GB2617208A - Information Management System - Google Patents

Abstract

A system and method of mapping a patient pathway within a medical environment wherein the method is AI-assisted. The medical environment may relate to an HIV service. Disclosed are a set of interrelated computer programs. A first application is for clinical decision-making, risk prediction, personalised treatment strategies, management of co-morbidity, drug interactions, resistances, and mutation. A second program simulates a pathway within an HIV service and may compare current practices against potential scenarios to aid in decision making. A third program provides personalised medical information to patients. A fourth program monitors patient interaction with the third program to improve the provision of services. A fifth program provides for patient recruitment, and a sixth program analyses electronic medical records.

Description

Intellectual Property Office Application No GI322065254 RTM Date:27 September 2022 The following terms are registered trade marks and should be read as such wherever they occur in this document: JAVA Spring Excel Intellectual Property Office is an operating name of the Patent Office www.gov.uk/ipo Information Management System

Description

This specification relates to information management in a healthcare setting. In particular, although not exclusively, this specification relates to information management in an HIV healthcare setting.

Organisations and institutions have many stakeholders with varying needs for the success of individuals and projects. For example, in healthcare context there are clinicians, nurses, service managers, policy makers, healthcare commissioners, charities, and pharmaceuticals, all investing significant amount of time, effort and money for the benefit of patients.

Their needs are usually met through systems and processes developed separately (if developed and available), independent from each other, where efforts are duplicated CO and the lack of communication between stakeholders leads to inaccurate and unreliable outcomes. There is a pressing need for a technology which brings all stakeholder needs within a single platform to facilitate correct and optimal decision making. This need is confirmed in a survey of HIV practitioners conducted in 2020 where 87% agree that this technology is probably or definitely a need. C\1

There is, therefore, a need to provide a user-friendly system which brings every stakeholder's perspective into one collaborative platform through Artificial Intelligence (Al) powered technology. Such a system which addresses the unmet needs of stakeholders is described herein.

A first aspect provides a method of mapping a patient pathway, wherein the method is Al-assisted.

Preferably the patient pathway relates to HIV.

A further aspect provides a method of management of information relating to a medical condition, wherein the method includes the steps of receiving information about a patient, receiving information about a scenario, analysing the information about the patient and about the scenario, and providing an output. -2 -

Conveniently, the information about the patient includes information regarding HIV.

Alternatively, the information about a scenario includes data regarding medication.

Another aspect provides asystem equipped to carry out the steps described above.

Embodiments of the system and method are described, by way of example, with reference to the accompanying drawings, in which: Figure 1 shows a schematic representation of the systems and methods described herein; Figure 2 shows a representation of a form of data capture used with the systems and methods described herein; Cr) 15 Figure 3 shows a diagrammatic representation of the interaction between systems and methods described herein; C\I Figure 5 shows a representation of an application; and Figure 6 shows a diagrammatic representation of a patient pathway.

The emergence of highly active antiretroviral therapy (HAART) has been the cornerstone of HIV care for some time. This type of therapy has enabled patients to live a normal life like the general population. Despite these life-changing developments, over the past two decades, several factors including co-morbidities, polypharmacy, ageing, and concurrent management of other chronic diseases are some of the challenges faced by patients and practitioners around the world.

Figure 4 shows a user interface and output representation used with systems and methods described herein; Noteworthy among the major challenges in HIV management, which cuts across all -3 -health settings, are the neglect of the psychosocial issues faced by patients and ineffective communication by the healthcare provider.

Central to this paradigm shift is the recognition that the management of HIV patients should go beyond medication-focused approach, to a robust, inclusive and multisectoral modality that addresses the heterogeneous and complex elements of HIV disease management.

It is expected that clinicians will be saddled with the responsibility of finding a workaround model or compromise between the convenience of care that patients experience with health models and the quality of care they receive from healthcare organizations. Clinicians will have to integrate newer and smarter technologies, such as remote monitoring, telehealth, analytics and artificial intelligence (Al), as an integral of care delivery system for an improved patients' engagement in their treatment, Cr) 15 provide personalized and targeted management, and reduce the extra burden on the health facility. Clinicians will have to advocate for patients before the executives and administrators for greater leadership in identifying opportunities, so that they can have a strong voice in all aspects of care delivery and innovation.

C\1 20 Despite the richness of HIV research conducted over the last 40 years, covering some thousands of clinical trials, cost-effectiveness analysis of ARTs, prevention measures (e.g. pre-exposure prophylaxis, condoms, and vaccines), education and mental health, there are no known user-friendly web-based systems within a single platform that can assist the needs expressed by experts and specialists. Two tools with limited features and potential drawbacks are acknowledged, namely HIV TRePS and HIV-ASSIST. HIV TRePS is a system that predicts the probability of virologic response to an ART therapy (using random forest technique), with a predictive power hovering around 80%. A classification accuracy of less than 95% is usually deemed to be unreliable.

HIV-ASSIST integrates clinical factors relevant to ART choice (e.g. mutations, comorbidities, and viral load) and generates a ranked list of recommended ART regimens. The method is based on multiple-criteria decision-analysis, which is an operational research technique that relies on rankings of clinical factors (known as weighted utility scores), either in the form of expert opinions or mathematical -4 -formulations. If the weightings applied to the clinical factors are not accurate, then the recommended ART regimens will not be reliable, and leading to a sub-optimal solution. It is obvious that there is significant shortcoming in both systems, methodologically and limitations in terms of features and usefulness (i.e. ART choice only).

The systems and methods described herein are developed to transform the way HIV disease care and management are deployed, bringing every stakeholder's perspective into one platform through an Al-powered technology that addresses gaps and unmet needs.

Figure 1 shows the system as a platform for all stakeholders to collaborate for the good of the patient and the disease. The dashboard panel is made up of four distinct solutions, "BSmart Chart App", SmartHIV Trialist, "SmartHIV Clinician", "SmartHIV Cr) 15 Manager" and HIV Smartlyfics.

Each of these solutions will be discussed in turn.

