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Article Title: Application of the OMERACT filter to measures of core outcome domains in recent clinical studies of acute gout
Journal: The Journal of rheumatology
doi: 10.3899/jrheum.131245
Figure Legend Snippet: Indices of test-retest reliability, smallest detectable difference and minimal important difference
Techniques Used: Activity Assay
Related Articles
Immunocytochemistry:Article Title: Application of the OMERACT filter to measures of core outcome domains in recent clinical studies of acute gout
Article Snippet: Floor effects were appreciable at final visit and ceiling effects were appreciable at baseline. table ft1 table-wrap mode="anchored" t5 caption a7 Measure Source Within-group (pooled) Between group Effect Size † GEE (Wald χ2) KW-statistic † GEE (Wald χ2) Pain (Likert) MSD * 2.32 NA NA NA Pfizer 2.72 816 p<0.001 17.6 p=0.001 16.8 p=0.001 Regeneron 1.20 NA 26.7 p<0.001 NA Novartis * 2.84 446.8 P <0.001 NA NA Pain (VAS) AUT * 1.58 NA NA NA Novartis * 4.46 602.2 P<0.001 NA NA Pain (NRS) Regeneron 1.62 NA 26.6 p<0.001 NA Joint tenderness MSD * 3.2 NA NA NA Pfizer 2.5 542 p<0.001 1.7 p=0.67 12 p=0.001 Regeneron NA NA NA NA Novartis * 2.25 598 p<0.001 NA NA AUT * NA NA NA NA Joint swelling MSD * 2.9 NA NA NA Pfizer 2.3 561 p<0.001 2.2 p=0.54 4.0 p=0.26 Regeneron NA NA NA NA Novartis * 2.5 523 p<0.001 NA NA AUT * NA NA NA NA Activity limitations MSD * NA NA NA NA Pfizer NA NA NA NA Regeneron 0.81 NA 5.4 p=0.067 NA§ Novartis * 1.04 159 (p<.0.001) NA NA AUT * 1.72 NA NA NA Patient Global MSD * NA ‡ NA NA NA Pfizer † NA ‡ NA 5.5 p=0.14 NA§ Regeneron NA NA NA NA Novartis * NA ‡ NA NA NA AUT * ¶ 1.46 NA NA NA Open in a separate window NA: not available or not applicable * MSD – Merck, Sharp & Dohme Corp.
Article Title: Application of the OMERACT filter to measures of core outcome domains in recent clinical studies of acute gout
Article Snippet: Significant floor effects were appreciable at final visit (47 to 64%) and ceiling effects (27 to 56%) were appreciable at baseline. table ft1 table-wrap mode="anchored" t5 caption a7 ICC SEM SDD MID Pain (Likert) MSD Between day 2 and 5 0.56 0.51 1.41 1 Between day 5 and 8 0.80 0.42 1.17 2 Pfizer * Between 2 and 4 hours 0.81 0.39 1.08 -- Between 2 and 8 hours 0.72 0.50 1.39 -- Between 2 and 12 hours 0.60 0.62 1.72 -- Pfizer † Between day 1 and 9 0.07 0.76 2.1 2 Between day 2 and 9 0.15 0.76 2.1 2 Between day 5 and 9 0.59 0.54 1.50 2 Novartis Baseline to 7 days post dose 0.35 0.85 2.36 1.0 24 hours post dose to 7 days 0.55 0.64 1.77 -- 48 hours post dose to 7 days 0.71 0.49 1.36 -- Pain (VAS) Novartis Baseline to 7 days post dose 0.35 3.66 10.15 19 24 hours post dose to 7 days 0.57 2.93 8.12 -- 48 hours post dose to 7 days 0.76 2.23 6.18 -- Joint tenderness MSD Between day 2 and day 5 0.50 0.46 1.28 2 Between day 5 and day 8 0.79 0.34 0.94 1 Pfizer Between Day 1 and 9 0.06 0.66 1.8 2 Between Day 5 and 9 0.11 0.59 1.6 2 Novartis Baseline to 7 days Post 0.0 ** 1.06 2.93 1.0 24 hours post dose to 7 days 0.50 0.54 1.51 -- 48 hours post dose to 7 days 0.49 0.54 1.50 -- 72 hours post dose to 7 days 0.49 0.54 1.50 -- Joint swelling MSD Between day 2 and day 5 0.48 0.53 1.47 1 Between day 5 and day 8 0.77 0.43 1.18 1 Pfizer Between Day 1 and 9 0.13 0.64 1.8 1 Between Day 5 and 9 0.37 0.73 2.0 1 Novartis Baseline to 7 days 0.0 1.07 2.97 1 24 hours post dose to 7 days 0.44 0.65 1.80 -- 48 hours post dose to 7 days 0.44 0.65 1.79 -- 72 hours post dose to 7 days 0.44 0.65 1.79 -- Activity limitations Novartis 0.55 0.45 1.25 0.5 Open in a separate window * Pain assessed as ‘current’ level of pain † Pain assessed as ‘over the last 24 hours’ ** Statistical software indicated that estimation of a negative variance parameter was attempted Indices of test-retest reliability, smallest detectable difference and minimal important difference
Article Title: Application of the OMERACT filter to measures of core outcome domains in recent clinical studies of acute gout
