AI app aims to help frontline workers diagnose neglected skin diseases

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

1. Frontline Health Workers (FHWs) Age Group * Age Range: 18 years and above o Justification: FHWs must be adults, legally eligible to provide healthcare services and consent to participate in the study Sex Distribution * Male and Female FHWs o Justification: Both male and female FHWs will be included to reflect the actual workforce distribution and to ensure generalizability of the results across genders. Inclusion criteria for FHWs: 1. Professional Role: o Must be working as a FHW at one of the selected health centers at the time of the validation study. ▪ Justification: The study aims to assess the diagnostic performance of those directly involved in primary patient care in the targeted settings. 2. Willingness to Participate: o Willing to provide written informed consent to participate in the study. ▪ Justification: Ethical standards require voluntary participation with informed consent. 3. Smartphone Usage: o Willing and able to use a smartphone during the study. ▪ Justification: The SkincAIr app is smartphone-based; therefore, FHWs must be willing to use and have access to such devices. 4. No Specialized Dermatology Training: * FHWs without specialised training in dermatology or extensive experience in skin disease diagnosis. * Justification: The study aims to evaluate the app's effectiveness among generalist healthcare workers who would benefit most from diagnostic support tools. Exclusion criteria for FHWs: 1\. Prior Specialised Training in dermatology: o FHWs with formal education or extensive experience in dermatology. * Justification: Including specialists could skew results, as their baseline diagnostic accuracy may already be high, reducing the observable impact of the app. 2\. Refusal or Inability to Consent: * FHWs unwilling or unable to provide written informed consent. * Justification: Ethical compliance requires informed consent for participation. 3. Inability to Use the App: o FHWs unable to use a smartphone due to technical limitations, physical impairments, or lack of familiarity with the technology. * Justification: Effective use of the app is essential for the intervention; inability to use it would prevent meaningful participation. 2. Patients with Skin complaints Size ● Total Patients: \~750 patients Age Group ● All Age Groups: o Justification: Skin-NTDs affect individuals of all ages; including all age groups enhances the generalizability of the findings and assesses the app's effectiveness across the lifespan. Sex Distribution * Male and Female Patients * Justification: Both sexes are included to capture the full spectrum of the disease burden and ensure the app's diagnostic accuracy is effective regardless of sex. Inclusion Criteria for Patients with Skin complaints: 1\. Presenting with Skin Complaints: o Patients presenting to participating health centres with symptoms suggestive of skin-NTDs (e.g., visible skin lesions, nodules, ulcers) but have not been diagnosed by a specialist for that specific skin condition. * Justification: The study aims to evaluate the app's effectiveness in real-world conditions, including all patients with potential skin-NTDs 2. Willingness to Participate: o Patients (or guardians, in the case of minors) willing to provide written informed consent for participation. * Justification: Ethical standards require informed consent from patients or their legal guardians. 3\. Ability to Comply with Study Procedures: o Patients are able to follow study instructions and attend necessary follow-up appointments. * Justification: Ensures complete data collection and accurate assessment of outcomes. 4\. Patients with Co-morbid conditions: * Justification: Immunosuppression that occurs in some comorbid conditions e.g. HIV/AIDS or severe malnutrition can reveal the Skin disease and can affect both the clinical progression and even severity of the Skin NTD. This also includes patients with multiple skin-NTDs. Exclusion Criteria for Patients with Skin complaints: 1. Refusal or Inability to Consent: o Patients (or guardians) unwilling or unable to provide written informed consent. ▪ Justification: Ethical compliance requires informed consent for participation. 2. Non-Skin-Related Complaints: o Patients presenting with complaints unrelated to skin conditions. ▪ Justification: The study focuses on skin-NTDs; including unrelated cases would not contribute to the study objectives. 3. Previous Participation in the Study: o Patients who have already participated in the study. ▪ Justification: To avoid duplicate data and potential bias in outcomes. Additional Considerations: Diversity and Representation ● Geographical Diversity: o Including health centres from different regions within each country ensures that the findings are representative of various settings (urban, peri-urban, rural). ● Cultural and Socioeconomic Factors: o The study acknowledges that cultural beliefs and socioeconomic status may influence healthcare-seeking behaviour and disease presentation. By including a diverse patient population, the study aims to capture these variations. Ethical Justification ● Inclusivity: * Including all age groups and both sexes aligns with ethical principles of justice and fairness, ensuring that the benefits of the research are accessible to all segments of the population. * Vulnerable Populations: * While including minors and potentially vulnerable adults, the study will implement additional safeguards to protect their rights and well-being, following ethical guidelines and obtaining consent from guardians when necessary.