SmartHIV Clinician is a comprehensive Al-powered clinical decision-making tool with many unique features, including risk prediction models (e.g. risk of hospitalization, C\I readmission, death, risk of cardiovascular disease); treatment strategies personalized and made precise for HIV patients; co-morbidity management; drug interaction management; resistance and mutation management, and adverse events monitoring. SmartHIV Clinician is where all credible evidence for HIV treatment strategies is delivered to physicians in a single platform to inform about potential clinical outcomes and engage patients to drive higher adherence to HAART.

SmartHIV Manager is an interactive planning platform for management of HIV services. It is based on simulating an entire patient pathway within a HIV service, from initial referral to discharge, including diagnostics, treatment, monitoring, counselling, suppression (virologic failures), adherence counselling and death. In real-time users can compare current practices versus thousands of potential scenarios and generate a wide range of results to assess the impact of change on service demand and utilization, prevention, budgeting and financial planning, resource planning and management, UNAIDS 90-90-90, and cost-effectiveness analysis. SmartHIV Manager -5 -is a platform that will enable key decision-makers evaluate decision options accurately. More importantly, the ability to test before implementing in practice to avoid the trap of "doing things and hoping for the best", thus the opportunity to generate efficiencies in the HIV patient pathway and improve performance.

BSmart Chart is a unique app for patients, which put patients' interest at the centre of the disease management. The app empowers the patient to take charge of their disease and get individualized evidence-based information and motivational nudges. It also allows them to track their adherence level and self-efficacy assessment over time. Patients are also able to track their nutrition, social, cognitive, emotional quality of life, and their impacts on progression. It also allows the presentation of individual patients risks of cardiovascular disease, metabolic syndrome, readmission, and hospitalization. Patients can engage their clinicians intellectually and in real-time, Cr) 15 especially their concerns about risk scores or general well-being.

It is therefore to be understood that the BSmart Chart App is a unique app that puts patients' interest at the centre of, and support patient to be involved in their disease management. This delivers anonymised real-world patient experience data for clinicians and trialist.

C\I 20 The BSmart Chart App may provide the ability to connect with clinicians in real-time globally. Support for HIV status disclosure which may shield the patient from an unexpected reaction. It may also provide the possibility to facilitate access to innovative medicine through willingness to participate in clinical trials, especially for patient in resource limited settings.

As an addition to the BSmart Chart App, SmartHIV Auditlyfics may support HIV practitioners in monitoring and evaluating patient and service outcomes in real-time from patients using the BSmart Chart app (e.g., medication adherence, stigma and discrimination, physical/mental health, etc).

SmartHIV Auditlyfics may provide data to HIV practitioners so as to aid in the provision of services. -6 -

Further, the "At Risk" feature of the BSmart Chart app may enable HIV community case detection and linkage through self-testing, ensuring consent procedures and confidentiality are protected, thus increasing access to HIV services and testing. "At Risk" offers a direct and immediate assessment of prevention services, including pre-exposure and post-exposure prophylaxis (PrEP/PEP), to HIV-negative clients found through testing in populations at elevated risk of HIV acquisition. If a client tests HIV negative, educational materials are sent on a regular basis in the form of notifications (via the app) and text messages, such as articles and newsletters (from credible sources) to ensure client minimises risk of HIV infection. If HIV positive, there is a direct and immediate linkage of patients from testing to treatment, supporting reduction in stigma and discrimination on service access pathways, especially for key populations.

SmartHIV Trialist helps the clinician to gain a real-life trial on the recruited patients, which is population-based, with planned inclusion/exclusion criteria, allowing for a Cr) 15 proper referral network and drive optimal patient recruitment globally at the click of a button. This would help save time, money, and effort, by shortening the amount of time spent on recruitment and monitor the progress over time which brings the medicine to patients earlier. Trialists will save time and run a cost-effective trial by generating necessary results comparing current clinical operations scenarios versus future C\I interventions.

HIV Smartlytics HIV Smartlytics is an Electronic Medical Record (EMR) integrated advanced analytics and visualisation platform, capable of predictive analytics, evaluation and monitoring of HIV patients, and real-world evidence insight. The full capabilities of all the products can be harnessed with this product.

An integral part of the presently described system is the ability to integrate routinely collected EMR database with a SmartHIV Solution. At the click of a button, HIV practitioners could power and automate a SmartHIV Solution (via EMR integration) and streamline the process of collecting and analysing massive amounts of data and making the results available in real time, e.g., past clinical conditions, treatments, outcomes and laboratory results. Furthermore, this innovatively disruptive Al powered -7 -technology may address gaps in care, quality, risk, utilization to support clinical and quality outcomes and financial performance.

SmartHIV Clinician SmartHIV Clinician is a compendium of evidence about HIV disease management for clinicians in the form of easy to use, smart and easy to understand dashboards. This system is backed by an Al powered evidence synthesis algorithm, whereby a comprehensive review of the literature is carried out, screening over 10,000 journal articles published post 2015. Data was captured, by the use of pre-specified keywords relating to all clinical trials related to HIV across information published on the world wide web, filtered based on pre-specified criteria and returns a database which is then mined to bring to the clinicians an easy to use tool for the management of HIV patients. Therefore, all available credible evidence for HIV treatment strategies delivered to Cr) 15 physicians in a single platform, including optimal treatment selection, comorbidity management, drug interactions management and risk of adverse drug reactions, among many other possibilities.

This is a point of use tool, such that for every patient consulting the clinician, it allows C\I the treatment to be tailored to patients in an efficient manner. It also suggests adherence level needed to achieve a targeted suppression and the time to achieve it. All the clinicians need to do is to complete a form, which then collects the attributes of the patient.

