Development and validation of an educational handout for improving glaucoma medication adherence: a patient-centred approach

doi:10.21203/rs.3.rs-2972352/v1

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Research Article

Development and validation of an educational handout for improving glaucoma medication adherence: a patient-centred approach

https://doi.org/10.21203/rs.3.rs-2972352/v1

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Background:

Educating patients with glaucoma through structured written information can improve their understanding of the disease and promote better adherence to prescribed medications.

Purpose:

This study aimed to develop and validate an educational handout for improving glaucoma medication adherence.

Methods:

This was a descriptive cross-sectional study design conducted in two phases namely; the design and development of the handout and the validation of the handout. Content development was done by assessing the educational needs of patients with glaucoma through a qualitative exploratory approach. The handout was drafted and formatted in consultation with a professional medical illustrator and a health promotion specialist. Thereafter, it was assessed by experts for content validity and by patients with glaucoma for face validity. The scale level content validity index (SCVI) and the intraclass correlation coefficient (ICC) were the main outcome variables. P-values of less than 0.05 were considered statistically significant and the confidence interval was set at 95%.

Results:

Twenty-four patients with glaucoma participated in the content development. Ten experts and 15 patients with glaucoma were involved in the content and face validation, respectively. The themes generated from the qualitative exploratory study included; knowledge about glaucoma and adherence, reasons for non-adherence, use of glaucoma medication, and the role of patients in managing glaucoma. The SCVI for the content validity was high

Conclusion:

The handout has a good content and face validity with an excellent inter-rater reliability and can be used as an educational resource to improve adherence to glaucoma medication.

Adherence

glaucoma

medication

validation

educational handout

Glaucoma is among the significant causes of preventable vision impairment and blindness globally.¹ Although effective topical medications exist to manage the condition, some patients still do not adhere to their prescribed regimen.² Non-adherence to topical glaucoma medication by patients is therefore a major challenge to eye care practitioners.^{3, 4}

Patients with glaucoma require a better understanding of their eye health as their treatment depends on their ability to practice self-care. In low-income countries where educational attainment is said to be low, non-adherence to glaucoma medication is known to be as high as 80%.⁵ In addition, inadequate eye health education tends to worsen the burden of glaucoma in such populations.⁵ Educating patients with glaucoma about the disease may improve their adherence to prescribed medication. Literature shows that providing patients with structured written information tends to improve their understanding of the disease and increase their attentiveness to vital health information.⁶ Thus, health educational information is useful in improving knowledge, adherence to treatment, patient satisfaction and self-care among patients.⁷

Health educational materials in the form of handouts, booklets, pamphlets, and leaflets are used widely for educating patients and the population on several health-related issues.^6,8−10 Furthermore, the World Health Organisation (WHO)¹¹ recommends the development of appropriate, context-specific educational materials to increase awareness of good eye health practices and prevention strategies as part of efforts to strengthen and provide effective health promotion, education and prevention strategies in the field of eye care. To achieve this, a systematic approach in developing, testing, evaluating and implementing interventions for improving adherence to medication is recommended.¹²

However, there is limited published glaucoma educational material designed to help improve patients’ adherence to glaucoma medication. We, therefore, sought to report the development and validation of an educational handout for improving glaucoma medication adherence. This handout will serve as learning material and will provide eye health education on glaucoma and adherence to glaucoma medications.

This was a descriptive cross-sectional study to develop and validate an educational handout for improving glaucoma medication adherence. This current study is part of a multi-centre randomized controlled trial to test the effectiveness of behavioural, educational and mixed interventions in improving adherence to glaucoma medications among adult patients with glaucoma.

The methodological steps in the development and validation of this handout involved two phases and are illustrated diagrammatically in Fig. 1. The first phase was the design and development of the handout and the second phase was the validation of the handout.

Phase 1: Design and development of the handout

Step 1: Content development

An educational needs assessment of patients with glaucoma was done through a qualitative exploratory study at the Eye Centre of the Korle Bu Teaching Hospital which is a referral hospital and one of the largest eye hospitals in Ghana and Sub-Saharan Africa. The facility serves as a training centre for undergraduate and postgraduate training in eye health.. Twenty-four adult patients with glaucoma aged 30 years and older were conveniently selected for a face-to-face in-depth interview and a focus group discussion (FGD). The main objective of the qualitative exploratory study was to assess the educational needs of patients with glaucoma using a patient-centred approach.

