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Fleeman N, Saborido CM, Payne K, et al. The Clinical Effectiveness and Cost-Effectiveness of Genotyping for CYP2D6 for the Management of Women with Breast Cancer Treated with Tamoxifen: A Systematic Review. Southampton (UK): NIHR Journals Library; 2011 Sep. (Health Technology Assessment, No. 15.33.)
The Clinical Effectiveness and Cost-Effectiveness of Genotyping for CYP2D6 for the Management of Women with Breast Cancer Treated with Tamoxifen: A Systematic Review.
Show detailsTo assesses quality, the following questions were posed, based on elements of checklists developed to assess the methodological quality of prognostic factor studies50 and pharmacogenetic studies,51 with the corresponding responses presented in the table:
Patient sample (sample)
- Is the source population clearly defined?
- Is the study population clearly defined?
- Does the study population clearly represent the source population or population of interest?
- Are details given of how the sample size was calculated?
Choosing the genes/single nucleotide polymorphisms to genotype (see ‘SNP’, table below)
- 5.
Are reasons given for choosing the genes and SNPs genotyped?
Reliability of genotypes (see ‘Test’, table below)
- 6.
Is the genotyping procedure described?
- 7.
Are the primers described?
- 8.
Were quality control methods used and described?
- 9.
Were findings from quality control methods, if used, described?
- 10.
Are any genotype frequencies previously reported quoted?
Missing genotype data (see ‘Data’, table below)
- 11.
Is it evident that there are any missing data?
- 12.
Where missing data are evident, are reasons given?
- 13.
Are checks for missingness at random reported?
- 14.
Is missing genotype data imputed?
- 15.
Does paper quote number of patients contributing to each analysis?
Confounding measurement and account (see ‘Confound’, table below)
- 16.
Are potential confounders described?
- 17.
Are potential confounders adjusted for?
Hardy–Weinberg Equilibrium (see ‘HWE’, table below)
- 18.
Was a test presented to check for HWE?
Choice and definition of outcomes (see ‘Outcomes’, table below)
- 19.
Does the paper clearly define the phenotypes?
- 20.
Does the paper clearly define all outcomes investigated?
- 21.
Is justification provided for the choice of phenotypes?
- 22.
Is justification provided for the choice of outcomes?
- 23.
Were the outcomes assessed blindly (i.e. did the assessor know the genotype/phenotype in relation to this?)
| Bonanni 2009112 | Henry 200987 | de Duenas 2009113 | Gjerde 2007104 | Goetz 200783 | Goetz 200982 on behalf of ITPC | Gonzalez-Santiago 200786 | Kiyotani 2010114 (efficacy) | Kiyotani 2010114 (metabolism) | Lim 200773 | Madlensky 200890 | Newman 200891 | Nowell 200592 | Okishiro 200993 | Onitilo 200994 | Ramon 201041 | Schroth 200796 | Schroth 2009108 | Stearns 200349 | Thompson 2009109 | Toyama 200997 | Wang 200798 | Wegman 2005100 | Wegman 200799 | Xu 2008101 | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sample | 1 | ✓ | ✓ | ✗ | ✓ | ✓ | ✓ | ✗ | ✓ | ✓ | ✓ | ✗ | ✓ | ✓ | / | ✓ | ✗ | ✓ | ✓ | ✗ | ✓ | ✓ | ✗ | ✓ | ✓ | ✓ |
