The Effort Trial And Evidence Based Medical Nutrition-Books Pdf

THE EFFORT TRIAL AND EVIDENCE BASED MEDICAL NUTRITION
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Maura There are many trials in the literature on the benefits of nutrition screening and nutrition intervention Why. did your research team want to do the EFFORT trial What were you hoping to show. Dr Sch tz Yes so when we started to look into this problem we actually did a systematic search and meta analysis. to look at all the different trials And we realized there are a lot of trials as you just mentioned and most of these. trials were small in number and didn t have the statistical power to show that nutrition can impact medical. outcomes such as mortality or morbidity And I think today when we talk about evidence based medicine it s really. important for physicians to know that actually these treatments are effective in reducing clinical adverse outcomes. of really improving the health of patients So the EFFORT trial is really the first large trial that was powered to show. the effect of nutritional support on clinically endpoint such as mortality and complication rates. Dr Sch tz So we really wanted to do a landmark trial to understand if malnutrition in the end is a modifiable. condition and whether nutritional support is effective in actually influencing these important outcomes. Maura Can you tell us a little bit about the methodology you followed for the EFFORT trial and what specifically you. did in your trial in terms of nutrition screening and intervention. Dr Sch tz Yes so the EFFORT trial was really a pragmatic trial Within all the different hospitals that participated. we started by doing a nutritional risk screen All medical inpatients that went to the medical ward were screened for. malnutrition And we used the nutritional risk screen 2003 which is a broadly used risk screen in Europe but also in. the US And so we screened these patients And patients that nutritionally at risk were eligible to be part of the trial. And so we have a couple of exclusion criteria We didn t want have any surgical patients or ICU patients or patients. with terminal disease We didn t want to include them in the trial But other than that we had a really broad patient. population, Dr Sch tz And so once patients entered the trial they were randomized either to the control arm and this was. just the standard of care The nutrition arm where patients were allowed to get any sort of nutrition but we didn t. have a team looking at their nutritional goals or providing them with oral nutritional supplements or any kind of. specialized nutrition formula So the intervention group we had a nutrition protocol which was administered by our. team the nursing team and a registered dietitian And basically we defined for each patient individualized goals. so we had protein goals we then defined an individual strategy on how to reach these goals So of course one. patient may prefer to work with oral supplements other patients had other preferences such as working more. within the hospital kitchen And for some patients it was even needed for a certain amount of time to use enteral. nutrition to reach these goals So in the end we compared what is the risk of patients to die or have severe. complications and whether he was treated just by usual nutritional care or whether we use the nutritional strategy. to reach these goals So we were very pleased to see in the end that the nutritional intervention was very effective. in our trial and it reduced the risk for severe complications by about 4 So we had a number needed to treat in the. trial of about 25 so we needed for 25 patients that were receiving nutritional support we were able to prevent. severe complication The same was true for mortality we had a number needed to treat of about 40 so for 40. patients that were treated according to protocol we were able to prevent one death in the trial. Maura What did you expect to find in the data, Dr Sch tz From the previous literature we found that a lot of studies have shown that nutrition is quite effective in. improving weight and nutritional outcomes But we were not sure how effective it was really in reducing mortality. and also complications So in the end we found that our nutritional protocols was very effective and had a strong. effect on clinical outcomes IN the end this was the ultimate proof we needed to show that malnutrition is really a. disease and condition we can be active about and we can improve patients health states by using nutritional. treatment plans So I think it was a very important trial because it did have a lot of patients and there was a lot of. statistical power to show that nutrition is working and a very effective treatment. Maura Can you go into a little more detail about what the data did show and how you cross checked it against what. you expected, Dr Sch tz Yes sure So we found that we had different end points We looked at worst outcomes which was. combined endpoints And we found that nutrition reduced the risk of adverse outcomes within 30 days from 27 to. 23 We also found a lower risk of mortality in patients who were treated with our nutritional treatment protocols. Patients also had better functional outcomes so the risk to have a decline in their functionality was reduced We. also looked at quality of life using the E25D quality of life score and we found a significant improvement in quality. of life in over 30 days in the trial So basically nutrition was very effective in reducing mortality risks and improving. outcomes and in functionality and quality of life So I think the results are very positive and really show these. patients have strong benefits from nutritional intervention. Maura How do you think these findings positively add to the base of evidence showing the benefits of good. nutritional care, Dr Sch tz That s a great question When we started the EFFORT project we did a meta analysis and we found that. there is quite a lot of trials many of these trials are small and a lot of them really didn t look at mortality and did. not find significant results There was also the NOURISH trial published recently which also was a large US based. trial and EFFORT and NOURISH both showed nutrition is effective in reducing mortality in this patient population So. we have recently finished a meta analysis where we gathered all the randomized control data around nutritional. interventions in medical inpatients The meta analysis basically shows that the nutritional intervention produces. about a 25 reduction in the risk of mortality This is very similar to the results we found in the EFFORT trial So I. think when we look globally at the problem of malnutrition these new trials now very much support that nutritional. treatment has a positive effect on patient outcomes and particularly can reduce mortality strongly by about 25. and I think this is an impressive number, Maura Did anything surprise you about your findings.
