Safety and quality of parenteral nutrition: Areas for improvement and future perspectives

Abstract

Purpose

This article is based on presentations and discussions held at the International Safety and Quality of Parenteral Nutrition (PN) Summit (held November 8-10, 2021, at Charleston, SC, and Bad Homburg, Germany) and aims to raise awareness concerning unresolved issues associated with the PN process and potential future directions, including a greater emphasis on patients’ perspectives and the role of patient support.

Summary

Ensuring that every patient in need receives adequate PN support remains challenging. It is important to have a standardized approach to identify nutritional risk and requirements using validated nutritional screening and assessment tools. Gaps between optimal and actual clinical practices need to be identified and closed, and responsibilities in the nutrition support team clarified. Use of modern technology opens up opportunities to decrease workloads or liberate resources, allowing a more personalized care approach. Patient-centered care has gained in importance and is an emerging topic within clinical nutrition, in part because patients often have different priorities and concerns than healthcare professionals. Regular assessment of health-related quality of life, functional outcomes, and/or overall patient well-being should all be performed for PN patients. This will generate patient-centric data, which should be integrated into care plans. Finally, communication and patient education are prerequisites for patients’ commitment to health and for fostering adherence to PN regimes.

Conclusion

Moving closer to optimal nutritional care requires input from healthcare professionals and patients. Patient-centered care and greater emphasis on patient perspectives and priorities within clinical nutrition are essential to help further improve clinical nutrition.

Key Points.

• There is a lack of knowledge and training concerning PN among many healthcare providers (HCPs), and PN is sometimes considered a “cost item” rather than a general service.

• Nutritional risk and requirements should be identified using appropriate screening and assessment tools, and where specialist expertise is lacking, collaboration with larger institutions or national nutrition societies is recommended.

• Clinicians should identify and adhere to optimal PN processes and use modern technology to help personalize patient care.

• Better education and communication between patients and HCPs, and adopting patient-centric care, can prove beneficial.

Parenteral nutrition (PN), originally introduced in the early 1960s,¹ is a therapeutic option for delivery of essential nutrients and can be a life-saving intervention in patients of all age groups with a compromised or absent bowel function.^2-4 PN can be given within an inpatient or outpatient setting, both in patients requiring short-term nutrition in acute situations and as long-term PN for patients with chronic conditions.^4,5

PN formulations or PN-related processes have continuously evolved, and PN use has become considerably safer and easier.⁴ Professional nutrition society clinical guidelines have helped set high standards.^3,6,7-9 However, PN still represents a highly complex medication and is thus prone to errors that can lead to serious complications.^3,10-14 To reduce potential risks associated with PN, international nutrition societies including the American Society for Parenteral and Enteral Nutrition (ASPEN) and the European Society for Clinical Nutrition and Metabolism (ESPEN), alongside other experts, have repeatedly advocated for standardization across the whole PN process.^10,15-18 While in the United States a high priority has been given to make prescription, transcription, and compounding safer, many European countries (and areas elsewhere in the world) have opted early on for a dual system of market-authorized multi-chamber bags (MCBs) (where possible) and compounding (where necessary).¹⁹ MCBs are available in two formats: either as a 2-chamber bag (2CB) containing glucose/dextrose and amino acids or the more modern 3-chamber bag (3CB) containing glucose/dextrose, amino acids, and lipids.²⁰ In particular, there has been movement towards more widespread use of multicomponent lipid emulsions containing fish oil as part of PN rather than pure soybean oil lipid emulsions, which is in line with evidence for improved clinical outcomes with this strategy.²¹

When using MCBs, fewer overall manipulations are required, reducing the risk of errors and infections compared with other PN systems.^15,22 Moreover, education of caregivers and patients, competency assessments, interdisciplinary communication and cooperation, and surveillance for complications are all key in optimizing the benefits of PN while minimizing the potential risk of patient harm.^2,10,18

There remains further room for improvement in numerous aspects of the PN process, including prescription, administration, and monitoring. Furthermore, the priorities of aspects within PN considered to be most important may change and new challenges may arise. The following commentaries are based upon presentations given and discussions held by a group of experts who convened at the International Safety and Quality of PN Summit held on November 8 to 10, 2021, at two locations (Charleston, SC, and Bad Homburg, Germany).¹⁸ Among other goals, the group aimed to identify challenges associated with the PN process, raise awareness of unresolved issues, and provide healthcare professionals (HCPs) involved in the prescribing and administration of PN with guidance and approaches for improvement. Core challenges identified are shown in Figure 1. We also refer to the other articles within this supplement that complement this manuscript, particularly the consensus statements concerning PN quality and safety, as detailed in the expert consensus statements and summary of proceedings publication.¹⁸ It is important to understand that this article does not constitute any recommendations—these are to be found in the expert consensus statement publication¹⁸—but does present and summarize aspects from the international summit as a learning experience.

Figure 1.

Improving the safety and quality of parenteral nutrition (PN): core challenges throughout the PN process.

Providing an adequate PN formulation for every patient

A key issue for the prescribing HCP is to ensure that every patient in need of PN receives a PN formulation appropriate for their requirements, as emphasized in statement 1 in the summary article,¹⁸ regardless of whether PN is prescribed and carried out at an expert center or centers where PN is just one of many services. The first step in the nutrition care process is to identify every patient with malnutrition or at risk for malnutrition and ensure that nutritional support is given in a timely manner. Hence, HCPs should be educated sufficiently regarding the importance of “closing nutritional gaps.” Moreover, a standardized approach to identify malnutrition and activate nutritional support should be a prerequisite.

