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Enteral nutrition therapy: protocol construction and validation


Francimary de Alencar CamposI; Joselany Áfio CaetanoII; Paulo César de AlmeidaIII; Viviane Martins da SilvaIV

I M.Sc in Nursing. Assistance Nurse at Hospital Universitário Walter Cantídio. Fortaleza, Ceará, Brazil. E-mail:
II Ph.D in Nursing Adjunct Professor Adjunta at Universidade Federal do Ceará. Fortaleza, Ceará, Brazil. E-mail:
III Ph.D in Public Health. Adjunct Professor Adjunto at Universidade Estadual do Ceará. Brazil. E-mail:
IV Ph.D in Nursing. Adjunct Professor at Universidade Federal do Ceará. Brazil. E-mail:





Objective: to develop and validate a protocol for enteral nutrition therapy for adult patients on enteral tube. Method: this descriptive study involved a literature review on the subject in order to construct the instrument and for its subsequent validation by experts. Fifteen experts participated in the validation, and data were collected between June and September 2012 using a form containing data on the experts and protocol evaluative data. Results: the final protocol resulted in two sections, each with six domains. After construction, protocol appearance and content validation returned a 0.837 rate of agreement, which is considered high reliability. Conclusion: the protocol is valid, applicable in practice, and able to inform intervention designs and choice of the best nursing practice.

Keywords: Diet therapy; nursing; validation studies protocol; enteral nutrition.




Malnutrition is a common reality regarding patients in hospital, with prevalence rate ranging from 30 to 65% in different investigations. That condition can be configured as early as the moment of hospital admission or can also be developed during hospital stay. Resort to tubes can occur on several occasions to ensure patient's nutritional levels. Nutritional deficit may require additional stay in hospital and generate higher vulnerability to infections as well as increasing hospital costs1,2.

There is a set of conditions on the hospital scene that favors aggravation of nutritional status. It should be highlighted that many a time patient's weight and height are not checked in upon admission. Therefore, malnutrition might not be identified; frequent failure to observe non acceptance of food by patients; surgical interventions on malnourished patients lacking the administration of a nutritional therapy as well as extensive use of venous hydration associated to fasting in such a condition may lead to atrophy of the intestinal mucous membrane. Several times there is neither tracking nor nutritional screening of patients in hospital3.

In face of that scenario, scholars have been developing techniques of artificial nutrition since the nineteenth century, aiming at life extension, prevention of weight loss and patients' malnutrition. Therefore, enteral nutrition provides food support to patients. It is known that when the gastrointestinal tract is functional, enteral diet turns out to be a way to recover or, in case of sudden damage, to ensure optimum nutritional standards1-3.

Enteral nutrition therapy consists of nutritional supply by means of tubes to those patients with functional gastrointestinal tracts but still incapable of a satisfactory oral food intake to meet their metabolic needs. It is regarded as an advantageous means for promoting intestinal mucous barrier integrity; for preventing bacteria translocation; for associating with the decrease of infection complication rates; and for proving economically feasible on the institutional level2,3.

Concerning enteral nutrition, nursing action is involved with standards defined by both the National Agency of Sanitary Surveillance (ANVISA) and by the Federal Nursing Council (COFEN). Both entities include the nurse as a member of a multidisciplinary team for enteral nutrition, and define their administrative, assistance, education and research standards4,5.

This research aims at developing and validating a protocol for enteral nutrition to adult patients on enteral tube.



To develop its activities, nursing practice makes use of a set of technologies, which may be employed by all of those professionals motivated to better humans' health care. Enteral nutrition therapy is related to life quality, to health management, to diseases, and ensuing problems. Standardization technologies on protocols, for example, highly favor the improvement of both nursing care and life quality of those subjects under care6,7.

The development of protocols brings about theoretical implications to scholarship, as well as to practices to health services, for that involves the adoption of standards developed on the basis of literature and institutional reality. Additionally, it is highlighted the relevance to develop, validate, and improve assistance protocols that are operational and that may favor changes in health care practice8.

The nurse's clinical practice related to enteral nutrition therapy must be associated to the implementation of interventions aimed at feeding support; to that end, scientific knowledge-based assistance proves fundamental. Therefore, the use of nursing protocols translates into a technological innovation which directly favors quality, efficacy, effectiveness, and safety in care.