Figure 2 shows a representation of the clinician's forms within the dashboard of the SmartHIV Clinician. Clinicians can select their individual patient attribute in order to tailor treatment to their patient. The information filled in here for an individual patient, is used by our smart and intelligent Al powered algorithm to suggest some evidence-based treatment options to the clinician but personalized to that patient. The users (i.e. clinicians) also have the option to see the treatment outcomes for some pre-selected choice of ARTS. Other forms available are those for comorbidity, drug interactions and resistance managements. -8 -

The dashboards may include clinical outcomes, comorbidity management, resistance management and risk predictions. The clinical outcome shows the selected ARTs by the patient attributes as selected by the clinician. Expected suppression data is presented for the 5 selected ARTs and over time, weeks 48, 96 and 144. This is also presented based on patient co-infection information e.g. if a patient has TB or HBV with HIV, or disease condition e.g. time from diagnosis, current viral load etc. Also presented is the expected level of adherence to be maintained by the patient to achieve the suppression level being presented.

Furthermore, expected chance of adverse drug reactions and mortality is also presented. The comorbidity dashboard is where a clinician can assess drug interaction for an HIV patient with a comorbidity condition and a comedication to treat the condition. It will also present the expected suppression in the presence of co-medication and comorbidity. If the patient is experienced and failed on the current ART Cr) 15 due to associated mutations, the resistance management dashboard can guide the treatment selection based on the pre-existing resistance associated mutation (RAM).

In summary, SmartHIV Clinician is a clinical decision-making tool where treatment strategies are personalized and made precise for patients, backed by an Al algorithm C\I which incorporates patients' characteristics, co-morbidities, co-medication in providing HIV medications precisely to patients' requirements.

SmartHIV Trialist.

SmartH IV Trialist is Al Powered Technology for HIV Clinical Trials. According to Judith Currier, M.D.: "You Can't Design Clinical Research Without Really Understanding the Patients". Successful recruitment and retention of patients is known to be one of the most challenging aspects in the conduct of randomized controlled trials, and HIV is no exception. To-date there are no known decision support systems in place to support clinical researchers for this purpose. Additional challenges faced by clinical investigators include robust/accurate estimates around costing and required resources for the trial. -9 -

Figure 3 provides a representation of the way in which SmartHIV Triallist may radically transform how HIV trials can be conducted now and in the near future.

Smart HIV Trialist will harness the capabilities in our BSmart Chart App and SmartHIV Manager to deliver bespoke services to HIV researchers. Our BSmart Chart app collects over 75 vital pieces of information about people living with HIV (PLWH) over time. Consent by users is given to indicate if they are willing to participate in a clinical trial. Through an exhaustive analysis of data collected through the BSmart Chart app, we are able to assist investigators identify optimal candidates, using real-world insights and according to any planned HIV study's exclusion/inclusion criteria.

Patients attributes including but not limited to current HIV medication, concomitant medication, comorbidities, etc. will help target optimal candidates and reduce the risk of adverse events caused by underlying conditions and concomitant drugs and reduce Cr) 15 the difficulty in deciding whether an adverse event should be attributed to the pre-existing condition or to the intended investigative HIV medication.

The app will support recruitment for the trial by locating real patients in real time globally tailored to investigators defined patient attributes, e.g., sex, age group, C\I concurrent medical conditions, etc. By creating real life segmented and targeted patient population, investigators can plan for and analyse behaviour in terms of adherence and other interesting attributes relevant to the planned study.

The app will maximize retention during the trial period by sending motivational nudges, medication/appointments reminders, and appropriate information (e.g. trial results, newsletters, updates and changes, Covid-19), thus minimizing loss to follow-up of patients (a major phenomenon faced by most clinical trials).

The app will also increase engagement during the trial period by sending cost effective patient reminders and nudges around their monitoring visits, progress, quality of life, comorbidities, co-medication, adherence, treatment satisfaction and general health over time.

-10 -Alert to clinician will also support both engagement and retention in the trial as when things are not going so well clinicians will be alerted so that interventions are made in time to prevent missing data and loss to follow-up.

Therefore, SmartHIV Trialist will save time, money and effort by shortening the amount of time spent on recruitment and monitor the progress of patients over time.

Having identified a potential trial population within the system, the sponsor can contact patients and their providers. The feasibility studies, that normally take a long time to conduct by most sponsors are already partially done within SmartHIV Trialist in a few minutes. Also, the sponsor has an idea of the budget even before contacting the sites and this budget would be refined based on the number of sites willing to participate. So, sponsors can contact all sites where patients have been identified to receive care for invitation to participate in the trial.

Cr) 15 All sites interested in the trials can then input their cost from the site-specific interface.

All cost data input from all the sites will be presented to the sponsor in real time saving time and cost. Chats and call capabilities will be implemented to facilitate quick communication between the site and the sponsor representatives.

C\1 20 SmartHIV Trialist has two sets of dashboards, 1) exhaustive analysis of patient level data collected through the App (i.e. optimal patient recruitment), and 2) a trial resource planning and budgeting tool, to assess and monitor the impact of scenarios on costing and resource requirements using SmartHIV Manager.

Analysis of data for optimal patient recruitment Sponsors/Researchers will be able to enter the dashboard via a secure login page and enter the attributes of the planned clinical trial population. The anonymised patient level data, of those who consent to participate in clinical trials, will be analysed using high dimensional visualisation techniques, including but not limited to: a) Summary statistics, e.g., graphical display of demographics (and patient attributes) of patients, e.g., gender, age group, method of HIV transmission, accommodation type, etc. b) Geographical location, e.g. countries, access to centres.

c) Summary of current and past HIV medication (known as Antiretrovirals) d) Summary of Co-morbidities/Co-medication over time e) Risk scores: Metabolic syndrome, cardio risk score, risk of hospitalisation, etc. f) Summary of adherence level and self-efficacy over time g) Summary of quality of life (emotion and happiness), cognitive symptoms, physical symptoms, treatment preferences, The above information will provide relevant intelligence in the recruitment process of patients for the trial.

In summary, SmartHIV Triallist is a HIV Clinical Trials planning and budgeting tool, developed to help clinical researchers gain a real-life trial population based on planned study inclusion/exclusion criteria.

