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INTRODUCTION AND HYPOTHESIS: Evidence on OAB management remains suboptimal and methodological limitations in randomized control trials (RCTs) affect their comparability. High quality meta-analyses are lacking. This study aimed to compare selection and reporting of outcomes and outcome measures across RCTs as well as evaluate methodological quality and outcome reporting quality as a first stage in the process of developing core outcome sets (COS). METHODS: RCTs were searched using Pubmed, EMBASE, Medline, Cochrane, ICTRP and Clinicaltrials.gov from inception to January 2020, in English language, on adult women. Pharmacological management, interventions, sample size, journal type and commercial funding were documented. Methodological and outcome reporting quality were evaluated using JADAD and MOMENT scores. RESULTS: Thirty-eight trials (18,316 women) were included. Sixty-nine outcomes were reported, using 62 outcome measures. The most commonly reported outcome domains were efficacy (86.8%), safety (73.7%) and QoL (60.5%). The most commonly reported outcomes in each domain were urgency urinary incontinence episodes (UUI) (52.6%), antimuscarinic side effects (76.3%) and change in validated questionnaire scores (36.8%). A statistically significant correlation was found between JADAD and MOMENT (Spearman's rho = 0.548, p < 0.05) scores. This indicates that higher methodological quality is associated with higher outcome reporting quality. CONCLUSIONS: Development of COS and core outcome measure sets will address variations and lead to higher quality evidence. We recommend the most commonly reported outcomes in each domain, as interim COS. For efficacy we recommend: UUI episodes, urgency and nocturia episodes; for safety: antimuscarinic adverse events, other adverse events and discontinuation rates; for QoL: OAB-q, PPBC and IIQ scores.
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Bexiga Urinária Hiperativa , Incontinência Urinária , Adulto , Feminino , Humanos , Antagonistas Muscarínicos/uso terapêutico , Avaliação de Resultados em Cuidados de Saúde , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do Tratamento , Bexiga Urinária Hiperativa/complicações , Bexiga Urinária Hiperativa/tratamento farmacológico , Incontinência Urinária/complicaçõesRESUMO
Traditional null hypothesis significance testing (NHST) incorporating the critical level of significance of 0.05 has become the cornerstone of decision-making in health care, and nowhere less so than in obstetric and gynecological research. However, such practice is controversial. In particular, it was never intended for clinical significance to be inferred from statistical significance. The inference of clinical importance based on statistical significance (p < 0.05), and lack of clinical significance otherwise (p ≥ 0.05) represents misunderstanding of the original purpose of NHST. Furthermore, the limitations of NHST-sensitivity to sample size, plus type I and II errors-are frequently ignored. Therefore, decision-making based on NHST has the potential for recurrent false claims about the effectiveness of interventions or importance of exposure to risk factors, or dismissal of important ones. This commentary presents the history behind NHST along with the limitations that modern-day NHST presents, and suggests that a statistics reform regarding NHST be considered.
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Projetos de Pesquisa , Humanos , Tamanho da AmostraRESUMO
AIMS: Increasing numbers of twin pregnancies necessitate investigation of the risk factors associated with obstetric anal sphincter injuries (OASIS). The aims of this study were to establish the incidence of OASIS, and compare women delivering twins to those delivering singletons in risk of OASIS plus maternal, neonatal, and obstetric outcomes. METHODS: A retrospective cohort study was undertaken and included women delivering in a tertiary London maternity unit between 1999 and 2015; 51 957 eligible women with singleton and 261 with twin pregnancies were identified. Women delivering twins were compared to those delivering singletons in the occurrence of maternal, neonatal, and obstetric outcomes using unadjusted relative risks. A secondary analysis was performed, and conditional logistic regression used to derive an adjusted relative risk of OASIS. Women delivering singletons were matched to those delivering twins for age, parity, ethnicity, gestation, and mode of delivery in a ratio of 2:1. RESULTS: Compared to the singleton group, mothers delivering twins had significantly more instrumental deliveries (RR [95%CI] 1.92 [1.67-2.27]; P < 0.0001), smaller fetuses (2754.1 vs 3383.8 g; P < 0.001), and were older (32.9 vs 31.0 years; P < 0.0001). The twin group was not significantly different to the singleton group in risk of OASIS (RR 0.61 [0.27-1.33], P = 0.205). The conditional logistic regression demonstrated similar results for the risk of OASIS (adjusted RR = 0.58 [0.22-1.47]; P = 0.253). CONCLUSIONS: Women delivering twins vaginally were not at a significantly higher risk of sustaining OASIS compared to those delivering singletons.
