Required Data Elements and Requirements of a Teleoncology System to Provide Treatment Plans for Patients with Breast Cancer

AUTHORS

Taleb Khodaveisi 1 , Farahnaz Sadoughi 2 , * , Kambiz Novin 3

1 Department of Health Information Management, School of Health Management and Information Sciences, Iran University of Medical Sciences, Tehran, Iran

2 Health Management and Economics Research Center, School of Health Management and Information Sciences, Iran University of Medical Sciences, Tehran, Iran

3 Department of Radiotherapy and Oncology, Haft-e-Tir Hospital, Faculty of Medicine, Iran University of Medical Sciences, Tehran, Iran

How to Cite: Khodaveisi T, Sadoughi F , Novin K. Required Data Elements and Requirements of a Teleoncology System to Provide Treatment Plans for Patients with Breast Cancer, Int J Cancer Manag. Online ahead of Print ; 13(9):e100522. doi: 10.5812/ijcm.100522.

ARTICLE INFORMATION

International Journal of Cancer Management: 13 (9); e100522
Published Online: September 13, 2020
Article Type: Research Article
Received: December 29, 2019
Revised: August 12, 2020
Accepted: August 13, 2020
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Abstract

Background: Teleoncology refers to the use of telemedicine for remotely providing multiple specialized services in clinical oncology processes, including screening, diagnosis, treatment planning, consultation, supportive care, pathology, surgery, and follow-up services.

Objectives: The aim of this study was to identify the required data elements and elicitation of requirements for developing a telemedicine system that aims at providing treatment plans for patients with breast cancer.

Methods: In this study, the required data elements for the teleoncology system were identified through both the investigation of clinical guidelines and review of patients’ medical records. Identified data elements were determined by breast cancer specialists through the questionnaire. Besides, an interview method was applied to elicit the requirements of this system.

Results: The identified data elements were categorized into 20 groups (e.g., clinical data, breast physical examinations, pathological results, tests, imaging results, etc.). From the 182 data elements included within the questionnaire, 125 were recognized to be necessary (n = 32, 100%). The lowest mean percentage were observed in magnesium blood test (Mg) (n = 21, 65.63%) and protein test (Pr) (n = 21, 65.63%). Other data elements with a minimum mean of 71.87% and a maximum mean of 100% were recognized necessary. In general, 2 major themes, 9 categories, and 45 related sub-categories were extracted from analyzing the findings of the interviews related to the system requirements.

Conclusions: The findings of the present study can be used as a basis for developing teleoncology systems that aim at providing treatment plans for patients with breast cancer.

Copyright © 2020, Author(s). This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/) which permits copy and redistribute the material just in noncommercial usages, provided the original work is properly cited.

1. Background

As the most common type of cancer, breast cancer is one of the leading causes of cancer-related deaths in Iranian women (1, 2). Thus, it has a significant influence on public health and is a key concern of health policymakers (3, 4). In general, the global incidence of breast cancer will be increasing, particularly in regions with a low rate of incidence (5). In developing countries, in addition to the growing incidence of breast cancer in recent decades, patients are often diagnosed in advanced stages (6). Moreover, costs associated with different stages of the cancer treatment are rising rapidly, in such a way that even the rich countries are faced with financial restrictions in providing high-quality care equally accessible for all their residents (7). One of the most effective approaches to managing the treatment process of patients with breast cancer is suggested to be the use of multidisciplinary teams (8), which is not a new concept and is on the verge of becoming a medical standard of care (9). Telemedicine, a relatively new technique for healthcare delivery by using telecommunication technology, is one of the innovative and appropriate tools that can be applied to increase access to care services, overcome geographical barriers, and provide remote healthcare services for such areas (10). Telemedicine can make changes in processes of different domains of healthcare, including prevention, diagnosis, education, and treatment (11). Telepathology, teleophthalmology, teleradiology, and teleoncology are some of the subsets of telemedicine that have been employed in various medical specialties (12). Teleoncology refers to the use of telemedicine for remotely providing multiple specialized services in clinical oncology processes, including screening, diagnosis, treatment planning, consultation, supportive care, pathology, surgery, and follow-up services (13). In this regard, many studies on the implementation of teleoncology have been performed for different types of cancers, including breast cancer in several countries (14-16).

The medical practice employs a combination of science and art to prevent, diagnose, and treat diseases. However, applying this approach without using appropriate guidelines will not guarantee the successful therapeutic and diagnostic outcomes (17). Recently, several clinical guidelines have been developed in the areas of prevention, diagnosis, and treatment for a wide range of medical specialties including oncology (18). Some of these clinical guidelines have been developed by professional organizations to provide up-to-date quality and specific evidence to assist clinicians in making decisions, better treatment options, and designing optimal care pathways for patients with breast cancer (19, 20). Therefore, it seems appropriate to employ the relevant identified clinical guidelines when a telemedicine system is used (21).

