(1) Background: Right anterior thoracotomy (RAT-AVR) has been the sole established sternum-sparing technique for minimally invasive aortic valve replacement (MICS-AVR) thus far. Nevertheless, transaxillary access, known as Minimally Invasive Cardiac LATeral Surgery (MICLATS-AVR), represents the latest and innovative advancement in sternum-sparing MICS-AVR access routes. In this study, procedural and clinical outcomes of a substantial transaxillary MICS-AVR cohort are compared to those of a RAT-AVR control group; (2) Patients and Methods: This retrospective study included 918 consecutive patients who underwent MICS-AVR at our facility between 2014 and 2022. This cohort was divided into two surgical access-related groups: RAT-AVR (n = 492) and MICLATS-AVR (n = 426). Procedural data, operative morbidity, and mortality were compared between groups. Further analysis was performed using propensity score matching; (3) Results: After matching, 359 pairs of patients were included and analyzed. There were no notable differences observed between the two groups regarding major adverse cardio-cerebral events. Despite longer cardiopulmonary bypass time in the MICLATS-AVR group (63.1 ± 20.4 min vs. 66.4 ± 18.2 min; p ≤ 0.001) the skin-to-skin time (129.4 ± 35.9 min. vs. 126.5 ± 29.8 min.; p = 0.790) and the aortic cross-clamp time was comparable between both groups (41.9 ± 13.3 min. vs. 43.5 ± 14.4 min.; p = 0.182). The overall hospital stay was significantly shorter in the MICLATS-AVR cohort (9.7 ± 5.2 days vs. 9.2 ± 4.5 days; p = 0.01). Both groups were comparable in terms of postoperative morbidities. However, significantly lower rates of postoperative impaired wound healing were noted in the MICLATS-AVR group (11.7% vs. 3.9%, p < 0.001); (4) Conclusions: In comparing MICLATS-AVR and RAT-AVR, our study found MICLATS-AVR to be at least as safe and time-efficient as RAT-AVR, with no significant differences in MACCE. MICLATS-AVR showed a shorter hospital stay and lower postoperative wound issues, indicating its feasibility and safety as an alternative. Notably, MICLATS-AVR is sternum- and bone-sparing, preserving the right mammary artery, and facilitates combined procedures like multiple valve surgeries.
BACKGROUND: Multiple sclerosis (MS) knowledge is a prerequisite for active patient engagement in medical decision-making. Treatment of relapses in MS is a clinical field with many uncertainties and each acute relapse requires decisions regarding possible options for action, indicating the need for patient involvement. However, there is no validated instrument assessing relapse knowledge in people with MS. Our study aims to develop a valid MS relapse questionnaire for use as an outcome instrument for educational interventions. METHODS: A multidisciplinary panel developed the relapse knowledge questionnaire (RKQ) based on a previously developed questionnaire. We tested the RKQ on MS patients for comprehensibility, usability and acceptance in qualitative think-aloud interviews and conducted a cross-sectional quantitative online survey to validate the questionnaire. People with suspected or confirmed relapsing-remitting MS and a recent relapse experience were eligible for inclusion. We checked normal distribution of the RKQ score and determined the item difficulty. Construct validity was analysed using correlational analysis. RESULTS: The final RKQ consists of 10 items. After minor changes of the RKQ during pre-testing (n = 2), pilot testing (n = 10) confirmed the usability and acceptance of the instrument. The subsequent validation study (n = 203) resulted in a mean item difficulty of 0.44, ranging from 0.18 to 0.83. Seven items were particularly difficult and answered incorrectly by more than 50 % of participants. Construct validity of the RKQ was satisfactory. The RKQ score correlated only weakly with participants' degree of education (|rp|>0.1), years since diagnosis (|rp|>0.1), and the intention to receive corticosteroids (|rp|>0.1). CONCLUSION: This study indicates the validity of the RKQ and proposes that the RKQ is a suitable instrument to assess relapse knowledge in people with MS participating in educational interventions.
