Awad Mataria¹, Reza Majdzadeh², Deena Al Asfoor³, Hassan Salah⁴ and Zafar Mirza^5,6

Director, Universal Health Coverage and Health Systems, World Health Organization Regional Office for the Eastern Mediteranean, Cairo, Egypt. ²Interdisciplinary Research and Practice Division, School of Health and Social Care, University of Essex, Colchester, United Kingdom. ³Consultant, Primary Health Care, Universal Health Coverage and Health Systems, World Health Organization Regional Office for the Eastern Mediteranean, Cairo, Egypt (Correspondence: D. Al Asfoor: عنوان البريد الإلكتروني هذا محمي من روبوتات السبام. يجب عليك تفعيل الجافاسكربت لرؤيته.). ⁴Regional Advisor, Primary and Community Health Care, Universal Health Coverage and Health Systems, World Health Organization Regional Office for the Eastern Mediteranean, Cairo, Egypt. ⁵Professor of Health Systems, Shifa Tameer-i-Millat University, Islamabad, Pakistan. ⁶Department of Health System Development, World Health Organization Regional Office for the Eastern Mediteranean, Cairo, Egypt.

Citation: Mataria A, Majdzadeh R, Al Asfoor D, Salah H, Mirza Z. Translating political commitments into actions by designing and implementing packages for priority services for universal health coverage in the Eastern Mediterranean Region. East Mediterr Health J. 2023;29(x):xxx-xxx https://doi.org/10.26719/emhj/23.112

Received: 29/11/22, Accepted: 26/04/23

Copyright: © Authors; licensee World Health Organization. EMHJ is an open access journal. All papers published in EMHJ are available under the Creative Commons Attribution Non-Commercial ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo).

Abstract

Background: All countries strive to deliver equitable, efficient, and sustainable health services, driven by the goal of achieving universal health coverage (UHC). However, identifying what and what not to deliver remains a challenge for policy-makers, especially in resource-constrained countries.

Aims: To develop guidance to support countries in the Eastern Mediterranean Region and develop packages of services for UHC.

Methods: We used narrative reviews, national experiences, and expert consultation to develop step-by-step guidance for developing national packages of services for UHC.

Results: The process of developing a package of services for UHC included preparation, development, and implementation phases, with several steps within each phase. These processes were iterative, and the package of services for UHC should be continuously monitored and reviewed according to the evolving morbidity pattern.

Conclusion: Developing a package of services is a significant milestone for UHC in the Eastern Mediterranean Region.

Keywords: universal health coverage, health benefits package, health systems, health services, prioritization

Introduction

Universal Health Coverage (UHC) means that all individuals and communities receive the health services they need, with good quality and without suffering financial hardship (1). The health services should include promotion, prevention, treatment, rehabilitation, and palliative care (2). However, limited resources, evolving health needs, increasing expectations of individuals, and rapid technological developments all challenge the realization of UHC in most countries (3, 4). To address the equity and efficiency dilemma associated with the trade-offs between the 3 UHC dimensions of whom to cover, what to cover, and to what extent to cover, the Lancet Commission on Investing in Health proposed in 2013 the progressive universalism approach (4). This approach hinges on defining a high-priority package of interventions for the entire population, while ensuring financial protection for all and introducing additional interventions as resources are made available.

In 2018, Member States of the WHO Eastern Mediterranean Region (EMR) endorsed the Salalah Declaration on UHC as a regional roadmap to achieve UHC by 2030 (5). This declaration is anchored on defining what to cover under a national health agenda as a basis for advancing UHC through progressive universalism. The programmes, services, and interventions to be considered are labelled packages of priority services for UHC (6, 7). Designing and implementing such a package allows governments to focus their financial, technical, and managerial support on prioritized programmes, services, and interventions with maximum impact on the health and well-being of the population (8).

