The Evaluation and Effectiveness of Regional Language Patient Information Leaflets for Persons with Chronic Kidney Disease

Abstract

Objectives: The objective of this study was to develop Chronic Kidney Disease Patient Information Leaflets (CKD-PILs) to test their understandability and assess their usefulness. Materials and Methods: Prospective observational research was carried out in a dialysis unit at renowned medical care for 9 months and 140 CKD patients enrolled in the study to evaluate prepared CKD-PILs. Patient Information Leaflets (PILs) is prepared by referring to various medical database and it's evaluated using computer-aided readability tools using the website "http://r eadabilityscore.com". Afterward, PIL was translated into a regional language and verified by a subject expert. The design and layout were analyzed using BADL criteria and user option tests. Results: Prepared CKD-PILs found to be good design and layout as per BALD and user opinion (BALD Assamese: 27, BALD English: 28; User opinion: 82.7% for Assamese PILs and 89.2% for English PILs). The mean scores on the knowledge evaluated using user testing methods and Disease management and lifestyle-related knowledge increased from 49.08±4.16 to 80.40±5.71 (p<0.001) and is statistically significant. Conclusion: The results showed significant improvement of their lifestyle and disease-related knowledge after the implementation of PILs. The Prepared CKD-based patient information leaflets have been found to be a good and effective educational tool for CKD patients.

Full text

Int. J. Pharm. Investigation., 2023; 13(2):359-366.
https://www.jpionline.org Original Article
International Journal of Pharmaceutical Investigation, Vol 13, Issue 2, Apr-Jun, 2023 359
DOI: 10.5530/ijpi.13.2.046
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The Evaluation and Eectiveness of Regional Language
Patient Information Leaets for Persons with Chronic
Kidney Disease
Ruhul Amin, Biplab Kumar Dey, Faruk Alam*
Faculty of Pharmaceutical Science, Assam Down Town University, Panikhaiti, Guwahati, Assam, INDIA.
ABSTRACT
Objectives: The objective of this study was to develop Chronic Kidney Disease Patient
Information Leaets (CKD-PILs) to test their understandability and assess their usefulness.
Materials and Methods: Prospective observational research was carried out in a dialysis unit
at renowned medical care for 9 months and 140 CKD patients enrolled in the study to evaluate
prepared CKD-PILs. Patient Information Leaets (PILs) is prepared by referring to various medical
database and it’s evaluated using computer-aided readability tools using the website “http://r
eadabilityscore.com”. Afterward, PIL was translated into a regional language and veried by a
subject expert. The design and layout were analyzed using BADL criteria and user option tests.
Results: Prepared CKD-PILs found to be good design and layout as per BALD and user opinion
(BALD Assamese: 27, BALD English: 28; User opinion: 82.7% for Assamese PILs and 89.2% for
English PILs). The mean scores on the knowledge evaluated using user testing methods and
Disease management and lifestyle-related knowledge increased from 49.08±4.16 to 80.40±5.71
(p<0.001) and is statistically signicant. Conclusion: The results showed signicant improvement
of their lifestyle and disease-related knowledge after the implementation of PILs. The Prepared
CKD-based patient information leaets have been found to be a good and eective educational
tool for CKD patients.
Keywords: Pharmaceutical care, Patient Information Leaets (PILs), Hemodialysis (HD), Chronic
kidney disease, BALD, CKD-PILs.
INTRODUCTION
Drug-related problems may be eectively managed via the
use of pharmaceutical care programmers (interventions that
oen include assessing the appropriateness of the treatment,
reconciling, and fostering adherence).1,2 Patients with chronic
kidney disease who are not properly educated and who do not
strictly stick to their prescribed treatment regimen have poor
health outcomes. Most patients will forget maximum of the
information what their doctors told them over the conversation.3
Knowledge preservation via the usage of printed materials would
be very helpful. PILs are popular toolsthat advise patients and
users about medications, illnesses, and healthy habits.4,5 PILs may
be used to improve health classes. PILs are particularly helpful
for patients who are dealing with long-term health issues such
diabetes, hypertension, asthma, and COPD.6,7 PILs are oen
written in English. Despite the widespread habit of translating
PILs into Indian languages, readability cannot be assessed
by conventional measures. Patients should be asked for their
feedback on PILs to determine acceptability and usability.8
Chronic Kidney Disease (CKD)is dened as a decline in renal
function (estimated glomerular ltration rate decreased to 60
mL/min/1.73 m2) or the development of symptoms of kidney
damage (albuminuria 3 mg/mmol or abnormalities in urine
volumes) that have adverse health eects.9,10 e estimated
850 million persons with CKD make it the 9th greatest cause of
mortality worldwide. Dialysis or kidney transplantation helped
2.6 million Americans with ESKD in 2010, and that number is
expected to rise to 5.4 million by 2030.11 ere is an increasing
nancial burden on governments, particularly in developing
countries, due to the prevalence of Chronic Kidney Disease
(CKD).12 us, chronic kidney disease has been recognized
as a non-communicable condition deserving of urgent global
attention.New infections with COVID-19 and death rates were
found to be higher in persons with CKD.13 Pharmacists are among
the frontline healthcare providers providing essential services
during this epidemic and health calamity. Patients undergoing
hemodialysis for end-stage renal failure typically take 12 drugs
and suer from 6 co-occurring medical conditions.14 To prevent
Received: 28-11-2022;
Revised: 07-12-2022;
Accepted: 04-01-2023.
Correspondence:
Dr. Faruk Alam
Associate Professor, Faculty of
Pharmaceutical Science, Assam Down
Town University, Panikhaiti, Guwahati,
Assam-781026, INDIA.
Email: faruk_2007a@redimail.com;
faruk.alam@adtu.in

