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Quality of Life in Reflux and Dyspepsia (QOLRAD)
Please note that this section is an archive (last updated in June 2006). [disclaimer]
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Overview |
Instrument Reviews |
Construct Overviews |
Book Compendium Reviews |
Internet Site Reviews
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Practical Information
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Instrument Name:
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Quality of Life in Reflux and Dyspepsia (QOLRAD)
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Instrument Description:
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The scale measures changes over the past week in health-related quality of life for patients suffering from dyspepsia and heartburn. (Ref: 1) The 25-item QOLRAD assesses frequency and intensity of discomfort caused by upper GI symptoms. (Ref: 4) Items were generated using focus groups of patients and then tested in 759 patients referred for endoscopy in five countries. The five subscales of the QOLRAD include emotional distress, sleep disturbance, food/drink problems, physical/social functioning, vitality. (Ref: 3)
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Price:
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Free (in public domain)
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Administration Time:
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Patients respond to 25 items; likely to take approximately 10-15 minutes.
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Publication Year:
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1998
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Item Readability:
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Flesch-Kincaid grade level of 8.7; almost all items are comprised of 10 or fewer words and are written in simple language.
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Scale Format:
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7-point Likert scale with responses as either degree of distress (none at all, hardly any at all, a little, some, a moderate amount, a lot, a great deal) or frequency of the problem.
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Administration Technique:
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Questionnaire or self-report survey. One study also researched a Touch-screen computer version. (Ref: 4) The computer-administered version of the QOLRAD correlated with the original QOLRAD at 0.87 (vitality subscale) to 0.94 (total scale). Paired t-tests yielded no significant differences between methods of administration (p>0.24). Internal consistency reliability of the computer version was 0.94 to 0.98. (Ref: 4)
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Scoring and Interpretation:
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Mean score calculated in each subscale and across the entire scale; scores on each subscale are the mean item score, so scores range from 1-7. (Ref: 3) Adding all 25-item responses and dividing by 25 calculates a total score. (Ref: 5) In one study, researchers added all item scores and did not divide by 25, so total scores ranged from 25-175. (Ref:2) Lower scores indicate worse quality of life/more distress; higher scores indicate higher quality of life/less distress.
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Forms:
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Only information on the original 25-item form was found.
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Research Contacts
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Instrument Developers:
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Ingela K. Wiklund, Ola Junghard, Eileen Grace, Nicholas J. Talley, Michael Kamm, Sander Veldhuyzen van Zanten, Pierre Paré, Naoki Chiba, Desmond S. Leddin, Marc-André Bigard, Raymond Colin, Philip Schoenfeld
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Instrument Development Location:
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Ingela Wiklund, MD
Quality of Life Research
Astra Hässle AB
SE-431 83 Mölndal
Sweden
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Instrument Developer Email:
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No information found.
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Instrument Developer Website:
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No information found.
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Annotated Bibliography
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1. Talley NJ, Fullerton S, Junghard O, Wiklund I. Quality of life in patients with endoscopy-negative heartburn: reliability and sensitivity of disease-specific instruments. Am J Gastroenterol. 2001 Jul;96(7):1998-2004. [PMID: 11467624]
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Purpose: To evaluate 2 measures of gastroesophageal reflux disease (GERD). |
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Sample: 1143 patients who identified heartburn as main symptom, aged 18 to 80 years. |
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Methods: Utilized patients already enrolled in randomized clinical trials; patients administered the QOLRAD and the Gastrointestinal Symptoms Rating Scale (GSRS) at baseline and at 2 and 4-week follow-up. |
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Implications: Test-retest reliability, responsiveness and effect sizes were good to excellent on both measures. |
