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Interpretation of consumer's perception on readability of Consumer Medical Information Leaflets on obesity and lipid lowering drugs with standard methods
j o u r n a l o f p h a r m a c y r e s e a r c h 7 ( 2 0 1 3 ) 6 0 6 e6 1 0
Available online at www.sciencedirect.com
journal homepage: www.elsevier.com/locate/jopr
Original Article
Interpretation of consumer’s perception on readability of Consumer Medical Information Leaflets on obesity and lipid lowering drugs with standard methods Elizabeth M. Mathew a,*, Kingston Rajiah b, Krishana Kumar Sharma c a Research Scholar, Shri Venkateshwara University, Department of Pharmacy, NH-24, Rajabpur, Gajraula, J.P.Nagar, Meerut 250001, U.P., India b Lecturer, International Medical University, Kuala Lumpur 57000, Malaysia c Asst. Prof., Bharat Institute Of Technology, School of Pharmacy, Meerut 250001, India
article info
abstract
Article history:
Aim: Printed education materials are often used to augment healthcare professional’s
Received 18 May 2013
verbal information to consumers so it serves as an important component of symptom
Accepted 31 July 2013
management. They also enhance the teaching process and can be used by consumers as a
Available online 19 August 2013
home reference. This study was aimed to interpret consumers’ perception on Consumer Medical Information Leaflets (CMILs) on obesity and lipid lowering drugs, according to the
Keywords:
standard formulae such as Flesch Reading Ease (FRE), FlescheKincaid Grade Level (FK-GL).
Readability
Method: The study was conducted over a period of 3 years in community pharmacy settings
FRE
in Tamil Nadu, India. CMILs were interpreted by using the formulae such as Flesch Reading
FK-GL
Ease (FRE) and FlescheKincaid Grade Level (FK-GL). Among the 1800 consumers, 300 con-
Obesity
sumers were excluded from the study due to lack of interest.
Consumer Medical Information
Results: Data revealed the consumer’s perception on readability of Consumer Medical
Leaflets
Information Leaflets on obesity and lipid lowering drugs based consumers rating. Conclusions: Pharmaceutical companies (leaflets providers) are not taking the reading level of consumers into consideration which may not achieve the intended purpose. There is a need for developing CMILs having good readability score according to Indian set up. Copyright ª 2013, JPR Solutions; Published by Reed Elsevier India Pvt. Ltd. All rights reserved.
1.
Introduction
Consumer Medical Information Leaflets (CMILs) are produced by either manufacturer or pharmacists for the benefit of the patients and are universally accepted as the most important tool to educate the patient about their medications and disease.1
Consumer Medical Information Leaflets are widely used by diverse health organizations and professionals as part of patient education or health promotion efforts, in support of preventive, treatment and compliance objectives.2 Consumers must be given sufficient information; in a way they can understand, to enable them to exercise the right to
* Corresponding author. Tel.: þ91 4634220457. E-mail address: [email protected] (E.M. Mathew). 0974-6943/$ e see front matter Copyright ª 2013, JPR Solutions; Published by Reed Elsevier India Pvt. Ltd. All rights reserved. http://dx.doi.org/10.1016/j.jopr.2013.07.024
607
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make informed decisions about their care.3 The provision of information requires effective communication primarily by discussion. Verbal information is useful if it is provided in manner intelligible to the hearer and at a pace at which the recipient can digest it. Leaflets allow consumers to digest information at their own speed and are a point of reference. Patient information leaflets could therefore provide a valuable contribution to informed consent.4 Printed education materials are often used to augment healthcare professional’s verbal information to consumers so it serves as an important component of symptom management.5 They also enhance the teaching process and can be used by consumers as a home reference. Information that is communicated in a readable and understandable manner helps people to become more knowledgeable about their diagnosis and to be more involved in their treatment plans.6 They are also more likely to initiate selfcare strategies for treatment related symptom relief. Yet none of these outcomes can occur unless consumers are able to read and understand the printed materials given to them.7
2.
Objective
The aim of this study is to interpret consumers’ perception on Consumer Medical Information Leaflets (CMILs) on obesity and lipid lowering drugs, according to the standard formulae such as Flesch Reading Ease (FRE), FlescheKincaid Grade Level (FK-GL).
Table 1 e Interpretation of Flesch Reading Ease score. Reading ease
Description of style
90e100 80e90 70e80 60e70 50e60 30e50 0e30
Very easy Easy Fairly easy Standard Fairly difficult Difficult Very difficult
4. Assessment of readability by FRE, FK-GL methods 4.1.
Flesch Reading Ease (FRE) score8
The Flesch Reading Ease formula has been developed by Flesch in 1948 and it is based on school text covering grade 3e12. It is wide spread, especially in USA, because of good results and simple computation. The index is usually between 0 (hard) and 100 (easy), Standard English documents does not delivers good results because of the different language structure. The higher the score, the easier it is to understand the document. For most standard documents, the score should be approximately 60e70 (see Table 1). FRE score ¼ 206:835 ð1:015 ASLÞ ð84:6 ASWÞ where: ASL ¼ average sentence length (the number of words divided by the number of sentences). ASW ¼ average number of syllables per word (the number of syllables divided by the number of words).
