Evaluation of the readability level of the package inserts of topical antifungal drugs

Abstract

Fungi can cause infections in a number of body parts, including the skin, nails, hair and vulva-vaginal tissues. Topical antifungal drugs are the ones most frequently used to treat these infections. The purpose of this study is to assess topical antifungal medicine package insert readability using the Simple Measure of Gobbledygook (SMOG) and Flesch-Kincaid Grade Level (FKGL) readability formulas. The package inserts of 97 topical antifungal medications from the drugs.com website was examined for this investigation. The SMOG and FKGL formulae were used to assess readability. The analysis determined that the Flesch Reading Ease Score was 60.76 ± 6.08, and the total average Flesch-Kincaid Grade Level for the entire prospectus was 7.59 ± 0.91. 11.45 ± 1.09 was the mean SMOG score. The package inserts for the miconazole group showed somewhat lower FKGL and higher Flesch Reading Ease ratings. This suggests that this group is more readable than the others. The majority of the prospectuses could be read by students in the seventh grade. Additionally, variations across various drug formulations were discovered. The most readable forms were cream and gel. Topical antifungal medication leaflets have a generally moderate literacy level, suitable for students in the seventh grade. To improve patient comprehension, some sections—especially those on possible adverse effects—might need to be further clarified. Making package inserts more readable could help improve patient outcomes by encouraging adherence to treatment plans.

Introduction

In primary healthcare, dermatological illnesses are among the most prevalent issues. Fungal infections can cause infection in many places in the body. The most common areas of fungal infection are skin, nails, hair and mouth^1,2. There is a 10–20% lifetime risk that an individual will get infected with any dermatophyte^3,4.

The vulva-vagina is another area where fungus infections are most prevalent. While fungal infections are not the main cause of vulva-vaginitis, they do play a major role⁵. In communities, vaginal infections are rather frequent and can cause itching and unpleasant odor in women. It is not unexpected that some women experience persistent, hard-to-diagnose, and difficult-to-treat vulva-vaginal issues, given that vaginitis is still a common ailment that prompts women to seek medical attention⁶. A definitive diagnosis is crucial for choosing the right course of therapy and for differential diagnosis, which covers both infectious and non-infectious causes of vulva-vaginitis^7,8.

Although fungal diseases are called based on their localization and have distinct presentations, their treatments are comparable³. Antifungal medications come in a variety of forms, including tinctures, creams, gels, lotions, nail lacquers, ointments, powders, shampoos, and sprays. It is possible for molds, yeasts, or dermatophytes to produce fungal infections.

Patients should also make sure they take their prescription drugs as directed on a regular basis and appropriately, and they should contact their doctor if they have any unexpected adverse effects. Patients should therefore be able to read and comprehend the medication leaflet.

This study aims to assess the readability of drugs leaflets for topical antifungals, with a focus on vulva-vaginal fungal diseases.

Materials and methods

Package inserts for antifungal drugs

The samples to be examined in this study were used as antifungal drugs on the drugs.com website dated 22.10.2023⁹. The entire text of five of the six components that typically comprise the packaging inserts were evaluated for readability:

1. What X is and how it works;

2. Potential adverse effects.

3. What you should know before using X.

4. How to use X.

5. Considerations for using X.

6. Storage instructions.” Since the part on “Contents of the pack and other information” was the same for every product and we felt it was less pertinent to patients, we decided to omit it.

Every package insert that was looked at for this study came from the drug.com website⁹. Topical antifungal medicines are available with a wide variety of active components. Three groups of medications were researched on this website.

Group 1: Miconazole, Miconazole/Zinc Oxide (n = 35).

Group 2: Ketoconazole, Nystatin, Naftifine, Tolnaftate (n = 30).

Group 3: All other active substances (efinaconazole, taneborol, terbinafine, econazole, oxiconazole, undecylenic acid, ciclopirox, clotrimazole, sertaconazole, salicylic acid/sodium thiosulfate, butenafine, luliconazole and sulconazole) (n = 32).

