Case study 5. New systems for patient self-reporting improve care and quality of life for cancer patients
Submitting InstitutionUniversity of Leeds
Unit of AssessmentAllied Health Professions, Dentistry, Nursing and Pharmacy
Summary Impact TypeHealth
Research Subject Area(s)
Medical and Health Sciences: Nursing, Public Health and Health Services
Summary of the impact
Researchers at the University of Leeds have designed and developed new
approaches and technologies for cancer patients to self-assess their
symptoms and quality of life. The work focused on electronic methods for
collecting patient-reported outcome measures (PROMs), developing PROMs for
neglected areas of patient care, and running trials of these techniques.
These approaches produced sizeable patient benefits including improved
symptom control and better quality-of-life. These findings have influenced
clinical guidelines in the UK and Canada, NHS policy and the endorsement
of PROMs in the Health and Social Care Act (2012). Electronic PROMs
systems based on the Leeds research have been implemented locally,
nationally and internationally, making measurable improvements to patient
welfare and health, such as a reported significant increase in completion
of chemotherapy treatment.
The diagnosis of cancer leaves patients having to shoulder a huge burden
and they face an uncertain future. Before the mid-1990s cancer clinicians
typically focused their attention on survival, rather than their patients'
quality of life. In 1996, researchers from the University of Leeds set out
to see whether cancer patient care could be improved by using routine
patient-centred assessment of their clinical symptoms, as well as
psychosocial issues and their quality of life. The team wanted to know if
patient self-reporting could make the detection, recording and management
of the disease and treatment-related problems more effective. Could the
introduction of self-reporting into cancer services enhance patient
quality of life and satisfaction with care, as well as inform and support
more effective service evaluation? With funding from the NHS [grant a], a
program of research was launched to develop and evaluate systems and
questionnaires to collect PROMs and assess their implementation in
practice. The team developed an electronic system for patient
self-reports, overcoming logistical challenges of large volume real-time
data collection in clinical practice. The research focused on (i)
technical development, (ii) clinical implementation and (iii) the
assessment of the social impact of cancer, detailed below.
In 1996, Peter Selby (Professor of Cancer Medicine,
1989-present), David Forman (Professor of Cancer Epidemiology,
1994-2010) and colleagues from Leeds developed a stand-alone computer
touchscreen system to deliver standard questionnaires to assess quality of
life in cancer patients [grant a]. Evaluations of the touchscreen system,
which were run in Leeds and in collaboration with Ann Cull (University of
Edinburgh) and Ann Gould (Scottish Cancer Intelligence Unit) in an
Edinburgh hospital, demonstrated its feasibility, acceptability and
reliability in the clinical setting; the researchers also demonstrated the
validity of the system and the score equivalence of paper versus
electronic questionnaires [1-2]. Over five years the system was enhanced
with funding from the Imperial Cancer Research Fund and Cancer Research
UK. A version was integrated into the electronic patient records system of
the Leeds Cancer Centre. An online standalone version was developed
between 2010 and 2013 [grants b, c, d, e].
More recent developments and evaluation research have shown how a secure
web-based questionnaire system allows clinicians to monitor patients.
Studies have also shown how self-reported data can be linked to national
cancer registration systems, helping clinicians to perform epidemiological
outcome assessments [grant d] .
Between 1999 and 2008 Galina Velikova (initially Clinical
Research Fellow, now Professor of Psychosocial and Medical Oncology,
1996-present), Julia Brown (initially Director of Clinical Trials
Research Unit, now Professor of Cancer Trials Research, 2006-present) and
Peter Selby evaluated the impact of regular patient reporting on
symptoms and quality of life. A proof-of-principle randomised controlled
trial showed for the first time that providing regular patient
self-reported data to oncologists improved patient quality of life,
focused doctor-patient communication, achieved better symptom control and
reduced distress, without lengthening clinic visits .
