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4 Case study
examples
Learn how we have
helped our clients
achieve success
1
4 Case studies – Table of
contents
3
4
Introduction
Evaluation of a chronic condition
symptom scale prior to translatability
assessment
5 Selecting the right patient reported
outcome (PRO) measure
7 Development of a patient and carer
outcome measure for outpatient services
8 Listening to cancer staff stories
9 About Health Outcomes Insights
Introduction
3
When commissioning research or seeking a new
research provider, we understand that you
require reassurance that we have relevant
experience and proven results. Out of respect
for client confidentiality, we are rarely able to
provide ‘full’ case studies, but we really do want
to give you a feel for the work we do and the
difference we make to our clients.
THE CHALLENGE
To undertake an evaluation of the content
of a chronic condition symptom frequency
scale prior to pre-translatability assessment
and inclusion in a clinical trial.
THE SOLUTION
The scale was evaluated using
QuesTReviewTM which is an evidenced-
based expert review diagnostic tool which
benchmarks a questionnaire against 32
design parameters of questionnaire design
good practice. The 32 parameters include,
word length, ambiguity, wording and bias
etc. Each parameter is rated using a traffic
light system: No defects identified, Revision
suggested, Major defects identified.
Fifty percent of questions were identified
requiring revision including instructions on
how to complete the questionnaire..
A total of 10 major design defects and 13
suggested revisions were identified across
5 questions.
Questionnaire overall performance
included, completion time, mean number of
words per question, reading ease, reading
grade.
OUTCOME
Based on our feedback the client decided
to remove the questionnaire from the trial
as the quality of data was of concern and in
relation to the cost of retaining the
questionnaire in the trial, it was excluded.
Evaluation of a chronic condition
symptom scale prior to
translatability assessment
4
THE CHALLENGE
A key hurdle facing outcome teams as with
the entire pharmaceutical industry is non-
adherence by patients to medication. This
problem is only likely to be surmounted if
patients believe that taking medication will
lead to immediate benefits through
reduction of symptoms, improvement in
physiological functioning and quality of life.
Outcome teams are faced with a plethora of
PROs, each purporting to measure – often
without a sound theoretical or
measurement model – a range of health
outcomes.
As a consequence, outcome teams often
make their choice of a PRO according to
whether it has been used in previous
studies or its name appears to be
appropriate for the intended use. We were
approached by an international
pharmaceutical company to develop
a workshop for their Outcomes Team to
demonstrate that data derived from patient
reported outcome (PROs) measures can
provide added value in supporting key
biomedical endpoints.
THE SOLUTION
A one-day workshop was convened for the
Outcome Team, the primary aim of which
was to provide them with a practical
measurement strategy which would assist
in the selection of appropriate PROs for their
Phase III & late phase DM studies. The
workshop addressed three specific
questions posed which were:
1. What is achievable using a PRO?
2. How can we distinguish between the
different measured endpoints?
3. How can we understand a PRO score in
relation to clinical endpoints?
Selecting the right patient
reported outcome (PRO)
measure
5
The workshop was initiated with a
comprehensive and interactive overview of
the benefits to the outcome team through
the patient’s perspective using PROs. This
was followed by an in-depth exploration of
key stages in the development of the
strategy.
• Making explicit the expected
treatment effects e.g. primary
biomedical endpoint(s)
• Linking these – through the
articulation of an endpoint model – to
outcome domains relevant to the
patient and disease from which the
most appropriate PRO can be selected
• Differentiation between the different
secondary endpoints
The PRO’s conceptual framework – the
linkage between the PRO’s item content
and its specific measurement
domains – was emphasised to the team, as
was its relationship with the expected
primary treatment outcome(s) and study
objectives.
OUTCOME
The workshop the Outcome Team was able
to differentiate more clearly between the
endpoints purported to be measured by
PROs such as QoL health status, HRQoL,
etc. and select the most appropriate for a
given purpose. The team also gained a
clearer understanding of the importance of
developing an explicit endpoint model to
ensure a strong link between the PRO’s
item content, what it should measure and
the objectives of the study for identifying
potential treatment benefits.
Selecting the right patient
reported outcome (PRO)
measure
6
THE CHALLENGE
We were approached by a leading London
university hospital to take on the role of
project leader and mentor of a project to
develop a patient reported outcome (PRO)
measure to evaluate the impact of patient
care and support on their outcomes.
