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The Short Form (SF)-36 health survey questionnaire as an outcome ...

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<strong>The</strong> <strong>Short</strong> <strong>Form</strong> (<strong>SF</strong>)‐<strong>36</strong> <strong>health</strong> <strong>survey</strong> <strong>questionnaire</strong> <strong>as</strong> <strong>an</strong><br />

<strong>outcome</strong> me<strong>as</strong>ure in contraceptive research<br />

(Ph<strong>as</strong>e 1 results of the HRQL ch<strong>an</strong>ges among DMPA users trial 2009)<br />

Dr. Sikolia W<strong>an</strong>yonyi<br />

Senior resident<br />

Dept. OBGYN<br />

Aga Kh<strong>an</strong> University Hospital<br />

NAIROBI, KENYA<br />

International conference on Family pl<strong>an</strong>ning: Research <strong>an</strong>d Best Practices, Kampala<br />

2009


•<br />

•<br />

•<br />

•<br />

•<br />

•<br />

Introduction<br />

Objective<br />

Methods<br />

Data m<strong>an</strong>agement<br />

Results<br />

Conclusions<br />

Outline<br />

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•<br />

•<br />

•<br />

•<br />

Introduction<br />

Contraceptive is often a lifestyle choice<br />

It could impact on the quality of life (QoL) of users<br />

Focus h<strong>as</strong> been on side effects <strong>an</strong>d contraceptive efficacy<br />

<strong>The</strong> effect of contraceptives on QoL could also affect<br />

acceptability, uptake <strong>an</strong>d discontinuation rates<br />

Trussell et al. Fam Pl<strong>an</strong> Pers 1999(31); www.who.int<br />

3


•<br />

•<br />

•<br />

Introduction<br />

Contraceptive users are presumably a <strong>health</strong>y population<br />

Knowledge on contraceptive related QoL ch<strong>an</strong>ges is essential<br />

for uptake <strong>an</strong>d continuation of use<br />

QoL tools e.g. <strong>SF</strong>‐<strong>36</strong>, have not been adequately used in<br />

contraceptive research<br />

Trussel et al. Fam Pl<strong>an</strong> Pers 1999(31), Brazier JE et al. BMJ 1992(308), Garrat et al. BMJ 1993(306)<br />

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Characteristics of Me<strong>as</strong>ures of Health-related Quality of Life<br />

Approach Strength Weakness<br />

Generic Instruments e.g.<br />

<strong>SF</strong>‐<strong>36</strong><br />

Specific instruments<br />

(condition or population<br />

specific)<br />

•Single instrument needed<br />

•Detects different <strong>as</strong>pects of<br />

<strong>health</strong> status<br />

•Comparisons across<br />

conditions possible<br />

•Clinically sensible<br />

•More responsive<br />

Guyatt, G. H. et. al. Ann Intern Med 1993;118:622-629<br />

•May not focus adequately<br />

on area of interest<br />

•Cross‐condition<br />

comparisons not possible<br />

•Limited in population <strong>an</strong>d<br />

intervention<br />

5


•<br />

•<br />

•<br />

What Makes <strong>SF</strong>‐<strong>36</strong> a good HRQL me<strong>as</strong>ure?<br />

High signal‐to‐noise ratio<br />

–<br />

Responsiveness enh<strong>an</strong>ced<br />

Validity<br />

–<br />

Consistency with theoretically derived predictions<br />

Interpretability<br />

–<br />

Differences between patients small/trivial<br />

Guyatt, G. H. et. al. Ann Intern Med 1993;118:622-629; http://www.r<strong>an</strong>d.org<br />

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Main Objective<br />

To determine the internal consistency <strong>an</strong>d reliability of<br />

<strong>Short</strong> <strong>Form</strong> (<strong>SF</strong>)‐<strong>36</strong> <strong>health</strong> <strong>survey</strong> <strong>questionnaire</strong>s<br />

among users of DMPA<br />

7


Research question<br />

•<br />

Methods<br />

Is the <strong>SF</strong>‐<strong>36</strong> a reliable tool in <strong>as</strong>sessing the effects of contraceptives<br />

on the <strong>health</strong> related quality of life?<br />

Main <strong>outcome</strong> me<strong>as</strong>ures<br />

•<br />

<strong>The</strong> eight scales of the <strong>SF</strong> <strong>36</strong> <strong>health</strong> <strong>survey</strong> profile<br />

