Patient-reported outcomes

A module for healthcare professionals. Educational resource on patient-reported outcomes and measures and how they can be used in PLHIV.

Patient-Reported Outcomes - Module for Healthcare Professionals (HCPs)

Educational resource on patient-reported outcomes and measures and how they can be used in PLHIV.

Date of preparation: January 2021 Job code: IHQ-HIV-2021-01-0004

How to use this module

Patient-Reported Outcomes – eLearning Module for HCPs

At the end of this module you will be able to:

  • Understand what PROs and PROMs are and how they can be used in clinical settings
  • Discuss the impact of PROs on long-term health in PLHIV
  • Outline the examples of commonly used PROMs and their use in PLHIV

 

Background

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Treatment priorities differ between patients in HIV care and their providers

Patients and providers were asked to rank their top 8 and bottom 3 priorities, from a set of 25 domains, they would address in the context of a routine HIV clinical care visit. The 25 domains included various aspects of symptoms and functioning.

References

*The extent to which an individual subjectively experiences positive moods such as joy, interest and alertness.
Fisher’s exact test: patients (n=206) and providers (n=17) showed high discordance in rank order priorities (X2 [24,223]=71.12; p<0.0001).
Patients’ priorities differed between men and women (X2 [24,188]=52.89; p<0.0001), Caucasian versus other races (X2 [24, 206]=48.32; p=0.0023), and Latino versus non-Latino (X2 [24,206]=48.65; p=0.0021).
IPV, intimate partner violence.
Fredericksen RJ, et al. AIDS Behav 2020;24:1170–80.

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Viral suppression is no longer the only goal of HIV care: the ‘fourth 90’

  • In 2016, the World Health Organization adopted a new Global Health Sector Strategy on HIV, establishing the ‘90-90-90’ target1
  • This called on health systems to reduce underdiagnosis of HIV, treat a greater number of those diagnosed and ensure that those being treated achieve viral suppression2
  • Lazarus et al. proposed adding a ‘fourth 90’ to the testing and treatment target1

References

ART, antiretroviral therapy; PLHIV; people living with HIV; HRQoL, health-related quality of life.

  1. Lazarus JV, et al. BMC Medicine 2016;14:94; 2. UNAIDS.org. Available at https://www.unaids.org/en/resources/909090. Last accessed: October 2020.

What are PROs and PROMs, and why use them?

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Patient-reported outcome measures are the tools to measure patient-reported outcomes

References

PRO, patient-reported outcome; PROM, patient-reported outcome measure; QoL, quality of life.

Weldring T, Smith SM. Health Serv Insights 2013;6:61-8.

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PROs are becoming one of the key areas of focus in HIV1-4

References

PRO, patient-reported outcome; PROM, patient-reported outcome measure.
1. Bristowe K. A novel patient reported outcome measure for people living with HIV: development, face and content validity and stakeholder views on implementation. Available at: https://www.bhiva.org/file/xRtasJbTvYFkh/KatherineBristowe.pdf. Last accessed: October 2020; 2. Buscher A, Giordano TP. JAMA 2010;3:340–1; 3. Greenhalgh J. Qual Life Res 2009;18:115–23; 4. Holmes M, et al. Qual Life Res 2017;26:245–57.

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PROs could help improve care models and patients’ outcomes1–3

  • PROs could enable HCPs to better engage with patients’ needs, values, perceptions and experiences of their care – ultimately helping to improve health services1
  • “Measures and methods to collect and use PRO data offer new opportunities to ensure that the patients’ voice is at the heart of healthcare models worldwide”2

References

HCP, healthcare professional; PRO, patient-reported outcome; PROM, patient-reported outcome measure; QoL, quality of life.
1. Yang C, et al. AIDS Care 2020;32:238–41; 2. Kall M, et al. Lancet HIV 2020;7:E59-68; 3. Bristowe K, et al. HIV Med 2019;20:542–54.

PROs in a new model of patient-centred care

  • A UK and Ireland multi-centre study to identify priority outcomes for PLHIV and devise a model for person-centred care incorporating PROs
  • Interviews with PLHIV, HIV HCPs and HIV commissioners revealed various perceived benefits of PROMs in routine HIV care:
    • Person-centredness
    • Patient empowerment
    • Fewer missed concerns
    • Increased engagement with services
    • Informed care commissioning and resource allocation to improve healthcare service design and delivery
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References

ART, antiretroviral therapy; HCP, healthcare professional; PLHIV, people living with HIV; PRO, patient-reported outcome; PROM, patient-reported outcome measure.
Bristowe K, et al. HIV Med 2019;20:542–54.

PROMs provide a structured, validated approach to person-centred care

A patient-centred approach to HIV treatment and care is needed, focusing on the individual rather than treating symptoms and concerns in isolation1

Why are PROMs so valuable in clinical practice?

