somewordstoolate/Q2CRBench-3 huggingface dataset:
Guideline: 2021 ACR RA
Clinical question:  Should patients with RA who have not been previously treated with boDMARD and tsDAMRD receive T2T strategies or usual care?
Population: Patients with RA who have not been previously treated with boDMARD and tsDAMRD
Intervention: T2T strategy
Comparator: usual care
Outcome: Death (follow up: mean 1.5 years)
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 lack of blinding.
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. Low number of events.
Other considerations: result: none
Study design: Randomized Controlled Trial
Certainty: VERY LOW
No of participants: T2T: 1/55 (1.8%)
Usual care: 3/55 (5.5%)
Effect: Relative Effect (95% CI): RR 0.33 (0.04 to 3.11)
Absolute Effect (95% CI): 37 fewer per 1,000 (from 52 fewer to 115 more)
Abbreviations: CI: Confidence interval; RR: Risk ratio; MD: Mean difference; HR: Hazard Ratio
Guideline: 2021 ACR RA
Clinical question: In patients with RA receiving T2T, should the treatment goal be low disease activity or remission?
Population: Patients with RA
Intervention: Treat to low disease activity
Comparator: treat to remission
Outcome: DAS remission (follow up: 1 year; assessed with DAS44 ≤ 1.6)
Importance: CRITICAL

Evidence assessment:
GRADE: Risk of bias: result: NOT_SERIOUS
rationales: Unclear risk of bias related to missing data as rate of those data not reported
In the remission goal group (DAS <1.6), baseline DAS was lower than in the low disease activity goal group (DAS ≤2.4) targeted group; symptom duration was shorter and baseline radiological damage was less often present. The investigators adjusted for these differences in their analyses, but this could have still favored the remission goal group
Inconsistency: result: NOT_SERIOUS
Indirectness: result: NOT_SERIOUS
Imprecision: result: NOT_SERIOUS
Other considerations: result: none
Study design: Observational Study
Certainty: LOW
No of participants: a treatment goal of low disease activity: 40/133 (30.1%)
a treatment goal of remission: 89/175 (50.9%)
Effect: Relative Effect (95% CI): RR 0.59 (0.44 to 0.80)
Absolute Effect (95% CI): 209 fewer per 1,000 (from 285 fewer to 102 fewer)
Abbreviations: CI: Confidence interval; RR: Risk ratio; MD: Mean difference; HR: Hazard Ratio
Guideline: 2021 ACR RA
Clinical question: In patients with RA receiving T2T, should the treatment goal be low disease activity or remission?
Population: Patients with RA
Intervention: Treat to low disease activity
Comparator: treat to remission
Outcome: Disease activity (follow up: 1 year; assessed with DAS-44 (Lower values – > benefit) (MCID -1.2)
Importance: CRITICAL

Evidence assessment:
GRADE: Risk of bias: result: NOT_SERIOUS
rationales: Unclear risk of bias related to missing data as rate of those data not reported
Inconsistency: result: NOT_SERIOUS
Indirectness: result: NOT_SERIOUS
Imprecision: result: NOT_SERIOUS
Other considerations: result: none
Study design: Observational Study
Certainty: LOW
No of participants: a treatment goal of low disease activity: 133
a treatment goal of remission: 175
Effect: Relative Effect (95% CI): -
Absolute Effect (95% CI): MD 0.1 lower (0.35 lower to 0.15 higher)
Abbreviations: CI: Confidence interval; RR: Risk ratio; MD: Mean difference; HR: Hazard Ratio
Guideline: 2021 ACR RA
Clinical question: Should patients with RA not tolerating MTX, on folic acid 1 mg/day, increase the dose of folic acid?
Population: Patients with RA not tolerating MTX on 1mg of folic acid
Intervention: Increase dose of folic acid to > 1mg per day
Comparator: Remain on folic acid 1 mg per day
Outcome: Disease activity (follow up: 6 months; assessed with: DAS28-ESR (Lower values – > benefit) (MCID -1.17)
Importance: CRITICAL

