The Art and Science of Infusion Nursing Ainsley Malone, MS, RD, CNSC, LD
Clinical Guidelines From the American Society for Parenteral and Enteral Nutrition: Best Practice Recommendations for Patient Care ABSTRACT The American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) is an interdisciplinary society whose vision is to ensure that every patient receives safe, efficacious, and high-quality nutrition care. The society has produced clinical guidelines to assist practitioners in enteral and parenteral nutrition decision making. A.S.P.E.N. clinical guideline development has evolved through the years, and recently has incorporated a rigorous and transparent development process using the Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) process. This article will examine A.S.P.E.N.’s guideline development process, discuss current populationand disease-specific practice guidelines, and highlight recommendations useful for the clinician involved in nutrition therapy decision making. Key words: clinical guidelines, evidence-based practice
T
he American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) is an interdisciplinary society composed of physicians, nurses, dietitians, pharmacists, researchers, and others whose vision is to create an environment in which every patient receives
Author Affiliation: Mount Carmel West Hospital, Columbus, Ohio. Ainsley Malone, MS, RD, CNSC, LD, is a dietitian and member of the nutrition support team at Mount Carmel West Hospital in Columbus, Ohio, where she participates in the management of patients requiring enteral and parenteral nutrition. She is a certified nutrition support clinician and currently serves as President of the American Society for Parenteral and Enteral Nutrition. The author of this article has no conflicts of interest to disclose. Corresponding Author: Ainsley Malone, MS, RD, CNSC, LD, Mount Carmel West Hospital, Columbus, OH 43222 ([email protected]). DOI: 10.1097/NAN.0000000000000035
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safe, efficacious, and high-quality nutrition care. Formed in 1975 for the purpose of providing optimal nutrition to all people under all conditions at all times, A.S.P.E.N. has consistently recognized the importance of providing guidance for nutrition practitioners in making decisions pertaining to the delivery of nutrition support therapies. This article will review the history of A.S.P.E.N.’s clinical guidelines, detail recently published guidelines, and provide insight regarding their use in clinical practice. The philosophy of evidence-based practice (EBP) was first introduced to the medical community in 1981 at a small Canadian university.1 The approach centered on the intention of teaching clinicians how to critically appraise the medical literature and use the knowledge in their approach to problems in patient care. The term evidence-based medicine was described in a landmark article in the Journal of the American Medical Association in 1992 and formed the beginning of what is now common to all aspects of medicine.2 EBP is the integration of clinical expertise, patient values, and the best research evidence into the decision-making process for patient care.2 EBP offers several benefits in the delivery of patient care. One important benefit is that it reduces the wide gap that can occur between what is demonstrated through research and evidence provided through anecdotal experiences and/or expert opinion. In addition, EBP can decrease the wide variation in practice among practitioners, both in the same health care setting and with a specific patient population. Finally, EBP allows clinicians to take advantage of expanding knowledge in a specific area of practice.3
THE FIRST GUIDELINES A.S.P.E.N. began developing clinical guidelines in the late 1980s. The organization recognized the need to promote the health and welfare of patients in need of enteral and parenteral nutrition. The organization
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produced 2 guidelines during this period: Guidelines for the Use of Total Parenteral Nutrition in the Hospitalized Adult Patient in 1986 and Guidelines for the Use of Enteral Nutrition in the Adult Patient in 1987. In 1993, A.S.P.E.N. developed and published its first comprehensive set of clinical guidelines. They were designed for health care professionals who provide parenteral and enteral therapies to adult and pediatric patients. The guidelines were intended to provide practical advice to clinicians who administer oral enteral tube feedings or total parenteral nutrition to patients.4 Sections in the guidelines included malnutrition, route of feeding, 16 disease states for adults, the same sections for pediatrics, and a section for low-birth-weight infants. The evidence supporting the guidelines had been evaluated and categorized by strength, ranging from prospective controlled clinical trials to expert opinion. Specific practice guidelines were coded A, B, or C, according to the strength of the supportive evidence.
support practices and/or diagnostic groups. Each set of guidelines would be developed by specific practice experts, with oversight and guidance from a guideline editorial board. A clinical guidelines editor-in-chief was appointed in 2008 to oversee the revision and publication of individual practice guidelines. Each expert workgroup developed common practice questions and conducted a thorough literature review to identify key evidence. The evidence was graded according to defined criteria, ranging from 1 (a large randomized trial) to 5 (case series or expert opinion). A practice recommendation was developed from the available evidence, with subsequent grading based on the level of evidence supporting the recommendation. Grades ranged from A (supported by level 1 evidence) to E (supported by lowest-level evidence). The revised clinical guidelines were created for health care professionals who provide nutrition support services and offer clinical advice for managing adult and pediatric (including adolescent) patients in inpatient and outpatient (ambulatory, home, and specialized care) settings.
