A Qualitative Evaluation of the Usability of a Hospital-Wide Electronic Medication Management System in the Oncology setting using the Unied Theory and Use of Technology Framework

Background: In light of the complexity of the medication process and the dicultly of examining it in isolation from other interrelated processes and contextual factors, this qualitative research aims to ll the gap in the literature by cohesively determining the usability of a hospital-wide Electronic Medication Management System in a specialised oncology unit by bringing in the perspective of three key user groups. Furthermore, it demonstrates how the UTAUT can be used to guide qualitative evaluation studies in evaluating the usability of an integrated EMMS. Methods: This was a qualitative study conducted in a 12-bed hospital outpatient Oncology unit in a major teaching hospital. In-depth semi-structured interviews were performed with the doctors, nurses and pharmacists to identify user’s requirements. Data were analysed by using the UTAUT framework for analysis. Results: The UTAUT framework facilitated the evaluation of interrelated aspects and provided a structured summary of user experience usability factors. The direct cross comparison between user groups illustrated that doctors and pharmacists were generally satised with the facilitating conditions (hardware and training), but had varying perceptions of performance (automation, standardised protocols and communication and documented) and effort (mental and temporal demand). On the other hand, nurses were generally satised across all constructs. It also illustrated the key role that ‘previous system experience’ plays in developing user’s system frustrations and acted as a moderator for these constructs. Conclusion: Considering the complexity of the medication process and the dicultly of examining it in isolation from other interrelated processes and contextual factors, this study cohesively demonstrated the need to explore perceptions of usability across user groups. It illustrated that doctors and pharmacists were satised with the EMMS if it provided desirable utility to their practice, and nurses when the EMMS was easy to use in the nursing processes using the UTAUT framework. As multidisciplinary teams are involved in cancer care, all potential users and their requirements should be considered.

acceptance and success have been designed and validated [1]. Usability can be de ned as the extent to which a product can be used by speci c users to achieve speci c goals, with effectiveness, e ciency, and satisfaction in a speci c context of use [15]. The usability of information technology has brought many implementation challenges, one of which is related to acceptance of the technology by individual users.
Studies looking at the oncology setting have found that some of the critical success factors include the design and usability of the EMMS [28] standardization of chemotherapy protocols [10; 12; 17; 28], seamless integration with other health information systems and user work ows [6; 9; 10; 12; 14; 20-22; 28], effective training and support [5; 10], support from leadership [4; 5; 10], collaborative project management [4], and effective ongoing maintenance and support [4; 6; 30]. To tackle these barriers, usability evaluation of Computerized Physician Order Entry (CPOE) systems aims to provide, from the perspective of human computer interaction, insight into the problems that hinder users during interaction with the EMMS. With the surplus of tools available to evaluate information systems, researchers must consider whether the tool explores all areas of usability.
Previous studies have found that the Uni ed Theory of Acceptance and Use of Technology (UTAUT) model is the most predictive model in the acceptance literature [18]. The use of the UTAUT framework provides an extensive scope of usability aspects of an EMMS in the healthcare system [27]. However, no study to date has used the UTAUT framework to explore usability in the Oncology EMMS setting. Whilst not originally designed for the healthcare setting, the frameworks exibility can be translated to the hospital environment. According to the UTAUT, the performance expectancy, effort expectancy, and social in uence constructs are theorised to in uence behavioural intention to use a technology, while behavioural intention and facilitating conditions determine technology use [35]. The UTAUT explores all areas of usability, integrating effectiveness, e ciency and satisfaction into its various domains.
Previous studies exploring Oncology EMMS have predominately focused on the usability from the perspective of one user group in isolation such as prescribers [32] or EMMS providers [15], or the user requirements before implementation [36] or its impact on medication safety [22; 34]. This study aims to evaluate the usability of an integrated EMMS in the Oncology setting from the perspective of nurses, doctors and pharmacists. In light of the complexity of the medication process and the di cultly of examining it in isolation from other interrelated processes and contextual factors, this qualitative research aims to ll the gap in the literature by cohesively determining the usability of a hospital-wide EMMS in a specialised oncology unit by bringing in the perspective of three key user groups. Furthermore, it demonstrates how the UTAUT can be used to guide qualitative evaluation studies in evaluating the usability of an integrated EMMS.

