Prescribing practices of tranexamic acid for melasma: Delphi consensus from the Pigmentary Disorders Society.

Introduction There is ambiguity regarding usage of tranexamic acid for melasma in India, be it in its pre-administration evaluation, administration route, dosing or monitoring. Hence, we conducted this study to understand various tranexamic-acid prescribing patterns and provide practical guidelines. Materials and methods A Google-form-based questionnaire (25-questions) was prepared based on the key areas identified by experts from the Pigmentary Disorders Society, India and circulated to practicing dermatologists across the country. In rounds 2 and 3, the questionnaire was re-presented to the same group of experts and their opinions were sought. The results of the practitioners' survey were denoted graphically alongside, to guide them. Consensus was deemed when at least 80% of respondents chose an option. Results The members agreed that history pertaining to risk factors for thromboembolism, cardiovascular and menstrual disorders should be sought in patients being started on oral tranexamic-acid. Baseline coagulation profile should be ordered in all patients prior to tranexamic-acid and more exhaustive investigations such as complete blood count, liver function test, protein C and S in patients with high risk of thromboembolism. The preferred oral dose was 250 mg orally twice daily, which can be used alone or in combination with topical hydroquinone, kojic acid and sunscreen. Repeated dosing of tranexamic-acid may be required for those relapsing with melasma following initial tranexamic-acid discontinuation. Coagulation profile should ideally be repeated at three monthly intervals during follow-up, especially in patients with clinically higher risk of thromboembolism. Treatment can be stopped abruptly post improvement and no tapering is required. Limitation This study is limited by the fact that open-ended questions were limited to the first general survey round. Conclusion Oral tranexamic-acid provides a valuable treatment option for melasma. Frequent courses of therapy may be required to sustain results and a vigilant watch is recommended for hypercoagulable states during the course of therapy.

A Delphi consensus on the nomenclature and diagnosis of lichen planus pigmentosus and related entities.

BACKGROUND: Although well known in clinical practice, research in lichen planus pigmentosus and related dermal pigmentary diseases is restricted due to lack of consensus on nomenclature and disease definition. AIMS AND OBJECTIVES: Delphi exercise to define and categorise acquired dermal pigmentary diseases. METHODS: Core areas were identified including disease definition, etiopathogenesis, risk factors, clinical features, diagnostic methods, treatment modalities and outcome measures. The Delphi exercise was conducted in three rounds. RESULTS: Sixteen researchers representing 12 different universities across India and Australia agreed to be part of this Delphi exercise. At the end of three rounds, a consensus of >80% was reached on usage of the umbrella term 'acquired dermal macular hyperpigmentation'. It was agreed that there were minimal differences, if any, among the disorders previously defined as ashy dermatosis, erythema dyschromicum perstans, Riehl's melanosis and pigmented contact dermatitis. It was also agreed that lichen planus pigmentosus, erythema dyschromicum perstans and ashy dermatosis did not differ significantly apart from the sites of involvement, as historically described in the literature. Exposure to hair colours, sunlight and cosmetics was associated with these disorders in a significant proportion of patients. Participants agreed that both histopathology and dermatoscopy could diagnose dermal pigmentation characteristic of acquired dermal macular hyperpigmentation but could not differentiate the individual entities of ashy dermatosis, erythema dyschromicum perstans, Riehl's melanosis, lichen planus pigmentosus and pigmented contact dermatitis. LIMITATIONS: A wider consensus involving representatives from East Asian, European and Latin American countries is required. CONCLUSION: Acquired dermal macular hyperpigmentation could be an appropriate conglomerate terminology for acquired dermatoses characterised by idiopathic or multifactorial non-inflammatory macular dermal hyperpigmentation.

Consensus in Brazil on the renaming of leprosy to Hansen's disease.

Brazil has been at the forefront in replacing the stigmatising term 'leprosy' with the non-pejorative alternative 'Hansen's disease' ('hanseníase'), with use of the former word prohibited by law since 1995. This change followed decades of advocacy, including by civil society organisations representing people affected by the disease. A survey of people affected by Hansen's disease in Brazil found that 111/112 respondents preferred the alternative term, supporting the view that consideration of non-stigmatising terminology that respects the wishes of people affected by the disease should be part of the WHO Global Leprosy (Hansen's disease) Strategy to achieve 'zero stigma' by 2030.

Consensus on the diagnosis and management of chronic leg ulcers - Brazilian Society of Dermatology.

