User Requirements for an Electronic Medical Records

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User Requirements for an Electronic Medical Records System for Oncology in Developing Countries: A Case Study of Uganda Johnblack K. Kabukye, MBChB, MSc1,2,3, Sabine Koch, PhD1, Ronald Cornet, PhD3 Jackson Orem, PhD2, Maria Hägglund, PhD1 1 Department of Learning, Informatics, Management and Ethics, Karolinska Institutet, Stockholm, Sweden 2 Uganda Cancer Institute, Kampala, Uganda 3 Department of Medical Informatics, Academic Medical Center, University of Amsterdam, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands Abstract Cancer is a major public health challenge in developing countries but the healthcare systems are not well prepared to deal with the epidemic. Health information technologies such as electronic medical records (EMRs) have the potential to improve cancer care yet their adoption remains low, in part due to EMR systems not meeting user requirements. This study aimed at analyzing the user requirements for an EMR for a cancer hospital in Uganda. A user-centered approach was taken, through focus group discussion and interviews with target end users to analyze workflow, challenges and wishes. Findings highlight the uniqueness of oncology in low-resource settings and the requirements including support for oncology-specific documentation, reuse of data for research and reporting, assistance with care coordination, computerized clinical decision support, and the need to meet the constraints in terms of technological infrastructure, stretched healthcare workforce and flexibility to allow variations and exceptions. Keywords: Medical Oncology, Developing countries, Electronic Health Records, User requirements, Requirements engineering, User-Centered Design Methods. Introduction Cancer is one of the leading causes of morbidity and mortality worldwide. According to the World Health Organization (WHO), there were an estimated 17.5 million cancer cases and 8.7 million deaths globally in 2015.1 Probably more striking is that developing countries bear the largest burden of cancer, a disease which was associated with affluence. Currently over 60% of cancer cases and over 70% of cancer deaths occur in these resource-poor settings and the numbers are projected to increase. Cancer is responsible for more deaths than HIV/AIDS, Tuberculosis and Malaria combined.2 Several reasons can be given to explain the cancer epidemic in developing countries including; 1) improved life expectancy, 2) infectious diseases such as HIV/AIDS, Hepatitis B and C, Epstein Barr Virus (EBV), Human papilloma virus (HPV) which are common in developing countries and are involved in pathogenesis of many cancers including Kaposi sarcoma, Non-Hodgkin lymphomas, Cervical cancer, liver cancers, 3) lifestyles that increase risk to cancer such as smoking, being sedentary, unhealthy diets, and 4) industrialization and pollution increasing exposure to carcinogens1–4. In addition, the healthcare systems in developing countries are ill-equipped and ill-prepared to deal with the cancer burden. Healthcare budgets are small and most of the spending is allocated to infectious diseases (cancer is not seen as a priority intervention area). There is also lack of critical cancer care infrastructure and services such as functional pathology and radiotherapy services as well as inadequately trained and insufficient staffing. Low health literacy within the population in developing countries leads to delayed presentation and treatment abandonment, and limited research on cancers (basic science, translational and clinical trials) also negatively affects cancer care.2,5 Health information technologies (HIT) such as electronic medical records (EMR) have been postulated to improve healthcare quality, safety, effectiveness, efficiency and to reduce healthcare cost. EMRs are more accessible and can easily be shared between healthcare providers to the benefit of the patient (timeliness, better care coordination, easy consultations, reduction of unnecessary repetition of tests, etc) and electronic data can be reused for research to improve medical knowledge, and for reporting for better healthcare planning/management. Features and functionalities such as computerized order entry and clinical decision support also improve time efficiency, enhance adherence to guidelines and improve safety, and enhance translation of research knowledge into clinical practice, among other benefits6,7. Several projects and studies have demonstrated the above benefits in a variety of contexts. In developed countries EMRs have been used in different clinical contexts including primary care, ambulatory care, oncology and for care of other non-communicable diseases; where EMRs have shown to reduce patient waiting times and improve time efficiency8,9 save costs10,11 improve communication12 etc. In developing countries, most of the experience is in