The face-to-face interview included 12 participants with each session lasting approximately 30 minutes while the two FGDs sessions, each with six participants and lasting about 45 minutes per session were conducted. The principal investigator (PI) provided an interview guide with structured questions. The interview guide focused on questions relating to what the patients knew about glaucoma and its associated causes, symptoms and signs, the use of glaucoma eye drugs, how they understood adherence and the reasons for failing to adhere to their medications. Socio-demographic characteristics of the participants such as age, gender, education, marital status, family history of glaucoma, duration of glaucoma, and duration of medication use were recorded on the interview guide. The PI moderated the interviews and a series of prompts were used to encourage the participants to volunteer more information when necessary. Participants who were unable to speak English had the questions translated from English into their local languages (Ga and Twi as the most dominant local languages understood and spoken by all the participants who could not speak English). To improve veracity, their responses were back-translated from the local language into English by the PI who is proficient in reading and writing both languages. After obtaining consent from participants, the interviews were audio-taped and transcribed verbatim immediately after each session. Field notes were also taken to supplement the information obtained. Credibility was established through the verification of the audiotapes to confirm accurate transcription. An interpretive content analysis of the data was performed to identify themes and sub-themes from the respondent’s narrations.

Themes generated from the qualitative exploratory study included; knowledge about glaucoma, knowledge about non-adherence, reasons for non-adherence, use of glaucoma medication and the role of patients in the management of glaucoma.

Step 2: Layout of the handout

The themes generated from the exploratory study were used as the foundation for developing the content of the handout. The content of the handout was then organised in a more didactic way by dividing the information into five main sections according to the themes generated as presented below. Questions and answers were then generated under each section of the handout.

Table 1

Layout of the content of the handout
Number	Sections
	A.Knowledge about glaucoma
1	What is glaucoma?
2	Can I become blind if I have glaucoma?
3	What are the types of glaucoma?
4	What are the symptoms of glaucoma?
5	Is glaucoma hereditary?
6	What is the main cause of glaucoma?
7	Who is at risk for glaucoma?
8	Is there a cure for glaucoma?
9	Can I get back my sight when my eyes are affected by glaucoma?
10	What is the good news about glaucoma care?
	B.Knowledge about non-adherence
11	What is non-adherence to medication?
12	What is the effect of non-adherence to glaucoma medication?
13	What are some tips for medication adherence in glaucoma?
14	What is the importance of glaucoma medication adherence?
	C.Reasons for non-adherence
15	What are some of the reasons for non-adherence?
	D.Use of glaucoma medication
16	What are some tips for the proper use of eye drops?
17	What are the proper ways of using glaucoma eye medications?
	E.Role of patients in the management of glaucoma
18	What is my role in glaucoma treatment as a patient?

Step 3: Designing, drafting and formatting the handout

The draft handout was arranged in consultation with a professional medical illustrator (who has a background in graphic design) at the College of Health Sciences, University of Ghana and a health promotion specialist from Ghana Health Services. These professionals assisted in designing, drafting and formatting the handout in a suitable and attractive layout that will promote readability, understandability and effectiveness in educating patients with glaucoma to improve their adherence to medication.

Phase 2: Validation of the handout

The validation of the handout followed three steps namely; the selection of experts for validation, content validation and face validation.

Step 4: Selection of experts for content validation

A panel of 10 experts based on the recommendations (for the robustness of rating in a validation process) of Pasqali¹³ were purposively selected and invited to evaluate and validate the handout. The experts were selected from different fields to make the handout more user-friendly and serve the need of educating patients with glaucoma on adherence to medication. Five experts were from the fields of ophthalmology, two from health promotion, one from public health, and two representatives were from the Glaucoma Association of Ghana (a non-governmental organisation for patients with glaucoma in Ghana).

