In the future, sensors mounted on uncrewed aerial systems (UASs) will play a critical role in increasing both the speed and safety of structural inspections. Environmental and safety concerns make structural inspections and maintenance challenging when conducted using traditional methods, especially for large structures. The methods developed and tested in the laboratory need to be tested in the field on real-size structures to identify their potential for full implementation. This paper presents results from a full-scale field implementation of a novel sensor equipped with UAS to measure non-contact transverse displacement from a pedestrian bridge. To this end, the authors modified and upgraded a low-cost system that previously showed promise in laboratory and small-scale outdoor settings so that it could be tested on an in-service bridge. The upgraded UAS system uses a commodity drone platform, low-cost sensors including a laser range-finder, and a computer vision-based algorithm with the aim of measuring bridge displacements under load indicative of structural problems. The aim of this research is to alleviate the costs and challenges associated with sensor attachment in bridge inspections and deliver the first prototype of a UAS-based non-contact out-of-plane displacement measurement. This work helps to define the capabilities and limitations of the proposed low-cost system in obtaining non-contact transverse displacement in outdoor experiments. US infrastructure is old and in poor condition, according to the 2021 infrastructure report card published by the American Society of Civil Engineers (ASCE) . RailroaIn the last few decades, private and public entities and owners have introduced the use of sensors in their infrastructure management protocols to overcome the limitations linked to visual inspection. One effective sensor-based method for detecting structural abnormalities is the measurement of dynamic displacement and its change under load ,5. HowevNon-contact sensing coupled with UASs provide an alternative and have gained popularity in the structural health monitoring of unconventional structures, such as bridges, because they can reach inaccessible structures and collect data safely and quickly and improvements in technology do not require replacing a large number of fixed sensors.Cameras have become one of the most popular non-contact sensors for bridge inspections, with several researchers using stationary cameras fixed on the ground for bridge inspections ,10,11,12On the other hand, the emergence of UASs, along with the attendant accessibility and safety advantages has created new opportunities for enhancing existing monitoring capabilities by incorporating cameras with other sensors into the UAS ,15,16,17One of the limited studies focusing on dynamic displacement measurement using a UAS-camera is led by Yoon et al. . They usnew aerial system with intelligent measurement integration II (NASAMI II). This paper presents new dynamic-displacement results from real-world experiments in an uncontrolled environment using a bridge in service. These field experiments lead in the learning of barriers for implementation, and new design using the field experience in a real bridge. In previous work, we developed a methodology that combines camera and laser data collected by UAS to measure the transverse component of the displacement for a moving structure ,33,34. TThe architecture of the paper is organized as follows: This paper presents the results of a true scale test with UAS system that is developed to measure dynamic transverse displacement called NASIMI II . The teaThe displacement measuring laser was powered using the 18-V power supply under the UAS, and the data loggers on the UAS were powered with light 9-V batteries. The payload on the UAS, including the weight of the lasers, data loggers, carbon bars, counterweight, and batteries was about 3800 g. The UAS was able to operate for 20 min with the designed payload, while its flight duration without a payload is 30 min. This yields a 19 km flight range for the platform which far exceeds federal aviation administration (FAA) regulations for line-of-sight flights and FCC regulations for maximum transmitter range (5 km). The UAS system in this research is designed to collect dynamic responses of the bridges which are usually short-term missions and can be carried out in minutes. To find transverse displacement, laser measurements were corrected using camera readings using the method proposed by Nasimi and Moreu . A checks is the varying scale factor; u, v are image points or the pixel coordinates of the checkerboard coordinates in an undistorted frame in pixels; U, V, and Z are the world or physical coordinates of the camera; and P is camera matrix (Equation (2)), which is calculated using intrinsic and extrinsic of the camera. U, V, Z provide the UAV trajectory which is discussed in detail in [K is intrinsic to the camera and R) and translational vectors (t) for each frame. Subsequently, UAV trajectory (translation and rotation) is used to compensate for the movement that the laser undergoes due to UAS movement. To subtract the UAV motion from the laser data, these two sets of data needed to be synchronized and resampled.As illustrated in etail in .(2)P=KRField implementation of the proposed system required validation. Due to the height of the test bridge, the validation instrument had to be capable of precise measurements from a distance. We selected a high-resolution Laser Doppler Vibrometer (LDV) from Polytec (RSV-150)  shown inBefore the flight near the bridge, the LDV values were compared with LVDT measurements in the ground. For field tests, a steel-truss, pedestrian bridge with a concrete deck was selected. The bridge is located at Arroya Del Oso Park, Albuquerque, New Mexico, USA. Permission from the City of Albuquerque to work with a bridge in active use was obtained prior to field testing. The bridge is 6 m tall and 45 m long. After laboratory evaluation of LDV and finalizing the location of the bridge experiment site, the research team designed a field test to characterize bridge movement using the ground laser. Information collected from the bridge underloading provided a benchmark against which the performance of NASAMI II could be compared. The bridge was subjected to a variety of human loading during this benchmarking, such as harmonic jumps and running by a human subject and bridge displacement was measured using the ground laser. The bridge displacement was collected when it was subjected to different loadings such as: running and jumping. The lateral displacement of the bridge was under 1 mm in all cases had the highest amplitude was observed under running, Measured displacement values reached a peak value of 1 mm when subjected to a running load. As the displacement was below the limit of detection by NASIMI II, the additional movement was manually induced in the target. This target could also help to have a wider area for data collection instead of thin bridge piles. The team conducted a total of five field experiments. In these experiments, the movement of a manually perturbed target was measured and analyzed. The experiments were conducted on a bridge in service, with the target movement designed to emulate railroad bridge displacements in different amplitudes. The objective of the manual displacement simulations were twofold: (1) the selected target was wider than the steel truss’ vertical cord on the bridge, which allowed easier targeting by the drone; (2) initial bridge tests with LDV showed that the pedestrian bridge displacement was less than a millimeter, which is beyond the capability of the selected low-cost system. Moving the target manually could enable imposing a higher displacement response similar to what is expected in railroad bridges under dynamic loading.The duration of data collection for each test lasted about 100 s, and the total duration for an experiment including the takeoff and landing lasted about 6–7 min. The batteries needed replacement after experiment three. To better have a comparative study between the time of data collection using the UAS and the time of sensor deployment in the bridge, it is worth noticing that the approximate time for a team of two people in charge of sensor deployment and retrieval at the bridge exceeds the time of flight using the UAS. Furthermore, access to the superstructure at times is not available and climbing gear may be needed. However, there are situations when flying the UAS may not be possible  and this needs to be considered case by case. Processing the data was prioritized based on the amount of collected information during each experiment, including the camera, ground laser and UAS laser. As listed in Among 5 experiments, two of them were selected for further analysis and checking the proposed system’s performance. Additionally, it is worth mentioning that the video captured from the camera contained a lot of frames that did not have the target inside, therefore those frames were ignored in data processing to save in computation. Due to the height of the bridges, we used a large checkerboard for camera motion estimation, however during the frame processing the checkerboard’s size was misdetected in numerous frames. To mitigate this the image contrast was adjusted to have more salient points for detection. We selected a checkerboard target because the down-facing camera in the proposed method captures the ground which is mostly sandy or asphalt and lacks any salient pattern for tracking purposes. This section presents the results of Experiment 2 and Experiment 5, respectively. First, the raw data from the sensors are plotted, including the measurements from the camera, ground reference laser, and UAS-mounted laser. Subsequently, dynamic displacement incidents are detected and some of them were selected for further processing. Finally, the transverse displacement results for each simulated rail car are estimated by the proposed non-contact approach and compared with measurements from the reference ground instrument.The red crosses or the abnormal jumps in the UAS laser measurements occurred when the laser on the UAS missed the target.This paper selected the train car displacement events of interest to illustrate the analysis capability of the proposed method in the context of real bridge environments. After obtaining the camera data, signal processing for combining the measurements is conducted as Following the steps shown in Estimates from the low-cost NASIMI II system compared to ground truth values from the reference laser. The peak-to-peak errors were large for some cars compared to the measurements obtained in an outdoor laboratory , this waHere, we present the result of experiment 5. Similar to the results from experiment 2, raw data from camera and laser measurements are combined to find transverse dynamic displacement, which is not presented for experiment 5. For experiment 5, estimates from the low-cost system matched ground truth values from the reference laser as well. This work extended the aerial NASIMI bridge dynamic translation measurement system to incorporate lessons from small-scale outdoor and laboratory experiments and advice from railroad engineering experts. We then evaluated the performance of the new system, NASIMI II, in the field at an actively used pedestrian bridge in comparison to a comparatively costly and cumbersome LDV reference ground-based system. Modifications to NASIMI included replacing the existing laser with higher-range one. Several field trials were conducted of which two were selected for analysis. The UAS measurements corresponded to the reference instrument . The peaThis paper presents the results of a bridge test using a UAS that is designed cost-efficiently to find transverse displacement. The low-cost UAS is designed for non-contact inspection of infrastructure. The proposed system integrates the data from a laser and camera mounted on a UAS to find dynamic transverse displacement which is of interest to railroad inspectors but difficult to measure in the field. The proposed UAS, for the first time, demonstrates how a drone-mounted camera laser system can be used to find transverse displacement in a real-scale testbed. The approach corrects the laser’s translation and rotation during measurements and estimates total dynamic transverse displacements, which cannot be collected with the camera or laser alone. A preliminary UAS was constructed and evaluated in a controlled environment. Using lessons from previous experiments and feedback from railroad engineers, the updated version was tested using a bridge in service. The system was redesigned and developed to adopt a higher-range laser more suited for real field conditions and uncertainties. Displacement of a manually moved target that simulated the displacement of railcars is measured and estimates using the proposed UAS system were compared with a relatively costly commercial LDV. The measurements for the two tests were compared and the mismatch between NASIMI II and the LDV varied between 7 and 17 mm. RMS errors were smaller for larger peaks. Due to flight elevation above the ground and the large distance between the camera and checkerboard, there was an increase in undetected frames during experiments. Data analysis showed that the proposed low-cost system can find displacements but when tests are conducted in a true scale and uncontrolled environment there is still room to make progress for a fully implementable system, especially in terms of resolution and missed data due to UAS movement during hovering. This movement was largely attributable to rotor wash and wind. Future work includes increasing camera detection and estimation performance by making use of optical zoom and leveraging measured responses to find structural and load information. Railroad managers are interested in alternative methods to measure displacements, so these results provide a first approach towards advancing and further improving the non-contact reference-free measurement for implementation.


