The BPI measures two things: how bad pain is, and how much it gets in the way of life. Four severity ratings and seven interference ratings, each 0 to 10, give two scores that chronic pain and cancer pain trials rely on.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Brief Pain Inventory · Day 28
Approved licensed version · short form
Pain severity
Worst pain
BPI03Average pain
BPI05Interference
Sleep
BPI09FAt a glance
In trials
Two people with the same pain rating can live very different lives. The BPI's interference items capture what the pain stops people doing, which is often what matters most to patients and regulators. A treatment that reduces average pain by one point but halves interference with sleep and walking is a different result from one that changes intensity alone.
That makes the BPI a common secondary endpoint in chronic pain, cancer pain, neuropathic pain and osteoarthritis trials, alongside a daily pain diary for the primary intensity endpoint. See EDC for chronic pain trials for how diaries and visit questionnaires fit together.
Scoring rules commonly allow the interference score to be calculated when at least four of the seven items are answered. Write your rule into the analysis plan, and consider making all items required on the electronic form so the question rarely arises.
Severity (mean of 4)
4.5
Interference (mean of 7)
3.9
Baseline interference
6.6
Structure
| Part | Content | Scale |
|---|---|---|
| Body diagram | Where the pain is | Shaded areas |
| Severity | Worst, least, average and current pain | 0 to 10 each |
| Treatment | Current pain treatments and relief received | Text and 0 to 100% |
| Interference | Seven areas of daily life | 0 to 10 each |
| Scores | Severity mean and interference mean | 0 to 10 |
Use the licensed wording and official translations. The body diagram is often handled as a separate site form or a list of body regions.
In Capture
Each rating is a 0 to 10 scale with its anchors, stored as a coded value. Participants complete the BPI from a secure link with reminders, and the form records the licence number, holder and expiry so collection stops if the licence lapses.
Evening diary
Question 3 of 8
How would you rate your fatigue today?
0 = no fatigue, 10 = worst imaginable
Build both in the free sandbox and test them on your phone.
Analysis
Decide which BPI score carries the weight. Some trials use the average pain item alone as the intensity endpoint; others use the severity mean or the worst pain item, which regulators have accepted as a primary endpoint in some cancer pain settings. The interference mean is the usual functional endpoint.
Responder definitions follow the same logic as other pain scales: reductions of about 30% are commonly described as moderately important and 50% as substantial. Pre-specify the definition, the time point and how rescue medication is handled. The NRS pain scale template explains those benchmarks.
Before go-live
From the copyright holder; licence details on the form.
Short form (24 hours) for most trials.
Worst pain, average pain, severity mean or interference mean.
In the analysis plan, or all items required.
Captured in the diary on the same days.
For every language used.
A questionnaire that measures pain severity and how much pain interferes with daily life, developed at MD Anderson Cancer Center.
The severity score is usually the mean of four 0 to 10 severity items and the interference score the mean of seven 0 to 10 interference items.
The short form asks about the last 24 hours. The long form covers a longer period.
No. It is copyrighted and use requires permission from the copyright holder.
Scoring rules commonly allow it when at least four of seven items are answered. Define the rule in your analysis plan.
Items are stored as coded values with labels, and scores are derived from them in analysis.
Keep exploring
Severity and interference on participants' phones. Free sandbox.