Attilly 
Email : ibenharrats@cognacq-jay.fr  
 
RESEARCH PROMOTER 
Clinical Research Office 
Forcilles Hospital-Cognacq-Jay Foundation 
Route de Servon 77150 Férolles-Attilly 
Telephone: 01.60.64.60.93 
Fax: 01.60.02.15.09 
aleneindre@cognacq-jay.fr 
 
Dear Sir or Madam, 
Dr. ..............................................., investigator of the study, practising in the short stay/SSR 
service of diabetology-obesity/pneumology/oncology/gastro-nutrition of the Forcilles-
Fondation Cognacq-Jay hospital, invites you to participate in this research. 
Your decision to participate is entirely free and voluntary. 
Please read the information below carefully, ask any questions you may have and take as 
much time as you wish to reflect on your decision to participate in this research. 
You are hospitalised in a short stay/SSR diabetes-obesity/pneumology/oncology/gastro-
nutrition department as part of the treatment of your pathology or a check-up. Your state of 
health requires screening for possible malnutrition in order to adapt your medical and 
paramedical care. 
 
 

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What is the purpose of this research? 
The objective of this research is to evaluate the discrepancy between the prevalences of 
undernutrition as defined by the French National Authority for Health and the Global 
Leadership Initiative on Malnutrition (international group of experts working on undernutrition). 
On the other hand, we also wish to compare the different tools for measuring muscle function, 
which are part of the diagnostic criteria for undernutrition. 
 
How does this research work? 
As part of your hospitalization in the department, we propose to study your body composition 
by performing a bioelectrical impedance measurement. 
This examination is painless, non-invasive and risk-free. It is carried out by the dietician by 
placing 4 electrodes: one on the hand, one on the wrist, one on the ankle and one on the leg. 
Connected to a computer, they will allow us to measure your lean mass and your fat mass. 
The impedance measurement will be performed once, within 48 hours of your admission to 
the department and will last approximately 15 minutes. 
In addition, we will ask you a few questions in the Mini-Nutritional Assessment questionnaire, 
which will take less than 5 minutes. 
 
Your constraints in this research? 
The constraints of this research consist of 1 bio-electrical impedance measurement and 1 
questionnaire, for a maximum total duration of 20 minutes. 
 
Possible adverse effects 
As your participation in this protocol does not involve any treatment other than that which is 
currently recommended or other changes to conventional management appropriate to your 
condition, no adverse effects are expected. 
- 
No additional treatment will be administered 
- 
No additional blood tests will be required. 
Impedance measurement is carried out transcutaneously, i.e. by placing electrodes on your 
skin. The examination is therefore non-invasive and completely painless. 
Your participation in this research will not incur any additional costs compared to those you 
would have had in the usual follow-up of your disease. 
 
 

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What are the expected benefits of this research? 
This study should make it possible to determine whether the use of French or international 
diagnostic criteria leads to a difference in the prevalence of undernutrition. If one or other of 
the definitions is associated with a greater prevalence, this will make it possible to monitor and 
adapt the medical and paramedical management of a greater number of people. In addition, 
the choice of tool for assessing muscle function could lead to a different estimate of the 
proportion of muscle mass loss, which is one of the diagnostic criteria for undernutrition. The 
choice of the tool allowing a wider screening would also allow to adapt the management of the 
patient. 
 
What are the conditions for participating in this study? 
In order to participate in this research, you must be affiliated to or benefit from a social security 
scheme. However, your participation in this research will not result in any additional costs for 
you compared to those incurred in the usual care. 
 
Number of patients planned and duration of research? 
This research will last 21 months with a 20-month recruitment period to include 266 patients. 
 