Evidence assessment:
GRADE: Risk of bias: result: NOT_SERIOUS
rationales: Concern about risk of bias associated with handling of incomplete outcome data.
Inconsistency: result: NOT_SERIOUS
Indirectness: result: SERIOUS
rationales: Downgraded by one level due to serious indirectness. The evidence is based on a population who are starting MTX treatment (MTX-naive and not on folic acid) with different folic acid doses (10 mg/week vs 30 mg/week).
Imprecision: result: SERIOUS
rationales: Downgraded by one level due to serious imprecision. Small sample size.
Other considerations: result: none
Study design: Randomized Controlled Trial
Certainty: LOW
No of participants: Remain on folic acid 1 mg per day: 51
Increase dose of folic acid to > 1mg per day: 49
Effect: Relative Effect (95% CI): -
Absolute Effect (95% CI): MD 0.28 higher (0.1 higher to 0.46 higher)
Abbreviations: CI: Confidence interval; RR: Risk ratio; MD: Mean difference; HR: Hazard Ratio
Guideline: 2021 ACR RA
Clinical question: Should patients with RA not tolerating MTX, on folic acid 1 mg/day, increase the dose of folic acid?
Population: Patients with RA not tolerating MTX on 1mg of folic acid
Intervention: Increase dose of folic acid to > 1mg per day
Comparator: Remain on folic acid 1 mg per day
Outcome: Disability (follow up: range 6 months to 12 months; assessed with: HAQ-DI or modified HAQ (Lower values – > benefit) (values>0.2 are considered clinically significant)
Importance: IMPORTANT

Evidence assessment:
GRADE: Risk of bias: result: NOT_SERIOUS
rationales: Concern about risk of bias associated with handling of incomplete outcome data.
Inconsistency: result: SERIOUS
rationales: Downgraded by one level due to serious inconsistency. I2=79%.
Indirectness: result: SERIOUS
rationales: Downgraded by one level due to serious indirectness. The evidence is based on a population who are starting MTX treatment (MTX-naive and not on folic acid) with different folic acid doses (5-10 mg/week vs 27.5-30 mg/week).
Imprecision: result: SERIOUS
rationales: 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.
Downgraded by one level due to serious imprecision. Confidence interval includes both values suggesting no effect and values suggesting harm.
Other considerations: result: none
Study design: Randomized Controlled Trial
Certainty: VERY LOW
No of participants: Remain on folic acid 1 mg per day: 76
Increase dose of folic acid to > 1mg per day: 75
Effect: Relative Effect (95% CI): -
Absolute Effect (95% CI): SMD 0.49 SD higher (0.16 higher to 0.82 higher)
Abbreviations: CI: Confidence interval; RR: Risk ratio; MD: Mean difference; HR: Hazard Ratio
Guideline: 2021 ACR RA
Clinical question: Should patients with RA not tolerating MTX, on folic acid 1 mg/day, increase the dose of folic acid?
Population: Patients with RA not tolerating MTX on 1mg of folic acid
Intervention: Increase dose of folic acid to > 1mg per day
Comparator: Remain on folic acid 1 mg per day
Outcome: Withdrawal due to 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 handling of incomplete outcome data.
Inconsistency: result: NOT_SERIOUS
Indirectness: result: SERIOUS
rationales: Downgraded by one level due to serious indirectness. The evidence is based on a population who are starting MTX treatment (MTX-naive and not on folic acid) with different folic acid doses (5-10 mg/week vs 27.5-30 mg/week).
Imprecision: result: VERY_SERIOUS
rationales: Downgraded by two levels due to very serious imprecision. Confidence interval includes both values suggesting no effect and values suggesting harm. Very low number of events.
Other considerations: result: none
Study design: Randomized Controlled Trial
Certainty: VERY LOW
No of participants: Remain on folic acid 1 mg per day: 3/76 (3.9%)
Increase dose of folic acid to > 1mg per day: 2/75 (2.7%)
Effect: Relative Effect (95% CI): RR 1.42 (0.29 to 6.92)
Absolute Effect (95% CI): 11 more per 1,000 (from 19 fewer to 158 more)
Abbreviations: CI: Confidence interval; RR: Risk ratio; MD: Mean difference; HR: Hazard Ratio
Guideline: 2021 ACR RA
Clinical question: Should patients with RA on oral MTX monotherapy 15 mg per week who are NOT at target increase the dose of oral MTX or switch to SC MTX?
Population: Patients with RA on oral MTX monotherapy 15 mg per week who are not at target
Intervention: Increase the dose of oral MTX
Comparator: Switch to SC MTX
Outcome: Disease activity (follow up: 6 months; assessed with: ACR 20)
Importance: CRITICAL