REVISING THE GUIDELINES In the late 1990s, A.S.P.E.N. established a Clinical Guidelines Task Force to revise the 1993 guidelines. The task force identified 3 key objectives for the revision:4 1. The guidelines had to be factually up-to-date and reflect an evidence-based approach to the practice of nutrition support. 2. The guidelines had to support the clinical and professional activities of nutrition support practitioners by articulating evidence-based recommendations on which to base personal and institutional practices. 3. The guidelines should serve as a tool to help guide policy makers, health care organizations, and others improve the systems under which nutrition support is administered. The revised clinical guidelines used the Institute of Medicine’s (IOM) official definition5 as “systematically developed statements to assist practitioner and patient decisions about health care for specific clinical circumstances.” The guidelines included sections that were more general in nature, such as nutrition assessment and nutrient requirements, as well as others specific to various diseases. General and disease-specific sections addressed adult and pediatric patients. The evidence strength was evaluated using a method similar to the one used for the 1993 guidelines; practice guideline recommendations were graded A, B, or C. In 2007, A.S.P.E.N. created a new process for revising clinical guidelines. Rather than develop an entire set of guideline practice recommendations, individual sets of guidelines would be developed for specific nutrition
EVALUATING QUALITY OF EVIDENCE In 2011, a change in the guideline development process was introduced to better evaluate the quality of the evidence supporting a specific practice recommendation. The Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) process, as used by a large number of organizations, including the Agency for Healthcare Research and Quality and the World Health Organization, was incorporated into practice guidelines beginning in 2012.6 Using the GRADE process provides the basis for clinically relevant recommendations and allows greater transparency in moving from evidence to recommendations. In the GRADE system, the quality of evidence is evaluated and defined as being high to low quality. Evidence that any further research is unlikely to change the confidence in the estimate of the effect is highquality evidence; low-quality evidence suggests that the estimate of the effect is uncertain. Once the evidence for a particular question is compiled, the quality of each individual study is evaluated. This is assessed through specific criteria related to study design and execution. Each study begins with a quality grade, which may be increased, decreased, or kept the same, on the basis of the grading criteria evaluation. A randomized control trial, for example, will begin with an initial high grade but may be changed to a moderate grade if there are significant study limitations. Conversely, an observational study receives a low initial grade but can receive a moderate grade if a large sample size is included. Once the evidence is evaluated and graded, the expert
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workgroup develops the practice recommendation and assigns a final grade through consensus.
GUIDELINES DEVELOPED USING THE GRADE SYSTEM Since the change in guideline development to individual practice guidelines, A.S.P.E.N. has completed and published 12 guidelines (Table 1). The most comprehensive to date is the guideline developed in collaboration with the Society of Critical Care Medicine (SCCM), Guideline for the Provision and Assessment of Nutrition Support Therapy in the Adult Critically Ill Patient. The guideline was created to provide key practice recommendations for adult patients who require ventilator support and are likely to remain in the intensive care unit (ICU) for more than 3 days. Recommendations in the guideline assist practitioners in making decisions for key questions, including the following: • Which method of nutrition support therapy should be used in ICU patients? • When should enteral nutrition be initiated?
TABLE 1
A.S.P.E.N. Individual Practice Guidelines 2009 Adult Critical Care (in conjunction with Society of Critical Care Medicine) Nutrition Support of the Critically Ill Child Nutrition Support Therapy During Adult Anticancer Treatment and in Hematopoietic Cell Transplantation Nutrition Support of Children With Human Immunodeficiency Virus Infection 2010 Nutrition Support of Hospitalized Pediatric Patients With Obesity Nutrition Support of Neonates Supported With Extracorporeal Membrane Oxygenation Nutrition Support in Adult Acute and Chronic Renal Failure 2011 Nutrition Screening, Assessment, and Intervention in Adults 2012 Hyperglycemia and Hypoglycemia in the Neonate Receiving Parenteral Nutrition Nutrition Support of Adult Patients With Hyperglycemia Nutrition Support of Neonatal Patients at Risk for Necrotizing Enterocolitis 2013 Neonatal Metabolic Bone Disease
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• Where should enteral nutrition be delivered (gastric versus small bowel)? • Should an immune-enhancing enteral formula be used? • How should tolerance to enteral nutrition be monitored? • When should parenteral nutrition be used in ICU patients? • Should parenteral nutrition be modified when it is used? Table 2 outlines practice recommendations related to these questions. They provide guidance for bedside clinicians when making nutrition intervention decisions for their patients. The 11 additional A.S.P.E.N. individual guidelines, which were published beginning in 2009, address pediatric and adult populations and practice settings. Pediatric critical care guidelines published in 2009 provide key aspects of nutrition support therapy in the pediatric ICU and offer best practice recommendations based on evidence from pediatric intensive care unit (PICU) patients (Table 3). Additional pediatric-specific guidelines published by A.S.P.E.N. include: • Pediatric Human Immunodeficiency Virus Infection • Nutrition Support of Neonates Supported with Extracorporeal Membrane Oxygenation • Nutrition Support of Hospitalized Patients with Pediatric Obesity • Hyperglycemia and Hypoglycemia in the Neonate Receiving Parenteral Nutrition • Nutrition Support of Neonatal Patients at Risk for Necrotizing Enterocolitis Guidelines published by A.S.P.E.N. for adult-specific practice areas include: • Nutrition Screening, Assessment and Intervention • Nutrition Support in Adult Acute and Chronic Renal Failure • Nutrition Support Therapy During Adult Anticancer Treatment • Nutrition Support Therapy in Hematopoietic Cell Transplantation • Nutrition Support of Adult Patients with Hyperglycemia The entirety of these guidelines for both pediatric and adult patient populations offers guidance in nutrition support therapy decision making. For nurse clinicians, the recommendations included in the guidelines help answer key questions pertaining to many aspects of providing nutrition care to patients. For example, for the adult critical care nurse, the guidelines7 offer background details about how gastric residual volume measurements should be evaluated. In addition, the guidelines for nutrition support of adult patients with hyperglycemia attempt to answer questions about what
