Background Although laboratory studies demonstrate that training programmes using auditory rhythmical cueing (ARC) may improve gait post-stroke, few studies have evaluated this intervention in the home and outdoors where deployment may be more appropriate. This manuscript reports stakeholder refinement of an ARC gait and balance training programme for use at home and outdoors, and a study which assessed acceptability and deliverability of this programme. Methods Programme design and content were refined during stakeholder workshops involving physiotherapists and stroke survivors. A two-group acceptability and deliverability study was then undertaken. Twelve patients post-stroke with a gait related mobility impairment received either the ARC gait and balance training programme or the gait and balance training programme without ARC. Programme provider written notes, participant exercise and fall diaries, adverse event monitoring and feedback questionnaires captured data about deliverability, safety and acceptability of the programmes. Results The training programme consisted of 18 sessions (six supervised, 12 self-managed) of exercises and ARC delivered by a low-cost commercially available metronome. All 12 participants completed the six supervised sessions and 10/12 completed the 12 self-managed sessions. Provider and participant session written records and feedback questionnaires confirmed programme deliverability and acceptability. Conclusion An ARC gait and balance training programme refined by key stakeholders was feasible to deliver and acceptable to participants and providers. Trial registration ISCTRN 12/03/2018.
Background The use of extracorporeal membrane oxygenation (ECMO) in pediatric patients with underlying malignancies remains controversial. However, in an era in which the survival rates for children with malignancies have increased significantly and several recent reports have demonstrated effective ECMO use in children with cancer, we aimed to estimate the outcome and complications of ECMO treatment in these children. Methods We searched MEDLINE, Embase and CINAHL databases for studies on the use ECMO in pediatric patients with an underlying malignancy from inception to September 2020. This review was conducted in adherence to Preferred Reporting Items for Systematic Review and Meta-Analysis statement. Study eligibility was independently assessed by two authors and disagreements resolved by a third author. Included studies were evaluated for quality using the Newcastle–Ottawa Scale (NOS). Random effects meta-analyses (DerSimonian and Laird) were performed. The primary outcomes were mortality during ECMO or hospital mortality. Results Thirteen retrospective, observational cohort studies were included, most of moderate quality (625 patients). The commonest indication for ECMO was severe respiratory failure (92%). Pooled mortality during ECMO was 55% (95% confidence interval [CI], 47–63%) and pooled hospital mortality was 60% (95% CI 54–67%). Although heterogeneity among the included studies was low, confidence intervals were large. In addition, the majority of the data were derived from registries with overlapping patients which were excluded for the meta-analyses to prevent resampling of the same participants across the included studies. Finally, there was a lack of consistent complications reporting among the studies. Conclusion Significantly higher mortalities than in general PICU patients was reported with the use of ECMO in children with malignancies. Although these results need to be interpreted with caution due to the lack of granular data, they suggest that ECMO appears to represents a viable rescue option for selected patients with underlying malignancies. There is an urgent need for additional data to define patients for whom ECMO may provide benefit or harm.
Valosin-containing protein (VCP) associated multisystem proteinopathy (MSP) is a rare inherited disorder that may result in multisystem involvement of varying phenotypes including inclusion body myopathy, Paget’s disease of bone (PDB), frontotemporal dementia (FTD), parkinsonism, and amyotrophic lateral sclerosis (ALS), among others. An international multidisciplinary consortium of 40+ experts in neuromuscular disease, dementia, movement disorders, psychology, cardiology, pulmonology, physical therapy, occupational therapy, speech and language pathology, nutrition, genetics, integrative medicine, and endocrinology were convened by the patient advocacy organization, Cure VCP Disease, in December 2020 to develop a standard of care for this heterogeneous and under-diagnosed disease. To achieve this goal, working groups collaborated to generate expert consensus recommendations in 10 key areas: genetic diagnosis, myopathy, FTD, PDB, ALS, Charcot Marie Tooth disease (CMT), parkinsonism, cardiomyopathy, pulmonology, supportive therapies, nutrition and supplements, and mental health. In April 2021, facilitated discussion of each working group’s conclusions with consensus building techniques enabled final agreement on the proposed standard of care for VCP patients. Timely referral to a specialty neuromuscular center is recommended to aid in efficient diagnosis of VCP MSP via single-gene testing in the case of a known familial VCP variant, or multi-gene panel sequencing in undifferentiated cases. Additionally, regular and ongoing multidisciplinary team follow up is essential for proactive screening and management of secondary complications. The goal of our consortium is to raise awareness of VCP MSP, expedite the time to accurate diagnosis, define gaps and inequities in patient care, initiate appropriate pharmacotherapies and supportive therapies for optimal management, and elevate the recommended best practices guidelines for multidisciplinary care internationally.
