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Use of healthcare resources among medically and surgically treated patients with gastroesophageal reflux disease: a population-based study1
Use of Healthcare Resources among Medically and Surgically Treated Patients with Gastroesophageal Reflux Disease: A Population-Based Study Michael D Holzman, MD, MPH, FACS, Edward F Mitchel, MS, Wayne A Ray, PhD, Walter E Smalley, MD, MPH Gastroesophageal reflux disease (GERD) is a common disorder that may be effectively managed medically or surgically. Direct evaluations of medical resource use are needed to better understand the relative costs of these alternatives. This study compared medical care use for a group of patients receiving surgical treatment for GERD with that for a comparable group of patients receiving medical management. STUDY DESIGN: We conducted a retrospective matched cohort study of Tennessee Medicaid (TennCare) patients with GERD undergoing surgical treatment in 1996 and a group of patients who received medical therapy during the same period. Administrative TennCare data provided computerized records that could be used to identify patients and measure healthcare use. There were 7,502 people who met all of the conditions for inclusion in the study, including at least two encounters with a diagnosis of GERD. One hundred thirty-five of these who underwent fundoplication constituted the surgically treated cohort. The 250 persons in the medically treated cohort were selected randomly from the remaining nonsurgical patients and matched to the surgical cohort by age, gender, race, managed care organization, and acid suppression drug use in the baseline year. The principal outcome of interest was total use of medical resources, including prescription medication. RESULTS: The surgical and medical cohorts did not differ significantly by demographic characteristics or by baseline use of pharmaceuticals. During the baseline year the surgically treated patients were prescribed 302 (95% CI: 270–334) days of GERD treatment and the matched medical patients were prescribed 292 (95% CI: 267–317) days of GERD treatment. Surgically treated patients used more GERD-related outpatient resources (physician visits and diagnostic testing) in the baseline year, particularly in the 3 months before operation, when they had a mean of more than four outpatient encounter-days. In the followup year, use of GERD-related pharmaceuticals decreased markedly in the surgical cohort. These patients were prescribed an average of 123 days (95% CI: 94–153) of therapy, which was only 36% of that for medical patients (339 days [95% CI: 308–370]). More than 29% of surgical patients were prescribed no GERD-related drugs in the followup year compared with 6% of the medically treated group. The mean number of inpatient days for the fundoplication procedure was 3.2 (95% CI: 2.7–3.6), with a range of 0 to 13 days. There were no differences between the two groups in other healthcare use. CONCLUSIONS: Our results show that in a 1-year period of followup, surgical treatment of severe gastroesophageal reflux disease led to a 64% postsurgical reduction in GERD medication use, with no increase in use of other medical services. (J Am Coll Surg 2001;192:17–24. © 2001 by the American College of Surgeons) BACKGROUND:
Gastroesophageal reflux disease (GERD) is one of the most prevalent conditions of the gastrointestinal (GI) tract, with an estimated prevalence of 360 affected individuals per 100,000 population.1,2 In 1985, heartburn was the primary or secondary reason for more than 2.5 million office visits in the United States.3 Endoscopic surveys suggest a 4% prevalence of esophagitis4 and pop-
No competing interests declared.
Supported in part by an Industry Scholar Award from the American Digestive Health Foundation (WS). Received December 30, 1999; Revised May 8, 2000; Accepted August 25, 2000. From the Departments of Surgery (Holzman, Smalley), Preventive Medicine (Mitchel, Ray, Smalley), and Medicine (Smalley), Vanderbilt University and Nashville Veteran Affairs Medical Center, Nashville, TN. Correspondence address: Walter Smalley, MD, MPH, C-2104 MCN, VUMC, Nashville, TN 37232.
© 2001 by the American College of Surgeons Published by Elsevier Science Inc.
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ISSN 1072-7515/01/$21.00 PII S1072-7515(00)00746-8
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ulation surveys of US adults estimate that GERD symptoms occur daily in 7%, weekly in 14%, and monthly in 40% of the population.5 For most patients the disease is a chronic disorder with significant morbidity and impaired quality of life many years after their initial diagnosis.6 This leads to a high use of medical resources, which is estimated to exceed $1 billion for persons with esophagitis.3 There is considerable controversy regarding treatment of this disorder.2,7-11 Attempts at lifestyle and diet modification fail frequently, and the majority of patients are treated either medically or surgically8,9,11 with the objectives of healing and prevention of esophagitis and symptoms of GERD. H-2receptor antagonist (H2RAs) and proton pump inhibitors (PPIs) are currently the mainstay of medical therapy. H-2receptor antagonists are efficacious in healing reflux esophagitis of mild to moderate severity and the proton pump inhibitors are effective even in the setting of more severe disease.7 But reflux esophagitis is likely to relapse after initial healing and maintenance acid-suppressive therapy is often necessary.7-9,11-13 So, this chronic condition might realistically require lifelong therapy with medications that are not always well tolerated.14-16 Surgery is also an effective means of controlling chronic reflux disease, although it is associated with possible complications.17-19 Recent reports of antireflux operations in large published series have reported efficacy rates of 84% to 93% in healing and prevention of esophagitis.18-20 There is one prospective randomized trial of medical versus surgical therapy.20 Although this study reported somewhat greater efficacy for surgical therapy, the numbers were relatively small and it was performed in the era before proton pump inhibitors were available for medical therapy and before laparoscopic surgery became the standard approach to antireflux surgery. Despite the controversy regarding medical versus surgical therapy, there is agreement that both modalities are efficacious for the treatment and prevention of esophagitis, so patient preferences and economic factors are likely to play a major role in therapy selection. There are few studies that have directly measured use of healthcare resources among patients treated medically and surgically for GERD. Some studies have used models to evaluate anticipated costs of interventions,21,22 but these may not always reflect actual medical practice and actual outcomes. One recent study reported the use of hospitalization, outpatient visits, and GERD-related
procedures, but did not include important information on pharmaceutical use.23 A summary of a consensus conference of leading gastroenterologists held in 1994 stated “comparative studies of clinical and economic outcome of medical versus surgical therapy (including the use of PPIs and laparoscopic surgery) are lacking, making recommendations for either approach problematic until more data are available.”7 Direct evaluations of medical resource use are needed to better understand the relative costs between medical versus surgical management of GERD. The objective of this study was to compare medical care use for a welldefined group of patients receiving surgical treatment for GERD with that for a comparable group of patients receiving medical management. METHODS Study design
We conducted a retrospective matched cohort study of a group of patients with GERD undergoing surgical treatment and a group of patients who received medical therapy. The study population was drawn from the Tennessee Medicaid program (TennCare),24 which at the time of the study had an annual enrollment of approximately 1.3 million persons. The program maintains an extensive system of data, including a registry of all enrollees and records of patient-provider encounters. Administrative TennCare data provided computerized healthcare records that could be used to identify patients treated medically and surgically for severe GERD. Source of data
The dataset for this study was compiled from four components of the Tennessee Medicaid research database. The Medicaid enrollment file is a central registry of all enrollees that includes demographic characteristics such as date of birth, gender, race, and county of residence and beginning and ending dates of each Medicaid enrollment period. The pharmacy file consists of records of all outpatient and nursing home prescriptions filled at the pharmacy for drugs and medical equipment and supplies included on the Medicaid formulary. An encounter record for each filled prescription includes the enrollee receiving the prescription, date the prescription was filled, the specific drug, and the dose, quantity, and prescribed-days supply of drug. Usually no more than a 30-day supply of medication can be dispensed at one time.