Defining a package of services for UHC

The EMR defines a package of services for UHC as a set of health interventions to which a population is guaranteed access through a range of government assurance mechanisms. These mechanisms may include direct financing or direct service provision for some groups, mandatory contribution and prepayment schemes, and regulatory structures that constrain what public and private entities must pay for or deliver. Packages are usually designed to: include interventions that are essential to meet people’s needs throughout their lifespan; include services for many diseases and population-specific programmes; and span the full spectrum of promotive, preventive, resuscitative, curative, rehabilitative, and palliative care (9, 10). Identifying what to include in a package of services for UHC should follow several principles, such as: (1) high quality and patient-centred care; (2) support of progressive universalism; (3) context specificity and based on explicit criteria; (4) coverage by relevant financial arrangements; (5) democratic and inclusive; (6) support for health system planning and implementation; (7) strengthening of health security; (8) use of evidence-informed and deliberative processes; and (9) openness and transparency in all steps of the process (11). Deciding upon what is in and what is out of a package of services for UHC requires a systematic and institutionalized process with clearly defined criteria. To support countries in designing their own package, the Regional Office for the Eastern Mediterranean has outlined a set of key considerations for Member States (12, 13).

Regional status and challenges

Natural and human-made emergencies in the EMR contribute to many challenges that undermine performance of the health system and limit health outcomes. Currently, 8 of 22 countries in the EMR face complex humanitarian emergencies (14). More than 30 million people in the EMR are displaced, and 108 million need humanitarian assistance (15). At the same time, changes in lifestyle and the environment are shifting the morbidity and mortality patterns in all countries, including in countries affected by fragility, conflict, and violence (16). Those factors, in addition to weak performing health systems in some countries that have inefficient governance structures and processes, inadequate financial protection arrangements, unregulated private sector delivery, shortage in the health workforce, and limited access to essential drugs and vaccines, have slowed progress towards UHC (17). In the EMR, the Service Coverage Index ranged between 25.0% and 77.0% in 2020, and in the same year, 6.1 million people experienced catastrophic health expenditure (18, 19). The situation became more challenging following the COVID-19 pandemic as essential health services in almost all countries were interrupted (20).

In most countries in the EMR, it is unclear which health services have been chosen based on defined criteria, such as the burden of disease or health needs, and whether those services were updated following any change in the epidemiological situation and population characteristics. Provision of relevant health services across the various levels of the health system, and defining clear patient pathways and referral systems, can improve the quality, equity, and efficiency of the health system. It is our conviction that all EMR countries could benefit from instituting evidence-informed decisions to expand their service coverage (21).

Many countries in the EMR have developed packages of services for UHC. However, some still maintain implicit entitlements, leaving room for inequity, ambiguity, and health system inefficiencies. Despite ample support of donors for development of packages of services for UHC in countries affected by fragility, conflict, and violence, the packages developed are not always adequately implemented, further compromising service coverage and financial protection (22). We argue that an evidence-informed approach to developing explicit packages of services for UHC can promote efficient utilization of resources, and enhance health equity, service quality, and governance structures and mechanisms.

Status of packages of services for UHC in selected EMR countries

Several countries have explicit packages of services for UHC under various names. The processes for developing those packages vary between countries, and it is unclear whether all relevant stakeholders are engaged in the process in many countries. The packages agreed upon may or may not be provided, and the quality standards of the services are unclear. Table 1 describes the process and stage of development of the packages in some EMR countries.

Designing a national package of services for UHC

We outline a proposed set of steps to be followed by countries as they define their packages of services for UHC. Some of these steps could be executed simultaneously.

Phase 1: preparation

Advocacy and awareness: initially, an advocacy campaign is planned to mobilize policy-makers and stakeholders, including academia, civil society, and parliamentarians, at the national and subnational levels.

