The validity of the SF-12 and SF-6D instruments in people living with HIV/AIDS in Kenya - PubMed (original) (raw)

The validity of the SF-12 and SF-6D instruments in people living with HIV/AIDS in Kenya

Anik R Patel et al. Health Qual Life Outcomes. 2017.

Abstract

Background: Health-related quality of life (HRQoL) and health state utility value (HSUV) measurements are vital components of healthcare clinical and economic evaluations. Accurate measurement of HSUV and HRQoL require validated instruments. The 12-item Short-Form Health Survey (SF-12) is one of few instruments that can evaluate both HRQoL and HSUV, but its validity has not been assessed in people living with HIV/AIDS (PLWHA) in east Africa, where the burden of HIV is high.

Methods: This cross-sectional study used baseline data from a randomized trial involving PLWHA in Kenya. Data included responses from a translated and adapted SF-12 survey as well as key demographic and clinical data. Construct validity of the survey was examined by testing the SF-12's ability to distinguish between groups known in advance to have differences in their health based on their disease severity. We classified disease severity based on established definitions from the US Center for Disease Control (CDC) and WHO, as well as a previously studied viral load threshold. T-tests and ANOVA were used to test for differences in HRQoL and HSUV scores. Area under the receive operator curve (AUC) was used to test the discriminative ability of the HRQoL and HSUV instruments.

Results: Differences in physical component scores met the minimum clinically important difference among participants with more advanced HIV when defined by CD4 count (4.3 units) and WHO criteria (compared to stage 1, stages 2, 3 and 4 were 2.0, 7.2 and 9.8 units lower respectively). Mental score differences met the minimum clinically important difference between WHO stage 1 and stage 4 patients (4.4). Differences in the HSUV were statistically lower in more advanced HIV by all three definitions of severity. The AUC showed poor to weak discriminatory ability in most analyses, but had fair discriminatory ability between WHO clinical stage 1 and clinical stage 4 individuals (AUC = 0.71).

Conclusion: Our findings suggest that the Kiswahili translated and adapted version of the SF-12 could be used as an assessment tool for physical health, mental health and HSUV for Kiswahili-speaking PLHWA.

Trial registration: Clinical trials.gov identifier: NCT00830622 . Registered 26 January 2009.

Keywords: HIV; Health state utility; Kiswahili; Quality of life; SF6D; Short-form 12.

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Conflict of interest statement

The study protocol was approved by the University of Manitoba and Kenyatta National Hospital ethics review boards. Research Ethics was approved by the UBC Behavioural Research Ethics Board under application number H10–00392.

N/A.

Competing interests

Richard T Lester is Executive and Scientific Director of the WelTel International mHealth Society and WelTel Incorporated, which develop and implement mobile health solutions. The remaining authors declare they have no competing interests.

Figures

Fig. 1

Fig. 1

The PCS and SF-6D ROC curves when comparing WHO stage one to more advanced stages. Caption: The area under the ROC curve (AUC) is a measure of signal to noise of an instrument. The signal appears to improve as the severity gap between the comparison groups increases. This indicates discriminatory ability of both survey scores and gives face validity to them since the survey is correctly measuring what it was designed to measure

Fig. 2

Fig. 2

The ROC curves of SF-12 derived PCS and MCS using CD4 and viral load thresholds. Caption: The signal was weaker in this comparison, partly because of the more general definitions of severity. However, both PCS and MCS showed some signal by CD4 severity threshold comparison

Fig. 3

Fig. 3

Histogram of survey scores. Caption: The PCS and MCS scores did not appear to have any floor or ceiling effects in this sample. However, the SF6D may have had both a floor effect at a score of 0.3 and a ceiling effect at a score of 1

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