Multiple Sclerosis, Relapsing-Remitting , Multiple Sclerosis , Humans , Multiple Sclerosis/diagnosis , Multiple Sclerosis/therapy , Cross-Sectional Studies , Multiple Sclerosis, Relapsing-Remitting/diagnosis , Multiple Sclerosis, Relapsing-Remitting/therapy , Surveys and Questionnaires , Chronic Disease , Recurrence , Reproducibility of Results
Background: The incidence of acetabular fractures in geriatric patients has increased. Although there are strong data supporting the early operative treatment of hip fractures in geriatric patients, the optimal timing for acetabular fractures remains unclear and for several reasons, delayed treatment after trauma is common. Methods: A retrospective analysis of the German Pelvis Registry between 2008 and 2017 was performed. Ultimately, 665 patients with fractures of the anterior column or anterior column and posterior hemitransverse were enrolled. Patients above and below 65 years of age with these fracture types were analyzed regarding surgery day (within 48 hours, between 2 and 4 days, after 4 days), complication rate, reduction quality, and hospital stay. Results: The complication rate of the geriatric group was twice as high as that of younger patients; however, this finding was independent of the timing of surgery. Reduction quality and hospital stay were independent of surgical timing. Conclusions: In contrast to other fracture types, such as proximal femur fractures, the timing of surgery for acetabular fractures does not have a significant impact on the patient's outcome. The optimal time for surgery cannot be determined using the current data. However, as expected, there is a significantly higher risk for postoperative complications in the geriatric population.
BACKGROUND: The two-dimensional (2D) imaging represents an essential and cost-effective component of intraoperative position control in fracture stabilization, even in the era of new three-dimensional (3D) imaging capabilities. OBJECTIVE: The aim of the present study, in addition to a current literature review, was to examine whether the intraoperative use of 2D images leads to a quality of fracture reduction comparable to postoperative computed tomographic (CT) analysis including 3D reconstructions. MATERIAL AND METHODS: A comparative retrospective analysis of intraoperative 2D and postoperative 3D image data was performed on 21 acetabular fractures stabilized via a pararectus approach according to an established protocol using the Matta criteria. RESULTS: The assessment of fracture reduction in intraoperative fluoroscopy compared with postoperative CT revealed a difference only in one case with respect to the categorization of the joint step reduction in the main loading zone. CONCLUSION: In the intraoperative use of 2D imaging for fracture treatment it is important to select the correct adjustment planes taking the anatomical conditions into account in order to achieve optimum assessability. In this way, the reduction result can be adequately displayed in fluoroscopy and is also comparable to the postoperative CT control. In addition, depending on the findings, optional intraoperative dynamic fluoroscopic assessment can have a direct influence on the further surgical procedure.
Fracture Fixation, Internal , Hip Fractures , Humans , Fracture Fixation , Fracture Fixation, Internal/methods , Retrospective Studies , Tomography, X-Ray Computed/methods
Cell-free, chemoenzymatic platforms are emerging technologies towards generating glycoconjugates with defined and homogeneous glycoforms. Recombinant oligosaccharyltransferases can be applied to glycosylate "empty," i.e., aglycosyalted, peptides and proteins. While bacterial oligosaccharlytransferases have been extensively investigated, only recently a recombinant eukaryotic single-subunit oligosaccharyltransferase has been successfully used to in vitro N-glycosylate peptides. However, its applicability towards synthesizing full-length glycoproteins and utilizing glycans beyond mannose-type glycans for the transfer have not be determined. Here, we show for the first time the synthesis of hybrid- and complex-type glycans using synthetic lipid carriers as substrates for in vitro N-glycosylation reactions. For this purpose, transmembrane-deleted human ß-1,2 N-acetylglucosamintransferase I and II (MGAT1ΔTM and MGAT2ΔTM) and ß-1,4-galactosyltransferase (GalTΔTM) have been expressed in Escherichia coli and used to extend an existing multi-enzyme cascade. Both hybrid and agalactosylated complex structures were transferred to the N-glycosylation consensus sequence of peptides (10 amino acids: G-S-D-A-N-Y-T-Y-T-Q) by the recombinant oligosaccharyltransferase STT3A from Trypanosoma brucei.