Evidence assessment:
GRADE: Risk of bias: result: VERY_SERIOUS
rationales: Downgraded by two levels due to very serious risk of bias. Lack of blinding and lack of allocation concealment.
Inconsistency: result: NOT_SERIOUS
Indirectness: result: NOT_SERIOUS
Imprecision: result: SERIOUS
rationales: Downgraded by one level due to serious imprecision. Very small sample size.
Other considerations: result: none
Study design: Randomized Controlled Trial
Certainty: VERY LOW
No of participants: Switch to SC MTX: 43/46 (93.5%)
Increase dose of oral MTX: 36/46 (78.3%)
Effect: Relative Effect (95% CI): RR 1.19 (1.01 to 1.42)
Absolute Effect (95% CI): 149 more per 1,000 (from 8 more to 329 more)
Abbreviations: CI: Confidence interval; RR: Risk ratio; MD: Mean difference; HR: Hazard Ratio
Guideline: 2021 ACR RA
Clinical question: Should patients with RA on oral MTX monotherapy 15 mg per week who are NOT at target increase the dose of oral MTX or switch to SC MTX?
Population: Patients with RA on oral MTX monotherapy 15 mg per week who are not at target
Intervention: Increase the dose of oral MTX
Comparator: Switch to SC MTX
Outcome: Disease activity (follow up: 6 months; assessed with: ACR 50)
Importance: CRITICAL

Evidence assessment:
GRADE: Risk of bias: result: VERY_SERIOUS
rationales: Downgraded by two levels due to very serious risk of bias. Lack of blinding and lack of allocation concealment.
Inconsistency: result: NOT_SERIOUS
Indirectness: result: NOT_SERIOUS
Imprecision: result: SERIOUS
rationales: Downgraded by one level due to serious imprecision. Very small sample size.
Other considerations: result: none
Study design: Randomized Controlled Trial
Certainty: VERY LOW
No of participants: Switch to SC MTX: 41/46 (89.1%)
Increase dose of oral MTX: 33/46 (71.7%)
Effect: Relative Effect (95% CI): RR 1.24 (1.01 to 1.53)
Absolute Effect (95% CI): 172 more per 1,000 (from 7 more to 380 more)
Abbreviations: CI: Confidence interval; RR: Risk ratio; MD: Mean difference; HR: Hazard Ratio
Guideline: 2021 ACR RA
Clinical question: Should patients with RA on oral MTX monotherapy 15 mg per week who are NOT at target increase the dose of oral MTX or switch to SC MTX?
Population: Patients with RA on oral MTX monotherapy 15 mg per week who are not at target
Intervention: Increase the dose of oral MTX
Comparator: Switch to SC MTX
Outcome: Disease activity (follow up: 6 months; assessed with: ACR 70)
Importance: CRITICAL

Evidence assessment:
GRADE: Risk of bias: result: VERY_SERIOUS
rationales: Downgraded by two levels due to very serious risk of bias. Lack of blinding and lack of allocation concealment.
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. Very small sample size.
Other considerations: result: none
Study design: Randomized Controlled Trial
Certainty: VERY LOW
No of participants: Switch to SC MTX: 5/46 (10.9%)
Increase dose of oral MTX: 4/46 (8.7%)
Effect: Relative Effect (95% CI): RR 1.25 (0.36 to 4.36)
Absolute Effect (95% CI): 22 more per 1,000 (from 56 fewer to 292 more)
Abbreviations: CI: Confidence interval; RR: Risk ratio; MD: Mean difference; HR: Hazard Ratio
Guideline: 2021 ACR RA
Clinical question: Should patients with RA on oral MTX monotherapy 15 mg per week who are NOT at target increase the dose of oral MTX or switch to SC MTX?
Population: Patients with RA on oral MTX monotherapy 15 mg per week who are not at target
Intervention: Increase the dose of oral MTX
Comparator: Switch to SC MTX
Outcome: Disability (follow up: 6 months; assessed with: HAQ)
Importance: IMPORTANT

Evidence assessment:
GRADE: Risk of bias: result: VERY_SERIOUS
rationales: Downgraded by two levels due to very serious risk of bias. Lack of blinding and lack of allocation concealment.
Inconsistency: result: NOT_SERIOUS
Indirectness: result: NOT_SERIOUS
Imprecision: result: SERIOUS
rationales: Downgraded by one level due to serious imprecision. Very small sample size.
Other considerations: result: none
Study design: Randomized Controlled Trial
Certainty: VERY LOW
No of participants: Switch to SC MTX: 46
Increase dose of oral MTX: 46
Effect: Relative Effect (95% CI): -
Absolute Effect (95% CI): MD 2.3 lower (4.06 lower to 0.54 lower)
Abbreviations: CI: Confidence interval; RR: Risk ratio; MD: Mean difference; HR: Hazard Ratio
Guideline: 2021 ACR RA
Clinical question: Should patients with RA on oral MTX monotherapy 15 mg per week who are NOT at target increase the dose of oral MTX or switch to SC MTX?
Population: Patients with RA on oral MTX monotherapy 15 mg per week who are not at target
Intervention: Increase the dose of oral MTX
Comparator: Switch to SC MTX
Outcome: Pain (follow up: 6 months; assessed with: VAS 0-10)
Importance: IMPORTANT

