Results: a significant decreased salt intake and increase in SS were found at 1.5 years. It significantly decreased the BP and salt intake in the non-drinking group at 1.5 years. Conclusions: long-term nutrition counseling according to BMS improved salt intake and BP in the non-drinking group. However, in the drinking group, increased salt intake might weaken the BP improvement. Temperance and low-sodium intake are essential factors that control BP, especially in drinkers.Background: the behavioral modification stages (BMS) are widely used; however, there are no reports on long-term nutrition counseling for cardiovascular disease (CVD) according to BMS. Aim: to study the effects of long-term nutrition counseling based on the BMS in patients with CVD. Methods: fifteen patients with CVD who participated in nutrition counseling were enrolled between June 2012 and December 2016. We provided BMS and dietary questionnaires to estimate the stage score (SS), salt intake, and drinking habits (non-drinking group ( Currently, cardiovascular disease (CVD) is the second leading cause of death along with malignant neoplasm in Japan . In JapaLifestyle-related diseases, such as hypertension, are strongly involved in the development of CVD or congestive heart disease (CHF). Therefore, to prevent CVD, daily habits should be improved from early in the day, such as implementing nutritional and exercise therapies and quitting smoking ,5. FurthHowever, no reports on nutrition counseling using the TTM and long-term follow-up in patients with CVD have been described. We evaluated the effects of long-term nutrition counseling based on the BMS in patients with CVD. Therefore, we hypothesized that long-term nutrition counseling, according to the BMS, should induce lifestyle modification, in particular improvement of high blood pressure and decreased salt intake.This study was conducted from June 2012 to December 2016.The participants were patients who had no coronary restenosis after percutaneous coronary intervention at Fukuoka University Nishijin Hospital. The study protocol is indicated in Informed consent was obtained from all patients via consent confirm. The investigation conforms to the principles outlined in the Declaration of Helsinki. The present study was approved by the ethics committee of Fukuoka Medical Association Hospital   and was prospectively performed form June 2012 to December 2016. Prior to individual nutrition counseling, patients were provided with self-administered BMS questionnaires about dietary intake . DietaryPatients were provided with three-day food record questionnaires , with seNutrition counseling involved making appropriate improvement suggestions in dietary habits and behavior. Cardiologists provided counseling and nutritional intake directions . Counseling to promote a diet focused on increased consumption of, vegetables, mushrooms, seaweed, and fish and decreased consumption of foods that are high in salt (sodium), deep-fried food, and food with added sugar. Recommendations applied to risk factors for CVD, such as high blood pressure and high cholesterol ,5. Long-Counseling was guided by referring to the Ministry of Health, Labor, and Welfare, Japan Safety, and Health Council (2018): the standard medical checkup and health guidance program (definitive) . There aThe precontemplation stage: the managerial dietician confirmed the many benefits of changing dietary habits. We explained that, without changing dietary habits, it is much easier for the recrudescence of CVD.The contemplation stage: the managerial dietician proposed a behavior change on the dietary habits. High blood pressure and high cholesterol can be improved by increasing consumption of vegetables, mushrooms, seaweed, and fish, while reducing the consumption of food high in salt (sodium), deep-fried food, and added sugars. We explained that such behavior changes could assist in reducing the risk of CVD.The preparation stage: when patients seemed to have a problem regarding dietary intake, the managerial dietician could assist to establish some behavioral objectives on how to improve. We proposed increasing the consumption of vegetables, mushrooms, seaweed, and fish while reducing consumption of high salt (sodium), deep-fried food, and food with added sugar.The action stage: the managerial dietician identified the behavior problem then provided appropriate correction actions. We suggested continuing consumption of vegetables, mushrooms, seaweed, and fish, while decreasing consumption of food high in salt (sodium), deep-fried food, and food with added sugar.The maintenance stage: the managerial dietician identified the plan that prevented interruptions in behavioral modifications, concerning dietary habits with patients. We insisted on the continued increase of consumption of vegetables, mushrooms, seaweed, and fish, and reduced consumption of food high in salt (sodium), deep-fried foods, and food with added sugar. We asked patients with concerns about dietary habits.We assumed a deviation from and retractability in BMS beforehand and established a target ,11. MoreDietary intake investigated energy, carbohydrate, protein, fat, dietary fiber, potassium, and sodium from a three-day food record questionnaire. The calculation of the salt intake was based on the Microsoft Excel software—Excel Eiyoukun version 8.0   from “Son = 8) and non-drinking groups (n = 7). The data on SS, salt intake, and alcohol intake at hospitalization, 6 months, 1 year, and 1.5 years after leaving the OPD, were compared.The data from the medical records were collected—that is, age, weight, BMI (weight (kg)/height (m) × height (m)), total cholesterol (T-Cho), high-density lipoprotein cholesterol (HDL-Cho), low-density lipoprotein cholesterol (LDL-Cho), hemoglobin A1c (HbA1c), uric acid (UA), estimated glomerular filtration rate (eGFR), BP. Regarding alcohol consumption, the patients were divided into the drinking (n = 7), the drinking group < thrice a week (n = 3), the drinking group > four times a week (n = 5)) and salt intake, the drinking habit and the respective compared with salt intake and BP were considered.The relation between salt intake and each factor  after 1.5 years of leaving was also determined. Regarding alcohol consumption .The calculation of the dietary intake was based on the Microsoft Excel software—Excel Eiyoukun version 8.0  , from thn = 7)/the drinking group (n = 8)), and the respective SS and salt intake, BP were performed by statistical analysis of one-way analysis of variance, subjected to the general linear model with replicate.All analyses were performed using SPSS Statistics Version 22 . The weight, BMI, T-Cho, HDL-Cho, LDL-Cho, neutral lipid, HbA1c, UA, eGFR, energy, carbohydrate, protein, fat, dietary fiber, and potassium, with their means expressed as mean (standard deviation), were compared with salt intake, alcohol intake, BP, SS about dietary intake, drinking habits (the non-drinking group (n = 7), drinking group < thrice a week (n = 3), drinking group > four times a week (n = 5)) and salt intake were done using the Bonferroni correction. The correlation between alcohol intake and salt intake were calculated using the Spearman’s rank correlation coefficient. Student’s t-test was used to between the non-drinking and drinking groups . Chi-squared test was used for the daily habits, and the medications between the non-drinking and drinking groups. Student’s t-test was used to compare SS and salt intake, BP between the non-drinking and drinking groups, with the two-way analysis of variance (without repetitions). p values < 0.05 were considered statistically significant (two-tailed test). Using the multiple regression analysis, the relation between salt intake (dependent variable) and each factor  1.5 years after leaving was identified. Then, a stepwise method was used. Furthermore, multiple comparisons regarding the drinking habits .Changes in daily habits are indicated in p < 0.01); SS at hospitalization, 6 months, 1 year, and 1.5 years after leaving were 2.7 (0.9), 3.3 (0.7), 3.8 (0.4), and 3.9 (0.3) points, respectively.Score results of the BMS questionnaire were indicated. Changes in SS regarding dietary intake are indicated in p = 0.0043, at 1.5 years p = 0.032) , 8.7 (1.4), 8.2 (1.4), and 8.3 (1.5) g/day, respectively. It decreased in 1 year as well as 1.5 years after leaving, compared with that at hospitalization (at 1 year = 0.032) b.Changes in the nutrient intake are indicated in p = 0.013, at 1 year p = 0.002); however, an upward trend was seen in 1.5 years from 1 year after leaving. Systolic BPs (SBPs) of patients at hospitalization and 6 months, 1 year, and 1.5 years after leaving were 134.1 (15.0), 124.9 (17.5), 122.9 (15.3), and 127.0 (19.7) mmHg, respectively c. SBPs sp = 0.049).Concerning the relation with salt intake at 1.5 years after leaving, each factor  was compared. A significant positive correlation coefficient of 0.515 was noted between the salt intake and drinking habit .Changes in the patient bodies in the non-drinking group were compared with the drinking group, as seen in There was no significant difference between the drinking and non-drinking groups at the time of hospitalization. n = 7) and drinking (n = 8) groups were compared , 3.1 (0.8), 3.8 (0.5), and 3.8 (0.5) points, respectively; all, p < 0.05). SS of the drinking group tended to be lower than that of the non-drinking group.SS in the non-drinking (compared a. In botp = 0.254). At 1.5 years after leaving, salt intake in the non-drinking group (n = 7), drinking group < thrice a week (n = 3), and drinking group > four times a week (n = 5) were 7.5 (0.7), 8.0 (0.6), and 9.7 (1.8) g/day, respectively. The non-drinking group had significantly lower salt intake than the drinking group >four times a week (p = 0.041). A significant positive correlation coefficient of 0.628 was noted between alcohol intake and salt intake (p = 0.012). Salt intake in the non-drinking (n = 7) and drinking (n = 8) groups were compared (p < 0.05). From hospitalization to 1.5 years after leaving, salt intake was lower in the non-drinking group than that in the drinking group (p < 0.01).Alcohol intake showed an upward trend in the drinking group at the time of hospitalization and 6 months, 1 year, and 1.5 years after leaving were 20.3 (26.7), 19.6 (27.1), 14.9 (20.3), and 24.6 (31.1) g/day, respectively (compared b. At hosn = 7) and drinking (n = 8) groups was determined. In the drinking group, SBPs tended to decrease at hospitalization, 6 months, and 1 year after leaving: 134.1 (11.6), 131.6 (17.0), and 124.4 (11.2) mmHg, respectively . However, 1.5 years after, it was 133.8 (17.4) mmHg, which was higher than that in 1 year after leaving (p < 0.05).Changes in the drinking habit and BP are indicated in p < 0.05). In the non-drinking group, DBPs at hospitalization and 6 months, 1 year, and 1.5 years after leaving had significantly decreased (81.0 (18.0), 65.0 (9.2), 65.4 (13.3), and 62.7 (17.2) mmHg, respectively; all, p < 0.05).In the non-drinking group, SBPs significantly decreased at hospitalization and 6 months, 1 year, and 1.5 years after leaving: 134.1 (17.3), 117.1 (13.0), 121.3 (17.9), and 119.3 (17.9) mmHg, respectively (This is the first report assessing the effects of long-term nutrition counseling according to behavioral modification stages for patients with CVD. We discussed on what kind of help we can assist. The decision-making and execution power are all left to the patient’s own initiative, and medical staff have no way to interfere. However, diet therapy can allow patients to be treated in their daily lives. In conjunction with changes in behavior, the long-term nutrition counseling is reflected in the reduction of salt intake and the improvement of blood pressure.This strategy improved long-term behavioral modification, salt intake, and hypertension, and its effectiveness was significant in non-drinking patients with CVD. It is well known that excessive salt intake increases BP ,18,19,20In the drinking group, SBPs had significantly decreased in the short term, but the effects of BP disappeared after 1.5 years. Long-term nutrition counseling with behavioral modification stages went wrong in the drinking group. It is necessary to grope the planning of temperance and abstinence as a target of behavioral modification in social concerns. Yoshimura et al. reported that alcohol consumption is associated with salt intake and BP, and salt sensitivity improved by reducing alcohol intake . Salt inMost of the patients in this study were elderly with an average age of 71 years old. Akita et al. reported that guideline-based drug therapy alone for elderly cardiovascular patients was insufficient to prevent recurrence of CHF , and TsuThe findings of this study have to be seen in light of some limitations. The small sample of patients with CVD. Since this study is small, a large-scale, prospective study is necessary to obtain a final conclusion. Moreover, we were not considering the change of medication in this study, but that was a number of minor changes. In conclusion, this study suggests that acquisition of effective behavior modifications by long-term nutrition counseling, according to behavioral modification stages, is important for patients with CVD.


This article aims to uncover novel insights into personality factors and consumer video game engagement modeling. This research empirically validates the role of specific HEXACO personality factors that foster consumer engagement (CE) in electronic sports (eSports) users. Using a survey-based approach, we incorporated the HEXACO 60 items and consumer video game engagement scales for data collection. Data were collected from eSports users, with 250 valid responses. WarpPLS 6.0 was used for partial least squares–structural equation modeling analyses comprising measurement and structural model assessment. The results showed that the reflective measurement model is reliable and sound, whereas the second-order formative measurement model also meets the criteria of indicator weights and collinearity values variance inflation factor (VIF). The results based on the structural model indicate that openness to experience, extraversion, agreeableness, and conscientiousness positively predict CE in eSports. This article is first among others that conceptualizes and validates the HEXACO personality traits as a reflective formative model using the hierarchical component model approach. The research model carries the explanatory capacity for CE in eSports concerning personality dimensions as indicated by the HEXACO model. It highlights the potential benefits of such research especially to marketers who could potentially employ personality modeling to develop tailored strategies to increase CE in video games. Electronic sports (eSports) has become an emergent form of entertainment, with more than 380 million global viewers. Global consumer spending on video games is rapidly growing: from a total of $137.9B in 2018 to a forecasted value of $180.1B by 2021 . Within Extensive assessment of CE in games requires unified and cross-disciplinary efforts toward understanding the relationship between users and analogous game play–related products/services . Video gGiven the fact that personality is a significant factor in influencing human–computer interaction in games , it makeThe existing research has mostly employed the Big Five personality attributes, and very limited research exists that has investigated the impact of the HEXACO personality factors on CE, especially in online video game settings. Consumer engagement is defined as “A psychological state that triggers due to two-way interactions between the consumer and video game product, i.e., eSports game, which generates a different level of consumer engagement states ” , p. 249.So far, however, there is little debate on personality traits that have the potential to trigger CE in eSports environment. Hence, we cover this phenomenon in our study. This research is novel as we extend the concept of CE in eSports video games and explore the role of HEXACO personality factors in predicting CE. Besides, our study is first among others who conceptualizes and validates the HEXACO personality traits as a reflective formative model using the hierarchical component model approach.The most commonly used personality trait models include the Big Five model and the “five-factor” model. Both these models carry the capacity to predict individual personality traits in terms of five major personality dimensions that include conscientiousness, agreeableness, extraversion, openness to experience, and neuroticism . In 2000According to In the context of video games, individuals with pronounced personality characteristic would avoid engaging in video games. Previous research supports the notion that honesty–humility is not associated with gaming preferences . Honest We thus hypothesize:H1: Honesty–humility has a negative association with consumer video game engagement.An emotional individual is often sensitive, touchy, restless, and fearful . EmotionSome studies indicate a positive relationship of emotionality with video game engagement , howeverH2: Emotionality has a negative impact on consumer video game engagement.An extravert is usually chatty, lively, dynamic, conversational, and enthusiastic . ExtraveH3: Extraversion has a positive association with consumer video game engagement.Highly agreeable individuals tend to be relatively more trustworthy, helpful, adaptable, accommodating, and forgiving . AgreeabHighly agreeable individuals care about the contentment of others and therefore would value their commitments on online platforms . FurtherH4: Agreeableness has a positive association with consumer video game engagement.Conscientiousness is a personality factor focused on achievement, success, discipline, accountability, and cautiousness . ConscieH5: Conscientiousness has a positive association with consumer video game engagement.Individuals who are open to experience tend to be more creative, versatile, open-minded, adventurous, and in pursuit of new ideas and experiences. Such personalities actively engage in shooting games, action-oriented games, role-playing, and other similar genres . These pH6: Openness to experience has a positive association with consumer video game engagement.Based on the six hypotheses above, A cross-sectional survey design was implemented that allowed us to gather responses instantaneously, thereby expediting the process of data collection . Another∗Power 3.1.9.2  analyses] with actual power = 0.950.This study involved teenagers aged between 14 and 19 years. Initially, data were gathered from different gaming zones in Rawalpindi and Islamabad. Furthermore, the study also collected data from teen students because this population has the highest tendency to actively engage in digital game-playing behavior . Once we 3.1.9.2 . During The questionnaire designed for this study has three major parts. The first part of the instrument is related to the demographics of respondents. It provides us with general information such as age, gender, qualification, frequency of video game play, average hours of play, genres of games played, commonly used platforms for game playing, and location where games are most frequently played.The second part of the instrument is related to HEXACO personality factors adopted from the 60-item English version of the HEXACO-PI-R , 2016. TThe final part of the instrument is related to consumer video game engagement. Responses were collected regarding cognitive, affective, and behavioral engagement of the players with online video games. The scale was adapted from the previous literature, which has been formerly applied to assess consumer video game engagement . We adapThe main variables consist of the higher-order formative constructs from the HEXACO personality model . The individual personality factors were derived from associated aspects of participants’ personality. For instance, honesty–humility involves modesty, greed avoidance, sincerity, and fairness. Emotionality was captured from fearfulness, anxiety, dependence, and sentimentality. Extraversion was extrapolated from social self-esteem, social confidence, sociability, and liveliness. Agreeableness was deduced from factors such as forgiveness, gentleness, flexibility, and patience. Conscientiousness was determined from aspects such as organization, diligence, perfectionism, and prudence. The final HEXACO personality factor called openness to experience was reasoned from aesthetic appreciation, inquisitiveness, creativity, and unconventionality .Similarly, consumer video game engagement stemmed from a mix of cognitive, behavioral, and emotional aspects of an individual’s personality. All these three states of engagement were further elaborated: cognitive aspects were further extended into conscious attention and absorption; emotional or affective aspects were garnered from factors such as dedication and enthusiasm; and finally, behavioral engagement was surmised from factors such as social connection and interaction.All