What data is collected for the research? 
The medical data collected during this study will be processed in a computerised, coded and 
confidential manner. The main data collected will be anthropometric data (age, weight, height, 
etc.), related to medical history, nutritional status, biological check-ups, and the results of 
check-ups by rehabilitation professionals (physiotherapists, dieticians, EAPA). No information 
bearing your name will be provided to anyone except the doctor in charge of the study and 
authorised personnel. All data collected will be confidential and coded and analysed in the 
clinical research office of the Forcilles-Fondation Cognacq-Jay Hospital, the research sponsor. 
The identification list (correspondence between your study code and your identity) will be kept 
strictly confidential. 
In accordance with the regulations in force, the data will be kept until the final research report 
is produced and then archived for 15 years. 
The data controller is the promoter, Hôpital Forcilles-Fondation Cognacq-Jay, route de Servon 
77150 Férolles-Attilly. 
 
Legal basis for data processing 

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The processing of the data is based on the legitimate interests of the controller, Article 6 
paragraph 1 point f, read in conjunction with the necessity of the processing for scientific 
research purposes, Article 9 paragraph 2 point j, of the European Regulation N° 2016/679 
(General Data Protection Regulation, GDPR). 
 
What are your rights? 
Your participation in this research is entirely free and voluntary. You have the right not to 
participate in this research. 
You cannot be included in an interventional research protocol with minimal risks and 
constraints without having been informed beforehand. Your doctor must provide you with all 
the necessary explanations concerning this research, which must comply with the provisions 
of Article 13 of European Regulation No. 2016/679 (General Data Protection Regulation, 
GDPR). In accordance with article L.1122-1 of the French Public Health Code, the entire 
research file has been submitted to the Comité de Protection des Personnes NORD OUEST 
III which issued a favourable opinion on xx/xx/xxxx. 
The Forcilles-Fondation Cognacq-Jay hospital has taken out insurance under contract no. 
163607 guaranteeing its civil liability and that of all those involved with the company SHAM. 
You can stop participating in the research at any time without justification. This will not affect 
the quality of the care and treatment provided to you or your relationship with your doctor. The 
data collected until you withdraw your consent will be used unless you expressly request it. 
Indeed, in accordance with Article 17 of the GDPR, you have the right to request the deletion 
of your data already collected. The withdrawal of your consent and the agreement to use or 
not your previously collected data will be traced in your medical file. 
 
In accordance with the provisions of Articles 15 and 16 of Regulation (EU) 2016/679 of 27 
April 2016 (General Data Protection Regulation), you have a right of access, rectification, 
erasure or restriction of processing. You can find out more about your rights by consulting the 
CNIL website page https://www.cnil.fr/fr/reglement-europeen-protection-donnees/chapitre3. 
In accordance with the provisions of Article 21 of the RGPD, you also have the right to object 
to the transmission of data likely to be used in the context of this research and to be processed. 
Your request must be addressed to the Data Protection Officer of the Cognacq-Jay 
Foundation, either by e-mail to the address dpo@cognacq-jay.fr or by post to the address: 
Hôpital Forcilles-Fondation Cognacq-Jay, Délégué à la Protection des Données, route de 
Servon 77150 Férolles-Attilly. You also have the right to lodge a complaint with the 
Commission Nationale de l'Informatique et des Libertés - CNIL (French personal data control 
authority, website: www.cnil.fr). 

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In application of the provisions of article L. 1111-7 of the Public Health Code, you may also 
access all of your medical data directly or through a doctor of your choice. 
Your medical file will remain confidential and can only be consulted under the responsibility of 
the doctor in charge of your treatment, as well as by the health authorities and by persons duly 
mandated by the Forcilles-Fondation Cognacq-Jay hospital for research and subject to 
professional secrecy. 
If, after having read all this information and discussed all aspects with the doctor in charge of 
the research, you have had sufficient time to reflect on your decision and you decide to 
participate in this research, the research information and your oral consent will be notified and 
dated in your medical file. 
 
The agreement to participate in this research is free and voluntary. 
You may refuse or withdraw your consent at any time without explanation or prejudice. 
 
Any questions? 
 
 
Dr. ________________________ (tel. ______________________) is at your disposal for any 
further information you may require before and during the research. 

