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1.
Eur Radiol ; 29(3): 1258-1266, 2019 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-30194473

RESUMO

OBJECTIVES: To evaluate the diagnostic performance of digital tomosynthesis (DTS) for the diagnosis of hip prosthesis loosening (PL) compared with conventional radiographs and CT with metal artifact reduction (CT-MAR). METHODS: Forty-nine patients with painful hip prosthesis were prospectively included and underwent anteroposterior and lateral radiographs, anteroposterior DTS and CT-MAR of the hip. This study was approved by the local ethics committee, and all patients signed an informed consent form. Images were evaluated independently by two radiologists. Periprosthetic radiolucent lines wider than 2 mm found in two or more Gruen or De Lee and Charnley zones were considered diagnostic of PL. All cases of PL were confirmed surgically. Patients with a stable radiological follow-up for at least 1 year with an alternative cause for the symptoms or with no surgical evidence of PL were considered PL negative. RESULTS: There were 21 cases of PL, 9 unilateral and 12 bilateral. For both the acetabular and femoral sides, DTS had a specificity for PL detection similar to that of conventional radiographs and CT-MAR (98.5-100%, 96.9%-100% and 96.9-95.4% respectively for both readers) and a sensitivity similar to conventional radiographs (39.9-45.4% versus 33.3-51.5% for both readers) but lower than CT-MAR (84.85% for both readers). The interobserver agreement was 0.84 for CT-MAR, 0.53 for DTS and 0.39 for conventional radiographs. CONCLUSION: DTS has a similar diagnostic performance to radiographs for the diagnosis of PL with a better interobserver agreement. The sensitivity however remains lower than that of CT-MAR. KEY POINTS: • Plain radiograph is still the first imaging step when hip prosthesis loosening is suspected. • Interobserver agreement is better with digital tomosynthesis than radiographs. • Sensitivity of CT with state-of-the-art metal artifact reduction is superior to that of digital tomosynthesis.


Assuntos
Acetábulo/diagnóstico por imagem , Artroplastia de Quadril/métodos , Artefatos , Fêmur/diagnóstico por imagem , Prótese de Quadril , Tomografia Computadorizada Multidetectores/métodos , Radiografia/métodos , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Falha de Prótese
2.
AJR Am J Roentgenol ; 211(1): 3-10, 2018 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-29708781

RESUMO

OBJECTIVE: The aim of this article is to provide an overview of newer techniques and postprocessing tools that improve the potential impact of CT in forensic situations. CONCLUSION: CT has become a standard tool in medicolegal practice. Postmortem CT is an essential aid to the pathologist during autopsies. Advances in technology and software are constantly leading to advances in its performance.


Assuntos
Autopsia/métodos , Medicina Legal/métodos , Tomografia Computadorizada por Raios X/métodos , Causas de Morte , Humanos , Interpretação de Imagem Radiográfica Assistida por Computador
3.
Int J Legal Med ; 130(5): 1299-301, 2016 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-26914799

RESUMO

Survival time and physical activity following fatal injury are especially important during investigation of homicide cases and the estimation of a victim's survival time and physical activity following a fatal injury from a sharp weapon is a commonly raised issue, particularly at trial. According to the literature, survival time and physical activity after cardiac damage are short-term estimates without high accuracy. We report the homicide case of a young man who died as a result of a left ventricle injury caused by a sharp pointed weapon. This case is based on evidence from a video surveillance camera that recorded the whole scene after the fatal injury: The victim showed an adapted physical activity for 38 s, although the left ventricle incision measured 2 cm. Despite several cases in the literature, it is not possible to correlate precisely the size of the wounds and the acting capability.


