Pilot BMC Nutrition for the Prevention of Malnutrition after Hepatopancreaticobiliary Surgery by Remote Monitoring | Full Text

2021-12-13 16:38:09 By : Ms. Nic Lee

BMC Nutrition Volume 7, Article Number: 82 (2021) Cite this article

Patients undergoing hepatopancreaticobiliary (HPB) surgery, such as pancreatic cancer, periampullary cancer, and liver cancer, are at high risk of malnutrition. Malnutrition can increase surgical complications and reduce overall survival. Although the situation is serious, there are limited interventions to address malnutrition after HPB surgery. The purpose of this pilot trial is to check the feasibility, acceptability, availability and preliminary efficacy of remote nutrition monitoring interventions after HPB surgery.

Participants received tailor-made nutrition consultations before and after surgery 2 weeks and 4 weeks after discharge. Participants also recorded their 30-day daily nutritional intake, which was remotely reviewed by a registered dietitian before the nutritional consultation visit. Descriptive statistics are used to describe research results.

Before HPB surgery, all 26 patients agreed to participate in the trial. Seven people were excluded after consent because they did not meet the eligibility criteria (for example, did not undergo surgery). Nineteen participants (52.6% women, median age = 65 years) are still eligible for remote monitoring after surgery. 19 people used the mobile app food diary, 79% of the participants recorded their food intake for more than 80% of the study days, 95% of the participants met with a dietitian during all interviews, and 89% of the participants responded to the intervention Very satisfied. Among participants with complete data, the average calorie target percentage obtained was 82.4% (IQR: 21.7).

This intervention is feasible and acceptable for patients undergoing HPB surgery. Preliminary efficacy data showed that most participants were able to reach the calorie intake goal. Future studies should examine the effects of interventions in larger randomized controlled trials.

Clinical trials.gov. Registered on September 16, 2019, https://clinicaltrials.gov/ct2/show/NCT04091165.

In the past 20 years, there has been an increase in hepatopancreaticobiliary (HPB) operations in the United States [1,2,3]. Part of the reason for this increase is the increase in pancreatic cancer, liver cancer, and periampullary cancer treated by HPB surgery [4,5,6]. HPB surgery is associated with widespread morbidity. After HPB surgery, about a quarter of patients will have serious complications such as infection and thrombosis[7,8,9], and about 15-20% of patients will be readmitted to the hospital within 30 days after HPB surgery [10, 11]] . One of the most challenging aspects of patient management after HPB surgery is malnutrition, that is, insufficient intake or absorption of nutrients needed to maintain health [12]. Up to 40% of HPB surgery patients develop malnutrition 30 days after surgery [13,14,15,16]. There is an urgent need to develop interventions to reduce malnutrition in patients undergoing HPB surgery.

There are many common causes of malnutrition after HPB surgery. HPB surgery changes the digestive system and usually causes symptoms that interfere with food intake and malabsorption of nutrients [17,18,19]. Patients may also have complications that further affect nutrition, such as pancreatic exocrine dysfunction (i.e. lack of digestive enzymes), endocrine dysfunction (i.e. glucose intolerance), and delayed gastric emptying due to impaired gastric motility [20,21 ,22,23,24]. Without treatment, malnutrition can have devastating consequences, such as impaired immune function, decreased lean body mass, increased risk of infection, decreased adjuvant therapy, and reduced survival rates [13, 25,26,27]. Despite its severity, there is limited evidence on how to treat malnutrition after HPB surgery [28, 29].

Nutrition counseling can effectively prevent malnutrition in cancer patients, but this strategy has not been fully utilized in patients undergoing HPB surgery [28, 30, 31, 32]. In order to prevent malnutrition after surgery, patients must make major dietary changes, such as eating small and frequent meals, and may require supplements or insulin to control exocrine or endocrine insufficiency of the pancreas. Although self-management of diet is important, patients undergoing HPB surgery are usually discharged from the hospital without any nutritionist support and report that they feel overwhelmed and not prepared to manage their nutrition [33, 34]. For example, less than a quarter of pancreatic resection patients receive any support from a dietitian after surgery [31, 35], although clinical guidelines recommend this [20]. Previous studies have shown that nutritional counseling will be strengthened when patients are provided with tools to track food intake. This method is called diet self-monitoring [36,37,38]. Self-monitoring of diet or recording of daily food and beverage intake is an evidence-based method of behavioral weight loss intervention [38]. In order for self-monitoring of diet to be effective, patients must keep track of their food intake every day [39]. However, self-monitoring can be cumbersome and will decline over time, especially when using paper food diaries [40]. Therefore, digital tools may be the best choice to promote self-monitoring of dietary adherence for HPB patients. However, this strategy has not been tested in HPB surgery patients.

