Well-characterized biomaterials of high quality have great potential for acceleration and quality improvement in translational biomedical research. To improve accessibility of local sample collections, efforts have been made to create central biomaterial banks and catalogues. Available technical solutions for creating professional local sample catalogues and connecting them to central systems are cost intensive and/or technically complex to implement. Therefore, the Translational Thematic Unit HIV of the German Center for Infection Research (DZIF) developed a Laboratory Information and Management System (LIMS) called HIV Engaged Research Technology (HEnRY) for implementation into the Translational Platform HIV (TP-HIV) at the DZIF and other research networks.monitoring of stored samples and associated informationdata selection via query tools or Structured Query Language (SQL)preparation of summary documents, including scannable search listscentralized management of the practical laboratory part of multicentre studies (e.g. import of drawing schemes and sample processing steps),preparation of aliquot shipments, including associated documents to be added to shipmentsunique and secure identification of aliquots through use of customizable Quick Response (QR) code labels directly from HEnRYsupport of aliquot data transmission to central registries.HEnRY is developed at the University Hospital of Cologne. It is an advanced LIMS to manage processing and storage of samples and aliquots of different sample types. Features include:In summary, HEnRY offers all features necessary for a LIMS software. In addition, the structure of HEnRY provides sufficient flexibility to allow the implementation in other research areas.HEnRY is a free biobanking tool published under the MIT license. While it was developed to support HIV research in Germany, the feature set and language options, allow much broader applications and make this a powerful free research tool. A biobank can be described as a biomaterial repository, in which biological samples and data of their respective donors are stored for use in biomedical research. It involves the systematic and standardized procurement, processing, annotation, storage, and ultimately distribution to the involved researchers . BiobankToday, indexing, labelling, and storage of samples in professional biobanks is usually handled by Laboratory Information Management Systems (LIMS) that support the user with administrative and coordinative tasks of sample processing as well as the collection and analysis of identified analytical data , 5. IdeaThe features of a LIMS have changed over the years from a basic sample tracking to a resource planning tool that manages multiple aspects of laboratory informatics. Common features of LIMS are workflow management, record keeping, inventory management, data exchange interfaces and reporting. They bring accuracy and accessibility to the flow of samples and laboratory data –9. One pBy using a LIMS with a database accessible to each employee, individually managed spreadsheets can be replaced. Representation of the collected and complex data is simplified by the use of database queries. Regular backups can ensure the safety and availability of laboratory data.Most LIM systems on the market have high initial costs or license fees. Small or newly founded working groups usually lack the financial means to purchase such a system . For thewww.tp-hiv.de. A first production version was made available for participants of the TP-HIV on the February 15th, 2017.HEnRY is released under the MIT licence . The cliAll data is stored in a Microsoft SQL (MSSQL) database on a MSSQL Server 2012 or greater . It is rDuring the developmental process of HEnRY, a close collaboration with the laboratory staff, which represents the primary target group of the tool, and study coordinators was established. Both user groups gave continuous feedback to developed and requested new features, which were tailored to their needs.User feedback in the form of meetings and questionnaires was obtained at regular intervals. Requests and bugs were fixed in the context of monthly updates. Additionally, the lead developer accompanied the lab employees in their daily work routine with HEnRY to streamline the program to the actual workflow in the lab.The HEnRY LIMS software is in use at the University of Cologne since 2016, with currently seven active working groups.HEnRY specializes in the documentation of the storage and processing of blood samples and aliquots in analytically working laboratories. It simplifies and accelerates laboratory work, increases the quality of documentation and minimizes potential sources of errors. Information about studies, patients, samples, aliquots and processing steps is stored in a structured manner see Fig. . This inFigure In a setting of limited resources, HEnRY can be used as a standalone LIMS on one computer with e.g. SQL Server Express editions for structured documentation of biomaterial and self-adhesive label creation. Via the transfer of XML files, data for biomaterial can be shared with other laboratories, clinics or project partners.HEnRY offers the opportunity to manage any number of studies and respective workflows to support practical work in the laboratory. The name of the study, start and end date, contact persons, and whole laboratory books, down to descriptions of the chemicals to use, can be added to a study see Fig. . More imStudy schemes with all the practical information  can be exported to XML files . A studyThis procedure was initially developed for the TopHIV study, which is centrally coordinated from working groups in Cologne and Hannover. The XML files for the study are available for download on the website of the TP-HIV .HEnRY offers the opportunity to work with different databases. The user chooses the database to work with when starting the program. Samples processed for different working groups or studies can be stored in separate databases to expedite analysis and restrict accessibility of the data.Patient records can be created directly in HEnRY or linked to another clinical database. One such interface is available for the HIV Observation Software (HIObS) of the German Robert Koch-Institute, Berlin . For datHEnRY offers a large range of properties, which can be documented for each sample or aliquot. Basic data, e.g. type of sample, sampling location, and creation date and time of the aliquot are mandatory. Identification of the person responsible for sample processing is stored with the sample or aliquot record. Container and storage location, including tower and rack , are stored see Fig. . For froSamples and aliquots can be created one by one or by using the copy function for existing aliquots. For studies, large amounts of aliquots can be generated by applying study schemes . The study supervisor can preselect the properties of the aliquots saved in the .csv file. A customization of the range of properties and their format is possible. In addition, a letter, to address the receiver of the shipment is printable.Important information such as the reason and way of shipment as well as the delivery address can be given by the study assigned to the aliquots.HEnRY features user management with different levels of access. The study supervisor has the right to manage and add studies within HEnRY. The study supervisor can monitor the completeness and the correctness of information contained in the HEnRY database. This guarantees ongoing and steady control of processing quality. After the end of a study, the study supervisor has the option to anonymize patient data in line with patient privacy rights. Laboratory staff is allowed to edit the sample processing protocol.If HEnRY is linked to a clinical database, clinical and personal data of patients can be viewed by users with the “physician” right. Otherwise, only pseudonymous data is shown. Users in the “IT” user group can administrate the SQL connection, manage HEnRY users, and adjust printing settings.Only pseudonymous data can be exchanged. Data of samples and aliquots can be exported into XML files , e.g. inHEnRY offers a variety of search functions. Aliquots can be selected by study, visit, storage or site.ne site is available. A graphical user interface offers a virtual view of a selected box, including the amount and placement of aliquots within the box. The monitoring status of all aliquots can be assessed and printed. All lists can be exported as XPS or CSV files.Data can also be selected via an SQL query interface, and printed as scanable search lists with QR codes for each aliquot. By use of this tool, researchers can perform complex and customized searches covering all data contained in the database.To connect external data sources, a separate module is available for HEnRY, offering extract, transform, and load processes for different source formats . The parser is not part of the primary program package.In view of the increasing requirements towards data protection standards in Europe and especially Germany, data privacy officers and clinical IT departments are sometimes reluctant to allow the use of LIMS tools based on cloud services and web interfaces, especially in the context of potentially stigmatizing diseases such as HIV. HEnRY can run with a locally administrated MSSQL database and offers hierarchical user rights on database and frontend levels. The storage of data, backup plans, and access to the data are fully controlled by the local IT of the hospital. Therefore, this tool can be seamlessly integrated into high security environments.For large working groups, HEnRY works with a central MSSQL Server  and multIn 2012, a survey was performed among HIV specialists and cohort researchers in the German Centre for Infection Research to identify the state of affairs and identify pressing needs in IT development across sites. Based on the survey results, a need for a harmonized collection and reporting of biomaterial samples was recognized. While some sites already had highly developed biobanks with professional software and storage solutions, most partners used legacy software products or standard spreadsheet software packages to maintain biomaterial and data collections. Based on the obvious demand for a cheap and efficient solution, the decision was made to develop a common tool for sample collection and exchange. A first list of desirable features was made and development of HEnRY started in 2014.The lead developer of HEnRY went to on-site half-day visits to various users to directly understand the current and desired workflow and better address concerns and queries. Two working groups took the role of key users, who received early designs for commenting and took part in workshops between users and developers to identify core workflow parameters. Many key features of HEnRY such as study schemes have been developed in direct collaboration with the laboratory staff of the key user groups. During 11 meetings with both key users groups between 2015 and 2018, features