the items in the questionnaire related to the main constructs were assessed on the Likert scales ranging from 1 to 5 .To test the reliability of the questionnaire, a pilot study was conducted to evaluate the feasibility of the key steps, as well as to check for clarity of questions, grammatical mistakes, the feasibility of sampling technique, determining appropriate sample sizes, and reckoning overall feasibility of scale . To testUpon getting the response from the pilot study, we did some revisions, to ensure the correctness of the questionnaires as well as to ensure that a proper sampling protocol can be achieved. We then distributed 350 questionnaires, and 280 responses were collected. Once the data were collected, missing values and incomplete responses were identified and deleted using casewise deletion . As a rePartial least squares–structural equation modeling is a complete multivariate statistical investigation tool that was employed in this study to verify the study model . We applThe present study followed a two-step process that is based on the measurement and structural model. First, the researcher assessed the measurement model for authenticating reliability and validity of the variables, and second, the structural model was appraised to explain the associations between the main variables.The theoretical model  shows thTo evaluate the reliability and validity of the model, the study first analyzes all the first-, second-, and third-order constructs in the stated order, respectively.To assess the reliability and validity of first-order reflective constructs, the study checked three criteria such as internal consistency using Cronbach α and composite reliability (> 0.70), outer loadings (should be ≥ 0.40), convergent validity (AVE > 0.50), and discriminant validity . The resP-value of indicator weights associated with second-order formative constructs and VIF of the variables; these values in To assess second-order formative constructs, a two-stage method was adopted . To findAgain, to assess the validity of the third-order construct, that is consumer video game engagement, the study used WarpPLS version 6.0. Initially, the value of VIF was assessed, and then the significance level of the indicator’s weight was checked. T-value and the significance of the R2 coefficient. Effect size measures the impact of the independent variable on the dependent variable. According to the values of the effect size given in The study used WarpPLS version 6.0 to check the framework model and hypotheses. For this, we assessed the value of path coefficient with effect size and itemPlayers’ honesty–humility and emotionality factors have no effect on predicting consumer video game engagement.itemIn contrast, players’ conscientiousness, openness to experience, agreeableness, and extraversion factors have more than a small effect on developing consumer video game engagement. Hence, our proposed hypotheses are accepted.P-value, T-value, and path coefficient for our study hypotheses. The results shown in T = 1.03; P = 0.15) – H1 is not accepted. Furthermore, the path coefficient, T-value, and P-value for depicting the relationship between emotionality and consumer video game engagement are 0.07, 1.12, and 0.132, respectively. Because this does not meet the set criteria, our second hypothesis is also rejected. This means that there is no significant relationship between emotionality and consumer video game engagement – hence, H2 is not supported. Extraversion has a significant relationship with consumer video game engagement with a path coefficient of 0.145, T-value of 2.33, and P-value of 0.01—and as a result, H3 is accepted. Similarly, agreeableness, conscientiousness, and openness to experience have path coefficient values of 0.232, 0.184, and 0.177 and T-values of 3.8, 2.87, and 2.9, respectively. Also, the P-values shown in the table are < 0.001, 0.002, and 0.002 accordingly – therefore, H4, H5, and H6 are accepted. See In addition to the effect size, we also calculated the In addition, we examined the correlations between the personality traits, and the results showed that there is no high correlation issue. See With the addition of different gaming platforms, eSport video game is rapidly gaining prominence in the gaming industry. This study employs the HEXACO personality model to establish a relationship between consumer personality and consumer video game engagement in the context of eSports. Quantitative methods were employed in this research, and HEXACO-PI-R 60 items were used to investigate the personalities of consumers engaged in eSports. The study empirically tested and validated the proposed model using WarpPLS version 6.0 for SEM analysis. This research presents novel insights in uncovering the specific personality factors that drive consumers’ video game engagement.According to the data analysis, honesty–humility, and emotionality factors carry an insignificant impact on consumer video game engagement, whereas extraversion, agreeableness, consciousness, and openness to experience have a significant effect on consumer video game engagement.As mentioned earlier, our first hypothesis indicates that honesty–humility has an insignificant impact on consumer video game engagement. Previously, Our second hypothesis revealed an insignificant relationship of emotionality with consumer video game engagement. In prior studies, a negative relationship was also confirmed between emotionality and daredevil preferences . It is iOur third hypothesis of the study showed a positive relationship of extraversion with consumer video game engagement. Previous literature also confirms the presence of an insignificant relation in the context of player game preferences , video gOur fourth hypothesis shows a positive relationship between agreeableness and consumer video game engagement. In previous research, agreeableness dimension carries a positive correlation in multiplayer games environment and “helping” style games , as wellOur fifth hypothesis shows that consciousness has a positive association with consumer video game engagement. In previous research, conscious individuals have demonstrated achievement-oriented behaviors in game-based settings . ZeiglerOur final hypothesis shows a positive relationship between openness to experience with consumer video game engagement. Literature confirms the same relationship: for instance, a study revealed that online-game players are higher in openness to experience than nonplayers . Also, oThis study makes several theoretical contributions. First, we present an empirical study of the HEXACO personality model and its association with consumer video game engagement in the context of eSports. Previous literature added that Big Five personality dimensions carry an impact on CE in the context of online brand communities such as social media platforms . HoweverThis study also makes critical managerial contributions. First, this article highlights how marketers can capitalize on consumers’ personality factors by focusing their investments on specific personality attributes that are predicted to optimize video game engagement. Secondly, our model offers marketing practitioners the opportunity to develop video game strategies based on their target consumers’ personality factors and their expected effect on CE, which are extremely substantial in today’s era of one-to-one marketing and big data analytics. Third, video game developers can also develop specific games by capturing consumer’s interest according to each personality factor; thus, ultimately, their market share and overall growth in the industry can be maximized. A clearer picture of consumers’ personality characteristics may also help practitioners garner a better understanding of how to strategically build a process to engage customers in video game settings actively.Despite its contributions, this study is still in its exploratory stage to understand the personality factors and consumer video game engagement and therefore subjected to several limitations. The first limitation is on the assumption that gamers and eSport gamers are assumed to take on the role as what is observed. With the six attributes that we have identified, we have taken the eSport gamers and personalities on the face value. We believe that it is also important to understand what takes place throughout the development of the attitude and behavior of these gamers. This could be done by using a longitudinal study (development of behavior through a process of sampling different sample groups) or conducting an experiment on the personality traits that are captured in the HEXACO 60 items. In experimental studies, control groups should be able to mobilize to capture the effects of the personalities. Second, to validate the HEXACO 60 items, the sample size is relatively small and focused on respondents from Pakistan. For a better generalization, there should be efforts to collect more samples, not only within a country but also to simultaneously expand the data collection to different countries (to capture the differences in cultures as well). Third, our study is limited in terms of the scope of its investigation within the context of eSports, whereas this study can also be extended to other genres of video games including intellectual games or virtual reality games and to investigate how consumers’ personality characteristics predict consumers’ preferred game-product preferences. Fourthly, with the advent of eSport gaming, games are not only played by men, but also by women. We acknowledge the unbalanced gender distribution in our study. Care should be taken to include a better representation of gender distribution in future studies. The condition of nongamers versus gamers  should also be defined, to understand and capture the unprecedented conditions and personality differences.The datasets generated for this study are available on request to the corresponding author.The studies involving human participants were reviewed and approved by the Departmental Ethical Review Committee Shaheed Zulfikar Ali Bhutto Institute of Science and Technology (Szabist). The patients/participants provided their written informed consent to participate in this study.AA, SN, and UR worked on the idea development and conceptual design. SN and AA worked on the data analyses. SN, UR, AA, and DT edited the manuscript and improved the contents of the manuscript. All authors contributed to the article and approved the submitted version.The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.


