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Table 5 Summary of the assessment on the research question

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

Domain Judgement Research evidence Additional considerations
Problem Is the problem a priority? With over 458,000 new cases and 131,000 deaths per year, breast cancer is one of the main killers in Europe, and its diagnosis, treatment and follow-up represent major public health priorities.
Despite the doubts that intensive follow-up care could improve survival in patients after breast cancer, intensive follow-up is quite common in clinical practice and represents a significant workload for radiotherapy, surgical and oncologic departments (Loprinzi 1994), and it is also costly.
 
No
Probably no
Probably yes
Yes
Varies
Don’t know
Desirable effects How substantial are the desirable anticipated effects? The evidence showed uncertain differences in overall mortality at 5 and 10-year follow-up (high quality evidence), and uncertain differences in recurrences at 5 years of follow-up (moderate quality evidence).
The evidence showed significant differences in reassurance of women in favour of intensive follow-up (very low quality evidence), and convenience in favour of non-intensive follow-up (low quality evidence).
There was missing research evidence in respect to the outcomes: 5 and 10-year breast cancer specific survival, 10-year breast cancer recurrences and quality of life of breast cancer patients 2 or 5 years after diagnosis.
 
Trivial
Small
Moderate
Large
Varies
Don’t know
Undesirable Effects How substantial are the undesirable anticipated effects?   Undesirable health effects are related to mental health (stress for false positive, false reassurance for false negative).
Large
Moderate
Small
Trivial
Varies
Don’t know
Certainty of evidence What is the overall certainty of the evidence of effects? The evidence on 5- and 10- year overall mortality was of high quality, and did not favour intensive versus standard follow-up.
The evidence on 5-year cancer recurrences was of moderate quality, and there were uncertain differences between intensive and standard follo-up; similar conclusions apply to cancer recurrences at any time.
The evidence of women satisfaction was of very low quality (reassurance domain) and of moderate quality (convenience domain).
The evidence on values for women was of low quality (inconsistency among studies).
The evidence on economic evaluations was of high quality, and favoured non-intensive follow-up.
 
Very low
Low
Moderate
High
No included studies
Values Is there important uncertainty about or variability in how much people value the main outcomes? Important variability was present among studies and within studies regarding women preferences for the intensity of follow-up (moderate confidence) (Gulliford 1997, Stemmler 2008, Kimman 2010).  
Important uncertainty or variability
Possibly important uncertainty or variability
Probably no important uncertainty or variability
No important uncertainty or variability
No known undesirable outcomes
Balance of effects Does the balance between desirable and undesirable effects favour the intervention or the comparison? The evidence on health outcomes favours the comparison.
The evidence on values for women is unclear: reassurance seems to favour the intervention (very low quality evidence), while convenience seems to favour the comparison (moderate quality evidence).The evidence on health outcomes favours the comparison.
 
Favours the comparison
Probably favours the comparison
o Does not favour either the intervention or the comparison
Probably favours the intervention
Favours the intervention
Varies
Don’t know
Resources required How large are the resource requirements (costs)? Moderate costs for the annual mammography option.
Large costs could result for more intensive follow-up schedules that could include more than one mammography per year, clinical examinations, or MRI, or bone scans or others. Moderate costs for the annual mammography option.
 
Large costs
Moderate costs
Negligible costs and savings
Moderate savings
Large savings
Varies
Don’t know
Certainty of evidence of required resources What is the certainty of the evidence of resource requirements (costs)? Evidence comes from a good quality cost-utility analysis study from the UK (Robertson 2011).  
Very low
Low
Moderate
High
No included studies
Cost effectiveness Does the cost-effectiveness of the intervention favour the intervention or the comparison? In the base-case scenario of a cost-utility analysis of different follow-up strategies carried out in the UK, the strategy with the highest net benefit, and most likely to be considered cost-effective, was surveillance mammography alone every 12 months at a societal willingness to pay for a quality-adjusted life year of either £20,000 or £30,000. The incremental cost-effectiveness ratio for surveillance mammography alone every 12 months compared with no surveillance was € 6051 (2008 value) (Robertson 2011). Even though different countries use different cost per QALY thresholds for deciding which interventions will be funded by public health services, € 6051 is far below the threshold used in most European countries.
Favours the comparison
Probably favours the comparison
Does not favour either the intervention or the comparison
Probably favours the intervention
Favours the intervention
Varies
No included studies
Equity What would be the impact on health equity?   With less intensive follow-up strategies, resources could be mobilised to other aspects of breast cancer care or other areas of health care that could increase equity.
Reduced
Probably reduced
Probably no impact
Probably increased
Increased
Varies
Don’t know
Acceptability Is the intervention acceptable to key stakeholders?   Some patients, relatives and health professionals might find it unacceptable to reduce the number of visits and tests performed.
No
Probably no
Probably yes
Yes
Varies
Don’t know
Feasibility Is the intervention feasible to implement?   Settings with more intensive follow-up strategies will need to consider what is the impact of implementing less intensive strategies (e.g. relocate healthcare professionals or equipment).
No
Probably no
Probably yes
Yes
Varies
Don’t know
  1. Legend: This table is the second part of the Evidence to Decision framework