were improved, performance optimized, and bugs removed. The current version is 2.2.After successfully deploying productive versions of HEnRY for the key user groups in 2015 and 2016, HEnRY was requested by several other groups at UHC and DZIF. Table To improve the accessibility of biomaterial within the scientific community, samples obtained with broad patient consent for certain biobanking studies are automatically reported to the central biomaterial registry  of the TI Biobanking . From thWe performed a comprehensive comparison of HEnRY with other LIMS based on information available on the respective product websites –32. SincOur software is not without limitations. One shortcoming of HEnRY compared to commercial tools is the current lack of support for robotics and rack scanners . HoweverWith HEnRY, we provide a free versatile LIMS tool published open source under the MIT license and designed for coordination of local biobanks, as well as central management of multicentre studies.The individual features of HEnRY, e.g. connecting sample and patient data, visualisation of boxes, sample tracking, and biorepository management, have already been offered through other biobanking systems in the past –32. We aIn conclusion, to our knowledge, HEnRY is the most comprehensive and versatile biobanking LIMS among the group of free and open source systems. HEnRY allows safe and rapid implementation of a local and/or central LIMS system, thus offering immense potential for emerging research groups, especially in the setting of limited resources and/or complex multicentre studies.We envisage an extension of the list of annotatable sample and aliquot types, organisms and associated diseases, as well as machines used for sample processing, in order to improve the depictable level of documentation precision in non-HIV scientific research. Given the growing role of connectivity features and data exchange, standard meta-data and support for current health data exchange protocols such as HL7 FHIR  and MIABAdditional file 1. Supplementary material 1: Class Diagram HEnRYAdditional file 2. Supplementary material 2: Database scheme for aliquots and samplesAdditional file 3. Supplementary material 3: Data flow 1Additional file 4. Supplementary material 4: Data flow 2Additional file 5. Supplementary material 5: Work flowAdditional file 6. Supplementary material 6: Use case with user rights


The pulsed high power microwave (HPM) technology has been developed worldwide for over 20 years. The sources of HPM pulses are a weapon of mass destruction. They pose danger especially to computer and telecommunications equipment and systems, both the military and civilian ones. This paper presents a survey of literature on electromagnetic wave radiation absorbing and shielding materials to be used in construction. Relevant protective measures should include the shielding of buildings or their parts and the absorption of radiation by building envelopes and their elements. The main focus is on the possibilities of improving the shielding and absorptive properties of common construction materials, such as concrete, mortars and synthetic resins. The survey covers the following groups of materials: carbon-based admixtures, nickel powder, iron powders, ferrites, magnetite and polymers. The final part of the survey is devoted to hybrid foam microwave absorbers in which the shape of the material’s inner structure and that of its surface play a special role. The pulsed HPM technology has been developed worldwide for over 20 years. This applies to both HPM pulses and ways of protecting against them ,2. The pWhen designing ways of protecting buildings against attacks with the use of this weapon one should take into account that HPM pulse energy can reach devices and systems through interfaces, loose building envelopes, utility inlets, window and door openings and also through space dividers. An attack on a building can lead to the paralysis of its subsystems. This interference into the building’s control and management systems can result in (besides the measurable losses to the infrastructure) loss of the health and even life of the people evacuated in panic from the endangered building devoid of power supply, ventilation, air-conditioning, etc.Protection against directed HPM pulse energy needs to be comprehensive, covering both the design and construction of a building. As regards construction, the protective measures should include the shielding of rooms, space enclosures and openings and the absorption of radiation by space enclosures and their components ,9. ImporThis survey is aimed mainly at improving the shielding and absorptive properties of construction materials, such as concrete, mortars and synthetic resins. Absorptive properties can be usually improved by dispersing suitably designed particles, having high electric conductivity or magnetic properties, in the base material . An additional improvement in the absorptive properties is achieved by suitably shaping the material’s surface or its inner structure. The aim of such modifications is to make the material subjected to the HPM pulse attenuate it as much as possible by dissipating its energy converting it into a heat. In general, the attenuation depends on the electrical permittivity (dielectric constant) and magnetic permeability of the material used but also on the frequency of microwaves and on the thickness of the absorbing layer. For a given frequency, the effectiveness of a specific absorber  is most often determined in the literature by providing a value of either shielding effectiveness or reflection loss. In view of the applications considered in this review, a high level of microwaves attenuation over a wide range of frequency is desirable for the absorbers. Taking this into account, the most complete characteristic of the effectiveness of the absorber would be either shielding effectiveness or reflection loss as a function of frequency in the entire microwave range. Such data, however, are not always available in the literature. Therefore, in this review, it was decided to provide the fullest possible information (in terms of quantitative characterization of microwave absorption), which is given in almost all of the analyzed works, i.e., either shielding effectiveness or reflection loss together with the corresponding frequency range.Most of this survey deals with microwave radiation absorbing admixtures and their effectiveness, as described in the literature on the subject. In particular, the possible uses of carbon-based materials  and the So far such carbon-based materials as graphite, coke, carbon fibers, carbon nanotubes, graphene, fly ash and carbon black have been used for protection against electromagnetic pulses.Graphite in the form of a powder is a highly electrically conductive filler. Tests have shown that the use graphite powder (from 17.5% up by volume) combined with high-alumina cement paste enhances the effectiveness of electromagnetic shielding . This efColloidal graphite can be obtained from very fine graphite powder by introducing the latter into water or alcohol together with a small amount of polyvinyl alcohol (PVA). After application the water or the alcohol evaporates from the solution, whereby the graphite particles come into contact with one another. Tests carried out on samples with a nominal thickness of 4.4 mm and a different graphite content showed that the composite obtained in this way was characterized by high shielding effectiveness . In addi2/g). Moreover, it is characterized by high conductance . Consequently, it is a material particularly effective in shielding against electromagnetic pulses. Its shielding effectiveness was estimated in )It should be clearly emphasized that the solutions discussed in this survey usually yield a good shielding effectiveness within a relatively narrow frequency range. In order to develop a technology that would comprehensively protect buildings against HPM it is necessary to ensure a proper level of protection in a wide range of electromagnetic wave frequencies. This probably can be achieved only by simultaneously using several partial solutions acting effectively in appropriate frequency ranges. The present authors are currently developing such a system, in the form of a hybrid multilayer wall, and they will soon publish the results of this research.Taking advantage of the present review and the experience gained by the authors from the ongoing works in the project acknowledged in the funding section the following general remarks can be formulated. A methodology of developing construction materials for the purpose of protecting buildings against HPM may consist of the following steps: (1) a testing program in small scale whose results would bring the information on promising absorbers that can be added as fillers to cement based materials; (2) preparation of the composites and tests in the large scale; (3) developing a hybrid solution  by combining a few different individual methods of protection; (4) getting approvals, certificates, etc., and (5) implementation of the production in the industrial scale.The most challenging in steps (1) and (2) is that apart from the microwave shielding performance properties, the materials being developed must meet the requirements for building materials in terms of strength, stiffness, chemical stability, durability, heat conductivity, frost resistance, etc. In addition, the anticipated production costs have to be in mind already at these early stages. However, the costs are not easy to determine because the price of the final product is not only influenced by the unit price of the filler. In addition to the content of the additive, the thickness of the absorbing layer, the possibility of mass production of the additive itself and the necessary technological measures to disperse it in the target material have to be also taken into account.Furthermore, it needs to be emphasized that the final product or technology must be comprehensive. As mentioned in the Introduction, the weakest element determines the effectiveness of the system. Thus, for instance, a special mortar must be prepared for the bricks or blocks. Moreover, all the elements of a developed technology have to be compatible with each other.Depending on the type of object protected against HPM, the optimal method of protection needs to be adjusted. For example, for an underground facility, equipped with EM-sensitive electronic devices , a method using radiation absorbing materials (RAM) added to structural concrete seems to be sufficient enough providing that installation connections or ventilation are properly protected. For other objects, it may be desirable to hide the function of HPM protection, i.e., to make the building appear like a typical one. Then, a helpful additional element apart from high performance structural elements like walls and ceiling would be the suitably developed windows, doors, gypsum boards, paints, sealings or thermal insulation with an additional function of HPM passive protection.