Amin, et al.: Patient Information Leaets for Chronic Kidney Disease and its Usefulness
International Journal of Pharmaceutical Investigation, Vol 13, Issue 2, Apr-Jun, 2023360
gra rejection and subsequent high medical expenditures,
patients who have undergone organ transplantation are needed to
take many drugs.15 Many people on dialysis have issues with their
medications. e objective of this study was to develop Chronic
Kidney Disease Patient Information Leaets (CKD-PILs) to test
their understandability and assess the usefulness of CKD-PILs.
MATERIALS AND METHODS
Study design
Prospective observational research was carried out in a dialysis
unit at a renowned medical Center from 4th October 2021 to
19th July 2022 (9-Months). e human ethics committee at the
university has approved this study (Approval no: AdtU/Ethics/
PhD scholar/2021/010). 140 CKD patients agreed to take part in
the research. Patient’s ages, sex, and ethnicities were documented.
It was decided not to include participants who had mental or
learning diculties. Block randomization methods are used
to select participate from each group. Detail of the participant
recruitment process is shown in Figure 1.
CONSORT Flow Diagram
Sample Size
e sample size was generated using the following method based
on the change in patient awareness of user-testing scores from
baseline to post-intervention scores.
n=
(
 Z 1−
α
_
2 + Z 1−β
)
2 σ 2
_
d 2
+ 2
σ=12, Z 1−
α
_
2  is 1.96 (for α=5%)
Z 1−β is 0.84 for power and d=5.
σ is the mean of the two groups standard deviation
d is the minimum signicant dierence between the two groups.
e minimum sample required for this study is 47.
P-PILs preparation, validation, and translation
e patient information leaets were prepared using by referring
primary, secondary, and tertiary sources. e tertiary resources
included textbooks on the nutritional value of Indian foods,
pharmacotherapy textbooks, National Kidney Foundation
guidelines, Kidney Disease Outcomes Quality Initiative Clinical
Practice guidelines, Indian Association of Nephrology guidelines,
and publications from the National Kidney Disease Education
Program and the Renal Nutrition Forum.17-19 Main materials
included many CKD articles, while secondary resources included
databases like Micromedex, Up-to-date, Medscape, Medline,
and Web MD. e leaet's content and illustrations were double
checked by a panel of experts consisting of 2 nephrologists
and 4 academic pharmacists. PIL utilizing layout and design
components were evaluated by Baker Able Leaets Design
(BALD) criteria, and three adjustments were made according to
the expert committee's instructions and readability score.20 e
nal version of English PILs were translated into Assamese using
a three-stage process consisting of forward translation, reverse
translation, and patient testing.
Readability testing of P-PILs
Each modication of the PILs resulted in an increase in the
readability as measured by the Coleman-Liau Index (CLI), Flesch
Reading-Ease (FRE), Flesch-Kincaid Grade Level (FK-GL) and
Automated Readability Index (ARI) scale factors. is readability
score was obtained by using website “http://readabilityscore.
com”. e user-testing questionnaire was used to evaluate the
readability of the translated CKD-PILs. 10 multiple-choice
questions were developed using the information presented in
the brochure for this round of user testing. e readability and
validity of the survey were both examined. Patients in group were
given a questionnaire during user testing to determine their base
level of understanding of CKD, and then the leaet was given
to each participated patient. Aerwards, patients were given
the same questionnaire to reassess their knowledge; this time,
however, they were given 20 min to read. On satised the result,
the translated PILs is administered to clinical study groups. A
formula was used to assess participant participation and results.
ResponseEvaluation = Totalnumberofcorrectresposespatient
_________________________________
Totalnumberofactualresponses × 100
Following the knowledge evaluation, patients were asked for
their thoughts on the PILscontent, layout, and design using a
4-question rating form with a 5-1 scale. Here are how the results
should be interpreted Table 1:
User-testing and user-opinion testing using
questionnaire
Prior to collecting patient feedback, we made our questionnaire
for user testing and user opinion testing was valid and reliable by
subgroup of patient’s. An advisory panel veried the accuracy of
the user feedback survey. Test the reliability opinion for prepared
PILs caried out in a sub sample of 15randomly chosen CKD
patients enrolled in two groups (Assamese group and English
group) and the test conducted for day. Aer statistics analysis of
subgroup the same questionnaire are used to evaluate the nal
PILs.
Statistical Analysis
Among a sample of CKD patient demographic data was
summarized using descriptive statistics, and pre ad post test
scores for Assamese group and English group user data were
calculated using a paired student t-test, with a p< 0.05 indicating
statistical signicance. IBM-SPSS version 21 soware was used to
analyze data.

