Low Back Pain Clinical Trial
Official title:
The Online Patient Satisfaction Index (OPSI): Development and Validation Among Patients With Low Back Pain
Low Back Pain (LBP) is the most common musculoskeletal disorder and a leading cause of
disability worldwide. It is the most frequent reason for consulting general practice and has
an impact on daily life and work capacity. A cornerstone in treating LBP is the provision of
information to patients, and the internet is increasingly being used as a source of health
information delivery. However, the effect of and satisfaction with online information have
been questioned. The investigators aimed to develop and validate a multi-item instrument to
measure an index score of satisfaction of online information for patients with LBP.
The conceptualization of a Patient Reported Outcome (PRO) to measure a multidimensional index
score is modelled on the assumption of a causal relationship between domains of experiences
with online information and patients' combined index score of satisfaction. Findings from 15
patient interviews was applied to draft the first version of the instrument. Followed by
pilot testing on patients (n=20) and experts (n=7) before validating the instrument on
patients (n=150). Patients were eligible for inclusion if they had their first onset of LBP
for 14 days. Patients were included regardless of pain intensity. Patients were excluded if
they did not have Internet access, were pregnant, did not speak Danish as their native
language, or had signs of serious underlying disease.
BACKGROUND Low back pain (LBP) is highly prevalent and a frequent reason for patients to
consult general practice. It is a common pain condition affecting both men and women at all
ages. LBP is rarely caused by only one specific factor but is eventually caused by multiple
and often unknown factors. This makes it difficult to perform a precise diagnosis based on a
single cause and for most patients, the LBP is diagnosed as nonspecific with or without nerve
root compression.
Patient education and information is a cornerstone in the management of LBP. Providing
information to patients is considered a crucial issue as it is necessary to support
self-management. However, the delivery of evidence based information by a healthcare
professional is time consuming and not straight forward to deliver during the available
consultation time in general practice.
The internet is a widely accessible source of medical information to patients and offer a
range of information provided by a variety of different sources. It has been reported that
about 50% of patients use internet search for health and medical advice, and evidence
suggests that patients willingness to use this source to obtain information about their
health is increasing. The advance of new technologies offer new opportunities to the delivery
of patient information on private computers, tablets, and smartphones. Online information can
be considered an inexpensive solution to extend the combined treatment in general practice.
Therefore, future optimization of information delivery has the potential to increase the
delivery of evidence-based treatment of LBP which may lead to better patient outcomes.
Patient satisfaction has been suggested as an important domain when evaluating the provision
of online information.
Measuring patient satisfaction is a recommended outcome measure when evaluating the effect of
interventions for LBP. Furthermore, patient satisfaction may be associated with compliance to
the recommended treatment. Patient satisfaction is, however, rarely applied as the primary
outcome in studies of LBP. To the investigators' knowledge, there exist no instrument to
evaluate specific satisfaction with information delivered online for LBP. The aim of this
study is to develop and validate a new questionnaire to inform about patients' satisfaction
with online information for LBP.
METHODS This is a development and validation study of a patient reported questionnaire to (1)
inform about the discrepancy in satisfaction of online information for LBP between groups and
(2) to evaluate changes in satisfaction over time. The conceptualization is based on a
formative model, which assumes a causal relationship between different domains of
satisfaction with online information and the construct of patients' combined index score of
satisfaction. The first version of the instrument was based on findings from an interview
study among patients consulting for LBP in Danish general practice. Data for further
developing on the first version were exclusively collected for piloting and validating the
instrument.
HYPOTHESIS The OPSI index scores among patients categorised as promoters will be compared to
the OPSI index scores of patients categorised as non-promotors on the Net Promotor Score.
Based on results from the pilot test. It is hypothesised that promotors will have an OPSI
score of minimum 2.5 points more than non-promotors (0-8 Points on the Net Promotor Score).
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