Exploring the Integration of a Patient Generated Health Data in a FAIR Digital Health System in Low-Resourced Settings: A User-Centered Approach

This article presents the initial user-centered research exploring the opportunities in the collection of Patient-Generated Health Data (PGHD) within the context of a project aimed at improving health management and outcomes among residents in African countries. Through interviews with a doctor, a patient and two data managers, the local status and opinions regarding PGHD collection, integration and use are investigated. The findings suggest that PGHD have only been encountered in paper forms - and are mostly patient driven, however opportunities for PGHD for the facility and patient were identified and included supporting the treatment of white-collar hypertension, treatment planning and self-management. One of the key findings is the observed formed opinion about the relationship between quality (reasonability and provenance) and trust of PGHD such that it appears there is a direct relationship between perceived quality and trust of PGHD by the healthcare personnel. Also, traditional digital home monitoring devices, such as blood pressure monitors combined with an Interactive Voice Response (IVR), offer a more practical approach to PGHD collection in the African (Nigerian) context compared to wearables, considering factors such as affordability, ease of use, and data extractability. The study highlights the importance of considering the specific circumstances and requirements of African countries while designing and implementing PGHD collection strategies.


INTRODUCTION
Patient-generated health data (PGHD) refers to diverse data types collected outside clinic settings that pertain to health.Such data can include body temperature, sleep patterns, dietary habits, medication usage, and readings from health monitoring devices like heart rate monitors, blood sugar meters, and activity trackers used at home [1].Long term health conditions require routine monitoring of patient health data, even outside the clinic.PGHD provides an opportunity for the patient to generate health-related data at home to help them self-manage their health, but also share with family, friends, and healthcare service providers [2,3].In addition, inclusion of PGHD in health systems can enable stakeholders to gain novel insights into the health of chronic disease patients, for personalized care and public health use [3][4][5].Due to these perceived benefits, researchers have attempted to integrate PGHD, especially from the monitoring devices and wearables, into electronic health records [5,6].In particular, research has favored wearables as a PGHD data source, with more work done in this regard in the Western, Educated, Industrialized, Rich, and Democratic (WEIRD) countries [6,7].As a result, our understanding about how PGHD sources can be integrated has largely been western society driven [8].
Furthermore, towards personalized medicine, disease management and population health, digital health systems (re)designs are getting more attention in many geographies including Africa.The recent pandemic suggests the importance of a health information system based on concept of FAIRification at source.FAIR principles relate to enriching data instances as Findable, Accessible (within conditions), Interoperable and Reusable, to strengthen the digital health system.Such data, which is machine-actionable and semantically enriched, can be visited by algorithms and machines (fully owned), but can also be shared and reused by authenticated data users within well-defined geographically relevant regulations and constraints [9].Patient data from such systems can also be combined with other data sources such as PGHD to provide better contextual meaning.In recent times, the Virus Data Outbreak Network for Africa (VODAN-Africa), a network of about eight (8) African countries has sought to pilot a digital health system that enables digital health data to be FAIR especially in low resource settings, where resources such as internet and electricity are limited [10].However, the system currently supports only data collected within the facility from outpatient department (OPD) and antenatal care (ANC) registers, hence this study.This study attempts to explore the opportunity of integrating the PGHD collected outside the health facility into the VODAN-Africa digital health system, towards personalized care and population health.It particularly aims to understand the current practices, environment, and opportunity for integrating the PGHD with digital systems.