To bridge this gap, the pilot trial tested the feasibility, acceptability, usability, and preliminary efficacy of interventions that provide remote nutrition monitoring for patients after HPB surgery. The intervention combines two evidence-based methods: 1) nutrition counseling provided by a dietitian, and 2) diet self-monitoring via a mobile application (app). The results of this pilot study can support future research to test the effectiveness of interventions in larger trials and expand the intervention to other patients at risk of malnutrition when the intervention proves to be effective.

A single-arm pilot trial was conducted at the Moffitt Cancer Center in Tampa, Florida.

Prospectively identify, agree and follow up through the Pancreas and Hepatobiliary Clinic from August 2019 to May 2020 with surgically treatable liver or pancreatic malignancies or precancerous lesions and with neoadjuvant chemotherapy or radiochemotherapy or pre-resection treatment plan Of patients. Patients who are 18 years of age or older, have a biopsy confirmed malignant tumor, or have a pre-malignant diagnosis, undergo planned pancreatectomy or hepatectomy. The patient was also required to have a smartphone, be willing to use a mobile application to track postoperative nutritional intake, answer nutrition-related questionnaires, and speak English. Patients are excluded if they are deemed unsuitable for surgery or require parenteral or enteral nutrition. The patient provided written consent to participate in the study before the operation. The target sample size is 20 patients, which is considered sufficient to test feasibility. The Advarra Institutional Review Board reviewed and approved all research activities, and the research is registered on ClinicalTrials.gov (NCT04091165).

The patient received dietary consultation from a registered dietitian with oncology experience in the preoperative, perioperative and postoperative settings. Before surgery, patients are screened for malnutrition using validated screening tools, which is a subjective overall assessment generated by the patient [41]. Information from malnutrition screening tools is used to develop a personalized calorie goal for each patient. The dietitian sets a calorie goal based on the Mifflin St Jeor equation, with an activity coefficient of 1.4-1.5, depending on malnutrition. Dietitians also meet with patients after surgery during their hospital stay to review dietary goals and provide food intake instructions. After discharge from the hospital, the dietitian meets with the patient in weeks 2 and 4 to provide advice on how to increase calorie intake to achieve goals (for example, high-calorie foods, oral nutritional supplements) and strategies to manage nutrition-related side effects.

In addition to diet counseling, during the first visit with the nutritionist, a mobile application was also provided for patients, namely the MyPlate mobile application (Leaf Group Ltd.; Santa Monica, California). The nutritionist helps the patient to download the nutritional goals and enter them into the app. Patients are required to use the app to record all dietary intake within 30 days after discharge. The application calculates the daily caloric intake based on the entered data. An entry for any food of the day is defined as using the application on that day. The dietitian remotely monitors the patient's food intake data and uses this information to guide nutrition consultation visits (for example, to provide feedback on calorie goals).

Feasibility is defined as recruitment, retention, and application usage rate. The basis for recruitment is that ≥50% of eligible patients agree to participate in the study. The baseline for retention is that ≥70% of the participants were retained during the study, and ≥70% submitted complete food intake data for ≥80% of the study days. Acceptability is defined as the patient's participation and satisfaction with the intervention. The benchmark for patient participation is that ≥70% of participants participated in all three dietitian visits (ie baseline, 2 weeks, 4 weeks). Intervention satisfaction is measured using an assessment of participants’ level of agreement with the statement, “I’m satisfied with using the mobile app to help follow my nutrition plan.” The project uses 5 points from total disagreement to complete agreement. The Kerte scale is used for measurement. The benchmark of acceptability is that ≥70% of participants fully agree with the statement.

Usability is defined as the self-reported ability to learn and use the application. Usability is measured by assessing the participants’ agreement with three statements: “Mobile apps are easy to learn”; “Mobile apps’ navigation is clear and easy to understand”; “It’s easy to record meals on mobile apps.” These items are measured using a 5-point Likert scale ranging from disagreement to complete agreement. The benchmark for usability is that ≥70% of participants agree or fully agree with all three statements.

We asked participants whether their informal caregivers (for example, spouses or family members) helped participants record their food intake.

The initial efficacy is defined as the target percentage of calories gained within 30 days. This is determined by calculating the average calories burned per day recorded in the MyPlate calorie counter mobile app based on the calorie goal determined by the nutritionist.

Descriptive statistics are used to describe research results. For categorical variables, the sample size and percentage are reported. For continuous variables, report the median and interquartile range (IQR).