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HIV/AIDS care and EMR have also been shown to improve time efficiency 13–15 increase adherence to guidelines 16 improve care coordination and reduction in loss to follow-up 17,18 among other benefits. These benefits if harnessed could potentially contribute to improved cancer care and reduction of the cancer burden in developing countries. However, the adoption of EMRs in oncology remains poor, especially in developing countries. One reason for low adoption and/or failure of EMRs in general is that many EMRs do not meet the requirements of the users. Requirements of a system are the attributes, capabilities, characteristics or qualities that a system must have for it to be of value to the user - the services that a system is expected to offer and the constraints under which it must operate 19–21. Requirements depend on the context of use i.e. the users (their experiences/skills, attitudes, prejudices, etc), tasks and equipment (hardware, software and materials), and the physical and social environments in which the system is used22. Oncology is a complex medical specialty with unique workflows, information management needs and challenges (chronic, multidisciplinary and multi-modality care, expensive and toxic treatments such as radiotherapy and chemotherapy, complex schedules and combinations, etc) thus it poses unique requirements on an oncology EMR. In developed countries such as the United States and the United Kingdom, there have been efforts to define the unique requirements for oncology EMRs so as to guide vendors to develop usable EMRs and users to select those that are likely to meet their need.23–26 But due to differences in socio-economic status and healthcare system organization/workflows (available technological infrastructure, policies, human resource, standard operating procedures, etc) the requirements for an oncology EMR for developing countries are likely to be different compared to developed settings. Yet there have been no studies on requirements for an EMR for use in cancer care in lowresource settings. Purpose: To elicit and analyze the requirements for an EMR suitable for use in oncology in developing countries. The study was party of the Master's thesis of the first author (JK), and contributes to the ongoing EMR implementation process of a national cancer hospital in Uganda, the Uganda Cancer Institute (UCI). Methods A qualitative study was carried out, consisting of a focus group discussion (FGD) and follow-up one-on-one interviews. These were held in English. This approach was chosen because of the explorative nature of the study. Requirements engineering (RE) as a key component of the user-centered design (UCD) process27 requires understanding the perspectives (views, opinions, attitudes, limitations, etc) of the users and the context of use of the system22 and FGDs and interviews allow for this2829. Since requirements are for the same system, some form of consensus is needed which can be got during FGD in addition to allowing a comprehensive exploration of views from different people, as opposed to interviews with one person. However, in-depth interviews allow for detailed discussion which is important in RE to understand the users' challenges and wishes so as to come up with a usable solution, since often the users doesn't know exactly what the solution or requirement is or there are misunderstandings and miscommunications.30 The FGD followed a semi-structured format where probes were used that sought to understand the different tasks that the target EMR users routinely do, the information they collect and how it is exchanged/reused, as well as challenges faced in cancer care and how these could be alleviated by the EMR. These probes (available as supplement up on request) were developed prior to the study by JK basing on literature review, and they were discussed and agreed up on with MH and SK who are senior researchers in health informatics. The follow-up interviews were unstructured but followed up on issues that had been raised during the FGD. Considering that the study site is at an early phase of EMR implementation and the participants have limited experience with EMRs, it was suspected that they might have had limited opinions on requirements. To give the participants more insight about EMR and RE, a two hour workshop was set up prior to the FGD where JK presented about these concepts. In addition, a mockup of RE was done for a chemotherapy management system, and a representative of the EMR vendor Clinic Master International † (an EMR used by several hospitals in Uganda) was invited to give a demonstration of the EMR during this workshop. Study site: The study was conducted at the Uganda Cancer Institute (UCI) in Kampala, Uganda. The UCI is a 100bed public cancer hospital established in 1967 by the Uganda Ministry of Health and Makerere University in collaboration with the US National Cancer Institute (NCI). It was an important center for research and advancement of cancer treatment especially for combination chemotherapy and description and treatment of Burkitt's lymphoma, Kaposi's sarcoma and other cancers common in this area. The UCI has grown to become the main cancer hospital in

