Internal Medicine and Medical Investigation Journal
E-ISSN: 2474-7750
Homepage: www.imminv.com
SYSTEMATIC REVIEW PROTOCOL
Personal Electronic Health Record for Patients with Diabetes; Health Technology Assessment
Protocol
Masoomeh Rahimi Alami1, Mahdieh Nemayande2, Omid Yousefianzadeh3, Mahnaz Samadbeik4, Amir Abbas Azizi5,
Robabeh Motaghedi6, Atefeh Zare1, Samaneh Ghasemian1, Abbas Barzegar1, Vahid Gholampour1, Hamidreza Dehghan7*
1
M.A student, Health Technology Assessment, Faculty of Health, ShahidSadoughi Yazd University of Medical Sciences, Yazd, Iran.
2
Doctor, Epidemiologist, Yazd Cardiovascular Research Center, ShahidSadoughi Yazd University of Medical Sciences, Yazd, Iran.
3
Ph.D. Candidate, Health Information Management, Member of Research Center for Management Science and Health Economics,
Faculty of Management and Medical Informatics, Iran University of Medical Sciences, Tehran, Iran.
4
Ph.D. in Health Information Management, Assistant Professor, Department of Health Information Technology, Faculty of
Paramedicine, Lorestan University of Medical Sciences, Khorramabad, Iran.
5
PhD in Medical Informatics, Department of Health Information Technology, Faculty of Paramedical Sciences, Ahwaz Jundishapur
University of Medical Sciences, Ahwaz, Iran.
6
M.A student, Health Technology Assessment, Faculty of Health, ShahidSadoughi Yazd University of Medical Sciences, Yazd, Iran.
7
Department of Medical Informatics, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.
Corresponding Author: Hamidreza Dehghan, E-mail: hamidreza.dehghan@gmail.com
ARTICLE INFO
ABSTRACT PROTOCOL
Article history
Received: Aug 17, 2017
Accepted: Sep 03, 2017
Published: Oct 05, 2017
Volume: 2
Issue: 4
Introduction: In recent decades, diabetes has contributed significantly to the burden of disease
in developed and developing countries, due to the considerable prevalence and involvement
of various age groups in the communities. Today, a variety of ways to manage and control the
disease are used, one of which is the use of personal electronic health records. Recently there
has been a remarkable upsurge in activity surrounding the adoption of personal electronic health
records systems for patients and consumers. personal electronic health records systems are
more than just static repositories for patient data; they combine data, knowledge, and software
tools, which help patients to become active participants in their own care. The present study was
conducted with the goal of Health Technology Assessment the impact of personal electronic
health records in Patients with Diabetes. Methods and Analysis: Writing is based on PRISMA
standards. This was a Health Technology Assessment study. It aimed to evaluate the technology
of personal electronic health record. The scoping review was conducted to evaluate 8 dimensions
(Health Problem and Current Use of the Technology, Description and technical characteristics
of technology, Safety, Costs and economic evaluation, Ethical analysis, Organizational aspects,
Patients and Social aspects, Legal aspects) of Personal electronic health record. This study was
based on answering questions which were developed based on Health Diagnostics Technology
Assessment Documents Framework and Health Technology Assessment (HTA) Core Model 3.0.
A systematic review was conducted to evaluate the Clinical Effectiveness dimension of personal
electronic health record in controlling diabetes. In order to gather evidences, Ovid databases,
Cochrane Library, PubMed, CRD, Trip database and EMBASE, and Randomized Controlled
Trial Registries, such as the Clinical Trial and Trial Registry, were searched using specific
keywords and strategies. Articles are evaluated on the basis of the quality criteria of JADAD.
The data is analyzed by the STATA software. Dissemination: The results of the study will be
published in a peer-reviewed journal and presented at relevant conferences. Policy makers and
healthcare decision-makers can use these results.