FlescheKincaid Grade Level (FK-GL) score8
3.
Methodology
4.2.
3.1.
Sampling
It rates text on a US grade-school level. For e.g., a score of 8.0 means that an eighth grader can understand the document. For most standard documents, the score should be approximately 7.0e8.0. So it is easy to see that shorter sentence with shorter words lowers the Readability score. Each readability score bases its rating on the average number of syllables per word and words per sentence. Current statistics report that the largest present of the population can only read at a 6the8th grade reading level (see Table 2).
Convenience sampling was done. The study was conducted over a period of 3 years in community pharmacy settings in Tamil Nadu, India. Name and identity card number of study participants were not taken to assure the confidentiality and anonymity of the participants. Study information sheet were shown and verbal consent were obtained from each individual prior to interview who agreed to participate in the study. People who are not interested to give consent for any reason were excluded from this study. Total of 1800 consumers who are using anti-obesity or lipid lowering drugs were interviewed. Among them 1500 consumers agreed to participate in the study while 300 consumers were not interested.
FK GL score ¼ ð0:39 ASLÞ þ ð11:8 ASWÞ 15:59 where: ASL ¼ average sentence length (the number of words divided by the number of sentences). ASW ¼ average number
Table 2 e Conversion table of FRE to an appropriate grade.
3.2.
Study design
The Consumer Medical Information Leaflets (CMILs) were randomly collected from different community pharmacies. Total of 19 CMILs which are commonly used by the consumers were collected and a major portion of the CMILs were selected and readability was analysed by using FRE, FK-GL formulae.
Grade level 5th grade 6th grade 7th grade 8th to 9th grade 10th to 12th grade (high school) 13th to 16th grade (college level) College graduate
FRE 90e100 80e90 70e80 60e70 50e60 30e50 0e30
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Table 3 e FRE scores of Consumer Medical Information Leaflets stratified into level of difficulty.
Table 5 e FK-GL scores of Consumer Medical Information Leaflets stratified into grade.
S. No
S. No
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19
Leaflets
Scores Level of difficulty
LipidManagement (Unichem) Xenical (Roche) Colestyramine Colestid (Pharmacia) Ezetrol (MSD) Lipantil (Solvay) Lescol (Novartis) Questran (Bristol) Benzalip (Roche) Modalim (Sanofi) Reductil (Abbott) Supralip (Solvay) Lopid (Pfizer) Lipitor (Pfizer) Crestor (Astra Zeneca) Lipostat (Squibb) Zocor (MSD) Inegy (MSD) Olbetam (Pharmacia)
27.0 29.4 46.2 37.6 40.6 48.2 38.3 59.6 51.7 57.5 67.5 67.5 64.5 62.6 70.3 70.8 70.5 78.2 76.0
Very difficult Difficult
Fairly difficult
Standard
Fairly easy
of syllables per word (the number of syllables divided by number of words). After the scores are calculated they are interpreted with the help of following tables.
4.3.
Assessment of consumers’ perception on readability
The leaflets which were classified by their difficulty according to the formulae were assigned as a batch. These leaflets were used to assess the perception of the consumers. For this, the consumers were allotted into three different groups with 500 consumers in each. Consumers who can read English were enrolled into the study. Consumers in group 1 got any one of the CMILs rated as difficult according to FRE Score. Consumers in group 2 got any one of the CMILs rated as standard according to FRE score. Consumers in group 3 got any one of the CMILs rated as fairly easy according to FRE score. Consumers were asked to rate the leaflets according to their perception as ‘very difficult’ ‘difficult’ ‘standard’ ‘easy’ and ‘very easy’ for readability.
5.
Results
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19
6.