Readability indices

The following readability indexes were used to gauge how readable packaging inserts are: the grade level of the Flesch-Kincaid (FKGL) and the Simple Measure of Gobbledygook (SMOG). SMOG and FKGL are quite simple and useful formulas for determining the readability of texts written in English. In addition, both formulas can be accessed via the internet. In the current study, FKGL and SMOG formulas were used because they are practical and accessible in the evaluation of English labeling instructions of topical antifungal drugs.

SMOG is advised for use in healthcare literature, because it is based on more contemporary criteria than previous algorithms for calculating reading grades and it views 100% expected comprehension as a crucial component in the context of healthcare^10,11. One of the most popular readability algorithms in newly released healthcare literature is FKGL^10,12. Websites were used to avoid any potential biases. To assess the prospectuses’ readability, both indexes were applied to each part.

The SMOG calculation uses the number of words with three or more syllables per phrase as a variable. By following McLaughlin’s instructions and performing hand computations rather than using readability software, a numerical number known as the SMOG grade—which indicates the approximate educational level needed to comprehend the text—was obtained. SMOG score is accepted as (4.9 or low = elementary school / 5-8.9 = middle school / 9-12.9 = high school / 13-16.9 = undergraduate / 17 or higher = graduate)¹¹. The SMOG algorithm were computed using the website https://charactercalculator.com/¹³.

The SMOG Formula = 1.0430(√ number of polysyllables x 30/ number of sentences) + 3.1291.

The quantity of words in a sentence and the number of syllables in a word are the two variables in the FKGL¹¹. This were calculated using the https://goodcalculators.com website¹⁴. The number FKGL represents the educational background needed to comprehend the material.

Flesch reading ease score

In 1948, the Flesch Reading Ease Score was introduced as a means of assessing a text’s readability¹⁵. The score indicates the approximate degree of education required for an individual to read a certain text with ease. A number between 0 and 100 on the Flesch Reading Ease Score indicates how understandable a document is. A score of 100 indicates how easy the material is to read, while a number of 0 indicates how intricate and challenging it is to understand.

The Flesch Reading Ease score is arrived at by using this equation:

Flesch-Kincaid grade level

The Flesch-Kincaid Grade Level indicates the minimum educational attainment required to comprehend a certain text. The Flesch-Kincaid Grade Level scores correspond to the US grade levels of education that readers must meet in order to understand a given text. For example, if a text has a Flesch-Kincaid Grade Level of 9, the reader would have needed to have completed about nine years of schooling in order to understand the document with ease.

The Flesch-Kincaid Grade Level score is arrived at by using this equation:

Therefore, the reading level or number of years of schooling indicated by both SMOG and FKGL can be used to calculate the age required to understand the text.

Statistical analysis

The data obtained in the study were analyzed statistically using SPSS software (IBM Corp. Released 2021. IBM SPSS Statistics for Windows, Version 28.0. Armonk, NY: IBM Corp.) Readability values ​​of antifungal drug leaflets were compared using mean, standard deviation and confidence interval.

Results

The SMOG algorithm, Flesch Reading Ease, and Flesch-Kincaid grade level were used in this study to evaluate the readability of topical antifungal medication leaflets. Analysis was done on the overall averages for the various medication classes.

The Flesch-Kincaid class level, Flesch Reading Ease score, and SMOG formula findings of the antifungal medicine package inserts were compared when the data in Table 1 was analyzed. Regarding the Flesch-Kincaid grade level, the miconazole/zinc oxide group’s first part average is 9.50 ± 1.18, whereas the group’s overall average is 7.50 ± 0.74. The results obtained for the ketoconazole, nystatin, and other groups were 7.83 ± 0.94 and 7.45 ± 1.04, respectively. For all medication groups combined, the total mean is 7.59 ± 0.91. There were no discernible variations found in the Flesch Reading Ease scores of any group. The miconazole group had an overall mean of 61.47 ± 4.94, while the other groups had respective means of 58.98 ± 6.35 and 61.65 ± 6.75. The total group average was determined to be 60.76 ± 6.08. The outcomes of the SMOG formula were comparable for each group. The miconazole group’s overall mean was 11.24 ± 0.86, the ketoconazole group’s 11.57 ± 1.15, and the other groups’ 11.57 ± 1.23. All groups combined have an overall SMOG average of 11.45 ± 1.09.

Table 1.

