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  • Zimmer Biomet Highlights Robotics & Musculoskeletal Product Innovations at 2025 AAHKS Annual Meeting

    Zimmer Biomet Highlights Robotics & Musculoskeletal Product Innovations at 2025 AAHKS Annual Meeting

    Company to Spotlight Comprehensive Hip & Knee Portfolios and Latest Advancements in Robotics, Including the mBôs™ System Following Recent Acquisition of Monogram Technologies

    WARSAW, Ind., Oct. 21, 2025 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global medical technology leader, today announced that it is highlighting bold innovations across its broad robotics and musculoskeletal portfolio at the 2025 annual meeting of the American Association of Hip and Knee Surgeons (AAHKS).

    During the meeting, the company’s booth will prominently feature its broad knee and hip portfolio of customer-centric solutions and infection solutions, along with the latest robotic technologies and data solutions to meet a vast array of surgeon techniques and preferences. Zimmer Biomet will also showcase the surgeon-guided robotic technology recently acquired through the Monogram Technologies Inc. acquisition.

    “Orthopedics is at a pivotal moment,” said Ivan Tornos, Chairman, President and Chief Executive Officer of Zimmer Biomet. “As the population ages and expectations rise, patients are demanding more: less disruption, faster recovery and care that fits their lives. Surgeons need solutions that match this urgency, and that’s why we’ve engineered next-generation hip and knee implants and curated an ecosystem of robotics, digital platforms and AI. This isn’t incremental innovation — it’s the most ambitious innovation cycle in our company’s history, positioning Zimmer Biomet to deliver the industry’s most comprehensive and adaptable suite of orthopedic robotics and navigation technologies designed to elevate surgical precision and transform patient outcomes.”

    The highlights at the Zimmer Biomet booth (#1206) include:

    Digital and Technology Solutions

    • mBôs™ TKA System : a CT-based, semi-autonomous, total knee arthroplasty (TKA) robotic technology that received U.S. Food and Drug Administration (FDA) 510(k) clearance. A surgeon-guided fully autonomous version of this technology is currently in clinical trials.
    • ROSA® Knee with OptimiZe ™: the newest version of the ROSA® Knee System that customizes and looks to enhance the surgeon’s experience with personalized and intelligent surgical planning, new positioning, tracking and alignment features to improve accuracy1 and reduce user variability,2 pending U.S. FDA 510(k) clearance.
    • TMINI® Miniature Robotic System : a state-of-the-art miniature, handheld, wireless CT-based robotic system designed to enable accurate and precise implant placement.
    • ZBEdge® Analytics : a data platform that delivers intra-operative, mobility and outcome insights directly on a smartphone application, enabling surgeons to objectively assess performance and understand the potential impact of clinical decisions on patient recovery.
    • mymobility® Care Management Platform : a digital care management platform that delivers continuous data and patient-reported feedback to facilitate care, outcomes and satisfaction about patients’ surgical preparation and recovery.

    Knee Reconstruction Technologies

    • Oxford® Cementless Partial Knee : the only FDA-approved mobile cementless partial knee implant in the U.S. that has been shown to be efficient3,4 in the operating room and has been proven to have excellent survivorship5,6 worldwide.
    • Persona® OsseoTi® Keel Tibia : a cementless tibia for TKA with a 3D printed porous tray that provides stable initial and biological fixation and intra-operative versatility.7
    • Persona® SoluTion™ PPS® Femur : a knee implant component designed to serve as an alternative metal for patients with certain metal sensitivities like nickel and cobalt-chrome (Co, Cr, Ni) and bone cement that features a porous coating for cementless fixation and leverages a proprietary surface treatment designed to enhance wear performance.8,9
    • Persona IQ® The Smart Knee® : a first-to-world smart knee implant that captures patient-specific gait and range of motion metrics directly from the knee during patient monitoring to provide post-operative recovery insights10,11 and trends, allowing care teams to monitor and personalize the TKA patient experience.10-12

    Hip Reconstruction Technologies

    • Z1® Femoral Hip System : offers an expansive size range and three distinct neck options designed to address a variety of patient anatomies and reconstructive needs.
    • OrthoGrid Hip AI® : an AI-powered, fluoroscopy-based technology that provides direct anterior hip surgeons with intuitive and instantaneous intra-operative tools to assist surgeons in achieving the desired surgical outcomes for component positioning.13
    • HAMMR® Automated Hip Impaction System : designed to address surgeon strain, fatigue and repetitive motion associated with the traditional mallet.

    For more information about Zimmer Biomet events at 2025 AAHKS, visit https://www.zimmerbiomet.com/en/aahks2025.html.

    About Zimmer Biomet

    Zimmer Biomet is a global medical technology leader with a comprehensive portfolio designed to maximize mobility and improve health. We seamlessly transform the patient experience through our innovative products and suite of integrated digital and robotic technologies that leverage data, data analytics and artificial intelligence. 

    With 90+ years of trusted leadership and proven expertise, Zimmer Biomet is positioned to deliver the highest quality solutions to patients and providers. Our legacy continues to come to life today through our progressive culture of evolution and innovation. 

    For more information about our product portfolio, our operations in 25+ countries and sales in 100+ countries or about joining our team, visit www.zimmerbiomet.com or follow on LinkedIn at www.linkedin.com/company/zimmerbiomet or X at www.x.com/zimmerbiomet. 

    Important Safety Information for Oxford Cementless Partial Knee:

    The Oxford® Cementless Partial Knee System is indicated for use in unilateral knee procedures with osteoarthritis or avascular necrosis limited to the medial compartment of the knee. It is intended to be implanted without the application of bone cement for patients whose clinical condition would benefit from a shorter surgical time compared to the cemented implant. The Oxford Partial Knee is not indicated for use in the lateral compartment or for patients with ligament deficiency, or for use in simultaneous bilateral surgery or planned staged bilateral procedures. Potential risks include, but are not limited to, loosening, dislocation, fracture, wear and infection, any of which can require additional surgery. For a full list of product indications, contraindications and warnings, please see the associated product Instructions For Use (IFU).

    Cautionary Statement Regarding Forward-Looking Statements

    This news release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements concerning Zimmer Biomet’s expectations, plans, prospects, and product and service offerings, including new product launches and potential clinical successes. Such statements are based upon the current beliefs and expectations of management and are subject to significant risks, uncertainties and changes in circumstances that could cause actual outcomes and results to differ materially. For a list and description of some of such risks and uncertainties, see Zimmer Biomet’s periodic reports filed with the U.S. Securities and Exchange Commission (SEC). These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in Zimmer Biomet’s filings with the SEC. Forward-looking statements speak only as of the date they are made, and Zimmer Biomet disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Readers of this news release are cautioned not to rely on these forward-looking statements, since there can be no assurance that these forward-looking statements will prove to be accurate. This cautionary statement is applicable to all forward-looking statements contained in this news release.

    Laboratory and animal studies are not necessarily indicative of clinical performance.

    THINK Surgical and TMINI are trademarks of THINK Surgical, Inc.