Leaflets
Scores
Grade
LipidManagement (Unichem) Crestor (Astra Zeneca) Colestid (Pharmacia) Ezetrol (MSD) Lipantil (Solvay) Lescol (Novartis) Questran (Bristol) Benzalip (Roche) Modalim (Sanofi) Reductil (Abbott) Supralip (Solvay) Lopid (Pfizer) Lipitor (Pfizer) Xenical (Roche) Antacids (Pfizer) Lipostat (Squibb) Zocor (MSD) Inegy (MSD) Olbetam (Pharmacia)
5.4 6.4 5.7 6.1 6.4 5.5 7.3 6.6 7.0 8.0 8.5 7.8 9.0 9.4 10.7 11.2 10.5 9.6 10.7
Very easy (5th grade) Easy (6th grade)
Fairly easy (7th grade) Standard (8the9th grade)
Fairly difficult (10th12th grade)
Discussion
According to FRE scores 2 leaflets were classified as ‘very difficult’ as their scores were <30. 5 leaflets were classified as ‘difficult’ as per FRE scores as their scores were in the range of 30e50. 3 leaflets were classified as ‘fairly difficult’ as per FRE scores as their scores were in the range of 50e60. 4 leaflets were classified as ‘standard’ since they had scores in the range of 60e70 as per FRE scores. 5 leaflets were classified as ‘fairly easy’ since they had scores in the range of 70e80 as per FRE scores (see Table 3). On average ‘fairly easy’ leaflets had a mean score of 72.91 2.76, ‘standard’ leaflets had a mean score of 64.86 2.87, ‘fairly difficult’ leaflets had a mean score of 54.96 3.46, ‘difficult’ leaflets had a mean score of 42.98 3.79 and ‘very difficult’ leaflets had a mean score of 28.20 1.20. When subjected to FRE text most of the leaflets 55.82% were found to be as ‘fairly difficult’ or more than that. Only 18.60% were ‘fairly easy’ and none was found to be ‘easy’ or ‘very easy’. This shows CMILs were written at the level of seventh grade or more (see Table 4). According to FK-GL scores one leaflets was classified as ‘very easy’ as their scores was 5th grade. 5 leaflets were
The following table shows the level of difficulty of CMIL according to FRE formula calculation. Table 6 e FK-GL results of Consumer Medical Information Leaflets. Table 4 e FRE results of Consumer Medical Information Leaflets. Sl No 01 02 03 04 05
Interpretation (score range)
No of leaflets
Fairly easy (70e80) Standard (60e70) Fairly difficult (50e60) Difficult (30e50) Very difficult (0e30)
05 04 03 05 02
Mean score with standard deviation 72.91 64.86 54.96 42.98 28.20
2.76 2.87 3.46 3.79 1.20
Sl no
Interpretation (score range)
No of leaflets
01 02 03 04
Very easy (5th grade) Easy (6th grade) Fairly easy (7th grade) Standard (8the9th grade) Fairly difficult (10th e12th grade)
01 05 03 05
05
05
Mean score with standard deviation 5.4 5.97 6.86 8.53
0 0.35 0.25 0.53
10.69 0.78
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Table 7 e Consumers’ perception on readability of difficult Consumer Medical Information Leaflets. Number of consumers 93 107 89 211
Consumers’ rating
Education qualification No. of post graduates
No. of graduates
No. of high school education
70 57 02 02
23 50 78 04
e e 09 207
Very easy Easy Standard Difficult
Table 8 e Consumers’ perception on readability of standard Consumer Medical Information Leaflets. Number of consumers 142 123 178 57
Consumers’ rating
Education qualification No. of post graduates
No. of graduates
No. of high school education
98 45 21 e
44 78 69 02
e e 88 55
Very easy Easy Standard Difficult
classified as ‘easy’ as per FK-GL scores as their scores were in the 6th grade. 3 leaflets were classified as ‘fairly easy’ as per FK-GL scores as their scores were in the 7th grade. 5 leaflets were classified as ‘standard’ since they had scores in the range of 8the9th grade as per FK-GL scores. 5 leaflets were classified as ‘fairly difficult’ since they had scores in the range of 10the12th grade as per FK-GL scores (see Table 5). On average ‘very easy’ leaflet had a mean score of 5.4, ‘easy’ leaflets had a mean score of 5.97 0.35, ‘fairly easy’ leaflets had a mean score of 6.86 0.25, ‘standard’ leaflets had a mean score of 8.53 0.53 and ‘fairly difficult’ leaflets had a mean score of 10.69 0.78 (see Table 6). According to FK-GL score 37.21% of leaflets were assessed to be ‘fairly difficult’ and 27.91% were assessed to be ‘standard’. This shows that companies do not give adequate attention for the importance of readability. This may make the leaflets less comprehensible. This study was well compared with other studies9,10 that fewer leaflets met the criteria of having less than eighth grade level.