The coronavirus disease 2019 (COVID-19) pandemic introduced challenges to the use of simulation, including limited personal protective equipment and restricted time and personnel. Our use of video for in situ simulation aimed to circumvent these challenges and assist in the development of a protocol for protected intubation and simultaneously educate emergency department (ED) staff. We video-recorded a COVID-19 respiratory failure in situ simulation event, which was shared by a facilitator both virtually and in the ED. The facilitator led discussions and debriefs. We followed this with in situ run-throughs in which staff walked through the steps of the simulation in the ED, handling medications and equipment and becoming comfortable with use of isolation rooms. This application of in situ simulation allowed one simulation event to reach a wide audience, while allowing participants to respect social distancing, and resulted in the education of this audience and successful crowdsourcing for a protocol amidst a pandemic. The coronavirus disease 2019 (COVID-19) pandemic posed new challenges to the execution of in situ simulation in the emergency department (ED), as well as time-sensitive pressures for the development of protected code blue and intubation protocols. Challenges included restricted time, personnel, and personal protective equipment (PPE), with changing guidelines on appropriate use. These factors were addressed together through an uncommon application of in situ simulation with mixed online and offline distribution.Previous work has demonstrated the utility of in situ simulation to advance health care provider skills and aid in the development of protocols and procedures.The aim of this innovation was: (1) to develop a protocol for protected intubation with input from front-line interprofessional teams under significant stress; and (2) to educate ED staff during a pandemic.3 However, the aforementioned difficulties of the pandemic challenged this, requiring the application of a different style of simulation, one which used video recording and sharing , as well as in the emergency department. The video was not released for independent review. Facilitators provided a pre-amble (explaining that this is not meant to be a model simulation and addressing the vulnerability of video participants), presented the video, and led a debrief. The debriefing mechanism asked participants what they saw, what could be improved, and how the simulation compared with current protected code blue protocols. The facilitator was able to provide education around points as needed. The protected code blue process and intubation protocol was designed by the education team in tandem to the virtual simulations. Following the debrief, an electronic survey was distributed by means of email to allow further anonymous feedback and to gauge team resilience and preparedness.This was complemented by additional in situ simulations on site to capture staff from different departments, including nursing, respiratory therapy, and clinical medicine. These were a run through of the simulation in real time, without manikins or PPE, with team members working together verbalizing procedures done in the context of isolation rooms and anterooms, and collecting required equipment. This allowed increased ED staff participation in the simulation after viewing the video with minimal expense, enhancing their educational experience and familiarity with proper use of negative pressure rooms and the locations of required equipment and medications.4 The described application of simulation consisted of video-recording an in situ simulation event, which allowed for protocol development and staff education, with discussions of patient management during this pandemic. There was significant staff participation at the leadership level from all departments . With the previous regular in situ simulations, there was feedback that this format was intimidating to mixed groups with varying levels of experience. These formats of virtual video-based simulation offered perhaps the most protected safe environment. This pilot project of education delivery using an in situ model has now branched out to include simulation educators across the region who have trialed a similar model.Video-based learning has been used previously in the classroom, but its use remotely in the same manner as an actual in situ event has not been reported.5 As an example, one such LST identified was the difficulty with clear communication between the patient room and the anteroom. This was identified in the initial simulation and debrief and echoed in video-related debriefs as well. This led to introduction of baby monitors to allow for clearer two-way communication between the two rooms. This was tested in isolation and improvements were made based on feedback from the run-through sessions, such as having a dedicated provider at the monitor to relay complex requests such as infusion medication orders.This model also allowed the teams to identify and modify site-specific latent safety threats (LSTs), which are system-based threats to patient safety that are not previously recognized.Using the debriefs and postsimulation surveys, we checked-in with staff and elicited their perceptions surrounding the pandemic. The survey revealed that more than half of the respondents were concerned about resource limitation, particularly PPE. Other concerns included the risk of infection to health care providers and their families, and the notion of being unprepared for the pandemic. Given these legitimate concerns, it is essential that simulation continues to be used, despite these difficult times. The utility of in situ simulation in increasing preparedness and allowing for the creation and improvement of protocols was leveraged as part of this virtual simulation method. In a time of uncertainty, this method allowed for the protocol to evolve daily and respond to challenges immediately, in parallel with the pandemic situation. This method offered a means of rapid knowledge dissemination, using very few resources and saving time, PPE, and simulation equipment, while allowing for social distancing and eliminating geography as a limitation to education delivery.We used a video-recorded simulation with virtual distribution to aid in the development of a protected code blue protocol, incorporating staff input and education under the constraints and pressures of a global pandemic.


