Abstract
Introduction and hypothesis
The objective of the study was to identify reasons why women declined participation in a pilot randomised controlled trial (RCT) comparing tension-free vaginal tape (TVT) under general anaesthetic (GA) with single incision sling (SIS) under local anaesthetic (LA). These data would inform the design of a larger trial to improve patient recruitment.
Methods
This was a qualitative interview study on women eligible to have a TVT for stress urinary incontinence in a tertiary referral hospital in the UK. Women were counselled in a standardised manner. They were informed that the short-term success rates were similar for both operations. Women who declined to take part in the RCT were interviewed using a topic guide. Themes and sub-themes on non-participation were identified by two independent observers using a constant comparison method.
Results
Twenty-three non-participants of the RCT were interviewed. Common themes for non-participation were a preference for TVT and request for GA. Sub-themes showed that the TVT was preferred due to its perceived better efficacy as well as a minimal benefit from a SIS and also an unwillingness to take unknown risks. GA was favoured due to fear of local awareness, past negative experiences and embarrassment. Additional tests and follow-up visits were not cited as a reason for non-participation.
Conclusions
The study found that non-participants are not research averse in general but they had strong preferences about specific aspects of treatment. Risk propensity and personality may also influence this behaviour. The study also demonstrates how a qualitative pilot study may improve trial design.
The objective of the study was to identify reasons why women declined participation in a pilot randomised controlled trial (RCT) comparing tension-free vaginal tape (TVT) under general anaesthetic (GA) with single incision sling (SIS) under local anaesthetic (LA). These data would inform the design of a larger trial to improve patient recruitment.
Methods
This was a qualitative interview study on women eligible to have a TVT for stress urinary incontinence in a tertiary referral hospital in the UK. Women were counselled in a standardised manner. They were informed that the short-term success rates were similar for both operations. Women who declined to take part in the RCT were interviewed using a topic guide. Themes and sub-themes on non-participation were identified by two independent observers using a constant comparison method.
Results
Twenty-three non-participants of the RCT were interviewed. Common themes for non-participation were a preference for TVT and request for GA. Sub-themes showed that the TVT was preferred due to its perceived better efficacy as well as a minimal benefit from a SIS and also an unwillingness to take unknown risks. GA was favoured due to fear of local awareness, past negative experiences and embarrassment. Additional tests and follow-up visits were not cited as a reason for non-participation.
Conclusions
The study found that non-participants are not research averse in general but they had strong preferences about specific aspects of treatment. Risk propensity and personality may also influence this behaviour. The study also demonstrates how a qualitative pilot study may improve trial design.
| Original language | English |
|---|---|
| Pages (from-to) | 969–975 |
| Number of pages | 7 |
| Journal | International Urogynecology Journal |
| Volume | 24 |
| Issue number | 6 |
| DOIs | |
| Publication status | Published - 1 Nov 2012 |
Keywords
- Non-participation
- Non-entry
- Randomised controlled trials
- Qualitative research methods