6.1. Interpretation of consumers’ perception on readability When ‘difficult’ leaflets were given to 500 consumers (Group 1), 93 consumers felt it was ‘very easy’, 107 consumers rated as ‘easy’, 89 consumers rated as ‘standard’ and 211 consumers rated as ‘difficult’. In this group 129 consumers were post-
graduates, 155 consumers were graduates and 216 consumers completed High school education (see Table 7). When ‘standard’ leaflets were given to 500 consumers (Group 2), 142 consumers felt it was ‘very easy’, 123 consumers rated as ‘easy’, 178 consumers rated as ‘standard’ and 57 consumers rated as ‘difficult’. In this group 164 consumers were post-graduates, 193 consumers were graduates and 143 consumers completed High school education (see Table 8). When ‘fairly easy’ leaflets were given to 500 consumers (Group 3), 196 patient felt it was ‘very easy’, 204 consumers rated as ‘easy’, 48 consumers rated as ‘standard’ and 52 consumers rated as ‘difficult’. In this group 188 consumers were post graduates, 212 consumers were graduates and 100 consumers completed High school education (see Table 9). In India, generally CMILs are continued to be prepared in English and with higher proportion of consumers with English illiteracy. CMILs, which are prepared without taking consideration of reading level of consumers and proper layout and design, may not achieve the intended purpose. This is an important aspect that any company has to reckon while preparing leaflets and at least in some major local languages in which CMILs have to be prepared. For assessing consumers’ perception, consumers were divided into 3 groups. Each group had 500 consumers. The leaflets which were classified by their difficulty according to the formulae were grouped together and given to the consumers. Group 1 was given difficult leaflet. Group 2 was given
Table 9 e Consumers’ perception on readability ‘fairly easy’ Consumer Medical Information Leaflets. Number of consumers 196 204 48 52
Consumers’ rating Very easy Easy Standard Difficult
Education qualification No. of post graduates
No. of graduates
No. of high school education
188 e e e
08 204 e e
e 48 52
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standard leaflet and group 3 was given ‘fairly easy’ leaflet. Consumers randomly picked a leaflet to read it and then rated it. Consumers who can read English were enrolled into the study. It was found that most of the consumers were graduates or having higher qualification. So, most of them could read the level of 8th standard. Only a few consumers with high school qualification found leaflets difficult. It can be observed that consumers with High school education level found it difficult to understand at the level of 7th standard (refer Tables 2 and 9). It is expected that CMIILs need to be written at the level of fifth or sixth standard level to help the consumers with limited reading skill. In our study most of the CMILs assessed by the FRE and FK-GL methods were either eighth standard level or above that. This observation shows that there is a lack of awareness among the providers regarding the readability issues. This highlights the need for development of scales for which will match Indian education levels.
7.
Conclusions
Flesch Reading Ease (FRE) and FlescheKincaid Grade Level (FKGL) methods were used for readability assessment and Baker Able Leaflet Design (BALD) method was used for assessing layout and designing. When consumers’ perceptions were assessed for readability, most of them were graduates and could read the CMILs tested. But with consumers of high school level could not read the CMILs tested. Consumer perception on readability and layout and design reflected the need for improvement of CMILs in these aspects. Consumers were not satisfied with the layout and design of the leaflets tested. Readability scores showed by the standard methods did not match the perception of the consumers studied. This is because the consumers were either highly qualified like graduates or with high school level education who cannot read English properly. Consumers with college level education only can understand the CMILs provided by pharmaceutical companies. This study concludes that many of the pharmaceutical companies (leaflets providers) are not taking the reading level of consumers into consideration which may not achieve the intended purpose. There is a need for developing CMILs having good readability score according to Indian set up. The
companies should also look for the possible ways to produce leaflets in national language of the country.
Conflicts of interest All authors have none to declare.
references
1. Kumaran Arul, yohannan Julie, John Jijie, Sivnandi Palanisamy, Jacob Shaise. Development and implementation of patient information leaflet on hypertension and to assess its effectiveness. Int J PharmTech Res. 2009;1(3):712e719. 2. Gal Iddo, Prigat Ayelet. Why organizations continue to create patient information leaflets with readability and usability problems: an exploratory study. Health Education Res. 2005;20(4):485e493. 3. Clerehan Rosemary, Buchbinder Rachelle, Moodie Jane. A linguistic framework for assessing the quality of written patient information: its use in assessing methotrexate information for rheumatoid arthritis. Health Education Res. 2005;20(3):334e344. 4. Ferguson Ruth. Communication skills. In: Parthasarathi G, Nyfort-Hansen Karin, Nahata Milap C, eds. A Textbook of Clinical Pharmacy Practice. 1st ed. India: Orient Longman; 2004:32. 5. Brown H, Ramchandani M, Gillow JT, Tsaloumas MD. Are patient information leaflets contributing to informed consent for cataract surgery? J Med Ethics. 2004;30:218e220. 6. Wallace Lorraine Silver, Lennon Elizabeth S. American Academy of Family Physicians patient education materials: can consumers read them? Fam Med. 2004;36(8):571e574. 7. Coulter Angela. Evidence based patient information. BMJ. 1998 July 25;317(7153):225e226. 8. Ahmed Osman H, Sullivan S John, Schneiders Anthony G, McCrory Paul R. Concussion information online: evaluation of information quality, content and readability of concussionrelated websites. Br J Sports Med. 2012;46(9):675e683. 9. Adepu Ramesh, Nagavi BG. Assessment of readability, layout and design of selected patient information leaflets. Indian J Pharm Educ. 2004;38(2):93e97. 10. Smith Craig R, Smith Carol A. Patient education information: readability of prosthetic publications. J Prosthetics Orthotists. 1994;6(4):113e118.