Every software system has requirements that should be identified before the development and implementation of the system because the success of a software system depends on how it meets the needs of its users (22). Therefore, determining the requirements of a software system, using the requirements engineering process, is the initial and fundamental stage in the design and development process of a system (23). The primary outcome of system requirements engineering is to determine the specifications of software systems achieved by investigating and analyzing the needs of its stakeholders (24). Healthcare environments have multiple stakeholders with several backgrounds and interests, including health professionals, patients, and managers. Moreover, software developed in the healthcare domain is more unique and specific than other software; so, the process of identifying the requirements of these software needs to be taken more seriously and comprehensively (25, 26).

Digital health technologies including telemedicine as a software system have considerably affected different aspects of healthcare delivery services by improving communication and facilitating data sharing between physicians and patients (27). However, many telemedicine projects have faced failure due to insufficient attention to the human, organizational, and other non-technological factors affecting these projects during the design and implementation phases, particularly in the requirements engineering phase (28). Therefore, the requirements engineering process for telemedicine projects, like any other software project, is crucial to identify its requirements (29).

2. Objectives

The aim of this study was to identify the required data elements (the data used by physicians to make decisions about presenting treatment plans to patients) and determine what requirements are needed and how to identify them for implementing a telemedicine system to provide treatment plans for patients with breast cancer.

3. Methods

3.1. Identifying the Required Data Elements

In this study, data elements required in the telemedicine system to provide treatment planning for patients with breast cancer were identified and determined in 3 stages. Firstly, validated clinical guidelines related to the provision of treatment plans for patients with breast cancer were examined and the related data elements were, then, extracted. Guidelines that were considered in this research were as follow:

1. Clinical Guidelines for the Management of Breast Cancer (West Midlands Expert Advisory Group for Breast Cancer) (30).

2. National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines) Breast Cancer (31).

3. St. Gallen/Vienna 2019: A Brief Summary of the Consensus Discussion on the Optimal Primary Breast Cancer Treatment (32).

4. Primary breast cancer: European Society for Medical Oncology (ESMO) Clinical Practice Guidelines for diagnosis treatment and follow-up (33).

5. 4th European School of Oncology-European Society for Medical Oncology (ESO-ESMO) International Consensus Guidelines for Advanced Breast Cancer (ABC 4) (34).

In addition to the clinical guidelines mentioned above, the clinical guidelines related to breast cancer in Iran, the clinical guideline for early detection of breast cancer developed by the Deputy of Treatment, Ministry of Health and Medical Education of Iran (35), was reviewed to identify the data elements associated with the diagnosis of breast cancer.

In the second step, several medical records of patients with breast cancer, receiving different treatment plans were examined. To meet the objectives of the study, the authors extracted the data elements, which were used by the physicians to develop the treatment plans.

In the third step, a questionnaire was designed based on the integration of data extracted from the previous steps. Then, the questionnaire was evaluated for reliability and validity (face and content validity). In doing so, reliability was evaluated, using Kuder Richardson 21 (KR-21). However, the qualitative method was used to determine face validity, which was determined by forming a specialized panel comprised of 4 breast oncologists. In this panel, the difficulty level of questions, the use of common and relevant terms in the field, the amount of mismatch, the ambiguity of the concepts, phrases and expressions, and word meaning were appraised and discussed. Afterward, their comments were applied to the questionnaire.

Content validity was assessed through qualitative and quantitative methods. In the qualitative content validity method, 5 breast oncologists different from the mentioned 4-person panel were asked to propose their corrective opinion in written form after a careful study of the questionnaire. It was further emphasized that in assessing the quality of content validity, the following criteria were taken into account: the grammar, use of appropriate words, importance and relevance of questions, the order of questions, and the time needed to complete the questionnaire. The necessary changes were made to the questionnaire after collecting the experts’ opinions. Then, the Content Validity Ratio (CVR) and Content Validity Index (CVI) were used to evaluate the content validity of the questionnaire by breast oncologists. In doing so, 8 copies of the questionnaire were given to radiation oncologists to rate each item of the questionnaire for measuring the CVR (based on 3-point scales: “necessary”, “useful but not necessary”, and “not necessary”) and the CVI (based on 4-point scales: “an irrelevant item”, “relevant but needs minor revision”, “relevant but needs serious revision”, and “extremely relevant item”).