Despite making great strides in improving the treatment of diseases, the minimization of unintended harm by medication therapy continues to be a major hurdle facing the health care system. Medication error and prescription of potentially inappropriate medications (PIMs) represent a prevalent source of harm to patients and are associated with increased rates of adverse events, hospitalizations, and increased health care costs. Attempts to improve medication management systems in primary care have had mixed results. Implementation of new interventions is difficult because of complex contextual factors within the health care system. Abstraction hierarchy (AH), the first step in cognitive work analysis (CWA), is used by human factors practitioners to describe complex sociotechnical systems. Although initially intended for the nuclear power domain and interface design, AH has been used successfully to aid the redesign of numerous health care systems such as the design of decision support tools, mobile patient monitoring apps, and a telephone triage system.This paper aims to refine our understanding of the primary care office in relation to a patient’s medication through the development of an AH. Emphasis was placed on the elements related to medication safety to provide guidance for the design of a safer medication management system in primary care.The AH development was guided by the methodology used by seminal CWA literature. It was initially developed by 2 authors and later fine-tuned by an expert panel of clinicians, social scientists, and a human factors engineer. It was subsequently refined until an agreement was reached. A means-ends analysis was performed and described for the nodes of interest. The model represents the primary care office space through functional purposes, values and priorities, function-related purposes, object-related processes, and physical objects.This model depicts the medication management system at various levels of abstraction. The resulting components must be balanced and coordinated to provide medical treatment with limited health care resources. Understanding the physical and informational constraints on activities that occur in a primary care office depicted in the AH defines areas in which medication safety can be improved.Numerous means-ends relationships were identified and analyzed. These can be further evaluated depending on the specific needs of the user. Recommendations for optimizing a medication management system in a primary care facility were made. Individual practices can use AH for clinical redesign to improve prescribing and deprescribing practices. Despite making great strides in improving the treatment of diseases, the minimization of iatrogenic harm continues to be a major hurdle. The process of treating illness often requires the use of medications with known adverse effects. The delicate balance of risk versus benefit is often complex and individualized, making it difficult to be addressed properly.. Medication safety encompasses preventing medication errors  as well as preventing harm associated with the intentional prescription of otherwise appropriate medications. Medication safety and thus the prevention of medical error require both the appropriate prescription of medication as well as their subsequent deprescription, a concept developed to address overprescribing [Medication error is a common cause of patient morbidity and mortality . Medicatscribing . Two important concepts in medication safety, especially significant in promoting deprescribing, are polypharmacy and potentially inappropriate medications (PIMs). The term polypharmacy is defined as the use of multiple medications concurrently by a single patient. These concepts assist with risk stratification for drug-drug interactions and adverse drug events. The exact number of medications varies among researchers and clinicians, but it is often considered to be 5 or more medications . MedicatFactors that contribute to medication safety are both at the system level, such as communication and system workflow, as well as the individual level, such as clinician education and experience. Screening tools, such as the Beers criteria, have been developed to assist in the identification of PIMs ,8,9 in hHowever, applying appropriate deprescribing concepts into clinical practice has proven to be not so straightforward. Individual clinicians report difficulty in addressing these issues due to barriers such as lack of time, lack of published clinical guidance of when and how to stop medications, and fear of poor disease outcomes related to stopping medications -20. MeanIn search of effective medication management strategies that support medication safety and deprescribing for everyday clinical practice, we propose to start by examining medication management in primary care as a system. To fully understand deprescribing, the management system as a whole can be evaluated with the long-term goal of promoting medication safety and removing PIMs. The primary care office represents a hub for clinicians and patients to exchange information and address medication issues on a regular basis. Exploring this hub in a systematic manner, informed by methods of human factors engineering, can help understand medication management and thus can be utilized to understand both barriers and facilitators of deprescribing.As a first step toward understanding current practices in deprescribing at the primary care level, this paper presents a model of primary care medication management in the form of an Abstraction Hierarchy (AH), which seeks to describe the possible actions and constraints of work performed within a system . By emphAH has been successfully applied in health care to understand domain constraints to facilitate the design of decision support tools , mobile Unlike other analysis methods, such as task analysis  or cognitive task analysis , the AH emphasizes the system constraints and capabilities that operators act on . These constraints and capabilities may then be used to explicitly identify information requirements for system design or redesign that can better support problem identification, efficient diagnosis, and effective problem solving. Information requirements extracted from an AH have been shown to differ from those generated from a hierarchical task analysis . One sigThe aim of this paper was to refine our understanding of the primary care office in relation to a patient’s medication through the development of an AH. In doing so, AH can be utilized as a guide for future studies, interventions, quality improvement as well as system and interface design. AH is a modeling tool that is a part of the work domain analysis, the first (out of 5) phase of cognitive work analysis (CWA), a human factors research approach for the analysis, design, and evaluation of work in complex sociotechnical systems. CWA was originally developed for use in the nuclear power industry to address the need for an optimized interface design of complex systems to prevent industrial accidents -31. The Stanton et al  describeusers of the system in our analysis. Determining the boundaries of the system, the first step in developing an AH requires capturing the appropriate amount of detail to describe the work taking place without populating the model with information irrelevant to the model’s objective . Our modnodes by 2 authors (TK and AB), one being a PhD student in human factors engineering and the other a resident physician in family medicine. Each node was subsequently added to an appropriate level of abstraction. Previous literature on AH methodology guided node creation and placement. Once the system of interest was determined, the AH was iteratively drafted in 2 alternating phases. The first phase included initial drafting of the components of the medication management system as means-ends links, were then made. A means-ends link represents the connection of a node with nodes on a different level of abstraction. Each node was connected below its supporting nodes. In addition, each node was connected above its higher-level function or purpose. For example, the Patient Assessment node is connected above its end goals of Patient-Centered Care and Appropriate Use of Medications. The Patient Assessment node is simultaneously connected to the means by which it is accomplished below, which includes Chart Review, History and Physical, Out-of-Office Communication Protocols, and Diagnostic Tests. Thus, the resulting AH has each component of the system categorized into 5 levels of abstraction, with relationships between nodes being clearly demarcated. Once each node was categorized at the appropriate level of abstraction, connections between nodes were made. Connections between nodes, also known as The second phase consisted of all authors coming together in an expert panel review of the draft AH. In addition to the student researchers, our team included 2 board-certified geriatric pharmacists, a clinical pharmacist, a family physician, a human factors engineering researcher, and social scientists. Collectively, the authors have extensive experience in education and research on PIMs, polypharmacy, deprescribing, and human factors analysis. Panel discussions provided key insights into a typical workflow of a primary care office, medication safety, ethical principles, and practical constraints in a clinical setting. Iterative discussions among the authors informed the subsequent revisions of the AH until a final model was agreed upon.Once finalized, the AH was accepted to successfully represent the medication management system in a primary care office. The authors then carefully reviewed the AH with a focus on medication safety and deprescribing. On the basis of the AH and the existing CWA literature, recommendations for system design and improvement were drawn.means-ends links. With a model of the system at hand via the AH, the system can subsequently be optimized and improved. Although this AH can be utilized for a broad range of medication-related systems issues, we focus on deprescribing and medication safety.The resulting AH graphically modeling the medication management system of a primary care office is depicted in The functional purpose of the system is depicted at the top level of the AH. This level represents the overall goals of the system ,32. ThisPatient Well-Being and maintain appropriate Healthcare Resource Stewardship. Maximizing Patient Well-Being refers to maintaining or improving the patient’s current health status. Healthcare Resource Stewardship, as we define it, entails the effective and efficient mobilization of resources for the population. Resource allocation includes appropriate use of clinician’s time and pharmaceuticals when beneficial to the patient, as well as professional restraint when clinical benefits are unclear or unproven or are outweighed by real or potential harm.A total of 2 functional purposes were identified in the AH: maximize Patient Well-Being over Healthcare Resource Stewardship.The modeled system depicts achieving both goals simultaneously. Typically, these goals work in sync with each other for the benefit of everyone involved. Both can be sufficiently achieved in most scenarios. However, extreme cases may make achieving both these goals difficult, thus highlighting the constraints of the system. For example, some circumstances may necessitate prioritizing By understanding the relationships between the overall goals and the individual components of the medication management system in primary care, the system can be optimized to achieve these goals more