Available online at www.sciencedirect.com
journal homepage: www.elsevier.com/locate/jopr
Original Article
Interpretation of consumer’s perception on readability of Consumer Medical Information Leaflets on obesity and lipid lowering drugs with standard methods Elizabeth M. Mathew a,*, Kingston Rajiah b, Krishana Kumar Sharma c a Research Scholar, Shri Venkateshwara University, Department of Pharmacy, NH-24, Rajabpur, Gajraula, J.P.Nagar, Meerut 250001, U.P., India b Lecturer, International Medical University, Kuala Lumpur 57000, Malaysia c Asst. Prof., Bharat Institute Of Technology, School of Pharmacy, Meerut 250001, India
article info
abstract
Article history:
Aim: Printed education materials are often used to augment healthcare professional’s
Received 18 May 2013
verbal information to consumers so it serves as an important component of symptom
Accepted 31 July 2013
management. They also enhance the teaching process and can be used by consumers as a
Available online 19 August 2013
home reference. This study was aimed to interpret consumers’ perception on Consumer Medical Information Leaflets (CMILs) on obesity and lipid lowering drugs, according to the
Keywords:
standard formulae such as Flesch Reading Ease (FRE), FlescheKincaid Grade Level (FK-GL).
Readability
Method: The study was conducted over a period of 3 years in community pharmacy settings
FRE
in Tamil Nadu, India. CMILs were interpreted by using the formulae such as Flesch Reading
FK-GL
Ease (FRE) and FlescheKincaid Grade Level (FK-GL). Among the 1800 consumers, 300 con-
Obesity
sumers were excluded from the study due to lack of interest.
Consumer Medical Information
Results: Data revealed the consumer’s perception on readability of Consumer Medical
Leaflets
Information Leaflets on obesity and lipid lowering drugs based consumers rating. Conclusions: Pharmaceutical companies (leaflets providers) are not taking the reading level of consumers into consideration which may not achieve the intended purpose. There is a need for developing CMILs having good readability score according to Indian set up. Copyright ª 2013, JPR Solutions; Published by Reed Elsevier India Pvt. Ltd. All rights reserved.
1.
Introduction
Consumer Medical Information Leaflets (CMILs) are produced by either manufacturer or pharmacists for the benefit of the patients and are universally accepted as the most important tool to educate the patient about their medications and disease.1
Consumer Medical Information Leaflets are widely used by diverse health organizations and professionals as part of patient education or health promotion efforts, in support of preventive, treatment and compliance objectives.2 Consumers must be given sufficient information; in a way they can understand, to enable them to exercise the right to
* Corresponding author. Tel.: þ91 4634220457. E-mail address: [email protected] (E.M. Mathew). 0974-6943/$ e see front matter Copyright ª 2013, JPR Solutions; Published by Reed Elsevier India Pvt. Ltd. All rights reserved. http://dx.doi.org/10.1016/j.jopr.2013.07.024
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j o u r n a l o f p h a r m a c y r e s e a r c h 7 ( 2 0 1 3 ) 6 0 6 e6 1 0
make informed decisions about their care.3 The provision of information requires effective communication primarily by discussion. Verbal information is useful if it is provided in manner intelligible to the hearer and at a pace at which the recipient can digest it. Leaflets allow consumers to digest information at their own speed and are a point of reference. Patient information leaflets could therefore provide a valuable contribution to informed consent.4 Printed education materials are often used to augment healthcare professional’s verbal information to consumers so it serves as an important component of symptom management.5 They also enhance the teaching process and can be used by consumers as a home reference. Information that is communicated in a readable and understandable manner helps people to become more knowledgeable about their diagnosis and to be more involved in their treatment plans.6 They are also more likely to initiate selfcare strategies for treatment related symptom relief. Yet none of these outcomes can occur unless consumers are able to read and understand the printed materials given to them.7
2.
Objective
The aim of this study is to interpret consumers’ perception on Consumer Medical Information Leaflets (CMILs) on obesity and lipid lowering drugs, according to the standard formulae such as Flesch Reading Ease (FRE), FlescheKincaid Grade Level (FK-GL).
Table 1 e Interpretation of Flesch Reading Ease score. Reading ease
Description of style
90e100 80e90 70e80 60e70 50e60 30e50 0e30
Very easy Easy Fairly easy Standard Fairly difficult Difficult Very difficult
4. Assessment of readability by FRE, FK-GL methods 4.1.
Flesch Reading Ease (FRE) score8
The Flesch Reading Ease formula has been developed by Flesch in 1948 and it is based on school text covering grade 3e12. It is wide spread, especially in USA, because of good results and simple computation. The index is usually between 0 (hard) and 100 (easy), Standard English documents does not delivers good results because of the different language structure. The higher the score, the easier it is to understand the document. For most standard documents, the score should be approximately 60e70 (see Table 1). FRE score ¼ 206:835 ð1:015 ASLÞ ð84:6 ASWÞ where: ASL ¼ average sentence length (the number of words divided by the number of sentences). ASW ¼ average number of syllables per word (the number of syllables divided by the number of words).
