Outbreaks of infectious etiology, particularly those caused by a novel virus that has no known treatment or vaccine, may result in the interruption of medical care provided to patients with cancer and put them at risk for undertreatment in addition to the risk of being exposed to infection, a life-threatening event among patients with cancer. This article describes the approach used to manage patients with cancer during a large-scale Middle East respiratory syndrome–coronavirus hospital outbreak in Saudi Arabia to ensure continuity of care and minimize harm from treatment interruption or acquiring infection. The approach taken toward managing this high-risk situation (COVID-19) could be easily adopted by health care organizations and would be helpful to ensure readiness for the occurrence of future outbreaks of different infectious etiologies like those recent episodes of new coronavirus. The recurrent outbreaks of coronaviruses in different parts of the world pose a major challenge to health care systems and expose patients and staff to serious risk. These outbreaks may lead to an interruption in health care services and the provision of care for patients, posing additional risks to them.2 Patients with cancer are immunocompromised and therefore more vulnerable to infection, which can often end in fatality. The vulnerability of patients with cancer was evident by the high risk of mortality during the previous Middle East respiratory syndrome–coronavirus (MERS-CoV) outbreaks . Besides the risk of infection for exposed patients, additional major risks occur because of the interruption of the health care services provided at these facilities when they are subsequently shut down.These outbreaks pose a greater threat to patients with a chronic disease in terms of morbidity and mortality compared with healthy individuals due to the increased vulnerability of the patient secondary to their disease.6 This is the situation internationally in normal daily practice without external complicating factors, such as war or infectious outbreaks. One can imagine the challenges that arise in developing countries while facing such external crises, which present an additional burden to inherently complex care.8Cancer is a life-threatening disease that should be treated in a timely fashion to avoid a detrimental outcome to patients and minimize their physical and emotional suffering. The provision of cancer care is complex and requires multiple teams of professionals with specialized expertise and access to sophisticated, expensive resources. The complexity of cancer care already presents major challenges to the health care systems in affluent countries; national reports from both the United States and United Kingdom identified the crisis situation already faced in the provision of this care.11 The outbreak of MERS-CoV in June 2015 led to the closure of our hospital, as well as other hospitals within the city of Riyadh.12 This crisis posed a serious challenge to our staff and patients. The Oncology Department, in particular, faced unique challenges because of many factors, including infected oncology patients, a large susceptible patient population, interruption of services provided to our patients, and additional risks to our staff.MERS-CoV was the cause of multiple outbreaks in Saudi Arabia, which spread internationally.With recent outbreaks of the new coronavirus in China and other countries, the factors related to oncology patients’ care and corresponding outcomes are a major concern for the oncology community; therefore, this article describes the approach used to manage oncology services in response to the MERS-CoV outbreak and the implications of hospital closure. The real-life experiences and subsequent recommendations may provide some guidance and a supportive framework for oncologists to use in affected areas.Key ObjectiveWith recurrent infection outbreaks from different pathogens, patients with cancer are at high risk for harm because of the susceptibility to infections and the interruption of care, in addition to the associated risk of underlying cancer and its treatment.Knowledge GeneratedIn response to the 2015 coronavirus outbreak in our country, we developed a detailed plan to help manage oncology services to prevent harm to our patients or staff. The plan focused on managing infected patients, preventing any new infections in patients or staff, ensuring continuity of cancer care, and incorporating measures to sustain these interventions far into the postoutbreak period.RelevanceThe described plan may serve as a platform to manage oncology services during similar crises that pose serious risks for patients and staff.In coordination with the organizational leadership, the oncology service leaders developed a plan to manage the crisis with 3 main objectives: to treat affected patients, prevent further infection to patients and staff, and deliver timely, safe cancer care for all patients. The Crisis Management Plan included 5 main components: leadership and communication, patient management, staff management, infection control, and recovery plan . This plTo be effective, leadership must be engaged and visible, and timely communication is imperative for any organization’s continuing functionality. These 2 issues are even more relevant during a crisis, making them paramount for crisis management.A leadership committee was formed to manage the oncology services during the crisis; this included the Chairman, Deputy Chairman, Section Heads, Operations Administrator, Nursing Manager, and Quality Improvement Specialist. The main objectives of this committee were to communicate to the oncology department staff the information received from the daily Hospital Command Center meetings, discuss the current status of the outbreak in the whole hospital, and assess the risk for oncology patients. The team discussed the current admitted patients under the oncology service and their management plan, and proposed a contingency plan for their management, if needed. The group met as a whole or as subgroup at least twice a week and discussed any updates related to the outbreak, any changes in patient care, challenges, and the communication plan.The leadership frequently corresponded by using social media tools, such as WhatsApp and organizational e-mails. The communication with the remaining departmental staff was performed in person through meetings with the Section Heads or through departmental e-mails to all staff regarding situational updates and organizational expectations.Staff were encouraged to review the MERS-CoV page within the organization Web site and to be aware of the Command Center correspondence by e-mail disseminated on a daily basis initially to all staff. Of note, these communications were bidirectional to ensure better awareness of all aspects of the crisis in a timely fashion .The patient management plan had 3 main aims: to prevent new infection in the oncology service, to manage currently infected patients, and to provide timely cancer care for the whole patient population. Specific plans were developed based on the setting, outpatient services, and inpatient services.Early in the outbreak, all the appointments were canceled for 4 days to obtain a better understanding of the situation and to develop an appropriate action plan.Medical records of all scheduled patients were reviewed by the primary oncologist, and patients were divided into 3 categories.Urgent (need to be seen on time): patients who were scheduled for chemotherapy that could not be postponed or were due for disease assessment; we kept the scheduled appointments for these patients.Intermediate: patients who could be rescheduled after a short delay (up to 2-4 weeks); the appointments for these patients were postponed.Routine follow-up: appointments were rescheduled as far in the future as deemed clinically safe for the patient without any foreseeable negative impact.All patients were screened before entering the clinic with a checklist that included clinical and epidemiologic criteria; anyone with a suspected infection was referred to a triage area segregated from the general population.am to 8:00 pm to accommodate any delayed patients. Medical staff coverage was secured onsite, and the working hours of the satellite pharmacy were extended.The infusion unit working hours were extended from 8:00 Walk-in patients: Patients who showed up to the clinic without an appointment were screened for infection and were either directed to the triage area for suspected infection or seen by physicians covering the clinic, according to the result of the screening checklist.Oncology physicians managed patients who could be seen in the outpatient setting. Patients who required admission were sent to an alternative hospital. Patients were transported via hospital ambulance if their condition was unstable; patients in stable condition were transferred by private car. All referred patients were accompanied by a completed Transfer Form and written medical summary report of their treatment with pertinent data.The inpatient management plan was designed with Infection Control and Nursing.a. Every patient’s condition was reviewed, and all stable patients were discharged, if possible. The census was reduced from 79 patients on August 19, 2015, to 23 patients on September 10, 2015. b. The patients who were not candidates for discharge remained in the hospital with close monitoring, and if any patient met the definition for suspected infection, she or he was placed on airborne isolation precautions .FIG 2MidThe organization reached an agreement to use a certain number of beds within an alternative hospital to enable the admission of our patients. A team of physicians and coordinators was assigned to cover the patients we admitted to that hospital. Timely information and support were provided to physicians in the other hospitals who were taking care of our oncology patients admitted to their services. This included a detailed treatment plan, updated medical reports, and chemotherapy order protocols.The aim of the staff management plan was to minimize staff exposure to infection, educate them about the crisis, streamline their work process by clarifying their roles and responsibilities, and minimize their anxiety and stress. Minimizing the risk of staff exposure included making sure that all the staff underwent N95 mask fit testing, scheduling all the department’s staff to attend the hospitalwide educational training on donning and doffing clothing, applying strict hand hygiene, and implementing infection prevention precautions. All staff (physicians and nurses) were familiarized with the case definition of suspected MERS-CoV infection.For the clinical staff, we clarified the essential tasks to manage patients, such as reviewing patients’ records, prioritizing their care, and providing timely care. All staff were instructed and educated about proper hand hygiene. Nonclinical staff were released from duty for a few days to make sure that they were not exposed to the infection, and on their return to work, minimal interaction with clinical staff was advised. All staff with respiratory symptoms were clearly instructed not to report to work; they were sent for further assessment and instructed not to have contact with other health care professionals.Managing infection control during an outbreak is aimed at stopping the spread of the infection among the patients and staff by ensuring implementation of appropriate policies and procedures. Dissemination of the correct knowledge and a thorough understanding of the transmission mechanism and protective measures were paramount to ensure that clinical practice was based on evidence, not myth and rumor.The plan for infection control included: a. Timely information was communicated from the leadership committee to the staff and all affected services via e-mail or in face-to-face meetings.b. Patient management included screening all patients coming to the outpatient clinic, screening all visitors before entering the oncology wards, and implementation of the MERS-CoV management plan for inpatient units.c. Staff and visitors were screened before entering the oncology wards with a sign-in log. Sick staff were kept away from the hospital. All staff were fitted for N95 masks, with training for all staff related to personal protective equipment. All staff were screened by nasal swab and MERS-CoV polymerase chain reaction testing to identify asymptomatic carriers; this was to ensure exclusion from the workplace and to enforce home isolation if a positive result was obtained.After assurance that the outbreak was under control, we implemented the recovery plan in phases, with the goal of resuming patient care at our facility based on clinical priority. The recovery phases were:Phase 1: Immediate phase, 0-4 weeks. Resumed the critical services that could not be performed in the alternative hospitals, such as certain specialized surgeries, chemotherapy administration, stem cell transplantation, or radiotherapy application. Observed all the precautions for the control of infection.Phase 2: Intermediate phase, 5-16 weeks. Resumed all services provided before the crisis.Phase 3: Long-term phase: Strategic transformation of the department to provide better and safer care, integrating all new processes into the workflow to avoid newer outbreaks or in-hospital transmission.The described plan resulted in the prevention of any new infection, manifested by zero cases of in-hospital transmission of MERS-CoV infection among oncology patients, not just during the months of the crisis, but over the next 4 years (the time of this report). There was a clear transformation of many work processes and departmental functions, especially among those focusing on preventing Emergency Department overcrowding, which was identified as the primary cause of the outbreak.The described plan was effective in the prevention of further harm to our patients from this deadly virus, a benefit that extended way beyond the outbreak. There are many lessons that can be applied to a similar crisis while taking into account that each health care facility has its own particular circumstances. The application of what we learned and the processes we implemented may vary depending on the health care facility’s specifications related to the type of patients served, the facility size and services, the health care system in the locality, and the community at large. Collaboration among different health care facilities and providers is critical, including exploring resources available outside the walls of the facility.The key lesson that we learned in managing such outbreaks was the importance of effective communication with all stakeholders and addressing everyone’s concerns, while bearing in mind the best interests of our vulnerable patient population. We learned that it is important to have a robust mechanism to prioritize patients to ensure the provision of timely care while preventing further harm by guiding staff to provide care while staying safe.Sustaining the improvement in the work process and flow is paramount; this cannot be achieved without support from the organization’s top leaders and stakeholders and the commitment and dedication of the staff, especially toward interventions that prevent the causes of the outbreak, such as Emergency Department overcrowding.