Shows the average readability scores for the package insert groups of antifungal drugs (N = 97).

Formula	Section	Miconazol, Miconazole/ Zinc Oxide (N = 35)				Ketoconazol, Nistatin, Nasftifine, Tolnaftate (N = 30)				The Others (N = 32)				Total (N = 97)
		x̄	SD	95% CI		x̄	SD	95% CI		x̄	SD	95% CI		x̄	SD	95% CI
				Lower	Top			Lower	Top			Lower	Top			Lower	Top
Flesch-Kincaid Grade Level	1. Section	9.50	1.18	9.10	9.91	9.74	1.47	9.19	10.28	9.66	2.13	8.89	10.42	9.63	1.62	9.30	9.95
	2. Section	7.30	1.01	6.96	7.65	7.64	1.33	7.15	8.13	7.20	1.29	6.74	7.66	7.37	1.21	7.13	7.62
	3. Section	8.12	1.10	7.74	8.50	8.00	2.00	7.26	8.75	7.92	1.78	7.27	8.56	8.02	1.63	7.69	8.34
	4. Section	6.80	1.70	6.22	7.38	6.89	1.53	6.32	7.47	6.72	1.36	6.24	7.21	6.80	1.53	6.50	7.11
	5. Section	7.59	1.06	7.22	7.95	7.71	0.87	7.39	8.04	7.45	1.10	7.05	7.85	7.58	1.01	7.38	7.78
	General	7.50	0.74	7.24	7.75	7.83	0.94	7.48	8.18	7.45	1.04	7.08	7.83	7.59	0.91	7.40	7.77
Flesch Okuma Ease Score	1. Section	48.11	9.86	44.72	51.50	46.93	11.03	42.81	51.04	47.17	14.34	42.01	52.34	47.44	11.74	45.07	49.80
	2. Section	60.10	7.36	57.58	62.63	57.92	9.02	54.55	61.29	60.97	9.36	57.59	64.34	59.71	8.58	57.98	61.44
	3. Section	60.75	6.41	58.55	62.96	59.22	13.10	54.33	64.11	59.63	10.50	55.84	63.41	59.91	10.12	57.87	61.95
	4. Section	66.65	12.53	62.35	70.96	65.89	10.35	62.02	69.75	67.08	8.24	64.11	70.05	66.56	10.50	64.44	68.67
	5. Section	60.63	6.60	58.37	62.90	60.13	5.57	58.05	62.21	62.19	7.50	59.49	64.90	60.99	6.61	59.66	62.32
	General	61.47	4.94	59.78	63.17	58.98	6.35	56.61	61.35	61.65	6.75	59.21	64.09	60.76	6.08	59.54	61.99
SMOG Formula	1. Section	12.14	1.21	11.73	12.56	12.49	1.45	11.95	13.03	12.50	2.15	11.72	13.27	12.37	1.64	12.04	12.70
	2. Section	12.51	1.63	11.95	13.07	12.10	1.53	11.53	12.67	11.70	1.50	11.16	12.24	12.12	1.58	11.80	12.43
	3. Section	12.71	1.18	12.30	13.11	12.39	2.16	11.58	13.19	12.31	1.78	11.66	12.95	12.48	1.72	12.13	12.82
	4. Section	9.73	1.41	9.25	10.21	10.12	1.73	9.47	10.77	9.98	1.22	9.54	10.42	9.94	1.45	9.64	10.23
	5. Section	10.58	1.15	10.19	10.98	11.06	0.87	10.74	11.39	11.64	2.16	10.86	12.41	11.08	1.55	10.77	11.39
	General	11.24	0.86	10.94	11.53	11.57	1.15	11.13	12.00	11.57	1.23	11.13	12.02	11.45	1.09	11.23	11.67

CI: Confidence Interval, SD: Standard Deviation, SMOG: Simple Measure of Gobbledygook.

Examining the distribution of antifungal drug leaflets based on SMOG and Flesch-Kincaid readability levels in Table 2, it is seen that most drug groups are distributed to students in grades 8 through 12. It was discovered to be grade-level readable. Similar distributions were seen in other groups, however 49% of the package inserts for the miconazole/zinc oxide group exhibited readability appropriate for university students. Readability was established in Chaps. 1 and 4, particularly for graduate and college students.