Cr) 15 By using the BSmart Chart app described herein, the ability to recruit patients for clinical trials globally and facilitate patient engagement and retention. It is also a clinical trial budgeting and financial planning tool developed using JAVA technology, when connected with SmartHIV Manager as described herein.

C\1 20 SmartHIV Manager for budgeting and resource planning Clinical trial costs are on the rise and it's a challenge for sponsor companies (predominantly pharmaceutical and biotechnology) to keep costing under control, whilst ensuring regulatory and quality compliance are met within the required timelines. Adding to this the growing amount of activity that is outsourced to consultancy companies and other service providers, and effectively controlling costs can be a near impossible task.

It is becoming the norm for sponsor companies to rely on clinical trial cost tracking tools and technologies to establish accurate and robust cost estimates, whilst also capturing forecasted costs of the trial. Sponsors are trying to incorporate these sorts of technologies from the earliest stage and utilizing them to set the clinical budget during the protocol development. However, there are concerns over the accuracy of these technologies in terms of forecasting budgets which are usually not achieved. There are many factors and unexpected issues at play that affect trial costs and no -12 -model or technology is able to provide reliable cost estimates for the entire trial period, which could be up to 10 years or more SmartHIV Manager has a statistically validated budgeting and financial tool that can be utilised for this purpose. Patient's recruited via the app at various trial sites globally coupled with the vast amount of data collected through BSmart Chart and analysed using SmartHIV Trialist dashboard panels, will provide all the necessary data needs for the trial.

Country level HIV treatment costs for budgeting and financial planning purposes were collected through an exhaustive review of the literature covering 139 countries globally. Costing data was collected in US dollars or Euro for each country, which included firstline/second-line ART costs per person per year; laboratory cost per person per year, and overhead and personnel cost per person per year. Overhead costs included facility Cr) 15 utilities (water, electricity, other), facility support staff (guards, cleaners), facility-level administrative staff, general consumables/other supplies at the site, transport/monthly running costs of vehicles Of used for ART). Additional clinical costs were also collected to ensure all trial related costs are considered.

SmartHIV Manager is then used to mimic every detail of the clinical trial within a validated computer simulation environment, covering the entire trial period, capturing all uncertainties and variation (through statistical distributions) to generate a comprehensive set of budgeting related outputs. Wide range of scenarios can then be tested to quantify the impact of various interventions during the trial period, e.g., inflation, unscheduled visits, protocol amendments etc. In addition, numerous other key outputs are generated, such as demand and service utilization, and human resource requirements.

Our SmartHIV Trialist will not only support clinical trials sponsor to streamline the planning, scoping, recruitment, engagement and budgeting of their studies, it will also help to expand medication access to underserve populations and patients in resource poor settings.

SmartHIV Manager -13 -Statistically validated models make it possible for informed decision making, thus minimizing the risks associated with the decisions been made. The selection of the methodology very much depends on the problem context and the system of interest.

Where systems and processes are complex, analytical techniques are limited in use, whereas simulation, in particular discrete event simulation (DES), has the capability of modelling very complex systems like HIV disease. DES is a technique used to depict a system within a computer simulation environment to observe its behaviour and state changes over time, and demonstrates adaptability, suitability, and scalability.

A holistic view of an entire patients' pathway within HIV care will enable us to capture all the uncertainties and variations (e.g. demand, resource utilization, patient outcomes). If the system is captured to a certain degree of accuracy and detail, endless "what if" scenarios can be examined to assess the impact of change, not just on one Cr) 15 aspect of the system, but its knock-on effect on other parts (either directly or indirectly).

For example, when assessing the impact of preventive measures (e.g. pre/postexposure prophylaxis), why just focus on the number of averted patients and its cost-effectiveness. What about the impact of prevention on service demand, utilization, personnel requirements, budgeting and financial planning? When solving such C\I problems, a myopic view can lead to inaccurate (incomplete) findings, and thus a sub-optimal solution.

It is therefore proposed to provide a DES model capturing individual patient's footsteps from initial referral to HIV clinic to treatment and monitoring over a period of 5 years (including all the activities and resources utilized at each visit like diagnostic activities, ART treatment, disease progression, counselling and intensified adherence counselling). The conceptualization process was carried out with services at several countries, within Nigeria, United Kingdom, South Africa, and Kenya. The team is made up of HIV physicians, HIV service managers, policy makers and HIV researchers.

Therefore, the pathway was captured to a sufficient level of details such that it is applicable to a wide range of HIV services around the world. Note that the World Health Organization (WHO) guidelines formed the baseline pathway, where necessary adjustments were made to ensure individual service provision of countries is considered.

-14 -A typical HIV patient pathway around the world is made up of five components, namely prevention, diagnosis, treatment, monitoring and disease progression. Necessary resources were attached for each patient at each stage of the pathway, including a clinic room, a physician, a counsellor, nurse(s), a pharmacist, lab technicians for diagnostic testing purposes and community/social services. Individual patient attributes within the pathway of care were also captured, e.g., patient type (naive or Tx experienced), sex, age group, pregnancy, ART treatment class (first/second line), HIV suppressed/failed, and viral load groups. Depending on patient attributes, frequency of monitoring per year, clinical outcomes, adherence/non-adherence, comorbidities and co-infections were modelled accordingly. All essential information was captured to ensure the simulation model depicted a real-life HIV service as much as possible.

To test and validate the model, a data template was created to collect the input Cr) 15 parameters from three different HIV centres, two in Nigeria and one in Kenya. A total of 93 input parameters were established covering the entire HIV pathway of care. Where data was not available, we resorted to the literature, expert opinions and online resources. Country level HIV treatment costs for "Budgeting and Financial Planning" purposes were collected through an exhaustive review of the literature covering 139 C\I countries globally. Costing data was collected in US dollars or Euro for each country, which included first-line/second-line ART costs per person per year; laboratory cost per person per year, and overhead and personnel cost per person per year. Overhead costs included facility utilities (water, electricity, other), facility support staff (guards, cleaners), facility-level administrative staff, general consumables/other supplies at the site, transport/monthly running costs of vehicles Of used for ART).