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Canal Anal/lesões , Parto Obstétrico/efeitos adversos , Complicações do Trabalho de Parto/epidemiologia , Gravidez de Gêmeos , Adolescente , Adulto , Feminino , Humanos , Incidência , Pessoa de Meia-Idade , Gravidez , Estudos Retrospectivos , Fatores de Risco , Adulto JovemRESUMO
This study assessed the agreement between arterial and venous blood lactate and pH levels in children with sepsis. This retrospective, three-year study involved 60 PICU patients, with data collected from electronic or paper patient records. The inclusion criteria comprised of children (≤17 years old) with sepsis and those who had a venous blood gas taken first with an arterial blood gas taken after within one hour. The lactate and pH values measured through each method were analysed. There is close agreement between venous and arterial lactate up to 2 mmol/L. As this value increases, this agreement becomes poor. The limits of agreement (LOA) are too large (±1.90 mmol/L) to allow venous and arterial lactate to be used interchangeably. The mean difference and LOA between both methods would be much smaller if derived using lactate values under 2.0 mmol/L. There is close agreement between arterial and venous pH (MD = -0.056, LOA ± 0.121). However, due to extreme variations in pH readings during sepsis, pH alone is an inadequate marker. CONCLUSION: A venous lactate ≤2 mmol/L can be used as a surrogate for arterial lactate during early management of sepsis in children. However, if the value exceeds 2 mmol/L, an arterial sample must confirm the venous result. What is known: ⢠In children with septic shock, a blood gas is an important test to show the presence of acidosis and high lactic acid. Hyperlactataemia on admission is an early predictor of outcome and is associated with a greater mortality risk. ⢠An arterial sample is the standard for lactate measurement, however getting a sample may be challenging in the emergency department or a general paediatric ward. Venous samples are quicker and easier to obtain. Adult studies generally advise caution in replacing venous lactate values for the arterial standard, whilst paediatric studies are limited in this area. What is new: ⢠This is the first study assessing the agreement between arterial and peripheral venous lactate in children with sepsis, with a significant sample of patients. ⢠This study shows that a venous sample with a lactate of ≤ 2 mmol/L can be used as a surrogate measurement for arterial lactate during early management of sepsis in children. However, if the venous lactate is above 2 mmol/L, an arterial sample must be taken to confirm the result.
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Ácido Láctico/sangue , Sepse/diagnóstico , Adolescente , Artérias , Biomarcadores/sangue , Criança , Pré-Escolar , Feminino , Humanos , Concentração de Íons de Hidrogênio , Lactente , Recém-Nascido , Unidades de Terapia Intensiva Pediátrica , Masculino , Estudos Retrospectivos , Sepse/sangue , VeiasRESUMO
Rabbit antithymocyte globulin (rATG; thymoglobulin, Genzyme) in combination with cyclosporine, as first-line immunosuppressive therapy, was evaluated prospectively in a multicenter, European, phase 2 pilot study, in 35 patients with aplastic anemia. Results were compared with 105 age- and disease severity-matched patients from the European Blood and Marrow Transplant registry, treated with horse ATG (hATG; lymphoglobulin) and cyclosporine. The primary end point was response at 6 months. At 3 months, no patients had achieved a complete response to rATG. Partial response occurred in 11 (34%). At 6 months, complete response rate was 3% and partial response rate 37%. There were 10 deaths after rATG (28.5%) and 1 after subsequent HSCT. Infections were the main cause of death in 9 of 10 patients. The best response rate was 60% for rATG and 67% for hATG. For rATG, overall survival at 2 years was 68%, compared with 86% for hATG (P = .009). Transplant-free survival was 52% for rATG and 76% for hATG (P = .002). On multivariate analysis, rATG (hazard ratio = 3.9, P = .003) and age more than 37 years (hazard ratio = 4.7, P = .0008) were independent adverse risk factors for survival. This study was registered at www.clinicaltrials.gov as NCT00471848.
