2. Implementing PROMs in Routine Practice
Disclosures
Research grants from:
1. DBT
2. MHRD
3. ICMR
4. LTMT
5. IDAIR
Developer of a indigenous ePROM solution used in clinical trials at TMC
3. Why
Why incorporate
PROMs in Routine
Clinical Practice ?
How
How we can go about
the integration ?
What
What PROMs to
incorporate ?
Who
Who are the
beneficiaries and
partners ?
When
When should these be
incorporated ?
Integration of
PROM in
Routine Clinical
Practice
5. Implementing PROMs in Routine Practice
Rationale
❖ Patients with cancer have significant
unaddressed burden of symptoms & issues
❖ Variety of reasons:
➢ Limited time with provider
➢ Limited / suboptimal communications
➢ Limited agency
➢ Concerns regarding treatment discontinuation (?)
Veitch ZW, Shepshelovich D, Gallagher C, Wang L, Abdul Razak AR,
Spreafico A, et al. Underreporting of symptomatic Adverse Events in phase I
clinical trials. J Natl Cancer Inst. 2021 Aug 2;113(8):980–8.
6. Implementing PROMs in Routine Practice
Does this improve outcomes ?
Author Pts Rx Objective Result
Berry L
(2011) -
ESRA-C
660
(mixed)
💊 Likelihood of discussion of symptom/QoL when
providers had access to a QoL report
✅ If problematic, increased discussion
of symptom/QoL
✅ Clinic visits same duration
Berry
(2014) -
ESRA-C II
752
(mixed)
💊 Impact of patient education added to self reported
assessment on symptom distress
✅ Reduced symptom distress
Mir
(2022)
CAPRI
559
(mixed)
💊 Impact of nurse navigator lead patient self reported
symptom management on relative dose intensity of
oral chemotherapy
✅ Improved chemo RDI
✅ Toxicity picked up earlier
Absolom
(2021)
eRAPID
508
(mixed)
💊 Automatic guidance for patients after self reported
symptoms - impact on symptom control, QoL, &
healthcare usage
✅ Improved physical well being
✅ Adherence associated with
provider’s data use
7. Implementing PROMs in Routine Practice
Impact on Survival
● Basch et al (2016)
● 766 patients randomly allocated to
symptom monitoring vs usual care
● 12 common symptoms
● Results
✅ Improved HRQL
✅ Reduced HRQL decline
✅ Less frequent ER visits and hospitalization
8. Implementing PROMs in Routine Practice
Key Benefits
In a systematic review the following benefits were identified in qualitative studies:
✅ Active patient involvement (goal setting and discussion of sensitive topics)
✅ Enhance focus of consultation with the patient.
✅ Enables tailored, holistic care and prompts action
✅ Enables standardized monitoring of patient outcomes
✅ Enhances the patient–clinician relationship
10. Implementing PROMs in Routine Practice
PROM Types
PROM Types
General QoL
Health Related
QoL
Symptom
Scales
Patient
Satisfaction
Patient
Experience
11. Implementing PROMs in Routine Practice
Considerations
● Questionnaire attributes:
○ Response format : verbal descriptor /
numeric scale
○ Focus of assessment :
■ Severity
■ Frequency
■ Interference
■ Bother
○ Time burden
○ Psychometric validity
○ Recall period
?
Symptoms
Functioning Quality of Life
12. Implementing PROMs in Routine Practice
Decision Making: Specificity of Questionnaire
General Questionnaires
✅ More common HRQoL domains captured
✅ Allow comparison to normative population
❌ Not sensitive to changes over time
Disease specific questionnaires
✅ More sensitive to symptoms experienced
by patients
✅ More sensitive to changes over time
❌ Miss domains affecting patients which are
not related to disease
13. Implementing PROMs in Routine Practice
Decision Making: Type of Questionnaire
Profile based measures
✅ Multiple scores are provided across broad
range of PRO domains
✅ Allows determination of aspect of health
affected
❌ More time-consuming to complete
Preference based measures
✅ Single score aggregated across multiple
PRO domains
✅ Provide a estimate of burden of disease
❌ Limited actionable data for individual
patient
14. Implementing PROMs in Routine Practice
Decision Making: Number of items
Single Item Scales
✅ Multiple domains can be measured with
single item for each.
❌ Less useful for tracking change over time
Multi Item Scales
✅ More reliable /sensitive / content valid
measurements
❌ Higher response burden for patients. May
impact compliance
15. Implementing PROMs in Routine Practice
Decision Making: Questionnaire Administration
Static Forms
✅ Work on physical and electronic media
❌ Higher response burden for patients.