Increasing life expectancy is associated with a growing number of people living in nursing homes, while the availability of outpatient medical care, especially from family doctors, is stagnating in this sector. Consequently, numerous and often avoidable, low-threshold hospitalizations of nursing home residents are observed. This results in unnecessary use of resources such as emergency services and emergency rooms as well as in potential health risks to the nursing home residents related to hospitalization. This study aims to improve this healthcare gap by implementing an intersectoral telemedicine approach.Twenty-five nursing homes are participating and provided with telemedical equipment to perform teleconsultations. Additionally, an early warning system and a digital patient record system are implemented. Telephysicians based at RWTH Aachen University Hospital are ready to support the nursing homes around the clock if the family doctor or an emergency service practice is not available in time. Mobile non-physician practice assistants from the telemedicine centre can be dispatched to perform delegable medical activities. General practitioners and the medical emergency practices also have access to the telemedical infrastructure and the non-physician practice assistants.Optimal@NRW adds a telemedicine component to standard care — combining elements of outpatient and inpatient health care as well as emergency service practices — to enable timely medical consultation for nursing home residents in case of the development of an acute medical condition. In addition to optimized medical care, the goal is to reduce unnecessary hospital admissions. The intersectoral approach allows for the appropriate use of resources to match the individually needed medical treatment.ClinicalTrials.govNCT04879537. Registered on May 10, 2021The online version contains supplementary material available at 10.1186/s13063-022-06613-1. The order of the items has been modified to group similar items (see ambulatory care-sensitive conditions (ACSH) . Obs. Obs8]. Nicht-ärztliche Praxisassistenz mit Zusatzaufgaben), who are allowed to perform delegable medical activities on-site at the nursing homes. They are also continuously available and based at the telemedicine centre. They are dispatched to the participating care facilities for activities that can be delegated by every physician .The study centre including the telemedicine centre is located at the Department for Acute and Emergency Medicine at the University Hospital RWTH Aachen, Germany. All teleconsultations for the participating nursing homes will be performed there by specially trained telephysicians with a focus on geriatric and general medicine, who are available 24/7/365. The treatment options are extended by the non-physician practice assistants . Some of the facilities are specialized to care for residents with advanced dementia while other nursing homes have a mixed geriatric clientele ranging from predominantly self-caring to permanently bedridden and in need of extensive care.https://www.ukaachen.de/kliniken-institute/optimal-at-nrw/traeger-partner/.A list of study locations is available at Resident of the participating nursing homesAge of majority (in Germany: 18 years)Valid health insurance statusWritten declaration of consent or written declaration of consent of the legal guardian of residents who are unable to give consentThe inclusion criteria for study participation are:Persons placed in an institution by order of the authorities or the courts and persons who are in a dependent or employment relationship with the investigatorNo valid health insuranceUncertain legal capacity of the personThe exclusion criteria are:Eligibility criteria for the participating nursing homes include the usage of the project’s own central electronic health record for documentation purposes and the use of the technical equipment provided. The technical requirements for the use of this equipment must be met (e.g. a wireless network connection). Due to the deployment of non-physician practice assistants, a maximum travel time of approx. 45 min is another criterion for the selection of the participating nursing homes.The non-physician practice assistants are qualified with a degree as a medical assistant or nurse. Special activities, such as placing a venous access or the insertion of a urinary catheter, are intensively trained before the start of the intervention phase.A good command of the German language is a prerequisite, especially when communicating with old people and those who may suffer from dementia.All non-physician practice assistants are trained in conducting teleconsultations prior to the intervention.The teledoctors’ main areas of experience are general medicine, geriatrics and emergency medicine. They are intensively trained in the use of telemedical equipment for carrying out teleconsultations.Informed consent is obtained by investigators trained in Good Clinical Practice (GCP). For this purpose, written patient information (brochures and handouts) and consent forms are distributed, which provide a comprehensive overview of the study contents. Furthermore, information sessions including oral presentations and film sequences illustrating the aim and execution of the trial are held in front of the individual or groups of residents, relatives and legal guardians.With written consent to participate in the study, permission is also granted to access secondary claims data from the statutory health insurance companies in order to increase the data quality of the primary data collected and thus the validity of these data.Optimal@NRW extends the current standard medical care by including telemedical acute care for geriatric nursing home residents. The intervention is studied under real-world conditions where the intervention is compared to the standard care in nursing homes. The stepped-wedge design ensures that each nursing home is scientifically accompanied and collects data both in the initial regular care operation — the control phase — and later in the intervention phase — i.e. with the use of telemedicine. The control phase serves to record the current state, especially for evaluating the length of stay in the hospital (primary outcome parameter) before the implementation of telemedicine vs. the length of stay after the implementation of teleconsultations and the early warning system (EWS) in the intervention phase.The 25 participating nursing homes are randomized into four clusters by an independent evaluator. A control phase lasting a minimum of 3 months is followed by a 3-month transition phase which in turn is followed by the intervention phase. Depending on the allocated cluster, the various nursing homes start the transition and the following intervention phase at different points in time, whereby the starting points are staggered 3 months apart .Arztrufzentrale NRW 116117)Standardized assessment via SmED  by a specialized dispatcher according to this study when a participating nursing home calls the medical emergency service NRW (Consecutive determination of urgency and next-level treatment: emergency service (with direct transfer of dataset by prior implementation of new interface), hospital admission, resident health service and telemedicineActivation of non-physician practice assistanceImplementation of a new telemedicine approach into the medical supply network by offering a “virtual hub,” which includes:Every participating nursing home is equipped with telemedical roller stands: bilateral communication via a high-resolution camera interface, measurement of vital signs , “digital” auscultation and 12-channel ECGTelephysician with specialized geriatric expertise available 24/7/365; furthermore, GPs and physicians of the ASHIPs can register for the study and use the telemedical equipment for teleconsultations as wellImplementation of an electronic health record with collection of patient information  that can be accessed by all study-related telephysicians and registered ASHIP physiciansDetermination of further treatment: acute admission, treatment by GP at nursing home, delegation of treatment steps to either nursing home staff  or non-medical practice assistance (e.g. administration of IV fluid)Opportunity of informed patient-to-physician communication by telemedical consultation:Regular measurement of vital signs (daily routine) and clinical aspects by nursing home staffTransfer of these data into the electronic health recordContinuous software-based assessment of parameters and transmission to the telemedicine centreIn cases of potential threatening changes, early alert and activation of newly implemented intersectoral treatment approach coordinated by the telephysicianImplementation of an early warning system in order to avoid critical health-related situations:The German healthcare system consists of outpatient care provided by the Association of Statutory Health Insurance Physicians (ASHIPs), emergency services and inpatient care . All three columns of medical care (sectors) are organized and financed differently so that in practice these three sectors work mainly separately. Until today, intersectoral care has not yet been established in Germany. Optimal@NRW strives for an intersectoral form of care by introducing three levels of intervention in parallel within each cluster:There are no conditions that necessarily lead to discontinuation or modification of the intervention on participant’s level.At any time, individual withdrawal of informed consent  or moving from the participating nursing home leads to termination of study participation. Furthermore, study termination for each participating resident is induced as a care facility discontinues project contribution.In case of occurring serious adverse events (SAEs), a Safety Board will be activated and finally decides on probable discontinuation and modification of interventions, respectively  principles, the Declaration of Helsinki, regulatory authority requirements and the standard operating procedures (SOPs) of the project.Prior to the start of the study, one or more monitoring visit(s) take place to verify and clarify the prerequisites.Meetings will be held one to two times per week to realign protocol adherence. Regular monitoring visits with spot checks of data entries are intended to uncover problems, reduce discrepancies and verify that data collection and documentation are in accordance with the ICH-GCP principles, the study protocol and the requirements of the regulatory authority.There is a regular exchange with the independent reviewer  to ensure compliance with the study design.To maintain proper study-related communication with all partners especially during the Corona pandemic, regular video conferences are held to promote dialogue, sharing of information about ongoing developments within the project and mutual exchange of experiences. Weekly coordination meetings are held with the technology providers and special issues addressed by appropriate working groups.In order to encourage the nursing home staff to utilize the telemedicine system and proper use of the early warning system, two technology workshops are conducted during the transition phase in each participating nursing home.In order to improve the cooperation with the participating care facilities, regular on-site visits of the study team and the monitors will take place. Regular standardized trainings of participating partners also take place to ensure proper use of the study’s own technology and database.The accessibility of the study team for all partners is guaranteed via a uniform telephone hotline and email address.N/a because intervention means additional aspects to