Patient Information Leaflet for a given chronic disease / disorder

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Introduction of Patient Information Leaflet

A Patient Information Leaflet (PIL) is a document provided with medication or medical products to inform patients about their prescription, over-the-counter drugs, or medical devices. The purpose of the Patient Information Leaflet is to provide essential information regarding the medication or device in a clear and understandable format. It serves to educate patients about the product, its uses, potential side effects, dosage instructions, and other relevant safety information.

Here’s a breakdown of what a typical Patient Information Leaflet might contain:

  1. Introduction: The leaflet usually starts with a brief introduction, outlining its purpose and encouraging patients to read it carefully before using the medication or device.
  2. Product Description: This section provides details about the medication or medical device, including its brand name, generic name, active ingredients, and what it is used for.
  3. Indications and Uses: It explains the medical conditions or symptoms that the medication or device is intended to treat or manage.
  4. Dosage and Administration: This section outlines the recommended dosage, frequency of use, and instructions on how to administer the medication or use the device correctly.
  5. Warnings and Precautions: Important safety information is provided here, including potential side effects, interactions with other medications or substances, and precautions to be taken while using the product.
  6. Contraindications: This section lists situations or conditions in which the medication or device should not be used due to potential risks.
  7. Adverse Reactions: It details potential side effects that may occur while using the medication or device and what actions to take if they occur.
  8. Storage and Handling: Instructions on how to store the medication or device properly to maintain its effectiveness and safety.
  9. Expiration Date: Information on the expiry date of the product and what to do with it after it has expired.
  10. Manufacturer Information: Details about the company that manufactures or distributes the medication or device, including contact information for reporting adverse reactions or seeking further assistance.
  11. Additional Information: Sometimes, additional details such as clinical trial information, references, or resources for further reading may be included.

The Patient Information Leaflet plays a crucial role in empowering patients to make informed decisions about their healthcare and to use medications or medical devices safely and effectively. It serves as a valuable tool for promoting patient safety and improving health outcomes.

Abstract

A patient information leaflet is an educational material for educating patients regarding a disease, medications and lifestyle modifications for better care. The present study aimed at preparing, validating and user-testing of diabetes and hypertension information leaflets in different languages among patients. The patient information leaflets on diabetes and hypertension were prepared by referring to the primary, secondary and tertiary resources. The content of the leaflet was validated by an expert committee. The readability of leaflets has been assessed by Flesch Reading Ease and Flesch-Kincaid Grade Level scores using MS Office 2007.

The patient information leaflets were translated into Kannada and Malayalam languages with the help of language experts. During the user-testing, baseline knowledge was assessed before providing the patient information leaflet followed by provision of leaflets to the patients. After allowing the patients to read the leaflet for a period of 20 min, patients have again been administered with a set of questions to assess their knowledge. The Flesch Reading Ease and Flesch-Kincaid Grade Level readability scores achieved for diabetes leaflets are 70.4 and Flesch-Kincaid Grade Level score achieved is 6.3 and for hypertension leaflets, the Flesch Reading Ease score is 68.3 and Flesch-Kincaid Grade Level score achieved is 6.9.

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User testing of the patient information leaflets on diabetes and hypertension in different languages have been carried out on 40 each diabetic and hypertensive patients using knowledge based questionnaire. Knowledge assessment after providing patient information leaflet, the mean scores have significantly risen from 44.80 to 87.99 and 63.19 to 90.13 with p<0.0001, respectively in diabetes and hypertensive patients. It showed that patient education added with a well-designed patient information leaflet has a greater impact on knowledge of the patients towards their disease management, so that the medication adherence is improved.

Patient information leaflet (PIL) is an educational material for conveying patient education regarding disease, medications and lifestyle modifications for better patient outcomes. A PIL is a legal document included in every medicine package to present written information about the medication use. Patient education is one of the major management strategies for curing or preventing the progression of many chronic diseases. Patient information leaflet are the best-utilized tools for the patients with chronic disorders such as diabetes, hypertension (HTN), asthma, chronic obstructive pulmonary disease, and rheumatoid arthritis.

