THE COVID‐19 PANDEMIC AND ITS EFFECTS ON MEDICATION USAGE

by

Margaret Elizabeth Adamo

A thesis submitted to the Johns Hopkins University in conformity with the requirements for

the degree of Master of Science

Baltimore, Maryland

May 2021
Abstract

Nearly everyone in the world has been affected by the COVID‐19 pandemic. Hundreds of

thousands of people have died in the U.S. alone, jobs have been lost, family and friends have

been separated both physically and emotionally, and the economy has been drastically

impacted in a negative way. Research of medication use, specifically H2 receptors, statins,

opiates, antidepressant/anti‐anxiety and OTC (over the counter) pain medications, during the

COVID‐19 pandemic determined that COVID‐19 has affected an individual’s need for certain

drugs and that their behaviors and practices contributed to new usage patterns. In addition to a

thorough literature review, data from the Gastroparesis Clinical Research Consortium (GpCRC)

in the Johns Hopkins School of Public Health data was used to determine a change in

medication usage. The data was collected via GpCRC patients’ responses to forms and

questionnaires regarding their medications and what they are used for, their current mood and

mental health, as well as their overall health in general. The same information collected

through these forms in 2019, prior to the pandemic, were compared to those that were

collected, and are still being collected, during the pandemic. After gathering the data and

comparing the pre‐COVID and post‐COVID numbers, it was determined that medication usage,

at this time, has indeed changed during the pandemic. There were some changes and usage did

go up in antidepressants/antianxiety and opiate medication usage as as well as over the

counter (OTC) pain medication.

ii
 Contents

ABSTRACT………………………………………………………………………………………………………………………………………………..ii
LIST OF TABLES……………………………………………………………………………………………………………………………………….iv
LIST OF FIGURES………………………………………………………………………………………………………………………………………v
List of Tables ................................................................................................................................................ iv

INTRODUCTION ............................................................................................................................................. 1

REVIEW OF LITERATURE ................................................................................................................................ 2

COVID‐19 deaths ....................................................................................................................................... 2

Job loss ...................................................................................................................................................... 2
Food Shortage ........................................................................................................................................... 4
Social Distancing ....................................................................................................................................... 4
Medications Affected ................................................................................................................................ 5
H2 receptors.......................................................................................................................................... 5
Statins (anti‐hyperlipidemic medications) ............................................................................................ 7
Opiates .................................................................................................................................................. 8
Antidepressants/antianxiety ................................................................................................................. 9
PROBLEM STATEMENT ................................................................................................................................ 10

RESEARCH METHODOLOGY USED............................................................................................................... 12

RESEARCH METHODOLOGY TOOLS ............................................................................................................. 13

STATISTICAL METHODS USED ..................................................................................................................... 14

DATA ANAYSIS ............................................................................................................................................. 15

CONCLUSION/LIMITATIONS ........................................................................................................................ 20

iii
 List of Tables

1 Baseline Demographics of Study Population……………………………………………………………….18

2 Medications and Medical Diagnosis by Quarter………………………………………………………….18

3 Medication and Medical Diagnosis Pre‐COVID and Post‐COVID (current)……………………19

iv
 List of Figures

1 Summary of survey results from the Pew Research Center…………………………………………………………5

2 An illustration of medication use over time (H2 receptors/PPI and Statins/hyperlipidemic)……..20

3 Am illustration of medication use over time (Opiates, Antidepressants/Antianxiety, OTC Pain

Medications)…………………………………………………………..…………………………………………..…………….……..20

v
INTRODUCTION

All of humanity has been facing the trials and tribulations that are brought on by pandemics

since the first noted epidemic disease (Plague of Athens) in 430 BC (1). Since then, various

diseases have emerged (and in some cases have reemerged) throughout history. Within the last

century, the world has seen diseases such as Spanish Influenza, Ebola, SARS, and Zika (1).

As of late, the world is now in the midst of the fifth documented pandemic recorded since the

flu pandemic of 1918 (2). This disease is COVID‐19, the novel human coronavirus. This new

pandemic has circled the world, causing a variety of problems while affecting everyone in one

way or another. COVID‐19 can be traced back to an outbreak of novel human pneumonia cases

that were discovered in Wuhan City in China in December, 2019 (2). Early diagnosis suggested

that the disease was a viral pneumonia, with symptoms including a dry cough and a fever (2).

The virus quickly became a world‐wide threat after rapidly spreading to other countries. The

World Health Organization (WHO) made the decision that COVID‐19 is, in fact, a pandemic on

March 11, 2020 (2). It was originally believed that the virus started in the Hunan Seafood and

Wildlife Market in Wuhan by way of selling wild animals for human consumption (2). However,

being that the first three patients did not have any prior exposure to the market shows that

COVID‐19 could have had a variety of sources to help the spread in the beginning.

So many changes have taken place throughout the world due to the pandemic, and behavior of

all kinds has been affected. Comparing 2019 and 2020 medication use data will determine

whether the pandemic has altered the way people are using prescription and non‐prescription

medication.

1
REVIEW OF LITERATURE

The effects that COVID‐19 have had on the human population world wide are insurmountable.

Not only has it been a cause of death worldwide, the disease also has led to job loss, food

shortages, social disruption and mental health issues.

COVID‐19 deaths

According to the WHO (World Health Organization) dashboard, as of March 27, 2021, globally

there has been 2,759,432 confirmed COVID‐19 deaths (3), with the United States ranking first

(4). It has been shown that the risk of death via COVID‐19 falls hardest on the older population

(4). For the younger population, 35 years or younger, it has been found that deaths related to

COVID‐19 such as drug overdoses and suicide surpassed the deaths from the disease itself (4).

According to The American Pediatric “Children and COVID‐1: State Level Data Report”, as of

March 18, 2021, 3.34 million children in the Unites States have tested positive for COVID‐19,

with a 0.00% ‐ 0.19% mortality rate since the pandemic began (5). This shows that illness due to

COVID‐19 is not common among children.

Job loss

COVID‐19 has also caused massive economic disruption throughout the world. Millions of

people have lost access to employment, with economists foretelling a possible global recession

that will not only affect the economies of many different counties, but will also allow numerous

industries to become vulnerable to a complete shutdown (6). Below is Figure 1 which was

2
obtained from the Pew Research Center demonstrating the percentage of people whose job

has been affected by Coivd‐19 (24).

Figure 1

According to a 2021 Statista monthly report, the monthly unemployment rate in the United

States in March of 2020, pre‐pandemic, was 4.4%, with a sharp rise to 14.7% in April 2020 and

finally decreasing to the March 2021 rate of 6% (25).

Financial struggles will more than likely follow job loss, and those who are unfortunate enough

to experience wage disruption are over twice as likely as those whose jobs have stayed intact to

3
say that they have struggled paying their rent or mortgage and other bills and have had to

utilized investment money or savings, or borrow money from family and friends (19).

Food Shortage

Globally, COVID‐19 has had a large impact on food systems and sources. Factors such as trade

restrictions, border closures and confinement measures have been severely affecting the food

supply (7). Farmers have been unable to access markets to sell their commodities and

agricultural workers are unable to harvest their crops (7). Surveys that have been completed

since March of 2020 show food insecurity levels at the highest since the Great Recession (8).

Food insecurity occurs when there is no, limited, or uncertain access to ample and nutritious

food that is required to live and maintain a healthy lifestyle (8). As with everything that seems

to accompany COVID‐19, experiencing food insecurity is extremely stressful and leads to

various harmful outcomes, both physical and mental, that are short term, and long term as well

(8).

Social Distancing

The COVID‐19 pandemic has forced most parts of the world to take the necessary steps in

stopping the spread of the virus. These steps included social distancing, quarantining, wearing a

mask and in some cases, and in the beginning stages, full lockdown. People are social in nature

and often depend on others to satisfy their physical needs as well as the overall need to belong

(9). Something as mundane as going to work daily was missed when the lockdown went into

effect. As mentioned before, prior research shows that the workplace is a major source of both

social interaction and a means to form relationships with others (6). Along with the

4
recommendation of wearing a mask comes the backlash from those who feel as though it is not

warranted. There are countless stories on social media about people refusing to wear a mask.

These debates often end up with people causing scenes in public places and innocent workers

being chastised publicly. Not only have family and friends been separated because of

quarantining and social distancing, they are also being separated emotionally as well. There

has been concerns conveyed by mental health experts that quarantining and longstanding

social distancing will lead to incidences of depression, alcohol abuse, anxiety, and even, in some

instances, domestic violence (6).

Medications Affected

Stress brought on by the pandemic may also change medication use in people as stress and anxiety

increases and unhealthy, sedentary lifestyles surge. The below groups of medications have been looked

at for this analysis due to the likeliness of them being added to a daily regimen if there is a continuous

amount of stress.

H2 receptors

The body reacts to stress in different ways, with gastrointestinal function being particularly

influenced (16) and the COVID‐19 pandemic has surely increased stress levels in people around

the world. When someone is faced with a stressful situation, their body automatically reacts in

several different ways. One way is to release the hormones epinephrine (which is adrenaline),

norepinephrine and cortisol (13). The sudden release of these hormones can cause several

health risk factors. For example, the heart must work harder when epinephrine is released,

leading to an increase in heart rate, breathing and blood pressure (13). The body will distribute

5
glucose and fatty acids to use as energy when cortisol is released, which can lead to an increase

in appetite and overeating, and an increase in obesity in the stomach area due to fat deposits,

as well as having a negative effect on fat in other parts of the body (13). Histamine H2

receptor antagonists and other gastrointestinal medications were looked at for this analysis due

to the above mentioned affects stress can potentially have on the gut. According to the

National Institute of Health U.S. Laboratory of Medicine, H2 blockers are regularly used for the

treatment of common heartburn, gastroesophageal reflux and acid‐peptic disease (11). H2

blockers were first approved for use in the United States in 1977, beginning with cimetidine,

with ranitidine, famotidine and nizatidine following, in that order, with all four medications

eventually being available over‐the‐counter as well as by prescription. (11) For the most part,

H2 receptor blockers are very well tolerated, have mild side‐effects if any, and are very

commonly used (11).

It has been shown through research that stress can have both short‐term and long‐term effects

on an individual’s gastrointestinal tract (15). Research on job stress of professional drivers has

shown that stress does have a negative effect on triglycerides, LDL (low density lipoprotein),

and HDL (high density lipoprotein) (14). When a person is exposed to stress, brain‐gut

interactions are compromised, which often leads to the advancement of a large variety of

gastrointestinal disorders (15). These illnesses include inflammatory bowel disease (IBD),

irritable bowel syndrome (IBS), gastroesophageal reflux disease (GERD), along with other food

antigen‐related adverse responses, and peptic ulcers (15).

Aside from the aforementioned disorders, other mentionable effects stress has on gut

physiology include: 1) an increase in visceral perception; 2) an increase in intestinal

6
permeability; 3) negative effects on intestinal microbiota; 4) alterations in gastrointestinal

mobility; 5) negative effects on regenerative capacity of gastrointestinal mucosa and mucosal

blood flow (15).

Statins (anti‐hyperlipidemic medications)

Anti‐hyperlipidemic medications (statins) are another group of medications that were looked at

to see if usage has changed since the start of the pandemic. Statins (HMG‐CoA reductase

inhibitors) are widely used to treat hypercholesteremia (high cholesterol) (17). Having high

cholesterol can increase a person’s risk of having a heart attack or a stroke by limiting blood

flow. When presented with a stressful situation, an individual could experience

hemoconcentration, which is a condition that causes blood to lose fluid, making the cholesterol,

and other components, more concentrated (17). Statins have been known to reduce the LDL

levels more effectively than other cholesterol‐lowering medications that are available, and also

have an excellent safety record while being well‐tolerated (17). Statins also have positive

effects on inflammation, endothelial function, plasma lipoproteins, plaque architecture and

stability, and thrombosis (17). As a way to handle stress, people sometimes make poor food

choices, often leading towards high fat and sugary “comfort” foods. This in turn could easily

cause an unexpected weight gain which could result in higher levels of cholesterol (13).

Unhealthy life choices made during stressful times such as abusing alcohol and tobacco and

maintaining a sedentary non‐active lifestyle would also be components of high cholesterol (13).

7
Opiates

Opiates (opioids) are very powerful narcotic prescription medications that are used for

moderate to severe pain (18). Opioids work by binding to opioid receptors found in the spinal

cord, the brain and other areas of the body (18). A few of the most commonly consumed, and

often abused opioids are Percocet, Codeine, Oxycodone and Vicodin (18). Unlike the

medication groups previously discussed, H2 receptors and statins, opioids do have many

different side effects, including the possibility of addiction and dependence on them.

It has been shown through research that people who are exposed to interpersonal trauma or a

stressful situation may be susceptible to more chronic pain conditions, therefore leading to the

possibility of opioid addiction (19). Possible mechanisms such as stress could easily influence

opioid abuse among people with a past, or reoccurring, history of trauma and stress (19).

As COVID‐19 began forcing shutdowns in March 2020, the deaths from drug overdose have

increased by 20% (19), and as of February 16, 2021, 81,003 people had died from drug

overdoses, the highest fatal overdose numbers recorded in the U.S. for a single year (19). With

the pandemic came isolation, economic difficulties and stress, which are all known to be

triggers for addiction, as well as relapses (19). And to make matters worse, the shutdown also

has taken away resources that help people achieve and maintain, sobriety (19). COVID‐19 has

forced various kinds of support groups to either temporarily or permanently close many

locations, along with some health care systems having to cut some of their recovery and

addiction treatment programs due to the plummeting economy (20).