FlescheKincaid Grade Level (FK-GL) score8
3.
Methodology
4.2.
3.1.
Sampling
It rates text on a US grade-school level. For e.g., a score of 8.0 means that an eighth grader can understand the document. For most standard documents, the score should be approximately 7.0e8.0. So it is easy to see that shorter sentence with shorter words lowers the Readability score. Each readability score bases its rating on the average number of syllables per word and words per sentence. Current statistics report that the largest present of the population can only read at a 6the8th grade reading level (see Table 2).
Convenience sampling was done. The study was conducted over a period of 3 years in community pharmacy settings in Tamil Nadu, India. Name and identity card number of study participants were not taken to assure the confidentiality and anonymity of the participants. Study information sheet were shown and verbal consent were obtained from each individual prior to interview who agreed to participate in the study. People who are not interested to give consent for any reason were excluded from this study. Total of 1800 consumers who are using anti-obesity or lipid lowering drugs were interviewed. Among them 1500 consumers agreed to participate in the study while 300 consumers were not interested.
FK GL score ¼ ð0:39 ASLÞ þ ð11:8 ASWÞ 15:59 where: ASL ¼ average sentence length (the number of words divided by the number of sentences). ASW ¼ average number
Table 2 e Conversion table of FRE to an appropriate grade.
3.2.
Study design
The Consumer Medical Information Leaflets (CMILs) were randomly collected from different community pharmacies. Total of 19 CMILs which are commonly used by the consumers were collected and a major portion of the CMILs were selected and readability was analysed by using FRE, FK-GL formulae.
Grade level 5th grade 6th grade 7th grade 8th to 9th grade 10th to 12th grade (high school) 13th to 16th grade (college level) College graduate
FRE 90e100 80e90 70e80 60e70 50e60 30e50 0e30
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Table 3 e FRE scores of Consumer Medical Information Leaflets stratified into level of difficulty.
Table 5 e FK-GL scores of Consumer Medical Information Leaflets stratified into grade.
S. No
S. No
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19
Leaflets
Scores Level of difficulty
LipidManagement (Unichem) Xenical (Roche) Colestyramine Colestid (Pharmacia) Ezetrol (MSD) Lipantil (Solvay) Lescol (Novartis) Questran (Bristol) Benzalip (Roche) Modalim (Sanofi) Reductil (Abbott) Supralip (Solvay) Lopid (Pfizer) Lipitor (Pfizer) Crestor (Astra Zeneca) Lipostat (Squibb) Zocor (MSD) Inegy (MSD) Olbetam (Pharmacia)
27.0 29.4 46.2 37.6 40.6 48.2 38.3 59.6 51.7 57.5 67.5 67.5 64.5 62.6 70.3 70.8 70.5 78.2 76.0
Very difficult Difficult
Fairly difficult
Standard
Fairly easy
of syllables per word (the number of syllables divided by number of words). After the scores are calculated they are interpreted with the help of following tables.
4.3.
Assessment of consumers’ perception on readability
The leaflets which were classified by their difficulty according to the formulae were assigned as a batch. These leaflets were used to assess the perception of the consumers. For this, the consumers were allotted into three different groups with 500 consumers in each. Consumers who can read English were enrolled into the study. Consumers in group 1 got any one of the CMILs rated as difficult according to FRE Score. Consumers in group 2 got any one of the CMILs rated as standard according to FRE score. Consumers in group 3 got any one of the CMILs rated as fairly easy according to FRE score. Consumers were asked to rate the leaflets according to their perception as ‘very difficult’ ‘difficult’ ‘standard’ ‘easy’ and ‘very easy’ for readability.
5.
Results
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19
6.