The use of monitoring sensors is increasingly present in the context of precision agriculture. Usually, these sensor nodes (SNs) alternate their states between periods of activation and hibernation to reduce battery usage. When employing unmanned aerial vehicles (UAVs) to collect data from SNs distributed over a large agricultural area, we must synchronize the UAV route with the activation period of each SN. In this article, we address the problem of optimizing the UAV path through all the SNs to reduce its flight time, while also maximizing the SNs’ lifetime. Using the concept of timeslots for time base management combined with the idea of flight prohibition list, we propose an efficient algorithm for discovering and reconfiguring the activation time of the SNs. Experimental results were obtained through the development of our own simulator—UAV Simulator. These results demonstrate a considerable reduction in the distance traveled by the UAV and also in its flight time. In addition, the model provides a reduction in transmission time by SNs after reconfiguration, thus ensuring a longer lifetime for the SNs in the monitoring environment, as well as improving the freshness and continuity of the gathered data, which support the decision-making process. Unmanned aerial vehicles (UAVs), popularly known as drones, are increasingly used in agriculture and livestock for monitoring, spraying, and tracking, as well as for imaging and sensory data collection. Advancements in UAV technology in recent years have significantly reduced costs. Higher accessibility for the technology translates into rapid dissemination of information via specialized websites and discussion forums, and the development of new features and applications for drones. Other areas, such as terrain mapping, search and rescue, security, cinematography and delivery, were revolutionized by this technology .Many studies about UAV applications aim to solve society modern problems. Klaine et al.  proposedEstimates made by the World Bank indicate that in 2050 there will be about 9.7 billion human beings living on our planet, demanding an increase of 70% in agricultural production . There iThe correct measurement of the water level present in the soil is fundamental for agriculture . The manThe use of UAVs to collect sensory data has been widely researched due to the need to increase productivity in the sector. Kashuba et al.  carried Although there are many studies on the application of UAVs in agriculture for collection of sensory data, many authors point out the difficulty in designing systems where SNs have their transmission and hibernation intervals scheduled according to the predefined UAV route ,24, stilThe main objective of this work is to propose a new strategy where we displace SNs over a large area with no direct communication between them. Then, we consider a UAV as a mobile sink to gather data, where the SN has it own timeslots to become active. The SN’s active timeslot can be shared or dedicated. As the UAV must fly over them to find out which are their active timeslots, along with the Prohibition List, we propose a new strategy ensuring UAV path length reduction, associated with a reduction in the SN active time after SNs are properly scheduled. Our focus was not to evaluate the quality of data transferred between UAV and SNs, or study energy constraints of the communication because these aspects were already explored by related authors ,21,22. OThe rest of this paper is structured as follows. For this work, we consider that the sensory data generated by SNs are gathered by a single UAV used as a sink node , as it fAs illustrated in Sensor nodes (SNs) are homogeneous, have fixed locations, and are known by the UAVs. We assume that they are composed of a set of sensors, processor, memory for sensory data storage, and also a Global Positioning System (GPS) interface. Besides that, we consider that SNs have a limited lifetime due to the capacity restrictions of their batteries. Thus, SNs must alternate their states between periods of activation and hibernation. We assume that there is no direct communication between SNs due to the distance between them and the limited communication capacity. Therefore, they depend on the UAV to collect data stored in memory and deliver it to the BS.Unmanned aerial vehicles (UAVs) have high mobility, are homogeneous, multi-rotor, and have ad hoc communication systems  for UAV-Base station (BS) has a fixed location known by the UAVs, and it is the final destination of the information generated by the SNs. It is primarily responsible for the post-processing of the sensory data delivered by the UAVs.The first step for gathering sensory data from SNs is to perform the UAV path planning. Thus, it is necessary to previously define a route between them, so the UAV must fly over each SN coverage area. However, mathematically there are countless potential trajectories, making it possible to create more economical routes in terms of flight distance. The TSP algorithm that provides the lowest path cost among all SNs has NP-Hard ,27 complnearest point nx=an-th sensor  and directing the UAV to other SNs, by changing its own route.Moreover, the UAV has the ability to calculate the arrival TS until the next SN, validating this information with its Prohibition List. Thus, it checks whether or not the next SN is classified as restricted for the calculated TS. If the destination is prohibited, the UAV continuously performs this calculation until there is an SN available for the TS. If there is no SN available, the UAV waits on its current position until next TS, performing the calculation for each pending SN in its list.The flowchart shown in In Upon arriving at the SN NearestPoint/DDNN coordinates, the UAV checks if it is in hibernation mode or not (step 8). If the SN is inactive, the UAV adds the SN to its Prohibition List for current TS (steps 9 and 10), and resumes its route to the next SN (step 2). If the UAV finds the SN in active mode (step 8), then it collects the sensory data from the SN, and reconfigure it to the calculated TS according to its route (step 11). The UAV then updates its Prohibition List (steps 12 and 13) and checks if there are any pending SNs (step 14). If so, the UAV resumes its initial SN search state (step 2). Otherwise, the UAV finishes the SN reconfiguration phase (step 23) and proceeds to scheduled flight according to each SN state (step 24).During the entire UAV journey between the SNs, the autonomy of its battery is continuously checked (step 6). If it gets below a critical level (as for instance 10% ), the UAAfter the reconfiguration phase (step 23), we present the flowchart in For the sake of simplicity, and without loss of generality, we assume that (i) when each SN wakes up its data are ready to be gathered by the UAV (few bytes); (ii) the transmission time of this information is negligible compared to the defined timeslot duration; and (iii) the cumulative impact of these times can also be neglected when considering the average battery life, since the total collection would not exceed the unit of kilobytes of information.In this line of study, due to the high cost of autonomous UAV platforms, it is very common to use simulators for mathematical validation of the route models, and to analyze the experimental results generated through them. Many researchers use general purpose systems such as Network Simulator , Matlab We have followed the latter path and chose to develop our own graphic simulator: UAV Simulator. Our platform was developed using Visual Studio 2017 as IDE and C-Sharp language; the source code is freely available at GitHub . The reaNumber of UAVs needed to reconfigure all SNs;Flight distance of each UAV;Flight time of each UAV;Total flight time;Number of hops by each UAV;Number of decisions taken by each UAV;UAVs pre-calculated path length;Timeslots assigned to the scenario;Timeslots elapsed until all SNs are reconfigured;UAV coordinates as a function of flight time/TS;SNs states as a function of time/TS;UAVs connections with each SN as a function of time/TS;SNs missed flights by UAV;SNs Active Time (before and after reconfiguration);Battery percentage and UAV autonomy as a function of time/TS.In terms of features and functionality, the graphical UAV Simulator allows the use of up to 30 SNs, along with up to 30 UAVs; resizing of the simulation area is also possible. It allows configuration of the communication range and connections from the UAV with SNs, other UAVs and BS. The management of the UAV autonomy by flight time, the SNs active time, and UAV time over each SN to collect the sensory data  are also configurable. The simulator has real-time monitoring of the active and hibernation timers from each SN, and their assigned timeslots. Furthermore, the simulator has a text panel, informing the viewer of each step and decision made by the UAV, and individual events from all SNs. For each simulation scenario, the simulator registers the following information:…, The proposed strategy was evaluated through simulation, considering five different scenarios , but we propose that the SN timeslots can be shared or dedicated. As the UAV must fly over them to find out which are their active timeslots, along with the Prohibition List, we propose a new strategy ensuring the UAV path length reduction, associated with a reduction in the SN active time after SNs are properly scheduled. In addition, the UAV decisions strategy is based on always consulting the Prohibition List database. Our focus was not to evaluate the quality of data transferred between UAV and SNs, or study energy constraints of the communication because these aspects were already explored by other authors, as cited before. Our focus in this work is on the dynamics of UAV flight to understand which scenario presents better results based on each functionality of the system.…, For each scenario (The parameters presented in In this work, we proposed a method for data collection from SNs by an UAV for use in precision agriculture applications. The introduced Prohibition List strategy used by the UAVs allowed us to save 63% in flight time with respect to the case where this strategy was not used, guiding the UAV efficiently among SNs during the reconfiguration phase. This fact makes the system highly adaptable to changes in wireless sensor networks, thus favoring the decision-making process by guaranteeing the freshness and continuity of the gathered data. Regarding the distance covered by the UAVs, we obtained a reduction of more than 20% in their flight path, due to their decision-making in terms of going or not to not yet visited SNs, which made the process more accurate. In relation to the SN, we obtained a significant reduction of 89% over its active time with the proposed strategy, minimizing it to only the reading time. This was done by positioning the UAV only a few moments before the SN becomes active and forces it to hibernate until its next cycle after the data collection.Future work may consider, for instance, the impact of SN battery depletion, so that the UAV must detect that a device is no longer operational and therefore recalculates the optimized route. A dual problem is the detection of new devices and consequential route recalculation. Other interesting issue is to consider more than one UAV simultaneously flying over the SNs, which allows the design of a collaborative system, exchanging messages among UAVs for discovering SNs. Another extension is to consider the effect of optimizing transmission rate and power at each SN, which may considerably impact the battery lifetime and flight time.


