Surg Endosc (1998) 12: 261–265

© Springer-Verlag New York Inc. 1998

Patient response to marketing minimally invasive surgery for heartburn M. de Vos Shoop,1 J. H. Peters,1 T. R. DeMeester,1 P. F. Crookes,1 M. M. Kline2 1

Department of Surgery, University of Southern California, School of Medicine, 1510 San Pablo Street, Sutie 514, Los Angeles, CA 90033-4612, USA 2 Department of Medicine, University of Southern California, School of Medicine, 1510 San Pablo Street, Suite 514, Los Angeles, CA 90033-4612, USA Received: 3 April 1997/Accepted: 10 June 1997

Abstract Background: Over 40% of Americans suffer from ‘‘heartburn’’ at least once a month. This and other manifestations of gastroesophageal reflux (GERD) are often treated with neglect by both patients and their primary care physicians. Diagnostic evaluation is all too often sought only in late stages of the disease. We studied the response to a media campaign promoting minimally invasive surgery as a cure for longstanding heartburn. Methods: The information was publicized on 14 TV and six radio stations over 4 weeks. Patients were referred to an 800-number and data on the following topics were obtained using a standardized questionnaire: demographics, reflux symptoms, previous specialist referral, diagnostic evaluation and treatment, insurance information, and reasons for and expectations in calling. All questionnaires were screened for likelihood of GERD (high, medium, low). A return call was placed to triage patients (surgical or medical appointment, information only, no contact). Results: We received calls from 1,389 potential patients. Based on symptoms, medical therapy, and previous evaluation, 891 (64%) were judged to likely have GERD and assigned high-priority status. Of the patients providing insurance information, 32% were enrolled in an HMO; 29% commercial; 16% Medicare; 14% employer based; and 9% had no insurance. Six hundred ninety-eight high-priority patients were contacted. Of these, 402 (58%) wanted information only; 228 (33%) desired surgical and 68 (%) medical appointments. Two hundred fifteen patients (16% of callers) were seen by a surgical or medical consultant. One hundred thirty-five underwent diagnostic studies, of which 77 (57%) had pathologic esophageal acid exposure. Eighty-three patients have undergone surgery to date—60 laparoscopic and

Presented in part at the Society of American Gastrointestinal Endoscopic Surgeons (SAGES), San Diego, California, USA, 22 March 1997 Correspondence to: J. H. Peters

14 open antireflux procedures; nine had other surgical procedures. Conclusions: Surprisingly, 64% of patients responding to a marketing campaign for heartburn have typical symptoms of GERD, have consulted one or more physicians and/or received medical treatment. More than half the patients tested (77/135) were found to have a positive 24-h pH study, and 78% (60/77) of these elected antireflux surgery to control their reflux symptoms. Key words: Antireflux surgery — Laparoscopic antireflux surgery — Heartburn — Marketing and antireflux surgery — Medical vs surgical antireflux therapy — Laparoscopic Nissen fundoplication — Marketing and laparoscopic Nissen fundoplication

Gastroesophageal reflux disease (GERD) has become an important health problem in contemporary society. Over 40% of Americans are alleged to suffer from ‘‘heartburn’’ at least once a month [6]. The wide prevalence of typical GERD symptoms leads to complacency and inadequate information amongst patients and primary care physicians, with the result that most patients are investigated by a specialist only late in the course of the disease. It is now realized that the umbrella term GERD encompasses a wide range of severity, with a majority of patients suffering from mild disease. However, approximately 25– 50% of patients develop progressive or recurrent disease, requiring lifelong medical treatment [13]. For these patients, surgical therapy has become the treatment of choice [7, 8]. The concept of chronic disease leading to progressive esophageal injury with complications of stricture, loss of esophageal function, and Barrett’s esophagus, a condition of particular significance in view of the rapidly increasing rate of esophageal adenocarcinoma in all western countries [1],