BACKGROUND: Chronic leg ulcers affect a large portion of the adult population and cause a significant social and economic impact, related to outpatient and hospital care, absence from work, social security expenses, and reduced quality of life. The correct diagnosis and therapeutic approach are essential for a favorable evolution. OBJECTIVE: To gather the experience of Brazilian dermatologists, reviewing the specialized literature to prepare recommendations for the diagnosis and treatment of the main types of chronic leg ulcers. METHODS: Seven specialists from six university centers with experience in chronic leg ulcers were appointed by the Brazilian Society of Dermatology to reach a consensus on the diagnosis and therapeutic management of these ulcers. Based on the adapted DELPHI methodology, relevant elements were considered in the diagnosis and treatment of chronic leg ulcers of the most common causes; then, the recent literature was analyzed using the best scientific evidence. RESULTS: The following themes were defined as relevant for this consensus - the most prevalent differential etiological diagnoses of chronic leg ulcers (venous, arterial, neuropathic, and hypertensive ulcers), as well as the management of each one. It also included the topic of general principles for local management, common to chronic ulcers, regardless of the etiology. CONCLUSION: This consensus addressed the main etiologies of chronic leg ulcers and their management based on scientific evidence to assist dermatologists and other health professionals and benefit the greatest number of patients with this condition.

Consensus on the diagnosis and management of chronic leg ulcers - Brazilian Society of Dermatology

Abstract Background: Chronic leg ulcers affect a large portion of the adult population and cause a significant social and economic impact, related to outpatient and hospital care, absence from work, social security expenses, and reduced quality of life. The correct diagnosis and therapeutic approach are essential for a favorable evolution. Objective: To gather the experience of Brazilian dermatologists, reviewing the specialized literature to prepare recommendations for the diagnosis and treatment of the main types of chronic leg ulcers. Methods: Seven specialists from six university centers with experience in chronic leg ulcers were appointed by the Brazilian Society of Dermatology to reach a consensus on the diagnosis and therapeutic management of these ulcers. Based on the adapted DELPHI methodology, relevant elements were considered in the diagnosis and treatment of chronic leg ulcers of the most common causes; then, the recent literature was analyzed using the best scientific evidence. Results: The following themes were defined as relevant for this consensus - the most prevalent differential etiological diagnoses of chronic leg ulcers (venous, arterial, neuropathic, and hypertensive ulcers), as well as the management of each one. It also included the topic of general principles for local management, common to chronic ulcers, regardless of the etiology. Conclusion: This consensus addressed the main etiologies of chronic leg ulcers and their management based on scientific evidence to assist dermatologists and other health professionals and benefit the greatest number of patients with this condition.

Treatment of histoid leprosy: a lack of consensus.

Histoid leprosy is a rare variant of leprosy with a unique clinical presentation and bacilli rich histology. These patients are large reservoirs for disease and vectors for spread, making prompt diagnosis and treatment crucial. To date, no consensus on treatment and duration exists. This paper aims to investigate the efficacy, safety, and duration of varying treatment regimens in patients with histoid leprosy. A systematic PubMed review of all articles published before January 2020 containing the key words histoid leprosy. All patients included must have completed their prescribed treatments with comment on outcomes and treatment duration. The review generated 165 articles containing 62 cases that met inclusion criteria. A majority of cases reported excellent clinical outcomes with limited adverse events. Regimens included variations of rifampicin, dapsone, clofazimine, minocycline, ofloxacin, and sulforthormadine with most treatment duration lasting 12 or 24 months. Existing literature is limited to case reports or case series and may be subject to publication bias of successful cases. Many reports lack quantifiable data regarding outcomes and rely on clinical judgment. Continued observation for complete clearance or relapse was limited. The findings demonstrate that multibacillary-multidrug therapy is an efficacious and safe treatment for histoid leprosy. No significant differences were observed between 12 and 24 months of treatment. There remains no consensus on treatment duration for histoid leprosy.

Lichen Planus Severity Index: A new, valid scoring system to assess the severity of cutaneous lichen planus.