Article Snippet: Significant floor effects were appreciable at final visit (47 to 64%) and ceiling effects (27 to 56%) were appreciable at baseline. table ft1 table-wrap mode="anchored" t5 caption a7 ICC SEM SDD MID Pain (Likert) MSD Between day 2 and 5 0.56 0.51 1.41 1 Between day 5 and 8 0.80 0.42 1.17 2 Pfizer * Between 2 and 4 hours 0.81 0.39 1.08 -- Between 2 and 8 hours 0.72 0.50 1.39 -- Between 2 and 12 hours 0.60 0.62 1.72 -- Pfizer † Between day 1 and 9 0.07 0.76 2.1 2 Between day 2 and 9 0.15 0.76 2.1 2 Between day 5 and 9 0.59 0.54 1.50 2 Novartis Baseline to 7 days post dose 0.35 0.85 2.36 1.0 24 hours post dose to 7 days 0.55 0.64 1.77 -- 48 hours post dose to 7 days 0.71 0.49 1.36 -- Pain (VAS) Novartis Baseline to 7 days post dose 0.35 3.66 10.15 19 24 hours post dose to 7 days 0.57 2.93 8.12 -- 48 hours post dose to 7 days 0.76 2.23 6.18 -- Joint tenderness MSD Between day 2 and day 5 0.50 0.46 1.28 2 Between day 5 and day 8 0.79 0.34 0.94 1 Pfizer Between Day 1 and 9 0.06 0.66 1.8 2 Between Day 5 and 9 0.11 0.59 1.6 2 Novartis Baseline to 7 days Post 0.0 ** 1.06 2.93 1.0 24 hours post dose to 7 days 0.50 0.54 1.51 -- 48 hours post dose to 7 days 0.49 0.54 1.50 -- 72 hours post dose to 7 days 0.49 0.54 1.50 -- Joint swelling MSD Between day 2 and day 5 0.48 0.53 1.47 1 Between day 5 and day 8 0.77 0.43 1.18 1 Pfizer Between Day 1 and 9 0.13 0.64 1.8 1 Between Day 5 and 9 0.37 0.73 2.0 1 Novartis Baseline to 7 days 0.0 1.07 2.97 1 24 hours post dose to 7 days 0.44 0.65 1.80 -- 48 hours post dose to 7 days 0.44 0.65 1.79 -- 72 hours post dose to 7 days 0.44 0.65 1.79 -- Activity limitations Novartis 0.55 0.45 1.25 0.5 Open in a separate window * Pain assessed as ‘current’ level of pain † Pain assessed as ‘over the last 24 hours’ ** Statistical software indicated that estimation of a negative variance parameter was attempted Indices of test-retest reliability, smallest detectable difference and minimal important difference Joint tenderness Joint tenderness was also measured using a 0–3 point Likert scale in most studies.
Article Title: Application of the OMERACT filter to measures of core outcome domains in recent clinical studies of acute gout
Article Snippet: The Likert scale had good construct validity ( ): strong correlation with patient global (Spearman’s correlation coefficient, 0.72) and NRS pain score (0.55 and 0.73), moderate-strong correlation with disability (0.58 and 0.31) and moderate correlation with joint tenderness (0.34, 0.36, 0.13) but weaker correlation with joint swelling (0.18, 0.18, 0.19). table ft1 table-wrap mode="anchored" t5 caption a7 Source Measure Pain (VAS or NRS) Joint tenderness Joint swelling Activity limitations * Patient global ‡ MSD Pain (Likert) NA 0.34 0.18 NA NA Joint tenderness 0.25 NA NA Joint swelling NA NA Activity limitations NA Pfizer Pain (Likert) NA 0.36 0.18 NA NA Joint tenderness 0.37 NA NA Joint swelling NA NA Activity limitations NA Regeneron Pain (Likert) 0.75 NA NA 0.31 NA Pain (NRS) NA NA 0.39 NA Joint tenderness NA NA NA Joint swelling NA NA Activity limitations NA Novartis Pain (VAS) 0.55 0.13 0.19 0.58 0.72 Pain (Likert) 0.15 0.17 0.58 0.70 Joint tenderness 0.46 0.18 0.56 Joint swelling 0.25 0.47 Activity limitations 0.50 Auckland University of Technology Pain VAS NA NA NA 0.66 0.73 Joint tenderness NA NA NA Joint swelling NA NA Activity limitations † 0.73 Open in a separate window NA: measure not available in the dataset * Activity limitations measured by single 0–10 NRS in Regeneron data, HAQ-II in AUT data and HAQ-DI in Novartis data † In addition the HAQ-II correlated highly with measures of specific foot function in this dataset.
Activity Assay:Article Title: Application of the OMERACT filter to measures of core outcome domains in recent clinical studies of acute gout
Article Snippet: Floor effects were appreciable at final visit and ceiling effects were appreciable at baseline. table ft1 table-wrap mode="anchored" t5 caption a7 Measure Source Within-group (pooled) Between group Effect Size † GEE (Wald χ2) KW-statistic † GEE (Wald χ2) Pain (Likert) MSD * 2.32 NA NA NA Pfizer 2.72 816 p<0.001 17.6 p=0.001 16.8 p=0.001 Regeneron 1.20 NA 26.7 p<0.001 NA Novartis * 2.84 446.8 P <0.001 NA NA Pain (VAS) AUT * 1.58 NA NA NA Novartis * 4.46 602.2 P<0.001 NA NA Pain (NRS) Regeneron 1.62 NA 26.6 p<0.001 NA Joint tenderness MSD * 3.2 NA NA NA Pfizer 2.5 542 p<0.001 1.7 p=0.67 12 p=0.001 Regeneron NA NA NA NA Novartis * 2.25 598 p<0.001 NA NA AUT * NA NA NA NA Joint swelling MSD * 2.9 NA NA NA Pfizer 2.3 561 p<0.001 2.2 p=0.54 4.0 p=0.26 Regeneron NA NA NA NA Novartis * 2.5 523 p<0.001 NA NA AUT * NA NA NA NA Activity limitations MSD * NA NA NA NA Pfizer NA NA NA NA Regeneron 0.81 NA 5.4 p=0.067 NA§ Novartis * 1.04 159 (p<.0.001) NA NA AUT * 1.72 NA NA NA Patient Global MSD * NA ‡ NA NA NA Pfizer † NA ‡ NA 5.5 p=0.14 NA§ Regeneron NA NA NA NA Novartis * NA ‡ NA NA NA AUT * ¶ 1.46 NA NA NA Open in a separate window NA: not available or not applicable * MSD – Merck, Sharp & Dohme Corp.