Assuntos
Ventrículos do Coração/lesões , Homicídio , Atividade Motora , Gravação em Vídeo , Ferimentos Perfurantes , Adolescente , Humanos , Masculino
4.
Sante Publique ; 27(4): 463-70, 2015.
Artigo em Francês | MEDLINE | ID: mdl-26751921

RESUMO

BACKGROUND: Therapeutic patient education, which advocates a change of behaviour, may affect the patient's and the patient's family's lifestyles. The aim of this survey was to describe the perception of heart failure patients and their families concerning the impact of TPE on their lifestyles. METHODS: A national self-administered questionnaire survey b was performed from january to May 2013 with patients and their relatives. A total of 2,153 questionnaires were sent to all patients registered in the Heart Failure Observatory registry (Odin), who forwarded them to a relative of their choice. Only relatives of educated patients were included. A total of 2,397 questionnaires were sent to patients. RESULTS: We obtained 149 responses from patient's families (7%). One half of them (50.3%) met our inclusion criteria. We obtained 257 responses from patients (11 %). Respondents noted a change in the patient's daily lifestyle after TPE (85.8% of the total population) and said that the patient had a more positive approach to his/her illness (70.7% of the total population). According to respondents, relatives had changed their lifestyle after their participation of TPE (67.8% of the total population). CONCLUSION: This study shows that patients and their relatives report a positive change in their lifestyle due to TPE. The patient's relatives appear to comply with the recommendations of health professionals, initially designed for the patient.


Assuntos
Saúde da Família , Insuficiência Cardíaca/terapia , Estilo de Vida , Educação de Pacientes como Assunto/métodos , Adulto , Idoso , Feminino , França , Humanos , Masculino , Pessoa de Meia-Idade , Percepção , Inquéritos e Questionários
5.
Skeletal Radiol ; 43(9): 1237-46, 2014 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-24910125

RESUMO

OBJECTIVES: To compare the image quality of CT with iterative reconstruction alone and in association with projection-based single-energy metal artifact reduction (SEMAR) for the visualization of specific periarticular soft tissue structures in patients with hip prostheses. METHODS: CT studies from 48 consecutive patients with a hip prosthesis (24 unilateral and 24 bilateral) were retrospectively reconstructed using two different methods: iterative reconstruction (IR) alone and IR associated with SEMAR. The influence of metallic artifacts on the identification of various periarticular structures was evaluated subjectively by two readers. The image quality was compared in patients with unilateral and bilateral prostheses. RESULTS: Visualization of periprosthetic soft tissue was significantly improved by the SEMAR algorithm (p < 0.0001). When SEMAR was associated with IR, the gluteus minimus and medius tendons, obturator internus muscle, prostate/uterus and bladder could be seen with medium or high confidence. There were no significant differences in image quality between patients with unilateral or bilateral prosthesis when SEMAR was used (p > 0.2). This algorithm increased the detection of periarticular masses by 30%. CONCLUSION: SEMAR significantly improves the image quality of periarticular soft-tissue structures in patients with hip prostheses.


Assuntos
Artefatos , Articulação do Quadril/diagnóstico por imagem , Prótese de Quadril , Metais , Músculo Esquelético/diagnóstico por imagem , Intensificação de Imagem Radiográfica/métodos , Tomografia Computadorizada por Raios X/métodos , Adulto , Idoso , Idoso de 80 Anos ou mais , Algoritmos , Feminino , Articulação do Quadril/cirurgia , Humanos , Masculino , Pessoa de Meia-Idade , Variações Dependentes do Observador , Reprodutibilidade dos Testes , Estudos Retrospectivos , Sensibilidade e Especificidade , Tendões/diagnóstico por imagem
6.
Eur J Orthop Surg Traumatol ; 24(4): 627-33, 2014 May.
Artigo em Inglês | MEDLINE | ID: mdl-24162583

RESUMO

BACKGROUND: Initially considered as an established salvage procedure for tibiotalocalcaneal arthrodesis (TTCA), intramedullary nailing indications have expanded as evidenced in recent literature. We have tried to identify factors influencing functional result and bone union. METHODS: In a retrospective study, 30 patients were treated by a TTCA between January 2006 and November 2011. Indications, operative technique, bone fusion, X-rays and functional result [American Foot and Ankle Society (AOFAS) and short-form health survey (SF-36) scores] before and after surgery were registered and analyzed. RESULTS: Thirty cases of TTCA were included. The patient's average age was 52 (range 24-90). Union rate was 86% for the tibiotalar joint and 74% for the subtalar joint with an average follow-up of 25.4 months (8-67). The mean AOFAS' score significantly improved (from 37 to 59) as the SF-36' score. Global complication rate was about 56%. It has not been possible to identify factors significantly influencing bone fusion or functional results. All septic cases achieved fusion without any septic resurgence. CONCLUSION: Retrograde intramedullary nailing in TTCA is an effective technique, which allows good clinical results even in case of septic history of the patient. Fusion rate and functional results were not significantly influenced by any of the factors examined in this study.


