Validation of a new tool for evaluating subjects’ satisfaction with medicine package leaflets: a cross-sectional descriptive study

Pires, Carla; Rosa, Pedro Joel; Vigário, Marina; Cavaco, Afonso

doi:10.1590/1516-3180.2019.0123160919

Carla Pires

PhD. Pharmacist and Invited Professor, Department of Pharmacotherapy, Research Center for Biosciences and Health Technologies (CBIOS), Universidade Lusófona, Campo Grande, Lisbon, Portugal.

https://orcid.org/0000-0003-4526-0271

Pedro Joel Rosa

PhD. Psychologist, Statistician and Assistant Professor, Psychology Department, School of Psychology and Life Sciences, Lusophone University of Humanities and Technologies (ULHT), Lisbon, Portugal; Human Environment Interaction Lab (HEI-lab), ULHT, Lisbon, Portugal; Instituto Universitário de Lisboa (ISCTE-IUL), Cis-IUL, Lisbon, Portugal.

https://orcid.org/0000-0001-8432-1802

Marina Vigário

PhD. Linguist and Associate Professor, Department of General and Romance Linguistics, School of Arts and Humanities & Centre of Linguistics, University of Lisbon, Lisbon, Portugal.

https://orcid.org/0000-0001-7640-4798

Afonso Cavaco

PhD. Pharmacist and Associate Professor, Department of Social Pharmacy, School of Pharmacy, Research Institute for Medicines and Pharmaceutical Sciences, University of Lisbon, Lisbon, Portugal.

https://orcid.org/0000-0001-8466-0484

Address for correspondence: Carla Pires. Research Center for Biosciences and Health Technologies (CBIOS), Universidade Lusófona, Campo Grande 376, 1749-024 Lisbon, Portugal. Tel. +351 217 515 500. E-mail: p5558@ulusofona.pt

Conflict of interest: The authors declare that there were no conflicts of interest

Tables (7)

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Table 1.
Descriptive statistics for the items that were designed to evaluate subjects’ satisfaction with the readability of package leaflets for medicines (LiS-RPL) (n = 469)

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Table 2.
Pattern matrix from exploratory factor analysis on the questionnaire that was designed to evaluate subjects’ satisfaction with the readability of package leaflets for medicines (LiS-RPL) (n = 469)

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Table 3.
Responda ao questionário assinalando com um número de 1 a 5 a opção que melhor se adequa à sua opinião:

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Table 4.
Selection of the leaflets among participants according to education level groups and the features of the package leaflets tested.

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Education level Features of package leaflets - part B Active substances Layout of the title Color Line Spacing En-dash‡ Length of sentences (average no. of words) No. of paragraphs Abbreviations Repetition of brand names 0-6 years of schooling Gelatin + glycerol Capitalized Black ≤ 1 pt 1 13.8 15 5 1 ‡‡ Minoxidil Capitalized Black > 1 pt 6 14.9 54 12 1 Cefatrizine Capitalized Black > 1 pt 5 14.2 39 12 1 Ipratropium bromide Capitalized Black > 1 pt 8 17.2 38 4 1 7-12 years of schooling Povidone-iodine Not capitalized Black > 1 pt 1 12.4 29 1 1 Oxymetazoline Not capitalized Yes > 1 pt 6 13.5 57 15 0 ‡ Ofloxacin Capitalized Black > 1 pt 5 14.5 30 1 1 Clomipramine Capitalized Black > 1 pt 4 17.6 28 16 1 > 12 years of schooling Choline salicylate Capitalized Black > 1 pt 1 14.7 6 3 1 Acetylsalicylic acid + ascorbic acid Capitalized Yes > 1 pt 8 14.8 31 16 0 Dexamethasone + neomycin Not capitalized Black > 1 pt 3 14.7 25 5 1 Methylprednisolone + lidocaine Capitalized Black > 1 pt 4 16.5 45 5 0 ‡ = Number of groups of items with en-dash; ‡‡ = The name of medicine appears at least once per more than 50 words.

