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Pilot Feasibility Stud. 2018 Nov 5;4:167. doi: 10.1186/s40814-018-0359-4. eCollection 2018.

Acute flares of knee osteoarthritis in primary care: a feasibility and pilot case-crossover study.

Author information

1
1Arthritis Research UK Primary Care Centre, Research Institute for Primary Care & Health Sciences, Keele University, Keele, Staffordshire ST5 5BG UK.
2
2Haywood Academic Rheumatology Centre, Midlands Partnership NHS Foundation Trust, Haywood Hospital, Burslem, Staffordshire ST6 7AG UK.
3
3Keele Clinical Trials Unit, David Weatherall Building, Keele University, Keele, Staffordshire ST5 5BG UK.
4
4Department of Medicine, Sections of Clinical Epidemiology Research and Training Unit, and Rheumatology, Boston University School of Medicine, 650 Albany Street, Clinical Epidemiology Unit, Suite X-200, Boston, MA 022118 USA.

Abstract

Background:

Osteoarthritis (OA) is a leading cause of persistent pain and disability. Traditionally viewed as a slowly progressive disease, the impact of symptom variability on prognosis remains unclear. 'Acute-on-chronic' episodes are a well-recognised feature of many long-term conditions but only recently formally described in OA. This study aimed to develop a web-based data collection platform and establish key methodological design parameters, to develop a larger community-based study investigating acute flares of knee OA in England.

Methods:

The study is a 9-week feasibility and pilot web-based observational case-crossover study. Adults aged ≥ 40 years registered with two general practices who had consulted their general practitioner for knee pain/OA in the last 2 years were recruited. Participants completed a baseline questionnaire and scheduled (control-period) questionnaires at follow-up weeks 1, 5, and 9. Participants were invited to self-declare via the website on any occasion they experienced a knee pain flare-up lasting ≥ 24 h. Upon notification, an event-driven (case-period) questionnaire comparable to the scheduled questionnaires was completed and daily measurements on the course and consequences were taken until resolution. A sub-study of 10 participants logged daily pain measurements. The analysis estimated key parameters including recruitment (selective non-participation, eligibility, consent), retention, and flare-up capture processes. Questionnaire completeness and website usability were evaluated.

Results:

Of 442 patients invited, 14 completed baseline questionnaires. Eligibility rate was 26.9% (95% CI 19.3, 36.2), consent rate 53.6% (35.8, 70.5), and overall recruitment rate 3.2% (1.9, 5.2). Compared to those mailed, baseline responders were more likely to be male and ≥ 65 years, as were those reporting ≥ 1 flare-up. Eleven scheduled questionnaires were completed (mean response 35%). Although seven participants (50%) self-declared 11 flare-ups, only one event-driven questionnaire was completed and three participants contributed daily flare measurement for four flares. Missing data was ≤ 3.7% across completed baseline, scheduled, and event-driven questionnaires. Aspects of website usability require minor refinement.

Conclusions:

Recruitment was not feasible with the current strategy. An evaluation of processes has suggested several substantial changes in design that may enhance recruitment, retention, and data quality in a future full-scale study.

KEYWORDS:

Case-crossover; Flare; Knee; Osteoarthritis; Web-based

Conflict of interest statement

Ethical approval for the study was obtained from North East – York Research Ethics Committee (REC Reference number: 16/NE/0390). All participants provided consent to participate in the study.GP has received consultancy fees from InFirst Healthcare Ltd. The other authors declare that they have no other competing interest to declare.Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

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