Abstract
Background and Aims:
It is essential that patients posted for day-care surgeries are adequately prepared preoperatively. Verbal information alone may not be always effective. This study aimed to prepare, validate, and evaluate the efficacy of a patient information leaflet (PIL) for patients undergoing day-care surgeries under general anesthesia (GA).
Material and Methods:
After approval from the hospital ethics committee a PIL was prepared in English. Readability and design of the leaflet were checked using standard tests: Flesch readability ease test (FRE), Flesch Kincaid grade level (FKGL), and Baker Able leaflet design (BALD). It was translated into three regional languages. The PIL was tested among patients using a questionnaire. Seventy-nine adult patients posted for elective day-care procedures were included while emergency surgeries were excluded. Patient knowledge pre and post-PIL was compared using paired 't' test. The influence of age, gender, and education level on the usefulness of PIL were analyzed using the Chi-square test and knowledge was compared using ANOVA.
Results:
The English leaflet had an FRE Score of 63.9 and FKGL of 6.4, which is “standard“. The BALD score for all leaflets was 25 (“above standard“). The overall knowledge scores significantly improved from 52.6% (preintervention) to 70.7% (postintervention), P < 0.001. Knowledge improvement was seen with the use of PIL in all four languages. Sixty eight percent of patients strongly recommended the PIL while 31% were willing to recommend it to others.
Conclusion:
The PILs developed in this study have standard readability, good design and validated for efficacy.
Keywords: Day-care surgery, health education, patient education handout, patient information leaflet
Introduction
Over the last few decades, there has been a surge in day-care surgeries. Developed countries conduct a large proportion of their surgeries as day-care procedures; 80% of surgeries in USA and 75% of surgeries in UK are day-care surgeries.[1,2] In India, this number was reported as around 20% in the last decade and is on a steep rise.[3] The key to successful functioning of a day-care surgery unit is proper patient selection and preparation, which needs good patient education.[4]
Providing information is the central focus of the patient's educational activities.[5] Patients often complain about the difficulty of obtaining enough and reliable information.[5] Information leaflets are inexpensive, and an effective means of providing information to patients. Leaflets allow patients to digest information at their own speed and are a point of reference at any time.
Our hospital is a tertiary referral center that caters to around 8000 major surgeries annually and 4000 day-care procedures on the surgical site. These cases include diagnostic procedures such as direct laryngoscopies, evaluation under anesthesia, and other minor surgical procedures including biopsies and secondary suturing. In majority of the cases, the preanesthetic checkup is done shortly before undertaking the procedure in the minor OT complex.[6] These patients receive verbal instructions from surgeons in the surgical outpatient department (OPD). It is not unusual to find that patients, due to lack of information, are not adequately prepared including oral intake as per accepted guidelines. This results in cancellation which further leads to patient distress and decreases the efficiency of the day-care complex.
With this background in mind, we felt the unmet need to prepare a patient information leaflet (PIL). The aim of the study was to prepare an information leaflet containing essential perioperative instructions for patients posted for elective day-care surgeries under general anesthesia (GA), to be given by the surgeons in their OPDs, on scheduling a patient for a day-care procedure under anesthesia. The primary objective was to validate the PIL in terms of content, readability, layout, and translate to regional languages. A secondary objective was to evaluate the PIL among patients.
Material and Methods
After approval by the institutional review board, (IEC/0916/1735/001), the study was conducted from September 2016 to November 2016. The study was done in two parts: firstly, preparation of the leaflet (including content preparation, validation, and translation [both forward and backward]), secondly by evaluation of leaflet among patients to test its efficacy.
Using standard textbooks,[7,8] internet resources (PubMed/Medline, Google scholar), and latest guidelines[9,10] available, a PIL was prepared for all adult patients undergoing elective day-care surgery under GA at our day-care center. The leaflet contained relevant information that any patient undergoing GA is expected to know prior to surgery and included preoperative instructions, postoperative instructions, and a few of the expected adverse effects and alerts postprocedure.
The validation of PIL was done based on the Delphi technique. An initial draft was based on available literature and current recommendations. Institution specific instructions were added to it. The leaflet was then circulated among a team comprising of senior anesthesiologists, who gave their feedback for suitable addition and deletion. Changes in the leaflet were incorporated based on the feedback and a final draft was prepared.
