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PURPOSE: The aim of this study is to explore the feasibility of using machine learning approaches to objectively differentiate the mobilization patterns, measured via accelerometer sensors, of patients pre- and post-intervention. METHODS: The intervention tested the implementation of a Frailty Care Bundle to improve mobilization, nutrition and cognition in older orthopedic patients. The study recruited 120 participants, a sub-group analysis was undertaken on 113 patients with accelerometer data (57 pre-intervention and 56 post-intervention), the median age was 78 years and the majority were female. Physical activity data from an ankle-worn accelerometer (StepWatch 4) was collected for each patient during their hospital stay. These data contained daily aggregated gait variables. Data preprocessing included the standardization of step counts and feature computation. Subsequently, a binary classification model was trained. A systematic hyperparameter optimization approach was applied, and feature selection was performed. Two classifier models, logistic regression and Random Forest, were investigated and Shapley values were used to explain model predictions. RESULTS: The Random Forest classifier demonstrated an average balanced accuracy of 82.3% (± 1.7%) during training and 74.7% (± 8.2%) for the test set. In comparison, the logistic regression classifier achieved a training accuracy of 79.7% (± 1.9%) and a test accuracy of 77.6% (± 5.5%). The logistic regression model demonstrated less overfitting compared to the Random Forest model and better performance on the hold-out test set. Stride length was consistently chosen as a key feature in all iterations for both models, along with features related to stride velocity, gait speed, and Lyapunov exponent, indicating their significance in the classification. CONCLUSION: The best performing classifier was able to distinguish between patients pre- and post-intervention with greater than 75% accuracy. The intervention showed a correlation with higher gait speed and reduced stride length. However, the question of whether these alterations are part of an adaptive process that leads to improved outcomes over time remains.

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BACKGROUND: Randomised controlled trials (RCTs) inform healthcare decisions. Unfortunately, some published RCTs contain false data, and some appear to have been entirely fabricated. Systematic reviews are performed to identify and synthesise all RCTs which have been conducted on a given topic. This means that any of these 'problematic studies' are likely to be included, but there are no agreed methods for identifying them. The INSPECT-SR project is developing a tool to identify problematic RCTs in systematic reviews of healthcare-related interventions. The tool will guide the user through a series of 'checks' to determine a study's authenticity. The first objective in the development process is to assemble a comprehensive list of checks to consider for inclusion. METHODS: We assembled an initial list of checks for assessing the authenticity of research studies, with no restriction to RCTs, and categorised these into five domains: Inspecting results in the paper; Inspecting the research team; Inspecting conduct, governance, and transparency; Inspecting text and publication details; Inspecting the individual participant data. We implemented this list as an online survey, and invited people with expertise and experience of assessing potentially problematic studies to participate through professional networks and online forums. Participants were invited to provide feedback on the checks on the list, and were asked to describe any additional checks they knew of, which were not featured in the list. RESULTS: Extensive feedback on an initial list of 102 checks was provided by 71 participants based in 16 countries across five continents. Fourteen new checks were proposed across the five domains, and suggestions were made to reword checks on the initial list. An updated list of checks was constructed, comprising 116 checks. Many participants expressed a lack of familiarity with statistical checks, and emphasized the importance of feasibility of the tool. CONCLUSIONS: A comprehensive list of trustworthiness checks has been produced. The checks will be evaluated to determine which should be included in the INSPECT-SR tool.

