Abstract
Understanding factors that impair quality of life (QOL) in gastroparesis is important for clinical management.
Aims:
1) Determine QOL in patients with gastroparesis; 2) Determine factors that impair QOL.
Methods:
Gastroparetic patients underwent history and questionnaires assessing symptoms (PAGI-SYM and Rome III), QOL (SF-36v2 and PAGI-QOL), depression (Beck Depression Inventory [BDI]), and anxiety (State Trait Anxiety Inventory).
Results:
715 gastroparesis patients (256 diabetic (DG), 459 idiopathic (IG)) were evaluated. SF-36 physical component (PC) score averaged 33.3±10.5; 41% had impaired score <30. SF-36 PC scores were similar between diabetic and idiopathic gastroparesis. Impaired SF-36 PC associated with increased nausea/vomiting and upper abdominal pain subscores, acute onset of symptoms, higher number of comorbidities, use of narcotic pain medications, and irritable bowel syndrome (IBS). SF-36 mental component (MC) score averaged 38.9±13.0; 26% had impaired score <30. Poor SF-36 MC associated with diabetic etiology, higher Beck depression inventory and state anxiety scores. PAGI-QOL score averaged 2.6±1.1; 50% had a score of <2.6. Low PAGI-QOL associated with higher fullness, bloating, and upper abdominal pain subscores, more depression and Trait anxiety, smoking cigarettes, need for nutritional support, progressively worsening symptoms and periodic exacerbations.
Conclusions:
Multiple measures show poor QOL present in gastroparesis. Several areas impacted on reduced QOL: 1) Symptoms of nausea, vomiting, and abdominal pain, as well as IBS; 2) Etiology and acute onset and progressively worsening symptoms; 3) Comorbidities and psychological factors such as anxiety and depression; 4) Patient related factors such as smoking. Targeting the modifiable factors may improve patient outcomes in gastroparesis.
Keywords: quality of life, health related quality of life, gastroparesis, diabetic gastroparesis, idiopathic gastroparesis
Introduction
Patients with gastroparesis have chronic symptoms which can include nausea, vomiting, early satiety, postprandial fullness, and abdominal pain (1). It is not surprising, therefore, that gastroparesis patients have an impaired general well-being or quality of life (QOL) (2,3).
The NIDDK/NIH Gastroparesis Clinical Research Consortium (GpCRC) Registry has also shown that QOL is impaired in patients with gastroparesis (4). This impaired QOL is present in both idiopathic and diabetic gastroparesis (4). Of note, QOL in gastroparesis is more impaired than that reported in Crohn’s disease (5). Studying individual symptoms, the GpCRC has reported that nausea (6), bloating (7), and abdominal pain (8) are each associated with impaired QOL, whereas the degree of gastric emptying delay on scintigraphy did not (4). There are a number of symptoms associated with gastroparesis, as captured with the Gastroparesis Cardinal Symptom Index. Which specific symptoms impact the QOL and what other factors might reduce QOL in patients with gastroparesis is not clear. Patients with gastroparesis can have other comorbid disorders that also impact on QOL. The GpCRC has reported a longitudinal study in gastroparesis showing several factors that are related to improvement in symptoms: age >50 years, severe gastroparesis symptoms, severe gastric retention, and an initial infectious prodrome (9). Factors related to a worse outcome include abdominal pain, being overweight or obese, smoking, presence of GERD, and use of pain modulators and anxiolytics.
Understanding factors that reduce QOL in gastroparesis has importance in determining how to personalize treatment of the patient. The aims of this study were to: 1) Determine QOL in a large cohort of patients with gastroparesis; 2) Compare QOL in idiopathic and diabetic gastroparesis; and 3) Determine factors that associate with impaired QOL.
Methods
Overview
The GpCRC is a cooperative network of six academic motility centers and one Scientific Data Research Center (SDRC) funded through the NIDDK (4,7). The NIDDK/NIH GpCRC Gastroparesis Registries were implemented as observational studies of patients with gastroparesis enrolled prospectively at each of the participating sites. This study combines patients from the first gastroparesis registry (GpR; ClinicalTrials.gov Identifiers NCT00398801) and second gastroparesis registry (GpR2; ClinicalTrials.gov Identifiers NCT NCT01696747) which were performed consecutively. All studies were approved by the Institutional Review Board at each Clinical Center and at the Scientific Data Coordinating Center. The data set for this study is deposited in our
Enrollment
Patients enrolled in the Registry studies met the following specific entry criteria: 18 years or older, symptoms of at least 12 weeks duration, gastric emptying scintigraphy (GES) using the 4-hour Eggbeaters protocol within 6 months of enrollment, and no structural abnormalities on upper endoscopy within one year of enrollment.
This report focuses on patients with either idiopathic or diabetic gastroparesis with documented delayed gastric emptying at enrollment. The diabetic patients could have either Type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) as defined by the physician and patient. The diagnosis of patients with the idiopathic etiology was based on the absence of previous gastric surgery, no diabetes history (before or after the onset of gastroparesis at enrollment), and no other known etiologies for gastroparesis including collagen vascular diseases and Parkinson’s disease.
Study Protocol
During face-to-face interviews with each subject at enrollment, the study physicians or coordinators completed case report forms including data related to gastroparesis disease onset, symptoms, disease profile, associated doctor-diagnosed medical conditions, including diabetes, and medication and supplemental therapies, and prior surgeries. Study physicians performed a comprehensive physical examination. Laboratory measures were obtained, including complete blood count (CBC), hemoglobin A1C values, antinuclear antibody (ANA), and erythrocyte sedimentation rate (ESR).
The clinical severity of gastroparesis (10) was graded by the investigator as follows: grade 1: mild gastroparesis (symptoms relatively easily controlled and able to maintain weight and nutrition on a regular diet); grade 2: compensated gastroparesis (moderate symptoms with only partial control with use of daily medications, able to maintain nutrition with dietary adjustments); grade 3: refractory gastroparesis (refractory symptoms that are not controlled as shown by the patient having ER visits, frequent doctor visits or hospitalizations and/or inability to maintain nutrition via an oral route).
Each patient completed the 20-item Patient Assessment of Upper Gastrointestinal Symptoms (PAGI-SYM) questionnaire, which assesses symptoms of gastroparesis, dyspepsia, and gastroesophageal reflux disease (GERD) (11). The nine symptoms of the Gastroparesis Cardinal Symptom Index (GCSI) are included (nausea, retching, vomiting, stomach fullness, inability to finish meal, excessive fullness, loss of appetite, bloating, and abdominal distension) (12). The patient scores each symptom severity in the previous 2 weeks using a 0 to 5 scale, where no symptoms=0, very mild=1, mild=2, moderate=3, severe=4, and very severe=5.
Rome III diagnostic questionnaires were administered, primarily focusing on the functional dyspepsia, irritable bowel syndrome, and functional constipation forms (13).
QOL was assessed by two instruments. The Medical Outcomes Study 36-Item Short-Form Health Survey version 2 (SF-36v2) was used to assess the patient self-report of overall physical and mental health in the past 4 weeks (standard recall form). The 8 subscales were standardized to the 1998 U.S. general population with a mean (±SD) of 50±10. Physical and mental health summary measures were computed. A higher score reflects higher QOL (14). Impaired QOL using SF-36v2 was <30, the mean −2 SD of normal people. The disease specific QOL instrument, Patient Assessment of Upper Gastrointestinal Disorders Quality of Life (PAGI-QOL) survey, which scores 30 factors from 0 (none of the time) to 5 (all of the time), was also used (15). Patients were asked how often in the past two weeks their gastrointestinal problems have been affecting different aspects of their QOL and well-being. There are five domains: Daily Activities, Clothing, Diet and Food Habits, Relationship, and Psychological Well-Being and Distress. Overall PAGI-QOL scores were calculated by taking means of all subscores after reversing item scores; thus a mean PAGI-QOL score of 0 represents poor QOL while 5 reflects the best life quality. Normal values are not available for the PAGI-QOL. Impaired QOL was set at 2.6, taken as the mean of our patients as well as the value for mean – 2 SD of QOL values from treated subjects with GERD and eosinophilic esophagitis, 2.57 (16,17). This 2.6 value is also the mean of the PAGI-QOL scores in our patient group.
Psychological functioning was assessed using Beck Depression Inventory (BDI) and State-Trait Anxiety Inventory (STAI). The BDI is a 21-question inventory assessing depression, cognition, and physical well-being (18). Each answer is scored on a scale of 0 to 3. Higher total scores indicate more severe depressive symptoms. The STAI consists of 20 questions relating to state anxiety (a temporary or emotional state) and 20 questions pertaining to trait anxiety (long standing personality trait anxiety with a general propensity to be anxious) (19).
Other medical problems were noted in the history. A modified Charlson comorbidity index was used to assess the number of other medical problems (20). The total number of comorbidities was summed from eleven categories of comorbidities including coronary artery disease, cerebrovascular disease, neurologic disorders (MS, Parkinson’s, ALS), seizure disorder or epilepsy, migraine headaches, psychiatric disease (Bipolar, Anxiety or Depression), rheumatologic/autoimmune disorder (fibromyalgia, RA, scleroderma, SLE, CVD, unidentified), endocrine disorders (thyroid, PCOS), Gynecologic/Urologic disorders, malignancy (cancer), and diabetes.
Gastric Emptying Scintigraphy (GES)
Patients underwent GES for solid gastric emptying. Patients stopped medications that could affect gastrointestinal motility (opioid, prokinetic, anticholinergic medications) for 72 hours prior to the study and were asked to come in the morning after fasting overnight. Diabetic patients had glucose checked to ensure <275 mg/dl. GES was performed using a standard low-fat, Eggbeaters® meal to measure solid emptying over 4 hours (21,22). The solid-phase meal was comprised of 99mTc-sulfur colloid-labeled egg substitute meals which included 120 g EggBeaters®, 2 slices of bread, 30 g strawberry jam, and 120 mL water (255 kcal, 72% carbohydrate, 24% protein, 2% fat, 2% fiber). Gastric retention of Tc-99m labeled study meal with >60% at 2 hrs and/or >10% at 4 hrs was considered delayed gastric emptying.