8
Antidepressants/antianxiety

Antidepressants’ aim is to treat and relieve severe depressive symptoms and prevent them from

returning, and the medication is taken so the patient can maintain a normal daily routine after starting

to feel emotionally stable (26). Antidepressants are also used to treat other symptoms such as anxiety,

restlessness and sleep issues (26). Antidepressants work when taken daily and should be continued

throughout the course of depression, leaving many people taking them for several years.

Anxiety disorders have been associated with a high burden of illness while being recognized as the most

predominant of psychiatric illnesses (27). Like antidepressants, anxiety medication is prescribed by a

physician once the diagnosis has been made. This analysis will determine whether GpCRC patients

started an anxiety/antidepressant regimen during the pandemic or maybe had to have their dosage

increased to be able to deal with the additional stress that has been brought on.

9
PROBLEM STATEMENT

Potentially underappreciated when discussing the various aforementioned COVID‐19 impacts is

whether or not there is a change in medication use during the pandemic. As previously stated,

COVID‐19 has had some sort of impact on almost everyone world‐wide, and another way of

determining this would be to compare the medication usage in people pre‐COVID and during

COVID. Determining, within our data set, whether COVID‐19 has affected an individual’s needs

for drugs and whether their behaviors and practices contributed to the new usage during the

pandemic would be beneficial by way of educating health departments and employers so they

are aware and can provide the appropriate support, and possibly even public health campaigns,

to prevent unnecessary further pain, isolation, suicide, etc.

The added stress of a pandemic may have a definitive effect on what medications, both

prescribed and unprescribed, people are taking and how they are taking them.

Throughout the pandemic, routine health care has changed significantly. In the beginning,

people were no longer willing to see their physician for routine exams and medication checks

for fear of contracting the virus. Also, in some cases, physicians were unable to see their regular

patients due to the widespread demand of health care professionals. This could have led to not

only patients making their own decisions about their monthly medication, but also patients

being left with expired medications or taking higher or lower doses than needed.

As people are continuously fed information about the pandemic through outlets such as the

new and social media, they are prone to experience higher levels of stress. This added stress

might have negative effects on the outcome of any chronic diseases or previous illness with

medication adherence (10). Not only would medication adherence be a problem, but might also

10
take its toll on patients mentally by leaving them in a hopeless state when it comes to

improving their health. The primary objective of this analysis to determine whether COVID‐19

has affected an individual’s needs for drugs and whether their behaviors and practices

contributed to new usage during the pandemic.

11
RESEARCH METHODOLOGY USED

GpCRC (Gastroparesis Clinical Research Consortium)

In order to determine whether medication use has changed throughout the pandemic, the data

that has previously been, and is currently being collected via the Gastroparesis Clinical Research

Consortium (GpCRC) within the Department of Epidemiology in the Johns Hopkins Bloomberg

School of Public Health will be used to compare various medication usages Pre‐COVID (2019)

and during COVID (2020 and part of 2021).

The GpCRC is sponsored by the NIDDK (National Institute of Diabetes and Digestive and Kidney

Diseases) and focuses on gastroparesis, including the natural history, therapy, and etiology of

the disease (23). The consortium’s primary objective is to provide an infrastructure that is able

to quickly and efficiently conduct clinical trials for medical and surgical interventions to improve

treatment for gastroparesis while also performing clinical, epidemiological, and therapeutic

research (23). The study follows patients who have gastroparesis by creating a patient registry

and tracking their condition and how it changes over time with the understanding that

collecting this data may help to gain a better understanding of gastroparesis, allowing for more

efficient diagnosis and treatment (23). A total of 300 participants in the ongoing NIH‐NIDDK

Gastroparesis Research Clinical Consortium (GpCRC) Gastroparesis Registry were included (23).

Adult participants were enrolled at six clinical centers throughout the United States, and have

gastroparesis or gastroparesis‐like symptoms. Institutional Review Boards at each clinical site

and the Data Coordinating Center reviewed and approved the study, and participants provided

written informed consent (23).

12
RESEARCH METHODOLOGY TOOLS

The data that was used was collected from the HADS (Hospital Anxiety and Depression Scale)

questionnaire (appendix 1), the GpCRC Baseline History form (appendix 2) and the GpCRC

Follow‐up Medical History form (appendix 3). These forms and questionnaires are completed by

participants in the GpCRC study. The information collected on these forms in 2019, prior to the

pandemic, were compared to those that were collected, and are still being collected, during the

pandemic. The types of medications that were looked at are H2 receptors, Statins/anti‐

hyperlipidemic, opioids, antianxiety/antidepressants and OTC pain meds.

13
STATISTICAL METHODS USED

Baseline and follow‐up data from phase 3 of the NIH‐NIDDK Gastroparesis Clinical Research

Consortium Gastroparesis Registry were used in this analysis. Descriptive statistics including

means, standard deviations, frequencies, and percentages were used to describe the

demographic and clinical characteristics of the population. All screening and follow‐up visits

between Jan 2019 and April 2021 were utilized, and dates of visits were categorized into

quartiles; January ‐ March 2019, April ‐ June 2019, July ‐ September 2019, October ‐ December

2019, January ‐ March 2020, April ‐ June 2020, July ‐ September 2020, October ‐ December

2020, and January ‐ March 2021. Medication use, including H2 receptors, anti‐hyperlipidemic,

opiates, and antidepressant/anxiety medication and a diagnosis of depression and anxiety,

were analyzed as binary 0/1 variables, and the HADS (Hospital Anxiety and Depression Scale),

questionnaire, the Gastroparesis Registry 3 Baseline Medical History Form, and the

Gastroparesis Registry 3 Follow‐up Medical History form were analyzed as continuous scores.

Trends in the percentage of medication use over time was examined, both in tabular and

graphical form, and p‐values were determined using GEE logistic and linear regression analysis,

to account for clustering by individual. Also compared were the frequencies of medication use,

diagnoses, and scores pre‐pandemic (ie, before March 15, 2020) and post‐pandemic (on or

after March 15, 2020). SAS v. 9.3 and Stata v. 15 were used for the analysis. P<0.05 was

considered statistically significant.

14
DATA ANAYSIS

Table 1: Baseline Demographics of Study Population (N=300)

Participant Characteristics N(%)

Age at enrollment (years) 45.4 (15.6)

Female Gender 258 (86)
Hispanic 66 (22)
Race
White 264 (89)
Black 27 (9)
Asian 4 (1)
Native Hawaiian 1 (<1)

Table 1 above is a Baseline Demographics of Study Population table. This information was

collected at the beginning of the GpCRC study and was used throughout the analysis. The

average age of the participant was 45 years and a large population of the participants were

white females.

15
The data below in Table 2, Medications and Medical Diagnosis by Quarter, represents

medication use, per quarter (January‐March, April‐June, July‐September, October‐December).

TABLE 2 Medications and Medical Diagnosis by Quarter

2019 2020 2021
Quarter 1 Quarter 2 Quarter 3 Quarter 4 Quarter 1 Quarter 2 Quarter 3 Quarter 4 Quarter 1 p-value
Medications/Diagnosis
Medicatons
H2 Receptors/PPI, N(%) 21 (81) 41 (73) 49 (78) 67 (77) 42 (71) 53 (80) 65 (81) 48 (71) 73 (76) 0.86
Statins/Antihyperlipidemics, N(%) 9 (35) 16 (29) 19 (30) 26 (30) 12 (20) 34 (52) 22 (28) 21 (31) 23 (24) 0.56
Opiates/Pain Medications (prescription), N(% 3 (12) 7 (13) 9 (14) 11 (13) 5 (8) 10 (13) 6 (9) 19 (20) 19 (20) 0.58
Antidepressants/Antianxiety, N(%) 12 (46) 32 (57) 29 (46) 36 (41) 27 (46) 23 (35) 50 (63) 25 (37) 44 (46) 0.54
Pain Medications (over the counter), N(%) 11 (42) 22 (42) 17 (37) 18 (33) 9 (31) 5 (71) 12 (40) 11 (39) 10 (38) 0.97

Diagnosis
Anxiety 8 (31) 16 (29) 12 (19) 26 (30) 13 (22) 12 (18) 21 (26) 18 (26) 20 (21) 0.37
HADS anxiety, mean (SD) 8.3 (4.3) 9.0 (4.6) 8.3 (5.0) 8.7 (4.9) 8.7 (4.9) 8.4 (4.7) 9.3 (4.3) 8.4 (4.9) 8.9 (5.1) 0.63

The Medications and Medical Diagnosis Pre‐COVID and Post‐COVID (current) table (Table 3

below) shows the number and percentage of participants who are taking the specific

medications as well as the number of those who were diagnosed with anxiety and depression

(either by a professional or self‐diagnosis).

TABLE 3 Medications and Medical Diagnosis Pre-COVID and Post-COVID (current)

Pre-COVID Present
p-value
N (%) N (%)

Medications/Diagnosis
Medicatons
H2 Receptors/PPI 217 (75) 244 (77%) 0.58
Statins/Antihyperlipidemics 82 (28%) 102 (32%) 0.26
Opiates/Pain Medications (prescription) 41 (14%) 42 (13%) 0.7
Antidepressants/Antianxiety 136 (47%) 143 (45%) 0.54
Pain Medications (over the counter) 77 (37%) 39 (42%) 0.44

Diagnosis
Anxiety 74 (26%) 73 (23%) 0.41
Depression 80 (28%) 73 (23%) 0.14

16
The following bar charts (Figure 1 and Figure 2) show the increase in medication use by quarter.

90%
Medication Use Over Time
80%
70%
60%
50%
40%
30%
20%
10%
0%
2019‐Q1 2019‐Q2 2019‐Q3 2019‐Q4 2020‐Q1 2020‐Q2 2020‐Q3 2020‐Q4 2021‐Q1
H2 Receptors/PPI Statins/antihyperlipidemics

Figure 2

80%
Medication Use Over Time
70%

60%

50%

40%

30%

20%

10%

0%
2019‐Q1 2019‐Q2 2019‐Q3 2019‐Q4 2020‐Q1 2020‐Q2 2020‐Q3 2020‐Q4 2021‐Q1

Opiates Antiepressants/Antianxiety Pain Medication (OTC)

Figure 3

17
DISCUSSION OF DATA RESULTS

The analysis found that there were no statistically significant changes in any of the medications

that were looked at throughout the pandemic. H2 Receptors/PPI medications showed a

fluctuation in usage but mostly remained in the 75% to 80% usage range. This shows that at

present, the stress of the pandemic does not have that strong of an effect on the participants’

blood pressure or the need to start a H2 receptor or other blood pressure medication regimen.

Although the literature review does confirm that stress and stressful situations can lead to an

increase in blood pressure, the data that was collected did not verify this as there was no

statistically significant relationship (p=0.86). Like H2 receptors and PPI medications, statin

usage both decreased and increased mildly throughout the pandemic. Furthermore, over the

counter pain medication usage also showed no signs of a statistically significant increase. Most

surprisingly, however, was that there was also no statistically significant change in anti‐

depression/antianxiety medications throughout the pandemic.

Although differences in medication usage throughout the pandemic were observed when

looking at the data, none of the changes were statistically significant (Table 2). And even if,

despite the lack of statistical significance, there appeared to be small observed differences in

medication usage, since none of the probability levels were statistically significant, the changes

could be due to chance as opposed to the pandemic. As mentioned in the limitations, the

sample size was smaller than anticipated. Given the potential for chance in the findings, this

warrants additional research if a more robust study design can be implemented. While the

findings of this analysis were null, the pandemic has entered its second year and the continued

18
stress of this unprecedented event and the known associations of stress and medication usage

highlight the need for increased attention to ensure that we do not have a crisis post‐pandemic.

The pandemic is still ongoing and there could still be negative repercussions that remain to be

seen in regards to medication use and increased decline in mental health.

19
CONCLUSION/LIMITATIONS

In this study, the original hypothesis of the COVID‐19 pandemic affecting certain medication

usage did prove to be true. There were changes in medication usage and the increases are

significant enough to definitively state that the COVID‐19 pandemic changed medication usage.

However, given that the sample size is only an N of 300, further investigation into this

important public health question could easily be done at a later date with hopefully a much

larger cohort. Unfortunately, although there have been major improvements and completed

milestones, the pandemic is not over. Meaning that it is not too late to continue with studies

dealing with medication use as we enter the second year of the pandemic. Just because the

changes in medication usage were not significantly seen during the first year, there are sure to

be some changes in usage before the pandemic is over. The pandemic is undoubtedly causing

stress and emotion distress to almost everyone, and as previously stated, stress has both

physical and mental negative effect on a person including elevated blood pressure, higher

cholesterol due to gut issues, depression and anxiety.

The research that was conducted had some limitations that are worth mentioning. There was

no prosepective questionnaire to give to the patients to see if there were any other conditions

that could have been associated with COVID‐19 that they would have otherwise personally

reported. Another limitation was the sample size. Due to COVID‐19 restrictions, our sample

size was not as large as we would have liked. Clinics that saw the patients had restrictions in

place for in‐person visits, and even when the clinics were cleared to once again see patients,

some were fearful and did not want to keep, or make their appointments. Also, based on the

20
first year of pandemic, and now that we are in the second, we could be missing a good portion

of the population by doing this one year in already. Furthermore, this is a cohort of patients

with gastroparesis and may not represent the general U.S. population.

Also, if the forms had listed allergy and asthma medication usage that could have been looked

at to determine whether quarantine affected those with either seasonal or indoor allergies and

asthma. Often combined, allergies and asthma, although are both upper respiratory problems,

are different conditions entirely. When someone has allergies, it is actually their immune

system responding to an allergen in the environment such as dust, mold, pet dander, and

pollen (21). Asthma, is somewhat of an immune system response to allergens as well, but has

additional triggers such as air temperature, strenuous exercises, and strong odors (21). When

an asthma attack occurs, the lungs become inflamed, constricting the muscles around the

airways, resulting in shortness of breath, wheezing, and chest tightness (21).