Numerous models, frameworks, and theories exist for specific aspects of implementation research, including for determinants, strategies, and outcomes. However, implementation research projects often fail to provide a coherent rationale or justification for how these aspects are selected and tested in relation to one another. Despite this need to better specify the conceptual linkages between the core elements involved in projects, few tools or methods have been developed to aid in this task. The Implementation Research Logic Model (IRLM) was created for this purpose and to enhance the rigor and transparency of describing the often-complex processes of improving the adoption of evidence-based interventions in healthcare delivery systems.The IRLM structure and guiding principles were developed through a series of preliminary activities with multiple investigators representing diverse implementation research projects in terms of contexts, research designs, and implementation strategies being evaluated. The utility of the IRLM was evaluated in the course of a 2-day training to over 130 implementation researchers and healthcare delivery system partners.Preliminary work with the IRLM produced a core structure and multiple variations for common implementation research designs and situations, as well as guiding principles and suggestions for use. Results of the survey indicated a high utility of the IRLM for multiple purposes, such as improving rigor and reproducibility of projects; serving as a “roadmap” for how the project is to be carried out; clearly reporting and specifying how the project is to be conducted; and understanding the connections between determinants, strategies, mechanisms, and outcomes for their project.The IRLM is a semi-structured, principle-guided tool designed to improve the specification, rigor, reproducibility, and testable causal pathways involved in implementation research projects. The IRLM can also aid implementation researchers and implementation partners in the planning and execution of practice change initiatives. Adaptation and refinement of the IRLM are ongoing, as is the development of resources for use and applications to diverse projects, to address the challenges of this complex scientific field. Contributions to the literatureDrawing from and integrating existing frameworks, models, and theories, the IRLM advances the traditional logic model for the requirements of implementation research and practice.The IRLM provides a means of describing the complex relationships between critical elements of implementation research and practice in a way that can be used to improve the rigor and reproducibility of research and implementation practice, and the testing of theory.The IRLM offers researchers and partners a useful tool for the purposes of planning, executing, reporting, and synthesizing processes and findings across the stages of implementation projects.https://www.nih.gov/research-training/rigor-reproducibility). The field of implementation science has similarly recognized a need for better specification with similar intent [In response to a call for addressing noted problems with transparency, rigor, openness, and reproducibility in biomedical research , the Natr intent . HoweverImplementation Science [This article describes the development and application of the Implementation Research Logic Model (IRLM). The IRLM can be used with various types of implementation studies and at various stages of research, from planning and executing to reporting and synthesizing implementation studies. Example IRLMs are provided for various common study designs and scenarios, including hybrid designs and studies involving multiple service delivery systems , 4. Last Science .Having an imprecise understanding of what was done and why during the implementation of a new innovation obfuscates identifying the factors responsible for successful implementation and prevents learning from what contributed to failed implementation. Thus, improving the specification of phenomena in implementation research is necessary to inform our understanding of how implementation strategies work, for whom, under what determinant conditions, and on what implementation and clinical outcomes. One challenge is that implementation science uses numerous models and frameworks  to describe, organize, and aid in understanding the complexity of changing practice patterns and integrating evidence-based health interventions across systems . These fSimilarly, reporting guidelines exist for some of these implementation research components, such as strategies  and outcLogic models, graphic depictions that present the shared relationships among various elements of a program or study, have been used for decades in program development and evaluation  and are Logic models can also be used in the context of program theory, an explicit statement of how a project/strategy/intervention/program/policy is understood to contribute to a chain of intermediate results that eventually produce the intended/observed impacts . ProgramThe IRLM began out of a recognition that implementation research presents some unique challenges due to the field’s distinct and still codifying terminology  and its In developing the IRLM, we began with the common “pipeline” logic model format used by AHRQ, CDC, NIH, PCORI, and others . This stThe most common IRLM format is depicted in Fig. The IRLM specifies the relationships between determinants of implementation, implementation strategies, the mechanisms of action resulting from the strategies, and the implementation and clinical outcomes affected. These core elements are germane to every implementation research project in some way. Accordingly, the generalized theory of the IRLM posits that (1) implementation strategies selected for a given EBI are related to implementation determinants (context-specific barriers and facilitators), (2) strategies work through specific mechanisms of action to change the context or the behaviors of those within the context, and (3) implementation outcomes are the proximal impacts of the strategy and its mechanisms, which then relate to the clinical outcomes of the EBI. Articulated in part by others , 28, 29,Determinants of implementation are factors that might prevent or enable implementation . Determinants may act as moderators, “effect modifiers,” or mediators, thus indicating that they are links in a chain of causal mechanisms . Common Implementation strategies are supports, changes to, and interventions on the system to increase adoption of EBIs into usual care . ConsideBecause implementation research occurs within dynamic delivery systems with multiple factors that determine success or failure, the field has experienced challenges identifying consistent links between individual barriers and specific strategies to overcome them. For example, the Expert Recommendations for Implementing Change (ERIC) compilation of strategies  was usedFrequently, the reporting of implementation research studies focuses on the strategy or strategies that were introduced for the research study, without due attention to other strategies already used in the system or additional supporting strategies that might be needed to implement the target strategy. The IRLM allows for the comprehensive specification of all introduced and present strategies, as well as their changes  during the project.Mechanisms of action are processes or events through which an implementation strategy operates to affect desired implementation outcomes . The mecImplementation outcomes are the effects of deliberate and purposive actions to implement new treatments, practices, and services . They caOne of the critical insights from our preliminary work was that the use of the IRLM should be guided by a set of principles rather than governed by rules. These principles are intended to be flexible both to allow for adaptation to the various types of implementation studies and evolution of the IRLM over time and to address concerns in the field of implementation science regarding specification, rigor, reproducibility, and transparency of design and process . Given tComprehensiveness increases transparency, can improve rigor, and allows for a better understanding of alternative explanations to the conclusions drawn, particularly in the presence of null findings for an experimental design. Thus, all relevant determinants, implementation strategies, and outcomes should be included in the IRLM.strong negative impact), – 1 (weak negative impact), 0 , 1 (weak positive impact), and 2 (strong positive impact). The use of such a coding system could yield better specification compared to using study-specific adjectives or changing the name of the determinant . It is critical to include all relevant determinants and not simply limit reporting to those that are hypothesized to be related to the strategies and outcomes, as there are complex interrelationships between determinants.Concerning determinants, the valence should be noted as being either a barrier, a facilitator, neutral, or variable by study unit. This can be achieved by simply adding plus (+) or minus (–) signs for facilitators and barriers, respectively, or by using coding systems such as that developed by Damschroder et al. , which iImplementation strategies should be reported in their entirety. When using the IRLM for planning a study, it is important to list all strategies in the system, including those already in use and those to be initiated for the purposes of the study, often in the experimental condition of the design. Second, strategies should be labeled to indicate whether they were (a) in place in the system prior to the study, (b) initiated prospectively for the purposes of the study , (c) removed as a result of being ineffective or onerous, or (d) introduced during the study to address an emergent barrier or supplement other strategies because of low initial impact. This is relevant when using the IRLM for planning, as an ongoing tracking system, for retrospective application to a completed study, and in the final reporting of a study. There have been a number of processes proposed for tracking the use of and adaptations to implementation strategies over time , 41. EacAlthough most studies will indicate a primary implementation outcome, other outcomes are almost assuredly to be measured. Thus, they ought to be included in the IRLM. This guidance is given in large part due to the interdependence of implementation outcomes, such that adoption relates to delivery with fidelity, reach of the intervention, and potential for sustainment . SimilarAlthough the IRLM has a generalized theory (described earlier), there is a need to indicate the relationships between elements in a manner aligning with the specific theory of change for the study. Researchers ought to provide some form or notation to indicate these conceptual relationships using color-coding, superscripts, arrows, or a combination of the three. Such notations in the IRLM facilitate reference in the text to the study hypotheses, tests of effects, causal chain modeling, and other forms of elaboration (see “Supporting Text and Resources”). We prefer the use of superscripts to color or arrows in grant proposals and articles for practical purposes, as colors can be difficult to distinguish, and arrows can obscure text and contribute to visual convolution. When presenting the IRLM using presentation programs , colors and arrows can be helpful, and animations can make these connections dynamic and sequential without adding to visual complexity. This principle could also prove useful in synthesizing across similar studies to build the science of tailored implementation, where strategies are selected based on the presence of specific combinations of determinants. As previously indicated , there iThis critical element will vary by the study design . This principle includes not only researchers but service systems and communities, whose consent is necessary to carry out any implementation design , 42, 43.a priori outcomes are not clearly indicated. We also suggest including downstream health services and clinical outcomes even if they