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17.7 Annex 7: Information note to the relative 
 
PROTEIN 
"Evaluation of the impact of the French and international 
definitions and of the muscle function measurement tool on the 
prevalence of undernutrition in hospitalized patients 
 
RCB ID: 2021-A02410-41 
 
PRINCIPAL INVESTIGATOR 
Dr Ilham BENHARRAT, internist 
Forcilles Hospital 
Gastro-Nutrition Service 
Route de Servon 77150 Férolles-Attilly 
Email : ibenharrat@cognacq-jay.fr  
 
RESEARCH PROMOTER 
Clinical Research Office 
Forcilles Hospital-Cognacq-Jay Foundation 
Route de Servon 77150 Férolles-Attilly 
Telephone: 01.60.64.60.93 
Fax: 01.60.02.15.09 
aleneindre@cognacq-jay.fr 
 
Dear Sir or Madam, 
 
Due to his condition which makes him unable to receive and understand the information that 
will be given to him, we are transmitting to you the information and the proposal of participation 
of Mr., Ms., Mr. (delete as appropriate) (last name, first name) ......................................... in 
the study presented below, under the responsibility of Dr. ............................................., the 
investigator of the study 
 
Your opinion on this participation is entirely free and voluntary. 
 
Please read the information below carefully, ask any questions you may have, and take as 
much time as you wish to reflect on your decision as to whether or not your loved one should 
participate in this research. 
 
 

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ATTENTION 
You can only give your consent : 
- if you and the patient you are caring for are not deprived by law of your right to give 
such consent; 
- whether the patient you are caring for is covered by social security; 
- if you consider that your decision would probably be that of the patient you are caring 
for; 
- if you feel fully informed; 
- if you were able to ask the doctor in charge of the study all the questions you wanted 
to ask about the research and the way it was going to be carried out and if you consider 
that you were given satisfactory answers (if, during the study, you have new questions, 
you can ask them to the doctor in charge of the study, in particular if they concern the interest 
of the study, the ratio of benefits and risks or the usefulness of collecting certain data from 
your family member) ; 
- if you feel free to give your consent to such participation; 
- if you accept that the patient you are caring for may not agree with you and when they 
get better and are consulted again, do not give consent to continue their participation. 
Even if you give your consent today, you may withdraw it at any time and study-related 
interventions will be stopped as quickly as possible so that no harm is done to the 
patient. The relationship and quality of current or future care that the patient will receive 
will not be changed in any way should this occur. The information collected previously 
to this stop will be used unless you do not want it to be used. You should then inform 
the patient's doctor who will suggest appropriate medical follow-up. 
 
Your 
relative 
is 
hospitalised 
in 
a 
short 
stay/SSR 
diabetes-
obesity/pneumology/oncology/gastro-nutrition department as part of the treatment of his or her 
pathology or for a check-up. His or her state of health requires screening for possible 
malnutrition in order to adapt medical and paramedical care. 
 
 

PROTEIN 
 
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53 
 
What is the purpose of this research? 
The objective of this research is to evaluate the discrepancy between the prevalences of 
undernutrition as defined by the French National Authority for Health and the Global 
Leadership Initiative on Malnutrition (international group of experts working on undernutrition). 
On the other hand, we also wish to compare the different tools for measuring muscle function, 
which are part of the diagnostic criteria for undernutrition. 
 
How does this research work? 
In the context of the hospitalisation of your loved one in the department, we propose to study 
his or her body composition by carrying out a bio-electrical impedance measurement. 
This examination is painless, non-invasive and risk-free. It is carried out by the dietician by 
placing 4 electrodes: one on the hand, one on the wrist, one on the ankle and one on the leg. 
Connected to a computer, they will allow us to measure your loved one's lean mass and fat 
mass. 
The impedance measurement will be performed once, within 48 hours of his admission to the 
department and will last approximately 15 minutes. 
In addition, we will ask him some questions in the "Mini-Nutritional Assessment" questionnaire, 
which will take less than 5 minutes. 
 
The constraints in this research? 
The constraints of this research for your loved one consist of 1 bio-electrical impedance 
measurement and 1 questionnaire, for a total maximum duration of 20 minutes. 
 
