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Table 1 Design and sample characteristics of the two questionnaires

From: Prognosis research ideally should measure time-varying predictors at their intended moment of use

 

PROG-RES

POST

Design

Prospective observational cohort

Cluster RCT

Registration

(Protocol [21])

Current Controlled Trials ISRCTN40721988

Intervention

Usual care

I: ultra-brief screening questions for anxiety and depression + pain intensity measurement

C: screen for pain intensity

Setting

5 general practices in North Staffordshire, England

45 general practices in West Midlands, England

Period of recruitment

Sep 2006–Apr 2007

Sep 2011–Nov 2012

Inclusion criteria

Consecutive patients aged 50+ years consulting for non-inflammatory musculoskeletal pain

Consecutive patients aged 45+ years consulting for suspected or diagnosed peripheral joint osteoarthritis

Exclusion criteria

Vulnerable patient (e.g. diagnosed with dementia); recent trauma associated with significant injury; inflammatory arthropathy

Vulnerable patient (e.g. diagnosed with a terminal illness); nursing home resident; recent trauma associated with significant injury; inflammatory arthropathy, crystal disease, SpA, PMR

Data collection pointsa

In GP consultation (point of care), post-consultation questionnaire, 3 months, 6 months, 12 months, 24 months, 36 months

In GP consultation (point of care), post-consultation questionnaire, 3 months, 6 months, 12 months

Candidate predictor of interest

Current pain intensity (0–10 NRS [23])

Timing of predictor measurement

1. Point of care

2. Post-consultation questionnaire

Outcome of interest

Patient global rating of change at 6 months (completely recovered/much improved/improved vs same/worse/much worse [22])

Participants eligible for inclusion in main analyses

296

756

Age (years): mean (SD)

64.8 (9.8)

65.8 (9.9)

Male: no. (%)

120 (40.5)

339 (44.8)

Current pain intensity at point of care (0–10): mean (SD)

5.9 (2.2)

6.2 (2.1)

Current pain intensity in questionnaire (0–10): mean (SD)

5.5 (2.6)

5.3 (2.6)

Interval between point of care and return of questionnaire (days): median (IQR; range)

17 (13, 27; 6–75)

21 (16, 30; 3–81)

Unfavourable outcome at 6 months: no. (%)

144 (48.7)

412 (54.5)

  1. Abbreviations: C control, GP general practitioner, I intervention, IQR inter-quartile range, NRS numerical rating scale, PMR polymyalgia rheumatica, POST Primary care Osteoarthritis Screening Trial, PROG-RES Prognostic Research Study, RCT randomised controlled trial, SD standard deviation, SpA spondyloarthritis
  2. aData collection points indicated in italics are the collection points used for this analysis