OBJECTIVE: Peer support is an established intervention in which people with mental illness receive support by trained peer support workers who have already overcome a mental health crisis. The implementation of peer support is complex due to interacting factors and can be achieved through the participatory Theory of Change method. Aim of this study is to develop a cross-site Theory of Change for the sustainable implementation of UPSIDES peer support in Germany. METHODS: Based on site-specific Theories of Change workshops from Ulm and Hamburg in which 47 participants took part, a cross-site Theory of Change was designed and verified in three follow-up workshops with 12 participants. Participants' professional and experiential backgrounds were diverse, including peer support workers, hospital directors and managers, mental health professionals (psychiatrists, psychotherapists, nurses), and researchers. RESULTS: The first pathway of the cross-site Theory of Change focuses on the training of peer support workers, whereas the second pathway emphasizes recognition and integration by mental health institutions and professionals. The third pathway specifies the building of a cross-professional care network to integrate various peer support services. Procedures to approach prospective peer clients are depicted in the fourth pathway. The fifth path addresses the clarification of the role description of peer support workers and the implementation in other institutions through cooperation. DISCUSSION: Many of the identified implementation steps have been validated in comparable studies. The development of this Theory of Change by bringing together multiple perspectives of key stakeholders is an important basis for the sustainable implementation of UPSIDES peer support. Furthermore, it may serve as a blueprint for the implementation of similar interventions to advance scaling-up of evidence-based user-led and recovery-oriented interventions. CONCLUSION: The Theory of Change approach is a well-accepted and feasible method, which can be recommended for the implementation of complex interventions such as UPSIDES peer support.
Mental Disorders , Humans , Prospective Studies , Mental Disorders/therapy , Counseling , Mental Health , Health Personnel
This paper aimed to contribute to answering three questions. First, how robust and reliable are early implicit measures of false belief (FB) understanding? Second, do these measures tap FB understanding rather than simpler processes such as tracking the protagonist's perceptual access? Third, do implicit FB tasks tap an earlier, more basic form of theory of mind (ToM) than standard verbal tasks? We conducted a conceptual replication of Garnham & Perner's task (Garnham and Perner 2001 Br. J. Dev. Psychol. 19, 413-432) simultaneously measuring children's anticipatory looking and interactive behaviours toward an agent with a true or FB (N = 81, M = 40 months). Additionally, we implemented an ignorance condition and a standard FB task. We successfully replicated the original findings: children's looking and interactive behaviour differed according to the agent's true or FB. However, children mostly did not differentiate between FB and ignorance conditions in various measures of anticipation and uncertainty, suggesting the use of simpler conceptual strategies than full-blown ToM. Moreover, implicit measures were all related to each other but largely not related to performance in the standard FB task, except for first look in the FB condition. Overall, our findings suggest that these implicit measures are robust but may not tap the same underlying cognitive capacity as explicit FB tasks.
Introduction: Despite the lack of high-quality evidence regarding its long-term effectiveness, intravenous corticosteroid therapy is recommended as the standard treatment of acute multiple sclerosis relapses in Germany. High financial expenses and the equivalent effectiveness of oral corticosteroid therapy contrast with this trend. There is an urgent need to provide patients with evidence-based and comprehensible information on relapse management and to actively involve patients in relapse treatment decisions. Web-based decision support on relapse management could be an effective measure to empower people with multiple sclerosis making informed treatment decisions. Objectives: To develop a web-based programme on relapse management for people with multiple sclerosis and evaluate the feasibility and acceptability of the intervention. Methods: The study followed the first two phases of the UK Medical Research Council Framework for complex interventions. The first phase involved the development of an interactive web-based programme on relapse management. The second phase focused on the feasibility and pilot testing of the programme with people with multiple sclerosis and experts with a professional background in multiple sclerosis. Data was obtained using questionnaires with closed- and open-ended questions as well as qualitative semi-structured telephone interviews. Quantitative data was analyzed descriptively, whereas qualitative data was clustered by topic. Results: Feasibility of the intervention programme was tested with 10 people with multiple sclerosis and 10 experts. Feasibility testing indicated good practicability and acceptance of the content. After revision, the programme was piloted with seven people with multiple sclerosis and three experts. The results showed good acceptance in both groups. Based on the feedback, a final revision was performed. Conclusion: Feasibility and pilot testing indicated good user-friendliness, acceptance, and practicability of the programme. The programme is currently evaluated in a randomized controlled trial (Registration Number on ClinicalTrials.gov: NCT04233970). It is expected that the programme will have a positive impact on patients' relapse management and strengthen their autonomy and participation.