METHOD
In the context of the project, we conducted separate interviews with four (4) key data stakeholders within one of the health facilities in Nigeria.The participants include a Doctor (D1), a Patient (P1), a Data Steward (DS1) and a Data Clerk (DC1).In the context of the VODAN project, a Data Steward provides support and technical assistance in all stages of the data lifecycle, including data production, collection, preparation, use, storage, and deletion.The purpose of data stewardship is to continually ensure high-quality data is produced.The Data Clerk, on the other hand, is responsible for data entry, analysis, and report generation.Each of them is important due to the perspectives they bring into the process of patient health data generation process.The interviews were carried out through Zoom, after obtaining participants' direct consent.Each interview lasted between 10 -25 mins.We employed a built-in recording tool to record the interviews.We undertook a thematic analysis of the interview data including a desk review of available publications in the area of PGHD [ [6]].Clarke et.al [11] refers to thematic analysis as a methodological approach that involves the identification, assessment, and acknowledgement of noteworthy patterns or themes within qualitative data.Braun and Clarke [12] suggest that the various stages of thematic analysis enable a systematic framework for observation, utilizing the technique of "coding" to analyze qualitative data.Following Braun and Clarke [12] six stages of thematic analysis (see Figure 1), the thematic analysis was undertaken as follows: The recordings of the interview were transcribed using otter.aianonline tool for transcription [13].Data was reviewed and cleaned for accuracy, such that the video recording was replayed where necessary to ensure completion and familiarity (step 1).From the word version of the data, each interview was analyzed to identify initial codes -open coding (step 2).Themes were identified from the text and codes generated (step 3).Each theme was then reviewed, with researchers reading the responses of each informant that participated in the study to gain in-depth understanding and to properly define the themes (steps 4&5).Thereafter, the draft paper was written up based on the following consolidated themes -data collection practice, quality of data, trust, PGHD value, PGHD Integration, and technology used for collecting PGHD.Thereafter, similar themes and subthemes were categorized and grouped together in the final analysis.Also, to ensure data accuracy, direct quotations from the informants were used to support the findings.Findings from the interviews are outlined in the discussion section below.

RESULTS AND DISCUSSION
Generally, all the study participants expressed great interest in the potential and opportunity of the value of PGHD.As shared by patient P1 -"Even in the absence of a doctor, I will know that my BP is okay or is above the range and I will know the next thing to do".However, the health professionals in our study have said that they have only been able to experience or see PGHD that is shared on the paper or book from patients.As the doctor in the study (D1) put it -: "It is useful if the patient can generate some of this information.But in our situation, we don't usually have that facility for patients to generate such data for us at (from) home.It's only when they come to the facility that is when we can get that information we need." PGHD from wearables and mobile applications are not experienced in the study facility.Nevertheless, participants shared valuable opinions about their impressions of wearables, but also gave insights to reasons why wearables are not commonly used.As opined by D1: "people may not use or know of such devices, and the devices may not be reliable at all times." They also shared their opinion on the value, position and use cases of PGHD in the facility.In this interview, we described hypothetical blood pressure data taken from the device at home as an example of PGHD to engage our study participants.The following subsections will highlight pertinent themes from the interview.