Assessment of the social impact of cancer
Cancer patients experience problems with everyday issues (domestic life,
family care, finance, employment, relationships, etc.). Prior to the work
of Leeds in this area there were no concise questionnaires for assessing
the effects of having cancer on daily life. With funding from Cancer
Research UK, Penny Wright (then Research Assistant, now Associate
Professor, 1996-present) and Selby began developing the Social
Difficulties Inventory (SDI-21) in 2000. Evaluations of this
self-reporting instrument showed it was reliable and valid, and
importantly had clinically meaningful interpretation of responses/scores
[5,6]. Between 2007-2009, Wright and Dan Stark (Senior
Lecturer in Cancer Medicine, Leeds, 2003-present) translated and evaluated
SDI-21 with patients of South-Asian origin from Leeds and Bradford
Teaching Hospitals NHS Foundation Trust (under the care of Chris Bradley),
showing that it was culturally and linguistically acceptable [grant h].
References to the research
1. Velikova G, Wright EP, Smith AB, Cull A, Gould A, Forman D,
Perren T, Stead M, Brown J, Selby PJ (1999). Automated
collection of quality-of-life data: a comparison of paper and computer
touch-screen questionnaires. Journal of Clinical Oncology, 17(3):998-1007
[SCOPUS citation: 196 (24/06/13)]
2. Wright EP, Selby PJ, Crawford M, Gillibrand A, Johnston C,
Perren TJ, Rush R, Smith A, Velikova G, Watson K, Gould A, Cull A
(2003). Feasibility and Compliance of Automated Measurement of Quality of
Life in Oncology Practice. Journal of Clinical Oncology, 21(2):374-382.
3. Ashley L, Jones H, Thomas J, Forman D, Newsham A, Morris E, Johnson O,
Velikova G, Wright P (2011). Integrating cancer survivors'
experiences into UK cancer registries: design and development of the ePOCS
system (electronic Patient-reported Outcomes from Cancer Survivors).
British Journal of Cancer, 105 Suppl 1:S74-81. DOI:
This study has won awards at three conferences (UKACR
& NCIN Conference 2010; Biennial Cancer Survivorship Research
Conference 2012; British Psychosocial Oncology Society 2013). It is
included in a systematic review (Thong, M. S. Y., F. Mols, et
al. (2013). "Population-based cancer registries for quality-of-life
research: A work-in-progress resource for survivorship studies?" Cancer
119 Suppl 11: 2109-2123).
4. Velikova G, Booth L, Smith AB, Brown PM, Lynch P, Brown JM,
Selby PJ (2004). Measuring quality of life in routine oncology
practice improves communication and patient well-being: a randomized
controlled trial. Journal of Clinical Oncology, 22(4):714-24.
[SCOPUS citation: 339 (24/06/13)].
This study won the International Society for Quality of Life
Research (ISOQOL) paper of the year award(2004). It is
included in a systematic review (Valderas, J. M., A. Kotzeva, et al.
(2008). "The impact of measuring patient-reported outcomes in clinical
practice: a systematic review of the literature." Quality of
Life Research 17(2):179-193).
5. Wright EP, Kiely M, Johnston C, Smith AB, Cull A, Selby PJ
(2005). Development and evaluation of an instrument to assess social
difficulties in routine oncology practice. Quality of Life Research,
14(2):373-86. DOI: 10.1007/s11136-004-5332-4 [SCOPUS citation:23
6. Wright P, Smith A, Roberts K, Selby P, Velikova G.
Screening for social difficulties in cancer patients: clinical utility of
the Social Difficulties Inventory. British Journal of Cancer.
2007; 97: 1063-70. DOI: 10.1038/sj.bjc.6604006 [SCOPUS citation:
The SDI-21 is included in a systematic review (Muzzatti,
B. and M. A. Annunziata (2012).
"Assessing the social impact of cancer: a review of available tools." Supportive
Care in Cancer 20(10): 2249-2257).
Note: All Leeds researchers in bold. Publications available on
request from the HEI.
The inclusion of the research in peer-reviewed, high-impact publications
(J Clin Oncol), and the publication of a range of clinical [4,6]
and methodological [1,2,3,4] papers, are indicative of the quality and
originality of the work.
a. Selby P. NHS Executive.1996-1999. £324,150.
b. Selby P. Imperial Cancer Research Fund Programme. 1999-2002.
c. Selby P. Cancer Research UK. (Two awards) 2001-2008. ~£1M.
d. Wright P. Macmillan Cancer Support. Title- Survivors of adult
cancer: a feasibility cohort study 2010-2012. £409,131.
e. Velikova G. NIHR (National Institute for Health Research)
Programme Development grant. Title-Towards safer delivery and monitoring
of cancer treatments. Electronic patient self-Reporting of
Adverse-events: Patient Information and aDvice
(eRAPID) (Grant ref: RP-PG-1209-10031). Dec 2010- Dec 2012. £99,986.
f. Velikova G. Cancer Research UK Clinician Scientist grant.