Responses to the items of the questionnaire were analyzed based on the CVR formula and were compared with the Lawshe table. Values above 75% were accepted for each item of the questionnaire (36). After measuring and determining CVR, the CVI of the survey was determined according to the Waltz and Basel content validity index. Then, based on the CVI results, each item in the questionnaire with a value above 79% was accepted (37). Ultimately, the final version of the questionnaire was distributed among 45 breast cancer specialists, who had at least 5 years of clinical experience for receiving their viewpoints and determining the data elements required to design treatment plans.

The final version of the questionnaire consisted of 2 parts with a total of 186 questions, including respondents’ demographic information (4 questions) and required data elements for providing treatment plans (182 questions). The second part of the questionnaire was divided into 20 sub-categories according to the type of data included. To determine the required data elements based on the responses obtained from breast specialists, researchers of this study assigned two options of “necessary” (one point) and “unnecessary” (zero points) to each question. Additionally, a blank space was provided at the end of each sub-category for receiving comments and other required data elements from the perspective of respondents.

3.2. Requirements Elicitation

In this study, an interview method was applied to elicit the requirements of a teleoncology system to provide treatment planning for patients with breast cancer. Subsequently, both quantitative and qualitative data were obtained. Using this method made it possible to have a deeper analysis of stakeholders’ feedback and needs.

3.2.1. Data Collection Tool

The initial interview guide was prepared based on the literature review (11, 12, 38, 39). Afterward, the final version of the interview guide was prepared, content and face validity of the interview questions were approved by using in-depth interviews with 3 experts in the field of health information management, medical informatics, and breast cancer treatment. The final interview guide included 2 main open questions about functional and non-functional requirements. In this regard, definitions and examples of such requirements were provided to learn more about these requirements in the interview guide. Two main open questions, used in our research, were as follow:

1. What do you think are the functional requirements of the telemedicine system to provide treatment planning for patients with breast cancer?

2. What do you think are the non-functional requirements of the telemedicine system to provide treatment planning for patients with breast cancer?

Furthermore, the questionnaire included requirements identified from studies in the field of telemedicine that were presented in the final interview guide to survey participants. To investigate the views of participants on the presented requirements, 2 options including “necessary” (one point) and “unnecessary” (zero points) were assigned to each question.

3.2.2. Data Collection Method

Face-to-face interviews were conducted with each of the participants according to the schedule agreed at the designated location by the researcher. A general explanation of the study and its objectives were given to all interviewees and written informed consent forms were obtained from all of them before the beginning of the interview. Moreover, the confidentiality of information gathered from the interviews was emphasized, and it was announced that the information extracted from the interviews would be presented to them for approval. The interviews were recorded in coordination with the interviewees, and important details were noted by the researcher during the interview process. The interviews were continued until the data were saturated.

3.2.3. Data Analyzing Method

The information from the interviews was analyzed, using content analysis. For this purpose, all recorded audio files were transcribed and completed by taking notes written during the interviews. Subsequently, all documents and information extracted from the interviews in the form of text files were entered into the MAXQDA software to perform coding and qualitative analyses. Finally, the interviewee’s suggestions and comments were extracted based on the themes, categories and sub-categories, and interpreted narratively.

4. Results

4.1. Results of Identifying the Required Data Elements

The results of the integration of data elements extracted from clinical guidelines and patients’ medical records were presented as a questionnaire. Upon the development of the initial questionnaire, the reliability and validity were assessed and minor changes were applied. In addition to partial changes in the arrangement of the data elements, “ethnicity” was the only data element removed from the initial questionnaire. Concerning CVI and CVR, the total average score of 0.87 and a mean score of 0.89, respectively, was obtained. The total inter-item reliability of the questionnaire was measured by KR-21 (ρKR21 = 0.81).

Overall, 45 questionnaires were distributed among radiation oncologists (n = 27), gynecologists (n = 6), specialists in blood and adult cancers (n = 6), and cancer surgeons (n = 6) working in hospitals and healthcare facilities. The total participation rate of specialists to fill out the questionnaire was 71.11%, including radiation oncologists (n = 19, 70.37%), gynecologists (n = 4, 66.66%), specialists in blood and adult cancers (n = 5, 83.33%), and cancer surgeons (n = 4, 66.66%). The mean age of specialists was 46.13 ± 5.41 years, and the meaningful work experience was 12.59 ± 6.08 years. The mean percentage of respondents regarding the required data elements to provide treatment plans for patients with breast cancer are shown in Tables 1-5.