are not measured, as these are important for understanding the logic of the study and the ultimate health-related targets.Indicate the primary outcome(s) at each level of the study design . The levels should align with the specific aims of a grant application or the stated objective of a research report. In the case of a process evaluation or an observational study including the RE-AIM evaluation components  or the PWhen quasi/experimental designs , 4 are uIn the context of comparative implementation trials , 4, a stA number of designs are now available that aim to test processes of optimizing implementation. These include factorial, Sequential Multiple Assignment Randomized Trial (SMART) , adaptivUsers of the IRLM are allowed to specify any number of additional elements that may be important to their study. For example, one could notate those elements of the IRLM that have been or will be measured versus those that were based on the researcher’s prior studies or inferred from findings reported in the literature. Users can also indicate when implementation strategies differ by level or unit within the study. In large multisite studies, strategies might not be uniform across all units, particularly those strategies that already exist within the system. Similarly, there might be a need to increase the dose of certain strategies to address the relative strengths of different determinants within units.Commensurate with logic models more generally, the IRLM can be used for planning and organizing a project, carrying out a project (as a roadmap), reporting and presenting the findings of a completed project, and synthesizing the findings of multiple projects or of a specific area of implementation research, such as what is known about how learning collaboratives are effective within clinical care settings.When the IRLM is used for planning, the process of populating each of the elements often begins with the known parameter(s) of the study. For example, if the problem is improving the adoption and reach of a specific EBI within a particular clinical setting, the implementation outcomes and context, as well as the EBI, are clearly known. The downstream clinical outcomes of the EBI are likely also known. Working from the two “bookends” of the IRLM, the researchers and community partners and/or organization stakeholders can begin to fill in the implementation strategies that are likely to be feasible and effective and then posit conceptually derived mechanisms of action. In another example, only the EBI and primary clinical outcomes were known. The IRLM was useful in considering different scenarios for what strategies might be needed and appropriate to test the implementation of the EBI in different service delivery contexts. The IRLM was a tool for the researchers and stakeholders to work through these multiple options.When we used the IRLM to plan for the execution of funded implementation studies, the majority of the parameters were already proposed in the grant application. However, through completing the IRLM prior to the start of the study, we found that a number of important contextual factors had not been considered, additional implementation strategies were needed to complement the primary ones proposed in the grant, and mechanisms needed to be added and measured. At the time of award, mechanisms were not an expected component of implementation research projects as they will likely become in the future.For another project, the IRLM was applied retrospectively to report on the findings and overall logic of the study. Because nearly all elements of the IRLM were known, we approached completion of the model as a means of showing what happened during the study and to accurately report the hypothesized relationships that we observed. These relationships could be formally tested using causal pathway modeling  or otherIn our preliminary work with the IRLM, we used it in each of the first three ways; the fourth (synthesizing) is ongoing within the National Cancer Institute’s Improving the Management of symPtoms during And Following Cancer Treatment (IMPACT) research consortium. The purpose is to draw conclusions for the implementation of an EBI in a particular context (or across contexts) that are shared and generalizable to provide a guide for future research and implementation.While the IRLM provides a good deal of information about a project in a single visual, researchers will need to convey additional details about an implementation research study through the use of supporting text, tables, and figures in grant applications, reports, and articles. Some elements that require elaboration are (a) preliminary data on the assessment and valence of implementation determinants; (b) operationalization/detailing of the implementation strategies being used or observed, using established reporting guidelines  and laben = 78) received additional questions about prior implementation research training  and related experiences  and the stage of their project  and one implementation partner  from each project were invited to attend a 2-day in-person summit in Chicago, IL, in October 2019. One hundred thirty-two participants attended, representing 63 of the 65 projects. A survey, which included demographics and questions pertaining to the Ending the HIV Epidemic, was sent to potential attendees prior to the summit, to which 129 individuals—including all 65 project directors, 13 co-investigators, and 51 implementation partners —responded. Those who indicated an investigator role (tainment ).not at all, 2 = a little, 3 = moderately, 4 = very much; see Table Approximately 6 weeks after the summit, 89 attendees (69%) completed a post-training survey comprising more than 40 questions about their overall experience. Though the invitation to complete the survey made no mention of the IRLM, it included 10 items related to the IRLM and one more generally about the logic of implementation research, each rated on a 4-point scale  of respondents indicated that their knowledge on the logic of implementation research had increased either moderately or very much after the 2-day training. At the time of the survey, when respondents were about 2.5 months into their 1-year planning projects, 44.6% indicated that they had already been able to complete a full draft of the IRLM.Table F = 2.460, p = .055), clearly reporting and specifying how the project is to be conducted , and knowledge on the logic of implementation research . In each case, scores were higher for the investigators compared to the implementation partners, suggesting that perhaps the knowledge gap in implementation research lay more in the academic realm than among community partners, who may not have a focus on research but whose day-to-day roles include the implementation of EBPs in the real world. Lastly, analyses using ordinal logistic regression did not yield any significant relationship between responses to the IRLM survey items and prior training (n = 42 investigators who attended the training and completed the post-training survey), prior related research experience (n = 42), and project stage of implementation (n = 66). This suggests that the IRLM is a useful tool for both investigators and implementers with varying levels of prior exposure to implementation research concepts and across all stages of implementation research. As a result of this training, the IRLM is now a required element in the FY2020 Ending the HIV Epidemic Centers for AIDS Research/AIDS Research Centers Supplement Announcement released March 2020 [Additional analyses using a one-way analysis of variance indicated no statistically significant differences in responses to the IRLM questions between investigators and implementation partners. However, three items approached significance: planning the project  and as implementation strategies . The IRLM has been used by our team to plan for large systemic changes and to initiate capacity building strategies to address readiness to change  through strategic planning and leadership engagement at multiple levels in the organization. This aspect of the IRLM continues to evolve.Among the drawbacks of the IRLM is that it might be viewed as a somewhat simplified format. This represents the challenges of balancing depth and detail with parsimony, ease of comprehension, and ease of use. The structure of the IRLM may inhibit creative thinking if applied too rigidly, which is among the reasons we provide numerous examples of different ways to tailor the model to the specific needs of different project designs and parameters. Relatedly, we encourage users to iterate on the design of the IRLM to increase its utility.The promise of implementation science lies in the ability to conduct rigorous and reproducible research, to clearly understand the findings, and to synthesize findings from which generalizable conclusions can be drawn and actionable recommendations for practice change emerge. As scientists and implementers have worked to better define the core methods of the field, the need for theory-driven, testable integration of the foundational elements involved in impactful implementation research has become more apparent. The IRLM is a tool that can aid the field in addressing this need and moving toward the ultimate promise of implementation research to improve the provision and quality of healthcare services for all people.Additional file 1. IRLM Fillable PDF formAdditional file 2. IRLM for Comparative ImplementationAdditional file 3. IRLM for Implementation of an Intervention Across or Linking Two ContextsAdditional file 4. IRLM for an Implementation Optimization StudyAdditional file 5. IRLM example 1: Faith in Action: Clergy and Community Health Center Communication Strategies for Ending the Epidemic in Mississippi and ArkansasAdditional file 6. IRLM example 2: Hybrid Type II Effectiveness–Implementation Evaluation of a City-Wide HIV System Navigation Intervention in Chicago, ILAdditional file 7. IRLM example 3: Implementation, spread, and sustainment of Physical Therapy for Mild Parkinson’s Disease through a Regional System of CareAdditional file 8. IRLM Quick Reference GuideAdditional file 9. IRLM Worksheets


Factor analysis (FA) allows us to simplify a set of complex variables or items using statistical procedures to explore the underlying dimensions that explain the relationships between the multiple variables/items. For example, to explore inter-item relationships for a 20-item instrument, a basic analysis would produce 400 correlations; it is not an easy task to keep these matrices in our heads. FA simplifies a matrix of correlations so a researcher can more easily understand the relationship between items in a scale and the underlying factors that the items may have in common. FA is a commonly applied and widely promoted procedure for developing and refining clinical assessment instruments to produce evidence for the construct validity of the measure.In the literature, the strong association between construct validity and FA is well documented, as the method provides evidence based on test content and evidence based on internal structure, key components of construct validity.The applications of FA depend on the purpose of the research. Generally speaking, there are two most important types of FA: Explorator Factor Analysis (EFA) and Confirmatory Factor Analysis (CFA).Exploratory Factor Analysis (EFA) is widely used in medical education research in the early phases of instrument development, specifically for measures of latent variables that cannot be assessed directly. Typically, in EFA, the researcher, through a review of the literature and engagement with content experts, selects as many instrument items as necessary to fully represent the latent construct . Then, using EFA, the researcher explores the results of factor loadings, along with other criteria  is applied and described, in error, as exploratory factor analysis.,When prior EFA studies are available for your intended instrument, Confirmatory Factor Analysis extends on those findings, allowing you to confirm or disconfirm the underlying factor structures, or dimensions, extracted in prior research. CFA is