Assuntos
Artrodese/métodos , Calcâneo/cirurgia , Fixação Intramedular de Fraturas/métodos , Tálus/cirurgia , Fraturas da Tíbia/cirurgia , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Articulação do Tornozelo/diagnóstico por imagem , Articulação do Tornozelo/cirurgia , Artrodese/instrumentação , Pinos Ortopédicos , Calcâneo/diagnóstico por imagem , Calcâneo/lesões , Avaliação da Deficiência , Feminino , Fixação Intramedular de Fraturas/instrumentação , Humanos , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias/diagnóstico , Complicações Pós-Operatórias/diagnóstico por imagem , Complicações Pós-Operatórias/cirurgia , Radiografia , Reoperação , Estudos Retrospectivos , Tálus/diagnóstico por imagem , Tálus/lesões , Fraturas da Tíbia/diagnóstico por imagem , Resultado do Tratamento , Adulto Jovem
7.
J Digit Imaging ; 26(6): 1013-9, 2013 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-23779150

RESUMO

The main goal of this study was to determine the reproducibility of the reading of wrist trauma case radiographs using three different media: laser film, a picture archiving and communication systems (PACS) workstation, and paper with an optimized layout. The study was conducted retrospectively in 200 consecutive patients consulting at the emergency department for wrist trauma and who underwent wrist X-ray investigation using a computed radiography system. There were 82 men and 118 women. The mean age was 48.3 years (16-95 years). Our institutional review board does not require patient approval or informed consent for retrospective review of case records. The readings were made by two independent readers who analyzed the 200 patient radiographs consecutively in one session for each type of media: paper, laser film, and on a PACS dual-screen workstation. The inter-reader agreements were substantial or almost perfect, with kappa values of 0.83 (0.76-0.90) for the PACS, 0.83 (0.76-0.90) for film, and 0.80 (0.72-0.87) for paper. The inter-technique agreement was almost perfect in all cases. There is a high interobserver agreement between PACS, laser film, and paper readings for wrist trauma cases. With a layout of one radiograph on each sheet, paper could replace laser films to communicate the results of wrist radiographs in trauma cases for outpatients.


Assuntos
Papel , Sistemas de Informação em Radiologia/estatística & dados numéricos , Traumatismos do Punho/diagnóstico por imagem , Filme para Raios X/estatística & dados numéricos , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Estudos de Coortes , Tomada de Decisões , Feminino , Humanos , Comunicação Interdisciplinar , Lasers , Masculino , Pessoa de Meia-Idade , Variações Dependentes do Observador , Reprodutibilidade dos Testes , Estudos Retrospectivos , Tomografia Computadorizada por Raios X/métodos , Centros de Traumatologia , Traumatismos do Punho/diagnóstico , Adulto Jovem
8.
Orthop Traumatol Surg Res ; 109(8): 103663, 2023 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-37474019

RESUMO

INTRODUCTION: Authors submitting to Orthopaedics & Traumatology: Surgery & Research (OTSR) must fulfill the criteria of scientific integrity (SI), including issues of plagiarism and disclosure of interest. These data have not been assessed for OTSR and we therefore conducted a retrospective study of (1) potential plagiarism rates, (2) deficient disclosure of interest (for French authors), and (3) correlation between the two. HYPOTHESIS: Suspected plagiarism rates exceed 20% and the non-disclosure rate exceeds 80%. MATERIAL AND METHODS: We analyzed 1 year's submissions to OTSR: January 24, 2022 to January 23, 2023. Articles were checked for plagiarism, using iThenticate software (Turnitin, Oakland, CA, USA), with a threshold of > 20% matching. Conflicts of interest, for French authors, investigated on the French Ministry of Health Transparence website (www.transparence.sante.gouv.fr), with non-disclosure defined by undeclared amounts exceeding €1000. RESULTS: In total, 851 submissions were analyzed. iThenticate identified 152 (17.7%) with > 20% matching to an already published article. This likely plagiarism varied (p<0.01) between geographic origins of submissions. In the 289 submissions by French authors, there were 275 (95%) failures to report amounts exceeding €1000. Combined non-disclosure and plagiarism was found in only 3 articles submitted by French authors (3/289: 1.03%). DISCUSSION: OTSR applies the Recommendations for the Conduct, Reporting, Editing and Publication of Scholarly Work in Medical Journals (www.icmje.org), adheres to the guidelines of the Committee On Publication Ethics (COPE) and the French Health Authority (HAS), and has an ethics committee. Plagiarism is a major SI breach, suspected in 20% of submissions. Also, 95% of French authors failed to properly disclose their interests on submitting an article, although this declaration is mandatory in France and is an integral aspect of SI. There are also other forms of misconduct, such as failure to comply with the French "Jardé" law on research involving human subjects, failure to obtain review board approval, unjustified claims to authorship or deficient archiving, that were not analyzed here. CONCLUSIONS: Although overall plagiarism rates were under 20% for submissions to OTSR, some geographic areas were more concerned than others. Also, despite reminders by the editorial board, only 5% of French authors made full disclosures; this is a major breach of SI, requiring correction on the part of French authors. LEVEL OF EVIDENCE: IV; retrospective study.


