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
Reason
Single Choice
Not CKD (at all)
Not CKD stage or disease of interest
Not HCV-related
N<10 per extractable arm (all arms)
Not primary study or SR
Included in 2018 CPG (ignore 2020 letter update)
Duplicate article
No unique data (vis a vis included publication)
Other
Not intervention of interest
No outcome of interest
Conference abstract (pre-2019)
Multi-organ transplant
Viral co-infection
Too short duration follow-up
Publication pre-2016
SR (references checked)
Could not parse results by population or regimen with each group n≥10 (GL 2)
Confirmed by CG
Multiple Choice
Yes
Question/Comment
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
Multiple Choice
CKD 4-5 (GFR <30)
CKD 5 dialysis
CKD T (transplant, any stage)
CKD, other (unclear stage or include more than CKD 4,5,T). Explain in f/up Q.
Cryoglobulinemia, unknown/unclear GN
Cryoglobulinemia with GN
Other or unclear (explain)
5. Treatment(s) investigated
Multiple Choice
DAA(s)
Interferon
Ribavirin
Immunosuppression (for cryoglobulinemia)
Other (for cryoglobulinemia, not IS or HCV-treatment)
Other
6. KQ/Topic
Multiple Choice
GL 2: DAA G4-G5D/T
GL 2: Other? (including non-DAA)
GL 4: DAA for D+/R- KTxp
GL 4: Other?
GL 5: HCV treatment (DAA or IFN/Riba)
GL 5: Immunosuppression
GL 5: Other?
7. KQ/Topic
Multiple Choice
GL 2: DAA G4-5 (non-dialysis)
GL 2: DAA G4-G5 HD
GL 2: DAA G4-G5 PD
GL 2: DAA Txp
GL 4: DAA D+/R- KTxp
GL 5: DAA HCV-GN
GL 5: IS HCV-GN
Other/Comment
8. Study design
Design
Single Choice
RCT
NRCS (comparison of treatment)
Single group (single treatment)
Unclear (one cohort, multiple treatments, unclear if comparison made)
Case-control
Systematic review
Other/unclear
Direction
Single Choice
Prospective
Retrospective
Prospective and retrospective
Unclear
Protocol
Single Choice
Protocol (only)
9. Study design
Design
Single Choice
RCT
NRCS (planned comparisons of interventions [N≥10 per group])
NRCS (unplanned comparison of interventions [N≥10 per group]; designed as "cohort")
Single group (planned single treatment [N≥10])
Single group (originally RCT or NRCS, but only single group of interest)
Case-control
Other
Direction
Multiple Choice
Prospective
Retrospective
Unclear
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)
NR
Single Choice
NR
11. Country/ies
Check citation title
Multiple Choice
US
Canada
Europe, multiple countries
France
Germany
Italy
Spain
UK
Egypt
India
Pakistan
China
Japan
S Korea
Australia/New Zealand
Other(s)
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

Outcome Details

1. Comment/Note
Patient death:

Risk of Bias Assessment

1. RCT only_Random sequence generation
Rating
Single Choice
Low
Unclear
High
Not applicable (not RCT)
Notes/Comments (add for high/unclear):
2. RCT only_Allocation concealment
Rating
Single Choice
Low
Unclear
High
Not applicable (not RCT)
Notes/Comments (add for high/unclear):
3. RCT only_Blinding of participants
Rating
Single Choice
Low
Unclear
High
Not applicable (not RCT)
Notes/Comments:
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.
Rating
Single Choice
Low
Unclear
High
Notes/Comments:
5. ALL_Incomplete outcome data (dropouts, missing data)
20% threshold (or imbalance between groups)
Rating
Single Choice
Low
Unclear
High
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.
Rating
Single Choice
Low
Unclear
High
Notes/Comments:
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
Rating
Single Choice
Low
Unclear
High
Not applicable (single group)
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
Rating
Single Choice
Y
PY
PN
N
No information
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.
Rating
Single Choice
Yes (comparable)
No (not comparable)
No information (cannot assess)
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)
Rating
Single Choice
Yes (adjusted)
No (crude)
Unclear
Notes/Comments (add for unclear):
11. ALL_Clear reporting with no discrepancies
Rating
Single Choice
Yes
No
Notes/Comments (add for no):
12. ALL_Were eligibility criteria clear?
Rating
Single Choice
Yes
No
Notes/Comments (add for no):
13. ALL_Were interventions adequately described?
Rating
Single Choice
Yes
No
Notes/Comments (add for no):
14. ALL_Were the outcomes adequately defined?
Rating
Single Choice
Yes
No
Notes/Comments (add for no):
15. ALL_Were the harms PRE-DEFINED using standardized or precise definitions
Rating
Single Choice
Yes
No
N/A: No harms data
Notes/Comments (add for no):
16. Other Bias:
Rating
Single Choice
Low
High
Notes/Comments:

Suggested Arms

NameDescription
Total All Arms combined

Please see downloadable data for more

Suggested Outcomes

TypeDomainSpecific measurement (i.e., tool/definition/specific outcome)
CategoricalAcute rejection
CategoricalAE due to treatment(specify)
CategoricalDelayed graft function
CategoricalDialysis, incident
CategoricalDiscontinuation due to AE
CategoricalDrug-drug interaction, clinical
CategoricalGraft loss(prioritize 1 year)
CategoricalLiver damage/failure(specify)
CategoricalPatient death(prioritize 1 year)
CategoricalProteinuria, incident
CategoricalResolution of GN(specify if needed)
CategoricalSVR12
ContinuouseGFR(specify units) (specify if CrCl)
ContinuousProteinuria(specify units)
ContinuousQoL/Functional status(specify)
ContinuousSCr(specify units)

Please see downloadable data for more