Comparing Satisfaction With a Participatory Driven Web-application and a Standard Website

Comparing Satisfaction With a Participatory Driven Web-application and a Standard Website for Patients With Low Back Pain: a Study Protocol of a Randomised Controlled Trial

The primary trial was stopped. Since, a feasibility study showed that recruitment was not feasible. We obtain a recruitment rate of 15 %.

The point-prevalence of low back pain (LBP) has been estimated to 9.4 % and LBP is in many countries the most frequent reason to consult a general practitioner. However, general practitioners are under pressure with increasing workloads. The increasing number of patients and the typical 10-15 minutes of available time for each patient are challenging the provision of sufficient information and advice. According to international guidelines information and advice are recommended for every patient with LBP, therefore, new methods to support general practitioners (GPs) are very much needed. Online technologies give new opportunities to extend the treatment. Furthermore, involving patients with LBP in the development of online information material may produce more user friendly content and design and thereby increasing patients' acceptance and usage. Thus, optimizing clinical outcome. This project will study patients' satisfaction and clinical outcomes of a web-application for patients with LBP consulted in general practice compared to best existing technology (the Patient Handbook).

The allocation sequence will be delivered by the statistician group at Aalborg University Hospital and delivered to a IT consultant at ProData (Viby, J, Denmark) and integrated in the web-application. The researchers conducting the analysis will be blinded. During the project, data will be stored on a server placed at Aalborg University. Another member of the author Group will prepare a data set with a dummy variable for allocation without free text information from patients and make this data set available for the assessors to analyse. Patients will be aware of their allocation. General practitioners will only be aware of the allocation if the patient chooses to tell it to the general practitioner.

The question: 'how likely is it that you would recommend this web-application to a friend or colleague?' will be applied to measure satisfaction. The patients will be asked to choose between 11 boxes displayed on a horizontal line (10-0 Points, higher score indicating more satisfaction). The scales will be labelled to the left at 10 (extremely likely) and at the right side as 0 (not at all likely). It is only possible to tick off one box, if the patient change decision while filling in the online questionnaire, another box can be ticked off and the first choice will automatically delete. Responses of 10-9 are grouped as 'satisfied' of the web-application and patients replying 8-0 will be grouped as 'not satisfied'. The proportion of patients being satisfied after 12 weeks is the primary analysis. The proportion of patients being satisfied after 1, 2, 4, and 8 weeks will be carried out as secondary analyses.

A analysis comparing the intervention group with the control group from a healthcare perspective. Including primary care costs such as public paid costs for GP contacts, physiotherapy services, and chiropractic services. Quality adjusted life years (QALYs) will be applied as measure of effect based on EQ-5D-5L. We will not include costs for developing and maintaining the new technology or other protocol driven costs. Based on the relative short time-horizon costs and effects will not be discounted.

For further exploration of reasons for the primary outcome we include a question regarding the general satisfaction with the web-application (10-0) and detailed questions/items regarding satisfaction with design (very, some, little, none), satisfaction with customisation (very, some, little, none ), satisfaction with usability (very, some, little, none ), satisfaction with readability (very, some, little, none), and satisfaction with credibility (very, some, little, none). It is only possible to tick off one box to each item, if the patient change decision while filling in the online questionnaire, another box can be ticked off and the first choice will automatically delete. Furthermore, these items will be validated against the primary outcome.

Inclusion Criteria: Contacting general practice with low back pain Exclusion Criteria: Spinal stenosis Spine fractures Cauda equina syndrome Spinal malignancy Osteoporosis Spondyloarthritis Without Danish reading skills Without internet access Pregnant women

Riis A, Rathleff MS, Hartvigsen J, Thomsen JL, Afzali T, Jensen MB. Feasibility study on recruitment in general practice for a low back pain online information study (part of the ADVIN Back Trial). BMC Res Notes. 2020 Jan 10;13(1):24. doi: 10.1186/s13104-020-4894-8.

Riis A, Hartvigsen J, Rathleff MS, Afzali T, Jensen MB. Comparing satisfaction with a participatory driven web-application and a standard website for patients with low back pain: a study protocol for a randomised controlled trial (part of the ADVIN Back Trial). Trials. 2018 Jul 25;19(1):399. doi: 10.1186/s13063-018-2795-0.