Table of Contents    
ORIGINAL ARTICLE
Year : 2019  |  Volume : 10  |  Issue : 3  |  Page : 62-67  

Validation of assessment tools for the early detection of ocular involvement in leprosy


1 Department of Dermatology and Venereology, Faculty of Medicine, Dr. Cipto Mangunkusumo National General Hospital, Universitas Indonesia, Jakarta, Indonesia
2 Department of Ophthalmology, Faculty of Medicine, Dr. Cipto Mangunkusumo National General Hospital, Universitas Indonesia, Jakarta, Indonesia

Date of Web Publication14-Jan-2020

Correspondence Address:
Vania Vashti Lasrindy
Departemen Ilmu Kesehatan Kulit dan Kelamin, Fakultas Kedokteran Universitas Indonesia, RSUPN Dr. Cipto Mangunkusumo Gedung G5, Jl. Diponegoro No. 71, Jakarta Pusat 10430
Indonesia
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jnsbm.JNSBM_55_19

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   Abstract 


Objective: Ocular leprosy needs early detection to prevent blindness, but early detection tools for ocular leprosy vary. Thus, it is important to develop a valid and sensitive screening tool that physicians other than ophthalmologists who treat leprosy can use. This study aims to validate and measure the sensitivity of an early detection checklist that we created for ocular examination in patients with leprosy. Materials and Methods: We designed a checklist according to the symptoms and signs of ocular leprosy based on suggestions from dermatovenereologists and ophthalmologists. Leprosy patients at the Dermatology and Venereology Outpatient Clinic of Dr. Cipto Mangunkusumo General Hospital were examined by a general practitioner (nonophthalmologist) using the checklist as a screening tool; then, they were re-examined by an ophthalmologist as a gold standard. We conducted data analysis to validate and determine the sensitivity of the screening tool. Results: The checklist had good validity, reliability, and sensitivity, with a correlation value of 0.664 (P < 0.05), a Cronbach's α of 0.715, 85.42% sensitivity, and 73.33% specificity. The prevalence of ocular involvement in this study was 77%, with dry eyes, cataract, madarosis, lagophthalmos, and glaucoma as the most common ocular complications found. Conclusion: The checklist in this study is validated and sensitive; thus, it can be used as a screening tool to detect ocular involvement in leprosy.

Keywords: Checklist, eye, leprosy


How to cite this article:
Lasrindy VV, Menaldi SL, Yusharyahya SN, Irawati Y. Validation of assessment tools for the early detection of ocular involvement in leprosy. J Nat Sc Biol Med 2019;10, Suppl S1:62-7

How to cite this URL:
Lasrindy VV, Menaldi SL, Yusharyahya SN, Irawati Y. Validation of assessment tools for the early detection of ocular involvement in leprosy. J Nat Sc Biol Med [serial online] 2019 [cited 2020 Jan 23];10, Suppl S1:62-7. Available from: http://www.jnsbm.org/text.asp?2019/10/3/62/275593




   Introduction Top


Leprosy is a disorder caused by Mycobacterium leprae affecting the peripheral nerves, skin, and other organs, including the eyes.[1],[2],[3] Ocular involvement in leprosy is caused by inflammation in the eyes, the direct invasion of bacteria in the eyes, damage in the trigeminal and facial nerves during reaction episodes, and granulomatous infiltration in structures in the vicinity of the eyes.[4] These processes lead to disorders, especially in the anterior segments, including lagophthalmos, ectropion, entropion, trichiasis, clofazimine crystallization in the conjunctiva, corneal nerve beading, corneal pannus, corneal ulcers, keratitis, atrophy of the iris, cataracts, glaucoma, madarosis, and others.[5],[6] Several of these disorders can lead to blindness if inappropriately treated.[7]

Epidemiological data on ocular involvement and blindness in leprosy are influenced by geographical factors, race, patients' conditions, types of leprosy, duration of the disease, and treatment received.[1],[4],[8] The existing data are often incomplete and differ in methodologies and reporting style, leading to difficulty in estimating the prevalence of ocular involvement in leprosy.[4],[8] Reliable vision is important, especially for leprosy patients who have lost the sensoric sensations in their limbs. Vision disturbance, especially blindness, complicates patients to care for and pay attention to other organ involvement, such as wounds in the hands and feet.[6],[8] Furthermore, leprosy is commonly found in people aged 20–30 who are in their prime productive years;[9] vision disturbance can further deteriorate a patient's quality of life. Ideally, integrated care is needed in managing ocular disorders in leprosy, which includes early detection, initial management, and appropriate referral in centers for primary care supported by more advanced centers.[9] General practitioners in Indonesia, as the frontline personnel in treating leprosy in primary health-care facilities, are expected to be able to detect the signs and symptoms of ocular involvement in leprosy, perform initial management, and appropriately refer patients according to the applicable standards of competence.[10]

