Comparison between electronic and paper versions of patient-reported outcome measures in subjects with chronic obstructive pulmonary disease: an observational study with a cross-over administration

Abstract

ObjectivesA wide range of electronic devices can be used for data collection of patient-reported outcome (PRO) measures in subjects with chronic obstructive pulmonary disease (COPD). Although comparisons between electronic and paper-based PRO measures have been undertaken in asthmatics, it is currently uncertain whether electronic questionnaires work equally as well as paper versions in elderly subjects with COPD. The aim of this study was to compare the responses to paper and electronic versions of the Evaluating Respiratory Symptoms in COPD (E-RS) and the COPD Assessment Test (CAT).DesignA randomised cross-over design was used to compare the responses to paper and electronic versions of the two tools. The interval between the two administrations was 1 week.SettingElectronic versions were self-administered under supervision using a tablet computer at our outpatient clinic (secondary care hospital in Japan) while paper questionnaires completed at home were requested to be returned by mail. It was intended that half of the patients completed the electronic versions of both questionnaires first, followed by the paper versions while the other half completed the paper versions first.ParticipantsEighty-one subjects with stable COPD were included.ResultsThe E-RS total scores (possible range 0–40) were 6.8±7.4 and 5.0±6.6 in the paper-based and electronic versions, respectively, and the CAT scores (possible range 0–40) were 10.0±7.4 and 8.6±7.8. In both questionnaires, higher scores indicate worse status. The relationship between electronic and paper versions showed significant reliability for both the E-RS total score and CAT score (intraclass correlation coefficient=0.82 and 0.89, respectively; both p<0.001). However, both the E-RS total and CAT scores were significantly higher in the paper versions (p<0.05).ConclusionsIn both cases, the two versions of the same questionnaire cannot be used interchangeably even though they have both been validated.

Learning from COVID-19 related trial adaptations to inform efficient trial design—a sequential mixed methods study

“…The accuracy of remote data collection has been assessed, with computer assisted data collection reported to be as accurate as paper surveys [35,36]. However, in two other studies, there were differences in responses to the questionnaires when comparing telephone vs mail, or paper to electronic versions [37,38]. In one systematic review aiming to review modes of collection of subjective outcomes, the mode of administration (in person or remote) was significantly associated with bias, but not changes to precision [39].…”

“…Due to concerns around the effect of these adaptations on the scientific validity of trials (e.g., changes to the sampling frame for recruitment adaptations, and outcome assessment bias), the majority of adaptations were perceived to only be useful in future trials as an adjunct to more traditional methods. However, even using certain adaptations as an adjunct may cause bias, if there are systematic differences in the way an outcome is collected remotely, compared to in-person [37][38][39]. Additionally, CTUs may struggle to undertake these adaptations due to limited infrastructure (e.g., computer systems for online consent, and limited staff capacity to undertake centralised trial tasks, especially outside of usual working hours), and a lack of clinical expertise to collect clinical measures.…”

“…We identified that a major barrier to implementing the identified adaptations were concerns around the effect on the scientific integrity of the trial. Other studies have also identified biases when different modalities are used to collect the same data [37][38][39], with one large systematic review identifying an impact on bias, but not precision [39].…”

In-person and online application of the Bronchiectasis Health Questionnaire: are they interchangeable?

“…Em outro estudo realizado com pacientes com DPOC, os autores observaram boa correlação, concordância e confiabilidade entre os formatos de administração presencial e online do CAT. (8) No entanto, os escores do CAT foram significantemente maiores na aplicação presencial (10,0 ± 7,4) do que no formato online (8,6 ± 7,8). A justificativa para tal diferença é que o formato online foi preenchido sem supervisão nas residências dos participantes, enquanto o presencial foi respondido sob supervisão no ambulatório.…”

“…A justificativa para tal diferença é que o formato online foi preenchido sem supervisão nas residências dos participantes, enquanto o presencial foi respondido sob supervisão no ambulatório. (8) Uma comparação realizada entre a administração presencial e online do Asthma Quality of Life Questionnaire e do Pediatric Asthma Quality of Life Questionnaire em pacientes com asma mostrou que o formato de administração online foi aceitável. Semelhante aos nossos achados, os participantes desses estudos preferiram o formato online ao presencial.…”