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Anemia Aplástica/tratamento farmacológico , Soro Antilinfocitário/uso terapêutico , Ciclosporina/uso terapêutico , Imunossupressores/uso terapêutico , Adolescente , Adulto , Idoso , Animais , Soro Antilinfocitário/efeitos adversos , Linfócitos T CD4-Positivos/efeitos dos fármacos , Ciclosporina/efeitos adversos , Quimioterapia Combinada , Europa (Continente) , Feminino , Cavalos , Humanos , Imunossupressores/efeitos adversos , Masculino , Pessoa de Meia-Idade , Projetos Piloto , Estudos Prospectivos , Coelhos , Análise de Sobrevida , Adulto JovemRESUMO
Arteriovenous fistulas (AVFs) play an important role in access for hemodialysis, yet premature thrombosis is a challenge. This study identifies factors influencing primary patency in a series of AVF creations. Postoperative systolic blood pressure (BP) was of principal interest; demographical information, comorbidities, smoking status, warfarin, aspirin, clopidogrel, and statins were considered. A retrospective review of AVF creations performed by one surgeon between January 2008 and September 2010 was conducted. Fistula patency was denoted by a bruit and measured at 3 weeks and 12 months after surgery. One hundred and fifty-one AVF creations were studied; 134 fistulas (88.7%) were patent at 3 weeks and 85 (56.3%) at 12 months. The odds ratio (OR) for thrombosis at 12 months was 0.16 (95% CI: 0.04, 0.62; p = 0.008) among patients with a postoperative systolic BP of 120-139 mmHg compared with those with a BP of ≤ 119 mmHg. Patients taking warfarin yielded an OR of 5.71 at 3 weeks (95% CI: 1.20, 27.11; p = 0.028), and 3.33 at 12 months (95% CI: 1.01, 10.99; p = 0.048). No other variables were statistically significant. Patients with postoperative systolic BP of 120-139 mmHg showed a reduction in fistula thromboses compared with patients with a systolic BP of ≤ 119 mmHg. Patients on warfarin were less likely to maintain a patent fistula.
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Derivação Arteriovenosa Cirúrgica/métodos , Pressão Sanguínea/fisiologia , Artéria Braquial/fisiopatologia , Veias Braquiocefálicas/fisiopatologia , Oclusão de Enxerto Vascular/epidemiologia , Diálise Renal , Grau de Desobstrução Vascular/fisiologia , Adulto , Idoso , Idoso de 80 Anos ou mais , Artéria Braquial/cirurgia , Veias Braquiocefálicas/cirurgia , Feminino , Seguimentos , Oclusão de Enxerto Vascular/fisiopatologia , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias , Estudos Retrospectivos , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Reino Unido/epidemiologia , Adulto JovemRESUMO
BACKGROUND: Patients with COPD are at risk of non-tuberculous mycobacterial infection (NTM). This study examined the histology of lung tissue from COPD patients following lung volume reduction with particular focus on evidence of mycobacterial infection. METHODS: Retrospective histological study of 142 consecutive lung volume reduction surgical specimens (126 separate patients) at Royal Brompton Hospital between 2000 - 2013, with prospectively collected preoperative data on exacerbation rate, lung function and body mass index. RESULTS: 92% of patients had at least one other histological diagnosis in addition to emphysema. 10% of specimens had histological evidence of mycobacterial infection, one with co-existent aspergilloma. Mycobacteria were only identified in those patients with granulomas that were necrotising. These patients had higher exacerbation rates, lower TLCO and FEV1. CONCLUSION: A proportion of severe COPD patients will have evidence of mycobacterial infection despite lack of clinical and radiological suspicion. This may have implications for long-term management of these patients.
