Protocol - Patient Global Impression of Change
Description
The Patient Global Impression of Change scale is a single, self-administered question asking respondents to rate how their condition has changed since a certain point in time. This protocol was validated in individuals aged 18 years and older who were being treated for chronic pain.
Specific Instructions
None
Availability
Protocol
Patient Global Impression of Change
Since the start of the study, my overall status is:
1 [ ] Very Much Improved
2 [ ] Much Improved
3 [ ] Minimally Improved
4 [ ] No Change
5 [ ] Minimally Worse
6 [ ] Much Worse
7 [ ] Very Much Worse
Personnel and Training Required
None
Equipment Needs
None
Requirements
| Requirement Category | Required |
|---|---|
| Major equipment | No |
| Specialized training | No |
| Specialized requirements for biospecimen collection | No |
| Average time of greater than 15 minutes in an unaffected individual | No |
Mode of Administration
Self-administered questionnaire
Lifestage
Adult, Senior
Participants
Adults aged 18 years and older being treated for chronic pain
Selection Rationale
The Patient Global Impression of Change is a short questionnaire that has been widely used in clinical trials for chronic pain and provides a responsive and interpretable assessment of how a participant evaluates changes in their status. Being short, it is easy to administer and interpret results, and it is reliable for testing and retesting over a 24-hour period. Additionally, there are strong correlations between patient satisfaction measures and results from this protocol.
Language
English
Standards
| Standard | Name | ID | Source |
|---|
Derived Variables
None
Process and Review
Not Applicable
Protocol Name from Source
Patient Global Impression of Change (PGIC)
Source
Farrar, J. T., Young, J. P., Jr, LaMoreaux, L., Werth, J. L., & Poole, M. R. (2001). Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain, 94(2), 149-158.
General References
British Pain Society, Faculty of Pain Medicine of the Royal College of Anaesthetists. (2019, January). Outcome measures. https://www.britishpainsociety.org/static/uploads/resources/files/Outcome_Measures_January_2019.pdf
Cooper, T. E., Hambleton, I. R., Ballas, S. K., Johnston, B. A., & Wiffen, P. J. (2019). Pharmacological interventions for painful sickle cell vaso-occlusive crises in adults. The Cochrane Database of Systematic Reviews, 2019(11).
Dworkin, R. H., Turk, D. C., Wyrwich, K. W., Beaton, D., Cleeland, C. S., Farrar, J. T., Haythornthwaite, J. A., Jensen, M. P., Kerns, R. D., Ader, D. N., Brandenburg, N., Burke, L. B., Cella, D., Chandler, J., Cowan, P., Dimitrova, R., Dionne, R., Hertz, S., Jadad, A. R., Katz, N. P., … Zavisic, S. (2008). Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. Journal of Pain, 9(2), 105-121.
Howard, J., Ataga, K. I., Brown, R. C., Achebe, M., Nduba, V., El-Beshlawy, A., Hassab, H., Agodoa, I., Tonda, M., Gray, S., Lehrer-Graiwer, J., & Vichinsky, E. (2021). Voxelotor in adolescents and adults with sickle cell disease (HOPE): Long-term follow-up results of an international, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Haematology, 8(5), e323-e333.
Kamper, S. J., Maher, C. G., & Mackay, G. (2009). Global rating of change scales: A review of strengths and weaknesses and considerations for design. Journal of Manual & Manipulative Therapy, 17(3), 163-170.
Kamper, S. J., Ostelo, R. W., Knol, D. L., Maher, C. G., de Vet, H. C., & Hancock, M. J. (2010). Global Perceived Effect scales provided reliable assessments of health transition in people with musculoskeletal disorders, but ratings are strongly influenced by current status. Journal of Clinical Epidemiology, 63(7), 760-766.e1.
Perrot, S., & Lantéri-Minet, M. (2019). Patients Global Impression of Change in the management of peripheral neuropathic pain: Clinical relevance and correlations in daily practice. European Journal of Pain (London, England), 23(6), 1117-1128.
Rampakakis, E., Ste-Marie, P. A., Sampalis, J. S., Karellis, A., Shir, Y., & Fitzcharles, M. A. (2015). Real-life assessment of the validity of patient global impression of change in fibromyalgia. RMD Open, 1(1), e000146.
Protocol ID
860801
Variables
Export Variables| Variable Name | Variable ID | Variable Description | dbGaP Mapping | |
|---|---|---|---|---|
| PX860801_Patient_Reported_Impression_Change_Status | ||||
| PX860801010000 | Since the start of the study, my overall more | N/A | ||
Measure Name
Patient Reported Impression of Change
Release Date
May 18, 2022
Definition
A measurement based on a report coming directly from the participant regarding the change in status of their overall health.
Purpose
This measure provides study participants the opportunity to assess the change in their health status.
Keywords
pain, treatment effectiveness, sickle cell, sickle cell disease, sickle cell disease pain
Measure Protocols
| Protocol ID | Protocol Name |
|---|---|
| 860801 | Patient Global Impression of Change |
Publications
There are no publications listed for this protocol.