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Table 1 Summary and short description of the six included randomised clinical trials

From: Intensive follow-up for women with breast cancer: review of clinical, economic and patient’s preference domains through evidence to decision framework

Study Participants Intervention Comparator Outcome Risk of bias
Oltra 2007
RCT
Spain, hospital setting, 58 cases and 63 controls Intensive follow-up:
Outpatient appointments (following ASCO guidelines in frequency) had: anamnesis and physical examination, biochemistry, blood count, and the markers carcinoembryonic antigen (CEA) and CA15–3. Annual check-up included: mammography, hepatic echography, chest X-ray, and bone scan.
Standard follow up:
Outpatient appointments (following ASCO guidelines in frequency) had anamnesis and physical examination; no complementary tests in absence of clinical symptoms. Annual check-up included mammography.
Cost-benefit evaluation (intensive vs. standard follow-up) in the early detection of breast cancer relapses. - Random sequence generation: unclear
- Allocation concealment: unclear
- Blinding of participants and personnel: high risk
- Blinding of outcome assessment: high risk
- Incomplete outcome data: low risk
- Selective reporting: low risk
Kokko 2003
Kokko 2005
RCT
Finland, hospital setting, 243 cases and 229 controls Patient-initiated follow-up:
Chest X-rays and other diagnostic tests taken only when clinically indicated.
Moreover, patients were further randomised into:
- outpatient appointments every 3 months (group A);
- outpatient appointments every 6 months (group C).
Standard follow-up:
Chest X-rays and other diagnostic tests taken routinely every 6 months.
Moreover, patients were further randomised into:
- outpatient appointments every 3 months (group B);
- outpatient appointments every 6 months (group D).
Main study: recurrences, free disease survival, overall survival.
Cost-benefit study: evaluation of the early detection of breast cancer relapses (appointments every 3 vs. 6 months, and routine vs. clinically-requested exams).
- Random sequence generation: unclear
- Allocation concealment: unclear
- Blinding of participants and personnel: high risk
- Blinding of outcome assessment: high risk
- Incomplete outcome data: low risk
- Selective reporting: low risk
Brown 2002
Multicentre RCT
England, hospital setting (4 clinics), 31 cases and 30 controls Patient-initiated follow-up: Patients received written information on the signs and symptoms of recurrence, and the invitation to contact the nurses by telephone in case of any problem. They did not attend routine clinic appointments.
Annual check-up with mammography.
Standard follow-up:
Outpatient appointments as standard clinic follow-up: anamnesis, physical examination, and possibility to ask questions.
Annual check-up with mammography.
Quality of life.
Psychological morbidity.
Satisfaction with follow-up.
- Random sequence generation: low risk
- Allocation concealment: unclear
- Blinding of participants and personnel: high risk
- Blinding of outcome assessment: high risk
- Incomplete outcome data: low risk
- Selective reporting: low risk
Gulliford 1997
Multicentre RCT
England, hospital setting (2 clinics), 97 cases and 96 controls Patient-initiated follow-up:
Outpatient visits only after mammography: yearly (lumpectomies done less than 5 years before; mastectomies performed less than 1 year before) or every other year (lumpectomies done more than 5 years before; mastectomies performed more than 1 year before).
Patient-initiated phone contact in case of symptoms.
Standard follow-up:
Outpatient visits according to conventional schedule: every 3 months if the surgery took place less than one year before; every four months if the surgery was between one and two years before; every six months if the surgery was between two and five years before; and annually if the surgery was more than five years before.
Mammography as the other arm.
Phone contact as the other arm.
Interim use of telephone and general practitioner.
Satisfaction with allocation to follow-up.
- Random sequence generation: unclear
- Allocation concealment: unclear
- Blinding of participants and personnel: high risk
- Blinding of outcome assessment: high risk
- Incomplete outcome data: low risk
- Selective reporting: low risk
Rosselli del Turco 1994
Palli 1999
Multicentre RCT
Italy, hospital setting (12 clinics), 622 cases and 621 controls Intensive follow-up:
Physical examination performed every 3 months in the first 2 years and every 6 months in the following 3 years; 2-view chest X-rays and bone scan performed every 6 months; mammography performed every year.
Standard follow-up:
Physical examination performed every 3 months in the first 2 years and every 6 months in the following 3 years; mammography performed every year during the study (5 years). Other diagnostic tests performed only in presence of symptoms.
Overall survival.
Relapse-free survival.
Distant metastases.
Death.
Event-free survival (distant metastases or death).
- Random sequence generation: unclear
- Allocation concealment: low risk
- Blinding of participants and personnel: high risk
- Blinding of outcome assessment: high risk
- Incomplete outcome data: low risk
- Selective reporting: low risk
GIVIO 1994
Multicentre RCT
Italy, hospital setting (26 clinics), 655 cases and 665 controls Intensive follow-up:
Physical exam every 3 months for 2 years and then every 6 months for 3 years; blood test every visit (ALP, gammaGT); chest X-rays every 6 months; annual radionuclide bone scan; annual liver echography; annual contralateral mammography.
Standard follow-up:
Physical exam every 3 months for 2 years and then every 6 months for 3 years; annual contralateral mammography.
Mortality/overall survival.
Recurrence (type of recurrence, time to detection of recurrence).
Symptomatic status at diagnosis of metastases.
Health-related quality of life.
- Random sequence generation: low risk
- Allocation concealment: low risk
- Blinding of participants and personnel: high risk
- Blinding of outcome assessment: high risk
- Incomplete outcome data: low risk
- Selective reporting: low risk