Socioeconomic, geographical, and professional characteristics
Of the 316 experts invited, 93 participated in the 1st Delphi round. The most common age group were the 40–49-year-olds (32%, n = 30) while the distribution of other age groups was similar, except for an underrepresentation of 20–29-year-olds (3%, n = 3) (Table 1). Most participants were women (77%, n = 72), from Europe (72%, n = 67) followed by Asia (14%, n = 13), and although 27 countries were represented, most hailed from the Netherlands, Türkiye, UK, and Portugal. Two-thirds (66%, n = 62) of the participants were either geriatricians or researchers while 16% (n = 15) were dietitians or nutritionists. A little more than half of the participants worked mainly in the hospital (55%, n = 51), 36% (n = 33) in the community and 10% (n = 9) in long-term care, while approximately half (48%, n = 45) responded that the main duration of follow-up of nutritional interventions in their setting was <12 weeks. The response rate for the 2nd Delphi round was 77.4% (n = 72). The distribution of the characteristics was similar between the 1st and 2nd rounds, and importantly, Europe was still overrepresented in the latter (75%, n = 54) (Table 1).
Delphi survey 1st round
The exclusion of nine non-critical outcomes was agreed by 71% (n = 66) of the participants but 20% (n = 19) considered that physical activity should be rated in the 2nd round, which was done. For all other outcomes, only ≤4 participants did not agree with their exclusion.
In this round, ≥75% of participants rated malnutrition status (88%), dietary intake (83%), body weight or BMI (75%), muscle strength (82%) and functional performance (85%) as critical, while ≥60% rated the PROs functional limitations (72%), quality of life (80%), and acceptability or adherence of the intervention (79%) as critical to be included in the COS (Fig. 1A, Table S2).
A Difference of the participants’ rating to the threshold of inclusion of selected outcomes (60% for PROs and 75% for non-PROs) for the 1st round (n = 93) and B the 2nd round of the Delphi survey (n = 72). Adverse events were excluded, and physical activity included in the 2nd round of the survey. C Final consensus meeting: percentage of participants that agreed to the inclusion of these outcomes in the Malnutrition COS (n = 15). Outcomes with ≥70% agreement were included in the COS. and
bars mean outcomes that were above and below consensus threshold according to protocol, respectively. *Outcomes to be voted together for exclusion included Body circumference(s), Skinfold(s), Mortality, Healthcare use, Healthcare costs, Complications, Health status, Dysphagia severity, Fatigue, Weakness, Self-perceived health, Pain, Cognitive status, Depression, Anxiety, Sleep disturbance, Self-esteem, Hydration status, Eating behaviour, Energy requirements, Blood marker(s), Nitrogen balance, Participation in social roles and activities, Peak expiratory flow, Bone health, Falls, Physical activity. It is worth noting that weight loss can be calculated from assessing body weight at baseline and follow-up. BMI body mass index, COS core outcome set.
No single outcome was considered sufficiently unimportant, warranting its re-rating in the subsequent Delphi round (≥75% not important and <15% critical for non-PROs and ≥60% not important and <15% critical for PROs). Therefore, because it was unclear which outcomes to exclude, participants were asked to re-rate these in a 2nd Delphi survey round.
Rating of outcomes from the 1st round of the Delphi survey were largely similar by setting (community n = 33, hospital n = 51 and long-term care n = 9) (Table S3) and duration of follow-up (<12 weeks n = 45, ≥12 weeks n = 48) (Table S3). However, there were some notable exceptions, that although not warranting a different COS by setting are important to mention. For example, in the hospital setting ≥75% of the participants (77%) rated mortality as a critical outcome to be included in the COS but only less than half (49%) did so in the community setting. Similarly, 71% of the participants from the hospital setting rated complications as critical while only 39% did so in the community. There were few participants who indicated long-term care as their main setting (n = 9), but it seemed that dysphagia severity (n = 8) and hydration status (n = 7) were rated as more important than in other settings (Table S3).