Experts with ten or more years of experience in their fields, a good professional image, and a willingness to be part of the validation process were included. Further considerations in the selection of experts included; having knowledge or skills acquired through experience, having special skills in a certain type of study; and having a high professional rating assigned by a recognised body.¹⁴ Experts who met at least two of the requirements described above were selected. An e-mail message which included an invitation letter explaining the objectives and methods of the study as well as informed consent and a copy of the draft handout (in Microsoft Word document) was sent to the experts.

Step 5: Content validation

Content validation was done to assess whether the content of the handout was representative of all aspects of the construct used. In the content validation process, the questions and answers generated under each theme had an item rating model with a five-point Likert scale ranging from strongly disagree − 1, disagree − 2, neutral − 3, agree − 4, and strongly agree − 5. The socio-demographic characteristics of the experts including age, gender, area of expertise, and years of experience were documented. The experts were tasked to rate the extent of their agreement with each of the questions and answers provided in the handout under each theme. In rating the extent of their agreement, the experts were requested to use the following criteria in validating the questions and answers; completeness/informative, understandability, legibility, clarity and usefulness of each question and answer to the development of the handout. Completeness/informative in this study refers to the state of the handout having all the necessary or appropriate parts as described in the content development layout. Understandability refers to the presentation of the handout in a manner readers can easily comprehend. Legibility refers to the quality of the handout being clear enough to be read. Clarity refers to the use of well-spoken and straight language such that readers can read and understand what the handout intends to communicate. Usefulness refers to the degree to which the handout meets the needs of the intended users. A field was added to each question for the experts to note down their recommendations.

Step 6: Face validation

The face validation was done to examine the extent to which the handout achieved its purpose of educating patients with glaucoma about the disease and the need for adherence to glaucoma medication. The face validation was done by conveniently selecting 15 patients with glaucoma from the glaucoma clinic at the Eye Centre of the Korle Bu Teaching Hospital (who were different from the group used for the face-to-face and focus group interviews). Previously diagnosed (more than one year) adult patients with glaucoma aged 30 years and older, who had been using topical anti-glaucoma medications for one or more years with at least a basic level education (from Primary to Junior High School level) in Ghana (equivalent to the US grade 9) were included. Those with coexisting psychiatric disorders and newly diagnosed patients with glaucoma were excluded. Consent was sought from these participants and their socio-demographic characteristics such as age, gender, education, marital status, family history of glaucoma, duration of glaucoma, and duration of medication use were recorded.

Participants were asked to rate the handout using the following criteria; readability, understandability, feasibility, general formatting, and usefulness. Readability refers to whether the style of presentation and the use of words are adequate to attract the readers to be compelled to read the handout from the beginning to the end. Understandability refers to the presentation of the handout in a manner readers can easily comprehend. Feasibility assesses whether the handout is practicable or capable enough to educate users about glaucoma and adherence to medication. Usefulness refers to the degree to which the handout meets the needs of the intended users. General formatting refers to the general physical appearance of the handout, its size, general makeup, arrangement, and choice of printing material. Each criterion was evaluated using a five-point Likert scale ranging from strongly disagree − 1, disagree − 2, neutral − 3, agree − 4, to strongly agree − 5, with a field added next to each criterion for comments.

The qualitative exploratory study aspect of the development and validation of this handout will be published elsewhere as an “assessment of health education needs of patients with glaucoma for a better adherence to glaucoma medication”.

Ethical approvals for the study were obtained from the Biomedical Research Ethics Committee of the University of KwaZulu-Natal in South Africa with approval number; BREC/00002965/2021, and the Korle Bu Teaching Hospital in Ghana with approval number KBTH-IRB/00048/2021. The study was done following the Helsinki Declaration for the conduct of scientific research. Consent for publication of the outcome of the study was obtained from all the participants.

Data analysis

Descriptive statistics were used to analyse the socio-demographic characteristics of the participants (both patients with glaucoma and experts) for each stage of the development and validation. For the qualitative exploratory study, an interpretive content analysis of the interview data was performed to identify themes from the respondent’s narrations. Figures and tables were used to present the results where necessary.

Content and face validity indices were calculated based on the scores from the Likert scale rating for each criterion of validation. The critical cut-off point for an agreement was marked at 4 and above (agree and strongly agree).¹⁵ The CVI was used to indicate the level of agreement among the panels on the item level content validity index (I-CVI) calculated for each item. The scale level content validity index (S-CVI) which is the average of all the I-CVI was then calculated.