Amin, et al.: Patient Information Leaets for Chronic Kidney Disease and its Usefulness
International Journal of Pharmaceutical Investigation, Vol 13, Issue 2, Apr-Jun, 2023 361
RESULTS
Patient demographic data
ere were 165 people in total receiving pharmacological
treatment for CKD. ere was total of 140 patients screened and
were enrolled in the research, 25 patients exclude from the study
out of 8 patients not meeting inclusion criteria and 17 patients
declined to participate at initial screening. e demographic and
physiological data of 140 patients was recorded in a standard
form. Later from the study groups 2 patients lost follow in
Assamese PILs group and 1 patient volunteer withdrawal from
English group (Figure 1). Following permission from hospital
administration, 68 patients were chosen for Assamese PILs, and
69 patients were chosen for English PILs validation. We gave
CKD-PILs to the patients aer obtained inform concern from
all the participants. e selection of the patient’s summaries in
Figure 1. During patient selection, we prioritized a ratio of male
to female patients (56.4% male and 43.6% female). Most patients
had completed undergraduate education and were of intermediate
socioeconomic background (41.8% male and 39.2% female).
Table 2 shows the outcomes of the patient’s socio-demographic
information, and Table 3 describes the patient physiological
variations.
Readability test
Readability of prepared English CKD-PILs was assed using
website http://readabilityscore.com,21 and modied accordingly.
Readability result of prepared PILs displayed in Figure 2.
Readability opinion for Assamese and English
version of PILs
Readability opinion on design and content carried out in
subsample of 30 patients (15 patients were evaluated using the
Assamese version of the questionnaire, while the remaining
15 were evaluated using the English form of CKD-PILs). Both
questionnaires had high levels of dependability, with ICCs
ranging from 0.83 to 0.98. Results for both the Assamese and
English versions are reported, with their corresponding ICC
reliability values, 95% condence intervals, mean, and standard
deviations Table 4.
Design and layout assessment of PILs
Evaluation of the design and layout according to the BALD
(Baker's Able Leaet Design) Criteria. Aer three rounds of
revisions, the nal CKD-PILs BALD evaluation scores for the
English and Assamese versions of the leaet were 28 and 27,
respectively. Figure 3 shows the PILs score.
User-testing PILs
Patients were given the PILs brochure as per the CONSORT Flow
Diagram (Figure 1). e total patient data analyzed aer dropped
out is 68 for Assamese CKD-PILs user and 69 for English CKD-
PILs user. e mean scores on the knowledge evaluation used in
the user testing increased from 48.74±4.63 to 78.22±6.21 (p<0.001)
in Assamese PILs user and 49.43±3.68 to 82.57±4.23 (p<0.001)
English PILs user. e overall mean knowledge improve was
49.08±4.16 to 80.40±5.71 (p<0.001). Table 5 provides a summary
of the results of user testing conducted on both the Assamese and
English versions of leaets. Leaets were well received by their
target audiences, with positive ratings for both readability and
substance (Assamese=84.3% and English=82.9%). Tabulated in
Table 6 below are summaries of the comprehensive user-opinion
rating ratings for the Assamese and English versions of leaets.
DISCUSSION
is study is the rst of its kind to be conducted in north-east
India on patients with CKD. Patient information leaets have
been studied in the past for a variety of medical conditions like
Chronic Obstructive Pulmonary Disease (COPD), diabetes,
hypertension, diabetic foot ulcer, rheumatoid arthritis, asthma,
peptic ulcer, and Tuberculosis (TB) for their eectiveness in
patient care.22-26 Similar kind of study conducted on HD patients
in southern part of India and they found P-PILs are very eective
tools for patients education.27 Health literacy and adoption of
the COVID-19 vaccination might be enhanced using readability
assessments and the subsequent analysis of written materials.28
To improve treatment and medication adherence and decrease
Figure 1: CONSORT Flow Diagram for patient recruitment.16
Content of the CKD-PILs Score Range
Good 14-20
Average 9-14
Poor Less than 9
Table 1: Table for Response evaluation of CKD-PILs content.

