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1.
J Am Coll Radiol ; 16(11): 1516-1521, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31585696

RESUMO

This is a condensed summary of an international multisociety statement on ethics of artificial intelligence (AI) in radiology produced by the ACR, European Society of Radiology, RSNA, Society for Imaging Informatics in Medicine, European Society of Medical Imaging Informatics, Canadian Association of Radiologists, and American Association of Physicists in Medicine. AI has great potential to increase efficiency and accuracy throughout radiology, but it also carries inherent pitfalls and biases. Widespread use of AI-based intelligent and autonomous systems in radiology can increase the risk of systemic errors with high consequence and highlights complex ethical and societal issues. Currently, there is little experience using AI for patient care in diverse clinical settings. Extensive research is needed to understand how to best deploy AI in clinical practice. This statement highlights our consensus that ethical use of AI in radiology should promote well-being, minimize harm, and ensure that the benefits and harms are distributed among stakeholders in a just manner. We believe AI should respect human rights and freedoms, including dignity and privacy. It should be designed for maximum transparency and dependability. Ultimate responsibility and accountability for AI remains with its human designers and operators for the foreseeable future. The radiology community should start now to develop codes of ethics and practice for AI that promote any use that helps patients and the common good and should block use of radiology data and algorithms for financial gain without those two attributes.

2.
Can Assoc Radiol J ; 70(4): 329-334, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31585825

RESUMO

This is a condensed summary of an international multisociety statement on ethics of artificial intelligence (AI) in radiology produced by the ACR, European Society of Radiology, RSNA, Society for Imaging Informatics in Medicine, European Society of Medical Imaging Informatics, Canadian Association of Radiologists, and American Association of Physicists in Medicine. AI has great potential to increase efficiency and accuracy throughout radiology, but it also carries inherent pitfalls and biases. Widespread use of AI-based intelligent and autonomous systems in radiology can increase the risk of systemic errors with high consequence and highlights complex ethical and societal issues. Currently, there is little experience using AI for patient care in diverse clinical settings. Extensive research is needed to understand how to best deploy AI in clinical practice. This statement highlights our consensus that ethical use of AI in radiology should promote well-being, minimize harm, and ensure that the benefits and harms are distributed among stakeholders in a just manner. We believe AI should respect human rights and freedoms, including dignity and privacy. It should be designed for maximum transparency and dependability. Ultimate responsibility and accountability for AI remains with its human designers and operators for the foreseeable future. The radiology community should start now to develop codes of ethics and practice for AI that promote any use that helps patients and the common good and should block use of radiology data and algorithms for financial gain without those two attributes.


Assuntos
Inteligência Artificial/ética , Radiologia/ética , Canadá , Consenso , Europa (Continente) , Humanos , Radiologistas/ética , Sociedades Médicas , Estados Unidos
3.
Insights Imaging ; 10(1): 101, 2019 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-31571015

RESUMO

This is a condensed summary of an international multisociety statement on ethics of artificial intelligence (AI) in radiology produced by the ACR, European Society of Radiology, RSNA, Society for Imaging Informatics in Medicine, European Society of Medical Imaging Informatics, Canadian Association of Radiologists, and American Association of Physicists in Medicine.AI has great potential to increase efficiency and accuracy throughout radiology, but also carries inherent pitfalls and biases. Widespread use of AI-based intelligent and autonomous systems in radiology can increase the risk of systemic errors with high consequence, and highlights complex ethical and societal issues. Currently, there is little experience using AI for patient care in diverse clinical settings. Extensive research is needed to understand how to best deploy AI in clinical practice.This statement highlights our consensus that ethical use of AI in radiology should promote well-being, minimize harm, and ensure that the benefits and harms are distributed among stakeholders in a just manner. We believe AI should respect human rights and freedoms, including dignity and privacy. It should be designed for maximum transparency and dependability. Ultimate responsibility and accountability for AI remains with its human designers and operators for the foreseeable future.The radiology community should start now to develop codes of ethics and practice for AI which promote any use that helps patients and the common good and should block use of radiology data and algorithms for financial gain without those two attributes.