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is increasingly embraced. Considering the estimated 2 million adults in the United States with Barrett’s esophagus [12] and reported rising death rates due to nonmalignant disease of the esophagus, largely complications of GERD [15], the continued controversy with respect to medical vs surgical treatment appears noteworthy. Since access to definitive treatment is often hampered by the attitude of primary care physicians, where specialist referral of large numbers of patients is felt not to be cost effective [5], we studied the response of the symptomatic public directly by instituting a media campaign promoting minimally invasive surgery as definitive treatment for symptomatic GERD. Methods To test the patient response to promoting minimally invasive surgery as a cure for GERD, we conducted a cross-disciplinary multimedia marketing study. Demographics, reflux symptoms, previous specialist referral, diagnostic evaluation and treatment, insurance information, as well as reasons for and expectations in calling were recorded. Amongst this patient population, not affected by prevailing referral mechanisms, special interest was directed toward the number of patients with positive 24-h pH monitoring qualifying as candidates for antireflux surgery.

Media material A professionally created video-clip explaining heartburn as a symptom of gastroesophageal reflux disease and introducing minimally invasive surgery as therapeutic option was publicized on 14 TV and six radio stations over 4 weeks.

Data collection Patients were referred to an 800 number to provide demographics, reflux symptoms, previous specialist referral, diagnostic evaluation and treatment, insurance information, and reasons for and expectations in calling. All calls were taken by the hospital’s referral services. The data were entered in a multiuser database utilizing the standardized questionnaire shown in Fig. 1.

Evaluation criteria All records were screened by a physician for likelihood of GERD (high, medium, low). High likelihood was defined as combination of typical GERD symptoms, prior specialist evaluation, and prior medical treatment; medium likelihood as typical GERD symptoms and prior medical treatment without specialist evaluation; and low likelihood as GERD symptoms but neither specialist evaluation nor medical treatment.

Evaluation A return call was placed by either a physician or a nurse to triage patients to surgical or medical appointment or information only. All patients were followed over a nearly 2-year period from 2/95 through 12/31/96. Date of consultation, type and result of diagnostic tests performed, as well as type and date of surgery were recorded on a spreadsheet.

Results Demographics Of the 1170 (84%) patients providing insurance information, 374 (32%) were enrolled in an HMO, 34 (29%) com-

mercial, 192 (16%) Medicare, 162 (14%), employer based, and 98 (9%) had no insurance (Fig. 2). Clinical characteristics We received calls from 1,389 potential patients. Eight hundred ninety-one (64%) had either typical reflux symptoms or were on H2-blocker or proton-pump inhibitor therapy or had been previously evaluated for the possibility of gastroesophageal reflux disease. These patients were considered high priority for a return call. One hundred forty-nine (11%) patients who had never been evaluated by a physician were classified as medium priority and 47 (3%) patients neither previously evaluated nor medically treated were classified as low priority (Table 1). Six hundred ninety-eight of the 891 high priority patients could be contacted. Four hundred two (58%) wanted information only; 228 (33%) opted for surgical and 68 (9%) for a medical appointment (Fig. 3). Follow-up Of those interested in an appointment, 215 patients (16% of callers) were ultimately seen by a surgical or medical consultant. As shown in Fig. 4, 135 of these patients underwent 24-h pH monitoring, and of those, 77 (57%) had pathologic esophageal acid exposure. Sixty of these 77 patients (78%) underwent minimally invasive antireflux surgery and 14 (17%) open antireflux procedures. Nine patients (11%) were found to have an underlying problem other than gastroesophageal reflux disease and had other surgical procedures including two Roux-en-Y gastro-jejunostomies, two laparoscopic cholecystectomies, one open cholecystectomy, one open diaphragm plication, one hemigastrectomy, one esophagectomy and one bronchoscopy (Fig. 5). Discussion Recent data have identified disturbing trends in the epidemiology of gastroesophageal reflux disease. The prevalence of Barrett’s esophagus is increasing at an alarming rate, as are its neoplastic sequelae, adenocarcinoma of the esophagus, and cardia [1, 4]. Equally important, death secondary to nonmalignant disease of the esophagus, largely complications of gastroesophageal reflux, has also been shown to be increasing in western countries [15]. That this has occurred despite significant improvements in the efficacy of medical therapy suggests that the present approach to the treatment of this disease is inadequate. The manifestations of gastroesophageal reflux, in particular heartburn, have traditionally been considered so common and trivial that they are of little or no concern. Not only patients, but often primary care physicians, are poorly informed of the potential complications of the disease [18]. As a result, heartburn and other manifestations of gastroesophageal reflux (GERD) are often treated with neglect by both patients and their primary-care givers. Diagnostic evaluation by a specialist is sought only in late stages of the disease, generally when the symptoms or complications have seriously compromised the patients’ well-being. These