PURPOSE: A common surgical treatment in anterior column acetabular fractures with preexisting osteoarthritis is THA, which is commonly combined with plate osteosynthesis. Implantation of a solitary revision cup cranially fixed to the os ilium is less common. The purpose of this study was to compare the stabilization of anterior column acetabular fractures fixed with a cranial socket revision cup with flange and iliac peg or with a suprapectineal plate osteosynthesis combined with an additional revision cup. METHODS: In 20 human hemipelves, an anterior column fracture was stabilized by either a cranial socket revision cup with integrated flange (CF = Cup with Flange) or by a suprapectineal plate combined with a revision cup (CP = Cup and Plate). Each specimen was loaded under a stepwise increasing dynamic load protocol. Initial construct stiffness, interfragmentary movements along the fracture line, as well as femoral head movement in relation to the acetabulum were analyzed. RESULTS: Both groups showed comparable initial construct stiffness (CP: 3180 ± 1162 N/mm and CF: 3754 ± 668 N/mm; p = 0.158). At an applied load of 1400 N, interfragmentary movements at the acetabular (p = 0.139) and the supraacetabular region (p = 0.051) revealed comparable displacement for both groups and remained below 1 mm. Femoral head movement in relation to the acetabulum also remained below 1 mm for both test groups (p = 0.260). CONCLUSION: From a biomechanical point of view, both surgical approaches showed comparable fracture reduction in terms of initial construct stiffness and interfragmentary movement. The potential benefit of the less-invasive cranial socket revision cup has to be further investigated in clinical studies.
Arthroplasty, Replacement, Hip , Fractures, Bone , Hip Fractures , Spinal Fractures , Acetabulum/injuries , Acetabulum/surgery , Arthroplasty, Replacement, Hip/methods , Biomechanical Phenomena , Fracture Fixation, Internal/methods , Fractures, Bone/surgery , Hip Fractures/surgery , Humans , Spinal Fractures/surgery
PURPOSE: Patients with surgically treated acetabular fractures using extensive dissection of hip muscles demonstrate an incomplete biomechanical recovery and limited joint mobility during movement. The purpose of this study was to evaluate the early biomechanical outcome in a series of patients with acetabular fractures treated using the less invasive anatomical pararectus approach. METHODS: Eight patients (48 ± 14 years, BMI 25.8 ± 3 kg/m2) were investigated 3.8 ± 1.3 months after surgery and compared to matched controls (49 ± 13 years, BMI 26 ± 2.8 kg/m2). Trunk and lower extremity kinematics and kinetics during gait and stair climb were calculated. SF-12 and the Merle d'Aubigné score were used for functional evaluation. Statistical analysis was conducted using Mann-Whitney test and Student's t test. Effect sizes were calculated using Cohen's d. RESULTS: No group differences for lower extremity kinematics during walking and stair climbing were found. During walking, patients showed significant reductions (p < 0.05) of the vertical ground reaction force (8%) and knee and hip extension moments (29 and 27%). Ipsilateral trunk lean was significantly increased by 3.1° during stair descend while reductions of vertical ground reaction force were found for stair ascend (7%) and descend (20%). Hip extension moment was significantly reduced during stair descend by 37%. Patients revealed acceptable SF-12 physical and mental component outcomes and a good rating for the Merle d'Aubigné score (15.9 ± 1.7). CONCLUSION: Patients showed some biomechanical restrictions that can be related to residual deficits in weight bearing capacity and strength of the hip muscles. In contrast, an immediate recovery of mobility was achieved by preserving lower extremity and pelvic movement. Therefore, the pararectus approach can serve as a viable strategy in the surgical treatment of acetabular fractures. CLINICAL TRIAL: Trial registration number DRKS00011308, 11/14/2016, prospectively registered.
Hip Fractures , Spinal Fractures , Adult , Biomechanical Phenomena , Gait , Hip Fractures/surgery , Humans , Knee Joint , Middle Aged , Spinal Fractures/surgery , Treatment Outcome
INTRODUCTION: Process evaluations accompanying complex interventions examine the implementation process of the underlying intervention, identify mechanisms of impact and assess contextual factors. This paper presents the protocol for a process evaluation conducted alongside the randomised controlled trial POWER@MS2. The trial comprises the evaluation of a web-based complex intervention on relapse management in 188 people with multiple sclerosis conducted in 20 centres. The web-based intervention programme focuses on relapse treatment decision making and includes a decision aid, a nurse-led webinar and an online chat. With the process evaluation presented here, we aim to assess participants' responses to and interactions with the intervention to understand how and why the intervention produces change. METHODS AND ANALYSIS: A mixed methods design is used to explore the acceptance of the intervention as well as its use and impact on participants. Participants are people with multiple sclerosis, neurologists, nurses and stakeholders. Quantitative semistandardised evaluation forms will be collected throughout the study. Qualitative semistructured telephone interviews will be conducted at the end of the study with selected participants, especially people with multiple sclerosis and neurologists. Quantitative data will be collected and analysed descriptively. Based on the results, the qualitative interviews will be conducted and analysed thematically, and the results will be merged in a joint display table. ETHICS AND DISSEMINATION: The process evaluation has received ethical approval from the Ethical Committee of the University of Lübeck (reference 19-024). Findings will be disseminated in peer-reviewed journals, at conferences, meetings and on relevant patient websites. TRIAL REGISTRATION NUMBER: NCT04233970.
