Rajbir Singh German Leprosy and TB Relief Association

A Study to assess the reasons for delayed presentation among newly detected adult leprosy patients with disability and develop appropriate recommendations to reduce the delay in endemic districts of Delhi, West Bengal, Gujarat, Maharashtra and Andhra Pradesh Rajbir Singh German Leprosy and TB Relief Association

Rationale for the Study Disability proportion is a sign of late case detection Disability rate is used as a proxy measure for delay in presentation A good number of patients continue to delay in presentation thereby; have an increased risk of nerve involvement or disability

Objectives To determine the risk factors associated with delayed presentation among newly detected adult leprosy patients with disability (Grade 1 and Grade 2) To measure the association of the potential risk factors for delayed presentation To develop appropriate recommendations to reduce the delay and promote early reporting and diagnosis

Methodology Study design: Case - Control Study (Observational Study) Setting: The study was a multi-centric across five selected states of India i.e. Delhi, West Bengal, Gujarat, Maharashtra, and Andhra Pradesh Study period: Two years (Aug 2014 to July 2016) 21-12-2017 4

Sample Size Study Samples per state n = 280 Gr II disability n = 70 Gr I disability n = 70 Control group n = 140 Total Study Samples n = 1400

Definitions Case: Adult leprosy patients who reported with Disability (WHO grade 1 or 2) at the time of diagnosis and registered for treatment in the preceding one year (1 st Jan 2013 or later) Controls: Controls were adult leprosy patients who reported without any disability (WHO grade 0) at the time of diagnosis and registered for treatment in the preceding one year (1 st Jan 2013 or later) 21-12-2017 6

Eligibility Criteria Inclusion Criteria Adult leprosy cases aged > 18 years Person registered in the district Person willing to give informed consent Exclusion criteria Persons with disabilities due to other reasons than leprosy Participants unable to give informed consent due to any reason (e.g, Mental disorders, developmental issues)/unwilling to sign informed consent form Suffering from severe illness

Ethical clearance was obtained from Institutional Review Board GLRA and approvals from State Leprosy Offices of all five states For every randomly selected case, two consecutive adult leprosy without disability registered next to the selected case in the Treatment register (LF 02) were enrolled as controls matched with age and gender. Participants were informed about the study and written informed consent was obtained

All participants had an opportunity to withdraw anytime during the course of the interview. Direct interviews were conducted with study participants by research assistant at health facility using structured questionnaire Reimbursed Rs. 150/- towards travel & Food

Data Management All the interviews were entered into the Epidata entry client software Descriptive statistics were conducted The strength of association between potential risk factors and disability was assessed using odds ratio (OR) and 95% confidence intervals (95% CI)

Key observations

The mean age of cases was 40 years and controls were 38 years. Males contributed 68% of total cases and 71% in control group Majority (58%) were in the age group of 30-60 years across all 5 states. 55% participants were literate Proportion of interviewed cases and controls were equally distributed in rural and urban locality. Majority of cases and controls were occupied in unorganized sector for their living.

First symptom noticed by patients and trigger symptoms Skin patch with loss of sensation in 58% cases with disability and 88% controls without any disability Numbness was noticed in 28% cases, ulcers in 6% cases. Nodules was noticed in 5% cases and 3% controls. Claw hands/foot drop/ lagophthalmos was noticed in 5% cases. Reaction related symptoms like fever, swollen face, pain) was noticed in 12% cases and 9% controls. Symptoms that triggered in health seeking behavior were found to be, increase in size of skin lesion (patch, nodules) in 64% cases. Sensory impairment (numbness, ulcers) triggered 30% cases to seek health care from the providers.

AFTER NOTICING THE INITIAL SYMPTOM, HEALTH SEEKING ACTION WAS INACTION! Reason for not seeking any health care provider immediately* Thought it was a not disease and would disappear by itself Cases n= 652 (%) 585 (90) No money to seek treatment 144 (22) Due to family commitments 81 (12) Health facility is far away 51 (8) *multiple response

Operational Definitions Patient delay: Time from first noticed symptom to the first visit to any health care provider Health care provider delay: Time from the first visit of any health care provider to confirmed diagnosis of Leprosy

Patient Delay: duration (in months) Delay in months Patient Delay HCP Delay Maharashtra Delhi Andhra Pradesh West Bengal Gujarat Controls Cases Controls Cases Controls Cases Controls Cases (n=700) (n=700) (n=700) (n=700) (n=700) (n=700) (n=700) (n=700) Cases (n=700) Controls (n=700) 5 2 5 2.8 18 8 12 5 7 4 4 2 4.6 1.5 3.2 1 1 0.1 1 0.6 Cases (n=700) Total Controls (n=700) 8 4 2 1 The overall mean patient delay was 17.6 months (median patient delay 8 months) among cases compared with mean patient delay of 10.3 months (median patient delay 4 months) among the controls. Andhra Pradesh and West Bengal reported highest patient delay among the study states Delhi and Maharashtra reported highest Health Care Provider delay among the study states

Healthcare Provider Delay: duration (in months) Delay (in months) Cases (n=700) Controls (n=700) Cases (n=700) Controls (n=700) Mean # Mean # Median* Median* HCP delay 6.4 3.1 2 1 Health care Provider wise mean duration of delay Cases (n=700) Controls (n=700) Qualified Private practitioner 3.7 1.6 Non-qualified practitioner 1.6 0.5 Public Health facility 1.1 1.0 The delay is more among qualified private practitioners?

