Patient-reported outcome measures
| Patient-completed measures | Description |
| Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO-41) | The QUALEFFO-41 is a specific questionnaire for patients with vertebral fractures. This questionnaire includes 41 questions in the domains of pain, physical function, social function, general health perception and mental function. The QUALEFFO-41 is repeatable, coherent and discriminates well between patients with vertebral fractures and matched control subjects.41 A scoring algorithm is used to determine the total score. |
| Numeric (pain) Rating Scale (NRS) | A segmented numeric subjective measure in which individuals rate their pain on an 11-point numerical scale.57 The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain). Scores range from 0 to 10 points with higher scores indicating greater pain intensity. |
| Oswestry Disability Index (ODI) | Gives a subjective score of level of function/disability in daily activities in patients rehabilitating from (lower) back pain.44 This questionnaire consists of 10 sections with a total possible score of 5 per section. Scoring is done by dividing the total score by the total possible score. Interpretation of scores: 0%–20% (minimal disability), 21%–40% (moderate disability), 41%–60% (severe disability), 61%–80% (crippled), 81%–100% (bed bound or exaggerating symptoms). |
| EQ-5D-5L | Health utility index with five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and five levels.58 Patients are asked to indicate their health state in each of the five dimensions which results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient’s health state. These are then converted to a single utility index for the entire EQ-5D. The evaluation component has patients who record their overall health status using a visual analogue scale (EQ-VAS). |
| International Physical Activity Questionnaire–Short Form (IPAQ-SF) | Assesses the types and intensity of physical activity and sitting time people engage in as part of their daily lives.45 Results are either reported in categories (low, moderate or high activity levels) or as a continuous variable (MET min/week). MET minutes represent the amount of energy expended during physical activity. |
| Health-Related Resource Use Measurement (RUM) Questionnaire consisting of the iMCQ and iPCQ | A healthcare cost questionnaire developed specifically for this, based on existing questionnaires, which will measure all relevant costs aspects.59 |
| Patient diary | Pain medication used will be assessed daily for the first 6 weeks and then weekly up to the 3-month follow-up by using a patient diary and quantified using the Medication Quantification Scale (MQS III). The questions asked in the patient diary will then be included in the questionnaire package for the later follow-up moments. |
All patient-related outcome measures (PROMs) are completed by all patients at all follow-up moments except for the Health-Related RUM Questionnaire which is completed at baseline, and 3, 6, 9 and 12 months.
EQ-5D-5L, 5-level EuroQoL-5 dimension; iMCQ, iMTA Medical Consumption Questionnaire; iPCQ, iMTA Productivity Cost Questionnaire; MET, metabolic equivalent of task.