ORIGINAL / Nutrición enteral

 

Development of a tool for quality control audits in hospital enteral nutrition

Desarrollo de una herramienta de auditorías de control de calidad en nutrición enteral hospitalaria

 

 

Guilherme Duprat Ceniccola^1,2, Wilma Maria Coelho Araújo¹ and Rita Akutsu¹

¹ Universidade de Brasilia-UnB. Departamento de Nutrição.
² Hospital de Base do D. F. Residência em Nutrição Clinica-HBDF.

Correspondence

 

 

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ABSTRACT

Background and aims: Malnutrition is very prevalent in hospitals, causing physical capacity deterioration, increasing complications and raising mortality. This scenario overloads public health costs enormously. Enteral nutrition (EN) is the first option to fight against malnutrition. Nutrition support teams (NST) work combating such conditions, promoting humanization, but also analyzing the cost benefit of EN therapy. Brazil is one of the first Latin American countries to develop EN laws. Quality control it is in the core of this legal instrument, playing an essential role in NST^vs task of providing care. Nowadays, tools to access quality control represent a gap in the area. The aim of this study was to develop a quality control tool, according to Brazilian law for EN Therapy regarding multidisciplinary approach, good practices, standard operating procedures, protocol implementation, proper registration and electronic health record.
Methods: A content validation method was utilized in this four stages development process: bibliographic research, expert opinion (subjective), semantic evaluation and expert opinion (objective). In the latter stage ten specialists, expressed their opinion, evaluating the tools by four different attributes: utility, simplicity, objective and low cost on a 5-point Likert scale (1-5).
Results: We elaborate three independent tools that together, represent the whole evaluation process, named: NST Activities, EN Preparation and EN Administration. Content Validation Index to the four different attributes ranged form 0,9 to 1.
Conclusion: This tool had positive approval from experts and is of great value guiding hospital audits, or even serving as checklist to implement a plan on EN therapy.

Key words: Malnutrition. Enteral nutrition. Quality control. Audit.

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RESUMEN

Introducción: La desnutrición es muy frecuente en hospitales provocando degradación de capacidad física, complicaciones y elevando la mortalidad. Este escenario sobrecarga enormemente los costos de salud pública. Nutrición enteral (NE) es la primera opción para luchar contra la desnutrición. Equipos de soporte nutricional (ESN) trabajan combatiendo tales condiciones, humanizando el tratamiento sino también analizando su costo-beneficio. Brasil fue uno de los primeros países latinoamericanos en desarrollar legislación específica para NE. El control de calidad es el centro de este instrumento legal, ejerciendo rol esencial para proporcionar atención nutricional de calidad. Actualmente, herramientas de acceso al control de calidad representan un vacío en este nicho.
Objetivo: Desarrollar una herramienta de control de calidad para NE, conforme la legislación brasileña, con respecto a ESN, buenas prácticas, implementación de protocolos y registros electrónicos.
Métodos: Se utilizó una validación de contenido desarrollada en cuatro etapas: investigación bibliográfica, opinión de expertos (subjetiva), evaluación semántica y opinión de expertos (objetivo). En la última etapa diez especialistas, evaluaran los instrumentos utilizando cuatro atributos diferentes: utilidad, simplicidad, objetividad y bajo costo en una escala Likert de 5 puntos (1-5).
Resultados: Elaboramos tres herramientas independientes que juntas, representan todo proceso de la NE: Actividades de ESN, Preparación de NE y Administración de NE. Indicies de validación de contenido calculados para los 4 atributos variaran entre 0,9 y 1,0.
Conclusión: Estas herramientas tienen aprobación positiva de los expertos y son de gran valor en auditorias hospitalarias, además de servir como una lista de verificación para implementar un plan de terapia nutricional.

Palabras clave: Malnutrición. Nutrición enteral. Control de calidad. Auditoría.

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Abbreviations:

BVS: Biblioteca virtual em Saude.
CVI: Content Validity Index.
EHR: Electronic Health Records.
EN: Enteral Nutrition.
ENT: Enteral Nutrition Therapy.
ICU: Intensive Care Unity.
MEDLINE: Medical Literature Analysis and Retrieval System Online.
NST: Nutrition Support Team.
NT: Nutritional Therapy.

