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Table of Contents
Year : 2022  |  Volume : 5  |  Issue : 2  |  Page : 150-156

Development and validation of a framework for type 2 diabetes patient self-management education program: A qualitative study

1 Department of Rehabilitation Sciences, College of Applied Medical Sciences, King Saud University, Riyadh, Saudi Arabia
2 Department of Nutrition, Imam Mohammad Bin Saud University, Riyadh, Saudi Arabia
3 Department of Family and community medicine, College of Medicine, King Saud University, Riyadh, Saudi Arabia

Date of Submission25-Dec-2020
Date of Decision03-Nov-2021
Date of Acceptance13-Jan-2022
Date of Web Publication28-Apr-2022

Correspondence Address:
Sulaiman Abdullah AlShammari
Department of Family and Community Medicine, College of Medicine, King Saud University, PO Box 2925, Riyadh 11461
Saudi Arabia
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/jnsm.jnsm_171_20

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Background and Objective: Patient self-management education has been a major factor in the intervention and management of chronic diseases as it engages and empowers patients to control and/or prevent complications of chronic diseases. The objective of this study was to develop and validate a framework standard for diabetic patient's self-management education. Methods: A quantified qualitative research method was applied to design and validate a patient self-management framework. Previously published 26 international diabetes management standards and guidelines were reviewed, analyzed, tabulated, and coded into three categories; systems, constructs, and themes. The resulting matrix with coding criteria was validated by a 3-session focus group for consensus, verification, and re-verification of the model. Co-researchers reviewed and reclassified the focus group re-verification data with >90% reliability. Results: The framework consisted of main three domains: the health system with four constructs and 96 items; the delivery system with five constructs and 139 items; and the system of decision, support, supervision, monitoring, and evaluation with 6 constructs and 32 items. Results are reported for the 3 focus group sessions and the co-researchers' review. It resulted in a modification of <30% of the original framework (N of items = 277 − 203 = 74 [26.7%]). Conclusion: A focus group methodology was effectively used to design and validate an appropriate patient self-management education framework. A valid framework of standards and guidelines for type 2 diabetes mellitus self-management was developed and validated to reflect the diabetic patients' needs. An outcome measurement tool would be developed based on the framework to assess the effectiveness of patient self-management outcomes in Saudi Arabian society.

Keywords: Focus groups, health-care standards, patient self-management

How to cite this article:
AlAbdulkarim L, AlHassan M, AlShammari SA, Albarrak A. Development and validation of a framework for type 2 diabetes patient self-management education program: A qualitative study. J Nat Sci Med 2022;5:150-6

How to cite this URL:
AlAbdulkarim L, AlHassan M, AlShammari SA, Albarrak A. Development and validation of a framework for type 2 diabetes patient self-management education program: A qualitative study. J Nat Sci Med [serial online] 2022 [cited 2022 Jul 7];5:150-6. Available from: https://www.jnsmonline.org/text.asp?2022/5/2/150/344205

  Introduction Top

Type 2 diabetes mellitus (T2D) is a chronic disease that has a significant long-term impact on health. There is a need to develop culturally modified self-education programs to combat diabetes in Saudi Arabia. T2D has been rising as an epidemic in Saudi Arabia impacting 13.4% of Saudis over the age of 15; 50.7% of those are undiagnosed, 20.2% treated uncontrolled, and 5.4% are untreated,[1],[2] leaving two-thirds of the affected population at high risk for diabetes chronic health complications. The estimated current annual cost for diabetes is 17 billion Saudi Riyals with an estimated future cost of 27 billion that may increase to 47 billion Riyals with progress of prediabetes. This cost presents a great challenge and burden on the country's human and financial resources.[3] The Ministry of Health (MOH) must develop sociocultural[2] and health programs and initiatives to combat diabetes. Development of patient-centered health care in medical intervention models for chronic disease has yielded patient self-management education programs. Chronic Disease Self-Management Program (CDSMP) developed by Lorig and co-researchers at Stanford University in the USA provided evidence-based outcome measures of improvement and retention of patient's self-management behaviors.[4],[5],[6],[7],[8],[9] Such evidence indicates that CDSMP could help patients control and/or prevent complications of this chronic disease. A modified self-management education program that adapts to the culture and norm behaviors of Saudi population affected by T2D would help patients to adapt more effectively to the program to normalize their behaviors to prevent or reduce T2D complications.

