Question Prompt List as a Communication Tool for Adults With Gastroesophageal Reflux Disease

Incorporation of Patients’ Perspectives

Abstract

Background: 

Question prompt lists (QPLs) are structured sets of disease-specific questions intended for patient use, enhancing the patient-physician communication by encouraging patients to ask relevant questions during a consultation. Recently, a preliminary 78 question gastroesophageal reflux disease (GERD) specific QPL was created by 12 esophageal experts through a modified Delphi (RAND/University of California, Los Angeles) technique. Patients’ perspectives and opinions on each question, however, had not been accounted for in the preliminary expert’ version.

Aim: 

The aim was to modify a preliminary experts’ QPL, specific to adults with GERD, following patient perspectives and opinions.

Methods: 

A preliminary GERD QPL was modified through patient input and opinions. Thirty-eight patients with a clinical diagnosis of GERD followed at Stanford University Esophageal Clinic between January and November 2019 were consented to modify the preliminary 78 question expert QPL version. After receiving the QPL in Qualtrics (Provo, UT) by a direct e-mail invitation, patients independently rated questions on a 5-point Likert scale, where 1=“should not be included,” 2=“unimportant,” 3=“don’t know/depends,” 4=“important,” and 5=“essential.” Questions were accepted for inclusion in the QPL with an a priori interagreement of 80% ranking in the range of 4 to 5. At the end, patients were encouraged to propose additional questions to incorporate into the QPL by open-endedly asking “Are there questions we didn’t ask, that you think we should?”

Results: 

Twenty-three patients with GERD (19 female, median age 64) fully participated and modified the existing QPL (60.5%). Of the 78 questions from the preliminary GERD QPL, 66 questions (84.6%) were accepted for inclusion. The question with the highest agreement among patients rating a question as essential consisted of “what habits, food, and drinks do I have to avoid?” (82.6%). Questions eliminated because of disagreement included “What is the natural history of GERD,” “Do I have a high chance to die from my Barrett’s?,” and “Why are you prescribing an antidepressant to treat my GERD?” Nine patients suggested additional questions totaling to 16 separate questions, including “What type of surgeries are there to help GERD?,” “What stage is my GERD?,” “What are the odds/percentage of getting cancer from GERD?” Incorporating the suggested questions, the final GERD QPL—created by esophageal experts and modified by patients—consisted of 82 questions.

Conclusion: 

Esophageal experts and GERD patients have a high level of agreement on important questions, though there is some variation in perspective. Future studies can simplify this list and measure the impact of a shared GERD QPL on patients’ decisional conflict and perceived involvement in care.

Clinical decision making should be patient centered, as promoted by the Institute of Medicine.¹ Shared decision making is the process of acquiring and integrating patients’ preferences and needs into clinical decisions on disease management. In this model, patients are seen as equal partners—a change from the traditional physician-dominated role, where doctors are the primary decision makers. Increasingly over recent years, such shared decision making has been encouraged and considered a key component of patient-centered high-quality care.²

Implementing shared decision making into clinical practice may be challenging, since patients may not feel prepared at the time of visit. To avoid this, communication interventions have been developed, including a question prompt list (QPL) booklet. These communication booklets are comprised of a list of questions specific to a disease, including the physical and psychosocial aspects that patients may have not considered asking. QPLs encourage patients to actively participate during their visit, by supporting an “it’s okay to ask” environment. QPLs have been introduced into various medical specialties, with overwhelmingly positive results that include reduction in anxiety scores and improved patient satisfaction.^3–6

Gastroesophageal reflux is a chronic condition that is diagnosed in up to 30% of North American adults and typically manifest by heartburn and acid regurgitation.⁷ These chronic symptoms impact a person’s quality of life by reducing physical and emotional well-being. When assessing features that impact patients’ health-related quality of life, anxiety about the underlying cause of symptoms plays an important role.⁸ Inspired by reports of effective QPLs specific to advanced cancer care,⁴ palliative care,⁹ and surgical oncology,¹⁰ the authors developed a preliminary gastroesophageal reflux disease (GERD) QPL among esophageal experts intended to be used for any patient with reflux-like symptoms.¹¹ However, a recognized limitation has been the absence of patients’ perspective on modifying questions to make them more patient centered and comprehensive. In this study, we aimed to modify a preliminary “expert” version of a GERD QPL by incorporating feedback on the overall QPL content from patients with GERD—since they are the ones who experience the disease on a daily basis.