Possible adverse effects 
As your loved one's participation in this protocol does not involve the administration of any 
treatment other than that which is currently recommended, nor any other modification of the 
conventional management adapted to his or her health condition, no adverse effects are 
expected. 
- 
No additional treatment will be administered 
- 
No additional blood tests will be required. 
Impedance measurement is performed transcutaneously, i.e. by placing electrodes on the 
skin . The examination is therefore non-invasive and completely painless. 
The participation of your loved one in this research will not result in any additional costs 
compared to those he or she would have had in the usual follow-up of his or her disease. 
 
 

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54 
 
What are the expected benefits of this research? 
This study should make it possible to determine whether the use of French or international 
diagnostic criteria leads to a difference in the prevalence of undernutrition. If one or other of 
the definitions is associated with a greater prevalence, this will make it possible to monitor and 
adapt the medical and paramedical management of a greater number of people. In addition, 
the choice of tool for assessing muscle function could lead to a different estimate of the 
proportion of muscle mass loss, which is one of the diagnostic criteria for undernutrition. The 
choice of the tool allowing a wider screening would also allow to adapt the management of the 
patient. 
 
What are the conditions for participating in this study? 
In order to participate in this research, your relative must be affiliated to or benefit from a social 
security scheme. However, participation in this research will not entail any additional costs for 
your family member compared to those incurred in the usual care. 
 
Number of patients planned and duration of research? 
This research will last 21 months with a 20-month recruitment period to include 266 patients. 
 
What data is collected for the research? 
The medical data collected during this study will be processed in a computerised, coded and 
confidential manner. The main data collected will be anthropometric data (age, weight, height, 
etc.), related to medical history, nutritional status, biological check-ups, and the results of 
check-ups by rehabilitation professionals (physiotherapists, dieticians, EAPA). No information 
bearing the name of your relative will be provided to anyone except the doctor in charge of the 
study and authorised personnel. All data collected will be confidential and coded and analysed 
in the clinical research office of the Forcilles-Fondation Cognacq-Jay Hospital, the research 
sponsor. The identification list (correspondence between the code of your relative for the study 
and his/her identity) will be kept strictly confidential. 
In accordance with the regulations in force, the data will be kept until the final research report 
is produced and then archived for 15 years. 
The data controller is the promoter, Hôpital Forcilles-Fondation Cognacq-Jay, route de Servon 
77150 Férolles-Attilly. 
 
Legal basis for data processing 

PROTEIN 
 
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55 
 
The processing of the data is based on the legitimate interests of the controller, Article 6 
paragraph 1 point f, read in conjunction with the necessity of the processing for scientific 
research purposes, Article 9 paragraph 2 point j, of the European Regulation N° 2016/679 
(General Data Protection Regulation, GDPR). 
 
What are your rights? 
Your relative's participation in this research is entirely free and voluntary. Your relative's 
doctor must provide you with all the necessary explanations concerning this research, which 
must comply with the provisions of Article 13 of European Regulation No. 2016/679 (General 
Data Protection Regulation, GDPR). In accordance with article L.1122-1 of the Public Health 
Code, the entire research file has been submitted to the Comité de Protection des Personnes 
NORD OUEST III which issued a favourable opinion on xx/xx/xxxx. 
The Forcilles-Fondation Cognacq-Jay hospital has taken out insurance under contract no. 
163607 guaranteeing its civil liability and that of all those involved with the company SHAM. 
You can stop your relative's participation in research at any time without justification. This will 
not affect the quality of the care and treatment provided to your relative or his or her 
relationship with the doctor. The data collected until the withdrawal of consent will be used 
unless expressly requested by you. Indeed, in accordance with Article 17 of the RGPD, your 
loved one has the right to request the deletion of s data concerning  already collected. The 
withdrawal of consent and the agreement to use or not to use the data previously collected 
will be traced in the medical file of your relative. 
 