    Persona IQ:
    The objective kinematic data generated by the CSE with CHIRP System are not intended to support clinical decision-making and have not been shown to provide any clinical benefit

    References:

    1 Data on File. DVaR-DS250106-01 ROSA Knee System v1.5 Validation Report.
    2 Data on File. FER-EMS230714-01 Formative Evaluation Report – July Lab 2023.
    3 Pandit, H., et al. “Improved fixation in cementless unicompartmental knee replacement: five-year results of a randomized controlled trial.” JBJS 95.15 (2013): 1365-1372.
    4 Stempin R, Kaczmarek W, Stempin K, Dutka J. Midterm Results of Cementless and Cemented Unicondylar Knee Arthroplasty with Mobile Meniscal Bearing: A Prospective Cohort Study. Open Orthop J. 2017 Oct 31;11:1173-1178. doi: 10.2174/1874325001711011173. PMID: 29290853; PMCID: PMC5721307.
    5 NJR- UK . The National Joint Registry 22st Annual Report 2025 London, 2024 [Available from: https://reports.njrcentre.org.uk/Portals/0/PDFdownloads/NJR%2022nd%20Annual%20Report%202025_Knees.pdf.
    6 AOANJRR. Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR). Hip, Knee & Shoulder Arthroplasty: 2023 Annual Report Adelaide, AOA2024 [updated 2024. Available from: https://aoanjrr.sahmri.com/documents/10180/1798900/AOANJRR+2024+Annual+Report.pdf/9d0bfe03-2282-8fc8-a424-b8d9abb82b1f?t=1727666185313.
    7 Mueller J.K., et al. Persona OsseoTi Keel Tibia Provides Stable Initial Fixation 4027.2-GLBL-en. November 2022.
    8 Improved Abrasion Resistance of Nitrogen-Hardened Titanium Alloy Surfaces. Current Topics in Orthopaedic Technology. Zimmer. Vol. 3, No. 6 (1991).
    9 Zimmer ZRR_WA_2537_12.
    10 Cushner FD, Yergler J, ElashoffB, Aubin PM, VertaP, Scuderi GR. Staying Ahead of the Curve: The Case for Recovery Curves in Total Knee Arthroplasty. The Journal of Arthroplasty. 2024;doi:10.1016/j.arth.2024.07.039
    11 Cushner FD, Sculco PK, Long WJ. The Talking Knee Is a Reality: What Your Knee Can Tell You After Total Knee Arthroplasty. J OrthopaedicExperience and Innovation. 2022;2022
    12 Cushner FD, Schiller P, Gross J, Mueller JK, Hunter W. A Total Knee Arthroplasty Prosthesis Capable of Remote Patient Monitoring. OrthopaedicProceedings. 2021/06/01 2021;103-B(SUPP_9):18-18 doi:10.1302/1358-992X.2021.9.018
    13 Cardenas JM, Gordon D, Waddell BS, Kitziger KJ, Peters PC Jr, Gladnick BP. Does Artificial Intelligence Outperform Humans Using Fluoroscopic-Assisted Computer Navigation for Total Hip Arthroplasty? Arthroplasty Today. 2024 May 27;27:101410. doi: 10.1016/j.artd.2024.101410. PMID: 38840694; PMCID: PMC11150909.

    SOURCE Zimmer Biomet Holdings, Inc.


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  • Association of lung field area with mortality in Mycobacterium avium complex lung disease: a longitudinal cohort study | BMC Infectious Diseases

    Association of lung field area with mortality in Mycobacterium avium complex lung disease: a longitudinal cohort study | BMC Infectious Diseases

    Study design and participants

    This study was conducted as a longitudinal cohort study through a retrospective review of medical records at NHO Fukuoka National Hospital. We reviewed 288 patients aged ≥ 20 years who met the American Thoracic Society/Infectious Diseases Society of America (ATS/IDSA) diagnostic criteria for MAC lung disease between April 1, 1996, and December 31, 2021 [6]. Of these, we excluded 42 patients with no available data of chest computed tomography (CT) scans between June 1, 2017, and December 31, 2021, 4 patients whose CT image data were unable to be processed for the present analysis by the software, 2 patients without any follow-up medical records after the date of CT scanning, 1 patient with no information concerning smoking history, and 7 patients without body mass index (BMI) data. Hence, the remaining 232 subjects with MAC lung disease were enrolled in the present study (Fig. 1). When multiple CT scans were available during the 2017–2021 period, the earliest scan was used for analysis. The follow-up period was defined as the time from the CT scan to either July 2023 or a maximum of 5 years.

    Fig. 1

    Quantitative CT image analysis

    CT examinations were performed with a 160-slice multidetector CT scanner (Aquilion Lightning, Canon Medical Systems, Otawara, Japan) with a slice thickness of 5 mm. Quantitative CT image analyses were performed using dedicated software (AZE Virtual Place, Canon Medical Systems, Otawara, Japan) by a radiologic technologist without prior knowledge of the clinical data. For each patient, the lung field areas (LFAs) were evaluated separately in six domains using three axial CT slices in accordance with the Goddard score assessment protocols—the levels of the upper margin of the aortic arch (right and left upper lung field), the carina (right and left middle lung field), and 1–3 cm above the top of the diaphragm (right and left lower lung field) [13]. To identify the extent of cavitary destruction of the lung, the low-attenuation areas (LAAs) were defined as lung areas below − 950 Hounsfield units (HU), as in previous literature [14], and were also semiautomatically estimated using the same images (see Fig. S1 in Additional file 1) [15]. Mean values of LFA and LAA were calculated and used for the present analyses. The LFA/LAA ratio was computed for each of the six lung fields, and the average of these six values was used in the analysis. When dividing the study subjects into three groups based on the tertile distribution of the mean LFA, the cutoff values were as follows: lowest, ≤ 69.54 cm2 (N = 78); middle, 69.55–85.59 cm2 (N = 77); and highest, ≥ 85.60 cm2 (N = 77). For validation analysis between the mean values of LFA and lung volume (LV), a total of 9 subjects were randomly selected in order to assess LV. LV was calculated with the following 3 steps: at first, the lung plus bronchus volume (LBV) was identified by extracting the area less than − 500 HU. Next, the bronchus volume (BV) was measured by extracting the area less than − 920 HU and by ensuring the continuity of connection to other bronchi. Lastly, the LV was calculated by subtracting the BV from the LBV.

    Clinical evaluations

    For each case, respiratory physicians reviewed the patient’s medical records and assessed the demographic and clinical characteristics: age, gender, height, weight, smoking history, medical history, and results of mycobacterial cultures. BMI (kg/m2) was calculated as weight divided by squared height. Smoking habit was dichotomized as never smokers and smokers, considering that smoking could have affected emphysematous changes of the lung, appearing as low-attenuation areas (< −950 HU). Antibiotic treatment for MAC disease was defined as the prescription of clarithromycin and/or rifampicin and/or ethambutol. MAC species were categorized into three groups: M. avium group, Mycobacterium intracellulare (M. intracellulare) group, and co-infection group (subjects with both M. avium and M. intracellulare detected).

