A Study of Micronutrient Deficiencies after Bariatric Surgery

Background: The United States is plagued with an obesity epidemic, with a resultant growing interest in bariatric surgery. Bariatric surgical procedures alter the GI tract, impeding absorption of micronutrients. Multivitamins (MVI) are an essential supplement after bariatric surgery to prevent nutritional deficiencies and related health problems. However, adherence to MVI supplements, like any medication, can be problematic. The prevalence of nutritional deficiencies after bariatric surgery is not well studied. Purpose: This quality improvement project aimed to evaluate current micronutrient screening practices in a selected bariatric surgical clinic, determine the frequency and type of micronutrient deficiencies by procedure, evaluate adherence of patients to MVI supplementation, and make recommendations to the practice based on findings. Methods: A retrospective chart review was performed on 125 patients from a local bariatric surgery clinic. Pre-surgical and 1-year post-surgical monitoring lab values were compared. A sample of patients were asked to complete the Morisky Medication Adherence Questionnaire (MMAQ) over a 2-month period to assess adherence to the daily MVI recommendation in order to evaluate patient teaching effectiveness. Results: Adherence to MVI supplementation was high in patients who completed the MMAQ. Micronutrient deficiencies varied among patients for whom different surgical procedures had been performed. Data accessibility and management of data for monitoring patients was found to be very problematic, requiring institution of better data management processes. Conclusions: The clinic is in need of several process improvements for data management to improve monitoring of MVI adherence and deficiencies. Patient education appears to be effective based on the very high MVI adherence rates noted in the sample of patients. However, micronutrient deficiencies appear to vary by surgical procedure. The surgeons were receptive to process improvement recommendations.

Running head: A STUDY OF MICRONUTRIENT DEFICIENCIES A Study of Micronutrient Deficiencies after Bariatric Surgery Alexa Nickel RN, BSN Project Chair: Pamela Phares PhD, APRN Content Expert: Steven Simper MD, FACS The University of Utah College of Nursing In partial fulfillment of the requirements for the Doctor of Nursing Practice 1 A STUDY OF MICRONUTRIENT DEFICIENCIES 2 Abstract Background: The United States is plagued with an obesity epidemic, with a resultant growing interest in bariatric surgery. Bariatric surgical procedures alter the GI tract, impeding absorption of micronutrients. Multivitamins (MVI) are an essential supplement after bariatric surgery to prevent nutritional deficiencies and related health problems. However, adherence to MVI supplements, like any medication, can be problematic. The prevalence of nutritional deficiencies after bariatric surgery is not well studied. Purpose: This quality improvement project aimed to evaluate current micronutrient screening practices in a selected bariatric surgical clinic, determine the frequency and type of micronutrient deficiencies by procedure, evaluate adherence of patients to MVI supplementation, and make recommendations to the practice based on findings. Methods: A retrospective chart review was performed on 125 patients from a local bariatric surgery clinic. Presurgical and 1-year post-surgical monitoring lab values were compared. A sample of patients were asked to complete the Morisky Medication Adherence Questionnaire (MMAQ) over a 2-month period to assess adherence to the daily MVI recommendation in order to evaluate patient teaching effectiveness. Results: Adherence to MVI supplementation was high in patients who completed the MMAQ. Micronutrient deficiencies varied among patients for whom different surgical procedures had been performed. Data accessibility and management of data for monitoring patients was found to be very problematic, requiring institution of better data management processes. Conclusions: The clinic is in need of several process improvements for data management to improve monitoring of MVI adherence and deficiencies. Patient education appears to be effective based on the very high MVI adherence rates noted in the sample of patients. However, micronutrient deficiencies appear to vary by surgical procedure. The surgeons were receptive to process improvement recommendations. Keywords: micronutrient deficiencies, bariatric surgery, retrospective chart review A STUDY OF MICRONUTRIENT DEFICIENCIES 3 Introduction Problem Description According to the American Society for Metabolic and Bariatric Surgery (ASMBS, 2016), the number of bariatric surgeries performed in the United States has increased from 158,000 in 2011 to 196,000 in 