Simplified Information System (SIS).

The Simplified Information System (SIS) was a system of record and report formats that facilitated data analysis at each PHC level. It consisted of 4 leprosy format (LF) forms: the patient case card (LF1), patient treatment record (LF2), MDT stock card (LF3) and monthly reporting form (LF4). One LF1 per patient containing patient details, diagnosis results and monthly treatment dates was maintained by the MPHW at the Sub-Centre level. LF2 and LF3 were records of all leprosy patients plus treatment dates and MDT stock levels within a block or urban area. These forms were contained within the master register which was maintained at block or hospital level. A similar register was maintained at the sector level. LF4 was used to report monthly leprosy indicators for each block or urban area to the District Nucleus. High leprosy indicators suggested areas that may require additional elimination activities (Table 1). The prevalence rate was used to monitor the progress of the local elimination programme, the new case detection rate, MB proportion and child case proportion may indicate high transmission areas, and disability proportions higher than zero may indicate a delay in diagnosis.

We reviewed leprosy records and registers at each PHC clinic for the period 1^st Dec 2004-1^st Dec 2005, to evaluate programme performance. In addition to leprosy indicators, the number of leprosy cases that were misdiagnosed, re-registered or defaulted from MDT was also deduced.

Suspect referral forms (new case validation).

New case validation was implemented in Orissa on 1^st April 2005. The PHC MO would make the initial diagnosis and then refer the suspect case for validation using a suspect referral form. Part 1 of the form remained at the PHC clinic and Part 2 was sent to the validating MO. The suspect referral form did not form part of the SIS system. The suspected case was usually seen by the validating MO within 1 month. If leprosy was confirmed, the patient was given the first dose of MDT and either registered and referred to the appropriate Sub-Centre for continuation of treatment or sent to his/her local PHC clinic.

We reviewed the suspect referral book and cross-matched with the master register. The proportion of suspect cases; misdiagnosed, put under observation (indeterminate diagnosis) or re-registered was deduced. The proportion for which validation was pending more than one month after referral was also deduced.

Diagnosis and treatment.

The quality of leprosy diagnosis and treatment services was generally of a high standard. All PHC staff were knowledgeable about the signs and symptoms of leprosy and methods of diagnosis. MDT treatment procedures and recording on patient cards were also followed correctly. Almost all PHC staff expressed satisfaction with the quality and frequency of training provided during functional integration.

MDT adherence was high in Bargarh district (the average defaulter rate was 3.83%), illustrating the high quality of leprosy treatment and counselling services in GHS (Table 3, Table 4).

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Table 3. Leprosy, MDT adherence and Validation indicators in Bargarh district, Orissa (Rural).

https://doi.org/10.1371/journal.pone.0008351.t003

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Table 4. Leprosy, MDT adherence and Validation indicators in Bargarh district, Orissa (Urban).

https://doi.org/10.1371/journal.pone.0008351.t004

Registration of leprosy cases and MDT stock management.

Patient cards, sector registers and master registers were well maintained in all PHC clinics. However there was much variability in responsibility for the master treatment register at block or hospital level. Usually the pharmacist or PMW managed the register but occasionally supervisors, Block extension educators or the DN non-medical supervisor took responsibility. This was particularly evident in urban hospitals where medical staff were extremely busy and the PMW or district nucleus therefore assumed many of the leprosy programme responsibilities. Although this did not appear to affect the quality of SIS, urban PHC staff acknowledged a minimal understanding of leprosy management indicating capacity-building of urban PHC staff was compromised. Conversely block or hospital MDT stock management was almost always managed by, and managed effectively, by the pharmacist.

The timing of defaulter tracing varied from 2–3 days to 2 months and was generally performed quicker in rural areas. The following illustrates the importance of defaulter tracing, continuous counselling and patient follow-up:

Patient 3E, 35 years old, was diagnosed with MB leprosy 4 years ago after developing clawing of his right hand and anaesthesia in his right foot. The MO explained about leprosy, the importance of regular treatment and how to carry out self-care. He was a poor man and had to find work so he stopped taking MDT after 6 months and travelled back to his home village (he did not know that he could take the remaining treatment with him). He did not inform the hospital and does not think they tried to trace him. He has since developed painful neuritis in his hand and a maggot-infested tropic ulcer on his right toe. He was charged 200 rupees for antibiotics which he could not afford and the toe was amputated. He was back now but too scared to restart MDT in case he was given more bad news.

Validation.