| 2 | ✓ | ✓ | ✗ | ✓ | ✓ | ✓ | ✗ | ✓ | ✓ | ✓ | ✗ | ✓ | ✓ | / | / | / | ✓ | ✓ | ✗ | ✓ | ✓ | ✗ | ✓ | ✓ | ✓ | |
| 3 | ✓ | ✓ | ✗ | ✓ | ✓ | / | ? | ✓ | ? | ✓ | ? | ✓ | ✓ | ? | ✓ | / | ✓ | ✓ | ? | ? | ✓ | ? | ? | ✓ | ✓ | |
| 4 | ✓ | / | ✗ | ✗ | / | – | ✗ | ✗ | ✗ | ✗ | ✗ | ✗ | ✗ | ✗ | ✗ | ✗ | ✗ | ✓ | ✗ | ✗ | ✗ | ✗ | ✗ | ✗ | ✗ | |
| SNP | 5 | ✗ | ✓ | ✓ | / | ✓ | / | / | ✓ | / | ✓ | / | / | / | ✓ | / | ✓ | ✓ | / | ✗ | / | ✓ | / | ✓ | ✓ | ✓ |
| Test | 6 | ✓ | ✓ | ✓ | ✓ | ✓ | ✗ | ✗ | ✓ | ✓ | ✓ | / | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| 7 | ✗ | ✗ | ✗ | ✓ | ✗ | ✗ | ✗ | ✗ | / | ✓ | ✗ | ✗ | ✗ | ✗ | ✗ | ✗ | ✗ | ✗ | ✗ | ✗ | ✗ | ✗ | ✗ | / | ✓ | |
| 8 | ✗ | ✗ | ✗ | ✓ | ✗ | ✗ | ✗ | ✗ | ✗ | ✗ | ✗ | ✓ | ✗ | ✗ | ✗ | ✗ | ✗ | ✗ | ✗ | ✗ | ✓ | ✗ | ✗ | ✗ | ✗ | |
| 9 | – | – | – | ✓ | – | – | – | – | – | – | – | ✓ | – | – | – | – | – | – | – | – | ✓ | – | – | – | – | |
| 10 | ✗ | ✗ | ✗ | ✗ | ✗ | ✗ | ✗ | ✓ | ✗ | ✗ | ✗ | ✗ | ✗ | ✓ | ✗ | ✓ | ✓ | ✗ | ✗ | ✗ | ✓ | ✗ | ✗ | ✗ | ✗ | |
| Data | 11 | ✓ | ✗ | ✗ | ✓ | ✓ | ✗ | ✗ | ✗ | ✗ | ✗ | ✗ | ✗ | ✗ | ✗ | ✓ | ✓ | ✓ | ✗ | ✗ | ✓ | ✓ | ✓ | ✓ | ✓ | |
| 12 | ✓ | ✓ | – | – | ✓ | ✓ | ? | – | – | – | – | – | – | – | – | ✗ | ✗ | ✓ | – | – | ✓ | ✗ | ✗ | ✓ | / | |
| 13 | ✗ | ✗ | ✗ | ✗ | ✗ | ✗ | ✗ | – | ✗ | – | ✗ | ✗ | ✗ | ✗ | – | ✗ | ✗ | ✗ | – | ✗ | ✗ | ✗ | ✗ | ✗ | ✗ | |
| 14 | ✗ | ✗ | ✗ | ✗ | ✓ | ✗ | ✗ | – | ✗ | – | ✗ | – | – | – | – | ✗ | ✗ | ✗ | – | ✗ | ✗ | ✗ | ✗ | ✗ | ✗ | |
| 15 | ✓ | ✓ | ✗ | ✓ | ✓ | ✓ | ✗ | ✓ | ✓ | ✓ | ✗ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||
| Confound | 16 | ✗ | ✓ | ✗ | ✗ | ✓ | ✗ | ✗ | ✓ | ✓ | ✗ | ✗ | ✗ | / | / | ✗ | ✓ | ✓ | ✓ | ✗ | ✓ | ✓ | ✓ | ✗ | / | ✗ |
| 17 | ✗ | ✓ | ✗ | ✓ | ✓ | ✗ | ✗ | ✓ | ✓ | ✗ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✗ | ✓ | ✓ | ✗ | ✓ | ✓ | ✓ | |
| HWE | 18 | ✗ | ✓ | ✗ | ✓ | ✗ | ✗ | ✗ | ✓ | ✓ | ✗ | ✗ | ✓ | ✗ | ✗ | ✗ | ✗ | ✓ | ✗ | ✗ | ✗ | ✓ | ✗ | ✗ | ✗ | ✗ |
| Outcomes | 19 | ✓ | ✓ | ✗ | ✓ | ✓ | ✗ | – | – | – | – | ✗ | ✓ | – | – | – | ✓ | ✓ | ✓ | – | ✓ | ✓ | – | – | – | ✓ |
| 20 | ✓ | ✓ | ✗ | ✓ | ✓ | ✗ | ✗ | ✓ | ✓ | ✗ | ✗ | ✗ | ✗ | ✗ | ✓ | ✓ | ✓ | ✓ | ✓ | ✗ | ✓ | ✗ | ✗ | ✗ | ✓ | |
| 21 | ✗ | ✓ | ✗ | ✗ | ✓ | ✗ | – | – | – | – | ✗ | ✓ | – | – | – | ✗ | ✓ | ✓ | – | ✗ | ✓ | – | – | – | ✗ | |
| 22 | ✗ | ✓ | ✗ | ✗ | ✓ | ✗ | ✗ | ✗ | ✗ | ✗ | ✗ | ✗ | ✗ | ✗ | ✓ | ✗ | ✗ | ✗ | ✗ | ✗ | ✗ | ✗ | ✗ | ✗ | ✗ | |
| 23 | ? | ? | ? | ? | ? | ? | ? | ? | ? | ? | ? | ? | ? | ? | ? | ? | ? | ? | ? | ? | ? | ? | ? | ? | ? |
✓, Yes; ✗, No; /, partially (yes/no); ?, unknown or not stated; –, not applicable.
- Quality assessment - The Clinical Effectiveness and Cost-Effectiveness of Genoty...Quality assessment - The Clinical Effectiveness and Cost-Effectiveness of Genotyping for CYP2D6 for the Management of Women with Breast Cancer Treated with Tamoxifen: A Systematic Review
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