The use of digital technology is increasing rapidly across surgical specialities, yet there is no consensus for the term ‘digital surgery’. This is critical as digital health technologies present technical, governance, and legal challenges which are unique to the surgeon and surgical patient. We aim to define the term digital surgery and the ethical issues surrounding its clinical application, and to identify barriers and research goals for future practice. 38 international experts, across the fields of surgery, AI, industry, law, ethics and policy, participated in a four-round Delphi exercise. Issues were generated by an expert panel and public panel through a scoping questionnaire around key themes identified from the literature and voted upon in two subsequent questionnaire rounds. Consensus was defined if >70% of the panel deemed the statement important and <30% unimportant. A final online meeting was held to discuss consensus statements. The definition of digital surgery as the use of technology for the enhancement of preoperative planning, surgical performance, therapeutic support, or training, to improve outcomes and reduce harm achieved 100% consensus agreement. We highlight key ethical issues concerning data, privacy, confidentiality and public trust, consent, law, litigation and liability, and commercial partnerships within digital surgery and identify barriers and research goals for future practice. Developers and users of digital surgery must not only have an awareness of the ethical issues surrounding digital applications in healthcare, but also the ethical considerations unique to digital surgery. Future research into these issues must involve all digital surgery stakeholders including patients.
Imbalances in mitochondrial and peroxisomal dynamics are associated with a spectrum of human neurological disorders. Mitochondrial and peroxisomal fission both involve dynamin-related protein 1 (DRP1) oligomerisation and membrane constriction, although the precise biophysical mechanisms by which distinct DRP1 variants affect the assembly and activity of different DRP1 domains remains largely unexplored. We analysed four unreported de novo heterozygous variants in the dynamin-1-like gene DNM1L , affecting different highly conserved DRP1 domains, leading to developmental delay, seizures, hypotonia, and/or rare cardiac complications in infancy. Single-nucleotide DRP1 stalk domain variants were found to correlate with more severe clinical phenotypes, with in vitro recombinant human DRP1 mutants demonstrating greater impairments in protein oligomerisation, DRP1-peroxisomal recruitment, and both mitochondrial and peroxisomal hyperfusion compared to GTPase or GTPase-effector domain variants. Importantly, we identified a novel mechanism of pathogenesis, where a p.Arg710Gly variant uncouples DRP1 assembly from assembly-stimulated GTP hydrolysis, providing mechanistic insight into how assembly-state information is transmitted to the GTPase domain. Together, these data reveal that discrete, pathological DNM1L variants impair mitochondrial network maintenance by divergent mechanisms.
Objectives This narrative synthesis of evidence identifies and explores issues that impact upon the expansion or effectiveness of Reporting Radiographers working in all diagnostic modalities within the United Kingdom (UK). The publication focuses on accessibility to training for prospective Reporting Radiographers as well as clinical support within and beyond training. Key findings Fifteen studies informed the themes of this article, they were published between 2014 and 2021. Reporting Radiographers often found it difficult find support during training and once qualified, this was usually due to the availability and workload of supervising staff. Although resistance and obstruction were experienced by many. Concerns relating to pay, promotion and interest were expressed by some respondents whilst access to courses and finance were highlighted as areas of variance across the UK. Conclusion Inadequate support of Reporting Radiographers is impairing expansion of the specialism, whilst impacting capability and morale. This increases risk of patient harm, delays to care and inefficiency, it also threatens the sustainability of services. Negative interactions between Reporting Radiographers and Radiologists or managers is disappointing considering development of the specialism; evidence of Reporting Radiographer effectiveness and current collaboration between Royal College of Radiologists and Society of Radiographers. Issues raised in relation to pay/promotion and litigation could be clarified with ease, this should be considered when guidance is updated. Access to finance and courses is a major barrier in some regions of the UK. Scope exists for further exploration of training. England has used grants to facilitate uptake, these may prove to be an important tool in other countries. Implications for practice Drivers to increase recruitment should be implemented alongside measures to facilitate accessibility to training and improvements to support infrastructure.