The basis of our evaluation of the validation system was the suspect referral book at block or urban hospital level. The proportion of suspect cases successfully validated, misdiagnosed, under observation, re-registered or with validation still pending was deduced from this book. However the suspect referral book was not included in the SIS system. Therefore the PHC clinics had no clear guidelines for recording the validation process. The result of validation was generally noted on Part 2 of the suspect referral form which the validating MO signed and returned to the PHC pharmacist or PMW. If the suspect case was not seen, the validating MO retained Part 2. If the validating MO, PHC pharmacist or PHC PMW did not note the result of validation on Part 1 of the form, still attached to the suspect referral book, there would be no validation record at the PHC clinic as Part 2 was often given to the patient as a record of the result (and to be used as a personal treatment card). If the suspect case did not appear in the master register as a confirmed leprosy case it was not clear whether the patient had been seen for validation or whether validation was still pending.

Generally the validation result was noted on Part 1 or it was possible to deduce using the master register. A missing result was noted as ‘validation pending’ for this study although it was possible that some cases had been validated but had not registered and initiated treatment. Sambalpur was removed from the validation analysis (although the numbers observed are shown in Table 4) as completion of suspect referral forms was carried out on the validation dates (i.e. for those suspect cases that had attended the validation session) instead of at the time of diagnosis. Therefore Sambalpur had no record of the true number of suspect cases for which validation was pending.

Mean misdiagnosis and re-registration were 4.45% (95% CI 0.46%–8.45%) and 4.92% (95% CI 3.23%–9.89%) respectively (Table 3, Table 4), lower than that suggested by the NIHFW [4], although particular attention should be paid to Barpali (mean misdiagnosis = 23.81%), Katapali (mean re-registration = 16.67%) and Sambalpur (mean proportion of suspect cases under observation = 25.0%). Misdiagnosis appeared to be higher in urban areas, 10.16% (95% CI 3.72%–16.59%), than rural blocks, 1.03% (95% CI 0%–3%), P = 0.001 although the opposite appeared to be the case for re-registration, rural, 7.39% (95% CI 3.74%–11.05%) versus urban, 2.38% (single observation), P = 0.008. Urban areas may thus benefit from increased training in leprosy diagnosis while increased counselling at RFT may be required in rural blocks.

The most striking observation was the proportion of suspect cases for which validation was still pending more than 1 month after initial diagnosis, 26.48% (95% CI 21.42%–31.53%). This was particularly evident in rural blocks, 31.69% (95% CI 24.78%–38.60%) compared with urban areas, 17.78% (95% CI 10.24%–25.33%), P = 0.01 and some cases dated back to April 2005 (although the majority, 21.4%, were awaiting validation 1–3 months after initial diagnosis). It was possible that recording error was responsible for some of these observations or that suspect cases were validated elsewhere. However follow-up of these cases was critical.

Validation has two objectives, firstly to reduce the proportion of misdiagnosis and re-registration and secondly to improve the leprosy diagnosis skills of PHC MOs by performing validation in their presence. However PHC MOs, particularly in urban areas, were often not present at validation and admitted that they had little further knowledge of patients after referring for validation. In addition, in an effort to reduce the multiple visits required of patients, PMWs and MPHWs often referred suspect cases directly to validation, bypassing the PHC MO. This reduced exposure of the PHC MOs to leprosy patients and reduced their capacity to diagnose leprosy. The following illustrates how the validation process can delay initiation of treatment and could lead to non-validation.

Patient 6C, 25 years old, was diagnosed with MB leprosy 6 months ago after noticing anaesthetic patches on his chest, back and knee and joint pains. He knew from TV and posters that this could be leprosy so he went straight to his local ‘PHC new’ clinic. However he was referred to the block PHC 8 km away for validation. The validating MO did not come so he was sent to another PHC clinic 12 km away for validation. Again he missed the validating team and was sent to the medical college 20 km away for validation. He was told that they were not permitted to validate his diagnosis. His diagnosis was eventually confirmed nearly 2 months after the initial diagnosis.

Counselling.

Counselling of leprosy patients should be carried out at all stages of the programme including at diagnosis, during treatment and at RFT. This ensures MDT adherence, allays fears and warns of possible drug side effects or complications. At RFT it was important to reassure patients if anaesthesia or deformities have not disappeared as these patients may otherwise try to obtain more MDT from another PHC clinic. Re-registration of RFT cases incorrectly raises the leprosy prevalence rate.

All PHC staff were knowledgeable in counselling messages. However initial counselling was generally carried out by validating staff, particularly in urban hospitals. In rural areas counselling during MDT and at RFT was usually carried out at the Sub-Centre level by MPHWs. However in urban hospitals or busy block PHCs, pharmacists often had no time to counsel patients. There appeared to be no further follow-up of patients post-RFT unless LEPRA Society was active in the area.

