EAPC - ipac

430 EAPC Abstracts
102 Oral Presentation
Research methodolgy and Audit
Teleform Usage in Clinical Trials: Database Management
Authors: Hue Quan Capital Health Regional Palliative Care Program Grey
Nuns Community Hospital CANADA
Carla Stiles Tom Baker Cancer Center Calgary CANADA
Patricia Biondo Tom Baker Cancer Center Calgary CANADA
Robin Fainsinger University of Alberta Edmonton CANADA
Neil Hagen Tom Baker Cancer Centre and University of Calgary Calgary
CANADA
Dwight Moulin London Regional Health Sciences Center London, Ontario
CANADA
Background: Multicenter trials require data collection methods that accurately
capture study information, while simultaneously minimizing workload
for research staff. All research teams – investigators, sponsors and
clinical research organizations – are concerned about fidelity of data collection,
transfer and accuracy. Direct data entry can potentially address
these concerns but further innovation is needed. Methods: Teleform
(Verity Software Inc., Vista, CA) is an optical recognition-based technology
that scans hand written data collection paper forms (quantitative and
free text) and exports digitized data to a computer database. A multidisciplinary
team converted hard copy data collection forms to teleform format
for a multicentre trial focusing on sublingual methadone for the treatment
of breakthrough pain. Each document was assigned a unique number and
visual identifier to ensure form recognition, data organization and patient
confidentiality. Sites used a teleform manual and individualized instruction
to support form completion and transmission of data. Independent reviewers
systematically evaluated submitted forms for missing data and inconsistencies.
Free text entries were deciphered and transferred to the MS
Access database. Queries were generated when necessary for clarification.
Results: 300 completed forms have been submitted to the database. Health
care providers and patients report that the format is easy to understand, and
easy to complete. Data queries have been uncommon. Data integrity and
patient confidentiality have been maintained. Conclusions: Teleforms support
detailed collection, transfer and storage of study information, are feasible
for both patient and professional data capture, and are financially
modest to implement. This technology can support international clinical
trials in palliative care, requiring little more than a fax machine from the
sending centre. Funding: CIHR Grant PET69772 & Alberta Cancer Board
High Risk Grant.
103 Oral Presentation
Research methodolgy and Audit
Quality indicators for palliative care
Authors: Anneke Francke NIVELNIVEL NETHERLANDS
Roeline Pasman Department of Public and Occupational Health, EMGO-
Institute, VU Medical Center Amsterdam NETHERLANDS
Hella Brandt NIVEL Utrecht NETHERLANDS
Luc Deliens Department of Public and Occupational Health, EMGO-
Institute, VU Medical Center Amsterdam NETHERLANDS
Riet Van Vliet IGZ Utrecht NETHERLANDS
Background: Main aim of this study is to develop a set of quality indicators
for palliative care that can be used in various settings (e.g. hospices, at
home, hospitals, nursing homes). This 2-year project consists of five phases:
(a) inventory of existing relevant quality indicators; (b) discussions with
experts about which existent indicators are highly relevant and which indicators
are being missed; (c) development of a draft set of quality indicators;
(d) testing the set in various care settings; (f) making of the final version.
The first phase already has been passed, and this presentation will mainly
focus on the process and results of the inventory of existing indicators.
Methods: Existing quality indicators were identified by searches in
Medline, PsycINFO, EMBASE and CINAHL. Search terms regarding palliative
care and quality indicators were combined. Only publications focusing
on measurable quality indicators for palliative care were included. We
considered an indicator “measurable” when a numerator, denominator or a
performance standard was given. The inclusion process was performed by
two reviewers independently. Results: The searches resulted in 580 potentially
relevant references. Eleven of these 580 fulfilled the inclusion criteria.
By reference tracking another 3 publications were identified. These
14 publications concerned 6 sets of indicators: 2 concerning palliative cancer
care, 1 concerning ICU end-of-life care, 1 concerning vulnerable elderly
in end-of-life care, 1 concerning palliative nursing home patients, and
1 concerning palliative care at home. In total about 100 (partly overlapping)
indicators were found. The indicators covered all aspects of palliative care
(physical, psychosocial and spiritual). Conclusions: The majority of the
indicators concerned the process of palliative care; only a few are related to
outcomes. In the next project phases choices have to be made regarding
which quality indicators are most applicable and relevant for various palliative
care settings.
104 Oral Presentation
Research methodolgy and Audit
Views of patients and healthcare professionals towards RCTs in
palliative care
Authors: Clare White Palliative MedicineNorthern Ireland Hospice Care
UNITED KINGDOM
Kristen Gilshenan Mater Research Support Centre, Mater Health Services
Brisbane AUSTRALIA
Janet Hardy Director of Palliative Care, Mater Health Services Brisbane
AUSTRALIA
Background: Randomised controlled trials (RCTs) are notoriously difficult
to complete in palliative care (PC). The study aimed to determine whether PC
patients are interested in participating in RCTs, and identify important factors
in their decision. It also considered the views of healthcare professionals
(HCPs) through a parallel survey. Methods: Questionnaires were developed
through literature review, a focus group of HCPs, and patient and relative
interviews. Pilot studies were performed. The questionnaire for patients and
HCPs assessed the same trial related factors, level of trial complexity, and
tolerability of trial inconvenience. Ethical approval was obtained.
Consecutive eligible PC patients were approached. The HCP survey was sent
to 597 Australian and New Zealand HCPs. Results: 101 patients participated.
Over 75% expressed altruistic views. 92% of patients would participate
in studies involving simple interventions, whereas only 26% would consider
studies of complex interventions. Financial burden and possibility of sideeffects
was off-putting to many. Concepts of ‘randomisation’, ‘placebocontrol’
and ‘blinding’ deterred approximately 50% of participants. Many
were prepared to complete short questionnaires, accept extra medications,
investigations, hospital visits or admissions within a trial context. 198 (33%)
questionnaires were returned from HCPs. Very few would refer to complicated
studies. Non-medical HCPs appeared less interested than doctors in
studies involving randomisation, placebo or double-blind methodology. The
majority would refer to non-pharmacological studies, but were less willing
for studies with possible side-effects. Two factors predicted greater willingness
to refer: previous research experience and male gender. Conclusions:
Many patients are willing to participate in PC research if trial design is
acceptable. Gatekeeping was an issue, with many HCPs unwilling to refer
patients. This study should aid the development of RCTs in PC.
105 Invited Lecture
The complexity in the understanding and treatment of
Depression in PC
Adjustment disorder with depressed mood – how to differentiate
from depression in palliative care patients
Authors: Luigi Grassi Professore Ordinario di Psichiatria Università di
Ferrara ITALY