New patient reported outcome (PRO) measures are regularly developed to assess various aspects of the patients’ perspective on their disease and treatment. For these instruments to be useful in clinical research, they must undergo a proper psychometric validation, including demonstration of cross-sectional and longitudinal measurement properties. This quantitative evaluation requires a study to be conducted on an appropriate sample size. The aim of this research was to list and describe practices in PRO and proxy PRO primary psychometric validation studies, focusing primarily on the practices used to determine sample size. A literature review of articles published in PubMed between January 2009 and September 2011 was conducted. Three selection criteria were applied including a search strategy, an article selection strategy, and data extraction. Agreements between authors were assessed, and practices of validation were described. Data were extracted from 114 relevant articles. Within these, sample size determination was low (9.6%, 11/114), and were reported as either an arbitrary minimum sample size (n = 2), a subject to item ratio (n = 4), or the method was not explicitly stated (n = 5). Very few articles (4%, 5/114) compared a posteriori their sample size to a subject to item ratio. Content validity, construct validity, criterion validity and internal consistency were the most frequently measurement properties assessed in the validation studies. Approximately 92% of the articles reported a subject to item ratio greater than or equal to 2, whereas 25% had a ratio greater than or equal to 20. About 90% of articles had a sample size greater than or equal to 100, whereas 7% had a sample size greater than or equal to 1000. The sample size determination for psychometric validation studies is rarely ever justified a priori. This emphasizes the lack of clear scientifically sound recommendations on this topic. Existing methods to determine the sample size needed to assess the various measurement properties of interest should be made more easily available.

/pdf/sample-size-used-to-validate-a-scale-a-review-of-2jzle0qink.pdf

Sample size used to validate a scale: a review of publications on newly-developed patient reported outcomes measures

Numerous questionnaires with a wide variety of characteristics have been developed for the assessment of gastroesophageal reflux disease (GERD) Four well-defined dimensions are noticeable in these GERD questionnaires, which are symptoms, response to treatment, diagnosis, and burden on the quality of life of GERD patients The aim of this review is to develop a complete overview of all available questionnaires, categorized per dimension of the assessment of GERD A systematic search of the literature up to January 2013 using the Pubmed database and the Embase database, and search of references and conference abstract books were conducted A total number of 65 questionnaires were extracted and evaluated Thirty-nine questionnaires were found applicable for the assessment of GERD symptoms, three of which are generic gastrointestinal questionnaires For the assessment of response to treatment, 14 questionnaires were considered applicable Seven questionnaires with diagnostic purposes were found In the assessment of quality of life in GERD patients, 18 questionnaires were found and evaluated Twenty questionnaires were found to be used for more than one assessment dimension, and eight questionnaires were found for GERD assessment in infants and/or children A wide variety of GERD questionnaires is available, of which the majority is used for assessment of GERD symptoms Questionnaires differ in aspects such as design, validation and translations Also, numerous multidimensional questionnaires are available, of which the Reflux Disease Questionnaire is widely applicable We provided an overview of GERD questionnaires to aid investigators and clinicians in their search for the most appropriate questionnaire for their specific purposes

Systematic review: questionnaires for assessment of gastroesophageal reflux disease

Background and Aim:  The Frequency Scale for the Symptoms of Gastroesophageal Reflux Disease (FSSG) is the standard questionnaire used in Japan for the diagnosis of gastroesophageal reflux disease (GERD) and assessment of the response to treatment We modified the FSSG in order to assess dyspepsia symptoms, and evaluated the modified questionnaire

Methods:  We modified the FSSG by adding two questions on interdigestive and postprandial epigastric pain We then assessed the modified FSSG with 100 new untreated symptomatic patients presenting to hospital and in 200 subjects undergoing health checks Endoscopic assessment of the esophagogastric junction was performed according to the modified Los Angeles classification with addition of Grade N (normal appearance) and Grade M (minimal change) Endoscopic images were assessed by five experienced endoscopists blinded to the questionnaire results

Results:  The 100 new patients included 16 with erosive GERD (>Grade A), 12 with peptic ulcer, and two with gastric cancer Among the 70 patients with no evidence of organic disease, the modified FSSG diagnosed functional dyspepsia (FD) in 41 and non-erosive gastric disease (NERD) in 29 A significant difference was seen in the dyspepsia score between patients with FD and NERD Subjects with endoscopic GERD undergoing health checks had significantly higher scores for all symptoms, reflux symptoms, and dyspeptic symptoms on the modified FSSG

Conclusion:  The modified FSSG can clearly distinguish FD from NERD, and is useful for the assessment of dyspeptic symptoms

Development and evaluation of a modified Frequency Scale for the Symptoms of Gastroesophageal Reflux Disease to distinguish functional dyspepsia from non-erosive reflux disease.