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INTRODUCTION: Testicular cancer is among the most common malignancies in men under the age of 50 years. Most testicular symptoms are linked to benign diseases. Men's awareness of testicular diseases and testicular self-examination behaviours are suboptimal. In this pilot feasibility study and process evaluation we examine the feasibility of conducting a future definitive randomised controlled trial (RCT) to test the effect of the Enhancing Men's Awareness of Testicular Diseases using Virtual Reality intervention (E-MATVR) compared to the Enhancing Men's Awareness of Testicular Diseases using Electric information control (E-MATE). The study protocol is registered on ClinicalTrials.gov (NCT05146466). METHODS: Male athletes, engaged in Gaelic games, and aged 18 to 50 years were included. Recruitment was via FacebookTM, XTM (formerly TwitterTM), and posters. Participants were individually randomised to either E-MATVR or E-MATE. Data were collected at baseline (T0), immediately post-test (T1), and three months post-test (T2) using surveys. Qualitative interviews were conducted with participants and researchers. RESULTS: Data were collected from 74 participants. Of those, 66 were retained. All E-MATVR participants and most E-MATE participants (n = 33, 89.2%) agreed/strongly agreed that the device was easy to use and that they were engaged to learn by the device. Most E-MATVR participants (n = 34, 91.9%) and all E-MATE participants agreed/strongly agreed that the time it took them to complete the intervention was reasonable. All 74 participants were extremely satisfied/somewhat satisfied with their overall participation in the study. E-MATVR was described as interactive, easy, fun, and close to real life. Initial difficulty using VR equipment, nausea, and technical issues were identified as challenges to engaging with E-MATVR. Recommendations were made to make VR more accessible, shorten the survey, and incorporate more interactivity. Across all participants, mean testicular knowledge scores (range 0-1) increased from 0.4 (SD 0.2) at T0 to 0.8 (SD 0.2) at T1. At T2, overall mean scores for participants were 0.7 (SD 0.2). Mean knowledge scores did not differ by trial arm at any timepoint. At T2, all E-MATVR participants and 29/32 E-MATE participants (90.6%) reported purposefully examining their testes within the past three months. CONCLUSION: Findings are promising, highlighting the feasibility of using VR to promote young athletes' awareness of testicular diseases. Considering the strengths, limitations, and lessons learned from this study, some modifications are required prior to conducing an RCT. These include but are not limited to shortening survey questions, incorporating more interactivity and visual content, and targeting more heterogenous male-dominated environments.

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Wastewater-based epidemiology (WBE) has been an important tool for population surveillance during the COVID-19 pandemic and continues to play a key role in monitoring SARS-CoV-2 infection levels following reductions in national clinical testing schemes. Studies measuring decay profiles of SARS-CoV-2 in wastewater have underscored the value of WBE, however investigations have been hampered by high biosafety requirements for SARS-CoV-2 infection studies. Therefore, surrogate viruses with lower biosafety standards have been used for SARS-CoV-2 decay studies, such as murine hepatitis virus (MHV), but few studies have directly compared decay rates of both viruses. We compared the persistence of SARS-CoV-2 and MHV in wastewater, using 50 % tissue culture infectious dose (TCID50) and reverse transcription quantitative polymerase chain reaction (RT-qPCR) assays to assess infectious virus titre and viral gene markers, respectively. Infectious SARS-CoV-2 and MHV indicate similar endpoints, however observed early decay characteristics differed, with infectious SARS-CoV-2 decaying more rapidly than MHV. We find that MHV is an appropriate infectious virus surrogate for viable SARS-CoV-2, however inconsistencies exist in viral RNA decay parameters, indicating MHV may not be a suitable nucleic acid surrogate across certain temperature regimes. This study highlights the importance of sample preparation and the potential for decay rate overestimation in wastewater surveillance for SARS-CoV-2 and other pathogens.

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BACKGROUND: Few studies have explored the feasibility of online language interventions for young children with Down syndrome. Additionally, none have manipulated dose frequency or reported on the use of music as a medium through which language and sign can be learned. PURPOSE: The purpose of this study was to (a) examine the feasibility and acceptability of an online language through music intervention for young children (1-3;6 years) with Down syndrome and (b) compare effectiveness at two intervention dose frequencies. METHOD: The study was carried out in two phases using a mixed-methods design. Phase 1: Qualitative data were gathered from parents to examine feasibility when implementing a video-based language intervention. Phase 2: Seventy-six families participated in an online language intervention at home. Effectiveness was examined comparing two groups, randomly assigned to a high and low dose frequency. The Down Syndrome Education (DSE) checklists (combined) were the primary outcome measure. Process data were gathered to determine intervention acceptability in practice and to identify factors that would improve successful future implementation. Acceptability data were analyzed with reference to the theoretical framework of acceptability (Version 2). RESULTS: Forty-three parents completed the Phase 1 scoping questionnaire, five of whom took part in focus groups. Once weekly morning sessions were indicated as the preferred scheduling choice. Phase 2 quantitative data were analyzed using beta regression adjusted for baseline scores and indicated no additional benefit to receiving the higher dose. However, exploratory interaction models suggested that the efficacy of the high-dose intervention was higher (than low-dose intervention) in participants with higher baseline DSE performance. Parents perceived the intervention to be effective and positive for the family. CONCLUSION: The results add to our knowledge of real-world effective online interventions and suggest that a critical minimum language level is required for children with Down syndrome to benefit optimally from a higher intervention dose frequency. SUPPLEMENTAL MATERIAL: https://doi.org/10.23641/asha.25979704.