effectively and efficiently.. They are the nodes most closely supporting the overall functional goals of the system. Each node at this level must be considered to support the above goals of the system. When optimizing a medication management system, these nodes must be utilized and balanced with each other to sufficiently support the functional purpose of the system.Values and priorities represent the way in which the system achieves its functional purpose ,32. TheyPatient-Centered Care, Effective Application of Resources, and Appropriate Use of Medications [A total of 3 categories of values and priorities were identified, which consist of ications . These cPatient-Centered Care refers to the clinician finding common ground with the patient to understand them and to better respond to their needs [Patient-Centered Care is consistent with existing literature. There are many documented benefits of patient-centered care for Patient Well-Being and Healthcare Resource Stewardship. This includes improved patient health, increased care efficiency, and reduction of unnecessary diagnostic testing and referrals.ir needs . The cenPatient-Centered Care can be further classified into Patient Autonomy, Satisfaction, and Privacy [If more specificity is required,  Privacy . Patient Privacy . Patient Privacy . The imp Privacy .Patient-Centered Care includes Reducing the Patient’s Burden of Disease and Reducing Iatrogenic Harm. These concepts refer to the worsening of a patient’s health status by the progression of their medical condition or through medical error [.In addition, al error .Effective Application of Resources. With limited health care resources and resources in high demand, any primary care office system must prioritize the effective application of resources to maximize value to their patient population. This includes minimizing out-of-pocket costs to the patient as well as minimizing costs for the health system at large. As expected, the impact of out-of-pocket expenses on health behavior is clearly observed by clinicians on a regular basis.Another category at this level of abstraction is Appropriate Use of Medications is another value and priority of the medication management system in primary care. Although medications carry an inherent risk of iatrogenic harm, an astute clinician balances this risk with the medication’s benefits to improve patient well-being and effectively apply health care resources. To increase the specificity required to optimize the system, Appropriate Use of Medications can be classified into several nodes. This includes Maximizing Medication Effectiveness by using a pharmacologic intervention in specific patients who will benefit most from its effects. It also includes reducing the use of both high-risk medications and medications with minimal benefit. In addition, patient-specific risk factors such as drug-drug interactions and drug-disease interactions must be minimized. These underlying values and priorities can be observed regularly when, for example, clinicians reserve high-risk and expensive medications for patients most likely to benefit from the medication.These values and priorities must be taken into consideration by the clinician while attempting to achieve the functional goals of the system. Although sometimes in sync with each other, certain circumstances may require the clinician to prioritize one above others. Understanding the competing values and priorities faced by the clinician is critical in optimizing medication management in primary care.The next level of abstraction represents the purpose-related functions. This level is more concrete than those listed above and represents the work performed by the clinician. These are the general functions that need to be carried out to support the above goals of the system ,32. WhenPatient Assessment, Plan-of-Care Formation, Plan Execution, and Information Exchange.The purpose-related functions of the medication management system in a primary care office include Patient Assessment includes the evaluation of all patient-related information by the associated clinicians and the subsequent consolidation of information into a diagnosis. The patient expects that this assessment will inform the clinician of what action needs to be taken to maintain or improve their health, provide a basis for communication between them and their clinician, and allow them to voice health concerns that are most important to them [ to them . SpecifiPlan-of-Care Formation involves the development of a plan to address the patient’s concerns and medical conditions revealed during the patient assessment. This plan may include items such as initiation, titration, or discontinuation of a pharmacologic agent, ordering a diagnostic test, regular monitoring, patient education, or referring to a specialist for further evaluation [aluation . AlthougPlan Execution is a critical node that is often performed outside of the office and therefore left up to the patients or their caregiver. This includes medication adherence, going for laboratory evaluation, or making appointments with specialty services. This is commonly referred to as patient compliance and its importance in supporting Patient Well-Being and Healthcare Resource Stewardship is well known to clinicians. In the outpatient primary care setting, Information Exchange among all relevant stakeholders is another key work function performed in the primary care setting by clinicians. When comparing our model to a real-world primary care office, this refers to the patient education forms, sharing of medical records with other offices, electronic communication with other services such as laboratories, radiology departments, insurance companies, and pharmacies.When observing the work of a clinician, it can be summarized into 1 of these 4 purpose-related functions. When optimizing the medication management system in a primary care office, understanding how these nodes relate to the rest of the system, including the overall functional purpose of the system, is critical. The fourth line in the AH represents object-related processes. These are the processes derived from physical objects, connecting physical objects to the higher functions of the system ,32. TheyPatient Visit. This includes Chart Review, Medication Reconciliation, History and Physical, Insurance Review, and Patient Education. These processes accurately reflect the components of a patient visit to a primary care office, reinforcing the model’s consistency to a real-world setting. Additional object-related processes include Continuing Medical Education (CME), Out-of-Office Communication Protocols, and Diagnostic Tests. There are numerous nodes at this level, as can be seen in Medication Reconciliation is the process of creating an accurate, up-to-date representation of what medications the patient is currently taking. However, in order for it to be clinically useful, it must be integrated with the information discovered in the Chart Review and History and Physical to be clinically useful. This occurs during the higher-level process of Patient Assessment, where the clinician interprets and applies this information to maximize higher-level goals such as Patient Well-Being. This relationship highlights how the lower level, more concrete nodes across the system interact with higher-level ones to achieve the overall goal. Similar to other levels of abstraction, these nodes must be integrated into the nodes above to serve the higher-level goals of the system. For example, a Patient Well-Being and Healthcare Resource Stewardship may appear initially difficult. However, the layers of abstraction between the object-related processes and the functional purposes facilitate the design of small components of the system to effectively support the overall goal of improved medication safety.Streamlining these processes with the goal of maximizing The fifth line and bottom of the AH represent the physical objects in the primary care office. At the bottom, these nodes are the most concrete of the AH. These are the resources and tools that clinicians use to make the system function ,32. HowePatient Room, Medication List, Educational Materials, Medical Literature, Medical Insurance Card, Communication Infrastructure, Office Space and the Electronic Medical Record (EMR).Although these may vary slightly depending on the specific office being evaluated, many of these objects are universal. This includes the Patient Well-Being without certain resources, like a patient’s Medication List. However, for the medication list to be most useful, the clinician needs to perform a Medication Reconciliation, incorporate it into the Patient Assessment and Plan of Care while negotiating various priorities such as Patient-Centered Care and Appropriate Use of Medications. These connections emphasize the complex task imposed upon the clinician. By understanding the relationships and processes required by the system, the medication management system can be optimized with the clinician in mind.An experienced clinician can note the difficulty of achieving the overall goals of the system, such as Once developed, the AH can be used as a model for the medication management system in primary care. It visually depicts the numerous components in a primary care setting that needs to be sufficiently supported to achieve the overall goals of the system. This model can then be used to facilitate system optimization by guiding future quality improvement initiatives, research studies, and system and interface design.By describing the system, it can then be analyzed for optimization. Our AH describes the medication management system in a primary care office. Further analysis reveals some general recommendations for building a primary care office designed with medication safety and deprescribing in mind. Patient Satisfaction, identified here as a value and priority, is already commonly used as a metric in clinical care due to its ability to provide feedback on the overall functioning of the system.Interpreting an AH may not be straightforward for those not accustomed to such representations. Examining a particular node of interest and its associated links may lead to a more complete understanding of the functions and constraints surrounding an element within the medication management system. The first characteristic to note about a node is the level of abstraction within which it is embedded. Certain general recommendations, described below, can be provided to optimize that node based on this information alone. For example, value and priority are typically used as metrics to evaluate the functioning of the system. means-ends [means. For the node of interest to work effectively, the supporting nodes must be designed to sufficiently support the node of interest. For example, Patient Assessment is supported by a Chart Review. Thus, the chart review process needs to be designed in such a way that it facilitates effective patient assessment to achieve the overall system goals. Some EHR systems clearly display medications that previously caused adverse events at the top of the patient’s chart, making Chart Review simpler and more streamlined. This quickly and effectively shares medication safety information for the clinician to incorporate into their assessment.To evaluate the node of interest even further, a ans-ends  analysisend. The node of interest must be designed with this function in mind, or else it is not relevant to the overall goal of the system. For example, Patient Assessment is connected above Patient-Centered Care. Therefore, patient assessment must be designed in a way