Evaluation of the SCAT 5 tool in the assessment of concussion in Para athletes: a Delphi study.

OBJECTIVES: To investigate if the sport concussion assessment tool version 5 (SCAT5) could be suitable for application to Para athletes with a visual impairment, a spinal cord injury, or a limb deficiency. METHODS: A 16-member expert panel performed a Delphi technique protocol. The first round encompassed an open-ended questionnaire, with round 2 onwards being composed of a series of closed-ended statements requiring each expert's opinion using a five-point Likert scale. A predetermined threshold of 66% was used to decide whether agreement had been reached by the panel. RESULTS: The Delphi study resulted in a four-round process. After round 1, 92 initial statements were constructed with 91 statements obtaining the targeted level of agreement by round 4. The expert panellist completion rate of the full four-round process was 94%. In the case of athletes with a suspected concussion with either limb deficiencies or spinal cord injuries, the panel agreed that a baseline assessment would be needed on record is ideal before a modified SCAT5 assessment. With respect to visual impairments, it was conceded that some tests were either difficult, infeasible or should be omitted entirely depending on the type of visual impairment. CONCLUSION: It is proposed that the SCAT5 could be conducted on athletes with limb deficiencies or spinal cord injuries with some minor modifications and by establishing a baseline assessment to form a comparison. However, it cannot be recommended for athletes with visual impairment in its current form. Further research is needed to determine how potential concussions could be more effectively evaluated in athletes with different impairments.

Methods behind oncolytic virus-based DC vaccines in cancer: Toward a multiphase combined treatment strategy for Glioblastoma (GBM) patients.

Glioblastoma (GBM) remains an orphan cancer disease with poor outcome. Novel treatment strategies are needed. Immunotherapy has several modes of action. The addition of active specific immunotherapy with dendritic cell vaccines resulted in improved overall survival of patients. Integration of DC vaccination within the first-line combined treatment became a challenge, and immunogenic cell death immunotherapy during chemotherapy was introduced. We used a retrospective analysis using real world data to evaluate the complex combined treatment, which included individualized multimodal immunotherapy during and after standard of care, and which required adaptations during treatment, and found a further improvement of overall survival. We also discuss the use of real world data as evidence. Novel strategies to move the field of individualized multimodal immunotherapy forward for GBM patients are reviewed.

The Application of Evidence-Based Medicine in Individualized Medicine.

The fundamental aim of healthcare is to improve overall health of the population by providing state-of-the-art healthcare for individuals at an affordable cost. The foundation for this system is largely referred to as "evidence-based medicine". Too often, evidence-based medicine is based solely on so-called "best research evidence", collected through randomized controlled trials while disregarding clinical expertise and patient expectations. As healthcare gravitates towards personalized and individualized medicine, such external clinical (research) evidence can inform, but never replace, individual clinical expertise. This applies in particular to orphan diseases, for which clinical trials are methodologically particularly problematic, and evidence derived from them is often questionable. Evidence-based medicine constitutes a complex process to allow doctors and patients to select the best possible solutions for each individual based on rapidly developing new therapeutic directions. This requires a revisit of the foundations of evidence-based medicine. A proposition as to how to manage evidence-based data in individualized immune-oncology is presented here.

Individualized Multimodal Immunotherapy for Adults with IDH1 Wild-Type GBM: A Single Institute Experience.

Synergistic activity between maintenance temozolomide (TMZm) and individualized multimodal immunotherapy (IMI) during/after first-line treatment has been suggested to improve the overall survival (OS) of adults with IDH1 wild-type MGMT promoter-unmethylated (unmeth) GBM. We expand the data and include the OS of MGMT promoter-methylated (meth) adults with GBM. Unmeth (10 f, 18 m) and meth (12 f, 10 m) patients treated between 27 May 2015 and 1 January 2022 were analyzed retrospectively. There were no differences in age (median: 48 y) or Karnofsky performance index (median: 80). The IMI consisted of 5-day immunogenic cell death (ICD) therapies during TMZm: Newcastle disease virus (NDV) bolus injections and sessions of modulated electrohyperthermia (mEHT); subsequent active specific immunotherapy: dendritic cell (DC) vaccines plus modulatory immunotherapy; and maintenance ICD therapy. There were no differences in the number of vaccines (median: 2), total number of DCs (median: 25.6 × 106), number of NDV injections (median: 31), and number of mEHT sessions (median: 28) between both groups. The median OS of 28 unmeth patients was 22 m (2y-OS: 39%), confirming previous results. OS of 22 meth patients was significantly better (p = 0.0414) with 38 m (2y-OS: 81%). There were no major treatment-related adverse reactions. The addition of IMI during/after standard of care should be prospectively explored.

