Author, yearStudy designRandom assignment?Allocation concealed?Groups similar at baseline?Eligibility criteria specified?Blinding: outcome assessors, care provider, patient?Clear definition of measures?Intention-to-treat analysis?Adjustment for potential confounders?Maintenance of comparable groups?Important outcomes considered?Reporting of attrition, contamination, etc.?Differential loss to follow-up or overall high loss to follow-up?Quality ratingExternal validity
Bish et al, 2002a155 Case seriesNoN/AN/AYesN/AYesN/ANoN/AYesYesNoFairFamily cancer clinic, London
Bish et al, 2002b164 Prospective cohortNoN/AInsufficient data to determineBroad criteria specifiedN/AYesNoNoYesYesYesYesPoorFamily cancer clinic, London
Brain et al, 2002156 RCTYesConcealed in baseline questionnaire and in clinic appointment letterYesYesImplied: individual randomization to trial or control clinic by computer-generated sequenceYesYesYesYesYesYesNoGoodCancer clinics, Wales
Friedman et al, 1999157 Prospective cohortNoN/ADemographic differences reflect those typical of the different risk groupsYesN/AYesN/ANoYesYesYesHigh loss to follow-up No data on declinersFairHighly educated Jewish persons in Houston, TX, community-based genetic testing program
Fry et al, 2003165 Group RCTYesNot reportedNoYesNot reportedSome measures not standard One not clearly definedNoNoNoYesParticipation bias presentHigh loss to follow-upPoorWomen in SE Scotland referred to clinical genetics dept. for breast cancer genetic risk counseling
Gilbert et al, 1998166 Time seriesYesN/AN/AYesN/AYesN/ANoNot able to determineYesYesDifficult to determine—data not given for + vs - family historyPoorWomen in NE Scotland in 3 health centers
Hopwood et al, 1998158 Non-comparativeNoN/AN/AYesN/AYesN/AYesN/AYesYesNoGood/ FairWomen in Manchester, England, family genetics clinic
Lerman et al, 1998159 Prospective cohortNoN/AN/AYesN/AYesN/AAdjustment for most potential confoundersYesYesYes30% of test decliners lost to follow-upFairUS hereditary breast/ovarian cancer registry composed of highly educated Caucasians
Lobb et al, 2004160 LongitudinalNoN/AYesYesN/AYesN/AYesYesYesYes19% loss to follow-upGoodWomen in any of 10 familial cancer clinics in four Australian states
Lodder et al, 2002167 Prospective cohortNoN/AN/AYesN/AYesN/AIncompleteNot able to determineIncomplete considerationYesHigh loss to follow-upPoorHighly selected European women
Lodder et al, 2001168 Case-ControlNoN/AYesYesN/AYesN/AAdjustment for some potential confoundersYesYesYesHigh loss to follow-upPoorWomen who applied for BRCA testing at University Hospital, Rotterdam, and their partners
Meiser et al, 2002161 Prospective cohortNoN/AYes (analysis)YesN/AYesN/APotential confounders evaluated and were not significantYesYesYesOverall follow-up 80%, by group 73% to 87%GoodWomen at 21 cancer clinics in Australia; more highly educated than general population
Meiser et al, 2001169 Before-AfterNoN/AN/AYesN/AYesN/ANoN/AYesYesHigh loss to follow-upPoorWomen at 21 cancer clinics in Australia; more highly educated than general population
Ritvo et al, 2000170 Prospective cohortNoN/AIncomplete informationGeneral criteria for Cohort A; none for Cohort BN/ANot all were clearly definedN/ANoIncomplete informationNoYesOverall follow-up 77%; Cohort B follow-up 71%; drop-outs younger & less optimisticPoorWomen at Toronto family cancer clinic seeking genetic risk assessment
Smith et al, 1999162 Prospective cohortNoN/AYesYesN/AYesParticipation analysisYesDifficult to assess due to attritionYesYesHigh loss to follow-upFairMembers of kindred 2082, most of whom are Mormons
Warner et al, 2003171 Before-AfterNoN/AYesYesN/ANoParticipation analysisNoYesNoYesHigh loss to follow-upPoorWomen patients with family history of breast cancer recruited by their doctors who are mambers of Canada's CFPC
Watson et al, 1999163 Before-AfterNoN/AOf 4 clinic sites, 1 had younger & 1 had higher risk womenYesN/AYesN/AYesYesYesVery low attritionLow loss to follow-up Differential loss data not reportedGoodWomen with a family history of breast cancer attending South London genetic clinic

CFPC, College of Family Physicians of Canada; RCT, randomized controlled trial.

From: Appendix N. Quality Ratings of Studies of Adverse Effects of Risk Assessment and Testing Studies

Cover of Genetic Risk Assessment and BRCA Mutation Testing for Breast and Ovarian Cancer Susceptibility
Genetic Risk Assessment and BRCA Mutation Testing for Breast and Ovarian Cancer Susceptibility [Internet].
Evidence Syntheses, No. 37.
Nelson HD, Huffman LH, Fu R, et al.

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