Internet-Based Intervention , Multiple Sclerosis , Chronic Disease , Humans , Multiple Sclerosis/therapy , Process Assessment, Health Care , Randomized Controlled Trials as Topic , Recurrence
BACKGROUND: Screws are the most frequently inserted orthopaedic implants. Biomechanical, laboratory-based studies are used to provide a controlled environment to investigate revolutionary and evolutionary improvements in orthopaedic techniques. Predominantly, biomechanical trained, non-surgically practicing researchers perform these studies, whilst it will be orthopaedic surgeons who will put these procedures into practice on patients. Limited data exist on the comparative performance of surgically and non-surgically trained biomechanical researchers when inserting screws. Furthermore, any variation in performance by surgeons and/or biomechanical researchers may create an underappreciated confounder to biomechanical research findings. This study aimed to identify the differences between surgically and non-surgically trained biomechanical researchers' achieved screw tightness and stripping rates with different fixation methods. METHODS: Ten orthopaedic surgeons and 10 researchers inserted 60 cortical screws each into artificial bone, for three different screw diameters (2.7, 3.5 and 4.5 mm), with 50% of screws inserted through plates and 50% through washers. Screw tightness, screw hole stripping rates and confidence in screw purchase were recorded. Three members of each group also inserted 30 screws using an augmented screwdriver, which indicated when optimum tightness was achieved. RESULTS: Unstripped screw tightness for orthopaedic surgeons and researchers was 82% (n = 928, 95% CI 81-83) and 76% (n = 1470, 95% CI 75-76) respectively (p < 0.001); surgeons stripped 48% (872/1800) of inserted screws and researchers 18% (330/1800). Using washers was associated with increased tightness [80% (95% CI 80-81), n = 1196] compared to screws inserted through plates [76% (95% CI 75-77), n = 1204] (p < 0.001). Researchers were more accurate in their overall assessment of good screw insertion (86% vs. 62%). No learning effect occurred when comparing screw tightness for the first 10 insertions against the last 10 insertions for any condition (p = 0.058-0.821). Augmented screwdrivers, indicating optimum tightness, reduced stripping rates from 34 to 21% (p < 0.001). Experience was not associated with improved performance in screw tightness or stripping rates for either group (p = 0.385-0.965). CONCLUSIONS: Surgeons and researchers showed different screw tightness under the same in vitro conditions, with greater rates of screw hole stripping by surgeons. This may have important implications for the reproducibility and transferability of research findings from different settings depending on who undertakes the experiments.
Bone Screws , Clinical Competence , Orthopedic Surgeons , Biomechanical Phenomena , Bone and Bones , Humans , Reproducibility of Results , Torque
BACKGROUND: At least two thirds of medical students are female. How can they be won over in the competition for the best heads and hands in the field of orthopedics and trauma surgery? 25% of the inpatient surgeons are female, while the proportion of women in managerial positions is only 5%. GOAL OF THE WORK (QUESTION): How do the specialist field and the specialist society have to change in order to be attractive for the younger generation, and be regarded as a dream job? MATERIAL AND METHODS: With the help of surveys and scientific literature, the following problem areas are identified and highlighted: What do today's young doctors want? How should employers and superiors behave in relation to the women-specific life events of pregnancy, maternity leave and breastfeeding? How to enable female surgeons to continue operating as desired in accordance with the law? Often in clinics, care is not taken to provide female surgeons with individually sized instruments. A manufacturer survey was carried out for this purpose. How can we counteract the sexual harassment and discrimination in the workplace? How can male and female professionals achieve a more equal balance between family and work in the clinic and practice? RESULTS: The Gender Bias, the glass ceiling, the lack of female role models and female mentors mean that female surgeons do not have equal opportunities. The gender pay gap and the gender care gap are discussed and presented with data. Significantly, there is a specific lack of data on the gender pay gap in Germany. The everyday clinical practice and the professional society are still a man's world. In order to attract a sufficient number of young professionals, the working environment and participation in committees must be transformed into a world that is equal for male and female surgeons. DISCUSSION: With regard to the identified problem areas, suggestions for improvement for active implementation are listed.