2. Wiklund IK, Junghard O, Grace E, Talley NJ, Kamm M, Veldhuyzen van Zanten S, Pare P, Chiba N, Leddin DS, Bigard MA, Colin R, Schoenfeld P. Quality of Life in Reflux and Dyspepsia patients. Psychometric documentation of a new disease-specific questionnaire (QOLRAD). Eur J Surg Suppl. 1998;(583):41-9. [PMID: 10027672]
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Purpose: “To develop a disease-specific quality of life instrument (QOLRAD) addressing patient concerns in gastroesophageal reflux disease and dyspepsia.” |
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Sample: 759 male and female patients, mean age=48.4 years (SD = 15.2), from Australia, Canada, US, UK, and France. Patients were referred for endoscopy with upper gastrointestinal symptoms or upper abdominal pain or discomfort. |
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Methods: The 34 item pilot form of the QOLRAD, the Gastrointestinal Symptoms Rating Scale (GSRS), and the SF-36 were completed before patients underwent endoscopy. |
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Implications: Final QOLRAD includes 25 items with high internal consistency reliability (alpha for overall scale=0.97, alpha for constructs=0.89 to 0.94). |
3. Borgaonkar MR, Irvine EJ. Quality of life measurement in gastrointestinal and liver disorders. Gut. 2000 Sep;47(3):444-54. Review. [PMID: 10940286]
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Purpose: To catalogue and evaluate published health-related quality of life instruments related to gastrointestinal diseases. |
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Sample: Samples are given for each of the studies reviewed. |
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Methods: Medline searches and research of published information. The QOLRAD was compared to the Gastrointestinal symptom rating scale (GSRS), the Gastro-Oesophageal Reflux Questionnaire (GORQ), and the Heartburn Quality of Life (HBQOL) measures on reliability and validity. |
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Implications: All four measures were developed with a literature review and expert opinion, only the GSRS and the QOLRAD had been factor analyzed, evidence for construct validity had been published for all measures except the GORQ, the QOLRAD had the highest internal consistency reliability coefficients, and only the GSRS had test-retest reliability information presented. |
4. Kleinman L, Leidy NK, Crawley J, Bonomi A, Schoenfeld P. A comparative trial of paper-and-pencil versus computer administration of the Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaire. Med Care. 2001 Feb;39(2):181-9. [PMID: 11176555]
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Purpose: To compare the psychometric properties of the QOLRAD when given by paper and pencil versus touch-screen computer. |
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Sample: 134 patients with GERD from the U.S.; random sample of 32 patients involved in test-retest. Sample populations included two government hospitals. |
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Methods: Crossover trial with patients randomized into two groups: paper and pencil administration followed by computer, and vice versa. Administrations were 3 days apart. Test-retest of the computer administration after 1 week. |
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Implications: Scores were the equivalent regardless of type of administration. Internal consistency, criterion related validity, and test-retest reliability for the computer version were high. |
5. Crawley J, Frank L, Joshua-Gotlib S, Flynn J, Frank S, Wiklund I. Measuring change in quality of life in response to Helicobacter pylori eradication in peptic ulcer disease: the QOLRAD. Dig Dis Sci. 2001 Mar;46(3):571-80. [PMID: 11318535]
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Purpose: To determine if the QOLRAD was responsive to clinical change when evaluating patients treated for peptic ulcer disease. Also, to examine the QOLRAD’s psychometric properties when used with patients with peptic ulcer disease. |
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Sample: 155 patients with peptic ulcer disease from 32 clinics across the US; patients were eligible if they had a current diagnosis of duodenal ulcer or were newly presenting with ulcer-like dyspepsia, were not currently being treated for their symptoms, and were Helicobacter pylori infected. |
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Methods: Clinical diagnosis was made during office visits, and then four weeks later. Within 5 days of the initial visit, patients were interviewed by phone. They were also interviewed within 7 days of the follow-up visit four weeks later. Patients were given the Gastrointestinal Symptoms Rating Scale (GSRS) to measure symptoms and the QOLRAD. |
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Implications: Changes in the QOLRAD scores were significantly correlated with clinical changes in symptoms. |
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Factors and Norms
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Factor Analysis Work:
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Principal components factor analysis with varimax orthogonal solution produced 5 factors: Emotional distress, sleep disturbance, food/drink problems, physical/social functioning, and vitality. (Ref: 3)
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Normative Information Availability:
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No information found.