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The hospital encounter file contains the records of hospitalizations for Medicaid enrollees. This record includes hospital admission and discharge dates, primary and secondary diagnoses (ICD-9-CM25), and up to two surgical procedures. The physician encounter file consists of encounter records for emergency room, hospital outpatient department, outpatient surgical facility, and physician visits for Medicaid enrollees. Each record included the date of the visit, the primary and secondary diagnoses (ICD-9-CM25), and any procedure performed (CPT codes26). Identification of the surgical and medical cohorts
Patients were classified as surgically treated if they had an antireflux operation as identified by fundoplication procedural codes (CPT-4 codes 43324–43326 and 56349; ICD-9 codes 44.65 and 44.66) during 1996. A total of 135 of these patients met all entry criteria for the surgical group. For each surgical patient we randomly selected two medically treated GERD patients matched by age (decade), race (Caucasian, African-American, or other/unknown), gender, managed care organization, and acid-suppression intensity (by quartile) in the baseline year. There was not a perfect 2:1 match on all matching criteria, but each patient had at least a 1:1 match for all of the matching criteria. There were 135 surgically treated patients and 250 medically treated patients in the final cohorts. Definition of “zero time”
A major objective of the study was to determine the effect of an operation on subsequent use of medical care. For surgical patients, the “zero time,” or date that the followup year began, was the date of admission for the fundoplication. For medical patients the zero time was the day after the second encounter associated with a GERD diagnosis. (Two encounters with a GERD diagnosis were required to be in either cohort). The baseline year included the 365 days before the zero time. Cohort of GERD patients
Study subjects were TennCare enrollees aged 18 years and older with either medical or surgical treatment for GERD during 1996. Both medical and surgical patients were included only if they met all of the following criteria: 1. Age greater than or equal to 18 years 2. Continuous enrollment for 365 days before and after the zero time, or the date that followup began, which was either the date of operation (for the surgical cohort) or the date of the second GERD encounter (for the medical cohort)
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Table 1. ICD-9-CM Codes Used for Determination of Medical Encounters Encounter
Gastroesophageal reflux disease Esophagitis Esophagitis, unspecified Reflux esophagitis Other esophagitis Ulcer of esophagus Stricture and stenosis of esophagus Other specified disorder of esophagus Gastroesophageal reflux (excludes esophageal reflux) Hiatal hernia Heartburn Gastrointestinal nongastroesophageal reflux disease Other gastrointestinal diagnoses Symptoms involving the digestive system All other diseases
ICD-9-CM code
530.1 530.10 530.11 530.19 530.2 530.3 530.8 530.81 553.3 787.1
531.00–579.99 789.0 ALL OTHER
3. At least two TennCare medical care encounters at least 30 days apart with a diagnostic code for GERD (Table 1) in the baseline year 4. Received at least 90 days of acid-suppression therapy in baseline year
Both medical and surgical patients had at least two encounters with a GERD diagnosis at least 30 days apart and both had received substantial acid-suppression therapy. These last two requirements ensured that both groups of patients had chronic GERD with active treatment. In 1996, the Tennessee Medicaid program had 1.3 million covered lives. We identified 629,454 of these who were older than 18 years and lived through the end of the study period. Of these persons 31,383 had at least one encounter with a GERD diagnosis and 11,765 had at least two GERD encounters. There were 7,502 persons who had at least 90 days of acid-suppression therapy in the baseline year. Study outcomes
The principal outcome of interest was total use of medical resources including prescription medications. Healthcare use was classified into five categories (pharmacy, physician encounters for reflux disease, gastrointestinal diagnostic tests, inpatient days, and all other use) and by the year (baseline or followup) the use occurred. Episodes of utilization were used instead of costs because the payments made to providers in Tennessee Medicaid
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Table 2. Baseline Characteristics of GERD Patients in the Surgical and Medical Cohorts
Characteristic
Age (mean) (y) Female, % Caucasian, % Prescription drug use in baseline year (%) Antibiotic Cardiovascular/hypertension Prescription analgesics Anxiolytic/antidepressant Diabetic Anticancer/metabolite Steroids
Surgical patients (n ⴝ 135)
Medical patients (n ⴝ 250)
46.4 61 84
47.3 60 87
86 56 84 79 7 1 32
90 58 81 76 11 2 30
p ⬎ 0.20 for all comparisons. GERD, gastrointestinal reflux disease
for medical services reflect stringent managed care costcontainment and may not be widely applicable. Pharmacy
The primary medications of interest were those used to treat GERD, which included histamine-2 receptor antagonists, proton pump inhibitors, promotility agents, and antacids. Other medications of interest were classified as all other GI drugs, analgesics, antibiotics, cardiovascular and antihypertensive drugs, diabetic drugs, antineoplastic drugs, pulmonary drugs, psychotropic drugs, corticosteroids, or any other drugs in the baseline and followup years. Exposure to acid-suppression medication was determined from computerized Tennessee Medicaid pharmacy files. Acid-suppression medical use was determined by date, dosage, and days-supply of the prescription. Because there was a wide variance in prescribing patterns (use of different agents, duration, and dose) a common metric for acid-suppression therapy was used. “Standard daily doses” for each individual acid-suppressive medication were defined by using the manufacturer’s recommended daily dose for the treatment of GERD as noted in the Physician’s Desk Reference.27 Standard daily acid-suppressive doses were cimetidine (1,600mg), ranitidine (300mg), famotidine (40mg), nizatidine (300mg), omeprazole (20mg), and lansoprazole (30mg). Using the prescribed-days supply, number of pills prescribed, and dose, we calculated the total number of milligrams of each acid-suppressing drug prescribed to each individual on a monthly basis.