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Granuloma/microbiologia , Granuloma/patologia , Pulmão/patologia , Infecções por Mycobacterium não Tuberculosas/patologia , Micobactérias não Tuberculosas/isolamento & purificação , Doença Pulmonar Obstrutiva Crônica/patologia , Adulto , Idoso , Idoso de 80 Anos ou mais , Índice de Massa Corporal , Progressão da Doença , Feminino , Volume Expiratório Forçado , Humanos , Masculino , Pessoa de Meia-Idade , Infecções por Mycobacterium não Tuberculosas/complicações , Necrose , Pneumonectomia , Período Pré-Operatório , Doença Pulmonar Obstrutiva Crônica/complicações , Doença Pulmonar Obstrutiva Crônica/fisiopatologia , Doença Pulmonar Obstrutiva Crônica/cirurgia , Estudos RetrospectivosRESUMO
Introduction: Fractures occur in children at an incidence only surpassed by women >85 years and account for 25 % of paediatric injuries. Over the last three decades, there has been a trend towards operative management of children's fractures including utilisation of flexible nails as popularised by the Nancy group in the 1980s. Between 5 and 11 % of paediatric forearm fractures are now fixed in this manner with complication rates of 12-42 %. This study shares the experience of a paediatric level one major trauma centre using this technique in managing long bone fractures in children. Methods and materials: This retrospective cohort study comprises a sequential series of 109 cases (71 children) of upper and lower limb fractures in children (aged 16 years and below) who underwent fracture fixation using flexible intramedullary nails between 1st April 2015 and 31st March 2019. Radiological and clinical outcomes and complications were assessed. Results: Ninety-three cases (10 in the lower limb, 83 in the upper limb) satisfied the inclusion criteria in 57 children with a mean age of 8.6 years. All cases were successfully reduced intra-operatively and 92 (98.9 %) achieved union. Taking into account all complications in the upper and lower limb, the overall complication rate is 30.1 % (28 cases) with the vast majority (13 cases, 46.4 %) occurring in the upper limb due to prominence of metalwork prompting early removal. Conclusions: This study has shown flexible intramedullary nailing to perform well with good stabilisation of a wide variety of paediatric long bone fractures with restoration of bone alignment, satisfactory outcomes with good union rates and a return to normal function. The technique is also safe and in the upper limb can be performed as day-case surgery by a generalist orthopaedic surgeon. Although the overall complication rate is not insignificant, major complications are rare.
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BACKGROUND: Pain management is a major unmet need in people with rheumatoid arthritis (RA). Although many patients are treated with disease modifying anti-rheumatic drugs (DMARDS), including biologic therapies, many people with RA continue to experience significant pain. We aimed to determine whether performing a comprehensive pain evaluation is feasible in people with active RA receiving conventional DMARDs and biologic therapies. METHODS: The BIORA-PAIN feasibility study was an open-label, randomised trial, which recruited participants suitable for treatment with biologic therapy. The primary feasibility outcomes were recruitment, randomisation and retention of eligible participants. All participants underwent pain assessment for nociceptive, neuropathic and nociplastic pain during the 12-month study period, with quarterly assessments for VAS (Visual Analogue Scale) pain, painDETECT and QST (quantitative sensory testing). This trial was registered in clinicaltrials.gov NCT04255134. RESULTS: During the study period, 93 participants were screened of whom 25 were eligible: 13 were randomised to adalimumab and 12 to abatacept. Participant recruitment was lower than expected due to the COVID-19 pandemic. Pain assessments were practical in the clinical trial setting. An improvement was observed for VAS pain from baseline over 12 months, with a mean (SEM) of 3.7 (0.82) in the abatacept group and 2.3 (1.1) in the adalimumab group. There was a reduction in painDETECT and improvement in QST measures in both treatment groups during the study. Participant feedback included that some of the questionnaire-based pain assessments were lengthy and overlapped in their content. Adverse events were similar in both groups. There was one death due to COVID-19. CONCLUSIONS: This first-ever feasibility study of a randomised controlled trial assessing distinct modalities of pain in RA met its progression criteria. This study demonstrates that it is feasible to recruit and assess participants with active RA for specific modalities of pain, including nociceptive, neuropathic and nociplastic elements. Our data suggests that it is possible to stratify people for RA based on pain features. The differences in pain outcomes between abatacept and adalimumab treated groups warrant further investigation. TRIAL REGISTRATION: NCT04255134, Registered on Feb 5, 2020.