Statistical Methods
Descriptive statistics (means, standard deviations, frequencies, percentages, medians, and interquartile ranges) were used to compare subgroups of gastroparesis patients. Enrollment characteristics were compared by etiology (idiopathic vs. T1DM vs. T2DM). P-values were determined from Fisher’s exact tests for categorical variables and analysis of variance for continuous variables; Wilcoxon rank sum test was used for continuous measures that were not normally distributed. Enrollment characteristics were also compared by QOL: impaired versus not-impaired QOL for SF-36 physical component, SF-36 mental component, and PAGI-QOL. P-values were determined from Fisher’s exact test for categorical variables, and two sample t-tests for continuous variables (23). Multiple logistic regression models were selected using minimization of Akaike Information Criterion (AIC) for three outcomes: SF-36 PC, and SF-36 MC, and PAGI-QOL. A candidate set of 22 enrollment variables were used for modelling analysis: age, gender, BMI, gastroparesis etiology (diabetic vs. idiopathic), ever smoked, ever drank alcohol, nature of gastroparesis symptoms, onset of symptoms (acute vs. insidious), hospitalization for gastroparesis in past year, need for nutritional support (TPN, G tube, J tube), percent gastric retention at 4 hours, opioid narcotic pain medication, total number of comorbidities, presence of IBS based on Rome III questionnaire, nausea/vomiting subscore, fullness/early satiety subscore, bloating subscore, upper abdominal pain subscore, GERD subscore, State anxiety score, Trait anxiety score, and Beck Depression Inventory score (24,25). All p-values are two-sided; values <0.05 were considered statistically significant. Analyses were performed using SAS version 9.3 (SAS Institute) or Stata version 16.1 (26).
Results
Patient characteristics
715 patients with gastroparesis (459 IG, 256 DG [128 T1DM and 128 T2DM]) were evaluated: 84% females, average age 43.1 years, 88% white race (Table 1). The average BMI was 27.3 kg/m2. 35% of patients were present or past smokers, and 43% presently or in the past had been drinking alcohol.
Table 1.
Characteristics of Gastroparesis Registry participants with delayed gastric emptying at enrollment, by gastroparesis etiology
| Gastroparesis Etiology |
|||||
|---|---|---|---|---|---|
| Participant Characteristics | Idiopathic (N=459) | T1DM (N=128) | T2DM (N=128) | Total (N=715) | P* |
|
| |||||
| Quality of Life at enrollment | |||||
| SF-36v2 Health Survey† | |||||
| Physical health subscore | |||||
| Total | 33.9 (10.5) | 32.7 (10.9) | 32.0 (10.2) | 33.3 (10.5) | 0.14 |
| Score<30 | 180 (39%) | 54 (42%) | 56 (44%) | 290 (41%) | 0.60 |
| Mental health subscore | |||||
| Total | 39.7 (12.8) | 36.3 (12.7) | 38.7 (13.6) | 38.9 (13.0) | 0.03 |
| Score<30 | 107 (23%) | 45 (35%) | 37 (29%) | 189 (26%) | 0.02 |
| PAGI-QOL‡ | |||||
| Total score | 2.6 (1.1) | 2.5 (1.2) | 2.7 (1.2) | 2.6 (1.1) | 0.40 |
| Score<2.6 | 235 (51%) | 67 (52%) | 56 (44%) | 358 (50%) | 0.28 |
| Anxiety and depression inventories | |||||
| State-Trait Anxiety Inventory§ | |||||
| State anxiety score | 43.5 (13.6) | 46.5 (14.0) | 44.4 (13.6) | 44.2 (13.7) | 0.08 |
| Severe state anxiety (score ≥50) | 153 (33%) | 56 (44%) | 42 (33%) | 251 (35%) | 0.08 |
| Trait anxiety score | 43.0 (12.3) | 46.0 (12.6) | 43.6 (13.5) | 43.7 (12.6) | 0.06 |
| Severe trait anxiety (score ≥50) | 141 (31%) | 53 (41%) | 40 (31%) | 234 (33%) | 0.08 |
| Beck Depression Inventory (BDI)∥ | |||||
| BDI score | 17.9 (10.7) | 20.3 (13.4) | 18.4 (11.1) | 18.4 (11.3) | 0.10 |
| Severe depression (BDI≥28) | 76 (17%) | 29 (23%) | 23 (18%) | 128 (18%) | 0.26 |
| Demographics and lifestyle | |||||
| Female | 406 (88%) | 89 (70%) | 103 (80%) | 598 (84%) | <0.001 |
| Age at enrollment, yrs | 41.3 (14.0) | 40.6 (11.6) | 51.9 (10.3) | 43.1 (13.6) | <0.001 |
| Hispanic ethnicity | 31 (7%) | 19 (15%) | 31 (24%) | 81 (11%) | <0.001 |
| Race | <0.001 | ||||
| White | 418 (91%) | 98 (78%) | 106 (83%) | 622 (88%) | |
| Black | 25 (5%) | 23 (18%) | 17 (13%) | 65 (9%) | |
| Other | 14 (3%) | 5 (4%) | 4 (3%) | 23 (3%) | |
| Married | 258 (56%) | 68 (53%) | 81 (63%) | 407 (57%) | 0.23 |
| Income ≥$50,000 | 258 (56%) | 49 (38%) | 49 (38%) | 356 (50%) | <0.001 |
| Ever smoked | 162 (35%) | 51 (40%) | 40 (31%) | 253 (35%) | 0.36 |
| Ever drink alcohol | 208 (45%) | 50 (39%) | 51 (40%) | 309 (43%) | 0.32 |
| PAGI-SYM symptom severities | |||||
| Gastroparesis Cardinal Symptom | |||||
| Index (GCSI)¶ | 2.9 (1.0) | 3.0 (1.1) | 2.9 (1.1) | 2.9 (1.1) | 0.87 |
| Nausea subscore | 2.3 (1.4) | 2.8 (1.5) | 2.6 (1.4) | 2.4 (1.4) | <0.001 |
| Nausea | 3.4 (1.4) | 3.4 (1.3) | 3.2 (1.5) | 3.4 (1.4) | 0.36 |
| Retching | 1.7 (1.7) | 2.3 (1.8) | 2.3 (1.7) | 1.9 (1.8) | <0.001 |
| Vomiting | 1.7 (1.8) | 2.6 (1.9) | 2.3 (1.8) | 2.0 (1.9) | <0.001 |
| Fullness/early satiety subscore | 3.5 (1.1) | 3.2 (1.2) | 3.2 (1.2) | 3.4 (1.2) | 0.003 |
| Stomach fullness | 3.7 (1.2) | 3.3 (1.4) | 3.5 (1.3) | 3.6 (1.3) | 0.02 |
| Inability to finish a meal | 3.6 (1.4) | 3.0 (1.6) | 3.1 (1.4) | 3.4 (1.5) | <0.001 |
| Excessively full after meals | 3.7 (1.3) | 3.5 (1.5) | 3.4 (1.4) | 3.6 (1.4) | 0.05 |
| Appetite loss | 3.0 (1.5) | 2.9 (1.6) | 2.7 (1.5) | 2.9 (1.5) | 0.18 |
| Bloating subscore | 3.1 (1.6) | 2.9 (1.6) | 3.0 (1.6) | 3.0 (1.6) | 0.58 |
| Bloating | 3.3 (1.5) | 3.1 (1.6) | 3.2 (1.6) | 3.2 (1.6) | 0.38 |
| Stomach visibly larger | 2.9 (1.7) | 2.8 (1.7) | 2.8 (1.8) | 2.9 (1.7) | 0.78 |
| Upper abdominal pain subscore | 3.1 (1.5) | 2.9 (1.7) | 2.9 (1.6) | 3.0 (1.5) | 0.15 |
| Upper abdominal pain | 3.0 (1.6) | 2.9 (1.8) | 2.7 (1.7) | 3.0 (1.7) | 0.17 |
| Upper abdominal discomfort | 3.2 (1.5) | 3.0 (1.7) | 3.0 (1.6) | 3.1 (1.6) | 0.15 |
| Abdominal pain subscore | 2.6 (1.3) | 2.6 (1.5) | 2.4 (1.3) | 2.6 (1.3) | 0.12 |
| GERD subscore** | 1.9 (1.4) | 2.0 (1.4) | 2.0 (1.4) | 2.0 (1.4) | 0.64 |
| Clinical characteristics | |||||
| BMI, kg/m2 | 25.9 (7.0) | 26.9 (6.3) | 32.4 (7.6) | 27.3 (7.4) | <0.001 |
| HbA1c, % | 5.4 (0.5) | 8.6 (2.1) | 7.8 (2.0) | 6.4 (1.9) | <0.001 |
| Gastric emptying scintigraphy | |||||
| Percent retained at 2 hours | 63.8 (16.5) | 68.4 (19.8) | 66.1 (20.9) | 65.0 (18.0) | 0.03 |
| Percent retained at 4 hours | 27.9 (18.6) | 42.6 (25.6) | 37.9 (25.0) | 32.3 (22.0) | <0.001 |
| Need for nutritional support (G-tube, J-tube, or TPN) | 40 (8.7) | 14 (10.9) | 7 (5.5) | 61 (8.5) | 0.28 |
| Medication use | |||||
| Antidepressants | 178 (39%) | 49 (38%) | 55 (43%) | 282 (39%) | 0.67 |
| Anxiolytics | 118 (26%) | 30 (23%) | 25 (20%) | 173 (24%) | 0.35 |
| Neuropathic pain modulators | 104 (23%) | 49 (38%) | 51 (40%) | 204 (29%) | <0.001 |
| Prokinetics | 215 (47%) | 82 (64%) | 63 (49%) | 360 (50%) | 0.002 |
| Antiemetics | 268 (58%) | 83 (65%) | 73 (57%) | 424 (59%) | 0.36 |
| Opioid narcotic pain medication | 161 (35%) | 54 (42%) | 52 (41%) | 267 (37%) | 0.24 |
| ROME 3 | |||||
| Functional Dyspepsia | 401 (87.4) | 101 (78.9) | 107 (83.6) | 609 (85.2) | 0.05 |
| Postprandial Distress Syndrome (PDS) but not (Epigastric Pain Syndrome (EPS) | 117 (25.5) | 29 (22.7) | 32 (25.0) | 178 (24.9) | 0.84 |
| EPS but not PDS | 17 (3.7) | 9 (7.0) | 12 (9.4) | 38 (5.3) | 0.03 |
| Both PDS and EPS | 267 (58.2) | 63 (49.2) | 63 (49.2) | 393 (55.0) | 0.07 |
| Irritable Bowel Syndrome (IBS) | 291 (63.4) | 86 (67.2) | 81 (63.3) | 458 (64.1) | 0.75 |
P-values determined from ANOVA or Fisher’s Exact Test.