 

Introduction

Hospital malnutrition affects a large number of patients. Its prevalence rate ranges from 20% to 50% of hospitalized patients worldwide, depending on the method of nutritional assessment and the main diagnostic of the patient.^1-5 An aggravating factor is that malnutrition is not routinely investigated and patients' degree of malnutrition tends to increase along with the length of hospital stay.^3,6 This scenario creates a cycle that decreases the chances of cure, lowering functional capacity, and further promoting social exclusion. On the other hand, it reduces hospital bed turnover and increases the cost of public health.^2,3,6

The ENT is considered a complex therapy and involves high operational costs. The service that regulates its NST according to legal precepts can get benefits at the administrative level as in healthcare itself. This administrative model can benefit through the Accreditation Service, by getting government reimbursement, already available in several countries.^1,7 Brazil is one of the first Latino American countries to develop specific laws applied for EN and NST Activities.³ Among other advantages, NSTs also perform administrative control and surveys of quality indicators related to cost and benefit. In the healthcare area, the most beneficiated is the patient, who has a service with quality standards controlled.

Quality control of ENT can be done better with specific tools, facilitating the process of getting periodical normative evaluations; strategy implementations and process follow up. The development of such tools is still incipient in Latino America. The aim of this study was to develop a quality control tool for EN regarding important aspects of its chain like Critical Points of Control Analysis, NST work, protocols implementation, registration, education programs, electronic health record utilization and audits in order to promote medical safeness.

 

Methods

This is a development project with content validity analysis that created tools to evaluate the safeness of EN in hospitals. These three tools are named: NST Activities, EN Preparation and EN Administration. The project was developed from October 2011 to March 2013, involving four different stages: Bibliographic Research, Expert Opinion (subjective), Semantic Evaluation and Expert Opinion (objective). Delphi method was utilized with adaptations⁸ to guide expert rounds. Stages description:

1. Bibliographic Research: The authors have done a research in the main databases (MEDLINE, BVS and Google Academics) in the last 10 years and in the Latino American legislation in order to encompass important studies done yet and to verify if there was any tool already available for quality control of EN that could contribute with the elaboration process. We utilized the descriptors: Malnutrition, enteral nutrition, quality control and audit with the Boolean connectors "AND" and "OR" This stage ended with an elaboration of the preliminary version of the questionnaire.

2. First Expert Stage (subjective): Specialists in tools elaboration and on EN could express their opinion about the preliminary version, legislation compliance and type of answers in order to implement the older version elaborated by the authors. This stage was developed through emails and produced another version of the questionnaire. This was characterized as a qualitative stage analysis.

3. Semantic Evaluation: In this stage, every item of the three tools was paraphrase to six selected respondents. They answered, explaining what they have understood about the item. This way, the researchers evaluated if the item really represented the initial idea.⁹ If the item was not well understood a modification was proceed at the moment and the process was repeated until reached comprehension. This stage was developed with presence interviews.

4. Second Expert Stage (objective): The content validation process made with experts was described by Pasquali,¹⁰ like it has been suggested, at least six experts must participate. The experts were invited to evaluate objectively every item of the three instruments about their importance to EN safeness. Besides that, every instrument was evaluated on four different attributes: utility, simplicity, objectivity and low cost by the same experts. These criterion were utilized by Verotti¹¹ to evaluate experts opinion on Quality Indicators for Nutritional Therapy and were applied here to observe the experts opinion about the questionnaire as a whole system of evaluation. The experts were selected because their work in the field and for their experience with NST. Every result of this stage evaluation was expressed on 5 points Likert scale. The item is considered approved if it achieves 80% of approval by the experts.¹⁰ This stage was developed through emails, with a specific questionnaire. After that, data was introduced in the Surveymonkey database and feedback was provided to the experts with this system. The research team have calculate the means resulting from experts opinion and sent to every expert in order to confirm previous answers, inform them about the others opinion, giving the chance to review their analysis.

After reaching consensus, the content validity index (CVI) was obtain to verify agreement among the experts.¹² CVI was calculated as the index resulting of the number of scores "4" and "5" divided by the number of grades. It was applied on every item, on the sum of items and on the 4 criteria of judgment (Utility, Simplicity, Objectivity and Low Cost). CVIs are considered approved form 0,8 to 1.¹²

The final version of the questionnaire was elaborated after the four stages. A pilot project was accomplished to bring the questionnaires to the practice field.¹³

The Ethics and Research Committee of the Fundacao de Ensino e Pesquisa em Ciencias da Saude, (Protocol Number 300/2012) approved this project, with the participants agreeing with the terms of the research.

