somewordstoolate/Q2CRBench-3 huggingface dataset:
Guideline: 2021 ACR RA
Clinical question: Should patients with RA on MTX + boDMARD or tsDMARD who are at target continue the boDMARD or tsDMARD at the same dose or lower the dose or increase the interval between doses of the boDMARD or tsDMARD (MTX continued at same dose)?
Population: Patients with RA on MTX + boDMARD or tsDMARD who are at target
Intervention: Continue the same dose of the boDMARD or tsDMARD
Comparator: increase the interval between the doses of the boDMARD or tsDMARD
Outcome: Flare (follow up: 18 months)
Importance: CRITICAL

Evidence assessment:
GRADE: Risk of bias: result: SERIOUS
rationales: Downgraded by one level due to serious risk of bias. Lack of blinding of participants and personnel in both studies and lack of blinding of non-radiographic outcome assessors in one study.
Inconsistency: result: SERIOUS
rationales: Downgraded by one level due to serious inconsistency. I2=75%.
Indirectness: result: NOT_SERIOUS
Imprecision: result: NOT_SERIOUS
Other considerations: result: none
Study design: Randomized Controlled Trial
Certainty: LOW
No of participants: Continue the same dose of the boDMARD or tsDMARD: 50/132 (37.9%)
Increase the interval between the doses of the boDMARD or tsDMARD: 137/185 (74.1%)
Effect: Relative Effect (95% CI): RR 0.48 (0.38 to 0.62)
Absolute Effect (95% CI): 385 fewer per 1,000 (from 459 fewer to 281 fewer)
Abbreviations: CI: Confidence interval; RR: Risk ratio; MD: Mean difference; HR: Hazard Ratio
Guideline: 2021 ACR RA
Clinical question: Should patients with RA on MTX + boDMARD or tsDMARD who are at target continue the boDMARD or tsDMARD at the same dose or lower the dose or increase the interval between doses of the boDMARD or tsDMARD (MTX continued at same dose)?
Population: Patients with RA on MTX + boDMARD or tsDMARD who are at target
Intervention: Continue the same dose of the boDMARD or tsDMARD
Comparator: increase the interval between the doses of the boDMARD or tsDMARD
Outcome: Disability (follow up: 3 months; assessed with: HAQ-DI (Lower values – > benefit) (MCID -0.22)
Importance: IMPORTANT

Evidence assessment:
GRADE: Risk of bias: result: SERIOUS
rationales: Downgraded by one level due to serious risk of bias. Lack of blinding of participants and personnel.
Inconsistency: result: NOT_SERIOUS
Indirectness: result: NOT_SERIOUS
Imprecision: result: SERIOUS
rationales: Downgraded by two levels due to very serious imprecision. Confidence interval includes both values suggesting benefit and values suggesting no effect.
Other considerations: result: none
Study design: Randomized Controlled Trial
Certainty: LOW
No of participants: Continue the same dose of the boDMARD or tsDMARD: 73
Increase the interval between the doses of the boDMARD or tsDMARD: 64
Effect: Relative Effect (95% CI): -
Absolute Effect (95% CI): MD 0.09 lower (0.41 lower to 0.23 higher)
Abbreviations: CI: Confidence interval; RR: Risk ratio; MD: Mean difference; HR: Hazard Ratio
Guideline: 2021 ACR RA
Clinical question:  Should patients with MTX-naïve and non-MTX csDMARDs naïve RA and moderate to high disease activity receive MTX monotherapy or boDMARD with MTX or tsDMARD with MTX?
Population: Patients with MTX-naïve and non-MTX csDMARDs naïve RA and moderate to high disease activity
Intervention: MTX monotherapy
Comparator: TNF Inhibitor + MTX
Outcome: Disease activity (follow up: range 6 months to 1 year; assessed with: ACR 20)
Importance: CRITICAL

