Ethics statement

The research was performed in accordance with the Declaration of Helsinki for Human Research of the World Medical Association and approval has been granted by The Leprosy Mission Trust India Ethics committee (Approval number: C-071/ TLMTI EC/24), DHR EC-Registered no. - EC/NEW/INST/2024/4670.

Study setting

A mixed methods approach, encompassing chart review and focus group discussions (FGD), was undertaken in six TLM Hospitals, two in Uttar Pradesh, two in West Bengal, one in Delhi and one in Tamil Nadu. The Leprosy Mission Hospitals are tertiary referral centres for leprosy, with expertise in diagnosing and managing the disease and its related complications. In addition to routine clinical data specific for leprosy, a routine set of laboratory investigations and individuals’ wellbeing status are recorded for all patients registered for treatment. A common Health Information System has been in use since 2008 across all hospitals of The Leprosy Mission with a unique identification number for patients coming for treatment.

Chart review involved cross-sectional analysis of secondary data extracted from the electronic medical records of patients affected by leprosy who attended TTLM Hospitals. Clinical assessment data collected at the time of leprosy diagnosis or during the first three visits were extracted for the analysis. All TLM hospitals systematically maintained electronic health records that included demographic and clinical information, disability status, and standardized assessments of activity limitation and social participation. Subjective wellbeing was assessed using the WHO-5 Wellbeing Index (ref) at baseline and during follow-up visits. Each patient record was stored under a unique hospital identification number.

Data included individuals aged 18 years and above who were registered for leprosy treatment or treatment of its complications at the 6 selected TLM hospitals across 4 states in India during 2021 and 2022. Patients with missing data on key variables were excluded from the final analysis.

Data extraction

De-identified data on WHO-5 wellbeing scores, hemoglobin (Hb), cataract and random blood sugar (RBS) levels were extracted, along with relevant clinical, demographic details, including type of leprosy (PB/MB), bacteriological index and disability status as WHO disability grade These routine laboratory values are usually collected prior to treatment initiation or when required, enabling identification of coexisting morbidities. Data was extracted by a software company that designed and maintains the Health Information System of TLM Hospitals. Data was extracted into Excel spreadsheets and checked for missing data and extreme values using validation rules.

The WHO-5 Wellbeing Index, validated for use in the Indian context, was used. It comprises five items scored from 0 (none of the time) to 5 (all the time). The raw score ranges from 0 to 25, which was converted to a percentage score (raw score × 4). A percentage score of ≤50 was considered indicative of low wellbeing.

India-specific cut-off values were used to identify elevated blood glucose levels as indicators of presence of diabetes. The presence of cataract is assessed using standard clinical assessment of eye.

FGD explored the perceived impact of multimorbidity. One FGD was conducted with persons affected by leprosy and the other with healthcare providers. Sampling was purposive to ensure representation of diverse experiences across different stages of disease progression among those affected. The health professionals comprised medical officers who were purposively selected based on having at least two years’ experience in managing leprosy in their clinics.

Participatory research principles were used for the FGDs, aiming to co-develop a causal model illustrating the relationship between multimorbidity, psychosocial challenges, and wellbeing (S1 File). Discussions were audio-recorded, transcribed verbatim in English, and supplemented by field notes taken by independent researchers to capture non-verbal cues and contextual information.

Analysis plan

Descriptive statistics were used to describe the study participants’ demographic and clinical details. Prevalence of individual each condition was presented as percentage of patients with either diabetes, poor wellbeing or cataract. Patterns of multimorbidity was presented as leprosy plus one, two or three conditions in individual patients. Factors associated with multimorbidity was assessed using multiple logistic regression analysis. Age, gender, treatment status (as newly diagnosed, on treatment, completed treatment and relapse), bacteriological index and disability status WHO disability grade was included as explanatory variables. Data was analysed using the R statistical program.

