Clinical Reporting to Alleviate the Nocebo Effect
Purpose
Terminology in radiology reports may cause patients harm by anchoring to or justifying a particular diagnosis. This phenomenon is known as the nocebo effect. MRI may cause patients to pursue more invasive procedures with little added benefit. This study aims to reproduce a study to determine the impact of clinical reporting on patient care and outcomes for those suffering from lower back pain.
Condition
- Nocebo Effect
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- History of lower back pain undergoing MRI - Greater than 18 years of age - Able to understand and willing to comply with all study procedures and is available for the duration of the study
Exclusion Criteria
- A potential subject who meets any of the following criteria will be excluded from participation in the study: - Acute lower back pain secondary to trauma within 1 months - Severe cord compression on MRI - Cord signal abnormality on MRI - Metastatic cancer - Spinal epidural abscess - Vertebral osteomyelitis - Judgement of the ordering physician (e.g. focal neurologic deficit) - Anything that, in the opinion of the investigator or team, would place the subject at increased risk or preclude the subject's full compliance with or completion of the study
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Survey, cross-sectional study of sixty (n=60) participants undergoing MRI for lower back pain will be randomized to receive an anatomic report (standard of care) versus a Clinical Report (CR). Ordering physicians receiving the Clinical Reports will be instructed to avoid terms that may result in cyberchondria or fear (e.g. disc bulge or nerve impingement) when discussing MRI results.
- Primary Purpose
- Health Services Research
- Masking
- Single (Investigator)
- Masking Description
- Interpreting radiologists will be blinded to survey data. The PI will be blinded to the intervention type during the review.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Standard of Care Report |
The subject will receive standard of care imaging report. |
|
|
Active Comparator Clinical Report |
The subject will receive a technical report that avoids language that may cause catastrophizing or evoke the nocebo effect. |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- University of Alabama at Birmingham