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Table 1 Outcome measures

From: Hand Osteoarthritis: investigating Pain Effects of estrogen-containing therapy (HOPE-e): a protocol for a feasibility randomised placebo-controlled trial

Primary objectives outcome measures

Secondary objectives outcome measures

 

Pain and function outcomes

Menopause symptoms

Joint appearance

• Rates of eligible participant identification (screening period)

• Rates of recruitment/randomisation from different sources (screening period)

• Retention rates (throughout study)

• Study medication compliance a

• Bang’s Blinding Index (likelihood of unblinding) [40] a

• Average hand pain (rated over 14 days preceding the study visit)c a

• Pain manikin–capturing pain in other joints in the 4 weeks preceding the study visita

• Functional Index for Hand OsteoArthritis (FIHOA) questionnaire [41, 42]b

• Grip strength, by Jamar dynamometer [43]b

• EQ-5D-5L questionnaire [44, 45]b

• Menopause-specific Quality of Life (MENQOL) questionnaire (Intervention 1-month recall version) [38, 46, 47]b

• Greene Climacteric Scale [48]b

• Cosmesis score (single question, Michigan Hand Questionnaire) [49]b

• Investigator-recorded tender and swollen joint counts a

• Photographic recording of swollen hand joints a

  1. aSee Fig. 1 for collection time points
  2. bSee “Questionnaires” in Table 2 for collection time points
  3. cProposed primary outcome for full trial