METHODS

Basic QPL

In a recent study,¹¹ 12 national and international esophageal experts developed a preliminary phase GERD QPL list applying a 2-rounded Delphi process. In round 1, experts provided proposed questions to the prompt: (1) “What you wish your patients would ask” and (2) “What questions do patients often not ask, that you wish they would ask?” In round 2, the panelists rated each proposed question on level of importance applying a 5-point Likert scale. Applying an a priori median Likert score of ≥4.0 cut off, the preliminary booklet consisted of 78 total questions separated into 6 specific topics: (1) “What does this illness mean?,” (2) “Lifestyle modifications,” (3) “General treatment,” (4) “Treatment with proton pump inhibitors,” (5) “Barrett’s esophagus,” and (6) “what I should expect for my future?” At the completion of the study, experts expressed feedback on the process and all (100%) agreed that the patient perspective should contribute to the final GERD QPL.¹¹ Our present study was performed between January and November 2019, utilizing a survey format among new or return patients with GERD to help modify and provide feedback upon the preliminary GERD QPL that was developed by the experts. This consisted of a 1-round voting process through an online survey. This study was approved by the Stanford University Institutional Review Board (IRB).

Patient Panel Recruitment

Participants of the patient panel were initially recruited and consented at their visit by the primary investigator (A.K.) at Stanford University Gastroenterology Clinic. Inclusion criteria included the presence of GERD symptoms as either a new or return patient, age above 18 years, and a background speaking English. A total of 38 patients were initially contacted directly by e-mail invitation, following an informed consent process at the clinic visit.

Survey Scoring

We administered a survey to obtain patient feedback and consensus on important and essential questions within the physician developed GERD QPL. Our study was comprised of a 1-round voting process organized by the primary investigator. We individually emailed consented patients a direct survey link hosted by Qualtrics (Provo, UT) and upon clicking on the link, patients were provided access to independently rate the 78 total questions developed in the preliminary phase. Rating included a similar 5-point Likert scale as experts had used, where 1=“should not be included,” 2=“unimportant,” 3=“don’t know/depends,” 4=“important,” and 5=“essential.” The survey concluded by asking in an open-ended box: “Are there questions we did not ask, that you think we should? Please list any questions you believe should be asked.” The survey host allowed patients to access the survey link on a personal electronic device (ie, cell phone) and we encouraged patients to complete the survey within 2 weeks. One reminder e-mail through Qualtrics was sent if this deadline was not met; afterwards if patients had still not completed, it was assumed they were no longer interested.

Statistical Analysis

At the completion of patient panelist voting, the primary investigator (A.K.) aggregated and analyzed the data. Baseline demographic data is reported as median and interquartile range or counts (percentage), as applicable. Patient responses to the 78 questions were then analyzed to calculate a median value. Accepted questions included those with an a priori interagreement of ≥80% ranking in the range of 4 to 5 (important or essential, respectively). We selected an interagreement of >80% to represent a high score of variance or similarity among the patients, whereas 20% would estimate error variance or differences within the patient group.¹² Questions were excluded when falling below this agreement scale. All calculations were performed using SAS statistical software version 9.4 (Cary, NC). We aimed to recruit patients at a 1:2 ratio between physicians whom developed the GERD QPL and current patients. In a prior study of 12 expert physicians, we aimed to recruit 24 patients. To accommodate for a possible high dropout rate applying an online survey among patients, the ideal sample size was increased by >50% to 36 to 40 GERD patients.

RESULTS

Patient Panel Members

Thirty-eight patients with GERD were invited and consented to the study; of these, 23 patients (60.5%) fully participated in this survey study. All panelists were recruited from Stanford University Gastroenterology Clinics. Median age of the patient panelists was 65 (interquartile range: 52 to 68). Majority of patients were female (82.6%), Caucasian (73.9%) and more than half with a college degree (Table 1).

TABLE 1 - Patient Characteristics

Demographics	n (%)
Age, median (IQR)	65.0 (52-68)
Gender
Male	4 (17.4)
Female	19 (82.6)
Race
Caucasian	17 (73.9)
Asian	3 (13.0)
Hispanic	1 (4.4)
Native Hawaiian	1 (4.4)
Other	1 (4.4)
Location (state)
California	22 (96.7)
Hawaii	1 (4.4)
Employment
Full-time	7 (30.4)
Part-time	1 (4.4)
Retired	9 (39.1)
Disabled	3 (13.0)
Unemployed	2 (8.7)
Homemaker	1 (4.4)
Highest academic achievement
Doctorate	3 (13.0)
Master’s/graduate degree	9 (39.1)
Trade school	2 (8.7)
Associate’s or bachelor’s	5 (21.7)
High school	3 (13.0)

IQR indicates interquartile range.

Survey Outcomes

Of the 78 questions proposed by esophageal experts in the GERD QPL version, patients rated with high inter-rater agreement on importance on 66 of these questions (84.6%). Table 2 highlights the 10 most highly rated questions by patients. The question with the highest agreement among patients rating a question as essential consisted of “what habits, food, and drinks do I have to avoid?” (82.6%). Twelve questions were eliminated because of interagreement < 80% including “What is the natural history of GERD,” “Do I have a high chance to die from my Barrett’s?” and “Why are you prescribing an antidepressant to treat my GERD?” (Table 3 and Fig. 1).