Table 2.

Distribution of Flesch-Kincaid and SMOG readability levels for antifungal drug package insert groups (N = 97).

Formula	Section	Level	Miconazol, Miconazole/ Zinc Oxide (N = 35)	Ketoconazol, Nistatin, Naftifine, Tolnaftate (N = 30)	The Other (N = 32)	Total (N = 97)
Flesch-Kincaid Grade Level	1. Section	7. Class	0	0	2	2
		8–9. Class	1	2	4	7
		10–12. Class	18	7	7	32
		College Student	15	19	15	49
		College Graduate	1	2	4	7
	2. Section	6. Class	0	1	1	2
		7. Class	3	0	2	5
		8–9. Class	17	16	18	51
		10–12. Class	13	8	7	28
		College Student	2	5	4	11
	3. Section	6. Class	0	2	0	2
		7. Class	2	0	3	5
		8–9. Class	10	14	12	36
		10–12. Class	20	6	10	36
		College Student	3	7	7	17
		College Graduate	0	1	0	1
	4. Section	6. Class	1	0	2	3
		7. Class	1	3	5	9
		8–9. Class	29	21	19	69
		10–12. Class	3	5	6	14
		College Graduate	1	1	0	2
	5. Section	7. Class	2	1	3	6
		8–9. Class	27	12	12	51
		10–12. Class	5	17	17	39
		College Student	1	0	0	1
	General	7. Class	1	0	4	5
		8–9. Class	25	13	13	51
		10–12. Class	9	16	14	39
		College Student	0	0	1	1
		College Graduate	0	1	0	1
SMOG Reading Level	1. Section	6. Class	0	0	1	1
		7. Class	27	24	20	71
		College Student	8	5	10	23
		Graduate	0	1	1	2
SMOG Reading Score	1. Section	Easy to Read	0	0	1	1
		Simple English	27	24	20	71
		Hard to Read	8	5	10	23
		Too Difficult to Read	0	1	1	2
SMOG Reading Level	2. Section	6. Class	1	1	2	4
		7. Class	21	21	22	64
		College Student	13	8	8	29
SMOG Reading Score	2. Section	Easy to Read	1	1	2	4
		Simple English	21	21	22	64
		Hard to Read	13	8	8	29
SMOG Reading Level	3.	6. Class	0	1	0	1
		7. Class	27	17	22	66
		College Student	8	12	10	30
SMOG Reading Score	3. Section	Easy to Read	0	1	0	1
		Simple English	27	17	22	66
		Hard to Read	8	12	10	30
SMOG Reading Level	4. Section	6. Class	11	2	5	18
		7. Class	23	27	27	77
		College Student	1	0	0	1
		Graduate	0	1	0	1
SMOG Reading Score	4. Section	Easy to Read	11	2	5	18
		Simple English	23	27	27	77
		Hard to Read	1	0	0	1
		Too Difficult to Read	0	1	0	1
SMOG Reading Level	5. Section	6. Class	2	0	1	3
		7. Class	32	30	28	90
		College Student	1	0	3	4
SMOG Reading Score	5. Section	Easy to Read	2	0	1	3
		Simple English	32	30	28	90
		Hard to Read	1	0	3	4
SMOG Reading Level	General	7. Class	33	29	30	92
		College Student	2	1	2	5
SMOG Reading Score	General	Simple English	33	29	30	92
		Hard to Read	2	1	2	5

SMOG: Simple Measure of Gobbledygook.

The package insert readability scores for several antifungal medication formulations are compared in Table 3. The average for the Flesch-Kincaid grade level is 7.91 ± 0.68 for gel, 7.55 ± 0.79 for cream, 7.96 ± 1.70 for powder, 8.20 ± 0.53 for solution, and 7.12 ± 1.06 for spray. The variant with the lowest average (5.20) is the shampoo. In general, notable distinctions were noted among the various forms, despite the fact that the cream form was the most prevalent. The Flesch Reading Ease scores for gel, cream, and powder forms are 58.81 ± 3.69, 61.13 ± 4.94, and 57.80 ± 13.66, respectively. All forms offer moderate readability, although there are variances between the spray form (64.78 ± 7.51) and the solution (55.13 ± 4.48). The gel form’s SMOG formula findings were 11.68 ± 0.95, the cream form’s 11.41 ± 1.02, the powder form’s 11.57 ± 2.02, and the solution form’s 12.13 ± 0.52. The average SMOG in shampoo form is 12.16, but in spray form it is 10.95 ± 0.92. The cream and gel versions of the pamphlets were found to be more comprehensible than the other forms, albeit there were generally only slight variations in readability levels between the forms.

