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The internal and external responsiveness of Functional Assessment of Cancer Therapy-Prostate (FACT-P) and Short Form-12 Health Survey version 2 (SF-12 v2) in patients with prostate cancer

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An Erratum to this article was published on 07 April 2016

Abstract

Purpose

To examine the responsiveness of Functional Assessment of Cancer Therapy-Prostate (FACT-P) and Short Form-12 Health Survey version 2 (SF-12 v2) in prostate cancer patients because there is a lack of evidence to support their responsiveness in this patient population.

Methods

One hundred sixty-eight subjects with prostate cancer were surveyed at baseline and at 6 months using the SF-12 v2 and FACT-P version 4. Internal responsiveness was assessed using paired t test and generalized estimating equation. External responsiveness was evaluated using receiver operating characteristic curve analysis.

Results

The internal responsiveness of the FACT-P and SF-12 v2 to detect positive change was satisfactory. The FACT-P and SF-12 v2 could not detect negative change. The FACT-P and the SF-12 v2 performed the best in distinguishing between improved general health and worsened general health. The FACT-P performed better in distinguishing between unchanged general health and worsened general health. The SF-12 v2 performed better in distinguishing between unchanged general health and improved general health.

Conclusions

Positive change detected by these measures should be interpreted with caution as they might be too responsive to detect “noise,” which is not clinically significant. The ability of the FACT-P and the SF-12 v2 to detect negative change was disappointing. The internal and external responsiveness of the social well-being of the FACT-P cannot be supported, suggesting that it is not suitable to longitudinally monitor the social component of HRQOL in prostate cancer patients. The study suggested that generic and disease-specific measures should be used together to complement each other.

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Abbreviations

HRQOL:

Health-related quality of life

FACT-P:

Functional Assessment of Cancer Therapy-Prostate

PWB:

Physical well-being

SWB:

Social well-being

EWB:

Emotional well-being

FWB:

Functional well-being

TOI:

Trial Outcome Index

PF:

Physical functioning

RP:

Role physical

BP:

Bodily pain

GH:

General health

VT:

Vitality

SF:

Social functioning

RE:

Role emotional

MH:

Mental health

PCS-12:

Physical composite summary

MCS-12:

Mental composite summary

SES:

Standardized effect size

SRM:

Standardized response mean

RS:

Responsiveness statistic

GRS:

Global Rating on Change Scale

SF-12 v2:

Short Form-12 Health Survey version 2

ROC:

Receiver operating characteristic

AUC:

Area under the receiver operating characteristic curve

PSA:

Prostate-specific antigen

GEE:

Generalized estimating equation

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Acknowledgments

The authors wish to express their gratitude to Professor Cindy L.K Lam for design and planning of this study and Charles Wong for his assistance in data collection.

Author information

Authors and Affiliations

  1. School of Nursing, University of Hong Kong, 4/F, William M.W. Mong Block, 21 Sassoon Road, Pok Fu Lam, Hong Kong

    Edmond P. H. Choi

  2. Department of Family Medicine and Primary Care, University of Hong Kong, Ap Lei Chau, Hong Kong

    Carlos K. H. Wong, Eric Y. F. Wan, W. Y. Chin & Kenny Kung

  3. Division of Urology, Department of Surgery, University of Hong Kong, Pok Fu Lam, Hong Kong

    James H. L. Tsu & M. K. Yiu

Authors
  1. Edmond P. H. Choi
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  2. Carlos K. H. Wong
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  3. Eric Y. F. Wan
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  4. James H. L. Tsu
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  5. W. Y. Chin
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  6. Kenny Kung
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  7. M. K. Yiu
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Corresponding author

Correspondence to Edmond P. H. Choi.

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Conflict of interest

All authors declare that he/she has no conflict of interest.

Ethics approval

The study protocol was approved by the institutional review boards: HKWC (Ref No.: UW13-239). All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Informed consent

Informed consent was obtained from all individual participants included in the study.

Appendix

Appendix

  • The SES was determined by dividing the differences between baseline and follow-up scores by the standard deviation of all subjects at baseline:

    $${\text{SES}} = \left( {{\text{Mean}}_{\text{Follow up}} - {\text{Mean}}_{\text{Baseline}} } \right)/{\text{Standard deviation}}_{\text{Baseline}}$$

  • The SRM was determined by dividing the differences between baseline and follow-up scores by standard deviation of observed difference:

    $${\text{SRM}} = \left( {{\text{Mean}}_{\text{Follow up}} - {\text{Mean}}_{\text{Baseline}} } \right)/{\text{Standard deviation}}_{{\left( {{\text{Follow up}} - {\text{Baseline}}} \right)}}$$

  • The RS was determined by dividing the differences between baseline and follow-up scores by the standard deviation of observed differences among “unchanged” group:

    $${\text{RS}} = \left( {{\text{Mean}}_{\text{Follow up}} - {\text{Mean}}_{\text{Baseline}} } \right)/{\text{Standard deviation}}_{{\left( {{\text{Follow up}} - {\text{Baseline}}} \right){\text{ no change}}}}$$

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Choi, E.P.H., Wong, C.K.H., Wan, E.Y.F. et al. The internal and external responsiveness of Functional Assessment of Cancer Therapy-Prostate (FACT-P) and Short Form-12 Health Survey version 2 (SF-12 v2) in patients with prostate cancer. Qual Life Res 25, 2379–2393 (2016). https://doi.org/10.1007/s11136-016-1254-1

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