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TABLE 2
Selected Practice Recommendations Included in the A.S.P.E.N./SCCM Guideline for the Provision and Assessment of Nutrition Support Therapy in the Adult Critically Ill Patient EN is the preferred route of feeding over PN for the critically ill patient who requires nutrition support therapy. (Grade C) If early EN is not feasible or available the first 7 days following admission to the ICU, no nutrition support therapy should be provided. (Grade C) • In the patient who was healthy before critical illness with no evidence of protein calorie malnutrition, use of PN should be reserved and initiated only after the first 7 days of hospitalization, when EN is not available. (Grade E) If a patient is expected to undergo major upper GI surgery and EN is not feasible, PN should be provided under very specific conditions: • If the patient is malnourished, PN should be initiated 5 to 7 days preoperatively and continued into the postoperative period. (Grade B) PN should not be initiated in the immediate postoperative period but should be delayed for 5 to 7 days should EN continue to be not feasible. (Grade B) PN should be initiated only if the duration of therapy is anticipated to be ≥ 7 days. (Grade B) In all ICU patients receiving PN, mild permissive underfeeding should be considered at least initially. • Once energy requirements are determined, 80% of the requirements should serve as the ultimate goal or dose of parenteral feeding. (Grade C) Eventually, as the patient stabilizes, PN may be increased to meet energy requirements. (Grade E) In the first week of hospitalization in the ICU, when PN is required and EN is not feasible, patients should be given a parenteral formulation without soy-based lipids. (Grade D) In patients stabilized on PN, periodically repeated efforts should be made to initiate EN. • As tolerance improves and the volume of EN calories delivered increases, the amount of PN calories supplied should be reduced. • PN should not be terminated until ≥ 60% of target energy requirements are being delivered by the enteral route. (Grade E) Bowel sounds, flatus, and stools are not required before feeding initiation. (Grade B) If repeated high residuals, withhold gastric and switch to jejunal feeding. (Grade E) Patients should be monitored for tolerance of EN. (Grade E) • Avoid inappropriate cessation of EN. (Grade E) • Avoid holding EN for GRVs < 500 mL in absence of other signs of intolerance. (Grade B) • Minimize periods of NPO for tests or procedures to promote EN delivery and avoid prolonged ileus. (Grade C) Use protocols to increase percentage goal calories provided. (Grade C) Abbreviations: EN, enteral nutrition; GI, gastrointestinal; ICU, intensive care unit; GRV, gastric residual volume; NPO, nothing by mouth; PN, parenteral nutrition. Grading system used for these guidelines is as follows: Grade of recommendation: A—supported by at least 2 level I investigations; B—supported by 1 level I investigation; C—supported by level II investigations only; D—supported by at least 2 level III investigations; and E—supported by level IV or level V evidence. Level of evidence: I—large, randomized trials with clear-cut results; low risk of false-positive (alpha) error or false-negative (beta) error; II—small, randomized trials with uncertain results; moderate to high risk of false-positive (alpha) and/or false-negative (beta) error; III—nonrandomized, contemporaneous controls; IV—nonrandomized, historical controls; and V—case series, uncontrolled studies, and expert opinion.7
range of glucose control is associated with the best outcomes.8 For the pediatric nurse caring for a child with human immunodeficiency virus (HIV), the pediatric HIV guideline offers guidance regarding when micronutrient supplementation may be desirable.9 Finally, the nutrition support of neonatal patients at risk for necrotizing enterocolitis (NEC) assists the neonatal nurse clinician in understanding when and how feedings should be started in infants at high risk for NEC, and
whether human milk offers an advantage in terms of NEC risk.10
EVALUATING THE DEVELOPMENT PROCESS An essential practice for organizations that produce clinical guidelines is frequent evaluation of the
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TABLE 3
Selected Recommendations Within the A.S.P.E.N. Clinical Guidelines: Nutrition Support of the Critically Ill Child Children admitted with critical illnesses should undergo nutrition screening to identify those with existing malnutrition and those who are nutritionally at risk. (Grade D) A formal nutrition assessment with the development of a nutrition care plan should be required, especially in those children with premorbid malnutrition. (Grade E) In critically ill children with a functioning gastrointestinal tract, EN should be the preferred mode of nutrient provision, if tolerated. (Grade C) Energy expenditure should be assessed throughout the course of illness to determine the energy needs of critically ill children. (Grade D) In a subgroup of patients with suspected metabolic alterations or malnutrition, accurate measurement of energy expenditure using indirect calorimetry is desirable. (Grade E) A specialized nutrition support team in the PICU and aggressive feeding protocols may enhance the overall delivery of nutrition, with shorter time to goal nutrition, increased delivery of EN, and decreased use of parenteral nutrition. (Grade E) Abbreviations: EN, enteral nutrition; PICU, pediatric intensive care unit.
development process. In 2011, the IOM convened a committee producing a consensus report titled Clinical Practice Guidelines We Can Trust.11 The committee suggested that the development process is a serious weakness of most guidelines in clinical use. The report provided key attributes of a development process that would yield guidelines considered “trustworthy” (Table 4). As highlighted in the editorial by Kelly Tappenden, PhD, RD, editor-in-chief of the Journal of Parenteral and Enteral Nutrition, A.S.P.E.N.’s chief scientific journal, the A.S.P.E.N. guideline process initiated in 2009 is “exceedingly aligned with the IOM process recommended to yield trustworthy guidelines.”12 This recognition should provide guideline users with confidence that A.S.P.E.N. clinical guidelines can be trusted for implementation in their practice setting.
TABLE 4
Key Attributes for Trustworthy Guidelines 11
• Based on a systematic review of the literature • Developed by a group of multidisciplinary experts, including representatives of key affected groups • Consider patient subgroups and preferences, as appropriate • Use an explicit and transparent process aimed to minimize distortions, biases, and conflicts of interest • Discuss alternative care options and health options, including ratings for both the quality of evidence and the strength of recommendations • Reconsidered and revised as warranted by new evidence
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A ROBUST FUTURE The future of A.S.P.E.N. clinical guidelines remains robust. Guidelines published in 2013 include: • Neonatal Metabolic Bone Disease • Parenteral Nutrition Safety • Adult Obesity Guidelines under development include Hospitalized Neonates, Adult Chronic Wound, and the revision of the 2009 Adult Critical Care. One of the most frequently cited A.S.P.E.N. guidelines is its first, Guidelines for the Use of Total Parenteral Nutrition in the Hospitalized Adult Patient.13 Although each individual guideline produced by A.S.P.E.N. includes a specific recommendation involving parenteral nutrition, a guideline similar to the one produced in 1986 has not been completed. The need to revise such a guideline has been recognized, and it is currently under development. A.S.P.E.N. embraces the vision of helping ensure that every patient receives safe, efficacious, and high-quality nutrition care. Creating and disseminating trustworthy clinical guidelines to assist practitioners is a key initiative toward realizing that vision. With more than 5900 members, A.S.P.E.N. will continue its tradition of championing the best evidence-based nutrition support for all patients.
OBTAINING A.S.P.E.N. CLINICAL GUIDELINES A.S.P.E.N. clinical guidelines are available at the A.S.P.E.N. Web site, https://www.nutritioncare.org/. Membership in A.S.P.E.N. is not required to obtain the
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full text of guideline documents. The first-time visitor to the Web site must register through a free account; once that is accomplished, the full text of all guidelines is available. REFERENCES 1. Guyatt G. Preface. In: Guyatt G, Rennie D, eds. Users’ Guides to the Medical Literature: A Manual for Evidence Based Clinical Practice. Chicago, IL: AMA Press; 2002:xiii-xvi. 2. Evidence-Based Medicine Working Group. Evidence-based medicine: a new approach to the teaching of medicine. JAMA. 1992;268:2420-2425. 3. Rosenberg W, Donald A. Evidence based medicine: an approach to clinical problem solving. BMJ. 1995;310:1122-1126. 4. American Society for Parenteral and Enteral Nutrition. Guidelines for the use of parenteral and enteral nutrition in adult and pediatric patients. J Parenter Enteral Nutr. 1993;17(suppl):1SA. 5. Institute of Medicine. Committee to Advise Public Health Service on Clinical Practice Guidelines. Clinical Practice Guidelines: Directions for a New Program. Washington, DC: National Academies Press; 1990.
6. Druyan ME, Compher C, Boulatta J, et al. Clinical guidelines for the use of parenteral and enteral nutrition in adult and pediatric patients: applying the GRADE system to development of A.S.P.E.N. clinical guidelines. J Parent Enteral Nutr. 2012;36:177-180. 7. McClave SA, Martindale B, Vanek V, et al. Guideline for the provision and assessment of nutrition support therapy in the adult critically ill patient. J Parenter Enteral Nutr. 2009;33:277-316. 8. Mehta N, Compher C. A.S.P.E.N. clinical guidelines: nutrition support of the critically ill child. J Parenter Enteral Nutr. 2009;33:260-276. 9. Sabery N, Duggan C. Nutrition support of children with human immunodeficiency virus infection. J Parenter Enteral Nutr. 2009;33:588-606. 10. Fallon E, Nehra D, Potemkin A, et al. Nutrition support of neonatal patients at risk for necrotizing enterocolitis. J Parenter Enteral Nutr. 2012;36:506-523. 11. Institute of Medicine. Clinical Practice Guidelines We Can Trust. Washington, DC: National Academies Press; 2011. 12. Tappenden K. Trustworthy clinical guidelines: how do we measure up? J Parenter Enteral Nutr. 2011;35:431. 13. A.S.P.E.N. Board of Directors. Guidelines for the use of total parenteral nutrition in the hospitalized adult patient. J Parenter Enteral Nutr. 1986;10:441-445.