Reaching recruitment targets in randomised controlled trials is a challenge. Media tools are increasingly used to engage participants, yet there is a paucity of research into the use of video to optimise recruitment. We therefore tested whether adding a participant information video clip to a standard participant information sheet improved recruitment into a parenting trial.n = 51) or an informational video clip (n = 56) as part of an email contact following a screening phase. All participants went on to receive the information sheet as part of the existing consent procedure.One hundred seven participants were randomised to receive either a participant information sheet (p = 0.003).The video condition did not increase the odds of recruitment into the trial, such that those in the video condition were significantly less likely to participate in the main trial (OR = 0.253, CI = 0.104–0.618, The introduction of a video clip into the recruitment stages of a parenting trial did not lead to an improvement in recruitment; however, the small sample size precludes definitive inferences. We offer reflections on challenges encountered in implementing the SWAT and suggestions for other researchers seeking to embed recruitment SWATs into similar trials.ISRCTN 58327365. Registered on 19 March 2015.Current controlled trials SWAT 106; Effects of a video clip on recruitment into a randomised trial. Registered on 20 December 2016. Randomised controlled trials (RCTs) are considered the gold standard in research design for evaluating interventions , 2. HoweA developing area of trial methodology, which can be used to investigate recruitment strategies, involves embedding a study within a trial (SWAT). SWATs are a means of evaluating methodology and formally assessing how effectively a study is running. Treweek and colleagues  defined The value of SWATs is increasingly being recognised, with several developments moving to raise their profile and encourage their routine use in RCTs . These iCurrently sharing an information sheet or form is the conventional format for providing study information to potential participants. Traditionally, this information sheet or participant information sheet (PIS) is a printed text document that aims to provide potential participants with comprehensive details of the study. These often become long and complex to ensure accordance with ethical guidance  and may Indeed, there has been an increase in the use of multimedia implemented within trial design . It has been suggested that video clips may be an acceptable means of promoting understanding of participation in RCTs with a small but growing number of studies assessing their utility. Meropol et al.  looked aMore recently, Jolly et al.  conducteResearch using SWATs to investigate the use of multimedia in recruitment processes could identify more effective and efficient recruitment methods in RCTs. As the utility of multimedia may differ depending on the target group, there is a need to investigate its inclusion during recruitment of diverse patient and public populations. SWATs themselves create a vital opportunity to evaluate methodology in real world trials; however, reporting of SWATs remains limited. Through sharing the challenges faced and the key learning points from the present study, we hope to provide information to help support the routine inclusion of SWATs in RCTs.This study aimed to use a SWAT to explore whether the inclusion of a video clip alongside a standard PIS improved the rate of recruitment, compared to a standard PIS alone. We further aimed to report our experience of embedding a SWAT during an active RCT and the challenges encountered, and offer reflections for consideration by other researchers.The present SWAT is hosted by the Healthy Start, Happy Start  study. The HS,HS study is a UK-based RCT funded by the NIHR. HS,HS aims to assess the effectiveness and cost-effectiveness of a Video-feedback Intervention to promote Positive Parenting and Sensitive Discipline (VIPP-SD) in preventing enduring behavioural problems in young children aged 12–36 months  trusts, via face to face contact and mailshots. The eligibility criteria for HS,HS included parents aged ≥ 18 years, child aged between approximately 12 and 36 months, a score in the top 20% on population norms for child behaviour problems using the Strengths and Difficulties Questionnaire  and wriAs is the case in many RCTs, recruitment for the HS,HS trial was initially slow, and therefore, an extension was granted for 9 months to enable the target sample size to be met. The HS,HS trial encountered challenges to recruitment in part due to changes to local health visiting services and NHS service provision which impeded the availability of staff time to support face-to-face recruitment. Consequently, the trial increasingly utilised mailshots to reach potential participants. These challenges also stimulated a dialogue surrounding alternative methods to optimise families’ initial engagement in the study and the recruitment process. We had previously revised the PIS to improve its readability and added a randomisation schematic to aid understanding. However, we were constrained by the PIS’s traditional text-based format, ethical requirements concerning the level of detail and topics requiring standardised institutional wording. Thus, we were interested in determining whether adding a short video clip to the PIS could be more appealing, help to personalise the research by introducing the research team and provide sufficient initial information to increase families’ engagement with the recruitment process. Also, as the intervention under study in the HS,HS trial used video clips of parents’ behaviour to enhance parenting, the clip could help to normalise the experience of being on camera. To explore this idea further the team decided to implement a SWAT 8 months into recruitment, after approval was sought through a substantial amendment. The SWAT sought to compare the effect of a video clip and PIS, to the PIS alone, on recruitment and to learn from both participant and researcher feedback, as well as reflecting on the process of embedding a SWAT in an active RCT.The HS,HS study had an active patient and public involvement (PPI) group that were involved in all aspects of the trial and were also consulted during video clip development. An indicative draft of the video was made by the research team and a dedicated PPI meeting was held to discuss the video. The group’s suggestions shaped the contents and design of the clip, which included adding an explanation of why the study is relevant for the population, highlighting the importance of research within the NHS, timing visual animation effects to match the voice over, what actors should demonstrate in terms of family participation and the inclusion of both senior (e.g. chief investigator) and junior staff (e.g. research assistants completing the research visits) in the video. Following these suggestions, a final version of the video was designed. A member of the PPI group and their family featured in the video to help explain what would be involved in the research visits. The video included a welcome by the chief investigator, outlined what would be involved in each trial arm and introduced the research assistants who would be conducting the home-based research visits. The duration of the video totalled 302 s (5 min).The development of the video required approximately 60 h of research assistant time. Video props and technological equipment were purchased for £250 and the actor family in the video was given a £50 honorarium for taking part. Both the video producer and graphic designer worked at a significantly reduced rate due to the nature of the research and were each given a £200 honorarium. An alternate quote for video production was £750. Costs for the PPI group consultation were approximately £350. The six attendees were provided with £50 vouchers as compensation for their meeting attendance, email contact and feedback about the design and content of the video, and approximately £50 spent on refreshments at the meeting. The total estimated costs for the development of the video are £1000 (not including researcher time).The PIS comprised of a 4-page word document structured in headed paragraphs describing the HS,HS study. The PIS included information on why participants had been asked to take part, the possible benefits and disadvantages of participation, confidentiality, information security, information about the funders and contact details of the principal investigator and trial manager. The PIS was amended during the trial phase of HS,HS to enhance understanding and readability following informal feedback from trial participants. Two schematics were included to illustrate the possible randomisation allocations to improve understanding of group allocation.The SWAT ran for 15 weeks between March and July 2017 until recruitment to the trial ended. Once eligibility for the trial phase of HS,HS was confirmed, participants were assessed for inclusion into the SWAT sample. The additional eligibility criteria required for SWAT inclusion was that participants needed to provide a valid email address. For example, those participants who only provided a telephone number as contact details were excluded. All participants who were invited into the trial during this time period were assessed for eligibility for the SWAT. Participants who were already participating in the HS,HS trial could not be included in the SWAT. See Fig. Participants were randomly allocated to receive one of two initial contacts from the research team: video and PIS or PIS alone. For ease of understanding the video and PIS group will be referred to as the ‘video group’ and the PIS only group will be referred to as the ‘PIS group’ hereafter. A randomisation list for the initial contact was prepared by the trial statistician, and allocation was released weekly to the research team. Each participant was allocated to their condition based on the week they returned their screening questionnaire. The research team were not blinded to group allocation.The initial randomised contact took place after participants completed the screening phase. Participants were sent an initial email thanking them for completing screening and informing them that a member of the research team would be in touch by phone within a couple of days. The email sent to both groups was identical except that the video group’s message included a link to the video clip, whereas the PIS group only had the trial’s standard PIS attached. Once a minimum of 24 h had passed, the research team called participants to ascertain their interest in participating in the full trial. Follow-up involved telephone call(s) and/or email(s) until contact was made.The contacts were spread over approximately 4–6 weeks, and there was a mean of 2.7 contacts per participant during this time frame (range 0–15). If contact was established with the participant, the study was explained by a member of the research team and they were then sent an email with the PIS attached, irrespective of group allocation, to ensure this did not affect the provision of the standard PIS to all participants at the time of booking a first research visit.Participants who were randomised into HS,HS during the SWAT period were then asked a few questions at the end of their first research visit. The aim of these questions was to ascertain feedback about their experience of receiving either the PIS or video clip, whether it affected their decision to take part in the study and how useful they found it  on the number of participants recruited into the trial (randomised vs not randomised). Despite randomisation, more participants in the PIS group (63%) were screened in person in comparison to other methods whereas only 40% of participants in the video clip condition were screened in person. Differences were identified between the groups in regard to baseline characteristics in education and number of contacts made by the team. Therefore, the regression was repeated to adjust for number of contacts made and education status. Educational status was defined in two levels  and number of contacts made by the team was continuous. Findings were presented using odds ratios (OR), and 95% confidence intervals (CI) were calculated to compare intervention strategy on recruitment.n = 5) and PIS (n = 12), which increased the