Article Title: Application of the OMERACT filter to measures of core outcome domains in recent clinical studies of acute gout
Article Snippet: Significant floor effects were appreciable at final visit (47 to 64%) and ceiling effects (27 to 56%) were appreciable at baseline. table ft1 table-wrap mode="anchored" t5 caption a7 ICC SEM SDD MID Pain (Likert) MSD Between day 2 and 5 0.56 0.51 1.41 1 Between day 5 and 8 0.80 0.42 1.17 2 Pfizer * Between 2 and 4 hours 0.81 0.39 1.08 -- Between 2 and 8 hours 0.72 0.50 1.39 -- Between 2 and 12 hours 0.60 0.62 1.72 -- Pfizer † Between day 1 and 9 0.07 0.76 2.1 2 Between day 2 and 9 0.15 0.76 2.1 2 Between day 5 and 9 0.59 0.54 1.50 2 Novartis Baseline to 7 days post dose 0.35 0.85 2.36 1.0 24 hours post dose to 7 days 0.55 0.64 1.77 -- 48 hours post dose to 7 days 0.71 0.49 1.36 -- Pain (VAS) Novartis Baseline to 7 days post dose 0.35 3.66 10.15 19 24 hours post dose to 7 days 0.57 2.93 8.12 -- 48 hours post dose to 7 days 0.76 2.23 6.18 -- Joint tenderness MSD Between day 2 and day 5 0.50 0.46 1.28 2 Between day 5 and day 8 0.79 0.34 0.94 1 Pfizer Between Day 1 and 9 0.06 0.66 1.8 2 Between Day 5 and 9 0.11 0.59 1.6 2 Novartis Baseline to 7 days Post 0.0 ** 1.06 2.93 1.0 24 hours post dose to 7 days 0.50 0.54 1.51 -- 48 hours post dose to 7 days 0.49 0.54 1.50 -- 72 hours post dose to 7 days 0.49 0.54 1.50 -- Joint swelling MSD Between day 2 and day 5 0.48 0.53 1.47 1 Between day 5 and day 8 0.77 0.43 1.18 1 Pfizer Between Day 1 and 9 0.13 0.64 1.8 1 Between Day 5 and 9 0.37 0.73 2.0 1 Novartis Baseline to 7 days 0.0 1.07 2.97 1 24 hours post dose to 7 days 0.44 0.65 1.80 -- 48 hours post dose to 7 days 0.44 0.65 1.79 -- 72 hours post dose to 7 days 0.44 0.65 1.79 -- Activity limitations Novartis 0.55 0.45 1.25 0.5 Open in a separate window * Pain assessed as ‘current’ level of pain † Pain assessed as ‘over the last 24 hours’ ** Statistical software indicated that estimation of a negative variance parameter was attempted Indices of test-retest reliability, smallest detectable difference and minimal important difference
Article Title: Application of the OMERACT filter to measures of core outcome domains in recent clinical studies of acute gout
Article Snippet: Significant floor effects were appreciable at final visit (47 to 64%) and ceiling effects (27 to 56%) were appreciable at baseline. table ft1 table-wrap mode="anchored" t5 caption a7 ICC SEM SDD MID Pain (Likert) MSD Between day 2 and 5 0.56 0.51 1.41 1 Between day 5 and 8 0.80 0.42 1.17 2 Pfizer * Between 2 and 4 hours 0.81 0.39 1.08 -- Between 2 and 8 hours 0.72 0.50 1.39 -- Between 2 and 12 hours 0.60 0.62 1.72 -- Pfizer † Between day 1 and 9 0.07 0.76 2.1 2 Between day 2 and 9 0.15 0.76 2.1 2 Between day 5 and 9 0.59 0.54 1.50 2 Novartis Baseline to 7 days post dose 0.35 0.85 2.36 1.0 24 hours post dose to 7 days 0.55 0.64 1.77 -- 48 hours post dose to 7 days 0.71 0.49 1.36 -- Pain (VAS) Novartis Baseline to 7 days post dose 0.35 3.66 10.15 19 24 hours post dose to 7 days 0.57 2.93 8.12 -- 48 hours post dose to 7 days 0.76 2.23 6.18 -- Joint tenderness MSD Between day 2 and day 5 0.50 0.46 1.28 2 Between day 5 and day 8 0.79 0.34 0.94 1 Pfizer Between Day 1 and 9 0.06 0.66 1.8 2 Between Day 5 and 9 0.11 0.59 1.6 2 Novartis Baseline to 7 days Post 0.0 ** 1.06 2.93 1.0 24 hours post dose to 7 days 0.50 0.54 1.51 -- 48 hours post dose to 7 days 0.49 0.54 1.50 -- 72 hours post dose to 7 days 0.49 0.54 1.50 -- Joint swelling MSD Between day 2 and day 5 0.48 0.53 1.47 1 Between day 5 and day 8 0.77 0.43 1.18 1 Pfizer Between Day 1 and 9 0.13 0.64 1.8 1 Between Day 5 and 9 0.37 0.73 2.0 1 Novartis Baseline to 7 days 0.0 1.07 2.97 1 24 hours post dose to 7 days 0.44 0.65 1.80 -- 48 hours post dose to 7 days 0.44 0.65 1.79 -- 72 hours post dose to 7 days 0.44 0.65 1.79 -- Activity limitations Novartis 0.55 0.45 1.25 0.5 Open in a separate window * Pain assessed as ‘current’ level of pain † Pain assessed as ‘over the last 24 hours’ ** Statistical software indicated that estimation of a negative variance parameter was attempted Indices of test-retest reliability, smallest detectable difference and minimal important difference Joint tenderness Joint tenderness was also measured using a 0–3 point Likert scale in most studies.