In accordance with the provisions of Articles 15 and 16 of Regulation (EU) 2016/679 of 27 
April 2016 (General Data Protection Regulation), your loved one has a right of access, 
rectification, erasure or restriction of processing. You can find out more about your loved one's 
rights by visiting the CNIL website https://www.cnil.fr/fr/reglement-europeen-protection-
donnees/chapitre3. In accordance with the provisions of Article 21 of the RGPD, your relative 
also has the right to object to the transmission of data likely to be used in the context of this 
research and to be processed. His/her request must be addressed to the Data Protection 
Officer of the Cognacq-Jay Foundation, either by e-mail to the address dpo@cognacq-jay.fr 
or by post to the address: Hôpital Forcilles-Fondation Cognacq-Jay, Délégué à la Protection 
des Données, route de Servon 77150 Férolles-Attilly. The user also has the right to lodge a 
complaint with the Commission Nationale de l'Informatique et des Libertés - CNIL (French 
authority for the control of personal data, website: www.cnil.fr). 
In application of the provisions of article L. 1111-7 of the Public Health Code, your relative 
may also access all medical data concerning him or her directly or through a doctor of his or 
her choice. 

PROTEIN 
 
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56 
 
Your relative's medical file will remain confidential and can only be consulted under the 
responsibility of the doctor in charge of your treatment, as well as by the health authorities and 
by persons duly mandated by the Forcilles-Fondation Cognacq-Jay hospital for research and 
subject to professional secrecy. 
If, after having read all this information and discussed all aspects with the doctor in charge of 
the research, you have had sufficient time to reflect on your decision and you agree to your 
relative taking part in this research, the information about the research and your oral consent 
will be recorded and dated in your relative's medical file . 
 
 
 
The agreement to participate in this research is free and voluntary. 
You may refuse or withdraw your consent at any time without explanation or prejudice. 
 
Any questions? 
 
 
Dr. ________________________ (tel. ______________________) is at your disposal for any 
further information you may require before and during the research. 
 
 

PROTEIN 
 
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57 
 
17.8 Appendix 8: Patient information note for further research 
 
PROTEIN 
"Evaluation of the impact of the French and international 
definitions and of the muscle function measurement tool on the 
prevalence of undernutrition in hospitalized patients 
 
RCB ID: 2021-A02410-41 
PRINCIPAL INVESTIGATOR 
Dr Ilham BENHARRAT, internist 
Forcilles Hospital 
Gastro-Nutrition Service 
Route de Servon 77150 Férolles-Attilly 
Email : ibenharrat@cognacq-jay.fr  
 
RESEARCH PROMOTER 
Clinical Research Office 
Forcilles Hospital-Cognacq-Jay Foundation 
Route de Servon 77150 Férolles-Attilly 
Telephone: 01.60.64.60.93 
Fax: 01.60.02.15.09 
aleneindre@cognacq-jay.fr 
 
Dear Sir or Madam, 
Due to your state of consciousness, we were unable to ask for your prior consent and you 
were included on ........../.........../........... in a research study entitled PROTEIN. 
In accordance with the law (article L.1122-1-3 of the Public Health Code), the trusted person 
that you had designated or your parent/relative was asked to agree to your participation in this 
research. 
Now that you are able to understand and express your wishes, we ask for your consent to 
continue your participation in this research. 
The doctor told you that you were free to accept or refuse further participation in this research. 
 
 
 

PROTEIN 
 
Version 2 of 14 /12 /2021 
58 
 
Your decision to participate is entirely free and voluntary. 
Please read the information below carefully, ask any questions you may have and take as 
much time as you wish to reflect on your decision to participate in this research. 
You are hospitalised in a short stay/SSR diabetes-obesity/pneumology/oncology/gastro-
nutrition department as part of the treatment of your pathology or a check-up. Your state of 
health requires screening for possible malnutrition in order to adapt your medical and 
paramedical care. 
 
What is the purpose of this research? 
The objective of this research is to evaluate the discrepancy between the prevalences of 
undernutrition as defined by the French National Authority for Health and the Global 
Leadership Initiative on Malnutrition (international group of experts working on undernutrition). 
On the other hand, we also wish to compare the different tools for measuring muscle function, 
which are part of the diagnostic criteria for undernutrition. 
 