Synergy between TMZ and individualized multimodal immunotherapy to improve overall survival of IDH1 wild-type MGMT promoter-unmethylated GBM patients.

The prognosis of IDH1 wild-type MGMT promoter-unmethylated GBM patients remains poor. Addition of Temozolomide (TMZ) to first-line local treatment shifted the median overall survival (OS) from 11.8 to 12.6 months. We retrospectively analyzed the value of individualized multimodal immunotherapy (IMI) to improve OS in these patients. All adults meeting the criteria and treated 06/2015-06/2021 were selected. Thirty-two patients (12f, 20m) had a median age of 47 y (range 18-69) and a KPI of 70 (50-100). Extent of resection was complete (11),

Concussion in para sport: the first position statement of the Concussion in Para Sport (CIPS) Group.

Concussion is a frequent injury in many sports and is also common in para athletes. However, there is a paucity of concussion research related to para sport, and prior International Concussion in Sport (CIS) consensus papers have not substantively addressed this population. To remedy this and to improve concussion care provided to para athletes, the concussion in para sport (CIPS) multidisciplinary expert group was created. This group analysed and discussed in-depth para athlete-specific issues within the established key clinical domains of the current (2017) consensus statement on CIS. Due to the onset of the COVID-19 pandemic, the group held all meetings by video conferencing. The existing Sport Concussion Assessment Tool 5 (SCAT5) for the immediate on-field and office-based off-field assessment of concussion was evaluated as part of this process, to identify any para athlete-specific concerns. Regular preparticipation and periodic health examinations are essential to determine a baseline reference point for concussion symptoms but pose additional challenges for the interpreting clinician. Further considerations for concussion management for the para athlete are required within the remove, rest, reconsider and refer consensus statement framework. Considering return to sport (RTS), the 2017 CIS consensus statement has limitations when considering the RTS of the para athlete. Case-by-case decision making related to RTS following concussion is imperative for para athletes. Additional challenges exist for the evaluation and management of concussion in para athletes. There is a need for greater understanding of existing knowledge gaps and attitudes towards concussion among athlete medical staff, coaches and para athletes. Future research should investigate the use and performance of common assessment tools in the para athlete population to better guide their clinical application and inform potential modifications. Concussion prevention strategies and sport-specific rule changes, such as in Para Alpine Skiing and Cerebral Palsy Football, also should be carefully considered to reduce the occurrence of concussion in para athletes.

Para sport translation of the IOC consensus on recording and reporting of data for injury and illness in sport.

In 2020, the IOC proposed a universal methodology for the recording and reporting of data for injury and illness in sport. Para sport is played by individuals with impairment, and they have a unique set of considerations not captured by these recommendations. Therefore, the aim of this addendum to IOC consensus statement was to guide the Para sport researcher through the complexities and nuances that should be taken into consideration when collecting, registering, reporting and interpreting data regarding Para athlete health. To develop this translation, experts in the field of Para sports medicine and epidemiology conducted a formal consensus development process, which began in March 2020 with the formation of a consensus group that worked over eight phases, incorporating three virtual consensus meetings to finalise the translation. This translation is consistent with the IOC consensus statement, yet provides more detailed Para athlete specific definitions and recommendations on study population, specifically, diagnostic and eligible impairment categorisation and recording of adaptive equipment, and defining and classifying health problems in the context of Para sport. Additionally, recommendations and Para athlete specific examples are described with regards to injury mechanism, mode of onset, injury and illness classification, duration, capturing and reporting exposure and risk. Finally, methods and considerations are provided to cater to the varied needs of athletes with impairment with respect to data collection tools. This harmonisation will allow the science to develop and facilitate a more accurate understanding of injury and illness patterns for tailoring evidence-informed prevention programmes and enabling better planning of medical services for Para sport events.

Conceptual model of sport-specific classification for para-athletes with intellectual impairment.

The present paper describes the conceptual basis of evidence-based classification of para-athletes with intellectual impairment (II). An extensive description of the theoretical and conceptual foundation of the system as currently conceived is provided, as are examples of its applications in the three sports included in the Paralympic programme for II-athletes in 2020 (i.e., athletics, swimming and table tennis). Evidence-based classification for II-athletes is driven by two central questions: i. How can intellectual impairment be substantiated in a valid and reliable way, and ii. Does intellectual impairment limit optimal sport proficiency? Evolution of the system and current best practice for addressing these questions are described, and suggestions for future research and development are provided. Challenges of understanding and assessing a complex (multifaceted and intersectional) impairment in the context of sport also are considered.