Data analysis

All the data related to the expert opinion were insert in the program Microsoft Excel (2009) and in the SPSS for Windows (V 19) were the means, the CVI and the Standard deviation of the scorers were obtain. The Surveymonkey system (http://pt.surveymonkey.com) was also utilized in the process of feedback for the experts.

 

Results

The design of this project regarding all the stages, the number of experts in each stage and the number of items can be seen in general terms in table I.

Bibliographic Research were done and the first search found 1,146 documents by title and Abstract analysis, what culminate in the final selection (content analysis) of 81 documents dated from 1980 to 2013, 29 documents (36%) in Portuguese and 52 (64%) in English. Many types of documents were included in the expanded version of this project, 51 Scientific articles, 11 Books, 4 Laws, 6 guidelines, 4 Master Thesis and 5 online publications.

By analyzing theses findings, the authors were able to build three tools that composed the first draft of the EN hospital evaluation: NST Activities with 44 items, EN Preparation with 163 items, and EN Administration with 69 items, total of 276 items. At this point, all the items had Yes or No type of answers, like the check-list presented in Brazilian law.¹⁴ In this stage, the researcher group found interesting material about electronic health records (EHR) that were introduced in the evaluation, increasing the quality of the care, especially on monitoring nutrient delivery and nutrition status registration.^15,16 It was also verified the importance of the Dietitian in the intensive care unity (ICU), the control of the nutrients infusion with proper registration and how all that could contribute with patient outcome.¹⁷

The First Expert Stage was formed by a group of four specialists: one Psychologist, two Dietitians, one Physician, and the authors. Six experts were invited but two could not complete this stage, claiming lack of time and complete knowledge of the topic. They were excluded. The participants in accordance with the authors introduced some important modifications. One important modification was the adoption of the Likert Scale of answer, what promote, a more comprehensive type ofjudgment of the evaluation, compressing partial accomplishment of the task, implying in more variability of the answers and better representation of the real scenario. It was also suggested the exclusion of 48 items, classified as redundant and less important for the analysis, regrouped of some existent items and incorporation of concepts presented in the International

Standard Organization regulation,¹⁸ what have implied in the inclusion of 10 items. This stage have finished the questionnaire been compose of 238 items.

Semantic Validation found thirteen items that need minimal modification; these modifications were done by the authors in accordance with the interviewee that found the problem. The follower respondents accepted all the modifications. This stage has finished when the last three respondents in a total of 6, reached 100% of compliance of the evaluation.

The final version of this evaluation tool was the result of the Second Expert Stage (objective). Nineteen experts including Physicians, Dietitians and Nurses were invited to participate in this last stage; three could not finish and were eliminated. Ten experts per instrument have done this judgment. All three tools were originally elaborated in Portuguese, being in accordance with the Brazilian requirements for hospital accreditation on EN made by the Ministry of Health.^7,14 The evaluation is divided in three questionnaires, NST Activities, EN Preparation and EN Administration. Every questionnaire is one independent module; they can be executed and understood separately. The questionnaires are divided into blocks for better allocation of subthemes. Regarding the results of the expert evaluation, only one item did not reach 80% (scoring 3,9 of 5) of approval in the last expert stage and was eliminated. The tree questionnaires together have a total of two hundred thirty seven items distributed in 2388 points (100%), NST Activities has 592 points (24.8% of the total), EN Preparation has 1,208 points (50.6%) and EN Administration has 588 points (24.6%).

The NST Activities questionnaire has seven blocks and fifty-four items distributed in 592 points. The blocks are named Identification of the hospital (with no participation in the score); Characteristics of the NST (8.1% of this questionnaire score); Protocols (21.6%); Educational program (5.4%); Quality Control (17.6%), General Considerations (29.1%) and Electronic Health Records Evaluation (18.2%).

The EN Preparation questionnaire has twelve blocks and one hundred nineteen items distributed in 1,208 points. It's main intention is to evaluate hospitals that works with open-system enteral nutrition, what is still the reality in the Brazilian public health system, but it can also be apply for hospitals working with closed-systems EN with no lost. The blocks are named according with the subtheme addressed: Identification of the hospital (no participation in the score); Physical Structure (15.9% of this questionnaire score); Human Resources (7.9%); Water (7.3%); EN Orders (6.3%); Stock (10.9%); Preparation (17.6%); Sanitization (7.3%); Anteroom (2.6%); Storage and Transportation (7.3%); Quality Control (7.3%); Quality Assurance (9.6%).

