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1.
Br J Surg ; 108(3): 315-325, 2021 04 05.
Artigo em Inglês | MEDLINE | ID: mdl-33760065

RESUMO

BACKGROUND: Primary endocrine therapy may be an alternative treatment for less fit women with oestrogen receptor (ER)-positive breast cancer. This study compared quality-of-life (QoL) outcomes in older women treated with surgery or primary endocrine therapy. METHODS: This was a multicentre, prospective, observational cohort study of surgery or primary endocrine therapy in women aged over 70 years with operable breast cancer. QoL was assessed using European Organisation for Research and Treatment of cancer QoL questionnaires QLQ-C30, -BR23, and -ELD14, and the EuroQol Five Dimensions 5L score at baseline, 6 weeks, and 6, 12, 18, and 24 months. Propensity score matching was used to adjust for baseline variation in health, fitness, and tumour stage. RESULTS: The study recruited 3416 women (median age 77 (range 69-102) years) from 56 breast units. Of these, 2979 (87.2 per cent) had ER-positive breast cancer; 2354 women had surgery and 500 received primary endocrine therapy (125 were excluded from analysis due to inadequate data or non-standard therapy). Median follow-up was 52 months. The primary endocrine therapy group was older and less fit. Baseline QoL differed between the groups; the mean(s.d.) QLQ-C30 global health status score was 66.2(21.1) in patients who received primary endocrine therapy versus 77.1(17.8) among those who had surgery plus endocrine therapy. In the unmatched analysis, changes in QoL between 6 weeks and baseline were noted in several domains, but by 24 months most scores had returned to baseline levels. In the matched analysis, major surgery (mastectomy or axillary clearance) had a more pronounced adverse impact than primary endocrine therapy in several domains. CONCLUSION: Adverse effects on QoL are seen in the first few months after surgery, but by 24 months these have largely resolved. Women considering surgery should be informed of these effects.


Assuntos
Antineoplásicos Hormonais/uso terapêutico , Neoplasias da Mama/terapia , Qualidade de Vida , Idoso , Idoso de 80 Anos ou mais , Neoplasias da Mama/metabolismo , Neoplasias da Mama/psicologia , Feminino , Humanos , Estudos Longitudinais , Mastectomia , Estudos Prospectivos , Receptores de Estrogênio/metabolismo
2.
Br J Surg ; 108(5): 499-510, 2021 05 27.
Artigo em Inglês | MEDLINE | ID: mdl-33760077

RESUMO

BACKGROUND: Rates of surgery and adjuvant therapy for breast cancer vary widely between breast units. This may contribute to differences in survival. This cluster RCT evaluated the impact of decision support interventions (DESIs) for older women with breast cancer, to ascertain whether DESIs influenced quality of life, survival, decision quality, and treatment choice. METHODS: A multicentre cluster RCT compared the use of two DESIs against usual care in treatment decision-making in older women (aged at least ≥70 years) with breast cancer. Each DESI comprised an online algorithm, booklet, and brief decision aid to inform choices between surgery plus adjuvant endocrine therapy versus primary endocrine therapy, and adjuvant chemotherapy versus no chemotherapy. The primary outcome was quality of life. Secondary outcomes included decision quality measures, survival, and treatment choice. RESULTS: A total of 46 breast units were randomized (21 intervention, 25 usual care), recruiting 1339 women (670 intervention, 669 usual care). There was no significant difference in global quality of life at 6 months after the baseline assessment on intention-to-treat analysis (difference -0.20, 95 per cent confidence interval (C.I.) -2.69 to 2.29; P = 0.900). In women offered a choice of primary endocrine therapy versus surgery plus endocrine therapy, knowledge about treatments was greater in the intervention arm (94 versus 74 per cent; P = 0.003). Treatment choice was altered, with a primary endocrine therapy rate among women with oestrogen receptor-positive disease of 21.0 per cent in the intervention versus 15.4 per cent in usual-care sites (difference 5.5 (95 per cent C.I. 1.1 to 10.0) per cent; P = 0.029). The chemotherapy rate was 10.3 per cent at intervention versus 14.8 per cent at usual-care sites (difference -4.5 (C.I. -8.0 to 0) per cent; P = 0.013). Survival was similar in both arms. CONCLUSION: The use of DESIs in older women increases knowledge of breast cancer treatment options, facilitates shared decision-making, and alters treatment selection. Trial registration numbers: EudraCT 2015-004220-61 (https://eudract.ema.europa.eu/), ISRCTN46099296 (http://www.controlled-trials.com).


Assuntos
Neoplasias da Mama/terapia , Tomada de Decisões , Técnicas de Apoio para a Decisão , Idoso , Idoso de 80 Anos ou mais , Antineoplásicos Hormonais/uso terapêutico , Neoplasias da Mama/mortalidade , Quimioterapia Adjuvante , Feminino , Conhecimentos, Atitudes e Prática em Saúde , Humanos , Qualidade de Vida
3.
Colorectal Dis ; 23(1): 307-315, 2021 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-32797702

RESUMO

AIM: Atrial fibrillation (AF) is a common cardiac arrhythmia, and is associated with worsening quality of life and complications such as stroke. Previous work showed that 8% of patients develop new-onset AF following colonic resection and highlighted factors that might predict the development of postoperative AF. The development of a new arrhythmia may have a negative effect on longer-term quality of life as well as cancer survivorship. The aim of this study is to accurately quantify the incidence of AF following colorectal cancer surgery and to validate a model to predict its development. METHOD: The Atrial Fibrillation After Resection (AFAR) study will recruit 720 patients aged 65 or over undergoing resection of colorectal cancer with curative intent. The primary outcome is development of AF within 90 days of surgery. Assessment of cardiac rhythm will be performed using 24-h Holter monitors at baseline, 30 and 90 days after surgery. An electrocardiogram (ECG) will be performed on the day of discharge. Baseline descriptors including model variables and quality of life will be recorded using EQ-5D-5L. The occurrence of complications and other key surgical outcomes will be recorded. An additional blood test for N-terminal pro B-type natriuretic peptide (NT-proBNP) will be performed prior to surgery. Statistical analysis will validate a previously derived model and will test the incremental value of added variables such as NT-proBNP. Finally, an exploratory analysis will assess whether changes in ECG measures between baseline and postoperative ECG can predict subsequent new-onset AF. CONCLUSION: This study will provide data that may allow us to stratify the risk of developing AF following colorectal cancer surgery. This may inform screening or prophylactic approaches.