PGHD Data Collection and Use in Health Facilities
In this section, the research highlight participant's response to the major theme about how PGHD is collected and used.This was done through three (3) sub-themes, viz PGHD collection as a pre-treatment tool, Mode of PGHD Collection and Use in Health Facilities, and Perception of Accuracy, Technical Failure and Contamination of PGHD.The following provide a detailed finding from the sub-themes • PGHD Collection and Use as a Pre-Treatment Tool • Clinicians have some familiarity with PGHD (from written notes shared by patients), so it is not entirely new in the study site.It has been identified and used in this facility as a pre-treatment tool for supporting patients experiencing white coat hypertension.According to the clinician in our study (D1): "...there are some patients that experience what we call the white coat hypertension in the sense that when they are in the hospital their BP tends to go up, but at home they usually have a normal blood pressure because they develop fright when coming to the hospital i.e. they are afraid that something is wrong with them, (so that) when they are well relaxed at home their blood pressure is usually normal.So, we will usually say to such kind of patient, okay, get a notebook, and be recording your blood pressure.When you are coming to the hospital, you come with it or when you see any abnormal value, you come to the hospital, let's recheck and institute appropriate treatment." • Mode of PGHD Collection and Use in Health Facilities • Despite the situation above, PGHD data collection and sharing from this facility is not institutionalized nor usually stored at the moment.Even when a patient presents PGHD that they have collected, there is no desire to keep the data if this is not longitudinal or historical data about the patient that will reveal more reliable information about their state of health.Asked if PGHD is to be collected over say 3 months about a patient daily, the doctor in the study (D1) said, "for a patient that normally takes his blood pressure at home on a daily basis (for 3 months), that one already give us an idea of patient's blood pressure and is, reliable yes, that results, I will take it as a reliable result for over three months, the patient has been consistently checking his blood pressure at home and he has a record of it, bringing it to the facility".This implies that historical data may be more trusted than episodic data.However, we realized that the clinician in the study seems to suggest that if the PGHD data is episodic data, then data needs to be further checked and validated.As he narrates below: If you have been my patient for a while and have had your blood pressure readings for maybe two or three (past) visits, I must have known your normal blood pressure.And you come with blood pressure reading at home, from home that this is the reading.My take is that I will compare it with the one I'm having (your previous reading) and now have to recheck it as at your presentation because blood pressure changes with time.So, it depends on the circumstance you are in as at that time, any blood pressure taken at home may be different from the blood pressure you are taking at the hospital.(D1) From the foregoing, it appears PGHD can be accepted during or as part of consultation, however, it has to be judged reliable by the doctor, who compares the data generated at home to the data he collected at the facility.
• Perception of Accuracy, Technical Failure and Contamination of PGHD • In our study participant's opinion, concerns such as accuracy and technical failure of devices lead to suspicion about the quality of the PGHD.According to D1 -"...most of the times they may have a battery issue, they may give a different reading.So, most of the time we prefer that, when you (patient) get some value from the home, we double check so that we can be sure that yes, your blood pressure is this".In addition, it appears that there is a fear that PGHD data can 'contaminate' the health records [14].So, the healthcare study participant (D1) preferred that PGHD readings are marked -'taken at home'.The participant (D1) states: ". ..And with that one, I will still put in this record (the readings) 'taken by the patient at home'. ..".

Quality and Trust in PGHD
One of the key findings is the observed formed opinion over the relationship between quality and trust of PGHD.It appears there is a direct relationship between perceived quality and trust of the PGHD by healthcare personnel.The more the perceived quality, the more trust given to the PGHD from home.Data quality is a multidimensional concept, so the list of what constitutes data quality is subjective; up to fifty (50) data quality measures were identified in health information literature [15].However, for PGHD, reasonability is an important dimension to the expected quality.By reasonability, we mean that the data is within the expected range, and this should not be confused with accuracy.
As shared by D1, when asked about PGHD, they said -"I will have to look at it.And I will say, okay, if the pressure is within the normal range, if it all is above the normal range, or whatever the reading is, I will take it that yes, this one is a true representation of the patient's blood pressure."Asked further if the data outside the normal range is not important and should be discarded, the participant (D1) responds: -"yes, it will give us an idea of how good the patient's control is, so if the blood pressure is normal within so so period.We will know that yes, it is, the ranges are within the normal within a certain period, and it makes us plan and check what could have caused a sudden change in the pressure or the sugar level.So those data are very important to us." Hence, a reasonable PGHD will be more trusted than a less reasonable PGHD.
Similarly, contextual information such as location appears to be very relevant.The data clerk participant (DC1) said: "Yes, they (PGHD) are important.Okay.They are very important because sometimes I even have some patients, they will tell you; it is when I travel to my village that is when my blood pressure starts going up doctor.So, if we can get those data from there when they are not within a range, it's very important to us and it will help in our planning.It is important to know where they took the data -as that may have influenced the readings".

Value and Importance of the PGHD in Clinical Care
In the interviews the respondents were asked about the relevance that the PGHD may have in clinical practice.The two aspects that were identified are: (i) self-management of risk tracking and (ii) building confidence in the treatment plan.The two issues were discussed as follows.
• PGHD for self-management • The study participants agree that PGHD is valuable to them in a number of ways -for patient self-management, early insight into a patient's health on meeting a clinician, confidence about efficacy of treatment plan and in emergency situations.D1 revealed: "Yes, it will definitely be helpful, because it will make the patients more aware of their illness and their management.If they have a glucometer that they use in checking their blood sugar regularly.They will know that okay, my blood sugar is within this range.At any point that thing goes higher.They will know that maybe it is something that has triggered it, maybe the food they are eating or something.That way we hit good management and early intervention for the patient".• PGHD gives health provider confidence about treatment plans.• PGHD is also directly beneficial to clinicians according to study participant (D1) when he said -"...yes, is a good way to give us an idea of the patient's ideal BP (blood pressure), whether control or not control. ..".In addition, it also gives the healthcare provider confidence about the treatment plan -as mentioned by the clinician (D1) when he said: "So if they can be sending it (PGHD) to us, then we will know that yes what we're doing, we are on the right track.(Given that the reading is taken) at home, the pressure is within this range, and it's within normal.We are getting the report daily.So, yes, we will have confidence that yes what we are doing is on the right track".

