| Methods |
Trial design: cross‐over study. Randomisation procedure: breast to receive the breast cushion and the order in which breasts were to be imaged were randomised by computer‐generated random numbers with permutated blocking procedures.
Allocation concealment: sealed envelopes.
Blinding: subject and technologist could not be blinded, but radiologist assessing image quality was blinded.
Drop‐outs: nil.
Intention‐to‐treat analysis: yes.
Country: USA |
| Participants |
415 women were invited to participate, of whom 394 agreed. The main reason given for non‐participation was time constraints. 394 women were randomised; no drop‐outs. The mean age of the women was 55.4 (SD 10.8) years and the majority were white/non‐Hispanic (75.3%). |
| Interventions |
Radiolucent cushions were attached to the compression paddle and film cassette holder when imaging one breast. No cushions were used when imaging the other breast. The breast to receive the cushion and the breast to image first were both randomised.
Two views were taken of each breast ‐ CC and MLO. Thus, 4 images were taken for each woman. The results for the CC and MLO views were presented separately. |
| Outcomes |
1) Pain using an 11‐point NRS.
2) Pain marked on a 10 cm VAS with the two extremes being 0 = no pain and 10 = severe pain.
3) Image quality: the radiologist directly compared the mammogram views obtained from the same woman with and without the use of cushions. |
| Notes |
This study was of good quality and is the only study on breast cushions included in this review. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Low risk |
A ‐ Adequate |