Amin, et al.: Patient Information Leaets for Chronic Kidney Disease and its Usefulness
International Journal of Pharmaceutical Investigation, Vol 13, Issue 2, Apr-Jun, 2023362
health-risk behaviours, it is important to pay attention to patient
and leaet aspects that impact understanding of information
in the PILs.29 Patients should rst consult their neighbourhood
pharmacy for guidance on treating common illnesses. Patients
may self-manage symptoms and evaluate the need for additional
assistance with the use of the patient information sheet on common
infections, which should be used in primary care and community
pharmacies.30 User testing is the most reliable approach for
determining whether leaets, in any language, are easily readable.
e readability determined using formulae can only be used to
the English version leaets and readability of other language
leaets was until unknown. Readability formulas discovered
in the west were applied to Indian languages, although it was
uncertain whether they were legitimate or readable. In addition
to user testing, the research also gathered feedback from actual
people who had used the leaets. Most of the existing studies did
not examine the user-opinion on the leaets which the current
research tried since they are one of the essential stakeholders in
patient education. According to the ndings of the research, over
82% of patients regarded the substance, readability, and design
of the leaets as satisfactory. It has been determined that the
dependability of the current research in terms of user-testing and
user-opinion of the questionnaire is excellent, and it is regarded
as being very dependable.
Category Sex
Male (n=56.4%) Female (n=43.6%)
Count Column N % Count Column N %
Education Postgraduate 5 6.3% 1 1.6%
Undergraduate 50 63.3% 35 57.4%
12th Pass 24 30.4% 25 41.0%
10th Pass 0 0.0% 0 0.0%
PhD 0 0.0% 0 0.0%
Socio-economic Upper 28 35.4% 29 47.5%
Middle 33 41.8% 24 39.3%
Lower 18 22.8% 8 13.1%
DM Ye s 33 41.8% 43 70.5%
No 46 58.2% 18 29.5%
HTN Ye s 55 69.6% 43 70.5%
No 24 30.4% 18 29.5%
Anemia No 9 11.4% 6 9.8%
Mild anemia 28 35.4% 20 32.8%
Moderate anemia 42 53.2% 35 57.4%
Severe anemia 0 0.0% 0 0.0%
Table 2: Demography of the patient enrolled in the study.
Category Sex
Male Female
Mean Standard Deviation Mean Standard Deviation
Pre-HD-Weight 54.90 7.68 58.61 9.07
Post-HD-Weight 53.43 7.55 57.32 8.84
Pre-HD-Systolic-BP 149 13 157 13
Post-HD-Systolic-BP 141 19 155 22
Pre-HD-Diastolic-BP 80 7 80 6
Post-HD-Diastolic-BP 76 4 78 4
HD-Time (Hr.) 3.928 .253 3.689 .450
Hemoglobulin level 10.51 1.12 9.48 1.05
Table 3: HD related physiological changes.