4.
Radiology ; 293(2): 436-440, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31573399

RESUMO

This is a condensed summary of an international multisociety statement on ethics of artificial intelligence (AI) in radiology produced by the ACR, European Society of Radiology, RSNA, Society for Imaging Informatics in Medicine, European Society of Medical Imaging Informatics, Canadian Association of Radiologists, and American Association of Physicists in Medicine. AI has great potential to increase efficiency and accuracy throughout radiology, but it also carries inherent pitfalls and biases. Widespread use of AI-based intelligent and autonomous systems in radiology can increase the risk of systemic errors with high consequence and highlights complex ethical and societal issues. Currently, there is little experience using AI for patient care in diverse clinical settings. Extensive research is needed to understand how to best deploy AI in clinical practice. This statement highlights our consensus that ethical use of AI in radiology should promote well-being, minimize harm, and ensure that the benefits and harms are distributed among stakeholders in a just manner. We believe AI should respect human rights and freedoms, including dignity and privacy. It should be designed for maximum transparency and dependability. Ultimate responsibility and accountability for AI remains with its human designers and operators for the foreseeable future. The radiology community should start now to develop codes of ethics and practice for AI that promote any use that helps patients and the common good and should block use of radiology data and algorithms for financial gain without those two attributes. This article is a simultaneous joint publication in Radiology, Journal of the American College of Radiology, Canadian Association of Radiologists Journal, and Insights into Imaging. Published under a CC BY-NC-ND 4.0 license. Online supplemental material is available for this article.

5.
Health Technol Assess ; 22(40): 1-92, 2018 07.
Artigo em Inglês | MEDLINE | ID: mdl-30045805

RESUMO

BACKGROUND: Chronic pelvic pain (CPP) symptoms in women are variable and non-specific; establishing a differential diagnosis can be hard. A diagnostic laparoscopy is often performed, although a prior magnetic resonance imaging (MRI) scan may beneficial. OBJECTIVES: To estimate the accuracy and added value of MRI in making diagnoses of (1) idiopathic CPP and (2) the main gynaecological causes of CPP. To quantify the impact MRI can have on decision-making with respect to triaging for therapeutic laparoscopy and to conduct an economic evaluation. DESIGN: Comparative test-accuracy study with cost-effectiveness modelling. SETTING: Twenty-six UK-based hospitals. PARTICIPANTS: A total of 291 women with CPP. METHODS: Pre-index information concerning the patient's medical history, previous pelvic examinations and ultrasound scans was collected. Women reported symptoms and quality of life at baseline and 6 months. MRI scans and diagnostic laparoscopy (undertaken and interpreted blind to each other) were the index tests. For each potential cause of CPP, gynaecologists indicated their level of certainty that the condition was causing the pelvic pain. The analysis considered both diagnostic laparoscopy as a reference standard for observing structural gynaecological causes and consensus from a two-stage expert independent panel for ascertaining the cause of CPP. The stage 1 consensus was based on pre-index, laparoscopy and follow-up data; for stage 2, the MRI scan report was also provided. The primary analysis involved calculations of sensitivity and specificity for the presence or absence of each structural gynaecological cause of pain. A decision-analytic model was developed, with a 6-month time horizon. Two strategies, laparoscopy or MRI, were considered and populated with study data. RESULTS: Using reference standards of laparoscopic and expert panel diagnoses, MRI scans had high specificity but poor sensitivity for observing deep-infiltrating endometriosis, endometrioma, adhesions and ovarian cysts. MRI scans correctly identified 56% [95% confidence interval (CI) 48% to 64%] of women judged to have idiopathic CPP, but missed 46% (95% CI 37% to 55%) of those considered to have a gynaecological structural cause of CPP. MRI added significant value, over and above the pre-index information, in identifying deep-infiltrating endometriosis (p = 0.006) and endometrioma (p = 0.02) as the cause of pain, but not for other gynaecological structural causes or for identifying idiopathic CPP (p = 0.08). Laparoscopy was significantly more accurate than MRI in diagnosing idiopathic CPP (p < 0.0001), superficial peritoneal endometriosis (p < 0.0001), deep-infiltrating endometriosis (p < 0.0001) and endometrioma of the ovary (p = 0.02) as the cause of pelvic pain. The accuracy of laparoscopy appeared to be able to rule in these diagnoses. Using MRI to identify women who require therapeutic laparoscopy would lead to 369 women in a cohort of 1000 receiving laparoscopy unnecessarily, and 136 women who required laparoscopy not receiving it. The economic analysis highlighted the importance of the time horizon, the prevalence of CPP and the cut-off values to inform the sensitivity and specificity of MRI and laparoscopy on the model results. MRI was not found to be a cost-effective diagnostic approach in any scenario. CONCLUSIONS: MRI was dominated by laparoscopy in differential diagnosis of women presenting to gynaecology clinics with CPP. It did not add value to information already gained from history, examination and ultrasound about idiopathic CPP and various gynaecological conditions. TRIAL REGISTRATION: Current Controlled Trials ISRCTN13028601. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 40. See the NIHR Journals Library website for further project information.


