Understood? Evaluating the readability and understandability of intranasal corticosteroid delivery instructions Intranasal Steroid Readability/Understandability

Abstract

Background

Allergic rhinitis is a widespread disease that has significant quality-of-life ramifications. Symptoms include rhinorrhea, nasal obstruction, cough, and post-nasal drip. Intranasal corticosteroids are a hallmark of treatment of allergic rhinitis. However, the benefits of treatment are dependent on correct nasal spray technique of which many patients are not aware. Patient instructions are included with the purchase of these medications. The readability and understandability for these educational materials has been minimally assessed in the medical literature. The aim of this study is to evaluate the readability and understandability of commonly used intranasal steroids.

Methods

Three readability measures (Gunning Fog, Simple Measure of Gobbledygook (SMOG), and FORCAST) and an understandability assessment (Patient Education Materials Assessment Tool for Printable Materials (PEMAT-P)) were used to evaluate the instructions for use of commonly prescribed intranasal steroids. Instructions with 6^th grade readability level or lower were considered to meet health literacy experts’ recommendations. Higher understandability values correlate to easier understandability.

Results

Instructions for ten intranasal corticosteroid brands were reviewed. Gunning Fog consistently estimated easiest readability, whereas FORCAST most difficult. 20% of analyzed instructions met National Institutes of Health and health literacy experts’ recommended reading levels. Understandability of instructions ranged from 33% to 90%, with an average of 66%.

Conclusion

The benefit of intranasal corticosteroids is contingent on correct use by patients. However, the pre-packaged instructions provided are most often above recommended reading levels and are difficult to understand. Future development of intranasal steroid instructions should meet recommended readability levels and be understandable to maximize their utility.

Introduction

Allergic rhinitis (AR) is an inflammatory, IgE-mediated disease resulting from an interaction of the immune system and inhaled allergens. This reaction is marked by a constellation of symptoms including rhinorrhea, nasal obstruction, cough, and post-nasal drip.^1,2,3 AR is one of the most common diseases in the United States affecting an estimated 15 to 30% of the population and has severe quality of life consequences for those affected.⁴ The disease burden also has significant financial and economic ramifications with high treatment costs and missed workdays.⁵ It is estimated to cost as much as two to five billion dollars annually in healthcare-related expenditures as well as two to four billion dollars annually in lost productivity.³

One of the first-line treatments of AR is intranasal corticosteroids.⁶ These are nasal sprays that inhibit the inflammatory cells and pro-inflammatory signaling that leads to the disease manifestation.⁷ Through the use of intranasal corticosteroids, there has been shown a decreased level of histamine, leukotrienes, and mast cells in the nasal mucosa of allergic rhinitis patients treated with these medications.⁸ This treatment has been proven to be the most effective single treatment for the symptoms of the disease, with a good safety profile.^{9,10,11,12,13} However, the efficacy of this treatment modality may, in fact, be dependent on correct utilization of the nasal spray. A review by Benninger et al describes essential steps for administration of intranasal corticosteroid: shake spray, blow the nose, point the end of the nozzle outwards and away from the nasal septum, squirt spray in the nose while breathing in, and breathing out through mouth.¹⁴ Further, the head should be held in a neutral position to maximize administration into the nasal mucosa.¹⁴ However, studies have demonstrated that many patients have suboptimal technique, preventing appropriate intranasal distribution of the medication.^15,16

Many patients express frustration with intranasal steroid therapy as they sometimes feel no benefit from treatment.¹⁷ Though the medication itself may be ineffective, the suboptimal technique that patients demonstrate may also drive the non-improvement of symptoms. While, these medications include pre-packaged inserts that describe the required steps for correct use, poor administration technique may be correlated with the readability and understandability of these instructions. The average reading level of an American adult is that of an eighth grader and only 12% of Americans have proficient health literacy.^18,19 As low health literacy is correlated with poor health outcomes, the National Institutes of Health (NIH) and other health organizations recommend the publication of healthcare-related information at or below the sixth grade level.^{20,21,22,23,24,25,26,27}

Literacy experts have developed many algorithms to assess readability, defined as the comprehension level a person must have to understand written materials. These algorithms objectively correlate difficulty of written material to an educational grade level.²⁸ Factors such as polysyllabic words and high word to sentence ratios are taken into account. Understandability can be measured using the content, wording, numbering, organization, layout, and diagrams of written material.²⁹ A 2008 study by Roskos et al evaluated readability of seven intranasal sprays, which found the mean reading level to be 6.9 using Fry’s readability graph.^30,31 However, the readability of these sprays has not been evaluated using algorithms better suited for healthcare related material.³² Further, an assessment of understandability with a validated quantifiable measure has also not been performed. Based on a literature review of healthcare readability studies, our hypothesis is that the readability of currently available commercial intranasal corticosteroid instructions is above the recommended readability criteria. To test this, patient instructions from widely utilized intranasal corticosteroids were analyzed using several scoring formulas to evaluate whether they met recommended readability criteria as well as to evaluate understandability.