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USC Care Marketing Calls

Clinical Information

Thank you for responding to the advertisement about heartburn. In order to provide you the best possible service, we would appreciate if you could answer a few questions that will help our health care professionals understand your needs before returning your call.

Patient Name:

These questions will take less than 5 minutes of your time. Are you ready to begin?

What is your main symptom? experiencing? Heartburn/Day Heartburn/night Hiatal hernia: Reflux: Regurgitation: Chest Pain: Difficulty Swallowing: Vomiting: Burping: Hoarseness: Sore Throat: Difficulty Sleeping:

Date: First Name: Daytime Phone: Zip:

Last Name: Evening phone:

Please answer yes or no regarding the following symptoms you may be experiencing: Heartburn/day heartburn/night chest pain Diff swallowing: Coughing: Burping: Vomiting/regur: Diff sleeping: Other:

Date of Birth:

Allergies What other symptoms have you been How Long? How Long? How Long? How Long? How Long? How Long? How Long? How Long? How Long? How Long? How Long? How Long?

Have you seen a doctor for this condition (Y/N) Further patient History: Please answer yes or no to the following treatments hat have been tried: Prescription Meds: Exercise: Diet No Treatment: Other: Have you ever had surgery for this condition? How did you become aware of the advertisement for hiatal hernia or heartburn.

Before today have you see a doctor for this condition? Specialty of doctor? Have you had previous studies: Radiology: Endoscopy: Which prescription medications have you taken?

What about this ad prompted you to call? Please answer yes or no to the following: Don’t like being on medications: It’s an embarrassing condition? Condition has worsened? Like the idea of a curve vs treatment Ad was convincing Looked like a procedure that I could trust Don’t Know What is your age?

Gender?

What are your expectations of this call? Please answer yes or no Making an appointment: Talking with someone: Discuss the minimally invasive procedure:

What medications are you on at the present time? Previous surgery? Date of return call #1: Date of return call #2: Date of return call #3:

Caller Caller Caller:

Disposition: Info sent to: Date of Appointment: Date of Surgery: Surgeon:

If caller does not want a return call and requests info only, please obtain the following: Address: Fig. 1. Standardized questionnaire for data collection.

facts become immediately evident in a surgical referral practice where large numbers of patients with gastroesophageal reflux are seen. The advent of laparoscopic fundoplication provides a means to relieve symptoms and interrupt the natural history of the disease process, with minimal morbidity and little disruption in the patient’s life. For these reasons we initiated a media campaign promoting minimally invasive surgery as a cure for longstanding heartburn. By introducing minimally invasive surgery as definitive treatment for GERD directly to the affected population, this study eliminated the influence of prevailing and traditional referral practices. The fact that 64% of the responding patients had typical symptoms of gastroesophageal reflux, had consulted one or more physicians, and/or had received

medical treatment for the disease was surprising. Clearly the promotion reached the targeted population. The desire for more information regarding the treatment of gastroesophageal reflux among these patients further suggests that (1) they continued to be symptomatic and (2) they were poorly informed regarding surgical treatment options. Remarkably, more than half of the patients tested were found to have a positive 24-h pH monitoring and qualified as candidates for antireflux surgery. This is surprising given the wide net cast by a marketing campaign. When given the option of medical versus surgical therapy, 78% of patients elected minimally invasive antireflux surgery to control their symptoms. Antireflux surgery has become increasingly accepted in the era of laparoscopy. This reflects a growing recognition

264 Table 1. Response Calls from potential patients GERD probability High Medium Low Information only Contacted (n 4 698) Surgical appointment Medical appointment Information only Patients seen by surgical or medical consultant (n 4 215) 24-h pH monitoring performed Positive 24-h pH studies Surgeries performed

1,389

100%

891 149 47 303

64% 11% 3% 22%

228 68 402

33% 10% 58%

135 77 83

100% 57%

Fig. 4. Findings on 24-h pH monitoring in tested patient population.