Evidence assessment:
GRADE: Risk of bias: result: NOT_SERIOUS
rationales: Concern about risk of bias associated with lack of allocation concealment and incomplete outcome data in one study is taken into account when rating down for imprecision.
Inconsistency: result: NOT_SERIOUS
Indirectness: result: NOT_SERIOUS
Imprecision: result: SERIOUS
rationales: Downgraded by one level due to serious imprecision. Confidence interval includes both values suggesting no effect and values suggesting benefit. According to the Cochrane's handbook, Cohen suggested that SMD=0.2 be considered a 'small' effect size, 0.5 represents a 'medium' effect size and 0.8 a 'large' effect size. This means that if two groups' means do not differ by 0.2 standard deviations or more, the difference is trivial, even if it is statistically significant.
Other considerations: result: none
Study design: Randomized Controlled Trial
Certainty: MODERATE
No of participants: TNFi + MTX: 521/742 (70.2%)
MTX monotherapy: 188/298 (63.1%)
Effect: Relative Effect (95% CI): RR 1.14 (1.03 to 1.26)
Absolute Effect (95% CI): 88 more per 1,000 (from 19 more to 164 more)
Abbreviations: CI: Confidence interval; RR: Risk ratio; MD: Mean difference; HR: Hazard Ratio
Guideline: 2021 ACR RA
Clinical question:  Should patients with MTX-naïve and non-MTX csDMARDs naïve RA and moderate to high disease activity receive MTX monotherapy or boDMARD with MTX or tsDMARD with MTX?
Population: Patients with MTX-naïve and non-MTX csDMARDs naïve RA and moderate to high disease activity
Intervention: MTX monotherapy
Comparator: TNF Inhibitor + MTX
Outcome: Disease activity (follow up: 6 months; assessed with: ACR 50)
Importance: CRITICAL

Evidence assessment:
GRADE: Risk of bias: result: NOT_SERIOUS
rationales: Concern about risk of bias associated with lack of allocation concealment and incomplete outcome data in one study is taken into account when rating down for imprecision.
Inconsistency: result: NOT_SERIOUS
Indirectness: result: NOT_SERIOUS
Imprecision: result: SERIOUS
rationales: Downgraded by one level due to serious imprecision. Confidence interval includes both values suggesting no effect and values suggesting benefit. According to the Cochrane's handbook, Cohen suggested that SMD=0.2 be considered a 'small' effect size, 0.5 represents a 'medium' effect size and 0.8 a 'large' effect size. This means that if two groups' means do not differ by 0.2 standard deviations or more, the difference is trivial, even if it is statistically significant.
Other considerations: result: none
Study design: Randomized Controlled Trial
Certainty: MODERATE
No of participants: TNFi + MTX: 426/742 (57.4%)
MTX monotherapy: 148/298 (49.7%)
Effect: Relative Effect (95% CI): RR 1.17 (1.02 to 1.33)
Absolute Effect (95% CI): 84 more per 1,000 (from 10 more to 164 more)
Abbreviations: CI: Confidence interval; RR: Risk ratio; MD: Mean difference; HR: Hazard Ratio
Guideline: 2021 ACR RA
Clinical question:  Should patients with MTX-naïve and non-MTX csDMARDs naïve RA and moderate to high disease activity receive MTX monotherapy or boDMARD with MTX or tsDMARD with MTX?
Population: Patients with MTX-naïve and non-MTX csDMARDs naïve RA and moderate to high disease activity
Intervention: MTX monotherapy
Comparator: TNF Inhibitor + MTX
Outcome: Disease activity (follow up: range 6 months to 12 months; assessed with: ACR 70)
Importance: CRITICAL

Evidence assessment:
GRADE: Risk of bias: result: NOT_SERIOUS
rationales: Concern about risk of bias associated with lack of allocation concealment and incomplete outcome data in one study is taken into account when rating down for inconsistency.
Inconsistency: result: SERIOUS
rationales: Downgraded by one level due to serious inconsistency. Unexplained heterogeneity I2=51%.
Indirectness: result: NOT_SERIOUS
Imprecision: result: NOT_SERIOUS
Other considerations: result: none
Study design: Randomized Controlled Trial
Certainty: MODERATE
No of participants: TNFi + MTX: 378/742 (50.9%)
MTX monotherapy: 108/298 (36.2%)
Effect: Relative Effect (95% CI): RR 1.36 (1.15 to 1.61)
Absolute Effect (95% CI): 130 more per 1,000 (from 54 more to 221 more)
Abbreviations: CI: Confidence interval; RR: Risk ratio; MD: Mean difference; HR: Hazard Ratio
Guideline: 2021 ACR RA
Clinical question:  Should patients with MTX-naïve and non-MTX csDMARDs naïve RA and moderate to high disease activity receive MTX monotherapy or boDMARD with MTX or tsDMARD with MTX?
Population: Patients with MTX-naïve and non-MTX csDMARDs naïve RA and moderate to high disease activity
Intervention: MTX monotherapy
Comparator: TNF Inhibitor + MTX
Outcome: Disease activity (follow up: range 6 months to 12 months; assessed with: DAS28 or DAS44 (Lower values -> benefit) (values>0.2 are considered clinically important)
Importance: CRITICAL