Dynamic Forms
✅ More efficient and allow more domains to
be evaluated
❌ Requires computer administration
17. Implementing PROMs in Routine Practice
Information Desired
Purpose Resources Advantages Disadvantage
Screening One time assessment with
feedback to clinician
Identify symptoms which
were missed
Temporal change is not
documented
Monitoring Serial assessments with
feedback to clinician
Track change over time
and determine utility of
interventions
Greater resource
requirement
Patient centered Care Serial assessments with
feedback to patients
Greater discussion,
involvement, improves
compliance, improved
outcomes and satisfaction
Extra resources needed for
feedback results
18. Implementing PROMs in Routine Practice
Trade Offs
Improved accessibility
Improved care
Trajectory of disease
Increased confidence
Increased Involvement
Increased burden
Alerts !
Increased cost
IT Infrastructure
Extra resources
20. Implementing PROMs in Routine Practice
Stakeholders
Patients:
● Ability to self report
● Literacy
Proxies:
● Should be identified in advance and noted
when proxy provides the response.
● Limited agreement between proxy and
parent (even for children and parents)
Providers
● Who will see the response is critical
● Staff needs additional training for PRO
results
● Interpretation of results should not be left
to subjective whims
● Referral pathways should be clearly outlined
21. Implementing PROMs in Routine Practice
Staff Training
Skovlund PC, Ravn S, Seibaek
L, Thaysen HV, Lomborg K,
Nielsen BK. The development
of PROmunication: a training-
tool for clinicians using
patient-reported outcomes to
promote patient-centred
communication in clinical
cancer settings. J Patient Rep
Outcomes. 2020 Feb 11;4(1):10.
(Link)
23. Implementing PROMs in Routine Practice
Electronic vs Paper
Electronic
✅ Immediate feedback possible to both
stakeholders
✅ Allows dynamic forms to be built with multi-
media prompts
✅ Result display using plots and other forms of
visualization
Paper
✅ Generally least expensive option
✅ Familiarity with administration
✅ Least resource intensive
24. Implementing PROMs in Routine Practice
How should questionnaires be displayed
● In patients own language
● Question by question format better
than all questions together
● Do not make all questions as required
● Large response options
25. Implementing PROMs in Routine Practice
Presentation
● Correct interpretation of PRO “scores” is essential.
● Variety of scoring mechanisms exist:
○ EORTC - All scores scaled to 100
○ FACT - Sum scores
○ NIH PROMIS - Scored such that normal population mean score is 50
● Variety of visualization options:
○ Tabulation of score
○ Line plots showing change in score - usually most preferred by clinicians
○ Bubble plots where size indicates score
○ Heat maps
26. Implementing PROMs in Routine Practice
Line Plots
Snyder CF, Smith KC, Bantug ET, Tolbert EE, Blackford AL, Brundage MD, et al. What do these scores mean? Presenting patient-reported outcomes data to patients and clinicians to improve
interpretability. Cancer. 2017 May 15;123(10):1848–59.
27. Implementing PROMs in Routine Practice
Line Plots
Interpretation of Directionality: 88.6 % Interpretation of Directionality: 93.9 % Interpretation of Directionality: 80 %
Clinical Importance (10 pt change): 84.6 % Clinical Importance (10 pt change): 85 % Clinical Importance (10 pt change): 84.6 %
28. Implementing PROMs in Routine Practice
Example Dashboard
Highlighting severe AE
Temporal AE with Grades
Ability to Select AE
30. Implementing PROMs in Routine Practice
Conclusions
● PROs are important
● PROMs are a quality metric also
● Important that our staff get comfortable with interpretation of PROM
● Routine use is feasible and demonstrated efficacy
● Region specific challenges are present - not insurmountable
31. Implementing PROMs in Routine Practice
Key Resources
📚 Di Maio M, Basch E, Denis F, Fallowfield LJ, Ganz PA, Howell D, et al. The role of patient-reported
outcome measures in the continuum of cancer clinical care: ESMO Clinical Practice Guideline. Ann
Oncol. 2022 Sep;33(9):878–92. (Link)
📚 User’s guide to implementing patient-reported outcomes assessment in clinical practice (ISOQOL)
(Link)
📚 Implementing patient reported outcome measures in clinical practice : A companion guide to
ISOQOL User’s guide (Link)
📚 van der Wees PJ, Verkerk EW, Verbiest MEA, Zuidgeest M, Bakker C, Braspenning J, et al. Development of a
framework with tools to support the selection and implementation of patient-reported outcome
measures. J Patient Rep Outcomes. 2019 Dec 30;3(1):75. (Link)
📚 Snyder CF, Smith KC, Bantug ET, Tolbert EE, Blackford AL, Brundage MD, et al. What do these scores
mean? Presenting patient-reported outcomes data to patients and clinicians to improve
interpretability. Cancer. 2017 May 15;123(10):1848–59. (Link)