    Statistical analysis

    R software version 4.1.2 (R Foundation for Statistical Computing, Vienna, Austria) was used to perform all statistical analyses. A two-sided P < 0.05 was considered to indicate statistical significance. For baseline characteristics, the heterogeneity in each variable among the levels of mean LFA was evaluated using the analysis of variance (ANOVA), chi-square test, or Kruskal–Wallis test. Pearson’s correlation coefficient was calculated to assess the correlation between the mean values of LFA and those of LV. Kaplan–Meier curves were constructed to show the survival rate over the follow-up period. The unadjusted and multivariable-adjusted hazard ratios (HRs) with their 95% confidence intervals (95% CIs) according to the levels of mean LFA for all-cause mortality were estimated using a Cox proportional hazards model. Adjustments were made for age, gender, BMI, smoking history, MAC treatment, MAC species, co-infection with NTM other than MAC, and mean LAA, which has been reported as a potential prognostic factor in patients with NTM lung disease [16, 17]. Relevant models were used to evaluate the linear trends in the risk of all-cause death across the tertile classification of mean LFA. We evaluated the ability of mean LFA and mean LAA to predict mortality using receiver operating characteristic curves and estimated the area under the curve (AUC) for each. The AUCs were compared using the DeLong method. The robustness of the main results was tested through sensitivity analyses limiting the subjects to M. avium-positive or M. intracellulare-positive cases individually. Since smoking exposure can accelerate emphysematous change and increase the value of LAA in the lung, stratified analysis was performed by smoking status.

    Ethical considerations

    The study was approved by the NHO Fukuoka National Hospital Institutional Review Board for Clinical Research (#F5-34). For this study, informed consent has been waived by the NHO Fukuoka National Hospital Institutional Review Board due to the anonymity and retrospective nature of the study. This study was conducted according to the principles of the Declaration of Helsinki.

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  • Professional quality of life is related to emotional intelligence, self-care, and work conditions in healthcare workers: findings from a moderated mediation analysis | BMC Health Services Research

    Professional quality of life is related to emotional intelligence, self-care, and work conditions in healthcare workers: findings from a moderated mediation analysis | BMC Health Services Research

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  • Variations in initiation of first antenatal care among women of reproductive age in sub-Saharan Africa: an event history analysis approach | Reproductive Health

    Variations in initiation of first antenatal care among women of reproductive age in sub-Saharan Africa: an event history analysis approach | Reproductive Health

    Data

    The data for this study were sourced from the most recent Demographic and Health Survey (DHS) conducted in thirty-six (36) sub-Saharan African countries. The DHS is a nationally representative sample survey that collects data on demographic and health indicators, including measures of reproductive health such as ANC attendance among women of reproductive age (15–49 years). The data for the current study were drawn from DHS surveys conducted between 2007 and 2019 in the thirty-six countries involved in the study. The data were downloaded from the MEASURE DHS website at http://dhsprogram.com/data/available-datasets.cfm on February 1st, 2021. The list of countries by sub-region and the respective survey years and corresponding sample sizes are presented in Appendix 1 as part of the supplementary results.

    Study sample and management of missing cases

    The sample for this study was based on the last pregnancies completed by women aged 15–49 years within the 2 years preceding the DHS survey and who made at least one ANC visit during this index pregnancy. After pooling the data for the most recent surveys in the thirty-six countries, 377,112 pregnancies were identified within the preceding five years of the survey. Among them, 119,657 pregnancies that were not the most recent were excluded. Approximately 105,321 such pregnancies were completed more than two years before the survey and were excluded from the analysis as shown in Fig. 1.

    Fig. 1

    Flow diagram showing the inclusion and exclusion criteria for selecting the study sample

    A total of 152,134 pregnancies were completed within the last two years, among which 16,373 pregnancies that did not receive any ANC were excluded. The percentage of missing data on related variables for the current study is low (less than 6% on single variable and less than 10% for the whole data set). The analyses were thus limited to cases with complete data employing listwise or case wise deletions. Excluding missing cases from the final sample does not pose a challenge for the analysis because it is generally accepted that if the presence of missing data on related variables are unrelated to any other variable, then the data are missing completely at random, and data missing completely at random with a small amount of missing data (less than 10% as in the case of the current study) still provide reliable and valid results as analysis of all cases with complete data [18, 19]. Thus, the final analysis was based on 123,134 completed pregnancies with valid data on all the variables included in the analysis. A table showing the percentage of missing cases per variable has been presented in the supplementary materials (see Appendix 2 in the supplementary materials).

    Variables

    Dependent variable

    The outcome variable for this study was a time variable measured for each pregnancy (pregnant woman) subject to the risk of ANC initiation. The dependent variable equals the duration before the event of the first ANC attendance. The duration of the dependent variable was measured in months and ranged from 1 to 9 months.

    Independent variables

    The predictor variables for this study included factors associated with ANC according to the literature and available in the data sets. Previous studies have identified the factors associated with the utilization of ANC services in LMICs to include household wealth quintiles [12, 13, 17, 20,21,22,23,24,25], place of residence [9, 12, 24,25,26], female education [9, 12, 13, 22,23,24,25], desire for pregnancy [8, 12, 13, 23, 25], female occupation [9, 23], age [12, 24,25,26,27], pregnancy rank/parity [9, 23, 25, 26], mass media exposure [12, 23, 25], number of children under five [8, 9], sociocultural norms and practices [20, 25], women’s autonomy [9, 25], marital status [25], and husbands’ education [9]. Additionally, some studies provide evidence that the odds of ANC coverage are lower among women from households belonging to the poor wealth quintile, women who have no formal education or who are less educated [17, 20, 21, 25] and women living in rural areas [12, 20, 25, 26]. There is also empirical evidence showing the link between family/community involvement and utilization of ANC services [5], while others have noted the role of sociocultural factors [21, 25]. For example, in Ghana, women in predominantly Muslim areas appear to be more limited in their ability to participate in reproductive health decision-making [21]. Additionally, other factors, such as exposure to mass media, especially locally driven mass media, have been shown to strongly impact health service utilization [28]. Furthermore, there has been extensive research on barriers to ANC utilization in SSA. A systematic review of outcome measures and determinants of unmet reproductive health needs revealed that economic constraints, long-distance travel to access services and low education are among the key predictors of ANC utilization among women in some West African countries [22]. Again, the results of a systematic review and meta-analysis in Ethiopia showed that improving female education and women’s empowerment could reduce the magnitude of delayed ANC uptake [9]. The results of other studies also indicate that women with wanted pregnancies are more likely to receive antenatal care [8, 13, 23]. The results regarding place of residence show that while some studies [9, 20, 26] have found a strong relationship between ANC uptake and place of residence, others [13] have reported weak or no significant associations. Additionally, while some studies have shown a negative relationship between female age and ANC uptake [26], another study [13] has shown no such association.

    The present study investigates variations in the first initiation of ANC over time during pregnancy and examines the influence of associated risk factors at the global SSA, controlling for covariates identified from previous research. Drawing on an adaptation of the Andersen behavioral model (1995), the various factors controlled for in this study were grouped into four categories consisting of environmental factors, predisposing characteristics, enabling factors and need factors, as shown in Fig. 2. The environmental/external factors included place of residence (urban or rural), country (all 36 countries included in the study) and sub-region (eastern, middle, southern or western Africa). Predisposing characteristics include respondent’s age at the birth of the child (in five-year age groups), highest level of education, type of occupation, marital status, mass media exposure (ranking variable from “very low” to “very high”)Footnote 1, and partner’s level of education. The enabling factors considered were household wealth quintile and women’s participation in the household’s decision-making processFootnote 2 (coded as involved in 0 – no decision; 1–1 decision; 2–2 decisions; 3–3 decisions; 4–4 decisions). Need factors included desire for pregnancy (wanted then, wanted later, wanted no more), number of births and ever had a pregnancy terminated. The list of independent variables and their categorization are shown in Table 1.