PROMs are increasingly incorporated into clinical practice. They allow clinicians to capture patient views, feelings and subjective experiences unlike traditional methods such as biophysical measures2

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References

PROM, patient-reported outcome measure.
1. Bristowe K, et al. Health Qual Life Outcomes 2020;18:214; 2. Holmes M, et al. Qual Life Res 2017;26:245–57.

PROMs aim to quantitatively assess a patient’s experience

PROMs provide key data on the aspects of patient health and treatment that may only be obtained from the patient1–3

Self-reporting can be problematic for some patients; in these situations, proxy-reporteda outcome measures may be used to report how the HCP thinks the patient would report on their HRQoL4

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References

aDefined as healthcare providers, spouses, parents or relatives who are closely involved with the patient and can act as alternative sources to obtain information about patients’ HRQoL4
HCP, healthcare professional; HRQoL, health-related quality of life; PROM, patient-reported outcome measure.
1. Porter I, et al. J Comp Eff Res 2016;5:507–19; 2. US Food and Drug Administration. Clinical trial endpoints. Available at: https://www.fda.gov/downloads/Training/ClinicalInvestigatorTrainingCourse/UCM337268.pdf. Last accessed: October 2020; 3. Deshpande PR, et al. Perspect Clin Res 2011;2:137–4; 4. Simpelaere I, et al. JBI Database of System Rev Implement Rep 2016;14:45–75;

PROMs aim to quantitatively assess a patient’s experience

PROMs provide key data on the aspects of patient health and treatment that may only be obtained from the patient1–3

Self-reporting can be problematic for some patients; in these situations, proxy-reporteda outcome measures may be used to report how the HCP thinks the patient would report on their HRQoL4

Click to zoom

References

HCP, healthcare professional; HRQoL, health-related quality of life; PROM, patient-reported outcome measure.
1. Porter I, et al. J Comp Eff Res 2016;5:507–19; 2. US Food and Drug Administration. Clinical trial endpoints. Available at: https://www.fda.gov/downloads/Training/ClinicalInvestigatorTrainingCourse/UCM337268.pdf. Last accessed: October 2020; 3. Deshpande PR, et al. Perspect Clin Res 2011;2:137–4; 4. Simpelaere I, et al. JBI Database of System Rev Implement Rep 2016;14:45–75;

PROMs aim to quantitatively assess a patient’s experience

PROMs provide key data on the aspects of patient health and treatment that may only be obtained from the patient1–3

Self-reporting can be problematic for some patients; in these situations, proxy-reporteda outcome measures may be used to report how the HCP thinks the patient would report on their HRQoL4

Click to zoom

References

HCP, healthcare professional; HRQoL, health-related quality of life; PROM, patient-reported outcome measure.
1. Porter I, et al. J Comp Eff Res 2016;5:507–19; 2. US Food and Drug Administration. Clinical trial endpoints. Available at: https://www.fda.gov/downloads/Training/ClinicalInvestigatorTrainingCourse/UCM337268.pdf. Last accessed: October 2020; 3. Deshpande PR, et al. Perspect Clin Res 2011;2:137–4; 4. Simpelaere I, et al. JBI Database of System Rev Implement Rep 2016;14:45–75;

PROMs help identify risk factors of non-adherence to ART

Case study – Harborview Medical Center

Patients at Harborview Medical Center (USA) were asked to complete a PROM

  • Same-day PRO assessment
  • Quality-of-care metrics compared in the
    8 months before and after feedback

Outcomes

Increased HCPs awareness of:

  • Depression
  • Inadequate adherence
  • Alcohol use
  • Substance use
  • Sexual risk behaviour

Incorrect documentation of good adherence fell from 42% to 24%

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References

*p<0.05. ART, antiretroviral therapy; HCP, healthcare professional; PRO, patient-reported outcome; PROM, patient-reported outcome measure.
Crane HM, et al. AIDS Behav 2017;21:3111–21.

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In clinical trials, PROMs can be used to investigate outcomes beyond traditional measures such as viral load

No gold-standard set of PROMs has been established, as PROMs continuously change to keep pace with improving care, and changing HIV epidemiology2

References

ART, antiretroviral therapy; PRO, patient-reported outcome; PROM, patient-reported outcome measure.
1. Engler K, et al. Patient 2017;10:187–202; 2. Kall M, et al. Lancet HIV 2020;7:E59-68; 3. Bristowe K, et al. Health Qual Life Outcomes 2020;18:214.