Evidence assessment:
GRADE: Risk of bias: result: VERY_SERIOUS
rationales: Downgraded by two levels due to very serious risk of bias. Lack of blinding and lack of allocation concealment.
Inconsistency: result: NOT_SERIOUS
Indirectness: result: NOT_SERIOUS
Imprecision: result: SERIOUS
rationales: Downgraded by one level due to serious imprecision. Very small sample size.
Other considerations: result: none
Study design: Randomized Controlled Trial
Certainty: VERY LOW
No of participants: Switch to SC MTX: 46
Increase dose of oral MTX: 46
Effect: Relative Effect (95% CI): -
Absolute Effect (95% CI): MD 1.43 lower (2.05 lower to 0.81 lower)
Abbreviations: CI: Confidence interval; RR: Risk ratio; MD: Mean difference; HR: Hazard Ratio
Guideline: 2021 ACR RA
Clinical question: this is a question?
Population: Patients with RA on maximally tolerated dose of MTX monotherapy (either oral or SC) who are not at target
Intervention: Add SSZ and HCQ
Comparator: add TNF Inhibitor
Outcome: Disease activity (follow up: 6 months; assessed with: ACR20)
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.
Inconsistency: result: NOT_SERIOUS
Indirectness: result: NOT_SERIOUS
Imprecision: result: VERY_SERIOUS
rationales: Downgraded by two levels due to very serious imprecision. Confidence intervals includes both values suggesting benefit and values suggesting harm. Concern about risk of bias associated with lack of allocation concealment taken into account when rating down for imprecision.
Other considerations: result: none
Study design: Randomized Controlled Trial
Certainty: VERY LOW
No of participants: Add SSZ+HCQ: 89/159 (56.0%)
Add TNFi: 90/163 (55.2%)
Effect: Relative Effect (95% CI): RR 1.01 (0.83 to 1.23)
Absolute Effect (95% CI): 6 more per 1,000 (from 94 fewer to 127 more)
Abbreviations: CI: Confidence interval; RR: Risk ratio; MD: Mean difference; HR: Hazard Ratio
Guideline: 2021 ACR RA
Clinical question: this is a question?
Population: Patients with RA on maximally tolerated dose of MTX monotherapy (either oral or SC) who are not at target
Intervention: Add SSZ and HCQ
Comparator: add TNF Inhibitor
Outcome: Disease activity (follow up: 6 months; assessed with: ACR50)
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.
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 harm and values suggesting no effect.
Other considerations: result: none
Study design: Randomized Controlled Trial
Certainty: LOW
No of participants: Add SSZ+HCQ: 41/159 (25.8%)
Add TNFi: 58/163 (35.6%)
Effect: Relative Effect (95% CI): RR 0.72 (0.52 to 1.01)
Absolute Effect (95% CI): 100 fewer per 1,000 (from 171 fewer to 4 more)
Abbreviations: CI: Confidence interval; RR: Risk ratio; MD: Mean difference; HR: Hazard Ratio
Guideline: 2021 ACR RA
Clinical question: this is a question?
Population: Patients with RA on maximally tolerated dose of MTX monotherapy (either oral or SC) who are not at target
Intervention: Add SSZ and HCQ
Comparator: add TNF Inhibitor
Outcome: Disease activity (follow up: 6 months; assessed with: ACR70)
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.
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: Add SSZ+HCQ: 8/159 (5.0%)
Add TNFi: 26/163 (16.0%)
Effect: Relative Effect (95% CI): RR 0.32 (0.15 to 0.68)
Absolute Effect (95% CI): 108 fewer per 1,000 (from 136 fewer to 51 fewer)
Abbreviations: CI: Confidence interval; RR: Risk ratio; MD: Mean difference; HR: Hazard Ratio
Guideline: 2021 ACR RA
Clinical question: this is a question?
Population: Patients with RA on maximally tolerated dose of MTX monotherapy (either oral or SC) who are not at target
Intervention: Add SSZ and HCQ
Comparator: add TNF Inhibitor
Outcome: Disease activity (follow up: 6 months; assessed with: DAS28-ESR (Lower values – > benefit) (MCID -1.17)
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.
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: Add SSZ+HCQ: 157
Add TNFi: 161
Effect: Relative Effect (95% CI): -
Absolute Effect (95% CI): MD 0.27 higher (0.01 lower to 0.55 higher)
Abbreviations: CI: Confidence interval; RR: Risk ratio; MD: Mean difference; HR: Hazard Ratio
Guideline: 2021 ACR RA
Clinical question: this is a question?
Population: Patients with RA on maximally tolerated dose of MTX monotherapy (either oral or SC) who are not at target
Intervention: Add SSZ and HCQ
Comparator: add TNF Inhibitor
Outcome: Remission (follow up: 6 months; assessed with: DAS28-CRP < 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.
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 harm and values suggesting no effect.
Other considerations: result: none
Study design: Randomized Controlled Trial
Certainty: LOW
No of participants: Add SSZ+HCQ: 20/157 (12.7%)
Add TNFi: 35/161 (21.7%)
Effect: Relative Effect (95% CI): RR 0.59 (0.35 to 0.97)
Absolute Effect (95% CI): 89 fewer per 1,000 (from 141 fewer to 7 fewer)
Abbreviations: CI: Confidence interval; RR: Risk ratio; MD: Mean difference; HR: Hazard Ratio
Guideline: 2021 ACR RA
Clinical question: this is a question?
Population: Patients with RA on maximally tolerated dose of MTX monotherapy (either oral or SC) who are not at target
Intervention: Add SSZ and HCQ
Comparator: add TNF Inhibitor
Outcome: Radiographic progression (follow up: 6 months; 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: Add SSZ+HCQ: 158
Add TNFi: 160
Effect: Relative Effect (95% CI): -
Absolute Effect (95% CI): MD 0.42 higher (0.22 lower to 1.05 higher)
Abbreviations: CI: Confidence interval; RR: Risk ratio; MD: Mean difference; HR: Hazard Ratio
Guideline: 2021 ACR RA
Clinical question: this is a question?
Population: Patients with RA on maximally tolerated dose of MTX monotherapy (either oral or SC) who are not at target
Intervention: Add SSZ and HCQ
Comparator: add TNF Inhibitor
Outcome: Disability (follow up: 6 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.
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 harm and values suggesting no effect.
Other considerations: result: none
Study design: Randomized Controlled Trial
Certainty: LOW
No of participants: Add SSZ+HCQ: 155
Add TNFi: 160
Effect: Relative Effect (95% CI): -
Absolute Effect (95% CI): MD 0.07 higher (0.11 lower to 0.25 higher)
Abbreviations: CI: Confidence interval; RR: Risk ratio; MD: Mean difference; HR: Hazard Ratio
Guideline: 2021 ACR RA
Clinical question: this is a question?
Population: Patients with RA on maximally tolerated dose of MTX monotherapy (either oral or SC) who are not at target
Intervention: Add SSZ and HCQ
Comparator: add TNF Inhibitor
Outcome: Malignancy (from SRs of harms)