Sample and setting
This study was undertaken in a 12-chair hospital outpatient Oncology unit in a major teaching hospital in Sydney, Australia. The oncology unit is an outpatient unit attached to a 750-bed teaching hospital treating a range of adult solid organ tumours and haematology malignancies. The evaluation began in December 2019, six months after EMMS implementation to minimise potential effects of initial user resistance. The EMMS is part of a single, integrated Electronic Medical Record (EMR) which contains most other aspects of patient care, including pathology, imaging, tests orders and electronic clinical documentation. The EMMS is used for chemotherapy and antineoplastic prescribing and administration. Oncology speci c order sets were also introduced (Fig. 1). Order sets are used to group orders together to ensure that potentially related orders are available in one place for the convenience of the prescriber. The order sets are in accordance with eviQ [1] regimens, evidence-based, consensus driven cancer treatment protocols and information for use at the point of care. EviQ is developed for the Australian context and supports health professionals in the delivery of cancer treatments [1]. Notably, not all protocols were available in the EMMS at roll-out due to time constraints in the development phase. Therefore, the clinic was temporarily adopting a hybridised setting where 70% of protocols were electronic and the remaining 30% were paper based. All orders are subjected to series of checks including drug allergies and interactions. The EMMS allows prescribing, pharmacy veri cation, documentation of drug administration and medication reconciliation. Following prescribing, orders appear on a summary view of medications prescribed, as well the Medication Administration Record screen for administration. Once orders have been prescribed, the medication protocol auto-populates as a sequence on its consequent due date. Once veri ed by a pharmacist, it requires activation by the nurse prior to administration.

Interview guide
In depth semi-structured interviews were conducted. Interview questions were guided by the constructs of the UTUAT and consisted of 16 questions (Appendix 1), allowing participants to express their attitudes towards latent issues relating to the constructs. UTAUT integrates eight theories on technology adoption and provides a comprehensive view of the factors related to users' adoption behaviour [35]. The main UTAUT constructs are [33]: Performance expectancy (PE): ''The degree to which an individual believes that using the system will help him or her attain gains in job performance''.
Effort expectancy (EE): "The degree of ease associated with the use of the system".
Facilitating conditions (FC): ''the degree to which an individual believes that an organizational and technical infrastructure exists to support use of the system'.
Social in uence (SI): "the degree to which an individual perceives that important others believe he or she should use the new system'.
Adopting these constructs to a qualitative study, explores key areas related to the 'acceptance of technology' and 'usability'. The model was chosen as it examines the presence of each construct in a "real world" environment, allowing assessment of an individual's intention to use a speci c system, thus allowing for the identi cation of the key in uences on acceptance in any given context [35] Participants and recruitment Purposive maximum diversity sampling was used to recruit nurses, doctors and pharmacists that care for oncology patients and were expected to have worked in the oncology unit three months prior to and during the implementation of the EMMS. For nursing staff, recruitment material was distributed by the ward's allocated education nurse. Doctors and pharmacists were recruited via email from their heads of department. Recruitment ceased once data saturation for each of the user groups had been achieved.
The same researcher (a pharmacist research student) interviewed all user groups. The researcher had not worked closely with interviewees previously or with cancer care. The interviewees were provided with an explanation of the purpose of the study, and an explanation that the interviewer is an employee of the hospital, however their role in this study is purely an investigator [31]. The interviewee's role in the study was also described to them as well as the opportunity to withdraw at any stage of the study [31].

Data analysis
Inductive and deductive methods [2] were used in the data analyses. Interviews and focus groups were transcribed verbatim and a process of inductive and iterative transcript analysis methods [25] were applied to identify new or emerging themes. Data collection and analysis were iterative, allowing themes in the data to be explored in depth and contradictory data to be investigated. Deductive components involved coding of data into categories developed as part of an analytical framework, mapped to the constructs of the UTAUT. The framework helped to guide the research; facilitate comparison of ndings between user groups and relate these ndings to the existing literature. Throughout this process additional themes emerged from the data, and inductive methods involved identifying these additional new insights. Integration of ndings was achieved by combining the framework categories with newly identi ed themes. The codes were independently developed by two of the researchers and the differences were resolved through discussion between the coders, assisted using NVivo 11 (QSR International Pty Ltd, released 2015, Version 1.0.1.1). Codes were grouped into themes by the research team and then deductively mapped to the constructs under the UTAUT. In addition, an ongoing review of the literature on the topic of EMMS implementation enabled us to validate, compare, and extend our ndings [40].

