Skip to main content
. 2018 Jul 19;2018(7):CD006732. doi: 10.1002/14651858.CD006732.pub4

Jouni 2017.

Methods Study design: randomized trial
Unit of allocation: patient
Unit of analysis: patient
Power calculation: unclear
Participants Care setting: ambulatory care, USA
Health professionals: 6; various types; fully trained; unclear gender
Patients: 207; coronary heart disease; male and female
Interventions Single intervention : patient‐mediated intervention(CRS: 10‐year risk of CHO based on conventional risk factors alone)
 Quote: "The Statin Choice decision aid was originally developed to disclose CHD risk and help patients as well as clinicians review the benefits and downsides of taking a statin medi­ cation to reduce CHD risk. The tool displays the 10‐year probability of CHD based on CRS in addition to the absolute risk reduction with the use of statin drugs, and the associated costs/side effects. lt can be freely accessed online at http://statindecisionaid.mayoclinic.org.The modified tool can be accessed online at http://migenesstudy.mayoclinic.org ( password: migenes‐use of this decision aid should be limited to research purposes only). Afterwards, the provider can discuss the benefits of starting standard versus high dose statins as well as potential sicle effects ( figure 3). CHD risk was disclosed using scripted language as follows: 'Out of 100 people like you ...' The benefit of statins was conveyed in a similar manner stressing the absolute risk reduction while minimizing framing by presenting the groups helped and not helped by using statins." page 683
Single intervention : patient‐mediated intervention (CRS + GRS: conventional risk factors alone with a genetic risk score)
 Quote: "The tool was also equipped with a report generating function and a frequently asked questions page that includes additional information about GRS." page 683
Outcomes SDM‐Q and OPTION5 (continuous)
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote:"Randomization was performed by means of a computer‐generated random sequence with stratification for age, gender, and positive family history for CGD using the Pocock and Simon method." page 682
Allocation concealment (selection bias) Low risk Quote: "One of the investigators (HJ) generated the random allocation sequence and study arm assignment using the computer software described earlier." page 682
Blinding (performance bias and detection bias) 
 Observer‐based outcome Unclear risk Quote: A random sample of 40 CRS encounters and 40 age‐ and sex‐matched CRS*GRS encounters was obtained and video recordings were analyzed by one of the authors (TSM). page 683
Comment : it is not said if the author was blinded.
Blinding (performance bias and detection bias) 
 Participant‐reported outcome High risk Quote: "The study sample size was relatively small and the intervention was not blinded." page 1186 (primary article)
Incomplete outcome data (attrition bias) 
 Observer‐based outcome High risk All encounters were not recorded.
Quote: "Encounters with the genetic counselor and physician were video‐recorded in 187 patients who consented to the recording." page 682
Quote: "A random sample of 40 CRS encounters and 40 age‐ and sex‐matched CRS*GRS encounters was obtained and video recordings were analyzed by one of the authors (TSM)." page 683
Incomplete outcome data (attrition bias) 
 Participant‐reported outcome Unclear risk Comment: The SDM survey was completed by 206 study participants, and the physician visit satisfaction survey was completed by al study participants (one missing data for SDM).
Selective reporting (reporting bias) High risk Comment: some relevant outcomes pre‐specified in the study protocol were not reported in the results (Trial registration number NCT01936675).
Other bias Unclear risk Quote: "Our study participation had higher than average educational and socioeconomic background and may have been more adept in understanding genetic results."
 Comment: Selection bias ; Study participants were recruited from the Maya Clinic BioBank and may not be fully representative of the general population." page 687
Baseline measurement? 
 Observer‐based outcome Unclear risk Comment: no baseline measure of primary outcome.
Baseline measurement? 
 Participant‐reported outcome Unclear risk Comment: no baseline measure of primary outcome.
Protection against contamination? High risk Comment: patients were randomized.
Baseline characteristics patients Low risk Quote: "Baseline characteristics including age, sex, smoking status, and other CHD conventional risk factor were similar between the two groups." page 684
Baseline characteristics healthcare professionals Unclear risk Comment: no characteristics reported.