Implementation of quality of life assessment in the care of individual
cancer patients through strategies for changing clinical practice (Ref
C7775/A2941). 2003-2008. £591,928.
g. Velikova G. Cancer Research UK programme grant. Title-Routine
assessment of symptoms, functioning, social difficulties and quality of
life of cancer patients to improve the process and outcomes of care (Ref
C7775/A7424). 2007-2013. £1,682,500.
h. Bradley C and Wright P. NIHR RfPB. Title- The social impact of
cancer on people of south Asian origin: patient interview study (Ref
Details of the impact
Contributing to clinical practice guidelines
The Leeds research has influenced clinical guidelines internationally.
For example, the trial demonstrating patient benefits from routine
measurement of quality of life using automated measurement significantly
contributed to clinical practice guidelines published in 2011 by the
International Society for Quality of Life Research [A]. The SDI-21 was
referenced in pan-Canadian clinical practice guidelines published in 2009
by the Canadian Partnership Against Cancer (Cancer Journey Action Group)
and the Canadian Association of Psychosocial Oncology (information on
downloads available only from Canadian Partnership Against Cancer
2012-June 2013 = 45) [B]. The National Cancer Survivorship Initiative
Vision, published in 2010 referenced SDI-21 as a questionnaire for
assessing the quality of life of cancer survivors [C] (Google analytics
unique page views www.ncsi.org.uk:
PAGE: /?s=vision+document 01/02/10-14/08/13: 59,688 document downloads)
Change in policy
NHS policy and the Health and Social Care Act 2012: The Health and
Social Care Act 2012 endorses the use of PROMs to put patients at the
centre of the NHS. Sir Michael Richards, National Cancer Director
(1999-2013) said: "Health services must become more patient centred.
We urgently require methods to measure this aspect of care. Leeds
researchers have provided us, not only with technologies for this
purpose but also evaluated their measurements in a positive randomised
controlled trial. This was very influential in development of policy and
the incorporation of Patient Reported Outcome Measures as a central
theme within the NHS" [D]. Since 2010 Velikova and Wright
have been members of a Department of Health/Macmillan National Cancer
Survivorship Initiative advisory group on metrics. This group reviews
research on PROMs; it made recommendations on which PROMs should be
included in the pilot and full NHS PROMs survey (see later).
Changes in practice
Adoption of electronic self-reporting tools in clinical practice:
In 2012, the Leeds Cancer Centre and the Yorkshire Cancer Network
pioneered electronic Holistic Needs Assessment within routine patient
care; the self-reported data are integrated into electronic patient
records. This facility allows nurses to assess quality of life issues,
leading to an agreed care plan in discussion with patients. The web-based
questionnaire system is undergoing quality assurance testing prior to
application for kite marking for use as a medical device.