Risk factors for grade 2/1 disability Characteristics Cases n=700 Controls n=700 Crude OR Adjusted OR n % n % 95% CI 95% CI Leprosy type MB 666 (95) 461 (66) 10.1(7.0-14.8) 9.2(6.2-13.6) PB 34 (5) 239 (34) 1.0 1.0 Distance to nearest public health facility More than 5 kms 274 (39) 248 (35) 0.9(0.7-1.1) 1.02(0.8-1.3) Less than or equal to 5kms 426 (61) 452 (66) 1.0 1.0 Patient delay (months) More than 3 months 449 (64) 345 (409) 1.8(1.5-2.3) 1.7(1.3-2.2) Less than 3 months 251 (36) 355 (51) 1.0 1.0 Message related to leprosy program Not heard/seen/read 554 (79) 517 (74) 1.3(1.1-1.6) 1.1(0.8-1.5) Heard/seen/read 146 (21) 183 (26) 1.0 1.0 Health care provider delay > 1 month 388 (55) 273 (39) 1.9(1.6-2.4) 1.2(0.9-1.6) 1 month 312 (45) 427 (61) 1.0 1.0 First health care provider consulted Non-qualified Practitioner 111 (16) 92 (13) 1.7(1.2-2.3) 1.1(0.7-1.6) AYUSH Private Practitioner 67 (10) 52 (7) 1.8(1.2-2.6) 1.1(0.7-1.8) Allopathy private practitioner 227 (32) 151 (22) 2.1(1.6-2.7) 1.6(1.1-2.2) Public health system 295 (42) 405 (58) 1.0 1.0 Failure to recognize leprosy in first 2 visits by public health facility Yes 240 (34) 191 (27) 1.4(1.1-1.7) 1.4(1.04-1.8) No 460 (66) 509 (73) 1.0 1.0 Failure to recognize leprosy in first 2 visits by Non-qualified practitioners Yes 79 (11) 38 (5) 2.2(1.5-3.3) 2.0(1.2-3.3) No 621 (89) 662 (95) 1.0 1.0 Failure to recognize leprosy in first 2 visits by qualified private practitioners Yes 224 (32) 142 (20) 1.8(1.5-2.4) 1.5(1.1-2.0) No 476 (68) 558 (80) 1.0 1.0 When the first sought health care provider was an allopathy private practitioner the risk of disability at the time of diagnosis among new leprosy patients was 1.6 times higher compared to the visit to the public health facility When the patient delay was more than 3 months the risk of grade 2/1 disability at the time diagnosis is 1.7 times higher compared when the patient delay was less than 3 months

Risk factors for grade 2/1 disability Characteristics Cases n=700 Controls n=700 Crude OR Adjusted OR n % n % 95% CI 95% CI Leprosy type MB 666 (95) 461 (66) 10.1(7.0-14.8) 9.2(6.2-13.6) PB 34 (5) 239 (34) 1.0 1.0 Distance to nearest public health facility More than 5 kms 274 (39) 248 (35) 0.9(0.7-1.1) 1.02(0.8-1.3) Less than or equal to 5kms 426 (61) 452 (66) 1.0 1.0 Patient delay (months) More than 3 months 449 (64) 345 (409) 1.8(1.5-2.3) 1.7(1.3-2.2) Less than 3 months 251 (36) 355 (51) 1.0 1.0 Message related to leprosy program Not heard/seen/read 554 (79) 517 (74) 1.3(1.1-1.6) 1.1(0.8-1.5) Heard/seen/read 146 (21) 183 (26) 1.0 1.0 Health care provider delay > 1 month 388 (55) 273 (39) 1.9(1.6-2.4) 1.2(0.9-1.6) 1 month 312 (45) 427 (61) 1.0 1.0 First health care provider consulted Non-qualified Practitioner 111 (16) 92 (13) 1.7(1.2-2.3) 1.1(0.7-1.6) AYUSH Private Practitioner 67 (10) 52 (7) 1.8(1.2-2.6) 1.1(0.7-1.8) Allopathy private practitioner 227 (32) 151 (22) 2.1(1.6-2.7) 1.6(1.1-2.2) Public health system 295 (42) 405 (58) 1.0 1.0 Failure to recognize leprosy in first 2 visits by public health facility Yes 240 (34) 191 (27) 1.4(1.1-1.7) 1.4(1.04-1.8) No 460 (66) 509 (73) 1.0 1.0 Failure to recognize leprosy in first 2 visits by Non-qualified practitioners Yes 79 (11) 38 (5) 2.2(1.5-3.3) 2.0(1.2-3.3) No 621 (89) 662 (95) 1.0 1.0 Failure to recognize leprosy in first 2 visits by qualified private practitioners Yes 224 (32) 142 (20) 1.8(1.5-2.4) 1.5(1.1-2.0) No 476 (68) 558 (80) 1.0 1.0 Multiple visits to any private providers (qualified or unqualified) increases the health care provider delay and an important risk factor for disability. This is a missed opportunity. 11% cases and 5% controls had more than 2 visits to unqualified private providers; 34% cases and 27% controls had more than 2 visits to public health facility; 32% cases and 20% controls have visited qualified private providers more than 2 times before their diagnosis.