†

http://clinicmaster.net/

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Uganda and in the East African region, with over 240 staff, about half of whom are clinicians (29 doctors, 58 nurses, 7 lab staff and 5 pharmacy staff, among others). Currently the UCI is in the process of implementing an EMR. Participants: Participants were selected strategically and purposively to represent the main target end user of the EMR at the UCI i.e. doctors, nurses, pharmacists, medical records officers, lab technicians, etc. These user groups interact directly with patients hence they understand the work processes and dynamics of patient care at the institute including its challenges. They will also be the ones most likely to directly interface with the EMR once it is implemented. Nine of the 12 participants approached agreed to take part, with 4 males and 5 females and age range between 27 and 51 years. All had worked at the UCI for at least 2 years each and were familiar with the work processes. All the participants had computer literacy at least to the level of comfortable day-to-day use such as internet and email, Office suite and have had exposure to tasks such as data entry for clinical research. Some had also used the Clinic Master EMR system in the past, but not in the setting of the UCI, rather in other private hospitals. The table below shows the professions/job of the participants and whether they had used an EMR software before. Table 1: Participants Number Gender 01 F 02 M 03 F 04 F 05 M 06 F 07 M 08 F 09 M

Title/Job Junior medical officer Doctor/Internist Doctor/Surgeon Senior Nursing officer Pharmacist Nursing officer - Pediatrics Doctor/Pediatrician Medical records officer Nursing officer - Community outreach

Prior exposure to an EMR No Yes No No Yes No Yes Yes No

One FGD lasting two hours was conducted, followed by five follow-up interviews with participants 01, 02, 05, 06, and 08 in the subsequent week after the FGD. The interviews lasted average 25 minutes each. Data collection: Data was collected as audio recordings of the FGD and follow-up interviews that were later transcribed verbatim. The FGD was moderated by an independent moderator who is experienced in qualitative research (a nurse). This moderator was first trained by the author in advance to make sure the moderator fully understands the probes to be followed in the FGD. The moderator also attended the workshop prior to the FGD. The author was present in the FGD as a note taker, and he also conducted the follow-up interviews which followed the notes taken during the FGD - to clarify on issues that were not fully explored in the FGD. Data analysis: The audio recordings were transcribed verbatim by the first author and printed out for manual content analysis. Throughout the process of transcription and from the FGD/interviews, the author gained insight into the contents of the transcripts by the time they were printed. The author then read all the transcripts carefully and thoroughly to identify meaningful units and assigned codes/themes following a deductive approach 31,32. Statements that mentioned tasks, challenges or wishes that could translate into EMR functionality or constraint were identified and a mind map made (available as a supplement). A logical workflow model was also made to summarize the key tasks (see figure 1). The figure summarizes a typical flow but variations and exceptions are common among individual patients e.g. some new patients who aren't very ill can do their staging workup as outpatient and some patients continuing with treatment occasionally get admitted if they become ill due toxicity of chemo or radiotherapy or when they are to undergo surgery. Requirements were derived33,34 following categories of EMR functionalities/features in literature especially in23. Throughout this process, JK had several meetings with MH and SK who were his academic supervisors, to discuss the findings and translate requirements from the transcripts. Study period: Data collection was done in February and March 2016 and analysis was done in April and May 2016 Ethics: The study was approved by the Uganda Cancer Institute Research and Ethics Committee (#UCI REC REF 01-2015). All participants gave written informed consent and their privacy and confidentiality was ensured during the study.