Results:
In this study, 27 participants took part in the interviews which represented 79% of all possible staff. The average length of interviews was 45 minutes. The demographic characteristics of the participants are presented in Table 1. Most of the participants (n = 23, 85%) were female and were represented by doctors (n = 10), pharmacists (n = 7) and nurses (n = 10). The impact of the EMMS on the various elements of the UTAUT have been described in detail below. Interviews generated rich data relating to usability and acceptability of the EMMS. The themes in these categories were mapped to the UTAUT framework ( Table  2).  Overall, all user groups felt that improved automation and standardization introduced by the EMMS improved their overall performance. However, doctors and pharmacists expected a greater impact on their performance. They were disappointed by the limited degree of automation, in uenced by pre-conceived ideas as well as experience with other systems.
-Automation And Medication Safety: Reduced 'mental energy' required by the EMMS was described by a registrar involved in transcribing medication charts as well as the automated calculation of Body Surface Area and Area Under the Curve were appreciated across all user groups, as described by doctor 1 (table 3). However, doctors and pharmacists believed the safeguards within the EMMS aren't adequate to prevent errors or inappropriate prescribing. As described by a pharmacist 4 (table 3).  Order sets have reduced the MD for simple regimens, however a general lack of system exibility, which was paradoxically often a symptom of the system attempting to improve safety (eg, by making certain tasks or viewing of screens compulsory or sequential).
• The Increased steps to perform simple tasks are mentally draining.
• 'Pharmacist 5: The number of steps to get one label out is just so much more. It's just very labour intensive'.
Greater time pressure due to: -More administrative tasks due to changed work ow • Pharmacist 3: If they don't want something you have to reverse the repeat, re-attach it, go nd the le again and like yeah, the amount of time you spend looking for stuff is ridiculous in an EMMS world.
• Pharmacist 4: We have to double product assign which against waste of time.
-Reliance of doctors to troubleshoot their prescribing issues, con rmed by a doctor's view that • Doctor 6: I think they frequently seem to prioritise those queries from us just not sure how much of a burden it puts on them'. Layout of charted medication as well as ease of access to all parameters required in treatment such as BSA and pathology has reduced the mental; demand required to determine the order of administration of medication.
• Nurse 2: 'I think it's great in the sense that it's all there, I can look at the bloods, I can look at the BSA I can look at the medication, it's listed out like following a recipe'.
Layout and remote access allow you to better prepare for patients and reduces time pressure to complete tasks.
• Nurse 2: 'We couldn't prepare earlier before. We didn't have the le in hand and sometimes you don't have time when the le arrives. But now say the patient was not there yet, I really look at their thing and I can communicate well and I know what exactly I need to do'.

-Standardizing Protocols And Dosing
Both nurses and doctors appreciated the impact of standardised protocols on their performance. The standardised layout of medication charts improved medication safety and positively impacted on nurses perceived performance as nurses described that there was less chance of chart misinterpretations, as described by nurse 3 (table 3) and a user-friendly layout that supports medication administration, nurse 5 (table 3). Similarly, doctors appreciated that 'the protocols written in there are set in there …and are established protocols' (doctor 3). The bene ts introduced by an automated dose variance report allowed management to oversee unusual prescribing, as described by doctor 3 (table 3). Collectively standardisation and the ability to track dose variance were perceived as bene cial in improving overall performance.

-Communication & Documentation
Doctors and pharmacists felt that communication and documentation improved to a degree, both due to the system itself as well as the system highlighting gaps in work ows. Pharmacists appreciated the clarity of communication regarding dose reductions as described by pharmacist 1 (table 3). The system also highlighted issues that previously existed, indicated by doctor 2 (table 3). However, there were concerns about the format of the treatment plan documents. The templates were being misused as described by pharmacist s (table 3). Further re ected in the doctor's perception of them being 'clunky'. From the nursing perceptive, it greatly improved communication between the multidisciplinary teams as well as amongst each other, as identi ed by nurse 2 (table 3).

Effort Expectancy:
Effort levels for the various user groups drew on various dimensions of effort such as mental demand and temporal demand. Users described varying impacts of the EMMS on these elements of effort and are Page 11/19 summarised in Table 4. For doctors and pharmacists there was consensus that greater effort was required to perform tasks previously described as simple, whilst previously complex tasks had eased.