Patient 3F, 42 years old was diagnosed with PB leprosy 1 year ago. He came to the urban hospital monthly for MDT but saw little improvement in the anaesthetic patch. He discontinued MDT for 2 months but then decided to continue. He received the remainder but saw no further improvement. He was not told that he had completed the course until a month later when he returned for his next dose. He wanted to continue because the patch was still anaesthetic but was told he couldn't. He believes treatment should continue until symptoms disappear. Now he feels it may get worse. He has since developed a silent ulcer on his foot. He thinks that he was diagnosed incorrectly and it wasn't leprosy because the treatment didn't work.

It was important that patients were advised to check families for symptoms as there were no longer active searches or surveys. New case detection now relied on voluntary reporting. In the rural system MPHWs often examined families in the home during patient follow-up visits. Otherwise patients were advised to refer family members with leprosy symptoms for examination. In the urban system patients were not usually advised about family members (except by AWWs in Bargarh municipality).

Management of complications.

PHC staff recognised the signs and symptoms of leprosy reactions such as Type I and II reactions (reversal reaction and erythema nodosum leprosum respectively) and neuritis and immediately referred patients to PHC MOs for prednisolone treatment. Reaction cases were generally followed up by MPHWs in rural blocks and PMWs in urban areas.

Prevention of disability (POD) and ulcer care however were much more variable. MOs would either advise self-care, prescribe antibiotics or refer patients to the attendant for dressing. MPHWs generally advised self-care but few carried out ulcer care. This may be due to lack of materials or lack of training. LEPRA Society and more recently GOI have organised POD camps in Bargarh district. These camps demonstrated practical skills in ulcer care and POD methods. The following illustrates how effective self-care and exercises can be in preventing disability:

Patient 7D, 29 years old, was diagnosed with MB leprosy after noticing some weakness in her right little finger. She started MDT and was advised to soak her hands and apply oil daily. She was given exercises to carry out daily, morning and night, to straighten the hand. She has been determined to prevent this disability and has followed the advice consistently. After 6 months she no longer has a claw hand but some weakness remains.

There may be an issue of stigma in relation to ulcer and POD care. Some MPHWs in rural blocks preferred not to treat ulcers (although this may not be related to leprosy stigma). There were claims that in urban hospitals the MOs or other PHC staff tried to dismiss leprosy patients as quickly as possible to avoid unease amongst other patients, medical staff (including dressers) and the leprosy patients themselves.

Provider 1GH, 34 years old, said that MOs (in an urban hospital) were extremely busy and usually had no time to explain leprosy to patients and convince them to take MDT. Also there was still stigma. Other patients would not stand next to leprosy patients. The MO immediately referred leprosy patients to the district nucleus. Ulcer cases did not generally come to the hospital. They usually went to nearby mission hospitals because there were no dressing facilities or the dressers would not dress leprosy patients, probably because of stigma because they would dress other wounds. Maybe other patients complain and tell him not to do it (this was denied by the dresser).

In urban areas, patients with deformities or disabilities could be referred to the orthopaedic surgeon within the hospital. However in rural areas where LEPRA Society was not active there was little knowledge of treatment options for patients with deformities. Socioeconomic rehabilitation advice was a much neglected area of leprosy care but often the most important to the patient. LEPRA Society and some PHC blocks were attempting to rectify this by helping patients apply for GOI pensions for the handicapped (a 3% quota has been allocated to leprosy). RFT certificates were issued by the PHC clinics to help with the application process.

Patient 3C, 34 years old, was diagnosed with MB leprosy 3 months ago after noticing anaesthesia and abnormality of her right foot. She has been unable to work since developing an ulcer there. She was very poor and has a very small house. She needs any assistance to help buy rice. There was a ‘Below Poverty Line’ (BPL) card that would be helpful but she doesn't have one. The Panchayat (local administrative council) did not record her in the book. Her eldest son has developed a hernia and was in pain and needs surgery but she cannot afford it. Nobody is listening.

IEC (community awareness).

Current GOI strategy was to carry out high profile IEC campaigns once or twice per year, using a range of methods such as TV, radio, posters, pamphlets, IEC vans, film shows and folk dances. These were effective in creating leprosy awareness in the community and encouraging new cases to come forward for detection. The low disability rate in Bargarh district (2.34% in October 2005) indicated that diagnosis was occurring at an early stage. In addition stigma appeared greatly reduced particularly in rural areas where patients were no longer ostracised from communities.

Between IEC campaigns there was very little IEC activity unless LEPRA Society was active in the area. MPHWs (and AWWs in Bargarh municipality) occasionally used flash cards in small meetings and carried out IPC (interpersonal communication) during field visits. However they had many responsibilities and often had too little time to carry out effective IEC.

Training (provider awareness).

Leprosy training during functional integration and subsequent capacity-building by DTSTs was generally considered thorough, useful and interesting. Most PHC staff felt they had gained from their increased knowledge and expertise in leprosy. The only area lacking and in which they wanted more practical experience was ulcer, POD and disability care. No evaluation, however, of training efficacy has been carried out.