Quality of life (QOL) is an important outcome of HIV treatment and a priority in the management of HIV. A new Patient-Reported Outcomes (PRO) questionnaire to measure the QOL in people living with HIV/AIDS (PLWHA) from different cultures and language groups has been developed. The instrument, PROQOL-HIV, has undergone psychometric validation in 791 individuals from 8 countries including 99 people from the WA HIV Cohort Study

Acquadro, C.

Duracinsky, M.

Herrmann, S.

Lalanne, C.

Mallal, S.

Nolan, D.

English

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  MURDOCH RESEARCH REPOSITORY  http://researchrepository.murdoch.edu.au/9396/             Herrmann, S., Duracinsky, M., Lalanne, C., Acquadro, C., Mallal, S. and Nolan, D. (2009) Health-related quality of life in the WA HIV Cohort: 2008. In: 21st Annual Conference of the Australasian Society for HIV Medicine (ASHM), 9 - 11 September, Brisbane, Australia.   Presentation              It is posted here for your personal use. No further distribution is permitted.    1Western AustralianHIV Cohort StudyWestern AustralianHIV Cohort StudyHerrmann S, Duracinsky M, Lalanne C, McKinnon E, Acquadro C, Mallal S, Nolan DHEALTH-RELATED QUALITY OF LIFE IN THE WA HIV COHORT: 2008  Introduction Introduction• Health related quality of life (HRQL) is a major concern in the clinical care of people living with HIV. • Measuring quality of life (QOL) is one way of assessing the patients experience with long term therapies  and other psychosocial dimensions  of living with the infection.• Patient reported outcomes (PRO), measure HRQL – their use is mandatory during the drug approval process.• PRO instruments currently used were devised for generic health assessment  and during the early  HAART period.1. EMEA/CHMP/EWP/139391/2004. Reflection paper on the regulatory guidance for the use ofhealth-related quality of life (HRQL) measures in the evaluation of medicinal products. London,EMEA, 2005.2. 2. Draft Guidance for Industry – Patient-reported Outcomes Measures: Use in Medical ProductDevelopment to support Labeling Claims. Docket 2006D-0044, FDA Federal Register, 2006.Introduction Introduction• A new Patient-Reported Outcomes questionnaire to measure QOL in people living with HIV/AIDS has been developed. • The instrument, PROQOL-HIV, has undergone psychometric validation in 791 individuals from 8 countries including 102 people from the WA HIV Cohort Study. Here we describe:1. Factors influencing HRQL in the WA HIV Cohort Study2. Some comparisons with other countries3. The reliability and validity of the PROQOL-HIV questionnaireMETHODS102 patients (792 globally) attending the Royal Perth Hospital Immunology Outpatient Clinic- completed three HRQL instruments: • (1) the 70-item PROQOL-HIV – to be tested• (2) the EQ-5D• (3) the MOS-HIV *• (4) a symptom questionnaire• Other information: Self reported missed doses in the preceding two weeks, demographic and biomedical data  ata The QOL score The QOL score† † from the PROQOL from the PROQOL- -HIV was expressed on a 0 HIV was expressed on a 0- -100  100 point scale with higher values indicating better QOL. point scale with higher values indicating better QOL.* *France, USA and Australia only,  France, USA and Australia only, †  † standardised standardised raw score raw scoreMETHODS: METHODS: (1) The PROQOL (1) The PROQOL- -HIV  Questionnaire HIV  Questionnaire• • Ability to work Ability to work• • Social life Social life• • Stigma  Stigma • • Family Family• • Sexuality  Sexuality • • Spirituality Spirituality• • Medication  Medication • • Energy/fatigue Energy/fatigue• • Psychological burden Psychological burden• • Leisure  Leisure • • Ability to travel Ability to travel• • Resources ResourcesQualitative input from semi directive interviews revealed 12 dominant themes which informed the 70 item PROQOL-HIV questionnaire to be validated:METHODS METHODS: (2) The  (2) The MOS-HIV SF 36• general health perceptions• physical functioning• role functioning• pain• social functioning• mental health • energy • health distress • cognitive functioning • quality of lifeA physical health summary score: PHS A physical health summary score: PHSA mental health summary score: MHS A mental health summary score: MHS2METHODS: (3, 4) The EQ-5D & Symptom Questionnaire The EQ-5D is a standardised instrument for use as a generic measure of health outcome. It assess 5 traits:• Mobility, self-care, usual activities, pain/discomfort, and anxiety/depression together with a general health state scored on a visual analogue scale.Symptoms/health conditions were measured using an modified version of the self completed HIV symptom index developed by Justice et al (2001)1. Physical