Looking at allergy and asthma medication usage before and during the pandemic could show

that quarantining may have changed people’s daily exposer to various allergy and asthma

triggers. Perhaps being at home for long periods of time increased exposure to pet dander,

mold and possibly even dust mites?

Additional studies that can be done to further investigate this area would be to look at people

that were negatively associated with the upticks of medication usage. Did they receive one of

the available COVID vaccines? Are they making any additional poor health choices due to

stress?

Further research could include a possible follow‐up with the same patient charts in the next

year to see if medication use increased or normalized. Also, as mentioned previously, a study to

21
determine whether or not allergy medicine increased during the quarantine could lead to the

discovery of new allergens and asthma triggers.

22
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3. WHO (World Health Organization). (2021). WHO coronavirus (COVID‐19) dashboard. Retrieved

April 15, 2021, from https://covid19.who.int/

4. Koh, H. M.; Geller, A. R.; VanderWeele, T. (2021). Deaths from COVID‐19. Jama, 325(2), 133‐134.

5. Children and COVID‐19: State data report (2020). (Joint Data Report, American Academy of

Pediatrics.

6. Crayne, M. (2020). The traumatic impact of job loss and job search in the aftermath of COVID‐

19. American Psychological Association, 12(81), 180.

7. ILO, FAO, IFAD, & WHO. (2020). Impact of COVID‐19 on people's livelihoods, their health and our

food systems (Joint statement WHO (World Health Organization).

8. Wolfson, J., & Leung, C. (2020). Food insecurity during COVID‐19: An acute crisis with long‐term

health implications. American Journal of Public Health, 110(12), 1763.

9. Baumeister, R. F., & Leary, M. R. (1995). The need to belong: Desire for interpersonal

attachments as a fundamental human motivation. Psychological Bulletin, 117(3)

10. Kretchy, I., Asiedu‐Danso, M., & Kretchy, J. (2021). Medication management and adherence

during the COVID‐19 pandemic: Perspectives and experience from low‐and middle‐income

countries. Research in Social and Administrative Pharmacy, 17, 2023‐2026.

23
11. NIDDK (National Institute of Diabetes and Digestive Kidney Diseases. (2018). Histamine type‐2

receptor antagonists (H2 blockers). LiverTox: Clinical and Research Information on Drug‐Induced

Liver Injury

12. Krieger, C. (2018). What makes opioid medications so dangerous? Retrieved April 15, 2021, from

https://www.mayoclinic.org/diseases‐conditions/prescription‐drug‐abuse/expert‐

answers/what‐are‐opioids/faq‐20381270

13. MacGill, M. (2019). How does stress levels affect cholesterol levels? Medical News Today.

14. Assadi, S. N. M. (2017). What are the effects of psychological stress and physical work on blood

lipid profiles? Medicine, 96(18), e6816.

15. Konturek, P., Brzozowski, T., & Konturek, S. (2011). Stress and the gut: Pathophysiology, clinical

consequences, diagnostic approach and treatment options. Journal of Physiology and

Pharmacology, 62(6), 591‐599.

16. Matz, H. M. Stress and the gut. UNC Center for Functional GI and Motility Disorders: UNC School

of Medicine.

17. Maron, D., FAzio, S., & Linton, M. (2000). Current perspectives on statins. Cardiovascular Drugs,

101(2), 207‐213.

18. Ratini, Melinda, DO, MS. (2020). Opioid (narcotic) pain medications. Retrieved April 15, 2021,

from https://www.webmd.com/pain‐management/guide/narcotic‐pain‐medications?page=‐769

19. Williams, J. R. (2020). Exploring stress, cognitive, and affective mechanisms of the relationship

between interpersonal trauma and opioid misuse. Plos One,

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overdose‐deaths‐reached‐new‐heights/

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20allergies.

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https://jhuccs1.us/gpcrc/default.asp

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25
 Appendices

Appendix A: Hospital Anxiety and Depression Scale (HADS)©

Appendix B: Gastroparesis Registry 3 Baseline History Form

(Confidential – not for sharing or citation)

Appendix C: Gastroparesis Registry 3 Follow‐up Medical History Form

(Confidential – not for sharing or citation)

26
 Hospital Anxiety and Depression Scale (HADS)

Tick the box beside the reply that is closest to how you have been feeling in the past week.
Don’t take too long over you replies: your immediate is best.
D A D A
I feel tense or 'wound up': I feel as if I am slowed down:
3 Most of the time 3 Nearly all the time
2 A lot of the time 2 Very often
1 From time to time, occasionally 1 Sometimes
0 Not at all 0 Not at all

I still enjoy the things I used to I get a sort of frightened feeling like
enjoy: 'butterflies' in the stomach:
0 Definitely as much 0 Not at all
1 Not quite so much 1 Occasionally
2 Only a little 2 Quite Often
3 Hardly at all 3 Very Often

I get a sort of frightened feeling as if

something awful is about to I have lost interest in my appearance:
happen:
3 Very definitely and quite badly 3 Definitely
2 Yes, but not too badly 2 I don't take as much care as I should
1 A little, but it doesn't worry me 1 I may not take quite as much care
0 Not at all 0 I take just as much care as ever

I can laugh and see the funny side I feel restless as I have to be on the
of things: move:
0 As much as I always could 3 Very much indeed
1 Not quite so much now 2 Quite a lot
2 Definitely not so much now 1 Not very much
3 Not at all 0 Not at all
Worrying thoughts go through my I look forward with enjoyment to
mind: things:
3 A great deal of the time 0 As much as I ever did
2 A lot of the time 1 Rather less than I used to
1 From time to time, but not too often 2 Definitely less than I used to
0 Only occasionally 3 Hardly at all

I feel cheerful: I get sudden feelings of panic:

3 Not at all 3 Very often indeed
2 Not often 2 Quite often
1 Sometimes 1 Not very often
0 Most of the time 0 Not at all

I can sit at ease and feel relaxed: I can enjoy a good book or radio or TV
program:
0 Definitely 0 Often
1 Usually 1 Sometimes
2 Not Often 2 Not often
3 Not at all 3 Very seldom
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 Keyed: ( )
Gastroparesis Registry 3
17 BH - Baseline Medical HistoryBH121 Dec 18 BH - Baseline Medical History

Purpose: To collect baseline history information about the patient to screen for potential enrollment into the Gas-
troparesis Registry 3.
When: Screening visit s.
Administered by: Clinical Coordinator, reviewed by Study Physician.
Respondent: Patient.
Instructions: Collect information by interview and/or chart review. Enter “ m” if the patient does not know the
answer to a query. If a is checked for any item, further review is necessary by the study physician who will
determine whether the diagnosis or condition in the item renders the patient ineligible for or unlikely to
comply with the requirements of the GpR 3 study. If a or is checked for any item, the patient is ineligi-
ble and cannot enroll in the Gastroparesis Registry 3 unless the item can be resolved within the 112 day screening
window. The BH form cannot be keyed to the data system if there is a or item present. The form
should be retained in a study file for further evaluation as appropriate.

A. Center, visit, and patient identification 10. Which best describes the onset of
gastroparesis or functional dyspepsia
1. Center ID: symptoms (check only one):
Acute start ( 1)
2. Patient ID: (
Insidious or gradual 2)

Other (specify) ( 3)
3. Patient code:

specify
4. Visit date (date this form is initiated):

day mon year

11. Did the patient have an initial infectious
prodrome with resultant chronic
gastroparesis symptoms:
5. Visit code: s Yes No
( 1 ) ( 2 )
6. Form & revision: b h 1 13.

7. Study: GpR 3 7 12. Specify infectious symptoms (check only one):

Upper respiratory flu-like illness
(fever, cough, body aches): ( 1 )
B. Gastroparesis history
Food-poisoning like symptoms
8. Has the patient had symptoms of (nausea, vomiting after eating bad
gastroparesis of at least 12 weeks food): ( 2 )
duration (do not have to be contiguous) Gastroenteritis
with varying degrees of nausea, (nausea, vomiting, diarrhea): ( )
3
vomiting, early satiety, or post-prandial
fullness: Other (specify): ( 4)
Yes No
( 1 ) ( 2 )
specify

These next 6 questions ask about the period in the

past when your gastroparesis symptoms started

9. Date symptoms of gastroparesis or

functional dyspepsia started:

day mon year

Form BH GpR 3
Revision 1 ()HE 1) BH - Baseline Medical History 1 of 17
 Patient ID:

13. What prompted the evaluation for 16. Which best describes the current
gastroparesis (check all that apply) gastroparesis severity (check only one):
a. Nausea: ( 1) (Grade 1) Mild gastroparesis:
( Symptoms mild to moderate and
b. Vomiting: 1)
relatively controlled. Able to maintain
c. Bloating: ( 1) weight and nutrition on a regular diet. ( )
1
d. Early satiety (a sense that your stomach (Grade 2) Compensated gastroparesis:
is full after eating only a small amount
of food): ( ) Moderate symptoms with only partial
1
control with use of daily medications.
e. Postprandial fullness (a sense of Able to maintain nutrition with dietary
fullness after the meal): ( )
1
adjustments. ( 2 )
f. Abdominal pain: ( 1)
(Grade 3) Gastroparesis with gastric
g. Diarrhea: ( 1) failure: Refractory symptoms that are
h. Constipation: ( 1)
not controlled, ER visits, frequent
( doctor visits or hospitalizations and/or
i. Anorexia (loss of appetite): 1)
inability to maintain nutrition via oral
j. Weight loss: ( 1) route. ( )
3
k. Weight gain: ( 1) (
Other (specify): 4)
l. Gastroesophageal reflux symptoms
such as heartburn: ( 1 )
specify
m. Problems with the management of
diabetes or glycemic control: ( 1)
17. What is the investigator’s assessment of
n. Other (specify): ( 1) the patient’s current symptoms of
gastroparesis:
specify None ( 0)
Very mild ( 1)
14. Select the one predominant symptom (
listed in item 13 (a through n) that
Mild 2)

prompted the evaluation for gastroparesis: Moderate ( 3)

These next 3 questions ask about your a-n
current symptoms of gastroparesis. Severe ( 4)

Very severe ( 5)
15. Which best describes the patient’s current
nature of gastroparesis symptoms 18. What is the present understanding of the
(check only one): primary etiology of the patient’s
Chronic symptoms, but stable severity gastroparesis
of symptoms ( 1 ) a. Diabetes: ( )
1
Chronic symptoms, but progressive
.
worsening of symptoms ( 2 ) b. Post fundoplication: ( )
1
Chronic symptoms, but with some
.
improvement over time ( 3 ) c. Idiopathic: ( )
1
Chronic symptoms with periodic
.
exacerbations with worsening of
symptoms ( ) d. Other (specify): ( 1 )
4

Cyclic pattern of exacerbations with

periods of feeling well in between ( 5)
Asymptomatic ( 6)

Other (specify): ( 7)
specify

specify

Form BH GpR 3
Revision 1 ()HE) BH - Baseline Medical History 2 of 17
 Patient ID:

19. Which form of fundoplication was used (check all 24. What was the patient’s approximate
that apply) weight when diagnosed with
a. Nissen: ( 1) gastroparesis or functional dyspepsia
(date in item 9):
b. Dor: ( 1)
c. Toupet: ( 1)
lbs

d. Other (specify) ( 1)
25. How does the patient’s current weight
compare to prior to the start of his/her
gastroparesis or functional dyspepsia
symptoms:
specify Increased ( 1 )
26a.
C. Family history Decreased ( 2 )
20. Have members of the patient’s family 26b.
been diagnosed with gastroparesis: Same ( 3 )
Yes No 27.
( 1 ) ( 2 )
23. 26. Weight compared to start of gastroparesis

21. Which family members (check all that apply) a. How much more does the patient
weigh now compared to the start of
a. Brother: ( 1) his/her gastroparesis:
b. Sister: ( 1)

c. Mother: ( 1)
lbs
d. Father: ( 1) 27.
( b. How much less does the patient weigh
e. Son: 1)
now compared to the start of his/her
f. Daughter: ( 1) gastroparesis:
g. Spouse/partner: ( 1)

h. Other (specify) ( 1)
lbs

27. Weight prior to gastroparesis

specify
a. What is the most the participant has
ever weighed prior to the gastroparesis
22. Which family members with diagnosis:
gastroparesis also have diabetes (check all that
apply)
a. Brother: ( 1) lbs
b. Sister: ( 1) b. At what age did the patient weigh
( the most:
c. Mother: 1) age in years
d. Father: ( 1)

e. Son: ( 1)
28. What is the least the patient has ever
weighed since age 18, but prior to the
f. Daughter: ( 1) start of gastroparesis or functional
g. Spouse/partner: ( 1)
dyspepsia symptoms:
h. Other (specify) ( 1)
lbs
specify
29. At what age did the patient weigh the
least since age 18, but prior to the
D. Weight history gastroparesis symptoms:
23. What is the patient’s current weight
(patient’s report): age in years

lbs
Form BH GpR 3
Revision 1 ()HE) BH - Baseline Medical History 3 of 17
 Patient ID:

30. Over the last six months, has the patient 37. On the average of the entire time that you
gained weight, lost weight, or stayed the smoked cigarettes, how many cigarettes
same: did you smoke per day:
Gained weight ( 1) cigarettes/day
Lost weight ( 2)

Stayed the same ( 3)

F. Alcohol consumption (AUDIT-C) history
(interview with patient; not from chart review)
31. What was the patient’s approximate 38. How often have you had a drink
weight six months ago: containing alcohol in the past year
(including beer and wine)
(check only one):
lbs
Never ( 0 )
32. Review flashcard #7 Which (picture) 41.
best describes your weight pattern over Monthly or less ( 1)
the past 5 years (check only one):
Two to four times a month ( 2)
Up and down, up and down ( ) (
Two to three times a week 3)
1

Up gradually ( 2) (
Four or more times a week 4)
Up sharply (gained a lot in a brief
interval) ( 3) 39. How many drinks containing alcohol do
( you have on a typical day when you are
Down gradually 4)
drinking (check only one):
Down sharply (lost a lot in a brief
interval) ( ) 1 or 2 ( 0)
5

( 3 or 4 ( 1)
No or minimal change 6)
5 or 6 ( 2)
E. Tobacco cigarette smoking history (interview with (
7 to 9 3)
patient; not by chart review)
10 or more ( 4)
33. Have you ever smoked tobacco cigarettes:
40. How often have you had six or more
No, never ( 1 ) alcoholic drinks on one occasion in the
38. past year (including beer and wine) ( ch ec k o nly
Yes, in the past but not anymore ( ) one):
2

( Never ( 0)
Yes, currently smoke cigarettes 3)
Less than monthly ( 1)
34. Did you smoke cigarettes regularly (“No” means Monthly ( 2)
less than 20 packs of cigarettes in a lifetime or less
than 1 cigarette a day for one year): Weekly ( 3)

Yes No Daily or almost daily ( 4)

( 1 ) ( 2 )
38. G. Menstrual history

35. How old were you when you first started 41. Is the patient female: Yes No
regular cigarette smoking:
( 1 ) ( 2 )
46.
years
42. Characterize the menstrual history in the
36. How old were you when you (last) past year (check only one):
stopped smoking cigarettes (code as “n” if the
patient did not stop smoking): Regular periods ( 1)
Irregular periods ( 2)
years
Rare periods ( 3)

No periods ( 4)

4.