Patient self-management support is a main component of a health-care model to providing high-quality care for chronic disease.[10] Implementation of patient support mechanism has been internationally variable. In a review of chronic disease management in European health systems, several European countries varied in the level of patient self-management support across services. The reported services were delivery of information: follow-up, regular assessment of clinical indicators, counseling, coaching, lifestyle intervention, and involvement of a patient in the treatment plan and assessing patient's needs.[10] Local observations indicated variability in Saudi patient self-management education programs to combat chronic disease. Hence, there is an eminent need to conduct a comprehensive review of the best practice international and national standards and guidelines with the purpose to develop an integrated and locally applicable critically needed self-management framework for diabetes.

Qualitative research methodology has been used in medical research for in-depth and focused investigations to obtain meaningful data to configure and solve patient's personal experiences with disease as well as supply health-care providers with knowledge-based tools for effective planning, decision-making, and improving quality of service delivery.[11],[12] Focus group method is a subjective analysis of qualitative outcome by simultaneously collecting open-ended data in medical research for initial investigation of a phenomenon from a group of participants.[13],[14] Such data are transcribed, classified, and coded by researchers with a descriptive data outcome. Research on diabetes patient-centered intervention programs has specifically used focus group methods (e.g., Vangeepuram et al.[15]). Krueger and Casey[16] highlighted the main benefit of focus groups as helping researchers to collect data with efficient time and cost from multiple participants. In certain world regions and with chronic disease, health researchers need to collect data within a short period of time to inform health policymakers and develop programs. Furthermore, interactions in focus groups among participants with diverse experiences yield significant outcome.[17] However, such classical focus group application is subjectively variable and time-consuming during and posts data collection including transcribing, analyzing, classifying, and coding open-ended data which renders it less cost-effective.

According to Steward and Shamdasani,[13],[18] focus groups may use valid procedures that ensure reliable and objective quantified outcomes. They added that focus group researchers should consider factors related to the nature of the research question, time, and budget to determine the choice of a qualitative versus quantitative method. In medical research, there is a need for a focused, efficient, and cost-effective focus group method that yields online reliable and quantifiable data during data collection.

The aim of this study was to develop a framework for chronic disease self-management education and management program in health-care settings in Saudi Arabia using focus group method for collecting and analyzing methodologically accurate data.

  Methods Top

The study design adapted the focus groups outlined by Onwuegbuzie et al.[14] and Krueger[19] which consisted of three steps.

Planning and organization of the focus groups

The planning for focus groups included multiple phases: stimulus design, selection and recruiting of participants, and conducting data collection. [Figure 1] summarizes the focus group process.
Figure 1: Phases of the focus group process to validate the Saudi patient Chronic Disease Self-Management Program framework

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Stimuli of the focus groups

The stimuli consisted of two major components. The first was a preclassified validated framework for patient CDSMP education consisting of constructs, themes, subthemes, and items. Beforehand, a review guide was developed with inclusion criteria for selecting key domains and indicators of standards and guidelines that best fit international benchmarks and Saudi national needs for T2D. Step-by-step instructions were provided in the guide for reading, retrieving, categorizing standards and guidelines into constructs, themes, and subthemes, citing references and creating item statements that were then classified, validated, and converted into questions. A search was conducted for major health electronic databases including Web of Science, PubMed, and Science Direct for evidence-based health care. Keywords included chronic disease self-management, T2D self-management, patient education, standards and guidelines as well as models and frameworks for chronic disease and T2D self-management programs.