Assuntos
Ortopedia , Má Conduta Científica , Traumatologia , Humanos , Plágio , Estudos Retrospectivos , Revelação
9.
Rev Prat ; 71(3): 333-334, 2021 Mar.
Artigo em Francês | MEDLINE | ID: mdl-34161043

RESUMO

"The causes of the failure of orthopedic registries in france.In France, in 2018, around 140,000 patients were operated on for a total hip replacement, 100,000,000 for a total knee replacement. Currently the only register that works is that of total ankle prostheses, which concerns only less than a thousand implants per year. The Swedish and Swiss registers have proved their effectiveness; they benefit from long-term public financial support and have no vocation to control the activity of the surgeon. In 2018, barely more than 10% of the implants were integrated into a register .The French orthopedic surgeon remains to this day awaiting structured and sustainable funding, simplicity of filling in a secure computer system, a return of information, all these elements having contributed to the success of the registers of the Nordic countries. Lastly, and above all, he wishes to clearly express the absence of the registers' vocation to serve as an instrument of supervision and / or supervision of medical teams."


"Les raisons de l'échec des registres en orthopédie en france. En France, en 2018, environ 140 000 patients ont été opérés d'une prothèse totale de hanche, 100 0000 d'une prothèse totale de genou. Actuellement le seul registre qui fonctionne est celui des prothèses totales de cheville qui ne concerne que moins de mille implants par an . Les registres suédois, suisse ont fait la preuve de leur efficacité ; ils bénéficient de soutiens financiers publics pérennes et n'ont aucune vocation à contrôler l'activité du chirurgien.En 2018 à peine plus de 10% des implants étaient intégrés dans un registre/Le chirurgien orthopédiste français reste à ce jour en attente de financements structurés et pérennes, d'une simplicité de remplissage dans un système informatique sécurisé, d'un retour d'information, tous ces éléments ayant contribué au succès des registres des pays nordiques. Enfin et surtout il désire que soit clairement exprimée l'absence de vocation des registres à servir d'instrument de supervision et/ou d'encadrement des équipes médicales."


Assuntos
Artroplastia de Quadril , França/epidemiologia , Humanos , Masculino , Sistema de Registros
10.
Orthop Traumatol Surg Res ; 107(5): 102968, 2021 09.
Artigo em Inglês | MEDLINE | ID: mdl-34033921

RESUMO

INTRODUCTION: The main aim of the present study was to compare motives between patients requesting secondary finger amputation following or unrelated to a work accident. The secondary objective was to assess correlation between sick leave duration and motive for amputation following a work accident. METHOD: A single-center retrospective study was conducted over an 11-year period in a hand clinic. Cases of secondary totalizing post-traumatic finger amputation at metacarpal base level were included. Exclusion criteria comprised non-traumatic amputation, age<16 years and thumb amputation. In all, 216 patients met the inclusion criteria. The main endpoints assessed motives in requests for secondary metacarpal base amputation: esthetic, functional or administrative. Secondary endpoints comprised accident-to-surgery interval, gender and age, amputated digit and dominant-side involvement. RESULTS: Motive correlated significantly with gender (p<0.05). Administrative motives almost exclusively concerned males (21 males, 1 female) and predominantly concerned work accidents (19 vs. 3). Accident-to-surgery intervals were significantly longer in case of administrative motive (25.7 months, vs. 10.8 months for functional and 9 months for esthetic motives). Accident-to-surgery intervals were significantly longer in case of work accidents (15.2 vs. 9.5 months). DISCUSSION: Age and gender influenced patients' attitudes in post-traumatic finger amputation. Work-accident status influenced attitudes in a quarter of cases; we consider it unlikely that this can be reduced to claims for compensation, but that it is rather a matter of undiagnosed pathological grief. These findings highlight the importance of early follow-up of victims of traumatic amputation and early screening for pathological grief.