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Examples of PROMs use in HIV clinical research | The START study

START Study:

ART initiation at CD4+ count >500 cells/mm3 versus ART initiation deferred until CD4+ count <350 cells/mm3 or clinical eventa

  • ART initiation at CD4+ count >500 cells/mm3 was associated with a significantly longer time to first primary event (AIDS related and non-AIDS related complications including grade 4 events and deaths from any cause) and significantly lower rates of serious AIDS- and non-AIDS-related events versus deferred ART start

At BL, Months 4 and 12, then annually, participants completed a VAS for ‘perceived current health’ and the SF-12 v2, from which a general health perception score, PCSS and MCSS were computed:

  • Earlier ART initiation was associated with a higher QoL versus deferred:
    estimated difference in PCSS was 0.8 (95% CI: 0.5, 1.1; p<0.001) and in MCSS 0.9 (95% CI: 0.4, 1.3; p<0.001)
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Examples of PROMs use in HIV clinical research | Phase 3 studies

Study 1489: Double blind, active controlled, phase 3 trial investigating treatment-naïve adults (n=631). The primary end-point of the study was percentage of patients achieving <50 copies/mL at 48 weeks1,2
Study 1844: Double blind, active controlled, phase 3 trial investigating virologically suppressed adults (n=563). The primary end-point of the study was patients with virological failure (HIV01 RNA ≥50 copies/mL) at week 481,2

The HIV Symptom Index questionnaire was used to evaluate differences in PROs between BIC/FTC/TAF    and DTG/ABC/3TC in two head-to-head trials (Studies 1489 and 1844)1,2a

References

*Multivariate regression model controlled for age, sex, race, baseline HIV Symptom Index score, VACS Index, history of serious mental illness, baseline SF-36 physical and mental scores and years since diagnosis (for study 1844 only); **Longitudinal modelling was performed using generalised mixed-effects models to show symptom patterns over each of the four study visits; aOnly symptoms where ≥2 time points/models showed significance in either study are presented; = Statistically significant (p<0.05), based on the adjusted logistic regression model, favouring the BIC/FTC/TAF group over the DTG/ABC/3TC group.
3TC, lamivudine; ABC, abacavir; BIC, bictregravir; CNS, central nervous symptom; DTG, dolutegravir; FTC, emtricitabine; GI, gastrointestinal; PRO, patient-reported outcome; SF-36, Short Form 36 Health Survey; TAF, tenofovir alafenamide; VACS, Veterans Aging Cohort Study Index.
1. Wohl D. Patient 2018;11:561–73; 2. Wohl D. IAC 2018. PEB148.

Selecting and implementing PROMs

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PROMs are tailored to different clinical scenarios, depending on the PROs to be assessed

Many PROs are available in multiple languages and formats (ie. paper or digital questionnaires, HCP-patient discussion guides)

References

HCP, healthcare professional; HRQoL, health-related quality of life; PRO, patient-reported outcome; PROM, patient-reported outcome measure
FDA. Guidance for Industry Patient-Reported Outcome Measures. Available at: https://www.fda.gov/downloads/drugs/guidances/ucm193282.pdf. Last accessed: October 2020.

PROMs can be used to initiate and support interventions at all levels

Recent technological advances have made PROMs more accessible to patients and investigators, streamlining data collection and analysis (eg. with electronic PROMs and linkage to medical records)

Considerations for selecting PROMs for clinical trials could be summarised as shown in the following images

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References

*Population-level refers to general population or to sub-sectors of the general population, such as PLHIV, or subgroups within PLHIV, such as women living with HIV.
DALY, disability-adjusted life years; PLHIV, people living with HIV; PROM, patient-reported outcome measure; QALY, quality-adjusted life years.
Kall M, et al. Lancet HIV 2020;7:E59-68.

PROMs can be used to initiate and support interventions at all levels

Recent technological advances have made PROMs more accessible to patients and investigators, streamlining data collection and analysis (eg. with electronic PROMs and linkage to medical records)

Considerations for selecting PROMs for clinical trials could be summarised as shown in the following images

Click to zoom

References

*Population-level refers to general population or to sub-sectors of the general population, such as PLHIV, or subgroups within PLHIV, such as women living with HIV.
DALY, disability-adjusted life years; PLHIV, people living with HIV; PROM, patient-reported outcome measure; QALY, quality-adjusted life years.
Kall M, et al. Lancet HIV 2020;7:E59-68.

PROMs can be used to initiate and support interventions at all levels

Recent technological advances have made PROMs more accessible to patients and investigators, streamlining data collection and analysis (eg. with electronic PROMs and linkage to medical records)

Considerations for selecting PROMs for clinical trials could be summarised as shown in the following images

Click to zoom

References

*Population-level refers to general population or to sub-sectors of the general population, such as PLHIV, or subgroups within PLHIV, such as women living with HIV.
DALY, disability-adjusted life years; PLHIV, people living with HIV; PROM, patient-reported outcome measure; QALY, quality-adjusted life years.
Kall M, et al. Lancet HIV 2020;7:E59-68.