Orthopedic Procedures , Orthopedics , Surgeons , Female , Germany , Humans , Male , Pregnancy , Sexism , Surveys and Questionnaires
INTRODUCTION: There have been 30 clinically suspected cases and 41 histopathologically confirmed cases of fibrocartilaginous embolism (FCE) reported in the literature. FCE often has a poor prognosis and is estimated to represent 5.5% of spinal cord infarctions, but may be more common than initially presumed given underdiagnosis due to its vague clinical presentation. CASE PRESENTATION: We report two cases, a 15-year-old male and a 15-year-old female, whose clinical history, examination, and imaging findings were consistent with spinal cord infarction secondary to FCE. DISCUSSION: These cases were unique given our patients' neurologic improvement; however, the commonly held assumption of poor prognosis may in part be fueled by the preferential case ascertainment via biopsy on autopsy. These cases highlight the importance of recognizing rare causes of spinal cord pathology and considering FCE in the differential diagnosis of acute myelopathy.
Cartilage Diseases , Embolism , Spinal Cord Ischemia , Embolism/complications , Embolism/diagnosis , Female , Humans , Male
BACKGROUND: Along with emerging open access journals (OAJ) predatory journals increasingly appear. As they harm accurate and good scientific research, we aimed to examine the awareness of predatory journals and open access publishing among orthopaedic and trauma surgeons. METHODS: In an online survey between August and December 2019 the knowledge on predatory journals and OAJ was tested with a hyperlink made available to the participants via the German Society for Orthopaedics and Trauma Surgery (DGOU) email distributor. RESULTS: Three hundred fifty orthopaedic and trauma surgeons participated, of which 291 complete responses (231 males (79.4%), 54 females (18.6%) and 5 N/A (2.0%)) were obtained. 39.9% were aware of predatory journals. However, 21.0% knew about the "Directory of Open Access Journals" (DOAJ) as a register for non-predatory open access journals. The level of profession (e.g. clinic director, consultant) (p = 0.018) influenced the awareness of predatory journals. Interestingly, participants aware of predatory journals had more often been listed as corresponding authors (p < 0.001) and were well published as first or last author (p < 0.001). Awareness of OAJ was masked when journal selection options did not to provide any information on the editorial board, the peer review process or the publication costs. CONCLUSION: The impending hazard of predatory journals is unknown to many orthopaedic and trauma surgeons. Early stage clinical researchers must be trained to differentiate between predatory and scientifically accurate journals.
Open Access Publishing , Orthopedics , Periodicals as Topic , Surgeons , Female , Germany , Humans , Male
INTRODUCTION: Multiple sclerosis is a chronic inflammatory, degenerative disease of the central nervous system manifesting at first with relapses in about 85% of cases. In Germany, intravenous therapy with high-dose corticosteroids is the treatment standard of acute relapses. The treatment leads to a faster reduction of symptoms in about 25 of 100 treated patients but has no proven long-term benefits over placebo treatment. Intravenous treatment is not superior to oral treatment. Therefore, informed decisions on relapse management are required. An earlier randomised controlled trial showed that evidence-based patient information and education on relapse management leads to more informed decisions and more relapses not treated or treated with oral corticosteroids. This study aims to evaluate whether a web-based relapse management programme will positively change relapse management and strengthen autonomy in people with multiple sclerosis. METHODS: The pragmatic double-blind randomised controlled trial is accompanied by a mixed-methods process evaluation and a health economic evaluation and follows the UK Medical Research Council guidance on developing and evaluating complex interventions. A total of 188 people with possible or relapsing-remitting multiple sclerosis with ≥ 1 relapse within the last year and/or ≥ 2 relapses within the last 2 years will be recruited and randomised using blocks. The intervention group receives a web- and dialogue-based decision aid on relapse management, a nurse-led webinar and access to a monitored chat forum. The control group receives standard information, which will be made available via the same online platform as the intervention. The primary endpoint is the proportion of relapses not treated or treated with oral corticosteroids. Key secondary endpoints are the annualised relapse rate, decision-making, empowerment, quality of life and cost-effectiveness. Facilitators and barriers will be assessed by mixed-methods process evaluation measures. The study ends when 81 relapses have been documented or after 24 months of observation per individual patient. Analyses will follow the intention-to-treat principle. DISCUSSION: We hypothesise that the intervention will enhance patient empowerment and have a positive impact on patients' relapse management. TRIAL REGISTRATION: ClinicalTrials.gov NCT04233970 . Registered on 18 January 2020.