Qualitative data was analysed thematically using NVivo software. A coding framework was developed inductively from the transcripts. Emerging themes and subthemes were organized into matrices to identify key patterns and relationships. These insights formed the basis for constructing a causal model and informed the development of a theory of change for future intervention study to manage multimorbidity and wellbeing in persons affected by leprosy.

Qualitative results

FGD with persons affected by leprosy included 16 individuals (12 male, 4 female), aged between 25 and 76 years with varying complications, including lepra reactions, disabilities, ulcers, diabetes, and hypertension.

1. Awareness of Multimorbidity

Participants were not aware that leprosy could coexist with multiple health conditions, even though some of them claimed to have more than one illness apart from leprosy. Some were surprised and worried, especially those recently diagnosed and not yet experiencing complications. One participant stated:

“After knowing that leprosy can coexist with multiple diseases, this disease should not come to anyone.” (Participant 04, 46 M)

2. Perceived Impact of Multimorbidity on Daily Life

Several participants reported that the coexistence of diseases had adversely affected their ability to work and fulfil family roles. One participant noted, “I am the only earning member. After leprosy and deformities in the hands, I stopped working due to weakness.” (Participant 07, 54 M)

More than half of the group mentioned that although their work capacity had declined, they continued to work in order to support their families. Fatigue, physical limitations, and fear of future complications were commonly voiced concerns. Participants expressed apprehension about the burden of taking multiple medications and coping with side effects: “If I get multiple problems, do I have to take more medicines? It will be difficult to take all medicines for each problem.” (Participant 02, 41 M)

3. Access to Treatment

Participants described fragmented and inconsistent access to care. While some preferred to seek care at district hospitals where they perceived services to be more comprehensive, many expressed a desire to receive care closer to home. Several participants reported first consulting local village doctors and only visiting higher-level facilities when symptoms persisted. They were uncertain whether comprehensive treatment for all conditions could be obtained at the primary care level. One participant with multiple morbidities stated, “have leprosy, diabetes and recently diagnosed with hypertension. It is difficult for me to take all medicines together and follow the doctor’s advice”. (Participant 13, 65 M)

4. Availing Healthcare and Costs

Logistical and financial barriers to accessing multiple health services were reported. Participants spoke of their desire to get treatment closer to home. While some expressed a preference for free government services, others acknowledged that these were often suboptimal, concerned about getting the correct treatment closer to home but remained the only viable option due to financial constraints. “I don’t know if I will get treatment for all the problems (multiple morbidities) near my home in the block hospital (Community Health Centres)”. (Participant 05, 50 M)

5. Social and Psychosocial Impacts

Participants, especially those with disabilities, felt challenged coping and were worried that addition of another chronic illness would burden them further. Worry and concern were the primary emotions expressed. There was confusion about where they could seek treatment if there were multiple conditions to be dealt with. The mental health impact of leprosy was unknown to them and they felt disturbed when they became aware. “Feeling concerned that person with leprosy can develop mental health problems”. Mental health complications were a source of fear and anxiety. (Participant 01, 37 M)

FGD with health care providers

A total of 14 healthcare providers (12 male, 2 female) participated in the FGD, with an age range of 25–62 years. Participants included medical officers (n = 5), rural health officers (n = 3), community health officers (n = 3), and non-medical supervisors (n = 3) and all of them were actively managing leprosy patients in their clinics.

1. Recognizing and Experience of Multimorbidity

Most healthcare providers acknowledged that multimorbidity was common in general practice, particularly among patients with non-communicable diseases (NCDs) such as diabetes and hypertension. However, the recognition of multimorbidity in the context of leprosy was less familiar. Several participants remarked that this was the first time they were consciously reflecting on multimorbidity in leprosy-affected individuals. One medical officer (participant) noted, “Multimorbidity is not new, but in leprosy we are hearing (about it) for the first time.” (MO_ 03_male)

While leprosy reactions and chronic complications were familiar clinical challenges, many providers had not considered co-existing chronic conditions among persons with leprosy, despite routinely treating them. One senior experienced leprosy health supervisor stated, “In leprosy, some problems you can tackle, but not all. If patients develop reactions multiple times, how much medicine can we give? With multiple problems, it will be even more difficult.” (MO_ 06_male)

2. Health System issues

Reduced drug availability, inadequate diagnostic capacity, and high patient load were commonly cited challenges. Many reported seeing 25–80 patients per day, leaving little time to explore complex health issues such as multimorbidity. One medical officer remarked, “We do not have sufficient time to talk to patients in detail, so we miss the diagnosis of many problems.” (MO_ 08_male)

Basic laboratory investigations required to confirm common comorbid conditions were often unavailable due to lack of reagents or equipment at primary health centre level.