Assuntos
Amputação Traumática , Traumatismos dos Dedos , Adolescente , Amputação Cirúrgica , Amputação Traumática/cirurgia , Feminino , Traumatismos dos Dedos/cirurgia , Dedos , Humanos , Masculino , Estudos Retrospectivos
11.
Orthop Traumatol Surg Res ; 106(7): 1419-1423, 2020 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-33077407

RESUMO

INTRODUCTION: After traumatic upper-limb amputation (TULA), one-third of patients develop traumatic pathological grief (PG). However, are the other two-thirds unscathed? The main aim of the present study was to assess the rate of TULA victims claiming to have dealt with the consequences and showing no PG. The secondary objective was to determine positive and negative factors enabling and preventing coping. METHOD: A retrospective clinical study was conducted over an 11-year period in all adult TULA cases in our department. Assessment was on questionnaire. PG was assessed on the ICG (Inventory of Complicated Grief). Factors were assessed on physical, psychological, social, functional, esthetic and epidemiological criteria. Statistical analysis used StatView software, with the significance threshold set at p<0.05. RESULTS: Functional and social impacts were significantly greater in case of PG. Thumb amputation was significantly associated with PG, while PG was significantly less frequent in case of amputation at the metacarpal base. Patients in PG had significantly more often undergone neuroma resection or stump revision surgery. DISCUSSION: Fewer than a half of TULA victims achieved cure. Long-term prognosis depends on the patient's ability to accept the new situation, much more than on amputation level. Patients need support from the very first minutes, with follow-up extended well belong scar healing. Onset and healing of the narcissistic wound are inevitably delayed compared to skin healing.


Assuntos
Amputação Traumática , Traumatismos do Braço , Adulto , Amputação Cirúrgica , Cotos de Amputação , Amputação Traumática/epidemiologia , Amputação Traumática/cirurgia , Humanos , Estudos Retrospectivos , Extremidade Superior/cirurgia
12.
Orthop Traumatol Surg Res ; 106(2): 297-300, 2020 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-32179019

RESUMO

INTRODUCTION: The main aim of the present study was to determine the existence of pathological grief in victims of traumatic upper-limb amputation. The secondary objective was to determine risk factors for onset of pathological grief. METHOD: A retrospective clinical study was conducted for an 11-year period, including all cases of traumatic upper-limb amputation in adults. Patients were assessed on a questionnaire including an adaptation of the Inventory of Complicated Grief (ICG). Risk factors were assessed on surgical, personal occupational and subjective criteria. Statistical analysis on StatView software used matched Chi2 tests for comparisons, with the significance threshold set at p<0.001. RESULTS: With 1058 questionnaires sent out, the response rate was 52%; 3% of returned questionnaires were non-interpretable. Thirty-nine percent showed a state of pathological grief. Risk factors comprised lack of attempted replantation (p<0.001), isolated thumb amputation (p<0.001), and multi-digit or macro-amputation (p<0.001). Subjective esthetic blemish or the feeling of being mutilated was significantly associated with pathological grief (both p<0.001). DISCUSSION: Traumatic upper-limb amputation victims incurred a risk of pathological grief (main endpoint), with identifiable risk factors (secondary endpoint). Victim accompaniment and screening for risk of pathological grief are essential to limit the psychological impact of trauma and promote social and occupational reintegration.