How does this research work? 
As part of your hospitalization in the department, we propose to study your body composition 
by performing a bioelectrical impedance measurement. 
This examination is painless, non-invasive and risk-free. It is carried out by the dietician by 
placing 4 electrodes: one on the hand, one on the wrist, one on the ankle and one on the leg. 
Connected to a computer, they will allow us to measure your lean mass and your fat mass. 
The impedance measurement will be performed once, within 48 hours of your admission to 
the department and will last approximately 15 minutes. 
In addition, we will ask you a few questions in the Mini-Nutritional Assessment questionnaire, 
which will take less than 5 minutes. 
 
Your constraints in this research? 
The constraints of this research consist of 1 bio-electrical impedance measurement and 1 
questionnaire, for a maximum total duration of 20 minutes. 
 
 
 

PROTEIN 
 
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59 
 
Possible adverse effects 
As your participation in this protocol does not involve any treatment other than that which is 
currently recommended or other changes to conventional management appropriate to your 
condition, no adverse effects are expected. 
- 
No additional treatment will be administered 
- 
No additional blood tests will be required. 
Impedance measurement is carried out transcutaneously, i.e. by placing electrodes on your 
skin. The examination is therefore non-invasive and completely painless. 
Your participation in this research will not incur any additional costs compared to those you 
would have had in the usual follow-up of your disease. 
 
What are the expected benefits of this research? 
This study should make it possible to determine whether the use of French or international 
diagnostic criteria leads to a difference in the prevalence of undernutrition. If one or other of 
the definitions is associated with a greater prevalence, this will make it possible to monitor and 
adapt the medical and paramedical management of a greater number of people. In addition, 
the choice of tool for assessing muscle function could lead to a different estimate of the 
proportion of muscle mass loss, which is one of the diagnostic criteria for undernutrition. The 
choice of the tool allowing a wider screening would also allow to adapt the management of the 
patient. 
What are the conditions for participating in this study? 
In order to participate in this research, you must be affiliated to or benefit from a social security 
scheme. However, your participation in this research will not result in any additional costs for 
you compared to those incurred in the usual care. 
 
Number of patients planned and duration of research? 
This research will last 21 months with a 20-month recruitment period to include 266 patients. 
 
What data is collected for the research? 
The medical data collected during this study will be processed in a computerised, coded and 
confidential manner. The main data collected will be anthropometric data (age, weight, height, 
etc.), related to medical history, nutritional status, biological check-ups, and the results of 
check-ups by rehabilitation professionals (physiotherapists, dieticians, EAPA). No information 
bearing your name will be provided to anyone except the doctor in charge of the study and 
authorised personnel. All data collected will be confidential and coded and analysed in the 

PROTEIN 
 
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60 
 
clinical research office of the Forcilles-Fondation Cognacq-Jay Hospital, the research sponsor. 
The identification list (correspondence between your study code and your identity) will be kept 
strictly confidential. 
In accordance with the regulations in force, the data will be kept until the final research report 
is produced and then archived for 15 years. 
The data controller is the promoter, Hôpital Forcilles-Fondation Cognacq-Jay, route de Servon 
77150 Férolles-Attilly. 
 
Legal basis for data processing 
The processing of the data is based on the legitimate interests of the controller, Article 6 
paragraph 1 point f, read in conjunction with the necessity of the processing for scientific 
research purposes, Article 9 paragraph 2 point j, of the European Regulation N° 2016/679 
(General Data Protection Regulation, GDPR). 
 
What are your rights? 
Your participation in this research is entirely free and voluntary. You have the right not to 
participate in this research. 
You cannot be included in an interventional research protocol with minimal risks and 
constraints without having been informed beforehand. Your doctor must provide you with all 
the necessary explanations concerning this research, which must comply with the provisions 
of Article 13 of European Regulation No. 2016/679 (General Data Protection Regulation, 
GDPR). In accordance with article L.1122-1 of the French Public Health Code, the entire 
research file has been submitted to the Comité de Protection des Personnes NORD OUEST 
III which issued a favourable opinion on xx/xx/xxxx. 
The Forcilles-Fondation Cognacq-Jay hospital has taken out insurance under contract no. 
163607 guaranteeing its civil liability and that of all those involved with the company SHAM. 
You can stop participating in the research at any time without justification. This will not affect 
the quality of the care and treatment provided to you or your relationship with your doctor. The 
data collected until you withdraw your consent will be used unless you expressly request it. 
Indeed, in accordance with Article 17 of the GDPR, you have the right to request the deletion 
of your data already collected. The withdrawal of your consent and the agreement to use or 
not your previously collected data will be traced in your medical file. 
 