Screening for nutritional risk is recommended for all hospitalized patients according to the 2011 ASPEN clinical guidelines for nutrition screening, assessment, and intervention in adults.²³ Patients identified to be at nutritional risk should then undergo a more detailed nutritional assessment to estimate nutrient requirements for the development of a nutrition therapy plan (Table 1).^23,24 Nutritional intervention is recommended to improve clinical outcomes for patients at risk for malnutrition or who are malnourished. ESPEN-endorsed 2015 recommendations state that those at risk for malnutrition should be identified by validated screening tools.²⁵ Current established tools for nutritional screening and assessment recommended by ASPEN²³ and/or ESPEN²⁶ are summarized in Table 2.^{7,9,23,24,26-41}

Table 1.

Nutritional Screening and Assessment^23,24

	Nutritional screening	Nutritional assessment
Who?	All hospitalized patients	Patients identified during screening as having malnutrition or at risk for malnutrition
When?	Within 24 hours after admission to the hospital	Following screening
Why?	To detect patients at risk for or with malnutrition to enable nutrition therapy to be defined and started in a timely manner	To allow patient-centered interventions supporting patients’ recovery
How?	Use of a validated screening tool: • Rapid and simple (≤5 min) • Noninvasive, no laboratory required	In-depth evaluation including diagnosis, disease history, laboratory tests, examination, assessment of gastrointestinal function, and medications
Assessor	Any HCP	Nutritional expert (eg, dietitian, trained physician, or nutrition nurse)

Abbreviation: HCP, healthcare professional.

Table 2.

Frequently Used and Validated Tools for Screening and Assessment of Nutritional Status^{7,9,23,24,26-41}

Tool	Includes	Parameters/procedure	Setting/formal recommendations	Developer/accessibility
Malnutrition Universal Screening Tool (MUST)24	Screening	5-step screening tool, quick and simple: 1. BMI score 2. Percentage unplanned weight loss score 3. Acute disease effect score 4. Add scores 1-3 to obtain overall risk of malnutrition 5. Use management guidelines and/or local policy to develop care plan	Validated in multiple care settings: • Hospital inpatients and outpatients27 • Oncology28 • Geriatrics27 Recommended by ESPEN for the community26 and for nutrition risk screening in patients with cancer27	Developed by BAPEN License-free for noncommercial use (for commercial use, a license fee may be required) Instructions and scoring tables in English are available (eg, from BAPEN)29
Nutrition Risk Screening (NRS-2002)30	Screening	2-step screening procedure, quick and simple: 1. Prescreening for nutrition risk: • BMI <20.5kg/m2 • Recent weight loss • Decreased nutritional intake during the past week • Presence of a severe disease If “yes” to one or more of the above, then continue with main screening 2. Main screening: • Grading of severity of malnutrition • Grading of severity of disease • Age	Recommended by ESPEN to detect the presence/risk of undernutrition in hospital setting,26 for nutrition risk screening in patients with cancer,9 and in the critically ill7	First developed in Denmark in collaboration with an ad hoc ESPEN working group License-free use Instructions in English are available from MDCalc Ltd31
Mini Nutritional Assessment (long form) (MNA)32	Screening and assessment	1. Screening: • Loss of appetite • Recent weight loss • Mobility • Acute illness • Depression/dementia • BMI 2. Assessment: includes 12 criteria specific to issues of aging, independence, medications, functionality, pressure sores, nutrition habits, self-rating, and anthropometric parameters	Developed and validated for older people (>65 years of age) and recommended as assessment tool for adults by ASPEN23	Copyright held by Nestlé Nutrition Institute License-free use Can be downloaded in several languages from Nestlé Nutrition Institute33
Mini Nutritional Assessment (Short Form) (MNA-SF)34	Screening	Abbreviated MNA containing only the screening part Can be completed in a few minutes	Validated specifically for older people in hospital, community, and long-term care settings35 and recommended by ESPEN for all geriatric settings26,36	Copyright held by Nestlé Nutrition Institute License-free use Can be download in several languages from Nestlé Nutrition Institute33
Subjective global assessment (SGA)37	Screening and assessment	Highly sensitive and specific assessment tool Efficient, cost-effective, easy to learn 1. Case history: • Weight loss • Dietary intake • Gastrointestinal symptoms • Functional capacity • Disease-related effects 2. Physical signs of malnutrition: • Loss of subcutaneous fat • Muscle loss • Edema • Ascites 3. Rating of nutritional status: A = well nourished B = moderately malnourished or suspected malnutrition C = severely malnourished	Validated in a variety of hospital settings (e.g. oncology, kidney disease, hepatology, cardiology) Recommended assessment tool for adults by ASPEN23	First used by Detsky et al. in Canada37 License-free use Can be downloaded in English (e.g. from Nutrition Care in Canada)38 For further information, see Nutrition Care in Canada39
Patient-generated subjective global assessment (PG-SGA)40	Screening and assessment	Assessment tool with patient-generated aspects Available in 12 languages Patient part can be completed in a few minutes Patient-generated aspects (PG-SGA SF): • Weight loss • Dietary intake • Gastrointestinal symptoms • Activity and function Form to be completed by the HCP: • Weight loss • Related effects • Metabolic demand • Exam • Global Assessment (A = well nourished, B = moderately malnourished or suspected malnutrition, C = severely malnourished) • Total numerical score, and nutritional triage recommendations	Reference method for proactive risk assessment (screening), assessment, monitoring, and triaging for interventions in patients with cancer40	Available in 12 languages Copyrighted and registered instrument; permission is needed prior to any and all use outside of patient clinical care For clinical patient care, permission is given when downloading the most recent version from the website of the organization (free download)41