Readability of our English PIL was checked online by using the website www.readabilityscore.com.[11] This website employs a battery of readability tests to evaluate the ease of reading of a document and assigns every document a readability score. Readability scores are a reflection of the reading level of a document and are based on the average number of syllables per word and the average number of words per sentence. Documents with a good readability score can be read by a majority of the population. The most commonly used tests are the Flesch Reading Ease (FRE), and the Flesch–Kincaid Grade Level (FKGL).[12,13]
The leaflet layout was designed using the Baker Able leaflets design (BALD) method.[14] The BALD score is based on several parameters such as length and separation between lines, type and color of the font used, white space, and so on. We used the tools as described above to modify the leaflet until we got the best possible score.
Being a tertiary referral center, the hospital caters to patients from all parts of India. Hence, an English leaflet alone would be impractical to meet the needs of all our patients. Translation to all regional languages is a mammoth task, and hence we restricted to four languages (English, Hindi, Marathi, and Bengali) based on current patient population trends, so as to include around 95% of our patient population. After preparing the English version, the leaflet was translated into Marathi, Hindi, and Bengali by professional linguistic experts. All the translated copies were then back-translated into English by independent experts in the respective language. The original English leaflet and the back-translated English leaflet were then compared and altered by another group of volunteers to ensure that there is no relevant change in the meaning of the two versions.
An initial evaluation in patients was done to calculate sample size for the validation, to study the effect of PIL on patients' knowledge, and to collect feedback about PIL. All adult patients undergoing any day-care procedure under GA were included; written informed consent was obtained from all the participating patients. Exclusion criteria included patients unwilling to take part, emergency surgeries, those undergone similar procedure on a prior occasion, and inability on the part of patients as well as accompanying persons to read and write.
Evaluation in patients was carried out in two phases.
Phase 1 (User testing for sample size calculation): A knowledge-based questionnaire was prepared by a group of senior anesthesiologists. The questionnaire consisted of 12 questions to be answered either as true or false or don't know, refer Annexure 1. It was translated into Hindi, Marathi, and Bengali by experts. The questions were based on the common knowledge that any layman undergoing the surgery under GA was expected to know. Eight patients per language group (total 32) were selected were included after informed consent, using simple random sampling technique. The questionnaire was administered to these patients to assess baseline knowledge. After answering the questionnaire, the patients were provided with the PIL (intervention) and they were allowed 15 min to go through it. The PIL included an information leaflet spread over four sides of a folded A4 size sheet of paper, refer Annexure 2-5. Basic instructions that need to be followed by patients before minor procedures under GA were included. It also had information regarding what the patient should bring on the day of the procedure and what would happen in the procedure room. A few postprocedure instructions and possible side effects after the procedure were also mentioned. Patients were readministered the same questionnaire to assess the knowledge postintervention. In addition, three questions focused on patient's feedback about the PIL and willingness to recommend to others on Likert scales, refer Annexure 1. In case of illiterate patients, the questionnaire was filled by the accompanying attendant in consultation with the patient after reading out the PIL to them. User testing scores pre and postinterventions were calculated using the following formula.[15] Based on the user testing scores the sample size for phase 2 was calculated.
Sample size calculation:
The sample size for phase 2 was calculated based on the response improvement in patients' knowledge as found in phase 1 using standard formula[15]
Za is 1.96 (for α = 5%), Z1-β is 0.84 (for 80% power), and σ is the mean of the standard deviations of both groups (derived from pre and postintervention user testing scores), △ is the minimum significant difference of user testing score of both groups (pre and postintervention).
Phase 2 (evaluation in patients): A total of 79 consenting patients were included in this phase, as per sample size calculation, this included 18 patients for English, 30 for Hindi, 20 for Marathi, and 11 for Bengali. The same knowledge-based questionnaire was administered to patients before and 15 min after reading the PIL. In addition, all patients were given a feedback form at the end to collect their opinion about the leaflet. Knowledge scores pre and postintervention were assessed based on the number of correct responses given by the patients to the questions asked in the questionnaire using the formula as below:
Data collected in phase 2 included sociodemographic parameters (age, gender, and education level), response to the knowledge-based questionnaire, patient's opinion about PIL, patient's willingness to recommend the PIL to others. Patient knowledge pre and post-PIL was compared using paired 't' test; Correlation between age and knowledge score was done using Pearson's correlation test, while the association with gender and education was compared using ANOVA. The influence of age, gender, and education level on usefulness of PIL were analyzed using Chi-square. The analysis was performed using statistical software (IBM SPSS Statistics for Windows, Version 20.0. Armonk, NY: IBM Corp.).