PROMs can be used to initiate and support interventions at all levels

Recent technological advances have made PROMs more accessible to patients and investigators, streamlining data collection and analysis (eg. with electronic PROMs and linkage to medical records)

Considerations for selecting PROMs for clinical trials could be summarised as shown in the following images

Click to zoom

References

*Population-level refers to general population or to sub-sectors of the general population, such as PLHIV, or subgroups within PLHIV, such as women living with HIV.
DALY, disability-adjusted life years; PLHIV, people living with HIV; PROM, patient-reported outcome measure; QALY, quality-adjusted life years.
Kall M, et al. Lancet HIV 2020;7:E59-68.

PROMs can be used to initiate and support interventions at all levels

Recent technological advances have made PROMs more accessible to patients and investigators, streamlining data collection and analysis (eg. with electronic PROMs and linkage to medical records)

Considerations for selecting PROMs for clinical trials could be summarised as shown in the following images

Click to zoom

References

*Population-level refers to general population or to sub-sectors of the general population, such as PLHIV, or subgroups within PLHIV, such as women living with HIV.
DALY, disability-adjusted life years; PLHIV, people living with HIV; PROM, patient-reported outcome measure; QALY, quality-adjusted life years.
Kall M, et al. Lancet HIV 2020;7:E59-68.

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Consider the diversity of people and their needs who will be completing PROMs to inform selection of the most appropriate instruments

References

aDefined as healthcare providers, spouses, parents or relatives who are closely involved with the patient and can act as alternative sources to obtain information about patients’ HRQoL.2

HCP, healthcare professional; HRQoL, health-related quality of life; PROM, patient-reported outcome measure.
1. Bristowe K. A novel patient reported outcome measure for people living with HIV: development, face and content validity and stakeholder views on implementation. Available at: www.bhiva.org/file/xRtasJbTvYFkh/KatherineBristowe.pdf. Last accessed: October 2020; 2. Simpelaere I, et al. JBI Database of System Rev Implement Rep 2016;14:45–75; 3. Kozak MS, et al. Clin Infect Dis 2012;54:141–7.

Examples of PROMs

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There are various generic and disease-specific PROMs

PROMs can measure various aspects of health and well-being – from overall HRQoL, to specific areas, such as fatigue or depression. Below are some examples of generic and disease-specific PROMs1

References

EQ-5D, EuroQol- 5 dimension; HIV-SI, HIV symptom index; HIV-QL, HIV quality of life; HIVTSQ, HIV treatment satisfaction questionnaire; HRQoL, health-related quality of life; PROM, patient-reported outcome measure; PROQOL-HIV, PRO quality of life-HIV; SF, Short Form Health Survey; WHOQOL-HIV, World Health Organization quality of life HIV instrument.
1. Bristowe K, et al. Health Qual Life Outcomes 2020;18:214;
2. Bristowe K. A novel patient reported outcome measure for people living with HIV: development, face and content validity and stakeholder views on implementation. Available at: https://www.bhiva.org/file/xRtasJbTvYFkh/KatherineBristowe.pdf. Last accessed: October 2020; 3. Duracinsky M, et al. J Acquir Immune Defic Syndr 2012;59:498–505.

Examples of HIV-specific PROMs

PROQOL-HIV

  • Covers 70 items across 11 themes using multiple languages and accounts for HAART treatment and AEs1
  • Themes include:
    • General health perception
    • Physical activity
    • Coping
    • Social relationships
    • Emotional distress
    • Future
    • Energy/fatigue
    • Impact on symptoms and side effects
    • Sleep
    • Treatment
    • Cognitive functioning

HIV-SI1

  • Covers 20 items across patient-reported symptoms and health-related quality of life, physician-assessed disease severity, CD4 cell count, and HIV-1 RNA viral quantification
  • Takes less than 5 minutes to complete

King’s College London’s HIV-specific PROM ‘Positive Outcomes’2

  • Reflects outcomes based on insights from PLHIV and HIV specialists
  • Six domains: physical, cognitive, psychological, welfare, social and information

HIV Stigma Scale

  • Patient stigma has historically contributed to higher morbidity and transmission of HIV3
  • Shorter PROMs (e.g. 12 items vs 40 items) may increase assessment of HIV stigma4

References

AE, adverse events; HAART, highly active antiretroviral therapy; PLHIV, people living with HIV; PRO, patient-reported outcome; PROM, patient-reported outcome measure; PROQOL-HIV, PRO quality of life-HIV.
1. Justice AC, et al. Appendices (Methods Papers) 2001;54(12):suppl 1 S77–S90;
2. Duracinsky M, et al. J Acquir Immune Defic Syndr 2012;59:498–505;
3. Bristowe K. A novel patient reported outcome measure for people living with HIV: development, face and content validity and stakeholder views on implementation. Available at: https://www.bhiva.org/file/xRtasJbTvYFkh/KatherineBristowe.pdf. Last accessed: October 2020;
4. Simbayi LC, et al. Soc Sci Med 2007;64:1823–31; 5. Reinius M, et al. Health Qual Life Outcomes 2017;15:115.