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Figure 1: Overview of typical workflow. Actors represent those majorly involved in documentation tasks: Records clerk in Records office register patients into electronic system and create paper file, Nurses and Doctors on wards and OPD (Out Patient Department) make clinical notes and document treatment, create orders, etc. Other clinicians generally don't contribute to the patient file but receive documents made by doctors e.g. prescriptions, investigation requests, etc. Results The user requirements were derived from understanding the target users' workflow and tasks they need to accomplish as they described them in the sessions, from the challenges and constraints as well as their wishes and what they envisioned if an EMR had would make their work easier or the adoption and usage of the EMR easier. Detailed descriptions of the requirements with explanation or motivation and illustrative quotes from the participants are available as a supplement up on request. The requirements can be categorized as follows: Documentation, Communication and care coordination, Computerized order entry and results management, Computerized clinical decision support, Inventory/Stock management, as well as "Meeting the constraints (Fit into context)". 1. Documentation. 1.1 Routine documentation: When discussing the workflow and tasks, documentation was repeatedly mentioned as crucial routine. The system should support clinical documentation including identification and demographics, clinical history and findings, treatment details, etc, as these are routinely recorded in any clinical setting. The added benefit expected from the EMR however is alleviation of the challenges that come with paper documentation such as paper getting lost or torn or being bulky to store and being inaccessible especially in the complex setting of multidisciplinary and multi-service cancer care. Another challenge that was pointed out is that the current paper files are not structured and documentation not standardized with resulting inconsistence and incompleteness, making the data hard to compute and reuse downstream e.g. in CDSS or for research and automatic report compilation. The EMR should thus address this challenge. "..we have no unified documentation system. Every oncologist reviews the patient the way he wants. You can write 2 lines, I can write 4 lines, another can write 8 lines. 4, no standardized [documentation]... I feel that if you have a standard template of what we want, every clinician to ask a patient of a class of disease, then such issues of omissions will be minimized... you'll have a consistent standard information... the computer.. should be able to give us all the detailed headlines of what we are supposed to do... such that we have consistence of information. If am reviewing the patient, I must enter something in all these areas, otherwise it will not go to the next page." -Participant 07, Pediatrician

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"We write on papers... that you just punch and fix in the files, so many times they can pluck out... So many times you find that you look for a chemotherapy recording paper, you cannot find it.. this patient has been on treatment for like 3 months so that means there should be some recording and you can't find it." -- Participant 06, Nurse ".. right now we don't have enough space in Records [storage room]..." -- Participant 08, Medical records officer "..we have a challenge of files getting lost.. and that usually comes for example a file will go to OPD and then somebody picks it for example for research -- Participant 08, Medical records officer 1.2 The EMR should support oncology specific documentation: Oncology as a medical specialty has differences from other specialties and these also show in the documentation. There are oncology specific data such as cancer diagnosis, tumor descriptions (size, location, metastasis, etc), cancer stage, cancer risk factors, special investigations (e.g. biopsy/histology results and metastatic workup), treatment (chemotherapy, radiotherapy), in addition to emphasis put on "routine" data such as patient height and weight which are important for calculating body surface are onto which chemotherapy prescriptions are tightly based, vital signs which often change frequently in cancer patients due to the severity e.g. neutropenic sepsis, drug dose to track ceiling/life time doses, etc. ".. the UCI is a specialized center, .. it's not.. where a malaria will walk in... It's a specialized center. So, the system should be tailored to an oncology center... frequency of investigations that are done at the UCI. It's much more...and the importance. Down there [referring to an non-cancer referral hospital] sometimes people request.. RFTS, LFTS, just for just. But here, we request things which we actually want to use...the system should incorporate something that can help us to analyze our investigations. Like, you know, CBC and chemistries, ok? And also a way to sort them out... which one is acceptable, which one is not acceptable, which one needs attention..." - Participant 01, Junior doctor "..a provision where we can fix our observations as a nurse,.. the chemotherapy sheets or checklist or whichever or road map as per patient treatment schedule.. and also this other supporting treatment cause, well most of them are admitted not for chemo but for other reasons for example neutropenic sepsis..." - Participant 06, Nurse The quote above also points out an important aspect about cancer care in that patients commonly have multiple medical conditions and co-morbidities besides the malignancy making documentation complex. In addition, care is chronic and information intensive so the participants mentioned a wish for the EMR to offer efficient ways of documentation e.g. by having pre-populated menus which they just check off. "...if there was a check-check-check...that would be very easy.." -- Participant 02, Doctor (Internist) 2. Communication and care coordination 2.1 The system should enable/facilitate communication between the different care teams including the clinical service points (Outpatient department and wards), laboratory, imaging/radiology, radiotherapy, surgery, etc which are not co-located. The EMR should connect and transmit messages between all these service points, so that each knows what the other is doing for the patient for better coordination, to avoid delays, conflicts and medical errors (such as doing surgery in a patient who has just received chemotherapy or radiotherapy, or giving chemotherapy to a neutropenic patient), and to ensure continuity of care. "..the time spent during movement, usually we have very ill patients and as a clinician you're moved to walk to the lab to get the report ... there's a lot of time lost that could be reduced." - Participant 02, Doctor (Internist) ".. many patients are sometimes lost up within the system because as you know this place UCI has more than three campuses ... and some patients tend to cut across all these areas. For instance a patient is seen by a surgeon, the surgeon does mastectomy ... sends the patient for radiation at the lower campus... the radiation oncologist .. attends to the radiation part of it and if the patient is not well informed that you need further chemotherapy, that patient may be lost to follow-up" -- Participant 02, Doctor (Internist) "...I would have loved having a prescription coming to me electronically with lab results ... that is very important because before I go ahead to prepare chemo I must know that the patient is suitable for chemo..." -- Participant 05, Pharmacist