Ocular involvement in leprosy is examined by physicians with varying levels of knowledge, leading to a higher number of ocular complications in the general population compared to the number of detected cases.[6] Therefore, we proposed a simple yet comprehensive clinical instrument that is compatible with applicable general practitioners' competence. It will guide physicians managing leprosy who are not ophthalmologists, especially in primary health-care facilities, in detecting the critical signs of ocular involvement in leprosy. Hopefully, the instrument proposed in the form of a checklist can help standardize the differences in examination techniques [11],[12] and assist in the early detection of ocular involvement in leprosy. Our study aimed to validate the proposed checklist for the detection of ocular involvement in leprosy. We also measured its sensitivity because it will be used as an early detection guide for leprosy patients with ocular involvement, especially in primary health-care facilities. In addition, this instrument can assist in data collection on the manifestations of ocular involvements in leprosy.


   Materials and Methods Top


This is a cross-sectional study conducted in Dr. Cipto Mangunkusumo General Hospital, Jakarta, Indonesia, from July 2016 until June 2017. The study is a validation of a proposed checklist and a subsequent diagnostic test to measure its sensitivity by reviewing the compatibility of ocular examination results in leprosy patients conducted by nonophthalmologists compared to the results by ophthalmologists using the same checklist.

We designed a checklist form based on the literature on the most common ocular involvements in leprosy and the most likely ocular involvements causing blindness. We listed and organized the symptoms and signs that can arise from these abnormalities according to suggestions from experts in ophthalmology and dermatology to ensure that physical examinations can be conducted in a systematic and easy manner. The checklist consists of subjective items, including items arising from patients' histories, and objective items, including ophthalmologic examination findings [Figure 1]. The checklist is used to assist ophthalmologic examinations in this study.
Figure 1: The checklist for ophthalmologic examination in leprosy proposed in this study

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The study participants were all patients with leprosy presenting to the Dermatology and Venereology Outpatient Clinic at Dr. Cipto Mangunkusumo General Hospital for treatment. They were chosen consecutively and met the inclusion criteria, which included ≥12 years of age, diagnosed with leprosy, agreed to participate in the study, and signed an informed consent form to participate. The exclusion criteria included patients whose ophthalmologic complaints were clearly unrelated to leprosy (e.g., physical trauma of the eyes) and patients who were uncooperative during the examination. During sampling, there were no patients who were not cooperative nor the ophthalmologic complaints were unrelated to leprosy. The primary researcher carried out a simple ophthalmologic examination on each patient at the Dermatology and Venereology Outpatient Clinic using a Snellen chart and a penlight. The examination was done according to the subjective and objective items on the checklist [Figure 1]. Afterward, the participants were referred to the Ophthalmology Outpatient Clinic in the Kirana Unit of Dr. Cipto Mangunkusumo General Hospital to be examined by the supervising ophthalmologist of this study. Specialist ophthalmologic examinations comprising a visual acuity test, examination of the ocular adnexa, examination of intraocular pressure using a tonometry, slit-lamp and ophthalmoscope examinations, Schirmer's test, cornea sensibility test, and fluorescent test were conducted. The results were documented according to the checklist of ophthalmologic abnormalities with the addition of any findings outside the parameters of the checklist as well as the participant's ophthalmologic diagnosis. Participants with ophthlamologic disorders were treated in accordance with the Dr. Cipto Mangunkusumo General Hospital's Ophthalmology Outpatient Clinic's clinical practice guidelines.

After the participant was examined, the documented data were placed inside a sealed envelope to be kept by the researchers' assistant. The primary researchers could not read the results of the ophthalmologic examinations carried out by the supervising ophthalmologist until all the data were collected and also, the supervising ophthalmologist could not access the ophthalmologic examination result reported by the primary researcher. The assistant who did not participate in the physical examinations verified and coded the documented data while overseen by the study's supervisor using IBM SPSS statistic version 23 at Universitas Indonesia, Jakarta, Indonesia and Microsoft Excel 2012. The variables which were the ocular examination results according to the subjective and objective items in the checklist in this study were analyzed descriptively and analytically by the researchers to validate the checklist, followed by a diagnostic test to assess the checklist's sensitivity. Data on the subjective items of the checklist were descriptive, whereas the data that were tested for validation as well as the diagnostic tests were the objective items in the checklist. We validated the checklist by evaluating its validity and reliability [13] through the correlation of examination results provided by the primary researcher and those reported by the supervising ophthalmologist; we also examined the Cronbach's α value of the checklist. We considered the checklist to have good validity if r >0.6 and good reliability if it had a Cronbach's α value >0.7. We considered the checklist to have good sensitivity if the sensitivity value was ≥85%. We considered P < 0.05 to be statistically significant. We included the additional findings from the ophthalmologic examinations carried out by the ophthalmologist as descriptive data in order to calculate the prevalence of ocular involvement in leprosy at Dr. Cipto Mangunkusumo General Hospital as a secondary result. This study has passed the Universitas Indonesia's Faculty of Medicine's Ethics Committee's ethical review (decision letter number 1021/UN2.F1/ETIK/2016). This study has also passed Dr. Cipto Mangunkusumo General Hospital's Ethics Committee's ethical review (decision letter number LB.02.01/X.2/0016/2017).


