Clinic Waiting Room-based Study of Swahili Language Artificial Intelligence-driven Symptom Assessments in Tanzanian Primary Health Care Facilities

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the accuracy of the condition suggestions and urgency advice of the Swahili language Ada symptom assessment application (SAA), when symptoms are input by a lay-person user and a medical professional; these SAA results will then be compared to the condition suggestions and urgency advice of different tiers of doctors and a gold standard created by a panel.

Detailed Description
-----------------
There will be two different wings of this study: (1) where a lay-person inputs their symptoms into the Swahili language Ada symptom assessment application (SAA); (2) where the usual care doctor asks a lay-person (the patient) the same questions from the SAA and determines their own condition suggestions based off this questioning and the SAA's condition suggestions. In both wings, the patient will be seeing their usual care doctor for a diagnosis and then a study-provided physician for a diagnosis. Separately, the doctors will list a ranking of other considered condition suggestions (diagnoses) and urgency advice, which will not be shared with the patient. These condition suggestions and urgency advice will be compared to a gold standard, which will be determined by a high level panel for each patient's case, based on the doctor notes and physical examination results of each patient's visit.

Official Title
-----------------
Clinic Waiting Room-based Pilot of Swahili Language Artificial Intelligence-driven Symptom Assessments in Primary Health Care Facilities, Dar es Salaam, Tanzania

Conditions
-----------------
Abdominal Pain/Gastrointestinal Issues, Lower Respiratory System Conditions, Upper Respiratory System Conditions, Mental Health Conditions, Ophthalmology Conditions, Orthopedic Conditions, Cardiovascular System Conditions, Genitourinary System Conditions, ENT Conditions, Dermatology Conditions, Gynecology/Obstetrics Conditions, Neurological Conditions

Intervention / Treatment
-----------------
* Device: Ada Waiting Room App (WRA) and Ada Diagnostic Support Application (HDA)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients who enter the clinic and that are willing/able to provide consent will be included, except those who fall under certain conditions listed below Exclusion Criteria: Patients with severe injury/illness requiring immediate treatment Patients with traumatic injury (many of these patients require minimal anamnesis, and it is not rational to include them in a pilot study) Patients incapable of completing a health assessment (e.g. due to illiteracy, mental impairment or inebriation or other incapacity).

Ages Eligible for Study
-----------------
Minimum Age: 2 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Wing A (Ada WRA)<br>Patients in this group will be filling out the Ada assessment themselves and then heading to a normal consultation by first the usual care doctor and then the study-provided physician. | Device: Ada Waiting Room App (WRA) and Ada Diagnostic Support Application (HDA)<br>* This device is a medical device but will be used only observationally--this device takes a patient's symptoms into account by asking questions and gives a ranked list of likely conditions that the patient might have based on the answers to these questions. The assessment report also includes urgency advice levels, that is, which care the patient should proceed to based on the condition suggestions. The WRA is used by the patient directly and the HDA is used by the doctor to ask the questions to the patient.<br>|
| Wing B (Ada HDA)<br>Patients in this group will be asked questions from the Ada assessment by a health care practitioner and then heading to a normal consultation by first the usual care doctor and then the study-provided physician. | Device: Ada Waiting Room App (WRA) and Ada Diagnostic Support Application (HDA)<br>* This device is a medical device but will be used only observationally--this device takes a patient's symptoms into account by asking questions and gives a ranked list of likely conditions that the patient might have based on the answers to these questions. The assessment report also includes urgency advice levels, that is, which care the patient should proceed to based on the condition suggestions. The WRA is used by the patient directly and the HDA is used by the doctor to ask the questions to the patient.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy and Comprehensiveness measures of Ada WRA and HDA | The condition-suggestion accuracy and comprehensiveness of the SAA, evaluated against the gold-standard differential diagnosis determined by the review panel, reported in the context of the accuracy of the usual care health practitioner. | through study completion, an average of 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of usual care doctor condition suggestions | In Wing B only, while using the Ada HDA, the difference between the usual care doctor's condition suggestion accuracy and urgency advice will be compared between (1) the study arm where they determine a ranked list of condition suggestions before seeing Ada's list and then will choose a new ranked list based on viewing Ada's list, and (2) the study arm where after using the HDA, the doctor will see Ada's ranked list of condition suggestions and then choose to use Ada's full list or add some condition suggestions of their own. The accuracy of these will then also be compared to the study-provided physician and the gold standard panel. | through study completion, an average of 4 months | 
| Urgency advice accuracy | The urgency advice accuracy of the SAA, evaluated against the gold-standard triage levels determined by the review panel, reported in the context of the accuracy of the usual care health practitioner. | through study completion, an average of 4 months | 
| Questionnaire data insights | Qualitative data on the usability, usefulness and acceptance of the SAA | through study completion, an average of 4 months |