    Table 1 Percentage distribution of study population by selected characteristics
    Fig. 2
    figure 2

    Conceptual Model Showing Factors Associated with initiation of antenatal care visits among women of reproductive age in sub-Saharan Africa

    To ensure the reliability and accuracy of the regression models, a comprehensive multicollinearity test was conducted to assess correlation between all independent variables. Variables found to be highly correlated were systematically excluded. These variables were language, sub-region, and year of interview which were highly correlated with country of residence. However, due to the importance of these variables in the understanding of the context and to assess the variations in the chances of ANC initiation across the various sub-Saharan African regions, an alternative model excluding country was implemented. The alternate model accommodated the categorization of countries by sub-region and controlled for survey year. The results of the alternate model are included as supplementary results (see Appendix 4). These adjustments were made to enhance the clarity and interpretability of the models while addressing multicollinearity concerns.

    Analytical strategy

    The characteristics of the study sample were described using percentage distributions. All the independent variables, including survey year, were coded as categorical variables. The association between the timing of the first ANC visit and each independent variable was assessed using cross-tabulation with the Pearson chi-square test. Kaplan-Meier survivor curves were generated to examine the extent to which ANC initiation occurred over time according to the selected covariates. The Kaplan-Meier curves were generated to explore temporal trends in ANC initiation and to construct survival curves for participants stratified according to the selected covariates. The log-rank test was used to determine the significance of differences in survival distributions. At the multivariate level, a number of modeling techniques were explored, and model diagnostics and fitness tests were used to determine the best fit model for the data. The first modeling approach that was explored was multilevel modeling considering the nesting of respondents in countries, clusters and households. The intraclass coefficient (ICC) from the null model showed that only 0.6% (ICC = 0.0063) of the variation in ANC initiation was explained by between-cluster differences, indicating that a conventional one-level regression model fits the data better than a multilevel model [29]. After ruling out multilevel modeling, event history analysis was explored given the nature of the dependent variable. Discrete–time logit models were specified to examine the unadjusted and adjusted effects of each covariate on the dependent variable. The discrete-time survival analysis employed does not require an assumption of proportional hazards as piecewise exponentials [30]. In conducting the statistical analysis, the data were weighted to make the findings generalizable to women of reproductive age (15–49 years) within each country, and differences were tested for significance at the 5% level. All the statistical analyses were performed in R [31]. The analyses employed many R packages including survival [32], dplyr [33], knitr [34], haven [35], survey [36], gtools [37], numDervi [38], car [39], vim [40], summarytools [41], discsurv [42], survminer [43], flextable [44], officer [45], jtools [46], and finalfit [47].

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  • Differences in swallowing efficacy of disease modifying treatment between infants receiving pre-symptomatic and symptomatic administration | Orphanet Journal of Rare Diseases

    Differences in swallowing efficacy of disease modifying treatment between infants receiving pre-symptomatic and symptomatic administration | Orphanet Journal of Rare Diseases

    Sample demographics and characteristics

    Sixty-nine infants (49% female) meeting eligibility criteria were identified and included in the investigation. The majority received treatment after symptom onset (N = 52, 75%) and had two copies of SMN2 (pre-symptomatic N = 17, 100%; symptomatic N = 48, 92%) with others having three copies. All infants were treated with available disease modifying therapies (Risdiplam [Evrysdi®], Nusinersen [Spinraza®],Onasemnogene-abeparvovec [Zolgensma®]), with nearly half having received a combination of treatments (pre-symptomatic N = 10, 59%; symptomatic N = 28, 54%). Interestingly, ten (19%) of the infants who received treatment after symptom onset were identified as having SMA following SMA screening without symptoms triggering a referral and diagnosis. Upon initial neurology evaluation eight of those infants (80%) already exhibited clear symptoms of SMA (ex. Loss of reflexes) which were identified at an average age of 16 days. The other two did not exhibit symptoms at the time of their initial neurology consultation, though developed symptoms before their treatment was administered an average of 7 days later.

    Infants treated pre-symptomatically received treatment at a younger age (median = 0.50, IQR 0.44 months), than those treated after symptom onset (2.81, IQR 3.56 months, t = 17.67, p < 0.001, δ = 0.89). Nine infants (13%) were born prematurely, with all but one being born in the late preterm period (median 36 weeks). Other comorbidities included laryngo or tracheomalacia (N = 3, 4%), biliary atresia (N = 1, 1%), craniosynostosis (N = 1, 1%), extralobar sequestration (N = 1, 1%), paraesophageal hernia (N = 1, 1%), and milk protein allergy (N = 1, 1%).

    Median age of infants at the time of their last VFSS was 7.92 months (IQR 4.83), with infants who received pre-symptomatic treatment younger at the time of their last exam (6.8 IQR 5.77 months) than those who received treatment after symptoms (8.35, IQR 4.71; t = 2.96, p = 0.04, δ = 0.33). Although the majority (80%, N = 55) of infants underwent swallow studies due to clinical symptoms, 20% (N = 14) underwent the exam without symptoms as part of a routine, high-risk workup. Significantly more infants who received pre-symptomatic treatment underwent a routine, high-risk VFSS (59%, N = 10) than did those who received symptomatic treatment (8%, N = 4, p < 0.001, OR 0.06). Nearly all infants (86%, N = 59) were evaluated while consuming thin liquids, with other consistencies observed including mildly thick (43%, N = 30), moderately thick (22%, N = 15).

    At the time of last VFSS, 50% (N = 26) of symptomatic treated infants were receiving noninvasive ventilation or mechanical ventilation via tracheostomy (22/26, 85% strictly nocturnal), while only one of those treated pre-symptomatic required these supports (strictly nocturnal) (χ2 = 9.43, p = 0.002, OR 17.28). CHOP INTEND scores were available for 66% of infants, with a median score of 46 [16] out of 64. Table 1 provides a full listing of infant demographics and clinical characteristics.

    Table 1 Sample demographics and characteristics (N = 69)

    Swallow biomechanics

    Raters achieved scores corresponding to a Landis-Koch category of moderate or greater (kappa > 0.55) agreement in their reliability of analyzing all BabyVFSSImP© and ICCs of ≥ 0.72 for the Swallowtail components. While profound impairments in BabyVFSSImP© swallowing biomechanics were rare among infants who received pre-symptomatic treatment, they were common among infants treated after symptom onset. This was reflected in significantly worse (higher) scores in four BabyVFSSImP© domains (ts > 3.25, ps ≤ 0.01, δ > 0.42): Palatal-Pharyngeal Approximation, Airway Invasion/Laryngeal Closure, Aspiration, and Pharyngeal Transport and Clearance (Table 2). Specifications of the oropharyngeal swallowing biomechanics underlying these differences across treatment groups are outlined below, with a full listing of BabyVFSSImP© component scores provided in supplemental Table 2.

    Table 2 Swallowing Biomechanics by Treatment Group (N = 69)

    Bolus Extraction: Though the majority (76%, N = 13) of infants who received pre-symptomatic treatment promptly initiated sucking when presented with the nipple, all but one had to suck > 3 times to express sufficient bolus to swallow. Prompt initiation of sucking tended to be less common in infants treated after symptom onset (40%, N = 21), with 55% (N = 28) of these infants not initiating sucking at all (χ2(1) = 3.59, p = 0.06, OR 0.28).