Materials and methods

Identification and Inclusion

This bibliometric review of intranasal corticosteroid instructions was exempt from the Institutional Review Board (IRB). Inclusion criteria for intranasal corticosteroids was based on a systematic review by Derendorf et al that identified eight intranasal corticosteroids used in management of AR including fluticasone propionate, fluticasone furoate, triamcinolone, budesonide, beclomethasone, ciclesonide, flunisolide, and mometasone.⁸ Intranasal steroids that had prescription information and instructions available on the public domain were included. Three versions of fluticasone propionate by different pharmaceutical companies, and one version each of the other intranasal steroids were identified and included. Overall, ten intranasal corticosteroid instructions in English were analyzed. Patient instructions were found in the United States Food and Drug Administration (FDA) prescribing information handouts for each intranasal corticosteroid.

Readability Measurement and Analysis

The readability of each intranasal corticosteroid instructions was evaluated using three readability scores: Gunning Fog, a Simple Measure of Gobbledygook (SMOG), and FORCAST formulas.^33,34 There are no explicit criteria for choosing readability algorithms, therefore the algorithm choices by authors were based on frequency of use in the literature as well as suitability for healthcare-related material.³² Calculations were performed using Readable© software (Added Bytes; East Sussex, UK). Data analysis was performed using Microsoft Excel^® (Microsoft Corporation, Redmond, WA, USA).

Gunning Fog

$$GradeLevel=0.4\times \left(\left(AverageSentenceLength\right)+\left(\mathrm{\%}PolysyllableWords\right)\right)$$

SMOG

$$GradeLevel=3+\sqrt{PolysyllableCount}$$

Where polysyllable count is measured from 30 sentence sampling. If the narrative is less than 30 sentences, the algorithm is adjusted to take this into account.

FORCAST

$$GradeLevel=20-\left(\frac{N}{10}\right)$$

Where N = number of monosyllable words in a 150-word sample.

With variations across readability indices, our study weighed all three readability algorithms as equal predictors of readability.

Understandability Measurement

Understandability of all intranasal corticosteroid instructions was evaluated by two co-authors (SL/WB and SL/MG) for accuracy using the Patient Education Materials Assessment Tool for Printable Materials (PEMAT-P)²⁹. The PEMAT-P is a validated 24-point measure developed by Shoemaker et al for the Agency for Healthcare Research and Quality that evaluates understandability of patient education materials through sub-category analysis of content, word choice & style, use of numbers, organization, layout & design, use of visual aids, and actionability. Higher scores correlate to more understandable materials.

Results

Readability

Two of ten (20%) intranasal steroids instructions met the sixth-grade readability level recommended by the NIH and other literacy organizations; specifically, fluticasone furoate (GlaxoSmithKline) and flunisolide (Bausch & Lomb). Mometasone (Schering) had the highest readability level of 10.3, corresponding to the equivalent numerical reading grade level (Table 1, Figure 1). Overall, the average readability was 8.5. Average readability levels by formula were Gunning Fog 7.1, SMOG 8.5, and FORCAST 9.8 (Table 1).

Table 1.

Readability scores of intranasal corticosteroid instructions by steroid.

Intranasal Corticosteroid	Gunning-Fog	SMOG	FORCAST	Average
Beclomethasone (GlaxoSmithKline)	8.6	9.5	10.6	9.6
Budesonide (AstraZeneca)	7.5	9.6	9.9	9.0
Ciclesonide (Sunovion)	7.3	8.9	9.6	8.6
Flunisolide (Bausch)	4.8	6	9.6	6.8
Fluticasone Furoate (Schering)	5.0	6.6	8.8	6.8
Fluticasone Propionate (Apotex)	7.3	8.3	9.7	8.4
Fluticasone Propionate (Hitech)	7.1	8.5	9.6	8.4
Fluticasone Propionate (Wockhardt)	6.8	9.3	10.2	8.8
Mometasone (Schering)	9.7	10.5	10.8	10.3
Triamcinolone (Sanofi)	6.6	7.9	9	7.8
Average	7.1	8.5	9.8	8.5

Figure 1.

Average readability of intranasal corticosteroid instructions by corticosteroids. Horizontal line delineates NIH recommended readability level.

Understandability

Understandability of instructions for intranasal steroids ranged from 33% to 90%, with an average understandability of 66% (Table 2, Figure 2). The most understandable instructions were for triamcinolone (Sanofi). The least understandable instructions were for mometasone (Schering).

Table 2.

Understandability of intranasal corticosteroid instructions calculated using PEMAT-P.