Establishment of an organizational structure and mechanism: with Ministry of Health leadership, a committee responsible for the planning and development of the package is established. This committee is composed of: policy-makers; health service managers; representatives of the national health insurance agency; representatives from the ministry of finance; epidemiologists; health economists; health system experts; patient associations; and representatives of nongovernmental organizations, WHO, and other development partners.

Stakeholder engagement: the stakeholder analysis identifies relevant groups and institutions and examines their perceptions, attitudes, and influence, and accordingly develops an engagement plan, taking stock of stakeholder power dynamics, and capitalizes on available resources within the country (23). Potential stakeholders who should be considered when mapping are: patients, the public and carers (the community), opinion leaders, healthcare providers and health professionals, purchasers, payers, policy-makers, product makers (manufacturers and technology producers), and academia (24).

Phase 2: development

Situation analysis: this describes the current package, health system functions and architecture, governance, and administrative arrangements, and the human and financial resources and capacities.

Data and evidence: priority health problems are identified from available data sources, such as the Global Burden of Diseases Study, electronic medical records, national official statistics, and peer-reviewed and grey literature. The mapping should also include the geographic and socioeconomic factors of illness.

Dialogue and selection criteria: the responsible focal point coordinates choosing a reference list of interventions as a benchmark. For this, the WHO Service Package Delivery & Implementation Tool is a valuable resource that incorporates several packages such as the EMRO reference package, EMRO reference package for emergency situations, and national service packages. While choosing their respective packages, countries should consider the benefits and drawbacks of the available resources and choose from the ones most consistent with the local context (13, 25–27). The package of services for UHC focal point and working groups determines the criteria that guide the selection of interventions through a consultative process. Some of the criteria used are (28): availability of resources; feasibility of implementation; cost-effectiveness of the proposed interventions; socioeconomic distribution of the health concern; availability and sustainability of funding; budget impact; political and community acceptance; and political interest and commitment. After the national team (the focal point and relevant working group) decide on the criteria, the package of services is chosen quantitatively using multiple-criteria decision analysis. Alternatively, the package focal point uses qualitative methods, such as policy dialogues and nominal group techniques, to choose relevant interventions (29–31).

Decision: at this stage, legal instruments are issued to adopt the package of services nationally. The laws and regulations are issued in compliance with the country’s legal and administrative environment.

Phase 3: implementation

Communication: the package of services for UHC is disseminated to relevant stakeholders, such as policy-makers, funders, service providers, and the community, using appropriate communication strategies and channels.

Institutionalization: implementation bodies should be aware of the package and their role in implementing it. Each body is responsible for devising the necessary institutional arrangements for implementation. Operational capacities and resource gaps could surface at this stage, and a mechanism should be installed to identify those gaps and coordinate relevant solutions.

Monitoring and evaluation: A monitoring body develops indicators for implementing the package, identifying implementation gaps, and evaluating the impact of the package. Also, a separate entity should monitor the epidemiological situation and highlight population health risks.

It is crucial to establish a systematic revision process through which interventions are added, removed, or modified according to the changing morbidity and mortality pattern in the country. The frequency of the review is country specific, and depends on the evolving epidemiological situation and anticipated modifications or health system reforms. For example, where the disease pattern is consistent, and no human-made or natural crises are anticipated, the package of services could be revised every 5 years. In more volatile situations, or in the event of a crisis, or a drastic shift in the population or epidemiological structure, such as when migrant numbers suddenly increase, health authorities may wish to revise the package more frequently, every 2 years, or even immediately after a crisis.

Conclusion

Despite the COVID-19 pandemic, health policy-makers worldwide must sustain progress towards UHC. Lack of access to services during the pandemic precipitated a broader healthcare access gap and drove more people into financial hardship (32). Undoubtedly, UHC indicators have worsened, and the disruption of essential health services has created a global rise in mortality and morbidity (33). The pandemic has highlighted gaps in the current service delivery, and the need to develop country-specific, fit-for-context models of care. Recovery from the pandemic provides an opportunity for integrating vertical health programmes, for example: communicable and noncommunicable diseases; mental health; and reproductive, maternal, neonatal, child, and adolescent health, to enhance people-centeredness, responsiveness, and efficiency, and define integrated, comprehensive, essential health service packages (34).