    Bolus Clearance: Infants who received pre-symptomatic treatment rarely exhibited profound impairments in the ability to clear the ingested liquid from their pharynx, with no infants exhibiting profound impairments in pharyngeal constriction ratio (PCR > 0.2cm2), tongue base retraction, or pharyngeal residue, and only one infant exhibiting profound reductions in soft palate elevation (6%, N = 1) and pharyngoesophageal segment opening (6%, N = 1). Clinical specifications of those pre-symptomatic infants with profound impairments are outlined in Table 3. This was in contrast to infants treated after symptom onset, for whom a significantly higher proportion of infants (23–43%) exhibited profound impairments in these processes (BabyVFSSImP©, χ2(1) > 4.45, p ≤ 0.03, OR > 9.21; SwallowTail pharyngeal constriction ratio, fisher’s exact p = 0.03, OR = 0). These deficits in the propulsion of the bolus through the pharynx among infants treated after symptom onset were reflected in elevated Swallowtail pharyngeal constriction ratio values (symptomatic m = 0.15, sd = 0.16; pre-symptomatic m = 0.03, sd = 0.02; t (53.80) = 5.10, p < 0.001, d = 0.88). No differences were observed between groups in pharyngoesophageal segment opening duration (symptomatic m = 0.24, sd = 0.09; pre-symptomatic m = 0.22, sd = 0.06); t(40.04) = 0.84, p = 0.41, d = 0.20).

    Table 3 Clinical Characteristics of Pre-Sympomatic Infants with Profound Swallowing Impairments

    Airway Protection: Penetration occurred in almost all infants in both pre-symptomatic (95%, N = 16) and symptomatic (90%, N = 47) treatment groups (p = 1). Although aspiration occurred less frequently, it was still commonly observed; occurring more frequently in infants treated after symptom onset (71%, N = 36) than pre-symptomatic (35%. N = 6, χ2(1) = 5.31, p = 0.02, OR 4.4). Interestingly, among those infants who aspirated, 17% (N = 7) were not reported to be exhibiting feeding difficulties, with VFSS’ done as part of high-risk referral (pre-symptomatic 67%, N = 4; symptomatic 8%, N = 3).

    Swallow function

    Although all pre-symptomatic treated infants were managing secretions without suctioning, and nearly all were consuming full age-appropriate nutrition (N = 15, 88%), similar to biomechanics, some pre-symptomatic treated infants did exhibit profound functional impairments. Clinical deficits among those pre-symptomatic treated infants who required alternative nutrition appeared 11 days following treatment, with the reason for tube provision ranging from swallowing deficits impeding safe oral nutrition to impairments in consuming sufficient oral nutrition to meet caloric requirements. Table 3 provides further specifications pertaining to the clinical conditions of those pre-symptomatic infants who exhibited profound impairments. Significantly more infants treated after symptom onset required suctioning for secretion management (38% vs 0%; fisher’s p = 0.002, OR 0) and were not consuming age-appropriate oral nutrition (50% vs. 12%; χ2 (1) = 17.33, p < 0.001, OR 20.35) than those treated pre-symptomatic. Table 4 provides a full listing of CEDAS scores.

    Table 4 Children’s Eating and Drinking Activity Scale (CEDAS)

    Swallow biomechanics were associated with swallowing function, with the odds of an infant requiring suctioning for secretion management increasing significantly with increases in BabyVFSSImP© domain V: pharyngeal transport and bolus clearance scores (β = 0.30, z = 2.76, p = 0.006) and Swallowtail pharyngeal constriction ratio (β = 3.76, z = 1.83, p = 0.047). Among those domain V components, pharyngeal stripping wave was particularly predictive of suctioning needs (fisher’s exact p = 0.001, OR = 9.78). In contrast, the odds of an infant not achieving age-appropriate nutrition or hydration was significantly predicted by increases in domain I: lingual motion/swallow initiation (β = 0.26, z = 2.49, p = 0.013).

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  • Efficacy and tolerability of a low-glycemic-index ketogenic diet in Angelman syndrome: findings from the DIANE study | Orphanet Journal of Rare Diseases

    Efficacy and tolerability of a low-glycemic-index ketogenic diet in Angelman syndrome: findings from the DIANE study | Orphanet Journal of Rare Diseases

    Our study, which included pediatric patients with Angelman Syndrome (AS), did not demonstrate that the low-glycemic-index diet (LGID) produces clinical improvement in any of the neurodevelopmental domains assessed using the Bayley Scales of Infant and Toddler Development-III.

    Although various publications explore the use of the ketogenic diet (KD) in patients with AS, most of these studies focus on its efficacy for epilepsy control. However, there are few studies where the primary objective is to analyze the potential effects of KD on neurocognitive and behavioral development in this population. Previous research has reported that KD has positive cognitive and behavioral effects in pediatric patients with epilepsy, regardless of seizure control or the number of concomitant antiepileptic drugs [11, 15,16,17]. These benefits include improvements in alertness, attention, reciprocal social interaction, mood, sustained attention, receptive vocabulary, and information processing speed. Furthermore, various reviews have reported subjective data from parents describing their children as “more awake” and “more attentive” after starting the diet [17].

    In the specific population with AS, Grocott et al. [18] retrospectively reviewed 23 patients treated with LGID and found that most achieved improved seizure control: 22% remained seizure-free, 43% experienced seizures only in specific contexts such as illness or non-convulsive status, and 30% showed a significant reduction in seizure frequency. Additionally, Thibert et al. [13] conducted a prospective study on the efficacy and tolerability of LGID in AS patients, reporting a reduction in seizure frequency in all patients, a reduction greater than 80% in five of them, and generalized improvements in EEG patterns. This study also reported a subjective perception of neurodevelopmental improvement from parents, although only some of these improvements were statistically significant in neuropsychological assessments.

    Our results align with these findings. In our study, we observed qualitative improvement in the EEGs of patients treated with LGID compared to the habitual diet group after 24 weeks of intervention (44% improvement in the LGID group versus 25% in the habitual diet group). Moreover, in the LGID group, only 11% of patients experienced clusters of epileptic seizures, compared to 25% in the habitual diet group, which included one case of non-convulsive status epilepticus.

    Although no statistically significant cognitive differences were achieved, a trend toward improvement was observed in receptive language, expressive language, and communication domains in the LGID group. Similarly, subjective parental perception reflected a global improvement in neurodevelopment in most cases. This outcome aligns with previous observations and reinforces the hypothesis that LGID may have neurocognitive benefits in patients with AS. In fact, five of the nine patients in the LGID group chose to continue the diet after completing the study, suggesting a positive impact perceived by families.

    Sleep plays a fundamental role in the development and maintenance of memory and learning. Improving sleep quality and structure can significantly enhance sustained attention and memory in children. In patients with Angelman Syndrome (AS), it is estimated that approximately 80% experience moderate to severe sleep disturbances. Pelc et al. [26] conducted a clinical review in a small group of AS patients and described specific sleep characteristics, such as reduced total sleep duration, increased sleep-onset latency, altered sleep architecture, frequent nighttime awakenings, and reduced REM phase. Similarly, Spruyt et al. [27] conducted a systematic review and meta-analysis of 14 heterogeneous studies, mostly observational, and concluded that characteristic sleep problems in AS include reduced total sleep time, increased latency, frequent awakenings, and reduced sleep efficiency.

    Additionally, Miano et al. [29] evaluated 10 children with AS using polysomnography and compared them with a control group of patients with intellectual disabilities with or without epilepsy. The results showed a significant increase in sleep state transitions, four times more frequent awakenings, and a 50% reduction in time spent in the deepest stage of sleep (NREM). This suggests considerably reduced sleep quality and lower sleep efficiency in AS patients.