Abbreviations: ASPEN, American Society for Parenteral and Enteral Nutrition; BAPEN, British Association for Parenteral and Enteral Nutrition; BMI, body mass index; ESPEN, European Society for Clinical Nutrition and Metabolism; HCP, healthcare professional.

A consensus report by the Global Leadership Initiative on Malnutrition (GLIM) identified core diagnostic criteria (3 phenotypic and 2 etiologic) for malnutrition in adults in clinical settings (Table 3).⁴² At least one phenotypic criterion and one etiologic criterion should be present to diagnose malnutrition. Thresholds for grading the severity of malnutrition as stage 1 (moderate) and stage 2 (severe) are based on phenotypic criteria. In line with ESPEN and ASPEN, GLIM recommends a 2-step approach for a malnutrition diagnosis: first, screening to identify “at risk” status by the use of a validated screening tool; and second, assessment for diagnosis and grading the severity of malnutrition.⁴² Unfortunately, this level of expertise is not available in all PN centers. Thus, at the summit, the experts encouraged smaller institutions without substantial PN expertise to form collaborations, either with larger institutions or with national nutrition societies. Moreover, in certain countries it may be advisable for national nutrition societies to offer a remote service.

Table 3.

Phenotypic and Etiologic Criteria for Diagnosis of Malnutrition According to Global Leadership Initiative on Malnutrition⁴²

Phenotypic criteria a	Weight loss: >5% within past 6 months, or >10% beyond 6 months
	Low body mass index: <20 kg/m2 if <70 years, or <22 kg/m2 if >70 years (in Asia: <18.5 kg/m2 if <70 years, or <20kg/m2 if >70 years)
	Reduced muscle mass: reduced by validated body composition measuring techniques. For example, fat-free mass index, dual-energy absorptiometry, or corresponding standards using other body composition methods like bioelectrical impedance analysis, computed tomography, or magnetic resonance imaging. When not available, or by regional preference, physical examination or standard anthropometric measures like mid-arm muscle or calf circumferences may be used. Thresholds for reduced muscle mass need to be adapted to race (Asia). Functional assessments like hand-grip strength may be considered as a supportive measure.
Etiologic criteria a	Reduced food intake or assimilation: ≤50% of energy requirements for >1 week, or any reduction for >2 weeks, or any chronic gastrointestinal condition that reduces food assimilation or absorption. Consider gastrointestinal symptoms as supporting indicators that can impair food intake or absorption (eg, dysphagia, nausea, vomiting, diarrhea, constipation or abdominal pain). Use clinical judgment to discern severity based upon the degree to which intake or absorption are impaired. Symptom intensity, frequency, and duration should be noted. Reduced assimilation of food/nutrients is associated with malabsorptive disorders like short bowel syndrome, pancreatic insufficiency, and after bariatric surgery. It is also associated with disorders like esophageal strictures, gastroparesis, and intestinal pseudo-obstruction. Malabsorption is a clinical diagnosis manifest as chronic diarrhea or steatorrhea. Malabsorption in those with ostomies is evidenced by elevated output volumes. Use clinical judgment or additional evaluation to discern severity based upon frequency, duration, and quantitation of fecal fat and/or volume of losses.
	Inflammation: caused by acute disease/injury, or chronic disease. Severe inflammation caused by acute disease or injury is likely to be associated with major infection, burns, trauma, or closed head injury. Other acute disease/injury-related conditions are likely to be associated with mild to moderate inflammation. Severe inflammation is not generally associated with chronic disease conditions. Chronic or recurrent mild to moderate inflammation is likely to be associated with malignant disease, chronic obstructive pulmonary disease, congestive heart failure, chronic renal disease, or any disease with chronic or recurrent inflammation. Note that transient inflammation of a mild degree does not meet the threshold for this etiologic criterion, and that C-reactive protein may be used as a supporting laboratory measure.

^aRequires at least 1 phenotypic criterion and 1 etiologic criterion for diagnosis of malnutrition.

Discrepancy between optimal and actual PN processes

When the nutritional needs of a patient requiring PN have been determined, this usually triggers PN ordering, prescription, compounding/preparation, and administration processes. However, experts have observed that there are gaps between optimal and actual processes. This is critical, as PN is highly complex and carries the risk of serious complications, including intestinal failure–associated liver disease, thrombosis, central line–associated bloodstream infection, and loss of central venous access.^43-45 Therefore, it is important that prescribed routines and safety precautions are followed as closely as possible and any obstacles or problems are addressed.