   Results Top


Data collection took approximately 3 months, from February 6 to May 2, 2017, after receiving approval from the ethics committees. There were 63 participants who met our inclusion criteria (126 eyes). The participants' characteristics are displayed in [Table 1].
Table 1: Characteristics of the study participants (n=63)

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There was a male predominance, with a male-to-female ratio of 2.15:1. The majority of the participants suffered from multibacillary (MB) leprosy, whereas paucibacillary (PB) leprosy was found in only one participant. MB and PB leprosy types were classified based on the 1995 World Health Organization (WHO) criteria. In contrast, when the participants were classified using the Ridley–Jopling classification, the types of leprosy found in the participants were borderline lepromatous (BL) (47.6%), borderline tuberculoid (BT) (34.9%), borderline (BB) (11.1%), and lepromatous (LL) (6.3%); no tuberculoid (TT) leprosy was found in our participants. Leprosy reaction was found in 90.5% of participants, with 85.7% of them receiving oral corticosteroids at the time of the study.

The participants' subjective complaints are displayed in [Table 2]. There were two participants with no ocular complaints and no ocular abnormalities on objective examination. There was one participant with ocular complaints (blurry vision) but with no abnormalities found on objective examination.
Table 2: Subjective data

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The objective finding, resulting from physical examination, showed that the prevalence of ocular abnormalities in the study participants was 77% of the total number of examined eyes, or 82% of the participants, as found by the ophthalmologist. The most prevalent abnormality was dry eyes, followed by cataract, madarosis, lagophthalmos, and glaucoma [Figure 2].
Figure 2: Proportions of ocular abnormalities found in the study participants

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We analyzed the objective data from our checklist and found a Cronbach's α of 0.715. The validity indicated by the correlation coefficient of each objective item in the checklist is summarized in [Table 3].
Table 3: Correlation coefficient of each objective item in the checklist

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The correlation coefficient of each objective item is seen from the value of the corrected item's total correlation. The value of each objective item varies, ranging from 0.005 to 0.718. The validity of the checklist in its entirety can be seen from the assessment of the correlation between the examination results from the nonophthalmologist and the results from the ophthalmologist. The r value found was 0.664, and the P value was 0.00 (<0.05).

After validation of the checklist, the checklist's diagnostic tests were analyzed to measure sensitivity using a 2 × 2 table [Table 4]. The results of the diagnostic test analysis according to the abnormal eye can be detected with the checklist, with 85.42% sensitivity and 73.33% specificity.
Table 4: Results of ophthalmologic examination done on participants using the checklist

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   Discussion Top


The majority of the participants in our study were MB leprosy patients, classified based on the WHO's 1995 classification guidelines. Using this criteria increases the proportion of MB leprosy compared to PB.[9] The higher proportion of MB leprosy is in line with the WHO's epidemiological data from 2015, where the proportion of new MB leprosy patients in Indonesia was 84.55%.[14] Meanwhile, when classified using the Ridley–Jopling system, most of the participants had borderline types, including BT, BB, and BL. This spectrum between TT and LL leprosy, are the most prevalent types of leprosy, which have a high tendency for leprosy reaction.[15] In our study, 90.5% of the participants experienced a reaction, 73% of which had a type 1 reaction and 34% had a type 2 reaction. The high occurrence of reactions in our participants might be due to our study population and location – a referral hospital featuring many cases of leprosy reaction. The high number of reactions contributed to the amount of participants undergoing corticosteroid treatment for their leprosy reaction, which could have also caused ocular disturbances as side effects of oral corticosteroids, which will be discussed later.

The prevalence of ocular involvement in leprosy in this study was 77%, with dry eyes as the most common disorder, followed by cataract, madarosis, lagophthalmos, and glaucoma. Our findings differ from the findings of Hersetyati et al.'s (2003), which showed cataract, madarosis, and loss of corneal sensibility as the most common ocular disorders.[16] Rao's study in India found ocular abnormalities in 48% of the patients, with madarosis, corneal involvement, and lagophthalmos as the most common diagnoses.[17] The discrepancy may be caused by the larger proportion of LL-type leprosy in Hersetyati et al.'s and Rao's (2015) studies, 23% and 75% respectively,[16],[17] leading to differences in the types of ocular involvement.