In 2012 Electronic Holistic Needs Assessment (eHNA) was piloted by the
Department of Health/Macmillan National Cancer Survivorship Initiative at
four sites in England. A larger scale rollout is currently underway at 25
sites using a new prototype system in 2013. This software implements the
2007 National Cancer Action Team's guidelines, which, were strongly
influenced by Leeds research into the social impact of cancer. The eHNA
tool included the Leeds-developed SDI-21 as one of the assessment measures
[E]. Velikova and Wright are both members of the eHNA
steering committee as experts in such electronic systems. The Leeds team
provides on-going advice regarding electronic assessment to the eHNA
The SDI-21, one of three validated questionnaires, has been used in national
evaluations of the quality of life of cancer patients and survivors:
in 2011 it was used to collect data for the Department of Health national
pilot PROMs survey of 4,992 cancer survivors [F]; it is also being
used in the full national PROMs survey of 50,000 cancer patients during
2013. Internationally, the SDI-21 is being used in routine cancer
practice in Canada as part of an electronic Distress Assessment and
Response Tool (DART) for assessing, monitoring and supporting cancer
outpatients. Between October 2009 to December 2012 47,661 DART assessments
were undertaken with 13,672 assessments including the SDI-21. The use of
DART has led to significant improvements in patient well-being (see below)
Velikova provided professional advice leading to the adoption of
the Leeds approach in a new clinical programme for lung-heart transplant
patients monitoring in Edmonton (Alberta, Canada) [H]. Clinicians
developed specific guidelines on the use of PROMs to individualize patient
care and the monitoring has become standard practice. By 2010, 172
lung-heart transplant patients participated, 98% were happy to complete
the assessments regularly; 91% of clinicians endorsed the use of PROMs in
routine practice [H]. Velikova's work and professional advice
significantly influenced the decision to launch the Patient Outcomes
Program to promote patient-centred care at Cancer Treatment Centers of
America (CTCA) at Midwestern Regional Medical Center (Zion, IL, USA;
private cancer hospitals in USA) [I]. The current quality of life database
of CTCA consists of 12,000 patients; the data are being used by the
clinical teams providing supportive care to patients on cancer treatment
Changes in health outcomes
Enhancement of the patient experience, improved well-being and clinical
outcomes: In Canada the evaluation of DART has provided evidence of
improved patient well-being (measured by reductions in SDI-21 scores over
four consecutive outpatient appointments) [G]. SDI-21 items are strong
predictors of suicidal thoughts [J]; use of the tool alerts clinicians to
patients with these ideas so they can offer appropriate support to prevent
harm. Overall, DART enhanced the patient experience with measured
improvement of patient's perception of treatment and support. A
differential benefit of DART was demonstrated for low income patients
(p=0.046). Clinical outcomes also improve with the use of DART. Clinician
assessment of high distress scores was associated with an increase in
patient's ability to complete chemotherapy from 50% to 85%. This
improvement in compliance was achieved with no change in health service
burden (clinic length or workload). Staff felt DART improved systematic
inquiry about concerns. Most patients (88%) felt DART improved
communication of symptoms and concerns with the health care team [G].
Sources to corroborate the impact
A. User's Guide to Implementing Patient-Reported Outcomes Assessment in
Clinical Practice. Version: November 11, 2011. Produced on behalf of the
International Society for Quality of Life Research. Available at
B. Howell, D., Currie, S., Mayo, S., Jones, G., Boyle, M., Hack, T.,
Green, E., Hoffman, L., Simpson, J., Collacutt, V., McLeod, D., and
Digout, C. A Pan-Canadian Clinical Practice Guideline: Assessment of
Psychosocial Health Care Needs of the Adult Cancer Patient, Toronto:
Canadian Partnership Against Cancer (Cancer Journey Action Group) and the
Canadian Association of Psychosocial Oncology, May 2009. Available at
C. Department of Health. Macmillan Cancer Support. NHS Improvement
(2010). National Cancer Survivorship Initiative Vision. London, Crown.
Available at http://www.ncsi.org.uk/wp-content/uploads/NCSI-Vision-Document.pdf
D. Individual corroboration: the National Clinical Director for Cancer,
Department of Health, 2013.
E. Individual corroboration: Chief Executive, Macmillan Cancer Support
and co-director National Cancer Survivorship Initiative, 2013.
F. Department of Health - Quality Health (2012). Quality of Life of
Cancer Survivors in England: report on a pilot survey using Patient
Reported Outcome Measures (PROMS). London, National Institute for Health
Research. Available at
G. Individual corroboration: Physician lead for DART, Psychosocial
Oncology and Palliative Care, University Health Network - Princess
Margaret Cancer Centre, Toronto, Canada, 2013.
H. Individual corroboration: Senior researcher, Lung Transplant
programme, Edmonton, Canada, 2013.
I. Individual corroboration: Vice president of Outcomes Research at
Cancer Treatment Centers of America at Midwestern Regional Medical Center,
Zion, IL, USA regarding the contribution of the Leeds approach to
electronic assessments in clinical practice in North America, 2013.
J. Y. Leung, M. Li, G. Devins, C. Zimmermann, C. Lo, G. Rodin. Routine
Screening for Suicidal Intention in Patients with Cancer. Psycho-Oncology,
in press. DOI: 10.1002/pon.3319. http://www.ncbi.nlm.nih.gov/pubmed/23878040