Current Practice of Integrating PGHD in clinical practice
Although healthcare study participants indicate some value in PGHD, it appears that PGHD is currently patient driven in the facility and only considered as a pre-treatment plan for the whitecollar hypertension.So, when asked how a patient is managed if they have chronic disease (diabetes or hypertension), one of the study participants from the facility said: "Yes, for chronic patients like those that are hypertensive, diabetic or any other chronic illness, we have different protocols for those that are diabetic or hypertensive.Most of the times when they come and we establish that yes, they are diabetic or they are hypertensive, we give them the normal medication and we always give them a follow up visit we tell them okay, in our facility, most of the time we do a monthly visit you come every month for checkup.At any point in time, if we find out that there are some that may come that are diabetic.The sugar level is high.We just say come back in one month.I know tell them okay, come back in a week.We do a current follow up until the blood pressure, the sugar stabilizes then, we'll give them a monthly visit and they come monthly for checkup" [D1].By the above account, in contrast to our assumptions, there is no institutional and intentional effort to request PGHD as part of routine treatment for chronic diseases.This does not imply that PGHD is not acceptable or used, it indicates a window of opportunity to institutionalize it as it is already in use as a supporting data for clinical diagnosis and treatment.However, another explanation for this could be that the socio-economic status of patients or poverty level or educational level had impacted on the subconscious or conscious decisions of clinicians' on adding PGHD to the kind of treatment protocol that patients receive.So, perhaps, there may be no point requesting a poor person who cannot afford daily meals and transport to buy a measuring device for their health.One participant (DC1) however noted that PGHD is especially relevant for high-risk patient -"...because they can easily get into an emergency situation that may warrant emergency treatment".

PGHD Communication with Health Facility using Technology.
During the interviews, an important objective was to assess patients' enthusiasm for utilizing PGHD devices to enhance their medical care experience.We sought to comprehend the level of interaction between the clinic and the patient by gathering insights from the doctor (D1), Data Clerk (DC1), Patient (P1) and Data Steward (DS1).This allowed us to gain perspective on how the D1 perceived PGHD compared to data collected by clinicians? during in-person visits.Such understanding helped us determine the types of data that patients find valuable.Asked about the experiences of PGHD communication using any technology, all participants have said they have no experience sending (P1) or receiving PGHD (DS1, DC1) beyond the paper forms we had earlier reported.However, they indicate that they are interested in the use of existing mobile phone features such as SMS to do so.Also, clinicians from the study prefer that the PGHD shared also include meta-data such as patient location towards treatment plan evaluation -"So if we can be getting those data (location data) from there when they are not within a range, it's very important to us and it will help in our planning".Alternative methods of PGHD communication, such as Interactive Voice Response System (IVR) and Short Message System (SMS), were suggested during the conversation.These methods were deemed practical, taking into account their economic feasibility in Nigeria, and subsequently became the core of the implementation stage.Participants were enthusiastic about the opportunity of PGHD from wearables.However, the challenges posed by infrastructure issues in Nigeria, including unreliable internet connectivity and limited access to power supply, were mentioned as barriers to pursuing the use of wearables, such as the Fitbit, for generating PGHD.

