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Table 1 Patient concerns regarding trials involving multiple biopsies

From: Patient advocate involvement in the design and conduct of breast cancer clinical trials requiring the collection of multiple biopsies

Patient concern

More likely to accept

Less likely to accept

Comfort and safety

• Accessible biopsy site

• Good post-biopsy care offered

• Collection of research tissue during standard procedures

• Challenging biopsy site

• Post-biopsy care not explained

• Additional visits or procedures for tissue collection

Risks and benefits

• Given sufficient information about purpose of the research and need for biopsies

• Risks of tumour seeding explained

• Other risks, including discomfort at biopsy site, fully explained

• Lack of direct benefit fully explained

• Research is considered ‘exciting’ – involving and educating patients

• Research will improve outcomes in future patients and exclude unnecessary treatment in future patients

• Not given sufficient information about purpose, risks and benefits

Timing

• Given adequate time to decide

• Badly timed or insensitive introduction to trial

Quality control

• Clear explanation of what happens to the samples

• Use of samples not adequately explained

History

• Patients with metastatic disease

• Family history

• Previous poor experiences of research