Dividing this amount by the standard daily dose for that drug yielded the “standardized acid-suppression days” for each individual on a monthly basis. Use in the baseline year was categorized in quartiles for the purposes of matching surgical with medical patients. Physician visits
Only one encounter was counted for multiple claims resulting from a single physician visit. Each encounter was classified as a GERD-related encounter, other gastrointestinal encounter, or other outpatient encounter based on diagnosis and procedure codes in Table 1. Diagnostic tests
Diagnostic tests during the study period were identified from physician visit encounters. These studies included upper GI tract endoscopy and barium x-ray studies as well as esophageal manometry and pH testing. Inpatient days
All hospitalizations during the study period were categorized as either gastrointestinal (GI code as admission diagnosis [Table 1]) or other illness. The gastrointestinal group was further subcategorized into GERD if a diagnosis of GERD was an admitting diagnosis or other gastrointestinal illness. Analysis
Mean use was determined and differences between groups were compared using a two-tailed Student’s t-test for continuous variables and the Fisher’s exact test or the Pearson’s chi-square where appropriate for categorical variables. Ninety-five percent confidence intervals were calculated as appropriate using STATA (Stata Corporation, College Station, TX). Comparisons between baseline and followup years were made for both the surgically and medically treated groups. RESULTS The study population was predominately female with a mean age of 47 years (range 18 to 91 years). The surgical and medical cohorts did not differ significantly by other demographic characteristics or by baseline use of several different drug groups (Table 2). By virtue of study matching, the baseline use of GERD medication, as measured by standardized therapy days, was similar in the medical and surgical groups. During the baseline year the surgically treated patients were prescribed 302 (95% CI: 270–334) days of standardized GERD treatment and matched medical patients
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Table 3. Healthcare Use During the Baseline Year for Surgically and Medically Treated Cohorts
Healthcare
GERD drug use (std. days) GERD physician visits Up to last 90 days In last 90 days Other GI physician visits Other physician encounters GERD inpatient days Non-GERD GI inpatient days All other inpatient days Esophageal dilation Esophagogastroduodenoscopy* UGI x-ray* GI motility study* Esophageal pH study*
Surgical cohort (n ⴝ 135) n 95% CI
Medical cohort (n ⴝ 250) n 95% CI
Difference (95% CI)
p Value
302
270–334
292
267–317
10 (⫺31–51)
ns
3.0 4.2 4.0 18 0.5 0.5 2.7 0.30 0.89 0.33 0.43 0.13
2.5–3.4 3.8–4.6 3.3–4.8 15–20 0.2–0.8 0.2–0.8 1.4–4.0 0.22–0.41 0.74–1.06 0.24–0.45 0.33–0.56 0.08–0.21
2.1 1.9 3.9 17 0.2 0.8 4.0 0.19 0.57 0.20 0.04 0.02
1.8–2.3 1.7–2.1 3.2–4.5 15–19 0.1–0.3 0.4–1.2 2.6–5.4 0.14–0.25 0.48–0.67 0.15–0.26 0.02–0.08 0.01–0.05
0.9 (0.4–1.3) 2.3 (1.9–2.7) 0.2 (⫺0.9–1.2) 0.3 (⫺3.0–3.6) 0.3 (0.1–0.6) ⫺0.3 (⫺0.9–0.3) ⫺1.3 (⫺3.4–0.8) 0.12 (0.01–0.22) 0.32 (0.13–0.50) 0.13 (0.02–0.25) 0.39 (0.27–0.50) 0.11 (0.04–0.17)
.05 .001 ns ns .05 ns ns .05 .05 .05 .05 .05
*Means or proportions for various outcomes (95% confidence intervals). GERD, gastrointestinal reflux disease; GI, gastrointestinal; UGI, upper gastrointestinal.
were prescribed 292 (95% CI: 267–317) days (Table 3). In the 3 months before the zero time, 49% of the surgical group and 44% of the medical group were prescribed recommended doses of pharmaceutical GERD therapy (p⫽ 0.40). In the last 3 months of the baseline year proton pump inhibitors were dispensed to 53% and 33% of the surgical and medical groups, respectively (p⫽0.001). There were also differences in the proportions of surgical and medical patients receiving H-2 antagonists (57% and 72%, p⫽0.003). In both groups 41% received motility agents in the last 3 months of the baseline year. Diagnostic testing in the baseline year was more common among patients in the surgical cohort: 89% of the surgical patients had upper GI endoscopy compared with 57% of the medically treated group. There were more marked differences in the use of esophageal manometry (43% surgical compared with 4% medical) and pH monitoring (13% surgical compared with 2% medical) (p⬍0.001 for all comparisons). Surgically treated patients used more GERD-related outpatient resources (physician visits and diagnostic testing) in the baseline year, particularly in the 3 months before surgery when they had a mean of more than four outpatient encounter-days. Use of other types of outpatient encounters was similar between the two groups. Hospitalizations with GERD-related problems during the baseline year occurred in 9% of surgically treated patients (2 to 13 days) and 4% of medically treated patients (1 to 7 days) (p⫽0.049). There were no significant differences be-
tween the medically and surgically treated groups in the use of outpatient or inpatient care for other types of (nonGERD) GI care during the baseline year. During the baseline year there were more inpatient days for nonstudy conditions in the medically treated cohort (4.03, 95% CI: 2.64–5.42) than in the surgical cohort (2.70, 95% CI: 1.40–4.00), but the difference between these estimates did not vary significantly from chance (p⫽0.22). In the followup year there was a marked decrease in the use of GERD-related pharmaceuticals in the surgical patients, who were prescribed an average of 123 days (95% CI: 94–153) of standardized daily doses (Table 4; Fig. 1). Use of GERD drugs in the medical cohort increased in the followup year to 339 (95% CI: 308–370) standardized days of therapy. Over 29% of patients in the surgical group were prescribed no GERD-related drugs in the followup year compared with 6% of the medically treated group (Table 5). Conversely, only 8% of the surgically treated patients received more than 365 days of standardized daily doses of GERD therapy during the followup year; 39% of the medically treated group received such intense therapy. The mean number of inpatient days for the fundoplication procedure was 3.2 (95% CI: 2.7–3.6) with a range of 0 to 13 days. Thirty-nine procedures (29%) were done in an outpatient surgical facility. During the followup year the mean number of diagnostic upper GI barium studies (including video fluoroscopy swallowing studies) was higher among those
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Table 4. Healthcare Use During the Followup Year for the Surgically and Medically Treated Cohorts
Healthcare
GERD drug use (std. days) GERD physician visits In first 90 days After the first 90 days Other GI physician visits Other physician encounters GERD inpatient days associated with fundoplication Other GERD inpatient days Non-GERD GI inpatient days All other inpatient days Esophageal dilation Esophagogastroduodenoscopy* UGI x-ray* GI motility study* Esophageal pH study*
Surgical cohort (n ⴝ 135) n 95% CI
Medical cohort (n ⴝ 250) n 95% CI
123
94–153
339
308–370
0.9 1.4 3.5 18
0.7–1.1 1.0–1.8 2.7–4.2 15–20
0.8 1.5 3.7 18
0.6–0.9 1.2–1.7 2.7–4.6 16–20
3.2 0.3 1.4 3.7 0.16 0.34 0.41 0.04
2.7–3.6 0.1–0.5 0.6–2.2 2.0–5.4 0.10–0.24 0.25–0.45 0.31–0.54 0.01–0.09 0
0.3 1.5 3.5 0.15 0.36 0.08 0.02 0.01
— 0.1–0.5 0.7–2.3 2.3–4.6 0.10–0.20 0.29–0.44 0.05–0.13 0.00–0.04 0.00–0.04
Difference (95% CI)
p Value
⫺216 (⫺216 to ⫺168)
⬍ 0.001
0.2 (⫺0.1–⫺0.4) ⫺0.1 (0.5–0.4) ⫺0.2 (⫺1.7–1.2) ⫺0.4 (⫺3.7–2.8) — ⫺0.1 (⫺0.4–0.2) ⫺0.1 (⫺1.3–1.1) 0.2 (⫺1.7–2.2) 0.01 (⫺0.07–0.09) ⫺0.02 (⫺0.14–0.40) 0.33 (0.22–0.44) 0.02 (⫺0.02–0.06) ⫺0.01 (⫺0.03–0.00)
ns ns ns ns — ns ns ns ns ns ⬍ 0.05 ns ⬍ 0.05
*Means or proportions for various outcomes (95% confidence intervals). GERD, gastrointestinal reflux disease; GI, gastrointestinal; UGI, upper gastrointestinal.
treated surgically (0.42 [95% CI: 0.33–0.50]) than medically (0.08 [95% CI: 0.05–0.12], p value for comparison between the two groups ⬍ 0.0001). But the use of upper GI endoscopy, esophageal pH tests,
esophageal motility studies, and esophageal dilation was similar in the two groups. In these study groups no patient received more than one of these specific diagnostic tests.