Of the 26 participants who agreed before surgery, 7 did not undergo surgery (for example, cancer metastasis). The median age of the study (n = 19) participants was 65 (IQR: 15) years (Table 1). The majority of participants were white (84.1%) and female (52.6%). The median Charlson comorbidity score was 6 (IQR: 2). The median body mass index (BMI) was 26.2 (IQR: 6.8). Most patients underwent pancreatectomy (78.9%), while a few patients underwent hepatectomy (21.1%). The PG-SGA score that measures the risk of malnutrition ranges from 0 to 16. Most patients have a score of 2-3 (36.8%), indicating that dietitian intervention is recommended, or a score of 4-8 (36.8%), indicating that dietitian intervention is required. Some patients (15.9%) with a score ≥9 indicate that intervention is urgently needed, while a few patients (10.5%) have a score of 0-1, indicating that immediate intervention is not required. All patients stated that they had used mobile apps before.

Of the 26 patients who were close to participating in the study, all 26 patients agreed to participate, and the recruitment rate was 100%. Seven participants were excluded after consent for failing to meet the inclusion criteria, including 1) unsafe resection due to metastatic disease or liver cirrhosis found during surgery or 2) patients requiring parenteral or enteral nutrition after surgery The operation was aborted. The remaining 19 eligible patients were retained during the study, with a retention rate of 100%. The percentage of patients who submitted food intake data for at least 80% of the study days was 15/19 (78.9%). The percentage of patients who attended all three dietician visits was 18/19 (94.7%). Almost all of the participants who completed the exit survey, 16/18 (88.9%) completely agreed that they were satisfied with the mobile application.

Among the participants who provided survey data, 13/18 (72.2%) completely agreed that the application is easy to learn. Most completely agree that 12/18 (66.7%) app navigation is clear and easy to understand. About half of the people totally agree that 10/18 (55.6%) is easy to record food through the app. Some participants pointed out the challenges of using the app, such as difficulty in finding specific foods or insufficient food choices in the app.

Of the participants who provided survey data, slightly more than a quarter of 5/18 (27.7%) reported that their informal caregivers helped them record their food intake.

Among participants with complete data (n = 15) (24/30-day data), the percentage of calorie goals achieved within 30 days was 82.4% (IQR: 21.7). In week 1, among participants with complete data (n = 17) (5/7 days of data), the target percentage of calories obtained was 51.8% (IQR: 26.5) (Figure 1). In week 2, among participants with complete data (n = 15), the calorie goal percentage achieved was 84.0% (IQR: 34.4). In week 3, among participants with complete data (n = 16), the target percentage of calories obtained was 87.5% (IQR: 18.6). In week 4, among participants with complete data (n = 15), the target percentage of calories obtained was 94.5% (IQR: 24.0).

Achievement of study participants’ weekly calorie goals

Overall, the goal of this study is to evaluate the feasibility, acceptability, availability, and preliminary efficacy of remote nutrition counseling interventions to promote nutritional recovery after HPB surgery. Our research found that the intervention meets a priori benchmarks of feasibility and acceptability. Most of the participants were retained during the study, were highly involved in mobile applications and nutritionist visits, and most reported a high degree of satisfaction with the intervention. Most participants found the app easy to use; however, some participants reported challenges in locating food in the app. In terms of initial efficacy, participants worked hard to reach their daily calorie goals in the first week after surgery; however, most participants started to achieve their calorie goals in the second week and were able to maintain their calorie goals in the 3rd and 4th weeks. Calorie goal.

Previous studies have shown that the transition from hospital to home after pancreatectomy and liver resection is challenging for many cancer patients [33, 34, 42]. Patients need to make complex dietary changes (e.g., track calorie intake) and change behaviors (e.g., eat smaller meals). However, few patients receive support to manage these changes. Current research shows that the combination of nutritional counseling and digital tools, such as a mobile application that tracks food intake, is feasible and acceptable in this patient population. For example, most patients (79%) recorded food intake for more than 80% of the study days, and almost all participants (95%) participated in all three dietician visits during the study period. These findings indicate that patients need to strengthen nutritional monitoring after HPB surgery. However, there is no public record of mobile app monitoring of postoperative caloric intake. As far as we know, this research is the first to use a mobile application for this purpose.

One of the main challenges in providing digital interventions is to develop a tool that is easy to learn and applicable to a wide range of patients. Our research found that most, but not all patients find the app easy to learn, navigate, and use to record food intake. Some challenges were also identified, such as difficulty finding specific foods or insufficient food choices in the app. Our dietitian pointed out that some participants reported challenges when there was no exact food item in the app (for example, a specific brand of yogurt). The dietitian clarifies to the patient that an approximate value (for example, choosing an available yogurt brand) is sufficient. In addition to optimizing patient guidance, future research may need to evaluate digital literacy (e.g., electronic health literacy scales) [43] to determine whether availability varies due to pre-existing digital literacy. Our research found that about a quarter of patients need informal caregiver assistance to help enter food intake data in mobile apps. Future research may add an informal caregiver training component to help informal caregivers also learn how to use the application.