2015, and the number is predicted to increase in years to come. The Center for Disease Control and Prevention (CDC, 2017) reports that the U.S. obesity rate increased from 10-15% in 1990 to 37.9% in 2015, and currently estimates the medical care cost of obesity to be between $147 and $210 billion annually (The State of Obesity, 2015). These trends indicate the need for weight reduction and obesity-related surgical procedures, which has resulted in an increased interest in bariatric surgery. However, bariatric surgery inherently places patients at high risk for malabsorption of essential micronutrients, which can lead to other health problems such as bone fracture or neurological conditions. Currently, data regarding the frequency with which these micronutrient deficiencies occur are lacking. The ASMBS (2016) recommends a daily multivitamin for all patients-who have undergone a bariatric procedure as a standard of care, but researchers have not investigated patient compliance with this recommendation. According to local bariatric surgeons and current research, another challenge with this patient population is that yearly testing and follow-up is low; few return for their necessary lab work, and many do not receive the appropriate follow-up care (Parrot et al., 2016). In addition, many bariatric clinics do not follow the recommended guidelines for annual testing and patient follow-up (Parrot et al., 2016). Therefore, more research on the sequelae of bariatric surgery is necessary to establishevidence based guidelines that ensure proper micronutrient deficiency monitoring and that improve patient adherence to supplementation in an effort to minimize the harm that can result from a deficiency. A STUDY OF MICRONUTRIENT DEFICIENCIES 4 Available Knowledge Researchers suggest micronutrient deficiencies may exist before and after bariatric surgery, but they have not been consistent with respect to the micronutrients examined or the time frames over which they were studied. Researchers in one study found deficiencies of vitamin B12 (25%), D (92%), K (40%), iron (44%), and folate (18%) prior to surgery, which can be exacerbated postoperatively (Ewang-Emukowhate, Harrington, Botha, McGowan, & Wierzbicki, 2015). Another group of researchers found a variable decrease in iron, copper, zinc, vitamin B12, and C levels throughout the 12-month post-operative period in study subjects who had undergone bariatric surgeries (Gesquiere et al., 2016). A study by Van Der Beek, Monpellier, Eland, Tromp, and Ramshorst (2015) found deficiencies in folic acid, vitamin D3, B12, and iron. Some case studies have also been published by clinicians whose patients have experienced Wernicke's encephalopathy, polyneuropathy, osteoporosis, myelopathy, and night blindness as a consequence of nutritional deficiencies related to bariatric surgery (AlHassany, 2104; Scarano, et al., 2012; Wilson & Datta, 2014). Due to the lack of consistency among study findings of micronutrient deficiencies and variables under study, it is difficult to determine the actual incidence and prevalence of these deficiencies. In an effort to address the problem, the American Society for Metabolic and Bariatric Surgery created the first set of guidelines for clinicians (Aills, Blankenship, Buffington, Furtado, & Parrott, 2008). These guidelines included recommendations for nutritional assessment, supplementation, and follow-up when monitoring for nutritional deficiencies in post-surgical bariatric patients: these guidelines were updated by the same organization in 2016 (Parrott, Frank, Dilks, Craggs-Dino, Isom, & Greiman, 2016). Despite these published guidelines, wide variation exists in actual practice among clinicians who treat and follow bariatric patients post-surgically. A STUDY OF MICRONUTRIENT DEFICIENCIES 5 Rationale This project used Stevens' (2013) Ace Star Model of Knowledge Transformation as a framework to explain how evidence is integrated into clinical practice. The Ace Star Model outlines five distinct steps: knowledge discovery, evidence summary, translation into practice guidelines, integration into practice, and evaluation. In the knowledge discovery stage, the clinician gains information through traditional research methodologies and scientific inquiry. As part of the evidence summary stage, the clinician transforms the information into a single meaningful statement that is more manageable for users. Collation of information from various sources, reduces bias and chance in the conclusion. In the translation into practice guideline stage, the information is then presented in the form of a recommendation or guideline that fits into time, cost, and care standards for patients. This guideline should include the benefits, harms, and costs of the various options that ultimately help providers make