Frequently, there is a lack of knowledge and proper training among nutritionists, physicians, pharmacists, and other HCPs involved in PN. Underlying causes are multifactorial, including a high workload and consequent lack of time spent per patient, lack of reimbursement, and insufficient education and awareness about the importance of nutrition support, leading to PN being considered a “cost item” rather than a general service. All these issues may contribute to an increased risk of errors. PN may also not be perceived as a medication in some settings, which may lead to underreporting of errors.¹⁸ To reduce the risk of errors and enhance the quality of care provided to patients, it is key to improve education in quality, product availability, sterility, and infection control across all professions involved in the PN process.

In the field of long-term PN, adherence to the optimal PN process poses a particular challenge, both for the patient and the providers who manage their care.⁴⁵ The transition of PN prescriptions from one institution to another may be a risk factor (statement HPN 2 in the summary manuscript).¹⁸ Problems related to the acquisition, distribution, and storage of compounded PN admixtures may also occur (eg, during storms, fires, and other emergencies), and these problems can make it impossible to acquire supplies, or lead to power failures interrupting the proper storage of PN.⁴⁵ The experts proposed to create a small emergency stockpile of market-authorized MCBs for home PN (HPN) patients to be prepared for such special circumstances. Product shortages are another factor that may delay or change therapy, threatening the health and welfare of patients owing to medication errors and worsened patient outcomes.⁴⁶ This issue is discussed in more detail in the publications on PN in clinical practice⁴⁷ and HPN⁴⁸ within this supplement.

Unclarified responsibilities and other challenges associated with the nutrition support team

PN should be prescribed, prepared, and administered by HCPs with demonstrated competency to do so, and institutions are encouraged to implement policies and procedures assuring that these competencies are regularly reassessed. Ideally, interdisciplinary nutrition support teams from various specialties consisting of dietitians, pharmacists, nurses, and physicians accompany the patient throughout the PN process^49-51 (statement 2 in the summary manuscript).¹⁸ These teams have a vital role to better align patients and HCPs, facilitate a safe transfer from the hospital to the home setting, and fulfill patients’ priorities such as maintaining their quality of life (QoL) and independence, as discussed in the following sections. The experts emphasized the importance of clarifying responsibilities and improving communications between the prescribing and care team members to enhance the safety and quality of care. Participation in interdisciplinary rounds to discuss patient cases can be an effective strategy to develop and improve knowledge.¹⁶ The introduction of regular jour fixes (scheduled meetings) may promote mutual understanding.

Education and challenges associated with guideline implementation

Evidence-based guidance for safe clinical practices involving PN prescribing, order review, and preparation was provided by ASPEN in 2014,¹³ and a standardized ASPEN model for PN administration competency was proposed in 2018.¹⁶ In theory, the implementation of these recommendations should ensure that everyone in need receives PN according to today’s state-of-the-art principles (as described in statement 14 in the summary manuscript).¹⁸ However, compliance with society guidelines in daily routine may be poor, as pointed out by meeting attendees working at the interface between centers of expertise and frontline providers. Perceived barriers include a lack of awareness and experience of the HCPs involved in PN, and/or reluctance to modify established processes. Furthermore, patient-related factors may play a role (eg, the clinical condition of the patient), as well as institutional factors (eg, resource constraints, slow administrative processes, and high workloads). Moreover, common weaknesses of existing guidelines, such as the high number and complexity of recommendations, paucity of evidence, and outdated evidence, may also hinder guideline compliance.⁵²

A critical lack of expertise in best-practice PN care consistent with current guidelines has been noted in clinical practice, owing to a variety of reasons such as disease rarity, chronicity, high patient acuity, and cost of care.^53,54 This underscores the need for effective distance education strategies to bring medical expertise to remote and/or underserved regions.⁵⁵ A dissemination plan and the simultaneous use of complementary education approaches/tools and repetition can help to increase awareness and implementation of guidelines among target populations.⁵⁶ In addition, the experts suggested the establishment of central service points that could offer PN expertise to other centers.

Another promising approach is the use of tele-education to “democratize” medical knowledge.⁵³ The Extension for Community Healthcare Outcomes (ECHO) model is one project that bridges the gap between frontline providers and specialty centers of excellence.⁵³ Project ECHO was founded at the University of New Mexico in 2003 to address disparities in hepatitis C care across the state’s rural and remote communities.⁵⁷ Universities and medical centers around the world have adopted the ECHO model for other local challenges.⁵⁸ Briefly, the ECHO model uses videoconferencing technology to move specialized medical knowledge from academic centers to primary care providers in the community, allowing them to deliver best-practice care for complex health conditions previously unavailable to people in underserved areas.^55,59 A systematic review has found that the ECHO model and similar tele-education models of healthcare delivery improve provider- and/or patient-related outcomes (eg, for patients with hepatitis C, chronic pain, dementia, and type 2 diabetes).⁶⁰

Based on the ECHO model, the Learn Intestinal Failure Tele-ECHO (LIFT-ECHO) project was launched in 2019 to support the treatment and management of patients with intestinal failure relying on long-term PN in the US.^53,54,61 As chronic intestinal failure is a rare disease, coverage by specialized centers across the country is scant and often not easily accessible for patients. Daily care is via local (community) nonexpert clinicians including physicians, pharmacists, nutritionists, and nurses. Scheduled meetings, which are like virtual roundtables combined with mentoring and case presentations, link an interdisciplinary specialist team with local teams and/or clinics to improve knowledge among the caring clinicians and ultimately to enhance patient outcomes.^53,54,61 More than 40 LIFT-ECHO clinics dedicated to intestinal failure and PN-related topics have been set up since this project was launched, and it is anticipated that the LIFT-ECHO project will contribute to improved healthcare for patients requiring long-term PN across the US.⁵³