Facilitating Condition
Training Doctors and pharmacists expressed varying levels of con dence and competence in using the EMMS. Di culties were associated with the inability to comfortably use the system when dealing with complex regimens, such as being unable to 'amend or interpret dose adjustments'. Some users attributed this to the system not being intuitive enough and inadequate training, as described below: Doctor 5: 'It should be intuitive enough but it's not. And to actually pick them up when you only do the clinic once every 2 or 3 months it's going to be hard'.

Pharmacist 3: 'I had 3 days to learn everything OHMIS and solve all problems and that wasn't enough time'.
Concerns were raised by pharmacists that the increased complexity in using the system had shifted their role to 'EMMS support' for doctors. Re ected in a doctor's perception that ' I do worry that I have done something, like I've forgotten 3 out of the 30 steps and that, but usually I have enough faith that the system will hold and a pharmacist will tell me that this is wrong (doctor 5)'. Whilst pharmacists believed they were best positioned to support prescribing, the unintended consequence meant that it was impacting on their limited sta ng and work ows.

Hardware:
Doctors and Pharmacists were generally satis ed with the hardware being used to support the EMMS. On the other hand, all nurses expressed concern for the ergonomics of the mobile trolleys that the computers were being supported on, describing them as 'ergonomically it's not very well set up. The screens are heavy and always falling forward, and everybody is going to have a bad back and a bad neck (nurse 5)'.

Social In uence
Amongst the user groups there was hierarchical in uence on user-groups. Both senior and junior doctors believed their superiors to be supportive of the system. Senior doctors felt the organizational support due to the 'bene ts of having the same EMMS facility wide'. However, some senior doctors 'would prefer another system' due to familiarity. Social structure however was not in uencing their juniors who described their heads of department as being 'very enthusiastic'. Similarly, across all nurses there was the perception that their seniors supported the EMMS. On the other hand, junior pharmacists were feeling the 'anxious or negative environment partially in uenced by their seniors' which they believed was brought about by the seniors being concerned about the increased workload and complexity.

Experience:
This study showed that the perception of the UTAUT constructs were moderated by previous experience in using an EMMS due to its indirect impact on pre-formed expectations ( Table 2). Previous experience was found to in uence expectations of the system related to performance and effort expectancy and resulted in frustrations with the current system. Previous experience using the EMMS meant that users expected a degree of automation and safeguards not achieved by the current EMMS.
Pharmacists 2: 'So the system shouldn't be so prone to errors like that. If you've selected one, other systems I've used will populate for the rest of the cycles, assuming things haven't changed, for this system to keep allowing each cycle to be different isn't right'.
Expectations were associated with concerns raised by both pharmacists and doctors related to the increased reliance on a clinician memory rather than automation. There were expectations that a system would prevent 'duplicated prescribed medications', include reminders such as 'standardised vitamin b12 every 3 cycles' as well as 'cycle 1 dose reductions carrying over to cycle 2', rather than putting greater reliance on prescriber's memory as outlined by the doctors 4 and 5: Doctor 4: 'Remembering that cycle 1 dose reductions don't carry over to cycle 2 and you have to do it manually…I nd it dangerous'. Doctor 5: 'I don't understand why things like vitamin b12 every 3 cycles isn't just integrated into the pemetrexate regimen and why we have to remember, like if it's a computer system it should be able to do those things automatically'.
Whilst nurses felt that a patient's previous experience at other hospitals, positively in uenced their perception, as described by nurse 5 ' But I think the patients think the computers are safer…there's been a few patients before we went onto the EMMS who said, well when I went to another hospital, every nurse has got a computer'.

Behavioural Intention:
Overall all user groups were enthusiastic about continuing to use the system in the short-term if they had a choice not to. For nurses this was attributed to the bene ts they're experiencing across all elements of the UTAUT model, whilst for doctors and pharmacist the major draw point was that the system was integrated with the remainder of the hospital's EMMS. However, in the long-term doctors and pharmacists believed it to be only sustainable if the system were 'optimised' and 'enhanced' based on their expectations around automation and safety of the EMMS.

