Methods for evaluating the extent to which different ways of presenting evidence of the effects of health care help people make decisions that are consistent with their own values: a randomised trial
| ISRCTN | ISRCTN14949974 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14949974 |
| Secondary identifying numbers | HIPPO 1 |
- Submission date
- 04/01/2007
- Registration date
- 28/02/2007
- Last edited
- 03/10/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Andrew Oxman
Scientific
Scientific
Norwegian Knowledge Centre for the Health Services
P.O. Box 7004
St Olavs Plass
Oslo
0130
Norway
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | HIPPO pilot |
| Study objectives | Pilot study - development of methodology to: 1. Analyse which of several presentations of evidence of treatment effects best help people to make treatment decisions congruent with their own values 2. Compare visual analogue scales and category rating scales as value elicitation instruments |
| Ethics approval(s) | This study was approved by the ethics review board at the University at Buffalo on the 15 May 2002 with several renewals. |
| Health condition(s) or problem(s) studied | N/A |
| Intervention | Six different summary statistics presenting ten year risk reduction effect of statins on coronary heart disease in the treatment of hypercholesteremia. The methodological aspects reported in this study include comparison of two value elicitation instruments (visual analogue scales and category rating scales), four theory-grounded approaches to weighting elicited values, and six summary statistics to evaluate the extent to which they promote decisions consistent with elicited values. In addition, we report hypothesis generation and sample size calculation for a randomised controlled trial comparing the same six summary statistics for communicating evidence of reduced risk of coronary heart disease, as well as on the feasibility of conducting this type of Internet-based randomised trial. |
| Intervention type | Other |
| Primary outcome measure | 1. Acceptance or rejection of statin treatment 2. Estimated probability to accept or reject statin treatment in relation to value score |
| Secondary outcome measures | 1. To investigate the feasibility of conducting Internet-based randomised trials comparing different risk reduction presentations 2. To compare two methods of eliciting values 3. Four ways of weighting the elicited values to calculate a total value 4. To generate hypotheses and calculate sample size for a confirmatory study comparing six summary statistics for communicating evidence of reduced risk of Coronary Heart Disease (CHD) with statin therapy for treatment of high cholesterol |
| Overall study start date | 31/10/2002 |
| Completion date | 04/12/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 770 |
| Key inclusion criteria | 1. 18 years old 2. Fluent in English or Norwegian 3. Must give informed consent |
| Key exclusion criteria | Not meeting inclusion requirements |
| Date of first enrolment | 31/10/2002 |
| Date of final enrolment | 04/12/2002 |
Locations
Countries of recruitment
- Norway
- United States of America
Study participating centre
Norwegian Knowledge Centre for the Health Services
Oslo
0130
Norway
0130
Norway
Sponsor information
Norwegian Research Council (Norway)
Government
Government
P.O. Box 2700
St. Hanshaugen
Oslo
0131
Norway
| Website | http://www.forskningsradet.no |
|---|---|
"ROR" |
https://ror.org/00epmv149 |
Funders
Funder type
Government
Norwegian Research Council (Norway) (project 135210 - A series of randomised trials comparing different ways of presenting health evidence on the Internet)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