Leaflets
Scores
Grade
LipidManagement (Unichem) Crestor (Astra Zeneca) Colestid (Pharmacia) Ezetrol (MSD) Lipantil (Solvay) Lescol (Novartis) Questran (Bristol) Benzalip (Roche) Modalim (Sanofi) Reductil (Abbott) Supralip (Solvay) Lopid (Pfizer) Lipitor (Pfizer) Xenical (Roche) Antacids (Pfizer) Lipostat (Squibb) Zocor (MSD) Inegy (MSD) Olbetam (Pharmacia)
5.4 6.4 5.7 6.1 6.4 5.5 7.3 6.6 7.0 8.0 8.5 7.8 9.0 9.4 10.7 11.2 10.5 9.6 10.7
Very easy (5th grade) Easy (6th grade)
Fairly easy (7th grade) Standard (8the9th grade)
Fairly difficult (10th12th grade)
Discussion
According to FRE scores 2 leaflets were classified as ‘very difficult’ as their scores were <30. 5 leaflets were classified as ‘difficult’ as per FRE scores as their scores were in the range of 30e50. 3 leaflets were classified as ‘fairly difficult’ as per FRE scores as their scores were in the range of 50e60. 4 leaflets were classified as ‘standard’ since they had scores in the range of 60e70 as per FRE scores. 5 leaflets were classified as ‘fairly easy’ since they had scores in the range of 70e80 as per FRE scores (see Table 3). On average ‘fairly easy’ leaflets had a mean score of 72.91 2.76, ‘standard’ leaflets had a mean score of 64.86 2.87, ‘fairly difficult’ leaflets had a mean score of 54.96 3.46, ‘difficult’ leaflets had a mean score of 42.98 3.79 and ‘very difficult’ leaflets had a mean score of 28.20 1.20. When subjected to FRE text most of the leaflets 55.82% were found to be as ‘fairly difficult’ or more than that. Only 18.60% were ‘fairly easy’ and none was found to be ‘easy’ or ‘very easy’. This shows CMILs were written at the level of seventh grade or more (see Table 4). According to FK-GL scores one leaflets was classified as ‘very easy’ as their scores was 5th grade. 5 leaflets were
The following table shows the level of difficulty of CMIL according to FRE formula calculation. Table 6 e FK-GL results of Consumer Medical Information Leaflets. Table 4 e FRE results of Consumer Medical Information Leaflets. Sl No 01 02 03 04 05
Interpretation (score range)
No of leaflets
Fairly easy (70e80) Standard (60e70) Fairly difficult (50e60) Difficult (30e50) Very difficult (0e30)
05 04 03 05 02
Mean score with standard deviation 72.91 64.86 54.96 42.98 28.20
2.76 2.87 3.46 3.79 1.20
Sl no
Interpretation (score range)
No of leaflets
01 02 03 04
Very easy (5th grade) Easy (6th grade) Fairly easy (7th grade) Standard (8the9th grade) Fairly difficult (10th e12th grade)
01 05 03 05
05
05
Mean score with standard deviation 5.4 5.97 6.86 8.53
0 0.35 0.25 0.53
10.69 0.78
609
j o u r n a l o f p h a r m a c y r e s e a r c h 7 ( 2 0 1 3 ) 6 0 6 e6 1 0
Table 7 e Consumers’ perception on readability of difficult Consumer Medical Information Leaflets. Number of consumers 93 107 89 211
Consumers’ rating
Education qualification No. of post graduates
No. of graduates
No. of high school education
70 57 02 02
23 50 78 04
e e 09 207
Very easy Easy Standard Difficult
Table 8 e Consumers’ perception on readability of standard Consumer Medical Information Leaflets. Number of consumers 142 123 178 57
Consumers’ rating
Education qualification No. of post graduates
No. of graduates
No. of high school education
98 45 21 e
44 78 69 02
e e 88 55
Very easy Easy Standard Difficult
classified as ‘easy’ as per FK-GL scores as their scores were in the 6th grade. 3 leaflets were classified as ‘fairly easy’ as per FK-GL scores as their scores were in the 7th grade. 5 leaflets were classified as ‘standard’ since they had scores in the range of 8the9th grade as per FK-GL scores. 5 leaflets were classified as ‘fairly difficult’ since they had scores in the range of 10the12th grade as per FK-GL scores (see Table 5). On average ‘very easy’ leaflet had a mean score of 5.4, ‘easy’ leaflets had a mean score of 5.97 0.35, ‘fairly easy’ leaflets had a mean score of 6.86 0.25, ‘standard’ leaflets had a mean score of 8.53 0.53 and ‘fairly difficult’ leaflets had a mean score of 10.69 0.78 (see Table 6). According to FK-GL score 37.21% of leaflets were assessed to be ‘fairly difficult’ and 27.91% were assessed to be ‘standard’. This shows that companies do not give adequate attention for the importance of readability. This may make the leaflets less comprehensible. This study was well compared with other studies9,10 that fewer leaflets met the criteria of having less than eighth grade level.