Article Title: Application of the OMERACT filter to measures of core outcome domains in recent clinical studies of acute gout
Article Snippet: The Likert scale had good construct validity ( ): strong correlation with patient global (Spearman’s correlation coefficient, 0.72) and NRS pain score (0.55 and 0.73), moderate-strong correlation with disability (0.58 and 0.31) and moderate correlation with joint tenderness (0.34, 0.36, 0.13) but weaker correlation with joint swelling (0.18, 0.18, 0.19). table ft1 table-wrap mode="anchored" t5 caption a7 Source Measure Pain (VAS or NRS) Joint tenderness Joint swelling Activity limitations * Patient global ‡ MSD Pain (Likert) NA 0.34 0.18 NA NA Joint tenderness 0.25 NA NA Joint swelling NA NA Activity limitations NA Pfizer Pain (Likert) NA 0.36 0.18 NA NA Joint tenderness 0.37 NA NA Joint swelling NA NA Activity limitations NA Regeneron Pain (Likert) 0.75 NA NA 0.31 NA Pain (NRS) NA NA 0.39 NA Joint tenderness NA NA NA Joint swelling NA NA Activity limitations NA Novartis Pain (VAS) 0.55 0.13 0.19 0.58 0.72 Pain (Likert) 0.15 0.17 0.58 0.70 Joint tenderness 0.46 0.18 0.56 Joint swelling 0.25 0.47 Activity limitations 0.50 Auckland University of Technology Pain VAS NA NA NA 0.66 0.73 Joint tenderness NA NA NA Joint swelling NA NA Activity limitations † 0.73 Open in a separate window NA: measure not available in the dataset * Activity limitations measured by single 0–10 NRS in Regeneron data, HAQ-II in AUT data and HAQ-DI in Novartis data † In addition the HAQ-II correlated highly with measures of specific foot function in this dataset.
Software:Article Title: Application of the OMERACT filter to measures of core outcome domains in recent clinical studies of acute gout
Article Snippet: Floor effects were appreciable at final visit and ceiling effects were appreciable at baseline. table ft1 table-wrap mode="anchored" t5 caption a7 Measure Source Within-group (pooled) Between group Effect Size † GEE (Wald χ2) KW-statistic † GEE (Wald χ2) Pain (Likert) MSD * 2.32 NA NA NA Pfizer 2.72 816 p<0.001 17.6 p=0.001 16.8 p=0.001 Regeneron 1.20 NA 26.7 p<0.001 NA Novartis * 2.84 446.8 P <0.001 NA NA Pain (VAS) AUT * 1.58 NA NA NA Novartis * 4.46 602.2 P<0.001 NA NA Pain (NRS) Regeneron 1.62 NA 26.6 p<0.001 NA Joint tenderness MSD * 3.2 NA NA NA Pfizer 2.5 542 p<0.001 1.7 p=0.67 12 p=0.001 Regeneron NA NA NA NA Novartis * 2.25 598 p<0.001 NA NA AUT * NA NA NA NA Joint swelling MSD * 2.9 NA NA NA Pfizer 2.3 561 p<0.001 2.2 p=0.54 4.0 p=0.26 Regeneron NA NA NA NA Novartis * 2.5 523 p<0.001 NA NA AUT * NA NA NA NA Activity limitations MSD * NA NA NA NA Pfizer NA NA NA NA Regeneron 0.81 NA 5.4 p=0.067 NA§ Novartis * 1.04 159 (p<.0.001) NA NA AUT * 1.72 NA NA NA Patient Global MSD * NA ‡ NA NA NA Pfizer † NA ‡ NA 5.5 p=0.14 NA§ Regeneron NA NA NA NA Novartis * NA ‡ NA NA NA AUT * ¶ 1.46 NA NA NA Open in a separate window NA: not available or not applicable * MSD – Merck, Sharp & Dohme Corp.
Article Title: Application of the OMERACT filter to measures of core outcome domains in recent clinical studies of acute gout
Article Snippet: Significant floor effects were appreciable at final visit (47 to 64%) and ceiling effects (27 to 56%) were appreciable at baseline. table ft1 table-wrap mode="anchored" t5 caption a7 ICC SEM SDD MID Pain (Likert) MSD Between day 2 and 5 0.56 0.51 1.41 1 Between day 5 and 8 0.80 0.42 1.17 2 Pfizer * Between 2 and 4 hours 0.81 0.39 1.08 -- Between 2 and 8 hours 0.72 0.50 1.39 -- Between 2 and 12 hours 0.60 0.62 1.72 -- Pfizer † Between day 1 and 9 0.07 0.76 2.1 2 Between day 2 and 9 0.15 0.76 2.1 2 Between day 5 and 9 0.59 0.54 1.50 2 Novartis Baseline to 7 days post dose 0.35 0.85 2.36 1.0 24 hours post dose to 7 days 0.55 0.64 1.77 -- 48 hours post dose to 7 days 0.71 0.49 1.36 -- Pain (VAS) Novartis Baseline to 7 days post dose 0.35 3.66 10.15 19 24 hours post dose to 7 days 0.57 2.93 8.12 -- 48 hours post dose to 7 days 0.76 2.23 6.18 -- Joint tenderness MSD Between day 2 and day 5 0.50 0.46 1.28 2 Between day 5 and day 8 0.79 0.34 0.94 1 Pfizer Between Day 1 and 9 0.06 0.66 1.8 2 Between Day 5 and 9 0.11 0.59 1.6 2 Novartis Baseline to 7 days Post 0.0 ** 1.06 2.93 1.0 24 hours post dose to 7 days 0.50 0.54 1.51 -- 48 hours post dose to 7 days 0.49 0.54 1.50 -- 72 hours post dose to 7 days 0.49 0.54 1.50 -- Joint swelling MSD Between day 2 and day 5 0.48 0.53 1.47 1 Between day 5 and day 8 0.77 0.43 1.18 1 Pfizer Between Day 1 and 9 0.13 0.64 1.8 1 Between Day 5 and 9 0.37 0.73 2.0 1 Novartis Baseline to 7 days 0.0 1.07 2.97 1 24 hours post dose to 7 days 0.44 0.65 1.80 -- 48 hours post dose to 7 days 0.44 0.65 1.79 -- 72 hours post dose to 7 days 0.44 0.65 1.79 -- Activity limitations Novartis 0.55 0.45 1.25 0.5 Open in a separate window * Pain assessed as ‘current’ level of pain † Pain assessed as ‘over the last 24 hours’ ** Statistical software indicated that estimation of a negative variance parameter was attempted Indices of test-retest reliability, smallest detectable difference and minimal important difference