SF-36v2 scores were normalized to the 1998 US general population with mean ± standard deviation of 50 ± 10. Lower scores reflect lower quality of life.
PAGI-QOL: Patient Assessment of Upper Gastrointestinal Disorders Quality of Life, scores range from 05, with lower scores reflecting a lower health-related quality of life.
State-Trait Anxiety Inventory: range 20–80, where higher scores reflect increased anxiety
Beck Depression Inventory: range 0–63, where higher scores reflect increased severity of depression, and scores≥28 indicate severe depression.
Gastroparesis Cardinal Symptom Index (GCSI): range 0–5, where higher scores reflect increased severity of symptoms.
GERD=gastroesophageal reflux disease
The onset of symptoms was insidious in 54% and acute in 46% with an initial infectious prodrome in 19%. The predominant symptom prompting evaluation for gastroparesis was nausea (31%), vomiting (22%), and abdominal pain (20%). At the time of enrollment, the most severe symptoms were postprandial fullness (3.6), early satiety (3.4), nausea (3.4), bloating (3.2), upper abdominal discomfort (3.1), and upper abdominal pain (3.0). Patients with diabetes had more severe retching and vomiting compared to idiopathic gastroparesis, whereas patients with idiopathic gastroparesis had more fullness, early satiety, and postprandial fullness (Table 1). The gastroparesis severity as rated by the investigators was mild (grade 1) in 16%, compensated (grade 2) in 59%, and gastric failure (grade 3) in 24%.
Gastric emptying overall was moderately impaired with an average of 65.0% retention at 2 hours and 32.3% retention at 4 hours. Patients with T1DM and T2DM had greater gastric retention at 2 and 4 hours. The HgbA1c of T1DM patients averaged 8.6% and for the T2DM patients averaged 7.8%. Of all patients, 18% scored >28 on the Beck Depression Inventory (BDI) suggesting severe depression; 35% scored severe trait anxiety with ≥50 and 33% scored with severe state anxiety with score ≥50.
Overall, 50% of patients were taking prokinetic agents, 59% taking antiemetic agents, 39% taking antidepressants, 37% taking opioid pain medications, 29% taking neuropathic pain modulators, and 24% taking anxiolytics. Patients with diabetes were more often taking prokinetic agents and neuropathic pain modulators than idiopathic gastroparesis patients. 7% of the patients were on TPN, 1% had gastrostomy tubes, and 2% had jejunostomy tubes.
QOL assessment
SF-36 physical
The average SF-36 PC score was 33.3±10.5, with normal being 50±10. 290 of 715 patients (41%) had poor QOL, as defined as SF-36 physical component score <30 (Table 2). The SF-36 PC scores were similar among the different etiologies of gastroparesis: idiopathic 33.9, T1DM 32.7, T2DM 32.0 (p=0.14) (Supplemental Table 1).
Table 2.
Characteristics of Gastroparesis participants with delayed gastric emptying at enrollment by low vs. high quality of life by the SF-36 Health Outcomes Survey, Physical Component
| SF-36 Health Outcomes Survey: Physical Component* |
||||
|---|---|---|---|---|
| Participant Characteristics | ≤30 (N=290) | >30 (N=425) | Total (N=715) | P† |
|
| ||||
| Demographics and lifestyle | ||||
| Female | 242 (83%) | 356 (84%) | 598 (84%) | 0.92 |
| Age at enrollment (years) | 44.0 (13.0) | 42.4 (14.0) | 43.1 (13.6) | 0.11 |
| Hispanic ethnicity | 27 (9%) | 54 (13%) | 81 (11%) | 0.19 |
| Race | 0.71 | |||
| White | 252 (87%) | 370 (88%) | 622 (88%) | |
| Black | 29 (10%) | 36 (9%) | 65 (9%) | |
| Other | 8 (3%) | 15 (4%) | 23 (3%) | |
| Married | 181 (62%) | 226 (53%) | 407 (57%) | 0.02 |
| Income ≥$50,000 | 139 (48%) | 217 (51%) | 356 (50%) | 0.40 |
| Ever smoked | 112 (39%) | 141 (33%) | 253 (35%) | 0.15 |
| Ever drink alcohol | 100 (34%) | 209 (49%) | 309 (43%) | <0.001 |
| Gastroparesis history | ||||
| Gastroparesis etiology | 0.34 | |||
| Diabetic | 110 (38%) | 146 (34%) | 256 (36%) | |
| Idiopathic | 180 (62%) | 279 (66%) | 459 (64%) | |
| Duration of Gp symptom onset (years), median (IQR) | 3.7 (1.9, 6.9) | 2.9 (1.3, 6.3) | 3.2 (1.5, 6.5) | 0.006 |
| Nature of gastroparesis symptoms | <0.001 | |||
| Chronic, but stable | 45 (16%) | 103 (24%) | 148 (21%) | |
| Chronic, but progressive worsening | 107 (37%) | 100 (24%) | 207 (29%) | |
| Chronic, but with some improvement | 9 (3%) | 26 (6%) | 35 (5%) | |
| Chronic with periodic exacerbations | 93 (32%) | 133 (31%) | 226 (32%) | |
| Cyclic exacerbations with periods feeling well | 33 (11%) | 60 (14%) | 93 (13%) | |
| Asymptomatic | 0 (0%) | 3 (1%) | 3 (<1%) | |
| Predominant symptom prompting evaluation for Gp | 0.02 | |||
| Nausea | 89 (31%) | 135 (32%) | 224 (31%) | |
| Vomiting | 67 (23%) | 90 (21%) | 157 (22%) | |
| Bloating | 17 (6%) | 49 (12%) | 66 (9%) | |
| Abdominal pain | 64 (22%) | 79 (19%) | 143 (20%) | |
| GERD‡ | 6 (2%) | 21 (5%) | 27 (4%) | |
| Other | 47 (16%) | 51 (12%) | 98 (14%) | |
| Onset of symptoms | 0.25 | |||
| Acute | 141 (49%) | 187 (44%) | 328 (46%) | |
| Insidious | 149 (51%) | 237 (56%) | 386 (54%) | |
| Initial infectious prodrome | 54 (19%) | 80 (19%) | 134 (19%) | 1.00 |
| Investigator-rated gastroparesis severity | <0.001 | |||
| Mild (Grade 1) | 26 (9%) | 91 (21%) | 117 (16%) | |
| Compensated (Grade 2) | 164 (57%) | 256 (60%) | 420 (59%) | |
| Gastric failure (Grade 3) | 97 (34%) | 77 (18%) | 174 (24%) | |
| Need for nutritional support | ||||
| TPN | 27 (9%) | 23 (5%) | 50 (7%) | 0.05 |
| G tube | 5 (2%) | 2 (<1%) | 7 (1%) | 0.13 |
| J tube | 10 (3%) | 4 (1%) | 14 (2%) | 0.03 |
| Any nutritional support (G-tube, J-tube, or TPN) | 34 (11.7) | 27 (6.4) | 61 (8.5) | 0.01 |
| Gastric electrical stimulator in place | 21 (7%) | 22 (5%) | 43 (6%) | 0.27 |
| History of nutrition consult | 111 (38%) | 155 (36%) | 266 (37%) | 0.64 |
| History of cholecystectomy | 129 (44%) | 147 (35%) | 276 (39%) | 0.008 |
| History of hysterectomy | 81 (36%) | 99 (31%) | 180 (33%) | 0.23 |
| Hospitalization for Gp in past year | 138 (48%) | 159 (37%) | 297 (42%) | 0.007 |
| Gastric Emptying Scintigraphy | ||||
| 2 hours (% retained), mean (SD) | 64.3 (18.6) | 65.4 (17.6) | 65.0 (18.0) | 0.42 |
| 4 hours (% retained), mean (SD) | 33.6 (22.2) | 31.5 (21.9) | 32.3 (22.0) | 0.21 |
| Clinical and laboratory characteristics | ||||
| BMI, kg/m2 | 28.2 (7.8) | 26.6 (7.1) | 27.3 (7.4) | 0.004 |
| HbA1c, % | 6.4 (1.8) | 6.4 (1.9) | 6.4 (1.9) | 0.79 |
| ANA positive | 43 (15%) | 76 (18%) | 119 (17%) | 0.31 |
| ESR | 15.0 (7.0, 29.0) | 12.0 (6.0, 26.0) | 13.0 (6.0, 27.0) | 0.04 |
| Medication usage | ||||