The EN Administration questionnaire is focus on EN delivery and nurse's activities in the ward. It has nine blocks and sixty-four items distributed in 588 points. They are named: Identification (no participation in the score); Human Resources (2.7% of this questionnaire score); Pre-requirements (18.4%); EN Administration (40.2%); Quality Control of the Administration (8.8%); EN Therapy Monitoring (8.8%); Storage in the Ward (6.8%); Responsibility and Authority (6.8%); General Considerations (7.5%).

These tools were elaborated based on critical points analysis. The American Society for Parenteral and Enteral Nutrition (ASPEN) recommends its approach to EN in their specific Guidelines.¹⁹ All the items were classified and received different score according to its importance to the critical points analysis. Items related to critical points situations received the classification of indispensable and score 4. Items less related to critical points are named necessary and receive score 2, items not related to critical points but could increase practice are called recommended and carry score 1.¹⁴ There are also Informative (INF) items that help to compose the scenario, but are not in the score evaluation. Every item must be answered on a 5 points Likert Scale (1-5) by the responsible for the evaluation. The Likert Scale application is represented by the equivalence of: 1 - Totally disagree; 2 - Partially disagree; 3 -Indifferent; 4 - Partially agree; 5 -Totally agree. From that so it comes the interpretation that values higher than 3 (positive answers) are considered desirable, and values lesser than 4 (neutral and negative answers) are associated with an insufficient scenario of practice. It means that one hospital must reach 75% of compliance of the evaluation to be considered approved.

NST Activities process of evaluation involved the opinion of ten experts, 50% of specialists and 50% of masters. The majority of the professionals (80%) had previous NST involvement and 10% represented sanitary authority. EN Preparation process also involved ten experts, 80% specialists and 20% masters, with 80% of NST involvement and 10% representing sanitary authority. EN Administration process of evaluation involved ten experts, 70% specialists and 30% masters, with 70% of previous NST involvement and 10% representing sanitary authority. All the experts had previous experience with nutritional therapy. Their scores of evaluation are represented in table II.

The Content Validity Index was calculated to quantify the agreement among the experts. The CVI Scores are represented in table III. CVIs were above ore equal to 0,8 in all the items besides 2. One of these items had already been eliminated by the experts, reaching mean below 4.0 in their judgment. The other item not approved by the CVI was approved by the experts and was maintain in the evaluation for this reason. This item had mean of 4.1 (82% of the score) in the expert evaluation and CVI of 0,7.

After the elaboration process a pilot project was design and was applied in 6 Brazilian public hospitals.¹³ With this project we were able to see the questionnaires utilization in the practice field, what have show promising results. Another lager trial, with more hospitals is needed to study the psychometrics properties of the questionnaire.

 

Discussions

The validity of an instrument is related to the degree of accuracy on which it assesses what is being proposed to measure.¹² The psychometricians identify the main techniques used to validate instruments, as content validity, criterion validity and construct validity.²⁰ In this work, due to the characteristics of the instruments, especially the size, we choose to perform a content validation. This method is a modality used in health science to implement the construction of instruments concerning on how the spectrum of the chosen items will measure such construct or, if the questions composing the instrument are representative of all the universe of questions that can be asked about a particular subject.¹²

Content validity process is necessarily based on a judgment, usually done by a panel of specialists. There is no single model proposed for this task. The number of experts involved is also not fixed and may vary depending on the complexity of the instrument, a minimum of 3 is required.^10,12 Usually these experts should evaluate the items independently and also the instrument as a whole. In this study experts were invited to propose changes to be made or even exclude items of the construct. According to Polit and Beck,²¹ one way to verify the agreement between the opinions of the experts is to create indexes. Under this analysis, a concordance threshold of 80% among experts indicates good content validity, what was seen in this evaluation by the experts. Because its characteristics, the realization of content validity does not eliminate the need to use additional psychometric measures to ensure a more solid statistic analysis, such as criterion validation.¹²

Content validation was proceeded in two distinct steps.¹² The first was dedicated to search the existing concepts of the area, i.e., a literature review. This is followed by the preparation of a first draft of the instrument, including findings from the search and the knowledge of the authors. Second stage was represented by a consensus obtained by the panel of experts, with qualitative and quantitative strategies, what was represented here by the second, third and fourth stages of the project. This way, the first step would also be a guarantee of the construction process, complemented with the second step.¹²

The experts were invited to judge the instruments on the concepts of clarity and relevance. The former identifies concepts related to the presentation of information, a type of semantic validation. The later infers whether the items actually reflect the concepts involved.¹² Expert stages can evolve subjective technics, expressing qualitative judgment where the expert can express their opinion regarding the item or objectively, using a Likert type of scale for example, where a score can be obtained by the judgment. The use of this assessment, combining qualitative and quantitative technics is known as methodological triangulation.¹² This was of great contribution to sharp the tool and obtain reliable opinion in the expert panel.