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Background: Randomised controlled trials (RCTs) inform healthcare decisions. Unfortunately, some published RCTs contain false data, and some appear to have been entirely fabricated. Systematic reviews are performed to identify and synthesise all RCTs which have been conducted on a given topic. This means that any of these 'problematic studies' are likely to be included, but there are no agreed methods for identifying them. The INSPECT-SR project is developing a tool to identify problematic RCTs in systematic reviews of healthcare-related interventions. The tool will guide the user through a series of 'checks' to determine a study's authenticity. The first objective in the development process is to assemble a comprehensive list of checks to consider for inclusion. Methods: We assembled an initial list of checks for assessing the authenticity of research studies, with no restriction to RCTs, and categorised these into five domains: Inspecting results in the paper; Inspecting the research team; Inspecting conduct, governance, and transparency; Inspecting text and publication details; Inspecting the individual participant data. We implemented this list as an online survey, and invited people with expertise and experience of assessing potentially problematic studies to participate through professional networks and online forums. Participants were invited to provide feedback on the checks on the list, and were asked to describe any additional checks they knew of, which were not featured in the list. Results: Extensive feedback on an initial list of 102 checks was provided by 71 participants based in 16 countries across five continents. Fourteen new checks were proposed across the five domains, and suggestions were made to reword checks on the initial list. An updated list of checks was constructed, comprising 116 checks. Many participants expressed a lack of familiarity with statistical checks, and emphasized the importance of feasibility of the tool. Conclusions: A comprehensive list of trustworthiness checks has been produced. The checks will be evaluated to determine which should be included in the INSPECT-SR tool.

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Objective: To implement and evaluate a Frailty Care Bundle (FCB) targeting mobilisation, nutrition, and cognition in older trauma patients to reduce hospital associated decline. Methods: We used a two group, pretest-posttest design. The FCB intervention was delivered on two orthopaedic wards and two rehabilitation wards, guided by behaviour change theory (COM-B) to implement changes in ward routines (patient mobility goals, nurse assisted mobilisation, mealtimes, communication). Primary outcomes were patient participants' return to pre-trauma functional capability (modified Barthel Index - mBI) at 6-8 weeks post-hospital discharge and average hospital daily step-count. Statistical analysis compared pre versus post FCB group differences using ordinal regression and log-linear models. Results: We recruited 120 patients (pre n=60 and post n=60), and 74 (pre n=43, post n=36) were retained at follow-up. Median age was 78 years and 83% were female. There was a non-significant trend for higher mBI scores (improved function) in the post compared to pre FCB group (OR 2.29, 95% CI 0.98-5.36), associated with an average 11% increase in step-count. Conclusion: It was feasible, during the Covid-19 pandemic, for multidisciplinary teams to implement elements of the FCB. Clinical facilitation supported teams to prioritise fundamental care above competing demands, but sustainability requires ongoing attention. ISRCTN registry: ISRCTN15145850 (https://doi.org/10.1186/ISRCTN15145850).

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OBJECTIVES: To (1) provide position-specific normative data for isometric cervical muscle strength and endurance in professional, male rugby players and (2) assess the relationship between age, height, weight, and playing position with cervical muscle strength and endurance. DESIGN: Cross-sectional study. METHODS: Professional rugby players completed peak isometric cervical strength testing followed by a test of cervical muscle endurance. Descriptive statistics for continuous variables with strength normalized to body weight were performed. Multiple linear regression was used to estimate associations between strength measurements. RESULTS: In total, 136 players participated including front-row forwards (27%), other forwards (28%), and backs (45%). Front-row forwards had significantly greater peak isometric cervical muscle strength than other position groups, with backs having the lowest strength. Extension produced the highest force for all 3 position groups (429 N ± 104 N), whereas flexion produced the least (275 N ± 65 N). Age was associated with increased isometric cervical muscle strength. There was a statistically significant relationship between peak flexion strength and flexion endurance (P = .003). The average time for the endurance tests were 55.7 (±17.1) seconds and 52.9 (±20.1) seconds for extension and flexion, respectively. Other forwards had lower cervical extension muscle endurance than backs and front-row forwards. CONCLUSIONS: Normative values for peak and endurance isometric strength in professional rugby players illustrate significant differences between playing position. Consider age, body weight, and intraindividual variability when interpreting cervical strength and endurance results. J Orthop Sports Phys Ther 2024;54(3):1-8. Epub 29 January 2024. doi:10.2519/jospt.2024.11830.