Competing priorities and financial pressures often influence the choice of health services to be maintained during emergencies. In such conditions, the need for rapid solutions renders evidence-informed policy decisions unlikely. However, having a package of services for UHC can support countries in defining a priority list of essential health services, thus fostering efficient and fair solutions in times of crisis (35).

A well-developed package of services for UHC can be the centrepiece of a healthcare system and help shape all other elements in the health system (6). Designing a package is the first step in ensuring that health services reach those who need them. All health system components must be rearranged to deliver those entitlements. Well-defined, coherent processes, an adequately trained health workforce, accountable institutions, rationally selected drugs and technologies, equitable and sustainable financing arrangements, and high-performing health information systems are all prerequisites for effective implementation of the package (36). Eliciting and managing people’s expectations and educating them about their entitlements are essential to advance the UHC goals of equity in access, quality, and financial protection (7). During implementation, countries could prioritize certain disadvantaged groups, such as poor people, and strengthen the referral systems between various delivery platforms to ensure timely and uninterrupted health services, and consequently, successful implementation of the package.

Health entitlements supported by the legislative tools can help mitigate the impact of protracted fragility and increased healthcare needs in countries affected by violence, natural disaster, or war. Intense efforts are needed to build member states’ capacities in priority setting, evidence generation and utilization, fiscal space analysis, intersectoral and community engagement, and the rule of law (37-).

Conflict of interest: None.

Table 1. Status of development and implementation of universal health coverage priority benefits packages in the Eastern Mediterranean Region

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Mohammad Zeinali^1,2, Mehdi Mohebali^1,3, Mohammad Shirzadi², Gholamreza Hassanpour³, Atefeh Behkar³, Mohammad Gouya², Siamak Samiee⁴, Hossein Afzali⁵

¹Department of Medical Parasitology and Mycology, School of Public Health, Tehran University of Medical Sciences, Tehran, Islamic Republic of Iran (Correspondence: M. Mohebali: عنوان البريد الإلكتروني هذا محمي من روبوتات السبام. يجب عليك تفعيل الجافاسكربت لرؤيته.). ²Center for Communicable Diseases Management, Ministry of Health and Medical Education, Tehran, Islamic Republic of Iran. ³Center for Research of Endemic Parasites of Iran, Tehran University of Medical Sciences, Tehran, Islamic Republic of Iran. ⁴Reference Health Laboratory, Ministry of Health and Medical Education, Tehran, Islamic Republic of Iran. ⁵Iranian Academy of Medical Sciences, Tehran, Islamic Republic of Iran.

Abstract

Background: The lack of an integrated national system prevents the Islamic Republic of Iran from registering and reporting all cases of cutaneous leishmaniasis (CL).

Aims: To establish a laboratory network to improve diagnosis and surveillance of CL in endemic areas of the Islamic Republic of Iran using parasitological and molecular methods.

Methods: This was a pilot study in the 2 endemic areas for CL in the Islamic Republic of Iran. Using the primary healthcare laboratory network, a 3-level surveillance system was established. We compared misdiagnosis, new cases, clinical relapses, treatment resistance, and treatment failure before and after establishment of the network.

Results: We studied 49 laboratories. Network implementation reduced relapse of CL. After the laboratory training, the average misdiagnosis rate decreased from 49.3% to 4.2% for positive microscopic slides and from 31.6% to 12% for negative slides.

Conclusion: Implementation of a CL laboratory network enhances diagnosis, unifies diagnostic methods, and improves patient care.