INTRODUCTION: Lichen planus is a chronic autoimmune inflammatory disorder. At present, there is a lack of any specific scoring system to judge the severity of cutaneous lichen planus. Hence, a study was undertaken to establish and validate a system to define the severity of cutaneous lichen planus, i.e. Lichen Planus Severity Index. MATERIALS AND METHODS: SETTING: Skin outpatient department, Krishna Institute of Medical Sciences, Karad. MODEL: The formulation model was Psoriasis Area Severity Index (PASI) and the validation model was Onychomycosis Severity Index (OSI). PARTICIPANTS: The consensus group included two dermatologists and two dermatology residents with special interest in lichen planus and a statistician. Results of the consensus group were compared with a preliminary reproducibility group of two dermatologists and four dermatology residents. Later, reliability assessment was carried out by two groups: 1. Twenty-one dermatologists scored 20 photographs of four patients of lichen planus after being trained to use Lichen Planus Severity Index. 2. Six doctors (three experts and three randomly selected physicians) evaluated ten real-world patients of lichen planus in skin outpatient department. The physicians were blind to the scores assigned by experts. STEPS TO CALCULATE SCORE: There are five morphological types of lesions seen in lichen planus, namely, erythematous papule, violaceous papule, violaceous plaque, hyperpigmented hypertrophic papule and plaque and postinflammatory hyperpigmentation. Total involved body surface area is determined and a body surface area factor is assigned. Area involvement factor for each of these morphological lesions is calculated and multiplied with the respective multiplication factor. Sum of all the products gives the lesion severity score. Product of lesion severity score with the body surface area factor gives the final Lichen Planus Severity Score. RESULTS: There was no significant difference between the scores of consensus group and preliminary reproducibility group. Both assessment groups showed high reliability. (Group 1: Cronbach alpha = 0.92, ICC = 0.85; Group 2: Cronbach's alpha = 0.99, ICC = 0.92). The correlation between Lichen Planus Severity Index and the standard Physician Global Assessment score was found to be positive (correlation coefficient = 0.73). LIMITATIONS: : The system is tedious and requires a steep learning curve. Possible uses of Lichen Planus Severity Index are yet to be explored and validated. CONCLUSION: Lichen Planus Severity Index is a new reproducible tool to grade the severity of lichen planus.

Guidelines for management of rheumatic diseases in developing countries from basics to real-world situation: relevance, need, and processes for development.

Guidelines or recommendations help to provide uniform standards in medical practice. The development of guidelines requires adherence to pre-defined norms prescribed by different international organizations such as the European League against Rheumatism (EULAR). We searched Pubmed and LILACS to identify published papers in five major rheumatic diseases (rheumatoid arthritis, systemic lupus erythematosus, spondyloarthropathies, osteoarthritis, and scleroderma) from different countries based on their economic prosperity and could find a lack of published literature from most economically weaker regions. Similarly, published guidelines in these rheumatic diseases were sparse from Asia and Africa, which are economically developed to a lesser extent than other regions of the world. Considering differing economic realities driving patient care in different regions of the world, unique challenges in certain geographic areas such as musculoskeletal manifestations of infectious diseases like leprosy and tuberculosis, as well as distinct risk of malignancies and other comorbid conditions, National Rheumatology societies should work towards developing more guidelines for rheumatic diseases from regions such as Asia and Africa, while following strictly the prescribed norms for the same. With a paucity of guidelines for such regions currently, an alternative (although less preferable) suggestion would be that major international societies, whose guidelines are widely read and followed the world over, should consider inputs from experts from diverse regions of the world while developing these guidelines.

Consensus numbering system for the rifampicin resistance-associated rpoB gene mutations in pathogenic mycobacteria.

The rpoB gene codes for the RNA polymerase ß subunit, which is the target of rifampicin, an essential drug in the treatment of tuberculosis and other mycobacterial infections. This gene is present in all bacteria, but its length and nucleotide sequence vary between bacterial species, including mycobacteria. Mutations in the rpoB gene alter the structure of this protein and cause drug resistance. To describe the resistance-associated mutations, the scientific and medical communities have been using, since 1993, a numbering system based on the Escherichia coli sequence annotation. Using E. coli reference for describing mutations in mycobacteria leads to misunderstandings, particularly with the increasing use of whole genome sequencing, which brought an alternative numbering system based on the Mycobacterium tuberculosis rpoB sequence. We propose using a consensus numbering system for the reporting of resistance mutations based on the reference genomes from the species interrogated (such as strain H37Rv for M. tuberculosis). This manuscript provides the necessary figures and tables allowing researchers, microbiologists and clinicians to easily convert other annotation systems into one common language.