Examples of generic PROMs used in HIV

  • 36-Item Short Form Survey (SF-36)
    • Validated 36-item, self-reported questionnaire evaluating the following eight domains: physical function, mental health, role limitations due to physical health problems, role limitations due to emotional problems, bodily pain, social functioning, general health perceptions, vitality (energy/fatigue)
    • Each domain receives a score from 0 to 100, with a higher score indicating better health
  • EuroQoL-5D (EQ-5D)
    • The EQ-5D is a family of instruments (3 versions) used to describe and value health
    • The EQ-5D-5L is widely used in clinical research, and comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression
    • Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems
  • Pittsburgh Sleep Quality Index (PSQI)
    • Determines sleep quality and disturbances over the previous month
    • 19-item, self-reported questionnaire evaluating the following seven domains: sleep quality, latency, duration, efficiency, disturbances, use of sleep medication and daytime dysfunction
    • Total score ranges from 0 to 21, with lower score indicating better sleep quality

References

PROM, patient-reported outcome measure.

SF-36. Available at: https://www.rand.org/health-care/surveys_tools/mos/36-item-short-form/scoring.html. Last accessed: October 2020;
2. EQ-5D. Available at: https://euroqol.org/publications/user-guides/ Last accessed: October 2020; 3. Buysse DJ et al. Psychiat Res 1989:28:193–213.

Examples of generic PROMs: SF-36 in PLHIV

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References

*Significant correlation with other summary measure; †PCSS and MCSS were computed using standard scoring algorithms and categorised into terciles
CI, confidence interval; HR, hazard ratio; MCSS, mental component summary score; PCSS, physical component summary score; PLHIV, people living with HIV; PRO, patient-reported outcome PROM, patient-reported outcome measure; SF, Short Form Health Survey.
1. Adapted from Ware JE, et al. SF-36 Physical and Mental Health Summary Scales: A User’s Manual. 1994; 2. Emuren L, et al. Health Qual Life Outcomes 2018;16:107.

Examples of generic PROMs: EQ-5D in PLHIV

EQ-5D is a prognostically useful predictor of HRQoL among PLHIV

  • A retrospective analysis of HIV clinic-based cohort (N=965) between 1996 and 2000
  • Each item is coded using three levels (1=no problems; 2=some problems; 3=severe problems)*

EQ-5D was also a meaningful predictor of hospitalisation and emergency department use in the same patient cohort

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References

* The instrument includes a global rating of current health using a visual analogue scale ranging from 0 (worst) to 100 (best); aItems 1–4 (mobility, self-care, usual activities, pain/discomfort) are EQ-5D health states. Health change is not part of EQ-5D. EQ-5D health states, VAS health change, CD4 category, and HIV-1 plasma viral load are modelled as time-varying covariates; bEach covariate is adjusted only for CD4 category (<50, 50–199, ≥200) and plasma HIV-1 viral load (<1000, ≥1000 copies), not for the other listed health status items. CD4 category and plasma HIV-1 viral load are modelled as time-varying covariates.
CD4, cluster of differentiation cells 4; CI, confidence interval; EQ-5D, EuroQol- 5 dimension; HR, hazard ratio; HRQoL, health-related quality of life; PLHIV, people living with HIV; PRO, patient-reported outcome;
PROM, patient-reported outcome measure; VAS, visual analogue scale.
Mathews WC, et al. Health Qual Life Outcomes 2007;5:5.

Examples of generic PROMs: PSQI in PLHIV

The PSQI determines sleep quality and disturbances over the previous month1

  • 19-item questionnaire evaluating seven domains (total score ranges from 0 to 21, with lower score indicating better sleep quality)

PSQI domains1

  • Sleep quality
  • Latency
  • Duration
  • Efficiency
  • Disturbances
  • Use of sleep medication
  • Daytime dysfunction

References

PLHIV, people living with HIV; PROM, patient-reported outcome measure; PSQI, Pittsburgh Sleep Quality Index.
1. Buysse DJ et al. Psychiat Res 1989:28:193–213;

Examples of generic PROMs: PSQI in PLHIV

  • A study of PLHIV attending routine HIV monitoring clinic (n=40)2
  • Participants were selected for PSQI assessment, of whom 37 (92.5% were scored ≥6 and were recruited for intervention of; sleep hygiene information leaflets or ARV switch if indicated2

Prompt diagnosis and treatment of sleep disturbances may improve quality of life1

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References

CI, confidence interval; OR, odds ratio; PLHIV, people living with HIV; PROM, patient-reported outcome measure; PSQI, Pittsburgh Sleep Quality Index.
1. Buysse DJ et al. Psychiat Res 1989:28:193–213; 2. Goorney B, et al. Poster presented at HIV Glasgow. P082; 3. Crum-Cianflone NF, et al. Clin Inf Dis 2012;54:1485–94.