Results
Four leaflets were designed in English, Hindi, Marathi, and Bengali. The average reading time of the PIL was 3.5 min. The English leaflet has an FRE score of 63.9 and FKGL of 6.4. All 4 versions of the leaflet have a BALD score of 25 each.
A total of 79 patients took part in the patient evaluation of PIL. The majority were men (69.6%) and belonged to the age group 45–59 years (50.6%), refer Table 1. Thirty patients (38%) were illiterate, and among these patients, the information leaflets were provided to their attendants.
Table 1.
Sociodemographic details of patients included in the evaluation phase
| Variable | n | % | |
|---|---|---|---|
| Age group (years) | Mean±SD | 49.2±11.9 | |
| 18-44 | 25 | 31.7% | |
| 45-59 | 40 | 50.6% | |
| 60 and above | 14 | 17.7% | |
| Sex | Male | 55 | 69.6% |
| Female | 24 | 30.4% | |
| Person filing the form | Patient | 35 | 44.3% |
| Attendant | 44 | 55.7% | |
| Education level of patients | Illiterate | 30 | 37.9% |
| School | 29 | 36.7% | |
| Undergraduates | 13 | 16.5% | |
| Post graduates | 7 | 8.9% | |
The overall knowledge scores significantly improved from 52.6% (preintervention) to 70.7% (postintervention), P < 0. 001. An improvement in knowledge was seen with the use of the PIL in all four languages (P < 0.001), refer Figure 1. We did not find any association between age and change in knowledge scores (P = 0.47). The results of ANOVA between influence of gender and education status with knowledge scores are elaborated in Table 2. Comparisons using post hoc tests revealed that illiterate/school-educated patients had a significantly lower pre-PIL score as compared to graduates/postgraduates (P-value < 0.001). An improvement in knowledge was seen across all groups.
Figure 1.
Knowledge based scores presented as per various languages of patient information leaflet. (PIL) Pre and post PIL scores were compared using a paired t-test. P <0.001 for all languages.
Table 2.
Influence of patient information leaflet on knowledge scores
| Variable | PRE-PIL Score | Post- PIL | Change in score | |
|---|---|---|---|---|
| Gender Mean scores |
Male | 52.4 | 70.1 | 17.7 |
| Female | 53.1 | 72.2 | 19.1 | |
| P for ANOVA | 0.9 | 0.6 | 0.5 | |
| Education | Illiterate | 47.5 | 68.1 | 20.6 |
| Primary Education | 45.1 | 63.7 | 18.6 | |
| Secondary Education | 67.3 | 80.7 | 13.4 | |
| Higher Education | 78.5 | 92.8 | 14.3 | |
| P for ANOVA | <0.001 | <0.001 | 0.03 | |
PIL=patient information leaflet P<0.05- significant
With respect to an opinion about the PIL, around 67% patients rated the leaflets very good, 28% rated it good, and the rest 5% rated it average. Nearly 48% of patients found it very easy to read, 39% found it easy to read, and 13% found it average. Around 68% of patients strongly recommended the PIL, 31% were willing to recommend it to others while one percent of the patient were neutral about the same. There was no association between age (P = 0.77), gender (P = 0.59), education (P = 0.59), and usefulness of PIL.
Discussion
The leaflets prepared in this study met the standard acceptable criteria as revealed by readability scores (applicable to English leaflet only), and BALD score. On patient evaluation, a positive change in knowledge scores was seen with leaflets in all four languages.
Current literature on patient information leaflets is mainly for chronic conditions.[16,17,18,19,20,21,22] There is a paucity of well-validated leaflets to prepare patients for surgical procedures especially day-care procedures. Hence, we undertook this study.
The English leaflet was validated by numerous tests/indices that are available to assess the readability of a leaflet.[12] Standard readability scales such as FRE, FK grade level has not been applied to other languages. Hence, to ensure the quality of the leaflet user testing and evaluation among the target population was carried out, using knowledge-based questionnaires.
It is important to understand the influence of patient factors such as age, education, and gender on patients' knowledge. We did not find any significant association between age and gender on the patients' knowledge both pre and postintervention. As regards education level, the PIL had an FK grade of 6.4, suggesting ease of reading for a sixth-grader or above (US grade level).[12] This has been widely used in studies across the globe including several Indian studies.[15,16,17,18,19,20,21,22] A significant proportion of patients in this study were illiterate and needed help from accompanying relatives to respond to the feedback form. A low preintervention knowledge score was seen in this group suggesting an inadequate information delivery or reluctance to discuss with the primary doctors in the outpatient department in contrast to higher baseline knowledge amongst the educated patients. Nevertheless, a positive increase in patients' knowledge was seen with the use of PIL, reinforcing the need for such information leaflets.