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Clinical Guidelines From the American Society for Parenteral and Enteral Nutrition: Best Practice Recommendations for Patient Care ABSTRACT The American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) is an interdisciplinary society whose vision is to ensure that every patient receives safe, efficacious, and high-quality nutrition care. The society has produced clinical guidelines to assist practitioners in enteral and parenteral nutrition decision making. A.S.P.E.N. clinical guideline development has evolved through the years, and recently has incorporated a rigorous and transparent development process using the Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) process. This article will examine A.S.P.E.N.’s guideline development process, discuss current populationand disease-specific practice guidelines, and highlight recommendations useful for the clinician involved in nutrition therapy decision making. Key words: clinical guidelines, evidence-based practice
T
he American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) is an interdisciplinary society composed of physicians, nurses, dietitians, pharmacists, researchers, and others whose vision is to create an environment in which every patient receives
Author Affiliation: Mount Carmel West Hospital, Columbus, Ohio. Ainsley Malone, MS, RD, CNSC, LD, is a dietitian and member of the nutrition support team at Mount Carmel West Hospital in Columbus, Ohio, where she participates in the management of patients requiring enteral and parenteral nutrition. She is a certified nutrition support clinician and currently serves as President of the American Society for Parenteral and Enteral Nutrition. The author of this article has no conflicts of interest to disclose. Corresponding Author: Ainsley Malone, MS, RD, CNSC, LD, Mount Carmel West Hospital, Columbus, OH 43222 ([email protected]). DOI: 10.1097/NAN.0000000000000035
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safe, efficacious, and high-quality nutrition care. Formed in 1975 for the purpose of providing optimal nutrition to all people under all conditions at all times, A.S.P.E.N. has consistently recognized the importance of providing guidance for nutrition practitioners in making decisions pertaining to the delivery of nutrition support therapies. This article will review the history of A.S.P.E.N.’s clinical guidelines, detail recently published guidelines, and provide insight regarding their use in clinical practice. The philosophy of evidence-based practice (EBP) was first introduced to the medical community in 1981 at a small Canadian university.1 The approach centered on the intention of teaching clinicians how to critically appraise the medical literature and use the knowledge in their approach to problems in patient care. The term evidence-based medicine was described in a landmark article in the Journal of the American Medical Association in 1992 and formed the beginning of what is now common to all aspects of medicine.2 EBP is the integration of clinical expertise, patient values, and the best research evidence into the decision-making process for patient care.2 EBP offers several benefits in the delivery of patient care. One important benefit is that it reduces the wide gap that can occur between what is demonstrated through research and evidence provided through anecdotal experiences and/or expert opinion. In addition, EBP can decrease the wide variation in practice among practitioners, both in the same health care setting and with a specific patient population. Finally, EBP allows clinicians to take advantage of expanding knowledge in a specific area of practice.3
THE FIRST GUIDELINES A.S.P.E.N. began developing clinical guidelines in the late 1980s. The organization recognized the need to promote the health and welfare of patients in need of enteral and parenteral nutrition. The organization
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produced 2 guidelines during this period: Guidelines for the Use of Total Parenteral Nutrition in the Hospitalized Adult Patient in 1986 and Guidelines for the Use of Enteral Nutrition in the Adult Patient in 1987. In 1993, A.S.P.E.N. developed and published its first comprehensive set of clinical guidelines. They were designed for health care professionals who provide parenteral and enteral therapies to adult and pediatric patients. The guidelines were intended to provide practical advice to clinicians who administer oral enteral tube feedings or total parenteral nutrition to patients.4 Sections in the guidelines included malnutrition, route of feeding, 16 disease states for adults, the same sections for pediatrics, and a section for low-birth-weight infants. The evidence supporting the guidelines had been evaluated and categorized by strength, ranging from prospective controlled clinical trials to expert opinion. Specific practice guidelines were coded A, B, or C, according to the strength of the supportive evidence.
support practices and/or diagnostic groups. Each set of guidelines would be developed by specific practice experts, with oversight and guidance from a guideline editorial board. A clinical guidelines editor-in-chief was appointed in 2008 to oversee the revision and publication of individual practice guidelines. Each expert workgroup developed common practice questions and conducted a thorough literature review to identify key evidence. The evidence was graded according to defined criteria, ranging from 1 (a large randomized trial) to 5 (case series or expert opinion). A practice recommendation was developed from the available evidence, with subsequent grading based on the level of evidence supporting the recommendation. Grades ranged from A (supported by level 1 evidence) to E (supported by lowest-level evidence). The revised clinical guidelines were created for health care professionals who provide nutrition support services and offer clinical advice for managing adult and pediatric (including adolescent) patients in inpatient and outpatient (ambulatory, home, and specialized care) settings.