Improved use of modern technology to decrease workloads, increase PN safety, and enhance patient care

HCPs involved in the PN process frequently complain about high workloads (ie, because of complexities surrounding PN), leaving insufficient time for the best patient care or to adhere to the intended PN processes, as mentioned previously. Thus, it is important to recognize where modern technology can assist in relieving the workload burden. In PN compounding, advanced technologies such as barcode-assisted medication preparation systems and electronic health record (EHR)/compounder interfaces have been used successfully to solve many issues, including the reduction of transcription errors and ensuring that safety precautions for compounding PN (eg, upper limits for electrolytes) are met.⁶² Implementation of a computerized PN prescription management system in a surgical/oncological department improved the clarity of PN orders significantly, as well as patients’ nutrition status.⁶³ Moreover, pharmacists’ workload was reduced, and the efficiency of prescription review also improved.⁶³ Nevertheless, leading experts in the field have pointed out that currently available EHR systems lack the functionality to deliver PN safely and optimally across the entire continuum of care.^64,65 The primary problem is that though EHRs are usually functional within one institution, as soon as several institutions are involved an interface problem arises. This aspect is particularly relevant to the care of long-term PN patients who are moving from a hospital either to their home or to alternative care settings (and vice versa). Owing to the inconsistency of the systems involved, a manual transcription of the PN orders is often needed, requiring a high level of coordination effort by the HCPs—time that would be better spent on patient care. (For further details about recommendations on the transition of care within HPN, please refer to the publication on long-term PN within this supplement.)⁴⁸

An alternative option to decrease workloads is the more frequent use of MCBs as described in statement 3a in the summary article.¹⁸ This is a common approach in parts of the world where a broad variety of MCBs are available. The availability of MCBs in the US, especially that of 3CBs, is limited, with only one 3CB formulation (containing soybean oil as the sole source of lipids) currently approved for use. For more information on this topic, please refer to the publications on PN in clinical practice⁴⁷ and PN in the home care setting⁴⁸ within this supplement. In particular, some limitations of MCBs are discussed in the article on PN in the home care setting.⁴⁸ Importantly, fixed-formula MCBs do not cover every patient’s nutritional needs: MCB customization or individually compounded PN may be necessary and, moreover, MCB use does not minimize the need for the careful evaluation of each patient’s nutritional and electrolyte requirements.

Telemedicine has been used to facilitate exchanges between patients and HCPs, connecting patients remotely to HCPs for virtual patient care and monitoring. There has been tremendous growth in telemedicine over the past decade,^66,67 and it gained widespread acceptance during the recent COVID-19 pandemic.⁶⁸ Telemedicine has been shown to be effective for diagnosis, preparation of treatment plans, and improving physician-patient interaction in numerous medical conditions (eg, in cardiovascular disease,⁶⁹ diabetes,⁷⁰ respiratory disease,⁷¹ inflammatory bowel disease,⁷² and stroke⁷³). Offering HPN patients the possibility of remote video consultations with specialists in a UK national intestinal failure referral center, carried out via internet video calls, obviated the need for clinic attendance in HPN patients.⁷⁴ This approach avoids travel for individuals with chronic illness while maintaining standards for follow-up.⁷⁴ Notably, the first telemedicine experiences with HPN patients were gained in the US during the COVID-19 pandemic, and lessons learned were carefully evaluated.⁶⁸ Given these promising examples, such an approach could reduce the challenges of patient-HCP exchanges, and thus ultimately improve PN patient care.

More emphasis on the patient’s perspective

Traditionally, medical care has been viewed as rather paternalistic, with clinicians making treatment decisions independently of patient preferences. However, it is increasingly recognized that patients often have different priorities and concerns than HCPs. This gives increased value to patient-centered factors such as health-related QoL (HRQoL) and autonomy, rather than clinical endpoints such as disease progression and longevity.^75,76 Furthermore, shared decision-making, patient empowerment, and the involvement of patients in the guideline development process are important, particularly for long-term PN patients. However, it must be assumed that patients have enough knowledge to make independent decisions based on scientific facts and clinical advice. Although these aspects have had a minor role in PN so far, the field could benefit from experience gained in other chronic diseases requiring long-term treatment.^77,78 The summit provided the opportunity to develop proposals for advancing patient-centered care, especially in the field of long-term PN and HPN.

Tools to identify the patient’s HRQoL in long-term PN care.

As in other chronic conditions, implementation of patient-centered care in the long-term PN setting involves the identification of health and lifestyle factors that contribute to patients’ HRQoL.⁴⁵ Thus, the experts emphasized the importance of generating and regularly reassessing patient-centric data and integrating these into the care plan (statement 13 in the summary manuscript).¹⁸ HRQoL in patients receiving long-term PN is affected by numerous physical and psychological factors.⁷⁹ From the patients’ perspective, a major benefit of receiving PN in their own home or care facility is that they can regain a normal life—or rather a “new normal” in the face of their current life circumstances and health status.⁸⁰ Improvements in nutritional and functional status associated with PN allow the patient to be more independent and engage in activities of daily living, such as working, attending school, completing household chores, socializing with friends and family, engaging in leisure sports, and traveling.⁸⁰ Nonetheless, the dependence on long-term PN can have adverse effects on HRQoL.^44,45,81 Factors impeding HRQoL include sleep disturbance, frequent urination, technical difficulties, fear of therapy-related complications, inability to eat, increased occurrence of depression, and medical risks because of the underlying disease.^45,82 Interference with activities of daily living is a critical issue in patients undergoing long-term PN, particularly because of daytime infusions. Emerging knowledge points to the importance of adapting schedules to circadian rhythms, indicating that an infusion for 12 to 16 hours during the daytime may have advantages in terms of improved metabolic functioning compared with an overnight or 24-hour continuous infusion.⁸³ Nevertheless, evidence in this field is scarce and there is an obvious research gap in finding a balance between patient independence and optimal nutrition in line with physiological rhythms.