standard care.After trial completion, the participating nursing home residents will receive the same established standard care as it was provided before the start of the trial. However, if the stakeholders agree and financing can be secured, the Optimal@NRW consortium will try to implement the provision of telemedical care into standard care as the hypotheses of the trial can be confirmed.The primary objective of the trial is to evaluate the length of stay in the hospital (including same-day discharge) of inpatient nursing home residents in the intervention versus control cohort. It is hypothesized that the intervention leads to a significant reduction in hospital admissions and thus less days spent in the hospital. This might not only be relevant on the individual patient level  but also from the health economic perspective with an assumed improvement of the cost-effectiveness ratio.Two secondary outcomes shall be assessed by the trial to account for the heterogeneity of treatment effects. The primary evaluation of the efficacy as well as the health economic aspects will be realized by the School of Public Health (Bielefeld University). The Human-Computer Interaction Centre (RWTH Aachen University) as well as the Institute for the History, Theory and Ethics of Medicine  is responsible for the secondary evaluation strand on the acceptance, ethics and usability of telemedicine in the nursing home setting.Overall number of hospital admissionsHospital admissions grouped by primary diagnosis and leading symptoms, respectively Length of ICU stayDays spent in the nursing homeNumber of ambulatory care-sensitive conditionsNumber of emergency calls and utilization of ambulance service: paramedic/ambulance, EMS physician (ambulance/helicopter), patient transport ambulanceSafety of medication Number of medical outpatient contacts The following parameters related to hospital admissions will be assessed during the study period in the control versus intervention cohort:Number and extent of teleconsultationFrequency of (suspected) diagnosesTime period from emergency call to physician contactInfluence of frequent teleconsultations on guideline-directed treatment adherence In relation to the novel telemedicine structure including the implementation of a central electronic health record, the following parameters will be investigated:All data will be collected within the study-specific electronic health record. The primary collected data is complemented and validated by claims data of participating statutory health insurers. Both are collected continuously throughout the entire study period.The individual health-related quality of life will be measured at three predefined time points during the entire study period  of an intersectoral telemedicine approach in an acute care setting and to derive conclusions about the cost-effectiveness of the intervention from a financing perspective.Current status of healthcare implementation and related problems in daily lifeCommunication issues with physicians and care staffIntersectoral information transfer including aspects of patient’s autonomy and data privacyIndividual perception of telemedicine approach and probable related problemsEvaluation of telemedicine approach based on ethical criteriaDue to the novel approach of telemedicine in a vulnerable group of geriatric patients, the ethical acceptability and the specific demands and needs of this special group will be assessed. The findings shall help to develop a needs-focussed, socially acceptable and sustainable transformation of acute geriatric care at the interface of the nursing home, GP, emergency service and emergency department/hospital. The evaluation is based on questionnaires and structured interviews with nursing home staff and nursing home residents as well as observations by an embedded researcher with focus on the following parameters:Due to the stepped-wedge, open-cohort design of the study, participants are continuously enrolled from the beginning of the study until the last cluster. Once enrolled, participants and nursing staff are required to fill in questionnaires regarding the health status  of the participants and their health-related quality of life  at baseline.All participating nursing homes commenced the control phase on May 1, 2021. Baseline data  of the currently enrolled participants are collected for the control phase and training of the documentation staff is started.The nursing homes of the first cluster switch to the transition phase on November 1, 2021. The other nursing homes follow according to their cluster after a defined interval of 3 months each. During the transition phase, the technical equipment is delivered and the nursing home staff is trained on the teleconsultation and the EWS. Baseline data of the enrolled patients are re-assessed to determine the health status and HRQoL of the intervention cohort.The first cluster transfers to the intervention phase on February 1, 2022. The other clusters follow according to the stepped-wedge design outlined above. During the intervention phase, the teleconsultation system is actively used whenever indicated and participants are then treated by the telephysician. Concurrently, measurement of vital signs via the EWS is performed by staff at regular intervals (independent of teleconsultation utilization). At the end of the study, HRQoL data of all participants is collected for the third time.β = 0.90, an assumed standard deviation of 4.5 and an intra-cluster correlation (ICC) of p=0.12, 43 participants per nursing home and interval are required to be enrolled. By applying a drop-out rate of 12% per quarter as a consequence of expected high mortality within a sample of nursing home residents [In accordance with the primary outcome, sample size calculation is based on the average length of stay in a geriatric cohort in need of care (13.22 days per quarter in residents >70 years)  for the The recruitment of participants takes place on-site at the participating nursing homes. The project was presented to the nursing home managers and their staff as well as the nursing home residents by members of the study team. For the latter group, appropriate language and supporting use of visual media was utilized to achieve a high rate of interest and acceptance. In nursing homes specialized in care of residents with dementia and therefore, a high number of potential participants who are incapable of giving consent, the project was presented to the residents’ legal guardians.Ongoing recruitment is necessary due to an expected high drop-out rate within a geriatric sample of nursing home residents  and in l◦ Small entities (< 80 beds per nursing home)◦ Great entities (> 80 beds per nursing home)Bed capacityPresence of specialization in dementia of the nursing homeDue to the study design, the crossover of clusters from control to intervention phase is randomly timed  and variA random number generator was applied that allows to reproduce the randomization results. Block randomization was done through stratification, where units that are grouped in blocks (stratification arguments) are assigned to the clusters using a complete random assignment within the blocks.To reduce bias of allocation, a concealment mechanism is performed by the independent evaluators of the project that are not involved in recruitment, data collection and intervention. The final list of cluster allocation is provided via mail to the principal investigator in line with the data protection requirements. There is no allocation to interventions, as each resident receives the same interventions and begin of intervention is determined by cluster allocation. An exception is the biosensors of the EWS, which can only be used in some of the nursing homes due to practical considerations.Eligible nursing homes are selected by the principal investigators. The health economists from Bielefeld University  design the allocation plan. Due to technical and organizational necessities, nursing home managers are informed about the allocated cluster in a specific meeting before the trial starts by the principal investigator. Enrolment of individual participants within nursing homes is managed by the study nurses creating a digital representation of the respective participant in the central electronic patient record, as soon as the signed consent form is available.Blinding is not applicable as the intervention is implemented in all participating nursing homes with visible differences in healthcare delivery (teleconsultation system).N/a because of the non-blinded study designAfter the creation of an electronic health record for each participating resident  by the study team, the medical history data is uploaded there by trained documentation staff or the nursing home staff. Training is provided at the beginning of data collection as well as throughout the course of the study when necessary to ensure maximal data quality. Primary data includes, amongst others, important parts of patient history such as previous diagnoses, allergies and current medication. This is consecutively linked to claims data provided by the participating statutory health insurance companies after study completion. The data collected during a teleconsultation  are also fed into the electronic health record via the teleconsultation device. These entries can be made by any of the authorized physicians .Teleconsultations are intended to be standardized, supported by symptom- or working diagnosis-based standard operating procedures. This ensures high-quality medical care as well as data collection for scientific purposes .In addition to medical care data, quality of life questionnaires will be collected as patient-reported outcomes (PRO) to allow for comparability and characterization of nursing home residents. Two specific questionnaires are used: VR-12  for patient-reported health-related quality of life (HRQoL) in the German validated translation  and QoL-The instruments are applied at baseline, at the beginning of the control phase or at any time of enrolment, at the beginning of the transition phase and at the end of the intervention phase  in a standardized and validated manner . The queThe Dementia Screening Score (DSS) is used to identify participants with dementia in inpatient geriatric care by means of third-party assessment (i.e. nursing staff) .Retrospectively, routine health insurance data are used to determine the weighted Charlson comorbidity index . By usinData quality is ensured through proper training and close external monitoring. In addition, GCP-compliant documentation that is meaningful in terms of content is monitored. If necessary, training sessions are repeated.After the completion of the intervention phase, the collected medical data are transferred to a study database (electronic case report form (eCRF)) for scientific analyses  will be recorded.zEPA) during the complete course of the study. Additionally, the paper-based questionnaires measuring HRQoL will be entered into the zEPA as well. This will be performed by specially trained documentation assistants of the participating nursing homes. For study purposes, the data sets are further transferred into an eCRF.All relevant medical and personal data are collected within a central electronic patient record  provide a predefined data set  for each enrolled participant within a predefined time frame (four quarters after study intervention and four quarters prior to study for risk adjustment).German SHIs are legally obliged to collect and store claims data. Participating SHIs . The documentation assistants of the nursing homes, who collect and enter the study-related medical and personal data, are specifically trained by