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2.2 Scheduling: Participants highlighted challenges with scheduling of patients, with "patients tend to walk in sometimes on days that are not theirs" and thought that "the computer system would be important in helping with patients' scheduling dates.. when they're supposed to come back". The EMR should therefore have functionalities to assist/coordinate scheduling of patients for the different appointments and care activities during active treatment and follow-up, according their care roadmap, which is fairly standard. 2.3 Communication with patients: Also due to the complexity of the treatment roadmaps and chronic nature of cancer care, loss to follow-up are common at the UCI and participants need a system that can assist in tracking patients and communicating with them e.g. through calls or SMS reminders. This also enables collecting survivorship data in addition to allowing better preparation and coordination of clinic visits. "..but we have people who got lost to follow up.. people who died at home.., we have to be able to track patients... a way of contacting patients.. maybe somewhere where we can incorporate a patient's contact.. maybe phone numbers.. to be able to call them.. also because our patients come periodically we have to be able to incorporate into the system a scheduling system for instance, if someone is on a 3 weekly schedule of chemotherapy, the system should be able to .. I don't know how it works but it should be able to say patient A, patient B, patient C, patient.. D are the ones who are supposed to come tomorrow or the other day, so that it helps one, the records people to prepare the files, 2, the nurses to know how many patients are coming, 3, to deal with people who.. unscheduled visits" - Participant 01, Junior doctor 3. Order entry and result management The system should assist in making orders for investigations and in managing the results - quickly selecting the orders (e,g from a predefined list) or automatically generating orders basing on previous information on a patient such as their histological diagnosis; communicating the order to appropriate target (e.g. lab or imaging) and communicating back the results to the sender in time. This is key because there is a myriad of tests done along the roadmap of care for the cancer patient, some at particular times and others routinely and more efficient ways of ordering them and transferring of results is needed to avoid wastage (e.g. in repetition of tests) and delays. "... communication between department, If I order for hemogram or chemistry, how quickly do I get results?...you need the renal function but you find it was ordered yesterday you don't have it yet you order it again, it is lost somewhere either is in the machine not printed yet because no paper or it is printed and kept in the file or printed and lost on the ward or printed and somebody's pocketed it. So some information that has been ordered for doesn't affectively get to the patient chart, which delays care and leads to misuse of resources..." --Participant 02, Doctor (Internist) Other orders such as instruction sets for a particular task or patient were also pointed out as sources of inefficiency that the EMR could alleviate by automating or reusing existing data or order sets, as exemplified by this quote: "There is a lot of repetition of things for example commonly we do feeding gastrostomies and there's a feeding protocol after, which is actually similar in all the patients, at least most of them. So you write for this patient Day 1 you give this and this and this day 2... then you if you've done 3 patients, maybe 5 patients on that day, you do that for each of the patients that you've done" - Participant 03, Surgeon 4. Computerized clinical decision support (CDSS) and safety checks 4.1 Adherence to protocols/guidelines and filling in knowledge gaps (expert system): Participants gave several examples of scenarios in which they would need assistance from the EMR in form of CDSS. The want the EMR to assist clinicians in making a cancer diagnosis and stage (according to clinical and investigations), and in making treatment decision (according to stage, co-morbidities, drug availability, drug interactions and contra-indications, etc). The CDSS is needed because some clinicians "lack specialized knowledge" or "oncology specific training", in addition to the complexity and large amount of information that has to be synthesized and acted up. "... a patient comes with breast cancer and you order for chest x-ray of abdominal scan, hemogram, liver function, renal function,.. the essence of all those tests is to map out that the disease stage. So if this program is able to get all this information that we feed it in at the end of the day it prescribes a specific stage, this would help us to treat a patient better. To follow up with that, once a stage of the cancer is prescribed then we need more guidance with the specific treatment." - Participant 02, Doctor (Internist)