Keywords: cutaneous leishmaniasis, laboratory network, capacity building, pilot study, Islamic Republic of Iran

Citation: Zeinali M, Mohebali M, Shirzadi MR, Hassanpour G, Behkar A, Gouya MM, et al. Integration and evaluation of cutaneous leishmaniasis laboratory diagnosis in the primary healthcare laboratory network. East Mediterr Health J. 2023;29(x):xxx-xxx https://doi.org/10.26719/emhj/23.105  Received: 22/10/22, Accepted: 03/03/23

Copyright: © Authors; licensee World Health Organization. EMHJ is an open access journal. All papers published in EMHJ are available under the Creative Commons Attribution Non-Commercial ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo). 

Introduction

Leishmaniasis encompasses a group of neglected tropical diseases caused by Leishmania parasites. According to WHO, leishmaniasis is endemic in at least 98 countries, with 12 million cases, 350 million at risk of infection, and > 20 000 deaths annually (1). There are three types of leishmaniasis: visceral, cutaneous, and mucocutaneous, and cutaneous leishmaniasis (CL) is the most prevalent. It affects the skin, causing lesions and ulcers on exposed areas, leaving permanent scars and stigma, or severe impairment (2).

The Islamic Republic of Iran is an area of CL endemicity (2). A recent meta-analysis estimated that the pooled prevalence of CL in the country was 45% (3), indicating that the disease requires attention. Although the Islamic Republic of Iran has 20 000 new cases of CL annually, the actual number is likely several times higher (4, 5). It appears that a significant number of cases of CL are neither reported nor registered in the Islamic Republic of Iran. This demonstrates the lack of an integrated national system that standardizes and unifies diagnostic tools and treatment plans. Establishment of a laboratory network would standardize and unify diagnostic techniques for CL and aid in differentiating it from other skin diseases. It would also assist in registering and reporting new cases, relapses, treatment failure, and treatment-resistant cases.

This study is believed to be the first effort to establish a laboratory network for CL in the Islamic Republic of Iran and other endemic countries in the Middle East. This study aimed to establish and evaluate a laboratory network to diagnose CL, which will aid in developing a model for improving health care for leishmaniasis in the Islamic Republic of Iran.

Methods

Study design and settings

This was a descriptive cross-sectional pilot study conducted from 2014 to 2016 in 2 areas of the Islamic Republic of Iran: Ilam in the west, which is endemic for zoonotic CL, and Mashhad in the east, which is endemic for anthroponotic CL. We used the primary healthcare laboratory network to establish a surveillance system for active and passive detection of CL during 6 months. The network consisted of 3 levels: sentinel laboratories, university reference laboratories, and national laboratories. The National Health Laboratory was responsible for monitoring the performance of laboratories at all levels and quality control of diagnostic tools (Figure 1). We conducted continuous monitoring of all centres for up to 2 years. The study protocol was approved by the Ethics Committee of Tehran University of Medical Sciences, and the findings were published confidentially with the approval of the authorities (IR TUMS.VCR.REC.1395-373). Figure 2 shows the process of implementation of a pilot cutaneous leishmaniasis laboratory network.

Sentinel laboratories

Urban and rural health service laboratories

These laboratories were responsible for collecting and sorting patients’ data, and referring new cases, treatment failures, and clinical relapses to the respective district health centre laboratory, as well as sending monthly performance reports.

District health centre laboratories

These laboratories played a crucial role in the diagnosis of CL. They were responsible for: preparing microscopic smears from skin lesions; referring clinically suspicious cases with no negative smear tests to higher-level laboratories; preparing smears from treatment failure/recurrent cases; registering smear test results in the laboratory office; sending the results to physicians daily; monitoring sampling procedures; training laboratory personnel in using national guidelines; and sending monthly reports to university reference laboratories.