Figure 1. Use of pharmacologic GERD therapy in surgically and medically treated patients, by month. GERD, gastrointestinal reflux disease.
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DISCUSSION In recent years there has been an increased awareness among patients and physicians of the diagnosis of gastroesophageal reflux disease. This has been accompanied by an increase in the apparent prevalence of the disease.9 This trend has substantial economic consequences because the majority of medically treated individuals with severe GERD will require lifelong therapy.7-9,11-13 We sought to better determine total healthcare use for patients with GERD treated medically or surgically. Our results suggest that surgically treated patients had a substantial decrease in the use of GERD pharmaceuticals and that use of other forms of healthcare did not increase in these patients. In this setting the reduction in drug use came at the cost of the fundoplication procedure and a mean of 3 hospital days associated with the procedure. Previous studies evaluating healthcare use in GERD patients have been based either on a single institutional experience or modeling with cost estimates.21,22,28-31 The current study is a population-based analysis, which includes a variety of practice settings in Tennessee. The use of administrative data from the Tennessee Medicaid program permitted measurement of the use of several types of healthcare resources from the perspective of a thirdparty payor. We studied use rather than costs because the latter would have only limited generalizability because of the steep discounts mandated by TennCare. Use of administrative data alone may limit the ability to definitively categorize diagnoses. Because information regarding each patient encounter is limited to diagnosis and procedural codes, the exact indication for surgical intervention or medical therapy cannot be determined. In this study limiting the inclusion criteria to those patients who had multiple encounters associated with GERD codes and who also used acid-suppressing drugs likely improved the overall diagnostic accuracy of gastroesophageal reflux in these patients. The cohorts of medical and surgical patients were very similar in their demographics and in baseline use of healthcare resources. An important limitation of administrative datasets is the lack of information on the patient’s health status or quality of life. So it is not possible to conclude from this study which therapy is more effective or if either cohort of patients was satisfied with their GERD therapy. The answers to these important questions will come from prospective studies (preferably randomized controlled trials). An additional limitation of the study is the lack of generalizability caused by the unique demographics of the TennCare pop-
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Table 5. Distribution of Prescribed GERD Therapy During Followup Year among Surgically and Medically Treated People in the Tennessee Medicaid Program, 1996 –1997 Standardized GERD therapy days
0 ⱕ 30 31–90 91–365 ⬎ 365
Surgical cohort (%)
Medical cohort (%)
29 18 16 29 8
6 4 7 44 39
Pearson’s chi-square test, p ⬍ 0.0001. GERD, gastrointestinal reflux disease.
ulation. Though the disease process itself should not vary from the general population, access to medical care, overall medical care use, and patient compliance may vary from the general population. Given the severe cost controls used in the Tennessee Medicaid (TennCare) model, use of expensive pharmaceuticals is probably less common in this population than in other insured settings. This study is limited by the short followup period and further studies will be necessary to demonstrate longterm effects of surgical therapy for GERD. If the decreased use of GERD pharmaceuticals seen among the surgical patients in this study persists, the potential cost savings of surgical treatment could be significant. The use of acid-suppression medications by surgically treated patients in the postoperative period could be the result of several factors. Whether this represents a surgical “failure” cannot be answered directly. It is possible that some patients who use acid suppression after fundoplication represent “surgical failures,” but this study design is limited by the inability to determine patient satisfaction or “quality of life.” In fact, some patients who use acid-suppressing drugs after surgical therapy may have fewer symptoms than before surgical therapy. In addition, this pharmaceutical use may represent “new prescriptions” or simply “continued dispensing” of older prescriptions—events which could not be well categorized determined from the database. Improvements in the efficient management of surgical patients could increase the economic benefits of surgical management. In this study, 28% of the fundoplication procedures were performed in the outpatient setting and the mean number of hospital days was more than 3 for the entire surgical cohort. It is likely that, in the time since the study period of 1996–1997, increased use of outpatient surgery has decreased inpatient use. The high use of GERD-related physician visits observed
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before and immediately after the operation likely represents visits for perioperative care. We would anticipate a continued decrease in GERD-related visits among postoperative patients during the period after perioperative time frame (90 days) in studies with longer followup. We expect that a longer followup period will allow better evaluation of important remaining questions. The longterm effects of fundoplication on resource use have yet to be well characterized. It is unclear what patient characteristics best predict successful outcomes. Finally, variations in outcomes by characteristics of individual surgeons could not be adequately assessed because of the small numbers in this study. This is a potentially important issue and needs to be further investigated using other, more extensive, study designs. In conclusion, gastroesophageal reflux disease is a common problem in the general population. Both medical and surgical therapies have been proved to be efficacious in the treatment of symptoms and esophagitis. But this is a chronic disorder that results in substantial financial burden to either the patient or their third-party provider. Our results show that a 1-year period of followup surgical treatment of severe gastroesophageal reflux disease led to a 64% postsurgical reduction in GERD medication use, with no increase in use of other medical services. REFERENCES 1. Richter JR. Surgery for reflux disease—reflections of a gastroenterologist. N Engl J Med 1992;326:825–827. 2. Klingman RR. The current management of gastroesophageal reflux. Adv Sur 1991;24:259–291. 3. Digestive diseases in the United States: Epidemiology and impact. Bethesda, MD: US Department of Health and Human Services; 1994. 4. Tibbling L. Epidemiology of gastro-oesphageal reflux disease. Scand J Gastroenterol 1984;19(Suppl 106):14–18. 5. Nebel OT, Fornes MT, Castell DO. Symptomatic gastroesophageal reflux: Incidence and precipitating factors. Am J Dig Dis 1976;21:953–956. 6. McDoughall NI, Johnsont BT, Kee F, et al. Natural history of reflux oesophagitis: A 10-year followup of its effect on patient symptomatology and quality of life. Gut 1996;38:481–486. 7. Fennerty MB, Castell D, Fendrick AM, et al. The diagnosis and treatment of gastroesophageal reflux disease in the managed care environment. Arch Intern Med 1996;156:477–484. 8. Weinberg DS, Kadish SL. The diagnosis and management of gastroesophageal reflux disease. Med Clin North Am 1996;80: 411–429. 9. Moss SF, Arnold R, Tygat GNJ, et al. Consensus statement for management of gastroesophageal reflux disease. J Clin Gastroenterol 1998;27:6–12. 10. Fuchs KH, Feussner H, Bonavina L, et al. Current status and trend in laparoscopic antireflux surgery: Results of a consensus meeting. Endoscopy 1997;29:298–308.