Evidence assessment:
GRADE: Risk of bias: result: SERIOUS
rationales: Downgraded by one level due to serious risk of bias. Lack of allocation concealment in 2 studies.
Inconsistency: result: SERIOUS
rationales: Downgraded by one level due to serious inconsistency. Unexplained heterogeneity I2=78%.
Indirectness: result: NOT_SERIOUS
Imprecision: result: SERIOUS
rationales: Downgraded by one level due to serious imprecision. Confidence interval includes both values suggesting no effect and values suggesting benefit. According to the Cochrane's handbook, Cohen suggested that SMD=0.2 be considered a 'small' effect size, 0.5 represents a 'medium' effect size and 0.8 a 'large' effect size. This means that if two groups' means do not differ by 0.2 standard deviations or more, the difference is trivial, even if it is statistically significant.
Other considerations: result: none
Study design: Randomized Controlled Trial
Certainty: VERY LOW
No of participants: TNFi + MTX: 0
MTX monotherapy: 0
Effect: Relative Effect (95% CI): -
Absolute Effect (95% CI): SMD 0.21 lower (0.37 lower to 0.05 lower)
Abbreviations: CI: Confidence interval; RR: Risk ratio; MD: Mean difference; HR: Hazard Ratio
Guideline: 2021 ACR RA
Clinical question:  Should patients with MTX-naïve and non-MTX csDMARDs naïve RA and moderate to high disease activity receive MTX monotherapy or boDMARD with MTX or tsDMARD with MTX?
Population: Patients with MTX-naïve and non-MTX csDMARDs naïve RA and moderate to high disease activity
Intervention: MTX monotherapy
Comparator: TNF Inhibitor + MTX
Outcome: Remission (follow up: range 6 months to 12 months; assessed with: DAS28<2.6)
Importance: CRITICAL

Evidence assessment:
GRADE: Risk of bias: result: SERIOUS
rationales: Downgraded by one level due to serious risk of bias. Lack of allocation concealment in 2 studies.
Inconsistency: result: SERIOUS
rationales: Downgraded by one level due to serious inconsistency. Unexplained heterogeneity I2=58%.
Indirectness: result: NOT_SERIOUS
Imprecision: result: NOT_SERIOUS
Other considerations: result: none
Study design: Randomized Controlled Trial
Certainty: LOW
No of participants: TNFi + MTX: 359/797 (45.0%)
MTX monotherapy: 116/353 (32.9%)
Effect: Relative Effect (95% CI): RR 1.49 (1.25 to 1.77)
Absolute Effect (95% CI): 161 more per 1,000 (from 82 more to 253 more)
Abbreviations: CI: Confidence interval; RR: Risk ratio; MD: Mean difference; HR: Hazard Ratio
Guideline: 2021 ACR RA
Clinical question:  Should patients with MTX-naïve and non-MTX csDMARDs naïve RA and moderate to high disease activity receive MTX monotherapy or boDMARD with MTX or tsDMARD with MTX?
Population: Patients with MTX-naïve and non-MTX csDMARDs naïve RA and moderate to high disease activity
Intervention: MTX monotherapy
Comparator: TNF Inhibitor + MTX
Outcome: Radiographic progression (follow up: 1 year; assessed with: mTSS (Lower values – > benefit) (MCID 4.6)
Importance: IMPORTANT

Evidence assessment:
GRADE: Risk of bias: result: SERIOUS
rationales: Downgraded by one level due to serious risk of bias. Lack of allocation concealment.
Inconsistency: result: NOT_SERIOUS
Indirectness: result: NOT_SERIOUS
Imprecision: result: NOT_SERIOUS
Other considerations: result: none
Study design: Randomized Controlled Trial
Certainty: MODERATE
No of participants: TNFi + MTX: 0
MTX monotherapy: 0
Effect: Relative Effect (95% CI): -
Absolute Effect (95% CI): MD 0 (0.64 lower to 0.64 higher)
Abbreviations: CI: Confidence interval; RR: Risk ratio; MD: Mean difference; HR: Hazard Ratio
Guideline: 2021 ACR RA
Clinical question:  Should patients with MTX-naïve and non-MTX csDMARDs naïve RA and moderate to high disease activity receive MTX monotherapy or boDMARD with MTX or tsDMARD with MTX?
Population: Patients with MTX-naïve and non-MTX csDMARDs naïve RA and moderate to high disease activity
Intervention: MTX monotherapy
Comparator: TNF Inhibitor + MTX
Outcome: Fatigue (follow up: 1 year; assessed with: VAS fatigue (Lower values – > benefit) (MCID -1.12 to -0.82))
Importance: IMPORTANT