| Antidepressants | 119 (41%) | 163 (38%) | 282 (39%) | 0.48 |
| Anxiolytics | 79 (27%) | 94 (22%) | 173 (24%) | 0.13 |
| Neuropathic pain modulators | 102 (35%) | 102 (24%) | 204 (29%) | 0.001 |
| Prokinetics | 153 (53%) | 207 (49%) | 360 (50%) | 0.32 |
| Antiemetics | 199 (69%) | 225 (53%) | 424 (59%) | <0.001 |
| Opioid narcotic pain medication | 147 (51%) | 120 (28%) | 267 (37%) | <0.001 |
| Comorbidities | ||||
| Autoimmune disorder | 78 (27%) | 57 (13%) | 135 (19%) | <0.001 |
| Cancer/malignancy | 24 (8%) | 20 (5%) | 44 (6%) | 0.06 |
| Coronary artery disease | 19 (7%) | 18 (4%) | 37 (5%) | 0.17 |
| Cerebrovascular disease/stroke | 9 (3%) | 5 (1%) | 14 (2%) | 0.10 |
| Diabetes | 110 (38%) | 146 (34%) | 256 (36%) | 0.34 |
| Endocrine disorder (thyroid disease, PCOS) | 78 (27%) | 97 (23%) | 175 (24%) | 0.22 |
| Gynecological/urologic disorder | 72 (25%) | 71 (17%) | 143 (20%) | 0.01 |
| Migraine headaches | 136 (47%) | 132 (31%) | 268 (37%) | <0.001 |
| Neurologic disorders | 5 (2%) | 4 (1%) | 9 (1%) | 0.50 |
| Psychiatric disease | 117 (40%) | 146 (34%) | 263 (37%) | 0.11 |
| Seizure disorder or epilepsy | 23 (8%) | 13 (3%) | 36 (5%) | 0.005 |
| Total number of comorbidities (sum of 11 conditions above) | 2.3 (1.6) | 1.7 (1.2) | 1.9 (1.4) | <0.001 |
| Additional comorbidities | ||||
| Severe anxiety disorder | 61 (21%) | 76 (18%) | 137 (19%) | 0.33 |
| Major depression | 89 (31%) | 104 (24%) | 193 (27%) | 0.07 |
| GERD‡ | 190 (66%) | 233 (55%) | 423 (59%) | 0.005 |
| Hypertension | 98 (34%) | 117 (28%) | 215 (30%) | 0.08 |
| Irritable bowel syndrome (ROME III) | 215 (74%) | 243 (57%) | 458 (64%) | <0.001 |
| Peptic ulcer | 32 (11%) | 14 (3%) | 46 (6%) | <0.001 |
| Peripheral neuropathy | 74 (26%) | 55 (13%) | 129 (18%) | <0.001 |
| PAGI-SYM symptom severities | ||||
| GCSI | 3.4 (0.9) | 2.7 (1.0) | 2.9 (1.1) | <0.001 |
| Nausea subscore | 2.9 (1.4) | 2.1 (1.4) | 2.4 (1.4) | <0.001 |
| Nausea | 3.8 (1.2) | 3.1 (1.5) | 3.4 (1.4) | <0.001 |
| Retching | 2.4 (1.8) | 1.6 (1.6) | 1.9 (1.8) | <0.001 |
| Vomiting | 2.5 (1.9) | 1.7 (1.8) | 2.0 (1.9) | <0.001 |
| Fullness/early satiety subscore | 3.7 (1.0) | 3.1 (1.2) | 3.4 (1.2) | <0.001 |
| Stomach fullness | 3.8 (1.1) | 3.4 (1.3) | 3.6 (1.3) | <0.001 |
| Inability to finish a meal | 3.8 (1.3) | 3.1 (1.5) | 3.4 (1.5) | <0.001 |
| Excessively full after meals | 4.0 (1.2) | 3.3 (1.4) | 3.6 (1.4) | <0.001 |
| Appetite loss | 3.3 (1.5) | 2.7 (1.5) | 2.9 (1.5) | <0.001 |
| Bloating subscore | 3.5 (1.4) | 2.7 (1.6) | 3.0 (1.6) | <0.001 |
| Bloating | 3.6 (1.4) | 2.9 (1.6) | 3.2 (1.6) | <0.001 |
| Stomach visibly larger | 3.4 (1.6) | 2.6 (1.8) | 2.9 (1.7) | <0.001 |
| Upper abdominal pain subscore | 3.6 (1.3) | 2.7 (1.6) | 3.0 (1.5) | <0.001 |
| Upper abdominal pain | 3.5 (1.4) | 2.6 (1.7) | 3.0 (1.7) | <0.001 |
| Upper abdominal discomfort | 3.7 (1.3) | 2.8 (1.6) | 3.1 (1.6) | <0.001 |
| Abdominal pain subscore | 3.1 (1.1) | 2.2 (1.3) | 2.6 (1.3) | <0.001 |
| GERD subscore‡ | 2.4 (1.4) | 1.7 (1.3) | 2.0 (1.4) | <0.001 |
| Anxiety and depression inventories | ||||
| State-Trait Anxiety Inventory∥ | ||||
| State anxiety score | 45.7 (13.7) | 43.2 (13.7) | 44.2 (13.7) | 0.02 |
| Severe state anxiety (score ≥50) | 110 (38%) | 141 (33%) | 251 (35%) | 0.20 |
| Trait anxiety score | 44.8 (12.8) | 42.9 (12.5) | 43.7 (12.6) | 0.05 |
| Severe trait anxiety (score ≥50) | 100 (34%) | 134 (32%) | 234 (33%) | 0.42 |
| Beck Depression Inventory (BDI)¶ | ||||
| BDI score | 20.7 (11.1) | 16.8 (11.2) | 18.4 (11.3) | <0.001 |
| Severe depression (BDI≥28) | 61 (21%) | 67 (16%) | 128 (18%) | 0.07 |
SF-36v2 scores were normalized to the 1998 US general population with mean ± standard deviation of 50 ± 10. Lower scores reflect lower quality of life.
P-values determined from t-tests or Fisher’s Exact Test.
GERD=gastroesophageal reflux disease
Gastroparesis Cardinal Symptom Index (GCSI): range 0–5, where higher scores reflect increased severity of symptoms.
State-Trait Anxiety Inventory: range 20–80, where higher scores reflect increased anxiety
Beck Depression Inventory: range 0–63, where higher scores reflect increased severity of depression, and scores≥28 indicate severe depression.
PAGI-QOL: Patient Assessment of Upper Gastrointestinal Disorders Quality of Life, scores range from 0–5, with lower scores reflecting a lower health-related quality of life.
Univariable analysis showed worse physical SF-36 QOL associated with being married, higher BMI, and not drinking alcohol (Table 2). Longer duration or severity of gastroparesis symptom/s, progressive worsening, investigator-rated gastroparesis severity grade 3, and hospitalizations within the last year were associated with impaired SF-36 PC. Treatments such as use of antiemetics, neuropathic pain modulators, opioid narcotic pain medications, use of TPN or J- tube was associated with poorer QOL. Total number of comorbidities, including a gynecological/urologic disorder, migraine headaches, seizure disorder, peripheral neuropathy, history of cholecystectomy, and IBS by Rome III questionnaire were associated with impaired SF-36 PC. Higher State anxiety and Beck Depression Inventory scores were associated with impaired SF-36 PC.
Multiple logistic analysis (Supplemental Table 1) showed increased odds ratio for worse physical SF-36 QOL compared to better QOL associated with increased nausea/vomiting subscore (OR=1.28; p<0.001), increased upper abdominal pain subscore (OR=1.27; p=0.001), higher total number of comorbidities (OR=1.19; p=0.009), use of narcotic pain medications (OR=1.61; p=0.009), acute onset of symptoms (OR=1.55; p=0.01), IBS by Rome III criteria (OR=1.60; p=0.02), and older age (OR=1.01; p=0.05). Drinking alcohol was associated with a higher physical QOL in this analysis (OR=0.63; p=0.01).
SF-36 QOL mental component
The average SF-36 MC score was 38.9±13.0, with normal being 50±10. 189 of 715 patients (26.4%) had impaired SF-36 QOL mental component, as defined by a score of <30 (Table 2). The SF-36 MC were slightly less for T1DM (36.3) than for idiopathic (39.7) or T2DM (38.7) (p=0.03) (Table 1).
Impaired SF-36 mental component QOL was associated with a higher percentage male, smoking, diabetic etiology (Table 3). Impaired SF-36 mental component was associated with each of the gastroparesis symptoms and grade 3 investigator-rated severity, as well as increased total number of comorbidities, including depression, anxiety, IBS by Rome III category, state anxiety, trait anxiety and Beck depression index.
Table 3.
