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
Suggested Outcomes
Type | Domain | Specific measurement (i.e., tool/definition/specific outcome) |
---|---|---|
Categorical | Acute rejection | |
Categorical | AE due to treatment | (specify) |
Categorical | Delayed graft function | |
Categorical | Dialysis, incident | |
Categorical | Discontinuation due to AE | |
Categorical | Drug-drug interaction, clinical | |
Categorical | Graft loss | (prioritize 1 year) |
Categorical | Liver damage/failure | (specify) |
Categorical | Patient death | (prioritize 1 year) |
Categorical | Proteinuria, incident | |
Categorical | Resolution of GN | (specify if needed) |
Categorical | SVR12 | |
Continuous | eGFR | (specify units) (specify if CrCl) |
Continuous | Proteinuria | (specify units) |
Continuous | QoL/Functional status | (specify) |
Continuous | SCr | (specify units) |
Please see downloadable data for more