TABLE 2 - Ten Most Highly Rated Questions Raised by Patients

Questions
GERD-Question Prompt List (QPL) Questions
1. What habits, food, and drinks do I have to avoid?
2. Do you have advice on life/diet modifications, before the use of drugs?
3. What lifestyle measures should I incorporate to manage my symptoms?
4. What is the prognosis of GERD complications if left untreated?
5. How helpful are lifestyle modifications in GERD?
6. How safe are PPI therapies for long-term use?
7. What are the next steps if the medication does not seem to help?
8. What are the interventional options to treat reflux?
9. Do you have any concerns about taking reflux medications long-term?
10. How can I tell if the symptoms I am having are related to GERD or something else?

GERD indicates gastroesophageal reflux disease; PPI, proton pump inhibitor.

TABLE 3 - Proposed Questions Eliminated by Patients Because of Disagreement

GERD-Question Prompt List (QPL) Questions	% Interagreement
Should I undergo early reflux testing? If so, why?	78.2
What are the risks and benefits of gastric bypass used to treat GERD?	69.6
I don’t want to take a medication for the rest of my life. Should I have surgery?	77.3
Do I need a pH testing? Do I need to repeat this after therapy?	78.3
Can I get pregnant on these therapies? Can I breastfeed on these therapies?	69.6
Why are you prescribing an antidepressant to treat my GERD?	78.3
Can I take PPI on demand?	72.7
Do I have a high chance to die from my Barrett’s?	76.2
Does my Barrett’s need to undergo surveillance endoscopy?	76.2
My Barrett’s was not confirmed at the second endoscopy. Why?	76.2
Does my Barrett’s need to be ablated?	71.4
What is the natural history of GERD?	71.4

GERD indicates gastroesophageal reflux disease; PPI, proton pump inhibitor.

FIGURE 1: Cluster bar graph demonstrating percentage of experts and patients rating questions important and/or essential. Questions listed include those eliminated because of low inter-rater agreement among patients (<80%). GERD indicates gastroesophageal reflux disease.

Nine patients participated in the open-ended response when asked “Are there questions we did not ask, that you think we should ask?” There were 14 suggested questions including “What type of surgeries are there to help GERD?,” “What stage is my GERD?,” “What are the odds/percentage of getting cancer from GERD?” (Table 4).

TABLE 4 - Proposed Questions Suggested by Patients

Questions
“Would it be a good strategy to take digestive enzymes to help with digestion or research proper food combining to as to prevent the conflict between a steak and baked potato at 2:00 am…??”
“What kind of physical activity/physical therapy is recommended or not recommended when you have GERD? Some exercises tend to bring on GERD. However, inactivity also makes things worse. How do I know what activity is right for me or can help with GERD symptoms?”
“Are new drug therapies for GERD on the way soon and should I wait for them rather than having surgery?”
“What changes in symptoms, should I notify my doctor?”
“Does the amount of exercise I get directly affect my GERD? What does the latest research say regarding chronic high stress and GERD?”
“What types of surgeries are there to help GERD?”
“What stage is my GERD? and what are the odds/percentages of getting cancer from GERD?”
“Did any of the medications I take to manage other diseases give me GERD/do they make my GERD worse? What caused my LES to become “loose”? Do I have a sensitive esophagus? If we find out I have a sensitive esophagus, do I still need to take heartburn medication? What is the national prevalence of Barrett’ esophagus/esophageal cancer? Is GERD caused or made worse by the presence of other gastrointestinal diseases? Are GERD and SIBO linked?”
“What are the mechanisms involved in allergy symptoms, supposedly brought on by GERD…sneezing, coughing, occasional vomiting, occasional shivers after ingesting food.”

GERD indicates gastroesophageal reflux disease.

Question Prompt List

Beginning with 66 questions meeting high patient inter-rater agreement and with the addition of 14 questions proposed by patients themselves, the completed GERD QPL consisted of 80 questions. The option included creating a separate category of questions proposed by the patients coined “questions proposed by patients when asked.” However, after considering flow and future use of the booklet, it was decided to incorporated proposed questions into the already established 6 themes of the GERD QPL (Fig. 2).

FIGURE 2: Flow diagram illustrating the individual steps of this completed gastroesophageal reflux disease (GERD) question prompt list (QPL) for adult patients.