    Our results are consistent with these observations, as patients in our series showed reduced total sleep time, increased latency, frequent awakenings, and decreased sleep efficiency.

    Pasca et al. [30] reviewed the effects of the ketogenic diet (KD) on sleep in neurological conditions such as autism spectrum disorders, epilepsy, and migraines, finding improvements in overall sleep quality, sleep-onset latency, reduction of nighttime awakenings, improved daytime sleepiness, and increased REM sleep. In our study, although a trend toward improvement in sleep quality was observed in the LGID group compared to the habitual diet group, these data were not statistically significant, preventing the assertion that LGID alone improves sleep structure.

    It is important to note the limitations of this study. These include the small sample size, inherent to rare diseases such as Angelman syndrome, which limits statistical power. Additionally, the 24-week follow-up may have been insufficient to detect clinically meaningful changes in neurodevelopmental parameters, which often require longer durations to reach statistical significance. Developmental age equivalents were used as the primary outcome measure instead of more sensitive psychometric scores such as the Person Ability Score (PAS). Although this choice aligned with standard practice in 2021, it may have limited the detection of subtle changes in this population. Similarly, the use of standard scores from the VABS-II may have lacked sensitivity to small variations over time, particularly in individuals with profound impairment. As with the Bayley-III, this approach was consistent with prevailing clinical guidelines and research practices in Angelman syndrome; however, more sensitive metrics such as PAS could not be derived due to the unavailability of item-level conversion tools. Finally, some missing data resulted from incomplete caregiver diaries, likely due to the emotional and time burden of caregiving, as well as issues with the use of the Actiwatch by some children, which limits the reliability of the data.

    In conclusion, although a trend toward greater evolutionary improvement was observed in the LGID group compared to the habitual diet group, these differences were not statistically significant in the various domains evaluated using the Bayley Scales of Infant and Toddler Development-III and cannot be solely attributed to the low-glycemic-index ketogenic diet. However, global improvements were identified in several variables evaluated at six months in the LGID group, and no serious adverse reactions attributable to the diet were reported.

    These preliminary results do not support recommending the low-glycemic-index ketogenic diet as a generalized treatment for cognitive improvement in AS patients. Further studies with larger sample sizes and robust designs are needed to evaluate the potential impact of this intervention in this population.

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  • Biopsy proteome-based classification of T cell-mediated kidney allograft rejection | Journal of Translational Medicine

    Biopsy proteome-based classification of T cell-mediated kidney allograft rejection | Journal of Translational Medicine

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  • Comparative analysis of codon usage bias and phylogenetic relationships in chloroplast genomes across 49 Dendrobium species | BMC Plant Biology

    Comparative analysis of codon usage bias and phylogenetic relationships in chloroplast genomes across 49 Dendrobium species | BMC Plant Biology

    Analysis of codon base composition

    The contents of T3, C3, A3, G3, GC1, GC2, GC3, and GCall in cp coding gene codons of 49 Dendrobium species were analyzed in this study (Figure S1, Table S3). The results revealed an asymmetric expression of the four nucleotides in these codons. Specifically, the third position of codons showed a higher frequency of A/T usage compared to G/C.The nucleotide expression frequencies at the third codon position were as follows: T3 (45.72%−47.79%), A3 (40.92%−43.96%), G3 (16.68%−19.13%), and C3 (16.64%−19.51%). Analysis of GC content across the coding regions showed values of 42.14%−48.65% for GC1, 37.37%−41.08% for GC2, and 28.81%−32.14% for GC3, all of which were below 50%. This indicates an overall preference for codons rich in A/T nucleotides. Notably, the GC content exhibited the trend GC1 > GC2 > GC3, highlighting a stronger preference for codons ending with A/T in the cp coding genes of Dendrobium species.

    GC content is a critical indicator of genomic characteristics. we analyzed the correlation among GC1, GC2, GC3, and GCall (Fig. 1, Table S4). The results revealed that GCall was significantly correlated with GC1, GC2, and GC3 (P < 0.01). Furthermore, GC1 and GC2 were significantly correlated (P < 0.05), indicating that the GC composition at the first and second codon positions may influence each other. In contrast, GC3 showed no correlation with GC1 or GC2, suggesting that the GC composition at the third position is independent of the first and second positions.

    Fig. 1

    Correlation analysis among the parameters of CUB (e.g., D. nobile). The numeric labels in the cells of the matrix represent correlation coefficients. These values typically range from -0.65 to 1. Dark blue indicates a positive correlation, while dark red indicates a negative correlation

    RSCU analysis

    RSCU is an important parameter for measuring codon preference. RSCU > 1 indicates a strong preference for that codon, categorizing as a high-frequency codon. Conversely, RSCU < 1 signifies a weak preference, classifying as a low-frequency codon. Excluding the initiation codon (AUG) and the termination codons (UGG, UAG, and UAA), there were 30 codons with RSCU > 1, representing 46.88% of the total number of codons (Fig. 2 and Table S5). Notably, 29 codons ended with A or U bases, accounting for 96.67% of the high-frequency codons. Among these, AGA, which encodes Arginine, exhibited the highest RSCU value, followed by GCU, which encodes Alanine. Additionally, 30 low-frequency codons with RSCU < 1 and 28 ended with G/C, accounting for 93.33%. These results indicated that the high-frequency codons tend to end with A/U, while the low-frequency codons are more likely to end with G/C.

    Fig. 2
    figure 2

    Heat Map for 49 Dendrobium species using RSCU values. The color and the degree of intensity indicate the RSCU value, and it varies from orange to blue with a low value to a high value of RSCU

    Factors affecting CUB in 49 Dendrobium species

    PR2-plot analysis

    A PR2-plot analysis was conducted to analyze the relationship between the third base of codons (A3/T3 and G3/C3) in CDS of cp genomes from 49 Dendrobium species. As shown in Fig. 3, cp coding genes in the four regions were unevenly distributed, with the majority located far from the center. This deviation suggests that CUB in these genes may be primarily governed by natural selection.

    Fig. 3
    figure 3

    PR2-Plot of 49 Dendrobium species

    Neutrality plot analysis

    To further explore the influence of natural selection and mutation pressure on CUB, neutrality plot analysis was conducted using GC12 and GC3 as lateral and vertical axes, respectively. The results showed that GC12 was distributed from 29.01% to 53.24%, while GC3 was distributed from 20.39% to 46.86% in the CDS of the cp genome (Fig. 4). Notably, few genes were distributed along the diagonal, indicating a weak correlation among the nucleotide compositions at GC12 and GC3. Furthermore, the regression coefficient (slope) ranged from −0.038 to 0.368.