Dr Sch tz Well I think it was hard at first to know whether patients would stay active in the trials because. nutritional care is difficult it needs a lot of team effort It needs the patient on board but also the nursing team. the dietitian team on board and so we found that in most of our patients we were able to reach their nutritional. goals within this trial And I think this was a positive experience for us to see that if you work together with the. dietitian team the nursing team but also the hospital kitchen and the patient the team effort you have there the. end result can be very positive, Maura I would say our listeners would definitely agree with that You and other authors went on to publish a new. meta analysis and systematic review by Gomes and others in November 2019 in JAMA Network Open is that right. Can you tell us what this review showed and how it was different from previous reviews on nutrition intervention in. malnourished patients, Dr Sch tz Yes so there are a lot of different reviews out there and a lot of them have been more qualitative or not. found conclusive results I think it was mainly based on the lack of larger trials which can prove in the end the. benefits of nutritional intervention So with our meta analysis that was published last year we really did an up to. date literature search We included the EFFORT trial which was the largest trial with more than 2 000 patients But. there were also other large trials such as the NOURISH trial And so in the meta analysis we found consistently that. nutritional support in patients who were malnourished and in the hospital that this was very effective and reduced. mortality by about 25 We also found that the risk of hospital readmission once the patient gets discharged is. reduced by about 25 And we also had the length of hospital stay shortened in the nutritional intervention group. for the patient groups who had established malnutrition. Dr Sch tz So different clinically relevant outcomes were significantly affected in a positive way by nutritional. support And so I think this meta analysis is very important because it summarizes all the evidence we have from the. different trials from different countries I think we had about 50 different countries So this is really a global picture. of malnutrition showing that the treatment for malnutrition by use of nutritional intervention work and are very. Maura What does it take for clinicians to change their clinical practice How can evidence like the EFFORT trial and. the new meta analysis impact change, Dr Sch tz I think nutrition has been seen as just a supportive treatment which a lot of physicians aren t aware it s a. very effective treatment Now nutrition is more difficult than just prescribing a patient another pill because it really. needs a team approach First you need your hospital to have an effective malnutrition screening in place you need. to identify the patient then you need a team going to the patient talking about nutrition talking about his goals. understanding his situation You also need the team to communicate with the kitchen to bring the foods to adapt. the food to the patient s individual goals And so it s a lot of team approach A lot of it is logistics It takes some. EFFORT to really establish a good nutrition team in the hospital. Dr Sch tz And so my recommendation is for physicians and clinicians to look into nutrition to make sure that in. their hospital they have a screening program in place that their patients are all being looked after in regard to the. nutritional goals they have, Maura I noticed you discussed the term evidence based medical nutrition in your EFFORT publications Can you. tell us a little about more about this, Dr Sch tz Evidence based medicine has become the gold standard for treatment and it means that for each and.
any treatment that we give our patients we need to have evidence that any treatment is effective and is not. associated with any side effects And also from a cost effectiveness perspective the treatment should be favorable. And I think the same standard in medicine for all our drugs and treatments we should use the same standard for. nutrition So the term evidence based nutritional therapy underlines this goal that we also need to have strong. evidence that our nutritional interventions is effective safe and cost effective. Maura When you look at all of this through the context of the COVID 19 pandemic around the globe how has this. affected patients in your hospital and their nutritional status. Dr Sch tz Yea I think Covid is an infection that has caused a lot of morbidity and mortality particularly in the. elderly polymorbid patients and a lot of these patients are malnourished And so if these patients are malnourished. they have very little reserve and so if they get sick if they get Covid 19 they are at high risk if they re. malnourished If they re malnutrition gets work the malnutrition will have a very negative impact on their outcomes. and increase their risk that the patient will not survive their hospital stay. Dr Sch tz And so particularly for the Covid 19 patient because of the vulnerable patient population that gets. infected and comes to the hospital we have to be very careful not only to focus on the infection Covid 19 but also. to focus on attention to their nutritional health It s something we can actually treat and positively influence while. for the Covid 19 infection there s still uncertainty how well the infection is actually treatable with all the different. drugs out there, Maura How then do you think the results of the EFFORT trial be used in care of these COVID 19 patients to. optimize their nutritional therapy, Dr Sch tz In the EFFORT trial we really included the broad medical inpatient population and we had about 400. patients who were coming to the hospital due to pneumonia So it is a very similar patient population than the one. we see now with Covid 19 And of course by that time we didn t have any Covid 19 patients in the EFFORT trial We. did have a lot of patients with COPD and a lot of patients with pneumonia and other types of infections And so in. the EFFORT trial we saw that these patients with lung infections other infections COPD if they were at risk for. malnutrition they had the benefit from nutritional intervention And so we strongly believe that the same would be. true now for the Covid 19 patient population, Maura Bringing it all home what learnings from this trial can or should clinicians apply to their practice. Dr Sch tz Well I think first of all it s important that someone cares You need in your hospital a nutrition care team. And you need to make sure patients are being screened And if we identify patients at high risk for malnutrition we. THE EFFORT TRIAL AND EVIDENCE BASED MEDICAL increased complications increased readmission rates increased health care costs and decreased quality of life The good news is that evidence shows how proper nutrition care for hospital patients by this I mean early nutrition screening assessment and intervention how all those things can really change this trajectory and improve

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