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OBJECTIVE: To evaluate the impact of a previous pregnancy and delivery on perineal trauma rates in the subsequent vaginal birth. METHODS: Retrospective cohort study. The perineal outcomes of secundiparous women with history of previous (first) delivery in one of three categories: failed operative vaginal delivery (FOVD) and second-stage emergency cesarean section (EmCS); elective cesarean section (ElCS), and vaginal delivery (VD) with intact perineum, were compared with a control primiparous group. RESULTS: The percentage obstetric anal sphincter injuries (OASIS)at first vaginal delivery was 17.3% (n = 9) after previous FOVD+EmCS, 12.9% (n = 18) after previous ElCS, and 0.6% (n = 9) after previous VD maintaining an intact perineum, compared with 6% (n = 1193) in the control primiparous group of women. Multivariate regression analysis demonstrated that previous FOVD+EmCS and ElCS were associated with a statistically significant increased risk of OASIS of 180% and 110% when compared with control (odds ratio [OR] 2.80; 95% confidence interval [CI] 1.35-5.78 and OR 2.10; 95% CI 1.27-3.48, respectively). Previous VD with intact perineum was associated with a statistically significantly reduced risk of OASIS (OR 0.09; 95% CI 0.04-0.17). CONCLUSIONS: Previous FOVD+EmCS and ElCS were associated with increased risk of OASIS in subsequent vaginal delivery compared with control, whereas previous VD with intact perineum was associated with decreased risk.
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Lacerações , Complicações do Trabalho de Parto , Feminino , Gravidez , Humanos , Períneo/lesões , Cesárea/efeitos adversos , Canal Anal/lesões , Estudos Retrospectivos , Parto Obstétrico/efeitos adversos , Fatores de Risco , Complicações do Trabalho de Parto/epidemiologia , Complicações do Trabalho de Parto/etiologia , Lacerações/epidemiologia , Lacerações/etiologiaRESUMO
The Oxford Knee Score (OKS) is a patient-reported outcome questionnaire typically used to assess function and pain in patients undergoing total knee replacement (TKR). However, research is inconclusive as to which preoperative factors are important in explaining variation in outcome following TKR. The operative records of 12,709 patients who underwent primary TKR over a 9-year period were analyzed. The following variables were collected for each patient: age, sex, body mass index (BMI), Index of Multiple Deprivation decile rank, side of operation, diagnosis, the American Society of Anaesthesiologists (ASA) grade, preoperative OKS, EQ-5D index score, EuroQol visual analog scale (EQ-VAS) score, the postoperative OKS at 1 and 2 years. Generalized linear regression models were performed at 1 and 2 years to investigate the effect of the preoperative variables on the postoperative OKS. The effect of age, sex, BMI, Index of Multiple Deprivation decile rank, diagnosis, ASA grade, preoperative OKS, EuroQoL five-dimensional (EQ-5D) index score, and EQ-VAS score were all statistically significant in explaining the variation in OKS at 1 and 2 years postoperatively, with critical level of significance of 0.05 (5%). Being male aged 60 to 69 years of normal BMI, ASA grade I (fit and healthy), living in an affluent area, not reporting preoperative anxiety/depression, were associated with an enhanced mean postoperative OKS at both 1 and 2 years. When adjusted for potential confounding, age of 60-69 years, male sex, normal BMI, lower ASA grade, higher Index of Multiple Deprivation and higher pre-operative EQ-5D, EQ-VAS and OKS were identified as factors that resulted in higher post-operative OKS after primary TKR.