Suitable scales are needed to identify the effect of long-term PN on HRQoL, and several tools are available (Table 4).^44,81,84-96 Two popular generic and non–disease-specific instruments to measure HRQoL are the EQ-5D and the Short Form-36 (SF-36).^84,86 Both have been reported in the scientific literature over 30 years and are available—in most cases without license costs—in numerous languages.^81,85,87 The HPN-QoL tool was designed specifically for patients receiving HPN by the Home Artificial Nutrition and Chronic Intestinal Failure special interest group of ESPEN,^90-93 while the Parenteral Nutrition Impact Questionnaire (PNIQ) was developed to assess the impact of PN on everyday life (so far it is only available in English).^44,94,95 For patients with short bowel syndrome, a specific Short Bowel Syndrome Quality of Life scale (SBS-QoL) tool has been designed and validated.⁹⁶ HCPs will gain valuable insights to ensure good patient-centered care by implementing routine determinations of HRQoL into the care of their long-term PN patients.⁹²

Table 4.

Tools for Assessment of Health-Related Quality of Life in Patients Receiving PN^44,81,84-96

Tool	Characteristics	Setting	Accessibility/developer
European Quality of Life 5 Dimensions (EQ-5D)81,84,85	Developed by the EuroQol Group as a simple, generic measure of health for clinical and economic appraisal. Consists of 5 dimensions: • Mobility • Self-care • Usual activities • Pain/discomfort • Anxiety/depression Available in 3 versions (EQ-5D-3L, EQ-5D-5L, and EQ-5D-Y) Additionally, a VAS is available (for quantitative measure) Used in clinical trials and real-world settings for >30 years	Generic HRQoL questionnaire; applicable to wide range of conditions and populations	Available in >200 languages Licensing and distribution managed by EuroQoL Group84 Free of charge for noncommercial use; registration required through EuroQoL Group
36-Item Short Form Survey (SF-36)86-88	36-item, self-administered questionnaire using a 4-week recall period Consists of 2 domains, physical (PCS) and mental (MCS), with 8 subdomains: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and general mental health Used in clinical trials and real-world settings for >30 years	Generic HRQoL questionnaire; applicable to wide range of conditions and populations	Available in >120 languages Use of SF-36 is license-free; no registration is required86 Shorter form versions available (SF-12, subject to license, and SF-20)
Home parenteral nutrition-quality of life (HPN-QOL)89,90-93	Self-assessment tool to assess the QoL of patients receiving HPN and to evaluate changes in individual patient QoL throughout treatment 48-item questionnaire containing: • functional scales • symptom scales • Global health status/quality of life numerical rating scales	HPN population	Available in 7 languages (English, Danish, Dutch, French, German, Italian, Polish, and Spanish) Copyright: Aberdeen University The use of HPN-QoL is subject to license/costs89
Parenteral Nutrition Impact Questionnaire (PNIQ)44,94,95	Patient-centric measure adopting the needs-based model 20 dichotomous items (true/not true) with focus on the effect of HPN on everyday life	HPN population	Available in English only Copyright: Galen Research Ltd The use of PNIQ is subject to license/costs94
Short Bowel Syndrome Quality of Life (SBS-QoL)96	Comprises 17 items including 2 subscales Based on a VAS Designed for self-administration by patients	Patients with short bowel syndrome

Abbreviations: EQ-5D-3L, 3-level version of EQ-5D; EQ-5D-5L, 5-level version of EQ-5D; EQ-5D-Y, young version of EQ-5D; HPN, home parenteral nutrition; HRQoL, health-related quality of life; MCS, mental component score; PCS, physical component score; QoL, quality of life; VAS, visual analog scale.

Functional tests to assess patients’ health and well-being during and after short-term PN.

Little attention has been paid to assessing HRQoL and/or well-being in patients during and after short-term PN. Critical illnesses, such as acute respiratory distress syndrome, can markedly impair HRQoL for up to 5 years after a stay in an intensive care unit (ICU).⁹⁷ To our knowledge, however, there are no disease-specific validated tools available to assess the effect of PN on patients’ HRQoL during and after short-term PN, and researchers and clinicians have to rely on generic instruments such as the aforementioned EQ-5D or SF-36. Moreover, commonly used tests to assess functionality are often not very meaningful within this setting. For instance, skeletal muscle wasting is common among patients with acute respiratory distress syndrome,^98,99 and 60% to 80% of critically ill patients are functionally impaired after their ICU stay.¹⁰⁰ This limits the use of established functional tests, such as handgrip strength and the 6-minute walk test, in patients during and after an ICU stay as they lack voluntary muscle tension.¹⁰¹