Multiple Sclerosis, Relapsing-Remitting , Multiple Sclerosis , Germany , Humans , Internet , Multiple Sclerosis/diagnosis , Multiple Sclerosis/drug therapy , Multiple Sclerosis, Relapsing-Remitting/diagnosis , Multiple Sclerosis, Relapsing-Remitting/drug therapy , Quality of Life , Randomized Controlled Trials as Topic , Recurrence
Traditionally, it had been assumed that meta-representational Theory of Mind (ToM) emerges around the age of 4 when children come to master standard false belief (FB) tasks. More recent research with various implicit measures, though, has documented much earlier competence and thus challenged the traditional picture. In interactive FB tasks, for instance, infants have been shown to track an interlocutor's false or true belief when interpreting her ambiguous communicative acts (Southgate et al. 2010 Dev. Sci. 13, 907-912. (doi:10.1111/j.1467-7687.2009.00946.x)). However, several replication attempts so far have produced mixed findings (e.g. Dörrenberg et al. 2018 Cogn. Dev. 46, 12-30. (doi:10.1016/j.cogdev.2018.01.001); Grosse Wiesmann et al. 2017 Dev. Sci. 20, e12445. (doi:10.1111/desc.12445); Király et al. 2018 Proc. Natl Acad. Sci. USA 115, 11 477-11 482. (doi:10.1073/pnas.1803505115)). Therefore, we conducted a systematic replication study, across two laboratories, of an influential interactive FB task (the so-called 'Sefo' tasks by Southgate et al. 2010 Dev. Sci. 13, 907-912. (doi:10.1111/j.1467-7687.2009.00946.x)). First, we implemented close direct replications with the original age group (17-month-olds) and compared their performance to those of 3-year-olds. Second, we designed conceptual replications with modifications and improvements regarding pragmatic ambiguities for 2-year-olds. Third, we validated the task with explicit verbal test versions in older children and adults. Results revealed the following: the original results could not be replicated, and there was no evidence for FB understanding measured by the Sefo task in any age group except for adults. Comparisons to explicit FB tasks suggest that the Sefo task may not be a sensitive measure of FB understanding in children and even underestimate their ToM abilities. The findings add to the growing replication crisis in implicit ToM research and highlight the challenge of developing sensitive, reliable and valid measures of early implicit social cognition.
BACKGROUND: Screws are the most commonly inserted orthopaedic implants. However, several variables related to screw insertion and tightening have not been evaluated. This study aimed firstly to assess the effect of insertion variables on screw tightness, secondly to improve methodologies used by researchers when testing screw insertion techniques and thirdly to assess for any learning or fatigue effects when inserting screws. METHODS: Two surgeons tightened a total of 2280 non-locking, 3.5 mm cortical screws, with 120 screws inserted to what they felt to be optimum tightness whilst varying each of the following factors: different screwdrivers for measuring torque, screwdriver orientation, gloves usage, dominant/non-dominant hand usage, awareness to the applied torque (blinded, unblinded and re-blinded), four bone densities and seven cortical thicknesses. Screws were tightened to failure to determine stripping torque, which was used to calculate screw tightness - ratio between stopping and stripping torque. FINDINGS: Screw tightness increased with glove usage, being blinded to the applied torque and with denser artificial bone and with thinner cortices. Considering all the insertions performed, the two surgeons stopped tightening screws at difference values of tightness ((77% versus 66% (p < 0.001)). A learning effect was observed with some parameters including sterile gloves usage and non-dominant hand application. INTERPRETATION: Different insertion conditions frequently changed screw tightness for both surgeons. Given the influence of screw tightness on fixation stability, the variables investigated within this study should be carefully reported and controlled when performing biomechanical testing alongside practicing screw insertion under different conditions during surgical training.
Bone Screws , Fracture Fixation, Internal/instrumentation , Mechanical Phenomena , Biomechanical Phenomena , Humans , Torque