Form BH GpR 3
Revision 1 ()HE) BH - Baseline Medical History 4 of 17
 Patient ID:

43. Are gastroparesis symptoms worse 49. Weight when diagnosed with
around the time of menstruation: diabetes:
Yes No lbs
( 1 ) ( 2 )
46. 50. Has the patient been diagnosed with any
complications of diabetes:
If yes, check all symptoms that are worse around Yes No
the time of menstruation (menstrual periods): ( 1 ) ( 2 )
a. Nausea: ( 1) 54.
b. Vomiting: ( 1)
If yes, check all that apply:
c. Bloating: ( 1)
a. Retinopathy (eye changes from
d. Early satiety: ( 1) diabetes): ( 1 )
e. Postprandial fullness: ( 1) b. Nephropathy (kidney disease from
( diabetes): ( )
f. Abdominal pain: 1)
1

( c. Peripheral neuropathy (numbness

g. Diarrhea: 1)
and/or tingling in distal legs and feet
h. Constipation: ( 1) from diabetes): ( 1 )
i. Anorexia: ( 1)

( 51. Has the patient had laser treatment for

j. Weight loss: 1) diabetic retinopathy:
k. Weight gain: ( 1) Yes No
( ( ) ( )
l. Gastroesophageal reflux symptoms: 1)
1 2

m. Problems with management of 52. Has the patient had prior episodes of
diabetes or glycemic control: ( 1) diabetic ketoacidosis (ketones present in
n. Other (specify): ( 1)
the blood requiring hospitalization):
Yes No
( 1 ) ( 2 )
specify
53. Describe the patient’s glucose control in
44. Is patient postmenopausal (natural or surgical): the past 6 months (interview with patient)
Yes No (check all that apply)
( 1 ) ( 2 ) a. Well controlled: ( )
1
46. b. Hypoglycemic events (symptomatic
and/or requiring intervention): ( 1)
45. What was the patient’s age at menopause: (
c. Glucose levels above 300 mg/dL: 1)

age in years d. Postprandial high glucose levels: ( 1)

e. Postprandial low glucose levels: ( 1)

H. Medical history
( means CAUTION; Flags conditions
that are exclusionary; verify with Study Physician)

46. Has the patient ever been diagnosed with

diabetes (NOT including gestational diabetes):
Yes No
( 1 ) ( 2 )
54.

47. Diabetes type:

Type 1: ( 1)
Type 2: ( 2)

Unknown: ( 3)

Other: ( 4)

48. Age when diagnosed with diabetes:

age in years
Form BH GpR 3
Revision 1 ()HE) BH - Baseline Medical History 5 of 17
 Patient ID:

54. Has the patient ever been diagnosed with s. Diverticulosis: ( 1)

or treated for any of the following (check all that (
apply; source of information can be interview
t. Endometriosis: 1)

and/or chart review): u. Blood clots: ( 1)

a. Gestational diabetes v. Hemophilia (bleeding disorder): ( 1)
(diabetes of pregnancy): ( 1)
w. Rheumatoid arthritis: ( 1)
b. Pyloric obstruction: ( )
1
x. Scleroderma: ( 1)

y. Systemic lupus erythematosus (lupus

c. Intestinal obstruction: ( 1 ) or SLE): ( 1)
z. Collagen vascular disease: ( 1)

aa. Raynaud’s phenomenon: ( 1)

d. Inflammatory bowel disease (IBD): ( 1 )
ab. Other unidentified systemic
autoimmune disorder: ( 1 )
e. Irritable bowel syndrome (IBS): ( ) ac. Thyroid disease
1
(hormonal abnormality): ( 1)
f. Eosinophilic gastroenteritis: ( 1)
ad. Malignancy (cancer): ( 1)

ae. Peripheral neuropathy (non-diabetic

( numbness or tingling in hands or legs)
g. Acute renal failure: 1)
(see 50c for diabetic neuropathy): ( 1)
af. Migraine headaches: ( 1)
h. Acute liver failure: ( 1 ) ag. Chronic headaches ≥ 15 per month
(other than migraines): ( 1)
ah. Seizure disorder or epilepsy: ( 1)
i. Advanced liver disease
(Child’s B or C; a CPT score of ai. Chronic fatigue syndrome: ( 1)
7 or greater): ( 1) aj. Postural orthostatic tachycardia
syndrome (POTS): ( 1)
ak. Hypertension: ( 1)
j. Hepatitis B: ( )
1
al. Heart attack, myocardial infarction: ( 1)
k. Hepatitis C: ( 1)
am. Coronary artery disease: ( 1)
l. Peptic ulcer disease: ( 1)
an. Cerebrovascular disease: ( 1)
m. GERD: Gastroesophageal reflux
disease: ( ) ao. Stroke, cerebrovascular accident
1
(CVA): ( 1 )
n. Celiac disease: ( 1)
ap. Hyperlipidemia
o. Small intestinal bacterial overgrowth (high cholesterol, high triglycerides): ( )
(SIBO): ( 1) 1

aq. Chronic pancreatitis: ( 1)

p. Colonic inertia: ( 1)
ar. Episode(s) of acute pancreatitis: ( 1)
q. Interstitial cystitis: ( 1)
as. How many episodes of acute
r. Bladder dysfunction: ( 1) pancreatitis has the patient ever had:
1-9
at. Cholelithiasis (gallstones): ( 1 )
au. Gallbladder disease without
gallstones including chronic
cholecystitis, gallbladder dyskinesia: ( 1)
av. Gout: ( 1)

aw. Polycystic ovary syndrome (PCOS): ( 1)

Form BH GpR 3
Revision 1 ()HE) BH - Baseline Medical History 6 of 17
 Patient ID:

ax. Dermatologic disorders: ( 1) 57. Has the patient ever had a

( gastroduodenostomy, gastrojejunostomy,
ay. Myopathy: 1) esophagogastrostomy or gastric bypass:
az. Autonomic nervous system Yes No
dysfunction: ( 1)
( 1 ) ( 2 )
ba. Fibromyalgia: ( 1)

bb. Multiple sclerosis: ( 1)

( 58. Has the patient ever had a subtotal gastric

bc. Parkinson’s disease: 1)
resection (vagotomy, pyloroplasty,
bd. ALS: Amyotrophic lateral sclerosis: ( 1) antrectomy):
be. Anorexia: ( 1)
Yes No
( 1 ) ( 2 )
bf. Bulemia: ( 1)

bg. Binge eating: ( 1)

bh. Avoidant/ Restrictive eating disorder

(ARFID): ( ) 59. Has the patient ever had surgical or
1 endoscopic pyloroplasty or
bi. Non-specific eating disorders: ( 1) pyloromyotomy (G-POEM or POP):
Yes No
bj. Posttraumatic Stress Disorder ( ) ( )
(PTSD): ( 1 ) 1 2

bk. Major (clinical) depression requiring

treatment: ( 1)
bl. Schizophrenia: ( 1)
60. Has the patient ever had a
esophagectomy:
bm. Bipolar disorder: ( 1) Yes No
( ( ) ( )
bn. Obsessive compulsive disorder: 1)
1 2

bo. Severe anxiety disorder requiring

treatment: ( 1 )
bp. Personality disorder requiring 61. Has the patient ever had stapling or
treatment: ( 1 ) banding of the stomach:
Yes No
bq. Dyslexia or learning problems ( ) ( )
including ADHD (attention deficit 1 2

hyperactivity disorder): ( 1 )
br. Primary neurologic conditions that
could cause nausea and/or vomiting 62. Has the patient ever had a Nissen, Dor, or
such as increased intracranial Toupe fundoplication for GERD:
pressure, space occupying or Yes No
inflammatory/infectious lesions: ( 1 ) ( 1 ) ( 2 )
6.
a. Date:
bs. Chronic renal failure and/or
hemodialysis or peritoneal dialysis: ( 1 )
day mon year
b. Did current gastroparesis symptoms
start before or after fundoplication for
bt. None of the above: ( 1) GERD:
Before ( 1)
55. Has the patient ever had any abdominal
and/or pelvic surgical procedures: After ( 2)
Yes No
( 1 ) ( 2 ) 63. Has the patient ever had any other
fundoplication (not Nissen, Dor or
68. Toupe):
Yes No
56. Has the patient ever had a total gastric ( 1 ) ( 2 )
resection:
Yes No
( 1 ) ( 2 )

Form BH GpR 3
Revision 1 ()HE) BH - Baseline Medical History 7 of 17
 Patient ID:

64. Has the patient ever had a 68. Has the patient visited the Emergency
cholecystectomy (gallbladder removal): Department for gastroparesis in the past
Yes No year:
( 1 ) ( 2 ) Yes No
( ) ( )
65. 1 2

a. Date: 7.

day mon year 69. How many times did the patient visit the
b. Were there gallstones in the Emergency Department for gastroparesis
gallbladder: in the past year:
Yes No
( 1 ) ( 2 )
c. Did the patient’s symptoms that led to 70. Has the patient been hospitalized for
the gallbladder removal improve after gastroparesis symptoms in the past year:
removal of the gallbladder: Yes No
Yes No ( ) ( )
( 1 ) ( 2 ) 1 2

73.
d. Did current gastroparesis symptoms
start before or after the removal of the
gallbladder: 71. How many times was the patient
hospitalized for gastroparesis in the
Before ( 1) past year:
After ( 2)

65. Has the patient had an appendectomy: 72. Reason(s) for hospitalization
Yes No
( (check all that apply):
1) ( 2)
a. Nausea: ( 1)
66.
a. Date: b. Vomiting: ( 1)

c. Abdominal pain: ( 1)
day mon year
d. Dehydration: ( 1)
b. Did current gastroparesis symptoms
start before or after the appendectomy: e. Hyperglycemia: ( 1)

Before ( 1) f. Hypoglycemia: ( 1)
After ( 2) g. GI bleed: ( 1)

h. Other (specify): ( 1)
66. Has the patient had a hysterectomy:
Yes No
( 1 ) ( 2 ) specify
67.
a. Date: I. Nutrition and Gastric Electrical Stimulator
(GES) use
day mon year
b. Did current gastroparesis symptoms 73. Has the patient ever had a formal
start before or after the hysterectomy: nutrition consult at any time after the
onset of gastroparesis:
Before ( 1)
Yes No
After ( 2) ( 1 ) ( 2 )
67. Has the patient had a Caesarean section: 74. On most days during the last 6 months,
Yes No did the patient follow a gastroparesis
( 1 ) ( 2 ) diet: small, more frequent meals, low fat,
68. low fiber meals:
a. Date: Yes No
( 1 ) ( 2 )
day mon year
b. Did current gastroparesis symptoms 75. Has the patient received total parenteral
start before or after the C-section: nutrition (TPN) in the past year:
Yes No
Before ( 1) ( ) ( )
1 2
After ( 2)

Form BH GpR 3
Revision 1 ()HE) BH - Baseline Medical History 8 of 17
 Patient ID:

76. What is the patient’s current source of 81. Does the patient have a central line/PICC:
nutrition (check all that apply): Yes No
( ( ) ( )
a. Oral feeding: 1)
1 2

( 83.
b. Enteral feeding: 1)
a. Central line/PICC has been in place
c. Parenteral feeding: ( 1) since:

77. Does the patient have a G tube: month year

Yes No
( 1 ) ( 2 ) 82. What does the patient use this central
79. line/PICC for (check all that apply):
a. G tube has been in place since: a. Nutrition: ( )
1

b. Hydration: ( 1)
month year
c. Medication: ( 1)
78. What does the patient use this G tube for ( c h e c k d. Other (specify): ( 1)
all that apply):
a. Nutrition: ( 1)
specify
b. Hydration: ( 1)
c. Medication: ( 1) 83. Does the patient have a gastric electrical
d. Decompression: ( 1)
stimulator (GES):
Yes No
e. Other (specify): ( 1) ( ) ( )
1 2