Selecting and implementing PROMs

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Use of PROMs in clinical practice is still hindered by awareness, knowledge and skills barriers among HCPs1,2

  • Education on the contribution of PROs to holistic health
  • Engagement and collaboration with a wider pool of colleagues, including as part of MDT, to expand horizons
  • Sharing best practice to challenge existing ways of thinking

References

HCP, healthcare professional; MDT, multidisciplinary team; PRO, patient-reported outcome; PROM, patient-reported outcome measure.
1. Roberts NA, et al. BMJ Open 2019;9:e027046; 2. Monroe AK, et al. BMC Health Serv Res 2018;18:419.

Engaging PLHIV in PRO reporting and encouraging HCP discussions may be achieved using simple collaborative tools

  • Initiative in the Netherlands in 2020
    • Awareness and education of PLHIV on the value of PROs to improve their QoL
    • Empowering PLHIV to take more control of their condition
  • Developed collaboratively with Dutch HCP experts on PROMs
  • Includes a video and infographic to be disseminated via/at:
    • Health digital apps (eg. Happi app)
    • Hospital websites
    • Waiting rooms
  • Planning to reach even more PLHIV through using a QR code and making the materials available in the clinic, as part of information packs, through patient organisations and HCPs’ emails
  • Available to any centre interested in implementing PROMs as part of the HIV care plan
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References

* The instrument includes a global rating of current health using a visual analogue scale ranging from 0 (worst) to 100 (best); aItems 1–4 (mobility, self-care, usual activities, pain/discomfort) are EQ-5D health states. Health change is not part of EQ-5D. EQ-5D health states, VAS health change, CD4 category, and HIV-1 plasma viral load are modelled as time-varying covariates; bEach covariate is adjusted only for CD4 category (<50, 50–199, ≥200) and plasma HIV-1 viral load (<1000, ≥1000 copies), not for the other listed health status items. CD4 category and plasma HIV-1 viral load are modelled as time-varying covariates.
CD4, cluster of differentiation cells 4; CI, confidence interval; EQ-5D, EuroQol- 5 dimension; HR, hazard ratio; HRQoL, health-related quality of life; PLHIV, people living with HIV; PRO, patient-reported outcome;
PROM, patient-reported outcome measure; VAS, visual analogue scale.
Mathews WC, et al. Health Qual Life Outcomes 2007;5:5.

The Happi app provides patient care in an accessible and patient-friendly format: www.happiapp.eu

  • Designed to provide PLHIV with knowledge, convenience and confidence in living with this condition
  • Disease-specific health goals to provide PLHIV with insights into their status/wellbeing
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References

CD4, cluster of differentiation cells 4; CVD, cardiovascular disease; PLHIV, people living with HIV; QoL, quality of life.
Happi app. Available at https://www.happiapp.nl/en. Last accessed: October 2020.

The Happi app provides patient care in an accessible and patient-friendly format: www.happiapp.eu

  • Designed to complement existing tools and enable collection of patient-reported outcomes
  • Provide PLHIV with knowledge, convenience and confidence in living with this condition
  • Disease-specific health goals to provide PLHIV with insights into their status/wellbeing
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References

CD4, cluster of differentiation cells 4; CVD, cardiovascular disease; PLHIV, people living with HIV; QoL, quality of life.
Happi app. Available at https://www.happiapp.nl/en. Last accessed: October 2020.

The Happi app provides patient care in an accessible and patient-friendly format: www.happiapp.eu

  • Designed to provide PLHIV with knowledge, convenience and confidence in living with this condition
  • Disease-specific health goals to provide PLHIV with insights into their status/wellbeing
Click to zoom

References

CD4, cluster of differentiation cells 4; CVD, cardiovascular disease; PLHIV, people living with HIV; QoL, quality of life.
Happi app. Available at https://www.happiapp.nl/en. Last accessed: October 2020.

The Happi app provides patient care in an accessible and patient-friendly format: www.happiapp.eu

  • Designed to provide PLHIV with knowledge, convenience and confidence in living with this condition
  • Disease-specific health goals to provide PLHIV with insights into their status/wellbeing
Click to zoom

References

CD4, cluster of differentiation cells 4; CVD, cardiovascular disease; PLHIV, people living with HIV; QoL, quality of life.
Happi app. Available at https://www.happiapp.nl/en. Last accessed: October 2020.

The Happi app provides patient care in an accessible and patient-friendly format: www.happiapp.eu

  • Designed to provide PLHIV with knowledge, convenience and confidence in living with this condition
  • Disease-specific health goals to provide PLHIV with insights into their status/wellbeing
Click to zoom

References

CD4, cluster of differentiation cells 4; CVD, cardiovascular disease; PLHIV, people living with HIV; QoL, quality of life.
Happi app. Available at https://www.happiapp.nl/en. Last accessed: October 2020.