University reference laboratories

University reference laboratories performed parasitological culture and microscopic examination of Leishmania spp., and identified the species using additional molecular (polymerase chain reaction; PCR) or immunological (monoclonal antibody) tests. They were responsible for: training employees of the CL diagnostic laboratories; managing and supervising other laboratories affiliated with the university; recording activities and sending results to the university disease control unit; and quality control. They supervised associated laboratories in outlying cities every 3 months through evaluating 20% of negative and 20% of positive slides in endemic regions and all slides in nonendemic regions. They were also responsible for developing an action plan for controlling CL in the areas under supervision of the university, in cooperation with the disease control unit. The action plan included: actively participating in the provincial leishmaniasis committee and reporting on the activities of the laboratory network in the province; holding training workshops to improve the capability of health laboratory experts; and monitoring the performance of subordinates.

National laboratories

National Reference Laboratory for Leishmaniasis

The National Reference Laboratory for Leishmaniasis was responsible for diagnostic confirmation, quality assurance, training, research, evaluation of diagnostic products, and collaboration in health laboratory monitoring. The details of these tasks were approved and notified by the National Health Laboratory. The National Reference Laboratory for Leishmaniasis was also responsible for: examining complex samples that were not diagnosed in the first- and second-level laboratories; collaborating on the compilation and revision of national educational standards and checklists; creating an operational plan in cooperation with the Health Reference Laboratory and Infectious Disease Management Center; designing and collaborating with research projects related to the goals of the network; and cooperating with other scientific institutions abroad and within the country in accordance with the goals of patient care, in close collaboration with the Infectious Diseases Management Center and the National Health Laboratory. Further responsibilities were: evaluation of diagnostic products according to the needs stated by the National Health Laboratory; cooperation with the External Quality Assurance Services programme for health laboratories; quality evaluation of samples from lower-level laboratories upon the request of the National Health Laboratory; participation in the final analysis of laboratory results in annual reports; and submission of a yearly report to the Health Reference Laboratory and Infectious Diseases Management Center detailing past activities and future goals.

National Health Laboratory

The National Health Laboratory was responsible for: developing and revising operational plans, educational guidelines, and checklists for the laboratory diagnostic network for CL in collaboration with the Center for Disease Management and National Reference Laboratory; monitoring laboratory performance at all levels; holding workshops for regional focal points and laboratory inspectors; implementing the External Quality Assurance Services programme for health; and financially assisting and equipping laboratories in accordance with the memorandum of agreement.

Determination of dominant Leishmania species

Samples were taken from individuals with CL who were referred to health centres and had not travelled to other endemic regions. Samples were free from blood and secondary microbial infection, as far as possible, and were taken from a wide area that included the main foci of leishmaniasis in the selected provinces. Sampling was conducted over the entire year.

Microscopic smears were prepared from suspicious cases by removing material from the edge of skin lesions using a sterile lancet, fixing with absolute methanol, and staining with Giemsa stain.

Nested PCR was used to identify the dominant species. The different species of Leishmania were identified by amplification of a high-resolution region of internal transcribed spacer rDNA, as demonstrated previously (9) . The PCR protocol is outlined in Supplementary Table S1.

Assessment tools and outcomes

We had 50 meetings with academics and experts from the Department of Medical Parasitology and Mycology of Tehran University of Medical Sciences, Zoonoses Department of the Center for Communicable Diseases Management, and National Health Laboratory. During these sessions, we developed a diagnostic guideline for CL, and monitoring and evaluation checklists for network implementation (Supplementary Table S2). We held training workshops for 41 individuals from Razavi Khorasan Province and 21 from Ilam Province. Details of the educational content of the workshops is presented in Supplementary Table S3. The design, details of the methodology, and impact of these workshops on knowledge, attitude, and practice of staff have been published previously (10).