The optimum time and place of administration of leaflets can be debated.[23] We selected patients present in the day-care center to accurately capture baseline knowledge post counseling by respective units. As the average reading time of the PIL was 3.5 min, we gave patients an adequate 15 min to read and reply to the post-PIL knowledge-based questionnaire.
This study has certain limitations. Our PIL focused on some useful instructions and a few basic side effects postprocedure. Most of our patients were planned for diagnostic procedures and had different disease profiles which were from different disease management groups, thus information about disease or its management was not incorporated. Information was restricted to anesthetic concerns with respect to day-care surgeries. Some information in the PIL like collection of reports are specific to our institute and can be easily modified if needed. The study includes only adult patients planned for discharge on the same day; children and indoor patients were excluded from the study. The leaflet is available in only four languages; this may not cover all the population in a diverse country like India, however based on our experience it would cater to 95% of our patients.
Although this study looked at patient's knowledge improvement, a significant contribution from the accompanying relative in answering the questionnaire cannot be ruled out. Hence, the knowledge improvement seen in this study is not restricted to the patient but includes the caregivers as well. However, the results are encouraging because in a country like our patients' caregivers have a substantial role in ensuring compliance with medical instructions.
An information leaflet ineffective if both the patient as well as the accompanying person are illiterate. Video communication in waiting areas may be a suitable alternative for these patients. Nevertheless, PIL does have an important role in patient satisfaction and the impact of this leaflet on the functioning of a busy day-care center is being assessed in another study. (ClinicalTrials.govPRS NCT03011840).
Conclusion
The PILs developed in this study have standard readability and good design. The positive feedback and improvement of patients' knowledge validate the PIL with respect to its efficacy.
Financial support and sponsorship
By Department of Anaesthesia, Critical Care and Pain, Tata Memorial Hospital and Homi Bhabha National Institute, Mumbai, India.
Conflicts of interest
There are no conflicts of interest.
Annexure
Annexure 1: Knowledge-Based Questionnaire
Patient's Age____________ Gender ________________
The education level of patient: (please tick highest qualification)
Illiterate/school/graduate/postgraduate
Are you filling this questionnaire for □ self or □ on behalf of the patient?
if so please tick your qualification: school/graduate/post-graduate?
Please tick/ encircle the most suitable answers for the following questions*
The patient should not eat or drink anything on the day of surgery.
Agree/Disagree/Don't know
Blood pressure (BP) tablet should be taken on the morning of surgery.
Agree/Disagree/Don't know
Smoking is allowed on the day of surgery.
Agree/Disagree/Don't know
Patient Identity band should be removed before entering the OT.
Agree/Disagree/Don't know
The patient should bring all the medicines that he takes regularly with him to the day-care complex.
Agree/Disagree/Don't know
After surgery patient will be kept under observation for some time.
Agree/Disagree/Don't know
The artificial denture should be removed before entering OT.
Agree/Disagree/Don't know
All reports including ECG will be available over hospital's computers.
Agree/Disagree/Don't know
Past medical records are not necessary before surgery.
Agree/Disagree/Don't know
Diabetes tablets can be taken on the morning of surgery.
Agree/Disagree/Don't know
Nausea and Vomiting are common after general anesthesia.
Agree/Disagree/Don't know
In case of any breathing difficulty after surgery, the patient should contact the hospital (casualty) immediately.
Agree/Disagree/Don't know
What is your opinion about the leaflet?
Very Good/Good/Average/Bad/Very Bad
Do you think this leaflet is easy to understand?
Very easy/Easy/Average/Slightly difficult/Very difficult
Would you recommend this leaflet to others?
Strongly recommend/Will Recommend/Neutral/Recommend reluctantly/Not recommend at all
Would you like to add any additional information to the leaflet?
(The above 4 questions were included in the post PIL feedback only.
* The right answers for the first twelve questions appear in bold.)
Annexure 2: Patient information leaflet in English ( Enclosed copy is a four paged leaflet and appears in the following order Page 4-1-2-3)
Annexure 3: Patient Information leaflet in Hindi ( Enclosed copy is a four paged leaflet and appears in the following order Page 4-1-2-3)
Annexure 4: Patient Information leaflet in Marathi ( Enclosed copy is a four paged leaflet and appears in the following order Page 4-1-2-3)
Annexure 5: Patient information leaflet in Bengali ( Enclosed copy is a four paged leaflet and appears in the following order Page 4-1-2-3)
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