6.1. Interpretation of consumers’ perception on readability When ‘difficult’ leaflets were given to 500 consumers (Group 1), 93 consumers felt it was ‘very easy’, 107 consumers rated as ‘easy’, 89 consumers rated as ‘standard’ and 211 consumers rated as ‘difficult’. In this group 129 consumers were post-
graduates, 155 consumers were graduates and 216 consumers completed High school education (see Table 7). When ‘standard’ leaflets were given to 500 consumers (Group 2), 142 consumers felt it was ‘very easy’, 123 consumers rated as ‘easy’, 178 consumers rated as ‘standard’ and 57 consumers rated as ‘difficult’. In this group 164 consumers were post-graduates, 193 consumers were graduates and 143 consumers completed High school education (see Table 8). When ‘fairly easy’ leaflets were given to 500 consumers (Group 3), 196 patient felt it was ‘very easy’, 204 consumers rated as ‘easy’, 48 consumers rated as ‘standard’ and 52 consumers rated as ‘difficult’. In this group 188 consumers were post graduates, 212 consumers were graduates and 100 consumers completed High school education (see Table 9). In India, generally CMILs are continued to be prepared in English and with higher proportion of consumers with English illiteracy. CMILs, which are prepared without taking consideration of reading level of consumers and proper layout and design, may not achieve the intended purpose. This is an important aspect that any company has to reckon while preparing leaflets and at least in some major local languages in which CMILs have to be prepared. For assessing consumers’ perception, consumers were divided into 3 groups. Each group had 500 consumers. The leaflets which were classified by their difficulty according to the formulae were grouped together and given to the consumers. Group 1 was given difficult leaflet. Group 2 was given
Table 9 e Consumers’ perception on readability ‘fairly easy’ Consumer Medical Information Leaflets. Number of consumers 196 204 48 52
Consumers’ rating Very easy Easy Standard Difficult
Education qualification No. of post graduates
No. of graduates
No. of high school education
188 e e e
08 204 e e
e 48 52
610
j o u r n a l o f p h a r m a c y r e s e a r c h 7 ( 2 0 1 3 ) 6 0 6 e6 1 0
standard leaflet and group 3 was given ‘fairly easy’ leaflet. Consumers randomly picked a leaflet to read it and then rated it. Consumers who can read English were enrolled into the study. It was found that most of the consumers were graduates or having higher qualification. So, most of them could read the level of 8th standard. Only a few consumers with high school qualification found leaflets difficult. It can be observed that consumers with High school education level found it difficult to understand at the level of 7th standard (refer Tables 2 and 9). It is expected that CMIILs need to be written at the level of fifth or sixth standard level to help the consumers with limited reading skill. In our study most of the CMILs assessed by the FRE and FK-GL methods were either eighth standard level or above that. This observation shows that there is a lack of awareness among the providers regarding the readability issues. This highlights the need for development of scales for which will match Indian education levels.
7.
Conclusions
Flesch Reading Ease (FRE) and FlescheKincaid Grade Level (FKGL) methods were used for readability assessment and Baker Able Leaflet Design (BALD) method was used for assessing layout and designing. When consumers’ perceptions were assessed for readability, most of them were graduates and could read the CMILs tested. But with consumers of high school level could not read the CMILs tested. Consumer perception on readability and layout and design reflected the need for improvement of CMILs in these aspects. Consumers were not satisfied with the layout and design of the leaflets tested. Readability scores showed by the standard methods did not match the perception of the consumers studied. This is because the consumers were either highly qualified like graduates or with high school level education who cannot read English properly. Consumers with college level education only can understand the CMILs provided by pharmaceutical companies. This study concludes that many of the pharmaceutical companies (leaflets providers) are not taking the reading level of consumers into consideration which may not achieve the intended purpose. There is a need for developing CMILs having good readability score according to Indian set up. The
companies should also look for the possible ways to produce leaflets in national language of the country.
Conflicts of interest All authors have none to declare.
references
1. Kumaran Arul, yohannan Julie, John Jijie, Sivnandi Palanisamy, Jacob Shaise. Development and implementation of patient information leaflet on hypertension and to assess its effectiveness. Int J PharmTech Res. 2009;1(3):712e719. 2. Gal Iddo, Prigat Ayelet. Why organizations continue to create patient information leaflets with readability and usability problems: an exploratory study. Health Education Res. 2005;20(4):485e493. 3. Clerehan Rosemary, Buchbinder Rachelle, Moodie Jane. A linguistic framework for assessing the quality of written patient information: its use in assessing methotrexate information for rheumatoid arthritis. Health Education Res. 2005;20(3):334e344. 4. Ferguson Ruth. Communication skills. In: Parthasarathi G, Nyfort-Hansen Karin, Nahata Milap C, eds. A Textbook of Clinical Pharmacy Practice. 1st ed. India: Orient Longman; 2004:32. 5. Brown H, Ramchandani M, Gillow JT, Tsaloumas MD. Are patient information leaflets contributing to informed consent for cataract surgery? J Med Ethics. 2004;30:218e220. 6. Wallace Lorraine Silver, Lennon Elizabeth S. American Academy of Family Physicians patient education materials: can consumers read them? Fam Med. 2004;36(8):571e574. 7. Coulter Angela. Evidence based patient information. BMJ. 1998 July 25;317(7153):225e226. 8. Ahmed Osman H, Sullivan S John, Schneiders Anthony G, McCrory Paul R. Concussion information online: evaluation of information quality, content and readability of concussionrelated websites. Br J Sports Med. 2012;46(9):675e683. 9. Adepu Ramesh, Nagavi BG. Assessment of readability, layout and design of selected patient information leaflets. Indian J Pharm Educ. 2004;38(2):93e97. 10. Smith Craig R, Smith Carol A. Patient education information: readability of prosthetic publications. J Prosthetics Orthotists. 1994;6(4):113e118.