Extraction form for project: Treatment of Hepatitis C in Chronic Kidney Disease. KDIGO 2022 update

Design Details

1. Reject Reason
Skip if not rejecting. Don't fill out rest if you are rejecting
Confirmed by CG
2. Secondary to other article?
List PMID(s) or other identifier for related article
3. Study or registry name
Skip if no identifying name available.
4. CKD stage
5. Treatment(s) investigated
6. KQ/Topic
7. KQ/Topic
8. Study design
9. Study design
10. Sample size
Answer in one row only (but ok to leave data in both rows 1 and 2). Row 1 refers to N who meet all CKD criteria. Row 2 refers to total N when data for row 1 unclear (ie, in abstract). Similarly, row 3 is applicable only to abstract mapping phase. Across all arms. Ensure that each counted arm has N>=10.
N eligible (Specific Population)
N total (Broad population)
11. Country/ies
Check citation title
12. Note/Comment



Arm Details

1. Regimen
For each drug: Drug name dose frequency. Split up specific drugs, even if they are given in a combination pill. Include duration only if the specific drug is used for a different duration than the whole regimen. (If duration varied by gt, note in next question.) Std abbreviations: qD, BID, TID, QID, qOD, qW, BIW; gt = genotype (put in parentheses if drug used only a specific gt). Eg: Ombitasvir 25 mg qD Paritaprevir 150 mg qD Dasabuvir 250 mg BID (gt 1) Ritonavir 100 mg qD (gt 1a, 4, cirrhosis)
2. Duration of treatment
If mean or median (with SD, IQR, etc.), specify explicitly. If duration (of whole regimen) varies by genotype or other factor, note it in parentheses. (If duration of one drug is different, note that in the prior question for that drug. Put the full duration of the regimen here.) Abbreviations: d, wk, mo (but try to convert to weeks). Eg, 12 wk 12 wk (gt 1b) 24 wk (gt 1a, 4, cirrhosis)
3. (GL 4) Time to start of DAA (relative to Txp)
4. Comment/Note

Sample Characteristics

1. Population characteristics
Enter as per template in row headers
2. Population
Should sum to 100% for each arm. We will treat groups >=90% as if they were 100%, but do note the <10% groups.
3. Note/Comment


TypeDomainSpecific measurement (i.e., tool/definition/specific outcome)PopulationsTimepoints
CategoricalGraft loss(prioritize 1 year)
  • All Participants
  • 1 (year)

Outcome Details

1. Comment/Note
Graft loss

Risk of Bias Assessment

1. RCT only_Random sequence generation
Notes/Comments (add for high/unclear):
2. RCT only_Allocation concealment
Notes/Comments (add for high/unclear):
3. RCT only_Blinding of participants
4. ALL_Blinding of outcome assessors
There is low risk of detection bias if the blinding of the outcome assessment was ensured and it was unlikely that the blinding could have been broken; or if there was no blinding or incomplete blinding, but the review authors judge that the outcome is not likely to be influenced by lack of blinding. WE SHOULD DISCUSS WHICH OUTCOMES (MAYBE ALL) THIS IS RELEVANT FOR.
5. ALL_Incomplete outcome data (dropouts, missing data)
20% threshold (or imbalance between groups)
Notes/Comments (add for high/unclear):
6. ALL_Selective Reporting (reporting bias)
There is LOW risk of reporting bias ONLY if the study protocol is available and all of the study’s pre-specified (primary and secondary) outcomes that are of interest in the review have been reported in the pre-specified way. There is a HIGH risk of reporting bias if not all of the study’s pre-specified primary outcomes have been reported (pre-specified either in protocol or in methods section). Also HIGH risk of bias if one or more outcomes of interest in the review are reported incompletely so that they cannot be entered in a meta-analysis. Usually UNCLEAR risk of bias.
7. ALL_Intention-to-treat-analysis
If self-describe ITT, confirm actually is ITT. If 100% reporting, then equivalent to ITT. Provide info about meaning of ITT or reason not ITT
Notes/Comments (add for high/unclear):
8. ALL_Was selection of participants into the study based on participant characteristics observed AFTER the start of intervention?
If yes, consider whether should reject. Try your best to select Y or N
Notes/Comments (add for Yes or Probably Yes):
9. COMPARATIVE only_Cohorts comparable?
E.g., based off of "Table 1". No statistically significant (or large) differences of a clinically important factor.
Notes/Comments (add for No):
10. COMPARATIVE only_Were potential confounders properly accounted for?
Comparative studies only (where we evaluate the analysis of the comparison)
Notes/Comments (add for unclear):
11. ALL_Clear reporting with no discrepancies
Notes/Comments (add for no):
12. ALL_Were eligibility criteria clear?
Notes/Comments (add for no):
13. ALL_Were interventions adequately described?
Notes/Comments (add for no):
14. ALL_Were the outcomes adequately defined?
Notes/Comments (add for no):
15. ALL_Were the harms PRE-DEFINED using standardized or precise definitions
Notes/Comments (add for no):
16. Other Bias:



Graft loss ((prioritize 1 year))