ID
Bron
Aandoening
Decision Aids, Shared Decision Making, Gallstones, Inguinal Hernia, Surgery, treatment preferences, PROMS
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The main study endpoint will be the change in patients treatment preference before and after the decision aid.
Achtergrond van het onderzoek
This study is a single centre, prospective cohort study. In this single centre decision aids, tools with balanced, patient adjusted information about the harms and benefits of treatments (surgery or no surgery), are standardized care for patients with gallstones and inguinal hernia. Patients will all be recruited in the Netherlands.
We aim to determine the change in patient treatment preference before and after the decision aid. Secondarily, we research patient reported outcomes with questionnaires after 3 and 6 months.
After inclusion of 350 patients and 6 months follow-up, statistical analysis will be carried out using IBM SPSS.
Onderzoeksopzet
t = 0 months
Decision Aid
Questionnaires:
Patient demographics
EQ5D
GSL / EuraHS
SDM-9
Treatment Preference
t = 3 months
Questionnaires:
EQ5D
GSL / EuraHS
SDM-9
Satisfaction and Painscore
t = 6 months
Questionnaires:
EQ5D
GSL / EuraHS
SDM-9
Satisfaction and Painscore
Onderzoeksproduct en/of interventie
Decision Aids:
Tools with balanced, patient adjusted information about the harms and benefits of treatments. Decision aids facilitate SDM.
Questionnaires:
EQ5D
Gallstone Symptom List (GSL) Or EuraHS
Shared Decision Making Questionnaire - 9 (SDM-9)
Satisfaction, Pain, Treatment preference
Publiek
Carmen Latenstein
Nijmegen 6500 HB
The Netherlands
06-19402554
carmen.latenstein@radboudumc.nl
Wetenschappelijk
Carmen Latenstein
Nijmegen 6500 HB
The Netherlands
06-19402554
carmen.latenstein@radboudumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 18 years of age or older
- refered for surgical consultation with gallstones or inguinal hernia
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- Complicated gallstone disease
- Mentally incompetent
- Insufficient knowledge of Dutch language
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL7292 |
| NTR-old | NTR7501 |
| Ander register | Commissie Mensgebonden Onderzoek : 2017-3972 |