Table 1. Patients’ Demographic Information and Clinical Data
CategoryData ElementsAverage (%) Necessary
1-Patients’ demographic information
1Name81.25
2Family81.25
3National code81.25
4Age100
5Sex100
6Weight100
7Height100
8BSA100
9BMI87.50
10Marital status87.50
11Job81.25
12Residential address87.50
13Patient contact number87.50
2-Clinical data
14The chief complaint100
15Symptoms other than the chief complaint 100
16The first symptom leads to doubt87.50
17PS100
18Drugs in use100
19Drug used100
20Menstrual status100
21Age of first menstruation87.50
22Pregnancy status100
23Age of first pregnancy87.50
24Number of gravidities81.25
25Number of parities75
26Number of live births75
27Number of abortions81.25
28Menopause age100
29Lactation status100
30Contraception and its methods100
31Duration of diabetes (in years)84.38
32Medications used for diabetes (oral, insulin)100
33Cardiovascular disease100
34Hypertension100
35Immune deficiency disease100
36Patient’s other comorbidities100
37History of surgery90.62
38Collagen and vascular diseases100
39Personal history of malignancy100
40History of hormone therapy and its type100
41History of chemotherapy100
42History of radiotherapy100
43Previous treatment plans100
44Duration of smoking (in years)87.50
45Daily cigarette consumption (pack of cigarettes per day)87.50
46History and level of alcohol consumption (low, medium, high)90.62
47Family history of malignancy100
48History of hepatitis78.13
49AIDS87.50

Abbreviations: BSA, body surface area; BMI, body mass index; PS, performance status; AIDS, acquired immunodeficiency syndrome

Table 2. Examination of the Breast, Lymph Nodes, Distant Metastasis, and Chest Wall
CategoryData ElementsAverage (%) Necessary
3-Physical examination of the breast
50The results of a physical examination of the breast (detectable mass?)100
51Location of the mass in the left breast (1. upper-outer, 2. upper-inner, 3. lower-outer, 4. lower-inner, 5.central)100
52Location of the mass in the right breast (1. upper-outer, 2. upper-inner, 3. lower-outer, 4. lower-inner, 5.central)100
53Size of breast mass (cm)100
54Fixation of the breast mass (yes, no)100
55Breast skin involvement (discoloration, scars, nodules, orange peel skin)100
56Area of breast skin involvement (less than 30%, between 30% and 50%, more than 50%)87.50
4-Examination of the lymph nodes
57The results of the examination of the lymph nodes (detectable mass?)100
58Location of enlarged lymph nodes (axilla, supraclavicular, mammary internal)100
59Fixation of the lymph nodes (yes, no)100
60Size of the lymph node (cm)100
61Matted lymph nodes100
5-Examination of distant metastasis
62Results of distant metastasis examination (bone tenderness, respiratory distress, ascites, organomegaly, etc.)100
6-Breast examination (in case of the previous lumpectomy)
63Evidence of local recurrence (left side [at the surgical scar site, away from the surgical scar])100
64Evidence of local recurrence (right side [at the surgical scar site, away from the surgical scar])100
65Type of local recurrence (ulcer, mass, discoloration)100
66Local recurrence size (cm)100
67Fixation of local recurrence (yes, no)100
7-Chest wall examination (in case of the previous mastectomy)
68Evidence of local recurrence (left side [at the surgical scar site, away from the surgical scar])100
69Evidence of local recurrence (right side [at the surgical scar site, away from the surgical scar])100
70Type of local recurrence (ulcer, mass, discoloration)100
71Local recurrence size (cm)100
72Fixation of local recurrence (yes, no)100
Table 3. Pathology of the Breast, Surgical, and Lymph Node Biopsy
CategoryData ElementsAverage (%) Necessary
8-Pathology of breast and lymph node biopsy
73Pathology of breast biopsy 100
74Pathology of lymph node biopsy100
9-IHC & FISH (or CISH) breast and lymph node biopsy
75Date of biopsy100
76ER (negative or positive) (percent of + cells… Positivity: week, moderate, strong)100
77PR5 (negative or positive) (percent of + cells… Positivity: week, moderate, strong)100
78HER2 (-, +1, +2, +3)100
79Ki-67100
80E-cadherin (negative or positive)84.38
81HER2 FISH (or CISH) (amplified, not amplified)100
82Other performed IHCs87.50
10-Surgical pathology
83Date of surgery100
84Pathology of breast surgery 100
85Pathology of lymph node surgery 100
86Surgery: breast (breast conservation surgery, total mastectomy, radical mastectomy, skin-sparing, nipple-sparing)100
87surgery: axillary (sentinel: negative [number of nodes removed])100
88surgery: axillary (sentinel: positive [number of positive nodes and number of nodes removed])100
89surgery: axillary (dissection: negative [number of nodes removed])100
90surgery: axillary (dissection: positive [number of positive nodes and number of nodes removed])100
91surgery: breast reconstruction (time: immediate or delayed)100
92surgery: breast reconstruction (type: prosthesis or autologous)100
93the number of tumor lesions100
94Size of the tumor (cm)100
95Skin involvement100
96Nipple involvement100
97LVSI100
98PNI100
99Extracapsular extension100
100Percentage of carcinoma in situ100
101Grade (1 or 2 or 3)100
102Margin status (R0, close, R1, R2)100
11-IHC & FISH (or CISH) surgery
103ER (negative or positive) (percent of + cells… positivity: week, moderate, strong)100
104PR (negative or positive) (percent of + cells… positivity: week, moderate, strong)100
105HER2 (-,+1,+2,+3)100
106Ki-67100
107E-cadherin (negative or positive)100
108HER2 FISH (or CISH) (amplified, not amplified)100
109Other performed IHCs87.50