Article Title: Application of the OMERACT filter to measures of core outcome domains in recent clinical studies of acute gout
Article Snippet: Significant floor effects were appreciable at final visit (47 to 64%) and ceiling effects (27 to 56%) were appreciable at baseline. table ft1 table-wrap mode="anchored" t5 caption a7 ICC SEM SDD MID Pain (Likert) MSD Between day 2 and 5 0.56 0.51 1.41 1 Between day 5 and 8 0.80 0.42 1.17 2 Pfizer * Between 2 and 4 hours 0.81 0.39 1.08 -- Between 2 and 8 hours 0.72 0.50 1.39 -- Between 2 and 12 hours 0.60 0.62 1.72 -- Pfizer † Between day 1 and 9 0.07 0.76 2.1 2 Between day 2 and 9 0.15 0.76 2.1 2 Between day 5 and 9 0.59 0.54 1.50 2 Novartis Baseline to 7 days post dose 0.35 0.85 2.36 1.0 24 hours post dose to 7 days 0.55 0.64 1.77 -- 48 hours post dose to 7 days 0.71 0.49 1.36 -- Pain (VAS) Novartis Baseline to 7 days post dose 0.35 3.66 10.15 19 24 hours post dose to 7 days 0.57 2.93 8.12 -- 48 hours post dose to 7 days 0.76 2.23 6.18 -- Joint tenderness MSD Between day 2 and day 5 0.50 0.46 1.28 2 Between day 5 and day 8 0.79 0.34 0.94 1 Pfizer Between Day 1 and 9 0.06 0.66 1.8 2 Between Day 5 and 9 0.11 0.59 1.6 2 Novartis Baseline to 7 days Post 0.0 ** 1.06 2.93 1.0 24 hours post dose to 7 days 0.50 0.54 1.51 -- 48 hours post dose to 7 days 0.49 0.54 1.50 -- 72 hours post dose to 7 days 0.49 0.54 1.50 -- Joint swelling MSD Between day 2 and day 5 0.48 0.53 1.47 1 Between day 5 and day 8 0.77 0.43 1.18 1 Pfizer Between Day 1 and 9 0.13 0.64 1.8 1 Between Day 5 and 9 0.37 0.73 2.0 1 Novartis Baseline to 7 days 0.0 1.07 2.97 1 24 hours post dose to 7 days 0.44 0.65 1.80 -- 48 hours post dose to 7 days 0.44 0.65 1.79 -- 72 hours post dose to 7 days 0.44 0.65 1.79 -- Activity limitations Novartis 0.55 0.45 1.25 0.5 Open in a separate window * Pain assessed as ‘current’ level of pain † Pain assessed as ‘over the last 24 hours’ ** Statistical software indicated that estimation of a negative variance parameter was attempted Indices of test-retest reliability, smallest detectable difference and minimal important difference Joint tenderness Joint tenderness was also measured using a 0–3 point Likert scale in most studies.
Article Title: Application of the OMERACT filter to measures of core outcome domains in recent clinical studies of acute gout
Article Snippet: The Likert scale had good construct validity ( ): strong correlation with patient global (Spearman’s correlation coefficient, 0.72) and NRS pain score (0.55 and 0.73), moderate-strong correlation with disability (0.58 and 0.31) and moderate correlation with joint tenderness (0.34, 0.36, 0.13) but weaker correlation with joint swelling (0.18, 0.18, 0.19). table ft1 table-wrap mode="anchored" t5 caption a7 Source Measure Pain (VAS or NRS) Joint tenderness Joint swelling Activity limitations * Patient global ‡ MSD Pain (Likert) NA 0.34 0.18 NA NA Joint tenderness 0.25 NA NA Joint swelling NA NA Activity limitations NA Pfizer Pain (Likert) NA 0.36 0.18 NA NA Joint tenderness 0.37 NA NA Joint swelling NA NA Activity limitations NA Regeneron Pain (Likert) 0.75 NA NA 0.31 NA Pain (NRS) NA NA 0.39 NA Joint tenderness NA NA NA Joint swelling NA NA Activity limitations NA Novartis Pain (VAS) 0.55 0.13 0.19 0.58 0.72 Pain (Likert) 0.15 0.17 0.58 0.70 Joint tenderness 0.46 0.18 0.56 Joint swelling 0.25 0.47 Activity limitations 0.50 Auckland University of Technology Pain VAS NA NA NA 0.66 0.73 Joint tenderness NA NA NA Joint swelling NA NA Activity limitations † 0.73 Open in a separate window NA: measure not available in the dataset * Activity limitations measured by single 0–10 NRS in Regeneron data, HAQ-II in AUT data and HAQ-DI in Novartis data † In addition the HAQ-II correlated highly with measures of specific foot function in this dataset.
Construct:Article Title: Application of the OMERACT filter to measures of core outcome domains in recent clinical studies of acute gout
Article Snippet: Floor effects were appreciable at final visit and ceiling effects were appreciable at baseline. table ft1 table-wrap mode="anchored" t5 caption a7 Measure Source Within-group (pooled) Between group Effect Size † GEE (Wald χ2) KW-statistic † GEE (Wald χ2) Pain (Likert) MSD * 2.32 NA NA NA Pfizer 2.72 816 p<0.001 17.6 p=0.001 16.8 p=0.001 Regeneron 1.20 NA 26.7 p<0.001 NA Novartis * 2.84 446.8 P <0.001 NA NA Pain (VAS) AUT * 1.58 NA NA NA Novartis * 4.46 602.2 P<0.001 NA NA Pain (NRS) Regeneron 1.62 NA 26.6 p<0.001 NA Joint tenderness MSD * 3.2 NA NA NA Pfizer 2.5 542 p<0.001 1.7 p=0.67 12 p=0.001 Regeneron NA NA NA NA Novartis * 2.25 598 p<0.001 NA NA AUT * NA NA NA NA Joint swelling MSD * 2.9 NA NA NA Pfizer 2.3 561 p<0.001 2.2 p=0.54 4.0 p=0.26 Regeneron NA NA NA NA Novartis * 2.5 523 p<0.001 NA NA AUT * NA NA NA NA Activity limitations MSD * NA NA NA NA Pfizer NA NA NA NA Regeneron 0.81 NA 5.4 p=0.067 NA§ Novartis * 1.04 159 (p<.0.001) NA NA AUT * 1.72 NA NA NA Patient Global MSD * NA ‡ NA NA NA Pfizer † NA ‡ NA 5.5 p=0.14 NA§ Regeneron NA NA NA NA Novartis * NA ‡ NA NA NA AUT * ¶ 1.46 NA NA NA Open in a separate window NA: not available or not applicable * MSD – Merck, Sharp & Dohme Corp.
