Download Definition of minimum data set for all pilots in Renewing Health

Definition of minimum data set for all pilots in Renewing Health
To assist the pilot teams in their production of the final protocols we have produced the following
description of data that must be collected in all pilots and included in the results from all pilots.
The description of the minimum data set includes:
1.
2.
3.
4.
5.
Demographic data
Data on effects on health related quality of life
Data on patient perception
Data included in the economic evaluation
Data on organisation of the telemedicine service
In relation to the assessment methodology used in Renewing Health, the MAST model, the
demographic data will be used in the description of the patients (domain 1) and in the comparison
of the intervention and patient group in the clinical study (domain 3). Data on quality of life will
also be used in the clinical study (domain 3). Measurement of the patients' perception will be
included in domain 4 and data on the economic aspects will be part of domain 5. Finally, data on
the organisation of the telemedicine services will be included in domain 6.
The described data sets are a minimum and will improve the possibilities for comparison of the
results from the pilots and secure that an analysis of data can be made at both cluster and overall
project level.
Note that the pilots are expected to collect a large number of more specific information that is
relevant for the individual pilot than those described in this document. This document only includes
data that are common to all pilots!
1
1. Description of minimum demographic data set in each pilots
In order to have a common description of the patients participating in the intervention and control
group in the pilots, all pilots must collect the following demographic data for each patient:
Question
Cluster no.
Response and coding
1 = cluster 1
2 = cluster 2
3 = cluster 3
4 = cluster 4
5 = cluster 5
6 = cluster 6
7 = cluster 7
8 = cluster 8
9 = cluster 9
Country
1 = Austria
2 = Denmark
3 = Germany
4 = Greece
5 = Finland
6 = Italy
7 = Norway
8 = Spain
9 = Sweden
Intervention or control group
1 = Intervention
2 = Control group
Diagnosis of the patients in the cluster
1 = Diabetes
2 = COPD
3 = CHF
Demographic data on each patient
Date of birth
DD-MM-YYYY
Gender
1 = Male
2 = Female
9 = Missing answer
What is the highest level of education you have
1 = No formal schooling
completed?
2 = Less than primary school
3 = Primary school completed
4 = Secondary school completed
5 = High school completed
6 = College/University completed
7 = Post graduate degree
88 = Refused
99 = missing answer
What is your present marital status?
1 = Never married
2 = Currently married
3 = Separated
4 = Divorced
5 = Widowed
6 = Cohabitating
88 = refused
99 = missing answer
Which of the following best describes your main
1 = Government employee
work status over the past 12 months?
2 = Non-government employee
3 = Self-employed
2
How many people older than 18 years, including
yourself, live in your household
4 = Non-paid
5 = Student
6 = Homemaker
7 = Retired
8 = Unemployed (able to work)
9 = Unemployed (unable to work)
88 = refused
99 = Missing answer
Number of people _ _
88 = Refused
99 = Missing answer
OTHER MEASURES
Do you currently smoke tobacco products daily?
During the past 12 months how frequently have
you had at least one alcoholic drink?
Your height is?
Your weight is?
Have you been diagnosed with other diseases?
Are you familiar with using a personal computer
(PC)?
Are you familiar with using a mobile telephone?
1 = yes
2 = No
8 = Refuse
9 = Missing answer
1 =Daily
2 = 5-6 days per week
3 = 1-4 days per week
4 = 1-3 days per month
5 = Less than once a months
88 = Refuse
99 = Missing answer
In centimetres (cm) _ _ _
888 = Refuse
999 = Missing answer
In kilograms (kg) _ _ _
888 = Refuse
999 = Missing answer
1 = Heart diseases
2 = Cerebrovascular disease
3 = Dementia
4 = Chronic pulmonary disease, incl. COPD
5 = Connective tissue disease or rheumatic disease
6 = Ulcer disease
7 = Liver disease
8 = Diabetes
9 = Hemiplegia
10 = Renal disease
11 = Cancer
12 = AIDS
13 = Other
88 = Refuse
99 = Missing answer
1 = yes
2 = No
8 = Refuse
9 = Missing answer
1 = yes
2 = No
8 = Refuse
9 = Missing answer
3
Most of the questions and the response categories and the coding of the responses are based on similar
questions in the questionnaire from a WHO project “Step approach to chronic disease risk factor
surveillance (STEPS), see www.whoint/chp/steps
The question on comorbidity is based on the disorders included in Carlsons comorbidityindex, but a
reduction has been made in the number of groups by putting together subgroups of patient in larger groups
(e.g. all patients with cardiovascular diseases in one group).
2. Data on effects on health related quality of life
All pilots will measure the effects of the telemedicine applications on the patients health related
quality of life by using:

SF36 v2
Based on the patients answers to the 36 questions an assessment can be made of 8 dimensions of
health:








Physical functioning
Role physical
Bodily pain
General health
Vitality
Social funtioning
Role emotional
Mental health
Measurement will be made for each patient in the intervention and control group at baseline and
after the intervention e.g. after 4, 8, 12 and 26 weeks.
4
3. Description of minimum measurement of patient perception
A literature review has been made to identify a validated and reliable instrument for assessment of
patient perception of telemedicine applications. Even though a number of instruments were found, it
has not been possible to find a suitable, validated questionnaire. A review has also been made of a
number of questionnaires used in telemedicine project for the EC. However, these were not tested
for validity and the statistical results were generally not well described.
Instead contact the NHS England Whole System Demonstrators (WSD) programme was contacted.
The programme is a two year research project funded by the Department of Health, UK to find out
how technology can help people manage their own health while maintaining their independence by
use of different telehealth and telecare applications. The programme was in 2009 probably the
largest randomised control trial of telecare and telehealth in the world.
Researchers under the leadership of Professor Stanton Newman at University College of London
have developed a patient acceptability questionnaire based on a literature review and testing in
qualitative studies. The questionnaire is used in WSD pilots including about 3000 patients. The
questionnaire can be self-completed by the patients. The wording of the questions does not include
"NHS-terms" and references to NHS and similar and thus can be used in other countries.
The wording of the 22 items in the Likert scale questionnaire is both positive and negative, and this
reduces the risk of bias. The topics include questions on:
•
•
•
•
•
•
Utility of the 'kit‘
Effect on health status
Effect on health care/social care
Privacy
Suitability of the kit
Satisfaction with the kit
Renewing Health has made a formal collaboration agreement with Professor Newman and has been
granted permission to use the same patient perception questionnaire as in the WSD programme,
although the questionnaire and the British results are unpublished at the moment. The advantages of
this solution are:


That the pilots in Renewing Health and the WSD programme can compare the estimated
patient acceptability.
That Renewing Health and the WSD programme in collaboration can collect information
from the largest sample of patients in the world and thereby produce unique scientific
studies of patient perception of telemedicine and contribute to the development of a solid
and well validated questionnaire to be used in future studies.
The questionnaire can be found in the appendix (the attached pdf-file).
5
4. Description of minimum indicators for the economic evaluation
The general guidelines for development of the pilots' economic evaluation are described in the
document “Six important steps in the estimation of the economic aspects of telemedicine
applications in Renewing Health”, submitted to the pilot teams in the fall 2010.
All pilots must collect data on:


Investments in the telemedicine application
Running costs of delivering the telemedicine service and the comparator
o Time used by the staff (number of minutes)
o Time used by the patient (number of minutes)
o Use of utensils, devices etc.
Each patient's use of health care service:
o Number of admissions (including readmissions)
o Number of bed days (days of hospitalisation)
o Number of GP visits
o Number of visits to emergency department
Reimbursement of the telemedicine service


The investment in the telemedicine service will vary from pilot to pilot but should generally include
both investments in hardware and software, physical changes and education of health care
professionals.
The running costs of delivering the telemedicine service and the comparator (e.g. usual care) must
be measured for each patient (at patient level) in the intervention and the control group. All pilots
should collect data on use of time by the health care professionals and the patient (including travel
time), and use of utensils and devices (if relevant). The decision on which health care professionals'
time to include and when to measure the use of time must be made locally by the individual pilot.
All pilots must collect data on the use of health care services in the intervention and control group
for each patient. This must include data on number of admissions at hospital, bed days, GP visits
and visits to emergency department.
Based on the collected data, all pilots must be able to include the following tables when reporting
the results from the studies:




Table: Types of resources included in the estimation of costs and data collection method
Table: Prices used in the calculation of costs
Table: Average use of resources per patient in the intervention and control group
(including information of variation e.g. confidence intervals)
Table: Average cost per patient in the intervention and control group (including both fixed
and running costs and effects on use of health care and information of variation e.g.
confidence intervals)
6
5. Description of minimum data on organisation of the telemedicine service
As described in MAST, an assessment of the organisational aspect of implementation of
telemedicine applications is important because telemedicine generally necessitate or enable major
organisational changes.
In Renewing Health all pilots must describe the following indicators:

Effects on work processes:
o Workflow: Effects on number of patients treated, procedures performed etc.
o Staff: Changes in distribution of work (task shifting)
o Resources: Changes in working hours for each profession
o Training: Time spent on training to learn to use the application
o Internal communication: Changes in the way the staff communicate within the
organisational unit
o External communication: Changes in the communication with staff in external units

Effects on structural outcomes:
o Description and number of units collaborating in the production of the service
o Changes in organisation of generalist and specialist tasks
o Changes in geographical spread
o Changes in time spent on travel

Cultural outcomes:
o Staff attitudes towards the application
o Staff experiences with the use of the application
Notice that the description of the intervention and the content of the telemedicine application is part
of domain 1 “Health problem and characteristics of the application” and therefore not included here,
e.g. the description of interoperability. However, the effects of e.g. interoperability on tasks and
time used by the different health care professions are included in the indicators above.
With regards to data collection methods most of the information described can be collected by
interview (qualitative studies) with the health care professionals. However, information on
quantitative effects on number of patients treated, use of resources for training and time used by
different professional must be collected as part of the economic analysis and thus can be used as the
basis for description of both domains.
In order to identify a questionnaire for assessment of the cultural outcomes, a review has been made
of previous EC projects on the effects of telemedicine applications. However, no well described and
validated questionnaire was found. Instead a number of questions from different EC projects will be
used to assess the perception of the health care professionals delivering the telemedicine
applications:
1. Have you experienced technical difficulties which may affect the quality of care delivered
by the telemedicine service?
2. Have you experienced difficulties in your collaboration with other professional groups in
relation to the telemedicine service?
3. Have you experienced difficulties in your collaboration with the staff at other institutions in
relation to the telemedicine service?
4. How would you describe the usability of the telemedicine application for you?
7
5. Has the use of the telemedicine application had any effect on your use of time?
6. Has the use of the telemedicine application had any effects on your tasks?
7. Has the use of the telemedicine application had any effects on the communication within
your institution?
8. Has the use of the telemedicine application had effects on the communication with other
institutions?
9. Would you like to continue to use the telemedicine service?
10. How would you describe your overall satisfaction with the use of the telemedicine service?
Because the telemedicine applications and the role of the health care professionals vary from cluster
to cluster, the wording of the questions are made quite general and the questions are open ended and
without response categories.
8