Assuntos
Fibrilação Atrial , Fibrilação Atrial/epidemiologia , Fibrilação Atrial/etiologia , Biomarcadores , Humanos , Incidência , Qualidade de Vida
4.
BJS Open ; 3(3): 354-366, 2019 06.
Artigo em Inglês | MEDLINE | ID: mdl-31183452

RESUMO

Background: Small bowel obstruction is a common surgical emergency, and is associated with high levels of morbidity and mortality across the world. The literature provides little information on the conservatively managed group. The aim of this study was to describe the burden of small bowel obstruction in the UK. Methods: This prospective cohort study was conducted in 131 acute hospitals in the UK between January and April 2017, delivered by trainee research collaboratives. Adult patients with a diagnosis of mechanical small bowel obstruction were included. The primary outcome was in-hospital mortality. Secondary outcomes included complications, unplanned intensive care admission and readmission within 30 days of discharge. Practice measures, including use of radiological investigations, water soluble contrast, operative and nutritional interventions, were collected. Results: Of 2341 patients identified, 693 (29·6 per cent) underwent immediate surgery (within 24 h of admission), 500 (21·4 per cent) had delayed surgery after initial conservative management, and 1148 (49·0 per cent) were managed non-operatively. The mortality rate was 6·6 per cent (6·4 per cent for non-operative management, 6·8 per cent for immediate surgery, 6·8 per cent for delayed surgery; P = 0·911). The major complication rate was 14·4 per cent overall, affecting 19·0 per cent in the immediate surgery, 23·6 per cent in the delayed surgery and 7·7 per cent in the non-operative management groups (P < 0·001). Cox regression found hernia or malignant aetiology and malnutrition to be associated with higher rates of death. Malignant aetiology, operative intervention, acute kidney injury and malnutrition were associated with increased risk of major complication. Conclusion: Small bowel obstruction represents a significant healthcare burden. Patient-level factors such as timing of surgery, acute kidney injury and nutritional status are factors that might be modified to improve outcomes.


Assuntos
Obstrução Intestinal/mortalidade , Obstrução Intestinal/cirurgia , Intestino Delgado/patologia , Doença Aguda , Injúria Renal Aguda/epidemiologia , Idoso , Idoso de 80 Anos ou mais , Tratamento Conservador/normas , Efeitos Psicossociais da Doença , Feminino , Mortalidade Hospitalar , Humanos , Unidades de Terapia Intensiva/estatística & dados numéricos , Obstrução Intestinal/diagnóstico , Obstrução Intestinal/etiologia , Masculino , Desnutrição/mortalidade , Pessoa de Meia-Idade , Morbidade , Mortalidade/tendências , Readmissão do Paciente/estatística & dados numéricos , Complicações Pós-Operatórias/epidemiologia , Estudos Prospectivos , Fatores de Tempo , Reino Unido/epidemiologia
5.
Clin Radiol ; 74(7): 527-533, 2019 07.
Artigo em Inglês | MEDLINE | ID: mdl-30987757

RESUMO

AIM: To estimate the rate of unexpected brain abnormalities detected by in utero magnetic resonance imaging (iuMRI) in fetuses without abnormalities at ultrasonography (USS). MATERIALS AND METHODS: A prospective cohort study of pregnant women whose fetus had no structural brain (or body) abnormalities recognised on antenatal ultrasonography. Women were recruited from 12 centres across the UK and underwent iuMRI at 18 gestational weeks or more in the [blinded for review]. The imaging studies were reviewed by an experienced neuroradiologist. The positive and negative predictive values of both USS and iuMRI have been calculated by combining the results of this study with the results from the main [blinded for review] study. RESULTS: One hundred and ninety-eight pregnant women were recruited and underwent iuMRI of 205 fetuses. Brain abnormalities were shown on iuMRI in two fetuses that were not recognised on USS (one case of a focal cortical abnormality and one case of mild ventriculomegaly). The negative predictive value for USS was 99.5% and 100% for iuMRI. CONCLUSIONS: To the authors' knowledge, this is the first study comparing USS and iuMRI in low-risk pregnancies. USS has a comparatively high rule-out for fetal brain abnormalities and should remain the screening tool of choice.