Stakeholder perspectives on research and development priorities for mobility assistive-technology: a literature review.

PURPOSE: Over one billion people with disabilities (PWDs) and older adults with mobility impairment are currently in need of assistive technology devices (ATDs) and only 10% of those population have ordinarily access to them. The need for advancement in mobility-assistive technology is growing to address the gap in ATDs provision globally. The purpose of this review is to identify potential future areas of development and research in mobility-assistive technology. METHOD: Publications were identified using scientific and medical electronic databases. Also, a limited grey literature search was conducted to muster a variety of sources. A combination of keyword search terms was used, corresponding to the medical subject heading (MeSH) terms. RESULTS: A total of 392 articles were identified, of which 75 were selected for detailed review. Twenty-eight articles were identified that met the review's inclusion criteria. Future areas of research for mobility-assistive technology were identified by grouping the publications into four main categories. The findings of this review identified several areas of research and development in ATDs in general and mobility-assistive technology, in particular, with special attention to the importance of engaging users and stakeholders in the process of research and design. CONCLUSIONS: It is apparent that users' needs and priorities vary between regions within countries. The majority of studies were noted to mainly identify consumers' perspectives on a national basis. The authors, therefore, suggest that further research should be conducted on a global level to determine the knowledge and perspectives concerning future research and development needs and priorities in mobility-assistive technologies.Implication for RehabilitationDespite the benefits derived from the use of ATDs, only 10% of people with disabilities have access to them.Increasing access, quality and affordable ATDs in all countries is global demand.Identifying mobility consumers' needs and priorities would help in enhancing their quality of life by translating research into new technologies that meet their environment and culture needs.Users' involvement in research and design process is a crucial approach to re-shape the future research agenda.

The impact of limb deficiency impairment on Para swimming performance.

Swimmers with limb deficiency are a core population within Para Swimming, accordingly this study examined the contribution of limb segments to race performance in these swimmers. Data were obtained for 174 male Para swimmers with limb deficiency. Ensemble partial least squares regression showed accurate predictions when using relative limb segment lengths to estimate Para swimmers' personal best race performances. The contribution of limb segments to performance in swim events was estimated using these regression models. The analysis found swim stroke and event distance to influence the contributions of limb segments to performance. For freestyle swim events, these changes were primarily due to the increased importance of the hand, and decreased importance of the foot and shank, as the distance of the event increased. When comparing swim strokes, higher importance of the thigh and shank in the 100 m breaststroke compared with other swim strokes confirms the separate SB class. Varied contributions of the hand, upper arm and foot suggest that freestyle could also be separated from backstroke and butterfly events to promote fairer classification. This study shows that swim stroke and event distance influence the activity limitation of Para swimmers with limb deficiency suggesting classification should account for these factors.

Maximal Fully Tethered Swim Performance in Para Swimmers With Physical Impairment.

The assessment of swimming propulsion should be a cornerstone of Paralympic swimming classification. However, current methods do not objectively account for this component. PURPOSE: To evaluate the swimming propulsion of swimmers with and without physical impairment using a 30-second maximal fully tethered freestyle swim test. METHODS: Tethered forces were recorded during maximal fully tethered swimming in 80 competitive swimmers with (n = 70) and without (n = 10) physical impairment. The relationships between absolute and normalized tether forces and maximal freestyle swim speed were established using general additive models. RESULTS: Para swimmers with physical impairment had lower absolute and normalized tether forces than able-bodied swimmers, and there were moderate positive correlations found between tether forces and sport class (τ = .52-.55, P < .001). There was a nonlinear relationship between tether force and maximal freestyle swim speed in the participant cohort (adjusted R2 = .78-.80, P < .001). Para swimmers with limb deficiency showed stronger relationships between tether force and maximal freestyle swim speed (adjusted R2 = .78-.82, P < .001) than did Para swimmers with hypertonia (adjusted R2 = .54-.73, P < .001) and impaired muscle power (adjusted R2 = .61-.70, P < .001). CONCLUSIONS: Physical impairments affect Para swimmers' tether forces during maximal fully tethered freestyle swimming, explaining a significant proportion of their activity limitation. It is recommended that maximal fully tethered swimming be included in Paralympic swimming classification as an objective assessment of swimming propulsion.