Assuntos
Amputação Traumática , Adulto , Amputação Cirúrgica , Humanos , Reimplante , Estudos Retrospectivos , Extremidade Superior
14.
Arch Cardiovasc Dis ; 108(8-9): 446-52, 2015.
Artigo em Inglês | MEDLINE | ID: mdl-26071349

RESUMO

BACKGROUND: Care provider support for therapeutic patient education (TPE), its results and relationships with patients are factors in the setting up and sustainability of this practice. AIM: With a view to understanding the factors determining TPE care provider participation and favouring its development, the aim of this study was to describe the perception healthcare providers have of TPE in heart failure. METHODS: A national survey by self-administered questionnaire was performed in 2013 in 61 Observatoire de l'INsuffisance cardiaque (ODIN; Heart Failure Observatory) centres participating in the I-CARE programme. The cardiologist in charge of each centre received five questionnaires: one for him/herself and four for other healthcare providers working with him/her. RESULTS: We received 116 responses out of the 305 questionnaires sent (38.0%). Almost all of the responders stated that the patients were more observant after TPE sessions (91.4%). According to the responders, patients were better informed thanks to TPE (53.9%); they stated that TPE had changed their relationships with patients (81.9%); they also felt that they were educating the patient's close family/friends at the same time as the patients (86.2%). CONCLUSION: The survey showed that TPE improves care relationships. Healthcare providers recognize that they have been working differently since the programme was set up, and want the patient's close family/friends to be involved in treatment.


Assuntos
Atitude do Pessoal de Saúde , Conhecimentos, Atitudes e Prática em Saúde , Insuficiência Cardíaca/terapia , Educação de Pacientes como Assunto , Percepção , Comunicação , França , Pesquisas sobre Atenção à Saúde , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/psicologia , Humanos , Estilo de Vida , Participação do Paciente , Relações Médico-Paciente , Relações Profissional-Família , Comportamento de Redução do Risco , Inquéritos e Questionários
17.
Presse Med ; 41(10): e530-8, 2012 Oct.
Artigo em Francês | MEDLINE | ID: mdl-22480854

RESUMO

INTRODUCTION: Stroke is presently the first cause of brain death in France. In this context, the question of elective non-therapeutic ventilation and resuscitation arises, aiming at enabling the patients for whom a decision to stop all the therapeutics has been made to evolve towards brain death and organ donation. In 2010, the French society of intensive care has released guidelines regarding stroke management including strategy on this topic. The question has also been referred to the Ethics Committee of Nancy university hospital by a chief-nurse of our hospital and we report here its conclusions and propositions. METHOD: A workgroup was appointed and has tackled the major issues: the justification, the risks for the patient and the society, the expression of the patient's consent, the legality of this care benefiting only a third party, and the practical details. CONCLUSIONS AND PROPOSITIONS: Elective intensive care following decision to stop any treatment after severe stroke seems to be justified with regard to public health as well as individual or collective ethics, providing the patient has expressed his/her consent or his/her non-opposition before stroke occurrence. In France there is no legal frame regulating this practice, no information of the general public, and a public debate has yet to be initiated. Regarding the practical details, a priori agreement of the organ procurement organisation, patient's consent, and approval of the consultant required by the law of April 22, 2005 relating to Patients' rights and to the end of life to rule out any conflict of interest, have to be checked before referring the patient to ICU. Advance directives drafting must be developed and their scope extended to organ donation and elective resuscitation. Therefore, fair information of the general public and clarity and transparency of the procedures are needed. The prolongation of the French moratorium on Maastricht III type non-heart beating organ donation - grounded on fears of possible conflicts on interest - seems obsolete with regard to the increasing respect of the patient's autonomy and to the risk of harmfulness entailed by elective resuscitation before death.


Assuntos
Cuidados Críticos/ética , Cuidados Críticos/legislação & jurisprudência , Assistência Terminal/ética , Assistência Terminal/legislação & jurisprudência , Doadores de Tecidos , Algoritmos , Cuidados Críticos/estatística & dados numéricos , França , Humanos , Consentimento Livre e Esclarecido/ética , Consentimento Livre e Esclarecido/legislação & jurisprudência , Experimentação Humana não Terapêutica/ética , Experimentação Humana não Terapêutica/legislação & jurisprudência , Autonomia Pessoal , Saúde Pública/ética , Saúde Pública/legislação & jurisprudência , Ordens quanto à Conduta (Ética Médica)/ética , Risco , Assistência Terminal/estatística & dados numéricos , Coleta de Tecidos e Órgãos/ética , Coleta de Tecidos e Órgãos/legislação & jurisprudência , Obtenção de Tecidos e Órgãos/ética , Obtenção de Tecidos e Órgãos/legislação & jurisprudência , Obtenção de Tecidos e Órgãos/métodos
18.
Arch Cardiovasc Dis ; 103(11-12): 595-602, 2010.
Artigo em Inglês | MEDLINE | ID: mdl-21147444