Setting<br />

•<br />

<strong>The</strong> Aga Kh<strong>an</strong> University Hospital <strong>an</strong>d Family Health Options clinics,<br />

Nairobi, Kenya.<br />

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Mode of administration of <strong>SF</strong>‐<strong>36</strong> Questionnaire<br />

•<br />

•<br />

Interviewer‐b<strong>as</strong>ed<br />

–<br />

–<br />

–<br />

Maximizes response rate<br />

Few if <strong>an</strong>y missing items<br />

Minimizes errors of misunderst<strong>an</strong>ding<br />

Other modes<br />

–<br />

–<br />

–<br />

Telephone<br />

Self administered<br />

Surrogate responders


•<br />

•<br />

•<br />

•<br />

Analysis: SPSS version 15.0<br />

Inter scale correlations‐<br />

Data m<strong>an</strong>agement<br />

Kline’s criterion of 0.4<br />

Internal consistency‐ Cronbach’s α (Nunnally’s criterion of<br />

0.7)<br />

Sub group <strong>an</strong>alysis done<br />

Kline P. A. H<strong>an</strong>dbook of test construction, London 1986; Nunnaly JL. Psychometric theory ,NY 1978<br />

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Study flow<br />

147 Screened<br />

131 recruited<br />

107 met eligibility criteria<br />

( For 6 months follow-up)<br />

16 Declined<br />

24 excluded<br />

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•<br />

•<br />

•<br />

•<br />

•<br />

Me<strong>an</strong> age: 31.4 years (SD 5.8)<br />

Results<br />

Average family size: 1.7 children<br />

Marital status: 90.8% married<br />

Level of education: 78.7%<br />

tertiary<br />

53% were contraceptives naive prior to DMPA<br />

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Internal consistency of <strong>SF</strong> <strong>36</strong> <strong>health</strong> <strong>questionnaire</strong><br />

<strong>SF</strong> Scale Items Alpha Me<strong>an</strong> Item scale<br />

correlation<br />

Physical Functioning 10 0.89 82.63 0.44<br />

Social Functioning 2 0.56 77.61 0.39<br />

Role limitation/physical 4 0.83 82.79 0.55<br />

Role limitation/emotional 3 0.79 76.83 0.55<br />

Energy fatigue 4 0.62 67.20 0.29<br />

Mental <strong>health</strong> 5 0.75 71.39 0.38<br />

Pain 2 0.73 79.05 0.57<br />

General Health 5 0.59 73.95 0.23<br />

NB: Reliability is considered acceptable if α exceeds 0.7 or Item scale<br />

correlations above 0.4<br />

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•<br />

•<br />

•<br />

Conclusions<br />

<strong>SF</strong>‐<strong>36</strong> is a potential me<strong>as</strong>ure of <strong>outcome</strong> among<br />

contraceptives users<br />

It is acceptable, internally consistent <strong>an</strong>d a reliable me<strong>as</strong>ure<br />

of <strong>health</strong> status<br />

This tool should be tested <strong>an</strong>d modified among FP users for<br />

possible adoption by researchers <strong>an</strong>d providers<br />

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•<br />

•<br />

•<br />

Conclusions<br />

Knowledge of the impact of contraceptives on QoL could lead<br />

to better uptake of FP <strong>as</strong> a lifestyle choice<br />

Motivated <strong>an</strong>d informed users are less likely to discontinue<br />

contraceptive methods chosen<br />

Specific psychometric tools could also be developed <strong>an</strong>d<br />

adopted<br />

W<strong>an</strong> GJ et al. Contraception 2007(7); Sonnenberg FA et al. Contraception 2004(69); Hubarcher<br />

D et al. Contraception 1999(60)<br />

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