| Methods |
Trial design: cross‐over study. Randomisation procedure: randomised order of application of the two procedures, though the breast to be examined first was not randomised.
Allocation concealment: unclear.
Blinding: subject and technologist could not be blinded, but the outcome assessor (radiologist) was.
Drop‐outs: accounted for.
Intention‐to‐treat analysis: yes.
Country: USA |
| Participants |
138 women invited of whom 109 women, aged 32‐71 years, agreed to participate. 2 women regarded as ineligible for the study because breast lumps detected, presumably at the time of recruitment. 109 women were randomised. Women who had taken analgesics or tranquillizers on the day of the mammogram (n = 24) were included in the study. Data from one participant were not used in the results because of a 'mixed assessment of views'. Therefore 108 women completed the study. Of these 72% were 'white' and 24% 'black', 80% were employed and 52% had a college (university) education. Women were evenly distributed between pre‐ and post‐menopausal groups. |
| Interventions |
2‐view mammogram with compression of 1 breast controlled by the technologist and compression of the other controlled by the woman being examined. The left breast was always examined first; however, the order of breast self‐compression and technologist‐controlled compression was determined by random assignment. |
| Outcomes |
1) Pain of mammography assessed for each patient for self‐compression and when the technologist applied the compression. Patients rated their pain on a 6‐item scale that ranged from 'very comfortable' to 'painful and intolerable'. This had been used in a previous study of compression force in mammography. (Sullivan 1991).
2) Quality of the mammogram was assessed by adequacy of compression according to American College of Radiology criteria. |
| Notes |
A very educated population of women, 24% black. 2 regarded as ineligible for the study because of breast lumps.
No information given on training of the women in e.g. placement of the breast on the mammography machine plates, criteria for an adequate mammogram, compression required etc. The machine was adapted so that compression could be controlled by a handheld button instead of a foot pedal. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
