Jouni 2017.
Methods |
Study design: randomized trial Unit of allocation: patient Unit of analysis: patient Power calculation: unclear |
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Participants |
Care setting: ambulatory care, USA Health professionals: 6; various types; fully trained; unclear gender Patients: 207; coronary heart disease; male and female |
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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 |
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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. |