Characteristics of Gastroparesis participants with delayed gastric emptying by low vs. high quality of life as measured by the SF-36 Health Outcomes Survey, Mental Component
| SF-36 Health Outcomes Survey: Mental Component* |
||||
|---|---|---|---|---|
| Participant Characteristics | ≤30 (N=189) | >30 (N=526) | Total (N=715) | P† |
|
| ||||
| Demographics and lifestyle | ||||
| Female | 149 (79%) | 449 (85%) | 598 (84%) | 0.04 |
| Age at enrollment (years) | 42.2 (13.1) | 43.4 (13.8) | 43.1 (13.6) | 0.32 |
| Hispanic ethnicity | 26 (14%) | 55 (10%) | 81 (11%) | 0.23 |
| Race | 0.61 | |||
| White | 164 (87%) | 458 (88%) | 622 (88%) | |
| Black | 16 (9%) | 49 (9%) | 65 (9%) | |
| Other | 8 (4%) | 15 (3%) | 23 (3%) | |
| Married | 109 (58%) | 298 (57%) | 407 (57%) | 0.86 |
| Income ≥$50,000 | 83 (44%) | 273 (52%) | 356 (50%) | 0.06 |
| Ever smoked | 79 (42%) | 174 (33%) | 253 (35%) | 0.03 |
| Ever drink alcohol | 74 (39%) | 235 (45%) | 309 (43%) | 0.20 |
| Gastroparesis history | ||||
| Gastroparesis etiology | 0.01 | |||
| Diabetic | 82 (43%) | 174 (33%) | 256 (36%) | |
| Idiopathic | 107 (57%) | 352 (67%) | 459 (64%) | |
| Duration of Gp symptom onset (years), median (IQR) | 3.0 (1.5, 6.1) | 3.4 (1.5, 6.6) | 3.2 (1.5, 6.5) | 0.42 |
| Nature of gastroparesis symptoms | 0.10 | |||
| Chronic, but stable | 31 (16%) | 117 (22%) | 148 (21%) | |
| Chronic, but progressive worsening | 68 (36%) | 139 (27%) | 207 (29%) | |
| Chronic, but with some improvement | 6 (3%) | 29 (6%) | 35 (5%) | |
| Chronic with periodic exacerbations | 59 (31%) | 167 (32%) | 226 (32%) | |
| Cyclic exacerbations with periods of feeling well | 24 (13%) | 69 (13%) | 93 (13%) | |
| Asymptomatic | 0 (0%) | 3 (1%) | 3 (<1%) | |
| Predominant symptom prompting evaluation for Gp | 0.19 | |||
| Nausea | 55 (29%) | 169 (32%) | 224 (31%) | |
| Vomiting | 43 (23%) | 114 (22%) | 157 (22%) | |
| Bloating | 17 (9%) | 49 (9%) | 66 (9%) | |
| Abdominal pain | 45 (24%) | 98 (19%) | 143 (20%) | |
| GERD‡ | 2 (1%) | 25 (5%) | 27 (4%) | |
| Other | 27 (14%) | 71 (13%) | 98 (14%) | |
| Onset of symptoms | 0.35 | |||
| Acute | 81 (43%) | 247 (47%) | 328 (46%) | |
| Insidious | 108 (57%) | 278 (53%) | 386 (54%) | |
| Initial infectious prodrome | 34 (18%) | 100 (19%) | 134 (19%) | 0.83 |
| Investigator-rated gastroparesis severity | 0.01 | |||
| Mild (Grade 1) | 21 (11%) | 96 (18%) | 117 (16%) | |
| Compensated (Grade 2) | 109 (58%) | 311 (59%) | 420 (59%) | |
| Gastric failure (Grade 3) | 58 (31%) | 116 (22%) | 174 (24%) | |
| Need for nutritional support | ||||
| TPN | 19 (10%) | 31 (6%) | 50 (7%) | 0.07 |
| G tube | 2 (1%) | 5 (1%) | 7 (1%) | 1.00 |
| J tube | 4 (2%) | 10 (2%) | 14 (2%) | 0.77 |
| Any nutritional support (G-tube, J-tube, or TPN) | 23 (12.2) | 38 (7.2) | 61 (8.5) | 0.05 |
| Gastric electrical stimulator in place | 15 (8%) | 28 (5%) | 43 (6%) | 0.21 |
| History of nutrition consult | 67 (35%) | 199 (38%) | 266 (37%) | 0.60 |
| History of cholecystectomy | 76 (40%) | 200 (38%) | 276 (39%) | 0.60 |
| History of hysterectomy | 45 (34%) | 135 (33%) | 180 (33%) | 0.75 |
| Hospitalization for Gp in past year | 83 (44%) | 214 (41%) | 297 (42%) | 0.44 |
| Gastric Emptying Scintigraphy | ||||
| 2 hours (% retained), mean (SD) | 65.1 (17.8) | 65.0 (18.1) | 65.0 (18.0) | 0.92 |
| 4 hours (% retained), mean (SD) | 34.0 (20.9) | 31.7 (22.4) | 32.3 (22.0) | 0.22 |
| Clinical and laboratory characteristics | ||||
| BMI, kg/m2 | 27.1 (7.5) | 27.3 (7.4) | 27.3 (7.4) | 0.66 |
| HbA1c, % | 6.8 (2.2) | 6.2 (1.7) | 6.4 (1.9) | <0.001 |
| ANA positive | 31 (16%) | 88 (17%) | 119 (17%) | 1.00 |
| ESR | 13.0 (6.0, 29.0) | 13.0 (6.0, 26.0) | 13.0 (6.0, 27.0) | 0.50 |
| Medication usage | ||||
| Antidepressants | 84 (44%) | 198 (38%) | 282 (39%) | 0.12 |
| Anxiolytics | 54 (29%) | 119 (23%) | 173 (24%) | 0.11 |
| Neuropathic pain modulators | 53 (28%) | 151 (29%) | 204 (29%) | 0.93 |
| Prokinetics | 92 (49%) | 268 (51%) | 360 (50%) | 0.61 |
| Antiemetics | 117 (62%) | 307 (58%) | 424 (59%) | 0.44 |
| Opioid narcotic pain medication | 81 (43%) | 186 (35%) | 267 (37%) | 0.07 |
| Comorbidities | ||||
| Autoimmune disorder | 31 (16%) | 104 (20%) | 135 (19%) | 0.33 |
| Cancer/malignancy | 11 (6%) | 33 (6%) | 44 (6%) | 1.00 |
| Coronary artery disease | 9 (5%) | 28 (5%) | 37 (5%) | 0.85 |
| Cerebrovascular disease/stroke | 4 (2%) | 10 (2%) | 14 (2%) | 0.77 |
| Diabetes | 82 (43%) | 174 (33%) | 256 (36%) | 0.01 |
| Endocrine disorder | 37 (20%) | 138 (26%) | 175 (24%) | 0.08 |
| Gynecological/urologic disorder | 41 (22%) | 102 (19%) | 143 (20%) | 0.53 |
| Migraine headaches | 72 (38%) | 196 (37%) | 268 (37%) | 0.86 |
| Neurologic disorders | 4 (2%) | 5 (1%) | 9 (1%) | 0.25 |
| Psychiatric disorder | 106 (56%) | 157 (30%) | 263 (37%) | <0.001 |
| Seizure disorder or epilepsy | 14 (7%) | 22 (4%) | 36 (5%) | 0.12 |
| Total number of comorbidities (sum of 11 conditions above) | 2.2 (1.4) | 1.8 (1.4) | 1.9 (1.4) | 0.006 |
| Additional comorbidities | ||||
| Severe anxiety disorder | 51 (27%) | 86 (16%) | 137 (19%) | 0.002 |
| Major depression | 87 (46%) | 106 (20%) | 193 (27%) | <0.001 |
| GERD‡ | 114 (60%) | 309 (59%) | 423 (59%) | 0.73 |
| Hypertension | 59 (31%) | 156 (30%) | 215 (30%) | 0.71 |
| Irritable bowel syndrome (ROME III) | 137 (72%) | 321 (61%) | 458 (64%) | 0.005 |
| Peptic ulcer | 10 (5%) | 36 (7%) | 46 (6%) | 0.60 |
| Peripheral neuropathy | 45 (24%) | 84 (16%) | 129 (18%) | 0.02 |
| PAGI-SYM symptom severities | ||||
| GCSI § | 3.2 (0.9) | 2.8 (1.1) | 2.9 (1.1) | <0.001 |
| Nausea subscore | 2.8 (1.4) | 2.3 (1.4) | 2.4 (1.4) | <0.001 |
| Nausea | 3.7 (1.3) | 3.2 (1.5) | 3.4 (1.4) | <0.001 |
| Retching | 2.3 (1.7) | 1.8 (1.7) | 1.9 (1.8) | <0.001 |
| Vomiting | 2.4 (1.9) | 1.8 (1.8) | 2.0 (1.9) | <0.001 |
| Fullness/early satiety subscore | 3.6 (0.9) | 3.3 (1.2) | 3.4 (1.2) | 0.001 |
| Stomach fullness | 3.8 (1.1) | 3.5 (1.3) | 3.6 (1.3) | 0.015 |
| Inability to finish a meal | 3.6 (1.2) | 3.3 (1.6) | 3.4 (1.5) | 0.004 |
| Excessively full after meals | 3.8 (1.2) | 3.5 (1.4) | 3.6 (1.4) | 0.03 |
| Appetite loss | 3.2 (1.4) | 2.8 (1.6) | 2.9 (1.5) | 0.004 |
| Bloating subscore | 3.3 (1.4) | 3.0 (1.6) | 3.0 (1.6) | 0.010 |
| Bloating | 3.5 (1.4) | 3.1 (1.6) | 3.2 (1.6) | 0.010 |
| Stomach visibly larger | 3.1 (1.6) | 2.8 (1.8) | 2.9 (1.7) | 0.02 |
| Upper abdominal pain subscore | 3.5 (1.3) | 2.9 (1.6) | 3.0 (1.5) | <0.001 |
| Upper abdominal pain | 3.5 (1.5) | 2.8 (1.7) | 3.0 (1.7) | <0.001 |
| Upper abdominal discomfort | 3.6 (1.4) | 3.0 (1.6) | 3.1 (1.6) | <0.001 |
| Abdominal pain subscore | 3.1 (1.2) | 2.4 (1.3) | 2.6 (1.3) | <0.001 |
| GERD subscore‡ | 2.4 (1.4) | 1.8 (1.4) | 2.0 (1.4) | <0.001 |
| Anxiety and depression inventories | ||||
| State-Trait Anxiety Inventory∥ | ||||
| State anxiety score | 56.6 (12.1) | 39.7 (11.3) | 44.2 (13.7) | <0.001 |
| Severe state anxiety (score ≥50) | 142 (75%) | 109 (21%) | 251 (35%) | <0.001 |
| Trait anxiety score | 55.3 (10.1) | 39.5 (10.7) | 43.7 (12.6) | <0.001 |
| Severe trait anxiety (score ≥50) | 132 (70%) | 102 (19%) | 234 (33%) | <0.001 |
| Beck Depression Inventory (BDI)¶ | ||||
| BDI score | 29.5 (11.0) | 14.4 (8.4) | 18.4 (11.3) | <0.001 |
| Severe depression (BDI≥28) | 101 (53%) | 27 (5%) | 128 (18%) | <0.001 |
SF-36v2 scores were normalized to the 1998 US general population - mean ± standard deviation of 50 ± 10. Lower scores reflect lower quality of life.
P-values determined from t-tests or Fisher’s Exact Test.
GERD=gastroesophageal reflux disease
Gastroparesis Cardinal Symptom Index (GCSI): range 0–5, where higher scores reflect increased severity of symptoms.
State-Trait Anxiety Inventory: range 20–80, where higher scores reflect increased anxiety
Beck Depression Inventory: range 0–63, where higher scores reflect increased severity of depression, and scores≥28 indicate severe depression.
PAGI-QOL: Patient Assessment of Upper Gastrointestinal Disorders Quality of Life, scores range from 0–5, with lower scores reflecting a lower health-related quality of life.
Multivariable analysis revealed poor SF-36 mental subscore was associated with diabetic etiology (OR=1.88; p=0.01), Beck Depression Inventory score (OR=1.12; p<0.001), and State anxiety score (OR=1.06; p<0.001) (Supplemental Table 2). A higher number of comorbidities was related to poor SF-36 MC in the univariable model (OR=1.17; p=0.007); however, when adjustment for other characteristics were included in the multivariable model, the relationship reversed direction (OR=0.81; p=0.02). This unexpected inverse relationship is likely due to residual confounding between the Beck Depression Inventory and the number of co-morbidities.
PAGI-QOL
The average PAGI-QOL score was 2.6±1.1. Of the components of the PAGI-QOL for the gastroparesis patients, there were lower QOL for diet subscore (1.6) and activity subscore (2.4) but higher QOL for the relationship subscore (3.1), psychological subscore (2.9) and clothing subscore (2.9).
358 of 715 patients (50%) had low QOL using PAGI-QOL, as defined as a PAGI-QOL score of <2.6 (Table 3). The PAGI-QOL score was similar among the different etiologies of gastroparesis: idiopathic 2.6, T1DM 2.5, T2DM 2.7 (p=0.40) (Table 1).