The effect of supplemental PN in ICU patients with acute respiratory failure was assessed in a randomized controlled trial (RCT) determining QoL and functional status at ICU and hospital discharge.¹⁰² Patients were randomized to receive either enteral nutrition plus supplemental PN or enteral nutrition alone. However, functional and QoL measures proved challenging to collect because of severe illness and significant disability following the ICU stay, often preventing patients from completing functional tests. For example, approximately half of the surviving patients could not complete the hospital discharge 6-minute walk test due to an inability to walk. Moreover, for handgrip strength, approximately a quarter of patients were unable to be tested at ICU discharge, and 17% were still unable to do so at hospital discharge. Similarly, in the EPaNIC trial, only approximately 26% of critically ill patients were able to provide data for the 6-minute walk test at ICU discharge.¹⁰³ The ability of patients to complete functional endpoints thus requires careful consideration when designing future trials, and potential alternative instruments should be considered.¹⁰² For ICU patients receiving PN, ICU-specific functional tests, such as the scored physical function ICU test (PFIT-s) or the Medical Research Council (MRC) sum score, could be suitable alternatives.^104-106

Education programs and simple information sheets as memory aids to improve patient knowledge.

Patients and their families should be involved as active participants in their care. Such a patient-centered care approach requires that patients are educated to gain adequate knowledge for shared decision-making and management of their condition. Key factors in engaging patients on long-term PN therapy in their own care include patient education on general aspects of their condition and its treatment, methods of self-administration, the importance of aseptic techniques, and self-monitoring and recognition of potential complications.⁴⁵ Education strategies need to be tailored to patient needs because patients use different channels of communication and education than HCPs.⁵⁶ To enable patients to better understand treatment goals and options, and the associated benefits and risks, information such as guideline recommendations should be translated into a lay version using language that is understandable.⁵⁶ Recommendations should also be made available in practical short documents such as clear, concise “one pagers” suitable for bedside use. Such simple tools may help to involve patients in their treatment and increase the success of information dissemination.⁵⁶ Furthermore, the attendees at the PN safety summit advocated for involving patients in the development of clinical practice guidelines. This is in accordance with the recommendations made by the US Institute of Medicine clinical practice guidelines¹⁰⁷ and is based on the following principles: (1) patients have the moral right to participate in decisions affecting them; (2) patient involvement can contribute to the implementation of guidelines in practice; and (3) patient involvement is thought to increase the relevance and quality of guidelines, as patients’ experiential knowledge can complement scientific evidence.¹⁰⁸ Such an approach may help overcome the recognized and repeatedly emphasized problem with existing PN recommendations: that they focus mainly on technical and/or medical aspects, largely ignoring patient preferences.

Fostering patient education and patients’ commitment to health and treatment adherence

Medical advances have led to a considerable reduction in ICU mortality in recent years, and so the number of surviving critical care patients requiring long-term PN (eg, after severe abdominal trauma, sepsis, or ischemia) has increased significantly.⁹⁷ Eventually, more patients present with conditions requiring volume limitation (eg, because of cardiac or renal insufficiency). Furthermore, the experts noted that there were a growing number of “nontraditional patients” receiving PN in their practices (eg, intravenous drug users, homeless people, and developmentally challenged patients). The risk of infections or other complications may be increased owing to inadequate sterility precautions or a lack of understanding of instructions provided. Understanding of the patient’s personal situation and the difficulties involved in adapting to the reality of long-term PN and the associated lifestyle adaptations are the basis for improvement in this area.

For all patients requiring long-term PN, it is critical to adhere to prescribed schedules and safety precautions. Poor treatment adherence, however, is a concern. There are many reasons for nonadherence to prescribed PN therapies in addition to unintentional forgetfulness.⁴⁵ Good patient-HCP communication, among other factors, can increase treatment adherence. Therefore, it is vital that efforts are made to improve patient-HCP communications to clarify patients’ healthcare values and goals and thus better align treatments with patients’ priorities. This patient-centered care approach involves engaging patients and their families or caregivers as active participants in their care, allowing the patient to take back some measure of control. A patient-centered approach to care thus considers what is meaningful and valuable to each patient. This may allow greater autonomy in daily life and improve patients’ ability to cope with the stress and burdens associated with HPN dependency and chronic disease.⁴⁵ Important lessons can also be learned from other diseases requiring treatment strategies that interfere considerably with patients’ independence and QoL (eg, chronic kidney disease and multiple sclerosis). Proposed actions for HCPs to help foster patient health engagement and treatment adherence are shown in Figure 2. Consideration of these issues in treatment plans may help HCPs to identify areas for improvement in the management of their long-term PN patients.

Figure 2.

Main actions that healthcare teams may offer to foster patient health engagement and adherence to treatment. HCP indicates healthcare professional.

Conclusion

Much progress has been made to improve the overall quality and safety of PN in recent decades, but there is still room for improvement, as mentioned throughout this publication and summarized in Table 5. It is vital to ensure that every patient in need of PN is identified and receives a tailored nutritional prescription, so the education of HCPs concerning nutrition screening and assessment to close nutritional gaps is key. Since errors along the entire PN process can lead to serious complications, closing obvious gaps between intended and actual clinical practice should be given high priority. Here, the use of modern technology could help improve standardization and reduce the risk of error, and also reduce HCP workloads—leaving more time for patient care. This should be the responsibility of interdisciplinary nutrition support teams consisting of HCPs from different specialties whose competencies are regularly reviewed and strengthened through training and interdisciplinary exchange. Distance education strategies such as tele-education have proven to be effective for the dissemination of best practices and to diminish disparities in healthcare provision, as well as for virtual patient care and education.