THE SOLUTION
We initially undertook discussions with the
research team to clearly identify the
purpose of the PRO and establish how
information from its implementation was to
be used. This was followed by conducting a
carousel group with all staff members to be
involved in ad mistering the questionnaire
to patients as the first stage in identifying
key themes to be covered by the scale.
Focus groups were also held with a range
of patients and carers to identify areas of
importance to them. Correspondence
between staff themes, patients and carers
areas of importance was assessed and was
found to be very high.
Draft patient and carer questionnaires
underwent evaluation through a series of
cognitive interviews until a final version of
the scales were produced. Questionnaires
were fielded in samples of nearly 200
patients and carers to evaluate their
psychometric properties. These were found
to be satisfactory meeting all but one of the
psychometric criteria set.
OUTCOME
A final patient and carer version of the scale
each comprising 15-items were developed
and are now part of the routine evaluation
of patient and carer outcomes in diabetes
and cancer outpatient services.
.
Development of a patient and
carer outcome measure for
outpatient services
7
THE CHALLENGE
In an open competition we were selected
by a leading cancer charity to undertake a
qualitative study to obtain a better
understanding of the relationship between
patient experience and staff experience in a
ward and or A&E setting and the
relationship between staff experience
notably, organisational culture,
management and the experience of
patients such as involvement in treatment
decisions and communication with the
clinical team.
THE SOLUTION
We approached the study first with a series
of in-depth interviews with patients having
received or currently under treatment
across two hospitals in two widely
dispersed geographical areas first, to obtain
the patients perspective on issues of their
care and secondly. To develop the patient
stories as vignettes for use in staff
interviews. Face-to-face interviews were
conducted with over 30 staff members
ranging from administrative through to
consultants. Vignettes were used to
generate more insights from staff by asking
them if or not they identified aspects of
these patient stories.
OUTCOME
A number of key themes relating to staff
experience and their impact on the delivery
of patient care were identified and
submitted to the charity as
recommendations.
Listening to cancer staff
stories
8
9
Health Outcomes Insights helps healthcare
agencies and pharmaceutical companies
across a range of conditions including
diabetes, get targeted answers to patient
behaviour whenever health outcomes are
part of your programme.
Email: info@healthoutinsights.com
Tel: +44 (0) 1367 615 052

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This week will see the launch of Health Outcomes Insights (Formerly DHP Research). Here are 4 case studies of the work we will continue to do.

  • 1. 4 Case study examples Learn how we have helped our clients achieve success 1
  • 2. 4 Case studies – Table of contents 3 4 Introduction Evaluation of a chronic condition symptom scale prior to translatability assessment 5 Selecting the right patient reported outcome (PRO) measure 7 Development of a patient and carer outcome measure for outpatient services 8 Listening to cancer staff stories 9 About Health Outcomes Insights
  • 3. Introduction 3 When commissioning research or seeking a new research provider, we understand that you require reassurance that we have relevant experience and proven results. Out of respect for client confidentiality, we are rarely able to provide ‘full’ case studies, but we really do want to give you a feel for the work we do and the difference we make to our clients.