Delphi survey 2nd round
Adverse events were excluded for re-rating in the 2nd round since the steering group considered that reporting adverse events is already mandatory for any trial, and therefore, did not need to be included in a specific COS. Furthermore, for the same reasons and because the concepts were too different, adherence to the intervention was removed from the outcome acceptability.
Almost all participants (99%) in the 2nd round agreed that malnutrition status, body weight or BMI, functional performance, dietary intake, muscle strength, functional limitations, quality of life and acceptability of intervention should be included in the COS. One participant disagreed with the inclusion of acceptability of intervention and quality of life (Fig. 1B, Table S3).
On top of these, ≥75% of participants re-rated muscle mass (82%) and frailty (79%) as being critical for inclusion in the COS, and ≥60% re-rated appetite (64%) as a PRO that was critical to be included in the COS.
Validation by PPI representatives
Five PPI representatives (three adults aged 80+ years: 1 malnourished and 2 at high risk, and two informal care givers) from the Netherlands, Türkiye and Portugal considered well-being, looking good, walking without help and fatigue, weight regain, strength, physical capacity, being able to do sports and memory as an important outcome for them. The steering group concluded that these outcomes largely reflected the results of the two Delphi rounds except for memory and looking better. However, cognitive status was rated low in both Delphi rounds. It was discussed that looking good might have some overlap with self-perceived health (rated low), self-esteem (rated low), and quality of life (included), and that this type of outcome would likely become more important in the future and would require a specifically designed study.
The PPI representatives also broadly agreed with the outcomes derived from the 2 Delphi rounds. However, there were five neutral votes (1xmalnutrition status, 1× muscle mass, 2× frailty and 1× acceptability of intervention) and one negative vote for functional performance.
Final consensus meeting
The final consensus meeting took place online on the 27th of July 2023 with 15 participants present plus the chair who abstained: 2 PPI representatives (where one joined halfway through the meeting), 6 steering group members, 5 participants from both Delphi rounds (selected for their involvement in health policy or being a dietitian) and 2 external guests from the medical nutrition industry.
Participants were asked if they agreed with the exclusion of the undecided outcomes from both Delphi rounds (i.e., body circumference(s), skinfold(s), mortality, healthcare use, healthcare costs, complications, health status, dysphagia severity, fatigue, weakness, self-perceived health, pain, cognitive status, depression, anxiety, sleep disturbance, self-esteem, hydration status, eating behaviour, energy requirements, blood marker(s), nitrogen balance, participation in social roles and activities, peak expiratory flow, bone health, falls and physical activity). Less than 70% of the participants (64%) agreed with the exclusion of these outcomes so no consensus was reached. Those that did not agree with the exclusion, did so for health care costs, or self-rated health, or hydration status, or physical activity, or body circumference(s), or adverse events, or complications, or mortality. This was followed by a group discussion. Healthcare costs were considered particularly important, but participants decided these should not be mandatory for smaller trials but advisable for larger trials where a cost-effectiveness analysis may be done. Self-rated health was considered to be at least partly reflected in quality of life and therefore unnecessary to be further included in the COS. The participants considered hydration status of lower importance considering the effects of malnutrition treatment but acknowledged that nutritional interventions are not only about foods and nutrients. Inclusion of physical activity in the COS was not supported since physical activity was rated low in the 2nd Delphi round, and consensus meeting participants considered that individuals could be physically active or inactive regardless of nutritional status. Body circumference was mentioned as being a simple and feasible measure of muscle mass. However, this comment referred to how an outcome should be measured, which is not relevant for this phase of the COS development. After the group discussion, 80% of the participants (out of 15 since both PPI representatives were now present) re-voted to exclude all undecided outcomes from the COS (Fig. 1C).
Outcomes that had reached consensus in at least one of the Delphi rounds were all voted in for inclusion in the final COS, with the exception of frailty as it did not reach ≥70% consensus in the final voting since the group considered that components of frailty largely overlapped with other COS outcomes (Fig. 1C).
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