REVISING THE GUIDELINES In the late 1990s, A.S.P.E.N. established a Clinical Guidelines Task Force to revise the 1993 guidelines. The task force identified 3 key objectives for the revision:4 1. The guidelines had to be factually up-to-date and reflect an evidence-based approach to the practice of nutrition support. 2. The guidelines had to support the clinical and professional activities of nutrition support practitioners by articulating evidence-based recommendations on which to base personal and institutional practices. 3. The guidelines should serve as a tool to help guide policy makers, health care organizations, and others improve the systems under which nutrition support is administered. The revised clinical guidelines used the Institute of Medicine’s (IOM) official definition5 as “systematically developed statements to assist practitioner and patient decisions about health care for specific clinical circumstances.” The guidelines included sections that were more general in nature, such as nutrition assessment and nutrient requirements, as well as others specific to various diseases. General and disease-specific sections addressed adult and pediatric patients. The evidence strength was evaluated using a method similar to the one used for the 1993 guidelines; practice guideline recommendations were graded A, B, or C. In 2007, A.S.P.E.N. created a new process for revising clinical guidelines. Rather than develop an entire set of guideline practice recommendations, individual sets of guidelines would be developed for specific nutrition
EVALUATING QUALITY OF EVIDENCE In 2011, a change in the guideline development process was introduced to better evaluate the quality of the evidence supporting a specific practice recommendation. The Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) process, as used by a large number of organizations, including the Agency for Healthcare Research and Quality and the World Health Organization, was incorporated into practice guidelines beginning in 2012.6 Using the GRADE process provides the basis for clinically relevant recommendations and allows greater transparency in moving from evidence to recommendations. In the GRADE system, the quality of evidence is evaluated and defined as being high to low quality. Evidence that any further research is unlikely to change the confidence in the estimate of the effect is highquality evidence; low-quality evidence suggests that the estimate of the effect is uncertain. Once the evidence for a particular question is compiled, the quality of each individual study is evaluated. This is assessed through specific criteria related to study design and execution. Each study begins with a quality grade, which may be increased, decreased, or kept the same, on the basis of the grading criteria evaluation. A randomized control trial, for example, will begin with an initial high grade but may be changed to a moderate grade if there are significant study limitations. Conversely, an observational study receives a low initial grade but can receive a moderate grade if a large sample size is included. Once the evidence is evaluated and graded, the expert
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workgroup develops the practice recommendation and assigns a final grade through consensus.
GUIDELINES DEVELOPED USING THE GRADE SYSTEM Since the change in guideline development to individual practice guidelines, A.S.P.E.N. has completed and published 12 guidelines (Table 1). The most comprehensive to date is the guideline developed in collaboration with the Society of Critical Care Medicine (SCCM), Guideline for the Provision and Assessment of Nutrition Support Therapy in the Adult Critically Ill Patient. The guideline was created to provide key practice recommendations for adult patients who require ventilator support and are likely to remain in the intensive care unit (ICU) for more than 3 days. Recommendations in the guideline assist practitioners in making decisions for key questions, including the following: • Which method of nutrition support therapy should be used in ICU patients? • When should enteral nutrition be initiated?
TABLE 1
A.S.P.E.N. Individual Practice Guidelines 2009 Adult Critical Care (in conjunction with Society of Critical Care Medicine) Nutrition Support of the Critically Ill Child Nutrition Support Therapy During Adult Anticancer Treatment and in Hematopoietic Cell Transplantation Nutrition Support of Children With Human Immunodeficiency Virus Infection 2010 Nutrition Support of Hospitalized Pediatric Patients With Obesity Nutrition Support of Neonates Supported With Extracorporeal Membrane Oxygenation Nutrition Support in Adult Acute and Chronic Renal Failure 2011 Nutrition Screening, Assessment, and Intervention in Adults 2012 Hyperglycemia and Hypoglycemia in the Neonate Receiving Parenteral Nutrition Nutrition Support of Adult Patients With Hyperglycemia Nutrition Support of Neonatal Patients at Risk for Necrotizing Enterocolitis 2013 Neonatal Metabolic Bone Disease
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• Where should enteral nutrition be delivered (gastric versus small bowel)? • Should an immune-enhancing enteral formula be used? • How should tolerance to enteral nutrition be monitored? • When should parenteral nutrition be used in ICU patients? • Should parenteral nutrition be modified when it is used? Table 2 outlines practice recommendations related to these questions. They provide guidance for bedside clinicians when making nutrition intervention decisions for their patients. The 11 additional A.S.P.E.N. individual guidelines, which were published beginning in 2009, address pediatric and adult populations and practice settings. Pediatric critical care guidelines published in 2009 provide key aspects of nutrition support therapy in the pediatric ICU and offer best practice recommendations based on evidence from pediatric intensive care unit (PICU) patients (Table 3). Additional pediatric-specific guidelines published by A.S.P.E.N. include: • Pediatric Human Immunodeficiency Virus Infection • Nutrition Support of Neonates Supported with Extracorporeal Membrane Oxygenation • Nutrition Support of Hospitalized Patients with Pediatric Obesity • Hyperglycemia and Hypoglycemia in the Neonate Receiving Parenteral Nutrition • Nutrition Support of Neonatal Patients at Risk for Necrotizing Enterocolitis Guidelines published by A.S.P.E.N. for adult-specific practice areas include: • Nutrition Screening, Assessment and Intervention • Nutrition Support in Adult Acute and Chronic Renal Failure • Nutrition Support Therapy During Adult Anticancer Treatment • Nutrition Support Therapy in Hematopoietic Cell Transplantation • Nutrition Support of Adult Patients with Hyperglycemia The entirety of these guidelines for both pediatric and adult patient populations offers guidance in nutrition support therapy decision making. For nurse clinicians, the recommendations included in the guidelines help answer key questions pertaining to many aspects of providing nutrition care to patients. For example, for the adult critical care nurse, the guidelines7 offer background details about how gastric residual volume measurements should be evaluated. In addition, the guidelines for nutrition support of adult patients with hyperglycemia attempt to answer questions about what