Objectives This narrative synthesis of evidence identifies and explores issues that impact upon the expansion or effectiveness of Reporting Radiographers working in all diagnostic modalities within the United Kingdom (UK). The publication focuses on working practices affecting trainees and qualified Reporting Radiographers. Key findings Fourteen studies informed the themes of this article, they were published between 2014 and 2021. Delays to commencement of reporting roles and variance in performance monitoring was common. Lack of formalisation, overly restrictive and out of date scopes of practice were also found. Whilst, staffing shortages contributed to underutilisation. Failure to utilise skills was most prevalent in cross sectional imaging modalities. Considerable variance in practice was also found between centres. Meanwhile, Reporting Radiographer involvement in professional development, education and research is far from universal and often dependant on individuals sacrificing their own time. Conclusion Governance in many centres would benefit from renewal and standardisation, particularly relating to scopes of practice and performance monitoring audits. Measures are also required to encourage compliance with guidance, address staffing issues and reduce variation between centres. Failure to address these issues has the potential to impair collaboration, delay patient care and increase economic inefficiencies whilst negatively impacting satisfaction for service users and staff. Lack of involvement in professional development, education and research suggests Reporting Radiographers are not accomplishing their full potential, educating the next generation of the reporting workforce and driving evidence-based change for further development of the specialism. Implications for practice Better use of the existing workforce is essential to increase productivity, value, and security of Reporting Radiographer services, which are essential to improve patient outcomes and efficiency.
Background The COVID‐19 pandemic offered a unique opportunity to understand inflammatory bowel disease (IBD) management during unexpected disruption. This could help to guide practice overall. Aims To compare prescribing behaviour for IBD flares and outcomes during the early pandemic with pre‐pandemic findings. Methods We performed an observational cohort study comprising patients who contacted IBD teams for symptomatic flares between March and June 2020 in 60 National Health Service trusts in the United Kingdom. Data were compared with a pre‐pandemic cohort after propensity‐matching for age and physician global assessment of disease activity. Results We included 1864 patients in each of the pandemic and pre‐pandemic cohorts. The principal findings were reduced systemic corticosteroid prescription during the pandemic in Crohn's disease (prednisolone: pandemic 26.5% vs. 37.1%; p < 0.001) and ulcerative colitis (UC) (prednisolone: pandemic 33.5% vs. 40.7%, p < 0.001), with increases in poorly bioavailable oral corticosteroids in Crohn's (pandemic 15.6% vs. 6.8%; p < 0.001) and UC (pandemic 11.8% vs. 5.2%; p < 0.001). Ustekinumab (Crohn's and UC) and vedolizumab (UC) treatment also significantly increased. Three‐month steroid‐free remission in each period was similar in Crohn's (pandemic 28.4% vs. 32.1%; p = 0.17) and UC (pandemic 36.4% vs. 40.2%; p = 0.095). Patients experiencing a flare and suspected COVID‐19 were more likely to have moderate‐to‐severely active disease at 3 months than those with a flare alone. Conclusions Despite treatment adaptations during the pandemic, steroid‐free outcomes were comparable with pre‐pandemic levels, although concurrent flare and suspected COVID‐19 caused worse outcomes. These findings have implications for IBD management during future pandemics and for standard practice.
Introduction Generic fibrates are used off-label as add-in therapy for the management of primary biliary cholangitis (PBC), but with unproven long-term liver-related survival benefit. The recently developed fibrate, seladelpar, has shown promising results in clinical trials, but these outcomes have been previously marred by safety concerns. Areas covered We summarise existing treatment options in PBC and evaluate current trial data for seladelpar in relation to liver biochemistry, symptomology and safety. Expert opinion Seladelpar leads to marked improvement in liver biochemistry and may improve symptoms. Safety concerns around liver toxicity appear to have been addressed. With likely increasing evidence compared to existing off-label fibrates, seladelpar has potential as an attractive future second-line agent in PBC.