RESUMO

BACKGROUND: In Europe, the increase in numbers of patients making legal claims might be due to better knowledge of their rights. In France, a law passed in 2002 provided new opportunities for claims. AIM: To assess patient claims related to care in a French cardiology department. METHODS: From 2003 to 2007, claims brought before the courts and actions of conciliation within the scope of the hospital were collected by year. Cardiology department claims were individualized and compared with those for other departments. Characteristics of patients at the time of the care that prompted the claim, percentage of deaths, reasons for claims and claim results were collected. RESULTS: During the 4-year study period, 14% (n=45,272) of hospital admissions concerned cardiology, uniformly distributed across the years. In the same period, 845 procedures were recorded, 81 of which related to cardiology. The complaints index was 2.59/1000 patients for the general population and 1.79/1000 for cardiology. The 81 cardiology complaints (52 mediations; 29 litigations) concerned patients aged 62±13 years (68% men). The number of cardiology claims remained stable from 2003 to 2007. Compared with claims concerning other departments, the nature of the plaintiff (more often heirs or husband/wife) and the reason for the claim (less frequently medical care problems; more often death and nosocomial infections) were statistically different. CONCLUSION: Claims related to cardiology care were low and relatively stable over the past 4 years. Nosocomial infections prompted a high proportion of claims and should lead physicians to be vigilant. Cardiology remains relatively protected from litigation. A national registry of hospital claims might be valuable.


Assuntos
Serviço Hospitalar de Cardiologia/legislação & jurisprudência , Regulamentação Governamental , Hospitais Universitários/legislação & jurisprudência , Responsabilidade Legal , Imperícia/legislação & jurisprudência , Adulto , Idoso , Serviço Hospitalar de Cardiologia/estatística & dados numéricos , Distribuição de Qui-Quadrado , Compensação e Reparação , Infecção Hospitalar/etiologia , Feminino , França , Hospitais Universitários/estatística & dados numéricos , Humanos , Masculino , Imperícia/estatística & dados numéricos , Pessoa de Meia-Idade , Negociação , Direitos do Paciente/legislação & jurisprudência , Sistema de Registros , Fatores de Tempo
20.
Int J Epidemiol ; 38(4): 1104-8, 2009 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-19336436

RESUMO

BACKGROUND: Research ethics have become universal in their principles through international agreements. The standardization of regulations facilitates the internationalization of research concerning drugs. However, in so-called observational studies (i.e. from data collected retrospectively or prospectively, obtained without any additional therapy or monitoring procedure) the modalities used for applying the main principles vary from one country to another. This situation may entail problems for the conduct of multi-centric international studies, as well as for the publication of results if the authors and editors come from countries governed by different regulations. In particular, several French observational studies were rejected or retracted by US peer-reviewed journals, because their protocols have not been submitted to an Institutional Review Board/Independent Ethics Committee (IRB/IEC). METHODS: National legislation case analysis. RESULTS: In accordance with European regulation, French observational studies from data obtained without any additional therapy or monitoring procedure, do not need the approval of an IRB/IEC. Nevertheless, these studies are neither exempt from scientific opinion nor from ethical and legal authorization. CONCLUSION: We wish to demonstrate through the study of this example that different bodies of law can provide equivalent levels of protection that respect the same ethical principles. Our purpose in writing this article was to encourage public bodies, scientific journals and researchers to gain a better understanding of the various sets of specific national regulations and to speak a common language.


Assuntos
Pesquisa Biomédica/legislação & jurisprudência , Ética em Pesquisa , Cooperação Internacional , Comitês de Ética em Pesquisa , França , Declaração de Helsinki , Humanos , Legislação de Medicamentos , Estudos Multicêntricos como Assunto/ética , Estudos Multicêntricos como Assunto/legislação & jurisprudência
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