informed decisions. Finally, the information is integrated into practice by changing individual and organizational clinical practice guidelines. The challenge of the integration stage is the variable rate at which individuals and systems adopt new practices and incorporate them into a sustainable system change. In the last stage, the clinician evaluates the outcomes, patient and provider satisfaction, efficacy, efficiency, economic analysis, and health status impact (Stevens, 2013). The ultimate goal of this project was to assess a current clinical practice guideline in a local bariatric clinic and make recommendations for improvement based on the findings. Several barriers can prevent the success implementing changes to a clinical practice guideline. The Ace Star Model identifies common barriers that can occur when attempting to incorporate evidence into practice and provides steps to convert one form of knowledge to the next (Stevens, 2013). A STUDY OF MICRONUTRIENT DEFICIENCIES 6 Specific Aims The objectives of this quality improvement project included (a) evaluation of current practice model and rates of deficiencies with a retrospective chart review; (b) assessment of patient adherence to daily multivitamin use and barriers to compliance with this recommendation to evaluate the practice's educational program; and (c) education of providers regarding micronutrient deficiency rates, compliance rates of daily multivitamin use, barriers to taking multivitamins, and recommendations for improvement of current practice model. All objectives were implemented in one bariatric clinic. The overarching objective of this project was to assess relevant micronutrient screening practices in the chosen setting and encourage use of evidence-based supplementation guidelines in a local bariatric surgery clinic for patients who have undergone a gastric bypass, sleeve gastrectomy, or duodenal switch procedures, in order to reduce the rate of deficiencies and attendant health problems. Methods Context Rocky Mountain Associated Physicians is a private practice clinic established in 1979 that specializes in bariatric and general surgery. The clinic is located in suburban Salt Lake County, Utah. The staffing at this clinic consists of three general surgeons and one physician assistant. This clinic performs over 500 bariatric surgeries a year, with more than 20,000 procedures performed since 1979. The patient population of the clinic is diverse in age, ethnicity, and socioeconomic status. A STUDY OF MICRONUTRIENT DEFICIENCIES 7 Intervention One hundred twenty five patients randomly selected from eClinicalWorks®, the electronic medical record (EMR) software used in the clinic to record clinic encounters, met the following criteria for a retrospective data collection analysis: had undergone a primary sleeve gastrectomy, gastric bypass, or duodenal switch in 2015 or 2016 and had documented pre-surgical and 1-year post-surgical labs. Vitamins B12, B1, D, and folate were analyzed for patients who had undergone a sleeve gastrectomy or gastric bypass. For patients who had undergone a duodenal switch, vitamins A, B12, B1, D, folate, and pro-time were analyzed. The clinic's medical assistants distributed the Morisky Medication Adherence Scale (MMAS8) to post-surgical patients from December 2017 to January 2018. This anonymous questionnaire assessed the medication adherence to the recommended daily multivitamin that all patients should have been taking post-operatively. Surveys were collected weekly by the researchers and were reviewed to ensue completeness in patient responses. In order to ensure integrity of data recording, one researcher input the data into an Excel spreadsheet, and a second researcher double-checked the entries. Measures The vitamins being monitored pre- and post-surgically in the bariatric clinic were analyzed in the retrospective chart review. The MMAS-8 a valid and reliable questionnaire that is pertinent to the clinical problem under study, was employed to determine specific patient adherence problems with the recommended daily multivitamin (Morisky, Ang, Krousel-Wood & Ward, 2009). The MMAS-8 contains eight questions that identify common reasons for medication non-adherence. The first seven questions elicit yes/no answers and the last question is a 5-point Likert response. Each "no" response is scored as 1 and each "yes" response is scored as 0. Question 5 is reversed scored, A STUDY OF MICRONUTRIENT DEFICIENCIES 8 meaning a "yes" response is scored as 1 and a "no" response is scored as 0. Question eight is a Likert scale response and if participants choose response "0" it is scored as 1, and if they choose response "4" is it scored as 0. Responses "1", "2", and "3" in question eight are scored as 0.25, 0.5, and 0.75 respectively. The total MMAS-8 score