Risk factors for grade 2/1 disability Characteristics Cases n=700 Controls n=700 Crude OR Adjusted OR n % n % 95% CI 95% CI Leprosy type MB 666 (95) 461 (66) 10.1(7.0-14.8) 9.2(6.2-13.6) PB 34 (5) 239 (34) 1.0 1.0 Distance to nearest public health facility More than 5 kms 274 (39) 248 (35) 0.9(0.7-1.1) 1.02(0.8-1.3) Less than or equal to 5kms 426 (61) 452 (66) 1.0 1.0 Patient delay (months) More than 3 months 449 (64) 345 (409) 1.8(1.5-2.3) 1.7(1.3-2.2) Less than 3 months 251 (36) 355 (51) 1.0 1.0 Message related to leprosy program Not heard/seen/read 554 (79) 517 (74) 1.3(1.1-1.6) 1.1(0.8-1.5) Heard/seen/read 146 (21) 183 (26) 1.0 1.0 Health care provider delay > 1 month 388 (55) 273 (39) 1.9(1.6-2.4) 1.2(0.9-1.6) 1 month 312 (45) 427 (61) 1.0 1.0 First health care provider consulted Non-qualified Practitioner 111 (16) 92 (13) 1.7(1.2-2.3) 1.1(0.7-1.6) AYUSH Private Practitioner 67 (10) 52 (7) 1.8(1.2-2.6) 1.1(0.7-1.8) Allopathy private practitioner 227 (32) 151 (22) 2.1(1.6-2.7) 1.6(1.1-2.2) Public health system 295 (42) 405 (58) 1.0 1.0 Failure to recognize leprosy in first 2 visits by public health facility Yes 240 (34) 191 (27) 1.4(1.1-1.7) 1.4(1.04-1.8) No 460 (66) 509 (73) 1.0 1.0 Failure to recognize leprosy in first 2 visits by Non-qualified practitioners Yes 79 (11) 38 (5) 2.2(1.5-3.3) 2.0(1.2-3.3) No 621 (89) 662 (95) 1.0 1.0 Failure to recognize leprosy in first 2 visits by qualified private practitioners Yes 224 (32) 142 (20) 1.8(1.5-2.4) 1.5(1.1-2.0) No 476 (68) 558 (80) 1.0 1.0 42% cases and 58% controls first sought a care from public health facility Only 21% cases and 26% controls had seen/heard/ read messages related to leprosy before their diagnosis

Key Recommendations 1.Appropriate IEC focusing on key messages like: symptoms, consequence of late detection, availability of free treatment in public health facility, etc. 2. Early case detection campaigns like periodic active survey in endemic spots can reduce duration of delay and promote early diagnosis; 3. A standard operating procedure for effective systematic contact management may be in place.

Key Recommendations 4. Missed opportunity to suspect or diagnose leprosy case among the public health care providers to be addressed. 5. Engage Private health care Providers in national programme for early detection and timely referral through effective public-private partnership 6. Disability audit in districts should be conducted on routine basis

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Acknowledgements Central Leprosy Division/ NLEP Indian Council of Medical Research ILEP Partners and locals NGOs OSD & EO. Joint DHS (Leprosy) & team, West Bengal Dr. Sukumar Das State Leprosy Officer & team, Andhra Pradesh Dr. Rajendra Prasad Addl Director (Health), SLO & team, Gujarat Dr. Dave & Dr. Thakar State Leprosy Officer & team, Maharashtra Dr. Sanjeev Kamble State Leprosy Officer and team, Delhi Dr. K.S. Baghotia Dissemination Support from Dr. Cairn Smith Patients participated in the study GLRA Team Members -Co-investigators (Dr. Vivek Lal, Dr. Sindoora, Mr. Kanagasabapathy) -Co-Principal Investigator Dr. Rajbir Singh -Principal Investigator Dr. Srinivas G 21-12-2017 24