Comparing patient-reported outcomes entered at home versus at hospital, and testing touch screens for initial recruitment to scientific trials in arthritis patients

Abstract

Objectives: Touch screens for entering patient-reported outcomes (PROs) are available at all Danish departments of rheumatology reporting to the nationwide DANBIO registry. This project comprises two substudies in patients with rheumatoid arthritis (RA) or axial spondyloarthritis (AxSpA), aiming to (A) investigate the feasibility of first line patient recruitment for research via touch screens, and (B) compare PROs collected at hospital versus at home, including patient preferences.

Method: Substudy A: using a touch screen, patients answered whether we could contact them about a clinical research project (yes/no). Characteristics of patients who accepted/declined were explored using chi-squared and Mann–Whitney U-tests. Substudy B (randomized crossover agreement study): a random sample of patients from the accepting group in substudy A was contacted by telephone. According to prespecified power and sample size estimation, 56 patients were included. After randomization, 50% of patients entered PROs and information on comorbidities and lifestyle from home and then at hospital, and 50% first from hospital and then at home. Finally, they stated their preference for data entry (hospital/home/equally good). Differences in PROs entered from home and in the hospital were compared (limits of agreement, 95% confidence intervals, and intraclass correlation coefficients).

Results: The touch-screen invitation was accepted by 428/952 patients (45%). Patients who accepted and those who declined had similar PROs and demographics. Substudy B was completed by 42 patients (22 RA, 20 AxSpA). They had no significant differences between PROs and lifestyle/comorbidity data entered from home and hospital, except for AxSpA patients on the Bath Ankylosing Spondylitis Functional Index and Bath Ankylosing Spondylitis Disease Activity Index item 5. The preferred method of data entry was hospital (10%), home (50%), and equally good (40%).

Conclusion: Touch screens seem feasible for first line research recruitment. PROs collected from home were similar to the touch-screen solution. Patients preferred data entry from home.

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Corrigendum

Acknowledgements

This work was supported by DANBIO. DANBIO is sponsored by unrestricted grants from the Danish hospital owners (Danish Regions), AbbVie, Bristol, Myers Squibb (BMS), Eli Lilly, Janssen-Cilag, MSD Denmark, Novartis, Pfizer, Roche, and UCB Nordic. The Parker Institute, Bispebjerg and Frederiksberg Hospitals are supported by a core grant from the Oak Foundation (OCAY-13-309).

Disclosure statement

BG received grant/research support from AbbVie and Biogen. HG has served on speakers’ bureaux for MSD and Pfizer. MLH received grant/research support from AbbVie, BMS, MSD, Pfizer, UCB, Biogen, Orion, Crescendo, Roche, and CellTrion. The remaining authors have no potential conflicts of interest to disclose.

Supporting Information

Additional Supporting Information may be found in the online version of this article.

Supplementary table S1. Patients invited on touch screen (substudy A) stratified by diagnosis and reply.

Supplementary table S2. Characteristics of invited patients (substudy A) who did not complete versus completers (substudy B).

Supplementary table S3. Degree of consistency between lifestyle and comorbidity answers from home and hospital (%), substudy B.

Supplementary figure S1. Touch-screen invitation to participate in the project in Danish (English translation), substudy A.

Supplementary figure S2. Automatic text message reminder to patients in Danish (English translation).

Supplementary figure S3. Patient answers regarding preferred method of data entry stratified by diagnosis and whether data entry occurred from home or at hospital first, substudy B.

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Additional information

Funding

This work was supported by the DANBIO;