Fig. 5. Patient population undergoing surgical therapy. Fig. 2. Demographics and clinical characteristics of responding patient population.

Fig. 3. Triaging results.

that surgery is an excellent means to interrupt the natural history of the disease. The laparoscopic approach minimizes complications related to surgical access as well as postoperative recovery time. Several early outcome analyses have reported successful relief of reflux symptoms in 90% of patients [2, 7–9, 16, 17, 19]. The disturbing trends in the epidemiology of gastroesophageal reflux alluded to above suggest that the traditional stepwise approach to the therapy of GERD is inadequate. Rather, we believe the time has come for a more aggressive diagnostic and therapeutic evaluation in which risk factors for persistent and progressive disease are identified early in the patient’s course, and antireflux therapy chosen accordingly. Patients presenting for the first time with symptoms suggestive of gastroesophageal reflux may be given initial

therapy with H2 blockers. Failure of H2 blockers to control the symptoms, or immediate return of symptoms after stopping treatment, suggests either that the diagnosis is incorrect or that the patient has relatively severe disease. Endoscopic examination at this stage of the patients evaluation provides the opportunity for early identification of complications including Barrett’s esophagus. The patient should be given the option of further diagnostic evaluation allowing an assessment of disease severity or continued empiric therapy. This decision is based largely on the severity of symptoms and the degree of lifestyle changes necessary to control them. Twenty-four-hour esophageal pH monitoring will confirm the diagnosis as well as detect supine and bipositional reflux, both risk factors for disease progression [14]. Esophageal manometry and/or ambulatory esophageal bile monitoring will identify features predictive of severe disease and medical failure, such as a mechanically deficient lower esophageal sphincter [3] and duodenogastroesophageal reflux [10]. In the absence of these risk factors and without endoscopic evidence of erosive esophagitis or Barrett’s metaplasia, the patient’s symptoms may be controlled with proton pump inhibitors [11]. Patients who have these risk factors should be given the option of surgery as a primary therapy with the expectation of long-term control of symptoms and complications.

References 1. Blot WJ, Devesa SS, Kneller RW, Fraumeni JF (1991) Rising incidence of adenocarcinoma of the esophagus and cardia. JAMA 265: 1287–1289