Assuntos
Encefalopatias/diagnóstico por imagem , Encefalopatias/embriologia , Imageamento por Ressonância Magnética/métodos , Ultrassonografia Pré-Natal/métodos , Adulto , Encéfalo/diagnóstico por imagem , Encéfalo/embriologia , Estudos de Coortes , Feminino , Humanos , Gravidez , Diagnóstico Pré-Natal/métodos , Estudos Prospectivos , Reprodutibilidade dos Testes
6.
Osteoporos Int ; 29(6): 1407-1417, 2018 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-29525970

RESUMO

The antiresorptive potency varies between different bisphosphonates. We investigated the effect of stopping oral bisphosphonate treatment for postmenopausal osteoporosis (ibandronate, alendronate, risedronate) on BTMs and BMD. After stopping treatment, all three groups showed an increase in BTMs and a decrease in hip BMD; however, none returned to pre-treatment baseline values. INTRODUCTION: Bisphosphonates (BPs) continue to suppress bone turnover markers (BTMs) after treatment has stopped, leading to the suggestion that a pause in treatment could be considered for low-risk patients. Indirect comparisons suggest that after cessation of treatment, the effects on bone may differ between drugs. We investigated the effects of stopping oral BP treatments for postmenopausal osteoporosis on BTMs and bone mineral density (BMD). METHODS: We studied postmenopausal osteoporotic women who had previously taken part in a 2-year randomised study of three oral BPs (ibandronate, alendronate, or risedronate). At the end of the study, women with hip BMD T-score > - 2.5 and considered clinically appropriate to discontinue treatment were invited to participate in a further 2-year observational study. Biochemical response was assessed using BTMs, and BMD was measured by dual-energy X-ray absorptiometry. RESULTS: All BTMs increased after treatment withdrawal but remained below the pre-treatment baseline with less suppression of BTMs for the risedronate group compared to alendronate and ibandronate up to 48 weeks. There was no difference between the BP groups 96 weeks after stopping treatment. The change in BMD during the 96 weeks after stopping treatment was - 1.6% (95% CI - 1.9 to - 1.2, P < 0.001) for the total hip and - 0.6% (95% CI - 1.1 to - 0.2, P = 0.17) at the lumbar spine with no difference between the three BP groups (P = 0.85 and P = 0.48, respectively). CONCLUSION: For all treatment groups, there was an increase in BTMs and a decrease in hip BMD after stopping BPs for 2 years; however, none returned to pre-treatment baseline values.


Assuntos
Conservadores da Densidade Óssea/administração & dosagem , Densidade Óssea/efeitos dos fármacos , Remodelação Óssea/efeitos dos fármacos , Difosfonatos/administração & dosagem , Osteoporose Pós-Menopausa/tratamento farmacológico , Absorciometria de Fóton , Administração Oral , Adulto , Idoso , Idoso de 80 Anos ou mais , Alendronato/administração & dosagem , Alendronato/farmacologia , Alendronato/uso terapêutico , Biomarcadores/sangue , Conservadores da Densidade Óssea/farmacologia , Conservadores da Densidade Óssea/uso terapêutico , Difosfonatos/farmacologia , Difosfonatos/uso terapêutico , Esquema de Medicação , Feminino , Articulação do Quadril/fisiopatologia , Humanos , Ácido Ibandrônico/administração & dosagem , Ácido Ibandrônico/farmacologia , Ácido Ibandrônico/uso terapêutico , Vértebras Lombares/fisiopatologia , Pessoa de Meia-Idade , Osteoporose Pós-Menopausa/fisiopatologia , Ácido Risedrônico/administração & dosagem , Ácido Risedrônico/farmacologia , Ácido Risedrônico/uso terapêutico , Suspensão de Tratamento
7.
Clin Radiol ; 73(2): 123-134, 2018 02.
Artigo em Inglês | MEDLINE | ID: mdl-29046228

RESUMO

There are a number of reasons why a pregnant woman might be considered to have an increased risk of carrying a fetus with a brain abnormality, but they fall broadly into two groups. First, there may be a relevant family history usually, but not always, when a fetus/child from a previous pregnancy has a developmental brain abnormality and a clinical geneticist judges that there is a risk of recurrence. Second, there may be findings in their current pregnancy that increases the risk of the fetus either having a developmental brain abnormality or accruing acquired brain pathology. Antenatal ultrasonography remains the mainstay of fetal screening and anomaly scanning, but there is now persuasive evidence that in utero magnetic resonance imaging should have an important supporting role. This is important, as more accurate and more certain diagnoses are central to providing parents with accurate information about the likely clinical outcome. In pregnancies at increased risk of brain abnormalities, it is also important to provide the best quality information that the fetal brain is normal to provide reassurance to parents. In this paper, we review the proposition that in utero magnetic resonance imaging should be used in pregnancies at increased risk of brain abnormalities, even if the consultant-led ultrasound examination is normal or showed non-specific findings only.


Assuntos
Encefalopatias/diagnóstico por imagem , Encéfalo/anormalidades , Encéfalo/patologia , Imageamento por Ressonância Magnética/métodos , Diagnóstico Pré-Natal/métodos , Encéfalo/diagnóstico por imagem , Encefalopatias/patologia , Feminino , Humanos , Gravidez
8.
Ultrasound Obstet Gynecol ; 50(6): 745-752, 2017 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-28397323

RESUMO

OBJECTIVE: To assess the diagnostic and clinical contribution of fetal magnetic resonance imaging (MRI) in fetuses of the MERIDIAN cohort diagnosed with abnormalities of the posterior fossa as the only intracranial abnormality recognized on antenatal ultrasound. METHODS: This was a subgroup analysis of the MERIDIAN study of fetuses with abnormalities of the posterior fossa (with or without ventriculomegaly) diagnosed on antenatal ultrasound in women who had MRI within 2 weeks of ultrasound and for whom outcome reference data were available. The diagnostic accuracy of ultrasound and MRI is reported, as well as indicators of diagnostic confidence and effects on prognosis and clinical management. Appropriate diagnostic confidence was assessed by the score-based weighted average method, which combines diagnostic accuracy with diagnostic confidence data. RESULTS: Abnormalities confined to the posterior fossa according to ultrasound were found in 81 fetuses (67 with parenchymal and 14 with cerebrospinal fluid-containing lesions). The overall diagnostic accuracy for detecting an isolated posterior fossa abnormality was 65.4% for ultrasound and 87.7% for MRI (difference, 22.3% (95% CI, 14.0-30.5%); P < 0.0001). There was an improvement in 'appropriate' diagnostic confidence, as assessed by the score-based weighted average method (P < 0.0001), and a three-fold reduction in 'high confidence but incorrect diagnosis' was achieved using MRI. Prognostic information given to the women changed after MRI in 44% of cases, and the overall effect of MRI on clinical management was considered to be 'significant', 'major' or 'decisive' in 35% of cases. CONCLUSIONS: Our data suggest that any woman whose fetus has a posterior fossa abnormality as the only intracranial finding on ultrasound should have MRI for further evaluation. This is on the basis of improved diagnostic accuracy and confidence, which impacts substantially on the prognostic information given to women as well as their clinical management. Copyright © 2017 ISUOG. Published by John Wiley & Sons Ltd.