Abbreviations: CISH, chromogenic in situ hybridization; ER, estrogen receptor; FISH, fluorescence in situ hybridization; HER2, human epidermal growth factor receptor 2; IHC, immunohistochemistry; LVSI, lymphovascular space invasion; PNI, perineural invasion; PR, progesterone receptor

Table 4. Recurrent Pathology and Pathology of Metastatic Biopsy and Staging by Tumor-Node-Metastasis (T-N-M)
CategoryData ElementsAverage (%) Necessary
12-Recurrent pathology
110Pathology of breast recurrence 100
111Pathology of lymph node recurrence 100
13-IHC & FISH (or CISH) recurrence
112ER (negative or positive) (percent of + cells… positivity: week, moderate, strong)100
113PR (negative or positive) (percent of + cells… positivity: week, moderate, strong)100
114HER2 (-, +1, +2, +3)100
115Ki-67100
116HER2 FISH (or CISH) (amplified, not amplified)100
117Other performed IHCs87.50
14-Pathology of metastatic biopsy
118Pathology of distant metastasis 100
119Pathology of lymph node metastasis 100
15-IHC & FISH (or CISH) metastasis
120ER (negative or positive) (percent of + cells… positivity: week, moderate, strong)100
121PR (negative or positive) (percent of + cells… positivity: week, moderate, strong)100
122HER2 (-, +1, +2, +3)100
123Ki-67100
124HER2 FISH (or CISH) (amplified, not amplified)100
125Other performed IHCs87.50
16-Staging by T-N-M
126T (TX, Tis, T0, T1, T2, T3, T4 (T4a, T4b, T4c, T4d))100
127By which modality the T was determined? (CT, MRI, Sonography, PET-Scan, Mammography, Pathology, Examination)100
128N (NX, N0, N1, N2, N3)100
129By which modality the N was determined? (CT, MRI, Sonography, PET-Scan, Mammography, Pathology, Examination)100
130M (M0, M1)100
131Metastasis location (bone, lung, liver, lymph nodes, brain, etc.)100
132Metastasis detection method (imaging (CT, MRI, Sonography, bone scan, PET-Scan) or biopsy)100
133The final result of staging (T-N-M)100

Abbreviations: CT, computerized tomography; MRI, magnetic resonance imaging; PET-Scan, positron emission tomography-scan; T-N-M, tumor-nodes-metastasis

Table 5. Tests, Imaging, Patient Preferences, and Consultations
CategoryData ElementsAverage (%) Necessary
17-Assess PD-L1 biomarker
134Assess PD-L1 biomarker status for triple-negative breast cancer78.13
18-Tests
135WBC100
136Neut100
137Lymph90.63
138Hb100
139Plt100
140Urea90.63
141Cr100
142AST100
143ALT100
144ALKP100
145Bill (total)100
146Bill (direct)100
147T375
148T475
149TSH78.13
150Uric acid75
151ESR81.25
152LDH100
153FBS100
154Na84.38
155K84.38
156Ca81.25
157P75
158Mg65.63
159Alb75
160Pr65.63
161β-HCG87.50
162FSH87.50
163LH87.50
164Estradiol87.50
165CA15-387.50
166CEA75
167CA12575
19-Imaging
168CT (neck, chest, abdomen, pelvis, brain, spine, etc.)100
169MRI (neck, chest, abdomen, pelvis, brain, spine, breast, etc.)75
170Sonography (abdomen, pelvis)100
171Sonography (breast)100
172Mammography100
173Bone scan100
174PET Scan71.87
175Simple X-ray (chest, spine, pelvis, etc.)71.87
176Important findings of imaging 87.50
20-Patient preferences and consultations
177Fertility counseling100
178Cardiovascular counseling100
179Images of cardiovascular counseling84.38
180Genetic counseling87.50
181Psychiatric counseling81.25
182Patient preferences100