Health & Symptoms  (PHS)2. Treatment Impact (TI) 3. Emotional Distress (ED)4. Health Concerns (HC)5. Body Image (BC)6. Intimate relationships (SR)7. Social Relationships(IR)8. Stigma (St)PROQOL sub-scales RESULTS - Psychometric validation RESULTS: Patient characteristics: AustraliaN=102• Mostly caucasian(80%) men (85%)• Agedbetween  37 – 53 yrs (mean 45)• The earliest diagnosis was in 1981 with half of the patients diagnosed before 2000 (n=47) and half since (n=55)• Transmissioncommonly msm (53%)• Hetero = 27%, IVDU = 20%• Living alone (39%) vs with a partner (33%) vs with others (28%) and employed (80% vs 18%)• Most common co-morbidity:  depression (24%) followed by HCV (17%), psychiatric disorder (5%), CVD (3%) and HBV (2%)RESULTS: Patient characteristics: Australiaantiretroviral therapy (ART),  n = 87• 87 pts  on ART, 76% were 100% adherent• 52% on protease inhibitors (PI)• 70% on a once daily regimen• 85% had an undetectable viral load• Mean CD4T cell count ranged from 6 – 62% average = 26%RESULTS:  RESULTS: Patients on protease inhibitors  Patients on protease inhibitors n = 42 (52%) n = 42 (52%)• More likely to be on BD regimen (p= 0.01)• Take more tablets (p<0.001)• Report more symptoms (p=0.007)RESULTS: PROQOL –HIV ScoreAll patients (n = 102) All patients (n = 102)50.2, 64.4, 77.6 50.2, 64.4, 77.6Naïve patients (n= 13) Naïve patients (n= 13)48.1, 64.1, 77.6 48.1, 64.1, 77.6Treated patients (n=87) Treated patients (n=87)50.9, 65.4, 79.8 50.9, 65.4, 79.8Lowest , median and highest score3RESULTS: All Countries RESULTS: All CountriesVariable  West AustraliaN = 102All countriesN = 692P - valueGender m/f 85/15%      (87/15) 60/40%     (419/273) <0.001Age (yrs) 45 41   <0.001Body Mass Index 25 23 <0.001Diagnosis (<2008) 3      7   16 2     5    9 <0.001TransmissionMsmHeteroIVDU53%   (54)27%   (28)20%   (20)26%   (175)55%   (374)10%   (68)<0.001<0.001NSLiving alone  39%  (40)  19% (131) <0.001Secondary education 98%   (100) 19%   (126) <0.001DemographicsRESULTS: All Countries RESULTS: All CountriesVariable  West AustraliaN = 102All countriesN = 692P - valueDepression 24%   (24) 10 %   (67) 0.037Psychiatric disorder 5%     (5) 6%      (41) NSHepatitis C  17% (17) 12% (72) NSHepatitis B 2% (2) 6%  (36) NSCardiovascular disease3%    (3) 11%    (69) NSAlcohol (>2/day) 15%    (15) 8%    (47) 0.027Tobacco (>2/day) 40%   (41) 28%   (163) 0.008Co-morbidities and SubstancesRESULTS: All Countries RESULTS: All CountriesVariable  West AustraliaN = 102All countriesN = 692P - valueTreatment/naive 85% (87) 86% (596) NSDosing scheduleOD, BD, >BD70.5% (62) = OD29.5 (26) = (BD)0 = >BD18%= OD82%= (≥BD)ART pill burden 3    5  <0.001100% Adherence (last 2 weeks)79% (84) 70% (512) <0.04CD4 T Cell copies/ml 579 405 <0.001Viral load (undetectable)75%   (77) 85%   377 NSNo of symptoms 7 9 0.018Treatments and OutcomesRESULTS: Rank order of factors influencing  Rank order of factors influencing Quality of Life Quality of LifeVariable All Countries West AustraliaSymptom burden (≥5) 1 2Depression 2 1Dosing schedule (≥BD) 3 6Pill burden (>2tablets) 4 8Psychiatric disorder 5 4CD4 T-cell count (<200cps/ml) 6 7Lack of Professional activity 7 3Gender (female) 8 5Living alone 9 7Cardiovascular disease 10 9PROQOL std score 47.4   60.8 61.3 50.2   64.4 7.6RESULTS: Differences in sub-scales according to countryAustralia, US & FranceBrazil & ThailandChina & CambodiaSenegal Social relationshipsPhysical health & symptomsGeneral healthTreatment impactBody imageHealth concernsEmotional distressStigmaIntimate relationshipsRESULTS: Differences in sub-scales according to countryAustralia, US & FranceBrazil & ThailandChina & CambodiaSenegal Social relationshipsPhysical health & symptomsGeneral healthTreatment impactBody imageHealth concernsEmotional distressStigmaIntimate relationships4Relationship of depression to PROQOL subscales (Each sub-scale contributes equally)Physical health & symptomsGeneral healthStigma & intimate relationshipsEmotional distress& health concernsTreatment impactDepressedNot depressed20 40 60 80 100N = 102 Western Australians RESULTS: Depression & Symptoms• Participants who reported depression scored on average 13 points lower (95% CI, [-20.8;-6.2]) • For each increase in the number of reported symptoms, there is a loss of about 2 points of HRQL (95% CI, [-2.3;1.1]).RESULTS: RESULTS: Multivariate analysis  Multivariate analysis - -Australians AustraliansNumber of symptoms   Number of symptoms   p < 0.001 p < 0.001Depression  Depression  p < 0.001 p < 0.001Living alone  Living alone  p = 0.005 p = 0.005Younger age   Younger age   p = 0.003 p = 0.003Heterosexual transmission Heterosexual transmission p = 0.008 p = 0.008On a protease inhibitor On