Assuntos
Fossa Craniana Posterior/anormalidades , Hidrocefalia/diagnóstico , Malformações do Sistema Nervoso/diagnóstico por imagem , Ultrassonografia Pré-Natal , Adulto , Fossa Craniana Posterior/anatomia & histologia , Fossa Craniana Posterior/diagnóstico por imagem , Feminino , Idade Gestacional , Humanos , Hidrocefalia/patologia , Imageamento por Ressonância Magnética , Malformações do Sistema Nervoso/patologia , Gravidez , Prognóstico , Estudos Prospectivos , Reprodutibilidade dos Testes
9.
Ultrasound Obstet Gynecol ; 50(6): 753-760, 2017 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-28436562

RESUMO

OBJECTIVE: To assess the contribution of fetal magnetic resonance imaging (MRI) in fetuses of the MERIDIAN cohort diagnosed with either agenesis or hypogenesis of the corpus callosum (referred to collectively as failed commissuration) on antenatal ultrasound. METHODS: This was a subgroup analysis of the MERIDIAN study of fetuses with failed commissuration (with or without ventriculomegaly) diagnosed on ultrasound in women who had MRI assessment within 2 weeks of ultrasound and for whom outcome reference data were available. The diagnostic accuracy of ultrasound and MRI was studied, as well as indicators of diagnostic confidence and effects on prognosis/clinical management. Appropriate diagnostic confidence was assessed by the score-based weighted average method, which combines diagnostic accuracy with diagnostic confidence data. RESULTS: In the MERIDIAN cohort, 79 fetuses were diagnosed with failed commissuration on ultrasound (55 with agenesis and 24 with hypogenesis of the corpus callosum). The diagnostic accuracy for detecting failed commissuration was 34.2% for ultrasound and 94.9% for MRI (difference, 60.7% (95% CI, 47.6-73.9%), P < 0.0001). The diagnostic accuracy for detecting hypogenesis of the corpus callosum as a discrete entity was 8.3% for ultrasound and 87.5% for MRI, and for detecting agenesis of the corpus callosum as a distinct entity was 40.0% for ultrasound and 92.7% for MRI. There was a statistically significant improvement in 'appropriate' diagnostic confidence when using MRI as assessed by the score-based weighted average method (P < 0.0001). Prognostic information given to the women changed in 36/79 (45.6%) cases after MRI and its overall effect on clinical management was 'significant', 'major' or 'decisive' in 35/79 cases (44.3%). CONCLUSIONS: Our data suggest that any woman whose fetus has failed commissuration as the only intracranial finding detected on ultrasound should have MRI examination for further evaluation. Copyright © 2017 ISUOG. Published by John Wiley & Sons Ltd.


Assuntos
Agenesia do Corpo Caloso/diagnóstico por imagem , Corpo Caloso/diagnóstico por imagem , Imageamento por Ressonância Magnética , Ultrassonografia Pré-Natal , Adulto , Agenesia do Corpo Caloso/patologia , Corpo Caloso/anatomia & histologia , Feminino , Idade Gestacional , Humanos , Aumento da Imagem , Gravidez , Prognóstico , Estudos Prospectivos
10.
Ultrasound Obstet Gynecol ; 50(6): 736-744, 2017 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-28337830

RESUMO

OBJECTIVE: To assess the contribution of fetal magnetic resonance imaging (MRI) in fetuses of the MERIDIAN cohort diagnosed with ventriculomegaly (VM) as the only abnormal intracranial finding on antenatal ultrasound. METHODS: This was a subgroup analysis of the MERIDIAN study of fetuses with only VM diagnosed on ultrasound in women who had a subsequent MRI examination within 2 weeks and for whom outcome reference data were available. The diagnostic accuracy of ultrasound and MRI was reported in relation to the severity of VM. The difference in measurements of trigone size on the two imaging methods and the clinical impact of adding MRI to the diagnostic pathway were also studied. RESULTS: In 306 fetuses with VM, ultrasound failed to detect 31 additional brain abnormalities, having an overall diagnostic accuracy of 89.9% for ultrasound, whilst MRI correctly detected 27 of the additional brain abnormalities, having a diagnostic accuracy of 98.7% (P < 0.0001). There were other brain abnormalities in 14/244 fetuses with mild VM on ultrasound (diagnostic accuracy, 94.3%) and MRI correctly diagnosed 12 of these (diagnostic accuracy, 99.2%; P = 0.0005). There was a close agreement between the size of trigones measured on ultrasound and on MRI, with categorical differences in only 16% of cases, showing that MRI did not systematically overestimate or underestimate trigone size. Complete prognostic data were available in 295/306 fetuses and the prognosis category changed after MRI in 69/295 (23.4%) cases. The overall effect of MRI on clinical management was considered to be 'significant', 'major' or 'decisive' in 76/295 (25.8%) cases. CONCLUSION: Our data suggest that a woman carrying a fetus with VM as the only intracranial finding on ultrasound should be offered an adjuvant investigation by MRI for further evaluation. Copyright © 2017 ISUOG. Published by John Wiley & Sons Ltd.