that promotes patient-centered care. This includes asking questions related to how a disease is impacting their life (Reduce Burden of Disease), their input for what the patient would like to be done (Patient Autonomy), and asking about any possible medication side effects (Reducing Iatrogenic Harm). Without these types of questions, the patient assessment is limited in its ability to maximize patient well-being, which is the overall goal of the system. Many clinicians already ask questions like these, intuitively understanding their significance.In addition, by looking at the connections above the node of interest, its goals can be seen. These are also referred to as the Although these examples reflect existing primary care practices, AH can also be used to suggest new practices that can be incorporated into quality improvement, research, and system and interface design. Some of the selected suggestions are explored in this analysis, leaving many more to be uncovered by further evaluations of the AH. The suggestions derived from the AH are inherently abstract but can be used to guide concrete improvements to the system. Patient Well-Being and Healthcare Resource Stewardship, represent the high-level design objectives [The 2 functional purposes, jectives ,32. WhenPatient Well-Being as well as Healthcare Resource Stewardship. A given project may benefit both simultaneously or benefit one while harming the other. Any negative impact can be addressed and mitigated ahead of time, preventing a needless headache later.For example, when a quality improvement project is being proposed, it should include an evaluation of its anticipated impact on both Values and priorities, representing the second highest goal of the system, reflect the overall functioning of the system. Monitoring these nodes provides insight into how the system is functioning . By usinAH suggests that other metrics should be considered. The number of high-risk medications currently being used in a given patient population can reflect the effectiveness of the system. This metric is already used in research protocols to evaluate the effectiveness of interventions designed to deprescribe PIMs. Continuous monitoring of medication effectiveness may reveal the prevalence of ineffective and unnecessary medications in the primary care office. Keeping track of a patient’s out-of-pocket costs can be an evaluation of the financial strain that the current prescribing practices are placing on the patient. All of these measurements, and others visually depicted as values and priorities in the AH, may provide deeper insight into the functioning of the medication management system in primary care.Patient Autonomy when making this difficult judgment call and thus morphing the conflict into an opportunity for the patient to take control of their care.It is important to note that these values and priorities may be in conflict with one another, highlighting constraints on the system. The reduction of high-risk medications, as with the example above, must be balanced by reducing the burden of illness. This conflict has been reported in the real world during interviews with providers -20. By iPurpose-related functions are the core work functions performed by clinicians. The design approach of task delegation, workflows, and user interfaces must be centered around these purpose-related functions to achieve the aforementioned values and priorities. Innovative and creative solutions are needed in the design of teams, user interfaces, task delegation, and workflow that effectively balance all the aforementioned values and priority nodes .Patient Assessment is completely delegated to the individual provider evaluating the patient. However, another model uses a more team-based approach. This may include delegating a component of this task to an in-house pharmacist dedicated to uncovering medication safety issues and making recommendations for deprescribing. This model has had some success in reducing the number of PIMs in a patient panel. In this situation, the pharmacist is utilizing the below means nodes such as Chart Review, Medication Reconciliation, and History and Physical to promote the higher-level end goals of the system, such as Appropriate Use of Medications and Patient-Centered Care [For example, red Care . The impPlan Execution, through the supporting nodes of Patient Education and Out-of-Office Communication Protocols the overall goals of the system may be better achieved. Examples of this could include a comprehensive patient education strategy as well as frequent follow-up after leaving the office.In addition, the importance of plan execution to support higher-level functions can be visually interpreted. Despite the primary care office being the coordinator of care, the actual execution of the care plan is often left up to the patient or their caregiver. This node may be the source of the deficiencies seen in the system. By supporting the end nodes. [These nodes represent the tools and subprocesses that connect the physical objects to the higher functions and goals of the system. This level of abstraction can be optimized by the creation of novel and flexible tools that can be used to support the above d nodes. .Medication Reconciliation is required to support Patient Assessment, Plan-of-Care Formation, and Information Exchange. Proper medication reconciliation, one that accurately documents the patient’s most up-to-date medication regimen, is therefore ripe for improvements that will have a large impact on the functioning of the system. As an example, one can envision an application that consolidates medication information from the patient, the pharmacy, and other prescribers and easily shares that information accurately with the primary care office. To be effective, this tool has to efficiently support the above Patient Assessment, Plan-of-Care Formation, and Information Exchange nodes. The AH shows how Many of the tools described in the medical literature are incorporated at this level. The creation of tools that are easy to use and fit efficiently within a workflow can be applied here to promote deprescribing. The Beers criteria, an existing screening tool, assists clinicians in formulating an assessment of the patient and has been used to assist with deprescribing. Another example of a hypothetical tool to promote deprescribing may be one for identifying and tracking previous adverse drug events (ADEs). Although a clinician may be able to find a previous ADE within the electronic medical record, this information is often not readily apparent. A tool that can perform this function is easy to use and fits into the existing workflow would support the patient assessment as well as information exchange.Physical objects, the lowest and most concrete level of the AH, are required to support all of the higher-level goals of the system. They are the means by which the clinician directly interacts with the system. For these objects to be most effective, they should be designed with flexibility in mind and offer clinicians choices that can be adapted for new and unforeseen circumstances . CommuniChart Review. Therefore, a user interface that facilitates this function is key. To adapt to new and unforeseen circumstances, EHR systems that are flexible and allow for customization by the clinician are ideal. For example, a clinician may want to review previously prescribed medications and reasons for their discontinuation to inform their patient assessment and plan of care. An EHR system that makes this cumbersome may prevent the clinician from engaging in a review that may be informative and fruitful for the overall goals of the system. In other circumstances, however, this additional information may be too clustering and cumbersome for the task at hand. EHRs are another opportunity for increased flexibility of the system. With the AH, it can be seen that EHR systems are required to support The same concepts of flexibility and variability can be applied to other nodes at this level. Patient educational materials should allow for variability based on patient health literacy, level of specificity, and preferred medium. For example, educational videos about medication side effects to monitor may be a more effective delivery tool for certain patients, whereas some patients wanting a deeper dive into the literature may prefer to be given direction to validated web-based resources.Our AH specifically evaluated the primary care medication management system from the clinicians’ perspective. Developing an AH from the patients’ perspective may yield a similar yet modified AH. The patients’ functional purposes are likely to be consistent with maximizing their well-being. Many values and priorities will likely overlap between a clinician’s perspective and a patient’s, including those related to patient-centered care and the reduction of harm. Greater differences between these models would be expected in the bottom 3 layers of the AH where these individuals would complete different tasks to achieve their goals.Our AH is based on an expert panel of clinicians and human factors researchers, not direct observation. Although we attempted to include many different perspectives, the inclusion of more clinicians may have yielded a slightly different AH. In addition, all contributors to the model were based in Western New York. Higher-level purposes and priorities are expected to be consistent across all primary care practices throughout the United States; however, the processes and physical objects with which the clinician interacts may differ from site to site. Each site may modify how they complete these overarching goals based on the resources available and the population served by the primary care office.Our future work includes an observational study, currently in planning, at a Western New York primary care clinic, and further observations at different types of primary care sites. Real-world data of clinical workflow and observed patient-clinician interactions would provide valuable data to help us better understand existing practices and barriers and to identify opportunities for appropriate prescribing and deprescribing opportunities. Such data will significantly add to the complex relationships modeled for medication management in general and deprescribing in particular.On the basis of the prevalence of PIMs, the current design of primary care work is inadequate in addressing the complex sociotechnical problems related to identifying and addressing PIMs. Deprescribing concepts, intended to improve medication safety, have been difficult to apply in the real-world setting. Our AH, depicted at a fairly general level for the medication management system in primary care, provides insights and suggestions for the optimization of the existing system. Some suggestions were explicitly mentioned in this paper, but numerous other interpretations can be made by those wishing to utilize this AH in the improvement of a specific primary care office.Through the interpretation of this AH, human factors practitioners, administrators, and clinicians may identify and develop strategies to optimize the medication management systems and promote deprescribing in various primary care settings. By using the available means-ends relationships, the AH can be visually interpreted to determine which subsystems and processes need to be supported to accomplish the overall goals of the system.Future studies, including our own efforts, should expand upon the subsequent steps in CWA to provide a more complete model of medication management work in the primary care setting.


