What is the effect of alternative summary statistics for communicating risk reduction on decisions about whether to take statins?
| ISRCTN | ISRCTN85194921 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN85194921 |
| Protocol serial number | N/A |
| Sponsor | Norwegian Knowledge Centre for the Health Services (Norway) |
| Funder | Norwegian Research Council (Norway) |
- Submission date
- 09/03/2007
- Registration date
- 04/05/2007
- Last edited
- 02/09/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Ms Cheryl Carling
Scientific
Scientific
PO box 7004
St Olavs Plass
Oslo
N-0130
Norway
| Phone | +47 (0)98627327 |
|---|---|
| cheryl.carling@kunnskapssenteret.no |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | HIPPO 2 (Health Information Project, Presentation Online) |
| Study objectives | In terms of congruence between decisions and values: 1. "Relative risk reduction" is inferior to the absolute summary statistics 2. "Absolute risk reduction" is superior to other absolute summary statistics, and 3. There is no congruence between decisions and values for "event rates" |
| Ethics approval(s) | Ethics approval received from the University at Buffalo (New York, USA), Health Sciences Institutional Review Board, approved on 15 May 2002. |
| Health condition(s) or problem(s) studied | Hypercholesterolaemia (hypothetical scenario) |
| Intervention | Presentations of summary statistic showing evidence of statins' effectiveness in preventing coronary heart disease over ten years. The participants viewed one of the following six presentations: 1. Relative risk reduction (RRR) 2. Absolute risk reduction (ARR) 3. Numbers needed to treat (NNT) 4. Event rates (ER) 5. Tablets needed to take (TNT) 6. Whole numbers (WN) |
| Intervention type | Other |
| Primary outcome measure(s) |
Hypothetical treatment decision to take or not to take statins. |
| Key secondary outcome measure(s) |
Understanding of and satisfaction with information, and preferred summary statistic. |
| Completion date | 31/07/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 4800 |
| Key inclusion criteria | 1. At least 18 years of age 2. Fluent in English or Norwegian |
| Key exclusion criteria | Previous participation in this trial |
| Date of first enrolment | 01/06/2003 |
| Date of final enrolment | 31/07/2005 |
Locations
Countries of recruitment
- Canada
- Norway
- United States of America
Study participating centre
PO box 7004
Oslo
N-0130
Norway
N-0130
Norway
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2008 | Yes | No | |
| Results article | results | 01/08/2009 | Yes | No |