Assuntos
Ventrículos Cerebrais/anormalidades , Hidrocefalia/diagnóstico por imagem , Imageamento por Ressonância Magnética , Ultrassonografia Pré-Natal , Adulto , Ventrículos Cerebrais/anatomia & histologia , Ventrículos Cerebrais/patologia , Feminino , Humanos , Hidrocefalia/patologia , Aumento da Imagem , Gravidez , Estudos Prospectivos , Reprodutibilidade dos Testes , Sensibilidade e Especificidade , Índice de Gravidade de Doença , Reino Unido
11.
Clin Radiol ; 72(6): 451-457, 2017 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-28238368

RESUMO

AIM: To measure possible change in diagnostic confidence by performing in utero magnetic resonance imaging (iuMRI) studies on fetuses with brain abnormalities recognised on ultrasonography (US). MATERIALS AND METHODS: The analyses are based on the primary cohort from the prospective MERIDIAN study, which consisted of 570 fetuses with brain abnormalities detected on US, with iuMRI performed within 2 weeks of US and complete outcome reference data. The cohort was recruited between July 2011 and August 2014, and written informed consent was obtained for all participants. They all had indicators of diagnostic confidence measured on US by fetal medicine experts and iuMRI by the reporting radiologists. Three assessments were carried out using the conventional uncorrected (C2-C1%) method, the conventional (C2-C1%) with the Omary correction, and the score-based weighted average method. RESULTS: All three assessments showed statistically significant (p<0·0001) positive effects indicating that iuMRI was potentially beneficial when included in the diagnostic pathway for prenatal structural brain anomalies (in terms of diagnostic confidence). CONCLUSION: These results strongly support the routine clinical use of iuMRI as an adjunct to US when assessing fetuses with structural brain abnormalities.


Assuntos
Encéfalo/anormalidades , Encéfalo/diagnóstico por imagem , Feto/anormalidades , Feto/diagnóstico por imagem , Imageamento por Ressonância Magnética , Diagnóstico Pré-Natal , Intervalos de Confiança , Feminino , Humanos , Gravidez , Diagnóstico Pré-Natal/métodos , Diagnóstico Pré-Natal/estatística & dados numéricos , Estudos Prospectivos
12.
Int J Surg ; 36 Suppl 1: S24-S30, 2016 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-27565245

RESUMO

BACKGROUND: Surgical trainees are expected to demonstrate academic achievement in order to obtain their certificate of completion of training (CCT). These standards are set by the Joint Committee on Surgical Training (JCST) and specialty advisory committees (SAC). The standards are not equivalent across all surgical specialties and recognise different achievements as evidence. They do not recognise changes in models of research and focus on outcomes rather than process. The Association of Surgeons in Training (ASiT) and National Research Collaborative (NRC) set out to develop progressive, consistent and flexible evidence set for academic requirements at CCT. METHODS: A modified-Delphi approach was used. An expert group consisting of representatives from the ASiT and the NRC undertook iterative review of a document proposing changes to requirements. This was circulated amongst wider stakeholders. After ten iterations, an open meeting was held to discuss these proposals. Voting on statements was performed using a 5-point Likert Scale. Each statement was voted on twice, with ≥80% of votes in agreement meaning the statement was approved. The results of this vote were used to propose core and optional academic requirements for CCT. RESULTS: Online discussion concluded after ten rounds. At the consensus meeting, statements were voted on by 25 delegates from across surgical specialties and training-grades. The group strongly favoured acquisition of 'Good Clinical Practice' training and research methodology training as CCT requirements. The group agreed that higher degrees, publications in any author position (including collaborative authorship), recruiting patients to a study or multicentre audit and presentation at a national or international meeting could be used as evidence for the purpose of CCT. The group agreed on two essential 'core' requirements (GCP and methodology training) and two of a menu of four 'additional' requirements (publication with any authorship position, presentation, recruitment of patients to a multicentre study and completion of a higher degree), which should be completed in order to attain CCT. CONCLUSION: This approach has engaged stakeholders to produce a progressive set of academic requirements for CCT, which are applicable across surgical specialties. Flexibility in requirements whilst retaining a high standard of evidence is desirable.


Assuntos
Certificação/normas , Educação de Pós-Graduação em Medicina/normas , Especialidades Cirúrgicas/educação , Instituições de Caridade , Técnica Delfos , Humanos , Irlanda , Sociedades Médicas , Reino Unido
13.
Eur J Neurol ; 23(6): 1071-8, 2016 06.
Artigo em Inglês | MEDLINE | ID: mdl-27029589

RESUMO

BACKGROUND AND PURPOSE: Amyotrophic lateral sclerosis (ALS) is a fatal neurodegenerative condition for which there is no single diagnostic test or biomarker. The level of the creatine kinase (CK) enzyme in serum may be mild to moderately elevated in some patients with ALS, the precise cause of which and its behaviour with disease progression is unknown. The aim of this study was to examine the usefulness of monitoring CK serially during the ALS disease trajectory and to determine whether CK levels mirror disease progression. METHODS: This was a prospective observational cohort study, using the clinical database of the olesoxime (TRO19622) investigational medicinal product trial. RESULTS: The baseline CK was raised in 52% of the trial participants with the mean CK ± SD being 257 ± 239 U/l. The mean CK was significantly higher in male participants than in female participants (P < 0.001) and amongst participants with limb onset ALS compared to participants with bulbar onset ALS (P < 0.001). There was no significant difference in the CK levels between upper limb and lower limb onset disease (P = 0.746). The CK level co-related positively with serum creatinine and estimated lean body mass but there was no relationship between CK and muscle scores and limb function. A higher CKlog was associated with significantly better survival, even when adjusted for prognostic co-variants (P = 0.013). CONCLUSIONS: The serum CK level seems to be an independent prognostic factor for survival in ALS. The cellular mechanism of CK enzyme suggests that it may be upregulated to provide energy in the face of metabolic stress in ALS.


