Design and rationale of the effect of early nutritional therapy on frailty, functional outcomes and recovery of malnourished medical inpatients trial (EFFORT): a pragmatic, multicenter, randomized-controlled trial

Schüetz, Philipp; Fehr, Rebecca; Baechli, Valerie; Geiser, Martina; Gomes, Filomena; Kutz, Alexander; Tribolet, Pascal; Bregenzer, Thomas; Hoess, Claus; Pavlíček, V.; Schmid, Sonja; Bilz, Stefan; Sigrist, Sarah; Brändle, Michael; Benz, Carmen; Henzen, Christoph; Mattmann, Silvia; Thomann, Robert V.; Brand, Claudia; Rutishauser, Jonas; Aujesky, Drahomir; Rodondi, Nicolas; Donzé, Jacques; Stanga, Zeno; Müeller, Beat

doi:10.18203/2349-3259.ijct20182085

Cited by 42 publications

(54 citation statements)

References 38 publications

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“…B. zu: kürzeren Hospitalisationszeiten, weniger Komplikationen, weniger Rehospitalisationen, einer verbesserten Energie-und Proteinaufnahme inklusive weniger Gewichtsverlust und Verbesserung der Faustschlusskraft, einer Verbesserung der Lebensqualität usw. [24,[46][47][48][49][50][51][52][53][54][55].…”

Section: Ernährungskommissionunclassified

Herausforderungen und Wirksamkeit eines klinischen Ernährungsteams

Reber¹,

Leuenberger²,

Stirnimann³

et al. 2019

Aktuel Ernahrungsmed

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Many patients are malnourished at hospital admission. This condition further worsens improve during the hospitalisation. Malnutrition itself prolongs the length of hospital stay and the rehabilitation time, increases complication rates, morbidity, and mortality. Prompt reaction is needed to prevent these negative consequences, to maximise the success of therapy and to offer patients a better quality of life and a maintained autonomy. The early recognition of a poor nutritional status is therefore indispensable to initiate an efficient and timely nutritional therapy, according to individual needs. Multidisciplinary knowledge is needed to avoid potential complications as well as clearly defined responsibilities and structured processes. Thus, inter- and multiprofessional efforts clinical nutrition support teams have been created since the 70ies, mainly in the larger hospitals, to manage nutritional therapies. The main task of a clinical nutrition support team is to detect the risk for malnutrition, to prevent malnutrition by targeted measures and, when appropriate, to adequately treat it quickest possible. In the following, we will provide more details about organisation, composition, tasks, challenges of clinical nutrition support teams as wells as efficacy regarding patients? outcome and briefly about costs.

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Section: Ernährungskommissionunclassified

Herausforderungen und Wirksamkeit eines klinischen Ernährungsteams

Reber¹,

Leuenberger²,

Stirnimann³

et al. 2019

Aktuel Ernahrungsmed

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“…First, the multicenter, randomized, placebo-controlled NOURISH trial (Nutrition effect On Unplanned ReadmIssions and Survival in Hospitalized patients) including 652 older adults affected by malnutrition found that a high-protein oral nutritional supplement containing beta-hydroxy-beta-methylbutyrate was associated with a significant reduction in 90 day mortality, with a number needed to treat (NNT) of 20 [8]. Second, the EFFORT (Effect of early nutritional support on Frailty, Functional Outcomes and Recovery of malnourished medical inpatients Trial) including 2028 medical inpatients at nutritional risk in eight Swiss hospitals showed that protocol-guided individualized nutritional support designed to achieve protein and energy targets results in significantly lower rates of severe complications (NNT = 25) and mortality (NNT = 37) compared to regular hospital food [9,10]. Moreover, functional decline was significantly lower, and quality of life as well as activities of daily living significantly improved.…”

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confidence: 99%

Nutritional Management and Outcomes in Malnourished Medical Inpatients in 2020: The Evidence Is Growing!

Schuetz

Stanga

2019

JCM

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Access to adequate food is a fundamental human right. There is no doubt that nutrition is essential in maintaining health and preventing or treating disease. Particularly when patients are affected by disease-related malnutrition, their risk of adverse clinical outcomes increases significantly and optimizing nutritional support becomes mandatory [1,2].There is ongoing debate about what constitutes an optimal nutritional care process in terms of screening, assessment, and use of nutritional support in different patient populations. Issues include dose and quality of proteins and total energy, route of delivery, and whether or how nutritional support needs to be adjusted for specific medical and metabolic conditions. As we move toward personalized medicine, which is based on patients' individual needs, an understanding of these different factors is important. Well-planned clinical studies of high methodological quality are needed to develop the best approach to providing individualized nutritional support [3].Historically, much of the evidence regarding effects of nutritional support has come from small interventional trials and observational studies with cross-sectional or cohort-study designs, whereas there was an important lack of large-scale randomized interventional research, which is needed to establish causal effects rather than just statistical associations [4,5]. As a consequence, the medical community has struggled to design efficient, evidence-based approaches for the prevention and treatment of malnutrition [4].Recently, however, the results of several high-quality trials have provided important new insights that advance nutritional science significantly and translate nutrition research into practice [6]. Regarding prevention of cardiovascular disease through nutrition, the PREDIMED (Prevención con Dieta Mediterránea) trial provided strong evidence that a Mediterranean diet supplemented with extra-virgin olive oil or with mixed nuts reduces the risk of cardiovascular and metabolic disease by about 30% over five years [7]. Regarding the use of clinical nutrition in patients at nutritional risk or with established malnutrition, two trials found nutritional support to be highly effective. First, the multicenter, randomized, placebo-controlled NOURISH trial (Nutrition effect On Unplanned ReadmIssions and Survival in Hospitalized patients) including 652 older adults affected by malnutrition found that a high-protein oral nutritional supplement containing beta-hydroxy-beta-methylbutyrate was associated with a significant reduction in 90 day mortality, with a number needed to treat (NNT) of 20 [8]. Second, the EFFORT (Effect of early nutritional support on Frailty, Functional Outcomes and Recovery of malnourished medical inpatients Trial) including 2028 medical inpatients at nutritional risk in eight Swiss hospitals showed that protocol-guided individualized nutritional support designed to achieve protein and energy targets results in significantly lower rates of severe complications

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“…(There was no explanation regarding how the assessors were so blinded.) It was stated that there were “no interim analyses planned or made during the trial.” The protocol was published in 2018 . The trial was initially registered at ClinicalTrials.gov sometime between July 30, 2015, and August 4, 2015.…”

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confidence: 99%

“…I also noted that on the May 1, 2018, entry, the anticipated date of trial completion was December 2018. Since the protocol was also submitted after the trial was over, the only information that I had from the time that the trial was initiated regarding a possible early stopping of this RCT was the previous and persistent estimate that over 400 more patients were to be entered. (The 2500 estimate was registered in 2015.…”

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confidence: 99%