independent monitors of the CTC-A to acquire valid, objective and reliable data sets. The training is conducted prior to the beginning of the trial and additional trainings will take place as needed. Furthermore, data entries will be completed and checked by two qualified study nurses of the CTC-A.The data collection is planned and conducted according to the standard operating procedures (SOPs) of the University of Bielefeld) before a detailed analysis is conducted. In case of major implausibility within the data, feedback to review data quality will be given via the trusted third party (TTP).The primary data as well as the claims data will undergo a plausibility assessment by the independent evaluation institution , independent evaluation institution (University of Bielefeld) and participating SHIs.To investigate the primary and secondary objectives of the trial, separate data sets are needed: firstly, study-related personal and medical data and secondly claims data from SHIs. Proper data management and transfer according to current regulations must be ensured between the following relevant institutions: study sites (participating nursing homes), trial centre  in accordance with local requirements and premises. After completion of the trial, proper storage and administration of all trial documents will be ensured for at least 10 years in accordance with the statutory provisions. Deletion will take place no later than 31.12.2034. After this date, personal data will be deleted, unless legal, statutory or contractual retention periods conflict with this.The patient list maintained by the TTP is available only until the end of the trial (30.04.2024). From this date onward, no re-identification based on personal data will be possible anymore.zEPA under a patient ID (IDAT with PID), are split into medical and identifying data. Identifying data are transferred in batches to the TTP, implementing the first step of pseudonymization  and maintaining a patient list for probable re-identification. The necessary pseudonyms are routed via the TTP, while study-related medical data (MDAT) are sent directly to a trial database for research-specific storage. Every batch of data can be linked via a batch ID and the respective index. At the end of the trial, all data are transferred in the same way to the independent evaluation institution, which, thus, has access to data under a second pseudonym (PSN2). Any other extraction of data from the trial database for research purposes has to be anonymized and approved by a Data Use and Access Committee (DUAC).The individual data, which are collected within the Bundesamt für Soziale Sicherung).Claims data are collected and stored according to the regulations of the participating SHIs that will be queried for the enrolled participants by the TTP . Utilization of those claims data while guaranteeing data protection according to §75 SGB X is verified by an application submitted to the Federal Office for Social Security (SDAT) requested by the TTP with a temporary ID (TempID) and the respective health insurance number. Data are provided in a pseudonymized manner (TempID) to the independent evaluation institution. Furthermore, the evaluation institution receives the two-staged pseudonymized data set (lookup table TempID to PSN2) from the TTP and the study-related medical data (MDAT labelled with PSN2) from the trial database. Now, a linkage between claims data and study-related data can be realized and further analyses for investigating primary and secondary objectives will be conducted . This approach implies that no participating institution has an insight into the personal and medical data (study-related and claims data) at the same time. Thus, a high standard of data protection related to personal data as stated in the GDPR will be achieved.The concept of scientific data management of the project was developed by the N/a because no biological specimens are collected.t-tests (otherwise Wilcoxon rank-sum tests) or chi-square tests for categorical variables. For the latter, if there are less than five observations in minimum of one cell of contingency tables, Fisher exact tests will be applied.First, sample characteristics are summarized using descriptive statistics like absolute and relative frequency distributions as well as dispersion . To identify group differences between study phases, control and intervention groups are compared regarding their primary and secondary outcomes by suitable statistical tests, e.g. for normally distributed continuous variables U-test for independent samples without normal distribution or Fisher exact test for binary outcomes). Data of the integrated transition phase is not considered in the evaluation. To assess the influence of regressors on the primary endpoint, a suitable regression model is applied. Hereby, a generalized linear regression model is anticipated to be estimated, where the length of stay (dependent variable) is considered as (zero inflated) Poisson- or negative-binomial distributed variable in the model. Due to time as a possible confounder in stepped-wedge studies, secular trends will be addressed in the applied regression model as an independent variable [Primary and secondary outcomes are further evaluated by inferential statistical analysis using appropriate statistical methods , intervention aspects  and data bases . These additional analyses will be evaluated using the same statistical methods as described above. Furthermore, besides evaluation over the entire cohort, analyses between clusters are carried out to evaluate the structure of data and its effects on the primary outcome.n = 500 random samples, and the parameters of the cost-effectiveness model will be calculated again for each sample. Results of it will be presented in a cost-effectiveness plane. The cost-effectiveness model is performed from a third-party payer perspective following the recommendations of the German Institute for Quality and Efficiency in Health Care (IQWiG) [Additionally, an economic evaluation of the intervention will be conducted to determine the incremental cost-effectiveness ratio (ICER). It is defined by dividing the difference of costs (nominator) and intervention effect (denominator) between the control and intervention phases. If at least one effect  is determined as significant or a trend of cost-effectiveness (less costs or more effectiveness) can be recognized, the cost-effectiveness model will be tested regarding its robustness. A probabilistic sensitivity analysis will be carried out using a bootstrapping technique with  (IQWiG) . The eco (IQWiG) , the rec (IQWiG)  and the  (IQWiG) .Adherence of the nursing homes to apply the intervention is checked through descriptive statistics based on the electronic health records data, where the number of teleconsultations is operationalized as a surrogate for adherence. The applied regression models will control for specific nursing home characteristics as interdependent variables of the equation including adherence to the intervention,As an intention-to-treat analysis of data is anticipated for evaluation, all included participants are considered in the analyses. The plausibility of data will be checked in advance. Missing and censored data are tested regarding their structure, e.g. their occurrence (random or non-random) and their absolute/relative frequencies. If these data occur randomly and the number of missing/censored data is relatively large limiting the study results significantly, imputation mechanisms are considered to apply. Possible methods encompass regression imputation or mean imputation. Results of models using imputed data are presented in comparison with the same models without imputed data to increase the validity of the method chosen and the transparency of the results. A sensitivity analysis following a complete case principle will also be performed.N/a because no interim analyses are intended.The full protocol is available as a Supplementary The study team of the coordinating centre  meets four times a week to coordinate on current and forthcoming tasks and issues concerning trial execution. Once a week, the study team meets with representatives of the technical provider to consider ongoing developments and potential changes of the technical equipment. Additionally, the whole study team meets once per month to review the current trial status according to a preliminary consented Gantt chart.The administrative project team coordinates the interaction of all stakeholders by scheduling monthly jours fixes and manages all regulatory issues.The medical members of the project team take care of ongoing recruitment, teleconsultations, interaction with the nursing homes, interaction with the monitoring team and training of the non-physician practice assistants.Two external monitors of the CTC-A are responsible for overseeing appropriate data collection in the participating nursing homes as well as GCP conform data management within the study. For this purpose, bi-weekly meetings are scheduled with the project team.The overall project is evaluated by an independent evaluator  and consulted at least once a month on the current status of the trial.A Data Monitoring Committee (DMC) is not necessary according to current recommendations  .A Data Use and Access Committee It consists of three independent members who are not involved in the implementation of the project. The Safety Board is alerted in case of (serious) adverse events (SAEs) and decides on trial discontinuation for individual participants if patient safety is compromised. The Safety Board can also encourage a change in interventions. The following points count as SAEs:Berufsordnung für Ärzte).Adverse events or serious adverse events are documented, evaluated and reported in accordance with GCP and the Professional Code of Conduct for Physicians .This trial will be reviewed by qualified monitors of the The monitors perform regular visits to the nursing homes prior to and during the trial period in order to detect and eliminate shortcomings. Furthermore, the main site is systematically checked focussing on verification of informed consent forms (ICFs) and essential documents. All staff members support the monitors and provide all necessary information including access to the original data.Adherence to the study protocol, the ICH-GCP principles, the Declaration of Helsinki and any according regulatory authority requirementsIntegrity of source data and eCRF entriesAccuracy of ICFsCorrect documentation and reporting of SAEsReview of relevant trial-related logs Accuracy and completeness of the Trial Master File (TMF)The processes listed below will be reviewed during those monitoring visits:Any changes to the protocol, the informed consent form and/or information provided to study participants will be coordinated with the independent evaluator. Subsequently, the changes are submitted to the responsible ethics committee for review and approval prior to implementation .Any amendment to the protocol will be signed by the principal investigator (PI).Deutsches Zentrum für Luft- und Raumfahrt (DLR)) prior to implementation.In addition to the approval of the responsible ethics committee, amendments also require the approval of the sponsor .The responsible ethics committee will also be informed of the trial results.Furthermore, the results will be discussed with clinical experts and leading authorities of the SHIs and the ASHIPs in order to implement the telemedicine approach into standard care.Optimal@NRW creates a new intersectoral approach of telemedical care. Cooperation between general practitioners, out-of-hour healthcare services, hospitals and emergency services has not