Assuntos
Esclerose Amiotrófica Lateral/sangue , Índice de Massa Corporal , Creatina Quinase/sangue , Creatinina/sangue , Biomarcadores/sangue , Progressão da Doença , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Prognóstico , Estudos Prospectivos
14.
Tech Coloproctol ; 19(7): 411-7, 2015 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-26081430

RESUMO

BACKGROUND: The use of biological materials for the repair of complex abdominal wall defects has increased over the years; however, the role of these materials in routine practice remains unclear. The aim of the study was to evaluate clinical outcomes following the use of Permacol™ porcine collagen surgical implant in complex abdominal wall repair. METHODS: This subset analysis of seven European sites from a multicentre retrospective study included patients undergoing open or laparoscopic surgery and treated with Permacol™ surgical implant. Inguinal, parastomal, diaphragmatic, perineal, and hiatal repairs were excluded. Only patients with at least 12 months of follow-up after surgery were included. RESULTS: A total of 109 patients (56 males and 53 females) were included. Patients had a median of two comorbidities (range 0-6). Thirty-three per cent of patients were treated for recurrent hernia. All but one case used an open approach. Sixty-six per cent were Center for Disease Control wound class II-IV at the time of surgery. Fascial closure was achieved in 69%. Median follow-up length was 720 days (range 368-2857). Recurrence rates at 1 and 2 years were 9.2 and 18.3 %, respectively, and were higher in cases without fascial closure. One-year recurrence was higher following use of an onlay technique (P = 0.025). In a multivariate analysis, among 16 comorbidities examined only fascial closure significantly impacted 1-year recurrence (P = 0.049). CONCLUSIONS: Data from this large retrospective multicentre European study strongly suggest the use of Permacol™ porcine collagen surgical implant to be safe and effective for complex abdominal wall repair. The recurrence rate was impacted by fascial closure.


Assuntos
Parede Abdominal/cirurgia , Materiais Biocompatíveis/uso terapêutico , Colágeno/uso terapêutico , Hérnia Ventral/cirurgia , Herniorrafia/instrumentação , Adulto , Idoso , Idoso de 80 Anos ou mais , Europa (Continente) , Fáscia/patologia , Feminino , Hérnia Ventral/classificação , Herniorrafia/efeitos adversos , Herniorrafia/métodos , Humanos , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Complicações Pós-Operatórias/etiologia , Recidiva , Estudos Retrospectivos , Resultado do Tratamento
15.
Clin Radiol ; 70(3): 248-53, 2015 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-25498575

RESUMO

AIM: To estimate the diagnostic performance of ultrasound in detecting agenesis of the corpus callosum (ACC). MATERIALS AND METHODS: A retrospective review was performed of 1722 in utero MRI examinations. All cases were identified in which the fetus had been referred from ultrasonography with a diagnosis of ACC and those in which ACC was given as a diagnosis on the in utero MRI study. The MRI was assumed to provide the correct diagnosis of ACC and descriptive statistics of diagnostic accuracy for ultrasound were calculated. RESULTS: Of the 1722 ultrasound examinations performed, 121 had a diagnosis of ACC and approximately 50% were confirmed at MRI. Forty-two fetuses with ACC not suspected at ultrasonography were also identified at MRI. Ultrasonography had a positive predictive value of 47% (95% CI: 38-56%) and a negative predictive value of 97% (95% CI: 96-98%) for detecting ACC. CONCLUSION: Ultrasound is poor in diagnosing ACC and in utero MRI should be performed if there is any suspicion on antenatal ultrasonography.


Assuntos
Agenesia do Corpo Caloso/diagnóstico por imagem , Ultrassonografia Pré-Natal/métodos , Corpo Caloso/diagnóstico por imagem , Corpo Caloso/embriologia , Corpo Caloso/patologia , Diagnóstico Diferencial , Feminino , Humanos , Imageamento por Ressonância Magnética/métodos , Imageamento por Ressonância Magnética/normas , Imageamento por Ressonância Magnética/estatística & dados numéricos , Valor Preditivo dos Testes , Gravidez , Reprodutibilidade dos Testes , Estudos Retrospectivos , Ultrassonografia Pré-Natal/normas , Ultrassonografia Pré-Natal/estatística & dados numéricos
16.
Osteoporos Int ; 23(12): 2815-28, 2012 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-22349910

RESUMO

UNLABELLED: Quantitative ultrasound (QUS) measurement variables vary between European countries in a different way to hip bone mineral density. Standardization of data can be achieved through statistical approaches to reduce any between-center differences in QUS measurement variables. However, further validation of this method is required before it can be widely applied. INTRODUCTION: European between-center differences in hip bone mineral density (BMD) have been shown to exist; however, little is known about the geographical heterogeneity of QUS measurement variables. We aimed to examine the differences in QUS variables between three different European countries. METHODS: Five calcaneal and phalangeal QUS devices in Sheffield, Aberdeen (UK), Kiel and Berlin (Germany), and three devices in Paris (France) were used to measure QUS variables in younger (n = 463, 20-39 years old) and older (n = 2,399, 55-79 years old) women participating in the European multicenter Osteoporosis and Ultrasound (OPUS) study. Broadband ultrasound attenuation, speed of sound, stiffness index, amplitude-dependent speed of sound, bone transmission time, and ultrasonic bone profiler index data were collected. Between-center differences were examined using ANOVA followed by post hoc Fisher's least significant difference tests, and ANCOVA with linear contrasts. p < 0.05 indicated statistical significance. RESULTS: Between-center differences in nonstandardized QUS measurement variables existed for younger (p = 0.0023 to p < 0.0001) and older women (p < 0.001). Anthropometric characteristics exerted a significant influence on nonstandardized data (p = 0.045 to p < 0.001). However, following statistical standardization, based on height and weight or based on measurements made in young people, geographical heterogeneity in QUS measurement variables was no longer apparent. CONCLUSIONS: QUS measurement variables vary between European countries in a different way to those for hip BMD. Standardization of data can be achieved through statistical approaches to reduce any between-center differences in QUS measurement variables. However, further validation of this method is required before it can be widely applied.