Abbreviations: Alb, albumin; ALT, alanine transaminase; ALKP, alkaline phosphatase; AST, aspartate transaminase; Bill, bilirubin; Ca, calcium; CA125, cancer antigen 125; CA15-3, cancer antigen 15-3; CEA, carcinoembryonic antigen; Cr, creatinine; ESR, erythrocyte sedimentation rate; FBS, fasting blood sugar; FSH, follicle-stimulating hormone; Hb, hemoglobin; K, potassium; LDH, lactate dehydrogenase; LH, luteinizing hormone; Lymph, lymphocytes; Mg, magnesium; Na, sodium; Neut, neutrophils; P, phosphorus; Plt, platelet; Pr, protein; WBC, white blood cell; T3, triiodothyronine; T4, thyroxine; TSH, thyroid-stimulating hormone; β-HCG, beta-human chorionic gonadotropin

Overall, form 182 data elements in the questionnaire, 125 were unconditionally considered necessary (n = 32, 100%) from the experts’ point of view. Based on the data in Tables 1-5, the lowest mean percentages are related to the magnesium blood test (Mg) (n = 21, 65.63%) and protein test (Pr) (n = 21, 65.63%). Other data elements in these tables range from 71.87% to 100%, which was considered necessary by experts.

4.2. Results of the Requirements Elicitation

As mentioned earlier, one of the aims of the present study was to identify the requirements of the teleoncology system to provide treatment plans to patients with breast cancer by using the interview method. Overall, 15 qualified specialists in the field of breast cancer treatment (having at least 3 years of clinical experience in providing treatment plans for patients with breast cancer), as well as 10 qualified faculty members of health information management and medical informatics (having at least 3 years of faculty experience and familiar with software information systems) were invited to participate in the interview. The interviews continued until the saturation of the data were obtained, with 18 experts participating in the interview. The average interview time was 30 minutes.

In total, 18 interviews were conducted with experts in various disciplines, including health information management (n = 4), medical informatics (n = 2), radiation oncology (n = 8), pathology (n = 2), and cancer surgeon (n = 2). The mean age of the respondents was 44.11 ± 6.98 years and most of them were males (n = 12, 66.66%). Moreover, most of the interviewees were clinical specialists (n = 12, 66.66%), who were radiation oncologists (n = 8, 44.45%).

As mentioned earlier, the interview guide was designed in such a way that it included a basic framework involved requirements that were pre-identified by the researcher by reviewing related research and software projects. All of these requirements were considered necessary by all interviewees in the study as essential requirements for the teleoncology system. Subsequently, a total of 2 main themes, 9 categories, and 41 related sub-categories were extracted from analyzing the findings of the interviews (Table 6).

Table 6. Main Themes, Categories, and Sub-Categories of Extracted Requirements
Main ThemesCategories Sub-Categories
FunctionalBasic operational requirements for all usersAbility to register users in the system
Existence of user profile for each user in the system
Ability to edit user information registered in the system
Ability to verify the identity of users who register in the system
Ability to print documents and report in the system
Ability to support standard devices such as laptops and tablets
Ability to access the system through web browsers without the need to install on a specific platform or operating system
Help for users to learn how to work with the system
Ability to search in the system
Operational requirements special for physicians involved in providing patient’s treatment planningAbility to create audio and video communication to discuss and consult with other physicians involved in the treatment process
Ability to create audio and video communication with the patient
Ability to access to information and medical history of the patient through the system
Ability to access to patient’s medical images through the system
Ability to access to patient’s lab results through the system
Ability to access the results of the consultations and patient preferences through the system
Ability to provide comments and suggestions by physicians involved in providing a treatment plan to the patient
Operational requirements special for residentsAbility to create medical records for the patients
Ability to send patient medical records for specialists
Residents’ ability to access clinical information and provide treatment plans for educational purposes
Ability to send the provided treatment plan to the patient
Ability to record and access information and medical history of the patient through the system
Ability to record and access to patient’s medical images through the system
Ability to record and access to patient’s lab results through the system
Ability to record and access to results of the consultations and patient preferences through the systems
Operational requirements special for patientsAbility to access patients’ medical records and provide treatment plans
Ability to access the patient’s medical images through the system
Ability to access the patient’s lab results through the system
Communication with other information systemsAbility to connect to the Electronic Health Record (EHR) system for sending and receiving patient medical records
Ability to connect to the Health Information System (HIS) for sending and receiving patient medical records
Ability to connect to information systems such as laboratory information systems or radiological information systems if these information systems are separate from the hospital information system for sending and receiving patient medical records
Ability to connect to the Personal Health Record (PHR) system for sending and receiving patient medical records
Non-functionalSecurity and privacySafe login to /logout from the system
Defining the access level of users
UsabilityUser-friendly system
Easy training and learning of the desired operation in the system
The availability of the system for all users
EfficiencyAppropriate response time for processing operations, communication, reporting, and data storage in the system
Reliability and supportabilityAbility to change and develop, configure and service the system
Appropriate response time when encountering an error
Appropriate response time to repair and update the system
Minimize the number and severity of system errors