Evidence assessment:
GRADE: Risk of bias: result: NOT_SERIOUS
rationales: Concern about risk of bias associated with lack of allocation concealment taken into account when rating down for imprecision.
Inconsistency: result: NOT_SERIOUS
Indirectness: result: NOT_SERIOUS
Imprecision: result: VERY_SERIOUS
rationales: Downgraded by two levels due to very serious imprecision. Confidence interval includes both values suggesting benefit and values suggesting harm.
Other considerations: result: none
Study design: Randomized Controlled Trial
Certainty: LOW
No of participants: TNFi + MTX: 55
MTX monotherapy: 55
Effect: Relative Effect (95% CI): -
Absolute Effect (95% CI): MD 5.2 lower (17.17 lower to 6.77 higher)
Abbreviations: CI: Confidence interval; RR: Risk ratio; MD: Mean difference; HR: Hazard Ratio
Guideline: 2021 ACR RA
Clinical question:  Should patients with MTX-naïve and non-MTX csDMARDs naïve RA and moderate to high disease activity receive MTX monotherapy or boDMARD with MTX or tsDMARD with MTX?
Population: Patients with MTX-naïve and non-MTX csDMARDs naïve RA and moderate to high disease activity
Intervention: MTX monotherapy
Comparator: TNF Inhibitor + MTX
Outcome: Pain (follow up: 1 year; assessed with: VAS pain (Lower values – > benefit) (MCID -11.9)
Importance: IMPORTANT

Evidence assessment:
GRADE: Risk of bias: result: NOT_SERIOUS
rationales: Concern about risk of bias associated with lack of allocation concealment taken into account when rating down for imprecision.
Inconsistency: result: NOT_SERIOUS
Indirectness: result: NOT_SERIOUS
Imprecision: result: SERIOUS
rationales: Downgraded by one level due to serious imprecision. Confidence interval includes both values suggesting no effect and values suggesting benefit. According to the Cochrane's handbook, Cohen suggested that SMD=0.2 be considered a 'small' effect size, 0.5 represents a 'medium' effect size and 0.8 a 'large' effect size. This means that if two groups' means do not differ by 0.2 standard deviations or more, the difference is trivial, even if it is statistically significant.
Other considerations: result: none
Study design: Randomized Controlled Trial
Certainty: MODERATE
No of participants: TNFi + MTX: 55
MTX monotherapy: 55
Effect: Relative Effect (95% CI): -
Absolute Effect (95% CI): MD 18.4 lower (30.88 lower to 5.92 lower)
Abbreviations: CI: Confidence interval; RR: Risk ratio; MD: Mean difference; HR: Hazard Ratio
Guideline: 2021 ACR RA
Clinical question:  Should patients with MTX-naïve and non-MTX csDMARDs naïve RA and moderate to high disease activity receive MTX monotherapy or boDMARD with MTX or tsDMARD with MTX?
Population: Patients with MTX-naïve and non-MTX csDMARDs naïve RA and moderate to high disease activity
Intervention: MTX monotherapy
Comparator: TNF Inhibitor + MTX
Outcome: Disability (follow up: range 6 months to 12 months; assessed with: HAQ-DI (Lower values – > benefit) (MCID -0.22)
Importance: IMPORTANT

Evidence assessment:
GRADE: Risk of bias: result: SERIOUS
rationales: Downgraded by one level due to serious risk of bias. Lack of allocation concealment in 2 studies.
Inconsistency: result: NOT_SERIOUS
Indirectness: result: NOT_SERIOUS
Imprecision: result: SERIOUS
rationales: Downgraded by one level due to serious imprecision. Confidence interval includes both values suggesting no effect and values suggesting benefit. According to the Cochrane's handbook, Cohen suggested that SMD=0.2 be considered a 'small' effect size, 0.5 represents a 'medium' effect size and 0.8 a 'large' effect size. This means that if two groups' means do not differ by 0.2 standard deviations or more, the difference is trivial, even if it is statistically significant.
Other considerations: result: none
Study design: Randomized Controlled Trial
Certainty: LOW
No of participants: TNFi + MTX: 0
MTX monotherapy: 0
Effect: Relative Effect (95% CI): -
Absolute Effect (95% CI): MD 0.18 lower (0.25 lower to 0.1 lower)
Abbreviations: CI: Confidence interval; RR: Risk ratio; MD: Mean difference; HR: Hazard Ratio
Guideline: 2021 ACR RA
Clinical question:  Should patients with MTX-naïve and non-MTX csDMARDs naïve RA and moderate to high disease activity receive MTX monotherapy or boDMARD with MTX or tsDMARD with MTX?
Population: Patients with MTX-naïve and non-MTX csDMARDs naïve RA and moderate to high disease activity
Intervention: MTX monotherapy
Comparator: TNF Inhibitor + MTX
Outcome: Quality of Life (follow up: range 6 months to 12 months; assessed with: SF-36 PCS (Higher values – > benefit) (MCID 4.4)
Importance: IMPORTANT