Assuntos
Laparoscopia/economia , Dor Pélvica/diagnóstico por imagem , Dor Pélvica/etiologia , Ultrassonografia/economia , Adaptação Psicológica , Adulto , Doença Crônica , Análise Custo-Benefício , Endometriose/complicações , Endometriose/diagnóstico , Feminino , Humanos , Laparoscopia/métodos , Laparoscopia/normas , Imagem por Ressonância Magnética , Saúde Mental , Cistos Ovarianos/complicações , Cistos Ovarianos/diagnóstico , Dor Pélvica/psicologia , Personalidade , Exame Físico , Qualidade de Vida , Reprodutibilidade dos Testes , Sensibilidade e Especificidade , Índice de Gravidade de Doença , Fatores Socioeconômicos , Fatores de Tempo , Ultrassonografia/métodos , Ultrassonografia/normas , Reino Unido
6.
BMJ Open ; 8(1): e014924, 2018 01 31.
Artigo em Inglês | MEDLINE | ID: mdl-29391360

RESUMO

INTRODUCTION: Chronic pelvic pain (CPP) affects more than 1 million UK women with associated healthcare costs of £158 million annually. Current evidence supporting interventions when no underlying pathology is identified is very limited and treatment is frequently inadequate. Gabapentin (a GABA analogue) is efficacious and often well tolerated in other chronic pain conditions. We have completed a successful pilot randomised controlled trial Gabapentin for Pelvic Pain 1 (GaPP1) and here describe the protocol for our definitive multicentre trial to assess the efficacy of gabapentin in the management of CPP in women Gabapentin for Pelvic Pain 2 (GaPP2). METHODS AND ANALYSIS: We plan to perform a double-blind placebo-controlled randomised multicentre clinical trial, recruiting 300 women with CPP from up to 40 National Health Service hospitals within the UK. After randomisation, women will titrate their medication (gabapentin or placebo) over a 4-week period to a maximum of 2700 mg or placebo equivalent and will then maintain a stable dose for a 12-week period. Response to treatment will be monitored with validated questionnaires and coprimary outcome measures of average and worst pain scores will be employed. The primary objective is to test the hypothesis that treatment with gabapentin has the potential to provide an effective oral treatment to alleviate pain in women with CPP in the absence of any obvious pelvic pathology. ETHICS AND DISSEMINATION: Ethical approval has been obtained from the Coventry and Warwick Research Ethics Committee (REC 15/WM/0036). Data will be presented at international conferences and published in peer-reviewed journals. We will make the information obtained from the study available to the public through national bodies and charities. TRIAL REGISTRATION NUMBER: ISRCTN77451762; Pre-results.


