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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.)

Appendix 3Quality assessment

To 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)

  1. Is the source population clearly defined?
  2. Is the study population clearly defined?
  3. Does the study population clearly represent the source population or population of interest?
  4. 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 2009112Henry 200987de Duenas 2009113Gjerde 2007104Goetz 200783Goetz 200982 on behalf of ITPCGonzalez-Santiago 200786Kiyotani 2010114 (efficacy)Kiyotani 2010114 (metabolism)Lim 200773Madlensky 200890Newman 200891Nowell 200592Okishiro 200993Onitilo 200994Ramon 201041Schroth 200796Schroth 2009108Stearns 200349Thompson 2009109Toyama 200997Wang 200798Wegman 2005100Wegman 200799Xu 2008101
Sample1/
2///
3/????/????
4//
SNP5///////////
Test6/
7//
8
9
10
Data11
12?/
13
14
15
Confound16///
17
HWE18
Outcomes19
20
21
22
23?????????????????????????

✓, Yes; ✗, No; /, partially (yes/no); ?, unknown or not stated; –, not applicable.

© 2011, Crown Copyright.

Included under terms of UK Non-commercial Government License.

Cover of The Clinical Effectiveness and Cost-Effectiveness of Genotyping for CYP2D6 for the Management of Women with Breast Cancer Treated with Tamoxifen: A Systematic Review
The Clinical Effectiveness and Cost-Effectiveness of Genotyping for CYP2D6 for the Management of Women with Breast Cancer Treated with Tamoxifen: A Systematic Review.
Health Technology Assessment, No. 15.33.
Fleeman N, Saborido CM, Payne K, et al.
Southampton (UK): NIHR Journals Library; 2011 Sep.

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