ranges from 0 to 8 and has been categorized into three levels of adherence: low with a score of 8, moderate with a score of 6 to less than 8, and high with a score less than 6 (Morisky et al., 2009). Upon completion of the retrospective chart review and questionnaire administration, the researchers analyzed the data using descriptive statistics and then presented the data to the local bariatric clinic providers on March 9, 2018 via a PowerPoint presentation. Analysis Descriptive statistics were used for analysis of the findings from the chart review. Reasons for nonadherence and percentage of patients who were not adherent to the daily multivitamin recommendation during their first year post-surgery were determined using the MMAS-8. Percentage of patients who were experiencing vitamin A, B12, B1, D, folate, and protime deficiencies pre-surgery and one year-post-surgery were also determined using a distribution analysis. Ethical Considerations The University of Utah Institutional Review Board determined this quality improvement project to be exempt from human subjects review. Results A total of 125 retrospective chart reviews were completed through the Rocky Mountain Associated Physicians office. Characteristics of the sample revealed that patients were predominantly Caucasian (81.6%) and female (73.6%), and that they had their surgical procedure A STUDY OF MICRONUTRIENT DEFICIENCIES 9 performed by a single doctor (64%). Table 1 shows the diversity in population characteristics in terms of age, pre-surgical BMI, post-surgical BMI, and surgical procedure. Data retrieval was accomplished through the use of the clinic's electronic health records as well as data retrieved from the electronic health records at St. Mark's Hospital, where the surgeries were performed, due to some missing data pertaining to pre-surgical lab variables that were missing in the office's EHR. Only patients with pre-surgery and post-surgery levels of the micronutrients were included in the analysis. The frequencies of vitamin B1 and folate deficiencies increased at one year post-surgery for gastric bypass and sleeve gastrectomy, whereas frequencies of deficiencies in vitamins B12 and D decreased (Figures 1 and 2). The percentages of vitamins B1, D, A, and folate increased at one year post-surgery for duodenal switch procedures, but vitamin B12 remained the same (Figure 3). Changes in prothrombin levels were not analyzed for change because pre-surgical prothrombin levels were not available. Forty seven MMAS-8 questionnaires were administered by medical assistants to patients at the clinic during post-surgical visits (Appendix A). The pre- and post-surgical intervals of participants ranged from one month to 11 years wherein 55.3% (n=26) underwent gastric bypass, 25.5% (n=12) underwent sleeve gastrectomy, and 19.1% (n=9) underwent duodenal switch. Of these participants, 97.9% (n=46) were found to have high medication adherence rates and only 2.1% (n=1) had moderate adherence. The most common reasons noted on the MMAS-8 surveys for missing multivitamin doses were forgetting to take the medication (n=22) and not taking it for reasons other than forgetting (n=23) (Figure 4). Pre-surgical procedural problems in the office were uncovered during the retrospective chart review. It was discovered that prothrombin levels were not being drawn pre-surgically in patients undergoing a duodenal switch procedure per office protocol. Another problem uncovered was that A STUDY OF MICRONUTRIENT DEFICIENCIES 10 many patients' pre-surgical labs were not available in the office's EHR, which required obtaining labs from the hospital where the surgeries were performed. Several patients were also missing documentation of requisite pre-surgical and post-surgical micronutrient labs. Only 50.4% (n=63) of patient charts reviewed had documentation of all required labs completed prior to surgery and one year post surgery. Missing pre-surgical labs by micronutrient were vitamin A (n=3), vitamin B1 (n=21), vitamin D (n=1), folate (n=1); in addition, no prothrombin times were found. Missing postsurgical micronutrient labs included vitamin A (n=4), vitamin B1 (n=16), vitamin D (n=3), folate (n=6), and prothrombin (n=3). The missing labs were either not performed or an insufficient sample to perform the test was noted. The chart review revealed that when samples were designated insufficient for testing, they were never repeated. Discussion Summary Findings suggest that micronutrient deficiencies prior to bariatric surgery either decrease or increase one year post operatively depending the procedure performed. Patients' post-operative adherence to the recommended daily multivitamin was found to be quite high in the sample of patients who were randomly surveyed, which suggests that patients understand the importance