Table 3.

Average readability scores for package insert forms of antifungal drugs (N = 97).

Formula	Section	Gel (N = 8)				Cream (N = 73)				Powder (N = 7)				Solution (N = 3)
		x̄	SD	95% CI		x̄	SD	95% CI		x̄	SD	95% CI		x̄	SD	95% CI
				Lower	Top			Lower	Top			Lower	Top			Lower	Top
Flesch-Kincaid Grade Level	1. Section	10.21	1.46	8.99	11.43	9.49	1.41	9.16	9.82	9.90	1.59	8.43	11.37	11.47	3.86	1.89	21.04
	2. Section	7.49	0.93	6.71	8.27	7.42	1.17	7.14	7.69	7.50	1.60	6.02	8.98	7.17	0.15	6.79	7.55
	3. Section	7.36	2.07	5.63	9.09	8.12	1.55	7.75	8.48	8.44	1.79	6.79	10.10	8.47	1.26	5.34	11.59
	4. Section	7.51	0.98	6.70	8.33	6.66	1.34	6.35	6.98	7.77	2.88	5.11	10.44	8.40	0.85	6.28	10.52
	5. Section	7.59	0.79	6.93	8.25	7.61	1.02	7.38	7.85	7.91	0.58	7.38	8.45	7.87	0.55	6.50	9.23
	General	7.91	0.68	7.35	8.48	7.55	0.79	7.37	7.74	7.96	1.70	6.38	9.53	8.20	0.53	6.89	9.51
Flesch Okuma Ease Score	1. Section	43.97	9.41	36.11	51.84	48.41	10.24	46.02	50.80	47.39	15.64	32.92	61.85	34.03	24.23	26.15	94.22
	2. Section	58.50	6.26	53.27	63.73	59.46	8.23	57.54	61.38	58.19	12.22	46.89	69.49	61.43	0.42	60.40	62.47
	3. Section	62.91	12.84	52.17	73.65	59.52	9.41	57.32	61.72	57.26	14.13	44.19	70.32	52.60	8.56	31.33	73.87
	4. Section	63.18	4.96	59.03	67.32	67.50	9.59	65.26	69.74	60.59	19.66	42.40	78.77	54.60	5.02	42.13	67.07
	5. Section	60.98	5.44	56.43	65.52	60.98	6.74	59.40	62.55	58.71	3.50	55.48	61.95	57.83	4.42	46.85	68.82
	General	58.81	3.69	55.73	61.90	61.13	4.94	59.98	62.29	57.80	13.66	45.16	70.44	55.13	4.48	44.00	66.27
SMOG Formula	1. Section	12.53	1.44	11.33	13.73	12.24	1.55	11.88	12.60	12.32	2.49	10.02	14.63	13.47	2.79	6.53	20.41
	2. Section	12.25	1.22	11.23	13.27	12.12	1.56	11.76	12.49	12.51	1.06	11.53	13.49	11.64	0.13	11.32	11.97
	3. Section	12.35	1.74	10.89	13.81	12.51	1.80	12.09	12.93	12.62	1.67	11.08	14.17	13.02	1.19	10.07	15.98
	4. Section	10.67	1.03	9.81	11.53	9.81	1.17	9.54	10.08	10.56	3.55	7.27	13.85	11.31	0.48	10.11	12.50
	5. Section	11.00	0.52	10.56	11.43	11.13	1.69	10.74	11.52	10.92	0.80	10.19	11.66	11.99	1.71	7.75	16.23
	General	11.68	0.95	10.88	12.47	11.41	1.02	11.17	11.65	11.57	2.02	9.70	13.44	12.13	0.52	10.85	13.42