Lower PAGI-QOL scores were associated with younger age (p=0.001), past or present cigarette smoking (p=0.008), not drinking alcohol (p=0.04), nature of gastroparesis symptoms (especially progressive worsening symptoms) (p<0.001), predominant symptom prompting evaluation of gastroparesis being abdominal pain rather than nausea (p=0.03) (Table 4). Greater severity of each of the symptoms of gastroparesis were associated with worse PAGI-QOL, as well as grade 3 investigator-rated gastroparesis severity (p<0.001), use of TPN (p<0.001), presence of gastric electric stimulator, hospitalizations in the past year, use of narcotic pain medication (p<0.001). Higher number of comorbidities, especially gynecological/urological disorder, migraine headaches, anxiety, depression, and presence of IBS by Rome III criteria were associated with lower PAGI-QOL. From the questionnaires, state anxiety, trait anxiety, Beck Depression Inventory score were associated with lower PAGI-QOL.
Table 4.
Characteristics of Gastroparesis Registry participants with delayed gastric emptying at enrollment by low vs. high quality of life, as measured by the PAGI-QOL
| PAGI-QOL Score* |
||||
|---|---|---|---|---|
| Participant Characteristics | <2.6 (N=358) | ≥2.6 (N=357) | Total (N=715) | P† |
|
| ||||
| Demographics and lifestyle | ||||
| Female | 304 (85%) | 294 (82%) | 598 (84%) | 0.36 |
| Age at enrollment (years) | 41.4 (12.5) | 44.7 (14.5) | 43.1 (13.6) | 0.001 |
| Hispanic ethnicity | 39 (11%) | 42 (12%) | 81 (11%) | 0.72 |
| Race | 0.45 | |||
| White | 306 (86%) | 316 (89%) | 622 (88%) | |
| Black | 35 (10%) | 30 (8%) | 65 (9%) | |
| Other | 14 (4%) | 9 (3%) | 23 (3%) | |
| Married | 213 (59%) | 194 (54%) | 407 (57%) | 0.17 |
| Income ≥$50,000 | 166 (46%) | 190 (53%) | 356 (50%) | 0.07 |
| Ever smoked | 144 (40%) | 109 (31%) | 253 (35%) | 0.008 |
| Ever drink alcohol | 141 (39%) | 168 (47%) | 309 (43%) | 0.04 |
| Gastroparesis history | ||||
| Gastroparesis etiology | 0.44 | |||
| Diabetic | 123 (34%) | 133 (37%) | 256 (36%) | |
| Idiopathic | 235 (66%) | 224 (63%) | 459 (64%) | |
| Duration of Gp symptom onset (years), median (IQR) | 3.3 (1.6, 6.3) | 3.2 (1.3, 6.7) | 3.2 (1.5, 6.5) | 0.94 |
| Nature of gastroparesis symptoms | <0.001 | |||
| Chronic, but stable | 51 (14%) | 97 (27%) | 148 (21%) | |
| Chronic, but progressive worsening | 129 (36%) | 78 (22%) | 207 (29%) | |
| Chronic, but with some improvement | 14 (4%) | 21 (6%) | 35 (5%) | |
| Chronic with periodic exacerbations | 120 (34%) | 106 (30%) | 226 (32%) | |
| Cyclic exacerbations with periods of feeling well | 41 (12%) | 52 (15%) | 93 (13%) | |
| Asymptomatic | 1 (<1%) | 2 (1%) | 3 (<1%) | |
| Predominant symptom prompting evaluation for Gp | 0.03 | |||
| Nausea | 93 (26%) | 131 (37%) | 224 (31%) | |
| Vomiting | 82 (23%) | 75 (21%) | 157 (22%) | |
| Bloating | 37 (10%) | 29 (8%) | 66 (9%) | |
| Abdominal pain | 82 (23%) | 61 (17%) | 143 (20%) | |
| GERD‡ | 11 (3%) | 16 (4%) | 27 (4%) | |
| Other | 53 (15%) | 45 (13%) | 98 (14%) | |
| Onset of symptoms | 0.41 | |||
| Acute | 158 (44%) | 170 (48%) | 328 (46%) | |
| Insidious | 199 (56%) | 187 (52%) | 386 (54%) | |
| Initial infectious prodrome | 70 (20%) | 64 (18%) | 134 (19%) | 0.63 |
| Investigator-rated gastroparesis severity | <0.001 | |||
| Mild (Grade 1) | 32 (9%) | 85 (24%) | 117 (16%) | |
| Compensated (Grade 2) | 218 (61%) | 202 (57%) | 420 (59%) | |
| Gastric failure (Grade 3) | 106 (30%) | 68 (19%) | 174 (24%) | |
| Need for nutritional support | ||||
| TPN | 38 (11%) | 12 (3%) | 50 (7%) | <0.001 |
| G tube | 2 (1%) | 5 (1%) | 7 (1%) | 0.29 |
| J tube | 9 (3%) | 5 (1%) | 14 (2%) | 0.42 |
| Any nutritional support (G-tube, J-tube, or TPN) | 44 (12.3) | 17 (4.8) | 61 (8.5) | <0.001 |
| Gastric electrical stimulator in place | 29 (8%) | 14 (4%) | 43 (6%) | 0.03 |
| History of nutrition consult | 133 (37%) | 133 (37%) | 266 (37%) | 1.00 |
| History of cholecystectomy | 147 (41%) | 129 (36%) | 276 (39%) | 0.19 |
| History of hysterectomy | 100 (37%) | 80 (29%) | 180 (33%) | 0.08 |
| Hospitalization for Gp in past year | 169 (47%) | 128 (36%) | 297 (42%) | 0.002 |
| Gastric Emptying Scintigraphy | ||||
| 2 hours (% retained), mean (SD) | 65.7 (18.0) | 64.3 (18.0) | 65.0 (18.0) | 0.28 |
| 4 hours (% retained), mean (SD) | 33.1 (21.4) | 31.6 (22.6) | 32.3 (22.0) | 0.37 |
| Clinical and laboratory characteristics | ||||
| BMI, kg/m2 | 27.3 (7.4) | 27.2 (7.5) | 27.3 (7.4) | 0.89 |
| HbA1c, % | 6.4 (1.9) | 6.4 (1.8) | 6.4 (1.9) | 0.91 |
| ANA positive | 50 (14%) | 69 (19%) | 119 (17%) | 0.07 |
| ESR | 13.0 (6.5, 27.0) | 13.0 (6.0, 27.0) | 13.0 (6.0, 27.0) | 0.62 |
| Medication usage | ||||
| Antidepressants | 149 (42%) | 133 (37%) | 282 (39%) | 0.25 |
| Anxiolytics | 98 (27%) | 75 (21%) | 173 (24%) | 0.06 |
| Neuropathic pain modulators | 109 (30%) | 95 (27%) | 204 (29%) | 0.28 |
| Prokinetics | 184 (51%) | 176 (49%) | 360 (50%) | 0.60 |
| Antiemetics | 225 (63%) | 199 (56%) | 424 (59%) | 0.06 |
| Opioid narcotic pain medication | 161 (45%) | 106 (30%) | 267 (37%) | <0.001 |
| Comorbidities | ||||
| Autoimmune disorder | 68 (19%) | 67 (19%) | 135 (19%) | 1.00 |
| Cancer/malignancy | 24 (7%) | 20 (6%) | 44 (6%) | 0.64 |
| Coronary artery disease | 14 (4%) | 23 (6%) | 37 (5%) | 0.13 |
| Cerebrovascular disease/stroke | 8 (2%) | 6 (2%) | 14 (2%) | 0.79 |
| Diabetes | 123 (34%) | 133 (37%) | 256 (36%) | 0.44 |
| Endocrine disorder | 85 (24%) | 90 (25%) | 175 (24%) | 0.66 |
| Gynecological/urologic disorder | 88 (25%) | 55 (15%) | 143 (20%) | 0.003 |
| Migraine headaches | 147 (41%) | 121 (34%) | 268 (37%) | 0.05 |
| Neurologic disorders | 5 (1%) | 4 (1%) | 9 (1%) | 1.00 |
| Psychiatric disease | 161 (45%) | 102 (29%) | 263 (37%) | <0.001 |
| Seizure disorder or epilepsy | 24 (7%) | 12 (3%) | 36 (5%) | 0.06 |
| Total number of comorbidities (sum of 11 conditions above) | 2.1 (1.5) | 1.8 (1.4) | 1.9 (1.4) | 0.004 |
| Additional comorbidities | ||||
| Severe anxiety disorder | 85 (24%) | 52 (15%) | 137 (19%) | 0.002 |
| Major depression | 127 (35%) | 66 (18%) | 193 (27%) | <0.001 |
| GERD‡ | 218 (61%) | 205 (57%) | 423 (59%) | 0.36 |
| Hypertension | 97 (27%) | 118 (33%) | 215 (30%) | 0.09 |
| Irritable bowel syndrome (ROME III) | 256 (72%) | 202 (57%) | 458 (64%) | <0.001 |
| Peptic ulcer | 28 (8%) | 18 (5%) | 46 (6%) | 0.17 |
| Peripheral neuropathy | 69 (19%) | 60 (17%) | 129 (18%) | 0.44 |
| PAGI-SYM symptom severities | ||||
| GCSI§ | 3.4 (0.9) | 2.5 (1.1) | 2.9 (1.1) | <0.001 |
| Nausea subscore | 2.8 (1.4) | 2.0 (1.4) | 2.4 (1.4) | <0.001 |
| Nausea | 3.7 (1.2) | 3.0 (1.5) | 3.4 (1.4) | <0.001 |
| Retching | 2.4 (1.8) | 1.5 (1.6) | 1.9 (1.8) | <0.001 |
| Vomiting | 2.4 (1.9) | 1.6 (1.8) | 2.0 (1.9) | <0.001 |
| Fullness/early satiety subscore | 3.7 (0.9) | 3.0 (1.2) | 3.4 (1.2) | <0.001 |
| Stomach fullness | 3.9 (1.1) | 3.2 (1.3) | 3.6 (1.3) | <0.001 |
| Inability to finish a meal | 3.8 (1.2) | 3.0 (1.6) | 3.4 (1.5) | <0.001 |
| Excessively full after meals | 4.0 (1.1) | 3.2 (1.5) | 3.6 (1.4) | <0.001 |
| Appetite loss | 3.2 (1.5) | 2.6 (1.6) | 2.9 (1.5) | <0.001 |
| Bloating subscore | 3.6 (1.3) | 2.5 (1.6) | 3.0 (1.6) | <0.001 |
| Bloating | 3.7 (1.3) | 2.7 (1.6) | 3.2 (1.6) | <0.001 |
| Stomach visibly larger | 3.4 (1.5) | 2.4 (1.8) | 2.9 (1.7) | <0.001 |
| Upper abdominal pain subscore | 3.6 (1.3) | 2.5 (1.6) | 3.0 (1.5) | <0.001 |
| Upper abdominal pain | 3.5 (1.4) | 2.4 (1.7) | 3.0 (1.7) | <0.001 |
| Upper abdominal discomfort | 3.6 (1.3) | 2.7 (1.6) | 3.1 (1.6) | <0.001 |
| Abdominal pain subscore | 3.1 (1.1) | 2.1 (1.3) | 2.6 (1.3) | <0.001 |
| GERD subscore‡ | 2.4 (1.4) | 1.5 (1.3) | 2.0 (1.4) | <0.001 |
| Anxiety and depression inventories | ||||
| State-Trait Anxiety Inventory∥ | ||||
| State anxiety score | 50.7 (12.8) | 37.6 (11.3) | 44.2 (13.7) | <0.001 |
| Severe state anxiety (score ≥50) | 187 (52%) | 64 (18%) | 251 (35%) | <0.001 |
| Trait anxiety score | 49.9 (11.5) | 37.4 (10.4) | 43.7 (12.6) | <0.001 |
| Severe trait anxiety (score ≥50) | 178 (50%) | 56 (16%) | 234 (33%) | <0.001 |
| Beck Depression Inventory (BDI)¶ | ||||
| BDI score | 24.6 (10.9) | 12.2 (7.8) | 18.4 (11.3) | <0.001 |
| Severe depression (BDI≥28) | 115 (32%) | 13 (4%) | 128 (18%) | <0.001 |
PAGI-QOL: Patient Assessment of Upper Gastrointestinal Disorders Quality of Life, scores range from 0–5, with lower scores reflecting a lower health-related quality of life.