Conflicts of interest: None
Funding: None
Key words
Diabetes,
Personal Electronic Health Record,
Health Technology Assessment,
Effectiveness,
Systematic Review,
Meta-Analysis
INTRODUCTION
Diabetes is a metabolic disorder that leads to absent the
ability of the body to produce insulin or make the body to
resistance against insulin; so, the produced insulin may not
do its normal function, and finally, the blood glucose will in-
crease. In long-term, the excessive amounts of blood glucose
level may damage various parts of the body such as cardiovascular system, eyes, kidneys, genital system, and nervous
system (1-3). In recent years, the incidence of diabetes has
increased in worldwide (4). According to latest statistics, the
Published by Mehrabani Publishing LLC.
Copyright (c) the author(s). This is an open access article under CC BY license (https://creativecommons.org/licenses/by/4.0/)
http://dx.doi.org/10.24200/imminv.v2i4.100
Personal Electronic Health Record for Patients with Diabetes; Health Technology Assessment Protocol
global prevalence of diabetes reached to 382 million people in 2013. It is predicted that in 2035, it will reach about
592 million people (5). In Iran, the number of individuals who
were infected with this disease was 9.9% in 2013; according
to predictions, it will reach to 10.1% in 2035 (6). Nowadays,
diabetes is epidemic in the world; the world’s prevalence of
diabetes increases by about 6% annually. Considering the increased prevalence of diabetes in the world, the treatment,
control, and acute complications of diabetes require considerable expenditure by both patients and community health
system. In a report which was published in 2001 by World
Health Organization (WHO), in which the global burden of
diseases was calculated, diabetes ranked 20th in years lived
with disability; in other words, 1.4% Years lost due to disability (YLD) was associated with this disease (7).
The economic and physical consequences of diabetes are
significant; it increases mortality and causes a lot of economic burdens (8). However, the negative consequences of diabetes may be prevented (9). The effective care and disease
management are the only available solutions. The management of diabetes is complex and requires basic healthcare,
coordinated care, nutritionist and endocrine experts’ cooperation, etc. The patient education including proper lifestyle,
healthy nutrition, having physical activity, and appropriate
use of medications therapy is necessary to facilitate controlling blood glucose levels (10). However, the increased
number of people with diabetes, low numbers of primary
care providers, and increasing healthcare costs have made it
harder to take care of diabetic patients. In 2001, the National
Academy of Medicine presented a solution to this problem
which was known as improving communication between patients with chronic disease and self-care (11).
The improved knowledge and performance of patients
with diabetes mean improved metabolic situation control
and performing proper self-care behaviors (12). Therefore,
the patients with diabetes will take care of him/herself well
if he/she will be aware of his/her illness and treatment, tests,
drugs, medical recommendations, follow-up visits, and
blood glucose monitoring blood glucose levels. Indeed, the
patients need conditions through which they may participate more in making decisions about their health status.To
achieve this, the electronic personal health record (ePHR)
is one of the appropriate tools which also empowers patients (13, 14). The concept of ePHR has existed from the
past and is not new. In the past, the patients hold their health
information in paper form. Archer et al. (2011) reported
that among 47% of patients who keep their health records,
87% stated that they keep them in paper form.Nowadays,
the ePHR maintains the health and medical information
of people in electronic form and they are available at anytime (15). The ePHR is an electronic software in which people access and manage their medical information. Hence,
people may access to this confidential information in a secure medium (16).
This study aims to evaluate the technology of ePHR
in patients with diabetes compared with those who only
received routine services and have not used ePHR. It can
helped policy-makers in entry, design, and how to use it.
133
In dictionary of International Bureau of Health Technology Assessment (HTAi), this field is defined as HTA is
a systematic evaluation of clinical effectiveness, cost-effectiveness, or social and ethical effects of health technology
on patient’s life and healthcare system. This process specifies that whether the desired health technology should be
used (17). If so, how should it be used and which patients
will benefit most from it? The evaluations are different, but
it mostly focuses on cost and impact of technology on population or society.