DISCUSSION

This is the first application of a 2-phase method to systematically develop a comprehensive adult-specific GERD QPL by: (1) original expert consensus in a modified RAND/UCLA Delphi process; and (2) subsequent input and modification by patients. Among the 12 esophageal experts participating in the preliminary GERD QPL comprising of 78 questions to be considered, in the following phase GERD patient panelists agreed with 66 of these questions. Questions most highly rated by patients included topics on dietary habits to avoid, lifestyle measures, and safety of long-term proton pump inhibitory use.

In patient-centered environments, providers are no longer viewed as the ones with authority; instead a partnership is formed to facilitate treatment goals. To support effective bidirectional communication between patients and their health care team, comprehensive QPLs have been developed throughout various subspecialties.⁴ Our study is the first to develop a comprehensive disease-specific QPL in the field of gastroenterology and more specifically to patients with GERD, with the strength of applying patient perspective in efforts to make the GERD QPL more patient centered.

Generally, academic researchers are the primary developers of the QPLs and only few authors have included patients in the process. Ahmed and colleagues designed a preliminary QPL intended for parents of children with attention-deficit/hyperactivity disorder (ADHD) and subsequently recruited a professional (36 ADHD experts) and nonprofessional panels (8 parents of children with ADHD) to participate in a 3-round modified Delphi process to reach consensus on important questions. Authors recognized the importance of parents’ participation in this modified Delphi process. Applying both expert and parent feedback, a total of 88 questions remained after the 3 rounds and 94% of panel members agreed with the statement “I believe the question prompt list will encourage discussion between parents of children with ADHD and healthcare professionals.”⁶ Eggly and colleagues developed a QPL specific to cancer treatment to reduce racial disparity by designing 2 phases: (1) development of the QPL and (2) conducting semistructured interviews. When oncologists provided questions on medical content, the authors recognized the value of patients’ perspectives on topics only experienced by patients. Therefore, the authors interviewed black patients who recently or nearly completed chemotherapy were interviewed to gain individual perspective and feedback on the QPL context. Only through this process did study authors obtain patient testaments on topics including: (1) not knowing what questions to ask, (2) feeling intimidated by the medical team, and (3) feeling some information is irrelevant.¹³

Patients with GERD commonly describe typical symptoms of heartburn and/or regurgitation, whereas the actual assessment on symptom severity and management strategy occurs by the treating provider. Clinicians make management judgements incorporating their interpretation of a patient’s symptom severity and effect on quality of life. But how well do clinicians interpret symptom severity?¹⁴ McColl and colleagues aimed to determine the extent of a disconnect between clinicians and patients perspective on symptom severity in GERD. The authors involved patients from 4 prior randomized clinical trials, measuring extent of agreement for symptom severity between the patients and their clinicians. Whereas agreement on symptom severity was highest for dysphagia (63%), the lowest included epigastric pain (24% to 35%) and regurgitation (36% to 43%). The study revealed clinicians commonly under-rated symptom severity, than what was experienced by patients.¹⁵ This disconnect demonstrates the need to improve physician-patient communication and only attempted previously by patient questionnaires, educational leaflets or agenda forms.¹⁶

The results of our study presented herein are not without specific process limitations. First, our patient panel size was overall small (n=23) with a 39.5% dropout rate following enrollment. This dropout rate likely reflects the nature of the study, as patients were required to complete the online survey later after their visit. Furthermore, our patient panel originated solely from one institution (Stanford University Hospitals and Clinics), with a higher proportion being female and with a college degree. Therefore external selection bias may be present in our survey results and therefore limiting generalizability among patients outside of our institution. Second, the total number of questions increased following patient perspective with the addition proposed questions. This process may transform the booklet into being less user friendly and practical during a clinic visit, however, the additional questions may make it more comprehensive when used in a preclinic setting when the patient has time to look through the possible questions at their leisure. Therefore we encourage this exhaustive list of questions as similarly seen in ADHD¹⁷ (88 questions) and palliative care¹⁰ (112 questions), where patients can pick from the long list and select a few questions to concentrate on. Lastly, and most importantly, the outcome effect of a GERD QPL has not yet been assessed in a clinical setting. Future efforts will evaluate the effectiveness of a paper-based GERD QPLs, compared with a sham booklet, in a randomized clinical trial. We will aim to measure differences in decisional conflict, perceived involvement in care, and anxiety scores. Such study results will provide foundational evidence for a national-scale, feasibility testing of this GERD QPL.

In conclusion, this study reflects a completed version of a GERD QPL developed by 12 esophageal experts and subsequently modified by 23 GERD patients through a 2-phase process. In the future we will measure the feasibility and impact on this GERD QPL on decisional conflict, perceived involvement in care, and overall anxiety scores in larger, multi-institutionally based patient cohorts. As the value of patient-centered care within the Institute of Medicine guidelines continues to be emphasized in the upcoming years, we hope that the implementation of a GERD QPL can facilitate an effective bidirectional communication between patients with GERD and their physicians.