A user-friendly, animated interface in a 2D isometric illustration was designed with necessary control buttons, so that users could change the input parameters accordingly, thus service-specific. SmartHIV Manager is a web-based platform, which can be used in real-time, enabling users to analyze the impact of alternative scenarios and interventions as and when needed. Dashboards were developed using Java Spring boot, Spring Data, Spring Security and Thymleaf, communicating with the simulation model, generating a comprehensive set of outputs in a simple, graphically appealing and easy to understand format. Our platform is very responsive which can -15 -be used on any device, i.e., mobile phones, tablet and desktop. The dashboards are made up of Service Demand and Utilization, Prevention, UNAIDS 90-90-90, Human Resource Management & Planning, and Budgeting and Financial Planning.

As shown in Figure 4, SmartHIV Manager has a simple user interface with a submerged highly complex simulation structure at the back end. The complex part is not visible to ordinary users as key decision-makers are not interested in the technical details of the model. SmartHIV Manager runs over a 5-year period, comparing the "Current" practice against a "Scenario". The front end produces high-level metrics (Figure 4 -top right), comparing the impact of change on "no. of patients", "no. of visits" to the HIV clinic and "total staff hours". Exhaustive set of exportable outputs On the form of PDF and Excel) are available in the dashboards (Figure 4 -far left) with graphical and numerical results. The dashboards, therefore, is designed and implemented to provide powerful insights via bespoke solutions through Al-powered Cr) 15 visualization.

As the simulation runs, the front interface is animated, enabling users to interact and communicate, thus the opportunity to observe the behaviour of their system under various conditions. For example, HIV patients do not only flow through instantaneously, C\I but also spend time and consume healthcare resources. DES provides insights on cause and effect relationship between demand and capacity. As a result, patients might wait if the resource is not available at that moment, which can be seen in the animation.

Verification and validation of a model is critical for accountability and to ensure the results are robust, reliable and accurate. This is a vital process in any simulation model building, where all stakeholders, made up of clinicians, service managers and nurses were engaged in every step of development, so that the model can be verified and validated. We also compared the simulation outputs with real-world outputs, which was 5% either side of the expected result, suggesting that the model is fit for purpose.

In summary, SmartHIV Manager is a resource and capacity management system for HIV service managers and policy makers in public and private sectors. This also feeds -16 -into SmartH IV Trialist providing the capabilities and data to generate the much-needed evidence to support clinical trial planning and budgeting.

SmartHIV Manager is a java-based technology depicting HIV services within a computer simulation environment, allowing tens of thousands of users running simultaneously and generate easy to understand dashboard outputs.

It is intended that the systems and methods described herein provide a technology for a holistic HIV/AIDS management with a focus on patients, which may support stakeholders as described below. The problems solved for each stakeholder are described alongside each stakeholder.

Patients: supporting day to day management of their disease (as and when needed), e.g., around adherence, nutrition, cognitive, emotional support, and the ability to Cr) 15 connect with their clinicians in real time (rather than waiting for weeks and months for their follow-up appointments). Patients may be assisted in monitoring parameters in day-to-day life, assisting in making better-informed therapy decisions (few examples can be given if needed). Patients may also be aided in connecting with healthcare professionals and sharing data reports for discussion of therapy (few examples can be C\I given if needed). Patients may also find that they experience better therapy compliance, which may include receiving motivational triggers, feedback on current therapy status, and for staying motivated by sticking to therapy (increased therapy compliance). It also offers support for the disclosure of HIV status to "Who needs to know" e.g., clinician and next of kins. Access to innovative therapies through participation in clinical trials, for patients who consent and willing to participated, is another advantage especially for patient in resource limited settings.

Clinicians: capability of providing the best possible treatment outcomes with all disease related complications for their patients. Clinicians may personalise HIV treatment tailored to their patients based on their needs and key attributes (e.g., age, gender, comorbidity, concurrent medication, adverse events, etc.). In addition, clinicians can smartly engage with their patients in real time (via the App) to drive adherence, improve outcomes and general health.

-17 -Service managers: support in better planning of services and identifying patient needs. Service managers may safely explore the impact of change in their service, e.g., increasing demand and change in resources. In addition, they may generate efficiencies in the HIV patient pathway and improve performance, and explore how the latest developments in HIV disease management might impact their service, e.g., Covid-19, HIV vaccine, full roll-out of an HIV prevention programme, etc. Service managers may also be enabled to develop a business case for change at the click of a button.

Policy makers, commissioners and donor organisations: support in establishing needs at local, regional and national level. Budget holders may now determine with confidence the needs of people living with HIV over an extended period time (short, medium and long term) at local, regional and national level. Needs are expressed in terms of key resources, such as financial needs, HIV doctors and nurses, etc. It is Cr) 15 imperative that the established needs are robust, accurate and reliable. This is where our algorithms (and invention) stand out and makes a true difference. (if needed further details about our simulation and JAVA technology can be provided).

Before an HIV prevention programme is rolled out at any level, those at the top of the C\I hierarchy for decision making needs evidence, e.g., costing implications, number of averted HIV cases over a 5, 10 and 20 year5-, 10-and 20-year period, etc. Our invention will provide all the required facts and figures, avoiding the trap of doing things and hoping for the best.

Clinical researchers: support in patient recruitment, retention, engagement and getting newly innovative products to patients through clinical trials. Using our state-of-the-art app, patients can be located Thein real time globally during a clinical study planning. During the trial period, the app will facilitate patient engagement (minimise missed visits) and patient retention (minimise loss to follow-up). Linked with our Al powered SmartHIV Manager, trialists can determine the optimal budgeting requirements.

Furthermore, plan, assess and monitor the impact of change on costing implications.

Figure 1 shows the flow diagram as a platform for all stakeholders to collaborate on HIV disease management with the primary focus on optimal care and treatment -18 -experience for the patient. The technology is made up of five distinct solutions, BSmart Chart app, SmartHIV Clinician, SmartHIV Manager, SmartHIV Trialist and HIV Smartlyfics (further description about each solution is provided below).