Evidence assessment:
GRADE: Risk of bias: result: SERIOUS
rationales: Downgraded by one level due to serious risk of bias. Lack of allocation concealment in 2 studies.
Inconsistency: result: NOT_SERIOUS
Indirectness: result: NOT_SERIOUS
Imprecision: result: SERIOUS
rationales: Downgraded by one level due to serious imprecision. Confidence interval includes both values suggesting no effect and values suggesting benefit. According to the Cochrane's handbook, Cohen suggested that SMD=0.2 be considered a 'small' effect size, 0.5 represents a 'medium' effect size and 0.8 a 'large' effect size. This means that if two groups' means do not differ by 0.2 standard deviations or more, the difference is trivial, even if it is statistically significant.
Other considerations: result: none
Study design: Randomized Controlled Trial
Certainty: LOW
No of participants: TNFi + MTX: 0
MTX monotherapy: 0
Effect: Relative Effect (95% CI): -
Absolute Effect (95% CI): MD 3.21 higher (0.63 higher to 5.79 higher)
Abbreviations: CI: Confidence interval; RR: Risk ratio; MD: Mean difference; HR: Hazard Ratio
Guideline: 2021 ACR RA
Clinical question:  Should patients with MTX-naïve and non-MTX csDMARDs naïve RA and moderate to high disease activity receive MTX monotherapy or boDMARD with MTX or tsDMARD with MTX?
Population: Patients with MTX-naïve and non-MTX csDMARDs naïve RA and moderate to high disease activity
Intervention: MTX monotherapy
Comparator: TNF Inhibitor + MTX
Outcome: Quality of Life (follow up: range 6 months to 12 months; assessed with: SF-36 MCS (Higher values – > benefit) (MCID 3.1)
Importance: IMPORTANT

Evidence assessment:
GRADE: Risk of bias: result: SERIOUS
rationales: Downgraded by one level due to serious risk of bias. Lack of allocation concealment in 2 studies.
Inconsistency: result: NOT_SERIOUS
Indirectness: result: NOT_SERIOUS
Imprecision: result: NOT_SERIOUS
Other considerations: result: none
Study design: Randomized Controlled Trial
Certainty: MODERATE
No of participants: TNFi + MTX: 0
MTX monotherapy: 0
Effect: Relative Effect (95% CI): -
Absolute Effect (95% CI): MD 0.54 lower (2.98 lower to 1.89 higher)
Abbreviations: CI: Confidence interval; RR: Risk ratio; MD: Mean difference; HR: Hazard Ratio
Guideline: 2021 ACR RA
Clinical question:  Should patients with MTX-naïve and non-MTX csDMARDs naïve RA and moderate to high disease activity receive MTX monotherapy or boDMARD with MTX or tsDMARD with MTX?
Population: Patients with MTX-naïve and non-MTX csDMARDs naïve RA and moderate to high disease activity
Intervention: MTX monotherapy
Comparator: TNF Inhibitor + MTX
Outcome: Withdrawal due to lack of efficacy (follow up: range 6 months to 12 months)
Importance: IMPORTANT

Evidence assessment:
GRADE: Risk of bias: result: SERIOUS
rationales: Downgraded by one level due to serious risk of bias. Lack of allocation concealment in 2 studies.
Inconsistency: result: NOT_SERIOUS
Indirectness: result: NOT_SERIOUS
Imprecision: result: NOT_SERIOUS
Other considerations: result: none
Study design: Randomized Controlled Trial
Certainty: MODERATE
No of participants: TNFi + MTX: 21/802 (2.6%)
MTX monotherapy: 24/359 (6.7%)
Effect: Relative Effect (95% CI): RR 0.38 (0.21 to 0.69)
Absolute Effect (95% CI): 41 fewer per 1,000 (from 53 fewer to 21 fewer)
Abbreviations: CI: Confidence interval; RR: Risk ratio; MD: Mean difference; HR: Hazard Ratio
Guideline: 2021 ACR RA
Clinical question:  Should patients with MTX-naïve and non-MTX csDMARDs naïve RA and moderate to high disease activity receive MTX monotherapy or boDMARD with MTX or tsDMARD with MTX?
Population: Patients with MTX-naïve and non-MTX csDMARDs naïve RA and moderate to high disease activity
Intervention: MTX monotherapy
Comparator: TNF Inhibitor + MTX
Outcome: Withdrawal due to adverse events (follow up: range 6 months to 12 months)
Importance: IMPORTANT