5. Discussion

According to the review of the studies, no research has been conducted in Iran regarding the implementation of telemedicine for oncology in breast cancer. However, many studies have been conducted on the use of telemedicine in oncology for a variety of cancers (40-42), including breast cancer in other countries (15, 43). In this regard, the results of studies show that healthcare professionals generally support the use of telemedicine technology in the field of oncology. Furthermore, the results of studies have shown that the quality of medical services provided to patients using this technology has been appropriate. Also, it is cost-effective and has reduced the cost of healthcare systems (15, 16, 44, 45). Therefore, in addition to using conventional methods (face to face) to manage breast cancer treatment in some countries, the facilities and capabilities of telemedicine technologies are also used as a tool to improve service delivery to patients.

5.1. Identifying the Required Data Elements

Teleoncology is a potential solution in the management of breast cancer worldwide. It can establish effective and systematic collaboration among healthcare providers in multiple oncology centers for improving cancer care services (46). Given that the development of such a system is in its early stage in Iran, identifying required data elements is the first step in developing a telemedicine system that aims at providing treatment plans for patients with breast cancer. There are various treatment plans available for patients with breast cancer and people suffering from this type of cancer often receive more than one treatment plan (47). Furthermore, selection of a treatment plan for patients with breast cancer is based on many factors, including the extent and location of the tumor (number and extent of lymph node involvement, number of lesions, size and location of the primary tumor), as well as age, patient’s general health status, and patient’s preferences (33). Therefore, the required data elements for the telemedicine system were identified by investigating the clinical guidelines and reviewing the medical records of patients with breast cancer in this study.

In some studies, identifying required data elements for telemedicine systems has been performed by reviewing the literature and designing a researcher-made questionnaire for receiving the users’ opinions (11, 12, 48, 49). However, for identifying the required data elements, this study scrutinized the latest clinical guidelines related to breast cancer and reviewed the medical records of patients with breast cancer, who received different treatment plans. Due to the multidisciplinary approach of the teams for optimally managing patients with breast cancer, knowledge, and views of healthcare providers with various specialties in oncology, including radiation oncologists, gynecologists, blood and adult cancer specialists, and cancer surgeons were considered (8).

Similar studies in the field of teleoncology for breast cancer have focused on the final clinical results and comparison of these systems with face-to-face models. To our knowledge, identifying the required data elements have not been addressed in those studies (15, 16, 44). In our study, experienced breast cancer specialists actively participated in the identification of required data elements for the teleoncology system, and their views and opinions were applied.

It is worth noting that there was no consensus on some data elements, which were identified necessary with a low average percentage and due to patients’ clinical conditions. For example, the existence of some data elements including some tests (Mg, Pr), imaging (PET scan, simple X-ray), and consultations (genetic counseling, psychiatric counseling) did not appear to provide a treatment plan for all patients.

Rudnisky et al. applied the clinical guidelines related to imaging, presentation, and diagnostic grading in a teleophthalmology system designed for diabetic retinopathy (50). Furthermore, in the study conducted by Hazin and Qaddoumi to investigate the current and future state of teleoncology, the authors noticed that the Mexican National Center for Health Technology Excellence has proposed comprehensive clinical guidelines in the Spanish language to be used in their telemedicine projects (46). The results of studies indicate that applying the clinical guidelines in telemedicine programs is important and valuable to provide quality healthcare services. In this regard, the use of clinical guidelines for the development of telemedicine systems has also been emphasized by prominent telemedicine associations including the American Telemedicine Association (ATA) in various fields of medicine (51). In addition to investigating the latest clinical guidelines related to the treatment of breast cancer and reviewing the patients’ medical records, the added value of the present study aimed at identifying the required data element is in applying the comments and suggestions of breast cancer specialists at all stages. Finally, the required data elements, identified by experts, were confirmed. Therefore, all the processes were performed scientifically and by applying experts’ opinions in the field of breast cancer treatment, thereby covering all aspects in this regard.