Article Title: Application of the OMERACT filter to measures of core outcome domains in recent clinical studies of acute gout
Article Snippet: Significant floor effects were appreciable at final visit (47 to 64%) and ceiling effects (27 to 56%) were appreciable at baseline. table ft1 table-wrap mode="anchored" t5 caption a7 ICC SEM SDD MID Pain (Likert) MSD Between day 2 and 5 0.56 0.51 1.41 1 Between day 5 and 8 0.80 0.42 1.17 2 Pfizer * Between 2 and 4 hours 0.81 0.39 1.08 -- Between 2 and 8 hours 0.72 0.50 1.39 -- Between 2 and 12 hours 0.60 0.62 1.72 -- Pfizer † Between day 1 and 9 0.07 0.76 2.1 2 Between day 2 and 9 0.15 0.76 2.1 2 Between day 5 and 9 0.59 0.54 1.50 2 Novartis Baseline to 7 days post dose 0.35 0.85 2.36 1.0 24 hours post dose to 7 days 0.55 0.64 1.77 -- 48 hours post dose to 7 days 0.71 0.49 1.36 -- Pain (VAS) Novartis Baseline to 7 days post dose 0.35 3.66 10.15 19 24 hours post dose to 7 days 0.57 2.93 8.12 -- 48 hours post dose to 7 days 0.76 2.23 6.18 -- Joint tenderness MSD Between day 2 and day 5 0.50 0.46 1.28 2 Between day 5 and day 8 0.79 0.34 0.94 1 Pfizer Between Day 1 and 9 0.06 0.66 1.8 2 Between Day 5 and 9 0.11 0.59 1.6 2 Novartis Baseline to 7 days Post 0.0 ** 1.06 2.93 1.0 24 hours post dose to 7 days 0.50 0.54 1.51 -- 48 hours post dose to 7 days 0.49 0.54 1.50 -- 72 hours post dose to 7 days 0.49 0.54 1.50 -- Joint swelling MSD Between day 2 and day 5 0.48 0.53 1.47 1 Between day 5 and day 8 0.77 0.43 1.18 1 Pfizer Between Day 1 and 9 0.13 0.64 1.8 1 Between Day 5 and 9 0.37 0.73 2.0 1 Novartis Baseline to 7 days 0.0 1.07 2.97 1 24 hours post dose to 7 days 0.44 0.65 1.80 -- 48 hours post dose to 7 days 0.44 0.65 1.79 -- 72 hours post dose to 7 days 0.44 0.65 1.79 -- Activity limitations Novartis 0.55 0.45 1.25 0.5 Open in a separate window * Pain assessed as ‘current’ level of pain † Pain assessed as ‘over the last 24 hours’ ** Statistical software indicated that estimation of a negative variance parameter was attempted Indices of test-retest reliability, smallest detectable difference and minimal important difference
Article Title: Application of the OMERACT filter to measures of core outcome domains in recent clinical studies of acute gout
Article Snippet: Significant floor effects were appreciable at final visit (47 to 64%) and ceiling effects (27 to 56%) were appreciable at baseline. table ft1 table-wrap mode="anchored" t5 caption a7 ICC SEM SDD MID Pain (Likert) MSD Between day 2 and 5 0.56 0.51 1.41 1 Between day 5 and 8 0.80 0.42 1.17 2 Pfizer * Between 2 and 4 hours 0.81 0.39 1.08 -- Between 2 and 8 hours 0.72 0.50 1.39 -- Between 2 and 12 hours 0.60 0.62 1.72 -- Pfizer † Between day 1 and 9 0.07 0.76 2.1 2 Between day 2 and 9 0.15 0.76 2.1 2 Between day 5 and 9 0.59 0.54 1.50 2 Novartis Baseline to 7 days post dose 0.35 0.85 2.36 1.0 24 hours post dose to 7 days 0.55 0.64 1.77 -- 48 hours post dose to 7 days 0.71 0.49 1.36 -- Pain (VAS) Novartis Baseline to 7 days post dose 0.35 3.66 10.15 19 24 hours post dose to 7 days 0.57 2.93 8.12 -- 48 hours post dose to 7 days 0.76 2.23 6.18 -- Joint tenderness MSD Between day 2 and day 5 0.50 0.46 1.28 2 Between day 5 and day 8 0.79 0.34 0.94 1 Pfizer Between Day 1 and 9 0.06 0.66 1.8 2 Between Day 5 and 9 0.11 0.59 1.6 2 Novartis Baseline to 7 days Post 0.0 ** 1.06 2.93 1.0 24 hours post dose to 7 days 0.50 0.54 1.51 -- 48 hours post dose to 7 days 0.49 0.54 1.50 -- 72 hours post dose to 7 days 0.49 0.54 1.50 -- Joint swelling MSD Between day 2 and day 5 0.48 0.53 1.47 1 Between day 5 and day 8 0.77 0.43 1.18 1 Pfizer Between Day 1 and 9 0.13 0.64 1.8 1 Between Day 5 and 9 0.37 0.73 2.0 1 Novartis Baseline to 7 days 0.0 1.07 2.97 1 24 hours post dose to 7 days 0.44 0.65 1.80 -- 48 hours post dose to 7 days 0.44 0.65 1.79 -- 72 hours post dose to 7 days 0.44 0.65 1.79 -- Activity limitations Novartis 0.55 0.45 1.25 0.5 Open in a separate window * Pain assessed as ‘current’ level of pain † Pain assessed as ‘over the last 24 hours’ ** Statistical software indicated that estimation of a negative variance parameter was attempted Indices of test-retest reliability, smallest detectable difference and minimal important difference Joint tenderness Joint tenderness was also measured using a 0–3 point Likert scale in most studies.