Evidence assessment:
GRADE: result_interpretation: The Systematic Review RefID=4638, 2012 (RCTs=9, n=3712) comparing csDMARD + placebo vs infliximab + MTX among RA showed that for cancer, the result was RR=0.83 (0.22-3.13) at 2 years and RR=0.56(0.22-1.47) at all time points (6 months, 1 year and 2 years combined)
Study design: Systematic Review
Guideline: 2021 ACR RA
Clinical question: Should patients with MTX-naïve and non-MTX csDMARDs naïve RA and low disease activity receive MTX monotherapy or an alternative csDMARD monotherapy?
Population: Patients with MTX-naïve and non-MTX csDMARDs naïve RA and low disease activity
Intervention: MTX monotherapy
Comparator: SSZ
Outcome: Disease activity (follow up: 1 year; assessed with: DAS28-ESR (Lower values – > benefit) (MCID -1.17)
Importance: CRITICAL

Evidence assessment:
GRADE: Risk of bias: result: SERIOUS
rationales: Downgraded by one level due to serious risk of bias. Lack of allocation and lack of blinding of outcome assessors of non-radiographic outcomes in the study with the higher weight,
Inconsistency: result: NOT_SERIOUS
rationales: I2= 41%
Indirectness: result: SERIOUS
rationales: Downgraded by one level due to serious indirectness. The evidence is based on a population with moderate to high disease activity. 
Imprecision: result: SERIOUS
rationales: Downgraded by one level due to serious imprecision. Small sample size. 
Other considerations: result: none
Study design: Randomized Controlled Trial
Certainty: LOW
No of participants: MTX monotherapy: 104
SSZ: 102
Effect: Relative Effect (95% CI): -
Absolute Effect (95% CI): MD 0.14 higher (0.18 lower to 0.47 higher)
Abbreviations: CI: Confidence interval; RR: Risk ratio; MD: Mean difference; HR: Hazard Ratio