Materials and Methods

He present study has been conducted for a period of eight months between August 2014 and March 2015 at a tertiary health care hospital in south Karnataka. Approval of the Institutional Ethics Committee (Ref. no. IEC 503/2014) has been obtained prior to the initiation of the study.


Preparation, validation, and translation of PILs on diabetes and HTN

Patient information leaflet were prepared for diabetes and HTN diseases and common drugs used for the treatment by referring primary, secondary and tertiary resources. The content of the leaflet includes information on diabetes/ HTN such as definition, risk factors, normal values of blood sugar level/blood pressure, complications, dietary requirements, exercise, lifestyle modifications and controlling blood sugar levels/blood pressure to overcome further complications and the information of commonly prescribed medications.

The content of the PIL was validated by an expert committee consisting of a physician and four academic pharmacists. The changes were affected as per the directions of the expert committee and the leaflet has been prepared accordingly. Prepared PILs were assessed for Flesch Reading Ease (FRE) and Flesch-Kincaid Grade Level (FK-GL) scores by using MS Office 2007. Readability of the leaflets as per FRE and FK-GL depends on the use of polysyllables, sentence length. Taking these issues into consideration, certain modifications were made in the leaflet in order to improve the scores of the leaflet.

The score between 60 and 70 is largely considered acceptable. The following scale is used to assess the ease of readability in a document. Very easy (90-100), easy (80-89), fairly easy (70-79), standard (60-69), fairly difficult (50-59), difficult (30-49) and very confusing (0-29).

Readability testing of PILs on the patients

Readability testing of Patient information leaflet on diabetes and HTN was performed on diabetic and hypertensive patients, who visited outpatient medical department of the hospital during the study period. Patients with minimum primary educational background have been selected from the three outpatient medicine units. The inclusion criterion was based on the patients who were diagnosed with diabetes and HTN more than 18 year of age with a written informed consent. The demographic details such as age, gender, and educational status, the length of disease, prescribed medications, and social habits of the all the included patients were documented in patient profile form.

Statistical analysis

Descriptive statistics was used to summarize the data and the user-testing data of baseline and after 20 min, scores were calculated by using paired student t-test with a p-value less than 0.05 considered as statistically significant. Data were analysed using SPSS version 15 software.

Results and Discussion

Patient information leaflet on diabetes, HTN and related medications were prepared in English version according to the guidelines. The prepared PILs were validated with the expert committee. After validation, the PILs were assessed for readability by FRE and FK-GL scores, and layout and design using BALD. The Patient information leaflet were then translated into Kannada and Malayalam languages with the help of language experts. The translated Patient information leaflet is validated with the experts and modifications have affected according to their suggestions. The final version of diabetes and HTN Patient information leaflet in English, Kannada and Malayalam languages was assessed for user-testing in patients with diabetes and HTN.

After the preparation of English version of diabetes and HTN PIL, The Patient information leaflet readability was assessed by using FRE and FK-GL scores. After the assessment of readability scores, to improve the scores, the leaflets were modified and readability scores were assessed, which have recorded improvement after each modification. The final FRE score achieved was 70.4 and FK-GL score achieved was 6.3 for diabetes Patient information leaflet and both the scores, rates the diabetes leaflet as ‘fairly easy’. The final FRE score achieved for HTN PIL was 68.3 and FK-GL score achieved was 6.9 and both the scores rate the HTN leaflet as ‘standard’.

Conclusion

Patient information leaflets can contribute to better patient understanding of chronic disease and its treatment. Information leaflets developed by pharmacists can play an important role in improving patient understanding not just of medications, but of disease conditions. It was also observed that pharmacist provided patient education together with information leaflets had a significant (p<0.05) impact on knowledge, attitude, and practice of the patients towards their disease management. The developed leaflets were found to be very useful by patients.

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