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Table 5.
Results from Schmid-Leiman solution produced through a questionnaire that was designed to evaluate subjects’ satisfaction with the readability of package leaflets for medicines (LiS-RPL), in a sample of 469 participants

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Table 6.
Internal consistency and homogeneity measurements for the questionnaire that was designed to evaluate subjects’ satisfaction with the readability of package leaflets for medicines (LiS-RPL)

Items of LiS-RPL*	Mean	SD	Skewness	Kurtosis
Item 1 - Font size	3.47	1.44	-0.55	-1.14
Item 2 - Font type	4.13	1.11	-1.38	1.13
Item 3 - Layout of the titles of the sections	4.07	1.02	-1.11	0.62
Item 4 - Color of the text	4.30	0.95	-1.53	2.20
Item 5 - Line spacing	3.85	1.23	-0.86	-0.45
Item 6 - Use of the en-dash throughout the text	4.14	0.98	-1.22	1.21
Item 7 - Clarity of the text	3.84	1.16	-0.91	-0.90
Item 8 - Length of the sentences	4.03	1.08	-1.05	0.33
Item 9 - Number of sentences in each paragraph	4.02	1.13	-1.07	0.30
Item 10 - Description of possible side effects	3.90	1.10	-0.87	-0.17
Item 11 - Comprehensibility of medical terms	3.66	1.17	-0.56	-0.74
Item 12 - Clarity of the instructions for the user	3.96	1.07	-0.99	0.24
Item 13 - Use of abbreviations throughout the text	3.45	1.18	-0.31	-0.78
Item 14 - Repetition of the brand name of the medicine throughout the text	4.01	1.01	-0.98	0.46

Items of LiS-RPL*	Factor 1 Clarity and comprehension of text	Factor 2 Format	h²
Item 12 - Clarity of the instructions for the user	1.01		0.74
Item 11 - Comprehensibility of medical terms	0.90		0.62
Item 7 - Clarity of the text	0.81		0.61
Item 10 - Description of possible side effects	0.76		0.66
Item 2 - Font type		1.10	0.67
Item 5 - Line spacing		0.86	0.61
Item 4 - Color of the text		0.80	0.61
Item 1 - Font size		0.78	0.34
Item 3 - Layout of the title of the sections		0.70	0.55
Item 9 - Number of sentences in each paragraph		0.57	0.68
Item 8 - Length of the sentences		0.57	0.62
Item 6 - Use of the en-dash throughout the text		0.52	0.55
Eigenvalue	6.74	1.29	-
Total variance explained (%)	56.10	10.76	-

		1 - Mau 2 - Pouco satisfeito 3 - Sem opinião 4 - Satisfeito 5 - Bom
	Como classifica:	Responda de 1 a 5
1.	O tamanho da letra
2.	O tipo de letra
3.	A apresentação dos títulos
4.	A cor do texto
5.	Os espaços entre as linhas
6.	A utilização de listas de informações no texto
7.	A simplicidade da linguagem
8.	O tamanho das frases
9.	O tamanho dos parágrafos
10.	A forma como é dada a informação sobre os efeitos secundários
11.	A simplicidade dos termos médicos
12.	A forma de dar instruções ao doente
13.	A repetição do nome do medicamento ao longo do folheto
14.	A sua satisfação geral com a forma como a informação é dada

Education level	Features of package leaflets - part A
Education level	Active substances	Therapeutic groups	Pharmaceutical presentations	Type of dispensing	Length (words)**	Font size	Font type
0-6 years of schooling	Gelatin (78 mg or 5532 mg) + glycerol (6.5 g)	Drugs altering gut motility	Rectal gel	Over-the-counter	≤ 1,500 (966 words)	7	Arial
	Minoxidil (50 mg/ml)	Topical products for hair loss	Solution	Over-the-counter	> 1,500 (2,220 words)	8	Arial
	Cefatrizine (50 mg/ml)	Antibacterial drugs	Oral suspension powder	Prescription medicine	≤ 1,500 (1,465 words)	8	Arial
	Ipratropium bromide (0.52 mg/2.5 ml) + salbutamol (3 mg/2.5 ml)	Antiasthmatics	Aerosol	Prescription medicine	> 1,500 (1,683 words)	8	Arial
7-12 years of schooling	Povidone-iodine (100 mg/ml)*	Vaginal disinfectant	Solution	Over-the-counter	≤ 1,500 (1,075 words)	6	Arial
	Oxymetazoline (0.5 mg/ml)	Nasal decongestants	Nasal spray	Over-the-counter	> 1,500 (1,714 words)	8	Arial
	Ofloxacin (3 mg/ml)	Topical antibacterials	Ophthalmic drops	Prescription medicine	≤ 1,500 (1,345 words)	8	Other sans serif
	Clomipramine (10/25/75 mg)	Antidepressants	Tablets	Prescription medicine	> 1,500 (2,699 words)	10	Arial
> 12 years of schooling	Choline salicylate (87 mg/g)	Anti-ulcerants	Oral gel	Over-the-counter	≤ 1,500 (924 words)	6	Arial
	Acetylsalicylic acid (400 mg) + ascorbic acid (240 mg)	Analgesic and antipyretics	Effervescent tablets	Over-the-counter	> 1,500 (2,346 words)	7	Arial
	Dexamethasone (1 mg/ml) + neomycin (10 mg/ml) + polymyxin B (10000 IU/ml)	Topical corticosteroids	Optical drops	Prescription medicine	≤ 1,500 (1,056 words)	8	Arial
	Methylprednisolone (40 mg/ml) + lidocaine (10 mg/ml)	Corticosteroids	Parenteral injection	Prescription medicine	> 1,500 (3,487 words)	7	Arial