We used the census sampling method to include all laboratories in Ilam and Khorasan Razavi. To identify the prevalent Leishmania species, we reviewed 192 positive smears of high quality with a 95% confidence interval and 7.5% margin of error. To evaluate the CL laboratory network, we reviewed 20% of the positive and 20% of the negative samples from each district health centre laboratory before and after implementing the network, using standard microscopic examination methods (11), to estimate the rate of false-positive and false-negative results. We recorded the number of new cases and treatment outcomes (number of relapses, treatment failures, and treatment-resistant cases) throughout the 2-year period before and after network implementation. We used ITS1 gene and nested PCR using kinetoplast DNA for identification of Leishmania major and Leishmania tropica, which were circulating in the pilot study areas (6–8, 12).

Statistical analysis

All statistical analyses were performed using IBM SPSS Statistics for Windows version 25.0 (Armonk, NY, USA). Quantitative data were reported using mean and standard deviation. Frequency was used to report qualitative variables. To assess the internal consistency of the questionnaire, Cronbach’s  was calculated, and > 0.7 indicated a high level of reliability. We used McNemar’s test to compare paired proportions, Fisher’s exact test to analyse the relationship between 2 categorical variables, Wilcoxon’s test to compare 2 paired samples, and the Kruskal–Wallis test to compare ≥ 3 independent groups. P < 0.05 was considered statistically significant.

Results

We studied 15 laboratories in Ilam (10 urban reference laboratories and 5 rural/urban laboratories) and 34 laboratories in Mashhad (19 urban reference laboratories and 15 rural/urban laboratories).

New cases and treatment outcomes

In Ilam, the frequency of new CL cases, relapse after systemic therapy, and relapse after topical therapy decreased following implementation of the network (Table 1). Despite a decline in the number of new cases in Mashhad, relapse, treatment resistance, and treatment failure increased.

Species of Leishmania causing CL

We reviewed 190 positive smears of high quality; 96 from Mashhad and samples from Ilam. In Mashhad, the average age of the individuals from whom smears were obtained was 17.75 years; 45 (46.9%) were women, 35 (36.5%) men, and 16 (16.7%) were unidentified (P = 0.314) (Table 2). The age group most frequently affected was 20–30 years, with a frequency of 19.8%. The number of cases differed significantly among the age groups (P = 0.002). There were significantly more nontravellers (72, 75%) than travellers (24, 25%) (P = 0.001). The season with the most significant number of CL cases was autumn. Ten (10.4%) of the 96 individuals had ulcers, 58 (60.4%) had nodules, and 28 (29.2%) were unreported. The face, cheeks, and hands were the most commonly affected body parts. The dominant species was L. tropica, with a frequency of 85.4%.

In Ilam, the average age of the individuals from whom smears were obtained was 23.47 years; 62 (66%) were men, 29 (30.9%) women, and 3 (3.2%) were unidentified (P = 0.001) (Table 2). The age group most frequently affected was 20–30 years, with a frequency of 17%. The number of cases in each age group did not differ significantly (P = 0.1). There were significantly more nontravellers (92, 97.9%) than travellers (2, 2.1%) (P = 0.001). The season with the highest number of CL cases was autumn. The hands and feet were the most commonly affected body parts. The dominant species was L. major, with a frequency of 79.8%.

Misdiagnosis rate before and after network implementation

We assessed smears at baseline (before network implementation), and 6 months (primary assessment), 12 months (secondary assessment), and 18 months (tertiary assessment) after network implementation (Table 3). The average misdiagnosis rate in the 2 studied areas was 49.3% for positive smears and 31.6% for negative smears. After implementing the network, following regular laboratory training, these rates were reduced to 4.2% and 12%, respectively. For ethical considerations, we removed the studied area names from the table. The total rate of correct diagnosis was significantly higher after intervention in both regions: 0.816 versus 0.93 in study area 1 (P = 0.015) and 0.358 versus 0.86 in study area 2 (P < 0.0001).

Discussion

This study described the establishment of a laboratory network for the diagnosis of CL and the impact of this network on the misdiagnosis rates for both positive and negative smears. Our findings suggested that implementation of a laboratory network for CL increased diagnostic accuracy and decreased diagnostic errors.