    Fig. 4
    figure 4

    Neutrality plot analysis results of GC12 and GC3 content values. A: Lowercase letters (a1 to y1) indicate D. nobile (a1), D. thyrsiflorum (b1), D. denneanum (c1), D. findlayanum (d1), D. polyanthum (e1), D. wattii (f1), D. bnymerianum (g1), D. jenkinsii (h1), D. salaccense (i1), D. fimbriatum (j1), D. wardianum (k1), D. falconeri (l1), D. christyanum (m1), D. huoshanense (n1), D. devonianum (o1), D. parishii (p1), D. crystallinum (q1), D. pulchellum (r1), D. ellipsophyllum (s1), D. terminale (t1), D. linawianum (u1), D. stuposum (v1), D. spatella (w1), D. chrysocrepis (x1), D. bicameratum (y1) respectively.B: Lowercase letters (a2 to x2) indicate D. loddigesii (a2), D. cariniferum (b2), D. sinense (c2), D. crepidatum (d2), D. hercoglossum (e2), D. ochreatum (f2), D. longicornu (g2), D. flexicaule (h2), D. chrysanthum (i2), D. tortile (j2), D. lituiflorum (k2), D. parciflorum (l2), D. pendulum (m2), D. wangliangii (n2), D. strongylanthum (o2), D. moniliforme (p2), D. moschatum (q2), D. lindleyi (r2), D. draconis (s2), D. sulcatum (t2), D. officinale (u2), D. scabrilingue (v2), D. sanderae (w2), D. chrysotoxum (x2) respectively

    ENC-plot analysis

    An ENC-plot analysis for GC3 was performed to investigate the factors influencing CUB in CDS of Dendrobium cp genome. When the CUB is influenced only by mutation pressure, the cp genes will fall on the ENC expected curve. If the cp genes fall below the ENC expected curve, then the CUB is mainly driven by other factors such as natural selection, in addition to mutation pressure [38]. As shown in Fig. 5, the Majority of the cp genes in the 49 Dendrobium species were far from the expected ENC curve, indicating that natural selection may be the primary factor driving CUB in the cp genome of Dendrobium, while mutation pressure plays a secondary role.

    Fig. 5
    figure 5

    ENC-GC3 plots of 49 Dendrobium species

    The calculated ENC ratios [(ENCexp-ENCobs)/ENCexp] range from −0.15 to 0.35 (Table 1), representing the difference between ENCobs values and ENCexp values. Approximately 73% of the genes have an ENC ratio greater than 0, which is consistent with the results of the ENC-plot analysis.

    Table 1 Frequency distribution of ENC ratios

    Optimal codons of Dendrobium

    Eleven to nineteen optimal codons were identified across 49 Dendrobium species, with most optimal codons ending with A/U. Notably, D. polyanthum and D. devonianum shared the same optimal codons: GCA, GAA, UUU, GGA, CAU, UUA, AAU, CCU, AGA, CGA, AGU, GUA, and GUU. Similarly, D. nobile, D. linawianum, D. flexicaule, and D. officinale shared the same optimal codons: GCA, GAA, UUU, GGA, GGU, CAU, AUU, AAA, UUA, CCU, CAA, CGA, CGU, AGU, ACU, and UAU (Figure S2 and Table S6).

    Phylogenetic analysis

    Phylogenetic trees of 49 Dendrobium cp genomes were constructed based on the cp genomics and CDS using the ML method, with C. hookerianum and C. lowianum as outgroups. The resulting phylogenetic topologies revealed that the Dendrobium species was divided into three distinct groups (Group A, Group B, and Group C), and some species showed overlap between the cp genomics and CDS phylogenetic trees (Fig. 6). Discrepancies were also observed between molecular biological evidence and traditional plant morphological classifications within individual clusters. Species in sct. Chrysotoxae is found across Groups A, B, and C, challenging traditional morphological classifications and suggesting that of sct. Chrysotoxae species may have maternal sources from sct. Dendrobium, sct. Holochrysa, and sct. Chrysotoxae. Similarly, D. hrysocrepis from sct. Holochrysa appeared in Group A, distinctly separated from Group B, indicating possible maternal lineage derived from sct. Dendrobium. D. hercoglossum as the sole representative from sct. Breviflores is more closely related to sct. Dendrobium. However, it is difficult to define the phylogenetic relationship between sct. Breviflores and sct. Dendrobium.

    Fig. 6
    figure 6

    ML trees of 49 Dendrobium species using CDSs and cp genomes by the maximum likelihood method

    Additionally, PLS-DA was conducted to evaluate the relationship between CUB and phylogeny based on RSCU values of Dendrobium species. The PLS-DA showed that Groups A and C were each divided into two subgroups, consistent with the phylogenetic trees derived from the cp genomics and CDS (Figure S3). In contrast, Group B could not form a distinct cluster. The species were dispersed into Groups A and C. These findings suggest that RSCU values are valuable tools for revealing the evolutionary relationships among Dendrobium species.

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  • “Just realising that I wasn’t alone… was profound”: a mixed-methods evaluation of a pilot peer-to-peer wellbeing program for carers of children with rare epilepsies | Orphanet Journal of Rare Diseases

    “Just realising that I wasn’t alone… was profound”: a mixed-methods evaluation of a pilot peer-to-peer wellbeing program for carers of children with rare epilepsies | Orphanet Journal of Rare Diseases

    This study was approved by the University of NSW (UNSW) Sydney Human Research and Ethics Committee: number HC220624.

    Study design

    Intervention components and adaptation

    The Raregivers Wellness Retreat programme was initially designed by Raregivers Inc to support family members caring for a loved one impacted by a rare disease. It included three virtual sessions per week delivered over 6 weeks, focusing on guided exercises, sensory self-care experiences, and the Raregivers Emotional Journey Map. The program also incorporated Sustainable Carer Workshops, providing practical strategies for self-care and resilience. Participants engaged in group-based sessions via Zoom™, ensuring flexibility and accessibility. Each session was designed to last approximately 60 min, with additional resources and exercises provided for participants to complete at their own pace throughout the week. The program was free to participants, and each carer received a wellness kit containing educational and self-care materials to enhance their experience.

    Adaptation of the program for the Australian context was led by consumer lead (KP) and Raregivers course coordinator (ML), who have lived experience caring for children with complex rare epilepsy syndromes. They co-designed the weekly program to ensure its relevance and acceptability for Australian participants. While the core structure of the program remained consistent with the original design, the adaptation integrated culturally and contextually relevant topics. The co-design process ensured that the program addressed the unique challenges faced by carers in Australia, enhancing its impact and resonance with participants. This iterative approach allowed sessions to evolve in response to participant needs, ensuring the program was both dynamic and participant-centred.

    Participants

    Carers were eligible to participate in the study if they had attended the retreat and met the following criteria: (i) were the primary carer of a child with a complex, rare epilepsy; (ii) were aged 18 years or older; (iii) were able to communicate in English; and (iv) had access to the internet and a computer. Carers were screened for psychological distress via the online expression of interest form, which incorporated a screening questionnaire with a validated Distress Thermometer (see Additional file 1) [14]. Because this was a pilot study, the Wellness Retreat was scoped to establish safety, feasibility, and acceptability. Individuals with high distress scores (≥ 9 on the Distress Thermometer) were therefore not included, as the program was designed as a strengths-based, preventative wellbeing initiative and was not equipped to provide acute psychological support. Eligible participants provided informed consent and were enrolled. Those screening with high distress were individually contacted by the research team, provided information on appropriate mental health services, and offered support to connect with these services if required.

    Consent to participate in evaluation of the retreat was given electronically, and implied consent was received from participants who completed and submitted the baseline and follow-up questionnaires. Participants also gave verbal consent prior to starting the interviews.