Assuntos
Aminas/uso terapêutico , Analgésicos/uso terapêutico , Dor Crônica/tratamento farmacológico , Ácidos Cicloexanocarboxílicos/uso terapêutico , Manejo da Dor/métodos , Dor Pélvica/tratamento farmacológico , Ácido gama-Aminobutírico/uso terapêutico , Adolescente , Adulto , Doença Crônica , Método Duplo-Cego , Feminino , Gabapentina , Humanos , Pessoa de Meia-Idade , Medição da Dor , Projetos Piloto , Projetos de Pesquisa , Inquéritos e Questionários , Resultado do Tratamento , Adulto Jovem
7.
Pain ; 159(4): 673-683, 2018 04.
Artigo em Inglês | MEDLINE | ID: mdl-29300277

RESUMO

Interdisciplinary multimodal pain therapy (IMPT) is a biopsychosocial treatment approach for patients with chronic pain that comprises at least psychological and physiotherapeutic interventions. Core outcome sets (COSs) are currently developed in different medical fields to standardize and improve the selection of outcome domains, and measurement instruments in clinical trials, to make trial results meaningful, to pool trial results, and to allow indirect comparison between interventions. The objective of this study was to develop a COS of patient-relevant outcome domains for chronic pain in IMPT clinical trials. An international, multiprofessional panel (patient representatives [n = 5], physicians specialized in pain medicine [n = 5], physiotherapists [n = 5], clinical psychologists [n = 5], and methodological researchers [n = 5]) was recruited for a 3-stage consensus study, which consisted of a mixed-method approach comprising an exploratory systematic review, a preparing online survey to identify important outcome domains, a face-to-face consensus meeting to agree on COS domains, and a second online survey (Delphi) establishing agreement on definitions for the domains included. The panel agreed on the following 8 domains to be included into the COS for IMPT: pain intensity, pain frequency, physical activity, emotional wellbeing, satisfaction with social roles and activities, productivity (paid and unpaid, at home and at work, inclusive presentism and absenteeism), health-related quality of life, and patient's perception of treatment goal achievement. The complexity of chronic pain in a biopsychosocial context is reflected in the current recommendation and includes physical, mental, and social outcomes. In a subsequent step, measurement instruments will be identified via systematic reviews.


Assuntos
Dor Crônica/psicologia , Dor Crônica/terapia , Terapia Combinada/métodos , Consenso , Cooperação Internacional , Resultado do Tratamento , Determinação de Ponto Final , Feminino , Humanos , Masculino , Qualidade de Vida
8.
JMIR Res Protoc ; 7(1): e8, 2018 Jan 15.
Artigo em Inglês | MEDLINE | ID: mdl-29335232

RESUMO

BACKGROUND: Female chronic pelvic pain (CPP) is defined as intermittent or constant pelvic or lower abdominal pain occurring in a woman for at least 6 months. Up to a quarter of women are estimated to be affected by CPP worldwide and it is responsible for one fifth of specialist gynecological referrals in the United Kingdom. Psychological interventions are commonly utilized. As waiting times and funding capacity impede access to face-to-face consultations, supported self-management (SSM) has emerged as a viable alternative. Mindfulness meditation is a potentially valuable SSM tool, and in the era of mobile technology, this can be delivered to the individual user via a smartphone app. OBJECTIVE: To assess the feasibility of conducting a trial of a mindfulness meditation intervention delivered by a mobile phone app for patients with CPP. The main feasibility objectives were to assess patient recruitment and app adherence, to obtain information to be used in the sample size estimate of a future trial, and to receive feedback on usability of the app. METHODS: Mindfulness Meditation for Women With Chronic Pelvic Pain (MEMPHIS) is a three-arm feasibility trial, that took place in two hospitals in the United Kingdom. Eligible participants were randomized in a 1:1:1 ratio to one of three treatment arms: (1) the intervention arm, consisting of a guided, spoken mindfulness meditation app; (2) an active control arm, consisting of a progressive muscle relaxation app; and (3) usual care (no app). Participants were followed-up for 6 months. Key feasibility outcomes included the time taken to recruit all patients for the study, adherence, and estimates to be used in the sample size calculation for a subsequent full-scale trial. Upon completion of the feasibility trial we will conduct focus groups to explore app usability and reasons for noncompliance. RESULTS: Recruitment for MEMPHIS took place between May 2016 and September 2016. The study was closed March 2017 and the report was submitted to the NIHR on October 26, 2017. CONCLUSIONS: This feasibility trial will inform the design of a large multicentered trial to assess the clinical effectiveness of mindfulness meditation delivered via a smartphone app for the treatment of CPP. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02721108; https://clinicaltrials.gov/ct2/show/NCT02721108 (Archived by WebCite at http://www.webcitation.org/6wLMAkuaU); BioMed Central: ISRCTN10925965; https://www.isrctn.com/ISRCTN10925965 (Archived by WebCite at http://www.webcitation.org/6wLMVLuys).