a theory or model-driven approach that tests how well the data “fit” to the proposed model or theory. CFA thus departs from EFA in that researchers must first identify a factor model before analysing the data. More fundamentally, CFA is a means for statistically testing the internal structure of instruments and relies on the maximum likelihood estimation (MLE) and a different set of standards for assessing the suitability of the construct of interest. Factor analysts usually use the path diagram to show the theoretical and hypothesized relationships between items and the factors to create a hypothetical model to test using the ML method. In the path diagram, circles or ovals represent factors. A rectangle represents the instrument items. Lines (→ or ↔) represent relationships between items. No line, no relationship. A single-headed arrow shows the causal relationship (the variable that the arrowhead refers to is the dependent variable), and a double-headed shows a covariance between variables or factors.If CFA indicates the primary factors, or first-order factors, produced by the prior PAF are correlated, then the second-order factors need to be modelled and estimated to get a greater understanding of the data. It should be noted if the prior EFA applied an orthogonal rotation to the factor solution, the factors produced would be uncorrelated. Hence, the analysis of the second-order factors is not possible. Generally, in social science research, most constructs assume inter-related factors, and therefore should apply an oblique rotation. The justification for analyzing the second-order factors is that when the correlations between the primary factors exist, CFA can then statistically model a broad picture of factors not captured by the primary factors ., Factor analysis methods can be incredibly useful tools for researchers attempting to establish high quality measures of those constructs not directly observed and captured by observation. Specifically, the factor solution derived from an Exploratory Factor Analysis provides a snapshot of the statistical relationships of the key behaviors, attitudes, and dispositions of the construct of interest. This snapshot provides critical evidence for the validity of the measure based on the fit of the test content to the theoretical framework that underlies the construct. Further, the relationships between factors, which can be explored with EFA and confirmed with CFA, help researchers interpret the theoretical connections between underlying dimensions of a construct and even extending to relationships across constructs in a broader theoretical model. However, studies that do not apply recommended extraction, rotation, and interpretation in FA risk drawing faulty conclusions about the validity of a measure. As measures are picked up by other researchers and applied in experimental designs, or by practitioners as assessments in practice, application of measures with subpar evidence for validity produces a ripple effect across the field. It is incumbent on researchers to ensure best practices are applied or engage with methodologists to support and consult where there are gaps in knowledge of methods. Further, it remains important to also critically evaluate measures selected for research and practice, focusing on those that demonstrate alignment with best practice for FA and instrument development.The authors declare that they have no conflicts of interest.


Homo sapiens. Likewise, mobility and a threshold level of exercise are essential across the lifespan from birth to old age to optimize growth and maturation early, and then to avoid deconditioning with advancing age. Connective tissues including bones, muscles, tendons, ligaments, cartilage, and menisci require mobility to maintain optimal integrity  and need to work within the boundary conditions of Earth. In addition, it is not only the human musculoskeletal (MSK) system that depends on mobility and exercise to maintain its integrity, but also the cardiovascular system (CVS), and brain and other highly vascularized systems . The articles in this Research Topic focus on understanding the role and effects of mobility and exercise in maintaining multiple physiological systems and avoiding the deconditioning that can accompany advancing age. The articles can be grouped into Three Themes: (1) Overview of how exercise is ingrained in human physiology, (2) Examination of how exercise can be assessed and used as an approach for disease prevention and risk mitigation in younger individuals, and (3) Examples of the effectiveness of exercise for enhancing successful aging. Given the “graying” of many global populations, the development of chronic diseases in the elderly, and the need to both prevent loss of mobility , as well as using mobility and exercise to mitigate the impact of early chronic diseases , many of the Research Topic articles focus on the elderly.Mobility and the ability to functionally navigate the environment are intrinsically ingrained in the evolution leading to Hart and Zernicke provide an overview of how mobility and exercise (patterned mobility) were ingrained into multiple physiologic systems during the evolutionary process leading to Homo sapiens. Mobility and exercise are critical for growth and maturation through to skeletal maturity as humans develop the ability to function in Earth's environment with its attendant gravitational forces. How biomechanics and biology are integrated to yield long-term functioning is also addressed.Patel et al. focuses on non-elite sport involvement and bone density in younger individuals (11–35 years). Peak bone density is acquired early in life, and enhanced bone density can reduce risk of osteoporotic fractures later in life, particularly for post-menopausal females, who comprise~75% of the elderly with osteoporosis (OP). The analysis by Patel and colleagues showed that weight-bearing sport involvement has a beneficial effect on calcaneal bone density, which may also portend beneficial effects on other skeletal tissues.The systematic review by Tuttor et al. compared two different exercise protocols designed to impact cardiometabolic risk factors in overweight “middle aged” males. Both protocols were effective, but a high-intensity resistance exercise was more effective. Two key findings emerged: (1) different exercise protocols can effectively have a positive influence on the CVS, and (2) variations exist between individuals regarding which type of exercise will yield the optimal response. As Hart and Zernicke note, it is known that some people respond better to resistance than aerobic exercise and vice versa.Renggli et al. indicate that controlled laboratory assessments yield different results when compared to uncontrolled mobility  in real-world environments assessed using wearable measurement devices. For assessing both young and elderly individuals, it is important to understand the type and intensity of mobility activity, as well as the environment in which the activity occurs. An uncontrolled environment likely requires incorporation of navigation cues more so than a laboratory setting.Assessing how individuals walk in different environments  can provide insights into how mobility is influenced by navigation cues, and how this may be also influenced by age. Mancinelli et al. examine the ability of neuromuscular electrical stimulation (NMES) to modify the muscles of the healthy elderly, using the vastus lateralis muscle of active, healthy older individuals. As older individuals may develop sarcopenia, which can impede mobility, using NMES to enhance muscle integrity could lead to more effective mobility and, thus, exert greater impact on physiological systems at risk due to a lack of mobility. Given the effectiveness of the intervention, one could also postulate that application of NMES to younger individuals may prevent or inhibit the development of some forms of sarcopenia.The final article in Theme Two bridges Themes Two and Three. Theme Three articles focus on the elderly and address issues in the context of mobility and successful, healthy aging.Endo et al. proposed to optimize skeletal muscle fitness using resistance training in the elderly. As noted earlier, during the aging process many individuals develop sarcopenia leading to impaired mobility, and Endo et al. used exercise—alone or in combination with other modalities—in an effort to blunt the potential for developing sarcopenia. Tavoian et al. also focus on resistance exercise in the elderly to diminish the risk for development of chronic diseases, and their results support the premise that resistance exercise is more beneficial than aerobic exercise. Hill et al. compare the advantages of downhill walking vs. level walking for the retention of muscular and physical function in the elderly. In aggregate, these three studies indicate that it is not just exercise that is important, but the type of exercise can also be important. The next article focuses on using SPARC metrics to assess variations in the “timed up-and-go” test in individuals over 80 years, who were at risk for falls vs. those who were not . As falls are a leading cause of low impact hip fractures, being able to predict who may be at risk with a relatively simple test could lead to preventative measures to mitigate such risk. Finally, building on the theme of mitigating risk for adverse events in the elderly, including falls, Freiberger et al. provide a narrative review focused on community-dwelling elderly and the risks presented by age-related loss of cognition, physical deconditioning, and other mobility limitations.The first contribution focuses on the MSK system in the elderly and how to optimize its integrity. Shojaa et al. provide a systematic review and meta-analysis of exercise on bone health in post-menopausal females. They evaluate and summarize existing research on optimal exercise protocols to use and their outcomes in this population. As osteoporosis (OP) is a prevalent disease in this cohort of women , and OP can predispose individuals to hip fractures and other fractures that can lead to morbidity and mortality, optimizing preventative measures is significant. With respect to the interactions among CVS health, exercise, and successful aging, a subset of three review articles is included in Theme Three. Santos and Umpierre address the links between exercise and risk for atherosclerosis and as such emphasize not only the elderly, but also those in younger age groups. The advantages and impact of exercise, as well as current gaps in information that need additional study, indicate that while some concrete evidence exists in this area, much research remains to be done. de Oliverira Sant'Ana et al. generated a review focused on the role of exercise as a preventative measure in the healthy elderly. As such, the exercise protocols were designed to maintain the integrity of the CVS and minimize the risk for deconditioning and emergence of disease . Finally, Xing et al. provide a mini-review that focuses on the role of exercise and mobility on recovery from a CVS event  . Collectively, extant data suggest that exercise protocols can have a positive impact on both prevention, as well as recovery from a loss of health as it pertains to the CVS.A cluster of articles in Theme Three focuses on the role of mobility and exercise in the elderly related to bone and CVS health. Hart and Zernicke). In sum, Prevention is better than Treatment for minimizing risk for loss of function for many human physiological systems.The collection of articles in this Research Topic support the concept that humans require mobility to maintain the integrity of the musculoskeletal system (MSK), as well as the CVS. Because CVS integrity is central to many physiological systems , there is a “cascade effect” for optimal health that can be traced back to the need to optimally maintain the MSK system and retain its functionality across the lifespan (DH wrote the initial draft of this Editorial. DH and RZ edited and polished the article. Both authors agree with the final version and its submission to Frontiers.The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.