265 2. Cadiere GB, Houben JJ, Bruyns J, Himpens J, Panzer JM, Gelin M (1994) Laparoscopic Nissen fundoplication: technique and preliminary results. Br J Surg 81: 400–403 3. Cadiot G, Bruhat A, Rigaud D, Coste T, Vuagnat A, Benyedder Y, Vallot T, Le Guludec D, Mignon M (1997) Multivariate analysis of pathophysiologic factors in reflux oesophagitis. Gut 40: 167–174 4. Cameron AJ, Zinsmeister AR, Ballard DJ, Adan-Carney J (1990) Prevalence of columnar-lined (Barrett’s) esophagus. Comparison of population-based clinical and autopsy findings. Gastroenterology 99: 918–922 5. De Vault KR, Castell DO (1995) Guidelines for the diagnosis and treatment of gastroesophageal reflux disease. Practice Parameters Committee of the American College of Gastroenterology. Arch Intern Med 155(20): 2165–2173 6. (1988) Heartburn across America: a Gallup Organization national survey. Gallup Organization, Princeton, NJ 7. Hinder RA, Filipi CJ, Wetscher G, Neary P, DeMeester TR, Perdikis G (1994) Laparoscopic Nissen fundoplication is an effective treatment for gastroesophageal reflux disease. Ann Surg 220(4): 472–483 8. Hunter JG, Trus TL, Branum GD, Waring JP, Wood WC (1996) A physiologic approach to laparoscopic fundoplication for gastroesophageal reflux disease. Ann Surg 223: 673–687 9. Jamieson GG, Watson DI, Britten-Jones R, Mitchell PC, Anvari M (1994) Laparoscopic Nissen fundoplication. Ann Surg 220: 137–145 10. Kauer WKH, Peters JH, DeMeester TR, Ireland AP, Bremner CG, Hagen JA (1995) Mixed reflux of gastric and duodenal juices is more harmful to the esophagus than gastric juice alone. The need for surgical therapy reemphasized. Ann Surg 222: 525–533 11. Klinkenberg-Knoll EC, Festen HPM, Jansen JB, Lamers CB, Nelis F, Snel P, Luckers A, Dekkers CP, Havu N, Meuwissen SG (1994) Long term treatment with omeprozole for refractory reflux esophagitis: efficacy and safety. Ann Int Med 121: 161–167 12. Levine DS (1994) Barrett’s esophagus. Sci Am Sci Med 1: 16–25 13. Ollyo JB, Monnier P, Fontolliet C, Savary M (1993) The natural history and incidence of reflux oesophagitis. Gullet 3: 3–10 14. Orr WC, Allen ML, Robinson M (1994) The pattern of nocturnal and diurnal esophageal acid exposure in the pathogenesis of erosive mucosal damage. Am J Gastroenterol 89: 509–512 15. Panos MZ, Walt RP, Stevenson C, Langman MJS (1995) Rising death rate from non-malignant disease of the oesophagus (NMOD) in England and Wales. Gut 36: 488–491 16. Peters JH, Heimbucher J, Kauer WKH, Incarbone R, Bremner CG, DeMeester TR (1995) Clinical and physiologic comparison of laparoscopic and open Nissen. J Am Coll Surg 180: 385–393 17. Pitcher DE, Curet MJ, Martin DT, Castillo RR, Gerstenberger PD, Vogt D, Zucker KA (1994) Successful management of severe gastro-

esophageal reflux disease with laparoscopic Nissen fundoplication. Am J Surg 168: 547–554 18. Sabesin SM, Brosgol FL, Earnest DL, Henderson MD, Jensen DM, Markello R, Orland BI, Peterson WL, Spiro AH, Toskes PP (1996) Results of a GI disease self-assessment test to evaluate primary care proficiency in managed care settings. DDW [abstract], A36 19. Weerts JM, Dallemagne B, Hamoir E, Demarche M, Markiewicz S, Jehaes C, Lombard R, Demoulin JC, Etienne M, Ferron PE, Fontaine F, Gillard V, Delforge M (1993) Laparoscopic Nissen fundoplication; detailed analysis of 132 patients. Surg Laparosc Endosc 3: 359–364

Discussion Dr. Schauer: We’ve certainly come a long way in the last decade, in terms of hospitals directly marketing to their consumers and patients. I have two questions in that regard. The first relates to whether or not you’ve had any ethical dilemmas, in terms of hospital administrators or other physicians, in directly marketing to patients. Secondly, if you could give us an idea how this study was funded. Was it hospital-based funding or corporate sponsor, and if there was corporate funding, was there a direct benefit to the corporation? Dr. de Vos Shoop: I’ll start with the second part of your question. It was a combined funding between corporate and hospital, because the expenses are somewhat substantial. Even so, the revenue we made is well above what we had to invest in it. The first part of your question—ethical concerns. I would ask back, why? All we do is provide the patients with the information—what is minimally invasive surgery in treating GERD. Obviously, there has been an information deficit, because, as you have seen, there were a high number of patients calling in just for information and for explanation—what is this procedure? How is it that they have not been told about it by their primary care physicians? I don’t think there is a real ethical concern, because it is still up to the patient to go back to the primary care physician, discuss the information he receives, and decide on his own. All we offer is information.