risk of bias.A secondary outcome of interest was participant and researcher attitudes towards method of recruitment via brief structured interviews. Our goal was to invite all SWAT participants to participate in an interview; therefore, data saturation was not used to inform data collection. However, due to time demands in research assessments, it was not possible to interview all SWAT participants. Where interview data were available, content analysis was used to analyse the text . HoweverN = 105, SD = 5.4), and the mean child age was 21.9 months (SD = 0.5); slightly more male than female children participated (58% vs. 41%). Table During the SWAT period, 317 potential HS,HS participants were screened, of whom 121 were eligible for the HS,HS trial, and of these, 107 were eligible to be included in the SWAT sample. Fourteen participants were excluded as they had not provided an email address. Of the 107 participants, most were identified as ‘White’ (79%), biological mothers (93%) and educated to postgraduate level (47%). The mean parent age was 33.59 years . There were initially 56 participants allocated to the video condition; however, 6 were then excluded from analysis as they were inadvertently allocated to the wrong group. Figure p = 0.003). Thus, the odds of consenting to the trial were statistically lower in the video group compared to the standard PIS group.Of the 50 participants given the video clip, 10 20%) consented to take part in the trial, compared with 26 (51%) of 51 participants given information only via the traditional PIS. The difference was 26%. Table 0% consenThe video was emailed to 50 prospective participant email accounts. Access to online metadata from the host website revealed that the link was accessed 38 times, and of these, 16 watched the entirety of the video clip. The average length of play was 190 s (of a possible 302 s).n = 36), for practical reasons (e.g. time demands of the assessment) and the importance of not overburdening participants, 17 participants were invited to interview. All 17 participants who were approached agreed to interview . Baseline demographics of interviewed participants are displayed in Table Whilst the initial aim was to gain feedback from all SWAT participants who were randomised (“I did find it helpful to watch it and thought that it gave quite a lot of information”. (video clip)“it was well explained”. (PIS)Irrespective of condition, all participants commented positively on how useful they found the introductory information. Participants from both groups commented that the information was easy to understand and that it was informative:However, participants within both groups stated that they had further questions that needed discussing over the phone.One PIS participant commented: “I think I needed a few things explained”.And one video clip participant indicated “I think I got more from actually chatting and asking questions that the actual video clip itself”.The participants in the video group tended to frame the material as introductory, whilst those in the PIS described the material as comprehensive.“I noticed a difference in how receptive they were just to our phone call [erm] because they’d had a chance -whatever they’d received they’d had the chance to consider the study a bit more”.The key finding from both researcher interviews was the shared perception that the initial email contact increased participants’ receptivity to the study team and engagement in the trial. Prior to the SWAT being implemented, participants were first contacted by telephone after completing the screening questionnaire. Notably, both researchers reported that participants, regardless of condition, were more open to phone calls after receiving an initial email.“they all commented on the understanding of the two groups”.“that was the hardest thing to explain to participants without a visual aid, over the phone I think it was helpful that they had seen those two groups”.Both researchers found that participants had often not watched the video clip or only viewed a portion of it, although those who had viewed it were reported as having a better understanding of randomisation:“I think for the families who had seen it I think that was really reassuring that it’s like ‘look we’re these harmless people who are coming to play with some toys and ask some simple questions’ it’s not this weird abstract visit that has no context”.The researchers also highlighted the advantage of participants seeing images of the research team and activities in the video clip:Contrary to our expectations, the inclusion of a video during recruitment did not result in an improvement in recruitment rates in this RCT of a parenting intervention. However, the interpretation of the results should be made cautiously given the small sample size and the exploratory nature of the study. This finding is consistent with both the findings of Jolly et al.  and CampMoreover, participants included in this SWAT were generally highly educated, particularly in those interviewed, and so have an assumed higher reading level. Therefore, it would be plausible that the enhanced PIS used was accessible and understandable. By extension, the video may not have had as much impact on understanding within this population, compared to a potential participant population who have a lower reading ability or based on previous research . EquallyAnother possible explanation for these findings may be linked to the format and use of the video clip. The metadata indicated that only one third watched the clip in full, assuming no participant watched it twice. Although studies on patient engagement with clips do not typically report metadata, research on the use of educational videos in the context of distance learning has found that the rate of in-video dropout is positively correlated with video duration, with a predicted drop-out rate of 53% for a 5-min video . Thus, iAn unexpected, but notable finding came from the researcher experience which suggested that email contact prior to the recruitment phone call, regardless of group allocation, helped promote participants’ engagement with the study. This finding is contrary to the Cochrane Review by Mapstone et al.  who repoWe encountered a number of challenges in implementing the SWAT during an active RCT.Whilst it is an advantage that the SWAT was responsive to recruitment challenges as they arose, the timeframe to implement the study significantly undermined the amount of data that could be collected. From initial idea to implementing the SWAT, the entire process took 13 months leaving just 4 months of data collection. This involved collaboration with the PPI group, submitting a substantial ethics amendment, creating the video clip and gaining local approvals from each of the trial sites. Thus, the sample size was small and this limited inferences that could be gleaned from the study. Future research would benefit from including SWAT procedure in the original ethics application and holding PPI consultations in the first instance to avoid delays. Indeed, in the UK, the NIHR Health Technology Assessment (HTA) programme now encourages the inclusion of SWAT protocols in funding proposals for host trials. To this end, the SWAT template provided by Smith et al.  may provThe SWAT also added time into the recruitment process and an additional step, an email contact, that had not been completed previously. This had the effect of a cumulative increase in workloads in the context of demanding recruitment targets and deadlines. Combined with the randomisation allocation which changed weekly, this may have increased the likelihood of human error. This can be seen in the randomisation phase where six participants were contacted with the incorrect study allocation. Embedding the SWAT at the beginning of the trial could provide further time for training; alternatively, automating aspects of the recruitment process could also minimise the scope for human error.It was difficult to control for a number of extraneous factors. For example, the number of contacts was conflated by the temporal factor of recruitment deadlines, such that the frequency of contacts increased in line with monthly deadlines. Ideally, the number of times the study team contacted participants would be standardised; however, this is not practical in the context of target-driven recruitment. Similarly, it was difficult to prioritise the interviews with participants about their SWAT experience at the risk of overburdening participants and without undermining the time allocated to outcome assessment. Thus, less interview data were collected than expected, particularly in the video condition, and this may have limited insight. Moreover, whilst participants were generally positive about the information they received through the SWAT, it would have been helpful to find out why they may not have watched the full duration of the video. Due to the limited sample size, we were unable to control for the initial contact type participants received during screening. For example, potential participants either completed screening in person with a member of the wider team or received questionnaires in the post. Whilst these were not notably different between groups, further research may benefit from controlling for extraneous factors of this nature. Moreover, participants were highly educated and often women; it is difficult to generalise these findings to other types of participants who may have different experiences which would influence their engagement with written material or video content.The optimal design would be to test the video clip in isolation against the PIS to identify effects on recruitment. However, due to ethics requirements, participants had to receive the PIS prior to the baseline visit limiting our ability to formally test the video on recruitment. In a time of increased use of multimedia, it would be instructive to formally test whether there are complete alternatives to standard PIS that may be more acceptable and effective whilst being ethically robust. We were also unable to gain feedback from families that may have viewed the initial information but not enrolled in the study, which limits our understanding of participants’ reasons for not engaging with the study.Although somewhat contrary to our expectations, it was encouraging that the PIS appeared to be effective for this sample. Moreover, participants and researchers perceived an initial email contact, regardless of whether it included the PIS or video, as being helpful. This suggests that initial contacts of this kind may be helpful in facilitating initial conversations about research as well as decision making about taking part. It would be helpful to test this formally using a SWAT design in future studies.Future research may be focused on testing the effectiveness of a video clip as an initial recruitment contact rather than following a screening phase. Moreover, it would add value to evaluate this recruitment method in different demographic populations  in order to better ascertain utility. The inclusion of data regarding participants’ engagement with a PIS would also be helpful to identify potential areas for improvement and general levels of engagement.We found involvement with our PPI group extremely helpful in developing the video and SWAT study. We strongly recommend that other researchers involve PPI groups when developing patient facing materials and designing trial procedures. The video may have benefited from several rounds of user testing to optimise its potential; however, due to timeframes and potential burden on the PPI group, this was not possible on this occasion.Future research could consider whether videos may be particularly helpful for specific groups, better utilised in shorter (e.g. 30 s) formats addressing specific topics (e.g. randomisation), or as a supplementary material after participants have read the PIS. It would also be of interest to examine the impact of either formats on participant retention.The inclusion of a video clip explaining the trial did not result in an increase in recruitment to the host trial of a parenting intervention. Future research could consider a shorter video clip and explore its effectiveness in different populations alongside collaboration with a PPI group.Additional file 1: Appendix 1. Interview schedule for participants. Appendix 2. Interview schedule for researchers.