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11. Reynolds JC. Influence of pathophysiology, severity, and cost on the medical management of gastroesophageal reflux disease. Am J Health-Syst Pharm 1996;53:S5–S12. 12. Hetzel DJ, Dent J, Reed WD. Healing and relapse of severe peptic esophagitis after treatment with omeprazole. Gastroenterol 1988;95:903–912. 13. Lee JM, O’Morain CA. Trends in the management of gastrooesophageal reflux disease. Postgrad Med J 1998;74:145–150. 14. Solvell L. The clinical safety of omeprazole. Scand J Gastroenterol 1989;24:106–110. 15. Brunner G, Creutfeldt W. Omeprazole in the long-term treatment of patients with acid-related disease resistant to ranitidine. Scand J Gastroenterol 1989;24:101–105. 16. Colin-Jones DG. Safety of lansoprazole. Aliment Pharmacol Therap 1993;7:56–60. 17. Seiwert JR, Feussner H. Surgical considerations for antireflux therapy. Scand J Gastroenterol 1989;24:50–59. 18. Hunter JG, Trus TL, Braun GD, et al. A physiologic approach to laparoscopic fundoplication for gastroesophageal reflux disease. Ann Surg 1996;223:673–687. 19. Lundell L, Abrhamsson H, Ruth M, et al. Long-term results of a prospective randomized comparison of total fundic wrap (Nissen-Rossetti) of semifundoplication (Toupet) for gastroesophageal reflux. Br J Surg 1996;83:830–835. 20. Spechler SJ, Department of Veterans Affairs Gastroesophageal Reflux Disease Study Group. Comparison of medical and surgical therapy for complicated gastroesophageal reflux in veterans. N Engl J Med 1992;326:786–792. 21. Hillman AL, Bloom BS, Fendrick AM, Schwartz JS. Cost and quality effects of alternative treatments for persistent gastroesophageal reflux disease. Arch Intern Med 1992;152:1467–1472. 22. Heudebert GR, Marks R, Wilcox CM, Centor RM. Choice of long-term strategy for the management of patients with severe esophagitis: A cost-utility analysis. Gastroenterol 1997;112: 1078–1086. 23. El-Serag HB, Sonnenberg A. Outcome of erosive reflux esophagitis after nissen fundoplication. Am J Gastroenterol 1999;94: 1771–1776. 24. Ray WA, Griffin MR. Use of Medicaid data for pharmacoepidemiology. Am J Epidemiol 1989;129:837–849. 25. US Department of Health and Human Services. The International Classification of Diseases, 9th Revision, Clinical Modification, ICD 9 CM. 2nd ed. Washington, DC: US Government Printing Office; 1980. 26. Kirshner CG, Burkett RC, Coy JA, et al. Physicians’ current procedural terminology. 4th ed. Chicago, IL: American Medical Association; 1993. 27. Arky R. Physicians desk reference. 51st ed. Montvale, NJ: Medical Economics; 1997. 28. Van Den Boom G, Go PMMYH, Hameeteman W, et al. Cost effectiveness of medical versus surgical treatment in patients with severe or refractory gastroesophageal reflux disease in The Netherlands. Scand J Gastroenterol 1996;31:1–9. 29. Lundell L, Dalenback J, Janatuinen E, et al. Comprehensive 1-year cost analysis of open antireflux surgery in Nordic countries. Br J Surg 1998;85:1002–1005. 30. Levin TR, Schmittdiel JA, Kunz K, et al. Costs of acid-related disorders to a health maintenance organization. Am J Med 1997;103:520–528. 31. Isolauri J, Luostarinen M, Viljakka M, et al. Long-term comparison of antireflux surgery versus conservative therapy for reflux esophagitis. Ann Surg 1997;225:295–299.
Gastroesophageal reflux disease (GERD) is one of the most prevalent conditions of the gastrointestinal (GI) tract, with an estimated prevalence of 360 affected individuals per 100,000 population.1,2 In 1985, heartburn was the primary or secondary reason for more than 2.5 million office visits in the United States.3 Endoscopic surveys suggest a 4% prevalence of esophagitis4 and pop-
No competing interests declared.
Supported in part by an Industry Scholar Award from the American Digestive Health Foundation (WS). Received December 30, 1999; Revised May 8, 2000; Accepted August 25, 2000. From the Departments of Surgery (Holzman, Smalley), Preventive Medicine (Mitchel, Ray, Smalley), and Medicine (Smalley), Vanderbilt University and Nashville Veteran Affairs Medical Center, Nashville, TN. Correspondence address: Walter Smalley, MD, MPH, C-2104 MCN, VUMC, Nashville, TN 37232.
© 2001 by the American College of Surgeons Published by Elsevier Science Inc.
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ulation surveys of US adults estimate that GERD symptoms occur daily in 7%, weekly in 14%, and monthly in 40% of the population.5 For most patients the disease is a chronic disorder with significant morbidity and impaired quality of life many years after their initial diagnosis.6 This leads to a high use of medical resources, which is estimated to exceed $1 billion for persons with esophagitis.3 There is considerable controversy regarding treatment of this disorder.2,7-11 Attempts at lifestyle and diet modification fail frequently, and the majority of patients are treated either medically or surgically8,9,11 with the objectives of healing and prevention of esophagitis and symptoms of GERD. H-2receptor antagonist (H2RAs) and proton pump inhibitors (PPIs) are currently the mainstay of medical therapy. H-2receptor antagonists are efficacious in healing reflux esophagitis of mild to moderate severity and the proton pump inhibitors are effective even in the setting of more severe disease.7 But reflux esophagitis is likely to relapse after initial healing and maintenance acid-suppressive therapy is often necessary.7-9,11-13 So, this chronic condition might realistically require lifelong therapy with medications that are not always well tolerated.14-16 Surgery is also an effective means of controlling chronic reflux disease, although it is associated with possible complications.17-19 Recent reports of antireflux operations in large published series have reported efficacy rates of 84% to 93% in healing and prevention of esophagitis.18-20 There is one prospective randomized trial of medical versus surgical therapy.20 Although this study reported somewhat greater efficacy for surgical therapy, the numbers were relatively small and it was performed in the era before proton pump inhibitors were available for medical therapy and before laparoscopic surgery became the standard approach to antireflux surgery. Despite the controversy regarding medical versus surgical therapy, there is agreement that both modalities are efficacious for the treatment and prevention of esophagitis, so patient preferences and economic factors are likely to play a major role in therapy selection. There are few studies that have directly measured use of healthcare resources among patients treated medically and surgically for GERD. Some studies have used models to evaluate anticipated costs of interventions,21,22 but these may not always reflect actual medical practice and actual outcomes. One recent study reported the use of hospitalization, outpatient visits, and GERD-related
procedures, but did not include important information on pharmaceutical use.23 A summary of a consensus conference of leading gastroenterologists held in 1994 stated “comparative studies of clinical and economic outcome of medical versus surgical therapy (including the use of PPIs and laparoscopic surgery) are lacking, making recommendations for either approach problematic until more data are available.”7 Direct evaluations of medical resource use are needed to better understand the relative costs between medical versus surgical management of GERD. The objective of this study was to compare medical care use for a welldefined group of patients receiving surgical treatment for GERD with that for a comparable group of patients receiving medical management. METHODS Study design
We conducted a retrospective matched cohort study of a group of patients with GERD undergoing surgical treatment and a group of patients who received medical therapy. The study population was drawn from the Tennessee Medicaid program (TennCare),24 which at the time of the study had an annual enrollment of approximately 1.3 million persons. The program maintains an extensive system of data, including a registry of all enrollees and records of patient-provider encounters. Administrative TennCare data provided computerized healthcare records that could be used to identify patients treated medically and surgically for severe GERD. Source of data
The dataset for this study was compiled from four components of the Tennessee Medicaid research database. The Medicaid enrollment file is a central registry of all enrollees that includes demographic characteristics such as date of birth, gender, race, and county of residence and beginning and ending dates of each Medicaid enrollment period. The pharmacy file consists of records of all outpatient and nursing home prescriptions filled at the pharmacy for drugs and medical equipment and supplies included on the Medicaid formulary. An encounter record for each filled prescription includes the enrollee receiving the prescription, date the prescription was filled, the specific drug, and the dose, quantity, and prescribed-days supply of drug. Usually no more than a 30-day supply of medication can be dispensed at one time.