Twenty-six best practice standards and guidelines frameworks were analyzed in a preliminary review. Using the framework of relevance to patient CDSMP as a guide, two interrogators examined each domain for its relevance to the healthcare delivery system and the system of decision-making support, supervision, monitoring, and evaluation (DSSME). The standards were included in the framework for focus group discussions when there was a significant disagreement; thus, to avoid excluding a relevant standard.

The second component of the focus group stimuli was a set of five closed data validation codes[14] developed by a panel of four researchers. The codes were as follows: (1) to keep valid items, (2) to modify current items, (3) to move valid items to relevant themes, (4) to merge items that address the same theme or have similar keywords, and (5) to delete irrelevant items.

A matrix of 26 standards and guidelines and codes constituted the focus group norms and guidelines for data analysis.[14] The matrix was reviewed by two researchers and practitioners in health care. The stimuli were carefully designed to facilitate and focus discussions leading to the outcome target of reaching consensus on the proposed framework. Thus, descriptive and interpretive validity would be increased and help researchers focus the framework to a better fit for further studies. A focus group guide was developed with an introduction for the topic and tasks. A detailed guideline was provided for each focus group to conduct multiple validation sessions and to review and validate the content of standards and guidelines. Every standard and guideline construct was designated a schedule of validation session and steps to complete the validation. This method allowed participants to focus on tasks,[17],[16] and to simultaneously analyze, classify, and code information.

Selection of the focus group participants

In-depth appraisal was sought from local health practitioners with extensive experiences about the fitness of the framework for health-care programs in Saudi Arabia. Participants were recruited via a purposive sampling technique of maximum variation sampling[14] where the group represents diverse health-care backgrounds with specialized knowledge and national and international experiences and of mixed gender. Each participant replied with agreement and consent to participate via a reply to an invitation email from the project supervisors. Small focus groups were planned for in-depth discussions and ideas sharing in a comfortable environment.[19] To avoid missing participants, participants were recruited with extra 20% added to the total number planned.[17] Invitations were emailed to a pool of candidates who fit the selection criteria. They included family physicians, diabetes specialists (dialectologists/endocrinologists), cardiologists, health educators, diabetes nurses, pharmacists, rehabilitation consultants, nutritionists/dietitians, quality specialists, and exercise education. There were three groups of 6–7 participants with a total of 20 participants. Prior to the sessions, stimulus materials were emailed as PDF files to all participants.

Conducting the focus group sessions

Three focus group sessions were conducted at King Khalid University Hospital, College of Medicine. Each focus group session lasted 3–4 h with at least 60 min allotted for each system as recommended for well-designed focus groups.[17] Two researchers moderated the sessions. At the beginning of each session, they guided the groups on the stimuli and methodology. They supervised groups' discussions, facilitated transitions to each session, created a conducive environment for discussions, and helped small group moderators facilitate their group discussions using structured format including verifying and documenting group consensus.[16],[19] They also supervised focus group data interpretation, classification, and reclassification. The groups' dynamics were monitored and observed to be coherent.[17]

First, the matrix obtained consensus at the beginning of the first focus group session. Then, each focus group read, discussed, reached consensus, classified, and coded the items of each system after sharing and discussing common values, understandings, and experiences.[19] In session 3 on day 2, to verify the data, a large focus group re-read, discussed, reached consensus, reclassified, and recoded the small focus group data. Discussions examined the relationships among the three systems for theme inclusion, differences, and similarities among themes and items and the needs of Saudi patients. Meanwhile, researchers evaluated whether the group has reached data saturation where no further information can add value, and the framework was adequately developed.[17]

Source of focus group data

This study relied on the focus groups' documented notes and a matrix to help researchers focus on the research question and develop an accurate interpretation of the framework under study .[19] The type of the focus group data in this study was group and group interaction data which was used as the unit of analysis.[17] Data of the third session were the result of validating of the data during the first two sessions. Groups validated coding through consensus until groups reached agreed on each code. The inter-group reliability was >85%.