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BACKGROUND: Total hip arthroplasty (THA) is a common procedure for end stage osteoarthritis. The learning curve for THA is complex and challenging. One of the most difficult skills to master is acetabular reaming. We wish to identify if experience in arthroplasty leads to preservation of more bone stock. AIM: To investigate if increasing surgeon experience will predict an ever decreasing acetabular cup size. METHODS: A retrospective case series of four attending orthopaedic surgeons was completed. All uncemented elective total hip arthroplasties since appointment were selected for inclusion. The size of acetabular cup used was noted and logistic regression was used to identify if a trend to smaller cups existed. RESULTS: A total of 1614 subjects were included with a mean age of 64 years. Overall cups were on average 0.18mm smaller per year (95% confidence interval -0.25 to -0.11, P < 0.001). Individual surgeon trends showed cup sizes to decrease 0.27 mm/year for surgeon A, 0.02 mm/year for surgeon B, 0.15 mm/year for surgeon C and 0.29 mm/year for surgeon D. Three of the four surgeons had a more pronounced trend to smaller cups for male subjects than their female counterparts. CONCLUSION: We found increasing surgeon experience to be associated with an ever-decreasing acetabular cup size. Smaller acetabular cup size may act as a surrogate marker of surgical proficiency by virtue of decreased acetabular reaming.

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OBJECTIVE: To evaluate the efficacy and safety of non-ablative vaginal Er:YAG laser device in stress urinary incontinence (SUI) treatment. METHODS: We conducted a multicenter blinded randomized sham-controlled trial in which women with urodynamic SUI were randomization to active arm using Er:YAG laser therapy, and sham arm using sham handpiece. Patients received two treatments 1 month apart. The primary outcomes measure was 1 h pad weight test measured at 6 months. Secondary outcomes were durability of treatment success at 12 months, and questionnaires for assessment of SUI severity (ICIQ-UI SF), sexual function (PISQ-12) and HRQoL (KHQ), and incidence and severity of device related adverse events and pain (VAS). RESULTS: A total of 110 participants with SUI were recruited; 73 in the active arm and 37 in the sham arm. Two participants were excluded; one was assigned the wrong treatment and one withdrew their consent. Treatment success was observed in 36% of the sham arm and 59% of the active arm; in the latter, odds of achieving treatment success were more than three-fold higher (OR 3.63, 95% CI: 1.3-11.2, P = 0.02). HRQoL by KHQ showed significant improvement in the active versus the sham arm (OR 0.36, 95% CI: 0.15-0.87, P = 0.003). Similarly, subjective patient assessment of general and sexual function improvement with PISQ-12 and PGI-I showed superior effect over sham (OR 2.8, 95% CI: 1.2-7.0, P = 0.02 and OR 0.13, 95% CI: 0.05-0.36, P < 0.001, respectively). CONCLUSION: Non-ablative vaginal Er:YAG laser therapy significantly improves SUI symptoms versus sham treatment. Er:YAG laser therapy should be considered as a non-surgical treatment option for SUI patients.

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This study reports on the feasibility of using the Test of Complex Syntax- Electronic (TECS-E), as a self-directed app, to measure sentence comprehension in children aged 4 to 5 ½ years old; how testing apps might be adapted for effective independent use; and agreement levels between face-to-face supported computerized and independent computerized testing with this cohort. A pilot phase was completed with 4 to 4;06-year-old children, to determine the appropriate functional app features required to facilitate independent test completion. Following the integration of identified features, children completed the app independently or with adult support (4-4;05 (n = 22) 4;06-4;11 months (n = 55) and 5 to 5;05 (n = 113)) and test re-test reliability was examined. Independent test completion posed problems for children under 5 years but for those over 5, TECS-E is a reliable method to assess children's understanding of complex sentences, when used independently.