of micronutrient replacement and that the importance of supplementation is being effectively communicated by surgeons. It also suggests that the office's educational program regarding micronutrient replacement therapy has been effective. Following data collection and analysis, the evaluation team presented findings to the surgeons. Several data monitoring and procedural problems were reported to the surgeons, as a result of this project. One of these was that prothrombin levels were not being done as assumed. In addition, there was no designated repository from which to consistently extract data regarding pre- and post- A STUDY OF MICRONUTRIENT DEFICIENCIES 11 surgical lab values. The surgeons reported that they allow patients to obtain post-surgical labs from any location convenient to them. The failure to return the lab results from the wide geographical area in which the labs are obtained is the main contributor to the incomplete lab database. The lab found to be missing most frequently was vitamin B1. During data collection it was found that this particular test had to be sent out to a special lab requiring different handling of the final results. Interpretation The study used data from a sample (n=125) that appears representative of the patient population served by the clinic, thus allowing generalization of the results to this setting. Current evidence suggest that several micronutrient deficiencies exist prior to patients undergoing bariatric surgery and that these deficiencies are potentially exacerbated by the procedure. The results of this study found that only one micronutrient, vitamin D, was highly deficient prior to patients undergoing two of three surgical procedures (gastric bypass and sleeve gastrectomy). A majority of the studies reviewed for this project found that deficiencies occurred in some form in nearly all lab values examined. Findings from this study did not correlate with previous studies, but the data were from a single practice only. Several patients in the practice who underwent bariatric surgery were self-pay. For that reason, surgeons reported that they attempt to reduce costs to patients by omitting pre-surgical labs that appear led to some micronutrient values not being obtained. This practice leads to inconsistent data collection making pre-surgical and post-surgical micronutrient deficiency monitoring difficult. More analysis needs to be done to determine which labs can safely be omitted for cost reduction without putting a patient's health at risk. Limitations A STUDY OF MICRONUTRIENT DEFICIENCIES 12 The study is limited in several ways. The sample was retrieved from a single practice characterized by variability in micronutrient monitoring and education between different clinics, which reduces the generalizability to any other practice outside the practice studied. Also the MMAS-8 questionnaires used in this study were self-reported, which may have biased results regarding the level of patient adherence. The time constraints over which the project was conducted did not allow for a larger number of charts to be reviewed and limited the number of participants who were able to complete the MMAS-8 surveys, both of which may have skewed the results. Conclusions The study brought several quality improvement opportunities to light. The high patient adherence rates to multivitamin supplementation indicate that the clinic's education process regarding micronutrient supplementation is effective. However, the electronic health record is lacking the necessary organization to effectively monitor pre- and post-surgical patient labs. Surgeons are now aware that the practice needs to review and implement a better data management system to ensure that patients' health can be monitored consistently and appropriately. It is also important moving forward to examine which micronutrient levels are critical to monitor and those that are not necessary. However, for this to happen there needs to be a consistency in labs drawn across clinics to be able to understand the prevalence of the deficiencies in this population. For example, vitamins B1, zinc and copper are very expensive to monitor and therefore several clinics choose to not monitor them. Whether or not these omissions adversely affect patients' health is unknown. More research needs to be conducted in this area. A STUDY OF MICRONUTRIENT DEFICIENCIES 13 References AlHassany, A. (2014). Night blindness due to vitamin A deficiency associated with copper deficiency myelopathy secondary to bowel bypass surgery. BMJ Case Reports. doi:10.1136/bcr-2013-202478 American Society for Metabolic and Bariatric Surgery. (2016). Estimate of bariatric surgery numbers, 2011-2015. Retrieved from https://asmbs.org/resources/estimate-of-bariatricsurgery-numbers Center for Disease Control and