From this perspective, the relevance of the nurse's continuous ongoing theoretical and practical training must be highlighted. On the front of practical clinic, new technologies must be sought, for professionals can thus associate their conceptual framework to the instruments developed. Therefore, integration and application of new technological standards to heath care process can be attained9.



This is descriptive research focusing on the validation or evaluation of tools which can improve either research or practice10.

Stetler's model was used to develop and validate the protocol, which consists of the following phases: setting forth the aims of literature review; critical analysis of the studies; comparative decision-making process; and validation of instrument developed11,12.

To apply the protocol adequately on assistance, validation was carried out with strategies such as evaluation by experts, whose opinions account for applicability and validity configuration10,11.

The concept of validity is always associated to that of faithful reliability of an item or of a set of items. Faithful reliability of a concept must be taken as the measure of agreement on the items that compose an instrument. To validate an instrument implies identifying whether the items comprising it can evaluate that which it is set forth to assess 10,11.

Two types of validation were carried out: appearance and contents. Appearance or face validity proves to be a subjective way to validate an instrument or a strategy. It consists of the judgment as to clarity and comprehension. However, as it is regarded as superficial evaluation, it cannot be used as a criterion in isolation. Thus, contents validity was also carried out. It ensures adequacy of concept representation, as well as representation of items of instrument within the universe of the entire product10,11.

Selection of experts was carried out on the basis of the Lattes Platform. Researchers acting on investigations related to both enteral nutrition therapy and development of nursing technologies were identified upon the use of the following descriptors: Nursing Ph.D. OR Nutrition Ph.D OR Nursing Technology Ph.D. Priority was given to those identified during integrative review. Identification of experts was carried out on the snowball-type sampling, by means of which one of the elected would refer somebody else who might be interested in the research. Exclusion criteria were comprised by either a request for an allowance or the non-return of the material to be filled up within 60 days.

The sample was comprised of 15 experts. Selection parameters were comprised of academic degree, professional practice, length of professional practice, publications in journals, and participation in research teams. The punctuation system used was adapted from other research to the criteria set forth by the subject in this research. Those attaining six points were regarded as experts10-12.

For data collection an evaluation form with the following data was used: clarity, readability, comprehension, presentation, in addition to applicability of interventions described in practice. The form for protocol evaluation was set on a Likert –type scale with five support levels: Inadequate, Partially inadequate, Somehow inadequate, Adequate, Completely Adequate; Room was made for suggestions related to additions, subtractions, or alterations about the items8,10,12.

Each expert received a form with a letter of invitation to participate in the evaluation process. Data collection took place from June to September, 2012.

Data were compiled on a Microsoft Office Excel 2007 sheet. Data processing and analysis were made on a descriptive basis. The sheet generated was exported to the Statistical Package for Social Scienses (SPSS) program, 19.0 version, so that descriptive and inference analyses could be made.

Concordance indexes were set up for all the items on the instrument, on an individual basis. Internal consistency was cheked on Cronbach alpha calculation. Value interpretation followed standards provided in specific literature, that is, very low: α ≤0.30; low:α=>0.30 and ≤ 0.60; average: α=>0.60 and ≤ 0.75; high:α=> 0.75 and ≤ 0.90; very high: α >0.9013,14.

The conduction of this study followed ethical standards for research with human beings. It was submitted to the Committee of Ethical Standards for Research on Human Beings of the Federal University of Ceará (Universidade Federal do Ceará), according to Resolution CNS #. 196/96, approved by Opinion # 05/12. Participants were required to provide their consent by means of signing the Informed Consent Form15.



The protocol developed was comprised of two sections. The first one had six domains and was related to the conceptual framework on enteral nutrition, on oro or nasogastric catheterization, on the confirmation of the tube right position, and on diet administration and medication through the tube. The second section was comprised of six domains which illustrated the situations interfering in diet administration: diarrhea, gastric residuum, surgical interventions, procedures, obstruction, and tube displacement6 . See protocol on Annex

Fifteen experts took part in the validation stage. Three of them had Ph.D's in clinical nutrition; seven had M.Sc's. (five in Nursing and two in Nutrition); the remaining were specialists in Nursing. Only three professionals acted as professors on an exclusive basis; the other, in addition to the teaching activity, acted on assistance, and was also the coordinator of a multidisciplinary team on enteral and parenteral nutrition.