9.
J Vasc Interv Radiol ; 27(10): 1478-1486.e8, 2016 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-27397619

RESUMO

PURPOSE: Chronic pelvic pain (CPP) in the presence of dilated and refluxing pelvic veins is often described as pelvic congestion syndrome (PCS), although the causal relationship between pelvic vein incompetence and CPP has not been established. Percutaneous embolization is the principal treatment for PCS, with high success rates cited. This study was undertaken to systematically and critically review the effectiveness of embolization of incompetent pelvic veins. MATERIALS AND METHODS: A comprehensive search strategy encompassing various terms for pelvic congestion, pelvic pain, and embolization was deployed in 17 bibliographic databases, with no restriction on study design. Methodologic quality was assessed. The quality and heterogeneity generally precluded meta-analysis. Results were tabulated and described narratively. RESULTS: Twenty-one prospective case series and one poor-quality randomized trial of embolization (involving a total of 1,308 women) were identified. Early substantial relief from pain was observed in approximately 75% of women undergoing embolization, and generally increased over time and was sustained. Significant pain reductions following treatment were observed in all studies that measured pain on a visual analog scale. Repeat intervention rates were generally low. There were few data on the impact on menstruation, ovarian reserve, or fertility, but no concerns were noted. Transient pain was common following foam embolization, and there was a < 2% risk of coil migration. CONCLUSIONS: Embolization appears to provide symptomatic relief of CPP in the majority of women and is safe, although the quality of the evidence is low.


Assuntos
Dor Crônica/prevenção & controle , Embolização Terapêutica/métodos , Dor Pélvica/prevenção & controle , Pelve/irrigação sanguínea , Escleroterapia/métodos , Varizes/terapia , Veias , Insuficiência Venosa/terapia , Dor Crônica/diagnóstico , Dor Crônica/etiologia , Dilatação Patológica , Embolização Terapêutica/efeitos adversos , Feminino , Humanos , Dor Pélvica/diagnóstico , Dor Pélvica/etiologia , Fluxo Sanguíneo Regional , Escleroterapia/efeitos adversos , Síndrome , Resultado do Tratamento , Varizes/complicações , Varizes/diagnóstico , Varizes/fisiopatologia , Veias/patologia , Veias/fisiopatologia , Insuficiência Venosa/complicações , Insuficiência Venosa/diagnóstico , Insuficiência Venosa/fisiopatologia
10.
Health Technol Assess ; 20(5): 1-108, 2016 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-26789334