Amin, et al.: Patient Information Leaets for Chronic Kidney Disease and its Usefulness
International Journal of Pharmaceutical Investigation, Vol 13, Issue 2, Apr-Jun, 2023 363
Figure 2: Readability score of prepared CKD-PILs.
User opinion
readability
responses
Mean ±SD (D1) Mean± SD (D7) Mean dierence ±
SD
ICC 95% CI P-value
Assamese (N15) 15.83± 1.48 16.17±1.77 0.34±2.35 0.93 0.86-0.98 P=0.047*
English
(N15)
15.97±1.92 16.23±1.86 0.25±2.6 0.95 0.83-0.97 P=0.038*
*p value is less than 0.05 is statistically signicant.
Table 4: Readability pilot test for Assamese and English version of CKD-PILs content.
Languages Pre-test
Mean ±SD*
Post-test
Mean ±SD*
Mean dierence ± SD,
(range)
95% CI P-value
Assamese
(N68)
48.74±4.63 78.22±6.21 29.48+5.55(23,24) 31.39-27.57 p<0.001
(Signicant)
English
(N69)
49.43±3.68 82.57±4.23 33.14+1.63(14,17) 33.7-32.5 p<0.001
(Signicant)
Overall (N137) 49.08±4.16 80.40±5.71 31.31+4.46(23-25) 32.37-30.25 p<0.001
(Signicant)
*SD: Standard division
Table 5: PILs user-testing scores of Assamese and English version.

Amin, et al.: Patient Information Leaets for Chronic Kidney Disease and its Usefulness
International Journal of Pharmaceutical Investigation, Vol 13, Issue 2, Apr-Jun, 2023364
Figure 3: PILs score after 3 modied version.
Language Count Percentage %
Assamese (n=68) Good 62 82.7
Average 6 8.0
Poor 7 9.3
Total 75 100.0
English (n=69) Good 58 89.2
Average 4 6.2
Poor 3 4.6
Total 65 100.0
Table 6: User rating of Prepared PIL.
e post-intervention CKD-PILs knowledge-based user-testing
scores increased signicantly from the baseline scores (49.08 ±
4.16) to the post-intervention values (80.40 ± 5.71) with a p<0.001.
e overall content of PILs consider to be highly readable as per
user rating and consider to be good (82.7% for Assamese PILs and
89.2% for English PILs). Leiia and Ros's (2003) investigation on
the impact of pictograms in PILs on participants' memorization
found similar advantages.31 Drug memory improved dramatically
between pre-and post-intervention PIL studies conducted in
a community pharmacy, from 30% to 65%. As reported by
Carina et al., (1996).32 Evidence suggests that students' ability to
correctly identify drug indications and side eects can improve
by as much as 67% when they receive both traditional classroom
instruction and PIL. Studies with similar designs have shown
that patient information leaets had a signicant impact on
patients' knowledge, attitudes, and practices regarding diabetes,
hypertension, asthma, COPD, peptic ulcer, and rheumatoid
arthritis.22-24,26,33,34
CONCLUSION
Patients’ education is integral part of pharmaceutical care. e
present study showed signicant improvement in knowledge
levels aer reading the prepared CKD-PILs of Assamese and
English version of leaets. Patients also rated the leaets content

Amin, et al.: Patient Information Leaets for Chronic Kidney Disease and its Usefulness
International Journal of Pharmaceutical Investigation, Vol 13, Issue 2, Apr-Jun, 2023 365
are found to be readable (82.7% for Assamese PILs and 89.2%
for English PILs). PILs design of each language was good as
per user opinion and BALD criteria. e Prepared CKD-based
patient information leaets have been found to be an eective
educational tool for patients.
ACKNOWLEDGEMENT
e authors would like to thank the Faculty of Pharmaceutical
Sciences, Assam Down Town University, Downtown hospitals
management for their assistance. e authors would like to express
their gratitude to Dr. N. N. Dutta (CMD), Assam Down Town
University, for providing a digital resource. We also appreciate the
owner of the domain 'http://readabilityscore.com' and the creator
of the readability formula and BALD grading system for their
assist with our project.
CONFLICT OF INTEREST
e authors declare that there is no conict of interest.
ABBREVIATIONS
BALD: Baker's Able Leaet Design; COPD: Chronic obstructive
pulmonary disease; CKD: Chronic kidney disease; CONSORT:
Consolidated Standards of Reporting Trials; PILs: Patient
Information Leaets; HD: Haemodialysis.
Ethical Approval Statement
e human ethics committee (approval no: AdtU/Ethics/PhD
scholar/2021/010).
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Cite this article: Amin R. The Evaluation and Eectiveness of Regional Language Patient Information Leaets for Persons with Chronic Kidney Disease.. Int. J.
Pharm. Investigation. 2023;13(2):359-66.