    Recruitment

    Participants were recruited via the mailing lists and social media platforms (Twitter, Facebook, LinkedIn) of relevant not-for-profit and community organisations, including Genetic Epilepsy Team Australia (GETA), Epilepsy Foundation Australia, Rare Voices Australia, Genetic Alliance Australia, and Syndromes Without A Name Australia. These organisations shared the study advertisement, which included a link to the expression of interest form. Eligible carers received an email invitation to participate, which included a link to the study information sheet and consent form. A maximum of two follow-up attempts (email or telephone call, using contact details provided in the expression of interest form) were made to non-responders.

    Evaluation design

    The acceptability, feasibility and impact of the Raregivers Wellness Retreat on carers’ self-reported wellbeing and social inclusion was evaluated using a mixed-methods pilot study. Participants completed a pre-intervention (upon enrolment, before their first session; see Additional file 2) and post-intervention (1 week after the final session; see Additional file 3) questionnaire, administered online via the Research Electronic Data Capture (REDCap) platform [15, 16]. Questionnaires were anticipated to take approximately 30 min to complete.

    Following the program, participants were invited to one-on-one semi-structured interviews via Zoom™. These interviews were audio recorded, de-identified, and transcribed for analysis (see Additional file 4 for the interview guide).

    Measures

    The primary outcomes of acceptability and feasibility were assessed post-intervention using 15 purpose-designed items (see Additional file 3).

    Secondary outcomes related to participant wellbeing, quality of life, social inclusion and the extent to which participants live consistently with their values (valuing) were assessed using validated scales at pre- and post-intervention (Table 1 and Additional files 2 and 3).

    Table 1 Overview of carer questionnaire measures/items

    Wellbeing

    The 15-item PERMA Profiler questionnaire was utilised to assess wellbeing across five domains [17]. The full PERMA Profiler contains 23 items, however a shortened version with 15 items was used for this study.

    Social inclusion

    The Social Inclusion Scale (SIS) assesses individuals’ self-perceived levels of social inclusion [18,19,20]. The overall SIS score was computed by summing all responses (which range from 16 to 64). This scale formulates three elements negatively and scores them in reverse order when calculating the overall score.

    Values

    The Valuing Questionnaire was used to assess the extent to which participants lived consistently with their values [21]. The Progress subscale evaluates personal adherence to values, and the Obstruction subscale measures the extent of barriers hindering the pursuit of a valued life. The ratings for each subscale were aggregated.

    Carer quality of life

    The ASCOT-SCT4 [22] was used to assess carer experience and social care-related quality of life across 7 domains: (1) Occupation; (2) Control over daily life; (3) Self-care; (4) Personal safety; (5) Social participation; (6) Space and time to be yourself; (7) Feeling supported and encouraged.

    Post-intervention interviews

    At the conclusion of the program, participants were invited to participate in a one-on-one semi-structured interview that covered their overall impressions of the program, what they liked/disliked, challenges, feasibility and acceptability of the program as well as their wellbeing, self-efficacy and social connectedness. The interview guide (see Additional file 4) was developed by the multidisciplinary team which included an epilepsy nurse, genetic counsellor, psychologist, clinical geneticist, consumer engagement expert and implementation science experts.

    Quantitative analyses

    Data was subjected to descriptive analysis by a statistician independent to the implementation team. Various descriptive statistics were computed, including count, mean, standard deviation, proportion, median, and range. We conducted a comparative analysis of various indicators at two time points, baseline and post-intervention, to examine the changes. Inferential testing for effect were not undertaken due to the small sample size.

    For the PERMA profiler [17], the domain specific change was calculated by subtracting participants’ baseline scores from their follow-up scores for each domain. A positive change score indicates improved wellbeing over time, while a negative change score indicates reduced wellbeing over time. We report this data as frequencies of change.

    The SIS domain-specific change was computed by subtracting baseline scores from follow-up scores for each domain. Positive change scores suggest greater and stronger sense of social inclusion over time, while negative change scores indicate weaker and lower inclusion.

    The domain-specific change for Valuing was calculated by subtracting baseline scores from follow-up scores in each domain. A positive change score in the Progress domain indicates a higher degree of valued living over time, whereas a higher score in Obstruction reflects a lower level of valued living.

    For each domain of the ASCOT-SCT4, we compared the pre- and post-intervention scores for each participant. A positive change was defined as one or more category shifts towards an ‘ideal state’, and a negative shift as one or more category shifts towards ‘high level needs’ from baseline to follow-up.

    Qualitative analysis

    The responses to open ended questions and interviews were analysed using a thematic analysis approach to explore the common experiences of participating in the program and highlight the impact of the program, as well as any barriers and facilitators to implementation. All transcripts were coded and analysed in NVivo© Version 12. The analysis followed five key stages outlined by Braun et al. (2019) [23]: data familiarisation, generation of codes, searching for themes, grouping and reviewing themes, and defining and naming themes. The transcripts were first independently read and coded by two researchers (KP, JM). These initial codes were then reviewed and updated following a discussion with the research team (KP, JM, SB). After the initial coding process, themes were generated and discussed with the research team (KP, JM, EEP), including the relationships between themes, and revision and collapsing of overlapping themes.

    Mixed methods analysis

    The quantitative and qualitative data were integrated narratively at the interpretation and reporting level using a weaving approach [24]. The quantitative and qualitative findings are presented together on a theme-by-theme basis according to the outcomes.

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  • Concerns over Cornwall being ‘sold off’ after solar farm approved

    Concerns over Cornwall being ‘sold off’ after solar farm approved

    Daniel Leal-Olivas/PA Wire A row of solar panels in a grass field.Daniel Leal-Olivas/PA Wire

    The development will operate as a solar farm for 30 years

    A Cornwall farmer claims the county is being “sold off” in a bid to hit net zero after plans for a 125,000-panel solar farm were approved.

    The scheme, near the A30 at Carland Cross, was turned down last year by Cornwall Council, but has since been approved by national inspectors after an appeal by the developers.

    Campaigner Marie Wills said she tried for years to overturn the solar application, and said she felt “the government are trying to sell Cornwall off just to hit net zero”.

    Downing Renewable Developments (DRD) said the the site would include sheep grazing and biodiversity improvements, as well as free solar panels for roofs of neighbouring people.

    Marie Wills is sitting on a chair in front of a log burner. She is wearing a navy jumper and is looking at the camera.

    Marie Wills said she tried for three years to overturn the application

    Rosalyn Kirby heard arguments for and against the solar farm on 80 hectares (200 acres) of agricultural land between Mitchell, Trispen, St Erme and Carland Cross.

    Ms Kirby concluded harm to the character and appearance of the area, and conflict with the development plan, was “outweighed by the benefits of the proposal”.

    Ms Wills, who has a family-farm adjacent to the site, is part of the Carland Action group.

    She said: “I call this the Mother of All Solar Farms because of all the policies it had against it.

    “I think the floodgates will open and more and more land will be put into solar.”

    ‘Solar rooftop initiative’

    Ms Wills said it was becoming “impossible” for farming families to purchase land “because of the price of land increasing due to these solar farms”.

    She added: “The amount that the developers are paying, I cannot see how they will decrease the cost of electricity.”

    Owner DRD said the Fair Park development would operate as a solar farm for 30 years, delivering up to 49.9MW of solar energy.

    It said its plans would include new hedgerows, wildflower meadows, and habitat improvements which would go beyond statutory planning requirements.

    Tony Gannon, of DRD, said the project would make a “valuable contribution to helping meet both national and Cornwall net zero targets”.

    “It also delivers a significant community benefit programme which provides those closest to the development with lower cost energy through our free domestic solar rooftop initiative,” he said.

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