Patient-generated reports, also known as Patient-Reported Outcomes (PROs), capture the patients' illness experience in a structured format and may help bridge the gap between patients and providers. PROs measure any aspect of patient-reported health (e.g., physical, emotional or social symptoms) and can help to direct care and improve clinical outcomes. When clinicians systematically collect patient-reported data in the right place at the right time, PRO measurement can effectively aid in detection and management of conditions, improve satisfaction with care and enhance the patient-provider relationship. This review article summarizes the latest approaches to PRO measuring for clinical trials and clinical practice, with a focus on use of PROs in gastroenterology.

Patient-Reported Outcomes in Gastroenterology: Clinical and Research Applications

https://onlinelibrary.wiley.com/doi/pdf/10.1111/1467-9566.ep10934593

Measuring Disease (A review of disease-specific quality of life measurement scales) (Book).

Summary

Background Although gastro-oesophageal reflux disease (GERD) has a well-established pathophysiology, the impact of GERD symptoms on the patients’ quality of life can be profound. Therefore, health-related quality of life (HRQOL) questionnaires have become standard instruments to evaluate the effect of treatment in clinical trials.



Aim  To evaluate the reliability, validity and responsiveness of available GERD-specific HRQOL.



Methods  A systematic literature search using the Medical Subject Headings terms: ‘Gastro-oesophageal reflux’, ‘Heartburn’ and ‘Oesophagitis’ with ‘quality of life’ and ‘questionnaires’ was preformed to identify the available HRQOL questionnaires. To analyse the psychometric properties of the respective tools, the actual guidelines for the use of patient-reported outcomes in clinical trials were applied.



Results  We identified five GERD-specific HRQOL questionnaires but none of them fulfilled all quality criteria; either they did not meet the actual standards for psychometric properties (HBQOL, GERD-HRQL, Jasani et al.Aust Fam Physician 1999; 28: 515), or were impracticable to use in clinical trials. The generic and hybrid instruments lack specificity and sensitivity and were not designed for treatment evaluation in GERD patients.



Conclusion  There is need for a new evaluative tool in the assessment of HRQOL during GERD therapy.

https://onlinelibrary.wiley.com/doi/pdf/10.1111/j.1365-2036.2008.03683.x

Systematic review: health-related quality of life (HRQOL) questionnaires in gastro-oesophageal reflux disease.

Summary


Background Although erosive gastro-oesophageal reflux disease (GERD) is a highly prevalent condition, there is no specific, valid, reliable and sensitive questionnaire that allows evaluating treatment-induced changes in health-related quality of life (HRQoL).



Aim  To design a self-administered questionnaire, the GERD Analyzer (GERDyzer), for use in clinical studies.



Methods  The GERDyzer comprises 10 dimensions each illustrated by pictogram-like drawings, simplifying communication with the patients. Self-assessment is performed by 100 mm Visual Analogue Scales. For validation, a 5-week clinical trial involving 395 patients (per-protocol) with oesophagitis was conducted. Patients were treated with pantoprazole (40 mg o.d.) for 28 days. Psychometric analyses included internal consistency, test–retest reliability, responsiveness and construct validity.



Results  Factor analysis showed consistency of the dimensions and no reduction was necessary. Validation of GERDyzer indicated high internal consistency (Cronbach’s α = 0.95) and test–retest reliability (intraclass correlation coefficient =0.91). Responsiveness of the total score expressed by nonparametric effect size was 1.38. Comparison of scores with other questionnaires resulted in logical correlation levels depending on the respected concepts measured.



Conclusions  GERDyzer proved to be highly valid, reproducible and responsive. It allows reliably assessing treatment-induced changes in HRQoL in erosive GERD.

https://onlinelibrary.wiley.com/doi/pdf/10.1111/j.1365-2036.2008.03922.x

International validation of a health-related quality of life questionnaire in patients with erosive gastro-oesophageal reflux disease.

Pantoprazole 40 Mg (PANTO) Is Superior to Esomeprazole 40 Mg (ESO) in Resolving Sleep Disturbances in GERD Patients: 1015

GERDyzer™ Treatment Satisfaction Module: Correlation with Symptom Assessment by ReQuest™-GI

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Systematic review: health-related quality of life (HRQOL) questionnaires in gastro-oesophageal reflux disease.

International validation of a health-related quality of life questionnaire in patients with erosive gastro-oesophageal reflux disease.

Pantoprazole 40 Mg (PANTO) Is Superior to Esomeprazole 40 Mg (ESO) in Resolving Sleep Disturbances in GERD Patients: 1015

GERDyzer™ Treatment Satisfaction Module: Correlation with Symptom Assessment by ReQuest™-GI