Discussion:
Considering the complexity of the medication process and the di cultly of examining it in isolation from other interrelated processes and contextual factors, this study cohesively determined the usability of a hospital-wide EMMS in a specialised oncology unit. As multidisciplinary teams are involved in cancercare, the three key user-groups and their inter-connected yet unique requirements were identi ed [36]. It illustrated that doctors and pharmacists were satis ed with the EMMS if it provided desirable utility to their practice, and nurses when the EMMS was easy to use in the nursing processes [24]. The UTAUT framework facilitated the evaluation of interrelated aspects and provided a structured summary of usability user experience factors. It allowed for a direct cross comparison and illustrated the key role that 'experience' plays as an in uencing moderator for these constructs.
This study identi ed the need for multi-disciplinary usability studies as EMMS usability impacts individual user group in unique ways. Outcomes of user's views illustrated that tasks related to effort expectancy differed not only between the user groups but also between social structures. Universally, across all user groups, there was a strong relationship between mental and temporal demand. Areas of the EMMS that reduced the mental demand had a downstream effect on temporal demand. Like previous studies it was identi ed that EMMS layout, con guration and output quality can reduce the mental energy required of searching for important information and the time taken to achieve this [11]. When users feel that the EMMS doesn't meet these needs and increases temporal demand, resistance is more likely [11]. The contrast in acceptance between nurses and doctors' highlights this. It illustrated that doctors and pharmacists were satis ed with the EMMS if it provided desirable utility to their practice, and nurses when the EMMS was easy to use for the nursing processes [24]. Nurses felt the layout presented the regimens in a uniform usable form that reduced the temporal demand. On the other hand, resistance by doctors to the EMMS was in uenced by the increased mental capacity required to prescribe complex regimens impacting on temporal demand. Similarly, our study highlighted from a managerial level, the bene ts of the EMMS integrating with the remainder of the hospital system and providing automated auditing from a managerial level [7] reduced the effort expectancy and is a key driver for uptake and support [11; 32].
The UTAUT framework facilitated direct comparison between user-groups, allowing for evaluation of interrelated aspects and provided a structured summary of factors to determine which are associated with poor usability. The UTAUT highlights the importance of contextual analysis in developing strategies for technology implementation within organisations [33]. Despite the ability of the existing models to predict intention and usage, current theoretical perspectives on individual acceptance are notably weak in providing prescriptive guidance to designers and demonstrates the need for qualitative investigations [33]. The interrelated nature of facilitating condition and its downstream impact on user groups demonstrated this. Lack of understanding of system functionality often results in independent troubleshooting by users, skipping steps or entering information in the EMMS differently to overcome system barriers [22]. By doctors not initially appreciating the source of the problem when prescribing, in a strongly multidisciplinary unit, it had downstream consequences for other user's (pharmacists and nurses) work ow. The ndings are consistent with those of previous studies that illustrate the role of facilitating conditions in user acceptance [19; 37]. Considerations should be made when system redesign isn't possible, to incorporate lessons learned from the troubleshooting incidents into the training of staff to improve usability across all groups [16].
User's previous experience with other EMMS resulted in pre-de ned expectations of the EMMS, moderating their perception across the UTAUT constructs [33] and perpetuating frustrations with the current system. The difference in expectations between user groups who had had previous experience (doctors and pharmacists) and those who didn't (nurses) in working with an EMMS, demonstrated a stark difference in user acceptance. Palm et al also demonstrated that con rmation of expectations were strongly associated with doctors' and nurses' satisfaction [24]. Previous studies have found that the main required system expectations were the possibility of searching data, security and con dentiality protocols, the availability of data analytic tools and collecting data about different types of cancer [36]. Achieving these expectations can potentially be achieved by the application of user centred design which has been shown to be more e cient and more usable than when not initially considered in the design [8]. However, user-centred design can also be limited by the nature of an integrated system. Whilst integrated systems facilitate the availability of information in one place, they also limit the customisability thus impeding innovation and potentially impacting on the usability in specialized settings [13; 23]. Interestingly, the UTAUT theorises experience is a moderating in uence on FC, SI and EE [33]. Our ndings illustrated that experienced with a 'best-of-breed' system in uenced by expectations was found to have moderating effects on PE and EE.
The nding that performance expectancy is related to intention to use the new EMMS aligns with previous studies that claim performance expectancy is an important determinant of doctors' intention to use a new technology [26].The greatest bene t and also disbene t on performance expectancy for doctors was introduced by pre-de ned order sets. Our ndings are consistent with other studies that found a key facilitator for user-acceptance were order sentences that increased prescriber e cacy [11; 32] and evidence-based practices, [3; 17; 32]. However, we also identi ed oncology speci c issues related to protocol-mandated care. A major limitation in exibility was found when doctors attempted to order outside the order sets [22], when adjusting doses or frequencies. The perception of the system was that it lacked the exibility required in the oncology setting, which was paradoxically often a symptom of systems attempting to improve safety [11].Like previous studies [17], automaticity contributed to a negative user experience to a degree [22], as users (doctors and pharmacists) felt reduced e cacy was being facilitated by a greater number of mouse clicks [32] and effort were required to prescribe or review medications outside of standardised order sets.
Limitations of this study are that it was conducted in a single-centre site and was conducted six months following EMMS implementation, therefore initial user resistance issues that may have arisen during the shakedown phase had not been overcome or ironed out. It is currently unknown if these issues would remain after 12 months of using the system. Evidence suggests that it may take up to two years postimplementation until the unit returns to complete stability as EMMS optimisation can be an iterative process [7], and up to 4 years before there is a return on investment [11]. Furthermore, the full EMMS had not been implemented at the time of the study, with only 70% of the protocols integrated into the EMMS creating a hybridised environment. We also did not directly measure safety or e ciency quantitatively, and perceptions around these domains can differ substantially from objective assessments. Mixed methods, however, provide complementary insights. This essential foundational work has allowed us to understand key users' experiences and will serve as a basis for further exploratory work.