Active Drag as a Criterion for Evidence-based Classification in Para Swimming.

INTRODUCTION: Paralympic classification should provide athletes with an equitable starting point for competition by minimizing the impact their impairment has on the outcome of the event. As swimming is an event conducted in water, the ability to overcome drag (active and passive) is an important performance determinant. It is plausible that the ability to do this is affected by the type and severity of the physical impairment, but the current World Para Swimming classification system does not objectively account for this component. The aim of this study was to quantify active and passive drag in Para swimmers and evaluate the strength of association between these measures and type of physical impairment, swimming performance, and sport class. METHODS: Seventy-two highly trained Para swimmers from sport classes S1 to S10 and 14 highly trained nondisabled swimmers were towed by a motorized winch while the towing force was recorded. Passive drag was measured with the arms held by the side; active drag was determined during freestyle swimming using an assisted towing method. RESULTS: Active and passive drag were higher in Para swimmers with central motor and neuromuscular impairments than for nondisabled swimmers and were associated with severity of swim-specific impairment (sport class) and maximal freestyle performance in these swimmers (r = -0.40 to -0.50, P ≤ 0.02). Para swimmers with anthropometric impairments showed similar active and passive drag to nondisabled swimmers, and between swimmers from different sport classes. CONCLUSIONS: Para swimmers with central motor and neuromuscular impairments are predisposed to high active drag during freestyle swimming that impacts on their performance. It is recommended that drag measures be considered in revised classification for these swimmers, but not for those with anthropometric impairments.

High incidence of injuries at the Pyeongchang 2018 Paralympic Winter Games: a prospective cohort study of 6804 athlete days.

OBJECTIVE: To describe the epidemiology of sports injury at the Pyeongchang 2018 Paralympic Winter Games. METHODS: 567 athletes from 49 countries were monitored daily for 12 days over the Pyeongchang 2018 Paralympic Winter Games (6804 athlete days). Injury data were obtained daily from teams with their own medical support (41 teams and 557 athletes) and teams without their own medical support (8 teams and 10 athletes) through two electronic data capturing systems. RESULTS: 112 of 567 athletes (19.8%) reported a total of 142 injuries, with an injury incidence rate (IR) of 20.9 per 1000 athlete days (95% CI 17.4 to 25.0). The highest IR was reported for para snowboard (IR of 40.5 per 1000 athlete days [95% CI 28.5 to 57.5]; p<0.02), particularly in the lower limb and head/face/neck anatomical areas. Across all sports at the Games, acute traumatic injuries (IR of 16.2 per 1000 athlete days [95% CI 13.2 to 19.8]) and injuries to the shoulder/arm/elbow complex (IR of 5.7 per 1000 athlete days [95% CI 4.2 to 7.8]) were most common. However, most injuries (78.9%) did not require time loss. CONCLUSION: The new Paralympic Winter Games sport of Para snowboard requires attention to implement actions that will reduce injury risk. The shoulder was the most injured single joint-a consistent finding in elite para sport.

Illness at a Para Athletics Track and Field World Championships under Hot and Humid Ambient Conditions.

BACKGROUND: Heat-related illness, including heat exhaustion and heat stroke, is seen as a major risk for athletes with a physical impairment. OBJECTIVE: Primary: To survey the illness statistics during the 2015 Para Athletics World Championships and report on any cases of significant heat-related illnesses. Secondary: To document the heat countermeasures taken on behalf of the organizing committee. DESIGN: Retrospective audit. SETTING: Medical records collected at medical centers during the 2015 Para Athletics World Championships. PARTICIPANTS: Athletes participating in the 2015 Para Athletics World Championships. METHODS: Illness statistics and records of hospitalizations of athletes participating in the championships were recorded by the medical officials during the precompetition (3 days) and competition (10 days) periods. Furthermore, wet-bulb globe temperatures (WBGTs) were measured at the competition venues. MAIN OUTCOME MEASUREMENTS: Incidence rates of illness during the precompetition and competition periods. RESULTS: WBGTs ranged from 24.6°C to 36.0°C, regularly exceeding the American College of Sports Medicine (ACSM) and International Association of Athletics Federations (IAAF) guidelines for cancelation in the morning both during the competition (ACSM, 52%; IAAF, 97%) and precompetition periods (ACSM, 75%; IAAF, 100%). These guidelines were not exceeded as regularly during the evening and noon for both the precompetition and competition periods (ACSM, 0%-5%; IAAF, 0%-58%). The illness incidence rate was 2.89 per 1000 athlete-days (incidence proportion = 3.76%; confidence interval = 2.69%-4.83%). Only seven cases of heat-related illness were recorded, of which three required hospitalization. CONCLUSION: This study indicates low rates of illness, including hospitalization and intravenous administration for heat-related illness among athletes participating in the 2015 Para Athletics World Championships. LEVEL OF EVIDENCE: III.