Data analysis

A modified classical content analysis was used where qualitative data analysis technique was mixed with quantitative method. Rather than creating ad hoc data categories, researchers used pre-defined constructs and themes to categorize the data, and they evaluated the frequency with which the focus groups used these codes. The researchers also provided interpretations of the codes and comments used by the various groups. This yielded a mixed-method content analysis.[14],[17] Limitations of individual focus group data[14] were controlled by the multiple group consensus and validation sessions and the preclassified framework. No dissenting views among group members were observed. Two co-researchers and two research assistants reviewed the reclassifications and codes and when reached consensus performed further reclassifications and recoding. All items were reviewed by their keywords and themes for any repeated measures or irrelevancy. A consensus was reached with an inter-rater reliability of >90%.

  Results Top

Twenty-six standards and guidelines were retrieved and adapted from international and national models. Standards and guidelines were selected based on the study objectives to create a best fit local model. [Table 1] summarizes the sources of the study. Standards and guidelines were related to patients' needs assessment, treatment plan, patient follow-up, self-monitoring and support, training, program plan, structure, and roles.
Table 1: Summary of international and national references for standards and guidelines

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The standard and guideline review yielded three systems. [Table 2] depicts constructs and themes for each system. Health system included four constructs: written evidence-based plan, department, orientation, and training; examples of themes were strategic plan, mission, vision, goals, structure, team, and resources. The total number of items was 96. Delivery system constructs addressed assessment of patient's needs, treatment plan, referral, follow-up, and outcome evaluation. A total number of 139 items were developed. The system of decision, support, supervision, monitoring, and evaluation contained the constructs of stakeholder, community, engagement, patient outcome evaluation, and program evaluation; there was a total of 32 items.
Table 2: Number of items per systems, constructs, and themes used for the study

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Data were cross-tabulated for each system. [Table 3] shows a quantifiable group consensus for the health system. The focus group tended to keep less items than the small focus group. The consensus of the large group reduced the (keep) items from 39 (45.8%) by the small group to 26 (27.1%). Furthermore, the co-researchers conducted a validation that yielded a more reduction of (keep) items to 22 (22.9%). The large focus group agreed on the code “delete” for almost double the items (n = 22 out of 96, 22.9%) verified by the co-researchers compared to the small focus groups (n = 10 out of 96, 10.4%). On the subject of modifying items, both focus groups and co-researchers reached a similar consensus 24, 25 and 26% respectively. As for the code “move” items to more appropriate constructs, the co-researchers showed agreement with the small focus group (25% and 26%), respectively. Collectively, validation outcome yielded similar distributions of four codes: keep, delete, modify, and move. The final validated items were 73 items.
Table 3: Percentages of focus groups validation for the small groups, the large consensus group, and co-researchers for the health system

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[Table 4] shows the focused and quantifiable group consensus on validation data for the delivery system. Item deletion progressively increased to the co-researcher verification review (14.4%, 24.6%, and 28.2%, respectively), while the code “keep” items decreased (63.3%, 30.3%, and 22.5%, respectively). The large focus group consensus modified and moved more than half of (26.8% and 18.3%) what the small focus groups did (11.5% and 8.6%). Three items were added by the large focus group consensus. The final validated items were 101.
Table 4: Percentages of focus groups validation for the small groups, the large consensus group, and co-researchers for the delivery system

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As for the decision support, supervision, monitoring, and evaluation system, [Table 5] depicts that the large focus group reduced the items for the code “keep” from 76% to 38.5%. A similar pattern was observed for the code “modify.” The large focus group and the co-researchers' review agreed on deleting 23% of the items. The final validated items were 30.
Table 5: Percentages of focus groups validation for the small groups, the large consensus group, and co-researchers for the decision support, supervision, monitoring, and evaluation system