The function of interleukin-22 (IL-22) in intestinal barrier homeostasis remains controversial. Here, we map the transcriptional landscape regulated by IL-22 in human colonic epithelial organoids and evaluate the biological, functional and clinical significance of the IL-22 mediated pathways in ulcerative colitis (UC). We show that IL-22 regulated pro-inflammatory pathways are involved in microbial recognition, cancer and immune cell chemotaxis; most prominently those involving CXCR2⁺ neutrophils. IL-22-mediated transcriptional regulation of CXC-family neutrophil-active chemokine expression is highly conserved across species, is dependent on STAT3 signaling, and is functionally and pathologically important in the recruitment of CXCR2⁺ neutrophils into colonic tissue. In UC patients, the magnitude of enrichment of the IL-22 regulated transcripts in colonic biopsies correlates with colonic neutrophil infiltration and is enriched in non-responders to ustekinumab therapy. Our data provide further insights into the biology of IL-22 in human disease and highlight its function in the regulation of pathogenic immune pathways, including neutrophil chemotaxis. The transcriptional networks regulated by IL-22 are functionally and clinically important in UC, impacting patient trajectories and responsiveness to biological intervention.
Background There are no clearly defined guidelines for the management of distal radial physeal injuries. We aimed to identify the risk factors for patients with distal radial physeal trauma for the risk of deformity, physeal closure, and revision procedure and develop a predictive model. Methods The retrospective study included patients less than 16 years old with displaced distal radial physeal injuries treated between 2011 and 2018 across five centers in the United Kingdom. Deformity was defined as a volar angulation of >11°, dorsal angulation of >15°, a radial inclination of <15° or >23°, or positive ulnar variance. Presence of a bony bar spanning the physis was considered physeal closure. Results This study comprised of 479 patients. In that, 32 (6.6%) patients had a second procedure. Also, 49 (10.2%) patients had closure of physis, and 28 (6%) patients had deformity at the end of follow-up. The occurrence of deformity had a strong correlation with age (p = 0.04) and immobilization duration (p = 0.003). Receiver operating characteristic analysis showed that age >12.5 years (p = 0.006) and sagittal angulation of >21.7° (p = 0.002) had a higher odd of deformity. Immobilization for <4.5 weeks (p = 0.01) had a higher revision rate. The nomograms showed good calibration, with a sensitivity of 70% and specificity of 75%. Interpretation The nomograms provide accurate, pragmatic multivariate predictive models. Anatomical reduction is recommended in patients >12.5 years of age with >22° of dorsal angulation with cast immobilization for no less than 4.5 weeks. Any revision procedure should be performed within 11 days from the date of injury to reduce the risk of physeal damage.
Objectives No copper intrauterine device (IUD) type is known to better suit young nulliparous women who tend to experience higher rates of IUD discontinuation compared with their older parous counterparts. A systematic review to determine which IUDs have higher continuation rates in young nulliparous women was undertaken. Design Systematic review and meta-analyses of available evidence based on IUD type. Data sources AMED, BNI, CINAHL, DARE, EMBASE, EMCARE, HMIC, MEDLINE, PsycINFO, PubMed, TRIP, and the Cochrane Library electronic databases were searched from inception to 11 May 2022; as well as the Bandolier, Medicines and Healthcare products Regulatory Agency, Faculty of Sexual and Reproductive Healthcare, Royal College of Obstetricians and Gynaecologists, Department of Health, National Institute for Health and Care Excellence, Scottish Intercollegiate Guidelines, WHO and Google Scholar websites. Eligibility criteria All studies on IUDs currently available in the UK or comparable (same design and size) to those available in the UK, involving nulliparous women of any age including those aged under 30. Data extraction and synthesis Independently extracted data were assessed as low risk of bias using the Mixed Methods Appraisal Tool. Random effects meta-analyses of proportions were performed where data, including subgroups, were amenable to quantitative synthesis. Heterogeneity was reported using tau ² and I ² statistics, and sensitivity analyses were also performed. Results Nineteen studies involving 13 045 nulliparous women were included but the heterogeneity of participant ages, parity and IUD types made quantitative synthesis of outcome data in totality inappropriate. The highest continuation rate obtained was 91.02% (95% CI 88.01% to 93.64%) for the smaller TCu 380A at 12 months post insertion. Conclusions Evidence for IUD use in young nulliparous women based on IUD type remains limited. Smaller sized IUD types appear better suited to this group of IUD users, however, more research is needed. PROSPERO registration number CRD42019120969.
