Characteristics of Trials of Cancer Risk Assessment Tools in Primary Care (N = 11)
| Author, Year, Risk Tool, Setting | Disease(s) | Sample | Study Design | Intervention(s) | Overall Risk of Biasa |
|---|---|---|---|---|---|
| Schroy et al22 2011 Your Disease Risk United States | CRC | 665 patients (223 combined intervention; 212 decision aid alone; 231 control) 50 clinicians (47 general internists; 3 nurse practitioners) 2 clinics | RCT (3 groups) Patients randomized before routine visit with primary care clinician | Control: usual care and generic lifestyle change advice for disease prevention Intervention 1: decision aid for CRC screening Intervention 2: decision aid for CRC screening plus CRC personalized risk assessment | Low/unclear |
| Schroy et al23 2012 Your Disease Risk United States | CRC | 825 patients (280 combined intervention; 269 decision aid alone; 276 control) 61 clinicians (47 general internists; 11 family physicians; 3 nurse practitioners) 2 clinics | RCT (3 groups) Patients randomized before routine visit with primary care clinician | Control: usual care and generic lifestyle change advice for disease prevention Intervention 1: decision aid for CRC screening Intervention 2: decision aid for CRC screening plus CRC personalized risk assessment | Low/unclear |
| Rubinstein et al24 2011 Family Healthware Impact Trial (1) United States | CRC, BC, and OC,b heart disease, stroke, and diabetes | 3,283 patients (2,077 intervention; 1,206 control) 41 clinics (23 intervention; 18 control) | Cluster RCT Cluster randomization at clinic level | Control: standard print messages about screening and lifestyle choices recommended for general health Intervention: patient self-completed risk assessment using the Family Healthware risk assessment tool; personalized risk prevention messages tailored to familial risk | Unclear |
| Ruffin et al25 2011 Family Healthware Impact Trial (2) United States | CRC, BC, and OC,b heart disease, stroke, and diabetes | 3,344 patients (2,105 intervention; 1,239 control) 41 clinics (23 intervention; 18 control) | Cluster RCT Cluster randomization at clinic level | Control: standard print messages about screening and lifestyle choices recommended for general health Intervention: patient self-completed risk assessment using the Family Healthware risk assessment tool; personalized risk prevention messages tailored to familial risk | Unclear |
| Wang et al26 2012 Family Healthware Impact Trial (3) United States | CRC, BC, and OC,b heart disease, stroke, and diabetes | 3,344 patients (2,105 intervention; 1,239 control) 41 clinics (23 intervention; 18 control) | Cluster RCT Cluster randomization at clinic level | Control: standard print messages about screening and lifestyle choices recommended for general health Intervention: patient self-completed risk assessment using the Family Healthware risk assessment tool; personalized risk prevention messages tailored to familial risk | Unclear |
| Emery et al27 2007 GRAIDS Trial England | CRC, BC, and OCb | 240 patients received GRAIDS intervention; 84 referred to cancer genetics clinic from control practices 45 clinics (23 intervention; 22 control) | Cluster RCT Cluster randomization at clinic level | Control: 45-minute presentation to all GPs in practice on cancer genetics and copy of referral guidelines for cancer genetics clinic Intervention: 45-minute presentation on cancer genetics to all GPs in practice and copy of referral guidelines for cancer genetics clinic; 1–2 “lead clinicians” per practice trained to use web-based GRAIDS risk assessment tool for OC, CRC, and BC | Low |
| Campbell et al28 1997 Health risk survey Australia | Cervical cancer | 679 female patients (354 intervention; 325 control) 2 clinics | RCT Randomization at patient level | Control: patient self-completed health risk survey Intervention: patient self-completed health risk survey and was given summary including eligibility for cervical screening and date of last Pap test | Low/unclear |
| Wilson et al29 2006 Risk assessment checklist Scotland | BC | 346 clinicians (230 intervention; 116 control) 86 clinics (57 intervention; 29 control) | Cluster RCT (2:1) Randomization at clinic level | Control: standard Scottish guidelines to assess risk for referral to cancer genetics sent to GPs Intervention: multifaceted intervention including risk assessment checklist for CRC, BC, and OC; information about cancer genetics; patient information booklets; web links cancer/genetics; e-mail link to cancer genetics services; referral letter proforma; education sessions about cancer genetics | Low |
| Emmons et al30 2004 Harvard Colorectal Cancer Risk Assessment Tool United States | CRC | 353 patients (134 absolute risk only; 146 absolute plus relative risk; 73 control) 2 clinics | RCT Randomization at patient level | All participants used the Harvard Colorectal Cancer Risk Assessment Tool Control: patients received passive risk communication without risk presentation Intervention: patient risk tool providing 4 different combinations of presentations of risk: (1) absolute and relative risk, (2) absolute risk only, (3) absolute and relative risk with the ability to manipulate the risk input to change the output, and (4) same as for (3) but absolute risk only | Low |
| Weinstein et al31 2004 Harvard Colorectal Cancer Risk Assessment Tool United States | CRC | 353 patients (134 absolute risk only; 146 absolute plus relative risk; 73 control) 2 clinics | RCT Randomization at patient level | All participants used the Harvard Colorectal Cancer Risk Assessment Tool Control: patients received passive risk communication without risk presentation Intervention: patient risk tool providing 4 different combinations of presentations of risk: (1) absolute and relative risk, (2) absolute risk only, (3) absolute and relative risk with the ability to manipulate the risk input to change the output, and (4) same as for (3) but absolute risk only | Low |
| Holloway et al22 2003 Risk assessment scale Wales | Cervical cancer | 1,890 female patients (772 intervention; 1,118 control) 29 clinics (15 intervention; 14 control) | RCT Randomization at clinic level | Control: no risk assessment Intervention: practice nurse risk communication package including a paper-based risk assessment scale based on level of education, current smoking status, number of years of oral contraceptive use, and number of sexual partners ever33 | Low |
BC = breast cancer; CRC = colorectal cancer; GP = general practitioner; GRAIDS = Genetic Risk Assessment on the Internet with Decision Support; OC = ovarian cancer; Pap = Papanicolaou; RCT = randomized controlled trial.
↵a Bias assessed using the Cochrane Collaboration risk of bias based on: (1) sequence generation; (2) allocation concealment; (3) blinding of participants, personnel, and outcome assessors; (4) assessment of incomplete outcome data; (5) selective outcome reporting; (6) “other” sources of bias not listed. Low risk of bias = low risk of bias across all domains. Unclear risk of bias = unclear risk of bias for 1 or more key domains. High risk of bias = high risk of bias for 1 or more domains.
↵b These trials assessed patients’ risk for BRCA mutation rather than specifically discussing ovarian cancer screening.