Evaluation of the Primary Care in leprosy control: proposal of an instrument for users / Evaluación de la atención primaria en el control de la hanseniasis: propuesta de una herramienta destinada a los usuarios / Avaliação da Atenção Primária no controle da hanseníase: proposta de uma ferramenta destinada aos usuários

Objective Developing an instrument to evaluate the performance of primary health care in the leprosy control actions, from the perspective of users and do the face and content validation. Method This is a methodological study carried out in four stages: development of instrument, face and content validation, pre-test, and analysis of test-retest reliability. Results The initial instrument submitted to the judgment of 15 experts was composed of 157 items. The face and content validation and pre-test of instrument were essential for the exclusion of items and adjustment of instrument to evaluate the object under study. In the analysis of test-retest reliability, the instrument proved to be reliable. Conclusion The instrument is considered adequate, but further studies are needed to test the psychometric properties.
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Objetivo Desenvolver um instrumento para avaliação do desempenho da atenção primária à saúde na realização das ações de controle da hanseníase na perspectiva dos usuários e realizar a validação de face e conteúdo. Método Trata-se de um estudo metodológico realizado em quatro etapas: desenvolvimento do instrumento, validação de face e de conteúdo, pré-teste e análise da confiabilidade teste-reteste. Resultados O instrumento inicial, submetido ao julgamento de 15 especialistas, era composto por 157 itens. A validação de face, conteúdo e pré-teste do instrumento foi fundamental para a exclusão de itens e adequação do instrumento para avaliar o objeto em estudo. Na análise de confiabilidade teste-reteste, o instrumento mostrou-se fidedigno. Conclusão O instrumento é considerado adequado, mas são necessários novos estudos para o teste das propriedades psicométricas.



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Objetivo Desarrollar un instrumento para la evaluación del desempeño de la atención primaria a la salud en la puesta en marcha de las acciones de control de la hanseniasis bajo la perspectiva de los usuarios y realizar la validación de cara y contenido. Método Se trata de un estudio metodológico llevado a cabo en cuatro etapas: desarrollo del instrumento, validación de cara y de contenido, pre-prueba y análisis de la confiabilidad de prueba-reprueba. Resultados El instrumento inicial, sometido al juicio de 15 expertos, estaba compuesto de 157 ítems. La validación de cara, contenido y pre-prueba del instrumento fue fundamental para la exclusión de ítems y la adecuación del instrumento para evaluar el objeto de estudio. En el análisis de confiabilidad de prueba-reprueba, el instrumento se mostró fehaciente. Conclusión Se considera el instrumento adecuado, pero son necesarios nuevos estudios para el test de las propiedades psicométricas.
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[Evaluation of the primary care in leprosy control: proposal of an instrument for users]. / Avaliação da atenção primária no controle da hanseníase: proposta de uma ferramenta desttinada aos usuários.

OBJECTIVE: Developing an instrument to evaluate the performance of primary health care in the leprosy control actions, from the perspective of users and do the face and content validation. METHOD: This is a methodological study carried out in four stages: development of instrument, face and content validation, pre-test, and analysis of test-retest reliability. RESULTS: The initial instrument submitted to the judgment of 15 experts was composed of 157 items. The face and content validation and pre-test of instrument were essential for the exclusion of items and adjustment of instrument to evaluate the object under study. In the analysis of test-retest reliability, the instrument proved to be reliable. CONCLUSION: The instrument is considered adequate, but further studies are needed to test the psychometric properties.


A Delphi consensus on criteria for contraindications, assessment indicators and expected outcomes related to tibialis posterior transfer surgery.

A team of experts in the field of reconstructive surgery for leprosy-affected people was identified. Using the Delphi method, an exercise was undertaken to ascertain whether a consensus on essential criteria and indicators for Tibialis Posterior Transfer (TPT) could be reached among the team. This paper describes the Delphi Exercise, giving results at each stage of consensus development. The final outcome was that essential criteria, including contraindications for surgery, pre- and post- operative assessments and expected outcomes, were agreed. The criteria are presented with recommendations.

Consensus methods: a bridge between clinical reasoning and clinical research?

Evidence-Based Practice does head the "hierarchy of evidence" upon which developments in clinical practice should be based. There are, however, situations where evidence is either unavailable, unclear, or results between studies are at variance. Consensus is a reliable contingency, and approaches to reaching consensus have acceptable construct validity (Nominal Group Technique, Delphi, and Consensus Development Conference). Consensus is reached when: (i) the method of investigation tightly controls communication to reduce the obscuring "noise" of divergent discussion; (ii) statistical measures of agreement or dissent screen out the bias that would otherwise be produced by the dictate of vociferous minorities or coalitions that may represent vested interests; (iii) all participants contribute equally to the product of the investigation.