Formula	Section	Spray (N = 5)				Shampoo (N = 1)		Total (N = 97)
		x̄	SD	95% CI		x̄	SD	x̄	SD	95% CI
				Lower	Top					Lower	Top
Flesch-Kincaid Grade Level	1. Section	8.76	2.47	5.69	11.83	11.9	-	9.63	1.62	9.30	9.95
	2. Section	7.28	1.15	5.85	8.71	3.50	-	7.37	1.21	7.13	7.62
	3. Section	7.64	0.80	6.65	8.63	3.40	-	8.02	1.63	7.69	8.34
	4. Section	5.68	1.51	3.81	7.55	5.50	-	6.80	1.53	6.50	7.11
	5. Section	6.78	1.50	4.92	8.64	5.90	-	7.58	1.01	7.38	7.78
	General	7.12	1.06	5.81	8.43	5.20	-	7.59	0.91	7.40	7.77
Flesch Okuma Ease Score	1. Section	52.98	12.51	37.45	68.51	16.90	-	47.44	11.74	45.07	49.80
	2. Section	62.14	10.87	48.65	75.63	81.60	-	59.71	8.58	57.98	61.44
	3. Section	64.44	4.34	59.05	69.83	82.00	-	59.91	10.12	57.87	61.95
	4. Section	73.98	8.67	63.21	84.75	65.70	-	66.56	10.5	64.44	68.67
	5. Section	66.66	9.72	54.59	78.73	59.30	-	60.99	6.61	59.66	62.32
	General	64.78	7.51	55.45	74.11	66.60	-	60.76	6.08	59.54	61.99
SMOG Formula	1. Section	12.87	1.28	11.28	14.46	14.55	-	12.37	1.64	12.04	12.70
	2. Section	12.39	2.51	9.27	15.51	7.79	-	12.12	1.58	11.80	12.43
	3. Section	11.92	1.31	10.29	13.54	11.21	-	12.48	1.72	12.13	12.82
	4. Section	9.13	0.82	8.11	10.16	8.84	-	9.94	1.45	9.64	10.23
	5. Section	10.09	1.18	8.62	11.55	11.21	-	11.08	1.55	10.77	11.39
	General	10.95	0.92	9.80	12.10	12.16	-	11.45	1.09	11.23	11.67

Table 4 shows the distribution of antifungal drug package inserts by Flesch-Kincaid and SMOG readability levels, broken down by package insert form. 8–9 class is the most prevalent, having been shown to be read at a grade level. There are 3 gel-form package inserts, 37 cream-form package inserts, 5 powder-form and 4 solution and spray form package insert at this level. 32 cream form leaflets were included at the 10–12 class level. When looking at SMOG readability levels, most prospectuses provide readability at the 7th grade level and Simple English level. The majority of drug leaflets are understandable to the general public; over 90% of gel, cream, powder, solution, and spray forms were evaluated at this level; limited prospectuses are difficult for university students to read; overall, the most common readability level across all forms is 7th grade level and Simple English.

Table 4.

Distribution of antifungal drug package insert forms according to Flesch-Kincaid and SMOG readability levels (N = 97).