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The hospital encounter file contains the records of hospitalizations for Medicaid enrollees. This record includes hospital admission and discharge dates, primary and secondary diagnoses (ICD-9-CM25), and up to two surgical procedures. The physician encounter file consists of encounter records for emergency room, hospital outpatient department, outpatient surgical facility, and physician visits for Medicaid enrollees. Each record included the date of the visit, the primary and secondary diagnoses (ICD-9-CM25), and any procedure performed (CPT codes26). Identification of the surgical and medical cohorts
Patients were classified as surgically treated if they had an antireflux operation as identified by fundoplication procedural codes (CPT-4 codes 43324–43326 and 56349; ICD-9 codes 44.65 and 44.66) during 1996. A total of 135 of these patients met all entry criteria for the surgical group. For each surgical patient we randomly selected two medically treated GERD patients matched by age (decade), race (Caucasian, African-American, or other/unknown), gender, managed care organization, and acid-suppression intensity (by quartile) in the baseline year. There was not a perfect 2:1 match on all matching criteria, but each patient had at least a 1:1 match for all of the matching criteria. There were 135 surgically treated patients and 250 medically treated patients in the final cohorts. Definition of “zero time”
A major objective of the study was to determine the effect of an operation on subsequent use of medical care. For surgical patients, the “zero time,” or date that the followup year began, was the date of admission for the fundoplication. For medical patients the zero time was the day after the second encounter associated with a GERD diagnosis. (Two encounters with a GERD diagnosis were required to be in either cohort). The baseline year included the 365 days before the zero time. Cohort of GERD patients
Study subjects were TennCare enrollees aged 18 years and older with either medical or surgical treatment for GERD during 1996. Both medical and surgical patients were included only if they met all of the following criteria: 1. Age greater than or equal to 18 years 2. Continuous enrollment for 365 days before and after the zero time, or the date that followup began, which was either the date of operation (for the surgical cohort) or the date of the second GERD encounter (for the medical cohort)
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Table 1. ICD-9-CM Codes Used for Determination of Medical Encounters Encounter
Gastroesophageal reflux disease Esophagitis Esophagitis, unspecified Reflux esophagitis Other esophagitis Ulcer of esophagus Stricture and stenosis of esophagus Other specified disorder of esophagus Gastroesophageal reflux (excludes esophageal reflux) Hiatal hernia Heartburn Gastrointestinal nongastroesophageal reflux disease Other gastrointestinal diagnoses Symptoms involving the digestive system All other diseases
ICD-9-CM code
530.1 530.10 530.11 530.19 530.2 530.3 530.8 530.81 553.3 787.1
531.00–579.99 789.0 ALL OTHER
3. At least two TennCare medical care encounters at least 30 days apart with a diagnostic code for GERD (Table 1) in the baseline year 4. Received at least 90 days of acid-suppression therapy in baseline year
Both medical and surgical patients had at least two encounters with a GERD diagnosis at least 30 days apart and both had received substantial acid-suppression therapy. These last two requirements ensured that both groups of patients had chronic GERD with active treatment. In 1996, the Tennessee Medicaid program had 1.3 million covered lives. We identified 629,454 of these who were older than 18 years and lived through the end of the study period. Of these persons 31,383 had at least one encounter with a GERD diagnosis and 11,765 had at least two GERD encounters. There were 7,502 persons who had at least 90 days of acid-suppression therapy in the baseline year. Study outcomes
The principal outcome of interest was total use of medical resources including prescription medications. Healthcare use was classified into five categories (pharmacy, physician encounters for reflux disease, gastrointestinal diagnostic tests, inpatient days, and all other use) and by the year (baseline or followup) the use occurred. Episodes of utilization were used instead of costs because the payments made to providers in Tennessee Medicaid
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Table 2. Baseline Characteristics of GERD Patients in the Surgical and Medical Cohorts
Characteristic
Age (mean) (y) Female, % Caucasian, % Prescription drug use in baseline year (%) Antibiotic Cardiovascular/hypertension Prescription analgesics Anxiolytic/antidepressant Diabetic Anticancer/metabolite Steroids
Surgical patients (n ⴝ 135)
Medical patients (n ⴝ 250)
46.4 61 84
47.3 60 87
86 56 84 79 7 1 32
90 58 81 76 11 2 30
p ⬎ 0.20 for all comparisons. GERD, gastrointestinal reflux disease
for medical services reflect stringent managed care costcontainment and may not be widely applicable. Pharmacy
The primary medications of interest were those used to treat GERD, which included histamine-2 receptor antagonists, proton pump inhibitors, promotility agents, and antacids. Other medications of interest were classified as all other GI drugs, analgesics, antibiotics, cardiovascular and antihypertensive drugs, diabetic drugs, antineoplastic drugs, pulmonary drugs, psychotropic drugs, corticosteroids, or any other drugs in the baseline and followup years. Exposure to acid-suppression medication was determined from computerized Tennessee Medicaid pharmacy files. Acid-suppression medical use was determined by date, dosage, and days-supply of the prescription. Because there was a wide variance in prescribing patterns (use of different agents, duration, and dose) a common metric for acid-suppression therapy was used. “Standard daily doses” for each individual acid-suppressive medication were defined by using the manufacturer’s recommended daily dose for the treatment of GERD as noted in the Physician’s Desk Reference.27 Standard daily acid-suppressive doses were cimetidine (1,600mg), ranitidine (300mg), famotidine (40mg), nizatidine (300mg), omeprazole (20mg), and lansoprazole (30mg). Using the prescribed-days supply, number of pills prescribed, and dose, we calculated the total number of milligrams of each acid-suppressing drug prescribed to each individual on a monthly basis.
