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Protocol - Patient Global Impression of Change

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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

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

Availability

Available

Personnel and Training Required

None

Equipment Needs

None

Requirements
Requirement CategoryRequired
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
StandardNameIDSource
caDSR Common Data Elements (CDE) Patient Global Change Impression Measurement Category 2848726 CDE Browser
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 IDVariable DescriptiondbGaP Mapping
Pain
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.