Demographic changes are taking place in most industrialized countries. Geriatric patients are defined by the European Union of Medical Specialists as aged over 65 years and suffering from frailty and multi-morbidity, whose complexity puts a major burden on these patients, their family caregivers and the public health care system. To counteract negative outcomes and to maintain consistency in care between hospital and community dwelling, the transitional of care has emerged over the last several decades. Our objectives were to identify and summarize the components of the Transitional Care Model implemented with geriatric patients  for the reduction of all-cause readmission. Another objective was to recognize the Transitional Care Model components’ role and impact on readmission rate reduction on the transition of care from hospital to community dwelling (not nursing homes).Randomized controlled trials , with geriatric patients were included. Electronic databases  were searched from January 1994 to December 2019 published in English or German. A qualitative synthesis of the findings as well as a systematic assessment of the interventions intensities was performed.p < 0.05), but the third trial did not report significant differences between the groups in the longer follow-up period (up to 12 months).Three articles met the inclusion criteria. One of the included trials applied all of the nine Transitional Care Model components described by Hirschman and colleagues and obtained a high-intensity level of intervention in the intensities assessment. This and another trial reported reductions in the readmission rate (Our findings suggest that high intensity multicomponent and multidisciplinary interventions are likely to be effective reducing readmission rates in geriatric patients, without increasing cost. Components such as type of staffing, assessing and managing symptoms, educating and promoting self-management, maintaining relationships and fostering coordination seem to have an important role in reducing the readmission rate. Research is needed to perform further investigations addressing geriatric patients well above 65 years old, to further understand the importance of individual components of the TCM in this population. Demographic changes are taking place in most industrialized countries. In Germany in 2014, the population 66–99 years of age accounted for 20% (16.1 million) of the total population .Geriatric patients are defined by the European Union of Medical Specialists as aged over 65 years, having “a high degree of frailty and active multiple pathology”  and ofteTo counteract negative outcomes , for this population of geriatric patients with multi-morbidity, and to maintain consistency in care between the hospital and community dwelling, the topic of transitional of care as both an area of research and practice has emerged over the last several decades –16. The Allen and colleagues , suggestA reduction of hospital readmission rates (from 12 to 75% reduction) has been reported in some randomized studies with the use of interventions approaching patient education, pre-discharge evaluation and domiciliary patient-centered care , 32. In hospital setting (and not Emergency Department (ED)) and community dwelling (and not nursing homes),targeting multi-morbidity (and not disease specific).Previously, some systematic reviews had evaluated randomized controlled trials (RCTs) in order to assess the effectiveness of transitional care interventions with older people. These studies were done with different focuses, e.g. special diseases such as stroke, heart failure, chronic obstructive pulmonary disease (COPD) and asthma, among other chronic illnesses , 38, outThere will be openness about the diseases to be studied, but meeting the definition of the geriatric patient by the EUMS  is mandaFor a better understanding of the transitional care literature and to address this gap, the present systematic review was conducted. Therefore, the aim was to identify and summarize the components of the Transitional Care Model implemented with geriatric patients to reduce all-cause readmissions as well as to recognize the TCM-components’ role and impact on readmission rate reduction on the transition of care from hospital to community dwelling .The systematic review was carried out according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines . In ordehttp://www.crd.york.ac.uk/PROSPERO/display_record.php?ID=CRD42018084604A standardized form was developed and used for eligibility screening as well as for data extraction of the identified included studies. The contents of the standardization were as follows:Only randomized controlled trials (RCT) published in either English or German language were included. The review included geriatric patients explicitly older than 65 years with comorbidities in order to comply with the European Union of Medical Specialists definition of a geriatric patient  and who The intervention tested in the trials required the inclusion of the transition process from hospital to community dwelling, and at least one component of the TCM components at pre-discharge and one at post-discharge has to be described in detail  (The Cochrane Library) from January the 1st 1994 through December 2019. English keywords were used for the electronic search , at the two different institutions (an author from one center and two authors from the other center) performed the initial screening of titles and abstracts and the subsequent assessment for eligibility of retrieved full texts independently. Any disagreement or potential discrepancies in double coding were resolved through discussion with a third review author (MR).p value used to evaluate statistical significance. In addition, to estimate the magnitude of the difference between the groups, percentage differences were calculated by dividing the absolute percentage difference between the groups by the percentage of the control group.The data extraction from the articles included: study design, sample size, sample characteristics , study setting, TCM components used, hospital readmission rate with follow-up period, secondary outcomes, type of healthcare professionals involved in the intervention, and adverse events. Each component (Cp) of the TCM was classified in the pre-discharge and post-discharge phases. The TCM components were as follows: Cp1: screening, Cp2: staffing, Cp3: maintaining relationships, Cp4: engaging patients and caregivers, Cp5: assessing/managing risks and symptoms, Cp6: education/ promoting self-management, Cp7: collaborating, Cp8: promoting continuity and Cp9: fostering coordination . In the Missing information was requested from study authors. The authors were contacted three times. If there was no reply, the study was excluded. In the case of studies with analyses based on the same sample and intervention study, the most complete and/or most recent article was selected for the review while the other studies were excluded.Once the final studies were chosen, the two reviewers independently used the Cochrane Risk of Bias Tool to assess the internal validity of eligible studies , 43. ThiAdditionally, external validity was assessed in order to identify accordance with everyday practice and clinical relevance of the included studies. The checklist proposed by Bornhoft and collaborators was used to perform this qualitative evaluation . This chDisagreements between the two interactive review authors (e.g. NM and MIC) over the risk of bias in internal and external validity of particular trials were resolved by discussion, with involvement of a third review author (LDU or MR).A qualitative synthesis of the findings from the included studies is provide in this review, structured around the primary outcome reduction of readmission rate, type of TCM components applied and relevant modifications, the target population characteristics, the healthcare profession or the multi-professional team involved on the intervention.Furthermore, in order to describe in more detail, the implementation of the TCM components considered in the selected studies, a systematic assessment of the interventions intensities was performed. Thus, seven parameters guided this assessment according to Verhaegh and collaborators  and VedeIn total, 3388 articles from electronic search and 320 articles from hand search were found. After removing duplicates, 3515 articles were yielded. A total of 3099 titles were excluded due to not meeting eligibility criteria. Of the remaining 416 articles 348 had to be excluded upon abstract revision. Reasons for exclusion were e.g. not an RCT, participant age (≤65 years old), or sample size (< 50). Therefore, 68 full-text reviews were carried out, with a total of three trials adhering to all the established inclusion and exclusion criteria  (Table p = 0.001). In addition, they carried out a long-term evaluation of the readmission rate reduction during the 9-month follow-up after the intervention was withdrawn, where a persistent readmission reduction in the heart failure group was observed .Rich and colleagues  observed3) Table . The autp = 0.46). The authors reported for the control group a percentage of 21.9 unplanned readmissions. This was corrected by the authors of the present systematic review using the data published by Clemson that corresponded to 20.9% (37 unplanned readmissions/ 177 N of the control group). Therefore, the percentage difference was estimated using the value 20.9% .In the case of Clemson and colleagues , overallp = 0.041) and 6 months  of follow up  and López Cabezas and colleagues [p = 0.0095). Finally, regarding the presence of adverse events, these were not reported by the authors of the three studies.Moreover, a survival curve for the probability of not being readmitted was estimated in two of the evaluated studies. That was the case of López Cabezas and colleagues  and Richlleagues  evidenceOnly the trial conducted by Rich and colleagues  applied p = 0.001).Other outcome measures reported by Clemson and colleagues , showed p = 0.017). Rich and colleagues did not observe significant differences in the assessment of this outcome, but observed differences in the percentage of deaths of the control group (12.1%) vs the intervention group (9.2%).Regarding the number of deaths, López Cabezas and colleagues found significant differences between the percentage of deaths of the control (29.7%) vs intervention (12.9%) group for the period of 12 months of follow-up , nor the intervention period , 24, 25.This systematic review found meaningful differences between the three included trials, which are important for designing future trials and for the identification of relevant aspects in the improvement of transitional care in