Tolerogenic dendritic cell (tolDC) therapies aim to restore self-tolerance in patients suffering from autoimmune diseases. Phase 1 clinical trials with tolDC have shown the feasibility and safety of this approach, but have also highlighted a lack of understanding of their distribution in vivo . Fluorine-19 magnetic resonance imaging ( ¹⁹ F-MRI) promises an attractive cell tracking method because it allows for detection of ¹⁹ F-labelled cells in a non-invasive and longitudinal manner. Here, we tested the suitability of nanoparticles containing ¹⁹ F ( ¹⁹ F-NP) for labelling of therapeutic human tolDC for detection by ¹⁹ F-MRI. We found that tolDC readily endocytosed ¹⁹ F-NP with acceptable effects on cell viability and yield. The MRI signal-to-noise ratios obtained are more than sufficient for detection of the administered tolDC dose (10 million cells) at the injection site in vivo , depending on the tissue depth and the rate of cell dispersal. Importantly, ¹⁹ F-NP labelling did not revert tolDC into immunogenic DC, as confirmed by their low expression of typical mature DC surface markers (CD83, CD86), low secretion of pro-inflammatory IL-12p70, and low capacity to induce IFN-γ in allogeneic CD4 ⁺ T cells. In addition, the capacity of tolDC to secrete anti-inflammatory IL-10 was not diminished by ¹⁹ F-NP labelling. We conclude that ¹⁹ F-NP is a suitable imaging agent for tolDC. With currently available technologies, this imaging approach does not yet approach the sensitivity required to detect small numbers of migrating cells, but could have important utility for determining the accuracy of injecting tolDC into the desired target tissue and their efflux rate.
Objectives: Interventions aimed at increasing tumour-necrosis factor-alpha inhibitor serum drug levels (SDLs) may improve treatment response; however, previous studies suggesting SDL cut-offs have not accounted for treatment adherence. The aim of this study was to establish the relationship between Adalimumab/Certolizumab SDLs and EULAR good vs non/moderate response, and to define SDL cut-offs associated with good response in fully adherent patients. Methods: In a prospective observational study, 475 patients with RA were treated with Certolizumab (n = 192) or Adalimumab (n = 283). At baseline, 3/6/12-months patients had DAS28, self-reported treatment adherence, and SDLs measured. Fully adherent patients were analysed as a subgroup. Follow-up data at 3/6/12-months was analysed separately. Median SDLs were compared in good vs non/moderate response, and receiver-operator characteristics curves (ROC) were used to establish cut-off SDLs. Results: Fully adherent good responders had significantly higher median Adalimumab/Certolizumab SDLs compared with non/moderate responders (p= 0·04 and p= 0·0005, respectively). ROC analysis reported 3-month non-trough Adalimumab SDLs discriminated good vs non/moderate response with an AUC of 0·63 (95% CI 0·52-0·75), with a cut-off of 7·5mg/l being 39·1% specific, and 80·9% sensitive. Similarly, 3-month non-trough Certolizumab SDLs discriminated good vs non/moderate response with an AUC of 0·65 (95% CI 0·51-0·78), with a cut-off of 26·0mg/l being 43·9% specific, and 77·8% sensitive. Conclusion: In fully adherent patients, higher SDLs are detected in good responders suggesting that interventions to improve SDLs such as encouraging adherence could improve treatment response. 3-month non-trough SDL cut-offs of 7·5mg/l for Adalimumab and 26·0mg/l for Certolizumab may be useful in clinical practice.
Flanged acetabular cups were developed with the rationale that, at insertion, they would increase the pressure of the cement and improve penetration of cement into the acetabular bone. Various studies have been inconclusive regarding their effectiveness. In this work, we aimed to eliminate all confounding factors and measure the pressures generated during acetabular pressurization and cup implantation using a simplified steel acetabulum, high precision pressure transducers, proper surgical techniques and two acetabular cups, identical apart from the addition of a flange to one. It was found that the flanged acetabular component did not significantly increase the pressure in the acetabulum and in some cases reduced the pressures generated when compared to an unflanged cup. The addition of a flange did not reduce the pressure differential between the pole and the rim of the acetabulum, nor did it have a significant effect on pressure lost over the cup implantation period. It was concluded that flanged acetabular cups provide no significant improvement in the pressures generated in the acetabulum during acetabular cup implantation. It is hypothesized that the flange may be seen as a design feature intended to slow the insertion of the cup into the cement, thus requiring the surgeon to apply a larger load in order to correctly position the acetabular cup; in this way larger pressure will be generated.