This research protocol illustrates the use of implementation science to support the development, dissemination and integration in primary care of effective and sustainable collaborative pharmacy services for chronic care management. The objective is to evaluate the implementation and the effectiveness of a pharmacist-led patient support program including regular motivational interviews; medication adherence, patient-reported outcomes, and clinical outcomes monitoring; and interactions with physicians, for patients with type 2 diabetes taking at least one oral antidiabetic medication in the French-speaking part of Switzerland. This is a prospective, multi-centered, observational, cohort study using a hybrid design to assess the patient support program. The evaluation includes three levels of analysis: (1) the implementation strategies, (2) the overall implementation process, and (3) the effectiveness of the program. Qualitative and quantitative methods are used, and outcomes are assessed at each stage of the implementation process: exploration, preparation, operation, and sustainability. This research project will provide key insights into the processes of implementing patient support programs on a large scale and adapting the traditional community pharmacy practices towards the delivery of person-centered and collaborative services. Chronic diseases are a major public health issue. The prevalence of patients with chronic diseases ranges from 20 to 30% for the whole population and from 55 to 98% for the elderly (≥60 years) . ChronicMedication non-adherence is a preventable risk factor in reaching successful clinical outcomes for chronic diseases . The WorAnother challenge for health care systems is patient safety and their integration into the care process. Pharmacists have a responsibility to ensure that when a patient receives and uses medications, it will not cause harm. In 2017, the goal of the WHO Medication Safety Challenge was to reduce global medication errors and related harm by 50% over five years [In 2012, the Swiss government recognized that pharmacists have an important role to play in acute and chronic primary care ,9. TheirOne of the promoted pilot projects is a chronic patient support model to optimize medication adherence and patient safety ,13,14. TAt the time the evaluation was launched, the Siscare program was being delivered by only a few pharmacies with limited collaboration with physicians. However, this pilot project aimed partially to evaluate the barriers and facilitators for disseminating and implementing it as a routine interprofessional practice across the French-speaking part of Switzerland. An effective health care intervention can only lead to benefits for the patients if a sustainable implementation succeeds. Therefore, methods of implementation science are key factors to understand and accelerate innovation. Implementation science is defined as the study of methods to promote the integration of research results or evidence-based practices into health care policy and practice . The impThis paper describes the protocol of the pilot study, promoted and funded by the FOPH, that aimed to assess the implementation process and effectiveness of the interprofessional support program for patients with type 2 diabetes (Siscare-DT2) taking at least one oral antidiabetic drug in the French-speaking part of Switzerland . The Fre(1)To evaluate the appropriateness of the implementation strategies for Siscare-DT2,(2)To describe the implementation process of Siscare-DT2 in the French-speaking part of Switzerland, and(3)To evaluate the effectiveness of Siscare-DT2 for patients with type 2 diabetes.The study’s objectives are:This is a prospective, multi-centered, observational study using an implementation-effectiveness hybrid type II design . The stuIn this study, the Framework for Implementation of Services in Pharmacies (FISpH) was used, which was adapted for the community pharmacy setting from the Generic Implementation Framework (GIF) . MoullinThe core concepts are the process of implementation (divided into stages), the innovation to be implemented, and the multi-level context  in which the implementation is to occur, which is influenced by factors, strategies, and evaluations . These tThe Siscare program aims to (1) assist patients in reaching their therapeutic goals and improving their general health, (2) support and strengthen medication adherence and patient safety, (3) strengthen continuity of care between the different health care professionals involved in the patient care pathway, and (4) control the escalation of overall health costs induced by non-optimal use of medicines.The program includes three major components: motivational interviews; medication adherence, patient-reported outcomes, and clinical outcomes monitoring; and interactions with physicians ,14. FirsA secure web platform   was desiAny community pharmacy member of the Sispha network can participate in the study. In 2011, a start-up (Sispha) was created aiming to facilitate the transition from the traditional role of pharmacists towards the implementation of remunerated, person-centered and collaborative pharmacy services. A small network of pharmacies has thus subscribed to the Siscare programs offered by Sispha, translating into practice the research evidence collected by the Community Pharmacy of Unisanté (Lausanne), a university development, education and research center for community pharmacy and public health.Any community pharmacy is free to join or exit the network at any time. Member pharmacies pay an annual fee to subscribe to Sispha and have a trained staff member responsible for the program. At least one pharmacist per pharmacy receives a minimum three-day standardized training course on how to deliver the intervention, use the platform and handle electronic monitoring .Recruitment happens at both the organizational (pharmacies and primary care physicians) and patient levels. First, Sispha informs and recruits their affiliated pharmacies for the project (Siscare-DT2) and, second, pharmacies and physicians recruit patients to benefit from the program. Participation by pharmacies is voluntary. The total planned duration of the project is three years including three months for pharmacy preparation and advertisement, nine months for the participant (patient) enrollment period, 15 months for the last patient included to complete follow up (as each patient is followed for 15 months for the study), and the remaining months to process and analyze the data.The other health care professionals involved are the referent physicians of the included patients and any health care professional involved in the patient’s care pathway. The creation of the local interprofessional network is the responsibility of the pharmacist who is in this project, the starting point to strengthen interprofessional coordination.Firstly, prior to recruiting and including patients, pharmacists approach their local physicians and other health care professionals to build their local interprofessional networks see . When a Patients are eligible if they attend a pharmacy in the Sispha network, are adults (≥18 years) diagnosed with type 2 diabetes, and take at least one oral antidiabetic medication. Patients with a diagnosis of type 1 diabetes, cognitive impairment discernable to the pharmacist or insufficient level of French to complete the questionnaires to be administered in the study are excluded. Patients may be recruited by their pharmacist or physicians and other health care professionals can inform patients about the program and refer them to the pharmacy.Pharmacies deliver a leaflet describing the program and an information statement about the study including the patient information and consent form to the patient who can thus confirm their readiness to participate  and the health insurance stakeholders, showing political support and a favorable context for the participation of pharmacists.Sispha has created a steering committee of stakeholders to discuss the methods and monitor the results of the study at bi-annual meetings in order to ensure continuous improvement. At each meeting, the research team is to present the study’s progress and the steering committee will discuss subsequent actions. The interprofessional steering committee was created by selecting (at least) one representative from each stakeholder with interprofessional experience if possible including a family physician, an endocrinologist, two pharmacy owners from two pharmacies taking part in the study, and one representative each from the FOPH, pharmaSuisse (Swiss association of pharmacists), a health insurance company (CSS), a national association committed to improving patient care , and a member of Sispha. A diabetic patient’s association was contacted but no agreement was reached on the inclusion of a patient or scientific advisor from this association and, therefore, no patient was included in the steering committee. No one had conflicts of interest with Sispha except Olivier Bugnon from the research team (as declared) and the member of Sispha leading the project in the company.Sispha communicates with health care professional associations and local newspapers  and tools.The tools include two hundred copies of the program leaflet per pharmacy, access to the web-based module specific to the project, and the instructional material, i.e., the documents to facilitate the implementation and organization of the program delivery. Materials delivered during the training include Sispha documents , documents specific to the research study such as questionnaires with coded envelopes and information and consent form for ten patients (the target number of patients to include per pharmacy), as well as a copy of the study protocol. Leaflets and instructional material are given out during the first training and are available on the web-based platform. The full list of instructional material is presented in At the first training, Sispha provides recommendations about fostering interprofessional collaborations, building capacity within the pharmacy team, and encouraging patient inclusion. First, the pharmacists are strongly encouraged to present the project to local physicians to develop their pharmacy network. Sispha encourages pharmacists to speak with physicians to reduce resistance, discuss their motivations and fears and define together how they want to collaborate. Second, each pharmacy selects one project leader or champion, who informs the entire team about the project, promotes the implementation of the program, keeps them motivated and responds in case of questions or evaluations. Third, to target patients who meet the inclusion criteria, Sispha proposes a procedure explaining how to generate a list of eligible patients with type 2 diabetes to the pharmacies. The pharmacist can then discuss this list with the physician, without