According to this definition, the HTA studies address
various dimensions of health technologies impacts; these
dimensions may be divided into nine general domains including (health problem and current use of the technology, description and technical characteristics of technology,
safety, clinical effectiveness, costs and economic evaluation, ethical analysis, organizational aspects, patients and
social aspects, and legal aspects) The examination of these
technology dimensions effects and their related results may
influence policy-maker and decision-making.The HTA Core
Model is a methodological framework for collaborative
production and sharing of HTA information. The HTA Core
Model is a registered trademark. According to HTA Core
Model 3.0, the technology dimensions study in HTA includes some elements; questions should be answered in
each element (18).
METHODOLOGY
This was a HTA study. It aimed to evaluate the technology of
ePHR. The scoping review was conducted to evaluate 8 dimensions (health problem and current use of the technology, description and technical characteristics of technology,
safety, clinical effectiveness, costs and economic analysis,
ethical issue, organizational aspects, patients and social aspects, and legal aspects) of ePHR. This study was based on
answering questions which were developed based on Health
Diagnostics Technology Assessment Documents Framework
and HTA Core Model 3.0 (18). A systematic review was conducted to evaluate the clinical effectiveness dimension of
ePHRin controlling diabetes.
Questions
Databases including Cochrane library, PubMed, Center for
Review and Dissemination(CRD), Trip database, and EMBASE, randomized controlled trial (RCT) studies register
databases (such as Clinical Trial and Trial Registry) were
searched bykeywords as follow: personal health record, personal medical records, ePHR, diabetes mellitus, and records.
The search was performed without any time and language
limitation.The final articles were collected for systematic
review based on the process of selecting specific resources; their quality was evaluated based on Critical Appraisal
Skills Program (CASP) critical evaluation checklist which is
designed for RCT studies. The structured questioning components (PICOD) at population, intervention, comparison,
outcome, and design levels are as follows Table 1 and 2 both
here .
IMMINV 2(4):132-138
134
Examined
dimension
Questions
Answers
1-Health problems
and current
technology use
What disease or major health problem is the target of intervention?
Define diabetes disease and categorize it?
What are the symptoms of diabetes?
What are the risk factors for diabetes?
What are the outcomes and consequences of disease?
How many people are in the group of patients with diabetes?
What is the burden of diabetes?
What is the rate of applying ePHR technology?
How the application of ePHR technology varies in different countries, regions, and programs?
How developed is the ePHR technology (study, emerging, stabilized, declining phases)?
Does ePHRtechnology fall into the basic services package of different countries? What is
the coverage of technology in other countries?
Who produces PHR technology?
Scoping review
2- Technology
features
What is ePHR? How is the scientific foundation and mechanism of its effect?
Why is ePHRused?
For whom the ePHR technology is applicable?
Is public information about technology necessary? What information is needed to inform people?
What are capital factors required to use ePHR technology?
What kind of specific platform is required to use ePHR technology?
What type of equipment is required to use ePHR technology?
What types of data are required to monitor the application of ePHR technology?
What type of training or information on PHR technology is required to be provided to
patients, their families, and the general public?
What are the proven and potential applications of ePHR technology?
Scoping review
3-safety
What are the potential risks and possible damages of PHR technology?
What is the range of risks which are associated with ePHR technology; incidence, severity,
duration?
How is the prevalence of technology-related damages?
When damage occurs (immediately or delayed)?
Which of the damages which are associated with ePHR technology are more important
considering their prevalence and severity?
Does the prevalence of ePHR-related damage changes over time?
How ePHR technology is safe compared to alternative technologies?
What are the ways to reduce user-related safety risks?
Is there any evidence of environmental damages?
What kind of environmental protection is needed?
Scoping review
4- Effectiveness
What is the effect of ePHR technology on overall mortality?
What is the effect of ePHR technology on the mortality rate of target disease?
What is the effect of ePHR technology on mortality which is caused by other reasons?