P-values determined from t-tests or Fisher’s Exact Test.
GERD=gastroesophageal reflux disease
Gastroparesis Cardinal Symptom Index (GCSI): range 0–5, where higher scores reflect increased severity of symptoms.
State-Trait Anxiety Inventory: range 20–80, where higher scores reflect increased anxiety
Beck Depression Inventory: range 0–63, where higher scores reflect increased severity of depression, and scores≥28 indicate severe depression.
SF-36v2 scores were normalized to the 1998 US general population with mean ± standard deviation of 50 ± 10. Lower scores reflect lower quality of life.
Multivariable regression analysis showed low PAGI-QOL to be associated with higher fullness subscore (OR=1.32; p=0.02), bloating subscore (OR=1.42; p<0.001), upper abdominal pain subscore (OR=1.18; p=0.04), increased depression score (OR=1.10; p<0.001), Trait anxiety (OR=1.06; p<0.001), smoking cigarettes (OR=1.70; p=0.01), need for nutritional support (via total parenteral nutrition, jejunostomy or gastrostomy tube) (OR=2.23; p=0.04), chronic symptoms with progressive worsening (OR=2.61; p=0.002), periodic exacerbations (OR=1.83; p=0.04), or with some improvement over time (OR=3.08; p=0.04) compared with patients with higher QOL (Supplemental Table 3).
Discussion
This study shows that QOL is impaired in gastroparesis based on several different measures. Specifically, QOL was impaired in 41% of gastroparesis patients according to the SF-36 PC, in 26% by the SF-36 MC, and 50% using the PAGI-QOL. Impairment in QOL was present both in patients with idiopathic and diabetic gastroparesis based on poor QOL defined by PC SF-36v2 and PAGI-QOL, but was more likely among patients with diabetes using the MC SF-36v2. Several areas impacted QOL: 1) Symptoms of gastroparesis, particularly nausea, vomiting, and abdominal pain, as well as IBS; 2) Etiology and acute onset of symptoms with progressive worsening of symptoms; 3) Other comorbidities and psychological factors of anxiety and depression; 4) Patient related factors such as smoking. This study points out areas that may improve QOL in gastroparesis, including treatment of symptoms, avoidance of narcotics, and treatment of psychological factors including anxiety and depression.
QOL is defined as the general well-being of individuals (27). Health-related QOL (HRQOL) is the functional effect of a medical condition and/or its treatment upon a patient. HRQOL is subjective and multidimensional, encompassing physical and occupational function, psychological state, social interaction, and somatic sensation (27). In this study, we used the general QOL instrument Short Form Health Survey (SF-36) that describes both physical and mental aspects of HRQOL (14). The SF-36 has been frequently used in a large number of disorders and has an impressive normal data base. We also used the disease specific instrument, PAGI-QOL which was developed and validated as a clinically relevant instrument for assessing quality of life in patients with upper gastrointestinal disorders, particularly gastroparesis.
This study, as well as several other already published observations (2,3), documents the decreased QOL in patients with gastroparesis. As might be expected, more patients were assessed having impaired QOL with the disease specific QOL instrument PAGI-QOL than the general SF-36v2. Our prior study comparing idiopathic to diabetic gastroparesis showed both groups of patients have impaired QOL (4). This study extends this work by evaluating a larger number of patients to identify factors associated with impaired QOL. While some patients from this prior study were also included in this analysis, the larger number of patients allows the detailed and robustly powered multivariate analysis performed in the current study.
Both SF-36 and PAGI-QOL have physical and mental components. Our patients with gastroparesis had greater reduction in the physical than the mental components of the QOL instruments. The SF-36 physical score was 33.3 compared to normal of 50 whereas the mental quality of life with SF-36 was 38.9, also with normal of 50. This is similar to the large online database reported by Yu et al of 33.1 for SF-36 PC, and 36.0 for MC (30). Our patients had a PAGI-QOL that averaged 2.6 which agrees with prior studies in gastroparesis patients by de la Loge of 2.6 (15) and Dibaise et al of 2.5 (31). Of the components of the PAGI-QOL, there were lower QOL scores for diet subscore, activity subscore, and clothing subscore than relationship and psychological subscores.
Gastroparesis symptoms adversely impacted QOL. Using multivariable analysis, increases in the subscores for nausea/vomiting, early satiety/postprandial fullness, bloating, and upper abdominal pain were associated with reduced QOL using PAGI-QOL. For the SF-36 PC, the two symptom areas significantly associated with impaired QOL were increased nausea/vomiting subscore and the upper abdominal pain subscore. An acute onset of symptoms as well as progressively worsening symptoms reduced QOL. Prior studies have shown nausea and vomiting were associated with impaired QOL (6,28,29). We have also shown that abdominal pain adversely impacts QOL (8). The IFFGD reported survey results in 1,423 adult patients with gastroparesis (30) showed physical health QOL score was negatively correlated with specific symptoms including nausea, upper abdominal pain, and early satiety.
Non-gastroparesis symptoms also affected the QOL. This included IBS; using the Rome III diagnostic questionnaire, it coexisted in 64% of our patients with gastroparesis. In addition, non-gastrointestinal disorders impacted QOL in the univariable analysis – gynecological, urological, neurological disorders. Psychological factors of anxiety and depression also were associated with reduced QOL. We have previously shown that higher depression and anxiety scores are associated with gastroparesis severity (31). Psychological features should be considered in managing gastroparesis. The number of comorbidities was significantly associated with lower QOL; this persisted in the multivariable analysis for the PC. In the SF36–2 MC, depression and anxiety were the main comorbidities that impacted on QOL.
Patient related factors such as body weight, smoking, and drinking were found to impact QOL. These modifiable factors are of particular interest and potential in improving patient outcomes. The GpCRC previously reported a longitudinal study in gastroparesis showing several factors related to a worse outcome include abdominal pain, being overweight or obese, smoking, presence of GERD, and use of pain modulators and anxiolytics (9). The current findings provide additional evidence with factors affecting QOL also associate with worse patient-reported outcomes over the disease course.
We did not find a relationship between the severity of gastric emptying delay and impaired QOL in our patients with delayed gastric emptying. Our clinical outcome study in gastroparesis showed that more severe gastric retention at 2 hours was associated with improved symptoms over 48 weeks (9). A report from Mayo Clinic described that patients with delayed gastric emptying had more severe impairment in QOL using the PAGI-QOL and SF-12 than patients with normal gastric emptying (32). This is similar to the initial PAGI-QOL validation studies showing worse QOL in patients with gastroparesis than with dyspepsia (15).
Treatments used by patients were associated with QOL; these may also be associated with the symptoms that impact QOL. Use of antiemetics improved QOL, presumably by decreasing symptoms of nausea and vomiting. Narcotics had disparate results: they were associated with worse QOL using SF-36 physical. Narcotics reduce acute pain, but may amplify chronic pain as well as slow gastric emptying and cause nausea and vomiting. Prior studies on use of domperidone in diabetic gastroparesis (2) and use of gastric electric stimulation (3) have shown reduced QOL that improved during treatment.
Our study has some limitations. Our patients were seen at a variety of centers, most being academic institutions, which might select for more severe patients. In addition, the data presented are QOL assessments obtained on enrollment to the Registry. Recall bias of patient’s recollection of symptoms may be a limitation. The PAGI-SYM and PAGI-QOL ask about symptoms over the last 2 weeks, the SF-36 asks about symptoms over the past 4 weeks, and the Rome III questionnaire asks about symptoms over the past 3 months. Some studies have suggested it is difficult assessing QOL in a fluctuating disease such as gastroparesis as the patients may, at any one time, be going through transitions in their symptoms (33)
In conclusion, this study demonstrates impaired QOL using multiple measures in patients with gastroparesis, both idiopathic and diabetic. Multiple areas were found to reduce QOL. The symptoms of gastroparesis that mainly reduced QOL were nausea, vomiting and abdominal pain. An acute onset of symptoms and progressive worsening of symptoms were associated with reduced QOL, as were symptoms of IBS. Other medical problems, psychological factors of anxiety and depression and patient-related factors such as smoking were associated with reduced QOL. This study points out areas that may be targeted to improve QOL in gastroparesis, including treatment of symptoms, avoidance of narcotics, and treatment of psychological factors including anxiety and depression.