Article Title: Application of the OMERACT filter to measures of core outcome domains in recent clinical studies of acute gout
Article Snippet: The Likert scale had good construct validity ( ): strong correlation with patient global (Spearman’s correlation coefficient, 0.72) and NRS pain score (0.55 and 0.73), moderate-strong correlation with disability (0.58 and 0.31) and moderate correlation with joint tenderness (0.34, 0.36, 0.13) but weaker correlation with joint swelling (0.18, 0.18, 0.19). table ft1 table-wrap mode="anchored" t5 caption a7 Source Measure Pain (VAS or NRS) Joint tenderness Joint swelling Activity limitations * Patient global ‡ MSD Pain (Likert) NA 0.34 0.18 NA NA Joint tenderness 0.25 NA NA Joint swelling NA NA Activity limitations NA Pfizer Pain (Likert) NA 0.36 0.18 NA NA Joint tenderness 0.37 NA NA Joint swelling NA NA Activity limitations NA Regeneron Pain (Likert) 0.75 NA NA 0.31 NA Pain (NRS) NA NA 0.39 NA Joint tenderness NA NA NA Joint swelling NA NA Activity limitations NA Novartis Pain (VAS) 0.55 0.13 0.19 0.58 0.72 Pain (Likert) 0.15 0.17 0.58 0.70 Joint tenderness 0.46 0.18 0.56 Joint swelling 0.25 0.47 Activity limitations 0.50 Auckland University of Technology Pain VAS NA NA NA 0.66 0.73 Joint tenderness NA NA NA Joint swelling NA NA Activity limitations † 0.73 Open in a separate window NA: measure not available in the dataset * Activity limitations measured by single 0–10 NRS in Regeneron data, HAQ-II in AUT data and HAQ-DI in Novartis data † In addition the HAQ-II correlated highly with measures of specific foot function in this dataset.
Biomarker Discovery:Article Title: Application of the OMERACT filter to measures of core outcome domains in recent clinical studies of acute gout
Article Snippet: Floor effects were appreciable at final visit and ceiling effects were appreciable at baseline. table ft1 table-wrap mode="anchored" t5 caption a7 Measure Source Within-group (pooled) Between group Effect Size † GEE (Wald χ2) KW-statistic † GEE (Wald χ2) Pain (Likert) MSD * 2.32 NA NA NA Pfizer 2.72 816 p<0.001 17.6 p=0.001 16.8 p=0.001 Regeneron 1.20 NA 26.7 p<0.001 NA Novartis * 2.84 446.8 P <0.001 NA NA Pain (VAS) AUT * 1.58 NA NA NA Novartis * 4.46 602.2 P<0.001 NA NA Pain (NRS) Regeneron 1.62 NA 26.6 p<0.001 NA Joint tenderness MSD * 3.2 NA NA NA Pfizer 2.5 542 p<0.001 1.7 p=0.67 12 p=0.001 Regeneron NA NA NA NA Novartis * 2.25 598 p<0.001 NA NA AUT * NA NA NA NA Joint swelling MSD * 2.9 NA NA NA Pfizer 2.3 561 p<0.001 2.2 p=0.54 4.0 p=0.26 Regeneron NA NA NA NA Novartis * 2.5 523 p<0.001 NA NA AUT * NA NA NA NA Activity limitations MSD * NA NA NA NA Pfizer NA NA NA NA Regeneron 0.81 NA 5.4 p=0.067 NA§ Novartis * 1.04 159 (p<.0.001) NA NA AUT * 1.72 NA NA NA Patient Global MSD * NA ‡ NA NA NA Pfizer † NA ‡ NA 5.5 p=0.14 NA§ Regeneron NA NA NA NA Novartis * NA ‡ NA NA NA AUT * ¶ 1.46 NA NA NA Open in a separate window NA: not available or not applicable * MSD – Merck, Sharp & Dohme Corp.