Intraclass correlation coefficients (ICC) were computed using SPSS version 25 (SPSS Inc, Chicago, IL) following a two-way random effect model with multiple raters and an absolute agreement. These were used to determine the inter-rater reliability among the experts and the selected patients with glaucoma for the content and face validities respectively with a significance level set at 5% and a 95% confidence interval. The ICC values which were less than 0.5 were interpreted as poor reliability, values between 0.5 and 0.75 were moderate reliability, values between 0.75 and 0.9 were suggestive of good reliability, and values greater than 0.90 were suggestive of excellent reliability.¹⁴

Socio-demographic characteristics of study participants

Twenty-four patients with glaucoma were included in the content development of the handout through qualitative exploratory interviews with a male preponderance (54.2%) and a mean age of 53.9 ± 8.5 years. Thirteen each had a basic level of education and were married while 14 had a family history of glaucoma. The mean duration of glaucoma diagnosis was 5.0 ± 1.6 years and the mean duration of medication use was 3.8 ± 1.4 years (Table 2).

The mean age and years of experience of the experts were 54.0 ± 5.5 years and 13.1 ± 2.7 years respectively. Other demographic variables for this category are shown in Table 2.

Fifteen patients with glaucoma participated in the face validation, eight of whom were females. The mean age for this group was 55.5 ± 8.3 years. Ten participants had a basic level of education and nine were married. Eight participants had a family history of glaucoma. The mean duration of glaucoma in this group was 5.1 ± 1.6 years and the mean duration of medication use was 4.1 ± 1.4 years (Table 2).

Table 2: Socio-demographic characteristics of study participants

Socio-demographic characteristics	Number (n)	Percentage (%)
Content development participants:
Mean age±SD: 53.9±8.5 years
Gender: Male Female	13 11	54.2 45.8
Education: Basic level Senior High School Tertiary	13 6 5	54.2 25.0 20.8
Marital status: Married Single Divorced	13 7 4	54.2 29.2 16.6
Family history of glaucoma:	14	58.3
Mean duration of glaucoma±SD: 5.0±1.6 years
Mean duration of medication use±SD: 3.8±1.4 years
Content validation participants:
Mean age±SD: 54.0±5.5 years
Gender: Male Female	6 4	60.0 40.0
Area of expertise: Ophthalmology Health promotion Public health Representative Glaucoma Association of Ghana	5 2 1 2	50.0 20.0 10.0 20.0
Mean years of experience±SD: 13.1±2.7 years
Face validation participants:
Mean age±SD: 55.5±8.3 years
Gender: Male Female	7 8	46.7 53.3
Education: Basic level Senior High School Tertiary	10 4 1	66.7 26.7 6.6
Marital status: Married Single Divorced	9 4 2	60.0 26.7 13.3
Family history of glaucoma	8	53.3
Mean duration of glaucoma±SD: 5.1±1.6 years
Mean duration of medication use±SD: 4.1±1.4 years

SD = Standard deviation.

Content development participants:

The themes generated from the qualitative exploratory study included; knowledge about glaucoma, knowledge about non-adherence, reasons for non-adherence, use of glaucoma medication and the role of patients in the management of glaucoma (Fig. 2).

Content Validity of the items in the handout:

Two (legibility and usefulness) out of the five items were completely agreed upon by all the validators with an ICVI value of 1.00 respectively. For completeness of the content, there was a total of nine agreements with an ICVI value of 0.90. Understandability assessment recorded a total of eight agreements with an ICVI value of 0.8. Clarity had a total of eight agreements with an ICVI value of 0.8. The SCVI value for the content validity was 0.88 (Table 3).

The intraclass correlation coefficient among the experts for the content validity of the handout was 0.94 (p-value = 0.0001) with a 95% CI [0.82, 0.99] (Table 3).

Notes on recommendations from the experts suggested changes in the writing and wording of three questions for clarity. The rest of the questions and answers remained unchanged.