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Artroplastia do Joelho , Osteoartrite do Joelho , Artroplastia do Joelho/métodos , Pré-Escolar , Feminino , Humanos , Lactente , Masculino , Osteoartrite do Joelho/diagnóstico , Osteoartrite do Joelho/cirurgia , Medidas de Resultados Relatados pelo Paciente , Qualidade de Vida , Fatores Socioeconômicos , Resultado do TratamentoRESUMO
BACKGROUND: The study objectives were to measure disability prevalence and severity, and examine disability risk factors, among adults living with HIV in London, United Kingdom (UK). METHODS: Self-reported questionnaires were administered: World Health Organization Disability Assessment Schedule 2.0 (WHODAS), HIV Disability Questionnaire (HDQ), Equality Act disability definition (EADD), and demographic questionnaire. We calculated proportion (95% Confidence Interval; CI) of "severe" and "moderate" disability measured using EADD and WHODAS scores ≥2 respectively. We measured disability severity with HDQ domain severity scores. We used demographic questionnaire responses to assess risk factors of "severe" and "moderate" disability using logistic regression analysis, and HDQ severity domain scores using linear regression analysis. RESULTS: Of 201 participants, 176 (87.6%) identified as men, median age 47 years, and 194 (96.5%) virologically suppressed. Severe disability prevalence was 39.5% (n = 79/201), 95% CI [32.5%, 46.4%]. Moderate disability prevalence was 70.5% (n = 141/200), 95% CI [64.2%, 76.8%]. Uncertainty was the most severe HDQ disability domain. Late HIV diagnosis was a risk factor for severe disability [Odds Ratio (OR) 2.71; CI 1.25, 5.87]. Social determinants of health, economic inactivity [OR 2.79; CI 1.08, 7.21] and receiving benefits [OR 2.87; CI 1.05, 7.83], were risk factors for "severe" disability. Economic inactivity [OR 3.14; CI 1.00, 9.98] was a risk factor for "moderate" disability. Economic inactivity, receiving benefits, and having no fixed abode were risk factors (P≤0.05) for higher HDQ severity scores in physical, mental and emotional, difficulty with day-to-day activities, and challenges to social participation domains. Personal factors, identifying as a woman and being aged <50 years, were risk factors (P≤0.05) for higher HDQ severity scores in mental and emotional, uncertainty, and challenges with social participation domains. CONCLUSIONS: People living with well-controlled HIV in London UK experienced multi-dimensional and episodic disability. Results help to better understand the prevalence, severity, and risk factors of disability experienced by adults living with HIV, identify areas to target interventions, and optimise health and functioning.
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Pessoas com Deficiência , Infecções por HIV , Adulto , Estudos Transversais , Avaliação da Deficiência , Feminino , Infecções por HIV/complicações , Infecções por HIV/epidemiologia , Infecções por HIV/psicologia , Humanos , Londres/epidemiologia , Masculino , Pessoa de Meia-Idade , Pacientes Ambulatoriais , Prevalência , Fatores de Risco , Autorrelato , Inquéritos e QuestionáriosRESUMO
OBJECTIVES: To define the mean angle of a series of diaphyseal nonunions based on radiographic analysis. DESIGN: A retrospective cohort study. SETTING: Two level-1 trauma centers. PATIENTS: One hundred twenty patients presenting with nonunion. INTERVENTION: A mean nonunion angle was calculated from a series of AP and lateral X-rays using a standardized technique. The nonunion angle was then estimated in a single plane by considering the greater of the 2 measured angles. Additional data collected included patient age, sex, nonunion site, initial fracture angle, and original fracture pattern. MAIN OUTCOME MEASUREMENT: Single plane nonunion angle. RESULTS: The mean angles of all nonunion in coronal plane was 42 degrees (SD 17 degrees) and 42 degrees in sagittal plane (SD 18 degrees) and 48 degrees (SD 15 degrees) in single plane. The single plane nonunion angle in fractures which were originally multiplanar was steeper to those occurring in originally single plane fractures (P 0.002) although both were close to 45 degrees. There was no significant difference in the nonunion angles on subgroup analysis of cohort location, sex, or anatomic location. CONCLUSIONS: This study demonstrates the mean angle of diaphyseal nonunions from long bones of the lower limb approaches 45 degrees. This is noted in all types of fractures and is irrespective of anatomic location or sex. This confirms the hypothesis that shear is likely to play a role in the development of a nonunion. This study provides further evidence that nonunions occur primarily because of mechanical instability. LEVEL OF EVIDENCE: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.