DNAH6, SPATA16, DPY19L2, PICK1, and CCIN related to globozoospermia, have been reported in the past few years. The DPY19L2 mutation is commonly found in patients with globozoospermia. Herein, a 180-kbp homozygote deletion at 12q14.2 (g.63950001–64130000) was identified by copy number variation sequencing (CNVseq) in a patient with a globozoospermia, including the complete deletion of DPY19L2.Male infertility is an increasing medical concern worldwide. In most cases, genetic factors are considered as the main cause of the disease. Globozoospermia (MIM102530)  is a rare and severe malformed spermatospermia caused by acrosome deficiency or severe malformation. A subset of genetic mutations, such as DPY19L2, which was further diagnosed as globozoospermia.A 27-year-old patient at the First Affiliated Hospital of Xiamen University was diagnosed with infertility because, despite normal sexual activity for 4 years, his wife did not conceive. The patient was in good health with no obvious discomfort, no history of adverse chemical exposure, and no vices, such as smoking and drinking. The physical examination revealed normal genital development. However, semen tests showed a normal sperm count of 0% and the morphology was the round head. Sperm cytology showed that acrosomal enzyme was lower than normal. Reproductive hormones were in the normal range. B ultrasound did not show any abnormal seminal vesicle, prostate, bilateral testis, epididymis, and spermatic veins. The karyotype was normal, 46, XY, and no microdeletion of Y chromosome was detected. However, a homozygous deletion mutation was found in DPY19L2 had a homozygous mutation, which was the primary cause of globozoospermia.The present study reported a male infertility patient who was diagnosed with globozoospermia. The analysis of gene mutations revealed that  Infertility has gradually become a medical issue attracting worldwide attention. In most cases, the gene factors are considered to be a major cause of the disease , 2. GlobDNAH6 [SPATA16 [DPY19L2  mutations affect sperm head elongation and acrosome formation and accounts for approximately 75% of the patients with globozoospermia [SPATA16 was the first gene reported to be involved in the pathogenesis of globozoospermia in humans [SPATA16 mutations have been identified in some acrosome absent cases that result in globozoospermia as the membrane is unable to bind the zona pellucida and fertilize the oocyte [PICK1 gene encoding a cytosolic protein is found in the proacrosomal vesicles of round spermatids; the mutations in this gene lead to the failure of the merge of proacrosomal vesicles, thereby resulting in globozoospermia [CCIN encodes a major basic protein of the mammalian sperm head cytoskeleton, and its absence or altered arrangement of the calicin protein is related to globozoospermia [Gopc [Hrb [Csnk2a2 [Hsp90beta1 [Vps54 [Mfsd14a [GM130 [DPY19L2 account for up to 75% of globozoospermia, the genetic mutation spectrum is not yet completely fully elucidated, necessitating an in-depth investigation to deduce the involvement of DPY19L2 in globozoospermia.Previous studies have suggested that gene mutations might be the pathology underlying human globozoospermia, and several genes, such as DNAH6  and SPAT[SPATA16 , cause gn humans . SPATA16e oocyte , 15. PICospermia . CCIN enospermia . In mousia [Gopc , Hrb [22opc [Hrb , Csnk2a2[Csnk2a2 , Hsp90bep90beta1 , Vps54 [1 [Vps54 , Mfsd14a[Mfsd14a , and GM1a [GM130  can replDPY19L2. This study confirmed that DPY19L2 mutation is the main cause of globozoospermia, which broadened the mutation spectrum of the gene.In the present study, we investigated an infertile patient with globozoospermia and identified a homozygous deletion mutation in 6/mL; prorsad percentage motility, 15–18%; non-prorsad percentage motility, 12–15%. Sperm morphology examined by Papanicolaou staining showed 0% normal morphology. The biochemical testing of seminal plasma showed that the content of sperm acrosomase was 32.6 uIU/10 × 6; neutral glycosidase, 20.6 mU; fructose level, 17.5 μmol; zinc level, 5.4 μmol. The reproductive hormones were within normal ranges (follicle-stimulating hormone (FSH) 4.56 mIU/mL, luteinizing hormone (LH) 5.87 mIU/mL, T 4.34 ng/mL, E2 33 pg/mL, PRL 12.62 ng/mL). B-ultrasound showed no abnormalities in the seminal vesicles, prostate, bilateral testes, epididymis, and spermatic veins. The chromosomal karyotype of the patient was normal, 46, XY, and no microdeletions were detected in the Y chromosome. The patient’s family had yet to undergo follow-up treatment.The proband  and his family were recruited from the First Affiliated Hospital of Xiamen University. Pedigree analysis revealed recessive autosomal (AR) inheritance  on the DNA samples of the proband and his parents. The mutation was detected in the DPY19L2 in the proband. A similar phenotype was detected in the mother’s genome, while no such variation was found in the father’s genome  further confirmed these defects, and the sperm from the patient showed numerous ultrastructural defects in the head. The ultrastructure of the sperm in the control patient was normal, while that of the proband was round Fig. c.We determined the levels of DYPL92 in the sperm using Western blotting and found that DYP19L2 was not expressed in the sperm of the patient Fig. .Fig. 3EDPY19L2 is a pathogenic gene underlying spermatogenic failure, which is an AR inheritance disorder; the homozygous variation might lead to morbidity [DPY19L2 was absent.Globozoospermia is a disease of sperm malformation characterized by round head sperm and lack of acrosome. These sperms cannot penetrate the zona pellucida of the oocyte, leading to failed fertilization and infertility . When thorbidity . In the DPY19L2 mutation types exhibit variations in frequency distribution, which might be attributed to the limited number of patients recruited or analyzed in these studies. Also, the frequency distribution of DPY19L2 mutation types may be different in pure Chinese patients with this AR genetic disease due to the change in social and cultural factors such as blood relationships [Previous studies have shown that ionships , 32.DPY19L2 in the sample through sequencing; however, the large fragment variation of the gene could not be determined. Thus, other quantitative PCR methods such as MLPA could be utilized to detect the large fragment variation of the gene [DYP19L2 and its pseudogene, selecting a highly specific probe with a unique sequence matching the specific DPY19L2 nucleotide to overcome the interference of DPY19L2 pseudogene is essential [Furthermore, reverse transcription-polymerase chain reaction (RT-PCR) detected the tiny variation of the gene . Nonethessential , 32. Morssential .DYP19L2. Complete gene loss leads to complete loss of DYP19L2, which might result in complete loss of DYP19L2 function; thus, the sperm of the patient presents globozoospermia. Therefore, this study broadens the mutation spectra of DYP19L2 mutations that cause globozoospermia.Herein study, we found that 180-kbp homozygous deletions (g.63950001–64130000) at 12q14.2 on chromosome 12 in the sample of the patient subjected to CNVseq, including complete loss of DYP19L2 are the major causes of globozoospermia in humans. The homozygosity deletion of DYP19L2 affects the normal development of sperm head, leading to the typical globozoospermia phenotype. Therefore, the current study provides researchers and clinicians with updated information about sperm with globozoospermia.In summary, our findings confirm that mutations in Additional file 1: Supplementary Table 1. Results of exon mutation test on proband and his parents


The mechanism of injury (MoI) for a patellar dislocation has not been fully established. The aim of this study was to use systematic video analysis to determine the MoI of a patella dislocation.p < 0.05).A systematic search was conducted of three video sharing websites and three popular search engines to identify videos demonstrating a patellar dislocation. Videos were reviewed by three surgeons trained in systematic video analysis, who commented on the position of the lower limb and the situation in which the injury occurred. The results were reviewed to build a consensus of the MoI for each video. Statistical analysis was conducted for interobserver agreement (n = 9) or whilst dancing (n = 4). The injury was predominantly sustained during a non-contact situation (n = 10). The most common mechanism was an unbalanced individual with a flexed hip sustaining a valgus force to their flexed knee with the tibia externally rotated.Initial search yielded 603 videos with 13 meeting the inclusion criteria. The injuries were sustained performing a sporting activity (This study provides some insight into the MoI for a patellar dislocation and the findings may assist in developing injury prevention programmes and rehabilitation protocols as well as guiding future research. A patella dislocation is a multifactorial phenomenon that can have numerous long-term sequelae  FollowinInjury prevention models require both the identification of risk factors and the mechanism of injury (MoI)  Fig. 1)1). VarioSystematic video analysis is now a common method of establishing a MoI. In the digital age this has progressed to the utilisation of online videos using websites such as YouTube. This method has been used in assessing the MoI of ankle fractures  and elboWhilst various theories on the mechanism of injury of a patella dislocation have been proposed, to date these theories have not been reproduced through video analysis. Previous video analysis has shown that theoretical models of MoI can be misleading, as demonstrated by Schrieber et al. in their analysis of the mechanism of elbow dislocations .The aim of this study was to identify the mechanism of injury of patella dislocations using systematic video analysis of publicly available videos on open-access video sharing websites.Three largest online video sharing websites  and three popular Internet search engines  were systematically searched on 1 February 2017 using combinations of the following search terms: ‘kneecap’ or ‘patella’ with ‘dislocation’, ‘dislocating’ or ‘dislocated’. Videos were initially reviewed by the lead author to confirm patella dislocation. Where possible, media reports were used to provide additional confirmation.Any video in which the quality was not sufficient to allow review, or in which there was any doubt about the diagnosis, was excluded from further analysis. The inclusion and exclusion criteria can be seen in Table Videos were assigned an anonymous study number and each video was reviewed independently by three fellowship trained orthopaedic surgeons with an interest in knee surgery and sports injuries. The reviewers received specific training in systematic video analysis.Sports-specific descriptionVital aspects of the playing situationE.g. Balance, concentrationInjured individual’s behaviour at the time of injuryE.g. Weight distribution, balanceWhole body biomechanical characteristicsHip positionKnee positionAnkle positionFoot positionBiomechanical characteristics of the lower limbEach reviewer conducted the systematic video analyses on “full screen” mode on a monitor of their choice. They were advised to do this on the largest monitor possible and permitted to view the footage as many times as required at the speed that they desired. They were required to report on the position of the lower limb at the time of injury and the circumstances in which it occurs Table . The aimThe reviewers were provided with a guidance tool containing definitions to assist them whilst reviewing. The reviews were conducted