The Development, Assessment, and Selection of Questionnaires

Abstract

Patient-reported outcome measurement has become accepted as an important component of comprehensive outcomes research. Researchers wishing to use a patient-reported measure must either develop their own questionnaire (called an instrument in the research literature) or choose from the myriad of instruments previously reported. This article summarizes how previously developed instruments are best assessed using a systematic process and we propose a system of quality assessment so that clinicians and researchers can determine whether there exists an appropriately developed and validated instrument that matches their particular needs. These quality assessment criteria may also be useful to guide new instrument development and refinement. We welcome debate over the appropriateness of these criteria as this will lead to the evolution of better quality assessment criteria and in turn better assessment of patient-reported outcomes.

Patient-reported outcomes (PRO's) in glaucoma: a systematic review

“…Next, all the selected and classified PRO's were assessed on their quality using both the FDA-guidelines 11 and the framework of Pesudovs et al 12 The FDA-criteria were applied, as they were specifically developed for PRO-instruments used for supporting medication labeling claims. The latter quality assessment tool was specifically created to determine if existing instruments are adequate for their intended use in the intended target population.…”

“…The latter quality assessment tool was specifically created to determine if existing instruments are adequate for their intended use in the intended target population. 12 These outlined quality criteria emphasize the importance of both the developmental history and the psychometric characteristics of PRO's and put forward the more modern methods of scoring and validation, namely Rasch-analysis. 13 This is a validation technique gaining more and more attention in the ophthalmic literature and transforms ordinal scores into interval scores to strengthen the instruments' content and validity.…”

“…More specifically, all PRO instruments were evaluated against the following criteria: (1) were the purpose of the instrument and its target population well defined; (2) were adequate steps taken in defining the content of the instrument, the rating scale and the scoring system and (3) is the instrument performing well in view of validity and reliability. 12 There are several existing guidelines and published standards for evaluating and judging these psychometric properties of PRO-instruments, [14][15][16][17][18][19] All papers included n=53 -Based on search strategy: n=41 -Hand search references: n=8 -Search using name instrument & first author name: n=4…”

“…In order to facilitate the choice for PRO instruments with a high quality to be included in future clinical trials, the primary aim of this review was to provide an overview of all existing PRO-instruments developed for glaucoma specifically or for a broad range of visual impairments including glaucoma, as well as to scrutinize their developmental process and psychometric properties by rating these characteristics based on the FDA-guidelines and quality criteria outlined by Pesudovs et al 12 To our knowledge, this is the first literature review addressing all PRO's available for glaucoma patients.…”

“…58 Second, many investigators only use expert opinion and/or a literature review to generate a preliminary list of items, yet the crucial factor to ensure a good breadth of relevance, which is the perspective of patients, was neglected in 11 instruments. According to the FDA 11 and the applied quality criteria, 12 PRO-instrument itemgeneration is incomplete without patient involvement (eg, patient interviews or focus groups) and should incorporate the input of a wide range of patients with the condition of interest to represent appropriate variations in severity and in population characteristics (eg, age, gender). 11 Third, only a limited number of investigators used an appropriate item reduction strategy on a pilot questionnaire using statistical techniques such as factor analysis or Rasch-analysis (60%).…”