Prevention. (2017). Overweight and obesity. Retrieved from https://www.cdc.gov/obesity/index.html Ewang-Emukowhate, M., Harrington, D.J., Botha, A., McGowan, B., & Wierzbicki, A.S. (2015). Vitamin K and other markers of micronutrient status in morbidly obese patients before bariatric surgery. The International Journal of Clinical Practice, 69(6), 638-642. doi:10.1111/ijcp.12594 Gesquiere, I., Foulon, V., Augustijns, P., Gils, A., Lannoo, M., Van der Schueren, B., & Matthys, C. (2016). Micronutrient intake, from diet and supplements, and association with status markers in pre- and post-RYGB patients. Clinical Nutrition. http://dx.doi.org/10.1016/j.clnu.2016.08.009 Morisky, D., Ang, A., Krousel-Wood, M., &Ward, H. (2009). Predictive validity of a medication adherence measure in an outpatient setting. Journal of Clinical Hypertension, 10(5), 348354. A STUDY OF MICRONUTRIENT DEFICIENCIES 14 Parrott, J., Frank, L., Dilks, R., Craggs-Dino, L., Isom, K., & Greiman, R. (2016). ASMBS integrated health nutritional guidelines for the surgical weight loss patient - 2016 update. Surgery for Obesity and Related Diseases. http://dx.doi.org/10.1016/j.soard.2016.12.018 Scarano, V., Milone, M., Minno, M., Panariello, G., Betogliatti, S., Terracciano, M., …Musella, M. (2012). Late micronutrient deficiency and neurological dysfunction after laparoscopic sleeve gastrectomy: A case report. European Journal of Clinical Nutrition, 66, 645-647. Stevens, K. (2013). The impact of evidence based practice in nursing and the next big ideas. The Online Journal of Issues in Nursing, 18(2). The State of Obesity. (2015). The healthcare costs of obesity. Retrieved from https://stateofobesity.org/healthcare-costs-obesity/ Van Der Beek, E., Monpellier, V., Eland, I., Tromp, E., & Ramshorst, B. (2015). Nutritional deficiencies in gastric bypass patients; incidence, time of occurrence and implications for post-operative surveillance. Obesity Surgery, 25(5), 818-823. doi:10.1007/s11695-0141456-y Wilson, H.O., & Datta, D.B. (2014). Complications from micronutrient deficiency following bariatric surgery. Annals of Clinical Biochemistry, 51(6), 705-709. doi:10.1177/0004563214535562 A STUDY OF MICRONUTRIENT DEFICIENCIES Table 1 Patient Population of Retrospective Chart Review ________________________________________________ Demographic N (%) ________________________________________________ Age 23-35 12 (9.6%) 36-50 55 (44%) 51-72 58 (46.4%) Gender Female 92 (73.6%) Male 33 (26.4%) Race Caucasian 102 (81.6%) Hispanic 7 (5.6%) Pacific Islander 1 (0.8%) Middle Eastern 1 (0.8%) Refuse to Report 14 (11.2%) Surgeon Mckinlay 80 (64%) Simper 41 (32.8%) Paulk 4 (3.2%) Procedure Gastric Bypass 63 (50.4%) Sleeve Gastrectomy 30 (24%) Duodenal Switch 32 (25.6%) 15 A STUDY OF MICRONUTRIENT DEFICIENCIES 0% 16 0% Figure 1. Percentage of micronutrient deficiencies pre-surgery and post-surgery with gastric bypass A STUDY OF MICRONUTRIENT DEFICIENCIES 0% 17 0% Figure 2. Percentage of micronutrient deficiencies pre-surgery and post-surgery with sleeve gastrectomy A STUDY OF MICRONUTRIENT DEFICIENCIES 0% 0% Figure 3. Percentage of micronutrient deficiencies pre-surgery and post-surgery with duodenal switch 18 A STUDY OF MICRONUTRIENT DEFICIENCIES Figure 4. Reason for non-adherence to daily multivitamin recommendation post operatively 19 A STUDY OF MICRONUTRIENT DEFICIENCIES 20 Appendix A You have undergone bariatric surgery, and it is recommended that you take a daily multivitamin. Individuals have identified several issues regarding their medication-taking behavior and we are interested in your experience. There is no right or wrong answer. Please answer each question based on your personal experience with your daily multivitamin. Your responses are anonymous. (Please Check The Correct Number) No=0 Yes=1 1. Do you sometimes forget to take your daily multivitamin? 2. People sometimes miss taking their medications for reasons other than forgetting. Think over the past two weeks, were there any days when you did not take your daily multivitamin? 3. Have you ever cut back or stopped taking your medication without telling your doctor, because you felt worse when you took it? 4. When you travel or leave home, do you sometime forget to bring along your daily multivitamin? 5. Did you take your daily multivitamin yesterday? 6. When you feel like your weight loss is under control, do you sometimes stop taking your multivitamin? 7. Taking medication every day is a real inconvenience for some people. Do you ever feel hassled about sticking to your daily multivitamin? 8. How often do you have difficulty remembering to take all your medications? (Please circle the correct number) Never/Rarely………………………………………..0 Once in a while……………………………………..1 Sometimes…………………………………………..2 Usually……………………………………………...3 All the time…………………………………………4