Our research found that calorie intake tends to increase within 30 days. Most participants had difficulty eating during the first week after discharge, but recovered quickly in the first 2-4 weeks. Our intervention started with a nutritionist visit 2 weeks after surgery. Future studies may consider starting a nutritionist visit 1 week after surgery, when patients have the most difficulty reaching their caloric intake goals. The increase in calorie intake over time can also be explained by the type of surgery examined. For example, at the first surgical follow-up, most patients undergoing Whipple/total pancreatectomy transitioned from a low-fat diet to a regular diet.

Remote monitoring of caloric intake may be used as a clinical indicator for patients undergoing HPB surgery, and intervention can be carried out through telephone consultation, safety messages or rapid clinic follow-up [44,45,46,47]. In our study, 2 of the 4 patients with application compliance below 80% experienced serious complications, including postoperative pancreatic hemorrhage and sepsis, which highlights this potential. The implementation of monitoring and counselling has the potential to expand the influence of dietitians in many people who believe that universal nutrition screening should be accepted [48, 49]. Although more research is needed, nutrition monitoring mobile apps have potential in pre- and post-recovery environments for cancer patients and other patients undergoing complex surgery. Patients with adequate nutrition benefit from fewer perioperative complications, shorter hospital stays, higher completion rates of multimodal treatments, and improved survival rates [50, 51].

This study has several limitations. First, the research was conducted at a comprehensive cancer center designated by the National Cancer Institute, which may have resources that are not available in all oncology settings (for example, on-site registered dietitians). Secondly, this research aims to evaluate the feasibility, acceptability, and application usability, and does not have the ability to evaluate efficacy. Larger trials are needed to determine the effectiveness of interventions. The results of this study indicate that the intervention is feasible and can be tested in larger trials. Third, the study is limited to English-speaking participants. For languages ​​other than English, app availability may vary. Future research should test the usability of mobile applications in Spanish and other languages ​​(for example, Arabic), available through the MyPlate application [52].

Malnutrition is a common and devastating consequence of cancer and surgical treatments (such as HPB surgery). Although the situation is serious, there are limited interventions to address postoperative malnutrition. During the postoperative period after HPB surgery, it seems feasible and acceptable to conduct self-monitoring of the patient's diet through a mobile application in conjunction with nutritionist consultation. Most patients are able to reach their calorie goals within 2-4 weeks after surgery, which indicates that this intervention can improve the patient's prognosis. Further research is needed to test this method in larger efficacy trials.

By establishing a data sharing agreement, the author will provide de-identified data upon request. Requests can be sent to kea.turner@moffitt.org.

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MyPlate [https://www.myplate.gov/resources/graphics/myplate-graphics]. Visited on December 7, 2021.

This research was supported by internal funding from Moffett Cancer Center. The funding agency played no role in the design of the research, the collection, analysis and interpretation of data, and the writing of the manuscript.

Department of Gastrointestinal Oncology, Moffett Cancer Center, Tampa, Florida, USA

Kelvin Allenson, Sarah Zhu, Alicia Chin, Melissa Adams, Laura Cooper, Diana Nguyen, Samer Naffouje, Diana L. Castillo, Jason Denbo, Jose M. Pimiento, Mokenge Malafa, Benjamin D. Powers, Jason B. Fleming, Daniel A. Anaya & Pamela J. Hodul

Department of Health Outcomes and Behavior, Moffett Cancer Center, Tampa, Florida, U.S.

Kea Turner, Brian D. Gonzalez, and Benjamin D. Powers

Morsani School of Medicine, University of South Florida, Tampa, Florida, USA

Kea Turner, Brian D. Gonzalez, Maria Kokab, and Brian James

Department of Nutritional Therapy, Moffett Cancer Center, Tampa, Florida, U.S.

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Conceptualization: PJH. Investigation: KA, EG, SZ, NM, AC, MA, LC, DN, SN, DLC, MK, BJ, JD, JMP, MM, BDP, JBF, DAA, PJH. Data analysis and interpretation: KA, KT, BDG, PJH. Manuscript writing, reviewing and editing: KA, KT, BDG, PJH. All authors have read and approved the final manuscript.

This study was approved by the Advarra Institutional Review Board. The patient provided written consent to participate in the study.

Dr. Gonzalez has received consulting fees from SureMed Compliance and KemPharm. Dr. Gonzalez participates in EllyHealth's advisory board. Dr. Hodul previously served in Abbvie's spokesperson's office. The other authors did not have any conflicts of interest to disclose.

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Allenson, K., Turner, K., Gonzalez, BD, etc. Pilot trial of remote monitoring to prevent malnutrition after hepatopancreaticobiliary surgery. BMC Nutr 7, 82 (2021). https://doi.org/10.1186/s40795-021-00487-3

DOI: https://doi.org/10.1186/s40795-021-00487-3

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