independently, and each reviewer was blinded to other reviewers’ results.Using a similar method to Krosshaug , who assp < 0.05.Statistical analysis was conducted using SPSS . Interobserver agreement was assessed by calculating the interclass correlation coefficient (ICC) with significance set at The search yielded a total of 603 videos on YouTube. No additional videos were identified on the other two video sharing websites or search engines. After review of the titles and content, 17 videos were deemed to be suitable for an initial review; 586 videos were excluded because they were either educational videos or on viewing the videos, it was found they did not actually show a patella dislocation occurring. Subsequently, further analysis of these videos meant that four were not suitable for review as it was not possible to confirm the diagnosis in three of them, and the quality of one video was not adequate to allow review..Therefore, 13 videos were left for review. This has been summarised in Fig. 5There were 12 videos that demonstrated a patella dislocation occurring whilst performing a dynamic action and 1 video that demonstrated a patella dislocation sustained whilst performing a static action (bench press). At the time of injury, it was found that the quadriceps was contracted in 12 out of 13 videos. The reviewers all stated that they were not able to comment on this element in the other video.p > 0.05). The positions of the hip and knee during the dislocation in these 10 cases are shown in Table 3.Of the 13 patella dislocations, 10 occurred in a non-contact situation, 5 of which were sustained whilst playing a contact sport. Of these 10 individuals, 7 were considered to be off-balance when the injury occurred, 2 were balanced and there was no consensus on balance at the time of dislocation in the remaining individual. Of the 10 non-contact injuries, 5 were sustained whilst the individual was moving at a low intensity (4 were dancing and 1 was doing an exercise activity): only 1 of these individuals was felt to be balanced at the time of dislocation with 3 considered unbalanced, and there was no consensus on the remaining individual. The mean body weight, as estimated by the reviewers, on the injured limb was 70.37%. The ICC for this was 0.410 . In three of these videos the individual was either carrying the ball or had just received possession of it. In the two remaining videos, they were not deemed to be in possession of the ball, with one individual having just passed the ball and the other involved in a defensive action. They were found to be landing in three videos, running straight in one and performing a plant and cut manoeuvre in the other one. In the videos involving ball sports, the individual was moving at a “very high” (sprinting) or “high” (below sprinting) intensity in four videos and at a low intensity (jogging) in the remaining video.p < 0.05). For the majority of cases the reviewers agreed on two or more parameters. On 50% of occasions they were all in agreement on their analysis of a particular parameter. This can be seen in Fig. There was excellent agreement between reviewers with respect to identifying the time at which the injury occurred. All times were within 1 s of each other. Statistical analysis using the ICC gave a value of 1.00 , it staWhilst our case series is small, we believe that we have been able to provide further insight into the circumstances in which a patella dislocation may occur. A patella dislocation is predominantly a non-contact injury. The most common mechanism of a patella dislocation in our series was that of an unbalanced individual with a flexed hip, sustaining a valgus force to their flexed knee with the tibia externally rotated. Our results provide some preliminary evidence that dislocations can occur across a wide variety of activities. Given the mechanism of injury we have identified, there may be a role in incorporating balance and landing exercises designed to prevent a valgus collapse of the knee into rehabilitation regimes and injury prevention programmes. However further research is needed to investigate this further and use the findings to help in the development of such regimes and programmes.


A preliminary test of the EAgLE technique is proposed in this paper on two sample measurements performed in proximity of an Italian highway. The results will show excellent performances in terms of agreement with the measured eqL and comparing with other RTNMs. These satisfying results, once confirmed by a larger validation test, will open the way to the development of a dedicated sensor, embedding the EAgLE model, with possible interesting applications in smart cities and road infrastructures monitoring. These sites, in fact, are often equipped (or can be equipped) with a network of monitoring video cameras for safety purposes or for fining/tolling, that, once the model is properly calibrated and validated, can be turned in a large scale network of noise estimators. Road infrastructures represent a key point in the development of smart cities. In any case, the environmental impact of road traffic should be carefully assessed. Acoustic noise is one of the most important issues to be monitored by means of sound level measurements. When a large measurement campaign is not possible, road traffic noise predictive models (RTNMs) can be used. Standard RTNMs present in literature usually require in input several information about the traffic, such as flows of vehicles, percentage of heavy vehicles, average speed, etc. Many times, the lack of information about this large set of inputs is a limitation to the application of predictive models on a large scale. In this paper, a new methodology, easy to be implemented in a sensor concept, based on video processing and object detection tools, is proposed: the Equivalent Acoustic Level Estimator (EAgLE). The input parameters of EAgLE are detected analyzing video images of the area under study. Once the number of vehicles, the typology (light or heavy vehicle), and the speeds are recorded, the sound power level of each vehicle is computed, according to the EU recommended standard model (CNOSSOS-EU), and the Sound Exposure Level (SEL) of each transit is estimated at the receiver. Finally, summing up the contributions of all the vehicles, the continuous equivalent level,  The problem of road traffic noise in urban and non-urban areas is becoming more and more important nowadays. The effect of noise on human health is well established . The recIn order to cope with this issue, many municipalities introduced fixed or temporary monitoring stations and implemented mitigation actions based on the results of the measurements. Expensive and not always accepted acoustic barriers are the most widespread solution to mitigate the noise produced by the main sources . PavemenOn the other hand, road infrastructures companies are obliged to perform environmental impact analysis, including noise monitoring and estimation. In addition, when critical situations are highlighted, action plans must be performed, according to the END  and to tIn any case, measurements are expensive and cannot be performed all over large areas, thus, road traffic noise predictive models (RTNMs) can be adopted to assess noise produced by vehicles. Extensive reviews of the standard statistical RTNMs can be found for instance in ,11, alsodenL evaluation), the need of a fast and effective model is more important than having an extreme precision (for instance lower than 1 dBA). The usage of advanced computing techniques is somehow growing in literature, even though it must still be demonstrated that the adoption of computationally demanding procedures introduces a widespread benefit in the predictions. In “non-standard” conditions (such as traffic jams or congestions or intersections) usually the common RTNMs fail. Therefore, in large areas case studies, such as big municipalities and big road infrastructures, and for long term average  and the classification of each vehicle (at least light and heavy categories), together with the geometrical detail of the source and receiver positions. Many other parameters can be included to take into account second order corrections, such as road pavement typology, gradient of the road, temperature, humidity, etc. All these data, compulsory and additional ones, are not always available, and thus the possibility to detect the inputs of any RTNM automatically is an important challenge. In this paper, the author presents the design of a new methodology, the Equivalent Acoustic Level Estimator (EAgLE), based on vehicles detection, counting and tracking, by means of a video processing tool, with a single vehicle noise emission and propagation model. There are several studies in literature about image processing, video analysis, object detection and tracking. In , a detaiThe research presented in this paper aims to partially fill this gap, proposing a methodology to embed these sensor networks with a noise level estimator. The proposed approach starts from the recognition of a moving object on the road. Once the object is tracked, it can be counted and categorized according to its dimension. Its speed can be estimated as well, allowing to assess the sound power level. This assessment can be performed in many ways, according to several noise emission models . In thiThe above brief description of the EAgLE methodology is detailed in The EAgLE technique adopted in this paper is based on the recognition of any moving object by means of background subtraction, defining a moving “blob” . The bloThe algorithm has been developed in the “Microsoft Visual Studio 2015” framework, with the aid of the “Open Source Computer Vision Library” (OpenCV). The code is written in Python. The source code of the recognition part has been created starting from codes shared in the “GitHub” platform . Main function: it performs calculations needed to count the vehicles and separate the categories. It is also used to estimate the speed of each vehicle;Blob auxiliary function: it initializes the parameters of the blob, determining the bounding box and diagonal dimensions. In addition, it includes the “predictNextPosition” function described below;Header function: the blob class is defined here, applying the parameters defined in the “blob” function to each continuous mass detected in the frame.The principal functions of the code areThe input file is a MPEG-4 file. At this stage, the algorithm works only in offline mode, analyzing the single frames after having processed the input video. The detection is performed by subtracting the background into two following frames. The tracking of the blob centroid is performed with an improved algorithm, proposed in . The claWhen a centroid crosses a chosen line , A and B table coefficients, and ΔwL the correction terms. Of course, other emission models can be easily implemented, according to the needs and the country of application of the EAgLE system.As mentioned in the introduction, among the several emission models that are presented in the literature , EAgLE wL is obtained for each vehicle, the instantaneous sound pressure level at the receiver pL(t) can be estimated using the pointlike source propagation formula, and the single event Sound Exposure Level (SEL) of each pass-by, i.e., the amount of acoustic energy of each transit “compressed” in 1 s, at the fixed receiver, is calculated:t0 = 1 s, t1, and t2, respectively, are the beginning and the end of the transit. This step is fundamental in order to make all the transits comparable, since they have strong differences in terms of duration, according to the speed of the vehicles [eqL