The number of questions in the questionnaire (186 questions) was one of the limitations of the present study; as the results of some studies show, using long questionnaires may reduce the accuracy of participants’ responses and their willingness to participate in the study (52, 53). However, reducing the number of questions might have hindered us in achieving the main purpose of the study. Therefore, we decided to decrease the effect of this limitation by organizing the questions into several sections based on the content and relevance of the items. Moreover, sufficient time was given to the participants, if they needed, to complete the questionnaire. According to the arrangements made with the participants, a text message to complete the questionnaire was sent to them one day before the visit.

5.2. Requirements Elicitation

As mentioned earlier, the interview method with end-users was employed to determine the requirements of the teleoncology system. Moreover, the questionnaire containing pre-identified requirements was used during the interview process. Considering the interviewees of the study did not have practical experience of working with telemedicine systems; the use of the questionnaire, by which we had already identified some requirements, helped guide the interviewees and identify the requirements by them. Similarly, interviews, questionnaires, or a combination of these two methods have been applied in various studies to identify the requirements of telemedicine systems (11, 54-56). Generally, the software requirements are divided into 2 main categories, which are functional and non-functional requirements (57). In this regard, the requirements identified in the present study were divided into two main functional and non-functional themes, and each of these themes was classified and sub-categories based on the analysis of the results of the interviews.

Since health information systems are more complex than other information systems and have multiple users with different levels of expertise and knowledge, one of the best approaches to identify such systems require to engage the users (28). Given that one of the aims of the present study was to identify the requirements of the telemedicine system to provide treatment plans for patients with breast cancer, and typically a multidisciplinary team consisting of various specialists is used to provide treatment plans for breast cancer, they should be involved to identify the requirements of such system. Indeed, one of the strengths of the present study was the fact that the users participating in the interview process were from the different specialized disciplines, leading to a comprehensive examination of the requirements of the system from different perspectives.

The results of the present study in the functional requirements section show that all participants remarked that they needed to register in the system and have their profiles to securely access the system and perform their duties. In this regard, our results are in line with other studies, in which web-based telemedicine programs have been applied (58, 59). In similar studies conducted in the field of telemedicine, capabilities, and features such as the ability to upload medical images, search and report in the system have been identified as the main requirements of such systems (11, 12). According to the findings of the present study, most of the interviewees mentioned that depending on the patient’s condition, special medical images, which could be uploaded, were needed. It is also necessary to provide the ability to search and report in the system for all users of the system with different roles.

Some studies have shown that human error is one of the major factors, leading to errors commonly observed in telemedicine systems. This could be due to the inability of users to use these systems. This problem can be resolved by providing a help section to train users of telemedicine systems (60, 61). Similar to other studies in this area (62-64), providing a help section for users of the teleoncology system is necessary to get informed about the capabilities of the system and to learn how to work with the system. There is evidence to suggest that connecting telemedicine systems to other clinical information systems provide positive outcomes such as easy access to various types of patients’ medical information and minimizing the repetition of unnecessary tests and procedures (65, 66). Likewise, the results of our study show that communicating the teleoncology system with other clinical information systems is one of the requirements recommended by the interviewees.

The results of Alencar et al.’s systematic mapping research on non-functional requirements in health information systems show that the interview method is the most widely used instrument to identify the non-functional requirements in this area. The result of their research also showed that security and privacy were observed more than other non-functional requirements in studies (39). Some of the non-functional requirements identified in health care software systems include communicativeness, confidentiality, integrity, efficiency, privacy, reliability, safety, security, traceability, and usability (67). In this regard, the non-functional requirements resulting from the analysis of interviews in our study were divided into 4 categories, including security and privacy, reliability and supportability, usability, and efficiency.

5.3. Conclusions

Based on the results of this study, identifying the required data elements for teleoncology systems is a key step for implementing such systems. In this regard, as clinical guidelines provide up-to-date and evidence-based information, it is recommended to use them to identify the required data elements of telemedicine systems. Besides, the data elements that are recorded in the patients’ medical records for providing treatment plans in the conventional model should also be examined. Finally, applying the opinions and knowledge of medical professionals to improve the process of identifying the required data elements is suggested.

Since the healthcare providers in various fields of oncology are potential users of such systems, developers should consider users’ requirements and needs when designing and developing telemedicine systems to increase its acceptance and use. In this regard, the findings of the present study can provide a fairly comprehensive view for determining the requirements of teleoncology systems for developers and researchers in their future research.

Acknowledgements

Footnotes

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