84.
specify a. Gastric electrical stimulator (GES) has
been in place since:
79. Does the patient have a J tube:
Yes No month year
( 1 ) ( 2 ) b. In the patient’s opinion, has the gastric
81. electrical stimulator (GES) improved
a. J tube has been in place since: his/her gastroparesis symptoms:
Yes No
( 1 ) ( 2 )
month year
c. Is the gastric electrical stimulator
80. What does the patient use this J tube for (check all (GES) currently turned on:
that apply): Yes No
a. Nutrition: ( 1) ( 1 ) ( 2 )
b. Hydration: ( ) 84.
1
d. Specify reason why it is turned off:
c. Medication: ( 1)

d. Decompression: ( 1) specify
e. Other (specify): ( 1)

specify

Form BH GpR 3
Revision 1 ()HE) BH - Baseline Medical History 9 of 17
 Patient ID:

J. Medication use 86. Has the patient used any other

antidiabetic medications in the past
84. Has the patient used insulin for diabetes 6 months:
in the past 6 months: Yes No
Yes No ( 1 ) ( 2 )
( 1) ( 2) 87.
86. (If yes, check all that apply):
(If yes, check all that apply): a. Biguanide: Metformin (Glucophage) ( )
1
a. Insulin glulisine (Apidra): ( 1) b. Thiazolidinediones: Pioglitazone
b. Insulin lispro (Humalog): ( 1)
(Actos), Rosiglitazone (Avandia) ( 1 )
c. Insulin aspart (Novolog): ( 1)
c. Sulfonylureas (first gen):
Chlorpropamide
d. Insulin glargine (Lantus): ( 1) (Diabinese),Tolazamide (Tolinase),
e. Insulin detemir (Levemir): ( 1) Tolbutamide (Orinase) ( 1 )
f. Insulin isophane (Humulin N, Novolin d. Sulfonylureas (second gen): Glyburide
N): ( 1 ) (Micronase, DiaBeta, Glynase),
Glimepiride (Amaryl):, Glipizide
85. Has the patient used an insulin pump in (Glucotrol) ( 1 )
the past 6 months: e. Meglitinides: Repaglinide (Prandin),
Yes No nateglinide (Starlix) ( 1 )
( ) ( )
1 2
f. Alpha-glucosidase inhibitors: miglitol
86. (Glycet), acarbose (Precose) ( 1 )
g. Injectable GLP analogs and agonists:
a. Is the patient currently using an Exenatide (Byetta, Bydureon),
insulin pump: Liraglutide (Victoza), Lixisenatide
Yes No (Lyxumia), Semaglutide (Ozempic) ( 1 )
( 1 ) ( 2 )
h. Dipeptidyl peptidase-4 (DPP-4)
inhibitors: Alogliptin (Nesina),
Sitagliptin (Januvia), Saxagliptin
(Onglyza), linagliptin (Tradjenta) ( 1 )
i. SGLT-2 inhibitors: Canagliflozin
(Invokana), Empagliflozin (Jardiance),
Dapagliflozin (Farxiga) ( 1 )
j. Rosiglitazone Maleate/Glimepiride
(Avandaryl) ( 1)
k. Pramlintide (Symlin) ( 1)

l. Other (specify): ( 1)

specify

Form BH GpR 3
Revision 1 ()HE) BH - Baseline Medical History 10 of 17
 Patient ID:

87. Has the patient taken any 89. Has the patient taken any systemic
anti-hyperlipidemic medications in the corticosteroids in the past 6 months:
past 6 months: Yes No
Yes No ( 1 ) ( 2 )
( ) ( )
1 2
90.
88. (If yes or unsure, check all that apply):
(If yes or unsure, check all that apply): a. Betamethasone sodium (Celestone): ( )
1
a. HMG-COA reductase inhibitors (
(Atorvastatin [Lipitor], Simvastatin
b. Cortisol: 1)

[Zocor], Rosuvastatin [Crestor], c. Cortisone: ( 1)

Fluvastatin sodium [Lescol], (
Lovastatin [Mevacor], Pravastatin
d. Dexamethasone (Decadron): 1)

sodium [Pravachol]):, ( 1 ) e. Hydrocortisone (Hydrocortone): ( 1)

b. Bile acid sequestrant (Colestipol f. Methylprednisolone (Solu-Medrol): ( 1)

hydrochloride [Colestid]: ( 1) (
g. Prednisolone (Prelone): 1)
c. Fibric acid (Gemfibrozil [Lopid], (
h. Prednisone: 1)
Fenofibrate [Tricor]): ( 1)
i. Triamcinolone (Acetocot, Amcort,
d. Nicotinic acid (Niaspan): ( 1) Aristocort, Kenacort): ( )
1
e. Other (specify): ( 1) (
j. Other (specify): 1)

specify specify

88. Has the patient taken any k. Other (specify): ( 1 )

anticoagulant/antiplatelet medications in
the past 6 months: specify
Yes No
( 1 ) ( 2 )
89.
(If yes or unsure, check all that apply):
a. Apixaban (Eliquis): ( 1)
b. Clopidogrel (Plavix): ( 1)

c. Dabigatran (Pradaxa): ( 1)

d. Dipyridamole (Persantine, Aggrenox): ( 1)

e. Enoxaparin (Lovenox): ( 1)

f. Heparin: ( 1)

g. Rivaroxaban (Xarelto): ( 1)

h. Ticlopide (Ticlid): ( 1)

i. Warfarin (Coumadin): ( 1)

j. Other (specify): ( 1)

specify

k. Other (specify): ( 1 )

specify

Form BH GpR 3
Revision 1 ()HE) BH - Baseline Medical History 11 of 17
 Patient ID:

90. Has the patient taken any 91. Has the patient taken any estrogen,
cardiovascular/antihypertensive progestin, hormone replacement therapy,
medications in the past 6 months: or selective estrogen receptor modulators
Yes No in the past 6 months:
( ) ( ) Yes No
1 2
( 1 ) ( 2 )
91.
(If yes or unsure, check all that apply): 92.
(If yes or unsure, check all that apply):
a. Class III antiarrhythmic agent
(Amiodarone [Pacerone]): ( ) a. Conjugated estrogen
1
(Premarin/Prempro): ( 1 )
b. Dihydropyridine calcium channel
blocker (Amlodipine besylate b. Diethylstilbestrol and
[Norvasc], Felodipine [Plendil], methyltestosterone (Tylosterone): ( 1)
Nifedipine [Adalat, Procardia]): ( 1) c. Esterified estrogen (Estratab, Menest): ( 1)
c. Beta1-adrenergic blocker (Atenolol (
d. Estradiol (Estrace): 1)
[Tenormin], Metoprolol [Lopressor]: ( )
1
e. Ethinyl estradiol (Estinyl): ( 1)
d. Non-selective beta blocker (Carvedilol
[Coreg], Propranolol [Inderal], f. Androgens (Fluoxymesterone
( [Android-F, Halotestin],
Timolol maleate [Blocadren]): 1)
Methyltestosterone [Android],
e. Angiotensin-converting-enzyme Nandrolone [Deca-Durabolin, Hybolin
inhibitors (Benazepril [Lotensin], Decanoate, Kabolin]): ( )
1
Captopril [Capoten], Enalapril
[Vasotec], Lisinopril [Prinivil, Zestril], g. Progestins (Norethindrone [Micronor],
Ramipril [Altace], Quinapril Progesterone [Prometrium],
[Accupril]): ( ) Norgestrel [Ovrette], Levonorgestrel
1
[Norplant], Medroxyprogesterone
f. Alpha-2 adrenergic agonist (Clonidine [Cycrin, Provera], Megestrol
[Catapres]): ( 1) [Megace]): ( 1 )
g. Digoxin (Lanoxin): ( 1) h. Combination oral contraceptives
( (Alesse, Demulen, Desogen,
h. Diltiazem (Cardizem): 1)
Estrostep, Genora, Intercon, Levlen,
i. Alpha-1 adrenergic blocker Levlite, Levora, Loestrin, Lo-Ovral,
(Doxazosin [Cardura], Terazosin Necon, Nelova, Nordette, Norethin,
[Hytrin]): ( 1) Norinyl, Ortho Cyclen, Ortho-Novum,
j. Furosemide (Lasix): ( 1)
Ortho Tri-Cyclen, Ovral, Tri-Levlen,
Triphasil, Trivora, Zovia): ( 1 )
k. Hydrochlorothiazide (Esidrix,
HydroDIURIL): ( 1 ) i. Synthetic anabolic steroids
(Oxandrolone [Oxandrin],
l. Hydrochlorothiazide + triamterene Oxymetholone [Anadrol]): ( )
(Dyazide): ( 1 ) 1

j. Selective estrogen receptor modulator

m. Angiotensin II receptor antagonist (Raloxifene [Evista], Tamoxifen
(Losartan potassium [Cozaar], [Nolvadex]): ( )
1
Valsartan [Diovan], Candesartan
[Atacand]): ( 1 ) k. Other (specify): ( 1)

n. Losartan potassium with

hydrochlorothiazide (Hyzaar): ( 1) specify
o. Verapamil (Calan): ( 1) l. Other (specify): ( )
1
p. Other (specify): ( 1)

specify
specify

q. Other (specify): ( 1 )

specify

Form BH GpR 3
Revision 1 ()HE) BH - Baseline Medical History 12 of 17
 Patient ID:

K. Medication use for gastroparesis symptoms 93. Is the patient currently taking any
For items 92-93: Have the patient use flashcard #8 prokinetic medications :
to indicate the duration of use and perceived bene- Yes No
fit for gastroparesis symptoms for each medication ( 1 ) ( 2 )
he/she uses/used
94.
92. Is the patient currently taking any proton
pump inhibitors, histamine H2 receptor (If yes, answer all that apply using flashcard #8):
antagonists or other similar medications: Duration Benefit
Yes No (1-5) (0-5)
( 1 ) ( 2 ) a. Azithromycin (Zithromax):
93. b. Bethanechol (Duvoid,
Urecholine):
(If yes, answer all that apply using flashcard #8): c. Clarithromycin (Biaxin):
Duration Benefit d. Domperidone (Motilium):
(1-5) (0-5)
a. Esomeprazole (Nexium): e. Erythromycin:

b. Omeprazole (Prilosec, f. Metoclopramide (Reglan):

Zegerid): g. Prucalopride (Resolor)
c. Lansoprazole (Prevacid): (see also 97l):

d. Pantoprazole (Protonix): h. Tegaserod (Zelnorm):

e. Rabeprazole (Aciphex): i. Cisapride (Propulcid):

f. Dexlansoprazole (Dexilant): j. Other (specify):

g. Ranitidine (Zantac):
specify
h. Famotidine (Pepcid):
i. Nizatidine (Axid): k. Other (specify):
j. Cimetidine (Tagamet):
specify
k. Antacids, (specify):

94. Has the patient ever had Botox injected

specify into pylorus for his/her gastroparesis
l. Other (specify): symptoms:
Yes No
( 1 ) ( 2 )
specify
96.
m. Other (specify):
a. Perceived benefit:
specify 0-5

95. Has the patient had botulinum toxin

(Botox) injected into pylorus for his/her
gastroparesis symptoms in the last 3
months:
Yes No
( 1 ) ( 2 )
96.

a. Perceived benefit:
0-5

Form BH GpR 3
Revision 1 ()HE) BH - Baseline Medical History 13 of 17
 Patient ID:

96. Is the patient currently using any of the Duration Benefit

following medications: (1-5) (0-5)
Yes No o. Benzodiazepines (Lorazepam
( 1 ) ( 2 ) [Ativan], Alprazolam [Xanax],
97. Diazepam [Valium], Oxazepam
(If yes, answer all that apply using flashcard #8): [Serax], Clonazepam [Klon-
opin], Temazepam [Restoril,
Duration Benefit Temaz], Flurazepam):
(1-5) (0-5)
a. Prochlorperazine p. Meprobamate (Equanil,
(Compazine): Meprospan):
b. Promethazine (Pentazine, q. Quetiapine fumarate
Phenergan): (Seroquel):
c. Trimethobenzamide r. Dicyclomine (Bentyl):
(Benzacot, Stemetic, Tigan): s. Olanzapine (Zyprexa):
d. Meclizine (Antivert): t. Tetrahydrocannabinol
e. Serotonin (5-HT3) antagonists (Syndros):
(Ondansetron [Zofran], Trop- u. Other (specify):
isetron [Navoban], Granis-
etron [Kytril, Sancuso Patch],
Palonosetron [Aloxi], specify
Dolasetron [Anzemet]):
v. Other (specify):
f. Neurokinin-1 receptor
antagonists (Aprepitant
[Emend]): specify
g. Tricyclic antidepressants
(Amitriptyline [Elavil], 97. Is the patient currently using any of the
Desipramine [Norpramin], following medications for constipation:
Nortriptyline [Aventyl, Yes No
Pamelor]): ( 1) ( 2 )
h. Dronabinol (Marinol): 98.
i. Tetracylcic antidepressants (If yes, answer all that apply using flashcard #8):
(Mirtazapine [Remeron]): Benefit
(0-5)
j. Bupropion (Wellbutrin):
a. Bisacodyl (Dulcolax):
k. Selective Serotonin Reuptake
Inhibitors (SSRI)[Citalopram b. Colchicine (Colcrys):
(Celexa), Escitalopram c. Docusate sodium (Colace):
(Lexapro), Fluoxetine
(Prozac), Paroxetine (Paxil), d. Fiber supplements:
Sertraline (Zoloft)]: e. Lactulose:
l. Venlafaxine (Effexor): f. Linaclotide (Linzess):
m. Anxiolytic (Buspirone g. Lubiprostone (Amitiza):
[BuSpar]):
h. Methylnaltrexone (Relistor):
n. Chlordiazepoxide (Librax):
i. Misoprostol (Cytotec):
j. Plecanatide (Trulance):
k. Polyethylene glycol
(Miralax):
l. Prucalopride (Resolor):
m. Naloxegol (Movantik):
n. Senna (Senokot):
o. Magnesium oxide:
p. Other (specify):

specify

Form BH GpR 3
Revision 1 ()HE) BH - Baseline Medical History 14 of 17
 Patient ID:

