STUDY POPULATION AND PRESCRIBED ENTERAL NUTRITION FORMULAS
In total, 414 patients were included, 254/414 (61.4%) of whom were women. The most prescribed EN formula was hyperproteic/hypercaloric without fibre (145/414; 35.0%). The main conditions diagnosed were neurodegenerative disease (Alzheimer's, Parkinson's, dementia) in 64.8% of cases (n=256), and stroke in 22.8% of cases (n=90). One hundred patients (25.3%) of the total sample were diagnosed with diabetes mellitus. The patients had a mean weight of 59.3 ± 10.4 kg and a BMI of 22.6 ± 3.2 Kg/m2 (Table 1). The prevalence of cardiovascular and neurodegenerative disease was higher in the female population compared to cancer patients (p<0.001). The prescription of an HP/HC formula with fibre was higher in cancer patients compared to patients with cardiovascular and neurodegenerative disease (p<0.001). However, the prescription of an NP/NC formula with fibre was higher in patients with cardiovascular and neurodegenerative disease compared to cancer patients (p<0.001) (Table 2).
NUTRITIONAL STATUS
At baseline, moderate protein-calorie malnutrition was predominant among the patients recruited for the study (n=192, 46.4%). The change at 6 months showed a significant improvement in nutritional status (Table 3). According to the changes that occurred between one period and another, nutritional status improved in more than 75% of patients (Table 4).
BIOCHEMICAL PARAMETERS
For the variables glucose, albumin, prealbumin, lymphocytes, transferrin, weight, body mass index (BMI) and mid-upper arm circumference (MUAC), an improvement was observed between baseline and 6 months (p-value <0.05) (Table 5).
ADVERSE EFFECTS
Adverse effects were recorded in no more than 6% of cases, except for tolerance problems, where the percentage was 16.3%. There was a reduction in all adverse effects between the 3-month and 6-month visits, with significant reductions observed for tolerance problems, diarrhoea and abdominal distension (Table 6).
ADMINISTRATION ROUTE AND ADVERSE EFFECTS
At 3 months there was a slight increase in NGT administration (58.3% to 63.2%) to the detriment of ostomies (41.7% to 36.8%). When analysing the association between the occurrence of adverse reactions and the access route, a higher occurrence of diarrhoea was observed in patients with NGT vs ostomy at 3 months (7.9% vs 2.3%; p=0.015).
The most commonly used administration regimen was intermittent in 300 patients (96.8%). Patients with intermittent administration had greater tolerance and diarrhoea problems than patients with continuous administration at 6 months (23.1% vs 4.3%; p=0.021 and 15.4% vs 0.8%; p=0.009, respectively). The most commonly used feedings/day regimens were 4 or 5 per day (41.1% n=156 and 53.7% n=204, respectively). When the association between the occurrence of abdominal distension and feedings/day at 3 months was analysed, it was found that the higher the number of feedings per day, the lower the occurrence of constipation (p=0.039). In the case of abdominal distension, the 5 feedings/day regimen was associated with greater nausea (p=0.001).
Patients who received intermittent EN had fewer tolerance-related effects in general (OR: 0.042; 95% CI: 0.006-0.279) and diarrhoea (OR: 0.042; 95% CI: 0.006-0.279), while those who received EN via NGT had fewer tolerance-related effects versus ostomy (OR: 0.042; CI 95%: 0.006-0.279).
NUTRITIONAL REQUIREMENTS
The established energy and protein requirements remained constant throughout the follow-up of the patients in the study. The mean energy requirements were 1548 ± 297, 1465 ± 295 and 1550 ± 291 kcal/day at baseline, 3 months and 6 months, respectively. Protein requirements were also very constant over the three visits; 70.7 ± 15, 70.5 ± 15.7 and 70.8 ± 15 g/day, respectively. In relation to the requirements by condition described, both protein and energy requirements were found to be higher in patients diagnosed with neoplastic disease than for the other conditions (p-value <0.05) (Table S1). When analysing the relationship between the onset of adverse reactions at 3 months with the need to adjust nutritional requirements, it was observed that these differences were significant for abdominal distension (p<0.001) and nausea (p=0.017). This statistical significance was maintained for abdominal distension at 6 months (p<0.001).
EDUCATIONAL PROGRAMME COMPLIANCE
At the baseline visit, compliance with the measures proposed by the prescriber was: delivery of clinical report (392; 100%), delivery of educational material (392; 100%), correct adherence to the diet (383; 100%), indications for access route (391; 100%) and proper handling of the diet (407; 99.3%), and at 6 months, correct adherence to the diet (387; 99.7%), indications for access route (382; 99.2%) and proper handling of the diet (381; 99.0%). There were very few interim and final suspensions (1; 0.3% and 2; 0.5%, respectively) in the 6-month review. However, 20% of patients required an adjustment to their nutritional regimen for various reasons. From the baseline to the 3-month visit, of all patients who had tolerance problems, almost 40% (39.4%, n=66) were offered an adjustment to requirements and/or feeding regimens (p-value <0.001), and between the 3-month and 6-month visit, 40% (n=20) of patients who had tolerance problems were also offered an adjustment to requirements and/or feeding regimens (p-value <0.001).