Pancreatic cancer is the seventh commonest cause of cancer-related death worldwide. Although prognosis is poor, both surgery and adjuvant chemotherapy improve survival. However, it has been suggested that not all pancreatic cancer patients who may benefit from treatment receive it. This systematic review and meta-analysis investigated the existence of age-related inequalities in receipt of first-line pancreatic cancer treatment. Medline, Embase, Cochrane Library and grey literature were searched for population-based studies investigating treatment receipt, reported by age, for patients with primary pancreatic cancer from inception until 4th June 2020, and updated 5th August 2021. Studies from countries with universal healthcare were included, to minimise influence of health system-related economic factors. A modified version of the Newcastle-Ottawa Scale was used to assess risk of bias. Random-effects meta-analysis was undertaken comparing likelihood of treatment receipt in older versus younger patients. Sensitivity and subgroup analyses were conducted. Eighteen papers were included; 12 independent populations were eligible for meta-analysis. In most studies, < 10% of older patients were treated. Older age (generally ≥65) was significantly associated with reduced receipt of any treatment (OR=0.14, 95% CI 0.10–0.21, n = 12 studies), surgery (OR=0.15, 95% CI 0.09–0.24, n = 9 studies) and chemotherapy as a primary treatment (OR=0.13, 95% CI 0.07–0.24, n = 5 studies). The effect of age was independent of methodological quality, patient population or time-period of patient diagnosis and remained in studies with confounder adjustment. The mean quality score of included studies was 6/8. Inequalities in receipt of healthcare interventions across social groups is a recognised concern internationally. This review shows that older age is significantly, and consistently, associated with non-receipt of treatment in pancreatic cancer. However, there are risks and side-effects associated with pancreatic cancer treatment. Further research on what influences patient and professional treatment decision-making is required to better understand these apparent inequalities.
The association between vascular Ehlers-Danlos Syndrome (vEDS) and amniotic band sequence (ABS) has been previously reported in the literature, mostly in single patient case reports. Here, we aim to extend the current knowledge of this association through a case series of five unrelated individuals with ABS in association with molecularly confirmed vEDS, in addition to undertaking a comprehensive literature review. All the individuals were recruited through the EDS national diagnostic service in the UK following appropriate history, physical examination and genetic investigations. Clinical presentation ranged from a single constriction ring to complex craniofacial clefts to limb reduction deformities, reflecting the spectrum of ABS presentation. vEDS was inherited paternally (n = 2), maternally (n = 2) and de novo (n = 1). Previously, maternal vEDS was considered the risk factor for ABS, but our findings suggest that it may be the disease status of the fetus which poses the main risk. It is established that amniotic membrane is derived from fetal tissue, which supports our conclusions. Our observations suggest the increased risk of ABS in fetuses with vEDS. Therefore, exploring family history and features that may suggest vEDS diagnosis in patients with ABS might be useful. We also recommend that a collaborative international study would be useful to help gain a better insight into this association.
Background Cardiovascular disease is the leading cause of mortality for females globally, yet females are underrepresented in studies of acute coronary syndrome (ACS). Studies investigating sex-related differences in clinical outcomes of patients with non-ST elevation ACS (NSTEACS) have reported divergent results, and it is unknown whether long-term outcomes for older people with NSTEACS differ between males and females. Methods The multi-centre prospective cohort study, ICON-1, consisted of patients aged ≥75 years undergoing coronary angiography following NSTEACS. The primary composite endpoint was all-cause mortality, myocardial infarction, unplanned revascularisation, stroke, and bleeding. We report outcomes at five-years by sex. Results Of 264 patients, 102 (38.6%) females and 162 (61.4%) males completed the five-year follow-up and were included in the analytic cohort. At admission, females were older than males (82 ± 4.3 years vs 80.0 ± 4.1 years p = 0.018). Co-morbidity profile and GRACE score were similar between the groups. There were no differences in the provision of invasive or pharmacological treatments between sexes. At five-years, there were no association between sex and the primary outcome. Conclusion In older adults with invasive treatment of NSTEACS, provision of guideline-indicated care and long-term clinical outcomes were similar between males and females.
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