98. Is the patient currently taking any pain 99. Is the patient currently taking any
relieving, analgesics, non-steroidal narcotic pain medications:
anti-inflammatory, or aspirin containing Yes No
medications (non-narcotic) either regular ( 1 ) ( 2 )
usage or as needed basis (prn):
101.
Yes No
( (If yes, answer all that apply using flashcard #8):
1) ( 2)
Duration Benefit
99. (1-5) (0-5)
(If yes, answer all that apply using flashcard #8):
a. Acetaminophen (30 mg)/
Benefit codeine phosphate
(0-5) (Tylenol #3):
a. Acetaminophen (Tylenol):
b. Acetaminophen (60 mg)/
b. Aspirin - 325 mg: codeine phosphate
c. Celecoxib (Celebrex): (Tylenol #4):

d. Ibuprofen (Advil, Motrin): c. Acetaminophen/hydrocodone

bitartrate (Lortab, Norco,
e. Indomethacin (Indocin): Vicodin):
f. Naproxen (Aleve, Naprosyn): d. Acetaminophen/oxycodone
g. Ketorolac (Toradol): hydrochloride (Percocet,
Tylox):
h. Other (specify):
e. Aspirin/oxycodone hydro-
chloride (Percodan):
specify f. Butalbital/acetaminophen/
caffeine (Esgic - Plus):
i. Other (specify):
g. Fentanyl transdermal (Dura-
gesic patch):
specify
h. Fentanyl oral (Fentora,
j. Other (specify): Actiq):
i. Hydromorphone hydro-
chloride (Dilaudid):
specify
j. Oxycodone hydrochloride
(OxyContin):
k. Methadone hydrochloride:
l. Morphine sulfate:
m. Pentazocine (Talacen):
n. Tapentadol (Nucynta):
o. Tramadol
hydrochloride/acetaminophen
(Ultram, Ultracet):
p. Other (specify):

specify

Form BH GpR 3
Revision 1 ()HE) BH - Baseline Medical History 15 of 17
 Patient ID:

100. Is the patient taking the narcotic pain L. Alternative therapies for gastroparesis
medication for (check all that apply) symptoms
For items 102-103: Have the patient use flashcard
a. Pain related to his/her gastroparesis #8 to indicate the duration of use and perceived
symptoms, including abdominal pain: ( 1) benefit for each alternative therapy they have used
b. Headache pain: ( 1)
for gastroparesis symptoms.
c. Leg pain: ( 1) 102. Has the patient ever used alternative
d. Back pain: ( 1) medicine or complementary medicine
( products or procedures for treatment of
e. Other pain (specify): 1)
his/her symptoms related to gastroparesis
(e.g., bloating, nausea, vomiting,
specify abdominal pain):
Yes No
( 1 ) ( 2 )
101. Has the patient taken any of the
following neuropathic pain medications 103.
in the past 6 months:
Yes No Duration Benefit
( 1) ( 2)
(1-5) (0-5)

102. a. Probiotics:
(If yes, answer all that apply using flashcard #8):
Duration Benefit specify
(1-5) (0-5)
a. Duloxetine (Cymbalta):
specify
b. Gabapentin (Neurontin):
c. Pregabalin (Lyrica): b. Herbal supplements:
d. Divalproex sodium
(Depakote): specify
e. Topiramate (Topamax):
f. Other (specify): specify

specify specify

c. Acupuncture:
d. Acupressure bands/bracelets
(ie, Relief band):
e. Reflexology:
f. Hypnotherapy:
g. Therapeutic Massage:
h. Ginger:
i. Iberogast:
j. Other (specify):

specify

Form BH GpR 3
Revision 1 ()HE) BH - Baseline Medical History 16 of 17
 Patient ID:

103. Does the patient use a cannabis product M. Administrative information

such as marijuana, THC
(tetrahydrocannabinol), CBD 106. Study Physician PIN:
(cannabidiol):
Yes No
( ) ( ) 107. Study Physician signature:
1 2

106.

(If yes, use flashcard #8 to answer 108. Clinical Coordinator PIN:

items 103 a and b):
a. Duration of use (1-5):
109. Clinical Coordinator signature:

b. Perceived benefit (0-5):

c. How often do you use these cannabis
products:
Rarely (less than once per month) ( ) 110. Date form reviewed:
1
About once per month ( 2) day mon year
About once per week ( 3)
Several times a month ( 4)
Several times per week ( 5)
About once per day ( 6)
More than once per day ( 7)

104. Which cannabis products do you use:

(check all that apply)
a. Marijuana (medical use): ( 1 )
b. Marijuana (non-medical/recreational
use): ( 1)
c. THC: ( 1)

d. CBD: ( 1)

e. Marinol (Dronabinol) (see also 96h): ( 1)

f. Nabilone (Cesamet): ( 1)

g. Tetrahydrocannabinol (Syndros) (see

also 96t): ( 1 )
105. For which reason(s) do you use these
cannabis products: (check all that apply)
a. Recreational: ( 1)
b. Reduce nausea: ( 1)

c. Reduce abdominal pain: ( 1)

d. Improve appetite: ( 1)

e. Other (specify): ( 1)

specify

Form BH GpR 3
Revision 1 ()HE) BH - Baseline Medical History 17 of 17
Gastroparesis Registry 

Which pattern best describes your

Flash Card #7
weight pattern over the past 5 years?

1 Up and down, up and down

2 Up gradually

Up sharply (gained a lot in

3 a brief interval)

4 Down gradually

Down sharply (lost a lot in a

5 brief interval)

6 No or minimal change

Flash Card 7 Weight Pattern Over Past 5 Years GpR 

Revision 1 ('HF) (for use with Form B+) 1 of 1
Gastroparesis Registry 

Which BEST DESCRIBES the DURATION of

Flash Card #8
use for the medication you took or are taking?

1 Less than 1 month

2 1-6 months

3 6-11 months

4 1-2 years

5 More than 2 years

Which BEST DESCRIBES the BENEFIT you

Flash Card #8 received from the medication you took or are
taking for your gastroparesis symptoms?

0 Not taking for gastroparesis symptoms

1 No or minimal benefit for gastroparesis symptoms

2 Better

3 Much better

4 Worse

5 Much worse

Flash Card 8 Gastroparesis Medication Use GpR 

Revision 1 ('HF) (for use with Form BH) 1 of 1
 Keyed: ( )

13 FH - Follow-up Medical History

Gastroparesis Registry 3
FH - Follow-up Medical History F H 115 Nov 18

Purpose: To collect follow-up medical information about the patient.

When: f024, f048, f072, f096, f120, f144.
Administered by: Clinical Coordinator, reviewed by the Study Physician.
Respondent: Patient.
Instructions: Collect information by interview and/or chart review.

A . Center, visit, and patient identification 11. Since the date in item 8, which best
describes the patient’s symptoms of
1. Center ID: gastroparesis (check all that apply):
a. Nausea: ( 1
)
2. Patient ID: b. Vomiting: ( )
1

c. Bloating: ( 1
)
3. Patient code:
d. Early satiety (a sense that your stomach
is full after eating only a small amount
4. Visit date (date this form is initiated): of food): ( 1
)
e. Postprandial fullness (a sense of
day mon year fullness after the meal): ( 1
)
f. Abdominal pain: ( 1
)
5. Visit code: f
g. D iarrhea: ( 1
)
h. Constipation: ( )
6. Form & revision: f h 1 1

i. Anorexia (loss of appetite): ( 1

)
7. Study: GpR 3 7 j. Weight loss: ( )
1

k. Weight gain: ( 1
)
B . Interval identification
l. Gastroesophageal reflux symptoms
such as heartburn: ( 1
)
8. Date of last Follow-up Medical History
form (if this is f024, record date of Baseline History m . Problems with the management of
form): diabetes or glycemic control: ( 1
)
n. Other (specify): ( 1
)
day mon year

specify
C . Gastroparesis evaluation
o. No symptoms related to gastroparesis: ( 1
)
9. Has the patient had an upper endoscopy 13.
since the date in item 8:
Yes No
( * 1) ( ) 12. Select the predominant symptom listed in
2
*Complete the EG form. item 11 (a through n):

13. Since the date in item 8, has the patient

10. Has the patient had a gastric emptying
experienced a significant improvement in
scintigraphy since the date in item 8:
Yes No
his/her gastroparesis symptoms:
( * 1) ( 2
) Yes No
*Complete the GE form. ( 1
) ( 2
)

Form FH GpR 3
Revision 1 ( -XO ) FH - Follow-up Medical History 1 of 13
 Patient ID:

14. Since the date in item 8, has the patient 18. Since the date in item 8, which best
experienced any exacerbation(s) of describes the patient’s gastroparesis
his/her gastroparesis symptoms: severity
Yes No (check only one):
( 1
) ( 2
)
(Grade 1) M ild gastroparesis:
17. Symptoms mild to moderate and
relatively controlled. Able to maintain
a. Number of Emergency room visits due weight and nutrition on a regular diet. ( 1
)
to gastroparesis symptoms: (Grade 2) Compensated gastroparesis:
Moderate symptoms with only partial
control with use of daily medications.
15. Since the date in item 8, has the patient Able to maintain nutrition with dietary
been admitted to the hospital for adjustments. ( 2
)
gastroparesis: (Grade 3) Gastroparesis with gastric
Yes No failure: Refractory symptoms that are
( 1
) ( 2
) not controlled. Having ER visits,
17. frequent doctor visits or hospitalizations
a. Since the date in item 8, how many and/or inability to maintain nutrition
times has the patient been admitted to via oral route. ( 3
)
the hospital for gastroparesis:
Other (specify): ( 4
)
16. Reason(s) for hospitalization
specify
(check all that apply):
a. Intractable nausea and vomiting: ( 1
)
D . Tobacco cigarette smoking history
b. Abdominal pain: ( 1
) (interview with patient)
c. Dehydration: ( 1
)
19. Since the date in item 8, have you
d. Hyperglycemia: ( 1
) smoked cigarettes regularly
(‘‘N o’’ means less than 1 cigarette a day
e. GI bleed: ( 1
)
per week on average):
f. O ther (specify): ( 1
) Yes No
( 1
) ( 2
)
specify
22.

17. Since the date in item 8, which best 20. On average, how many days per week
describes the nature of the patient’s have you smoked cigarettes:
gastroparesis symptoms (check only one):
Chronic symptoms, but stable severity # days

of symptoms ( 1
)
21. On the days that you smoked, about how
Chronic symptoms, but progressive
many cigarettes did you smoke per day:
worsening of symptoms ( 2
)
Chronic symptoms, but with some
improvement over time ( 3
) # cigarettes/day

Chronic symptoms with periodic

exacerbations with worsening of
symptoms ( 4
)
Cyclic pattern of exacerbations with
periods of feeling well in between ( 5
)
Asymptomatic ( 6
)
Other (specify): ( 7
)

specify

Form FH GpR 3
Revision 1 (-XO) FH - Follow-up Medical History 2 of 13
 Patient ID:

E . Alcohol consumption (AUDIT-C) since the 27. Are gastroparesis symptoms worse
date in item 8 (interview with patient) around the time of menstruation
(menstrual periods):
22. Since the date in item 8, how often have Yes No
you had a drink containing alcohol ( 1
) ( 2
)
(including beer and wine)
32.
(check only one):
If yes, check all symptoms that are worse around
Never ( 0
) the time of menstruation:
25. a. Nausea: ( 1
)
Monthly or less ( 1
)
b. Vomiting: ( 1
)
Two to four times a month ( 2
)
c. Bloating: ( 1
)
Two to three times a week ( 3
)
d. Early satiety: ( )
Four or more times a week ( 4
) 1

e. Postprandial fullness: ( 1
)
23. Since the date in item 8, how many f. Abdominal pain: ( 1
)
drinks of alcohol, beer, or wine have
you had on a typical day when you are
g. D iarrhea: ( 1
)
drinking (check only one): h. Constipation: ( 1
)
1 or 2 ( 0
) i. Anorexia: ( 1
)
3 or 4 ( 1
) j. Weight loss: ( 1
)
5 or 6 ( 2
) k. Weight gain: ( 1
)
7 to 9 ( 3
) l. Gastroesophageal reflux symptoms: ( 1
)
10 or more ( 4
) m . Problems with management of
diabetes or glycemic control: ( 1
)
24. Since the date in item 8, how often have n. Other (specify): ( )
1
you had six or more drinks of alcohol,
beer, or wine on one occasion (check only one): specify
Never ( 0
)
Less than monthly ( 1
) 28. Has the patient been pregnant since the
date in item 8:
Monthly ( 2
)
Yes No
W eekly ( 3
) ( 1
) ( 2
)
Daily or almost daily ( 4
) 29.
a. If yes, what is the status of the
F. Menstrual history pregnancy:

25. Is the patient female: Yes No

Still pregnant ( )
( 1
) ( 2
) 1

Delivery of child ( 2
)
32.
M iscarriage ( 3
)
26. Characterize the menstrual history since Abortion ( 4
)
the date in item 8 (check only one):
29. Since the date in item 8, did the patient
Regular periods ( 1
) have a hysterectomy:
Irregular periods ( 2
) Yes No
Rare periods ( ) ( 1
) ( 2
)
3

No periods ( 4
)
30. Is the patient postmenopausal
28. (surgical or natural): Yes No
( 1
) ( 2
)
32.