evaluated in the time range Δt is finally obtained with the following formula:Once the vehicles . This prTo acquire the video from cameras;To run the counting and recognition algorithm ;To remove fake counts and adjust category recognition ;To feed the noise level estimator with input data;To calculate noise emission levels (according to CNOSSOS-EU);To calculate the SEL of each vehicle;To calculate the overall SEL for light and heavy duty vehicles’ categories;eqL on the required time basis (it should coincide with the video duration).To estimate the A résumé of the main steps of the EAgLE methodology iseqL can be tuned according to the needs of the case study. For instance, for urban planning purposes, in urban areas with specific limits, the denL  can be calculated by running the algorithm on the video recordings of one year. Several other applications are possible, changing and tuning the parameters of the EAgLE methodology, depending on the aim of the investigation and on the case study. Of course, once the EAgLE methodology is embedded in existing sensors for video recording and validated with on-site measurements and calibration, the choice of time basis and time range to calculate the A preliminary application of the EAgLE methodology has been performed on a site located along the Italian highway A2 “Autostrada del Mediterraneo”. This highway is managed by ANAS S.p.a. and goes from the crossing between A30 and RA2, in Fisciano, to Reggio Calabria. The video recording and the measurements have been performed in the city of Baronissi a, in thepA,F, Leq,A, percentile levels, acoustic spectrum in third of octaves, etc., and the video of the vehicles passing-by have been recorded in parallel. Temperature was approximately in the range 11 °C–14 °C and wind speed was below 5 m/s on average. Furthermore, to protect the sound level meter from sudden wind peaks, the wind cover was used . In addition, it occurred that in some cases two light vehicles moving very closely to each other were recognized as a single heavy vehicle, leading to a small overestimation in this category. The author believes that these problems can be solved by means of a more stable video camera, an optimized angle of view, and a more advanced recognition tool.The distributions of the speed estimated with the EAgLE algorithm are reported in The missing bins in light vehicles’ speeds distribution figures are due to the discretization in detection of the speed. The frame rate of the camera (30 fps), in fact, influences the speed estimation, that is performed converting the number of frames per second needed to go from the trigger line to the “arrival” line. In particular, the discretization due to the frame rate introduces a discretization in the speed estimated as well. The resulting “delta” is a function of the speed itself (it grows according to the growth of the speed), of the frame rate and of the position of the lines. This position is the result of a compromise between a distance large enough to estimate the speed in a sufficiently large range, and the best location for vehicles pass-by detection. The delta ranges from about 4 km/h in the low speeds part of the distribution to about 14 km/h in the high speeds zone. It is expected that a more advanced camera, with a higher frame rate, will lead to a more precise estimation of the speed, with a consequently better distribution plot. Additional error sources can be the uncertainty on the centroid position, for instance, due to the shadow effect and the resolution of the image, since it influences the bounding box shape. eqL on the 15 minutes time range, the levels predicted with some predictive statistical models, the levels predicted with CNOSSOS-EU model, and the eqL simulated with the EAgLE technique, are resumed in Due to the results obtained in the first phase with the detection algorithm, basically, once the identification and the speeds vectors for light and heavy vehicles have been detected, the noise levels estimation has been performed in Matlab framework. As already described in eqL, while the models that consider the speed of the flow  give a much better estimation of the noise levels. It can be immediately noticed that the statistical models overestimate the measured eqL. Furthermore, it should be underlined that at the moment the methodology presents some limitations and shortcomings. The preliminary results reported in First of all, the EAgLE technique is strongly affected by the video recording. In particular, the critical points seem to be the angle of recording, which affects the parallax and the conversion between frames and real world distances, the resolution of the camera, which influences the speed estimation, the light conditions, and the shadow effects. The former two points can be quite easily solved with a calibration of the system and with the adoption of high resolution cameras. In regards to the latter two points, of course, a dark image is not feasible for EAgLE at the moment. Problems can occur during the first and last hours of the day, when the sun is barely perpendicular to the road and shadows can modify the size of the bounding boxes, leading to a misclassification of the vehicle. This means that the proposed methodology can be used continuously, during day and night, only in places with artificial lights, but by calibrating the angle of view and the sensibility of the bounding box can include effects of the shadows. It should be also underlined that the actual video recording sensors are always placed on illuminated sites, since it makes no sense to place a video camera on dark sites. For this reason, the EAgLE methodology is still interesting to be embedded in existing sensors, and, for new installation, should be designed in proper locations to avoid the night (or little light) issues and the shadow effects. Moreover, tests with the light projectors of the cars should be performed to see if the recognition efficiency can be kept using the moving lights. Furthermore, tests at different hours of the day have to be performed, to assess the effect of the sunrays inclination on the recognition performance.Another important issue concerning the video recording is the detection ability in crowded and congested roads. While the exclusion of other “non-noisy” moving objects  can be performed with a proper placement of the video camera, the possibility of giving bad results in congested situations is a critical point, especially in urban areas. In highways, in fact, congestions are quite rare, especially out of the rush hours. In the author’s opinion, this is a problem that can be solved by improving the detection and classification code of EAgLE. As mentioned in the introduction, several techniques have been developed for this purpose, much more advanced that the one implemented in this preliminary application, based on machine learning, deep learning, neural network, etc. (see for instance ). For thAnother limitation of the EAgLE methodology lies in the estimation of non-standard events, such as honking, sirens, extremely noisy vehicles, external sources, etc. It must be underlined that none of the predictive models present in literature nowadays can predict such events, thus, from this point of view, EAgLE, at the moment, is somehow aligned with the other models. In any case, trigger events could be implemented in the recognition code, for instance, using the lights of the ambulances or of the police cars, to tag these events as non-standard and treat them in a proper way.The preliminary application presented in previous sections is limited due to the small number of measurements and to the free flow condition. More on this part must be done in future researches in order to validate the technique on a larger sample of measurements, with different traffic conditions and geometric features of the sites. Looking at the comparison in Even with the above mentioned limitations of this study, the EAgLE methodology is really promising, because of its easiness in application in any place controlled by video camera recordings. The actual algorithm is quite easy and can be implemented in real time monitoring, to produce raw estimations of noise levels. Of course, for a more reliable estimation, an offline analysis is mandatory in order to clean the raw data from mistakes in counting or the classification of vehicles, such as in estimating the speed. The integration of this system in a complex sensor, including video recording, online analysis, data transmission, and offline processing, is encouraged by the preliminary results obtained in the case study application. The author believes that with a more powerful video camera network and an improved data processing system, this methodology can be extremely useful in qualitative noise monitoring systems, especially in urban areas and big infrastructures, where usually video recording is already present for safety reasons or for tolling/fining systems.Future studies should include the production of a test sensor that embeds the EAgLE methodology, with a video camera, a sound level meter, and a processor able to run the algorithm at a local site. In this way, the sensor can be tested on a large scale validation, with a continuous recording of pressure levels and video images in order to test the online performances and the criticisms. A sensibility analysis of the sensor can be performed, testing the variations according to the detection and propagation critical elements  and to the source parameters . Moreover, the non-standard events, such as honking, ambulances, police sirens, etc., should be investigated, since the noise produced is due to both the vehicle and to external loudspeakers. denL estimation can be performed, using real traffic data, instead of simulating ideal conditions in noise predictive software. This could help local policy makers and infrastructure managers in finding the critical points of their networks and, if needed, in committing to implement further investigations, based on standard noise level measurements or other tools.Once the EAgLE methodology will be validated, a large spatial scale can be tested, with the aim to produce a noise map of a city or of a transportation infrastructure, taking advantage of the existing video camera networks. When long term recordings are available, for instance, in more than a year, the In this paper, the EAgLE  technique has been presented. This technique, based on image analysis, vehicle tracking, and dynamic noise modeling, aims at producing a robust estimation of the continuous equivalent noise level on given time ranges, by using just a video camera recording. A preliminary application of the technique, in a short time range (630 s) related to a case study along a highway in South Italy, has been presented, showing how, with a good recognition efficiency, the noise levels estimated with EAgLE are extremely close to the measured levels in this reduced sample of measurements performed in free flow and standard conditions. More tests are needed to validate the EAgLE procedure. Moreover, beside the shortcomings discussed in the previous sections, several strength points arise from the first tests. In particular, the possibility to provide reliable qualitative estimations of the noise level in any place embedded with a video camera, in cities, or along transportation infrastructures, is definitively the key point of the proposed sensor. These estimations can be used on one side to cope with the need of a large spatial monitoring, and on the other side to provide first level alarms of exceeding limit thresholds, to be checked with follow-up interventions at specific sites.