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Fraturas Ósseas , Fraturas não Consolidadas , Estudos de Coortes , Diáfises/diagnóstico por imagem , Fraturas não Consolidadas/diagnóstico por imagem , Humanos , Radiografia , Estudos Retrospectivos , Resultado do TratamentoRESUMO
AIMS: As the world continues to fight successive waves of COVID-19 variants, we have seen worldwide infections surpass 100 million. London, UK, has been severely affected throughout the pandemic, and the resulting impact on the NHS has been profound. The aim of this study is to evaluate the impact of COVID-19 on theatre productivity across London's four major trauma centres (MTCs), and to assess how the changes to normal protocols and working patterns impacted trauma theatre efficiency. METHODS: This was a collaborative study across London's MTCs. A two-month period was selected from 5 March to 5 May 2020. The same two-month period in 2019 was used to provide baseline data for comparison. Demographic information was collected, as well as surgical speciality, procedure, time to surgery, type of anaesthesia, and various time points throughout the patient journey to theatre. RESULTS: In total, 1,243 theatre visits were analyzed as part of the study. Of these, 834 patients presented in 2019 and 409 in 2020. Fewer open reduction and internal fixations were performed in 2020 (33.5% vs 38.2%), and there was an increase in the number of orthoplastic cases in 2020 (8.3% vs 2.2%), both statistically significant results (p < 0.000). There was a statistically significant increase in median time from 2019 to 2020, between sending for a patient and their arrival to the anaesthetic room (29 vs 35 minutes; p = 0.000). Median time between arrival in the anaesthetic room and commencement of anaesthetic increased (7 to 9 minutes; p = 0.104). CONCLUSION: Changes in working practices necessitated by COVID-19 led to modest delays to all aspects of theatre use, and consequently theatre efficiency. However, the reality is that the major concerns of impact of service did not occur to the levels that were expected. Cite this article: Bone Jt Open 2021;2(10):886-892.
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AIMS: The first death in the UK caused by COVID-19 occurred on 5 March 2020. We aim to describe the clinical characteristics and outcomes of major trauma and orthopaedic patients admitted in the early COVID-19 era. METHODS: A prospective trauma registry was reviewed at a Level 1 Major Trauma Centre. We divided patients into Group A, 40 days prior to 5 March 2020, and into Group B, 40 days after. RESULTS: A total of 657 consecutive trauma and orthopaedic patients were identified with a mean age of 55 years (8 to 98; standard deviation (SD) 22.52) and 393 (59.8%) were males. In all, 344 (approximately 50%) of admissions were major trauma. Group A had 421 patients, decreasing to 236 patients in Group B (36%). Mechanism of injury (MOI) was commonly a fall in 351 (52.4%) patients, but road traffic accidents (RTAs) increased from 56 (13.3%) in group A to 51 (21.6%) in group B (p = 0.030). ICU admissions decreased from 26 (6.2%) in group A to 5 (2.1%) in group B. Overall, 39 patients tested positive for COVID-19 with mean age of 73 years (28 to 98; SD 17.99) and 22 (56.4%) males. Common symptoms were dyspnoea, dry cough, and pyrexia. Of these patients, 27 (69.2%) were nosocomial infections and two (5.1%) of these patients required intensive care unit (ICU) admission with 8/39 mortality (20.5%). Of the patients who died, 50% were older and had underlying comorbidities (hypertension and cardiovascular disease, dementia, arthritis). CONCLUSION: Trauma admissions decreased in the lockdown phase with an increased incidence of RTAs. Nosocomial infection was common in 27 (69.2%) of those with COVID-19. Symptoms and comorbidities were consistent with previous reports with noted inclusion of dementia and arthritis. The mortality rate of trauma and COVID-19 was 20.5%, mainly in octogenarians, and COVID-19 surgical mortality was 15.4%.Cite this article: Bone Joint Open 2020;1-7:330-338.