Dry eyes was the most common diagnosis found in this study: 75 eyes, or 59.5% of all the examined eyes. The existing literature described no differences between dry eyes in normal individuals and in leprosy patients;[18] however, dry eyes still need to be treated to maintain moist and healthy corneas.[6] Cataract was diagnosed in 31 participants, or 24.6% of all the eyes examined. From all the cataracts diagnosed in this study, 32% of the cases were found in participants over 50 years old, increasing the possibility of senile cataract. We did not find cataracts due to iritis or uveitis in this study. We found posterior subcapsular cataract in 64% of the diagnosed cases, which might be a side effect of long-term corticosteroid use.[19] We also found increased intraocular pressure in seven of the examined eyes (four participants, or 5.5%) without any cases of uveitis-related glaucoma. We predicted the glaucoma found in this study to be caused by corticosteroid use for the management of leprosy reaction.[20] Therefore, ophthalmologists should periodically examine individuals who consume corticosteroids to manage leprosy reactions.

Validating a checklist is done by assessing its reliability and validity.[13] The Cronbach's α value of our checklist was 0.715, which indicates internal consistency or good reliability because it is greater than the acceptable value of 0.7.[21] The validity of a checklist is seen through the correlation coefficient of each objective item. An acceptable correlation coefficient in an assessment tool is >0.3; thus, there are a few items on the checklist with unsatisfactory validity.[13] However, if we look at the “α if item deleted” value, which is the collective correlation coefficient if one of the items were to be deleted, the general correlation coefficient will decrease, lowering the checklist's validity. Therefore, this checklist has good validity if it is used as a whole. In addition, experts in dermatology and ophthalmology have approved this checklist, ensuring the validity of its content.[1] We assessed the validity of the checklist as a whole by looking at the correlation between the examination results of the primary researcher (nonophthalmologist) and those of an ophthalmologist. The correlation value (r) obtained was 0.664 (P < 0.05), which is a strong correlation coefficient because it is >0.6.[22] Our calculation regarded the right and the left eyes of the participants as two different items because the diagnosis made for the right eye of a participant might differ from the left eye's diagnosis. Nonetheless, the checklist's validity test could not verify whether an objective finding in one eye detected by our researcher using the checklist was the same as the objective finding of the ophthalmologist in the same eye.

We hope that the checklist tested in this study can be used for the early detection or screening of ocular involvement in leprosy to ensure prompt follow-up or early management of ocular abnormalities. Therefore, we expect this checklist to have a high sensitivity value.[23] Our analysis revealed a sensitivity of 85.42%, meeting the expectation set in this study (≥85%). Based on the satisfactory sensitivity, this checklist can be utilized to simplify the early detection of ocular involvement in leprosy, fulfilling this study's objective. Methods to screen ocular involvement in leprosy vary. Usually, ocular examination in leprosy patients is done as part of larger screenings to detect disability in leprosy, which consists of documenting disability found in the hands, feet, and eyes. One of the simple methods of ocular examination in leprosy is the method proposed by the Indian Association of Leprologists and an ocular leprosy workshop in Boxbourne England in 2001. The method used included examining lagophthalmos, visual acuity, red eyes, and facial patches, a method that helped physicians and medical workers manage leprosy in the field used.[6],[7] Courtright and Lewallen also summarized the signs and symptoms of major ocular abnormalities that were helpful in detecting ocular leprosy,[7] but this was not in the form of a checklist. The Dermatology and Venereology Clinic at Dr. Cipto Mangunkusumo General Hospital uses the Prevention of Disability Form proposed by the Indonesian Department of Health, which only includes a lagophthalmos examination for ocular examination in leprosy patients.[24] Other examinations of the eye as a part of the form recording nerve function impairment vary, but they usually record visual acuity and abnormalities found in the eyelid, conjunctiva, and cornea.[25],[26] The checklist provided in this study is more comprehensive and systematic in detecting ocular abnormality than these simpler methods or forms because it considers both subjective and objective findings. With the validation of this checklist, it can be used easily, especially in primary care by nonophthalmologist physicians who treat leprosy, as a helpful guide when performing ocular examinations in leprosy patients because it has been adapted to the standard of competence of general practitioners. Any eye abnormality found and recorded in the checklist during examination should raise the suspicion of probable ocular leprosy that needs further attention and referral to an ophthalmologist. This checklist is validated and sensitive; it can be used to enable the early detection of ocular involvements in leprosy.

Financial support and sponsorship

The 3rd ICE on IMERI committee supported the peer review and manuscript preparation of this article.

Conflicts of interest

There are no conflicts of interest.



 
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  [Table 1], [Table 2], [Table 3], [Table 4]



 

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