Note that each solution has innovative algorithms powering the backend engine (described below), e,g. SmartHIV Manager, a java-based simulation technology developed for the first-time, allowing tens of thousands of users plan their HIV service simultaneously, in real-time, at the click of a button.

Furthermore, the magnitude of the invention can be appreciated by the capability of communicating between solutions, which is vital to generate robust findings and improve patient outcomes. For example, through our app, the worsening of a patient's adherence to medication and deterioration in their psychological condition will prompt our system to immediately alert their clinician, and information about the patient is made readily available within the SmartHIV Clinician dashboard, thereby saving lives Cr) 15 and minimising further damage on patients. Given that our technology addresses the width and depth of the challenges faced by HIV practitioners and patients, it is fair to say that we have developed a technology that is innovatively disruptive. According to our survey conducted in 2020, 80% of practitioners agree that the technology is very C\I 20 innovative or extremely innovative.

Without the SmartHIV Solution described herein, the problems above for each stakeholder would not have been possible to solve. In addition, the systems and methods described herein provide the possibility to have medical laboratories information systems connected to the platform for direct pooling of patients lab data, which may lead to improvements in the efficiency and effectiveness of such systems and methods.

While the invention has been illustrated and described in detail in the drawings and preceding description, such illustration and description are to be considered illustrative or exemplary and not restrictive; the invention is not limited to the disclosed embodiments.

Other variations to the disclosed embodiments can be understood and effected by those skilled in the art in practicing the claimed invention, from a study of the drawings, -19 -the disclosure, and the appended claims. Each feature of the disclosed embodiments may be replaced by alternative features serving the same, equivalent or similar purpose, unless stated otherwise. Therefore, unless stated otherwise, each feature disclosed is one example of a generic series of equivalent or similar features.

In the claims, the word "comprising" does not exclude other elements or steps, and the indefinite article "a" or "an" does not exclude a plurality. Any reference signs in the claims should not be construed as limiting the scope.

CO C\I C\1 CO C\I C\1 -20 -APPENDIX 1 -BSmart Chart Application User Guide Bohemian Smartlytics Comprehensive HIV AIDS Review and Treatment -BSmart Chart App User Manual 1. Intended Use BSmart Chart App puts HIV patients interest at the centre of disease management with features and functionalifies beyond imagination. A first of a kind app that supports the optimization of HIV therapy in seven ways: 1. Monitor: by monitoring your parameters in day-to-day life, you are assisted in making better-informed therapy decisions.

2. Connect: by connecting with your healthcare professional, you can be involved in your disease management by sharing your data reports for discussion of therapy.

3. Therapy Compliance: by receiving motivational triggers (e.g. medication and appointment reminders), feedback on your current therapy status and rewards, you increase therapy compliance 4. Knowledge Hub: by accessing your desired information from legitimate sources on HIV-related issues and general health, you will get the intended benefit with up to date information and ensure the care you get is truly around your needs.

5. Support Engagement: by improving engagement in care, ART adherence and social support with other people living with HIV, through daily discussions, peer sharing, you will empower your mental and emotional wellbeing, leading to better health outcomes.

6. Brain Builders: by enhancing your knowledge and skills in HIV disease through interactive quizzes and exercises, you will better understand its symptoms, how it may progress, what treatment options are available, and understand what your doctor is doing and be part of the treatment journey.

7 Access to Medicine: by participating in clinical trials you will have the possibility to access innovative therapy.

1. Key Features -21 -Some of the key features include: * Connect with your clinician in real-time, notify them of changes, and share your HIV health and well-being status * Visualise your HIV health and well-being over time * Express your views freely, speak out loud and let your voice be heard * Track your adherence, nutrition, social, cognitive, emotional and quality of life * Become a mentor by challenging yourself and the opportunity of winning a small gift * Take charge of your HIV by getting individualized evidence-based information * Set appointment reminders * Monitor your metabolic and cardiovascular risk scores * Receive daily motivational quotes; an inspiration for the day Cr) 15 * Manage your HIV & non-HIV medication, examine drug interactions and keep track of your medications * Set goals and build knowledge and skills * Gain knowledge and skills about HIV disease via quizzes and interactive exercises C\I * Access up-to-date information depending on your needs * Support engagement through daily discussions and connect with others around the globe.

2. Getting Started To use BSmart Chart app you have to create an account using your email or phone number.

3. My Survey To unleash the full capabilities of BSmart Chart, you start by completing My Survey.

BSmart Chart app needs to know some details about your HIV disease management to function properly. For example, your medication adherence, your emotional, cognitive and physical symptoms, your quality of life and treatment preferences, and your viral load and CD4 count measurements.

-22 -The survey may take up to 20 minutes -please be as accurate (and patient) as you can, and if you are not able to answer a question, you could always come back to it.

Note that it is mandatory to complete all questions in My Survey for the first time. We understand it's a little daunting and time consuming, but it's well worth the effort.

You are strongly advised to repeat the survey regularly so that you keep track of your HIV health status, e.g., monthly, quarterly or even before your next doctor's appointment (or a routine check-up). The frequency of survey completion can also be agreed upon with your healthcare professional too.

You have the choice to select the categories you would like to complete in repeated Survey's. Tap on Show/Hide Categories. If you want the same responses to be submitted in My Survey, you could skip completing some of those categories by Cr) 15 checking the checkbox e.g., to skip demographics, which does not change very often, click the check box.

4. HIV Health Status HIV Health Status is the main dashboard, which can be accessed by tapping on the C\I side menu (0) bar, to see high-level health and well-being statuses, such as your medication adherence, expected suppression and risk scores. This is also where you manage your medications, list your appointments to get a reminder before time, access your information needs, and alert your clinician for any issues of critical importance.

4.1. Medication Management Depending on the number of times you take your HIV medicine and time of day, to receive your notifications and refill reminders, you need to set your medication management plan. To do this, tap on MEDICATION in the HIV Health Status dashboard, then ADD+ or the plus icon (a), and set your medication.