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".. once a nurse or somebody makes an observation and they are entered patient's e-file then probably they can give a siren or can give a warning that you know this temperature you need to act this BP you need to act."- Participant 02, Doctor (Internist) Because many protocols and guidelines used at the UCI are adopted from developed countries where clinical trials and research are performed, the logic for the CDSS should be according to accepted modifications of such or local consensus because there are observed differences in patients in the two contexts as this participant explains: "Nutritional issues may vary, immune status may vary, especially when I deal with children. So, if I get the protocol developed in the UK or the US to be used here,... we must modify them based on some small criteria like nutrition status of the patient." -- Participant 07, Pediatrician 4.2. Chemotherapy safety checks: Participants reiterated the complexity and difficulty of chemotherapy management including correct dose calculation, monitoring of ceiling doses, side effects and contra indications such as allergies, co-morbidities that might require modification of doses e.g. HIV/AIDS, malnutrition or organ dysfunction (e.g. renal failure) or cytopenias. One requirement they had of the EMR therefore is for it to assist in checking these to ensure safe chemotherapy use because errors can be detrimental. "It's really very easy for someone to write chemotherapy twice... but if we had a system that has everyone's name once, ok? and you know these are the people for chemotherapy... a centralized system that has all the patients.. But we have a very erratic recording system that allows for a lot of mistakes." - Participant 01, Junior doctor "If the patient was treated with doxorubicin the program gives an alert: echo at six months, echo at 1 year, echo every year after treatment..." - Participant 02, Doctor (Internist) 5. Inventory/stock management The system should keep track of stock of medications and supplies, and update the different users (prescribers, pharmacists, etc). Participants need this functionality because stock management is hard in the current paper-based system, yet it greatly affects patient care. Prescriptions and protocols for treatment are chosen in part basing on available drugs, and stock records are needed to make orders for drugs and other supplies in time to avoid stockouts. "...to manage stock and supplies.. monitor drugs in my store rather than going there in the last minute and am putting in a request in the store and they tell me it's out of stock, it got finished, I gave you the last stock last week... then you can be able to prioritize...in terms of ordering... Then the other thing would be the cost attached to that because in most cases we don't know these costs. It may not be that patients are going to pay but it is important to know how much the government is spending on the patients..." -- Participant 05, Pharmacist 6. Meeting the constraints (Fit into context) Participants mentioned several conditions and pre-requisites that an EMR suitable for their context should meet. These stem mainly from the fact that the UCI is in a low-resource setting, while others are due to the unique workflow of cancer care at the UCI. The following are the key constraints: i) The system should allow for mobility or "computer on wheels" because users need to access the system at the bedside during ward rounds. ii) The system should fit into the technological infrastructure e.g. working with unreliable internet connection and electricity supply (or backups should be in place. As one participant noted, "In 24 hours, there are 10 blackouts in Uganda... Even when you talk about a backup generator, with fuel, this fuel must come from ministry of energy". iii) The system should allow flexibility to accommodate variations and exceptions that are common in healthcare, and to accommodate new requirements that may arise (such incorporation of new medical knowledge). iv) In addition, functionalities such as CDSS should not take over control from the clinician. Authorized users should be able to make modifications to the rules/functionalities. "..there should be room for clinicians to have control over system,.. and I think that also still need to be restricted, not every clinician should have... because if that is the case, a nurse can sit somewhere and modify a protocol, a pharmacist can sit somewhere and single handedly modify a protocol. I think the lead clinicians who are authorized by the Institute to actually prescribe should be given the administrator access administrator password to modify some protocols." -- Participant 07, Pediatrician