RESUMO

BACKGROUND: Pelvic congestion syndrome (PCS) is described as chronic pelvic pain (CPP) arising from dilated and refluxing pelvic veins, although the causal relationship between pelvic vein incompetence (PVI) and CPP is not established. Non-invasive screening methods such as Doppler ultrasound and magnetic resonance venography are used before confirmation by venography. Percutaneous embolisation has become the principal treatment for PCS, with high success rates often cited. OBJECTIVES: Our proposal aimed to systematically and critically review the definitions and diagnostic criteria of PCS, the association between PVI and CPP, the accuracy of various non-invasive imaging techniques and the effectiveness of embolisation for PVI; and to identify factors associated with successful outcome. We also wished to survey clinicians and patients to assess awareness and management of PCS and gauge the enthusiasm for further research. DATA SOURCES: A comprehensive search strategy encompassing various terms for pelvic congestion, pain, imaging techniques and embolisation was deployed in 17 bibliographic databases, including MEDLINE, EMBASE and Web of Science. There was no restriction on study design. METHODS: Methodological quality was assessed using appropriate tools. Online surveys were sent to clinicians and patients. The quality and heterogeneity generally precluded meta-analysis and so results were tabulated and described narratively. RESULTS: We identified six association studies, 10 studies involving ultrasound, two studies involving magnetic resonance venography, 21 case series and one poor-quality randomised trial of embolisation. There were no consistent diagnostic criteria for PCS. We found that the associations between CPP and PVI were generally fairly similar, with three of five studies with sufficient data showing statistically significant associations (odds ratios of between 31 and 117). The prevalence of PVI ranged widely, although the majority of women with PVI had CPP. Transvaginal ultrasound with Doppler and magnetic resonance venography are both useful screening methods, although the data on accuracy are limited. Early substantial relief from pain symptoms was observed in approximately 75% of women undergoing embolisation, a figure which generally increased over time and was sustained. Reintervention rates were generally low. Transient pain was a common occurrence following foam embolisation, while there was a < 2% risk of coil migration. Confidence in the embolisation technique is reasonably high, although there is a desire to strengthen the evidence base. Even among women with CPP, fewer than half had any knowledge about PCS. CONCLUSIONS: The data supporting the diagnosis and treatment of PCS are limited and of variable methodological quality. There is some evidence to tentatively support a causative association, but it cannot be categorically stated that PVI is the cause of CPP in women with no other pathology, as the six most pertinent drew on clinically disparate populations and defined PVI inconsistently. Embolisation appears to provide symptomatic relief in the majority of women and is safe. However, the majority of included studies of embolism were relatively small case series and only the randomised controlled trial was considered at risk of potential biases. There is scope and demand for considerable further research. The question of the association of PVI and CPP requires a well-designed and well-powered case-control study, which will also provide data to derive a diagnostic standard. An adequately powered randomised trial is essential to provide evidence on the effectiveness of embolisation, but this faces methodological challenges. STUDY REGISTRATION: This study is registered as PROSPERO CRD42012002237 and CRD42012002238. FUNDING: The National Institute for Health Research Health Technology Assessment programme.


Assuntos
Doença Crônica/terapia , Embolização Terapêutica , Dor Pélvica/terapia , Pelve/irrigação sanguínea , Insuficiência Venosa/terapia , Feminino , Humanos , Angiografia por Ressonância Magnética , Dor Pélvica/etiologia , Avaliação da Tecnologia Biomédica , Resultado do Tratamento , Insuficiência Venosa/complicações , Insuficiência Venosa/diagnóstico
11.
Arch Gynecol Obstet ; 283(5): 1069-73, 2011 May.
Artigo em Inglês | MEDLINE | ID: mdl-20473762

RESUMO

PURPOSE: To analyse and to compare how female patients are informed about adhesions and their related problems by surgeons preoperatively. METHODS: Over 8 weeks 105 patients (Germany) and 82 (UK) patients admitted for laparoscopic or open abdominopelvic surgery were interviewed preoperatively in a multi-centre study in Germany and the UK. 212 responses to an online survey were also analysed. RESULTS: Less than 50% of patients are made aware of adhesions. Even fewer patients were told about complications caused by adhesions. Lack of knowledge is cited by 46% of patients as a reason for health professionals not informing them about adhesions. 41% considered adhesions as not sufficiently important. Patients who had previously heard of adhesions were most commonly informed by physicians. CONCLUSIONS: There is lack of information among patients and physicians about adhesions and their complications. Written information before surgery and computer-based applications may help raise patient's awareness.


Assuntos
Conhecimentos, Atitudes e Prática em Saúde , Educação de Pacientes como Assunto/estatística & dados numéricos , Complicações Pós-Operatórias , Aderências Teciduais , Adulto , Feminino , Alemanha , Humanos , Internet , Pessoa de Meia-Idade , Inquéritos e Questionários , Reino Unido
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