Intranasal Corticosteroid	Understandability (%)
Beclomethasone (GlaxoSmithKline)	85.7
Budesonide (AstraZeneca)	63.6
Ciclesonide (Sunovion)	77.3
Flunisolide (Bausch)	59.1
Fluticasone Furoate (Schering)	76.2
Fluticasone Propionate (Apotex)	52.4
Fluticasone Propionate (Hitech)	76.2
Fluticasone Propionate (Wockhardt)	47.6
Mometasone (Schering)	33.3
Triamcinolone (Sanofi)	90.5
Average	66.2

Figure 2.

Understandability of intranasal corticosteroid instructions.

Discussion

A majority of pre-packaged instructions provided for intranasal corticosteroids are written at readability levels beyond those recommended by the NIH and health literacy experts. The understandability measurements of these instructions also correlate with their readability, with a significant percentage of these instructions not being understandable. With previous studies clearly demonstrating the relationship of health literacy to adherence of medication, and with the correlation of lower health literacy to medication errors and non-adherence, the difficult readability and understandability of these medication instructions likely play a role in adherence.^35,36,37 Some of the difficulty patients endorse with use of intranasal corticosteroids as well as their poor technique exhibited in prior studies likely may be attributed to the instructions.^{17,38,39,40,41}

With non-adherence or incorrect application of these nasal sprays their potential benefit is muted. Failure of this first-line treatment can lead to the escalation of therapeutic modalities with prescriptions of oral leukotriene receptor antagonists, immunotherapy, or surgical options. All of these have the potential for serious side effects, require prolonged follow-up, and have financial ramifications for patients.³ With the high prevalence of AR, these potentially unnecessary treatment pathways contribute to an overall increased economic burden. If patients used intranasal corticosteroids correctly then they might discover that this is the only treatment required to control their disease, decreasing costs to themselves and the system as a whole.

With difficult readability and understandability levels for nasal sprays, the onus may be higher on healthcare providers, whether it be physicians, nurses, pharmacists to provide in-person education for patients. Other medications that rely similarly on delivery technique for benefit, such as inhalers, have been shown to have improved disease control and even medication adherence with in-person teach back techniques by healthcare personnel. Some companies have begun to develop online videos for patient education, one of which exists for fluticasone furoate.⁴² With video demonstration of intranasal spray use, this may parallel closer to in-person education, with the added benefit of not requiring the in-person resources of a healthcare provider. However, to our knowledge, there have been no studies that compare the utility of patient education through written materials against a video format.

The prevalence of AR is correlated with lower socioeconomic status, which in turn mirrors literacy levels.^43,44 This is particularly significant as socioeconomic status has a strong inverse association with mortality and morbidity.⁴⁵ With AR’s correlation to other systemic diseases, such as the atopic triad, poor control of AR may serve as a reflection of the overall health status of patients.⁴³ Higher readability levels of medication instructions put up yet another barrier to healthcare and put the underserved at further disadvantage.

There are a few limitations to our study. The readability formulas utilized were designed with narrative texts in mind, rather than medical literature. They were, therefore, not intended to measure the readability of medical jargon. Thus, these measurements likely under-estimate the “real world” readability of medical instructions since the algorithms rely solely on syllable count and word length. On the other hand, each nasal steroid instruction includes diagrams for spray application, which likely aids patient understanding of the material and is not accounted for in calculations of readability levels.^46,47,48 Also, when considering the understandability analysis, there are no current recommendations for a PEMAT-P “target” to help guide writing. So, while higher is better, there is no clear bar set.

However, despite these limitations, we feel that evaluating these ubiquitous patient instructions could have far-reaching benefit. We found that with several simple tweaks, the readability and understandability of package insert instructions could be significantly improved. Simply, companies and physicians should avoid using medical jargon, use everyday language, break down instructions into short, concrete steps, and supply clear diagrams and/or drawings to help aid understanding. This issue of readability unfortunately is not limited to intranasal steroids, but has also been seen throughout the medical literature.^49,50,51 A study on readability of instructional material for inhalers, most similar to intranasal steroids in that medication delivery technique is related to efficacy, also showed readability levels to be beyond that recommended by health literacy organizations.⁴⁹ Though these changes may seem common sense, our study finds that far too often these companies’ inserts fail to deliver on these simple ideas.

Conclusions

Our study demonstrates that a minority of patient instructions for intranasal corticosteroids meet recommended readability levels. Higher readability levels are an added barrier to appropriate patient care, potentially leading to patient dissatisfaction, inappropriate allocation of medical resources, and unnecessary financial and treatment burdens on patients. For improved management and patient-centric care of AR it is paramount that readability and understandability are assessed during development of patient instructions for therapies such as intranasal corticosteroids, the benefit of which is contingent on correct application by patients.