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Observational studies often dance around the issue of causality. We propose guidelines to ensure that papers refer to whether or not the study aim is to investigate causality, and suggest language to use and language to avoid.

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During April-July 2022, outbreaks of severe acute hepatitis of unknown etiology (SAHUE) were reported in 35 countries. Five percent of cases required liver transplantation, and 22 patients died. Viral metagenomic studies of clinical samples from SAHUE cases showed a correlation with human adenovirus F type 41 (HAdV-F41) and adeno-associated virus type 2 (AAV2). To explore the association between those DNA viruses and SAHUE in children in Ireland, we quantified HAdV-F41 and AAV2 in samples collected from a wastewater treatment plant serving 40% of Ireland's population. We noted a high correlation between HAdV-F41 and AAV2 circulation in the community and SAHUE clinical cases. Next-generation sequencing of the adenovirus hexon in wastewater demonstrated HAdV-F41 was the predominant HAdV type circulating. Our environmental analysis showed increased HAdV-F41 and AAV2 prevalence in the community during the SAHUE outbreak. Our findings highlight how wastewater sampling could aid in surveillance for respiratory adenovirus species.

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BACKGROUND: Children with Down syndrome have speech and language difficulties that are disproportionate to their overall intellectual ability and relative strengths in the use of gesture. Shared book reading between parents and their children provides an effective context in which language development can be facilitated. However, children with Down syndrome often take a passive role in shared book reading and the use of key word signing (KWS) as a shared book reading technique has never been investigated. AIMS: This study aimed to compare children with Down syndrome's participation and use of KWS across two methods of shared book reading - one in which a book had key-word sign prompts embedded (signed condition) and the other in which a book was read as normal (unsigned condition). Measures of child and parent communicative behaviour were taken in each condition to establish if differences emerged. METHODS & PROCEDURES: A total of 36 children with Down syndrome (aged between 18 and 61 months) and their mothers took part in the study. Parent-child dyads were videoed at home reading two books, one in a signed and one in an unsigned condition. Child measures included total number of signs produced in each condition and levels of attention and initiation as measured by the Pivotal Behaviour Rating Scale. Parent measures included total number of utterances, mean length of utterance (MLU) in morphemes and vocabulary diversity (VOCD). Parental measures were transcribed using the Codes for Human Analysis Transcripts (CHAT) software and analysed by the Computerised Language Analysis software (CLAN). Contrasts in outcomes between the signed and unsigned conditions were estimated using Poisson and linear mixed-effects models, determined by the type of data. OUTCOMES & RESULTS: Results showed that children attempted to sign significantly more in the signed than unsigned condition, as well as showing significant increases in their levels of attention and initiation. There was also a significant increase in the total number of utterances used by parents in the signed versus unsigned condition and a decrease in MLU. VOCD was similar in both conditions. CONCLUSIONS & IMPLICATIONS: This study shows that the simple act of embedding key word signs into commercially available books, during shared book reading between parents and young children with Down syndrome, positively affects children's participation (initiation and attention) and use of KWS. The use of KWS as a core shared book reading technique may therefore be a fruitful avenue to facilitate growth in the language abilities of young children with Down syndrome. WHAT THIS PAPER ADDS: What is already known on this subject Most children with Down syndrome have significant speech and language difficulties, with relative strengths in the use of gesture. Shared book reading is an activity reported to positively affect language. However, children with Down syndrome are reported to take a passive role in shared book reading and are therefore more dependent on their parents to use techniques that facilitate their levels of participation, in order to maximise potential benefits. To the best of our knowledge, the communicative effects of embedding key word signing (KWS) in shared book reading have never been examined with children with Down syndrome. What this paper adds to existing knowledge This is the first study to investigate the communicative impact of parents embedding KWS in a shared book reading activity with their young children with Down syndrome. Our findings show that this relatively simple manipulation resulted in Increase in children's sign attempts. Increase in children's overall participation in shared book reading (indicated by levels of attention and initiation). Increase in the number of utterances produced by parents (primarily as a result of repetitions). Decrease in parental mean length of utterance. These findings suggest that embedding KWS in shared book reading is likely to facilitate increased language abilities in this cohort. What are the potential or actual clinical implications of this work? Shared book reading is part of the daily routine for many parents and their children with Down syndrome. Integrating KWS is a relatively simple adaptation to this activity which is likely to enhance children's language skills. Therapists can encourage parents to do this at home to support work carried out at school and in a clinical setting.