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Discussion This study aimed at eliciting and analyzing the user requirements for an EMR for the UCI as a cancer hospital in a low-resource setting. A user centered approach was taken where target end users were involved in a FGD and interviews to analyze the workflow, their challenges and wishes and to derive the requirements. The key findings were that cancer care is complex - chronic, multidisciplinary with many care points, and it is faced with many challenges that a usable EMR could help in solving. The target end users thus require an EMR that supports structured and standardized clinical documentation, and in particular, oncology specific documentation such as cancer diagnosis, stage, tumor descriptions and treatment details (such as chemotherapy roadmaps) among other things. Consistent and complete structured data can also be reused for reporting and research which are key tasks/processes for the UCI. Participants also require functionalities to assist/support tasks such as scheduling and coordination of the complex, multi-disciplinary care for cancer patients, CDSS to compliment the limited expertise in oncology and offer automated safety checks as well as taking stock for better planning. The system should however fit into the context and function despite such limitations as unreliable internet and electricity supply, it should be flexible to allow exceptions/variations (such as authorized modifications of the guidelines/protocols on which CDSS is based) and shouldn't take over control or decision making from the clinicians. On a high level, these requirements are similar to those described for oncology EMR in resource-rich countries possibly because cancer care is quite similar in terms of care coordination, scheduling, documentation needs, etc23–26 However, due to differences in the context, extra constraints and often context specific requirements are posed to the EMR on a detailed level. For instance, technological infrastructure such as internet and electricity supply is not usually considered a key issue in HIT in developed countries yet is it a major constraint in developing settings. Policy and organization of healthcare e.g. reporting requirements to ministry of health or other stakeholders or the procurement process for drugs and supplies (drugs are procured by a central national body on behalf of the hospitals so timely orders from this national medical store are required) also call for EMR features and functionalities at the UCI to serve these needs hence requirements like stock management which might not be emphasized in oncology EMR specifications for other contexts. Moreover, there is more emphasis on CDSS because of the overstretched healthcare workforce and limited number of cancer care experts making automation very crucial if cancer care in this setting is to be improved. Users' experience e.g. prior use of EMR or computer skills which are generally less compared to developed settings might lead to usability challenges when a system is developed, in addition to limiting the opinions of the participants during requirements elicitation. Demographics and identification data can also be different e.g. use of social security numbers or RFID in 23 which was never suggested or not feasible in the context of UCI because such systems aren't in place. Other key requirements specified for oncology EMRs in developed countries that were not mentioned or emphasized included billing features (possibly because the UCI is generally a public facility and healthcare is free), clinical trials support (because the UCI is not involved in many complex clinical trials), and provisions for a patient portal or mechanisms for patients to access their records and contribute to them e.g. through patient reported outcomes (because health and computer literacy levels are relatively low in developing countries and patients probably wouldn't use this feature even if it was available. Besides, there were no patient representatives among the participants)35. It is worthwhile noting that some of the challenges and wishes by the participants in this study do not necessarily need a technological solution and are rather organizational. For instance, proper documentation (consistence and completeness) should be organizational culture with or without an EMR. Implementing an EMR before such issues are streamlined might actually lead to failure of the EMR even when it is in fact a good system. Nevertheless, the RE process allows organizations to review their workflows and identify inefficiencies 36. As an example, a key organizational challenge that came out during the data collection in this study was the fact that there was no triage area and patients would first meet with the records personnel up on arrival to the UCI. Because the records personnel aren't clinical, there would be challenges of dealing with patients who came in critical conditions and needed urgent evaluation. This challenge has since be addressed by setting up a triage area at the UCI where new patients report first and a doctor is present to do a quick assessment. It is also common, especially in the initial phases of implementation, that EMR implementation leads to reduced productivity and inefficiency and this might further negatively affect care in the setting of an overstretched healthcare workforce.3738 An analysis of such potential impact on productivity or workflow changes was beyond the scope of this study but needs critical thought during EMR implementation process. Strengths of the study: Target end users who understand the workflow and intended context of use of the EMR were involved as participants (UCD). In addition, two qualitative methods, FGD and interviews were used, and