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TABLE 2
Selected Practice Recommendations Included in the A.S.P.E.N./SCCM Guideline for the Provision and Assessment of Nutrition Support Therapy in the Adult Critically Ill Patient EN is the preferred route of feeding over PN for the critically ill patient who requires nutrition support therapy. (Grade C) If early EN is not feasible or available the first 7 days following admission to the ICU, no nutrition support therapy should be provided. (Grade C) • In the patient who was healthy before critical illness with no evidence of protein calorie malnutrition, use of PN should be reserved and initiated only after the first 7 days of hospitalization, when EN is not available. (Grade E) If a patient is expected to undergo major upper GI surgery and EN is not feasible, PN should be provided under very specific conditions: • If the patient is malnourished, PN should be initiated 5 to 7 days preoperatively and continued into the postoperative period. (Grade B) PN should not be initiated in the immediate postoperative period but should be delayed for 5 to 7 days should EN continue to be not feasible. (Grade B) PN should be initiated only if the duration of therapy is anticipated to be ≥ 7 days. (Grade B) In all ICU patients receiving PN, mild permissive underfeeding should be considered at least initially. • Once energy requirements are determined, 80% of the requirements should serve as the ultimate goal or dose of parenteral feeding. (Grade C) Eventually, as the patient stabilizes, PN may be increased to meet energy requirements. (Grade E) In the first week of hospitalization in the ICU, when PN is required and EN is not feasible, patients should be given a parenteral formulation without soy-based lipids. (Grade D) In patients stabilized on PN, periodically repeated efforts should be made to initiate EN. • As tolerance improves and the volume of EN calories delivered increases, the amount of PN calories supplied should be reduced. • PN should not be terminated until ≥ 60% of target energy requirements are being delivered by the enteral route. (Grade E) Bowel sounds, flatus, and stools are not required before feeding initiation. (Grade B) If repeated high residuals, withhold gastric and switch to jejunal feeding. (Grade E) Patients should be monitored for tolerance of EN. (Grade E) • Avoid inappropriate cessation of EN. (Grade E) • Avoid holding EN for GRVs < 500 mL in absence of other signs of intolerance. (Grade B) • Minimize periods of NPO for tests or procedures to promote EN delivery and avoid prolonged ileus. (Grade C) Use protocols to increase percentage goal calories provided. (Grade C) Abbreviations: EN, enteral nutrition; GI, gastrointestinal; ICU, intensive care unit; GRV, gastric residual volume; NPO, nothing by mouth; PN, parenteral nutrition. Grading system used for these guidelines is as follows: Grade of recommendation: A—supported by at least 2 level I investigations; B—supported by 1 level I investigation; C—supported by level II investigations only; D—supported by at least 2 level III investigations; and E—supported by level IV or level V evidence. Level of evidence: I—large, randomized trials with clear-cut results; low risk of false-positive (alpha) error or false-negative (beta) error; II—small, randomized trials with uncertain results; moderate to high risk of false-positive (alpha) and/or false-negative (beta) error; III—nonrandomized, contemporaneous controls; IV—nonrandomized, historical controls; and V—case series, uncontrolled studies, and expert opinion.7
range of glucose control is associated with the best outcomes.8 For the pediatric nurse caring for a child with human immunodeficiency virus (HIV), the pediatric HIV guideline offers guidance regarding when micronutrient supplementation may be desirable.9 Finally, the nutrition support of neonatal patients at risk for necrotizing enterocolitis (NEC) assists the neonatal nurse clinician in understanding when and how feedings should be started in infants at high risk for NEC, and
whether human milk offers an advantage in terms of NEC risk.10
EVALUATING THE DEVELOPMENT PROCESS An essential practice for organizations that produce clinical guidelines is frequent evaluation of the
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TABLE 3
Selected Recommendations Within the A.S.P.E.N. Clinical Guidelines: Nutrition Support of the Critically Ill Child Children admitted with critical illnesses should undergo nutrition screening to identify those with existing malnutrition and those who are nutritionally at risk. (Grade D) A formal nutrition assessment with the development of a nutrition care plan should be required, especially in those children with premorbid malnutrition. (Grade E) In critically ill children with a functioning gastrointestinal tract, EN should be the preferred mode of nutrient provision, if tolerated. (Grade C) Energy expenditure should be assessed throughout the course of illness to determine the energy needs of critically ill children. (Grade D) In a subgroup of patients with suspected metabolic alterations or malnutrition, accurate measurement of energy expenditure using indirect calorimetry is desirable. (Grade E) A specialized nutrition support team in the PICU and aggressive feeding protocols may enhance the overall delivery of nutrition, with shorter time to goal nutrition, increased delivery of EN, and decreased use of parenteral nutrition. (Grade E) Abbreviations: EN, enteral nutrition; PICU, pediatric intensive care unit.