Initially the total index of internal consistency of the items set on the instrument was evaluated. A 60% total index of concordance was found acceptable. The Cronbach alpha matrix generated by the program was further evaluated, on which the correlation indexes between each one of the items were presented. Each item of the instrument was evaluated individually in relation to the remaining ones13,14.

Total internal consistency index on the interclass correlation attained 0.837 value, regarded as high reliability.

Concordance index of the items on the protocol determined by Cronbach alpha showed the following results: item1= 0.8; item 2=0.73; item 3= 0.86; item 4=0.66, and item 5=0.6.

Evaluation of language readability to health professionals who shall make use of the protocol attained an index of 0.86. As for presentation of materials and methods on nursing conducts to patients undergoing enteral nutrition therapy, an index of 0.66 was attained. An index of 0.6 was obtained for basing conducts on best evidence levels.

Data collection instrument refinement followed evaluation of data collection instrument by experts. They suggested exclusions, reorganization, and even additions of items. That guidance allowed for suggestions regarded as appropriate, which were taken in for protocol improvement.

Protocol items signed by the experts were as follows: tube size to be introduced - 2(13.3%); tube diameter- 2 (13.3%); removal of tube guidewire- 2 (13.3%); cuff checking – 4(26%); head level - 2( 13.3%).

The following items in the second section were marked by experts: diarrhea – 4(26%); gastric residuum – 4( 26%); physiotherapy and nursing procedures– 4(26%). As for tube obstruction, 6 (40%) experts made considerations and 2(13.3%) remarked on tube displacement7.

Additions to the protocol were made. Experts suggested glycemic screening – 2(13.3%); daily weight check -2(13.3%); and conduction of oral hygiene -2(13.3%).

As for the sample of experts, difficulties to define them for validation studies must be recalled. In addition to a lack of consensual understanding in the literature, there is also the barrier related to education and professional improvement. However, the sample proved to be qualified. It brought together professional background and commitment to scholarly activities and research11-14.

Standardization by means of protocols is regarded as a management tool today, for that is the safest way to productivity and competitiveness. It comprises one of the basis for contemporary management6.

In assistance practice, protocols are important because they evaluate intervention efficacy and safety, and they generate scientifically valid results. They can be reproduced and generalized in such a way as to reduce costs and improve assistance quality. They are important in the treatment of diseases, in the investigation and identification of problems. Developed out of present scientific knowledge, protocols are sustained by experts or by experienced professionals. They are used to guide flux, conducts, and procedures6-8.

Thus, the development of nursing procedures is paramount to the conduction of actions Nursing is involved with. Protocol use in care ensures the integration of theory to assistance practice, discouraging ritual actions7,8.

The nurse has a relevant role in promoting health of those on enteral nutrition, as well as as in acting as a health educator, in charge of patient's care and of the search for health quality promotion. Thus, by making use of the protocol for enteral nutrition therapy, the nurse as well as the remaining health professionals, account for special attention where research and assistance practice are brought together in care6,7 .

When nursing care results from a scientifically organized and systematic job, life is enhanced6-8.

Hence the need for new trends to be followed up and for the nurse to participate in the development of alternatives, which can face challenges to improve care quality supply. In addition, the nurse must exercise the role of a producer, on the implementation and control of nursing assistance actions7.

Clinical validation of the protocol is sought, for a valid and reliable instrument is paramount to patient's adequate nutrition, in addition to being essential to health promotion to quality attainment in service care.



Protocol development and validation in enteral nutrition therapy have gone through a thorough evaluation process by experts. It met content scope related to nursing action on enteral nutrition therapy.

Primary constraints to this research were basically related to time extension and volunteer assistance by experts.

The present protocol is expected to be nursing technology to guide professionals in handling patients on enteral nutrition therapy, as well as to ensure intervention plans and to elect the best way to act in face of those patients.



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Enteral Nutrition Therapy Protocol (ENT)

Source: The writer's

Direitos autorais 2016 Francimary de Alencar Campos, Joselany Áfio Caetano, Paulo César de Almeida, Viviane Martins da Silva

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