been implemented that way in Germany yet.During the planning phase, many interesting aspects have already become apparent, some of which are highly relevant for a later incorporation into standard medical care. Currently, there are some limitations concerning effective communication with the rescue coordination centres. For example, the digital interface between the doctors’ call centre and the emergency service coordination centres established in the project is still in many ways restricted (due to e.g. data protection requirements) and should be significantly expanded in the future. Additionally, there is still no interface between the telemedicine centre at RWTH Aachen University Hospital and the emergency service coordination centres. This will be of significant relevance for consultations during which the telephysician identifies the need to alert the emergency services and responsible emergency service coordination centre.Timely access to medication for the treatment of an acute medical condition represents a grave care gap for which the current healthcare system has no applicable solution. At present, the German Pharmaceuticals Act prohibits nursing homes to stockpile medications which have not been previously prescribed for a patient. If a nursing home resident requires medication outside regular practice and pharmacy opening hours, there are currently no regulations governing either the prescription of the medication by a telephysician or the delivery of the medication to the nursing home. In the future, a telemedical infrastructure will simplify the process of prescribing medication for nursing home residents. However, the delivery of the medication must also be ensured outside regular pharmacy opening hours. Optimal@NRW will initially achieve this by dispatching the non-physician practice assistance to nursing homes in need of assistance. During the course of the trial, the frequency, type and impact of telemedically prescribed medication will become apparent, thereby documenting the potential for this new kind of medical care.The novel kind of intersectoral care being provided by this project establishes innovative forms of doctor-patient communication and ways to prescribe and deliver medication in an acute medical setting. It should also help to provide a starting point from which to clarify and streamline the regulations governing these processes. Above all else, it establishes an intersectoral care authority which can provide qualified help and personnel on-site in a timely manner. This can at least partially compensate for the current deficit in remote care.A training curriculum for so-called non-physician practice assistants already exists at the German Medical Association. Modification of the curriculum to include skills specific to the delivery of telemedical care, as they are required for Optimal@NRW, has not yet been considered. Optimal@NRW will investigate and define the skills required by non-physician practice assistants in order to develop a proposal for modifying the training curriculum.When contemplating the considerable potential benefits telemedical care can bring, one must also consider the large challenges still ahead: The capability and extent of implementation of digital care software used for, amongst other things, documentation in nursing homes is heterogenous. As of now, there is still no uniform interface which could facilitate seamless communication between telemedical and nursing home software systems. On top of this, deficient network quality within nursing homes but also around them in rural areas will make the provision of telemedical care, which requires broadband speeds, a challenge. But if these obstacles can be removed, the intersectoral and telemedical approach to health care holds great promise for patients and society alike.Start of recruitment: 05/03/2021Nursing homes of the first cluster in the intervention phase, the second cluster in the transition phase, third and fourth clusters in the control phaseRecruitment is ongoing up until 04/2023 due to the open-cohort stepped-wedge cluster designProtocol version 02, 09/03/2021Additional file 1.


The high prevalence of childhood obesity is a concern for public health policy and practitioners, leading to a focus on early prevention. UK health visitors (HVs) are well-positioned to prevent excessive weight gain trends in pre-school children but experience barriers to implementing guideline recommended practices. This research engaged with HVs to design an intervention to strengthen their role in prevention of early childhood obesity.We describe the processes we used to develop a behaviour change intervention and measures to test its feasibility. We conducted a systematic review to identify factors associated with implementation of practices recommended for prevention of early childhood obesity. We carried out interactive workshops with HVs who deliver health visiting services in County Durham, England. Workshop format was informed by the behaviour change wheel framework for developing theory-based interventions and incorporated systematic review evidence. As intended recipients of the intervention, HVs provided their views of what is important and acceptable in the local context. The findings of the workshops were combined in an iterative process to inform the four steps of the Implementation Intervention development framework that was adapted as a practical guide for the development process.Theoretical analysis of the workshop findings revealed HVs’ capabilities, opportunities and motivations related to prevention of excess weight in 0-2 year olds. Intervention strategies deemed most likely to support implementation  were combined to design an interactive training intervention. Measures to test acceptability, feasibility, and fidelity of delivery of the proposed intervention were identified.An interactive training intervention has been designed, informed by theory, evidence, and expert knowledge of HVs, in an area of health promotion that is currently evolving. This research addresses an important evidence-practice gap in prevention of childhood obesity. The use of a systematic approach to the development process, identification of intervention contents and their hypothesised mechanisms of action provides an opportunity for this research to contribute to the body of literature on designing of implementation interventions using a collaborative approach. Future research should be directed to evaluate the acceptability and feasibility of the intervention.The online version contains supplementary material available at 10.1186/s12889-022-14092-x. Childhood obesity is an urgent global public health concern. Improved understanding of maternal and infant risk factors has put emphasis on the role of primary care practitioners (PCPs) in prevention of excess weight gain during the first 2 years of life . In EnglTrained practitioner-led family-based childhood obesity prevention programmes hold promise . A progrInterventions designed to change practice behaviours and improve the uptake of guidelines are invariably complex as they usually require an integrated set of actions and processes to address specific barriers. The Medical Research Council (MRC) recommends using best available evidence and appropriate theory (to understand the likely pathway(s) of behaviour change and how change is to be achieved) for intervention development . The BehInterventions developed through a collaborative approach between researchers and stakeholders are regarded as more likely to be feasible to deliver, to maximise uptake of the intervention, and to facilitate the process of translating research evidence into practice . One colThis paper describes the systematic development of an intervention in which stakeholder engagement was combined with the steps of the BCW framework and an evidence-based approach. The aim of this research was to develop an intervention to strengthen HVs’ role in prevention of excess weight gain in 0-2 year olds.The study which formed part of a doctoral research project, was suggested and co-funded by Durham County Council (DCC) public health department to support professional practice development of HVs who deliver the HCP 0-5 across areas within County Durham. During the time this research was undertaken (2019), the HCP 0-5 was delivered in the County by the Growing Healthy Team, Harrogate, and District NHS Foundation Trust (HDFT). County Durham is a large predominantly rural area home to around 530,000 people (2019 estimates) in Northeast England; children aged 0-4 years constitute around 6% of the population . County HVs and their supervisors (as the stakeholder group) were involved as research participants in this study. Five HV teams were identified who worked across different rural and urban areas within County Durham. In February 2019, there were a total of 128 HVs  in post across the County, with the number of HVs per team ranging between 21 and 32.Ethical approval was granted by Health and Care Research Wales (19/HRA/0920) in February 2019. HDFT which employed the HVs who participated in this study granted permission to conduct the study.The intervention development process involved a series of steps, as shown in Fig. Prior to seeking approvals for this project, the lead researcher (DR) consulted with health visiting service managers and all five HV teams and presented an overview of the research project, including the anticipated role of HVs as end-users of the intervention. Purposive sampling of teams with respect to which team participated in which workshop was used to ensure representativeness of the views and experiences of the HVs who worked in different areas within the county.Eleven workshops  were conducted. The workshops lasted between 60 and 75 minutes. The decision about the number of workshops conducted at each of the four stages was informed by the nature of data generated from each workshop. The workshops were held at venues across the local authority area where HVs hold routine monthly staff meetings and followed on immediately after those meetings. The scheduling of dates and time slots for the workshops and the choice of workshop location ensured members of all the five HV teams had the opportunity to take part in a minimum of two workshops. The number of participants in each workshop was determined by the size of the HV team which took part in that workshop. Table HVs were engaged in the ‘informed’ mode of co-design  where inThe workshop activities generated diverse types of data. These data represented participants’ decisions about contextual relevance, priority ranking and rating for acceptability/importance of items; ideas about intervention content; and preliminary analytical work carried out by participants of self-generated data from workshop activities. Data analysis was an iterative and ongoing process. Qualitative data were analysed using the Framework Analysis method . DescripBecause of the iterative nature of this work, the development of the intervention is reported step by step, including the objectives, methods, and findings relevant for that step.The work completed in this step laid the groundwork for the designing of the intervention.The behaviours were identified from the HCP 0-5 framework for action , guideliA number of practice behaviours that are relevant to this research were identified. The behaviours that form part of a larger behaviour were grouped together into “behaviour areas” and specified according to the AACTT framework, as shown in Table We conducted a mixed-methods systematic review (SR), the methods and the findings of which have been published elsewhere . The revOur SR included 50 studies from