What is the effect of ePHR technology on severity and frequency of disease symptoms and
findings?
What is the effect of ePHR technology on the progression of disease?
What is the effect of ePHR technology on recurrence of disease symptoms?
What is the impact of ePHR technology on health-related life quality?
What is the impact of ePHR technology on quality of life which is associated with target
disease?
What is the effect of ePHR technology on patient’s return to work and previous life
situation?
What is the impact of ePHR technology on patient’s daily activities?
Is ePHR technology valuable to the patient?
Systematic
review
5- Costs and
economic
assessment
What types of resources are used to provide evaluated technology and comparing
it (identification of used resources)?
How many resources are used in providing evaluated technology or competing
technologies (costs which are specifically related to technology)?
What is the unit price of consumed resources at the time of providing evaluated technology
and its comparators?
What is the effect of PHR technology on indirect costs?
What are the incremental effects of technology relative to comparators?
What is the incremental cost-effectiveness ratio?
Scoping review
(Contd...)
Personal Electronic Health Record for Patients with Diabetes; Health Technology Assessment Protocol
135
Examined
dimension
Questions
Answers
6-Ethical
Is ePHR technology a new and innovative technology which adds to standard care or
replaces a standard?
Does ePHR technology challenge the religious, cultural, or spiritual principles and beliefs
of some groups or change the current social principles of society?
What are the unanticipated and unwanted results and implications of ePHR technology?
Does the use of ePHR technology affect the patient’s ability?
Does PHR technology have any risks or challenges that the patient needs to know it?
Does the institutionalization and use of ePHR technology affect human status?
Does institutionalization and use of ePHR technology affect human dignity?
What are the benefits and dangers for the patients, and how will there be a balance
between the benefits and risks when the technology is institutionalized and when it is not
institutionalized? Who creates a balance between risks and benefits? And how?
Can ePHR technology harm other stakeholders?
What are the effects of institutionalizing and not institutionalizing of technology on justice
in health care? Are the principles of equality, justice, and integrity respected?
Scoping review
7-Organizational
What kind of workflow and disease flow will be required?
What kind of partnership of patients and relatives is needed to be developed in the process
of treatment and care?
What type of staff training and other human resources is needed?
What will be the results of the centralized and decentralized expansion of implementing
new technology?
What investment (material and immaterial) should be undertaken to set up and expand
technology?
What effect will the technology implementation have on government spending and
budgets?
What are the challenges and management opportunities which are associated with
technology?
Who decides about whether the patient uses ePHR technology?
How will the new ePHR technology be accepted?
Scoping review
8-Social
What social domains are affected by ePHR technology?
In addition to the patient, what is the effect of technology on other important people?
What kind of support and resources are needed when PHR technology is used?
How will technology affect the position, role, and functions and important life issues of the
patient in society?
How the use of ePHR technology changes the physical and psychological functioning of
patients in main living areas?
How do patients and other important people react to ePHR technology?
How is the understanding and knowledge of patients and other important people about
ePHR technology?
How are the information on using ePHR technology analyzed and exchanged?
Scoping review
9-Legal
Whether the use of technology by patient needs an informed consent from the patient?
Whether in the case of using alternative technologies of evaluated technology, the patients
should be informed?
Considering patient’s conditions, whether they have enough time to decide on technology?
Is it possible to obtain the informed consent of the patient before using technology?
Does the use of technology require access to personal and private information of patient?
Do all people need (or will have) same access to evaluated technology?
Does the technology require a specific registration mechanism?
Does the technology need a specific assessment and monitoring mechanism?
Are there enough rules for technology use?
Are certain rules and regulations required for using technology? What areas are considered
in using these rules?
