Abstract
BackgroundCurrently, there are no outcome measures assessing the ability of people with non-specific low back pain to self-manage their illness. Inspired by the ‘Patient Enablement Instrument’, we developed the Patient Enablement Instrument for Back Pain (PEI-BP). The aim of this study was to describe the development of the Patient Enablement Instrument for Back Pain (PEI-BP) and investigate content validity, construct validity, internal consistency, test–retest reliability, measurement error, responsiveness and floor and ceiling effects.MethodsThe PEI-BP consists of 6 items that are rated on a 0–10 Numeric Rating Scale. Measurement properties were evaluated using the COSMIN taxonomy and were based on three cohorts from primary care with low back pain: The content validity cohort (N = 14) which participated in semi-structured interviews, the GLA:D® Back cohort (N = 272) and the test–retest cohort (N = 37) which both completed self-reported questionnaires. For construct validity and responsiveness, enablement was compared to disability (Oswestry Disability Index), back pain beliefs (Brief Illness Perception Questionnaire), fear avoidance (Fear-Avoidance Beliefs Questionnaire—physical activity), mental health (SF-36), educational level and number of previous episodes of low back pain.ResultsThe PEI-BP was found to have acceptable content validity, construct validity, reliability (internal consistency, test–retest reliability and measurement error) and responsiveness. The Smallest Detectable Change was 10.1 points illustrating that a patient would have to change more than 1/6 of the scale range for it to be a true change. A skewed distribution towards the high scores were found at baseline indicating a potentially problematic ceiling effect in the current population.ConclusionsThe PEI-BP can be considered a valid and reliable tool to measure enablement on people seeking care for non-specific LBP. Further testing of the PEI-BP in populations with more severe LBP is recommended.Trial registration: Not applicable.
Highlights
There are no outcome measures assessing the ability of people with non-specific low back pain to self-manage their illness
Development of the patient enablement instrument for back pain (PEI‐BP) The Patient Enablement Instrument’ (PEI)-BP was adapted from the original PEI [5, 7, 8] with the aim of being able to measure patients’ perceived change in ability to understand and cope with their back problem
We convened a group of experienced back pain researchers from Denmark and Sweden (JH, AK, BÖ, PE, AA) and discussed needed modifications and arrived at the following changes from the original PEI: (1) The questions in Patient Enablement Instrument for Back Pain (PEI-BP) focus on back pain and not illness in general, (2) it enquires about the patient’s state during the past week which allow for measuring time specific changes by repeating measures of PEI-BP before and after an intervention and, (3) the responses to the 6 questions are rated on 0–10 point Numeric Rating Scales as opposed to 0–2 point scales with the aim of increasing sensitivity to change over time, i.e. responsiveness
Summary
There are no outcome measures assessing the ability of people with non-specific low back pain to self-manage their illness. Currently there are Molgaard Nielsen et al Health Qual Life Outcomes (2021) 19:116 no reliable ways of measuring the concept of the patients’ ability to manage their illness specific to non-specific LBP, as the most commonly used outcome measures are pain, disability and quality of life [4]. In order to measure enablement, they developed the ‘Patient Enablement Instrument’ (PEI) based on the theory that other important outcomes will improve if the patients experience increased enablement after a consultation in primary care [5,6,7,8]. There are limitations with the use of the PEI as an outcome measure [13] including that the PEI provides a retrospective transition rating at one time-point after an intervention challenging the measurement of change over time (responsiveness) [18]
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