nine countries . Nurses Participants of stage one workshops spontaneously mentioned factors at the level of the parent/family, HVs, and the service provider organisation that they perceived as barriers to and facilitators of their practices in the local context. Subsequently, participants rated the contextual relevance of the barriers and facilitators that were identified in the recently completed SR.The majority of barriers and facilitators spontaneously mentioned by participants  . These findings suggested that several interventions appear to be necessary to address key barriers at the level of the individual practitioner, service provider organisation, and the parent/family. The findings are in accordance with the evidence synthesised from the SR  which suTo select the most suitable intervention strategy, we took into consideration the priorities of DCC which commissions the HV-led HCP 0-5 service at the research site, and the needs of HVs. The findings from stage one workshops revealed several modifiable HV-level barriers; importantly, the top four priority ranked barriers were HV-level barriers. The findings of the SR and practitioner-focused interventions identified by stage two workshop participants demonstrated the importance for obesity prevention training. Improving HVs’ implementation of guidelines will also require addressing key organisational-level barriers . Policies to support those changes  will need to be implemented at the national rather than the local level . These fThe HV-level barriers, including HVs’ beliefs and assumptions about parent-level factors, were mapped to the COM-B model components to identify what changes in capability, opportunity, and motivation might be needed to increase HVs’ uptake of guideline recommended practices.The COM-B analysis of the barriers revealed that psychological capability, motivation (reflective and automatic), and opportunity  are all potentially relevant drivers for HVs to perform the recommended practices. This ‘behavioural analysis’ informed what needs to happen for the target behaviours to occur and what, in terms of capability, motivation and opportunity, needs to change, as shown in Table affordability, practicability, effectiveness/ cost-effectiveness, acceptability, side-effects/safety, and equity.The guidance from the BCW along with the APEASE criteria  informedFive intervention functions were assessed as potentially capable of addressing the changes required at individual HV-level and meet the APEASE criteria. They were Education, Training, Persuasion, Modelling and Enablement. The APEASE criteria ratings for the different intervention functions are presented in Additional file Informed by the behaviour change technique (BCT) taxonomy , empiricWe identified an initial list of twenty-five BCTs that are potentially capable of delivering the five chosen intervention functions. Of these, 18 BCTs were assessed as potentially relevant for the intervention. The rationale for selecting them is presented in Additional file The majority of participants at all stage three workshops rated the proposed 18 BCTs  as important and acceptable  of an intervention refers to the way the components of the Intervention are delivered to the recipients of the intervention . The FoDThe proposed intervention comprises an incentivised  interactive face-to-face one-day training session for HVs; a training pack and resources for HVs ; a handbook for the facilitator, and awareness raising of the intervention  amongst staff. An outline of the form of delivery that could be used for the intervention when it is ready for feasibility testing is suggested, using an adapted version of the TIDieR framework  and their role as collaborators in research that is relevant to their practice was appreciated.‘a priori’) by DCC’s public health department. The BCW guidance suggests identifying appropriate policy-related categories to support the selected intervention functions. This research focused on behaviour change at the level of the individual, and therefore, changing policy was judged as outside the scope of this study. It was assumed that this intervention would fit under the category “service provision”.This paper describes the systematic development of a training intervention for HVs that is also conceptualised as a behaviour change intervention. The aim of the intervention is to change HVs’ skills, confidence, intention, and eventually their practice behaviours. The process described here outlines how the theory-driven and evidence-based intervention was developed by involving HVs throughout and integrating their perspectives and preferences. While guided by the BCW, the design process was collaborative and iterative. Not all the steps specified in the BCW framework  needed tThe study provides an example of how BCTs can be operationalised and assembled together into a coherent intervention that can be pragmatically delivered. The COM-B analysis of the barriers and facilitators to the behaviours enabled the identification of key behavioural processes to target with an intervention. The proposed links between the COM-B and the TDF facilitated the identification of the specific theoretical domains of behaviour that represented the relevant change processes for this intervention. Targeting specific change processes is recommended, as this may increase the potential for effectiveness of the intervention . The sysThe selection of potentially useful BCTs was informed by recent methodological work by which BCTs have been mapped to relevant theoretical constructs of behaviour . HoweverA key strength of this study is that it adopted a systematic approach, using both evidence and theory, as recommended by the MRC . AnotherAn important consideration was that the behaviours of interest for this intervention are multiple behaviours. Accounting for both reflective (cognitive) and automatic  motivational processes is strongly recommended for designing of interventions for healthcare professions that aim at multiple behaviour change . The incAnother strength of this research is the use of an established behaviour change taxonomy (BCT taxonomy v1)  to selecOne criticism that can be levelled at this research is that the perspectives of parents of children aged 0-2 years (the service-user or “client” group) were not sought, as additional input, to inform the contents of the intervention. Rather, the barriers and facilitators at the parent/family level were inferred from HVs’ narratives. Evidence suggests that childhood obesity prevention efforts can benefit from an understanding of parental views about infant weight gain , the infExploratory work with workshop participants identified contextually relevant determinants of practice and related interventions. It is possible that participants may not have identified all determinants of practice and may have missed determinants that they did not prioritise. Further, the data representing HVs’ perspectives may not have completely revealed the actual cause of their behaviours) but may rather represent attributions HVs made to rationalise their behaviours .This research was undertaken in County Durham where 98% of the population identify themselves as British White/other White. In addition to the socioeconomic environment, cultural and societal factors are important influences on parental beliefs about healthy weight and infant feeding practices, and their efforts to implement practices recommended for healthy child weight . The proCo-production approaches and the BCW framework are both resource-intensive methods. Involvement of HVs through the different stages of the design process had implications on the use of their time. Using a collaborative approach also presented uncertainties, particularly when workshop participants’ preferences did not align with existing evidence. In the proposed intervention, the BCT ‘behavioural practice/rehearsal’, for which there is evidence  that it The decision-making processes throughout the different stages of the intervention development process required making subjective judgments and pragmatic decisions. It is possible that another researcher would have operationalised selected BCTs in a different way. The literature on intervention development studies often reports using multi-disciplinary consensus meetings and/or workshops to inform decision making throughout the development process , 74. TheFirstly, this study emphasises the need for training and education for HVs (and other practitioner groups) who have a role in prevention of obesity in children. Evidence from the HENRY programme has demonstrated the importance of training for HVs and early years practitioners to enhance their skills and confidence, and work more effectively with parents of pre-school children around excess weight and healthy lifestyle . The neeSecondly, this research emphasises the importance of a supportive policy and practice environment. In addition to training needs, HVs have identified various resource needs as important facilitators of practices recommended for addressing childhood obesity. The findings from the workshops support existing evidence , 78 thatThis research has produced the first draft of a new intervention. The next stage of this research is to evaluate the acceptability and feasibility of the intervention in a feasibility study. Prior to formal feasibility testing, this draft version will require further optimisation (refinement). The optimisation process will require working with stakeholders, with the aim to design a prototype version that is ready for feasibility testing. A feasibility study could offer HVs an opportunity to evaluate the content and delivery of the intervention and suggest improvements, to better suit their needs and preferences.Prevention of excess weight in children is a challenging public health issue. This paper has described a comprehensive process of developing a face-to-face interactive BCT-based training intervention for HVs to strengthen their role in prevention of excess weight gain in 0-2 year olds in primary care. The intervention was developed by systematic application of theory, collaboration with the target recipients of the intervention, and review of the evidence base. Revisions and adaptations and further refinements will likely be required, informed by input from relevant stakeholders, including the deliverers of the intervention. Subsequently, the intervention should be tested for feasibility and acceptability. The systematic and transparent approach used in the designing of this intervention will facilitate a thorough evaluation via a feasibility study.Additional file 1. Rating of perceived contextual relevance of the SR-identified barriers.Additional file 2. Rating of the perceived contextual relevance of the SR-identified facilitators.Additional file 3. Priority ranking of the barriers.Additional file 4. List of top ten priority ranked barriers.Additional file 5. APEASE criteria rating of the intervention functions that were considered for the study.Additional file 6. Rationale for the selection of the initial list of behaviour change techniques.Additional file 7 Details of the behaviour change techniques that were assessed as not practical or likely to be unacceptable by health visitors.Additional file 8. a. Findings of the rating of importance and acceptability of 13 BCTs by workshop participants. b. Findings of the rating of the importance and acceptability of 5 BCTs by workshop participants.Additional file 9. Suggested form of delivery of the intervention informed by the TIDieR framework.Additional file 10. Participants’ rating of proposed outcome measures and methods for a feasibility study of the intervention.