development process. In 2011, the IOM convened a committee producing a consensus report titled Clinical Practice Guidelines We Can Trust.11 The committee suggested that the development process is a serious weakness of most guidelines in clinical use. The report provided key attributes of a development process that would yield guidelines considered “trustworthy” (Table 4). As highlighted in the editorial by Kelly Tappenden, PhD, RD, editor-in-chief of the Journal of Parenteral and Enteral Nutrition, A.S.P.E.N.’s chief scientific journal, the A.S.P.E.N. guideline process initiated in 2009 is “exceedingly aligned with the IOM process recommended to yield trustworthy guidelines.”12 This recognition should provide guideline users with confidence that A.S.P.E.N. clinical guidelines can be trusted for implementation in their practice setting.
TABLE 4
Key Attributes for Trustworthy Guidelines 11
• Based on a systematic review of the literature • Developed by a group of multidisciplinary experts, including representatives of key affected groups • Consider patient subgroups and preferences, as appropriate • Use an explicit and transparent process aimed to minimize distortions, biases, and conflicts of interest • Discuss alternative care options and health options, including ratings for both the quality of evidence and the strength of recommendations • Reconsidered and revised as warranted by new evidence
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A ROBUST FUTURE The future of A.S.P.E.N. clinical guidelines remains robust. Guidelines published in 2013 include: • Neonatal Metabolic Bone Disease • Parenteral Nutrition Safety • Adult Obesity Guidelines under development include Hospitalized Neonates, Adult Chronic Wound, and the revision of the 2009 Adult Critical Care. One of the most frequently cited A.S.P.E.N. guidelines is its first, Guidelines for the Use of Total Parenteral Nutrition in the Hospitalized Adult Patient.13 Although each individual guideline produced by A.S.P.E.N. includes a specific recommendation involving parenteral nutrition, a guideline similar to the one produced in 1986 has not been completed. The need to revise such a guideline has been recognized, and it is currently under development. A.S.P.E.N. embraces the vision of helping ensure that every patient receives safe, efficacious, and high-quality nutrition care. Creating and disseminating trustworthy clinical guidelines to assist practitioners is a key initiative toward realizing that vision. With more than 5900 members, A.S.P.E.N. will continue its tradition of championing the best evidence-based nutrition support for all patients.
OBTAINING A.S.P.E.N. CLINICAL GUIDELINES A.S.P.E.N. clinical guidelines are available at the A.S.P.E.N. Web site, https://www.nutritioncare.org/. Membership in A.S.P.E.N. is not required to obtain the
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full text of guideline documents. The first-time visitor to the Web site must register through a free account; once that is accomplished, the full text of all guidelines is available. REFERENCES 1. Guyatt G. Preface. In: Guyatt G, Rennie D, eds. Users’ Guides to the Medical Literature: A Manual for Evidence Based Clinical Practice. Chicago, IL: AMA Press; 2002:xiii-xvi. 2. Evidence-Based Medicine Working Group. Evidence-based medicine: a new approach to the teaching of medicine. JAMA. 1992;268:2420-2425. 3. Rosenberg W, Donald A. Evidence based medicine: an approach to clinical problem solving. BMJ. 1995;310:1122-1126. 4. American Society for Parenteral and Enteral Nutrition. Guidelines for the use of parenteral and enteral nutrition in adult and pediatric patients. J Parenter Enteral Nutr. 1993;17(suppl):1SA. 5. Institute of Medicine. Committee to Advise Public Health Service on Clinical Practice Guidelines. Clinical Practice Guidelines: Directions for a New Program. Washington, DC: National Academies Press; 1990.
6. Druyan ME, Compher C, Boulatta J, et al. Clinical guidelines for the use of parenteral and enteral nutrition in adult and pediatric patients: applying the GRADE system to development of A.S.P.E.N. clinical guidelines. J Parent Enteral Nutr. 2012;36:177-180. 7. McClave SA, Martindale B, Vanek V, et al. Guideline for the provision and assessment of nutrition support therapy in the adult critically ill patient. J Parenter Enteral Nutr. 2009;33:277-316. 8. Mehta N, Compher C. A.S.P.E.N. clinical guidelines: nutrition support of the critically ill child. J Parenter Enteral Nutr. 2009;33:260-276. 9. Sabery N, Duggan C. Nutrition support of children with human immunodeficiency virus infection. J Parenter Enteral Nutr. 2009;33:588-606. 10. Fallon E, Nehra D, Potemkin A, et al. Nutrition support of neonatal patients at risk for necrotizing enterocolitis. J Parenter Enteral Nutr. 2012;36:506-523. 11. Institute of Medicine. Clinical Practice Guidelines We Can Trust. Washington, DC: National Academies Press; 2011. 12. Tappenden K. Trustworthy clinical guidelines: how do we measure up? J Parenter Enteral Nutr. 2011;35:431. 13. A.S.P.E.N. Board of Directors. Guidelines for the use of total parenteral nutrition in the hospitalized adult patient. J Parenter Enteral Nutr. 1986;10:441-445.
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