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BACKGROUND: The improved survival rate for many cancers in high-income countries demands a coordinated multidisciplinary approach to survivorship care and service provision to ensure optimal patient outcomes and quality of life. This study assesses the feasibility of introducing a Women's Health Initiative cancer survivorship clinic in Ireland. METHODS: The trial https://spcare.bmj.com/content/9/2/209.short comprises an intervention and control arm. Two hundred participants will be recruited. Key eligibility (1) women with early-stage hormone receptor-positive breast or gynecologic cancer (cervix or endometrial), within 12 months of completion of primary curative therapy, and (2) access to the Internet. The complex intervention comprises a nurse-led clinic targeting symptom management through a trigger alert system, utilizing electronic patient-reported outcome (ePRO) assessments at baseline, and 2, 4, 6, 8, 10, and 12 months. It also includes input from a dietitian monitoring diet and nutritional status. The control group will receive their usual care pathway standard of care and attend the cancer survivorship clinic and complete ePRO assessments at the start and end of the study. The primary endpoint (feasibility) includes the proportion of enrolled participants who complete baseline and follow-up ePRO surveys and partake in health professional consultations after ePRO data triggers. Secondary endpoints include changes in cancer-related symptom scores assessed by ePROs, health-related Quality of Life Questionnaire (QLQ) scores, Appraisal Self-Care Agency-R scores, and adjuvant endocrine therapy medication adherence. A process evaluation will capture the experiences of participation in the study, and the healthcare costs will be examined as part of the economic analysis. Ethical approval was granted in December 2020, with accrual commencing in March 2021. DISCUSSION: This protocol describes the implementation of a parallel arm randomized controlled trial (RCT) which examines the feasibility of delivering a Cancer Survivorship Clinic. The ePRO is an innovative symptom monitoring system which detects the treatment-related effects and provides individualized support for cancer survivors. The findings will provide direction for the implementation of future survivorship care. TRIAL REGISTRATION: ClinicalTrials.gov , NCT05035173 . Retrospectively registered on September 5, 2021.

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SARS-CoV-2 RNA quantification in wastewater is an important tool for monitoring the prevalence of COVID-19 disease on a community scale which complements case-based surveillance systems. As novel variants of concern (VOCs) emerge there is also a need to identify the primary circulating variants in a community, accomplished to date by sequencing clinical samples. Quantifying variants in wastewater offers a cost-effective means to augment these sequencing efforts. In this study, SARS-CoV-2 N1 RNA concentrations and daily loadings were determined and compared to case-based data collected as part of a national surveillance programme to determine the validity of wastewater surveillance to monitor infection spread in the greater Dublin area. Further, sequencing of clinical samples was conducted to determine the primary SARS-CoV-2 lineages circulating in Dublin. Finally, digital PCR was employed to determine whether SARS-CoV-2 VOCs, Alpha and Delta, were quantifiable from wastewater. No lead or lag time was observed between SARS-CoV-2 wastewater and case-based data and SARS-CoV-2 trends in Dublin wastewater significantly correlated with the notification of confirmed cases through case-based surveillance preceding collection with a 5-day average. This demonstrates that viral RNA in Dublin's wastewater mirrors the spread of infection in the community. Clinical sequence data demonstrated that increased COVID-19 cases during Ireland's third wave coincided with the introduction of the Alpha variant, while the fourth wave coincided with increased prevalence of the Delta variant. Interestingly, the Alpha variant was detected in Dublin wastewater prior to the first genome being sequenced from clinical samples, while the Delta variant was identified at the same time in clinical and wastewater samples. This work demonstrates the validity of wastewater surveillance for monitoring SARS-CoV-2 infections and also highlights its effectiveness in identifying circulating variants which may prove useful when sequencing capacity is limited.

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