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Table 3 Description of outcome measures

From: Effectiveness and cost-effectiveness of a multimodal, physiotherapist-led, vocational intervention in people with inflammatory arthritis: study protocol of the Physiotherapy WORKs trial

Measures

Description

General characteristics

 Sociodemographic and work characteristics; comorbidity

Year of birth, gender, weight and height to calculate the body mass index, civil state, household composition, education level, work status, type of work and employment, number of working hours and days a week, smoking, comorbidities

 Disease characteristics (retrieved from rheumatologist)

Clinical diagnosis (RA/axSpA), year of diagnosis, prescribed medication, erythrocyte sedimentation rate (ESR, mm/hr) or level of C-reactive (CRP, mg/L) and disease activity measured by Bath Ankylosing Spondylitis Disease Index (BASDAI) [47] for axSpA and Disease Activity Score 28 joint count (DAS28) for RA [48]) will be retrieved from the participant’s rheumatologist

Primary outcome

 WAS (Work Ability Index-Single Item Scale) [31]

The WAS is a responsive outcome measure to assess the status and progress of work ability and is highly predictive for future sick leave. It consists of one scale (NRS) indicating the level of work ability a participant experiences at the moment of measuring ranging from 0 = completely unable to work at all, to 10 = work ability at its best, and distinguishing the following well-accepted categories: 0–5 = poor, 6–7 = moderate, 8–9 = good, and 10 = excellent work ability

Secondary outcomes

Work-related

 

  WPAI (Work Productivity and Activity Impairment questionnaire) [49, 50]

The WPAI assesses presenteeism, absenteeism and productivity at work specific for RA patients [50] or axSpA patients [49]. It consists of six items from which overall score for % of overall work restriction due to RA/axSpA can be calculated

  Job satisfaction [51]

This one item questionnaire, derived from Linton and Halldén 1998 [51], assesses job satisfaction on a 0–10 scale (0 = totally dissatisfied, 10 = very satisfied)

  Self-efficacy at work [52]

A single question, derived and translated from the work subscale of the Basic Psychological Need Satisfaction and Frustration Scale (BPNSFS) [52], measuring self-efficacy at work on a 1–5 scale (1 = totally disagree, 5 = totally agree)

Clinical

 

  NRS pain (Numeric Rating Scale pain) [53]

Pain severity in the past 7 days on NRS; 1 item on 0–10 scale (0 = no pain, 10 = worst pain possible). Clinically relevant difference is a two point change between baseline and follow-up

  NRS fatigue (Numeric Rating Scale fatigue) [34]

Fatigue in the past seven days on NRS; 1 item on 0–10 scale (0 = no fatigue, 10 = worst possible fatigue). Clinically relevant difference is a two point change between baseline and follow-up

  PSC NRS (Patient specific Complaints Numeric Rating Scale) [32]

The PSC NRS is an individualized outcome measure designed to detect changes in a participants’ perception of functioning over time. It consists of three scales (NRS) indicating the level of difficulty participants encounter while executing activities that are most relevant for them ranging from 0 = easy, to 10 = impossible to do. In this study the first activity has to be work-related, the next two activities may also concern activities related to other domains of daily life

  PROMIS-SF Physical Function PF-10 (Patient Reported Outcome Measurement Information System‐Short Form Physical Activity) [54,55,56]

PROMIS is a standardized metric for measuring health across chronic diseases, developed using the item response theory. In this study the PROMIS Short Form v2.0— Physical Function 10a will be used to measure the patient reported physical function. The questionnaire consists of 10 questions. All questions have five answer options ranging from 1 = easy to 5 = impossible to do. From the raw score a T‐score is derived, with the Dutch/Flemish population mean and a standard deviation. A high score indicates a poor patient reported physical function

  a BASFI (Bath Ankylosing Spondylitis Functional Index) [47, 57]

BASFI is a validated instrument to assess the degree of limitations in activities in patients with axial spondyloarthritis. It includes 10 questions on how well activities went in the past week on a NRS scale, ranging from 0 = easy to 10 = impossible to do. The BASFI score is calculated by taking the mean of the score of the 10 individual questions. Scores can range from 0 to 10, with a high score referring to severe limitations

  m-SQUASH (Modified Short Questionnaire to Assess Health-enhancing physical activity) [58]

m-SQUASH is a 17 item questionnaire to assess physical activity level and includes items regarding physical activities, sports activities and work activities

  HADS (Hospital Anxiety and Depression Scale) [59]

The HADS measures levels of anxiety and depression in the past four weeks. It comprises seven items on anxiety and seven items on depression ranging from 0 to 3. Scores higher than 8 on the anxiety and depression items separately indicate problems concerning anxiety and depression

Health care use, costs and quality of life

  Societal costs [60]

Including general practitioner visits, outpatient visits, hospital days, rehabilitation center days, nursing home days, physiotherapy use, home care, (change in) medication use, informal care, costs for patients related to RA/axSpA, work situation and productivity related costs. Similar questionnaires have been used in previous studies on physiotherapy in inflammatory arthritis

  EuroQol (EQ‐5D‐5L) [61, 62]

The EuroQol is a standardized instrument including 5 dimensions of health (mobility, selfcare, daily activities, pain/complaints and anxiety/depression), resulting in a score anchored at 0–1, with a higher score indicating better health. It also includes a ‘thermometer’, a visual analog scale with a score ranging from 0 (worst possible health) to 100 (perfect health)

Expectancy of treatment and global perceived effect

  Expectancy of intervention

One question constructed by the research group to ask the participant to what extent they expect the intervention to effect their work ability. On a NRS scale ranging from 0 (not at all) to 10 (very)

  GPE (Global Perceived Effect)

Contains the anchor question on the perceived effect: “Has the vocational PT-led intervention changed your daily functioning?”

  1. aMeasured only in the study population of axial spondyloarthritis patients