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BACKGROUND: The aim was to assess the feasibility of conducting a randomised controlled trial (RCT) of induction of labour comparing use of two methods in the outpatient setting. METHODS: An open-label feasibility RCT was conducted in two UK maternity units from October 2017 to March 2019. Women aged ≥ 16 years, undergoing induction of labour (IOL) at term, with intact membranes and deemed suitable for outpatient IOL according to local guidelines were considered eligible. They were randomised to cervical ripening balloon catheter (CRB) or vaginal dinoprostone (Propess). The participants completed a questionnaire and a sub-group underwent detailed interview. Service use and cost data were collected via the Adult Service Use Schedule (AD-SUS). Women who declined to participate were requested to complete a decliners' questionnaire. RESULTS: During the study period, 274 eligible women were identified. Two hundred thirty (83.9%) were approached for participation of whom 84/230 (36.5%) agreed and 146 did not. Of these, 38 were randomised to Propess (n = 20) and CRB (n = 18). Decliner data were collected for 93 women. The reasons for declining were declining IOL (n = 22), preference for inpatient IOL (n = 22) and preference for a specific method, Propess (n = 19). The intended sample size of 120 was not reached due to restrictive criteria for suitability for outpatient IOL, participant preference for Propess and shortage of research staff.The intervention as randomised was received by 29/38 (76%) women. Spontaneous vaginal delivery was observed in 9/20 (45%) women in the dinoprostone group and 11/18 (61%) women in the CRB group. Severe maternal adverse events were recorded in one woman in each group. All babies were born with good condition and all except one (37/38, 97.4%) remained with the mother after delivery. No deaths were recorded. - 21% of women in the dinoprostone group were re-admitted prior to diagnosis of active labour compared to 12% in the CRB group. CONCLUSIONS: A third of the approached eligible women agreed for randomisation. An RCT is not feasible in the current service context. Modifications to the eligibility criteria for outpatient IOL, better information provision and round the clock availability of research staff would be needed to reach sufficient numbers. TRIAL REGISTRATION: NCT03199820. Registered on June 27, 2017.
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Cystic fibrosis (CF) is the one of the most common inherited diseases. It affects around 10,000 people in the UK, and the median survival age is 47. Recent developments making use of longitudinal patient registry data are producing more detailed and relevant information about predicted life expectancy in CF based on current age and clinical measurements. The objective of this study was toconduct an online survey of adults with CF living in the UK using a web-based questionnaire to investigate: (i) if and how they access information on life expectancy; (ii) what they use it for; (iii) if they want more personalised information on life expectancy or the time until other milestones. The survey was advertised through the Cystic Fibrosis Trust using social media. There were 85 respondents, covering men (39%) and women (61%) aged 16-65. 75% had received information on life expectancy either from their CF care team (34%) or other sources (71%), the most common being the Cystic Fibrosis Trust website and research literature. Most people who received information found it to be beneficial and reported using it in a variety of ways, including to plan strategies for maintaining as best health as possible and to psychologically manage current health status. 82% of respondents were interested in more personalised information about their life expectancy, and participants also noted interest in other outcomes, including time to needing transplant or reaching a low level of lung function. Themes arising in text responses included the importance of good communication of information, the difficulty of relating general information to one's own circumstances, and a desire for increased information on factors that impact on survival in CF. As an outcome from this work, research is underway to establish how information on life expectancy can be presented to people with CF in an accessible way.
Assuntos
Fibrose Cística/epidemiologia , Expectativa de Vida , Mídias Sociais , Adolescente , Adulto , Idoso , Fibrose Cística/patologia , Feminino , Humanos , Internet , Masculino , Pessoa de Meia-Idade , Sistema de Registros , Inquéritos e Questionários , Adulto JovemRESUMO
Mitochondrial neurogastrointestinal encephalomyopathy (MNGIE) is an autosomal recessive disorder which primarily affects the gastrointestinal and nervous systems. This disease is caused by mutations in the nuclear TYMP gene, which encodes for thymidine phosphorylase, an enzyme required for the normal metabolism of deoxynucleosides, thymidine, and deoxyuridine. The subsequent elevated systemic concentrations of deoxynucleosides lead to increased intracellular concentrations of their corresponding triphosphates, and ultimately mitochondrial failure due to progressive accumulation of mitochondrial DNA (mtDNA) defects and mtDNA depletion. Currently, there are no treatments for MNGIE where effectiveness has been evidenced in clinical trials. This Phase 2, multi-centre, multiple dose, open label trial without a control will investigate the application of erythrocyte-encapsulated thymidine phosphorylase (EE-TP) as an enzyme replacement therapy for MNGIE. Three EE-TP dose levels are planned with patients receiving the dose level that achieves metabolic correction. The study duration is 31 months, comprising 28 days of screening, 90 days of run-in, 24 months of treatment and 90 days of post-dose follow-up. The primary objectives are to determine the safety, tolerability, pharmacodynamics, and efficacy of multiple doses of EE-TP. The secondary objectives are to assess EE-TP immunogenicity after multiple dose administrations and changes in clinical assessments, and the pharmacodynamics effect of EE-TP on clinical assessments.