HA). While these procedures have specific advantages, they are also limited in terms of the invasiveness as well as the stability and strength of implants. In the present study, we describe the use of a CTP to achieve minimally invasive midface plastic surgery with the superior moldability of a 3D structure and reliable stability compared to the use of autologous tissue.In our department, we have been performing bone reconstructions on a case-by-case basis using vascularized free tissue transfers and custom-made artificial bones  had bone malformation or hemifacial microsomia following surgery for maxillary cancer or multiple facial fractures. Based on Although the amount of soft tissue was insufficient in some cases, all patients were able to maintain the desired morphology without developing any complications such as infections, significant soft tissue atrophy, or implant failure.CTP model created by CAD/CAM was effective in contouring surgery of the midface as it had the superior stability and biocompatibility of titanium. Changes to the soft tissue should also be considered in order to further improve the procedure.Our  •The technical advancements have led to the development of CAD/CAM techniques.•CTP model created by CAD/CAM was effective in contouring surgery of the midface.•All patients were able to maintain the desired morphology.•CTP fabricated with additive manufacturing has the advantages of titanium. These techniques have enabled surgeons to create an accurate plan for reconstruction surgery and predict cosmetic outcomes CTP to achieve minimally invasive midface plastic surgery with the superior moldability of a 3D structure and reliable stability compared to the use of autologous tissue. We further discuss the advantages and limitations of the procedure with literature evidence.On the other hand, technical advancements have led to the development of 2A total of 3 patients were included. These surgeries were performed in all cases by the author, who has 20 years of clinical experience. This case report is compliant with the SCARE Guidelines 2020 3D models were created on a computer using CAD/CAM techniques. The models were compared in simulations to determine the optimal structure. These 3D models were used in additive manufacturing systems to create a CTP for facial reconstruction. CRANIOFIT , which was fabricated in additive manufacturing, was used for the CTP. The CTP was fit to a model created based on the mirror image of the unaffected side of the face. The morphology of the model was further adjusted for each patient based on the characteristics of the soft tissue and the morphology of the malformed bone surface. In all cases, the CTP was fixed directly to the facial bone using titanium screws. The result of this procedure showed that patient satisfaction had been high using CTP.Based on 2.1The patient was a 66-year-old woman who had previously undergone surgery for maxillary cancer which resulted in right maxillary bone defect -a. This CTP. Preoperatively, we observed the maxillary defect as well as swelling of the soft tissue that was reconstructed using the flap. Based on the mirror image of the unaffected side, we created a CTP model of the buccal region including the orbital floor (CTP model was designed so that it can be directly fixed over the stump of the bone defect using screws (CTP. Excess soft tissues were trimmed to match the facial contour (We therefore performed contouring surgery using a al floor -c, allowg screws -d. An in contour -e.2.2CTP model specifically for the purposes of contouring the left buccal region and improving the appearance of left enophthalmos (CTP model was created to reproduce the shape of the cheek, and was fixed to the orbital margin using a screw (The patient was an 18-year-old woman who had previously undergone open reduction and internal fixation surgery for multiple zygoma-orbital fractures -a, allow a screw -d. The s a screw -e.Fig. 22.3CTP to treat hypoplasia of the left zygomatic bone, and HA block transplant surgery was performed to augment hypoplasia of the left mandible (CTP was fixed to the diaphysis of the zygomatic bone using screws. While the facial contour improved postoperatively, there remained some deficiency (The patient was a 35-year-old woman who had previously undergone otoplasty for hemifacial microsomia during childhood. When she visited our clinic, we observed malformation of the left side of her face due to hypoplasia of the left zygomatic bone and left mandible -a, b. Famandible -d *. Theficiency -e.Fig. 33CAD/CAM techniques, implants are being made with a number of different materials and used in a wide variety of cases. Since facial bones have complex 3D structures, various methods of using autologous tissues and artificial materials have been reported for the reconstruction of facial bone defects and malformations. In our department, we have also been using CAD/CAM techniques in facial reconstruction procedures.Conventionally, silicone had been used in custom implants for facial reconstruction CAD/CAM techniques can be classified into 4 categories based on the methods of creating artificial bones and templates CTP models also allow us to design and pre-define the position of small holes for fixation. Thus, we determine the position of the small holes based on the state of the bones to which the CTP model will be fixed. CTP also has fine asperities on the surface, which helps minimize misalignments with the surrounding tissues. Thus, CTP differs from conventional titanium plates that are glossy and flat on the surface. In practice, the initial step of creating the model was to design the artificial bone using CAD, followed by some adjustments to create a 3D image data. Based on the data, the model was created using a 3D printer based on additive manufacturing by HOYA Technosurgical Inc.Facial reconstruction procedures based on HA is suitable for augmentation since it promotes cell adhesion and growth CTP fabricated with additive manufacturing not only has the advantages of titanium, such as biocompatibility and mechanical strength, but also has flexibility in terms of the design and screw fixation that facilitates accurate fixation to recipients. A CTP is particularly considered effective for mandibular reconstruction due to its mechanical properties In general, reconstruction using artificial materials is considered advantageous as it does not involve a donor and is minimally invasive. The use of artificial materials also enables the construction of complex structures and may help reduce the operative time, number of personnel involved, need for intensive care, and healthcare cost per patient as a result of early discharge In our study, none of the patients developed infection or soft tissue atrophy, or implant failure. The procedure was also successful in contouring the morphology of the midface. However, the amount of soft tissue was insufficient in some cases. Thus, in addition to considering the symmetry of hard tissue, it is also important to simulate possible changes in the morphology of the soft tissue.4CTP model created by CAD/CAM was effective in contouring surgery of the midface as it had the superior stability and biocompatibility of titanium. Changes to the soft tissue should also be considered in order to further improve the procedure.Our HAhydroxyapatiteCTPcustomized titanium plate3Dthree-dimensionalDICOMdigital imaging and communications in medicineCTcomputed tomographyCADcomputer aided designCAMcomputer aided manufacturingNot applicable.Our report is not an experiment on human subjects.The titanium plates used are already commercially available in Japan.Written informed consent was obtained from the patient or their parents for publication of this case report and accompanying images. A copy of the written consent is available for review by the Editor-in-Chief of this journal on request.Tadaaki Morotomi - Writing work, discussion and final approval; conception and design of the study.Tomomi Iuchi - Literature review.Mitsugu Fujita - Literature review.Narihiko Hirano - Execution of the surgical step; acquisition of data.Koji Niwa - Analysis and interpretation of imaging exams; analysis and interpretation of data.Our report is not ‘First in Human’ study, so we don't need to register.The titanium plates used are already commercially available in Japan.Tadaaki Morotomi, M.D., Ph.D. will take the primary responsibility of the study.Not commissioned, externally peer-reviewed.Not applicable.