Assuntos
Densidade Óssea/fisiologia , Calcâneo/diagnóstico por imagem , Falanges dos Dedos da Mão/diagnóstico por imagem , Osteoporose/diagnóstico por imagem , Absorciometria de Fóton/normas , Adulto , Distribuição por Idade , Idoso , Antropometria , Calcâneo/fisiologia , Europa (Continente)/epidemiologia , Feminino , Colo do Fêmur/fisiologia , Falanges dos Dedos da Mão/fisiologia , Articulação do Quadril/fisiologia , Humanos , Pessoa de Meia-Idade , Osteoporose/epidemiologia , Osteoporose Pós-Menopausa/diagnóstico por imagem , Osteoporose Pós-Menopausa/epidemiologia , Valores de Referência , Reprodutibilidade dos Testes , Ultrassonografia , Adulto Jovem
17.
Health Technol Assess ; 15(23): iii-xi, 1-102, 2011 May.
Artigo em Inglês | MEDLINE | ID: mdl-21616014

RESUMO

OBJECTIVES: To evaluate the clinical effectiveness and cost-effectiveness of using a point-of-care cardiac marker panel in patients presenting to the emergency department (ED) with suspected but not proven acute myocardial infarction (AMI). DESIGN: Multicentre pragmatic open randomised controlled trial and economic evaluation. SETTING: Six acute hospital EDs in the UK. PARTICIPANTS: Adults presenting to hospital with chest pain due to suspected but not proven myocardial infarction, and no other potentially serious alternative pathology or comorbidity. INTERVENTIONS: Participants were allocated using an online randomisation system to receive either (1) diagnostic assessment using the point-of-care biochemical marker panel or (2) conventional diagnostic assessment without the panel. All tests and treatments other than the panel were provided at the discretion of the clinician. MAIN OUTCOME MEASURES: The primary outcome was the proportion of patients successfully discharged home after ED assessment, defined as patients who had (1) either left the hospital or were awaiting transport home with a discharge decision having been made at 4 hours after initial presentation and (2) suffered no major adverse event (as defined below) during the following 3 months. Secondary outcomes included length of initial hospital stay and total inpatient days over 3 months, and major adverse events (death, non-fatal AMI, life-threatening arrhythmia, emergency revascularisation or hospitalisation for myocardial ischaemia). Economic analysis estimated mean costs and quality-adjusted life-years (QALYs), and then estimated the probability of cost-effectiveness assuming willingness to pay of £20,000 per QALY gained. RESULTS: We randomised 1132 participants to point of care and 1131 to standard care, and analysed 1125 and 1118, respectively [mean age 54.5 years, 1307/2243 (58%) male and 269/2243 (12%) with known coronary heart disease (CHD)]. In the point-of-care group 358/1125 (32%) were successfully discharged compared with 146/1118 (13%) in the standard-care group [odds ratio (OR) adjusted for age, gender and history of CHD 3.81; 95% confidence interval (CI) 3.01 to 4.82, p < 0.001]. Mean length of the initial hospital stay was 29.6 hours versus 31.8 hours (mean difference = 2.1 hours; 95% CI -3.7 to 8.0 hours, p = 0.462), while median length of initial hospital stay was 8.8 hours versus 14.2 hours (p < 0.001). More patients in the point-of-care group had no inpatient days recorded during follow-up (54% vs 40%, p < 0.001), but mean inpatient days did not differ between the two groups (1.8 vs 1.7, p = 0.815). More patients in the point-of-care group were managed on coronary care [50/1125 (4%) vs 31/1118 (3%), p = 0.041]. There were 36 (3%) patients with major adverse events in the point-of-care group and 26 (2%) in the standard-care group (adjusted OR 1.31; 95% CI 0.78 to 2.20, p = 0.313). Mean costs per patient were £1217 with point-of-care versus £1006 with standard care (p = 0.056), while mean QALYs were 0.158 versus 0.161 (p = 0.250). The probability of standard care being dominant (i.e. cheaper and more effective) was 0.888. CONCLUSIONS: Point-of-care testing increases the proportion of patients successfully discharged home and reduces the median (but not mean) length of hospital stay. It is more expensive than standard care and unlikely to be considered cost-effective. TRIAL REGISTRATION: Current Controlled Trials ISRCTN37823923. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 15, No. 23. See the HTA programme website for further project information.