3. Uncoordinated Care and Continuity Challenges

Care for persons with leprosy and multimorbidity provided was fragmented, with patients visiting multiple care providers across the health system. Migration for seasonal work was identified as a major barrier to treatment adherence. Patients often sought treatment in their home village but relocated before follow-up which disrupted the care for both leprosy and coexisting conditions.

Inadequacy of referral systems, inconsistent documentation, and lack of care coordination were barriers to effective management. One provider noted, “Documentation is a central issue. As we do not see the same patient every time, it is difficult to track progress or manage problems effectively.” (MO_ 05_female)

4. Guideline Gaps and Clinical Confidence

Existing guidelines—including those from the National Leprosy Eradication Programme (NLEP) and organizational protocols—were limited in scope and did not consider multimorbidity. Several medical professionals expressed uncertainty about deviating from disease-specific guidelines to accommodate complex cases. They acknowledged the need to use clinical discretion in the absence of clear guidance. As one provider put it, “Although we do not have guidelines, we need to use clinical discretion to decide on management. However, we need some basic guidance on how to manage multiple problems in leprosy.” (MO_ 08_ male)

Guidelines for multimorbidity were desired to be flexible, context-specific, and feasible within the constraints of Indian primary care settings. Many felt that guidelines developed in high-income countries were not applicable to their setting.

5. Person-Centred Care and Outcome Expectations

All agreed that the primary goal of managing multimorbidity should not be limited to disease-specific outcomes but should aim to improve overall functioning and quality of life. One participant stated, “The outcome should be focused on the person, not specific to disease—for example, improvement in diabetes, hypertension, and leprosy together.” (DLO_15_Male). Providers supported the need for shared decision-making, considering both clinical risks and financial burden, especially in the context of limited resources.

6. Suggestions for Intervention and Improvement

Participants recommended several measures to improve the management of multimorbidity in primary care settings. The key points mentioned were

• Developing flexible, locally relevant guidelines for multimorbidity management in leprosy.
• Include guidelines on managing multiple conditions in leprosy in the existing guidelines
• Strengthening documentation and continuity of care mechanisms.
• Enhancing screening and early identification of comorbid conditions during routine leprosy care.
• Allocating more consultation time to enable comprehensive patient assessments.
• Building awareness among healthcare providers and communities regarding multimorbidity and its impact.

The importance of provider–patient communication was repeatedly emphasized. One provider noted, “Giving correct information to patients is very important if we have to tackle multiple problems in leprosy.” (DLO_15_Male)

Strengths and limitations

As far as we are aware this is the first study to document Multimorbidity in persons affected by leprosy. A strength of this study is the inclusion of participants from six large, specialized leprosy hospitals with extensive expertise in managing leprosy and its associated complications. All hospitals use a common contexualized standard WHO approved protocol for managing leprosy. A large sample of 10,441 patients were seen over 2 years. However, studying also has several limitations. First, the diagnosis of diabetes was based on random blood sugar (RBS) cut-off values. Second, the recording of ICD codes for specific conditions was inconsistent across medical records. Third, the WHO-5 Wellbeing Index measures subjective well-being and does not provide a clinical diagnosis of mental health conditions. All this may have led to an overestimation of its prevalence. Additionally, participants with missing clinical data were excluded from the regression analysis, which may have affected the study findings. It is important to note that, as a retrospective chart review, the study was limited by the quality and completeness of the existing medical records.