geriatric patients.Aspects such as the length of the intervention were different between the three trials. The trial of Rich and colleagues  evidenceThe included trials were rated in this systematic review as moderate- to high-intensity interventions of transitional care Table . Based oIn relation to the multicomponent intervention approach, recent literature reviews evidenced a significant association between the number of transition components included in an intervention and the probability of success in the reduction of readmissions , 52–54. All of the three trials performed this component due to the study design. However, geriatric patients should also be identified in the daily routine of the hospital. According to Greysen and colleagues  participAlthough the traditional TCM uses advanced practice registered nurses to provide the hospital to community dwelling intervention, one positive aspect of our finding is that different professions seem to successfully implement the TCM model, which broadens the possible implementation process of this model. All three studies used different professions to implement their transitional care intervention. Trained occupational therapists, who aimed to provide patients with self-care skills that allow them to cope with daily living issues and return to their daily life activities, conducted the intervention in the trial of Clemson and colleagues . PharmacIt has to be taken into account that internationally there are different standards in the education of the healthcare team. For example, nurses or therapists are educated academically or non-academically, depending on the country of their education.Finally, it could be possible that the impact of the contact given by the different professionals of the studies evaluated, could vary mainly because of the nature of the professions included , as well as by the uni- or multidisciplinary aspect of the work team. This difference may have had an impact not only on the desired outcomes but operationally on the transition components that could be applied according to the professions carrying out the interventions and follow-up. Therefore, it could be suggested that the joint work of a multidisciplinary team would have a greater impact on patient contact.This component was included in all three trials by caring for the patients and their family caregivers, both in the hospital and in the community dwelling. The healthcare professionals keep a relationship with patients and their caregivers through visits and telephone calls to prepare and accompany the patients during the implementation of the care plan and to meet their current and future needs. This approach is fairly consistent with the description of the TCM , in whicThis component was applied only in two of the three trials , 30. TheRich and colleagues  used a lIt should be noted that a limited approach to caregiver engagement may reduce the impact of this component in the transition process, considering that care after hospital discharge generates a difficult burden on families . If careThis component was included by the two trials, only in the setting of the hospital. However, in the course of the transition from one setting to the other, adjustments to the care plan may become necessary. Therefore, it is likely to be important to adjust the care plan also in the home environment. Thus, at home the patients and their family caregivers should be engaged again. In addition, it is worth mentioning to include the individual values and preferences in the care plan .De Wit and Schuurmans  stronglyThis component was applied in all three trials. However, the implementation of this component was carried out differently in each study, based on the type of assessments and its goal. Clemson and colleagues  conducteEspecially in the geriatric population with the burden of multi-morbidity, it may be necessary to assess and manage the risk and symptoms individually. By looking at the domains of activity and participation, further undiscovered needs or dangers could be revealed. In general, Burke and colleagues  showed tIt became evident, that only the two trials , 30 thatRich and colleagues affirmed that their educational component focused on intensive teaching and contributed to achieve significant readmission reductions. Particularly, since the educational component allowed to reinforce patient’s knowledge in the follow up, to guarantee adherence with medications and to provide information to recognize and manage persistent symptoms. These findings are in line with the research of Koelling and colleagues  and BurkThis component was only included by Rich and colleagues . It was Promoting continuity could help to prevent breakdowns in care across settings . SeveralWith respect to this component, Rich and colleagues  providedIn conclusion of the applied TCM components in our systematic review experiencing the “real” environment of geriatric patients will reveal barriers as well as supportive factors that can often not be detected from an inside-hospital view. This demonstrates the need of the community dwelling components of the TCM. Although not all components have been used by the three included trials, they addressed both care settings  demonstrating the need of such an approach to reduce successfully the re-admission rate in a geriatric population.Another interesting difference between the three trials is the nature of the TCM team. Looking at the history of the TCM, the focus is on a nurse-led intervention. However, in the included trials the configuration of the care team was not limited to this profession.Regarding the multidisciplinary care team, the need for a team approach to improve the care of patients with chronic conditions has previously been emphasized . In thisIn conclusion, our systematic review demonstrated that the sum of the integrated components of the TCM is also responsible for a successful transition from the hospital to the community especially in geriatric patients. According to the results of this review, these factors are the intensity level and length of intervention, a multicomponent intervention approach and the specific role of each component, and the multidisciplinary nature of the care team. Future studies should focus on the optimal combination of these factors. In general, all of the nine defined TCM components by Hirschman and colleagues  were incThere were also different results in relation to the secondary outcomes of interest.In case of the QoL, only one of the evaluated trials  found a Clemson and colleagues  did not Finally, it is important to highlight the need to conduct trials focused in the geriatric population over 65 years, which allow a better identification of the TCM role according to the care needs of this population. The results previously reported in the literature on the effects of the TCM, vary greatly, especially due to the variety of populations evaluated. For instance, the systematic review carried out by Coffey and colleagues evaluated studies that applied transition care, each with a specific study population such as new mothers, infants and children, adolescents, older people, among others. They observed mixed findings, in which the results of some studies varied in relation to the cost effectiveness, outcomes as the number of hospitalizations as well as the quality of life . Added tIn the present review, only three trials were included that met the precise inclusion criteria on which the present review was based. The still existing fragmentation in most public health care systems especially in geriatric patients’ needs growing realization to overcome this barrier. Our strict inclusion criteria with the special focus on geriatric patients could have excluded other studies with valuable information.In addition, it was not possible to obtain a clear description of the control group conditions of each trial. As different care and discharge routine could have effects on the acceptance and implementation on the results of TCM implementation it was interesting to see that in all three studies the components of maintaining relationship and continuity was applied. One could hypothesize that in daily discharge and transitional routine being applied for the control group, especially these components of the TCM are not applied. It should be considered that these were carried out in countries with different health systems, where the standard hospital discharge procedure may vary.Moreover, a gap related to the evaluation of the fidelity of interventions was evidenced, which did not allow this aspect to be addressed in the present review and could pose a bias on the results. Nevertheless, as we followed strictly the protocol with obtaining risk of bias we think that no fidelity information is needed with regard to our main objective. Even so, we consider the inclusion of fidelity assessment criteria in further trials to be relevant, especially in studies that evaluate transitional care interventions in geriatric populations (over 65 years old). Given that characteristics such as multi-morbidity, the application of interventions in multiple sites  and the complexity of these interventions  could limit the maintenance of the trials fidelity.On the other hand, the strength of our review is the strict focus on the geriatric population, providing concrete information on the effects of multi-component interventions in reducing readmission in the geriatric population – individuals over 65 years of age with multi-morbidity. In view of the significant increase in this population in the upcoming years, effective and realistic approaches are needed to reduce the readmission rate of these highly vulnerable people. We therefore think that this systematic review will add valuable information not disease oriented but addressing a growing percentage of population putting the health care systems on the edge in the future. Furthermore, the health of the informal carer in this population needs to be taken into account as well. An additional strength of our study is – although we only included three trials – all trials had more than 50 participants in each trial arm, and were of good quality, strengthening our findings and providing a solid base for future research, and designing new transitional care intervention in the geriatric population.The findings of the present systematic review suggest that high intensity multicomponent, multidisciplinary interventions are likely to be effective reducing readmission rates and improving quality of life in geriatric patients, without increasing cost , 30. OurAdditional file 1. MEDLINE Search strategy.Additional file 2. Hand search in other sources.Additional file 3. Parameters for the intervention intensity evaluation.