Once the medication details are provided and added to the list, you could always go back and make changes or remove them from the list. To do this, select the medication in Active Meds, then tap Edit in the top right and change accordingly.

-23 - 4.2. Suppression Your HIV medicine reduces the amount of HIV in the body (known as viral load) to a very low level, which keeps the immune system working and prevents illness. This is called viral suppression. Taking HIV medicines every day and exactly as prescribed by your doctor is called medication adherence.

BSmart Chart provides your expected overall suppression from taking your medication and expected adherence necessary for your HIV regimen on a scale of 0% to 100% (the higher the better) to guarantee the suppression. This is presented in the SUPPRESSION section of the HIV Health Status dashboard. Make sure you have chosen the correct HIV medication you are taking in My Survey, category HIV and Non-HIV Medications.

4.3. Appointment Reminder Cr) 15 We've all forgotten an appointment before and felt the sting of guilt. BSmart Chart has this covered too. In the HIV Health Status dashboard, tap on APPOINTMENT REMINDER, then ADD+ or (ii) to set your doctor's appointments and check-ups and receive timely notifications. Should you want to make changes later, select the C\I appointment under Appointments and tap on Edit. C\I

4.4. Alert to Clinician You could allow your clinician to access high-level set of reports generated by BSmart Chart. To do this, you need to alert your clinician by providing their contact details (email address and phone number) in Alert to Clinician section of HIV Health Status dashboard.

A personalized link will be generated and shared with your clinician for them to access via a secure web-based portal, known as SmartHIV Solution.

Note that a comprehensive set of easy to understand data reports in real time can be viewed only when the app is downloaded by your clinician, where they need to create an account and establish a connection with you (see section 7 for further details).

-24 - 4.5. Your Information Needs BSmart Chart provides your information needs on both HIV-related issues and general health by gathering a bank of credible online resources, including up-to-date publications and reports.

To activate this feature, you must select Your Information Needs from My Survey 5. Reports Reports (I) from the menu bar allows you to see an exhaustive set of easy to understand vital metrics necessary to support the management of your HIV over time.

At the top of the Reports, screen specifies the period you would like to generate your report (Start Date to End Date), e.g., 6 months, 1 year or 2 years. By default, it's set to CO 15 3 months.

5.1. Your Adherence o Tap on Your Adherence to check your level of adherence to medication (ranging from 0%-100%) and if it's below the threshold of 50%, tap on What's Holding Me Back to find out how you could improve your adherence. Remember, 100% means you are committed and adhering to your treatment plan, whereas 0% means NO adherence.

5.2. Viral Load and CD4 Count Tap on Viral Load and CD4 Count to check your viral load and CD4 count measurements over the specified period.

A happy emoji face (NI) would indicate an HIV viral load less than 50 copies/mL (HIV suppressed), whereas a sad emoji face (E) means greater or equal to 50 copies/ml (unsuppressed).

A similar interpretation is valid for CD4 count measurements.

5.3. Cognitive Problems, Physical Symptoms and Quality of Life -25 -Our easy to understand graphs will allow you to keep track of your general health and well-being. Tap on Cognitive Problems, Physical Symptoms and Quality of Life.

5.4. Risk Calculator BSmart Chart predicts your risk of metabolic syndrome (MS) and Cardiovascular disease (CVD) Your CVD risk score is calculated as a percentage (the lower the better) and grouped as "Low", "Moderate", "Increased" and "Markedly Increased", whereas the risk of MS is presented as "Yes" or "No".

Metabolic syndrome is the medical term for a combination of blood sugar, high blood pressure (hypertension) and obesity, whereas CVD is a group of disorders of the heart and blood vessels, such as coronary heart disease (heart attack).

Cr) 15 To see your risk scores, you must complete all the questions in My Survey for Metabolic Syndrome and Cardiovascular 6. Profile and Settings Use the side menu to access Profile & Settings. C\I

If you need to change your password, photo, PIN Code, name, email address, and sex, it all happens here. Tap on YOU, then Edit (") to make these changes.

If you want to give consent for your clinician to access your data and reports; Bohemian Smartlytics Limited to process your medical data for research purposes and willingness to participate into a clinical trial, then tap on SETTINGS then My Consent.

7. Connect 7.1. As a Patient, Connect with Your Clinician The most commonly used feature of the BSmart Chart app is the ability to connect with healthcare professionals, most often your HIV Doctor.

There are two ways to connect with your clinician, 1) find your clinician by specifying Country, City and Organisation, 2) if your clinician cannot be found, invite by entering their email and phone number.

-26 -An invitation will be sent and upon acceptance, your clinician will have access to your report, as and when changes and updates are made in real-time, via a dedicated platform for clinicians within the BSmart Chart app and web-portal (known as SmartHIV Clinician).

This process starts by tapping Connect in the menu bar.

7.2. As a Clinician, Connect with Your Patient If an account isn't created, register to BSmart Chart by tapping on I'M A CLINICIAN then CREATE ACCOUNT. This is dedicated to Clinicians only.

There are two ways to connect: the first is by accepting your patient's invitation to connect, and upon acceptance, your patient will be listed within My Patients. You will Cr) 15 see all the invitations sent by your patients in Connection Request The second option is to invite your patient by tapping on Invite Patients and entering their email and phone number. An email and a text message will be sent for them to download the BSmart Chart app, register and connect with you as described in section C\I 6.1.

Your Patient's Report Once connection is established with your patient, you have access to a comprehensive set of reports as described in Section 5. Tap on My Patients and select your patient or search using the search facility at the top (by name and last name). Additional outputs are provided, such as quality of life, patient satisfaction and depression and treatment preferences.

Attention requiring issues are alerted at the top of Patient Info, just below their name and last name, e.g., if your patient adherence is below a threshold of 50%, if they have suicidal thoughts, etc. APPENDIX 2-Questions for Initial Patient Survey

HIV-ASES

-27 -Have you been adhering to your treatment plan even when side effects begin to interfere with your daily activities? Please select a value ranging from 0 to 10, where 0 means no adherence to your treatment plan and 10 means complete adherence.