Three groups were identified using the AIMES measure of CN with its focus on five types of connection to nature. The high CN group comprised about one-third (35.4%) of participants while the group with the lowest profile of scores contained around a fifth (18.6%) of participants. The majority (46.0%) of participants registered CN levels between the high and low groups. These classes were then regressed on predictor variables to further understand differences between the groups. The largest, consistent predictors of class membership were biocentric and social-altruistic value orientations, stronger intentions to perform pro-environmental behaviours in public , the amount of time spent in nature, and the age of participants.Individuals can interact and develop multiple connections to nature (CN) which have different meanings and reflect different beliefs, emotions, and values. Human population are not homogenous groups and often generalised approaches are not effective in increasing connectedness to nature. Instead, target-group specific approaches focusing on different segments of the population can offer a promising approach for engaging the public in pro-environmental behaviours. This research employed latent class analysis to identify subgroups of individuals in a large, representative sample ( Increasing interactions and connection with nature have been a priority for many government agencies because of its positive outcomes for humans and nature ,2. SpendThe urban public is not a homogenous group and often generalised approaches are not effective in increasing connectedness to nature. Instead, target-group specific approaches focusing on different segments of the population appear to be promising in engaging the public in pro-environmental behaviours ,10. SegmBuilding on the findings about connection-to-nature (CN) components over the last two decades, Meis-Harris, Borg and Jorgensen  developeThe AIMES is based on Ives, et al.  theoretiThe Attachment dimension describes positive and negative feelings toward nature and entails elements of Perkins  Love andThe AIMES scale showed that people differ along the five dimensions. That means the Victorian population is not a homogenous group and therefore one-size-fits all approaches to increase connectedness to nature seem less effective. Instead dividing the Victorian population along the five dimensions of CN may result in more detailed information about the different styles in which Victorians express their connectedness to nature. This segmentation can be used to develop more effective strategies that more specifically meet the needs of the different parties as research has shown that policies are more likely to be accepted when they are designed to fit around individuals’ beliefs and lifestyles ,23. SlatSegmentation has been widely applied in environmental management to maximise the efforts of communication and engagement strategies. A number of models have focused on major environmental topics such as climate change ,28,29,30Based on the AIMES, how are latent classes defined to represent individual connections to nature?What is the relationship between CN subgroup membership and key environmental variables  and socio-demographic characteristics.The current research employs latent class analysis to identify subgroups of individuals that are similar within groups and different between groups. Group formation is based on the items of the AIMES with its focus on five types of connection to nature. These subgroups are then regressed on key variables from the environmental social science literature to further understand differences between the groups. These objectives are reflected in the following research questions:Victoria is Australia’s second most populated State with a population of over 6.6 million. Over the last twenty years, Victoria has had a significant biodiversity loss, leading to the extinction of more than 50 animals and over 50 plant species . ConsequThis study thus contributes to the literature, but equally, findings can help to develop targeted interventions that more directly align with the specific sub-groups of how people connect to nature, which may lead to greater connection and pro-conservation behaviours.Participants and sampling. We conducted an online survey in the Australian state of Victoria. The Online Research Unit (ORU), an online survey panel company, recruited a representative sample of adults (18 years or older). Stratified random sampling was employed to ensure the responding sample reflected the Victorian population in relation to gender, age group, and metro versus regional. Participants received an email invitation stating the length, incentive, and close date of the survey. The survey subject was not included to avoid sample selection biases. Email invitations were distributed to 30,753 survey panel members, with a response rate of 9.95%. For more information about data recruitment and survey development see Meis-Harris, Borg and Jorgensen  and the n = 3090 participants ranging in age from 18 to 89 years. In line with population data from the Australian Bureau of Statistics (ABS)  50.2% of the sample identified as female (ABS: 50.9%), 23.9% lived in regional Victoria (ABS: 24.5%), and the mean age of respondents was 47 years (SD = 16.31) which is higher than the population (median = 37) as the sample did not include those aged under 18 years. This research was approved by the authors’ University Human Research Ethics Committee (#14010).The final sample consisted of To determine the number of classes, four Latent Class Analysis (LCA) models were estimated using MPlus 8. Following Asparouhov and Muthén  each modThe results from the first subsample indicated that the model specifying two classes was preferred see . Both thThe results of the second subsample suggested that the model with three classes is preferred. In support of the 3-class model, the entropy statistic was highest and the LMR and VLMR tests were significant when three classes were compared with two, but not significant when four classes were compared with three. These results notwithstanding, the Model LL, AIC, BIC and SABIC decreased as more classes were introduced, but these reductions were small following 2-class model.To choose between the two models, the means of the 20 items were compared between the two and three classes identified in each subsample see . These cThree classes were selected for further investigation because the third class was located between the high- and low-CN groups offering greater discrimination between participants on an ordinal metric. The mean scores of each item were plotted to illustrate the high, medium, and low levels of CN that characterise the classes in each subsample see . First, p < 0.000) except for one Materialism item  which was not significant . For the means in the second subsample, the item means were significantly different (p < 0.000) except for the means of the three Materialism items noted above .Tests were conducted on the item means between subsamples and revealed a similar pattern of results in the two datasets. In subsample 1, all item means were significantly different between classes , medium CN (46.0%), and low CN (18.6%). The entropy value indexing the classification quality of the model equalled 0.91.Latent Class Analysis (LCA) with auxiliary variables was conducted to identify significant predictors of class membership ,40. HaviThe predictors were those shown in p < 0.000). The results of the analysis indicated that the correlation between the two value orientations was influencing the sign of the coefficient for the social-altruistic values variable. The coefficient was positive when the biospheric orientation was included in the analysis but negative when it was omitted. For this reason, separate analyses were conducted using either the biospheric variable or the social-altruistic variable.Prior to the analysis, zero-order correlations among the predictor variables were examined to identify examples of high collinearity. The largest correlation was between biospheric values and social altruistic values  of participants while the group with the lowest profile of scores on the AIMES items contained around a fifth (18.6%) of participants. The majority (46.0%) of participants registered CN levels between the high and low groups.When generalised to the population of adults in Victoria   approximately 1.6 million Victorian adults are likely to experience a relatively strong connection to nature. On the other hand, about 900,000 adults have relatively little connection. The large class of participants defined by medium levels of CN (about 2 million adults), as well as the smaller yet still substantial proportion of participants classified as low CN, suggests there is considerable scope to improve the range and quality of Victorians’ connections to nature and, therefore, the wellbeing they might derive from these connections and the benefits to biodiversity ,5,6.No matter what the CN group, beliefs about the material consumption of nature were not a defining characteristic in terms of membership. This is unsurprising given that the Material Consumption factor of the AIMES is largely independent of the other factors ,43. TherOne might suppose that the anthropocentric underpinnings of beliefs in the primacy of the material goods and services supplied by nature would stand in direct contrast to the more biospheric orientations of CN. For example, other work with the AIMES has shown that the Material Consumption dimension was significantly correlated with egocentric values and positively correlated with biospheric and social-altruistic values . HoweverComparison of the low CN and medium CN classes with the high CN class revealed a subset of predictor variables that are consistently significant in predicting CN group membership. Participants’ age was the only demographic variable that was significant across all regressions showing that those in the two lower CN groups were likely to be younger than members of the highest-scoring group on the AIMES. Furthermore, participants in the low and medium CN groups were less likely to report public pro-environmental intentions, spent less time in nature, and were less supportive of both biospheric and social-altruistic value orientations than those in the highest CN group.Of the remaining variables in the analyses, pro-environmental intentions to perform behaviours in private contexts was a significant predictor in all regressions but the one comparing the medium and high CN classes. This is evidence suggesting that the biospheric value orientation explains the relationship between intentions and membership in these classes whereas social-altruistic values do not.Other predictors showed a pattern of relationships with CN class membership that appeared to be independent of whether biospheric or social-altruistic value orientation was include in the regression analysis. For example, support for egoistic values had a small-to moderate predictive effect only when the lowest level CN class was compared with the highest. Egoistic value orientation was not a significant predictor of membership in the medium CN class compared with the high CN group. Similarly, whether participants spent their childhood outside Australia or within it, and whether they identified as male or female, depended to an extent on which CN classes constituted the dependent variable. Regression coefficients tended to be larger when membership in the low and high CN classes was the focus of analysis rather than membership in the medium and high groups.That social-altruistic and biospheric values were held by individuals reporting strong connections to nature is consistent with previous research . The obsPrevious research by Bouman, et al.  reportedIn related research, Hansla, et al.  reportedThe aforementioned studies, while examples of contexts in which egocentric and biospheric value positions appear to support pro-environmental behaviour and concern for the environment, values research has tended to report that biospheric and egocentric orientations operate counter to each other when predicting connection to nature and pro-environmental outcomes generally (e.g., ,51,52,53Evidence for this counter relationship notwithstanding, interventions have engaged egocentric beliefs and values to promote pro-environmental behaviour change. For example, environmental campaigns have sought to reduce energy and water consumption by pointing to the cost savings accruing from resource conservation. Further, the protection of endangered species is underpinned by the opportunity to continue experiencing them first-hand as much as the importance of the biodiversity of ecological systems. Environmental behaviours can be underpinned by multiple motives that span all three value orientations.An earlier construct validity analysis of the AIMES  showed tRecall that the Material consumption dimension of the AIMES was not a strong contributor to the formation of the CN classes and the classification of participants. Therefore, the effect of egocentric values that might counter the effects of biospheric and social-altruistic value orientations was diminished or negated. Without the influence of material consumption in the formation of the classes, the effect of egocentric values that did emerge supported, rather than contradicted, the effects of the other two value orientations.While this explanation is speculative at this stage, future research might attempt to focus on how the relationships between value positions can influence environmental variables of interest. A study by de Groot and Steg  begun reThe AIMES measure of CN was used to classify a large representative sample into three latent classes which were ordered on a continuum ranging from lower to higher levels of CN. Beliefs about the primacy of nature as an input to material goods and their consumption was the only dimension of the AIMES that did not contribute to the formation of the latent classes. This suggests that materialism as measure by the AIMES is a relatively distinct type of connection compared to other types of connections studied in previous CN research.On the basis of the representative sample employed in the research, it was possible to generalise the sample statistics to the wider population of adults aged 18 years or more. The majority of the population were classified as having medium and high levels of connection to nature, and classification into the different classes was consistently predicted by public pro-environmental intentions, time in nature, and both biospheric and social-altruistic value orientations.Future research might further explore the validity of the AIMES and multidimensional approaches to CN in general . RiecherThis study has provided further evidence that individuals do not make sense of material connections to nature in the same way they experience connections of identity, affect, experience in nature, or spirituality. Baird, Dale, Holzer, Hutson, Ives and Plummer  have sug