  • 4. THE CHALLENGE To undertake an evaluation of the content of a chronic condition symptom frequency scale prior to pre-translatability assessment and inclusion in a clinical trial. THE SOLUTION The scale was evaluated using QuesTReviewTM which is an evidenced- based expert review diagnostic tool which benchmarks a questionnaire against 32 design parameters of questionnaire design good practice. The 32 parameters include, word length, ambiguity, wording and bias etc. Each parameter is rated using a traffic light system: No defects identified, Revision suggested, Major defects identified. Fifty percent of questions were identified requiring revision including instructions on how to complete the questionnaire.. A total of 10 major design defects and 13 suggested revisions were identified across 5 questions. Questionnaire overall performance included, completion time, mean number of words per question, reading ease, reading grade. OUTCOME Based on our feedback the client decided to remove the questionnaire from the trial as the quality of data was of concern and in relation to the cost of retaining the questionnaire in the trial, it was excluded. Evaluation of a chronic condition symptom scale prior to translatability assessment 4
  • 5. THE CHALLENGE A key hurdle facing outcome teams as with the entire pharmaceutical industry is non- adherence by patients to medication. This problem is only likely to be surmounted if patients believe that taking medication will lead to immediate benefits through reduction of symptoms, improvement in physiological functioning and quality of life. Outcome teams are faced with a plethora of PROs, each purporting to measure – often without a sound theoretical or measurement model – a range of health outcomes. As a consequence, outcome teams often make their choice of a PRO according to whether it has been used in previous studies or its name appears to be appropriate for the intended use. We were approached by an international pharmaceutical company to develop a workshop for their Outcomes Team to demonstrate that data derived from patient reported outcome (PROs) measures can provide added value in supporting key biomedical endpoints. THE SOLUTION A one-day workshop was convened for the Outcome Team, the primary aim of which was to provide them with a practical measurement strategy which would assist in the selection of appropriate PROs for their Phase III & late phase DM studies. The workshop addressed three specific questions posed which were: 1. What is achievable using a PRO? 2. How can we distinguish between the different measured endpoints? 3. How can we understand a PRO score in relation to clinical endpoints? Selecting the right patient reported outcome (PRO) measure 5
  • 6. The workshop was initiated with a comprehensive and interactive overview of the benefits to the outcome team through the patient’s perspective using PROs. This was followed by an in-depth exploration of key stages in the development of the strategy. • Making explicit the expected treatment effects e.g. primary biomedical endpoint(s) • Linking these – through the articulation of an endpoint model – to outcome domains relevant to the patient and disease from which the most appropriate PRO can be selected • Differentiation between the different secondary endpoints The PRO’s conceptual framework – the linkage between the PRO’s item content and its specific measurement domains – was emphasised to the team, as was its relationship with the expected primary treatment outcome(s) and study objectives. OUTCOME The workshop the Outcome Team was able to differentiate more clearly between the endpoints purported to be measured by PROs such as QoL health status, HRQoL, etc. and select the most appropriate for a given purpose. The team also gained a clearer understanding of the importance of developing an explicit endpoint model to ensure a strong link between the PRO’s item content, what it should measure and the objectives of the study for identifying potential treatment benefits. Selecting the right patient reported outcome (PRO) measure 6
  • 7. THE CHALLENGE We were approached by a leading London university hospital to take on the role of project leader and mentor of a project to develop a patient reported outcome (PRO) measure to evaluate the impact of patient care and support on their outcomes. THE SOLUTION We initially undertook discussions with the research team to clearly identify the purpose of the PRO and establish how information from its implementation was to be used. This was followed by conducting a carousel group with all staff members to be involved in ad mistering the questionnaire to patients as the first stage in identifying key themes to be covered by the scale. Focus groups were also held with a range of patients and carers to identify areas of importance to them. Correspondence between staff themes, patients and carers areas of importance was assessed and was found to be very high. Draft patient and carer questionnaires underwent evaluation through a series of cognitive interviews until a final version of the scales were produced. Questionnaires were fielded in samples of nearly 200 patients and carers to evaluate their psychometric properties. These were found to be satisfactory meeting all but one of the psychometric criteria set. OUTCOME A final patient and carer version of the scale each comprising 15-items were developed and are now part of the routine evaluation of patient and carer outcomes in diabetes and cancer outpatient services. . Development of a patient and carer outcome measure for outpatient services 7
  • 8. THE CHALLENGE In an open competition we were selected by a leading cancer charity to undertake a qualitative study to obtain a better understanding of the relationship between patient experience and staff experience in a ward and or A&E setting and the relationship between staff experience notably, organisational culture, management and the experience of patients such as involvement in treatment decisions and communication with the clinical team. THE SOLUTION We approached the study first with a series of in-depth interviews with patients having received or currently under treatment across two hospitals in two widely dispersed geographical areas first, to obtain the patients perspective on issues of their care and secondly. To develop the patient stories as vignettes for use in staff interviews. Face-to-face interviews were conducted with over 30 staff members ranging from administrative through to consultants. Vignettes were used to generate more insights from staff by asking them if or not they identified aspects of these patient stories. OUTCOME A number of key themes relating to staff experience and their impact on the delivery of patient care were identified and submitted to the charity as recommendations. Listening to cancer staff stories 8
  • 9. 9 Health Outcomes Insights helps healthcare agencies and pharmaceutical companies across a range of conditions including diabetes, get targeted answers to patient behaviour whenever health outcomes are part of your programme. Email: info@healthoutinsights.com Tel: +44 (0) 1367 615 052