Table 3

Participants’ agreement on the items in the handout for content validity
Item	Experts										No. of agreements	ICVI
	1	2	3	4	5	6	7	8	9	10
Completeness	5	5	5	5	5	5	5	5	5	3	9	0.90
Understandability	3	4	4	4	4	4	3	4	4	4	8	0.80
Legibility	5	5	5	5	5	5	5	5	5	5	10	1.00
Clarity	4	4	5	5	3	4	4	4	4	4	8	0.80
Usefulness	5	5	5	5	5	5	5	5	5	5	10	1.00
S-CVI/mean												0.88
Intraclass Correlation Coefficient = 0.94; 95% CI[0.82, 0.99]; p-value = 0.0001

Face validation of the handout

The face validity of the handout was assessed by the following criteria; readability, understandability, feasibility, general formatting and usefulness. In assessing the readability of the handout, a total of 14 validators agreed that the handout is readable with a face validity index value of 0.93. Understandability recorded a total of 14 agreements with a face validity index of 0.93. A total of 13 validators agreed that the handout was feasible to use with a face validity index value of 0.87. General formatting had fourteen agreements and a face validity of 0.93. All the validators for the face validation of the handout agreed that it was useful. The SCVI value for the face validation of the handout was 0.93 ( Table 4).

The intraclass correlation coefficient for the face validation of the handout was 0.90 (p-value = 0.0001) with a 95% CI[0.60, 0.98] (Table 4).

Table 4

Patients’ agreement on the items in the handouts for face validity
Item	Patients															No. of agreements	ICVI
	1	2	3	4	5	6	7	8	9	10	11	12	13	14	15
Readability	5	5	5	5	5	5	4	4	5	3	4	5	5	5	5	14	0.93
Understandability	4	4	4	4	4	4	5	3	4	4	4	4	4	4	4	14	0.93
Feasibility	5	5	5	5	5	5	5	5	5	5	3	5	5	4	3	13	0.87
General formatting	5	5	5	5	5	5	5	5	5	5	5	3	5	5	5	14	0.93
Usefulness	5	5	5	5	5	5	5	5	5	5	5	5	5	5	4	15	1.00
SCVI/mean																	0.93
Intraclass Correlation Coefficient = 0.90; 95% CI [0.60, 0.98]; p-value = 0.0001

Advocacy for increased adherence to glaucoma medications has been endorsed as one of the strategies for eliminating avoidable blindness.⁷ This study used a patient-centred approach to develop and validate an educational handout for improving glaucoma medication adherence. We followed the recommended methodological steps by Doak et al¹⁶ concerning the use of common words, the inclusion of examples to explain complex situations, and collaboration with the target population to promote understandability and acceptance of the handout by the end-users.

The high SCVI and ICC values in our findings demonstrate good content validity and further indicate a good level of agreement among the experts in the content validation and the selected participants in the face validation of the handout respectively.

The validators positively evaluated the handout and described the material as a good resource for educating patients with glaucoma.

To the best of our knowledge, there have not been significant work done in the area of developing and validating educational materials for helping non-adherent patients with glaucoma in both developed and developing countries. We, therefore, used studies conducted in other areas of health care to support the discussion of our findings.

Although conducted in different geographical locations, other studies have reported findings which are consistent with ours with validations coming from both professionals and patients.^17–19 These consistencies may be attributed to the similarities in the methodological designs used in these studies. For instance, in Brazil, Jesus et al.¹⁷ in their development and validation of educational material for promoting the health and quality of life of individuals living with the human immunodeficiency virus (HIV) recorded good content validity and a high-reliability index among raters with a mean item-level I-CVI for each item higher than 0.8 and a S-CVI of 0.97 which were similar to our findings. Jesus et al.¹⁷ used the educational needs of the target population which were assessed through a qualitative study, similar to the strategy employed in this study.

In India, Khurana et al.¹⁸ in their validation of an educational leaflet as a supplementary guide for caregivers to promote better development of their preterm infants also demonstrated a good intra-rater reliability with item I-CVI ranging from 0.73-1.00 and S-CVI found to be 0.91. An in-depth literature review and a focus group discussion with experts were conducted to formulate the content of the leaflet. The validation was done by 14 experts with higher academic backgrounds using a set of questionnaires relating to the completeness, understandability, legibility, clarity, and utility of educational material for caregivers. Scores were calculated using a 5-point Likert scale for each item in the material.