Formula	Section	Level	Gel (N = 8)	Cream (N = 73)	Powder (N = 7)		Solution (N = 3)	Spray (N = 5)	Shampoo (N = 1)	Total (N = 97)
Flesch-Kincaid Grade Level	1. Section	7. Class	0	1		0	0	1	0	2
		8–9. Class	0	6		0	1	0	0	7
		10–12. Class	2	26		3	0	1	0	32
		College Student	5	38		3	0	3	0	49
		College Graduate	1	2		1	2	0	1	7
	2. Section	6. Class	0	1		0	0	0	1	2
		7. Class	1	4		0	0	0	0	5
		8–9. Class	2	39		3	3	4	0	51
		10–12. Class	5	21		2	0	0	0	28
		College Student	0	8		2	0	1	0	11
	3. Section	6. Class	0	1		0	0	0	1	2
		7. Class	2	3		0	0	0	0	5
		8–9. Claa	2	27		2	1	4	0	36
		10–12. Class	3	27		4	1	1	0	36
		College Student	1	15		0	1	0	0	17
		College Graduate	0	0		1	0	0	0	1
	4. Section	6. Class	0	2		0	0	1	0	3
		7. Class	1	7		0	0	1	0	9
		8–9. Class	3	55		6	1	3	1	69
		10–12. Class	4	8		0	2	0	0	14
		College Graduate	0	1		1	0	0	0	2
	5. Section	7. Class	0	4		0	0	2	0	6
		8–9. Class	5	39		4	1	2	0	51
		10–12. Class	3	29		3	2	1	1	39
		College Student	0	1		0	0	0	0	1
	General	7. Class	0	4		0	0	1	0	5
		8–9. Class	3	37		5	1	4	1	51
		10–12. Class	4	32		1	2	0	0	39
		College Student	1	0		0	0	0	0	1
		College Graduate	0	0		1	0	0	0	1
SMOG Reading Level	1. Section	6. Class	0	1		0	0	0	0	1
		7. Class	5	56		6	1	3	0	71
		College Student	3	15		0	2	2	1	23
		College Graduate	0	1		1	0	0	0	2
SMOG Reading Score	1. Section	Easy to Read	0	1		0	0	0	0	1
		Simple English	5	56		6	1	3	0	71
		Hard to Read	3	15		0	2	2	1	23
		Too Difficult to Read	0	1		1	0	0	0	2
SMOG Reading Level	2. Section	6. Class	0	3		0	0	0	1	4
		7. Class	5	49		5	3	2	0	64
		College Student	3	21		2	0	3	0	29
SMOG Reading Score	2. Section	Easy to Read	0	3		0	0	0	1	4
		Simple English	5	49		5	3	2	0	64
		Hard to Read	3	21		2	0	3	0	29
SMOG Reading Level	3. Section	6. Class	0	1		0	0	0	0	1
		7. Class	6	48		6	1	4	1	66
		College Student	2	24		1	2	1	0	30
SMOG Reading Score	3. Section	Easy to Read	0	1		0	0	0	0	1
		Simple English	6	48		6	1	4	1	66
		Hard to Read	2	24		1	2	1	0	30
SMOG Reading Level	4. Section	6. Class	1	13		2	0	1	1	18
		7. Class	7	59		4	3	4	0	77
		College Student	0	1		0	0	0	0	1
		College Graduate	0	0		1	0	0	0	1
SMOG Reading Score	4. Section	Easy to Read	1	13		2	0	1	1	18
		Simple English	7	59		4	3	4	0	77
		Hard to Read	0	1		0	0	0	0	1
		Too Difficult to Read	0	0		1	0	0	0	1
SMOG Reading Level	5. Section	6. Class	0	2		0	0	1	0	3
		7. Class	8	68		7	2	4	1	90
		College Student	0	3		0	1	0	0	4
SMOG Reading Score	5. Section	Easy to Read	0	2		0	0	1	0	3
		Simple English	8	68		7	2	4	1	90
		Hard to Read	0	3		0	1	0	0	4
SMOG Reading Level	General	7. Class	7	70		6	3	5	1	92
		College Student	1	3		1	0	0	0	5
SMOG Reading Score	General	Simple English	7	70		6	3	5	1	92
		Hard to Read	1	3		1	0	0	0	5

SMOG: Simple Measure of Gobbledygook.

Discussion

In this study, the Flesch-Kincaid, Flesch Reading Ease, and SMOG formulas were employed to assess the readability levels of topical antifungal medication package inserts. The bulk of the prospectuses could be read in simple English at a level equivalent to the seventh grade, according to the findings. This finding is consistent with the general population’s level of health literacy; yet, it’s vital to remember that certain insert portions call for a greater reading proficiency. This result is consistent with the study by Mariani et al.¹⁶.

The package inserts for the miconazole and miconazole/zinc oxide groups were found to be more comprehensible than those for the other drug groups in the current investigation. This could be because the manufacturers’ writing styles differ from one another. This discrepancy might also have been brought about by the vocabulary employed and the prospectus’s organizational structure. It was also discovered that ketoconazole, nystatin, and other groups were usually comprehensible; however, the use of more medical terminology in some sections (such the side effects section) made reading them more challenging. For people with limited health literacy, it becomes more difficult to interpret these box inserts. People could be able to comprehend the prospectus more easily if these sections were written in a more understandable manner.