Have you been able to integrate your treatment into your daily routine? Please select a value ranging from 0 to 10, where 0 means no integration and 10 means complete integration.

Have you been able to integrate your treatment into your daily routine even if it means taking medication or doing other things in front of people who don't know you are HIV-infected? Please select a value ranging from 0 to 10, where 0 means no integration and 10 means complete integration.

Do you stick to your treatment schedule even when your daily routine is disrupted? Cr) 15 Please select a value ranging from 0 to 10, where 0 means you do not stick to your treatment plan at all, and 10 means you completely stick to the plan.

Do you stick to your treatment schedule when you aren't feeling well? Please select a value ranging from 0 to 10, where 0 means I do not stick to my treatment plan at all, C\I and 10 means completely stick to treatment plan.

Do you stick to your treatment schedule when it means changing your eating habits? Please select a value ranging from 0 to 10, where 0 means I do not stick to my treatment plan at all, and 10 means completely stick to treatment plan.

Do you continue with your treatment even if doing so interferes with your daily activities? Please select a value ranging from 0 to 10, where 0 means I do not continue with my treatment at all and 10 means completely continue.

Do you continue with the treatment plan for the next three months as prescribed by your physician even if your CD4 Count drops significantly? Please select a value ranging from 0 to 10, where 0 means I do not continue with the treatment plan, and 10 means completely continue with the treatment plan -28 -Do you continue with your treatment even when you are feeling discouraged about your health? Please select a value ranging from 0 to 10, where 0 means I do not continue with my treatment at all and 10 means completely continue.

Do you continue with your treatment even when getting to your clinic appointments is a major hassle? Please select a value ranging from 0 to 10, where 0 means do not continue with my treatment at all and 10 means completely continue.

Do you continue with your treatment even when people close to you tell you that they don't think that it is doing any good? Please select a value ranging from 0 to 10, where 0 means I do not continue with my treatment at all and 10 means completely continue.

Do you get something positive out of your participation in treatment, even if the medication you are taking does not seem to improve your health? Please select a value Cr) 15 ranging from 0 to 10, where 0 means you do not get anything positive at all and 10 means completely positive.

Total HIV-ASES Score Please specify the number of days for which medications were missed during the last one week.

Please select a category that describes your self-reported adherence during the last month, from very bad to excellent.

HIV and Non-HIV Medications Please select your current HIV regimen.

Any co-medication (Non-HIV).

Concurrent medical conditions.

Demographics Age (years) or year of birth.

-29 -Please specify any concurrent medical conditions.

Please select your Age Group Please include your year of birth (e.g. 1973) Please select your sex Ethnic origin Country of birth In what country do you currently live? Cr) 15 In which city do you receive care? Where do you live? C\I 20 Type of accommodation? Is your disease diagnosed within the last year? Year of diagnosis of HIV (e.g. 2013)? Most current viral load, copies/mL (within the last 3 months)? Most current CD4 count, copies/mL (within the last 3 months)? Mode of Transmission? How do you pay for your health care? (check all that apply) Cognitive Problems Do you suffer any memory loss? -30 -Do you suffer difficulties planning activities and solving problems? Do you have difficulties paying attention? Physical Symptoms Do you have excessive night sweats? Do you have Headache? Do you have Dizziness? Do you have muscle pain? CO 15 Do you have Lack of appetite? ClI Do you have Nausea or vomiting? C\I 20 Do you have Diarrhoea? Do you have Fatigue? Do you have Sleep disturbances? Have you had a weight loss: >= 3kg over the last 6 months? Quality of Life What can you say about your current general health? What can you say about your current health compared to 1 year ago? What can you say of your happiness about life? Depression -31 -Have you ever felt depressed? Have you ever had loss of interest about life? Have you ever had suicidal ideation? Cardiovascular How many days of 30-min physical activity/week do you engage in? Your weight (kg), e.g., if you are 74.5 enter 75.

Are you a smoker? Do you use alcohol? Cr) 15 Do you use any illicit drugs? Do you use any tobacco products? Please select your sex at birth.

METABOLIC SYNDROME SCORE

If MALE, please specify your waist circumference.

If MALE, please specify your fasting high-density lipoprotein (HDL) cholesterol level.

If FEMALE, please specify your waist circumference.

If FEMALE, please specify your fasting high-density lipoprotein (HDL) cholesterol level.

What is your blood pressure (Systolic/Diastolic)? Your fasting triglyceride (TG) level? -32 -Your fasting blood sugar? Metabolic Syndrome Sexual and Reproductive Health Previously (before HIV diagnosis) were you sexually active? Currently On the last 6 months) have you been sexually active? Vaccination Information If sexually active, do you use any Contraceptives? Have you had any new partner/s in last 6 months (number)? VVhich of these vaccinations have you had? If you selected Other, please specify: Treatment Preferences Which of these best represent your treatment preferences If you selected Other, please specify: Is/Are your physician/s aware of your needs and wishes as a patient with HIV? Satisfaction How satisfied are you with your Regimen? How satisfied are you with your provider/doctor? How satisfied are you with the whole HIV care system? Your Information Needs I would like more information, education, or counselling about: (check all that apply) -33 -If you selected Other, please specify: Please leave your email address to receive information tailored to you.

CO C\I C\I C\I C\1

Claims (6)

1. -34 -Claims A method of mapping a patient pathway, wherein the method is Al-assisted.
2. 2. The method of claim 1, wherein the patient pathway relates to HIV.
3. 3. A method of management of information relating to a medical condition, wherein the method includes the steps of receiving information about a patient; receiving information about a scenario; analysing the information about the patient and about the scenario; and providing an output.Cr) information regarding HIV.
4. 4. The method of claim 3, wherein the information about the patient includes C\I
5. 5. The method of claim 3, wherein the information about a scenario includes data regarding medication.C\1
6. 6. A system equipped to carry out the steps of any one of claims 1 to 5.