Coping review
IMMINV 2(4):132-138
136
Table 1. Structured questioning components (PICOD)
Population
Intervention
ePHR
Comparison
received regular care
Outcome
Health problems and current use of the
technology, description and technical
characteristics of technology, safety, clinical
effectiveness, costs and economic evaluation,
ethical issue, organisational aspects, patients
and social aspects, legal aspects
Design
HTA, systematic review, RCT, non
Clinical -trial studies, economic evaluation,
guidelines
Table 2. Applied search strategy in electronic databases
CRD York
Result
Search Name Cochran:
0
library
Search
Query
Items
found
1#
((((“”Personal Health Record “”[Title/
Abstract]) OR “”Personal Health
Records “”[Title/Abstract]) OR
“”Personal Medical Records””) OR
“”Personal Electronic Health Records
“”) OR “”Personal Electronic Health
Records “”[Title/Abstract]”,
844
(((((“”Diabetes Mellitus””[Title/
Abstract]) OR “”Diabetes Mellitus,
Type 1 “”[Title/Abstract]) OR “”Diabetes
Mellitus, Type 2 “”[Title/Abstract])
OR “”Glucose Intolerance “”[Title/
Abstract]) OR “”Diabetic Ketoacidosis
“”[Title/Abstract]) OR “”Diabetes
Insipidus””[Title/Abstract]”,
177851
((((((“”Personal Health Record
“”[Title/Abstract]) OR “”Personal
Health Records “”[Title/Abstract])
OR “”Personal Medical Records””)
OR “”Personal Electronic Health
Records “”) OR “”Personal Electronic
Health Records “”[Title/Abstract]))
AND ((((((“”Diabetes Mellitus””[Title/
Abstract]) OR “”Diabetes Mellitus,
Type 1 “”[Title/Abstract]) OR “”Diabetes
Mellitus, Type 2 “”[Title/Abstract])
OR “”Glucose Intolerance “”[Title/
Abstract]) OR “”Diabetic Ketoacidosis
“”[Title/Abstract]) OR “”Diabetes
Insipidus””[Title/Abstract])”,
21
3#
((((((“”Personal Health Record
“”[Title/Abstract]) OR “”Personal
Health Records “”[Title/Abstract])
OR “”Personal Medical Records””)
OR “”Personal Electronic Health
Records “”) OR “”Personal Electronic
Health Records “”[Title/Abstract]))
AND ((((((“”Diabetes Mellitus””[Title/
Abstract]) OR “”Diabetes Mellitus,
Type 1 “”[Title/Abstract]) OR “”Diabetes
Mellitus, Type 2 “”[Title/Abstract])
OR “”Glucose Intolerance “”[Title/
Abstract]) OR “”Diabetic Ketoacidosis
“”[Title/Abstract]) OR “”Diabetes
Insipidus””[Title/Abstract]) Filters:
Randomized Controlled Trial”
2
ID
Search hits
#1
Personal health record: ti, ab, kw (Word
variations have been searched)
374
#2
Personal health records
1682
#3
Personal medical records/
1531
#4
Computerized patient records/
612
#5
ePHR s/
1426
#6
patient-held record
51
#7
personally controlled health record
103
#8
#1 or #2 or #3 or #4 or #5 or #6 or #7
2404
Searches
(Personal Health Record OR Personal Health
Records OR Personal Medical Records )
AND (Diabetes Mellitus, Type 1 OR Diabetes
Mellitus, Type 2 OR Glucose Intolerance OR
Diabetic Ketoacidosis OR Diabetes Insipidus): TI
IN DARE, NHSEED, HTA
2#
4#
Patients with diabetes
Items
found
#9
Diabetes Mellitus, Type 1
18472
#10
Diabetes Mellitus, Type 2
21837
#11
Glucose Intolerance
1356
#12
Diabetic Ketoacidosis
375
#13
Diabetes Insipidus
#14
#10 or #11 or #12 or #13 or #14
#15
#9 and #15
366
#16
#9 and #15 Publication Year from 2000 to
2016, in Trials
27
139
24447
Selection of studies
The phase of searching and reviewing quality of articles
will be done by two individuals independently. In the case
of disagreement, the judgment was made by the third person. After completing the search, all found articles were
entered into EndNote software, and the duplicates items
will be deleted.Then, the titles and abstracts of articles
will be reviewed by two people based on inclusion and
exclusion criteria. In the case of unclear title and abstract,
the full text was extracted. Also, articles’ references will
be reviewed and the related studies will be searched.The
inclusion and exclusion criteria in the first (based on title
and abstract) and second (based on full text) stages are as
follows:
Inclusion and exclusion criteria of study
• Population:
Personal Electronic Health Record for Patients with Diabetes; Health Technology Assessment Protocol
•
•
•
•
The studies that have survey the other diseases more
than diabetes will be excluted.