The Delphi technique allows the realization of an expert's panel in order to validate content, facilitating a consensus on their opinion.⁸ This was used to guide the steps of experts' judgment, making them interact with the research group with structured individual rounds, where it was proposed the evaluation of the instrument. Finally we elaborate a feedback where the experts could see the other expert's opinion by the means of the scores and modify or confirm their earlier opinions after conclude the process. This final feedback, also suggested by the Delphi technic assures a more organized interaction with the experts, what is also seen as an advantage of this method.⁸

Quality control systems on EN should be instituted in all hospitals that practice NT, especially for patients in ICU. This control is justified due to the weakened state of the patients, high incidence of diarrhea, risk of sepsis, but mainly to ensure the final quality of the EN and to promote conditions of recovery for the patient. In hospitals where there is a heavy load of work and the compliance schedule is rigid, quality can suffer. However, efforts should be made in any step of the process.²² Many have mentioned in the literature the necessity of audits and quality control for nutritional therapy.^16,23-26

When indicated properly, the impact of treatment is reflected in lower costs due to a better promotion of reestablishment, even with greater investment in staff and a greater amount of direct spending with enteral nutrition and related products. This notion is not so clearly observed by health administrators yet; they still consider nutrition as a cost and not as an investment.²⁷ These improvements in patient care are translating into lower final incidence of complications and reduced hospital length of stay.²⁸ In order to have a positive cost benefit relation, quality control is demanding.²³

Quality Control audits assure that established protocols are being followed. They can also find misunderstood routines, make correct changes in order to ensure final quality and find the best cost benefit ratio of NT. It has been reported in the literature some resistance to protocol adherence by health professionals and lack of registration.²⁹ Many of the protocols and guidelines are only followed when it is known that monitoring exists.^22,30 Bringing that notion to EN we found that, ENT is the first strategy available to fight against the state of convalescence caused by malnutrition and must start early to further collaborate with healing, especially in the ICU.^4,6,31 These expensive therapies characterize a complex service in need for periodical supervision.^6,14,23

To provide such specific care, NSTs were created in 1960^vs, in the United States. Their attributions include promoting safety ENT; establish good practices, introduce standard operating procedures, protocol implementation, staff training, registration of the process, periodical audits and Electronic Health Record utilization. Every concept listed must be implemented and controlled periodically by the local NST.^7,14,23 Even with some positive results of NSTs proved and documented, their existence is still not a reality worldwide.^32-34 This nutritional support team evaluation comes as an effort to help to consolidate that field. Table IV brings an example of block, where is possible to verify the structure of the questionnaire. Table V present the three questionnaires in the Portuguese language.

Limits for this project are represented by the lack of an analysis of internal consistency in the items that compose the test, such as Cronbach α,³⁵ what is suggested in other methods of validation and could bring stronger concept of validity. This is planning for the future and could be facilitated by disclosing the evaluation.

 

Conclusions

According to what was presented, nutritional support teams can act positively in the chain of EN by applying safety measures and controlling EN Therapy process with regular audits. The utilization of such kind of tools is mainly focus on guiding periodical evaluations, compiling quality indicators and also to implement for the first time, a new model of EN Therapy for hospitals. These lines of work are focusing on reducing the cost of the EN Therapy and optimizing patient's reestablishment when it is possible.

 

Acknowledgments

The authors acknowledge the contribution of the professor Elida C. PhD, for supporting this study and Guillermo Ramirez for his work, revising the text. Special thanks must be made to all the experts involved in the process and to the University of Brasilia (UnB) that granted the authors a place to do the research.

 

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Correspondence:
Guilherme Duprat Ceniccola.
University of Brasilia. Department of Nutrition.
Fundação Universidade de Brasilia.
Campus Universitario Darcy Ribeiro, Asa Norte.
70910-900, Brasilia-DF, Brazil.
E-mail: gui_duprat1@hotmail.com

Recibido: 23-X-2013.
Aceptado: 1-XII-2013.