Assuntos
Creatina Quinase Forma MB/sangue , Infarto do Miocárdio/sangue , Infarto do Miocárdio/diagnóstico , Mioglobina/sangue , Troponina/sangue , Adulto , Idoso , Biomarcadores , Análise Custo-Benefício , Serviço Hospitalar de Emergência/economia , Serviço Hospitalar de Emergência/estatística & dados numéricos , Feminino , Nível de Saúde , Humanos , Tempo de Internação/economia , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/terapia , Satisfação do Paciente , Sistemas Automatizados de Assistência Junto ao Leito/economia , Sistemas Automatizados de Assistência Junto ao Leito/estatística & dados numéricos , Anos de Vida Ajustados por Qualidade de Vida , Fatores de Risco , Sensibilidade e Especificidade
18.
Osteoporos Int ; 22(10): 2721-31, 2011 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-21170641

RESUMO

UNLABELLED: Premenopausal women with low calcium intakes consumed calcium-fortified ice cream daily for 28 days. Bone markers, NTX, CTX and PTH decreased significantly by 7 days, with some evidence of a calcium dose-dependent effect. Bone marker responses were observed within 1 h of consuming ice cream. Body weight remained constant over 28 days. INTRODUCTION: Dietary calcium is important for lifelong bone health. Milk is a good source of bioavailable calcium, but consumption has declined among young adults. The aims were to determine whether calcium-fortified ice cream, a palatable source of calcium, produces significant, sustainable changes in bone turnover markers and parathyroid hormone (PTH) in premenopausal women with calcium intake below recommended UK levels. METHODS: Eighty women, ages 20-39 years (calcium intake <750 mg/day) were randomised to consume lower saturated fat/sugar ice cream containing 96, 244, 459 or 676 mg calcium daily for 28 days. Urinary NTX/Cr, serum CTX, PINP, 1,25D and PTH were measured (baseline, days 1, 7 and 28). Acute changes in CTX and PTH were measured over 5 h (n = 29 women). RESULTS: There were significant mean decreases by 7 days in NTX/Cr, CTX, PTH and 1,25D and increases in PINP (one sample t tests), with a significant dose-dependent effect on CTX analysis of covariance. Only CTX remained suppressed at 28 days. Serum CTX and PTH decreased within 1 h. Body weight did not change significantly between baseline and 28 days. CONCLUSIONS: Daily consumption of calcium-fortified ice cream by premenopausal women may significantly reduce levels of the bone resorption marker serum CTX, without stimulating weight gain. The ice cream could be incorporated into the diet to replace low-calcium snacks and thus help individuals with habitually low calcium intakes to meet recommended intakes. The 244 mg calcium preparation would provide more than a quarter of the UK daily recommended nutrient intake for premenopausal women.


Assuntos
Remodelação Óssea/efeitos dos fármacos , Cálcio na Dieta/farmacologia , Alimentos Fortificados , Sorvetes , Adulto , Cálcio na Dieta/administração & dosagem , Colágeno Tipo I/metabolismo , Método Duplo-Cego , Feminino , Humanos , Hormônio Paratireóideo/sangue , Peptídeos/metabolismo , Adulto Jovem
19.
Health Technol Assess ; 9(26): 1-134, iii-iv, 2005 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-16014203

RESUMO

OBJECTIVES: To survey the frequency of use of indirect comparisons in systematic reviews and evaluate the methods used in their analysis and interpretation. Also to identify alternative statistical approaches for the analysis of indirect comparisons, to assess the properties of different statistical methods used for performing indirect comparisons and to compare direct and indirect estimates of the same effects within reviews. DATA SOURCES: Electronic databases. REVIEW METHODS: The Database of Abstracts of Reviews of Effects (DARE) was searched for systematic reviews involving meta-analysis of randomised controlled trials (RCTs) that reported both direct and indirect comparisons, or indirect comparisons alone. A systematic review of MEDLINE and other databases was carried out to identify published methods for analysing indirect comparisons. Study designs were created using data from the International Stroke Trial. Random samples of patients receiving aspirin, heparin or placebo in 16 centres were used to create meta-analyses, with half of the trials comparing aspirin and placebo and half heparin and placebo. Methods for indirect comparisons were used to estimate the contrast between aspirin and heparin. The whole process was repeated 1000 times and the results were compared with direct comparisons and also theoretical results. Further detailed case studies comparing the results from both direct and indirect comparisons of the same effects were undertaken. RESULTS: Of the reviews identified through DARE, 31/327 (9.5%) included indirect comparisons. A further five reviews including indirect comparisons were identified through electronic searching. Few reviews carried out a formal analysis and some based analysis on the naive addition of data from the treatment arms of interest. Few methodological papers were identified. Some valid approaches for aggregate data that could be applied using standard software were found: the adjusted indirect comparison, meta-regression and, for binary data only, multiple logistic regression (fixed effect models only). Simulation studies showed that the naive method is liable to bias and also produces over-precise answers. Several methods provide correct answers if strong but unverifiable assumptions are fulfilled. Four times as many similarly sized trials are needed for the indirect approach to have the same power as directly randomised comparisons. Detailed case studies comparing direct and indirect comparisons of the same effect show considerable statistical discrepancies, but the direction of such discrepancy is unpredictable. CONCLUSIONS: Direct evidence from good-quality RCTs should be used wherever possible. Without this evidence, it may be necessary to look for indirect comparisons from RCTs. However, the results may be susceptible to bias. When making indirect comparisons within a systematic review, an adjusted indirect comparison method should ideally be used employing the random effects model. If both direct and indirect comparisons are possible within a review, it is recommended that these be done separately before considering whether to pool data. There is a need to evaluate methods for the analysis of indirect comparisons for continuous data and for empirical research into how different methods of indirect comparison perform in cases where there is a large treatment effect. Further study is needed into when it is appropriate to look at indirect comparisons and when to combine both direct and indirect comparisons. Research into how evidence from indirect comparisons compares to that from non-randomised studies may also be warranted. Investigations using individual patient data from a meta-analysis of several RCTs using different protocols and an evaluation of the impact of choosing different binary effect measures for the inverse variance method would also be useful.


Assuntos
Pesquisa Biomédica/métodos , Metanálise como Assunto , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Literatura de Revisão como Assunto , Viés , Humanos , Projetos de Pesquisa , Resultado do Tratamento
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