DISCUSSION
Poor system design, which has led to usability issues, has been recognized as a barrier to PGHD integration [16].The development of such systems has been hampered by a lack of understanding and evaluation of users' workflow, making them difficult to use and lacking the necessary context to grasp such datasets [17].In this study, an effort was made to understand design needs of PGHD integration with a digital health system in Africa.The study provides insights into the current practices and opportunities for integrating PGHD with digital systems in low-resource settings, contributing to the understanding of PGHD integration in African countries.Our findings reveal that clinicians are happy to receive PGHD in their health facility and this is already manifest in the current practice of the study site.It is considered valuable to patients and clinicians towards enhanced treatment.Consistent with findings by Huba and Zhang [18], study participants indicate that such data are encouraged to be collected (for self-management) and shared by patients, to serve as a pre-treatment tool for patient with chronic diseases such as hypertension.However, beyond self-management and pre-treatment, PGHD in this location is perceived to be helpful in boosting clinicians' confidence over the performance of a patient's treatment plan.Also, unlike most PGHD collected in health facilities in the global North, where these data are often collected using technologies (such as patient portals or wearables) [6], PGHD has only been experienced on paper in this facility due to a lack of awareness but also perceived reliability of the data.
Trust is a known barrier to the integration of PGHD with health records [19].Similarly, this study found that trust in relation to quality was a factor in PGHD integration.Our study participants indicate that they may not trust the PGHD if it cannot be relied upon.PGHD has to be judged reliable by clinician, who compares the data generated at home to the data they have collected within the facility.They associate the perceived non-reliability of PGHD with inaccuracy, technical failure, and contamination of PGHD.In addition, data quality factors such as reasonability (meaning that the data made sense to the clinician) were also identified as contributing to trust in PGHD.Also, although the available mode of communication or sharing of PGHD in the study location was paper-based, participants indicated interest in using wearables and mobile phones features (SMS and IVR) as a means to communicate or share PGHD in the future.However, this will need to be further studied given that studies have shown that collecting PGHD using wearables over a long period can be challenging [20].For instance, in a study of diabetic patients, 77% of patients had complete PGHD data accessible at 2-week follow-up [3], while only 59% did so after 6-week follow-up.This was brought on by failure to use wearable technology as instructed over time, and because patients favored wrist-based sensors to belt-based ones [3].
Overall, this study highlights the potential benefits and challenges of integrating PGHD into health records in low-resourced settings, particularly in African countries.It emphasizes the importance of considering the specific context and requirements of these settings and provides design recommendations for sustainable integration.

DESIGN RECOMMENDATIONS FOR PGHD INTEGRATION WITH DIGITAL HEALTH SYSTEM IN LOW RESOURCE SETTING
PGHD lives within an interesting socio-technical environment, whose context can determine how it is designed to be collected, shared, integrated into health records, and used within healthcare.
Based on these, we propose the following design recommendations from this exploratory study, towards effective integration of PGHD with health records in a limited constraint environment.
I. To integrate PGHD, designers must employ technologies that are supportive of the economic conditions of the users, intuitive to the patient and accessible to the clinicians, such as the IVR and SMS.II.Towards enhanced trust, designers should ensure PGHD data shared are accompanied with metadata such as location and data quality features such as reasonability.III.To safeguard against 'contamination', designers must ensure that PGHD data is separated from clinical data to provide confidence.IV.For sustained engagement, designers must also ensure that PGHD is embedded as part of the clinical workflow such that it is provider-requested especially for chronic disease management or high-risk patients.

CONCLUSION AND FUTURE WORK
This paper examines stakeholders' understanding of how PGHD can be integrated into the health records for enhanced healthcare delivery in settings with limited resources.The objective of the study was to gain a better understanding of the present state of PGHD data collection and usage as it relates to routine clinical health in the study site.The study reveals that PGHD is already in use in the study site, although not in digital form, nor integrated.It has been used as part of a pre-treatment plan for white collar hypertension patients, among other use cases.Also, clinicians have shown interest in receiving this type of data electronically including through wearables, SMS, and IVR, although IVR and SMS appear to be most practicable within the study community.In addition, the study identified data quality features (reasonability and provenance) that clinicians are interested in to trust the data shared.In the future, we will attempt to design and evaluate an IVR application for PGHD integrated with the digital health system used in the facility.

Figure 1 :
Figure 1: Braun & Clarke's six-phase framework for doing a thematic analysis.