31. Since the date in item 8, has the patient

entered natural menopause: Yes No
( 1
) ( 2
)

Form FH GpR 3
Revision 1 (-XO) FH - Follow-up Medical History 3 of 13
 Patient ID:

G . Medical history 35. Since the date in item 8, has the patient
been diagnosed with or treated forany of
32. Is the patient diabetic: Yes No the following (check all that apply;source
( 1
) ( 2
) of information can be interview
35. and/or chart review):
a. Is this diagnosis of diabetes new since a. Gestational diabetes
the date in item 8: Yes No (diabetes of pregnancy): ( )
1
( 1
) ( 2
)
b. Pyloric obstruction: ( 1
)
33. Describe the patient’s glucose control c. Intestinal obstruction: ( 1
)
since the date in item 8 (interview d. Inflammatory bowel disease (IBD): ( )
1
with patient; check all that apply):
e. Irritable bowel syndrom (IBS): ( 1
)
a. Well controlled ( 1
)
f. Eosinophilic gastroenteritis: ( 1
)
b. Hypoglycemic events (symptomatic
and/or requiring intervention) ( ) g. Acute renal failure: ( 1
)
1

c. G lucose levels above 300 mg/dL: ( ) h. Acute liver failure: ( 1

)
1

d. Episodes of diabetic ketoacidosis: ( ) i. Advanced liver disease

1
(Child’s B or C; a CPT score of
e. Postprandial high glucose levels ( 1
) 7 or greater): ( 1
)
f. Postprandial low glucose levels ( 1
) j. Hepatitis B: ( 1
)
k. Hepatitis C: ( 1
)
34. Since the date in item 8, has the patient
been diagnosed with or treated for any of l. Peptic ulcer disease: ( 1
)
the follow ing complications of diabetes: m . G E R D : Gastroesophageal reflux
Yes No disease: ( 1
)
( 1
) ( 2
) n. Celiac disease: ( )
1
35. o. Small intestinal bacterial overgrowth
If yes, check all that apply: (SIBO): ( 1
)
a. Retinopathy (eye changes from p. Colonic inertia: ( 1
)
diabetes): ( )
1
q. Interstitial cystitis: ( 1
)
b. Nephropathy (kidney disease from
diabetes): ( ) r. Bladder dysfunction: ( 1
)
1

c. Peripheral neuropathy (numbess s. Diverticulosis: ( 1

)
and/or tingling in distal legs and feet t. Endometriosis: ( )
from diabetes): ( 1
) 1

u. B lood clots: ( 1
)
v. Hemophilia (bleeding disorder): ( 1
)
w . Rheumatoid arthritis: ( 1
)
x. Scleroderma: ( 1
)
y. Systemic lupus erythematosus (lupus
or SLE): ( 1
)
z. Collagen vascular disease: ( 1
)
aa. Raynaud’s phenomenon: ( 1
)
ab. Other unidentified systemic
autoimmune disorder: ( 1
)
ac. Thyroid disease
(hormonal abnormality): ( 1
)
ad. Malignancy (cancer): ( 1
)
ae. Peripheral neuropathy (non-diabetic
numbess or tingling in hands or legs)
(see 34c for diabetic neuropathy): ( 1
)
af. M igraine headaches: ( 1
)
ag. Chronic headaches  15 per month
(other than migraines): ( 1
)

Form FH GpR 3
Revision 1 (-XO) FH - Follow-up Medical History 4 of 13
 Patient ID:

ah. Seizure disorder or epilepsy: ( 1

) 36. Since the date in item 8, has the patient
had any abdominal/pelvic surgical
ai. Chronic fatigue syndrome: ( 1
) procedures:
aj. Postural orthostatic tachycardia Yes No
syndrome (POTS): ( 1
) ( 1
) ( 2
)
ak. Hypertension: ( 1
) 37.
al. Heart attack, myocardial infarction: ( 1
) (Check all that apply):
a m . Coronary artery disease: ( 1
) a. Total gastric resection: ( 1
)
an. Cerebrovascular disease: ( 1
) b. Subtotal gastric resection
ao. Stroke, cerebrovascular accident (vagotomy, antrectomy): ( 1
)
(CVA): ( 1
)
ap. Hyperlipidemia c. Stapling or banding of the stomach: ( 1
)
(high cholesterol, high triglycerides): ( 1
)
aq. Chronic pancreatitis: ( 1
) d. Gastrojejunostomy: ( 1
)
ar. Episode(s) of acute pancreatitis: ( 1
)
e. Fundoplication for GERD: ( )
as. Cholelithiasis (gallstones): ( 1
) 1

at. Gallbladder disease without

gallstones including chronic f. Cholecystectomy
cholecystitis, gallbladder dyskinesia: ( ) (gall bladder removal): ( 1
)
1

au. Gout: ( 1
)
g. Gastrostomy (surgical or endoscopic): ( 1
)
av. Polycystic ovary syndrome (PCOS): ( 1
)
a w . Dermatologic disorders: ( 1
) h. Jejunostomy: ( )
1
ax. Myopathy: ( 1
)
ay. Autonomic nervous system i. Appendectomy: ( 1
)
dysfunction: ( 1
)
az. Fibromyalgia: ( 1
) j. Hysterectomy: ( 1
)
ba. Multiple sclerosis: ( 1
)
bb. Parkinson’s disease: ( ) k. Surgical pyloroplasty or
1
pyloromyotomy: ( 1
)
bc. ALS: Amyotrophic lateral sclerosis: ( 1
)
bd. Anorexia: ( 1
) l. Endoscopic pyloromyotomy (G-POEM
be. Bulemia: ( ) or POP): ( 1
)
1

bf. B inge eating: ( 1

)
m . Peroral endoscopic myotomy
bg. Avoidant/ Restrictive eating disorder (POEM) for esophageal motility
(ARFID): ( 1
) disorder: ( 1
)
bh. Non-specific eating disorders: ( 1
)
bi. Major (clinical) depression: ( ) n. Gastroduodenostomy: ( 1
)
1

bj. Schizophrenia: ( 1
)
o. O ther GI procedure (specify): ( 1
)
bk. Bipolar disorder: ( 1
)
bl. Obsessive compulsive disorder: ( 1
) specify

b m . Severe anxiety disorder: ( 1

)
bn. Personality disorder: ( 1
)
bo. Post-traumatic Stress Disorder
(PTSD): ( 1
)
bp. Dyslexia or learning problems
including ADHD (attention deficit
hyperactivity disorder): ( 1
)
bq. O ther (specify): ( 1
)

specify

br. None of the above: ( 1

)
Form FH GpR 3
Revision 1 (-XO) FH - Follow-up Medical History 5 of 13
 Patient ID:

H . Nutrition and gastric electrical stimulator I. Medication use

(GES) use
43. Since the date in item 8, has the patient
37. What is the patient’s current source of used insulin for diabetes:
nutrition (check all that apply):
Yes No
a. Oral feeding: ( ) ( 1
) ( 2
)
1

b. Enteral feeding: ( ) 44.

1
(If yes, check all that apply):
c. Parenteral feeding: ( 1
)
a. Insulin glulisine (Apidra): ( 1
)
38. Since the date in item 8, has the patient b. Insulin lispro (Humalog): ( )
1
had a formal nutrition consult:
Yes No
c. Insulin aspart (Novolog): ( 1
)
( 1
) ( 2
) d. Insulin glargine (Lantus): ( 1
)
e. Insulin detemir (Levemir): ( 1
)
39. Since the date in item 8, has the patient
received total parenteral nutrition (TPN): f. Insulin isophane (Humulin N, Novolin
Yes No
N): ( 1
)
( 1
) ( 2
)
44. Since the date in item 8, has the patient
40. Since the date in item 8, has the patient used an insulin pump:
had any of the following placed: Yes No
Yes No ( 1
) ( 2
)
a. G tube: ( 1
) ( 2
) a. Is the patient currently using an
insulin pump:
b. J tube: ( 1
) ( 2
)
Yes No
c. Central line/PICC: ( 1
) ( 2
) ( 1
) ( 2
)
d. Gastric electrical stimulator: ( 1
) ( 2
)

41. Is a gastric electrical stimulator present:

Yes No
( 1
) ( 2
)
42.
a. Is gastric electrical stimulator
currently turned on:
Yes No
( 1
) ( 2
)

42. Since the date in item 8, has the patient

had any of the following removed:
Yes No

a. G tube: ( 1
) ( 2
)
b. J tube: ( 1
) ( 2
)
c. Central line/PICC: ( 1
) ( 2
)
d. Gastric stimulator: ( 1
) ( 2
)

Form FH GpR 3
Revision 1 (-XO) FH - Follow-up Medical History 6 of 13
 Patient ID:

45. Since the date in item 8, has the patient 46. Since the date in item 8, has the patient
used any other antidiabetic medications: taken any anti-hyperlipidemic
Yes No medications:
( 1
) ( 2
) Yes No
( 1
) ( 2
)
46.
(If yes, check all that apply): 47.
(If yes or unsure, check all that apply):
a. Biguanide: Metformin (Glucophage) ( 1
)
a. H M G -COA reductase inhibitors
b. Thiazolidinediones: Pioglitazone
(Atorvastatin [Lipitor], Simvastatin
(Actos), Rosiglitazone (Avandia) ( 1
) [Zocor], Rosuvastatin [Crestor],
c. Sulfonylureas (first gen): Fluvastatin sodium [Lescol],
Chlorpropamide Lovastatin [Mevacor], Pravastatin
(Diabinese),Tolazamide (Tolinase), sodium [Pravachol]):, ( 1
)
Tolbutamide (Orinase) ( 1
) b. B ile acid sequestrant (Colestipol
d. Sulfonylureas (second gen): Glyburide hydrochloride [Colestid]: ( 1
)
(Micronase, DiaBeta, Glynase),
c. Fibric acid (Gemfibrozil [Lopid],
Glimepiride (Amaryl):, Glipizide
(Glucotrol) ( ) Fenofibrate [Tricor]): ( 1
)
1

e. Meglitinides: Repaglinide (Prandin),

d. Nicotinic acid (Niaspan): ( 1
)
nateglinide (Starlix) ( 1
) e. O ther (specify): ( 1
)
f. A lpha-glucosidase inhibitors: miglitol
(Glycet), acarbose (Precose) ( 1
) specify

g. Injectable GLP analogs and agonists:

Exenatide (Byetta, Bydureon), 47. Since the date in item 8, has the patient
Liraglutide (Victoza), Lixisenatide taken any anticoagulant/antiplatelet
(Lyxumia), Semaglutide (Ozempic) ( 1
) medications:
h. Dipeptidyl peptidase-4 (DPP-4) Yes No
inhibitors: Alogliptin (Nesina), ( 1
) ( 2
)
Sitagliptin (Januvia), Saxagliptin
(Onglyza), linagliptin (Tradjenta) ( ) 48.
1
(If yes or unsure, check all that apply):
i. SGLT-2 inhibitors: Canagliflozin
(Invokana), Empagliflozin (Jardiance), a. Apixaban (Eliquis): ( 1
)
Dapagliflozin (Farxiga) ( 1
)
b. C lopidogrel (Plavix): ( 1
)
j. Rosiglitazone Maleate/Glimepiride
(Avandaryl) ( 1
) c. Dabigatran (Pradaxa): ( 1
)
k. Pramlintide (Symlin) ( 1
) d. Dipyridamole (Persantine, Aggrenox): ( 1
)
l. Other (specify): ( 1
) e. Enoxaparin (Lovenox): ( 1
)
f. Heparin: ( 1
)
specify
g. Rivaroxaban (Xarelto): ( 1
)
h. Ticlopide (Ticlid): ( 1
)
i. Warfarin (Coumadin): ( 1
)
j. O ther (specify): ( 1
)

specify

k. Other (specify): ( 1
)

specify

Form FH GpR 3
Revision 1 (-XO) FH - Follow-up Medical History 7 of 13
 Patient ID:

48. Since the date in item 8, has the patient 49. Since the date in item 8, has the patient
taken any systemic corticosteroids: taken any cardiovascular/
Yes No antihypertensive medications: Yes No
( 1
) ( 2
) ( 1
) ( 2
)
49. 50.
(If yes or unsure, check all that apply): (If yes or unsure, check all that apply):

a. Betamethasone sodium (Celestone): ( ) a. Class III antiarrhythmic agent

1
(Amiodarone [Pacerone]): ( 1
)
b. Cortisol: ( 1
)
b. Dihydropyridine calcium channel
c. Cortisone: ( 1
) blocker (Amlodipine besylate
[Norvasc], Felodipine [Plendil],
d. Dexamethasone (Decadron): ( 1
) Nifedipine [Adalat, Procardia]): ( )
1
e. Hydrocortisone (Hydrocortone): ( 1
) c. Beta 1 -adrenergic blocker (Atenolol
f. Methylprednisolone (Solu-Medrol): ( 1
) [Tenormin], Metoprolol [Lopressor]: ( 1
)
g. Prednisolone (Prelone): ( ) d. Non-selective beta blocker (Caryedilol
1
[Coreg], Propranolol [Inderal],
h. Prednisone: ( 1
) Timolol maleate [Blocadren]): ( 1
)
i. Triamcinolone (Acetocot, Amcort, e. Angiotensin-converting-enzyme
Aristocort, Kenacort): ( 1
) inhibitors (Benazepril [Lotensin],
Captopril [Capoten], Enalapril
j. O ther (specify): ( 1
) [Vasotec], Lisinopril [Prinivil, Zestril],
Ramipril [Altace], Quinapril
specify [Accupril]): ( 1
)
k. Other (specify): ( ) f. A lpha-2 adrenergic agonist (Clonidine
1
[Catapres]): ( 1
)
specify g. D igoxin (Lanoxin): ( 1
)
h. Diltiazem (Cardizem): ( 1
)
i. Alpha-1 adrenergic blocker
(Doxazosin [Cardura], Terazosin
[Hytrin]): ( 1
)
j. Furosemide (Lasix): ( 1
)
k. Hydrochlorothiazide (Esidrix,
HydroDIURIL): ( 1
)
l. Hydrochlorothiazide + triamterene
(Dyazide): ( 1
)
m . Angiotensin II receptor antagonist
(Losartan potassium [Cozaar],
Valsartan [Diovan], Candesartan
[Atacand]): ( 1
)
n. Losartan potassium with
hydrochlorothiazide (Hyzaar): ( 1
)
o. Verapamil (Calan): ( 1
)
p. Other (specify): ( 1
)

specify

q. Other (specify): ( 1
)

specify

Form FH GpR 3
Revision 1 (-XO) FH - Follow-up Medical History 8 of 13
 Patient ID:

50. Since the date in item 8, has the patient J. Relevant medication use
taken any estrogen, progestin, hormone For items 50-58: Have the patient use flashcard
replacement therapy, or selective
#9a to indicate the frequency of use and flashcard
estrogen receptor modulators :
Yes No #9b to indicate the perceived benefit for gas-
( ) ( ) troparesis symptoms for each medication he/she
1 2
uses/used
51.
(If yes or unsure, check all that apply): 51. Since the date in item 8, has the patient
a. Conjugated estrogen taken any proton pump inhibitors,
(Premarin/Prempro): ( ) histam ine H2 receptor antagonists or
1
other sim ilar medications:
b. Diethylstilbestrol and
methyltestosterone (Tylosterone): ( 1
) Yes No
( 1
) ( 2
)
c. Esterified estrogen (Estratab, Menest): ( 1
)
52.
d. Estradiol (Estrace): ( 1
) (If yes, answer all that apply using flashcards
e. Ethinyl estradiol (Estinyl): ( 1
) #9a and 9b):
f. Androgens (Fluoxymesterone Frequency Benefit
[Android-F, Halotestin], (1-6) (0-5)
Methyltestosterone [Android],
Nandrolone [Deca-Durabolin, Hybolin a. Antacids, (specify):
Decanoate, Kabolin]): ( 1
)
specify
g. Progestins (Norethindrone [M icronor],
Progesterone [Prometrium], b. C imetidine (Tagamet):
Norgestrel [Ovrette], Levonorgestrel
[Norplant], Medroxyprogesterone c. Dexlansoprazole (Dexilant):
[Cycrin, Provera], Megestrol
[Megace]): ( ) d. Esomeprazole (Nexium):
1

h. Combination oral contraceptives e. Famotidine (Pepcid):

(Alesse, Demulen, Desogen, f. Lansoprazole (Prevacid):
Estrostep, Genora, Intercon, Levlen,
Levlite, Levora, Loestrin, Lo-Ovral, g. N izatidine (Axid):
Necon, Nelova, Nordette, Norethin,
Norinyl, Ortho Cyclen, Ortho-Novum, h. Omeprazole (Prilosec,
Ortho Tri-Cyclen, Ovral, Tri-Levlen, Zegerid):
Triphasil, Trivora, Zovia): ( 1
) i. Pantoprazole (Protonix):
i. Synthetic anabolic steroids j. Rabeprazole (Aciphex):
(Oxandrolone [Oxandrin],
Oxymetholone [Anadrol]): ( 1
) k. Ranitidine (Zantac):
j. Selective estrogen receptor modulator l. Other (specify):
(Raloxifene [Evista], Tamoxifen
[Nolvadex]): ( 1
) specify
k. Other (specify): ( 1
)
m . Other (specify):
specify
specify
l. Other (specify): ( 1
)

specify

Form FH GpR 3
Revision 1 (-XO) FH - Follow-up Medical History 9 of 13
 Patient ID:

52. Since the date in item 8, has the patient 54. Since the date in item 8, has the patient
taken any prokinetic medications: used any of the following medications:
Yes No
Yes No
( ) ( ) ( 1
) ( 2
)
1 2
54.
53.
(If yes, answer all that apply using flashcards
(If yes, answer all that apply using flashcards
#9a and 9b):
#9a and 9b):
Frequency Benefit
Frequency Benefit
(1-6) (0-5)
(1-6) (0-5)
a. Prochlorperazine
a. Azithromycin (Zithromax): (Compazine):
b. Bethanechol (Duvoid, b. Promethazine (Pentazine,
Urecholine): Phenergan):
c. Clarithromycin (Biaxin): c. Trimethobenzamide
d. Domperidone (Motilium): (Benzacot, Stemetic, Tigan):
e. Erythromycin: d. Meclizine (Antivert):
f. Metoclopramide (Reglan): e. Serotonin (5-HT3) antagonists
(Ondansetron [Zofran], Trop-
g. Prucalopride (Resolor) isetron [Navoban], Granis-
(see also 55m): etron [Kytril Sancuso Patch],
Palonosetron [Aloxi],
h. Tegaserod (Zelnorm): Dolasetron [Anzemet]):
i. C isapride (Propulcid): f. Neurokinin-1 receptor
j. O ther (specify): antagonists (Aprepitant
[Emend]):
specify g. Tricyclic antidepressants
(Amitriptyline [Elavil],
k. Other (specify): Desipramine [Norpramin],
Imipramine [Tofranil],
specify Nortriptyline [Aventyl,
Pamelor]):
h. Dronabinol (Marinol)
53. Since the date in item 8, has the patient (see also 60e):
had Botox injected into the pylorus for
his/her gastroparesis symptoms: i. Tetracylcic antidepressants
Yes No (Mirtazapine [Remeron]):
( 1
) ( 2
)
j. Bupropion (Wellbutrin):
54. k. Selective Serotonin Reuptake
Inhibitors (SSRI)[Citalopram
(Celexa), Escitalopram
a. Perceived benefit (use flashcard #9b): (Lexapro), Fluoxetine
0-5 (Prozac), Paroxetine (Paxil),
Sertraline (Zoloft)]:

b. Number of weeks since last injection: l. Venlafaxine (Effexor):

m . Anxiolytic (Buspirone
[BuSpar]):
00-48
n. Chlordiazepoxide (Librax):

Form FH GpR 3
Revision 1 (-XO) FH - Follow-up Medical History 10 of 13
 Patient ID:

Frequency Benefit 56. Since the date in item 8, has the patient
(1-6) (0-5) taken any pain relieving, analgesics,
o. Benzodiazepines (Lorazepam non-steroidal anti-inflammatory, or
[Ativan], Alprazolam [Xanax], aspirin containing medications
D iazepam [Valium], Oxazepam (non-narcotic) either regular usage or as
[Serax], Clonazepam [Klon- needed basis (prn):
opin], Temazepam [Restoril, Yes No
Temaz], Flurazepam): ( ) ( )
1 2
p. Meprobamate:
57.
q. Quetiapine fumarate (If yes, answer all that apply using flashcards
(Seroquel): #9a and 9b):
r. D icyclomine (Bentyl): Frequency Benefit
s. Olanzapine (Zyprexa): (1-6) (0-5)

a. Acetaminophen (Tylenol):
t. Tetrahydrocannabinol
(Syndros) (see also 60g): b. Aspirin - 325 mg:
u. Other (specify): c. Celecoxib (Celebrex):
d. Ibuprofen (Advil, M o trin):
specify
e. Indomethacin (Indocin):
v. O ther (specify):
f. Naproxen (Aleve, Naprosyn):
specify g. Ketorolac (Toradol):
h. Other (specify):
55. Since the date in item 8, has the patient
used any of the following medications for specify
constipation:
Yes No i. Other (specify):
( 1
) ( 2
)
specify
56.
(If yes, answer all that apply using flashcards j. O ther (specify):
#9a and 9b):
specify
Frequency Benefit
(1-6) (0-5)

a. Bisacodyl (Dulcolax):
b. Colchicine (Colcrys):
c. Docusate sodium (Colace):
d. Fiber supplements:
e. Lactulose:
f. Linaclotide (Linzess):
g. Lubiprostone (Amitiza):
h. Methylnaltrexone (Relistor):
i. M isoprostol (Cytotec):
j. Naloxegol (Movantik):
k. Plecanatide (Trulance):
l. Polyethylene glycol
(Miralax):
m . Prucalopride (Resolar):
n. Senna (Senokot):
o. Magnesium oxide:
p. Other (specify):

specify

Form FH GpR 3
Revision 1 (-XO) FH - Follow-up Medical History 11 of 13
 Patient ID:

57. Since the date in item 8, has the patient 58. Is the patient taking the narcotic pain
taken any narcotic pain medications: medication for (check all that apply)
Yes No
( ) ( ) a. Pain related to gastroparesis
1 2 symptoms, including abdominal pain: ( 1
)
59. b. Headache pain: ( )
1
(If yes, answer all that apply using flashcards
#9a and 9b): c. Leg pain: ( 1
)
Frequency Benefit d. Back pain: ( 1
)
(1-6) (0-5) e. O ther pain (specify): ( )
1
a. Acetaminophen (30 mg)/
codeine phosphate specify
(Tylenol #3):
b. Acetaminophen (60 mg)/ 59. Since the date in item 8, has the patient
codeine phosphate
(Tylenol #4): taken any of the following neuropathic
pain medications:
c. Acetaminophen/hydrocodone Yes No
bitartrate (Lortab, Norco, ( ) ( )
1 2
V icodin):
60.
d. Acetaminophen/oxycodone
hydrochloride (Percocet, (If yes, answer all that apply using flashcards #9a
Tylox): and 9b):
e. Aspirin/oxycodone hydro- Frequency Benefit
chloride (Percodan): (1-6) (0-5)

f. Buprenorphine a. Duloxetine (Cymbalta):

(Butrans patch): b. Gabapentin (Neurontin):
g. Butalbital/acetaminophen/ c. Pregabalin (Lyrica):
caffeine (Esgic - Plus):
d. Divalproex sodium
h. Fentanyl transdermal (Dura- (Depakote):
gesic patch):
e. Topiramate (Topamax):
i. Fentanyl oral (Abstral,
Actiq, Fentora): f. O ther (specify):
j. Hydromorphone hydro-
chloride (Dilaudid): specify

k. Oxycodone hydrochloride
(OxyContin):
l. Methadone hydrochloride:
m . Morphine sulfate:
n. Pentazocine (Talacen):
o. Tapentadol (Nucynta):
p. Tramadol HCl (Ultram/
Ultracet):
q. Other (specify):

specify

Note: Participants should not be taking narcotic

medications more than 3 days per week.

Form FH GpR 3
Revision 1 (-XO) FH - Follow-up Medical History 12 of 13
 Patient ID:

K . Alternative therapies 61. Since the date in item 8, has the patient
For item 60: Have the patient use flashcard #9a used a cannabis product such as
marijuana, THC (tetrahydrocannabinol),
to indicate the frequency of use and flashcard #9b
CBD (cannabidiol):
to indicate perceived benefit for gastroparesis
Yes No
symptoms for each medication he/she uses/used ( ) ( )
1 2

60. Since the date in item 8, has the patient 63.

used alternative medicine or (If yes, answer all that apply using flashcards
complementary medicine products or #9a and 9b):
procedures for treatment of his/her Frequency Benefit
symptoms related to gastroparesis (1-6) (0-5)
(e.g., bloating, nausea, vomiting,
abdominal pain): a. Marijuana (medical use):
Yes No b. Marijuana (non-medical/
( 1
) ( 2
) recreational use):
61. c. T H C :
(If yes, answer all that apply using flashcards d. C B D :
#9a and 9b):
e. Marinol (Dronabinol)
Frequency Benefit (see also 53h):
(1-6) (0-5)
f. Nabilone (Cesamet):
a. Probiotic #1 (specify):
g. Tetrahydrocannabinol
specify
(Syndros) (see also 53t):

b. Probiotic #2 (specify): 62. For which reason(s) do you use these

cannabis products: (check all that apply)
specify
a. Recreational: ( 1
)
c. Herbal supplement #1
(specify): b. Reduce nausea or vomiting: ( 1
)
c. Reduce abdominal pain: ( 1
)
specify
d. Improve appetite: ( 1
)
d. Herbal supplement #2 e. O ther (specify): ( )
(specify): 1

specify
specify

e. Herbal supplement #3
(specify): L . Administrative information

63. Study Physician PIN:

specify

f. Acupuncture:
64. Study Physician signature:
g. Acupressure bands/bracelets:
h. Reflexology:
i. Hypnotherapy: 65. C linical Coordinator PIN:
j. Therapeutic Massage:
k. Ginger: 66. C linical Coordinator signature:

l. Iberogast:
m . Other (specify):
67. Date form reviewed:
specify

day mon year

Form FH GpR 3
Revision 1 (-XO) FH - Follow-up Medical History 13 of 13
Gastroparesis Registry 

Which BEST DESCRIBES the FREQUENCY of

Flash Card #9a
use for the medication you took or are taking?

1 Used only one or two times since the date in item 8

2 Less than once per week

3 About once a week

4 Several times a week

5 About once per day

6 More than once per day

Which BEST DESCRIBES the BENEFIT you

Flash Card #9b received from the medication you took or are
taking for your gastroparesis symptoms?

0 Not taking for gastroparesis symptoms

1 No or minimal benefit for gastroparesis symptoms

2 Better

3 Much better

4 Worse

5 Much worse

Flash Card 9 Gastroparesis Medication Use GpR 

Revision 1 ('HF) (for use with Form )H) 1 of 1