Incidence rate and burden of illness at the Pyeongchang 2018 Paralympic Winter Games.

OBJECTIVE: To describe the incidence rate (IR) and illness burden (IB) at the Pyeongchang 2018 Paralympic Winter Games. METHODS: A total of 567 athletes from 49 countries were monitored for 12 days over the Pyeongchang 2018 Games (6804 athlete days). Illness data were obtained daily from teams with (41 teams, 557 athletes) and teams without (8 teams, 10 athletes) their own medical support, through electronic data capturing systems. RESULTS: There were 87 illnesses reported, with an illness IR of 12.8 illnesses per 1000 athlete days (95% CI 10.2 to 16.0) and IB of 6.8 days lost per 1000 athlete days (95% CI 3.4 to 13.5). The highest IR was reported for Para snowboard (IR of 19.7 [95% CI 12.0 to 32.2]). Illnesses in the respiratory system (IR of 4.1 [95% CI 2.9 to 5.9]; IB of 1.4 [95% CI 0.6 to 3.0]), skin and subcutaneous system (IR of 2.5 [95% CI 1.5 to 4.1]; IB of 0.6 [95% CI 0.1 to 2.9]), and eye and ocular adnexa (IR of 1.6 [95% CI 0.9 to 3.1]; IB of 0.5 [95% CI 0.1 to 3.3]) were the most common. CONCLUSION: This is the first study to report both the IR and IB in this setting. There was a high IR of illness in the new sport of Para snowboard. The respiratory system had both the highest IR and IB.

A battery of strength tests for evidence-based classification in Para swimming.

This study examined the validity of isometric strength tests for evidence-based classification in Para swimming. Thirty non-disabled participants and forty-two Para swimmers with physical impairment completed an isometric strength test battery designed to explain activity limitation in the freestyle discipline. Measures pertaining to dominant and non-dominant limb strength and symmetry were derived from four strength tests that were found to be reliable in a cohort of non-disabled participants (ICC = 0.85-0.97; CV = 6.4-9.1%). Para swimmers had lower scores in strength tests compared with non-disabled participants (d = 0.14-1.00) and the strength test battery successfully classified 95% of Para swimmers with physical impairment using random forest algorithm. Most of the strength measures had low to moderate correlations (r = 0.32 to 0.53; p ≤ 0.05) with maximal freestyle swim speed in Para swimmers. Although, fewer correlations were found when Para swimmers with hypertonia or impaired muscle power were analysed independently, highlighting the impairment-specific nature of activity limitation in Para swimming. Collectively, the strength test battery has utility in Para swimming classification to infer loss of strength in Para swimmers, guide minimum eligibility criteria, and to define the impact that strength impairment has on Para swimming performance.

Classifying motor coordination impairment in Para swimmers with brain injury.

OBJECTIVES: The International Paralympic Committee has mandated that International Sport Federations develop sport-specific classification systems that are evidence-based. This study examined the predictive and convergent validity of instrumented tapping tasks to classify motor coordination impairments in Para swimming. DESIGN: Cross-sectional. METHODS: Thirty non-disabled participants and twenty-one Para swimmers with brain injury completed several instrumented tapping tasks as an assessment of upper and lower limb motor coordination. Para swimmers also completed a maximal freestyle swim to obtain a performance measure. The predictive and convergent validity of instrumented tapping tasks was examined by establishing differences in test measures between participants with and without brain injury and defining the strength of association between test measures and maximal freestyle swim speed in Para swimmers, respectively. RESULTS: Random forest successfully classified 96% of participants with and without brain injury using test measures derived from instrumented tapping tasks. Most test measures had moderate to high correlations (r=0.54 to 0.72; p<0.01) with maximal freestyle swim speed and collectively explained up to 72% of the variance in maximal freestyle swim performance in Para swimmers with brain injury. CONCLUSIONS: The results of this study evidence the predictive and convergent validity of instrumented tapping tasks to classify motor coordination impairments in Para swimmers with brain injury. These tests can be included in revised Para swimming classification to improve the objectivity and transparency in determining athlete eligibility and sport class for these Para athletes.