Table 2.

Quality Assessment

Study	Pekmezaris et al, 2019 13	Young et al, 2016 14	Caldwell et al, 2005 16	Dracup et al, 2014 15	Lefler et al, 2018 17
Was the study described as randomized, a randomized trial, a randomized clinical trial, or an randomized controlled trial?	Yes	Yes	Yes	Yes	Yes
Was the method of randomization adequate (ie, use of randomly generated assignment)?	Yes	Yes	NR	Yes	NR
Was the treatment allocation concealed (so that assignments could not be predicted)?	Yes	Yes	NR	Yes	NR
Were study participants and providers blinded to treatment group assignment?	NR	No	NR	Yes	NR
Were the people assessing the outcomes blinded to the participants' group assignments?	No	Yes	NR	Yes	NR
Were the groups similar at baseline on important characteristics that could affect outcomes (eg, demographics, risk factors, comorbid conditions)?	Yes	No	Yes	Yes	NR
Was the overall drop‐out rate from the study at end point 20% or lower of the number allocated to treatment?	Yes	Yes	NR	Yes	Yes
Was the differential dropout rate (between treatment groups) at the end point 15 percentage points or lower?	Yes	Yes	NR	Yes	Yes
Was there high adherence to the intervention protocols for each treatment group?	Yes	Yes	NR	Yes	Yes
Were other interventions avoided or similar in the groups (eg, similar background treatments)?	Yes	Yes	NR	Yes	Yes
Were outcomes assessed using valid and reliable measures, implemented consistently across all study participants?	Yes	Yes	No	Yes	Yes
Did the authors report that the sample size was sufficiently large to be able to detect a difference in the main outcome between groups with at least 80% power?	No	Yes	No	Yes	No
Were outcomes reported or subgroups analyzed prespecified (ie, identified before analyses were conducted)?	Yes	Yes	Yes	Yes	Yes
Were all randomized participants analyzed in the group to which they were originally assigned (ie, did they use an intention‐to‐treat analysis?)?	Yes	No	No	Yes	No
Quality	Fair	Fair	Poor	Good	Poor
Limitations	Low power >20% Drop out in intervention group The results are not generalizable (single‐center study) Multiple testing error Outdated technology by the end of study	The results are not generalizable (single‐center study, convenience sampling) Multiple testing error Selection bias	The results are not generalizable (single‐center study, small sample size) Multiple testing error Selection bias Short duration of study Change in the intervention setting and measures in the middle of study Reporting bias (medical records and physician logs were not considered)	Multiple testing error Change in patients' treatment plans was not captured and it might have caused the difference in cardiac mortality between intervention and control groups Competing risk of death was not considered	The results are not generalizable (single‐center study, low power, small sample size) Didn't collect demographic data

NR indicates not reported.