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Reliability Evidence
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Test-retest:
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Stability was assessed as the ratio of the variability between patients to the total variability for 73 patients who reported little or no change over two and four weeks of treatment. Coefficients ranged from 0.65 to 0.76. (Ref: 1) Total score correlation correlated from baseline to the four-week follow-up was 0.77. The range for the 5 subscales over this same time period was 0.69 to 0.81. (Ref: 5)
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Inter-rater:
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Unknown
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Internal Consistency:
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Alpha = 0.89 to 0.94 (Ref: 2); alpha = 0.98 for the whole scale, while alpha >= 0.87 for all subscales. (Ref: 5) For the entire scale, alpha = 0.97. For the separate subscale, internal consistency was reported as follows (Ref: 3):
| Subscale
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Alpha
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| Emotional distress
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0.94
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| Sleep disturbance
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0.94
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| Food/drink problems
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0.91
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| Physical/social functioning
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0.89
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| Vitality
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0.97
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Alternate Forms:
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No information found.
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Validity Evidence
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Construct/ Convergent/ Discriminant:
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QOLRAD subscales and total scores correlate with the GSRS at a value at or above 0.75 (p<0.001) (Ref: 5), and in the range of r=0.29 to 0.63. (Ref: 2) QOLRAD correlated with almost all domains of the SF-36 (r=0.44 to 0.71). (Ref: 2) In the developmental study, the pain domains of the SF-36 and the GSRS were most strongly correlated to all QOLRAD domains (QOLRAD and SF-36 r=0.58 to .71; QOLRAD and GSRS r=0.54 to .63). (Ref: 3) The QOLRAD was negatively correlated with measures of frequency and severity of upper GI symptoms as rated by a clinician (less distress is negatively correlated with more frequency and severity of pain) with r=-0.27 to –0.38. (Ref: 3) There was a significant difference in the means of responders to a treatment for GI disease and nonresponders, on all subscales and the total scale, with differences ranging from 0.75 to 1.05 (p<.05). (Ref: 5)
| QOLRAD
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Total
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| GSRS total
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-0.814*
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| Symptom by clinician
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0.455
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| Outcome by clinician
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0.169
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| Outcome by patient
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0.402*
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* p < 0.05
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Note: While correlation of QOLRAD with clinician’s rating of symptom was not significant for the total score, however, was significant for each individual subscale.
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Criterion-related/ Concurrent/ Predictive:
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No information found.
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Content:
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The original items were developed based on qualitative interviews with patients using eight focus groups. (Ref: 3)
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Responsiveness Evidence:
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Responsiveness, estimated by standard response means, was 0.81 to 1.43 for the 5 domains. (Ref: 1) Mean QOLRAD change scores for responders to treatment, from baseline to follow-up, were significant (2 tailed t-tests, p<0.0001). (Ref: 5) Effect sizes ranged from 0.51 for the sleep subscale to 0.75 for the vitality subscale (according to Cohen, cutoffs of 0.50 are moderate effect sizes and 0.80 are large effect sizes)(Ref: 5).
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Scale Application in VA Populations:
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Yes. (Ref: 1,3-5)
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Scale Application in non-VA Populations:
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No information found.
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Comments
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This quality of life measure has been thoroughly tested in patients with dyspepsia, duodenal ulcers, and peptic ulcer disease. The factor analysis was conducted only with patients referred for treatment because of abdominal pain or discomfort. No evidence has been presented to verify that these same factors are present for more specific subgroups of patients, such as those with peptic ulcer disease. Future research on this measure might include factor analytic work with subgroups of patients with gastrointestinal symptoms. Test-retest reliability for patients reporting little or no change in symptoms was relatively high over two and four-week periods, especially since abdominal discomfort would not be expected to remain stable over long periods of time. The internal consistency was very high, often exceeding 0.90. Therefore, this measure appears reliable for both group comparisons and individual comparisons. Substantial convergent and discriminant validity evidence has been presented on the QOLRAD with various populations, and that the items were developed based on focus group interviews with patients supports the content validity of the measure. Furthermore, the responsiveness evidence suggests that changes in the QOLRAD are capable of reflecting clinical changes. The QOLRAD has not been used with veterans, however, and future research evaluating its application in VA populations is needed. Overall, this quality of life measure demonstrates strong measurement properties in non-VA populations with heartburn or upper abdominal pain and seems promising as a measure for use with veterans.
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