Japan has been aging faster than other industrialized nations, and its experience offers useful lessons to others. Japan has been willing to expand its welfare state with a long-term care (LTC) insurance to finance home care and nursing home care for frail elderly. As Ikegami shows, it created new facilities and expanded specialized staffing for home care, developed a country-wide assessment system and shifted responsibilities between the central and local authorities over that assessment and the determination of co-payments for LTC. Faced with rapid growth in demand for LTC, the government felt the need for new cost control measures. The Japanese experience illustrates that new social policies take time to develop. There is often a need to adjust. But there are also other lessons. The main one is that there is no direct relation between the degree of population aging and total health spending. While aging requires adjustments in the organization of care, and expanding LTC for frail elderly, international studies show there is no need to worry about the ‘unaffordability’ of aging. In this commentary, we have framed four "What, Why, Who, and How" questions about LTC to (re-)define the borderlines between public and private responsibilities for the range of activities for which some  frail elderly as well as many non-elderly require support in daily life. Japan has been aging faster than any other industrialized nation. Its experience is therefore important to others: how can we adapt to the aging of our populations, especially in the fields of pensions and healthcare?4 Many Organisation for Economic Co-operation and Development (OECD) (and other) countries have already taken such measures.Brief, there are three possible policy directions. One is to counter that demographic process by trying to encourage families to have more babies to reverse the aging process . The results of those policies have been mixed, to say the least, and do not seem to have turned around the trend of leveling off and even declining population size in many nations. It is also not clear whether the world need more population growth. The second policy direction is adjustment of public pension systems. German’s chancellor Bismarck set the threshold for old age pension for industrial workers in 1883 at 65 years. In 1883, policy-makers knew, these workers would live, on average, another 3 years after 65. Today, we live, on average, almost 30 years after that age but we still think of 65 as the retirement age . This demographic change obviously requires adjustments in pensions, for example, reversing trends of early retirement, freezing or even cutting pension payments and encouraging higher labor market participation.7 Some nations with much older population than the United States, for example Japan, Germany, or the United Kingdom, spend much less on healthcare, often with better outcomes in terms of life expectancy or child mortality. The incomes of health professionals, the use of medical technology and the organization of healthcare services are all factors that have played a greater role in determining the level of health spending than aging.9 That is also true for the costs of end-of life care.11There is little or no relation, however, between population aging and the level of healthcare spending.12 Nowadays the vast majority of people in their 60s and 70s have good health and live independently.14 Some studies show that the total value of transfers of the older generation to their children and grandchildren is larger than the net cost of (public) pensions and long-term care (LTC). Many of the currently retired support their offspring financially and materially in paying for education, lending money to buy an apartment or house, and providing childcare or transportation services to grandchildren (see Gusmano and Okma7). Depicting populations over 65 as ‘frail dependent elderly’ is at least misleading.A century ago, working people, especially the blue-collar beneficiaries of the German social insurance schemes, were generally worn out by the end of their working lives. Aging as a demographic process is no longer just a burden to society. There are several positive sides to aging.The need for support by family or external professionals generally only rises substantially after elderly reach 80 or 85 years, and even at that age, only for a minority. The number of dependent frail elderly is growing rapidly, but it still represents a modest share of the total population.The third policy direction is therefore to accept the reality of aging populations and design policies that support this demographic change, including LTC. This brings us to our four “What, Why and Who, and How” questions. What is LTC; Why is it important to find an operational definition of the range of activities that fall under LTC; Who is involved; and How can we draw lessons from the experience of Japan (and from other OECD nations that have implemented LTC insurances)?15 refers to the definition of the Institute of Medicine: “…. a variety of ongoing health and social services provided for individuals who need assistance on a continuing basis because of physical or mental disability. Services can be provided in an institution, the home, or community, and include informal services provided by professionals or agencies.” That the Institute of Medicine definition is not very operational, however. As Ikegami argues, we need to define better what is it we are discussing. There is no clear borderline between services ‘for the elderly’ and others. For example, we all start our lives 100% dependent as pretty helpless babies and that dependency can last for many years. Second, adults with mental or physical handicaps may need life-long external support in their daily living.  many of the daily activities that would fall under the above definition of ‘LTC’). Even while focusing on the needs of disabled and elderly population groups we still need to make the term LTC more operational.When becoming frail, elderly need more support by family and others, including long-term  care. IkegamiThere are two important dimensions to LTC: time and scope. The time dimension means that in practice there is often a gradual expansion of the scope of LTC. For example, elderly who still live by themselves do need some help, first with filling in taxes or walking their dog, for example, then with gardening. The next stage may be some shopping and housekeeping. These are all activities often done by close relatives or neighbors, mostly spouses and children. Then, there may be increased need for daily personal care, like preparing food and dressing. That stage becomes more intimate with assistance in eating, showering, helping to go to the toilet and preparing to go to bed. It also overlaps with nursing care to preventing bed sores, wound care, taking medicines, and keeping contact with other medical care when needed, eg, in refilling prescriptions, referral and after hospital care. We thus take a wider perspective of LTC than Ikegami who mostly focuses on professional medical and nursing care.The gradual increase of frailty or sometimes sudden onset of dependency, for example after hospitalization, often leads to a situation where spouses or children and other family members find themselves in care roles they had not really expected or planned for. Acknowledging the two dimensions of LTC requires planning ahead and thinking about future shifts in activities and responsibilities.Family members responsible for the LTC of the parents, grandparents or other aging relatives face important decisions during all those stages, often implicitly. Are spouses and children willing and able to face the growing burden of LTC? At what stage do they formally or de facto take over the decision-making power of their frail parents? How can they respect the preferences of the elderly themselves? Who is responsible for the finances? Is there enough money to hire external help for housekeeping and other daily activity (or long-term stay in a nursing facility)? What range of services is covered by public or private insurance? What are the financial conditions? Who is responsible for the copays and services not covered by insurance? Are there time limits of the coverage? Who is responsible for the coordination between the formal and informal services?Answering these questions requires a political debate about the shifting responsibilities between the private and the public domains. All industrialized nations have expanded public financing of LTC for elderly and other populations. At the same time, the largest part of LTC is still provided by spouses, children, neighbors and other informal caregivers . In some cases, as in Japan, Germany and the Netherlands, informal care givers can receive financial compensation financed out of the cash benefit schemes. In parallel, there has been expansion of LTC services by (both for profit and non-profit) agencies. While there has been some growing acknowledgement of the principle of public (state) responsibility over LTC financing across nations, there is wide variety in the actual provision and organization of those services. In all cases, LTC involves many different stakeholders.7). We argue that redefining ‘aging’ for the purpose of LTC takes much of the sting out of the ‘tsunami of aging’ debate (for this argument see Gusmano and Okma7). A new, more realistic definition of aging as the population share of over, say, 80 will show that we face demographic change, but the consequences are not as dramatic as many policy-makers or politicians have assumed or feared. Moreover, demographic change is slow, so we have decades to adjust. So what adjustments?As noted above, most people over 65 live independently and consider themselves in good health . At the same time, there is no reason to generally exclude elderly citizens from fiscal arrangements. The current generation of elderly is, on average, not poor. Many have accumulated investments, pension savings and other wealth and there is no reason to exclude those from taxing merely because of age.The first are fiscal ones. As mentioned above, the major extension of average life expectancy in the last century means that we have to adjust our pension systems. We have to make sure that the public pension systems include as many people as possible, as long as possible, joining early in life and contributing all trough working lives. Moreover, there is no reason to encourage early retirement or full retirement benefits without a minimum of, say, 35 to 40 years of contribution. The systems should also become more flexible in including part time workers and providing credits for taking time off to take care for very small children and frail parents or relatives. Importantly, the pension benefits should be high enough to cover a decent minimum cost of living .After defining LTC as the range of activities above for which frail elderly (and others) need assistance from relatives and or others, we thus have to (re-)establish borderlines between public and private (family) responsibilities for incomes, housing and other daily needs. The good news is that in general, the need for LTC only kicks in at a later age—and only for a smaller share of the population over 80. We can plan for that, fiscally, organizationally, and in regard to manpower.18 Germany followed the Dutch model and introduced its own LTC insurance in 1995. This social insurance mostly benefitted the existing welfare agencies that already were providing both home care and inpatient services. It also included a cash benefit scheme for families providing care for their frail elderly. The introduction of the LTC arrangements, in all three nations, expanded the public responsibilities for the financing and provision of LTC. While the organizational form and administrative responsibilities have shifted over time, in all three nations these arrangements became firmly embedded as integral part of the modern welfare states, fueling public expectation that the state would take responsibility for LTC for the elderly.Japan’s experience is not unique. Holland was the first country that introduced its population-wide LTC insurance . The AWBZ aimed to alleviate families and private charities from the financial burden of taking care of frail elderly and handicapped relatives. That fueled a rapid expansion of the capacity of retirement homes, nursing homes and other care institutions. It also allowed the existing (private but non for profit) home care organizations to expand their services. Three decades later, in an effort to rein in public LTC spending (in particular the popular cash benefit scheme) and to reduce the volume of institutional care, Dutch government basically dismantled this LTC insurance and largely shifted responsibilities to the municipal level.Not applicable.Authors declare that they have no competing interests.Both authors worked on conceptualization, writing, and editing of the manuscript.1Independent Researcher. 2School of Public Health, Rutgers University, New Brunswick, NJ, USA. 3The Hastings Center, Garrison, NY, USA.