Article Title: Application of the OMERACT filter to measures of core outcome domains in recent clinical studies of acute gout
Article Snippet: Significant floor effects were appreciable at final visit (47 to 64%) and ceiling effects (27 to 56%) were appreciable at baseline. table ft1 table-wrap mode="anchored" t5 caption a7 ICC SEM SDD MID Pain (Likert) MSD Between day 2 and 5 0.56 0.51 1.41 1 Between day 5 and 8 0.80 0.42 1.17 2 Pfizer * Between 2 and 4 hours 0.81 0.39 1.08 -- Between 2 and 8 hours 0.72 0.50 1.39 -- Between 2 and 12 hours 0.60 0.62 1.72 -- Pfizer † Between day 1 and 9 0.07 0.76 2.1 2 Between day 2 and 9 0.15 0.76 2.1 2 Between day 5 and 9 0.59 0.54 1.50 2 Novartis Baseline to 7 days post dose 0.35 0.85 2.36 1.0 24 hours post dose to 7 days 0.55 0.64 1.77 -- 48 hours post dose to 7 days 0.71 0.49 1.36 -- Pain (VAS) Novartis Baseline to 7 days post dose 0.35 3.66 10.15 19 24 hours post dose to 7 days 0.57 2.93 8.12 -- 48 hours post dose to 7 days 0.76 2.23 6.18 -- Joint tenderness MSD Between day 2 and day 5 0.50 0.46 1.28 2 Between day 5 and day 8 0.79 0.34 0.94 1 Pfizer Between Day 1 and 9 0.06 0.66 1.8 2 Between Day 5 and 9 0.11 0.59 1.6 2 Novartis Baseline to 7 days Post 0.0 ** 1.06 2.93 1.0 24 hours post dose to 7 days 0.50 0.54 1.51 -- 48 hours post dose to 7 days 0.49 0.54 1.50 -- 72 hours post dose to 7 days 0.49 0.54 1.50 -- Joint swelling MSD Between day 2 and day 5 0.48 0.53 1.47 1 Between day 5 and day 8 0.77 0.43 1.18 1 Pfizer Between Day 1 and 9 0.13 0.64 1.8 1 Between Day 5 and 9 0.37 0.73 2.0 1 Novartis Baseline to 7 days 0.0 1.07 2.97 1 24 hours post dose to 7 days 0.44 0.65 1.80 -- 48 hours post dose to 7 days 0.44 0.65 1.79 -- 72 hours post dose to 7 days 0.44 0.65 1.79 -- Activity limitations Novartis 0.55 0.45 1.25 0.5 Open in a separate window * Pain assessed as ‘current’ level of pain † Pain assessed as ‘over the last 24 hours’ ** Statistical software indicated that estimation of a negative variance parameter was attempted Indices of test-retest reliability, smallest detectable difference and minimal important difference
Article Title: Application of the OMERACT filter to measures of core outcome domains in recent clinical studies of acute gout
Article Snippet: Significant floor effects were appreciable at final visit (47 to 64%) and ceiling effects (27 to 56%) were appreciable at baseline. table ft1 table-wrap mode="anchored" t5 caption a7 ICC SEM SDD MID Pain (Likert) MSD Between day 2 and 5 0.56 0.51 1.41 1 Between day 5 and 8 0.80 0.42 1.17 2 Pfizer * Between 2 and 4 hours 0.81 0.39 1.08 -- Between 2 and 8 hours 0.72 0.50 1.39 -- Between 2 and 12 hours 0.60 0.62 1.72 -- Pfizer † Between day 1 and 9 0.07 0.76 2.1 2 Between day 2 and 9 0.15 0.76 2.1 2 Between day 5 and 9 0.59 0.54 1.50 2 Novartis Baseline to 7 days post dose 0.35 0.85 2.36 1.0 24 hours post dose to 7 days 0.55 0.64 1.77 -- 48 hours post dose to 7 days 0.71 0.49 1.36 -- Pain (VAS) Novartis Baseline to 7 days post dose 0.35 3.66 10.15 19 24 hours post dose to 7 days 0.57 2.93 8.12 -- 48 hours post dose to 7 days 0.76 2.23 6.18 -- Joint tenderness MSD Between day 2 and day 5 0.50 0.46 1.28 2 Between day 5 and day 8 0.79 0.34 0.94 1 Pfizer Between Day 1 and 9 0.06 0.66 1.8 2 Between Day 5 and 9 0.11 0.59 1.6 2 Novartis Baseline to 7 days Post 0.0 ** 1.06 2.93 1.0 24 hours post dose to 7 days 0.50 0.54 1.51 -- 48 hours post dose to 7 days 0.49 0.54 1.50 -- 72 hours post dose to 7 days 0.49 0.54 1.50 -- Joint swelling MSD Between day 2 and day 5 0.48 0.53 1.47 1 Between day 5 and day 8 0.77 0.43 1.18 1 Pfizer Between Day 1 and 9 0.13 0.64 1.8 1 Between Day 5 and 9 0.37 0.73 2.0 1 Novartis Baseline to 7 days 0.0 1.07 2.97 1 24 hours post dose to 7 days 0.44 0.65 1.80 -- 48 hours post dose to 7 days 0.44 0.65 1.79 -- 72 hours post dose to 7 days 0.44 0.65 1.79 -- Activity limitations Novartis 0.55 0.45 1.25 0.5 Open in a separate window * Pain assessed as ‘current’ level of pain † Pain assessed as ‘over the last 24 hours’ ** Statistical software indicated that estimation of a negative variance parameter was attempted Indices of test-retest reliability, smallest detectable difference and minimal important difference Joint tenderness Joint tenderness was also measured using a 0–3 point Likert scale in most studies.
Article Title: Application of the OMERACT filter to measures of core outcome domains in recent clinical studies of acute gout
Article Snippet: The Likert scale had good construct validity ( ): strong correlation with patient global (Spearman’s correlation coefficient, 0.72) and NRS pain score (0.55 and 0.73), moderate-strong correlation with disability (0.58 and 0.31) and moderate correlation with joint tenderness (0.34, 0.36, 0.13) but weaker correlation with joint swelling (0.18, 0.18, 0.19). table ft1 table-wrap mode="anchored" t5 caption a7 Source Measure Pain (VAS or NRS) Joint tenderness Joint swelling Activity limitations * Patient global ‡ MSD Pain (Likert) NA 0.34 0.18 NA NA Joint tenderness 0.25 NA NA Joint swelling NA NA Activity limitations NA Pfizer Pain (Likert) NA 0.36 0.18 NA NA Joint tenderness 0.37 NA NA Joint swelling NA NA Activity limitations NA Regeneron Pain (Likert) 0.75 NA NA 0.31 NA Pain (NRS) NA NA 0.39 NA Joint tenderness NA NA NA Joint swelling NA NA Activity limitations NA Novartis Pain (VAS) 0.55 0.13 0.19 0.58 0.72 Pain (Likert) 0.15 0.17 0.58 0.70 Joint tenderness 0.46 0.18 0.56 Joint swelling 0.25 0.47 Activity limitations 0.50 Auckland University of Technology Pain VAS NA NA NA 0.66 0.73 Joint tenderness NA NA NA Joint swelling NA NA Activity limitations † 0.73 Open in a separate window NA: measure not available in the dataset * Activity limitations measured by single 0–10 NRS in Regeneron data, HAQ-II in AUT data and HAQ-DI in Novartis data † In addition the HAQ-II correlated highly with measures of specific foot function in this dataset.
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