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There are various outstanding needs in the field of HIV PROs

References

HCP, healthcare professional; PRO, patient-reported outcome; PROM, patient-reported outcome measure.
1. Kall M, et al. Lancet HIV 2020;7:E59-68; 2. Mercieca-Bebber R, et al. Contemp Clin Trials Commun 2017:23;9:23-32.

Summary

PROs is any information directly reported by the patient without interpretation by a clinician or anyone else that pertains to patient’s health, QoL or functional status associated with healthcare or treatment1

PROs could help improve care models and patients’ outcomes through helping HCPs better engage with patients’ needs, values, perceptions and experiences of their care and prioritise patient values in clinical decision-making in HIV treatment2

PROMs are identifiable, valid and reliable tools or instruments used to measure PROs1

PROMs are tailored to different clinical scenarios, depending on the PROs to be assessed; considering who will be completing PROMs and how results will be used is essential for selecting the most appropriate instruments

PROs have the potential to increase quality of care and facilitate resource optimisation if key HCP and PLHIV barriers are addressed6,7

References

EQ-5D, EuroQol- 5 dimension; HCP, healthcare professional; HIV-SI, HIV symptom index; HIV-QL, HIV quality of life; PLHIV, people living with HIV; PRO, patient reported outcome; PROM, patient-reported outcome measure; PROQOL-HIV, PRO quality of life-HIV; PSQI, Pittsburgh Sleep Quality Index; QoL, quality of life; SF, Short Form Health Survey; WHOQOL-HIV, World Health Organization quality of life HIV instrument.
1. Weldring T, Smith SM. Health Serv Insights 2013;6:61-8;
2. Yang C, et al. AIDS Care 2020;32:238–41;
3. Emuren L, et al. Health Qual Life Outcomes 2018;16:107;
4, Mathews WC, et al. Health Qual Life Outcomes 2007;5;
5. Crum-Cianflone NF, et al. Clin Inf Dis 2012;54:1485–94;
6. Roberts NA, et al. BMJ Open 2019;9:e027046; 7. Monroe AK, et al. BMC Health Serv Res 2018;18:419.

Interactive case study (discussed by Dr Guido van den Berk, the Netherlands)

Click the video to play the interactive case study

What three therapeutic goals will you prioritise in this patient?

Choose three options that apply most

  • Mitigating the potential effects of ART on the risks of comorbidities
  • Diagnosis of potential comorbidities and referral for appropriate specialist management
  • Supporting adherence to ART
  • Mitigating the potential effects of therapy on the quality of life
  • Virological suppression
  • Mental health

What would the expert opinion be?

  • Mitigating the potential effects of ART on the risks of comorbidities
  • Mental health
  • Supporting adherence to ART

Why?

This is because Paul has a history of mental health problems. While this is under control at the moment, it has affected his adherence to treatment and subsequent viral control in the past. Also, any further support with adherence, particularly given Paul’s irregular work schedule would be important to prioritise.

Lastly, his family history of diabetes would suggest that supporting Paul to lead a healthy lifestyle to avoid this possible complication would be the best step for his overall health.

What would be your top three actions?

Choose THREE options that apply most

  • Re-evaluate the ART regimen for potential associations with the long-term comorbidities profile
  • Refer for diagnostic work-up to detect potential comorbidities
  • Re-evaluate the ART regimen for potential impact on the quality of life
  • Counsel around the benefits of healthy weight and lifestyle modifications required to achieve it
  • Refer to psychological services

What would the expert opinion be?

  • Re-evaluate the ART regimen for potential associations with the long-term comorbidities profile
  • Re-evaluate the ART regimen for potential impact on the quality of life
  • Counsel around the benefits of healthy weight and lifestyle modifications required to achieve it

Why?

As Paul’s mother has diabetes, his risk is increased. I’d recommend re-evaluating his treatment and offering advice for Paul around maintaining a healthy weight and lifestyle to decrease his risk in the future.

Although Paul considers his mental health problems to be managed well at the moment, we cannot rule out the impact of his treatment on his quality of life and the potential for relapse.

Do you feel you had enough information to select those three actions as priorities?

Choose one option

  • Yes
  • No
  • I am not sure

What would the expert opinion be?

I am not sure

Why?

I am aware that Paul had already been referred to Psychological services, so there should be no need for a further referral. Also, as Paul is showing no signs of diabetes, screening is probably unnecessary at this point. Therefore, neither of these aspects currently need further investigation.
However, implementing the use of PROMs would help to assess if his treatment is having any effect on his quality of life.

Click the video to play the interactive case study

Long-term health in PLHIV can be impacted by multiple factors that may go unnoticed in a conventional consultation

With focus shifting away from virological suppression as the ultimate goal of HIV care, we now look towards addressing overall health. This includes the social and psychological aspects of HIV that can lead to poor health outcomes.