Education level	Features of package leaflets - part B
Education level	Active substances	Layout of the title	Color	Line Spacing	En-dash‡	Length of sentences (average no. of words)	No. of paragraphs	Abbreviations	Repetition of brand names
0-6 years of schooling	Gelatin + glycerol	Capitalized	Black	≤ 1 pt	1	13.8	15	5	1 ‡‡
	Minoxidil	Capitalized	Black	> 1 pt	6	14.9	54	12	1
	Cefatrizine	Capitalized	Black	> 1 pt	5	14.2	39	12	1
	Ipratropium bromide	Capitalized	Black	> 1 pt	8	17.2	38	4	1
7-12 years of schooling	Povidone-iodine	Not capitalized	Black	> 1 pt	1	12.4	29	1	1
	Oxymetazoline	Not capitalized	Yes	> 1 pt	6	13.5	57	15	0 ‡
	Ofloxacin	Capitalized	Black	> 1 pt	5	14.5	30	1	1
	Clomipramine	Capitalized	Black	> 1 pt	4	17.6	28	16	1
> 12 years of schooling	Choline salicylate	Capitalized	Black	> 1 pt	1	14.7	6	3	1
	Acetylsalicylic acid + ascorbic acid	Capitalized	Yes	> 1 pt	8	14.8	31	16	0
	Dexamethasone + neomycin	Not capitalized	Black	> 1 pt	3	14.7	25	5	1
	Methylprednisolone + lidocaine	Capitalized	Black	> 1 pt	4	16.5	45	5	0

Item	F1 First-order factor	F2 First-order factor	G Second-order factor
Item 1 - Font size	-0.15	0.24	0.51
Item 2 - Font type	-0.19	0.34	0.72
Item 3 - Layout of the title of the sections	0.03	0.22	0.71
Item 4 - Color of the text	-0.15	0.25	0.74
Item 5 - Line spacing	-0.06	0.27	0.73
Item 6 - Use of the en-dash throughout the text	0.14	0.16	0.71
Item 7 - Clarity of the text	0.43	-0.01	0.65
Item 8 - Length of the sentences	0.14	0.18	0.76
Item 9 - Number of sentences in each paragraph	0.16	0.18	0.79
Item 10 - Description of possible side effects	0.41	0.02	0.70
Item 11 - Comprehensibility of medical terms	0.48	-0.04	0.62
Item 12 - Clarity of the instructions for the user	0.55	-0.07	0.66
Variance explained (%)	76.40	18.10	5.50

	Cronbach’s alpha	Ordinal alpha	Mean inter-item correlation	McDonald’s total omega	McDonald’s hierarchical omega
Factor 1 - Clarity and comprehension of text	0.85	0.92	0.58	-
Factor 2 - Format	0.86	0.90	0.45	-
Overall scale score	-	-	0.43	0.93	0.85

[1] Address for correspondence: Carla Pires. Research Center for Biosciences and Health Technologies (CBIOS), Universidade Lusófona, Campo Grande 376, 1749-024 Lisbon, Portugal. Tel. +351 217 515 500. E-mail: p5558@ulusofona.pt

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Validation of a new tool for evaluating subjects’ satisfaction with medicine package leaflets: a cross-sectional descriptive study

ABSTRACT

BACKGROUND:

OBJECTIVE:

DESIGN AND SETTING:

METHODS:

RESULTS:

CONCLUSION: