Nonadherence to medication is a major issue in patients with chronic disorders such as Parkinson’s disease (PD). Many interventions for increasing adherence have been tested, and these have shown weak-to-moderate efficiency. Although the best methods to improve adherence remain unclear, it is reasonable to use tailored interventions instead of the “one-size-fits-all” approach.A randomized, controlled, triple-blinded trial in elderly patients with PD is conducted to test the efficacy of AdhCare, a tailored intervention to enhance adherence compared with that achieved with routine care (64 participants per arm). Motor function, quality of life, and adherence measures will be assessed at baseline and at 3 and 6 months of follow-up. The type of intervention depends on the main personal reason for nonadherence .The results of this study will provide valuable information for health professionals and policymakers on the effectiveness of tailored interventions in elderly patients with PD.German Clinical Trials Register DRKS00023655. Registered on 24 February 2021. Last update on 22 March 2023. The order of the items has been modified to group similar items  quoted, “increasing the effectiveness of adherence interventions may have a far greater impact on the health of the population than any improvement in specific medical treatments” .In the geriatric population, nonadherence contributes to adverse drug events, increased length of hospital stay and readmissions to hospitals, and lower quality of life , 2. HoweMany factors contribute to nonadherence . NonadheMore than 20% of adults aged ≥ 60 years experience a mental or neurological disorder (excluding headache disorders), and 6.6% of all disabilities (disability-adjusted life years) among adults aged ≥ 60 years are attributed to neurological and mental disorders . TherefoCan a specific intervention with either behavioral or educational strategy improve motor function and adherence?How are these interventions transduced and recognized by the various players in the health care system?Based on the existing data from our large observational trial in the Department of Neurology of the University Hospital Jena, this project will develop a complex intervention to improve adherence in elderly patients with PD. The novel aspect of this intervention is to apply tailored interventions depending on the main personal reason for nonadherence. These personal reasons will be assessed using a detailed adherence self-report, named German Stendal Adherence with Medication Score (SAMS), and include modifications of medication without consulting the physician, forgetting to take the medication, and lack of knowledge about the prescribed medication –18. The It has been shown that the choice of intervention depends on the feasibility and availability . In thisThe objective of this study is to improve or maintain motor function by using a tailored intervention to improve adherence to medication in elderly patients with PD.This study is based on the NeuGerAd study, a longitudinal observational study of adherence in older adults with neurological disorders . The Adhn = 64) or control group with standard of care (n = 64).A total of 130 participants are randomized in a 1:1 ratio: intervention in the AdhCare arm  with PD according to the Movement Disorder Society (MDS) criteria, self-management of medication, Montreal Cognitive Assessment (MoCA) ≥ 19, and nonadherence according to SAMS (SAMS ≥ 1).The SAMS score serves as a basis for comparison and is an established questionnaire utilized to assess nonadherence. A threshold of ≥ 1 point is chosen to determine nonadherence. A score of 1 or higher is indicative of nonadherence, with the severity increasing as the score increases, leading to greater clinical significance.The exclusion criteria are as follows: MoCA < 19, acute psychotic symptoms, delirium, no active involvement in drug management , and inability to provide informed consent.The participants are screened by trained personnel and informed about the study by the subinvestigator if meeting the inclusion criteria. Informed consent is given in writing.N/a, as no biological specimens or data relating to this are collected.We chose a comparison and control arm to review the effect of the tailored intervention. Eligible Patients are randomized and either included in the control arm called AdhCare, where participants receive an additional tailored intervention according to their nonadherence pattern, or include in the comparison arm, where they do not receive any additional tailored intervention apart from the regular education sessions (standard of care).Participants with any degree of nonadherence according to SAMS SAMS ≥ 1) are randomized to the control arm or the AdhCare intervention arm. As it has been shown that implementation of fewer intervention strategies (in one patient) leads to better adherence outcomes , our app are randThe following interventions are provided to the AdhCare (intervention) group:Modifications: explain the medication, discuss barriers, and strive for patient empowerment to discover ways to improve the medication regimen and emphasize different ways of dealing with emerging problems other than cutting out on medications for instanceMissing knowledge: explain the medication and its indications, provide information about individual risks, and indicate other sources of informationForgetfulness: present and apply habit-based techniques to help the patient remember to take the medication and strive for patient empowerment to improve the medication regimenA standardized, informational talk to improve patient empowerment to take responsibility and control of their own health. Depending on the main reason for their nonadherence, we, among other things, perform the following interventions:A written summary of the most significant aspects for their individual improvement of adherence.Their physician, who continue to provide treatment, are contacted and informed about the study, individual patients’ adherence problems and barriers, and possible strategies to minimize nonadherence in the particular patient.A follow-up telephone call to reinforce the respective focus about the medications and adherence after 2 weeks.The control group received standard information about the course and therapy of PD.Whenever a participant expresses the desire to terminate the intervention or withdraws their consent, a discontinuation or modification of the assigned interventions is facilitated.Strategies to improve adherence to intervention protocols are not required because improving the adherence is the objective of the study and is measured in the participants. Patients are being called in advance by trained personnel to remind them of their appointments, so that the intervention and follow-ups could be carried out. Also, the collection of multiple questionnaires is facilitated by contacting patients by telephone and guiding them through the assessment.There is no concomitant care/treatment allowed or prohibited during the study. We conscientiously inquire about and document the treatments that patients receive in order to be able to make statements regarding adherence (improvement) in this regard as well.Arrangements for post-study care and compensation for individuals harmed by participation in the study are not necessary because of a cognitive- or behavioral-focused intervention.Because the overall goal is to improve patient-reported outcomes, the primary endpoint is motor function, which is assessed using the combined MDS revised Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) II and MDS-UPDRS III after 6 months in the control versus AdhCare arm (intent-to-treat).The secondary outcomes are as follows: self-reported adherence (SAMS), medication adherence scores, and number of primary care visits Table . MoreoveAt baseline and follow-up, the participants complete a staff-administered assessment and a self-report paper-based assessment. These assessments are summarized in Table t-test. The assumed values are based on the literature  and cliTo maximize participant enrollment, several strategies are being employed, including screening of both inpatients and outpatients of our movement disorder unit in the Department of Neurology at the University Hospital Jena, Germany, to capture a wider range of participants with varying medical conditions, severity levels, and treatment settings. Also, the first patient information is taking place through the attending physicians of our movement disorder unit. During this first contact, the advantages that the study brings to the participants are highlighted.A block randomization with the help of computer-generated random numbers is performed to ensure that the number of participants in the study groups is approximately equal. Outpatients and inpatients are randomized separately.Allocation concealment is ensured as the computer-generated randomization code will not be released until the patient has been recruited into the trial. This serves to avoid a selection bias .The subinvestigators perform computerized randomization once the patient has consented to participate and then assign the patient to the treatment group accordingly.A triple-blinded design is used. The participants will not be aware if they are in the control or AdhCare group. The study personnel assessing the outcome parameter as well as the data analyst are blinded as well.The persons administering the cognitive or behavioral intervention are not blinded, so there will be no unblinding. In later phases, as well as at the scheduled follow-up, unblinding is not required because all patients, regardless of group, receive support and assistance for adverse events and problems that arise (which may or may not be due to the intervention).In the study, paper questionnaires are administered. Trained staff collects PD-related data and data on remaining pill counts and verifies the test results. Table Plans to promote participant retention and full follow-up include detailed education of participants about the study timeline and number of consults. They get written information about their next scheduled appointments and assignments. In addition, our study team is instructed to promote successful study completion through their communication style during data collection. Also, the study team contacts participants to ensure data collection via telephone.A comprehensive data management plan is implemented to ensure data quality, security, and storage. This includes using standardized templates and guidelines for data entry, conducting regular quality checks and validation procedures, and implementing strict protocols for data security and storage. Data are collected by trained study staff and entered into a dedicated study database (by the same person). This guarantees a secure and direct transfer of data to the study office without any intermediary steps. Additionally, regularly conducted checks ensure the detection of any potential duplicate records and verification of value ranges.Personal information about potential and enrolled participants is collected, shared, and retained by means of an identifier so that patients can only be matched to the identifier by the study investigators during the study. After completion of the study, only the data with the identifier are used to maintain confidentiality. The data are stored in a password-protected manner on the clinic’s internal drive. The individual trial identification numbers are numbered consecutively in ascending order starting with AC001.Ensuring the appropriate level of anonymity, confidentiality, and de-identification when maintaining human subject data is crucial for reducing the risk potential for participants, researchers, and the university in alignment with the General Data Protection Regulation (GDPR) of the European Union. All trial data are recorded, processed, handled, and stored without disclosing the personal data of the subjects, so that they can be accurately reported, interpreted, and verified, while protecting the confidentiality of the records and the personal data of the subjects in accordance with the applicable law on the protection of personal data. Appropriate technical and organizational measures are in place to safeguard processed information and personal data from unauthorized or unlawful access, disclosure, dissemination, alteration, or destruction, including accidental loss, particularly when the processing entails transmission over a network.Plans for collection, laboratory evaluation, and storage of biological samples for genetic or molecular analyses are not necessary for the study because no biological samples are collected.Analysis will take place after full recruitment and follow-up. There are no planned interim analyses for efficacy. Statistical analysis will be tested at the 2-sided 5% significance level with any estimates displayed with 95% confidence intervals (CIs). The mean, standard deviation, and any other statistics other than quantiles will be reported to one decimal place greater than the original data. Quantiles, such as median, or minimum and maximum will use the same number of decimal places as the original data. All outcomes will be presented using descriptive statistics: normally distributed data by the mean and standard deviation (SD) and skewed distributions by the median and interquartile range (IQR). Binary and categorical variables will be presented using counts and percentages.Baseline characteristics of the study population will be summarized separately within each randomized group using means (with standard deviations), medians (with interquartile ranges), and numbers (with percentages) where appropriate. Baseline characteristics will also be presented for dropouts and completers within each treatment group. Similarly, the primary and secondary outcomes at baseline and all follow-up by treatment groups will be described.Further analyses will be conducted on all the primary and secondary outcomes. These will be performed based on the intention-to-treat principle and will utilize all available follow-up data from all randomized participants. For the main analysis of treatment effects, crude change in outcomes for both groups from baseline to follow-up will be provided as the mean change scores with standard deviations or proportions, and the corresponding 95% confidence interval (CI) will be presented. The primary outcome (motor function) will be analyzed with a linear mixed effects model. Study subjects will be considered as random effects. Treatment (control or AdhCare group), month (baseline and 3 and 6 months), setting (outpatient and inpatient), and the interaction of treatment with months will be considered as fixed effects. The baseline value of the motor function will be included as a covariate.Secondary continuous outcomes will be analyzed analogously. However, there will be no adjustment for multiplicity of testing among effect estimates and corresponding 95% CIs for nonprimary outcomes, which therefore should be interpreted cautiously as hypothesis-generating results.Interim analyses are not included in this study. Early discontinuation is also not planned due to the study design.Additional analyses are not planned.The data are captured in the electronic case report form and will be transferred anonymously from this to the statistician for processing . Automated checks will be implemented, and manual checks will be done against the data to ensure completeness and consistency of data. The database and check programming will be validated prior to implementation. Data identified as erroneous or inconsistent, or key data that are missing, will be referred to the subinvestigators and to the principal investigator for clarification. After these forms are returned, the data will be corrected as required. All modifications to the data will be logged in the audit trail. Prior to the closure of the database, an audit of the raw data will be performed. All errors detected during the audit will be corrected prior to database closure. Visual and computerized methods of data validation will be applied in order to ensure accurate, consistent, and reliable data for the subsequent statistical analysis. These procedures aim to detect out-of-range values, contradictory data, abnormal evolutions over time, and possible protocol deviations .The sensitivities of all treatment effect estimates to missing outcome data will be explored; these models will explore the robustness of the treatment estimates to whatever small amount of missing data there is. The main analysis will use all available data that we believe are valid under the assumption of missing at random . We will then use a suite of sensitivity analysis to explore the robustness of the primary analysis to departures from assumptions, including all randomized participants. If required, sensitivity analyses will include multiple imputation and imputing a range of values for missing data under missing not at random assumptions.Granting public access to the full protocol, participant-level data set, and statistical code is not currently anticipated but can all be obtained from the author.The research team encompasses a range of expertise, including behavioral and medical management, research design, multicenter data collection, epidemiology and biostatistics, patient engagement, practice transformation, continuing education, quantitative outcomes assessment, and qualitative analysis of processes and outcomes. We did not establish a trail steering committee or Stakeholder and Public Involvement Group in the context of this study.A data monitoring committee is not necessary, and not required by the local ethics committee, due to the short duration and the known minimal risks in this kind of cognitive- and behavioral-focused intervention.Inadequate knowledge, skills, and experience among trained study staff can lead to adverse events such as personal insult, frustration, loss of motivation, emotional distress, and loss of trust being linked to inappropriate practices. If participants report adverse events of any kind, it will be recorded, assessed internally by the team to prevent future adverse events, and reported as part of the planned publication.Because there are no sponsors for the study, information on the frequency and procedures for possible review of the study process and the independence of this process from the investigators and sponsors is not required.However, the project management group meets once a week to discuss the current state of data collection and address potential problems and difficulties. In addition, the trial steering group with experts of different disciplines will meet regularly, initially every month and during the course of the study quarterly, or semi-annually unless unscheduled necessary.The study is conducted by the staff in accordance with the submitted study protocol. Changes to the study protocol regarding study objectives, study design, eligibility criteria, sample size, or significant changes affecting study conduct, potential benefit, or participant safety will be approved in advance by the study management. Subsequently, the proposed changes will be submitted to the local ethics committee of Jena University Hospital and the relevant regulatory authority for approval before they are implemented. In cases where there is an immediate risk to study participants or unavoidable medical reasons, a change will be implemented prior to regulatory approval. Participants will be notified of any changes to the study and will sign an updated informed consent form reflecting these changes. All deviations from the protocol will be carefully documented in the original records and appropriate reporting of noncompliance will be made.Journal of Clinical Medicine. Further dissemination will be achieved by the project itself (via practitioners), by including professional societies  and by providing informative literature and handouts/flyers to physicians. A meeting with the practicing neurologists and general practitioners is planned. The goal is to translate and transfer our results into health care and to implement recommendations to improve communication between health care providers after the project is completed. In principle, knowledge will be shared by all partners. Participants are asked at the beginning of the study if they want to be informed about the results. If this is the case, information will be provided by telephone or email. In addition, the results will be published after completion of the follow-up.At the end of the study, a final report will be prepared. In addition, we will actively disseminate our results through publications in high-ranking scientific peer-reviewed international and national journals. All results will be reported with reference to the study protocol. Target journals that might be of interest are open-access journals like Frontiers, BioMed Central, or With regard to public dissemination, we will use the Jena University Hospital website to set up a German language webpage to provide information on the study and to report on the study progress and outcomes. The website will give access to all study materials including the intervention program after the trial. The homepage will address patients, caregivers, researchers, clinicians, and health care providers. Furthermore, we will actively disseminate our results through press reports released via the Jena University Hospital Press and Public Relations Office. We will also present the results to relevant stakeholders such as medical associations and professional societies at meetings, symposia, and poster presentations. In particular, we will organize events for patients and caregivers in order to sensitize them to this topic and to provide ways to reduce barriers of implementation. We will organize regular meetings with the self-help groups and patients with distinct neurological disorders  in order to inform them about the current developments in the study. We will organize a closing event for the involved physicians to present and discuss the project results.This protocol presents the design of a randomized controlled trial to evaluate the efficacy of a tailored intervention to improve medication adherence in elderly patients with PD. The AdhCare study has several relevant features. First, we focus on the elderly population. This is because the prevalence of chronic disorders and polypharmacy is high in this population, with a high risk for nonadherence. In addition to testing the efficacy of the intervention, we provide information about the mechanisms and reasons for nonadherence. The results of this study will provide valuable information for health professionals and policymakers on the effectiveness of interventions in elderly patients with PD. The key features of the AdhCare trial are as follows: (i) a carefully characterized target group; (ii) a tailored intervention based on theory and evidence from earlier studies; (iii) a quality-assured delivery enabled by training, ongoing supervision, and protocols; and (iv) objective geriatric assessments and measurements of functional parameters as well as a self-report of functional status, mood, and quality of life.Protocol version: version 2.0, 14 August 2023.Start of recruitment: 26 April 2021.End of recruitment: 03 March 2023.Planned study completion date: 30 September 2023.Due to the COVID-19 pandemic, we had to allocate our available personnel extensively to the execution of the study. This resulted in staffing shortages and increased workload, which caused a delay in processing papers and submitting this protocol. Furthermore, staff shortages due to illness, the need to assist in other areas of the health care facility, and maternity leave are reasons that also contributed to the delay.


This article aims to determine the effectiveness and extent of measures taken to decrease the severity of traffic crashes in Barcelona from 2013 to 2018. This will be achieved through an analysis of the traffic crash data.Our approach involves the use of binary logistic regression models. We rely on the traffic crash dataset from 2010-2019 available in the Open Data Barcelona platform.The outcomes obtained from the suggested models are contrasted with the strategies outlined in the Local Road Safety Plan 2013-2018 to minimize the severity of crashes. Effective preventive actions were identified, such as road safety educational programs, creating calm zones, enhancing pedestrian crossings, or expanding bicycle lanes. However, certain measures were found to be ineffective or their impact remained uncertain.Our findings indicate that the measures implemented in Barcelona may have participated in and influenced the decrease in the severity of traffic incidents over the past decade. Notably, fatalities have decreased more than severe injuries. More attention should be given to less effective measures such as speed controls and drug/alcohol testing. In recent years, the Barcelona City Council has approved several local plans aimed at improving road safety and urban mobility. The Local Road Safety Plan (LRSP) for the period of 2013-2018 The study of traffic crashes may help to assess the efficacy of measures implemented by policymakers in reducing the frequency and severity of such crashes. Researchers have examined various factors that contribute to road traffic crashes and assessed the impact of countermeasures in addressing them. For example, The purpose of this paper is to assess the effectiveness of measures implemented in the LRSP 2013-2018 to reduce fatalities and serious injuries in traffic crashes in Barcelona. The technical actions planned in the LRSP 2013-2018 focused on preventive and corrective actions, as well as educating people on road safety. The city council's local road safety plans serve as the primary tool for enhancing road safety, reducing crashes, and regulating traffic flow within the city. From 2004 to 2011, Barcelona witnessed a consistent decline in both the overall number of traffic-related incidents and the severity of resulting injuries. However, in 2012, a shift in this trend became evident, highlighting the need to reevaluate road safety policies. In 2012, crashes involving pedestrians, motorcycles and bicycles accounted for 81% of incidents. Therefore, it became imperative to update the road safety policies while continuing with ongoing projects and identifying new priority areas for intervention. This gave rise to the Barcelona LRSP 2013-2018, aimed at continuing efforts to reduce the number of serious injuries and fatalities. In the LRSP 2013-2018, the priority areas for intervention were incidents involving running down, casualties with motorcycles, and vulnerable groups such as cyclists, pedestrians, and moped users. The Local Road Safety Plan in Barcelona 2019-2022 To evaluate the impact of the measures introduced in the LRSP 2013-2018 aimed at decreasing fatalities and severe injuries in Barcelona, we have employed a dataset obtained from the local police department's traffic database. This dataset comprises information on traffic crashes involving victims spanning from 2010 to 2019. Our primary objective is to determine whether the implementation of these measures has resulted in a decline in both fatalities and severe injuries over time. To facilitate our analysis, we have categorized the years during which these crashes occurred into three distinct periods. The first period, from 2010 to 2012, serves as our reference or control period, representing the time before the measures were put into effect. The second period, spanning from 2013 to 2016, corresponds to the phase during which the majority of the measures were actively implemented. Finally, the third period, from 2017 to 2019, signifies a stage where the implementation of the plan can be considered nearly completed. According to local police The analysis of crash-injury severity in literature is highly developed. For an in-depth examination of the modeling frameworks employed, please refer to In our study, we employed this latter binary classification approach to categorize the severity of traffic crash injuries into two groups: fatal/serious versus non-serious (minor or slight). We then applied multiple binary logistic regression models to assess how various risk factors influence the severity of injuries resulting from crashes. First, as previously mentioned, we plan to assess the effectiveness of LRSP measures in reducing fatal and seriously injured victims during the entire examined period. Our second aim is to determine whether the impact of other risk factors on crash severity has undergone any significant changes and to evaluate the impact of the implemented measures on this phenomenon. To achieve this, we have tailored a specific logistic regression model for the 2010-2012 reference subperiod and a separate one for the concluding subperiod of 2017-2019. Finally, we have employed various logistic regression models for different severity levels to evaluate the impact of traffic measures on fatalities and serious injuries separately. This study provides a discussion and summary of the results of these analyses.2The dataset on traffic crashes during the period of 2010-2019 in Barcelona was sourced from the local police department's traffic accident database. This database is available to the public through Open Data BCN, which enables access to information generated or maintained by public entities. For each year, there are five interlinked datasets with a record code that provide information on the crashes, the mediate cause of the crash, the type of crash, as well as the vehicles and victims involved in the crash.The dataset contains a total of 96,728 motor-vehicle crashes reported by police, which occurred between 1 January 2010 and 31 December 2019. To consolidate the information and ensure that each crash had only one entry in the database, some modifications were made to each dataset (e.g. eliminating redundant variables and creating dummy variables for crashes with multiple observations). After merging the datasets, the final database included 87,823 traffic crashes that involved victims during the study period. Traffic crashes that did not involve victims were excluded for two reasons: firstly, minor crashes often do not require police presence and therefore the sample of these types of crashes would be biased; secondly, the focus of the study is on crashes resulting in fatal, serious or non-serious injuries. The victims are divided into three categories: fatal (deaths), seriously injured , and non-serious injured .Severity, which separates crashes into two categories: those with either fatal or serious injuries and those with only non-serious injuries. Typically, as used here, crash severity is assessed by measuring the level of injury suffered by the most seriously injured vehicle occupant The variables used in the analysis are shown in Period during which the crash occurred enables us to assess the effectiveness of the measures implemented to reduce the severity of crashes. For this purpose, we have categorized the Period variable into three distinct phases: the first (2010-2012) as a reference or control period before measures were implemented, the second (2013-2016) as the active implementation phase of most measures, and the third (2017-2019) as a stage where implementation was nearing completion. The evolution of injury severity over time for these three periods is presented in Second, as previously discussed in the introduction, it is reasonable to assume that observing the Finally, numerous additional factors may impact the severity of a traffic crash. To comprehensively evaluate the LRSP 2013-2018's effectiveness, it is essential controlling for other relevant factors that can either mitigate or exacerbate injury severity in such incidents. Many studies have been conducted to identify the factors that impact the severity of crashes. For instance, Period variable, the time of the crash contains Daytype (distinguishing between working day and weekend day) and Daypart . The crash site (Via) refers to the type of road where the incident took place, which is categorized into street, avenue or fast lane. The study classified the factors Period, Daytype, Daypart and Via into several categories, with the first category serving as the reference. The variables related to vehicles include the number (Vehicles) and type of vehicles involved, such as Bicycle, Twowheel, Heavy and Light. Vehicles is a dichotomous variable with two categories (crashes with more than one vehicle involved and other). Regarding the type of vehicles involved, we have defined four dichotomous variables that indicate the presence or absence of each type of vehicle in the crash. Related causes of the crash include variables such as Pedestrian (when the crash is due to the behavior of a pedestrian), Bloodalcohol , Speed  and Roadcondition (when the state of the road is the registered cause of the crash). In this case, we have also defined four dichotomous variables that indicate the presence or absence of each cause according to the police report. Please note that a single crash may include more than one type of vehicle involved or related cause. Finally, crash type variables include Rundown (when a person has been hit by the car and as a result is lying down on the ground), Twowheelfall , Collision (when a vehicle collides with another vehicle), and Shock (when a vehicle collides with a stationary object). As the above variables, they were defined as dichotomous variables indicating the presence or absence of each type of crash. These potential influencing factors have been widely used in several studies Leaving aside the For descriptive purposes, the data presented in The explanatory variables related to type of vehicle presented in Shock) are more likely to result in fatalities or serious injuries. This finding is consistent with previous research such as The variables related to the type of crash and their incidence are presented in Severity with two levels . The logistic regression model, expressed in terms of the logit transformation of the i-th individual's response probability, In this study, we have employed binary logistic regression models to determine the associations between the probability of severity outcomes  and all contributory factors 3Within this section, we will present and discuss upon the outcomes achieved from applying various logistic regression models to the data that has been previously introduced.Severity variable. Specifically, the severity is assessed based on a dichotomous variable where the 0-valued category  consists of 85,429 cases, and the 1-valued category includes incidents involving 1, 2, 3 or 4 fatalities/serious injuries per crash, which constitute 2,394 cases. For each risk factor, the estimated coefficients, standard error, and p-value statistic are reported. A confidence level of 90% was used in this study to compensate for efficiency reduction, and variables with a p-value greater than 0.1 were kept in the model to facilitate comparison between models. A positive significant coefficient indicates that the presence of the respective factor increases the severity odds ratio . Conversely, a negative significant coefficient reduces this odds ratio.To begin, Period variable to a large extent reflects the changes introduced by LRSP Plan, the negative coefficients for this variable assesses the reduction of fatalities and serious injuries in traffic crashes during the periods 2013-2016 and 2017-2019 compared to the reference period of 2010-2012, controlling for all other risk factors included in the model. Specifically, the risk of fatal or serious injuries is lower during the period 2013-2016, with a severity odds ratio reduction of 10%. Furthermore, the risk is even lower during the period 2017-2019, with a severity odds ratio reduction of 18%. Therefore, we can conclude that the measures taken have had a positive effect in reducing the severity of traffic crashes.The results shown in Additionally, the model enables us to distinguish this effect from other risk factors. The likelihood of a fatal or serious crash is lower on working days compared to weekends, and the highest risk is during evening and night shifts. The severity odds ratio is reduced by 25% during working days, while the ratio is increased by 49% during evening and night shifts compared to morning shifts. Research has shown that crashes are more severe during night shift Setting regular streets as the reference category, there is a higher risk of a fatal/serious injury in fast lanes, with a 28% increase in severity odds ratio. Conversely, the presence of more than one vehicle in a crash reduces the odds ratio by 61% compared to incidents with only one vehicle. These findings are consistent with other studies When examining factors related to the cause of the crash, excessive speed is found to be the most risky, increasing the likelihood of serious injuries or death even more than pedestrian behavior. If a crash is caused by excessive speed, the severity odds ratio increases by a factor of 3.7. While excessive alcohol consumption is also a risk factor, it is not as significant, likely due to its correlation with speed and night shift driving. Road conditions do not appear to impact negatively on the risk of serious injury or death. Analysis of different crash types reveals that collisions with stationary objects or being struck by a vehicle are the most likely to result in fatalities or serious injuries, with severity odds ratios increasing by about 4 times.3.1To study the consistency of the measures applied, we divide our data set in subsamples according to the period which crash occurred. Subsequently, we proceed to estimate two binary logistic regression models: one for the reference subperiod of 2010-2012 and another for the final subperiod of 2017-2019. Period variable in To begin with, the primary modification observed between the two periods pertains to the intercept coefficient. Its sustained reduction indicates an overall decline in crash severity. This reduction encompasses both the impact observed for the In the morning shift, when elderly and school-going youth are more likely to be in transit, the continuous implementation of informative and educational sessions promoting safe mobility from the inception of the plan may have had a positive impact refer to . The redBeginning with the initial risk factor of the crash day type and considering its evolution, there has been a more significant reduction in crashes resulting in fatal or serious injuries during weekdays compared to weekends. This trend could be attributed to the impact of the road safety training sessions conducted since 2014 in companies, which aim to provide employees who commute to work and those who operate motorcycles, trucks, or vans for work-related purposes with appropriate safety measures. In the year 2014, work-related trips accounted for 36% of the severe crashes that occurred in the city When it comes to the time of day when crashes occur, the likelihood of an incident being severe is higher in the afternoon and especially at night compared to the morning. This trend has remained relatively consistent over the years for the afternoon shift, but the crash severity in the night shift has varied more. While both the morning and afternoon shifts have seen a similar reduction in crash severity over time refer to , indicatConsidering the aforementioned consistent reduction in the severity of crashes on regular streets over time refer to , it is nLooking at the type of vehicle, there has been an increase over time in the likelihood of severe injuries for victims involved in crashes with the presence of bicycle, two-wheel, heavy, and light vehicles compared to those without such vehicles. Despite attempts to reduce the severity of crashes involving motorcycles and heavy vehicles, such as stricter power controls and implementation of road safety plans, the effectiveness of these measures remains unclear. As outlined in Regarding the variables related to the underlying cause of the crash, there is an increasing trend in the greater risk factors for severe crashes, such as excessive alcohol consumption and inappropriate speed, particularly with regards to the latter. Despite the implementation of controls since 2014 to reduce the rate of crashes caused by excessive alcohol consumption, as well as static and dynamic surveillance campaigns aimed at preventing risky behavior through speed controls, the aforementioned risk factors continue to persist. Nevertheless, upon examining their progression (as depicted in Leaving aside road conditions (with non-significant coefficients), there has been a rise over time in the likelihood of severe injuries for victims involved in pedestrian-attributed crashes when compared to those not involving pedestrians. It is crucial to emphasize that this increase is a result of a more substantial reduction in the severity of crashes not involving pedestrians. In fact, as Concerning the type of crash, particularly focusing on those with a greater impact on crash severity, it is evident that the severity odds ratios of run-downs and shocks have remained stable over the years. Measures such as the improvement of pedestrian crossings and intersection configurations may have contributed to reducing crash severity in these cases to the same extent as in other types of crashes.In contrast, we can observe a slight increase over time in the likelihood of severe injuries for victims involved in two-wheel fall and collision crashes compared to those without such circumstances. However, a closer look at their evolution refer to  reveals 3.2Previously, we addressed crashes that involved either fatalities or victims with severe injuries. In this section, our objective is to examine whether there are distinctions between these two levels of severity. Firstly, we seek to determine if both outcomes experienced a similar reduction during the analyzed period. Secondly, we aim to evaluate if the risk factors incorporated in the models influence both types of crashes similarly.The results of modeling the different levels of severity are presented in By comparing the coefficients of the first two models for the 2017-2019 period, it is evident that the risk of a severe injury crash compared to one with minor injuries has decreased over time, although not as much as the risk of a fatal crash. In parallel, the corresponding coefficient of the third model indicates a 43% reduction in the probability of a fatal crash relative to a crash with severely injured victims. Therefore, as stated in the introduction, it can be inferred that the LRSP measures have had a more significant impact on reducing fatalities than on reducing severely injured victims.When considering the impact of risk factors on each of these severity levels, we can see notable differences between them. On the one hand, certain factors have a more significant influence on the severity of crashes resulting in fatalities than those resulting in serious injuries. By comparing the corresponding coefficients of the first two models in On the other hand, there are certain factors that have a larger impact on serious injury crashes than on fatalities, although in smaller numbers. 4This study aims to evaluate the impact of actions implemented by the Local Road Safety Plan (2013-2018) of Barcelona City Council, whose objective it was to reduce fatalities and serious injuries caused by traffic crashes in the city of Barcelona.In general terms, by fitting several logistic regression models to the traffic data gathered by the local police between 2010 and 2019, we have found that the implementation of most measures between 2013 and 2016 contributed to a reduction in fatal/serious injuries. This decrease was even more pronounced between 2017 and 2019, which coincided with the conclusion of the plan. These findings suggest that some of the measures had a positive impact on reducing the severity of crashes. Furthermore, we have also seen that fatalities were reduced more significantly than severe injuries.The findings of the study corroborated earlier research on the link between certain risk factors and the likelihood of sustaining severe or deadly injuries in road crashes. However, we have concentrated on the relationship between crash severity and risk factors such as time and location of the incident, vehicle characteristics, causes related to the crash, and the type of crash to evaluate the consistency of the road safety measures implemented.On the one hand, it has been observed that certain preventive actions such as road safety educational programs for the elderly and school-going youth, and training sessions in companies, have proven to be effective in mitigating the risk of serious crashes during daytime hours and on workdays. Additionally, the adoption of corrective measures with a structural nature, such as the creation of calm zones, enhancements to pedestrian crossings, reinforcement of speed controls in Zone 30 and on single-lane roads, and the expansion of bicycle lanes, may have resulted in a reduction in the severity of crashes: on regular streets (and to a lesser extent avenues), involving bicycles, and caused by run-down incidents.On the other hand, we have come across certain measures that appear to be ineffective or whose impact is uncertain. For instance, despite targeted control campaigns for motorcycles and heavy vehicles, the likelihood of severe crashes involving these vehicles remains high compared to those not involving them, and furthermore, this likelihood has continued to rise over the years. Likewise, the likelihood of serious crashes persists even when measures such as stricter controls to prevent drink-driving and speeding are implemented.As previously mentioned and based on the findings of the logistic regression models, it can be inferred that the LRSP measures may have resulted in a more significant impact on reducing fatalities than on reducing severely injured victims. Nevertheless, when considering fatalities, the highest risk profile pertains to crashes occurring during the night shift on fast roads, involving speeding and impact (shock). This underscores the need for the Barcelona City Council to persist in reinforcing the measures designed to mitigate such incidents.To conclude, the LRSP measures implemented in Barcelona have contributed to lessen the severity of traffic crashes over the past decade. Besides that, the study reported here might be extended by employing a spatial regression modeling framework to account for spatial autocorrelation and spatial heterogeneity. From a spatial perspective, it would be interesting to analyze the evolution of crash severity across different areas of Barcelona. This perspective should aim at identifying potential disparities between different areas, providing insight into the effectiveness of measures implemented by the LRSP.No additional information is available for this paper.Lluís Bermúdez: Writing – review & editing, Writing – original draft, Visualization, Validation, Supervision, Software, Resources, Project administration, Methodology, Investigation, Funding acquisition, Formal analysis, Data curation, Conceptualization. Isabel Morillo: Writing – review & editing, Writing – original draft, Visualization, Validation, Supervision, Software, Resources, Project administration, Methodology, Investigation, Funding acquisition, Formal analysis, Data curation, Conceptualization.The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.


Food choice motivations were assessed using an online questionnaire validated by the EATMOT project. Using K-Means cluster analysis, participants were divided into two clusters of six motivational categories for food choices. Regarding the most and least important motivations, participants in cluster 1 chose food based on emotional motivations, and in cluster 2, they chose based on environmental and political motivations. In addition, younger and obese individuals had more pronounced emotional motivations. In conclusion, this study emphasizes the need to address emotional motivations for healthier food choices among overweight and young people. In addition, the prevalence of health motivations and growing awareness of sustainability indicate a willingness to take actions that benefit personal health and the environment. Apart from providing education, it is society’s responsibility to create an environment that promotes the implementation of acquired knowledge and changes in dietary habits.Motivation for food choices is one of the most important determinant of eating behavior, because it comes from within the person. The aim of this study was to observe food choice motivations and estimate differences in demographic and health characteristics towards food choice motives in the adult population ( Today, is known that a healthy diet can maintain health and protect against the development of the non-communicable diseases, such as obesity, diabetes, cardiovascular disease, cancer, etc. . The WorFood choice is a dynamic process that lasts a lifetime. It is estimated that on average, people make a food consumption decision 220 times a day ,6,7. AccThe motivations, one of the interpersonal food choices determinants, are interesting because they come from within the person. The motivation can range from extrinsic to the intrinsic. According to the expectancy-value theories, the individuals measure the outcome of the behavior as beliefs about expected outcome and value of outcome ,9. MotivConsidering the health problems of the Croatian population ,20, it in = 633,116; census according to the Croatian Bureau of Statistics from 2011) with regard to participants’ age and sex [The study was cross-sectional and took place within the framework of the international project Psycho-social motivations associated with food choices and eating practices (EATMOT) coordinated by the CI&DETS Research Centre of the Polytechnic Institute of Viseu, Portugal (PROJ/CI&DETS/2016/0008&PROJ/CI&DETS/CGD/0012). In the study, 675 adults (≥18 years old) from the city of Zagreb voluntarily participated. The minimum number of participants of 384  ensures the representativeness of the sample of adults from the city of Zagreb  was obtained from body weight and height and used to evaluate the weight status of participants according to World Health Organization cut-offs [Data collection was through anonymous interviews and online form (Google form). Participants were recruited at the college by email and word of mouth. The validated questionnaire was used to determine the motivation for food choices . Originacut-offs . In ordecut-offs ,25. For t-test. The chi-square test for homogeneity was used to estimate differences in adult demographic and health characteristics between two clusters. In all analyses, statistical significance was set at p < 0.05.The computer program IBM SPSS Statistics v. 23.0, released in 2015  was utilized for the data analyzes. Depending on the type of variable, percentages or mean and standard deviation were used to represent the data. The Shapiro–Wilk test was used to determine the continuous data distribution. For the present dataset on food choice motivations the two clusters were proposed by the agglomeration schedule of the Hierarchical cluster analysis with Squared Euclidean distance and Ward’s method. Accordingly, the participants were divided into two clusters of six main groups of food choice motivations using K-Means cluster analysis. The differences in motivation scores between adults in the clusters were analyzed using Student’s The characteristics of the total sample and their health characteristics are shown in More than 50% of the participants had an adequate weight status . One thip < 0.001), and in cluster 2 , they chose based on environmental and political motivations . Although significant differences were observed between the clusters in health motivations  and economic and availability motivations , both were important motivations in each cluster. The least important motivations and not statistically significant difference in both clusters were marketing and commercial, and social and cultural motivations. If we look at the individual types of motivations  young adults  belonged to cluster 1, whereas cluster 2 had an even distribution of participants in all three age groups. Regarding health characteristics, significantly more participants in cluster 1  were obese than participants in cluster 2. No difference was found in physical activity levels, special diet regime, non-communicable diseases, food allergies or intolerances, or eating disorders.The demographic and health profiles of participants in each cluster are shown in The results of the present study show the food choice motivations of adults from the urban setting, with health motivation being the strongest. However, there are differences between individuals. For some of the population, emotional motivations tend to dominate alongside health motivations, while for others, environmental and political motivations. Since there are limited data in this area in the Croatian population, the results of this study may be helpful in developing nutrition interventions and communication strategies with consumers.The present study confirms the results of previous studies, which found that the health motivations was one of the most important motivation among adults from different populations ,27,28. TThe results of the cluster analysis from the present study show that 16.9% of the participants belong to the cluster in which the choice of food based on emotional motivations predominates, while environmental and political motivations dominate in 83% of participants. The study with a representative Italian sample showed the dominance of the same three motivations for food choice as in the present study. However, they estimated that environmental and political motivations most strongly influence food choice in the overall population, and the population can be divided into two groups in which health or emotional motivations predominate . This maGiven that emotions can play an important role in food choices, it is not surprising that in the present study population, as in the population of Italian adults, a group of people stands out who make their food choices according to emotional motivations ,38,41,42This study attempts to answer the question of whether participants differ by demographic and health characteristics. No differences were found between clusters in terms of sex in the present study, as Wongprawmas et al. (2021) found no difference in the proportion of participants in terms of sex between health-driven consumers and emotional eating consumers . HoweverIn terms of health characteristics, only body mass index differed between the two clusters, with obese participants having stronger emotional motivations for their food choices. The relationship between weight status and emotional motivations is inconclusive in the available literature. Wongprawmas et al. (2021) found no relationship between weight status and emotional motivations , while oSeveral limitations must be considered when interpreting the results. The study sample is from the city of Zagreb, and the results are not indicative of the motivations of the entire Croatian population in making food choices. However, Zagreb is the capital city of Croatia, where almost one fifth of the total Croatian population over 18 years of age lives . In addiThere is an overlap of motives for food choices, and there is not just one motivation that could determine food choices among individuals. Among adults from the urban setting, health motivations were most prominent, while there were differences in emotional, environmental, and political motivations. Younger and obese individuals exhibited more pronounced emotional motivations, meaning that they choose foods based on their feelings and regularly consciously consume foods that may have negative health consequences. The results of this study suggest that intervention in obese and young people’s emotional motivations is needed to help them make better food choices and adopt healthier eating habits. In addition, it would be desirable to apply the Health Belief Model in the interventions and link the influence of diet on health, as health motivations for food choices dominated in the study group. Moreover, the large number of respondents who have a more pronounced environmental and political motivations in their food choices, in addition to the health motivations, suggests that people are becoming more aware of the unsustainability of the current food system and that they can influence it through their behavior. This finding suggests that people are ready for interventions that lead to changes in eating behavior that not only maintain their health but also contribute to the environment. Aside from delivering education, there is a broader social responsibility to create an environment supportive of the implementation of acquired knowledge and fostering dietary habit changes. This responsibility encompasses not only the dissemination of information but also the creation of a supportive framework wherein individuals are empowered and motivated to translate knowledge into tangible and sustained improvements in their eating behaviors.


In the research field of robotic spine surgery, there is a big upcoming momentum for surgeon-like autonomous behaviour and surgical accuracy in robotics which goes beyond the standard engineering notions such as geometric precision. The objective of this review is to present an overview of the state of the art in non-visual, non-radiative spine sensing for the enhancement of surgical techniques in robotic automation. It provides a vantage point that facilitates experimentation and guides new research projects to what has not been investigated or integrated in surgical robotics. Studies were identified, selected and processed according to the PRISMA guidelines. Relevant study characteristics that were searched for include the sensor type and measured feature, the surgical action, the tested sample, the method for data analysis and the system’s accuracy of state identification. The 6DOF f/t sensor, the microphone and the electromyography probe were the most commonly used sensors in each category, respectively. The performance of the electromyography probe is unsatisfactory in terms of preventing nerve damage as it can only signal after the nerve is disturbed. Feature thresholding and artificial neural networks were the most common decision algorithms for state identification. The fusion of different sensor data in the decision algorithm improved the accuracy of state identification. Spine surgery is a complex procedure, the outcome of which often depends on the experience of the surgeon. Pedicle screw placement has become one of the most practiced procedures in spine surgery but screw misplacement remains a major complication, even for very experienced surgeons, as pedicle screw misplacement rates have been reported between 5 and 41% in the lumbar spine and between 3 and 55% in the thoracic spine . Long-teA major cause of the mentioned issues is the limited visualisation in the surgical site and limited feedback to the surgeon of where the spinal implant is within the anatomy during the insertion and which tissue is being manipulated by surgical instruments such as a drill, probe, or forceps. In those cases, tactile and auditory senses are the only available feedback to the surgeon. The problem of limited visualisation and feedback becomes more evident in the case of minimally invasive spine surgery (MISS). A review by Camacho et al. on MISS in spinal trauma lists that MISS has many advantages over open surgery such as reduced blood loss, the lower risk of surgical site infection and an improvement in postoperative care and rehabilitation . HoweverThe technology in the operating theatre has evolved together with the problems that are being faced and many inventions have been made to improve intraoperative visualisation for  spine surgery. The latest advancements include augmented reality wearables to project the underlying anatomical structures and pre-planned operating paths on the patient to improve the operative workflow . HoweverSuch human-like sensing and decision making could possibly be performed and even enhanced by an integrated surgical robot system, as robots are currently employed more and more in the operating theatre because of their high precision and repeatability. In the research field of robotic spine surgery, there is a big upcoming momentum for surgeon-like autonomous behaviour and surgical accuracy in robotics which goes beyond the standard engineering notions such as geometric precision or resolution. As Staub et al. concludes that current technology does not allow for true autonomous robotic spine surgery but rather for the guidance of the surgeon, it shows that now is the time to boost that research . A systeTo summarise, surgeons and surgical robotic systems are facing limited sensory feedback in spine surgery which can lead to severe complications such as pedicle screw malpositioning and hematoma by unplanned breach during spinal drilling. Moreover, standard visualisation and imaging techniques in the operating theatre cause radiation exposure to the patient and medical staff, which should be minimised due to its health hazards. This systematic review investigates which sensor types and sensing methods can be applied in spine surgery and integrated in a multisensor platform to provide redundancy in the operational feedback to surgeon or robot. As the visual field is limited in spine surgery and there is a shift towards MISS, this study focuses on non-visual, non-radiative technology. The investigated categories of sensing methods were based on two review studies on tissue classification methods in spine surgery ,11. The -Which sensors are the state-of-the-art in non-visual, non-radiative, intraoperative sensing for spinal surgery with a focus on sensing forces, vibrations and bioelectrical properties?-Which physical properties are measured?-How are the gathered data processed?-What is the accuracy of the proposed measurement system?This systematic review is novel in the fact that it tries to offer a condensed summary of the available and tested sensor technologies for future research in robotic spine surgery. It provides a vantage point that facilitates experiment and prototype design and guides new research projects to what has not been thoroughly investigated or integrated in robotics to date. The included tables listing the sensors, their application and their performance can be used to select which sensors or algorithms for signal processing can be combined to perform real-time decision-making based on a multitude of feedback signals.The structure of this systematic review is shown in spine, vertebra, pedicle, intervertebral disc, screw, instrumentation, fusion, discectomy, drill*, mill*, cutting, condition, state, tissue, breach, perforat*, breakthrough, sensor, distinguish*, classif*, discriminat* recogni*, identif*, force, torque, haptic, sound, acoustic, vibration, emission impedance, resistance, conductivity, electrical. No further search filters were applied in the aforementioned databases. The keywords were combined in a string that was used as a search input in the databases. An example is given for the one used in PubMed: (condition OR state OR tissue OR breach OR perforat* OR breakthrough) AND (screw OR instrumentation OR fusion OR discectomy OR drill* OR mill* OR cutting) AND (sensor OR distinguish* OR classif* OR discriminat* OR recogni* OR identif* OR quantif*) AND  AND (force OR torque OR haptic OR sound OR acoustic OR vibration OR emission OR impedance OR resistance OR conductiv* OR electric*). The strings for the other databases were similar, with the exception that some databases accept no or a limited number of wildcards. Then, all the search terms with wildcards were replaced by their noun. e.g., recogni* was replaced by recognition. The search was performed within the title, abstract and keywords of the studies in each database. Two independent reviewers used the exact same strings of keywords to search the four databases, completely blinded to each other’s results to reduce the risk of bias. The search was performed on 26 April 2021 by the first reviewer and on 7 May 2021 by the second one. An iteration of the search was performed on 17 August 2022. The resulting studies were reviewed based on title and abstract. The following inclusion criteria based on relevance to the topic were utilised:Sensing is performed on bone tissue or artificial  alternatives.The sensors fall within the category of measuring force and torque, sound and vibration or bioelectrical properties.The proposed sensing method is non-radiative and non-visual.Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines  were foln = 5, three studies included, two excluded) were resolved by consensus. Consecutively, the review was performed on the full text for all studies that were agreed on. The following eligibility criteria were acquired:The studies are written in English and a full text is available.The journal in which the study was published has a SJR score with a Q-index of Q1 or Q2.The studies are published not earlier than 2005.The list of selected studies of each reviewer was compared and disagreements , tissue origin , data analysis and decision-making procedure, accuracy, whether or not the sensor was used in combination with a robotic system, and finally, the possibility of real-time sensing. The primary outcome measures were the sensor type and sensing method. The secondary outcome measures were the decision-making procedure and the accuracy. For the goal of the sensing method or its use in surgery, often the following expressions were used: ‘tissue discrimination’ and ‘drilling/milling state identification’. In this review, we consider this as the same goal since the drilling or milling state during surgery mainly depends on the type of tissue.The literature search identified a total of 765 studies. After the removal of duplicate results, 718 papers remained for screening based on title and abstract. Based on relevance, 672 papers were excluded because of relevance, for example, they did not cover spine sensing. From the 46 remaining studies, no full text could be retrieved for one study so that 45 papers were assessed for eligibility. Finally, ten studies were rejected because they did not meet one or more of the eligibility criteria. From all the studies identified via databases through a systematic search, 35 studies were included in the review. Through searching within the references of the 35 included studies, fifteen more studies were identified based on the title and their reason for citation in the included studies. After a full review, three of those studies were excluded because they lacked relevant information on the sensor and sensing method. No full-text was available for one study and three other studies were too old. This means that seven studies were included based on reference searching, hence the total number of included studies was 43.Fifteen studies cover force or torque sensing during spinal surgery. A summary of the sensor types and the objectives of sensing during spine surgery is shown in Five different surgical actions or procedures were involved in the studies that discussed force or torque sensing: drilling state identification, milling state identification, intraoperative bone quality assessment, breakthrough detection during pedicle drilling and the prediction of milling depth see . Seven sEight studies mentioned the use of a 6DOF force/torque sensor ,27,29,30One study made use of the LC0505 piezoelectric quartz force sensor  to measure the thrust force in the robot milling of the lamina . The datF, V, and S in Equation . The motion of the robot was compensated based on the real-time position of the bone such that the feed rate remained constant relative to the bone ,24. RossAI(f)=F(fp = 0.002).Finally,  used theSix studies analysed the accuracy of the used sensing and classifying methods. Tian et al. analysed the pilot holes for pedicle screws: the drill did not penetrate the second cortical layer for all 32 holes, even for deliberately incorrectly planned trajectories . The accFor force and torque sensing, the most commonly used sensor in this literature study is the 6DOF force/torque sensor see . This seTwenty-one studies were found that performed sensing in spine surgery using sound and vibration. Three of those studies combined sound and vibration sensing with force sensing ,19,20. AThe studies using sound and vibration sensing contained five different surgical actions or procedures: drilling state identification, milling state identification, cutting state identification, breakthrough detection during bone drilling, and monitoring of bone and implant integrity see . Eight sFour studies from the group of Dai et al. mentioned the use of an accelerometer ,38,39,40t-test was performed to correlate the ‘fingerprint’ of the frequency spectrum with the milling state [In five studies from the same group from Nankai University , a microphone was used to capture the sound of the machining process ,38,39,43ng state .In one study, the researchers used a low-cost, self-produced contact microphone that was connected to the skin with a kinesiology tape to detect AE-signals during bone drilling . The meaFour studies from one research group mentioned the use of the LK-H082 laser displacement sensor  ,36,37,41a, b, c, and d are the coefficients that are adjusted to fit the measured data best. The coefficients of the obtained function are used as input for an ANN that can then identify, based on the different combinations of high and low values for each coefficient, the different bone layers encountered during drilling. The same sensor was applied by [Four studies describe the use of an acoustic emission (AE) sensor ,20,45,49plied by ,20 to peTwelve studies assessed the accuracy of the tested measurement system. With a laser displacement sensor, Dai et al. were able to achieve a success rate of 94.7% (18/19 breakthrough experiments) in detecting the thrust-in point of the drill in the inner cortical layer . The samFor sound and vibration sensing, there is not one type of sensor that is reported drastically more often than other sensors see . In fiveTen studies were found that measured the bioelectrical properties such as the impedance of the tissues in and around the vertebra to monitor unintentional tissue damage. A summary of the sensor types and the objectives of sensing during spine surgery is shown in Four different surgical actions were identified in the studies that measured bioelectrical properties: cutting state identification, breakthrough detection during drilling, detection of screw malpositioning and detection of spinal motor tract injury see . The relThe three studies that monitored pedicle perforation during probing all used the same sensor: the PediGuard electrical conductivity measuring device  ,53,54. IIn six studies, electromyography (EMG) was performed to detect the occurrence of pedicle breach or the injury of soft tissue see . MonopolTwo studies that used EMG technology to detect a breach in the pedicle track before the placement of the screw used a ball probe to stimulate the pedicle track:  used theNine studies assessed the accuracy of the tested measurement system. In , the perFor the sensing of the bioelectrical properties, most studies in this review investigated electromyography see . Since sWhen all included studies are taken into account, only nine sensor types could be distinguished. The most commonly used sensors were microphones and 6DOF f/t sensors see . CoincidThe pie chart in Important when dealing with sensors is not only the hardware but also the way in which the gathered sensor data are processed and how decisions are made based on the data. Simple thresholding of the recorded signal based on a pre- or intraoperatively determined threshold was the most common procedure in the included literature see . The sliA similar set of graphs is shown in This systematic review was performed to create an overview of the state of the art in non-visual, non-radiative spine sensing, constrained to measuring forces and torques, vibrations and sound and bioelectrical properties. The objectives of this review are to provide an overview of the state-of-the-art in sensing technologies in spine surgery, to identify trends in the use of certain sensors or in data processing and to investigate whether there are research gaps for future developments in the research field.Most of the discussed sensors were tested on human or animal vertebrae and do not hinder the actions during spine surgery. The most commonly used animal substitute for human vertebrae were porcine samples, typically because of their anatomical likeness. However, there are still significant differences both anatomically and biomechanically between human and porcine vertebrae . All forFor sound and vibration sensing, there are many non-contact sensors such as microphones or laser vibrometers available that avoid the presence of the sensor in the sterile area surrounding the patient. However, the surgeons’ actions might be hindered because complete silence is required or because the presence of the surgeons’ hands and arms can block the laser beam. Accelerometers and AE-sensors have also been attached to the sample or patient to detect events such as vertebral fractures or drill breakthrough ,49,50. SFrom all investigated setups, only two sensors are commercially available as a finalised system in which data processing and decision making are integrated. These are the Ostell ISQ device used by Voumard et al.  and the The main objective in the majority of included studies is to obtain a sort of state identification during a surgical action. This includes the ability to recognise in which type of tissue the tool is operating and to detect specific events such as the first contact with a certain tissue or the breakthrough of a cortical bone layer. For force and torque sensing, that is most commonly done by thresholding the thrust force see . In the Overall, the accuracies mentioned in the reviewed studies were high, with many cases reporting detection or (correct) classification rates of more than 80%. In general, the accuracy was lower when several types of soft tissue such as muscles and the spinal cord had to be identified. For solely bony tissues, the classification rates were over 90% for 16 out of 22 studies that mentioned the accuracy or performance in bony tissues. From Three studies performed a combination of force and vibration sensing ,20,39. TA final remark on the accuracy relates to how the respiration of the patient influences the fidelity of state identification. This problem was brought to attention in the literature by Jiang et al. where it was shown that the success rate of detecting the inner cortical wall and stopping the drill was increased from 60 to 100% when the compensation of the drilling feed for the respiration was applied .The decision concerning which literature to include in a review can never be performed in a completely objective manner. However, there are methods such as the PRISMA guidelines that were followed in this systematic review to minimise bias by introducing a systematic and reproducible strategy to search for and select scientific literature. In our review, the eligibility criteria limited the literature to studies that are written in English and published no earlier than 2005 in a journal with a Q-index of Q1 or Q2. It is likely that a large group of studies has been excluded in this way and some sensors or sensing methods were not identified because of this. Nevertheless, in this review, we aimed to outline the state-of-the-art and thus only recent papers, starting from 2005, were included. The PRISMA guidelines advocate to only include high-quality research in one’s review but no strict definition is given of what can be considered ‘high-quality research’ so we decided to only include studies from journals having a SJR score with a Q-index of Q1 or Q2.Care should be taken when interpreting the results relating to the accuracy of the sensors in this review. The experimental sample size in each study varied widely, and for many studies, the accuracy was derived from a small number of measurements. Furthermore, As this systematic review tries to provide a vantage point for future research in more automated and safer spine surgery, some suggestions are given for potential research directions. More research should be performed into human tissue. Animal alternatives are easier to obtain both in the physical sense  as in the administrative sense  but there are still important anatomical and biomechanical differences between animal spines and human spines that limit the ability to thoroughly validate the sensor setup.Sensor fusion was very limitedly present in this literature review. Only three studies investigated the effect of sensor fusion on the accuracy of the sensing method. All three studies showed improved outcomes when data from different sensors were fused. Preferably, the sensors that are fused should be of different sensing categories  as it is more likely to measure something with one sensor that a sensor from another category missed. The potential for sensor redundancy is much higher in that case.This review also showed that the application of machine learning to decision making is very present in the case of robotic setups but almost completely lacking in non-robotic setups. It appears that there is a big research gap in machine learning applications for hand-held instruments in spine surgery. It is, nevertheless, an important direction as it combines the potential of multisensor technology and artificial intelligence with well-trained human senses and the experience of the surgeon. It also provides a larger sense of control for the surgeon than robotic setups do.Finally, the next steps in sensing methods for spine surgery is to include more realistic situations such as a ‘breathing’ sample, which was shown to complicate drilling state identification by Jiang et al. . MultiseAll sensors mentioned in this literature review, except for the EMG electrodes, show promising results in (robotic) spine surgery to improve the outcome of surgical procedures such as pedicle screw placement, laminectomy, discectomy, etc. Application in a robotic system is common for 6DOF force/torque sensors, microphones, and AE-sensors. Various studies provide a good example of how to integrate the sensor in the tool or robot seamlessly. In many cases, the simple thresholding of the measured signal is able to distinguish between operating a tool in cancellous or in cortical bone. Classifiers and neural networks can also perform real-time tissue classification and can accurately predict critical events during surgery such as breakthrough into soft tissue, given that the algorithm is trained well. The accuracy of the measurement systems discussed in this review was good, with many detection rates well over 90% when differentiation between different types of soft tissue is not taken into account. Redundancy by combining several different sensors and different measured features can improve this accuracy but synchronous data acquisition for all the sensors is essential. A research gap was found in the application of machine learning for data processing and decision making in the case of hand-held, non-robotic setups.


Global disease registries are critical to capturing common patient related information on rare illnesses, allowing patients and their families to provide information about their condition in a safe, accessible, and engaging manner that enables researchers to undertake critical research aimed at improving outcomes. Typically, English is the default language of choice for these global digital health platforms. Unfortunately, language barriers can significantly inhibit participation from non-English speaking participants. In addition, there is potential for compromises in data quality and completeness. In contrast, multinational commercial entities provide access to their websites in the local language of the country they are operating in, and often provide multiple options reflecting ethnic diversity. This paper presents a case study of how the Global Angelman Syndrome Registry (GASR) has used a novel approach to enable multiple language translations for its website. Using a “semi-automated language translation” approach, the GASR, which was originally launched in English in September 2016, is now available in several other languages. In 2020, the GASR adopted a novel approach using crowd-sourcing and machine translation tools leading to the availability of the GASR in Spanish, Traditional Chinese, Italian, and Hindi. As a result, enrolments increased by 124% percent for Spain, 67% percent for Latin America, 46% percent for Asia, 24% for Italy, and 43% for India. We describe our approach here, which we believe presents an opportunity for cost-effective and timely translations responsive to changes to the registry and helps build and maintain engagement with global disease communities. Registries for Evaluating Patient Outcomes released by the Agency for Healthcare Research and Quality [Angelman syndrome (AS) is a severe neurodevelopmental disorder caused by dysfunction of the maternally inherited UBE3A gene. It is estimated that 500,000 people live with AS worldwide . Global  Quality  and Rare Quality , 7. Anot Quality . Towards Quality . BarrierFindings from a review of articles on methodological approaches to the cross-cultural adaptation of surveys and tools indicated that translators should be fluent in the source and target languages, understand both cultures, and knowledgeable about the content of the instrument being adapted . AddressMachine translation (MT) involves using software tools to translate text or speech from the source language to the target language [language . The prolanguage .Translation memories (TM) are a related technology which involves storing previously completed human translations, including the source text and translated text, in a database and matching segments of text, such as a sentence, from the TM database with new source text to create translations [slations . Matchesslations .Crowdsourcing refers to an organisation (such as a research institution or not for profit) outsourcing a task previously undertaken internally to an external community to complete a task or solve a problem for mutual benefit [ benefit . In rese benefit . Organis benefit .Rare disease registries may present a unique opportunity for crowdsourcing translations, as rare disease communities often drive the development of registries and have strong involvement in registry governance and ownership. While crowdsourcing may seem advantageous in this context, projects must be managed effectively to prevent negative outcomes such as translator or researcher burnout or malicious translations. Blohm et al.  reviewedFacilitate participant recruitment for clinical trials;Collect the natural history of a large cohort of individuals with AS;Identify demographic, phenotypic and genotypic variation in clinical features and outcomes; andAid in service provision planning for individuals with AS and their families.The Global Angelman Syndrome Registry was launched in English in September 2016 . The regThe registry was originally deployed using the Rare Disease Registry Framework (RDRF) –33, an iSince its launch, AS organisations have expressed an interest in translation into multiple languages. Initially, the translation process was to include three steps: (1) Forward translation; (2) Back translation; and (3) Pilot testing. The forward translation process was completed for Italian, Spanish, French and Hebrew, and partially completed for Portuguese and Chinese.In 2020, the registry was moved to the Trial Ready Registry Framework (TRRF) , 34–39. Due to changes to the registry content and function, and the likelihood of the requirement for updates for existing translations and the addition of more languages, alternative methodologies for translations were explored that were less burdensome on the community and research team. The current study reports on the establishment of the GASR translation project.Crowdin [Crowdin software with crowdsourcing translations from the Angelman community and manage the translation process.To facilitate timely translation of the GASR, Crowdin  was seleThe GASR features a series of forms, or modules that collect information on an individual with AS’s condition. The forms cover demographic, clinical, behavioural and developmental information. The content of the GASR modules and other patient facing information including the registration form, standard emails, and website messages constituted the information to be translated. There were approximately 13 000 words on the GASR across the 20 sections to be translated.Prior to the availability of the translations, 1625 families have joined the registry, 1614 of whom had provided geographic data. As shown in Table Crowdin Enterprises project, hereafter referred to as Crowdin, (https://eresearchqut.crowdin.com/) was established to manage the project. Crowdin allows for different levels of access to ensure that participants only have access to tasks to which they are assigned by the project administrator. As the registry was pre-translated, the volunteers were assigned one of two roles: community proofreader or final proofreader. Community proofreaders review and modify existing machine translations, while final proofreaders are trusted professionals from the AS community who review and correct community proofread translations.A https://trrf.qa.angelmanregistry.info/. The website enables users to view the translations in the context of the website and access the Crowdin editor tool for each string. The editor tool shows the source text and several translations obtained from translation memory files or machine translations. The proofreader can revise, add or approve translations, and leave comments for other project team members.Proofreaders access the registry content via a testing site located at Crowdin tool. For the purposes of scalability, one language was selected for pilot testing and refining the translation process. To date, training sessions have been held with community proofreaders for the Italian, Spanish, Chinese, Portuguese and French languages. Hindi was subsequently translated by an external company capable of interfacing with Crowdin.Community proofreaders participated in a small group training session with one of the authors (M.T.), who explained the workflow of the project and how to use the The author running the training sessions checked in with a nominated translator from each group weekly to receive updates about progress and obtain feedback.The registry team submitted ethics amendments to incorporate translations into the protocol. Approval was granted for the translation of registry materials using the methods described above from the Mater Health Services Human Research Ethics Committee .The Spanish, Traditional Chinese, Italian and Hindi versions of the registry were launched in 2022 on the 6th January, 22nd March, 27th of April and 13th October respectively. Growth in registry enrolments post translations for each country or region where the language is spoken are shown in Fig. The Crowdin tool was user friendly. Proofreaders utilised a mix of the Crowdin editor tool and in-context editing tool. The editor tool displayed the source text and available translations side by side, enabling users to correct existing translations or add new translations. The Crowdin editor tool was the primary method used for proofreading, as all strings were displayed in the interfacing, ensuring comprehensive proofreading. The in-context editing tool was implemented on a test website which replicated the GASR site, which was valuable to view how the translations would appear to users in the context of the registry. A list of examples of source text, machine translations, and community and professional proofreading corrections is shown in Table Larger groups reduced the workload for individual proofreaders and enabled more comprehensive review of translations prior to the final proofreading step. For instance, the Spanish proofreading group identified that the word for “boy” and “child” was the same and could thus lead to Spanish speaking families reading sections of the registry as “boy/ adult” rather than “child/ adult.” The author in communication with the translation team (MT) was able to put them in contact with another author (RB) whose first language was Spanish.Newborn and Infancy module completed since the translations were implemented. This module was selected as being the first module users encounter in the registry, it had the highest completion rate, and responses were thought to be less impacted by the age and genotype of the person with Angelman syndrome. Responses to Likert scale items from the Newborn and Infancy module are shown in Table p = 0.002. Out of the 25 questions, only two demonstrated significant differences between the English and Spanish samples, reflecting that:Spanish speaking parents perceived their infant with Angelman syndrome to be placid more frequently than English speaking parents.English speaking parents perceived their infant with Angelman syndrome to experience more frequent reflux/gastro/oesophageal problems than Spanish speaking parents.Although validation is a separate step beyond translation, the authors compared 107 English and 55 Spanish responses to the The GASR was translated into Spanish, Traditional Chinese, Italian and Hindi. After completion of the community and final proofreading steps, acceptable translations were obtained and made available to the Angelman community. During our experience of managing and governing the translation and proofreading project, we refined the process to reduce burden on the research team and our proofreaders for future translations utilising crowdsourcing . These rCrowdin. The second step is to break the registry content into individual tasks based on word count and create a document with (1) links to the Crowdin editor for each task, (2) task name and description, and (3) task word count. The third step is to administer training covering completing tasks in the editing tool, and access to the in-context tool for reviewing content within the website to proofreaders. The translation projects would continue to be managed by the author (MT). Further to this, greater efforts would be made to validate the translations generated. An initial validation of the Newborn and Infancy module of the registry was promising, with few differences between English and Spanish responses.With respect to establishing translation project for future languages, our first step is to source machine translations to create the initial language translation on There were two possible limitations identified in the current study. These limitations relate to the translations, but may also be relevant to validation testing.In some cases, participants were unavailable to complete translation tasks due to competing priorities and responsibilities. Future strategies to assist families may include recruiting a larger number of proofreaders, facilitating support and connection between proofreaders, ensuring that larger proofreading tasks are broken down into smaller chunks, and providing incentives such as a donation to their local Angelman organization.Crowdin, with Crowdsourcing reserved for registry revisions once families have become more engaged for the Hindi language.As participation in the registry was very low for some regions, such as Asia, Africa and the Middle East, it was difficult to source proofreaders for languages spoken in these regions such as Arabic or Hindi. As a result, the team opted for professional translation via vendors who can integrate with Crowdin helps to manage ongoing translation and proofreading needs for research projects and maintain community participation and buy-in. However, further efforts are needed beyond translation to validate the translation of the registry for different communities.Crowdsourcing was an effective tool for upgrading translations, facilitating proofreading and integrating translated versions of the Global Angelman Syndrome Registry on an online platform. The availability of translations has led to greater participation and engagement of Angelman populations from regions where Spanish, Italian, Traditional Chinese and Hindi are spoken. The use of Crowdsourcing via online translation software such as