Dividing this amount by the standard daily dose for that drug yielded the “standardized acid-suppression days” for each individual on a monthly basis. Use in the baseline year was categorized in quartiles for the purposes of matching surgical with medical patients. Physician visits
Only one encounter was counted for multiple claims resulting from a single physician visit. Each encounter was classified as a GERD-related encounter, other gastrointestinal encounter, or other outpatient encounter based on diagnosis and procedure codes in Table 1. Diagnostic tests
Diagnostic tests during the study period were identified from physician visit encounters. These studies included upper GI tract endoscopy and barium x-ray studies as well as esophageal manometry and pH testing. Inpatient days
All hospitalizations during the study period were categorized as either gastrointestinal (GI code as admission diagnosis [Table 1]) or other illness. The gastrointestinal group was further subcategorized into GERD if a diagnosis of GERD was an admitting diagnosis or other gastrointestinal illness. Analysis
Mean use was determined and differences between groups were compared using a two-tailed Student’s t-test for continuous variables and the Fisher’s exact test or the Pearson’s chi-square where appropriate for categorical variables. Ninety-five percent confidence intervals were calculated as appropriate using STATA (Stata Corporation, College Station, TX). Comparisons between baseline and followup years were made for both the surgically and medically treated groups. RESULTS The study population was predominately female with a mean age of 47 years (range 18 to 91 years). The surgical and medical cohorts did not differ significantly by other demographic characteristics or by baseline use of several different drug groups (Table 2). By virtue of study matching, the baseline use of GERD medication, as measured by standardized therapy days, was similar in the medical and surgical groups. During the baseline year the surgically treated patients were prescribed 302 (95% CI: 270–334) days of standardized GERD treatment and matched medical patients
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Table 3. Healthcare Use During the Baseline Year for Surgically and Medically Treated Cohorts
Healthcare
GERD drug use (std. days) GERD physician visits Up to last 90 days In last 90 days Other GI physician visits Other physician encounters GERD inpatient days Non-GERD GI inpatient days All other inpatient days Esophageal dilation Esophagogastroduodenoscopy* UGI x-ray* GI motility study* Esophageal pH study*
Surgical cohort (n ⴝ 135) n 95% CI
Medical cohort (n ⴝ 250) n 95% CI
Difference (95% CI)
p Value
302
270–334
292
267–317
10 (⫺31–51)
ns
3.0 4.2 4.0 18 0.5 0.5 2.7 0.30 0.89 0.33 0.43 0.13
2.5–3.4 3.8–4.6 3.3–4.8 15–20 0.2–0.8 0.2–0.8 1.4–4.0 0.22–0.41 0.74–1.06 0.24–0.45 0.33–0.56 0.08–0.21
2.1 1.9 3.9 17 0.2 0.8 4.0 0.19 0.57 0.20 0.04 0.02
1.8–2.3 1.7–2.1 3.2–4.5 15–19 0.1–0.3 0.4–1.2 2.6–5.4 0.14–0.25 0.48–0.67 0.15–0.26 0.02–0.08 0.01–0.05
0.9 (0.4–1.3) 2.3 (1.9–2.7) 0.2 (⫺0.9–1.2) 0.3 (⫺3.0–3.6) 0.3 (0.1–0.6) ⫺0.3 (⫺0.9–0.3) ⫺1.3 (⫺3.4–0.8) 0.12 (0.01–0.22) 0.32 (0.13–0.50) 0.13 (0.02–0.25) 0.39 (0.27–0.50) 0.11 (0.04–0.17)
.05 .001 ns ns .05 ns ns .05 .05 .05 .05 .05
*Means or proportions for various outcomes (95% confidence intervals). GERD, gastrointestinal reflux disease; GI, gastrointestinal; UGI, upper gastrointestinal.
were prescribed 292 (95% CI: 267–317) days (Table 3). In the 3 months before the zero time, 49% of the surgical group and 44% of the medical group were prescribed recommended doses of pharmaceutical GERD therapy (p⫽ 0.40). In the last 3 months of the baseline year proton pump inhibitors were dispensed to 53% and 33% of the surgical and medical groups, respectively (p⫽0.001). There were also differences in the proportions of surgical and medical patients receiving H-2 antagonists (57% and 72%, p⫽0.003). In both groups 41% received motility agents in the last 3 months of the baseline year. Diagnostic testing in the baseline year was more common among patients in the surgical cohort: 89% of the surgical patients had upper GI endoscopy compared with 57% of the medically treated group. There were more marked differences in the use of esophageal manometry (43% surgical compared with 4% medical) and pH monitoring (13% surgical compared with 2% medical) (p⬍0.001 for all comparisons). Surgically treated patients used more GERD-related outpatient resources (physician visits and diagnostic testing) in the baseline year, particularly in the 3 months before surgery when they had a mean of more than four outpatient encounter-days. Use of other types of outpatient encounters was similar between the two groups. Hospitalizations with GERD-related problems during the baseline year occurred in 9% of surgically treated patients (2 to 13 days) and 4% of medically treated patients (1 to 7 days) (p⫽0.049). There were no significant differences be-
tween the medically and surgically treated groups in the use of outpatient or inpatient care for other types of (nonGERD) GI care during the baseline year. During the baseline year there were more inpatient days for nonstudy conditions in the medically treated cohort (4.03, 95% CI: 2.64–5.42) than in the surgical cohort (2.70, 95% CI: 1.40–4.00), but the difference between these estimates did not vary significantly from chance (p⫽0.22). In the followup year there was a marked decrease in the use of GERD-related pharmaceuticals in the surgical patients, who were prescribed an average of 123 days (95% CI: 94–153) of standardized daily doses (Table 4; Fig. 1). Use of GERD drugs in the medical cohort increased in the followup year to 339 (95% CI: 308–370) standardized days of therapy. Over 29% of patients in the surgical group were prescribed no GERD-related drugs in the followup year compared with 6% of the medically treated group (Table 5). Conversely, only 8% of the surgically treated patients received more than 365 days of standardized daily doses of GERD therapy during the followup year; 39% of the medically treated group received such intense therapy. The mean number of inpatient days for the fundoplication procedure was 3.2 (95% CI: 2.7–3.6) with a range of 0 to 13 days. Thirty-nine procedures (29%) were done in an outpatient surgical facility. During the followup year the mean number of diagnostic upper GI barium studies (including video fluoroscopy swallowing studies) was higher among those
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Table 4. Healthcare Use During the Followup Year for the Surgically and Medically Treated Cohorts
Healthcare
GERD drug use (std. days) GERD physician visits In first 90 days After the first 90 days Other GI physician visits Other physician encounters GERD inpatient days associated with fundoplication Other GERD inpatient days Non-GERD GI inpatient days All other inpatient days Esophageal dilation Esophagogastroduodenoscopy* UGI x-ray* GI motility study* Esophageal pH study*
Surgical cohort (n ⴝ 135) n 95% CI
Medical cohort (n ⴝ 250) n 95% CI
123
94–153
339
308–370
0.9 1.4 3.5 18
0.7–1.1 1.0–1.8 2.7–4.2 15–20
0.8 1.5 3.7 18
0.6–0.9 1.2–1.7 2.7–4.6 16–20
3.2 0.3 1.4 3.7 0.16 0.34 0.41 0.04
2.7–3.6 0.1–0.5 0.6–2.2 2.0–5.4 0.10–0.24 0.25–0.45 0.31–0.54 0.01–0.09 0
0.3 1.5 3.5 0.15 0.36 0.08 0.02 0.01
— 0.1–0.5 0.7–2.3 2.3–4.6 0.10–0.20 0.29–0.44 0.05–0.13 0.00–0.04 0.00–0.04
Difference (95% CI)
p Value
⫺216 (⫺216 to ⫺168)
⬍ 0.001
0.2 (⫺0.1–⫺0.4) ⫺0.1 (0.5–0.4) ⫺0.2 (⫺1.7–1.2) ⫺0.4 (⫺3.7–2.8) — ⫺0.1 (⫺0.4–0.2) ⫺0.1 (⫺1.3–1.1) 0.2 (⫺1.7–2.2) 0.01 (⫺0.07–0.09) ⫺0.02 (⫺0.14–0.40) 0.33 (0.22–0.44) 0.02 (⫺0.02–0.06) ⫺0.01 (⫺0.03–0.00)
ns ns ns ns — ns ns ns ns ns ⬍ 0.05 ns ⬍ 0.05
*Means or proportions for various outcomes (95% confidence intervals). GERD, gastrointestinal reflux disease; GI, gastrointestinal; UGI, upper gastrointestinal.
treated surgically (0.42 [95% CI: 0.33–0.50]) than medically (0.08 [95% CI: 0.05–0.12], p value for comparison between the two groups ⬍ 0.0001). But the use of upper GI endoscopy, esophageal pH tests,
esophageal motility studies, and esophageal dilation was similar in the two groups. In these study groups no patient received more than one of these specific diagnostic tests.