Conclusion:
Our research has attempted to identify important constructs from the user acceptance literature by using the popular UTAUT as a base model. Overall the evaluation revealed disparate views between user groups on the usability of the Oncology EMMS. Unique requirements of users in the Oncology setting surfaced and illustrated that amongst the different groups there were differing usability needs. It demonstrated that EMMS can both improve performance and reduce effort as well as act as a barrier due to the lack of usability and exibility. Nurses demonstrated overall satisfaction with the EMMS, whilst doctors and pharmacists highlighted that changes were required to increase the ability of the EMMS to better serve their needs. There were some required system features are already in use in the EMMS and simply needed optimisation; whilst others still needed to be added. The greatest usability problems concerned restricted automaticity and system complexity, which hindered user uptake and EMMS success. Whilst there were concerns by doctors and pharmacists, both groups indicated short-term acceptance however questioned the long-term sustainability if the necessary changes weren't achieved. The study also illustrated the versatility of the UTAUT framework in adapting it to the healthcare setting to evaluate the usability for key user groups. The UTAUT framework was useful in the design of the evaluation of the EMMS and allowed methodological exibility.

Effort Expectancy:
What is it about the EMMS that you nd easy to use?
In general, what is it about the EMMS that you nd di cult to use? Describe what your interaction is like using the EMMS?
Describe di culties you faced in becoming skilful in using the EMMS? 2. Performance Expectancy: In what ways do you see using the EMMS useful in your job? Can you explain your thoughts on the quality of information provided by the EMMS?
In what ways do you see using the EMMS impacts your productivity?
Describe the impact the EMMS has on the time it talks to accomplish your tasks.

Facilitating Condition:
What support has been made available to you since go live? Comment of each type of support. Describe the support resources that have been made available to you, do you nd you have the resources necessary to use the system? How con dent are you in your own ability to adapt to the new way of working with EMMS?
To what extent is the new way of working with OHMIS compatible with other systems you use.

Social In uence:
Generally speaking, who are the colleagues that are important and in uential to your work?

Authors' contributions:
RD lead (1) the conception and design of the study, acquisition of data, analysis and interpretation of data, (2) drafting the article or revising it critically for important intellectual content, (3) nal approval of the version to be submitted JP contributed to (1) the conception and design of the study, (2) revising it critically for important intellectual content, (3) nal approval of the version to be submitted SP contributed to (1) the conception and design of the study, (2) revising it critically for important intellectual content, (3) nal approval of the version to be submitted AR contributed to (1) the conception and design of the study, (2) revising it critically for important intellectual content, (3) nal approval of the version to be submitted RB contributed to (1) the conception and design of the study, (2) revising it critically for important intellectual content, (3) nal approval of the version to be submitted