Unlike many other infectious diseases, the incidence of CL is increasing globally, including in the Islamic Republic of Iran (1, 2, 4). Also, the number of visceral leishmaniasis epicentres has grown significantly (1). The reasons for these increases include: indiscriminate development of large cities in the form of satellite towns; an increase in wild rodents as disease reservoirs; increased number of sandflies; movement of people, and settlement of nonimmune groups in contaminated areas; and settlement of infected people in areas susceptible to becoming epicentres of the disease (13, 14).

Currently, there is no proven and cost-effective way to control CL (14, 15). There is a mistaken belief among the general population that epidemics of this disease, like other infectious diseases, can be quickly controlled. However, even with appropriate and costly measures, control can take several months to a year. Treatment of CL is time-consuming and associated with numerous complications (16, 17). The disease is more prevalent among poor people, and producing new treatments by pharmaceutical companies is costly. Therefore, there is no motivation to manufacture drugs that are safer and easier to use.

New methods for rapid diagnosis of CL have not yet been implemented in the Islamic Republic of Iran. As a result, patients are occasionally referred to university reference laboratories for CL when they can no longer be treated. In addition to increasing the accuracy and precision of laboratory diagnosis of CL, standardization and unification of diagnostic methods, and the establishment of a unified and active care system in endemic and nonendemic areas would contribute to the improvement of disease management.

The results of our pilot study showed that implementation of a leishmaniasis laboratory network, which included national guidelines for the validation of diagnostic methods, led to consistency in providing uniform training for all laboratory personnel and facilitated diagnosis and referral of patients. Network implementation resulted in accurate identification and reporting of CL, treatment failure, relapse, and treatment resistance. This is important because laboratory confirmation is essential given the time, money, and complications involved in treating CL. Accurate and prompt diagnosis leads to complete registration of cases, decreased prevalence, reduced scar size and disease complications, and a drop in mortality rates.

To identify the dominant species of Leishmania, we used molecular methods of nested PCR and DNA sequencing. Previous studies have identified the predominant CL species in different regions of the Islamic Republic of Iran, with L. major the most prevalent in Ilam (18, 19) and L. tropica the dominant species in Mashhad (20–22). Our findings were consistent with these studies. Although L. major was the predominant species in Ilam, L. tropica was also reported, and although L. tropica was the dominant species in Mashhad, L. major was also documented. These findings highlight the importance of developing a consistent approach for identifying and managing each Leishmania species rather than focusing only on the most prevalent in each region. A standardized national programme should be established to investigate and monitor all relevant Leishmania species on a regular basis. This programme could be administered by universities and research institutes under the supervision of the Infectious Diseases Center and the National Health Laboratory.

The reduction in misdiagnosis rates observed in our study highlighted the importance of providing professional skill and experience-based training to laboratory personnel to improve diagnostic accuracy and ensure the success and progress of quality improvement initiatives.

The main limitation in our study was turnover of laboratory staff. Future steps should include: (1) development of a strategic plan for CL diagnosis and assisting universities to develop short- and long-term plans to establish a national laboratory network for CL diagnosis; (2) estimating the financial, human, and laboratory equipment resources required to establish a nationwide laboratory network; and (3) communication with international organizations to exchange information and gain insight into best practices for establishing and maintaining a successful laboratory network.

Conclusion

Our study revealed that implementation of a laboratory network for CL increased the accuracy of laboratory diagnosis, unified diagnostic methods, and improved the care system for management of CL.

Acknowledgements

We acknowledge the assistance of the Department of Health and Labor Affairs of Ilam and Razavi Khorasan Provinces.

Funding: This project was financially supported by the Tehran University of Medical Science (Grant No: 9121123006); Center for Communicable Diseases Management, Ministry of Health and Medical Education, Tehran; and Reference Health Laboratory, Ministry of Health and Medical Education, Tehran.

Conflicts of interest: none.

Tables and Figures

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