a protease inhibitor p = 0.046 p = 0.046Linear Regression AnalysisRelative importance of scoresDepression Symptoms Age Transmission Treatment Pill burden LivingLower scores were associated with more symptoms, depression, younger age, heterosexual transmission, not living with a partner, PI treatment and higher pill burdenReliability and ValidityQ Is the PROQOL-HIV  a ‘valid’ PRO questionnaire? Does it measure what it is required to measure? Q Is the PROQOL-HIV  a ‘reliable’ PRO questionnaire? Are the observed scores reproducible when the questionnaire is readministered?Physical Health ScoreMental Health ScoreJoint distribution of PROQOL-HIV scores and the composite scores for MOS-HIV  PHS and MHSR = 0.667                R = 0.8145Joint distribution of PROQOL-HIV scores and EQ-5D *visual analogue scoreThe visual analogue scale = “your own health state today”: *Best imaginable health state = 100%                              worst imaginable = 0%VALIDITYr = 0.632RELIABILITY RELIABILITYScores reliability was assessed using ￿ Cronbach’s alpha = 0.936 ￿ (95% CI = 0.929 – 0.943) ￿ Intra- class correlation coefficient = 0.859￿ (n= 34, 95% CI = 0.701-0.959) SUMMARYIn Western Australia in 2008• The most significant health condition influencing quality of life was depression • 30% of depressed patients also had hepatitis C• Depression and the number of reported symptoms were related• People who acquired HIV heterosexually seem to have worse quality of life• Patients on PIs reported more symptoms/health conditionsSUMMARY SUMMARY￿ The PROQOL-HIV  is a ‘valid’ PRO questionnaireIt measures what it purports to measure￿ The PROQOL-HIV  is a ‘reliable’ PRO questionnaire The scores observed are reproducible when the questionnaire is readministeredCOMMENTSThere is an indication to examine: • The ‘social drivers’ of depression in the context of HIV and coinfections • The  role of stigma and shame and how stigma affects PLWHA￿ There exists a need to • Consider how societal inequalities for example within gender and ethnicity are exacerbated by HIV and impact on QOL*• Intervene to reduce substance use and prevent significant associated morbidity*Kippax et al 2007CONCLUSION• The data demonstrate the validity and utility of the PROQOL-HIV to measure QOL in this population. • The implications of a high frequency of depression is concerning• Rates of adherence are encouraging and are probably the outcome of active ongoing adherence support• The information is a useful adjunct to national surveys and can be used to inform HIV services in WA. 6FranceProf. JF. DelfraissyService de Médecine Interne et de Maladies Infectieuses Hopital Universitaire de Bicetre (AP-HP)BrazilMauro Schechter, MD PhDProfessor of Infectious DiseasesHead, AIDS Research LaboratoryHospital Universitario Clementino Fraga FilhoUniversidade Federal do Rio de JaneiroChinaProf. Ji-Qian Fang PhdChair Professor, School of Public HealthSun Yat-Sen UniversityGuangzhou, China IndiaDr RewaKholiBehavioural ScientistNational AIDS Research InstitutePune INDIASénégalPr Papa Salif SawCHNU de Fann, Dakar, SénégalThaïlandMarc Lallemant, MD - Programs for HIV Preventionand Treatment (PHPT) Sopie LecoeurChiang Mai, ThailandCambodiaESTHEREnsemble pour une Solidarité ThérapeutiqueHospitalière En RéseauHôpital Calmette, Phnom PehnDr LY Cheng Huy,USAProf Robert L. Murphy, MD, Director of ClinicalResearchBaiba Berzins, MPHDivision of Infectious DiseasesNorthwestern University, Chicago, Acknowledgements:  study sitesNursing, Medical and Allied Health Ambulatory HIV Service Royal Perth HospitalThe Centre for Clinical Immunology & Biomedical StatisticsThe Department of Immunology & ImmunogeneticsParticipants in the WA HIV Cohort StudyAcknowledgementsThe National Health & Medical Research CouncilS Herrmann received an ASHM scholarship to attend the conferenceThe study at RPH was partly supported by SidactionDisclosure slide Disclosure slideSusan HerrmannMartin DuracinskyCatherine AcquadroChristophe LalanneSimon Mallal David NolanGrants/Research SupportNone Gilead Sciences Hospitals of Paris (AP-HP)SidactionGilead SciencesNone None NoneConsultants None None Mapi Group None Merck, GlaxoSmithKline,J&J (Tibotec)GlaxoSmithKline, Gilead SciencesSpeaker’s BureauNone None None None GlaxoSmithKline Abbott Laboratories, Boehringer Ingelheim, Gilead Sciences, GlaxoSmithKline, MerckStock Holder None None None None None NoneOther None Scientific Advisor for Sanofi Aventis, GileadNone None None None

Health-related quality of life in the WA HIV Cohort: 2008

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Health-related quality of life in the WA HIV Cohort: 2008

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