PLHIV report symptoms such as depression, anxiety, and pain more commonly than the general population. These can lead to poor adherence to treatment, poor quality of life, mental health problems, sexual risk-taking, and viral rebound.

References

Kall M, et al. HIV outcomes beyond viral suppression 2020;7(1):E59-68.

PROs can help identify issues impacting treatment goals

Patient-reported outcomes (PROs) can be defined as any report of the status of a patient’s health condition that comes directly from the patient, without interpretation by anyone else.

PRO tools measure patients’ perceptions of their own health that are invisible, or difficult to see. They present an opportunity to gain a fuller understanding of quality of life, symptoms, and physical, mental, and social wellbeing than what is possible with standard clinical tests alone.

References

Kall M, et al. HIV outcomes beyond viral suppression 2020;7(1):E59-68.

What therapeutic goals will you prioritise for this patient now that you have this additional information?

Choose four options that apply most

  • Mitigating the potential effects of ART on the risks of comorbidities
  • Diagnosis of potential comorbidities and referral for appropriate specialist management
  • Mitigating the potential effects of therapy on the quality of life
  • Virological suppression
  • Mental health
  • Supporting adherence to ART

What would the expert opinion be?

  • Mitigating the potential effects of ART on the risks of comorbidities
  • Mental health
  • Supporting adherence to ART
  • Mitigating the potential effects of therapy on the quality of life

Why?

Focusing on adherence will be important for Paul as he has experienced issues with this in the past. This could be done through helping improve his management of his mental health. But also through increasing his doctor’s awareness of the impact of treatment and his condition on his quality of life. In particular, Paul mentioned his sleep has been affected which would be important to try and address.

What would be the three key things you do next now that you have this additional information?

Choose THREE options that apply the most

  • Re-evaluate the ART regimen for potential associations with the long-term comorbidities profile
  • Re-evaluate the ART regimen for potential impact on the quality of life
  • Refer for diagnostic work-up to detect potential comorbidities
  • Counsel around the benefits of healthy weight and lifestyle modifications required to achieve it
  • Refer to psychological services

What would the expert opinion be?

I would rank them in the following order:

  1. Refer to psychological services
  2. Re-evaluate the ART regimen for potential impact on the quality of life
  3. Counsel around the benefits of healthy weight and lifestyle modifications required to achieve it
  4. Re-evaluate the ART regimen for potential associations with the long-term comorbidities profile
  5. Refer for diagnostic work-up to detect potential comorbidities

Why?

Focusing on helping Paul improve his management of his mental health would be an important priority, so a second referral to psychological services could potentially avoid a negative spiral. Also, I would continue to re-evaluate his treatment using PROMs to assess for any impact on his quality of life. Lastly, to help Paul with his overall wellness and wellbeing, which he has identified as a potential issue, I think support with adopting a healthy lifestyle would be critical.

Summary

Viral suppression is no longer the only goal of ART. PLHIV report physical and psychological challenges more commonly than the general population. These can lead to poor adherence to treatment, poor quality of life, mental health problems, sexual risk-taking, and viral rebound1

As we increasingly focus on QoL and healthy aging in HIV, PROs have an increasing role in helping understand how PLHIV ‘feel’ on ART and move towards achieving holistic health in body and mind1

While further research is needed to link improvements in PROs to advancements in health and clinical care, latest evidence suggests that PROs could help improve care models and PLHIV outcomes1–3

Module homepage

References

  1. Kall M, et al. HIV outcomes beyond viral suppression 2020;7(1):E59-68; 2.Yang C, et al. AIDS Care 2020;32(2):238–41; 3. Bristowe K, et al. HIV Med 2019;(8):542–54.

Patient-reported outcomes – Module for healthcare professionals

This eLearning module on patient-reported outcomes (PROs) aims to equip healthcare professionals with practical knowledge of PROs and PRO measures (PROMs). The module includes examples of widely used PROMs and how these can be applied in the clinical care of people living with HIV (PLHIV) to improve their long-term health monitoring

 

Overview of topics covered in the module:

What are PROs and PROMs, and why use them?      

  • PROMs are structured, validated tools that can be tailored to different clinical scenarios and help objectively assess the patient’s experience to facilitate person-centred care
  • PROs are an increasing area of focus in HIV clinical practice and research

 

What PROMs are available for PLHIV?

  • HIV-specific PROMs that were designed and validated to specifically look at aspects of life most relevant to PLHIV
  • Generic PROMs that are used across different conditions and may help put the quality of life in PLHIV into a broader context of other chronic diseases

 

How to facilitate the use of PROMs in clinical practice?

  • Example of engaging PLHIV in PRO reporting and encouraging HCP discussions
  • Outstanding educational and implementation needs for PROs in HIV