Development and Validation of a Disease-Specific Treatment
Development and Validation of a Disease-Specific Treatment
Background: Currently, no disease-specific, patient-based, treatment satisfaction instruments related to gastro-oesophageal reflux disease exist.
Aim: To develop and validate a treatment satisfaction questionnaire for gastro-oesophageal reflux disease (TSQ-G).
Methods: A new questionnaire was developed from patient focus groups, clinician input and literature review. A validation study was conducted in treated gastro-oesophageal reflux disease patients. Ancillary measures included the Medical Outcomes Study Short Form-36, Quality of Life in Reflux and Dyspepsia, Gastrointestinal Symptom Rating Scale, Socially Desirable Response Scale, Patient Satisfaction Questionnaire-18 and physician and patient measures of symptoms and satisfaction. Statistical analyses included exploratory factor analysis, Cronbach's alpha, intra-class correlations, analyses of variance and t-tests.
Results: A total of 198 gastro-oesophageal reflux disease patients participated in the study, with a mean age of 50.7 years, 68% female and 84% Caucasian. The physician-rated severity of gastro-oesophageal reflux disease was mild (32%), moderate (50%) and severe (18%); 83% were on proton pump inhibitors. The final TSQ-G consisted of 28 items with seven sub-scales; Cronbach's alpha ranged from 0.58 to 0.94. Correlations with the expected sub-scales of the ancillary measures were moderate to strong. The TSQ-G sub-scales discriminated significantly between levels of physician-rated disease severity, symptom days and patient and physician ratings of satisfaction.
Conclusions: The TSQ-G has excellent reliability and construct validity and appears to be a useful tool for the evaluation of treatment satisfaction in gastro-oesophageal reflux disease patients.
Treatment satisfaction may be a very useful outcome in clinical trials to provide insight into a patient's attitude towards treatment. This is particularly important when comparative treatments may be equally efficacious, as satisfaction is likely to lead to patient preferences for one treatment over another. Increased patient satisfaction with a treatment has also been shown to be related to adherence to prescription regimens. Thus, evaluation of the satisfaction with treatment may assist health care providers to understand the issues that influence adherence and to identify aspects of the treatment that require improvement to enhance long-term treatment outcomes.
A number of studies have addressed the issue of treatment satisfaction related to anti-reflux procedures (e.g. Nissen fundoplication) and medication response in GERD. However, the single questions or few items used in these studies to assess treatment satisfaction have not been well developed or validated; few treatment satisfaction questionnaires have been developed in a rigorous manner. In addition, to obtain a meaningful assessment of treatment satisfaction, factors such as patient expectations, relationship with their health care provider and cost must also be considered, as they have been shown to influence patient satisfaction. As such, the purpose of this study was to develop and validate a new treatment satisfaction questionnaire for GERD.
Background: Currently, no disease-specific, patient-based, treatment satisfaction instruments related to gastro-oesophageal reflux disease exist.
Aim: To develop and validate a treatment satisfaction questionnaire for gastro-oesophageal reflux disease (TSQ-G).
Methods: A new questionnaire was developed from patient focus groups, clinician input and literature review. A validation study was conducted in treated gastro-oesophageal reflux disease patients. Ancillary measures included the Medical Outcomes Study Short Form-36, Quality of Life in Reflux and Dyspepsia, Gastrointestinal Symptom Rating Scale, Socially Desirable Response Scale, Patient Satisfaction Questionnaire-18 and physician and patient measures of symptoms and satisfaction. Statistical analyses included exploratory factor analysis, Cronbach's alpha, intra-class correlations, analyses of variance and t-tests.
Results: A total of 198 gastro-oesophageal reflux disease patients participated in the study, with a mean age of 50.7 years, 68% female and 84% Caucasian. The physician-rated severity of gastro-oesophageal reflux disease was mild (32%), moderate (50%) and severe (18%); 83% were on proton pump inhibitors. The final TSQ-G consisted of 28 items with seven sub-scales; Cronbach's alpha ranged from 0.58 to 0.94. Correlations with the expected sub-scales of the ancillary measures were moderate to strong. The TSQ-G sub-scales discriminated significantly between levels of physician-rated disease severity, symptom days and patient and physician ratings of satisfaction.
Conclusions: The TSQ-G has excellent reliability and construct validity and appears to be a useful tool for the evaluation of treatment satisfaction in gastro-oesophageal reflux disease patients.
Treatment satisfaction may be a very useful outcome in clinical trials to provide insight into a patient's attitude towards treatment. This is particularly important when comparative treatments may be equally efficacious, as satisfaction is likely to lead to patient preferences for one treatment over another. Increased patient satisfaction with a treatment has also been shown to be related to adherence to prescription regimens. Thus, evaluation of the satisfaction with treatment may assist health care providers to understand the issues that influence adherence and to identify aspects of the treatment that require improvement to enhance long-term treatment outcomes.
A number of studies have addressed the issue of treatment satisfaction related to anti-reflux procedures (e.g. Nissen fundoplication) and medication response in GERD. However, the single questions or few items used in these studies to assess treatment satisfaction have not been well developed or validated; few treatment satisfaction questionnaires have been developed in a rigorous manner. In addition, to obtain a meaningful assessment of treatment satisfaction, factors such as patient expectations, relationship with their health care provider and cost must also be considered, as they have been shown to influence patient satisfaction. As such, the purpose of this study was to develop and validate a new treatment satisfaction questionnaire for GERD.