Intervention:
The studies which have examined PHR will be excluded
from.
Comparison:
The studies which have not studied target comparison
group will be excluded.
Outcome:
The studies which have considered unrelated impact
will be excluded from the study.
Design:
Other types of studies other than related studies will be
excluded.
137
ues of I2 index, the heterogeneity level is presented as
follows: low heterogeneity (25%- 50%), medium heterogeneity (50%-75%), and high heterogeneity (more than
75%). If the numerical value of this index will be zero,
it indicate that the results are homogeneous and if the
score will be higher, it suggest that the results are heterogeneous. If the heterogeneity in results of various studies
will be confirmed, the analysis will be conducted in subgroup analysis. Indded, the studies will be grouped based
on probabilistic factors causing heterogeneity, and separate statistical analysis will be performed in each group. In
the case of meta-analysis, the Forest Plot and Funnel Plot
will be drawn.
Missing Items
Data Extraction
The data extraction checklist will be designed based on articles data. To ensure all authors who participate in study
will obtain comparable data, the data of some articles will
be entered in the pilot checklist. After modifying it, the final
checklist will be designed and articles data will be extracted
according to designed checklist.The checklist includes several parts as follow: the first part consist of main data of article such as title, corresponding author name, year of study,
year of publication, place where the study was conducted,
date on which the study began and ended, age of patients,
and conflict of interests; the next parts includes items that
are related to population and outcome of study. The selected
studies will be divided into two groups, and each of them
will be assigned to two colleagues for data extraction; each
of them will independently extract the data from articles. After completing data extraction checklist, each of colleagues
examine other colleague’s data extraction checklist.
Evaluation of Bias Risk in Articles which are Entered
into Meta-Analysis
If all studies will be RCT, the Cochrane Collaboration’s Risk
Bias (RoB) tool will be used. The bias risk in studies may
be assessed using Cochrane Collaboration tool. We will use
GRADE template making software to facilitate the presentation of findings of this evaluation. This assessment includes selection bias, relationship bias, performance bias, and biases in
the identification, the report, and other bias sources including
intervention compatibility, validity, and reliability of studies.
Analysis and Aggregation of Data
After a systematic search, if meta-analysis is possible, the
selected studies will be entered into Rev Man and Stata software and based on a fixed or randomized model (the fixation
model will be used in this study), the mean difference and
confidence interval will be calculated.
Heterogeneity Assessment
The I2 and Chi-squared tests will be used to examine the
heterogeneity of studies. In this method, according to val-
Some articles will be excluded due to various reasons such
as inaccessibility of full text. The data of missing items will
not be considered (for primary or secondary outcomes) and
will not affect results of this study.
Sensitivity Analysis
If necessary, the sensitivity analysis will be performed by
re-running analyses without using studies that have high bias
risk.
Evaluation of Quality of Studies
The JADAD criterion will be used to evaluate the quality
of clinical trials studies. This checklist includes three main
items including randomization, blindness, and description of
results; the standard score for first and second items is 2 and
for the third item is 1. Also, the expert views will be used to
check the quality of articles. Among the factors which are
considered for the evaluation of the quality of articles are
validity of results, method of assigning participants to intervention and control groups, checking that the results are
achievable, the external validity of results, etc.
ACKNOWLEDGMENT
The corresponding author appreciates all authors of this article.
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