In accordance with the provisions of Articles 15 and 16 of Regulation (EU) 2016/679 of 27 
April 2016 (General Data Protection Regulation), you have a right of access, rectification, 
erasure or restriction of processing. You can find out more about your rights by consulting the 
CNIL website page https://www.cnil.fr/fr/reglement-europeen-protection-donnees/chapitre3. 

PROTEIN 
 
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61 
 
In accordance with the provisions of Article 21 of the RGPD, you also have the right to object 
to the transmission of data likely to be used in the context of this research and to be processed. 
Your request must be addressed to the Data Protection Officer of the Cognacq-Jay 
Foundation, either by e-mail to the address dpo@cognacq-jay.fr or by post to the address: 
Hôpital Forcilles-Fondation Cognacq-Jay, Délégué à la Protection des Données, route de 
Servon 77150 Férolles-Attilly. You also have the right to lodge a complaint with the 
Commission Nationale de l'Informatique et des Libertés - CNIL (French personal data control 
authority, website: www.cnil.fr). 
In application of the provisions of article L. 1111-7 of the Public Health Code, you may also 
access all of your medical data directly or through a doctor of your choice. 
Your medical file will remain confidential and can only be consulted under the responsibility of 
the doctor in charge of your treatment, as well as by the health authorities and by persons duly 
mandated by the Forcilles-Fondation Cognacq-Jay hospital for research and subject to 
professional secrecy. 
If, after having read all this information and discussed all aspects with the doctor in charge of 
the research, you have had sufficient time to reflect on your decision and you decide to 
participate in this research, the research information and your oral consent will be notified and 
dated in your medical file. 
 
The agreement to participate in this research is free and voluntary. 
You may refuse or withdraw your consent at any time without explanation or prejudice. 
 
 
 
 
 
Any questions? 
 
Dr. ________________________ (tel. ______________________) is at your disposal for any 
further information you may require before and during the research. 
 
 

PROTEIN 
 
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62 
 
 
18 List of investigators 
 
 
LIST OF INVESTIGATORS 
FIRST NAME, LAST 
NAME 
ROLE 
FUNCTION 
CONTACT INFORMATION 
Ilham BENHARRATS 
Principal 
investigator 
Internist 
ibenharrats@cognacq-jay.fr 
01.60.64.61.78 
Virginie COLELLA 
Co-investigator 
APA teacher 
vcolella@cognacq-jay.fr 
Aymeric LE NEINDRE 
Co-investigator 
Physiotherapist 
aleneindre@cognacq-jay.fr 
 
Carlos DIAZ LOPEZ 
Co-investigator 
Physiotherapist 
clopez@cognacq-jay.fr  
Salima KALLA  
Co-investigator 
Oncologist 
skalla@cognacq-jay.fr  
Leïla NAHAL 
Co-investigator 
Dietician 
lnahal@cognacq-jay.fr  
Mohand TAGZIRT  
Co-investigator 
Geriatrician 
mtagzirt@cognacq-jay.fr  
Cécile SERON 
Co-investigator 
Dietician 
cseron@cognacq-jay.fr  
Maxime CADORET 
Co-investigator 
Dietician 
mcadoret@cognacq-jay.fr  
Tom BARBOSA 
Co-investigator 
APA teacher 
tbarbosa@cognacq-jay.fr  
Caroline O'CONNELL  
Co-investigator 
Pneumologist 
Co'connell@cognacq-jay.fr  
Sophie VIDAL-JESSEL 
Co-investigator 
Diabetologist 
svidaljessel@cognacq-jay.fr