Supplementary Material
Funding:
The NIH/NIDDK Gastroparesis Clinical Research Consortium (GpCRC) is supported by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (grants U01DK073975 [Parkman], U01DK073983 [Pasricha], U01DK074007 [Abell], U01DK073974 [Koch], U01DK112194 [Shulman], U01DK074035 [McCallum], U01DK112193 [Kuo], U01DK074008 [Tonascia]).
Footnotes
Competing Interests: the authors have no competing interests.
ClinicalTrials.gov Identifiers: NCT00398801 and NCT01696747
DATA AVAILABILITY STATEMENT:
The data that support the findings of this study are openly available in NIDDK Central Repository at https://repository.niddk.nih.gov/home/, under two studies: GpR - https://repository.niddk.nih.gov/studies/gpr/ and GpR2 - https://repository.niddk.nih.gov/studies/gpr-2/
References
- 1.Parkman HP, Hasler WL, Fisher RS. American Gastroenterological Association technical review on the diagnosis and treatment of gastroparesis. Gastroenterology 2004;127:1592–622. [DOI] [PubMed] [Google Scholar]
- 2.Farup CE, Leidy NK, Murray M, Williams GR, Helbers L, Quigley EM. Effect of domperidone on the health-related quality of life of patients with symptoms of diabetic gastroparesis. Diabetes Care 1998;21:1699–706. [DOI] [PubMed] [Google Scholar]
- 3.Abell T, McCallum R, Hocking M, Koch K, Abrahamsson H, Leblanc I, Lindberg G, Konturek J, Nowak T, Quigley EM, Tougas G, Starkebaum W. Gastric electrical stimulation for medically refractory gastroparesis. Gastroenterology 2003;125:421–8 [DOI] [PubMed] [Google Scholar]
- 4.Parkman HP, Yates K, Hasler WL, Nguyen L, Pasricha PJ, Snape WJ, Farrugia G, Koch KL, Calles J, Abell TL, McCallum RW, Lee L, Unalp-Arida A, Tonascia J, Hamilton F. Similarities and Differences between idiopathic and diabetic gastroparesis. Clin Gastroenterol Hepatol 2011;9:1056–64. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 5.Blondel-Kucharski F, Chircop C, Marquis P, Cortot A, Baron F, Gendre JP, Colombel JF. Health-related quality of life in Crohn’s disease: a prospective longitudinal study in 231 patients. Am J Gastroenterol 2001;96:2915–20. [DOI] [PubMed] [Google Scholar]
- 6.Parkman HP, Hallinan EK, Hasler WL, Farrugia G, Koch KL, Calles J, Snape WJ, Abell TL, Sarosiek I, McCallum RW, Nguyen L, Pasricha PJ, Clarke J, Miriel L, Lee L, Tonascia J, Hamilton F; NIDDK Gastroparesis Clinical Research Consortium (GpCRC). Nausea and vomiting in gastroparesis: similarities and differences in idiopathic and diabetic gastroparesis. Neurogastroenterol Motil 2016;28:1902–1914. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 7.Hasler WL, Wilson LA, Parkman HP, Nguyen L, Abell TL, Koch KL, Pasricha PJ, Snape WJ, Farrugia G, Lee L, Tonascia J, Unalp-Arida A, Hamilton F. Bloating in Gastroparesis: Severity, Impact, and Associated Factors. Am J Gastroenterol 2011;106:1492–502. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 8.Hasler WL, Wilson LA, Parkman HP, Koch KL, Abell TL, Nguyen L, Pasricha PJ, Snape WJ, McCallum RW, Sarosiek I, Farrugia G, Calles J, Lee L, Tonascia J, Unalp-Arida A, Hamilton F. Factors related to abdominal pain in gastroparesis: contrast to patients with predominant nausea and vomiting. Neurogastroenterol Motil 2013;25:427–38. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 9.Pasricha PJ, Yates KP, Nguyen L, Clarke J, Abell TL, Farrugia G, Hasler WL, Koch KL, Snape WJ, McCallum RW, Sarosiek I, Tonascia J, Miriel LA, Lee L, Hamilton F, Parkman HP. Outcomes and Factors Associated with Reduced Symptoms in Patients with Gastroparesis. Gastroenterology 2015;149:1762–1774. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 10.Abell TL, Bernstein VK, Cutts T, et al. Treatment of gastroparesis: a multidisciplinary clinical review. Neurogastroenterol Motil 2006;18:263–83. [DOI] [PubMed] [Google Scholar]
- 11.Rentz AM, Kahrilas P, Stanghellini V, et al. Development and psychometric evaluation of the patient assessment of upper gastrointestinal symptom severity index (PAGI-SYM) in patients with upper gastrointestinal disorders. Qual Life Res 2004;13:1737–49. [DOI] [PubMed] [Google Scholar]
- 12.Revicki DA, Rentz AM, Dubois D, et al. Development and validation of a patient-assessed gastroparesis symptom severity measure: the Gastroparesis Cardinal Symptom Index. Aliment Pharmacol Ther 2003;18:141–50. [DOI] [PubMed] [Google Scholar]
- 13.Drossman DA, Corazziari E, Delvaux M, et al. Rome III and the Functional Gastrointestinal Disorders. 3rd edition. 2006. [Google Scholar]
- 14.Ware JE, Kosinski M, Dewey JE. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: QualityMetric Incorporated, 2000. [Google Scholar]
- 15.De la Loge C, Trudeau E, Marquis P, et al. Cross-cultural development and validation of a patient self-administered questionnaire to assess quality of life in upper gastrointestinal disorders: the PAGI-QOL. Qual Life Res 2004; 13: 1751–1762. [DOI] [PubMed] [Google Scholar]
- 16.Wyrwich KW, Mody R, Larsen LM, Lee M, Harnam N, Revicki DA. Validation of the PAGI-SYM among healing and maintenance of erosive esophagitis clinical trial participants. Qual Life Res 2010;19:551–564. [DOI] [PubMed] [Google Scholar]
- 17.Menard-Katcher P, Marks KL, Liacouras CA, Spergel JM, Yang Y-X, Falk GW. The natural history eosinophilic oesophagitis in the transition from childhood to adulthood. Aliment Pharmacol Ther 2013;37:114–121. [DOI] [PubMed] [Google Scholar]
- 18.Richter P, Werner J, Heerlein A, et al. On the validity of the Beck Depression Inventory. A review. Psychopathology 1998;31:160–168. [DOI] [PubMed] [Google Scholar]
- 19.Spielberger C, Gorsuch R, Lushene R. Manual for the state-trait anxiety inventory. Consulting Psychologists Press, Palo Alto, CA, 1970. [Google Scholar]
- 20.Sundararajana V, Hendersona T, Perrya C, Muggivana A, Quanb H, Ghalib WA. ICD-10 version of the Charlson Comorbidity Index predicted in-hospital mortality J Clinical Epidemiology 2004;57:1288–1294. [DOI] [PubMed] [Google Scholar]
- 21.Tougas G, Eaker EY, Abell TL, et al. Assessment of gastric emptying using a low fat meal: establishment of international control values. Am J Gastroenterol 2000;95:1456–62. [DOI] [PubMed] [Google Scholar]
- 22.Abell TL, Camilleri M, Donohoe K, et al. Consensus Recommendations for Gastric Emptying Scintigraphy. Am J Gastro 2008;103:753–763. [DOI] [PubMed] [Google Scholar]
- 23.Agresti A Categorical Data Analysis. New York: John Wiley & Sons, Inc.; 1990. [Google Scholar]
- 24.Akaike H A new look at the statistical model identification. IEEE Transactions on Automatic Control 1974;19:716–723. [Google Scholar]
- 25.Hosmer D, Lemeshow S. Applied Logistic Regression. Second ed. New York: John Wiley & Sons, Inc.; 2000. [Google Scholar]
- 26.SAS Institute, Inc. SAS software, version 9.3 of the SAS system for Windows. Cary, NC, 2002–2010. StataCorp. 2011. Stata statistical software: release 12. College Station, TX: StataCorp LP. [Google Scholar]
- 27.CDC website on HRQOL. https://www.cdc.gov/hrqol/index.htm. Visited 5/24/2020.
- 28.Jaffe JK, Paladugu S, Gaughan JP, Parkman HP. Characteristics of nausea and its effects on quality of life in diabetic and idiopathic gastroparesis. J Clin Gastroenterol 2011;45:317–21. [DOI] [PubMed] [Google Scholar]
- 29.Cherian D, Parkman HP. Nausea and vomiting in diabetic and idiopathic gastroparesis. Neurogastroenterol Motil 2012;24:217–22. [DOI] [PubMed] [Google Scholar]
- 30.Yu D, Ramsey FV, Norton WF, Norton N, Schneck S, Gaetano T, Parkman HP. The Burdens, Concerns, and Quality of Life of Patients with Gastroparesis. Dig Dis Sci 2017;62:879–893. [DOI] [PubMed] [Google Scholar]
- 31.Hasler WL, Parkman HP, Wilson LA, et al. Psychological dysfunction is associated with symptom severity but not disease etiology or degree of gastric retention in patients with gastroparesis. Am J Gastroenterol 2010;105:2357–67. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 32.Dibaise JK, Patel N, Noelting J, Dueck AC, Roarke M, Crowell MD. The relationship among gastroparesis symptoms, quality of life, and gastric emptying in patients referred for gastric emptying testing. Neurogastroenterol Motil 2016;28:234–42. [DOI] [PubMed] [Google Scholar]
- 33.Velanovich V Difficulty in assessing quality of life outcomes in a fluctuating disease: a hypothesis based on gastroparesis. Gastroenterol Res Pract 2009;2009:396190. [DOI] [PMC free article] [PubMed] [Google Scholar]
Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
Data Availability Statement
The data that support the findings of this study are openly available in NIDDK Central Repository at https://repository.niddk.nih.gov/home/, under two studies: GpR - https://repository.niddk.nih.gov/studies/gpr/ and GpR2 - https://repository.niddk.nih.gov/studies/gpr-2/