In Nigeria, Adeyinka & Gershim¹⁹ validated the content of educational material on maternal depression through a cross-sectional design involving six bilingual health professionals and 50 maternal child health service users/clients (nursing mothers and pregnant women).¹⁹ The materials were evaluated by the maternal-child health clients using understandability, clarity, and cultural appropriateness. The content validity index was computed on the professionals’ rating of the educational materials using the 6 items (content, literacy, graphics, layout, simulation, and cultural appropriateness) on the Suitability Assessment of Materials (SAM).²⁰ Similar to our findings, the outcome of their validation showed a high content validity index of 0.94 for each of the items with an excellent inter-rater agreement (ICC > 0.8) among the health professionals. Additionally, more than 80% of nursing mothers and pregnant women rated the suitability of each material as superior.

In agreement with the above-mentioned studies,, our study also adopted a similar approach to exploring the eye health needs of persons with glaucoma through a qualitative study. We also included experts with high academic qualifications and used similar validation criteria on a 5-point Likert scale for each item in the handout. The outcome of our inter-rater reliability is suggestive of excellent inter-rater reliability and less disparity among the validators of the handout. The small disparity between the raters confirms the consistency of our validation process and further demonstrates that different raters were used in the validation. This outcome could be attributed to the higher educational qualification attainment among the content validators who may have demonstrated some sort of level-headedness or soundness in their judgements. All the experts in our content validation had a tertiary level of education with an average of 13 years of experience. It is also possible that the use of professionals and academicians who are stakeholders in the management of glaucoma could contribute to the achievement of this excellent reliability and fewer disparities. In our face validation process, participants were selected from a clinic known to be consistent in the delivery of morning talks on eye health to patients before the commencement of clinic daily. This could have also enhanced participants’ knowledge about glaucoma to some extent which may contribute to the high indices documented in the face validation of the handout.

The validation of the educational material in this study aligns with recommendations to ensure the rigor, quality, and usefulness of educational materials created.²¹ The criteria used in the validation process underscored the significance of keeping the handout in a simple form that could provide adequate health information about glaucoma to avoid readers becoming overwhelmed with too much information which may result in a loss of interest in reading the material.²²

Our qualitative exploratory study in the content development process revealed five health educational needs of patients with glaucoma namely; the need for knowledge about glaucoma, and non-adherence, reasons for non-adherence, use of glaucoma medication, and the role of patients in the management of glaucoma. Similarly, other studies have also demonstrated the need for adequate knowledge about glaucoma and non-adherence among patients with glaucoma.^3,4,23,24

Inadequate knowledge about glaucoma may result in an underestimation of the debilitating effects of the disease and contribute to the non-adherence challenge. Knowledge about glaucoma and non-adherence to medication could enhance patients’ understanding of the disease, improve adherence to treatment, improve patient satisfaction, and promote self-care among patients.⁷

Knowing the reasons for non-adherence to glaucoma medication could be beneficial to patients in promoting tailored interventions designed to mitigate non-adherence.

Several reasons for non-adherence to glaucoma medication have been mentioned which include; inadequate knowledge about glaucoma, lack of motivation in administering drugs, cost of medication, forgetfulness, and difficulty with drop administration.^{3, 25–31}

The appropriate use of anti-glaucoma medication and the role of patients in glaucoma management as educational needs can be achieved through cognitive educative interventions which incorporate the teaching of skills in drug administration to improve eye health care quality.

The participants in this exploratory study were also selected from a clinic where routine morning eye health education is a common practice. Hence, these participants might have been sensitized about the debilitating effect of glaucoma and their need for more eye health information on glaucoma.

The use of representatives of the target population (patients with glaucoma) for this handout and experts’ opinions was very important in enhancing the credibility and acceptability of the handout. To this end, the handout becomes more complete, effective and scientifically rigorous in meeting its construct objective.