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participants were from different medical backgrounds representing different perspectives. Moreover, involvement of the target end users also has an advantage of giving them ownership which enhances buy-in. Weakness of the study: Only opinions can be obtained from FGDs or interviews and before these are implemented and tested, one can never be sure of how users will perceive and if they will accept it. More pragmatic and interactive RE techniques such as prototyping need to be applied, and more importantly the process needs to be iterative until usability is achieved. Future steps This study elicited a comprehensive list of user requirements from the perspective of different stakeholders involved in documentation and care of patients at the UCI without any form of prioritization. Since all the requirements might not be delivered at once, a next step of prioritization is needed e.g. in terms of which requirements, if delivered, provide maximum benefit. The resulting prioritized requirements should then be availed to EMR developers/vendors such as Clinic Master Int'l to guide customization of their product to fit the UCI's needs. In addition, an analysis is needed of other organizational and human issues such as training, availability of human resource, funding and other support from management, workflow changes, etc which influence (or might be influenced by) implementation of an EMR, as well as engaging potential users beyond the UCI to ensure generalizability. Conclusion Oncology is a unique medical specialty and cancer care is complex with many challenges in terms of documentation, care coordination and need for support from "expert systems" to ensure patient safety and standardized care based on guidelines, among others. If an EMR is to be used in the context of low resource settings, extra constraints are imposed to it resulting from the resource limitation (limited funding, lack of human resource, technical infrastructure and skills) and differences in organization of healthcare (reimbursement/billing, procurement process for medication, etc). These context-specific constraints and requirements have to be met to ensure usability and acceptability of the EMR, and might require customization of existing EMRs or specifically developing one targeted for this context. Acknowledgments:  The Swedish Institute (www.si.se) for the scholarship that funded the masters studies for the first author  Uganda Cancer Institute for funding the logistics of this study including travel from Sweden to Uganda  The participants who volunteered to take part in this study References 1 World Health Organization. WHO | Cancer. WHO 2017. 2 Moten A, Schafer D, Farmer P, Kim J, Ferrari M. Redefining global health priorities: Improving cancer care in developing settings. J Glob Health 2014; 4: 10304. 3 Orem J, Otieno MW, Remick SC. AIDS-associated cancer in developing nations. Curr Opin Oncol 2004; 16: 468–476. 4 Jemal A, Bray F, Forman D, O’Brien M, Ferlay J, Center M et al. Cancer burden in Africa and opportunities for prevention. Cancer 2012; 118: 4372–4384. 5 International Network for Cancer Treatment and Research. Cancer in developing countries. 2016.http://www.inctr.org/about-inctr/cancer-in-developing-countries/ (accessed 30 Jun2016). 6 Menachemi N, Collum TH. Benefits and drawbacks of electronic health record systems. Risk Manag Healthc Policy 2011; 4: 47–55. 7 Evans RS. Electronic Health Records: Then, Now, and in the Future. IMIA Yearb 2016; : S48–S61. 8 Sicotte C, Lapointe J, Clavel S, Fortin MA. Benefits of improving processes in cancer care with a care pathway-based electronic medical record. Pract Radiat Oncol 2016; 6: 26–33. 9 Niazkhani Z, Pirnejad H, Berg M, Aarts J. The Impact of Computerized Provider Order Entry Systems on Inpatient Clinical Workflow: A Literature Review. J Am Med Informatics Assoc 2009; 16: 539–549. 10 Wang SJ, Middleton B, Prosser LA, Bardon CG, Spurr CD, Carchidi PJ et al. A cost-benefit analysis of electronic medical records in primary care. Am J Med 2003; 114: 397–403. 11 Beresniak A, Schmidt A, Proeve J, Bolanos E, Patel N, Ammour N et al. Cost-benefit assessment of using electronic health records data for clinical research versus current practices: Contribution of the Electronic Health Records for Clinical Research (EHR4CR) European Project. Contemp Clin Trials 2016; 46: 85–91. 12 Makoul G, Curry RH, Tang PC. The use of electronic medical records: communication patterns in outpatient encounters. J Am Med Inform Assoc; 8: 610–5.

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