Table 5.

Main Challenges in PN Process and Some Possible Solutions

Challenge	Possible solution
Make sure that every patient in need of PN is identified and receives a PN formulation in line with individual requirements	Educate HCPs about the importance of “closing nutritional gaps” Implement a standardized approach to identify malnutrition and initiate nutrition support
	Use validated screening and assessment tools to identify and grade the severity of malnutrition (see Table 2) If required, collaborate with larger institutions or with national nutrition societies for a consultancy service
Close the gaps between the optimal and actual clinical practice processes for PN ordering, prescription, compounding, and administration	Improve both patients’ and caregivers’ education in quality, product availability, sterility, and infection control Use barcode-assisted medication preparation systems and EHR-compounder interfaces to reduce transcription errors and ensure that safety precautions for compounding PN are met
	Enhance available EHR systems to facilitate inter-operability (eg, the transition between hospital and alternative care settings/home PN) Create a small emergency stockpile of market-authorized MCBs for HPN patients to be prepared for special circumstances affecting the acquisition, distribution, and storage of compounded PN admixtures
Ensure that PN is prescribed, prepared, and administered by HCPs with demonstrated competency in this service	Implement policies and procedures assuring that the competencies of all HCPs involved in the PN process are regularly reassessed Build interdisciplinary nutrition support teams consisting of dietitians, pharmacists, nurses, and physicians from various specialties to accompany the patient throughout the PN process
	Clarify responsibilities and improve communication between the prescribing and care team members Hold interdisciplinary rounds to discuss patient cases and to develop and improve knowledge Introduce regular jour fixes (scheduled meetings) to promote mutual understanding
Improve compliance with society guidelines in daily routine	Use distance education strategies (eg, tele-education) to bring medical expertise to remote and/or underserved regions and thus “democratize” medical knowledge Establish central service points that could offer PN expertise to other centers
Make use of technological advancements to decrease HCPs workload and leave more time for patient care	Improve the use of modern technologies for PN prescription, preparation, and administration Consider market-authorized MCBs when the patient’s condition allows Use tele-medicine for virtual patient care and monitoring to improve patient-HCP communication, especially in remote regions
Put more emphasis on the patient’s perspective	Involve patients and their families as active participants in their nutrition care Implement the routine determinations of patients’ quality of life into the care of long-term PN patients to gain valuable insights to ensure good patient-centered care
Foster patient education and patients’ commitment to health and treatment adherence	Educate patients to gain adequate knowledge for shared decision making and self-management of their condition using simple tools and practical short documents (e.g. lay versions of guidelines)
	Be understanding of the patient’s personal situation and the difficulties involved in adapting to the reality of long-term PN Improve patient-HCP communication to clarify patients’ healthcare values, goals, and preferences, and to better align treatments with patients’ priorities

Abbreviations: HCP, healthcare professional; MCB, multichamber bag; PN, parenteral nutrition.

More emphasis should be put on the patient’s perspective and patient-centered outcomes since patient adherence is a decisive factor for the quality and safety of PN. Moreover, patients and their families should be involved as active participants in their care, QoL should be assessed routinely, and technical information translated into plain language, to allow shared decision-making. It is also critical to improve patient-HCP communication so treatments can be better aligned with patients’ priorities. Ultimately, it is important to find a balance between safety and QoL to meet both guideline specifications and the preferences and personal situations of patients.

Data availability

No new data were generated or analyzed in support of this article.

Disclosures

Fresenius Kabi Deutschland GmbH and Fresenius Kabi USA provided financial support to organize and invite experts to participate as speakers, based on knowledge and international reputation within the areas of clinical nutrition, to the International Safety and Quality of Parenteral Nutrition Summit, as well as financial support for the development of this summary of proceedings. Fresenius Kabi had no involvement in the study design; collection, analysis, and interpretation of data; or writing of the manuscript. Dr. Martina Sintzel (mcs medical communication services, Erlenbach, Switzerland) drafted the manuscript, and Dr. Richard Clark (freelance medical writer, Dunchurch, UK) provided editorial and consultancy services; all were funded by Fresenius Kabi. These services complied with international guidelines for Good Publication Practice (GPP2022). Dr. Monczka has received consulting fees from Fresenius Kabi. Dr. Ayers is a consultant and speakers bureau member for Fresenius Kabi, and has received speaker’s honoraria from Baxter. Dr. Berger has received speaker’s honoraria from Baxter, Fresenius Kabi, and Nestlé. Dr. Wischmeyer has received investor-instigated grant funding related to his work from the National Institutes of Health, US Department of Defense, Abbott, Baxter, Fresenius Kabi, Mend Inc., and Nutricia; consulting fees from Abbott, Baxter, Fresenius Kabi, Mend Inc., and Nutricia; and honoraria or travel expenses for continuing medical education lectures on improving nutrition care from Abbott, Baxter, DSM, Fresenius Kabi, Nestlé, and Nutricia. He has received an unrestricted gift donation for nutrition research from Musclesound and DSM.