Through the support of an educational psychologist and a health promotion officer, the handout was designed to serve the need of both young people and adults with different levels of literacy, from individuals with Basic level education (from Primary to Junior High School level, which is equivalent to the US grade 9) in Ghana to those with a higher level of education (Senior High School to Tertiary). This was necessary to avoid incongruity between the content of the handout and the intended users.³²

We used a pictorial presentation in our handout to demonstrate the proper instillation of eye drops through cognitive teaching of skills in the use of glaucoma medications. Studies have shown that written educational materials with pictorial presentations, provided to patients are essential in improving their understanding of the disease, increasing attentiveness to health information, adherence to the treatment regimen, and improving comprehension, especially among patients with low literacy level.^6,7,33

Our handout is currently limited to English speakers and readers. There is, therefore, a need to to translate this handout into other languages to further enhance its opportunity to reach others who cannot read the English language. The developed handout is not an all-inclusive material, but a supplementary guide for ameliorating non-adherence to glaucoma medication. Future investigations should consider assessing the efficacy of this handout in improving adherence to glaucoma medications among non-adherent patients and sustaining the level of adherence among those who are adherent.

This study reported high SCVIs with high intraclass correlation coefficients among the validators demonstrating good content and face validity and excellent inter-rater reliability. The development of this handout was patient-centred and the evaluators demonstrated a positive evaluation of the handout showing its significance as an excellent educational resource for improving medication adherence among patients with glaucoma.

CI- Confidence interval

FGD- Focus Group Discussion

HIV - Human Immunodeficiency Virus

IBM - International Business Machines Corporation

ICC- Intraclass correlation coefficient

ICV1- item level content validity index

IRB – Institutional Review Board

KBTH- Korle Bu Teaching Hospital

PI- Principal investigator

SAM - Suitability Assessment of Materials

SCVI- Scale level content validity index

SD Standard deviation

SPSS - Statistical Package for the Social Sciences

STROBE - STrengthening the Reporting of OBservational studies in Epidemiology

WHO - World Health Organisation

Ethics approval and consent to participate

Ethical approvals for the study were obtained from the Biomedical Research Ethics Committee of the University of KwaZulu-Natal in South Africa with approval number; BREC/00002965/2021, and the Korle Bu Teaching Hospital in Ghana with approval number KBTH-IRB/00048/2021. Permission to conduct the study was obtained from the study site and informed consent was also obtained from study participants. The study was done following the Helsinki Declaration for the conduct of scientific research.

Consent for publication

Written informed consent for publication of the outcome of this study was obtained from all the participants. A copy of the consent form is available for review by the Editor of this journal.

Availability of data and materials

The dataset for this study is available from the corresponding author upon reasonable request.

Competing interests

The authors declare that they have no competing interests.

Funding

This is a self-funded project by the principal investigator.

Authors' contributions

Conceptualization: BA.

Data curation: BA.

Formal analysis: BA.

Funding acquisition: BA.

Investigation: BA.

Methodology: BA, KPM, PG, PB.

Project administration: BA.

Supervision: KPM, PG.

Writing original draft: BA.

Writing review & editing: BA, KPM, PG, PB.

All authors read and approved the final manuscript.

Acknowledgement

The authors would like to acknowledge the support provided by all the experts and participants in the development and validation processes of the handout.

Authors' information

BA is research officer at the University of Ghana Medical School and a PhD candidate at the University of KwaZulu-Natal, Durban, South Africa.

KPM is a Professor in Optometry at the School of Health Sciences, University of KwaZulu-Natal, Durban, South Africa.

PG, is a Lecturer in Optometry at the School of Health Sciences, University of KwaZulu-Natal, Durban, South Africa.

PB is a Professional Graphic Designer at the Medical Illustration Unit, College of Health Sciences, University of Ghana.

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No competing interests reported.

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Development and validation of an educational handout for improving glaucoma medication adherence: a patient-centred approach

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Abstract

Figures

INTRODUCTION

METHODS

Phase 1: Design and development of the handout

Step 1: Content development

Step 2: Layout of the handout

Step 3: Designing, drafting and formatting the handout

Phase 2: Validation of the handout

Step 4: Selection of experts for content validation

Step 5: Content validation

Step 6: Face validation

Data analysis

RESULTS

Socio-demographic characteristics of study participants

Content development participants:

Content Validity of the items in the handout:

Face validation of the handout

DISCUSSION

Conclusion

Abbreviations

Declarations

References

Additional Declarations

Supplementary Files

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