| Methods |
Design: three group parallel trial
Purpose: examine the effect of acustimulation on chemotherapy‐induced nausea in women with breast cancer |
| Participants |
Patients: patients about to receive their second chemotherapy treatment who experienced nausea or vomiting after the first treatment |
| Interventions |
Placebo: acustimulation wrist‐band without stimulation
Untreated: no acustimulation wrist band
Experimental: acustimulation wrist band with stimulation
(Co‐intervention: standard clinical antiemetic prophylaxis, including a 5‐HT3 receptor antagonist) |
| Outcomes |
Acute nausea (7‐point scale)
Delayed nausea
Vomiting
Quality of life
Antiemetic medication |
| Notes |
SE values were provided in the original publication and these values were converted to SDs. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
NS |
| Allocation concealment? |
Unclear risk |
NS |
| Blinding?
Treatment provider |
Unclear risk |
NS |
| Blinding?
Outcome assessor |
Unclear risk |
Not relevant as patient reported outcome |
| Incomplete outcome data addressed?
All outcomes |
Low risk |
Drop‐out < 15% |
| Free of selective reporting? |
Unclear risk |
No protocol available |
| Free of other bias? |
Low risk |
|
| No signs of variance inequality or skewness? |
Low risk |
No variance inequality (F‐test not statistically significant) and no skewness (1.64 standard deviations does not exceed the mean) |
| Trial size > 49? |
Low risk |
N = 64 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Allocation not clearly concealed |