The study’s findings are consistent with those of Cai et al.‘s 2022 investigation of the readability of textual documents pertaining to health. According to this study, health documents often have a medium degree of readability; as a result, particularly complex medical jargon should be made simpler¹⁷. Likewise, Hub et al.‘s 2023 study indicated that health prospectuses are often readable by students in grades 7–8. It was determined to be grade level, and it was stressed how crucial it is to make language simpler in order to appeal to a larger audience¹⁸. In a study by Akkus et al., and in another study conducted on antidepressant drug package inserts, it was concluded that the understandability of the text increased patient compliance¹⁹. In another study conducted in 2020, the importance of readability and understandability of prospectuses was emphasized²⁰.

A strength of this study is that, to the best knowledge of the authors, it is the first to evaluate the relationship between readability and various antifungal drug insert types (gel, cream, powder, solution, etc.). Gel and cream formulations, for instance, have been proven to be easier to understand than other forms. This finding implies that the language and organization employed in prospectus writing may be influenced by the formulation of the medicine. The readability ratings in the shampoo form were found to be lower. These findings imply that the informational materials for specialized or less widely used medication forms could not be sufficiently clear or comprehensible.

Statistical analyses Differences between groups were reported using descriptive statistical analyses. For example, the confidence intervals presented in Table 1 show that the miconazole group had lower FKGL scores than the others, supporting that the miconazole group is understandable to a wider range of patients. Similarly, formulation-based analyses in Table 3 revealed that the cream and gel forms had higher readability levels. These results are critical for identifying areas of drug information that need to be simplified, such as side effects, and for designing them appropriate to the education level of the target audience.

The present investigation is not without limits. Initially, only pamphlets sourced from the drugs.com website were analyzed; thus, pamphlets from other databases or those composed in various languages and nations were excluded. This could restrict how broadly the findings can be applied. Only descriptive statistical analyses were used in this study. In future studies, the use of methods such as Generalized Estimating Equations (GEE) may be beneficial in modeling correlations between repeated measurements or drug formulations. Furthermore, drug inserts in other therapeutic areas were not assessed; only a particular subset of antifungal medications was looked at. More participants and alternative drug classes may be used in future research. In future studies, other readability formulas other than FKGL and SMOG can be used. In addition, although readability is a valid concept, the intended purpose can be better conveyed to the other party by using graphs, figures, pictures, or videos²¹. There were no such visual materials in the inserts included in the current study, but pharmaceutical companies may include such visual materials in their printed or online sites.

As a consequence, this study offers significant insights into determining if the writing style of medication prospectuses is suitable for the public’s general health literacy level. While the majority of the medicine package inserts appear to be moderately comprehensible, more in-depth sections require simplification studies. These rules will guarantee proper drug use and improve patient compliance, especially for people with limited health literacy. However, it should not be forgotten that, apart from these, the understandability, applicability and accuracy of the instructions for use also play an important role in the correct use of medicines by the readers. The upshot of all this is that incorporating patient feedback into the preparation of drug leaflets can help increase their readability.

Conclusion

This study demonstrated that topical antifungal medication leaflets have a readability level that is suitable for the general public’s reading ability, albeit this level might be raised by use more straightforward language. By investigating the impact on package insert readability and patient compliance, future research may help design techniques for the more efficient use of medicine package inserts.

Abbreviations

FKGL

Flesch-Kincaid Grade Level

SPSS

Statistical Package for the Social Sciences

SMOG

Simple Measure of Gobbledygook

Author contributions

Study conception and design: EU Designed and prepared the text messages: EU Performed the analysis: EU Wrote the Manuscript: EU Collected the data: EU All of the authors reviewed the results and approved the final version of the manuscript.

Funding

No specific funding for this research.

Data availability

The datasets used in this study are available from the corresponding author upon request.

Declarations

Ethics approval and consent to participate

Ethical approval for the study was obtained from the Ethics Committee of Necmettin Erbakan University (Decision number: 2023/4632).

Consent for publication

Not applicable.

Competing interests

The authors declare no competing interests.