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  Discussion Top

The prevalence of T2D in Saudi Arabia has increased during the last two decades which requires developing new measurements that are up to date with international standards to combat the disease and its complications on health as well as a burden on health-care cost. Several findings were obtained from this study. One finding relates to the applicability of variations of international frameworks to the local culture. The focus group validated 70% of the original framework. In total, 203 items were validated out of 277, thus supporting previous findings that patient self-management programs vary according to the culture.[10] A culturally appropriate and internationally referenced framework was conceptualized to regulate chronic disease self-management and education program for health-care settings in Saudi Arabia and prevent its complications among Saudi population.

Another finding concerns the methodology used to validate the framework and elicit data. The classified three systems were to focus the data validation and documentation as well as create a structured content for an outcome measurement tool. The literature referenced matrix helped focus group participants and researchers to design and focus a valid framework of standards and guidelines. The validation codes tremendously facilitated the members of the focus groups to discuss and agree on the consensus. The focus groups tended to mainly verify data by three codes: “keep,” “modify,” and “delete.” Out of the three most used codes, “keep” and “modify” seemed the most applied. This indicated that the main content of the framework was relevant. Hence, the method of the study showed that it was effective in eliciting quantifiable, focused, and valid data that could be reliably quantified and tabulated for best interpretation of the appropriateness of the framework content. The method was cost-effective and yielded a high correlation between group validation consensus and co-researchers' review. Data review, validation, and documentation were focused with reduced time and errors compared to open-ended focus group methods. This method represents a formative research that developed with a team of multidisciplinary researchers and health practitioners in health care a CDSMP design, scope, and content to be a framework for a measurement to identify current practices, norms, gaps, and barriers in patient CDSMP in local health organizations. Furthermore, if researchers needed to develop frameworks and models for other health service issues, this focus group method would be entirely appropriate and cost-effective.

As for the clinical applications, the validated framework could serve as a content for a digitalized outcome measurement platform. This digital platform may be implemented to evaluate hospital capacity in developing, delivering, and monitoring patient self-management education programs for T2D toward the goal to improve the diabetes management and diabetes outcomes. This digital platform would serve to upload and track data on patient self-management progress and outcomes so that health practitioners may make clinical decisions to improve the quality of the programs. Health decision-makers would also have access to data-supported strategic plans to improve program outcomes. Adaptation of such a digital platform into the hospital service delivery system is hoped to promote the integration of patient self-management education within the community to help combat the disease.

  Conclusion Top

This study revealed the adequacy of utilizing a quantifiable focus group method to validate international standards and guidelines for a local framework in T2D management. The content of this framework is ready to be used for developing a questionnaire to evaluate clinical programs of health-care providers. The framework may be used for designing clinical education programs to improve patients' compliance with intervention standards of care. The standards and guidelines may also be referred to for training health professionals in the diabetic centers on clinical practice procedures. Further, it is highly recommended that patient health education programs for diabetes can be created by the MOH toward a more efficient preventive care in Saudi Arabia. Such programs can also become an offshoot to the improvement of all hospitals in maintaining standards with guidelines properly disseminated to all stakeholders as initiated by this study.

Ethics considerations

The Research and Ethical Committee approved the present study. King Abdulaziz City for Science and Technology, KSU, The National Plan for Science and Technology (11-MED-2121-02) May 28, 2012. Written informed consent was obtained from all participants in the study.


This study was supported by the National Plan for Science, Technology and Innovation (MAARIFAH), King Abdul-Aziz City for Science and Technology, Kingdom of Saudi Arabia, the Research Chair of Informatics at the College of Medicine, the Female Campus Research Center, and the Tawasol Research Excellence Program, King Saud University. We would like to thank all focus group members who participated.

Financial support and sponsorship


Conflicts of interest

There are no conflicts of interest.[36]

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  [Figure 1]

  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5]


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