Evidence assessment:
GRADE: Risk of bias: result: SERIOUS
rationales: Downgraded by one level due to serious risk of bias. Lack of allocation concealment in 2 studies.
Inconsistency: result: NOT_SERIOUS
Indirectness: result: NOT_SERIOUS
Imprecision: result: SERIOUS
rationales: Downgraded by one level due to serious imprecision. Low number of events.
Other considerations: result: none
Study design: Randomized Controlled Trial
Certainty: LOW
No of participants: TNFi + MTX: 61/801 (7.6%)
MTX monotherapy: 24/357 (6.7%)
Effect: Relative Effect (95% CI): RR 0.94 (0.60 to 1.49)
Absolute Effect (95% CI): 4 fewer per 1,000 (from 27 fewer to 33 more)
Abbreviations: CI: Confidence interval; RR: Risk ratio; MD: Mean difference; HR: Hazard Ratio
Guideline: 2021 ACR RA
Clinical question:  Should patients with MTX-naïve and non-MTX csDMARDs naïve RA and moderate to high disease activity receive MTX monotherapy or boDMARD with MTX or tsDMARD with MTX?
Population: Patients with MTX-naïve and non-MTX csDMARDs naïve RA and moderate to high disease activity
Intervention: MTX monotherapy
Comparator: TNF Inhibitor + MTX
Outcome: Serious adverse events (follow up: range 6 months to 12 months)
Importance: IMPORTANT

Evidence assessment:
GRADE: Risk of bias: result: NOT_SERIOUS
rationales: Concern about risk of bias associated with lack of allocation concealment in two studies taken into account when rating down for inconsistency and imprecision.
Inconsistency: result: SERIOUS
rationales: Downgraded by one level due to serious inconsistency. Unexplained heterogeneity I2=72%.
Indirectness: result: NOT_SERIOUS
Imprecision: result: VERY_SERIOUS
rationales: Downgraded by one level due to serious imprecision. Low number of events.
Other considerations: result: none
Study design: Randomized Controlled Trial
Certainty: VERY LOW
No of participants: TNFi + MTX: 91/801 (11.4%)
MTX monotherapy: 45/357 (12.6%)
Effect: Relative Effect (95% CI): RR 1.00 (0.71 to 1.43)
Absolute Effect (95% CI): 0 fewer per 1,000 (from 37 fewer to 54 more)
Abbreviations: CI: Confidence interval; RR: Risk ratio; MD: Mean difference; HR: Hazard Ratio
Guideline: 2021 ACR RA
Clinical question:  Should patients with MTX-naïve and non-MTX csDMARDs naïve RA and moderate to high disease activity receive MTX monotherapy or boDMARD with MTX or tsDMARD with MTX?
Population: Patients with MTX-naïve and non-MTX csDMARDs naïve RA and moderate to high disease activity
Intervention: MTX monotherapy
Comparator: TNF Inhibitor + MTX
Outcome: Death (follow up: range 6 months to 12 months)
Importance: IMPORTANT

Evidence assessment:
GRADE: Risk of bias: result: SERIOUS
rationales: Downgraded by one level due to serious risk of bias. Lack of allocation concealment and incomplete outcome data in one study.
Inconsistency: result: NOT_SERIOUS
Indirectness: result: NOT_SERIOUS
Imprecision: result: SERIOUS
rationales: Downgraded by one level due to serious imprecision. Low number of events.
Other considerations: result: none
Study design: Randomized Controlled Trial
Certainty: LOW
No of participants: TNFi + MTX: 2/746 (0.3%)
MTX monotherapy: 1/302 (0.3%)
Effect: Relative Effect (95% CI): RR 0.66 (0.06 to 7.23)
Absolute Effect (95% CI): 1 fewer per 1,000 (from 3 fewer to 21 more)
Abbreviations: CI: Confidence interval; RR: Risk ratio; MD: Mean difference; HR: Hazard Ratio