selecting patients according to their a priori level of medication adherence.During the operation stage, patients are informed of the program and the study via a program leaflet and advertisements. Posters and video spots are available to be distributed at the pharmacy and articles published in a patient newspaper.To keep pharmacies motivated and focused on the objective, Sispha provides regular coaching calls to the project leader . Newsletters are sent on a monthly basis to keep pharmacies up to date. The newsletters are a means to provide feedback to participants informing them about the number of inclusions of all pharmacies in real time, news, answers to questions received from pharmacies, tips, testimonials, and stories. A free hotline is also available for questions about Siscare  or the study  during working hours.Sispha proposes ongoing training sessions during the study period  on different topics such as how to propose the program to the patient, motivational and listening techniques, patient follow-up interview, and other topics according to the implementing pharmacies’ needs. A coach and a patient-actress are present at the training sessions to enable pharmacists to practice in real-life situations. Other training, given by a physician, aims to provide pharmacists with key insights to improve physician–pharmacist collaboration. Sispha also offers its standard training about medication adherence for new subscribers.The program costs for patients are covered by the patients’ basic health insurance. There is no financial incentive for the study, as the objective is to promote long-term integration of a new practice. In parallel, an assessment of the cost of the program from a pharmacy perspective is conducted to establish the potential for a return on investment .Following the 15 month operation stage of the program, every pharmacy has the possibility to continue the delivery of the Siscare program for patients with type 2 diabetes as well as for other groups of chronic patients. Sispha experts are available to provide ongoing support for all the community pharmacies and will continue to provide training.No special medical monitoring is required for the study. However, if it proves necessary, data subjects may contact their physician.In terms of adverse reactions or incidents, article 59  of the Federal Act on Medicinal Products and Medical Devices  applies . This AcIn accordance with Article 21 of the Ordinance on Human Research with the Exception of Clinical Trials , if serious events occur in participants during the research project, the research project must be interrupted . A serioElectronic data are stored on the web-based platform and their collection, use and storage shall comply with the relevant requirements of data protection legislation . The interviews will include standardized questions related to five main topics of the preparation and initial operation stages on the internal organization of the pharmacies  and local networking with physicians and other health care professionals.Moreover, the satisfaction and usefulness of all the proposed strategies are to be evaluated. The influencing factors (barriers and facilitators) of the preparation and initial operation stages, including patient inclusion, are investigated through semi-structured focus groups with volunteer pharmacists, using an initial grid of questions .Results provided by the research team, in partnership with the Sispha team, will lead to improvement of the implementation strategies by adapting them to implementer needs (PDCA approach).The implementation process is evaluated by the indicators of progress along the different implementation stages . The impPatient characteristics include socio-demographic variables , reason(s) for inclusion and reason(s) for stopping the program, the specialty of the referent physician, and the use of the electronic pillbox. Data will be collected through the web-based platform and a questionnaire completed at baseline or during follow up.Pharmacy characteristics include the type of pharmacy, geographical zone, type of patient-centered services offered, and quality certification , if theTo explore influencing factors when delivering the program and to assess pharmacists’ satisfaction with the program, semi-structured focus groups with volunteer pharmacists using a grid of questions  are conducted at the operation stage. Physician’s experience and satisfaction are assessed by a short questionnaire comprising 6 closed-ended questions (and a free text field if they wanted to express themselves on a point) sent by the pharmacist to referent physicians of patients.The number and type of medications and clinical outcomes  are collected through the web-based platform at baseline and during the study period (15 months).Medication adherence is measured using the data from electronic pillbox for at least one oral antidiabetic medication for 15 months. The pharmacist makes the choice of medications and the number of medications to be monitored according to the patient’s needs. During the 3 h training session, instructions were given on how to select the appropriate medications to be included in an electronic pillbox. A flowchart was developed based on another study  in order® Health Survey SF-12 , which is a 12-item questionnaire covering eight domains of health outcomes also represented by the Physical Component Summary  and the Mental Component Summary  [General and specific quality of life is assessed using two different self-report questionnaires at baseline, 6 and 12 month follow up. General quality of life is assessed using the Short Form-12 health) . Specifi health) ,52. ThisThe patient’s satisfaction with the program is evaluated using a self-report questionnaire  and through qualitative interviews (for some patients) at the end of the study, i.e., 15 month follow up, or earlier if patient follow up is stopped before 15 months. The research team developed the questionnaire see  and the The Siscare concept aims, among other aims, to strengthen the involvement of patients in their care and the therapeutic alliance between the pharmacist, referent physician and other caregivers. The observation of interprofessional collaboration will consider four levels of increasing interrelationships: (1) unidirectional transmission of information; (2) bidirectional exchanges of information; (3) concerted measures on objectives calling for complementary skills; (4) sharing of decisions and actions in line with a common objective see . These dDescriptive statistics are used for quantitative data to describe participant and pharmacy characteristics, clinical outcomes (at baseline ± 3 months), quality of life score questionnaires (at 3 time points), patient satisfaction questionnaires and to report implementation results  mixed-effects linear regression models are conducted to take into account that data measured on the same patient are not independent, that patients are seen by different pharmacies and that there are several patients per pharmacy. Medication adherence is assessed through implementation, persistence, and adherence (see definitions in 2.9.3. Program effectiveness). For each day, patients behavior regarding their treatment are dichotomized: in “correct”, when the patient opens the electronic pillbox at least the number of times prescribed , and in “incorrect”, when the patient opens the electronic pillbox less than the number of times prescribed . The implementation is represented as a function of time and modeled using the exchangeable Generalized Estimating Equations (GEEs) model, where the time is introduced using polynomials ,49,55. PWith respondents’ consent, all focus groups and patient interviews are audio-recorded and transcribed, and data are subjected to formal analysis. Telephone interviews are also audio-recorded if pharmacists consent, and data are introduced into the database immediately after the call.p = 0.05.Microsoft Excel software  is used for preparing and coding all data. Descriptive statistics are conducted on Microsoft Excel, specific clinical outcomes and quality of life analysis on Stata  and medication adherence analysis on R . MAXQDA Standard 12 (VERBI software GmBH) is used for the analysis of the qualitative data from focus groups and patient interviews. The significance level is set at This manuscript describes the protocol of an implementation-effectiveness hybrid type II study of an interprofessional support program for patients with type 2 diabetes in primary care in the French-speaking part of Switzerland.Using implementation science is crucial to assess the influencing factors for implementation projects and an effective innovation can fail to be implemented if strategies are not appropriate to the setting . ImplemeAn important component of this study is the provision of a multi-faceted intervention tailored to the patient’s needs based on a social, behavioral, and cognitive approach. As the project takes place in a real care situation, the new involvement of the pharmacist, in collaboration with physicians, should have economic consequences that need to be estimated. It is expected that therapeutic goals would be reached at the end of the study period. The increase in better clinical outcomes  has been shown to increase better glycemic control, preventing complications, emergency department visits and hospitalizations . Taking Several limitations in this current research project were considered when designing the study. First, our study does not include a comparison group. The analysis occurs on data over time and with before and after testing, and must take into account the fact that results may be influenced by factors other than the patient support program. Second, quality of life and patient satisfaction assessment are self-reported, and these data can be subject to bias. However, to minimize that bias, stamped addressed envelopes are delivered to the patients so that they can fill out the questionnaires at home and send them to the research team without passing through the pharmacies. Data are kept anonymous. Third, the study is proposed to pharmacies subscribed to Sispha. However, this is a selection of pharmacies that are more innovative, called the “early adopters,” and may not represent the majority. Nevertheless, all pharmacies were free to subscribe to Sispha for participating in the study.This project aims to implement the Siscare concept as a collaborative patient support program for chronic patients such as those with type 2 diabetes. The scientific evaluation observes the process in stages, which will provide insights on both the effectiveness and the identified barriers and facilitators for its implementation in primary care. In particular, the results will add new knowledge on the recommendations regarding the need to adapt the framework conditions  to broaden the application of these collaborative models.