Figure 1. Use of pharmacologic GERD therapy in surgically and medically treated patients, by month. GERD, gastrointestinal reflux disease.
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DISCUSSION In recent years there has been an increased awareness among patients and physicians of the diagnosis of gastroesophageal reflux disease. This has been accompanied by an increase in the apparent prevalence of the disease.9 This trend has substantial economic consequences because the majority of medically treated individuals with severe GERD will require lifelong therapy.7-9,11-13 We sought to better determine total healthcare use for patients with GERD treated medically or surgically. Our results suggest that surgically treated patients had a substantial decrease in the use of GERD pharmaceuticals and that use of other forms of healthcare did not increase in these patients. In this setting the reduction in drug use came at the cost of the fundoplication procedure and a mean of 3 hospital days associated with the procedure. Previous studies evaluating healthcare use in GERD patients have been based either on a single institutional experience or modeling with cost estimates.21,22,28-31 The current study is a population-based analysis, which includes a variety of practice settings in Tennessee. The use of administrative data from the Tennessee Medicaid program permitted measurement of the use of several types of healthcare resources from the perspective of a thirdparty payor. We studied use rather than costs because the latter would have only limited generalizability because of the steep discounts mandated by TennCare. Use of administrative data alone may limit the ability to definitively categorize diagnoses. Because information regarding each patient encounter is limited to diagnosis and procedural codes, the exact indication for surgical intervention or medical therapy cannot be determined. In this study limiting the inclusion criteria to those patients who had multiple encounters associated with GERD codes and who also used acid-suppressing drugs likely improved the overall diagnostic accuracy of gastroesophageal reflux in these patients. The cohorts of medical and surgical patients were very similar in their demographics and in baseline use of healthcare resources. An important limitation of administrative datasets is the lack of information on the patient’s health status or quality of life. So it is not possible to conclude from this study which therapy is more effective or if either cohort of patients was satisfied with their GERD therapy. The answers to these important questions will come from prospective studies (preferably randomized controlled trials). An additional limitation of the study is the lack of generalizability caused by the unique demographics of the TennCare pop-
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Table 5. Distribution of Prescribed GERD Therapy During Followup Year among Surgically and Medically Treated People in the Tennessee Medicaid Program, 1996 –1997 Standardized GERD therapy days
0 ⱕ 30 31–90 91–365 ⬎ 365
Surgical cohort (%)
Medical cohort (%)
29 18 16 29 8
6 4 7 44 39
Pearson’s chi-square test, p ⬍ 0.0001. GERD, gastrointestinal reflux disease.
ulation. Though the disease process itself should not vary from the general population, access to medical care, overall medical care use, and patient compliance may vary from the general population. Given the severe cost controls used in the Tennessee Medicaid (TennCare) model, use of expensive pharmaceuticals is probably less common in this population than in other insured settings. This study is limited by the short followup period and further studies will be necessary to demonstrate longterm effects of surgical therapy for GERD. If the decreased use of GERD pharmaceuticals seen among the surgical patients in this study persists, the potential cost savings of surgical treatment could be significant. The use of acid-suppression medications by surgically treated patients in the postoperative period could be the result of several factors. Whether this represents a surgical “failure” cannot be answered directly. It is possible that some patients who use acid suppression after fundoplication represent “surgical failures,” but this study design is limited by the inability to determine patient satisfaction or “quality of life.” In fact, some patients who use acid-suppressing drugs after surgical therapy may have fewer symptoms than before surgical therapy. In addition, this pharmaceutical use may represent “new prescriptions” or simply “continued dispensing” of older prescriptions—events which could not be well categorized determined from the database. Improvements in the efficient management of surgical patients could increase the economic benefits of surgical management. In this study, 28% of the fundoplication procedures were performed in the outpatient setting and the mean number of hospital days was more than 3 for the entire surgical cohort. It is likely that, in the time since the study period of 1996–1997, increased use of outpatient surgery has decreased inpatient use. The high use of GERD-related physician visits observed
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before and immediately after the operation likely represents visits for perioperative care. We would anticipate a continued decrease in GERD-related visits among postoperative patients during the period after perioperative time frame (90 days) in studies with longer followup. We expect that a longer followup period will allow better evaluation of important remaining questions. The longterm effects of fundoplication on resource use have yet to be well characterized. It is unclear what patient characteristics best predict successful outcomes. Finally, variations in outcomes by characteristics of individual surgeons could not be adequately assessed because of the small numbers in this study. This is a potentially important issue and needs to be further investigated using other, more extensive, study designs. In conclusion, gastroesophageal reflux disease is a common problem in the general population. Both medical and surgical therapies have been proved to be efficacious in the treatment of symptoms and esophagitis. But this is a chronic disorder that results in substantial financial burden to either the patient or their third-party provider. Our results show that a 1-year period of followup surgical treatment of severe gastroesophageal reflux disease led to a 64% postsurgical reduction in GERD medication use, with no increase in use of other medical services. REFERENCES 1. Richter JR. Surgery for reflux disease—reflections of a gastroenterologist. N Engl J Med 1992;326:825–827. 2. Klingman RR. The current management of gastroesophageal reflux. Adv Sur 1991;24:259–291. 3. Digestive diseases in the United States: Epidemiology and impact. Bethesda, MD: US Department of Health and Human Services; 1994. 4. Tibbling L. Epidemiology of gastro-oesphageal reflux disease. Scand J Gastroenterol 1984;19(Suppl 106):14–18. 5. Nebel OT, Fornes MT, Castell DO. Symptomatic gastroesophageal reflux: Incidence and precipitating factors. Am J Dig Dis 1976;21:953–956. 6. McDoughall NI, Johnsont BT, Kee F, et al. Natural history of reflux oesophagitis: A 10-year followup of its effect on patient symptomatology and quality of life. Gut 1996;38:481–486. 7. Fennerty MB, Castell D, Fendrick AM, et al. The diagnosis and treatment of gastroesophageal reflux disease in the managed care environment. Arch Intern Med 1996;156:477–484. 8. Weinberg DS, Kadish SL. The diagnosis and management of gastroesophageal reflux disease. Med Clin North Am 1996;80: 411–429. 9. Moss SF, Arnold R, Tygat GNJ, et al. Consensus statement for management of gastroesophageal reflux disease. J Clin Gastroenterol 1998;27:6–12. 10. Fuchs KH, Feussner H, Bonavina L, et al. Current status and trend in laparoscopic antireflux surgery: Results of a consensus meeting. Endoscopy 1997;29:298–308.
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